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| # | nctid | status | why_stop | prediction | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01308528 | completed | 0.7621288299560547 | phase 3 | ['venous thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['sodium enoxaparin', 'sodium enoxaparin clexane'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Men and women aged above 18 years undergoing abdominal surgery with general high risk for developing venous thromboembolism; - Who have provided their consent by signing the consent form. Exclusion Criteria: - Clinical evidence of Venous thromboembolism (VTE) in the selection; - treatment requirement with anticoagulant Low Molecular Weight Heparin, Unfracted Heparin, oral anticoagulant - suspicion or history of coagulumpathia - Heparin, enoxaparin allergy or hypersensitiviy known to heparin, enoxaparin, but not restrict to thrombocytopenia and/or induce thombose by heparin ou enoxaparin (thrombocytopenia induce by heparin [TIH], thrombocytopenia associate with heparin [TAH] or thrombotic thrombocytopenia syndrome induce by heparin [STTIH] - Active bleeding that can be increased by enoxaparin. - Previous history of known intracranial hemorrhage - Artery-venous malformation or a suspicion or known cerebral aneurism - Spinal, Epidural ou lumbar puncture analgesia in the last 24 hours previous of the first dose of the administration of the enoxaparin. - erosive diseases of the digestive tract especially gastroduodenal - Uncontrolled hypertension (systolic blood pressure [BP]> 180mmHg or diastolic BP> 100 mm Hg) at randomization or clinical hypertensive urgency; - bacterial endocarditis - heart valve prosthesis - characterized by severe renal insufficiency creatinine clearance <30 ml / min - Intra-arterial thrombolic therapy - Thrombolic therapy within 24 hours. - Low Molecular Weight Heparin or Unfraction Heparin treatment with prophylactic dose over 48 hours before surgery or oral anticoagulant within 5 days before surgery - disturbance of consciousness and coma - Less than 6 months of expectative time life - Chemical dependency - Patient with anesthetic risk ASA III or ASA IV - morbid obesity with Body Mass Index ≥ 40 - Chronic use of corticosteroids - History of allergy to Unfraction Heparin, Low molecular weight heparin or pork products. - History of severe allergic episode, systemic anaphylaxis, or major urticarial disease Steven-Johnson - Participation in another clinical study within 12 months prior to inclusion - Potentially fertile woman without β-HCG negative harvested until 48 hours before operation or not using acceptable contraception for participation in this study - Changes the security checks up to 48 h before randomization: - Hemoglobin <10 mg / dL; - ALT or AST ≥ 2.5 times ULN; - Platelet count <100.000/mL; - INR ≥ 1.5; - Any condition which in the opinion of the investigator, could lead to increased risk for the patient or who makes it inappropriate for this study. | |
| 2 | NCT01670552 | completed | 0.8645533323287964 | phase 3 | ['acute and chronic inflammation', 'dyspepsia'] | ["['K30']"] | ['nimesulide + pantoprazole', 'naproxen + esomeprazole'] | ['COC1=C(OC)C(CS(=O)C2=NC3=C(N2)C=C(OC(F)F)C=C3)=NC=C1', 'COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1'] | Inclusion Criteria: - Adults male or female aged ≥ 18 years old; - Comply with all the purposes and procedures of the study by signing and dating the Informed Consent. - Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days. Exclusion Criteria: - Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period - History of peptic ulcer or gastric surgery; - Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days; - Contraindication to the use of NSAIDs or PPIs; - Renal or hepatic impairment; | |
| 3 | NCT01786824 | terminated | patient pathway has become infeasible due to pressure for shorter hospital stays. not enough inclusions. | 0.5331950783729553 | phase 3 | ['acute kidney injury', 'renal insufficiency'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['hydration strategy using saline', 'hydration strategy using sodium bicarbonate', 'l-carnitine'] | ['NS(=O)(=O)C1=C(Cl)C=C(NCC2=CC=CO2)C(=C1)C(O)=O', 'NS(=O)(=O)C1=C(Cl)C=C(NCC2=CC=CO2)C(=C1)C(O)=O', 'C[N+](C)(C)C[C@H](O)CC([O-])=O'] | Inclusion Criteria: - The patient must have given his/her informed and signed consent - The patient must be insured or beneficiary of a health insurance plan - The patient is scheduled for a coronarography - The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up - The patient has moderate to severe renal insufficiency (glomerular filtration rate < 60 ml / min / 1.73 m^2) - The patient has not had any oral antidiabetic treatments, or diuretic treatments, within 48 hours preceding the coronarography - Lack of treatment with ACE inhibitors or ARA2 24 hours prior to coronary Exclusion Criteria: - The patient is participating in another study - The patient is in an exclusion period determined by another study - The patient is under judicial protection - The patient is under any kind of guardianship - The patient refuses to sign the consent form - It is impossible to correctly inform the patient - The patient is unable to participate in follow-up visits at days 2 and 7 after the coronarography - The patient is pregnant or breastfeeding - The patient is taking L-carnitine - The patient has a contra indication for a treatment used in this study - Acute heart failure - Infarction, acute phase - Hemodialysis patient - Myeloma - Epileptic patient treated with Depakine (valproic acid) (carnitine can lower epilepsy-related thresholds by speeding up the metabolism of Depakine) |
| 4 | NCT01877668 | completed | 0.876274585723877 | phase 3 | ['psoriatic arthritis'] | ["['L40.52']"] | ['tofacitinib 5 mg bid', 'tofacitinib 10 mg bid', 'adalimumab', 'placebo', 'placebo'] | ['[H][C@@]1(C)CCN(C[C@]1([H])N(C)C1=NC=NC2=C1C=CN2)C(=O)CC#N', '[H][C@@]1(C)CCN(C[C@]1([H])N(C)C1=NC=NC2=C1C=CN2)C(=O)CC#N', 'O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Males or females, aged >= 18 years at time of consent. - Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months - Meet the Classification Criteria of PsA (CASPAR) at time of screening - Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD). - Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required - Must not have taken a biologic Tumour Necrosis Factor Inhibitor - Must have 3 or more swollen joints AND 3 or more tender joints - Must have active psoriasis skin lesions Exclusion Criteria: - Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed - Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception - New York Heart Association Class III and IV congestive heart failure - History of hypersensitivity or infusion reaction to biologic agents - Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection | |
| 5 | NCT01887717 | terminated | poor accrual. | 0.41040709614753723 | phase 3 | ['hepatocellular carcinoma'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['sorafenib'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Participants over 18 years of age, regardless of race or gender - Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria European Association for the Study of the Liver [EASL]/American Association for the Study of Liver Diseases [AASLD], mandatory by histology in non-cirrhotic participants); can be naive or recurrent HCC after curative treatment ( >6 months before randomization) - Unilobar disease - Child Pugh A - Tumor volume ≤70% of liver volume (determined by visual estimation) - At least one uni-dimensional HCC target lesion assessable by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - Platelets ≥ 50*10^3/microliter (µL) - White blood cell (WBC) ≥1.5*10^3/microliter (µL) - Aspartate transaminase (AST)/ alanine aminotransferase (ALT) ≤5 times upper limit of normal - Creatinine ≤2.0 mg/deciliter (dL) - Life expectancy >3 months - Signed informed consent Exclusion Criteria: - Confirmed extra hepatic metastases. Participants with indeterminate hepatic hilar lymph nodes up to 2.5 centimeters (cm) in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter of ≤2 cm) may be included if metastatic disease is deemed unlikely - Known contraindication to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, and renal failure including dialysis - Evidence of hepatic vein invasion or caval thrombosis - Evidence of chronic obstructive pulmonary disease - Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation) - Previous treatment with sorafenib for more than 4 weeks during the previous 2 months; prior sorafenib-related toxicity - Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study - Prior transarterial chemoembolization (TACE) <6 months prior to screening phase in case of participants progressing from an intermediate to an advanced stage due to occurrence of PVT - On a transplant list - History of organ allograft - Contraindications to angiography or selective visceral catheterization - History of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically - Prior external beam radiation therapy to the liver - Evidence of continuing adverse effect of prior therapy - Active gastrointestinal (GI) bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents - Evidence of any disease or condition that would place the participant at undue risk and preclude safe use of TheraSphere treatment - Females of child-bearing potential must have a negative serum test - No participation in concurrent clinical trials |
| 6 | NCT01899742 | completed | 0.8881111741065979 | phase 3 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['umeclidinium/vilanterol 62.5/25 mcg', 'tiotropium 18 mcg'] | ['OCC1=C(O)C=CC(=C1)[C@@H](O)CNCCCCCCOCCOCC1=C(Cl)C=CC=C1Cl', '[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1'] | Inclusion Criteria: - Type of subject: Outpatient. - Informed Consent: A signed and dated written informed consent prior to study participation. - Age: Subjects 40 years of age or older at Visit 1. - Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact): - Abstinence - Oral Contraceptive, either combined or progestogen alone - Injectable progestogen - Implants of levonorgestrel - Estrogenic vaginal ring - Percutaneous contraceptive patches - Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) - Bronchodilator Treatment: Subjects must have been prescribed tiotropium either via the HandiHaler device or Respimat for at least 3 months prior to screening (Visit 1). - COPD Diagnosis: A diagnosis of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]. - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day /20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history - Severity of Disease: A pre and post-albuterol/salbutamol FEV₁/FVC ratio of <0.70 and post-albuterol/salbutamol FEV₁ of ≤70% and ≥50% predicted normal values calculated using reference equations at Visit 1 [Quanjer, 2012]. - Dyspnoea: A score of ≥1 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1. Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: A current diagnosis of asthma. - Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Allergic rhinitis is not exclusionary. - Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - Exacerbations: Has had more than 1 moderate or severe COPD exacerbation in the past 12 months. Subjects with a moderate exacerbation within 6 weeks or severe exacerbations within 10 weeks prior to Visit 1 are excluded from study. A moderate COPD exacerbation is defined as worsening symptoms of COPD that require treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that require in-patient hospitalization. - Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. - Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1). - 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12-lead ECG which causes the underlying rhythm and ECG to be obscured. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject eligibility are listed in Appendix 3. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 3. Appendix 3: - Sinus tachycardia ≥120 bpm. *Note: sinus tachycardia ≥120bpm should be confirmed by two additional readings at least 5 minutes apart. - Sinus bradycardia <45bpm. *Note: Sinus bradycardia <45bpm should be confirmed by two additional readings at least 5 minutes apart. - Multifocal atrial tachycardia. - Supraventricular tachycardia (>100bpm). - Atrial fibrillation with rapid ventricular response (rate >120bpm). - Atrial flutter with rapid ventricular response (rate >120bpm). - Ventricular tachycardias (non sustained, sustained, polymorphic, or monomorphic). - Ventricular flutter. - Ventricular fibrillation. - Torsades de Pointes. - Evidence of Mobitz type II second degree or third degree atrioventricular (AV) block. - AV dissociation. - 2:1 AV block. - Trifascicular Block. - For subjects with QRS duration <120 ms: QTc(F) ≥450msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). - For subjects with QRS duration≥120: QTc(F) ≥480msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave). - Myocardial infarction (acute or recent) * Note: Evidence of an old (resolved) myocardial infarction is not exclusionary - Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. - Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1. Use as maintenance treatment in the 3 months prior to Visit 1 is not permitted. Maintenance treatment is defined as use for ≥ 14 consecutive days (at any time in the 3 months prior to Visit 1). - Inhaled Corticosteroid (ICS)/Inhaled long acting beta2-agonists combinations - Phosphodiesterase 4 (PDE4) inhibitors - LABA - Other Long acting muscarinic antagonists (does not include tiotropium) - LAMA/LABA combinations - Theophyllines - Oral beta2-agonists (long-acting and short-acting) Use within 12 weeks is not permitted. - Depot corticosteroids Use within 6 weeks is not permitted. - Systemic, oral or parenteral corticosteroids - Antibiotics (for lower respiratory tract infection) - Cytochrome P450 3A4 strong inhibitors Use within 4 hours is not permitted. - Inhaled short acting beta2-agonists, short-acting anticholinergics, and short-acting anticholinergic/short- acting beta2-agonist combination products (Use of study provided prn albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing. Subjects who are taking short acting bronchodilators (beta-agonists or muscarinic antagonists) as their only form of bronchodilation at screening may NOT be recruited into the study). Any other investigational medication use within 30 days or within 5 drug half-lives (whichever is longer) is not permitted Note: if a LABA, LAMA (non-tiotropium), ICS/LABA, LAMA/LABA, theophylline, oral beta-agonist,or PDE4 inhibitor was taken on a non-maintenance basis (i.e., < 14 consecutive days over the 3 months prior to screening) the following minimum washouts must be observed prior to visit 1: twice-daily LABAs and ICS/LABAs = 48 hours; once-daily LABAs and ICS/LABAs= 14 days; LAMAs (excluding tiotropium) = 7 days; once-daily LAMA/LABA = 14 days, twice-daily LAMA/LABA = 7days; theophyllines = 48 hours; oral beta2 agonists = 48 hours; PDE4 inhibitor = 14 days. - Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤12 hours per day) is not exclusionary. - Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. - Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 12 weeks prior to Visit 1 or are in the maintenance phase of a pulmonary rehabilitation program are excluded. - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. - Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study. - Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or write would not be able to complete a questionnaire. | |
| 7 | NCT01900327 | terminated | recruitment failure | 0.2190370261669159 | phase 3 | ['pancreatic cancer'] | ["['C25.3']"] | ['gemcitabine neoadjuvant', 'gemcitabine adjuvant'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | Inclusion Criteria: - Histology-proven adenocarcinoma of the pancreatic head/uncinate process with a tumor size greater 2 cm (≥cT2) and/or close contact to the superior mesenteric vessels (≤3 mm in preoperative staging). - No evidence of metastasis to distant organs (liver, peritoneum, lung, others). - For determination of resectability, a multi-detector CT (MDCT) with at least 16 rows applying both oral and intravenous contrast media is performed. MDCT-based imaging focuses on the upper abdomen with native, arterial, and parenchyma phase, where the parenchyma phase should include the pelvis. Imaging criteria derived from the recent consensus definition of the Society of Surgical Oncology, the American Society of Clinical Oncology and the American Hepato-Pancreatico-Biliary Association [1] are applied for preoperative assessment of local resectability. - Potential Resectability: visualizable fat plane around celiac and superior mesenteric arteries, and patent superior mesenteric/portal vein (SMV/PV). - Borderline Resectability: substantial superior mesenteric/portal vein impingement, tumor abutment on the SMA < 180°, GDA encasement up to the origin of the hepatic artery, or colonic/mesenteric root invasion. - Karnofsky performance status ≥ 80% - Serum creatinine level ≤ 3.0 mg/dl - Serum total bilirubin level ≤ 3.0 mg/dl in the absence of biliary obstruction (In the event of biliary obstruction, patients allocated to the CRT group must undergo interventional endoscopy or percutaneous drainage for biliary decompression. Post-interventionally, bilirubin levels should be ≤ 3.0 mg/dl before patients are subjected to CRT. In control patients undergoing upfront surgery, serum total bilirubin levels ≤ 10.0 mg/dl are tolerated, unless clinical and laboratory signs of severe cholangitis take place. Patients with serum total bilirubin level > 10.0 mg/dl undergo preoperative biliary decompression, preferentially by interventional endoscopy) - White blood cell count ≥ 3.5 x 109/ml, platelet count ≥ 100 x 109/ml - Ability to understand and willingness to consent to formal requirements for study participation - Written informed consent Exclusion Criteria: - Age ≤ 18 years - Neuroendocrine, acinar cancer - Cancers of the pancreatic body or tail, i.e. lesions left to the SMV - Recurrent disease - Infiltration of extrapancreatic organs (except duodenum and transverse colon) - Persistent cholestasis/cholangitis despite adequate biliary stenting - Gastric outlet obstruction, especially in the event of endoscopically evidenced tumor invasion into the gastroduodenal mucosa. - Tumor specific pre-treatment - History of gastrointestinal perforation, e.g. perforated colonic diverticulitis, abdominal abscess or intestinal fistula within 6 months prior to potential study participation - Radiographic evidence of severe portal hypertension/cavernomatous transformation that may, at the discretion of the participating investigators, hamper surgery - Other concurrent malignancies except for basal cell cancer of the skin and in-situ cervical cancer - Premalignant hematologic disorders, e.g. myelodysplastic syndrome - Severe organ dysfunctions (e.g. Liver cirrhosis ≥ Child B; Cardio-pulmonal diseases (NYHA ≥III, arrhythmia Lown III/IV, global respiratory insufficiency); Ascites; Acute pancreatitis; bleeding diathesis, coagulopathy, need for full-dose anticoagulation or INR > 1.5; other severe diseases that might prevent completion of the treatment regimen) - Chronic infectious diseases, especially immune deficiency syndromes, e.g. HIV infection, active tuberculosis within 12 months prior to potential study participation - History of severe neurologic disorders, e.g. cerebrovascular ischemia - History of prior deep venous thrombosis or pulmonary embolism - Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months following the trial - Serious medical, psychological, familial, sociological or geographical conditions or circumstances potentially hampering compliance with the study protocol and follow-up Participation in other clinical trials during the last 6 months before allocation to trial |
| 8 | NCT01905059 | completed | 0.5175803899765015 | phase 3 | ['hiv infection'] | ["['Z21']"] | ['monopi - boosted lopinavir or boosted darunavir', 'bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine'] | ['CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1', 'NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1'] | Inclusion Criteria: - HIV infection on second line treatment in the 2lady trial for at least 48 weeks - VL ≤ 200 copies/ml since at least 6 months - No change in ART in the last 3 months previous to the study - CD4> 100 cells/ml - Signed informed consent - Adherence >90 Exclusion Criteria: - Previous viral failure (at least 2 consecutive HIV RNA >1000 copies/ml) while receiving a PI - Ongoing pregnancy and breast feeding women - HBsAg positive patients - opportunistic infection or any severe or progressive disease ongoing or treated in the 3 months before screening - Subject who in the investigator's opinion is unable to complete the study - History or symptoms of HIV encephalopathy | |
| 9 | NCT01905592 | active, not recruiting | 0.3365864157676697 | phase 3 | ['neoplasms, breast', 'carcinoma of breast', 'human epidermal growth factor 2 negative carcinoma of breast', 'brca1 gene mutation', 'brca2 gene mutation', 'ovarian neoplasms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['niraparib', "physician's choice"] | ['NC(=O)C1=CC=CC2=CN(N=C12)C1=CC=C(C=C1)[C@@H]1CCCNC1', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: 1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation. 2. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent. 3. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy. 4. Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a. Hormone receptor positive patients must also have hormone resistant disease; either relapsed while on adjuvant endocrine treatment, or within one year of completing adjuvant endocrine treatment, or progression on at least one line of endocrine treatment for advanced cancer. 5. ECOG performance status 0-2 6. Adequate bone marrow, kidney and liver function Exclusion Criteria: 1. Patients with platinum resistant cancer 2. Symptomatic uncontrolled brain metastases 3. Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval 4. Known hypersensitivity to the components of niraparib 5. Invasive cancer other than breast cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated) 6. Pregnant or breast feeding patients 7. Immunocompromised patients 8. Known active Hepatitis B or C 9. Prior treatment with a PARP inhibitor 10. Known history of myelodysplastic syndrome (MDS). 11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment. | |
| 10 | NCT01911364 | completed | 0.8816511034965515 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['bdp/ff/gb', 'tiotropium', 'bdp/ff + tiotropium'] | ['[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1', '[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1'] | Inclusion Criteria: - Male and female COPD patients aged ≥ 40 years - Current smokers or ex-smokers - FEV1<50% predicted (FEV1/FVC <0,7) - at least 1 documented exacerbations in the last 12 Mo Exclusion Criteria: - Pregnant or lactating women and all women physiologically capable of becoming pregnant - Diagnosis of asthma, history of allergic rhinitis or atopy - Patients treated for exacerbations 1 Mo prior to screening - Patients treated with non-cardioselective β-blockers - Patients treated with long-acting antihistamines - Known respiratory disorders other than COPD - Patients who have clinically significant cardiovascular condition | |
| 11 | NCT01917331 | completed | 0.8846892714500427 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['beclometasone/formoterol/glycopyrrolate', 'beclometasone/formoterol'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1'] | Inclusion Criteria: - Male or female adults aged ≥ 40 years with a diagnosis of COPD - Current smokers or ex-smokers - A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/FVC < 0.7 - At least one exacerbation in the 12 months preceding the screening visit Exclusion Criteria: - Pregnant or lactating women - Diagnosis of asthma or history of allergic rhinitis or atopy - Patients treated with non-cardioselective β-blockers in the month preceding the screening visit - Patients treated for exacerbations in the 4 weeks prior to screening visit - Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN - Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia - Known respiratory disorders other than COPD - Patients who have clinically significant cardiovascular condition | |
| 12 | NCT01926236 | completed | 0.3485771417617798 | phase 3 | ['biliary tract cancer', 'gallbladder cancer', 'cholangiocarcinoma', 'ampullary cancer'] | ["['C24.9', 'C24.8']", "['C23', 'D37.6']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['l-folinic acid', '5 fu', 'oxaliplatin'] | ['NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', 'FC1=CNC(=O)NC1=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Histologically / cytologically verified, non-resectable or recurrent / metastatic cholangiocarcinoma, gallbladder or ampullary carcinoma. - Patients must have failed no more than one prior course of chemotherapy (gemcitabine and cisplatin) with clear evidence of disease progression. - ECOG performance status 0-1. - Age >=18 years and life expectancy >3 months. - Adequate renal function with serum urea and serum creatinine < 1.5 times upper limit of normal (ULN) and creatinine clearance >= 30ml/min - Adequate haematological function: Hb >= 100g/l, WBC >= 3.0 x 10*9/L, ANC >= 2 x 10*9/L, platelet count >= 100 x 10*9/L - Adequate liver function: total bilirubin < 60 μmol/L and ALP, along with AST and/or ALT ≤ 5 x ULN - Adequate biliary drainage, with no evidence of ongoing infection (patients on maintenance antibiotics are eligible when acute sepsis has resolved). - Women of child bearing age must have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 4 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy - Men must be willing to use an adequate method of contraception during chemotherapy and until 6 months after chemotherapy - Patients must have given written informed consent - Patients must be randomised and those allocated chemotherapy must start treatment within 6 weeks of diagnosis of disease progression Exclusion criteria: - Incomplete recovery from previous therapy or unresolved biliary tree obstruction (includes ongoing neuropathy of grade >1 from cisplatin) - Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial - Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial - Any patient with a medical or psychiatric condition that impairs their ability to give informed consent - Any other serious uncontrolled medical conditions - Clinical evidence of metastatic disease to brain - Any pregnant or lactating woman - Clinically significant cardiovascular disease. [i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension]. **Hypertension grading of ≥ 3 is an exclusion criteria (CTCAE v4.03). However, patients who have controlled hypertension with medication and/or diet may be included at the investigator's discretion. (This should be noted in the medical history section of the CRF). - Patients must not have a history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix). | |
| 13 | NCT01936844 | completed | 0.49413082003593445 | phase 2/phase 3 | ['heart failure'] | ["['I50.814', 'I09.81', 'I50.82', 'I50.89', 'I50.9', 'T86.22', 'I11.0']"] | ['anakinra (high dose)', 'anakinra (standard dose)', 'placebo', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: All 5 criteria need to be met for enrollment of the patient in the study 1. Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following: 1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion 2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met); i. pulmonary congestion/edema at physical exam OR chest x-ray; ii. plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/mL; iii.invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg. 2. Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months. 3. Age ≥18 years old 4. Willing and able to provide written informed consent. 5. Screening plasma C-reactive protein levels >5 mg/L. Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria. 1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias. 2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration. 3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries. 4. Previous or planned implantation of left ventricular assist devices or heart-transplant. 5. Chronic use of intravenous inotropes. 6. Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]). 7. Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus). 8. Active infection (of any type); 9. Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS). 10. Prior (within the past 10 years) or current malignancy. 11. Any comorbidity limiting survival or ability to complete the study. 12. End stage kidney disease requiring renal replacement therapy. 13. Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3). 14. Pregnancy. 15. Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing. | |
| 14 | NCT01940887 | terminated | 0.6210234761238098 | phase 3 | ['age-related macular degeneration'] | ["['H35.3130', 'H35.3230', 'H35.3110', 'H35.3120', 'H35.3131', 'H35.3132', 'H35.3190']"] | ['e10030', 'bevacizumab or aflibercept', 'e10030 sham injection'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Subjects of either gender aged ≥ 50 years - Active subfoveal choroidal neovascularization (CNV) secondary to AMD - Presence of sub-retinal hyper-reflective material (SD-OCT) Exclusion Criteria: - Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals - Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids) - Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication - Subjects with subfoveal scar or subfoveal atrophy are excluded - Diabetes mellitus | |
| 15 | NCT01949337 | active, not recruiting | 0.37603577971458435 | phase 3 | ['adenocarcinoma of the prostate', 'hormone-resistant prostate cancer', 'recurrent prostate cancer', 'stage iv prostate cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['enzalutamide', 'abiraterone', 'prednisone'] | ['CNC(=O)C1=C(F)C=C(C=C1)N1C(=S)N(C(=O)C1(C)C)C1=CC=C(C#N)C(=C1)C(F)(F)F', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C'] | Eligibility Criteria: 1. Documentation of Disease - Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features 2. Patients must have measurable or non-measurable disease: 1. Measurable Disease - For visceral or extra nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT. For lymph nodes to be considered measurable (ie, target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT. 2. Non-Measurable Disease - All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions. Lesions that are considered non-measurable include bone lesions (only). 3. Patients with node only disease (ie, no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure ≥ 15 mm in short axis. 3. Progressive Disease - Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression. 1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is ≥ 4 weeks since last flutamide, bicalutamide or nilutamide. The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL) . 2. Soft tissue disease progression defined by the protocol 3. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan 4. Prior Treatment 1. No treatment with prior taxane-based chemotherapy for metastatic disease - Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration - Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable 2. No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor 3. No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment: - Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin- releasing hormone (GnRH) analogues or antagonists is allowed. - Chemotherapy - Biologic therapy - Investigational therapy - Immunotherapy 4. No use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment 5. No use of systemic steroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks prior to enrollment 6. No prior use of ketoconazole for greater than 7 days 7. No prior radiation therapy or radionuclide therapy for the treatment of metastasis within four weeks prior to enrollment 8. Patients receiving bisphosphonate therapy or denosumab must have been on a stable dose for at least 4 weeks prior to enrollment 9. Patients must maintain ongoing androgen deprivation therapy with a GnRH analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) 5. Patient History 1. No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed) 2. No planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery 3. No structurally unstable bone lesions suggesting impending fracture 4. No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma). No history of transient ischemic attack (TIA) within 12 months of enrollment 5. No clinically significant cardiovascular disease including: - Myocardial infarction (MI) within 6 months - Uncontrolled angina within 3 months - Congestive heart failure (CHF) with New York Heart Association (NYHA) class 3 or 4, or patients with NYHA class 3 or 4 in the past, unless a screening echocardiogram (echo) or multigated acquisition scan (MUGA) performed within three months demonstrates an ejection fraction (EF) > 45% - History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) - History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place - Hypotension (systolic blood pressure [BP] < 86 mmHg) or bradycardia (< 50 bpm) at screening - Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg at screening) 6. No gastrointestinal (GI) disorder that negatively affects absorption 7. No major surgery within 4 weeks prior to enrollment 6. Age and performance status 1. Age ≥ 18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 3. Asymptomatic or mildly symptomatic from prostate cancer 7. Required Initial Laboratory Values 1. Granulocytes ≥ 1,500/µL 2. Platelet count ≥ 100,000/µL 3. Hemoglobin ≥ 9 g/dL 4. Creatinine ≤ 2 x upper limits of normal (ULN) 5. Bilirubin ≤ 1.5 x ULN 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 x ULN 7. Albumin ≥ 3 g/dl 8. Total testosterone ≤ 50 ng/dL (1.7 nmol/L) | |
| 16 | NCT01950299 | completed | 0.939182698726654 | phase 2/phase 3 | ['acute myocardial infarction'] | ["['I21.9', 'I23.8', 'I23.0', 'I24.0', 'I23.1', 'I23.2', 'I23.4']"] | ['anakinra 100 mg', 'anakinra 100 mg', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | INCLUSION CRITERIA: In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria. 1. Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new 2. Planned or completed coronary angiogram for potential intervention 3. Age>21 EXCLUSION CRITERIA: - Inability to give informed consent - Pregnancy - Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV) - Preexisting severe left ventricular dysfunction (EF<20%) - Preexisting severe valvular heart disease - Active infections (acute or chronic) - excluding Hepatitis C Virus (HCV)+ with undetectable RNA - Recent (<14 days) or active use of anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs [NSAIDs] or corticosteroids used for IV dye allergy only) - Chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) - Active malignancy - excluding carcinoma in situ [any organ] and non-melanoma skin cancer - Anticipated need for cardiac surgery - Neutropenia (absolute neutrophil count<1,800/mm3) | |
| 17 | NCT01964391 | completed | 0.46681272983551025 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['trastuzumab', 'doxorubicin', 'cyclophosphamide', 'paclitaxel', 'docetaxel', 'carboplatin', 'neo-adjuvant chemotherapy'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'ClCCN(CCCl)P1(=O)NCCCO1', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Hormonal therapy will be allowed as per institutional guidelines - Prior use of anti-HER2 therapy will be allowed, except for early breast cancer participants in the neo-adjuvant setting - Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment - HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast - No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant) - Use of concurrent curative radiotherapy will be permitted Exclusion Criteria: - History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible - Severe dyspnea at rest or requirement for supplementary oxygen therapy - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness - Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension - Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) - Pregnant or lactating women - Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment - Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma - Inadequate bone marrow, hepatic or renal function | |
| 18 | NCT01964430 | active, not recruiting | 0.442630797624588 | phase 3 | ['pancreatic neoplasms', 'digestive system neoplasms', 'neoplasms by site', 'neoplasms', 'endocrine gland neoplasms', 'pancreatic diseases', 'digestive system diseases', 'endocrine system diseases', 'gemcitabine', 'antimetabolites, antineoplastic'] | ["['C25.3']", "['D49.0', 'C26.9', 'D13.9']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C75.9', 'D35.9', 'D44.9', 'D35.7', 'D49.7', 'Z85.858']", "['K90.3', 'K86.81', 'Q45.2', 'C25.3', 'E16.9', 'E16.8', 'Q45.3']", "['K92.9', 'B57.30', 'B57.39', 'K92.89', 'O99.611', 'O99.612', 'O99.613']", "['E89.810', 'E89.820', 'E89.822', 'E36.8', 'E36.01', 'E36.11', 'E89.811']", "['D61.810', 'Z51.11', 'Z51.12', 'D64.81', 'Z51.0', 'Z92.21', 'P04.11']"] | ['nab-paclitaxel', 'gemcitabine'] | ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: 1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded. 2. Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0. 3. Subject should be able to start treatment no later than 12 weeks postsurgery. 4. ≥18 years of age at the time of signing the informed consent form (ICF). 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Acceptable hematology parameters: - Absolute neutrophil count (ANC) ≥1500 cell/mm^3 - Platelet count ≥100,000/mm^3 - Hemoglobin (Hgb) ≥9 g/dL 7. Acceptable blood chemistry levels: - Aspartate aminotransferase (AST)/ serum glutamic oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/ serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN) - Total bilirubin ≤ upper limit of normal (participants with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN) - Alkaline phosphatase ≤ 2.5 x ULN - Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m^2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead 8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization 9. Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%) Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma 2. Presence of or history of metastatic pancreatic adenocarcinoma 3. Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization) 4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment 5. Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications 6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients 7. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to: 1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder | |
| 19 | NCT01966822 | completed | 0.8224380016326904 | phase 3 | ['hiv-1 infection'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['dolutegravir, 50mg every 24 hours', 'protease inhibitor/ritonavir'] | ['[H][C@]12CN3C=C(C(=O)NCC4=CC=C(F)C=C4F)C(=O)C(O)=C3C(=O)N1[C@H](C)CCO2'] | Inclusion Criteria: 1. HIV-infected patients over 18 years. 2. In current antiretroviral therapy with abacavir and lamivudine (Kivexa) plus ritonavir-boosted PI, at least 6 months. 3. Viral suppression (HIV RNA <50 copies / ml) for at least 12 months. 4. T-score ≤ -1 evaluated by DEXA (done in the last 6 months). 5. Signed informed consent. 6. In potential childbearing women, commitment to use barrier contraceptive method throughout the study. Exclusion Criteria: 1. Suspected or documented resistance to integrase inhibitors or reverse transcriptase inhibitors, nucleoside analogues. 2. Osteoporosis / osteopenia secondary (testosterone deficiency, thyroid disease ...), except vitamin D deficiency 3. Treatment with bisphosphonates in the last 6 months. 4. Have used integrase inhibitors 5. Pregnant or breastfeeding. 6. Patients with alanine aminotransferase (ALT)> 5 times the upper limit of normal (ULN) or ALT ≥ 3 times ULN and bilirubin ≥ 1.5 times ULN (direct bilirubin> 35%) 7. Patients with severe hepatic dysfunction (Class B or C) according to the Child-Pugh classification 8. Patients infected with hepatitis B virus (HBV) who can not use entecavir or telbivudine. 9. Patients infected with hepatitis C virus (HCV) in which is expected to begin treatment during the study. | |
| 20 | NCT01967173 | completed | 0.8279861211776733 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['flovent diskus® 100 mcg', 'flovent diskus® 250 mcg', 'flovent diskus® 500 mcg', 'advair diskus® 100/50 mcg', 'advair diskus® 250/50 mcg'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', '[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', '[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', 'OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1', 'OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1'] | Inclusion Criteria: 1. Individuals who self-report Black ancestry (with at least 1 Black grandparent). 2. Able to perform reproducible spirometry according to ATS criteria. 3. Clinical history consistent with asthma. 4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted. 5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year 6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score <20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20. 7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment. 8. Non-smoker (total lifetime smoking history < 5 pack-years if <18, or <10 pack-years if ≥18 years of age; no smoking for at least 1 year). 9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent. Exclusion Criteria: 1. Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients. 2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment. 3. Unwilling to provide a blood sample for DNA extraction and genetic analysis. 4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk. 5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year. 6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years. 7. History of a respiratory tract infection within 4 weeks of enrollment. 8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method. 9. Pregnancy or lactation or planning to get pregnant during the course of the trial. 10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment. 11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study. | |
| 21 | NCT01968213 | active, not recruiting | 0.3706565499305725 | phase 3 | ['ovarian cancer', 'fallopian tube cancer', 'peritoneal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C57.00', 'C57.01', 'C57.02']", "['K65.1', 'K66.0', 'N99.4', 'N73.6', 'R88.0', 'Z49.32', 'Z49.02']"] | ['rucaparib', 'placebo'] | ['CNCC1=CC=C(C=C1)C1=C2CCNC(=O)C3=C2C(N1)=CC(F)=C3', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. - Received ≥2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance therapy in this trial. - Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen. - Must have had at least a 6-month disease-free period following prior treatment with the penultimate platinum-based chemotherapy and achieved a response. - For the last chemotherapy course prior to study entry, patients must have received a platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined by RECIST) and/or a GCIG CA-125 response. - Have sufficient archival tumor tissue for analysis. Exclusion Criteria: - History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer. - Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible. - Untreated or symptomatic central nervous system metastases. - Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drug. - Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study. | |
| 22 | NCT01969708 | active, not recruiting | 0.943192720413208 | phase 3 | ['central retinal vein occlusion'] | ["['H34.8132', 'H34.8131', 'H34.8111', 'H34.8121', 'H34.8191', 'H34.8112', 'H34.8122']"] | ['aflibercept', 'bevacizumab'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Participants must have center-involved macular edema secondary to CRVO. Eyes may be enrolled as early as the time of diagnosis of the macular edema. The definition of CRVO used in SCORE will also be used for the purposes of SCORE2: a CRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g., telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in all 4 quadrants. - Due to the similarities of a hemiretinal vein occlusion (HRVO) to CRVO,HRVO will be classified as CRVO for the purposes of this clinical trial. Eyes classified as having a HRVO will be limited to no more than 25% of the planned sample size. A HRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in 5 or more clock hours but less than all 4 quadrants. Typically, a HRVO is a retinal vein occlusion that involves 2 altitudinal quadrants. - E-Early Treatment Diabetic Retinopathy Study (ETDRS)visual acuity score of greater than or equal to 19 letters (approximately 20/400) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol. The investigator must believe that a study eye with visual acuity between 19 and 33 letters is perfused. - Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater. - Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs. Exclusion Criteria: - A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers indicating difficulty in long term follow-up, likelihood of survival of less than 12 months). - Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at time of study entry. - History of allergy to any anti-VEGF agent, corticosteroid, or component of the delivery vehicle. - The participant will be moving out of the area of the clinical site to an area not covered by another clinical site during the 12 months of the study. - Positive urine pregnancy test: all women of childbearing potential (those who are pre-menopausal and not surgically sterilized) may participate only if they have a negative urine pregnancy test, and if they do not intend to become pregnant during the timeframe of the study. Women who are sexually active with a male partner must agree to use at least one of the following birth control methods: hormonal therapy such as oral, implantable or injectable chemical contraceptives; mechanical therapy such as spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner. - Women who are breast-feeding. - Examination evidence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT thought to be contributing to macular edema. - An eye that, in the investigator's opinion, would not benefit from resolution of macular edema such as eyes with foveal atrophy, dense pigmentary changes or dense subfoveal hard exudates. - Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, iris neovascularization, Irvine-Gass Syndrome, prior macula-off rhegmatogenous retinal detachment). - Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract). - History of laser photocoagulation for macular edema within 3 months prior to randomization. - History of intravitreal corticosteroid within 4 months of randomization. - Intravitreal anti-VEGF injection within 2 months of randomization. Note: Enrollment will be limited to no more than 25% of the planned sample size with any history of anti-VEGF treatment. Once this number of eyes has been enrolled, any history of anti-VEGF treatment will be an exclusion criterion. For enrollment of study eyes with prior intravitreal anti-VEGF agents, in the opinion of the investigator, the treatment response to prior anti-VEGF treatment must be either incomplete or the study eye had developed recurrent CRVO-associated macular edema, such that the study eye would benefit from additional anti-VEGF treatment. - History of peribulbar or retrobulbar corticosteroid use for any reason within 2 months prior to randomization. - History of panretinal scatter photocoagulation (PRP) or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 3 months following randomization. - History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to randomization or anticipated within the next 6 months following randomization. - History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization. - Aphakia. - Presence of an anterior chamber intraocular lens - Examination evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis. - History of macular detachment. - Examination evidence of any diabetic retinopathy. | |
| 23 | NCT01973790 | completed | 0.871902585029602 | phase 3 | ['dyspepsia'] | ["['K30']"] | ['z-338'] | ['COC1=C(OC)C=C(C(=O)NC2=NC(=CS2)C(=O)NCCN(C(C)C)C(C)C)C(O)=C1'] | Inclusion Criteria: - Subjects to provide written informed consent prior to any study procedures being performed - Subjects with a diagnosis of FD (postprandial distress syndrome) as defined by the Rome III Criteria - Subjects must present Postprandial Fullness or Early Satiation as the most bothersome symptom during the 6 months prior to informed consent. - Subjects must have a normal endoscopy result within the 6 months (3 months in case of subjects who are Helicobacter pylori positive) prior to informed consent or during the screening period. Exclusion Criteria: - Subjects on PPI(s) who are unable to discontinue PPI medication by the end of the screening period - Subjects taking drugs that affect gut motility, gut sensitivity and/or acid secretion who are unable to discontinue these drugs by the end of the screening period - Subjects who have received H. pylori eradication therapy during the 3 months prior to informed consent - Subjects with confirmed organic gastrointestinal disease - Subjects presenting with predominant complaints relieved by stool movements (irritable bowel syndrome) - Subjects presenting with predominant GORD symptoms - Subjects presenting with predominant complaints of chronic idiopathic nausea - Subjects with Type I or Type II diabetes - Subjects with body mass index (BMI) over 30 kg/m2 - Subjects with any condition which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study | |
| 24 | NCT01974752 | completed | 0.40407678484916687 | phase 3 | ['metastatic', 'uveal melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['75mg selumetinib', 'placebo', 'dacarbazine'] | ['CN1C=NC2=C1C=C(C(O)=NOCCO)C(NC1=C(Cl)C=C(Br)C=C1)=C2F', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'N1C=CN=C1'] | Inclusion Criteria: Clinical diagnosis of metastatic uveal melanoma; Written consent from female or male patients aged 18 years and over. Histological or cytological confirmation of melanoma who are suitable for treatment with dacarbazine chemotherapy. - At least one lesion that can be accurately measured at baseline as>/=10mm in the longest diameter. (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements - ECOG performance status 0-1 - life expectancy >12 weeks - Normal organ and marrow function - Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients - Patients should be able to swallow selumetinib/placebo capsules Exclusion Criteria:-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) - Previous randomisation in the present study - Patients cannot have previously been treated with a systemic anti-cancer therapy. Patients can have prior intra-hepatic or non-systemic therapy. -Having received any of the following within the specified timeframe: Any prior systemic anti-cancer therapy for the treatment of this current diagnosis, An investigational drug within 30 days of starting treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the Investigator), or have not recovered from side effects of an investigational drug Any non-systemic anti-cancer therapy which has not been cleared from the body by the time of starting study treatment Radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment, Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time, Previous treatment with dacarbazine. Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia -History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine --Symptomatic brain metastases or spinal cord compression (patients must be treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study) Cardiac conditions as follows: - Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) - Acute coronary syndrome within 6 months prior to starting treatment - Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy - Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,- Prior or current cardiomyopathy - Baseline LVEF <55% measured by echocardiography or MUGA. Appropriate correction to be used if a MUGA is performed - Severe valvular heart disease - Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest - QTcF >450 ms or other factors that increase the risk of QTc prolongation - Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) - Refractory nausea and vomiting, chronic gastrointestinal diseases (eg inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption - History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study - Ophthalmologic conditions: - Current or past history of central serous retinopathy - Current or past history of retinal vein occlusion - IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP) - Female patients who are breast-feeding a child and male or female patients of reproductive potential who are not employing an effective method of birth control - Clinical judgement by the Investigator that the patient should not participate in the study. | |
| 25 | NCT01980875 | terminated | 0.8960109949111938 | phase 3 | ['chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['idelalisib', 'chlorambucil', 'obinutuzumab'] | ['[H][C@@](CC)(NC1=NC=NC2=C1N=CN2)C1=NC2=CC=CC(F)=C2C(=O)N1C1=CC=CC=C1', 'OC(=O)CCCC1=CC=C(C=C1)N(CCCl)CCCl'] | Key Inclusion Criteria: - Not a candidate for fludarabine therapy based on either: 1. creatinine clearance < 70 mL/min, or 2. Cumulative Illness Rating Scale score > 6, by assessment of the investigator - Diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) - No prior therapy for CLL other than corticosteroids for disease complications. - CLL that warrants treatment - Presence of measurable lymphadenopathy - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) - Known presence of myelodysplastic syndrome - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization - Ongoing liver injury - Ongoing drug-induced pneumonitis - Ongoing inflammatory bowel disease - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy other than corticosteroids - Concurrent participation in another therapeutic clinical trial - Undergone major surgery within 30 days prior to randomization - Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil - History of non-infectious pneumonitis - Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply. | |
| 26 | NCT01980888 | terminated | 0.9017661809921265 | phase 3 | ['chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['idelalisib', 'bendamustine', 'rituximab', 'placebo'] | ['[H][C@@](CC)(NC1=NC=NC2=C1N=CN2)C1=NC2=CC=CC(F)=C2C(=O)N1C1=CC=CC=C1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Key Inclusion Criteria: - Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) - No prior therapy for CLL other than corticosteroids for disease complications - CLL that warrants treatment - Presence of measurable lymphadenopathy - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) - Known presence of myelodysplastic syndrome - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization - Ongoing liver injury - History of non-infectious pneumonitis - Ongoing inflammatory bowel disease - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation - Ongoing immunosuppressive therapy other than corticosteroids - Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply. | |
| 27 | NCT01986101 | completed | 0.713446855545044 | phase 3 | ['bipolar depression'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['placebo', 'sm-13496', 'sm-13496'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@@]12[C@H]3CC[C@H](C3)[C@]1([H])C(=O)N(C[C@@H]1CCCC[C@H]1CN1CCN(CC1)C1=NSC3=CC=CC=C13)C2=O', '[H][C@@]12[C@H]3CC[C@H](C3)[C@]1([H])C(=O)N(C[C@@H]1CCCC[C@H]1CN1CCN(CC1)C1=NSC3=CC=CC=C13)C2=O'] | Inclusion Criteria: - Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. - Outpatients aged 18 through 74 years at the time of consent - Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. Exclusion Criteria: - Patients with imminent risk of suicide or injury to self, others, or property. - Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening. - Patients who are otherwise considered ineligible for the study by the investigator. | |
| 28 | NCT01986127 | terminated | slow recruitment | 0.3641783595085144 | phase 3 | ["crohn's disease"] | ["['K50.90', 'K50.913', 'K50.914', 'K50.911', 'K50.912', 'K50.918', 'K50.919']"] | ['adalimumab', 'placebo'] | ['O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients of both sexes older than 18 years - Patient diagnosed of CROHN´s disease - Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum) - Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy) - Dilated stenosis according to endoscopist criteria (pass or no the endoscopy) - Patient capable of participate in the examinations required by the study - Patient after being informed, give his/her informed consent in writing Exclusion Criteria: - Patients with large intestinal stenosis (more than 6cm) and multiples - Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs - Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV - Patients with positive screening to Tuberculosis(positive PPD) - Established contraindication to anti-TNF drugs - Existence of fistulous tracts associated with intestinal stenosis - Neoplastic process associated with stenosis or in another location - Pregnancy or breastfeeding |
| 29 | NCT01987479 | completed | 0.8855574727058411 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['non-biologic dmards', 'tocilizumab', 'methotrexate'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O'] | Inclusion Criteria: - Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria. - Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline. - Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant. Exclusion Criteria: - Presence of clinically significant medical conditions. - History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation. - Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections. - Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening. - Clinically significant findings on laboratory tests. - Positive hepatitis B surface antigen or hepatitis C antibody. - Active tuberculosis requiring treatment within the previous 3 years. - Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years. - History of alcohol, drug, or chemical abuse within 1 year prior to Screening. - Neuropathies or other conditions that might interfere with pain evaluation. - Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline. - Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted. - Functional Class IV as defined by the ACR Classification of Functional Status in RA. - Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years. - Prior history of or current inflammatory joint disease other than RA. - Exposure to tocilizumab (either intravenous or SC) at any time prior to Baseline. - Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening. - Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation. - Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline. - Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline. | |
| 30 | NCT01987895 | completed | 0.6619917750358582 | phase 3 | ['clostridium difficile infection'] | ["['A05.2', 'A04.71', 'A04.72', 'B96.7']"] | ['cadazolid', 'vancomycin', 'cadazolid-matching placebo', 'vancomycin-matching placebo'] | ['OC[C@H]1CN(C(=O)O1)C1=CC(F)=C(OCC2(O)CCN(CC2)C2=C(F)C=C3C(=O)C(=CN(C4CC4)C3=C2)C(O)=O)C=C1', 'CCCCCCCCCC(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H]1[C@@H](C)OC(=O)[C@H](CC(=O)C2=C(N)C=CC=C2)NC(=O)[C@@H](NC(=O)[C@@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCN)NC(=O)CNC1=O)[C@H](C)CC(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Signed Informed Consent. - Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception. - Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization. Exclusion Criteria: - More than one previous episode of CDAD in the 3-month period prior to randomization. - Evidence of life-threatening or fulminant CDAD. - Likelihood of death within 72 hours from any cause. - History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea. - Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF) - Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones. - Unable or unwilling to comply with all protocol requirements. - Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol | |
| 31 | NCT01989676 | completed | 0.41700899600982666 | phase 3 | ['metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['paclitaxel', 'paclitaxel'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | Inclusion Criteria: - Histologically confirmed diagnosis of breast cancer. - Presence of metastatic disease. - Documentation of HER2 gene amplification or overexpression. - Available tumor tissue for central review of HER2 status. - At least 1 measurable lesion as defined by RECIST 1.1. - Eastern Cooperative Oncology Group status of 0 to 2. - Left ventricular ejection fraction within institutional range of normal, measured by either two dimensional echocardiogram or multigated acquisition scan. Exclusion Criteria: - Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment (except endocrine therapy) and within 1 year before randomization. - Prior systemic therapy for metastatic disease (except endocrine therapy). - Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin. - Inflammatory breast cancer. - Active uncontrolled or symptomatic central nervous system metastases. | |
| 32 | NCT01991795 | completed | 0.7759829759597778 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ticagrelor 60 mg', 'ticagrelor placebo'] | ['CCCSC1=NC2=C(N=NN2[C@@H]2C[C@H](OCCO)[C@@H](O)[C@H]2O)C(N[C@@H]2C[C@H]2C2=CC(F)=C(F)C=C2)=N1', '[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl'] | Inclusion Criteria: Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery. Key Exclusion Criteria: History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis | |
| 33 | NCT01994720 | completed | 0.5314173698425293 | phase 3 | ['acute ischaemic stroke', 'transient ischaemic attack'] | ["['R29.5', 'F95.0', 'G45.4', 'P61.0', 'P61.5', 'D80.7', 'H53.123']"] | ['ticagrelor', 'acetylsalicylic acid (asa)'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - Men or women equal or elder 40 years of age - Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms Key Exclusion Criteria: - Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days. | |
| 34 | NCT01995266 | completed | 0.8953680396080017 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['asunaprevir', 'daclatasvir'] | ['COC1=CN=C(O[C@@H]2C[C@H](N(C2)C(=O)[C@@H](NC(=O)OC(C)(C)C)C(C)(C)C)C(=O)N[C@@]2(C[C@H]2C=C)C(=O)NS(=O)(=O)C2CC2)C2=C1C=CC(Cl)=C2', 'COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and females, ≥ 18 years of age - Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either: 1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening or 2. Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation) - Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below: 1. Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to < 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin < 10.0 g/dL and ≥ 8.5 g/dL OR 2. Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to < 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC < 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L OR 3. Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts < 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of < 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L - HCV RNA ≥ 10,000 IU/mL - Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg) - Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2 at screening - Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease Exclusion Criteria: - Prior treatment with HCV direct acting antiviral (DAA) - Evidence of a medical condition contributing to chronic liver disease other than HCV - Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Uncontrolled diabetes or hypertension - History of moderate to severe depression. Well-controlled mild depression is allowed - Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease - Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN) - Confirmed albumin < 3.5 g/dL (35 g/L) - Alpha-fetoprotein (AFP) > 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded - Confirmed hemoglobin < 8.5 g/dL - Confirmed ANC < 0.5 x 10(9) cells/L - Confirmed platelet count < 50,000 cells/mm3 | |
| 35 | NCT01996319 | completed | 0.9038419723510742 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['qva149', 'placebo'] | ['C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Patients with stable COPD according to the current GOLD guidelines (GOLD 2013). Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs).. Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70 Exclusion Criteria: Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof, anticholinergics, long and short acting beta2 agonists, sympathomimetic amines, lactose or any of the other excipients Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min. Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study. Patients with a body mass index (BMI) of more than 40 kg/m2. Women who are pregnant or breast feeding Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening. Patients who have had a respiratory tract infection within 4 weeks prior to screening. Patients with any history of asthma. Patients with concomitant pulmonary disease Patients with clinically significant bronchiectasis. Other protocol-defined inclusion/exclusion criteria may apply | |
| 36 | NCT02000622 | active, not recruiting | 0.3551882803440094 | phase 3 | ['breast cancer metastatic', 'brca 1 gene mutation', 'brca 2 gene mutation'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['D68.52', 'J84.83']", "['D68.52', 'J84.83']"] | ['olaparib', "physician's choice chemotherapy"] | ['OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious. - Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. - Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting. - Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed. - ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. - ECOG performance status 0-1. - Adequate bone marrow, kidney and liver function. Exclusion Criteria: - Prior treatment with PARP inhibitor. - Patients with HER2 positive disease. - More than 2 prior lines of chemotherapy for metastatic breast cancer. - Untreated and/or uncontrolled brain metastases. - Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed. - Known HIV (Human Immunodeficiency Virus) infection. - Pregnant or breast-feeding women. | |
| 37 | NCT02004392 | terminated | study has been suspended due to clinical hold. | 0.6227999925613403 | phase 3 | ["alzheimer's disease", 'dementia'] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']", "['G31.09', 'G31.83', 'F01.50', 'F01.51', 'F03.90', 'F03.91', 'F18.17']"] | ['evp-6124'] | ['ClC1=C2SC(=CC2=CC=C1)C(=O)N[C@H]1CN2CCC1CC2'] | Inclusion Criteria: - Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into study EVP-6124-024 or EVP-6124-025 - Informed consent form (ICF) for this extension study signed by the subject or legally acceptable representative and an ICF signed by the support person/caregiver before initiation of any study-specific procedures - Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025 - No clinically significant change in the judgment of the investigator in the subject's medical status during study EVP-6124-024 or EVP-6124-025 - In the judgment of the investigator, extension treatment is in the best interest of the subject - Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception [including at least 1 barrier method]) - Reliable and capable support person/caregiver, who if not living in the same household, interacts with the subject approximately 4 times per week and will be available to attend clinic visits in person when possible Exclusion Criteria: - Significant risk of suicidal or violent behavior in the judgment of the investigator - Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation - Any condition that would make the subject in the judgment of the investigator unsuitable for the study - Female subjects who are pregnant, nursing, or planning to become pregnant during the extension study |
| 38 | NCT02005471 | active, not recruiting | 0.8964756727218628 | phase 3 | ['chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['bendamustine', 'venetoclax', 'rituximab'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CC1(C)CCC(CN2CCN(CC2)C2=CC=C(C(=O)NS(=O)(=O)C3=CC=C(NCC4CCOCC4)C(=C3)[N+]([O-])=O)C(OC3=CN=C4NC=CC4=C3)=C2)=C(C1)C1=CC=C(Cl)C=C1', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Diagnosis of CLL per diagnostic criteria for relapsed or refractory CLL per the international workshop on chronic lymphocytic leukemia (iwCLL) guidelines - Previously treated with 1-3 lines of therapy (example: completed greater than or equal to [>/=] 2 treatment cycles per therapy), including at least one standard chemotherapy-containing regimen - Participants previously treated with bendamustine only if their duration of response was >/= 24 months - Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 1 - Adequate bone marrow function - Adequate renal and hepatic function - Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding - For participants with the 17p deletion, previously treated with 1-3 lines of therapy, including at least one prior standard chemotherapy-containing regimen or at least one prior alemtuzumab-containing therapy Inclusion Criteria R/C Substudy: - Participants randomized to Arm A or Arm B with a confirmed disease progression of CLL per iwCLL criteria - Participants who have not received new anti-CLL therapy following disease progression in Arm A or Arm B - Adequate renal and hepatic function per laboratory reference range Exclusion Criteria: - Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system (CNS) involvement by CLL - Undergone an allogenic stem cell transplant - A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease - Hepatitis B or C or known human immunodeficiency virus (HIV) positive - Receiving warfarin treatment - Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug - Received any anti-cancer or investigational therapy within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy - Received cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamazapine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax - History of prior venetoclax treatment - Participants with another cancer, history of another cancer considered uncured on in complete remission for <5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolved - Malabsorption syndrome or other condition that precludes enteral route of administration - Other clinically significant uncontrolled condition(s) including, but not limited to, systemic infection (viral, bacterial or fungal) - Vaccination with a live vaccine within 28 days prior to randomization - Consumed grapefruit or grapefruit products, seville oranges (including marmalade containing seville oranges), or star fruit within 3 days prior to the first dose of study treatment - A cardiovascular disability status of New York Heart Association Class >/=3. Class 3 is defined as cardiac disease in which participants are comfortable at rest but have marked limitation of physical activity due to fatigue, palpitations, dyspnea, or anginal pain - Major surgery within 30 days prior to the first dose of study treatment - A participant who is pregnant or breastfeeding - Known allergy to both xanthine oxidase inhibitors and rasburicase Exclusion Criteria R/C Substudy: - Transformation of CLL to aggressive NHL (e.g., Richter's transformation, prolymphocytic leukemia, or DLBCL) or CNS involvement by CLL - Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal) - Development of other malignancy since enrollment into the study, with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix - Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia - History of severe (i.e., requiring permanent discontinuation of prior rituximab therapy) prior allergic or anaphylactic reactions to rituximab - Known HIV positivity - Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbsAg] serology) - Positive test results for hepatitis C virus (HCV; HCV antibody serology testing) - Requires the use of warfarin (due to potential drug interactions that may potentially increase the exposure of warfarin) - Has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy - Received potent CYP3A4 inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment - Received potent CYP3A4 inducers (such as rifampin, carbamazepine, phenytoin, St. John's wort) within 7 days prior to the first dose of study treatment - Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study treatment - A cardiovascular disability status of New York Heart Association Class >/= 3 - A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the participants's participation in this study or interpretation of study outcomes - Major surgery within 30 days prior to the first dose of study treatment - A participant who is pregnant or breastfeeding - Malabsorption syndrome or other condition that precludes enteral route of administration - Known allergy to both xanthine oxidase inhibitors and rasburicase - Vaccination with a live vaccine within 28 days prior to randomization | |
| 39 | NCT02006121 | completed | 0.7537528872489929 | phase 3 | ["parkinson's disease"] | ["['G20']"] | ['apomorphine hydrochloride', 'placebo'] | ['[H][C@]12CC3=C(C(O)=C(O)C=C3)C3=CC=CC(CCN1C)=C23', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female patients aged ≥30 years - Diagnosis of idiopathic PD of >3 years' duration, defined by the UK Brain Bank criteria (with the exception of >1 affected relative being allowed), without any other known or suspected cause of Parkinsonism - Hoehn & Yahr stage up to 3 in the ON and 2 to 5 in the OFF state - Motor fluctuations not adequately controlled on medical treatment including levodopa which was judged by the treating physician to be optimal - Average of OFF time > 3 hours/day based on screening and baseline diary entries with no day with < 2 hours of OFF time recorded - Stable medication regimen, with a stable dose of levodopa administered in at least 4 intakes, for at least 28 days prior to baseline. All oral or transdermal antiparkinsonian drugs were permitted, with the exception of budipine. This regimen might include the use of levodopa/DDCI rescue medication, if this occurred up to 2 times a day, at doses of up to 200 mg levodopa/day - Patients must be able to differentiate between the ON and OFF state and between troublesome and non-troublesome dyskinesias - Male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study and for the 12-month OLP, if sexually active - Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) or urine pregnancy test at screening - Ability to accurately complete a paper diary on designated days (with assistance from caregivers, if required), recording periods when they are "ON without troublesome dyskinesia", "ON with troublesome dyskinesia", OFF, and sleeping - Written informed consent prior to enrolment, after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the study treatments - Patients considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator Exclusion Criteria: - History of respiratory depression - Hypersensitivity to apomorphine or any excipients of the medicinal product - High suspicion of other parkinsonian syndromes - Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state - Concomitant therapy or within 28 days prior to baseline with: apomorphine pen injections; alpha-methyl dopa, metoclopramide, reserpine, neuroleptics, methylphenidate, or amphetamine; intrajejunal levodopa - Previous use of apomorphine pump treatment - History of deep brain stimulation or lesional surgery for PD - Any medical condition that is likely to interfere with an adequate participation in the study, including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months - Symptomatic, clinically relevant and medically uncontrolled orthostatic hypotension - Patients with a borderline QT interval corrected for heart rate according to Bazett's formula (QTcB) of >450 msec for male and >470 msec for female at screening or history of long QT syndrome; or >450 msec absolute duration - Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, alanine transaminase [ALT] and aspartate transaminase [AST] >2 times the upper limit of normal) - Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL) - Pregnant and breastfeeding women - Clinically relevant cognitive decline, defined as MMSE ≤24 or according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for dementia - Active psychosis or history of at least moderate psychosis in the past year, or with medically uncontrolled severe depression; very mild illusions or hallucinations in the sense of "feelings of passage or presence" with fully retained insight are not an exclusion criterion - Known history of melanoma - Any investigational therapy in the 4 weeks prior to randomization - History or current drug or alcohol abuse or dependencies | |
| 40 | NCT02006641 | completed | 0.44962266087532043 | phase 3 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['placebo', 'idalopirdine'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'FC(F)C(F)(F)COC1=CC=CC(CNCCC2=CNC3=CC(F)=CC=C23)=C1'] | Inclusion Criteria: - The patient has a knowledgeable and reliable caregiver. - The patient is an outpatient. - The patient has probable AD. - The patient has mild to moderate AD. - Stable treatment with donepezil. - The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile. - The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit. Exclusion Criteria: - The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD. - The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD. - The patient has evidence of clinically significant disease. - The patient's donepezil therapy is likely to be interrupted or discontinued during the study. - The patient is currently receiving memantine or has taken memantine within 2 months prior to screening. Other inclusion and exclusion criteria may apply. | |
| 41 | NCT02006654 | completed | 0.4578379690647125 | phase 3 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['placebo', 'idalopirdine'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'FC(F)C(F)(F)COC1=CC=CC(CNCCC2=CNC3=CC(F)=CC=C23)=C1'] | Inclusion Criteria: - The patient has a knowledgeable and reliable caregiver. - The patient is an outpatient. - The patient has probable AD. - The patient has mild to moderate AD. - Stable treatment with an AChEI. - The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile. - The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit. Exclusion Criteria: - The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD. - The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD. - The patient has evidence of clinically significant disease. - The patient's current AChEI therapy is likely to be interrupted or discontinued during the study. - The patient is currently receiving memantine or has taken memantine within 2 months prior to screening. Other inclusion and exclusion criteria may apply. | |
| 42 | NCT02006745 | completed | 0.8019369840621948 | phase 3 | ['hiv'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['ribavirin', 'telaprevir'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', '[H][C@@]12CCC[C@]1([H])[C@H](N(C2)C(=O)[C@@H](NC(=O)[C@@H](NC(=O)C1=NC=CN=C1)C1CCCCC1)C(C)(C)C)C(=O)N[C@@H](CCC)C(=O)C(=O)NC1CC1'] | Inclusion Criteria: - 1. Is male or female aged 18 years or above 2. Has signed the Informed Consent Form voluntarily 3. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below: 1. HCV RNA positive AND 2. Prior negative anti-HCV antibody or HCV RNA test within 6 months OR 3. rise of liver transaminases above 2.5 x ULN within the past 6 months with prior normal transaminases during the year before AND 4. exclusion of other causes of acute hepatitis 4. Confirmed HIV infection 5. Receiving a atazanavir- or efavirenz- or raltegravir-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study 6. CD4 T cell count >200/µl at screening in patients under ART, CD4 T cell count >500/µl at screening in patients without ART 7. If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 4 months after the last dosage of ribavirin (ie 4 months after week 12, 24 or 48, depending on study arm and treatment response). Routine monthly pregnancy tests must also be performed during this time. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential 8. Heterosexually active male participants or their female partners must use effective birth control methods (as agreed by the investigator) during the trial and for at least 7 months after the last dosage of ribavirin (ie 7 months after week 12, 24 or 48, depending on study arm and treatment response). Exclusion Criteria: - . HCV infection with non-1 genotype 2. Acute opportunistic infection requiring treatment 3. Malignancy requiring chemotherapy or radiotherapy 4. Active HBV infection (HBs Ag + with positive hepatitis B DNA) 5. Known autoimmune disease 6. Hepatic failure 7. History of ischaemic heart disease or other serious cardiac disease 8. Serious psychiatric disease which in the view of the investigator precludes the use of interferon 9. Haemoglobinopathy or severe anaemia of any cause 10. Serious abnormality on screening blood tests including, but not limited to: Hemoglobin <10g/dl, absolute neutrophil count <1000/mm3, platelets <90,000/mm3, creatinine clearance <60ml/min 11. If female, she is pregnant or breastfeeding 12. Known hypersensitivity to one of the trial drugs or its excipients 13. Other contraindicated concomitant treatment 14. Any condition (including drug/alcohol abuse), or laboratory results which in the investigators opinion, interfere with assessments or completion of the trial 15. Any other reason why, in the opinion of the investigator, the patient should not be enrolled in the trial. | |
| 43 | NCT02007629 | completed | 0.4925485849380493 | phase 3 | ['hypertension, pulmonary'] | ["['I27.0', 'I27.20', 'I27.21', 'I27.24', 'I27.29', 'P29.30', 'I27.22']"] | ['riociguat (adempas, bay63-2521)'] | ['COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2'] | Inclusion Criteria: - Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated PAH due to congenital heart disease (Group I / Dana Point Classification of PH) demonstrating insufficient response to treatment with PDE-5i for at least 3 months - Patients with and without endothelin receptor antagonist (ERA) therapy - World Health Organization Functional Class (WHO FC) III at screening - 6-minute walking distance (6MWD) of 165-440 m - Cardiac index <3.0 L/min/m*2. Exclusion Criteria: - All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria - Evidence of clinically significant restrictive or obstructive parenchymal lung diseases - Diffusing capacity of the lung for carbon monoxide (DLCO) <30% predicted - History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization - Patients unable to perform a valid 6MWD test - Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study. | |
| 44 | NCT02008227 | completed | 0.2927809953689575 | phase 3 | ['non-squamous non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['atezolizumab', 'docetaxel'] | ['CCCNCC(O)COC1=C(C=CC=C1)C(=O)CCC1=CC=CC=C1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens - Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: - Known active or untreated central nervous system (CNS) metastases - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome - History of autoimmune disease - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted - Active hepatitis B or hepatitis C - Prior treatment with docetaxel - Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents | |
| 45 | NCT02008318 | completed | 0.8456419110298157 | phase 2/phase 3 | ['myelodysplastic syndromes'] | ["['D46.9', 'D46.C', 'D46.Z']"] | ['galunisertib', 'placebo'] | ['CC1=CC=CC(=N1)C1=NN2CCCC2=C1C1=C2C=C(C=CC2=NC=C1)C(N)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Confirmed diagnosis of MDS based on the World Health Organization (WHO) criteria - Participants with 5q deletions are allowed only if they have failed or are intolerant of lenalidomide treatment - Participants must have a Revised International Prognostic Scoring System (IPSS-R) category of very low-, low-, or intermediate-risk disease - In the 8 weeks prior to registration, participants in phase 2 should have anemia with Hb ≤10.0 g/dL (based on the average of 2 baseline measurements and untransfused for at least 1 week) with or without red blood cell (RBC) transfusion dependence confirmed for a minimum of 8 weeks before enrollment - For phase 3, participants should have anemia with RBC transfusion dependence confirmed within 8 weeks before enrollment - Performance status ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale Exclusion Criteria: - No history of moderate or severe cardiac disease - No prior history of acute myeloid leukemia (AML) | |
| 46 | NCT02008916 | completed | 0.5912075042724609 | phase 3 | ['spondylitis, ankylosing'] | ["['M08.1', 'M45.6', 'M45.2', 'M45.3', 'M45.4', 'M45.5', 'M45.7']"] | ['secukinumab', 'placebo secukinumab'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy. | |
| 47 | NCT02008942 | completed | 0.8682131767272949 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['pl2200 aspirin capsules', 'enteric-coated aspirin caplets'] | ['CC(=O)OC1=CC=CC=C1C(O)=O', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - Non-Insulin-Dependent Diabetes Mellitus - Adults 21 to 79 years, inclusive - Body mass index between 30 and 40 kg/m2, inclusive Exclusion Criteria: - Currently prescribed aspirin or anti-coagulants - Contraindications to aspirin - Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus - Patient requires insulin | |
| 48 | NCT02012959 | terminated | issues with participant recruitment & enrollment which made the trial impossible or highly impracticable. trial termination was not due to safety reasons. | 0.7354061007499695 | phase 3 | ['hyponatremia'] | ["['P74.22', 'E87.1']"] | ['tolvaptan'] | ['CC1=CC=CC=C1C(=O)NC1=CC(C)=C(C=C1)C(=O)N1CCC[C@@H](O)C2=C1C=CC(Cl)=C2'] | Inclusion: - Male and female participants ≥4 weeks (or ≥44 weeks adjusted gestational age) to <18 years old - Participants hospitalized with euvolemic or hypervolemic hyponatremia resistant to initial standard background therapy - Persistent euvolemic or hypervolemic hyponatremia defined as being documented as <130 milliequivalent (mEq)/L and present for at least 48 hours, evidenced by at least 2 serum sodium assessments (12 hours apart) - Ability to maintain adequate fluid intake (orally or intravenously) - Ability to take oral medications - Ability to comply with all requirements of the trial - Completion of the trial-specific informed consent/assent as age appropriate - Ability to commit to remain fully abstinent or practice double-barrier birth control as required by the trial Exclusion: - Evidence of hypovolemia or intravascular volume depletion - Serum sodium <120 mEq/L - Use of potent cytochrome P450 3A4 (CYP3A4) inhibitors in participants <12 kilogram (kg) or moderate CYP3A4 inhibitors in participants <6 kg - Lacks free access to water (inability to respond to thirst) or without intensive care unit level fluid monitoring and management - History or current diagnosis of nephrotic syndrome - Transient hyponatremia likely to resolve - Hyperkalemia - Estimated glomerular filtration rate <30 milliliters/minute/1.73 meters squared - Acute kidney injury - Severe or acute neurological symptoms requiring other intervention - Prior treatment for hyponatremia with hypertonic saline within 8 hours of qualifying serum sodium assessments; urea, lithium, demeclocycline, conivaptan, or tolvaptan within 4 days of qualifying serum sodium assessments; any other treatments for the purpose of increasing serum sodium concurrent with dosing of trial medication - Anuria or urinary outflow obstruction, unless participant is/can be catheterized - History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives - Psychogenic polydipsia - Uncontrolled diabetes mellitus (defined as fasting glucose >300 milligrams/deciliter) - Screening liver function values >3 times the upper limit of normal - Participants who have cirrhosis and meet any of the following conditions: a major GI bleed within the past 6 months, evidence of active bleeding, platelet count <50,000/microliter, or use of concomitant medications known to increase bleeding risk - Hyponatremia due to the result of any medication that can safely be withdrawn or that is most appropriately corrected by alternative therapies - History of drug or medication abuse within 3 months prior to screening or current alcohol abuse - Participants who require suspension formulation and have a Hereditary Fructose Intolerance - Has hyponatremia that is more appropriately corrected by alternative therapies - Is pregnant or currently breastfeeding - Has any medical condition that could interfere with evaluation of trial objectives or participant safety - Has participated in another investigational drug trial in the last 30 days - Weighs <3 kg - Unable to swallow tablets, if suspension unavailable - Is deemed unsuitable for trial participation in the opinion of the investigator |
| 49 | NCT02013167 | terminated | 0.5887270569801331 | phase 3 | ['relapsed/refractory b-precursor acute lymphoblastic leukemia'] | ["['C83.57', 'C83.50', 'C91.01', 'C91.02', 'C83.52', 'C83.56', 'C83.53']"] | ['blinatumomab', 'standard of care chemotherapy'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | - Subjects with Philadelphia negative B-precursor ALL, with any of the following: - refractory to primary induction therapy or refractory to salvage therapy, - in untreated first relapse with first remission duration <12 months - in untreated second or greater relapse - relapse at any time after allogeneic HSCT - Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy. - Greater than 5% blasts in the bone marrow - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria - Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease - Diagnosis of Burkitt's leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder - Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement - Isolated extramedullary disease - Current autoimmune disease or history of autoimmune disease with potential CNS involvement - Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment - Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment - Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert) - Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy - Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min. | |
| 50 | NCT02014467 | completed | 0.8013140559196472 | phase 3 | ['osteoporosis, postmenopausal'] | ["['N95.0', 'N95.2']"] | ['denosumab', 'placebo'] | ['CC(=O)OC1=CC=CC=C1C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subject is willing and able to provide written informed consent. - Of Chinese origin - defined as being born in China, having four ethnic Chinese grandparents. - Ambulatory woman between the age of 60 and 90 years, inclusive. - The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at either the lumbar spine or total hip. - All subjects must have at least one of following additional the risk factors: history of fracture parental history of hip fracture increased bone turnover rate at screening (s-CTX >1.0 SD above the mean in healthy premenopausal women) low body weight (BMI≤19kg/m2) elderly (age≥70y) current smoker - Postmenopausal defined as >5 years postmenopausal, which can be >5 years of spontaneous amenorrhea or >5 years post surgical bilateral oophorectomy. Use follicle stimulating hormone (FSH) levels >40 mIU/mL to confirm surgical postmenopausal status, where bilateral oophorectomy status is uncertain. Exclusion Criteria: - Bone/metabolic disease: Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings. Paget's disease Cushing's disease Hyperprolactinemia - Current hyperparathyroidism or hypoparathyroidism by medical record - Thyroid condition: Hyperthyroidism or hypothyroidism. Only subjects with hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed per the following criteria: If TSH level is below normal range, subject is not eligible for the study. If TSH level is elevated (>5.5 μIU/mL and ≤10.0 μIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study. If TSH level is > 10.0 μIU/mL, subject is not eligible. - Rheumatoid arthritis - Malignancy: Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5years. - Malabsorption syndrome: malabsorption syndrome or any gastrointestinal disorders associated with malabsorption, for example Crohn's Disease and chronic pancreatitis. - Renal disease - severe renal impairment - Liver disease: Cirrhosis of the liver Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if the subject otherwise meets study entry criteria (e.g., presence of hepatitis B surface antigen or positive Hepatitis C test result within 3 months of Screening). - Drug or alcohol abuse: Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study. - Biological abnormalities: Any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures. Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results. Known to have tested positive for human immunodeficiency virus (HIV). - Vitamin D deficiency: Vitamin D deficiency (25-(OH) vitamin D level <20 ng/mL). Vitamin D repletion will be permitted and after repletion subjects may be re-tested once for 25-(OH) vitamin D levels. - Oral/Dental Conditions Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. Active dental or jaw condition which requires oral surgery. Planned invasive dental procedure. Non-healed dental or oral surgery. Concomitant Medications: - Previous strontium or IV bisphosphonate: Administration of intravenous (IV) bisphosphonate, fluoride, or strontium for osteoporosis within the last 5 years. - Oral bisphosphonate: Oral bisphosphonate treatment for osteoporosis: If used for ≥3 years cumulatively, subject is ineligible. If used for >3-months but <3 years cumulatively: If the last dose was <1 year before enrolment, subject is ineligible. If the last dose was ≥1 year before enrolment, subject is eligible. If used ≤3 months, cumulatively, subject is eligible. - Bone metabolism drugs: Administration of any of the following treatments within the last 6 weeks: Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. Anabolic steroids or testosterone. Glucocorticosteroids (>5 mg prednisone equivalent per day for more than 10 days). Systemic hormone replacement therapy. Selective estrogen receptor modulators (SERMs), e.g., raloxifene Tibolone. Calcitonin. Calcitriol or vitamin D derivatives. Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin. Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists. - Investigational drug exposure: Currently enrolled in an investigational device or drug trial(s) or it has not been at least 30 days since the last study visit in an investigational device or drug trial(s), or subject is receiving other investigational agent(s). - Sensitivity: Known sensitivity to mammalian cell-derived drug products. - Clinically significant hypersensitivity to denosumab Abnormal laboratory values - General: Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results. - Abnormal serum calcium: current hypocalcemia or hypercalcemia. Albumin adjusted serum calcium levels must be within normal limits of the central laboratory. - Liver transaminases: Serum aspartate aminotransferase (AST) ≥2.0 x upper limits of normal (ULN). Serum alanine aminotransferase (ALT) ≥2.0 x ULN. Alkaline phosphatase and bilirubin ≥1.5 x ULN (isolated bilirubin ≥1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%. - DXA measurements: Less than two lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth which may preclude accurate DXA measurements. - Subjects with a history of greater than 2 vertebral fractures. - Subjects at very high risk of fracture who must be treated with active drugs in the opinion of investigator. | |
| 51 | NCT02019420 | completed | 0.6132328510284424 | phase 3 | ['pneumonia'] | ["['A01.03', 'A02.22', 'A54.84', 'B01.2', 'B06.81', 'B77.81', 'J12.0']"] | ['tedizolid phosphate', 'linezolid'] | ['CN1N=NC(=N1)C1=CC=C(C=N1)C1=CC=C(C=C1F)N1C[C@H](COP(O)(O)=O)OC1=O', 'CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1'] | Inclusion Criteria: - Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia - Gram-positive bacteria on respiratory Gram stain Exclusion Criteria: - Pneumonia of community, viral, fungal or parasitic etiology - Structural lung abnormalities - Immunosuppression - Previous antibiotics for > 24 hours - Expected survival of < 72 hours | |
| 52 | NCT02019472 | completed | 0.8667410612106323 | phase 3 | ['arthritis, rheumatoid'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening - Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline - Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, (including MTX-naïve subjects for whom it is inappropriate to administer MTX) and/or an inadequate responder to methotrexate - Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent - C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening Exclusion Criteria: - Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept - Has ever used tofacitinib therapy or any other JAK inhibitor - Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration - Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable | |
| 53 | NCT02020278 | terminated | issues with recruitment and enrollment made the trial impossible or highly impracticable. termination of this trial was not due to safety reasons. | 0.7275283336639404 | phase 3 | ['hyponatremia'] | ["['P74.22', 'E87.1']"] | ['tolvaptan'] | ['CC1=CC=CC=C1C(=O)NC1=CC(C)=C(C=C1)C(=O)N1CCC[C@@H](O)C2=C1C=CC(Cl)=C2'] | Core Safety Follow-up Component Inclusion Criteria: Participation in a prior pediatric trial with tolvaptan for euvolemic or hypervolemic hyponatremia. Exclusion Criteria: None Optional Tolvaptan Treatment Component (per treatment cycle) Eligibility Criteria: 1. Male and female participants ≥ 4 years of age (or per local Health Authority age restrictions) and ≥ 10 kilograms (kg). 2. Participant must have been off treatment with the investigational medicinal product for at least 7 days following the end of treatment in the previous tolvaptan trial for hyponatremia (euvolemic or hypervolemic). 3. Persistent dilutional (euvolemic or hypervolemic) hyponatremia defined as being documented as present for at least 48 hours, evidenced by at least 2 serum sodium assessments < 130 milliequivalents (mEq)/liter (L) (millimole [mmol]/L) drawn at least 12 hours apart (these values can be documented using historical values previously obtained per standard of care); a third (STAT) serum sodium assessment < 130 mEq/L (mmol/L), which will serve as the baseline value for efficacy endpoints, had to be obtained within 2 to 4 hours prior to the first dose of tolvaptan. 4. Ability to swallow tablets. 5. Ability to maintain adequate fluid intake whether orally or via intravenous support with adequate monitoring. 6. Ability to comply with all requirements of the trial. 7. Trial-specific written informed consent/assent obtained from a parent/legal guardian or legally acceptable representative, as applicable per age of participant or local laws, prior to the initiation of any protocol-required procedures. In addition, the participant as required by local laws must provide informed assent at the pretreatment baseline for this trial and must be able to understand that he or she can withdraw from the trial at any time. All informed consent/assent procedures must be in accordance with the trial center's Institutional Review Board/Independent Ethics Committee and local regulatory requirements. 8. Ability to commit to remain fully abstinent (periodic abstinence [for example, calendar, ovulation, symptothermal, post-ovulation methods] or withdrawal are not acceptable methods of contraception) or practice double-barrier birth control during the trial and for 30 days following the last dose of IMP for sexually active females of childbearing potential. Ineligibility Criteria: 1. Had evidence of hypovolemia or intravascular volume depletion (for example, hypotension, clinical evidence of volume depletion, response to saline challenge); if the participant had systolic blood pressure or heart rate outside of the normal range for that age, then volume status was to be specifically clinically assessed to rule out volume depletion. 2. Had serum sodium < 120 mEq/L (mmol/L), with or without associated neurologic impairment (that is, symptoms such as apathy, confusion, or seizures). 3. Use of potent CYP3A4 inhibitors in participants ≤ 50 kg or moderate CYP3A4 inhibitors in participants < 20 kg. 4. Lacked free access to water (inability to respond to thirst) or without ICU-level fluid monitoring and management. 5. Had a history or current diagnosis of nephrotic syndrome. 6. Had transient hyponatremia likely to resolve (for example, head trauma or post-operative state). 7. Had hyperkalemia defined as serum potassium above the upper limit of normal (ULN) for the appropriate pediatric age range. 8. Had estimated glomerular filtration rate (eGFR) < 30 milliliters (mL)/minute (min)/1.73 meters squared (m^2) calculated by the following equation: eGFR (mL/min/1.73 m^2) = 0.413 x height (centimeter [cm])/serum creatinine (mg/deciliter [dL]). 9. Had acute kidney injury defined as: Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 micromoles [μmol]/L) within 48 hours; or increase in serum creatinine to ≥ 1.5 times baseline, which was known or presumed to have occurred within the prior 7 days; or urine volume < 0.5 mL/kg/hour for 6 hours. 10. Had severe or acute neurological symptoms requiring other intervention (for example, hyperemesis, obtundation, seizures). 11. Had had treatment for hyponatremia with: - Hypertonic saline (including normal saline challenge) within 8 hours of qualifying sodium assessments; - Urea, lithium, demeclocycline, conivaptan, or tolvaptan within 4 days of qualifying serum sodium assessments; - Other treatment for the purpose of increasing serum sodium concurrent with dosing of trial medication 12. Had anuria or urinary outflow obstruction, unless the participant was, or could be, catheterized during the trial. 13. Had a history of drug or medication abuse within 3 months prior to the pretreatment visit or current alcohol abuse. 14. Had a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril). 15. Had psychogenic polydipsia (participants with other psychiatric illness may be included per medical monitor approval). 16. Had uncontrolled diabetes mellitus, defined as fasting glucose > 300 mg/dL (16.7 mEq/L [mmol/L]). 17. Had screening liver function values > 3 x ULN. 18. Had cirrhosis and met any of the following conditions: a major gastrointestinal bleed within the past 6 months, evidence of active bleeding (for example, epistaxis, petechiae/purpura, hematuria, or hematochezia), platelet count < 50,000/μL, or use of concomitant medications known to increase bleeding risk. 19. Had hyponatremia due to the result of any medication that can safely be withdrawn (for example, thiazide diuretics). 20. Had hyponatremia (for example, hyponatremia in the setting of adrenal insufficiency, untreated hypothyroidism, or hypotonic fluid administration) that is most appropriately corrected by alternative therapies. 21. Was currently pregnant or breastfeeding. 22. Had any medical condition that, in the opinion of the investigator, could interfere with evaluation of the trial objectives or safety of the participants. 23. Was deemed unsuitable for trial participation in the opinion of the investigator. 24. Participation in another investigational drug trial within the past 30 days, without prior approval from the sponsor medical monitor. 25. Participants < 4 years of age (or per local Health Authority age restrictions), weight < 10 kg, or who were unable to swallow tablets. |
| 54 | NCT02022007 | completed | 0.6339741945266724 | phase 3 | ['polycystic ovary syndrome', 'disorder of glucose regulation'] | ["['E28.2', 'Q61.3', 'Q61.2', 'Q61.19', 'Z82.71']", "['P81.9', 'P81.8']"] | ['metformin xr', 'saxagliptin', 'saxagliptin-metformin xr'] | ['CN(C)C(=N)NC(N)=N', 'N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', 'CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: - Females 18 years to 42 years of age with polycystic ovary syndrome(NIH PCOS criteria) with prediabetic hyperglycemia determined by an 75 gram oral glucose tolerance test (OGTT). Study subjects will be inclusive of PCOS women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT). - Written consent for participation in the study Exclusion Criteria: - Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2) - Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance) - Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia - Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %) - Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg) - Use of hormonal medications, drugs known to affect gastrointestinal motility, lipid-lowering (statins, etc.) and/or anti-obesity drugs or medications that interfere with carbohydrate metabolism (such as isotretinoin, hormonal contraceptives, gonadotropin releasing hormone (GnRH) analogues, glucocorticoids, anabolic steroids, C-19 progestins) for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone, flutamide) for at least 4 weeks - Prior history of a malignant disease requiring chemotherapy - Known hypersensitivity or contraindications to use of insulin sensitizers such as metformin or thiazolidinediones - History of hypersensitivity reaction to saxagliptin or other DPP-4 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions) - Current use of metformin, thiazolidinediones, glucagon-like peptide -1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or OTC) Patients must stop use of insulin sensitizers or antidiabetic medicines such as metformin for at least 4 weeks or thiazolidinediones, GLP1 agonists or DPPIV inhibitors for 8 weeks. - Prior use of medication to treat diabetes except gestational diabetes - Use of drugs known to exacerbate glucose tolerance - Eating disorders (anorexia, bulimia) or gastrointestinal disorders - Suspected pregnancy (documented negative serum pregnancy test), desiring pregnancy during the study treatment interval, breastfeeding, or known pregnancy in last 2 months - Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol or history of alcoholism - Patient not willing to use adequate barrier contraception during study period (unless sterilized or have an IUD). - Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables - Inability or refusal to comply with protocol - Not currently participating or having participated in an experimental drug study in previous three months | |
| 55 | NCT02022930 | completed | 0.8309846520423889 | phase 3 | ['osteoarthritis of the knee'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['triamcinolone acetonide'] | ['[H][C@@]12C[C@@H](O)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA. - Symptoms in the index knee for at least 12 months. - Fully ambulatory Subject (ability to perform a 15 meters walk test). - Male and female Subjects 40 through 85 years of age. Exclusion Criteria: - BMI >40 kg - Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease. - Intra articular steroid therapy in last 3 months - Intra articular viscosupplementation in last 6 months | |
| 56 | NCT02025621 | completed | 0.6183544397354126 | phase 3 | ['coronary artery bypass grafting', 'mitral valve surgery', 'low cardiac output syndrome'] | ["['I25.84', 'I25.41', 'I25.42', 'Z98.61', 'Q24.5', 'T46.3X6S', 'I25.82']"] | ['levosimendan', 'placebo'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Documented LVEF ≤35% measured by ventriculogram, echocardiogram (ECHO), nuclear scan, or MRI within 60 days before surgery. - Scheduled or urgent 1) CABG surgery, 2)CABG with aortic valve surgery, 3) CABG with mitral valve surgery, or 4) mitral valve surgery with or without other valves - Surgery will employ CPB pump - Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria: - Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return. - Evidence of systemic bacterial, systemic fungal, or viral infection within 72 hours before surgery. - Dialysis at randomization (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration). - Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2. - Weight ≥ 170 kg. - Patients whose SBP cannot be managed to ensure SBP > 90 mmHg at initiation of study drug. - Heart rate ≥ 120 bpm, persistent for at least 10 minutes screening and unresponsive to treatment. - Hemoglobin < 80 g/L. - Serum potassium < 3.5 mmol/L and > 5.5 mmol/L at baseline. - A history of Torsades de Pointes. - Mechanical assist device (IABP, LVAD, ECMO) in the patient at the start of surgery or pre-planned to be inserted during surgery before coming off CPB. - Patients with aortal femoral occlusive disease that would prohibit use of IABP unless VAD or ECMO not available. - Liver dysfunction Child Pugh Class B or C - Patients having severely compromised immune function - Pregnant, suspected to be pregnant, or breast-feeding. - Received an experimental drug or used an experimental medical device in previous 30 days. - Known allergic reaction or sensitivity to Levosimendan or excipients. - Received commercial Levosimendan within 30 days before the planned start of study drug. - Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator. | |
| 57 | NCT02025725 | completed | 0.7535301446914673 | phase 3 | ['diabetic gastroparesis'] | ["['K31.84']"] | ['metoclopramide nasal spray', 'placebo nasal spray'] | ['CCN(CC)CCNC(=O)C1=CC(Cl)=C(N)C=C1OC', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Non pregnant, non lactating female subjects between the ages of 18 and 75 years - Willingness and ability to give written informed consent - The ability to read, understand and speak English - Prior diagnosis of Type 1 or Type 2 diabetes - Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying - A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization - Subjects of childbearing potential must agree to use contraception - Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study Exclusion Criteria: - Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility - A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product - A history of, or physical findings suggestive of, tardive dyskinesia - A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening - A history of allergy to any of the ingredients in the study drug formulation - A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS) - Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening - Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening - Hemoglobin A1c >11.5% at screening - Subjects who are trying to conceive, are pregnant, or are lactating | |
| 58 | NCT02029157 | completed | 0.2748006582260132 | phase 3 | ['liver cancer'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']"] | ['arq197', 'placebo'] | ['O=C1NC(=O)[C@H]([C@@H]1C1=CNC2=CC=CC=C12)C1=CN2CCCC3=C2C1=CC=C3', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Informed consent form - ≥20 years old - Inoperable HCC which is not eligible for locoregional therapy - Diagnosed as c-Met high in tumor sample - Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 - Child-Pugh Class A - Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, - Negative pregnancy test results - Adequate organ function - Life expectancy of at least 12 weeks Exclusion Criteria: - More than 2 prior systemic chemotherapy. - Prior therapy of c-Met inhibitor (including antibody) - Any systemic therapy within ≤2 weeks prior to the randomization - Locoregional therapy within ≤4 weeks prior to randomization. - Major surgery within ≤4 weeks prior to the randomization - Concurrent cancer within ≤5 years prior to the randomization - History of cardiac diseases - Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0 - Any psychological disorder affecting Informed Consent - Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody - Blood or albumin transfusion within ≤14 days prior to the screening test - Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV) - Symptomatic brain metastases - History of liver transplantation - Inability to swallow oral medications - Confirmed interstitial lung disease - Pleural effusion and/or clinically significant ascites - Pregnancy or breast-feeding - Without consent to effective single or combined contraceptive methods | |
| 59 | NCT02030600 | completed | 0.8506988883018494 | phase 3 | ['diabetes', 'diabetes mellitus, type 2'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin degludec', 'insulin glargine'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1 | |
| 60 | NCT02031081 | completed | 0.782638669013977 | phase 2/phase 3 | ['gastroparesis', 'diabetes mellitus'] | ["['K31.84']", "['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['prucalopride', 'placebo'] | ['COCCCN1CCC(CC1)NC(=O)C1=C2OCCC2=C(N)C(Cl)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Age of 18-64 years - Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms - Sufficiently symptomatic at time of proposed study (Minimum baseline postprandial satiety/fullness subscale of the Gastroparesis Cardinal Symptoms Index (GCSI) score of 1.5 or higher) - Delayed gastric emptying (>10% retention at 4 hours) on standard solid meal scintigraphic emptying study within the previous year - Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms - If female of childbearing potential, a negative urine pregnancy test administered between consent and screening appointments - Able to provide written informed consent Exclusion Criteria: - Clinical evidence (including physical exam and/or ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns, including pregnancy or breastfeeding. - Study entry ECG showing second or third degree heart block, left bundle branch block (LBBB) or acute ischemic changes - Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal reference ranges (except during an acute gastroparesis flare-up) - Use of narcotics or promotility agents which cannot be stopped prior to study entry. - Use of tricyclic antidepressants (at doses exceeding 25 mg/day) and/or macrolide antibiotics. (Stable doses of SSRI/SNRI antidepressants and/or non-macrolide antibiotics are permitted) - Laxative use that cannot be stopped prior to the start of the study - Participated in clinical trial with motility agents within past 30 days - History of gastrointestinal surgery excepting appendectomy and/or cholecystectomy in the past, or any other major surgeries within 3 months - Estimated GFR<30 measured within past 6 months. - History of cardiovascular disorder including myocardial infarction, pacemaker or implanted defibrillator, or history of life-threatening arrhythmia | |
| 61 | NCT02031744 | completed | 0.2971594035625458 | phase 3 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['erlotinib [tarceva]', 'placebo', 'onartuzumab [metmab]'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female, 18 years or older. - Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Histologically confirmed incurable Stage IIIB/IV NSCLC tumor. - Met-positive status and results of epidermal growth factor receptor (EGFR)-activating mutation testing. - Available tumor tissue sample or agreement to take such a sample. - Radiographic evidence of disease. Lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has occurred at that site since radiation. - Prior treatment with at least one platinum-based line of treatment for locally advanced, unresectable/inoperable disease or metastatic disease, and no more than one additional line of chemotherapy treatment, defined as follows: - Adjuvant/neoadjuvant chemotherapy or chemoradiation counts as a line of therapy if < 12 months have elapsed between the last dose and the date of recurrence. Combined treatment with chemotherapy and radiation constitutes a single regimen; surgery is not considered a regimen. - Cytotoxic maintenance therapy that differs from first-line therapy is considered an additional line of therapy. However, changes in treatment due to intolerance or excessive toxicity are not considered an additional regimen. - The last dose of prior chemotherapy must have been given >/= 21 days prior to Day 1 (>/= 14 days for vinorelbine or other vinca alkaloids or gemcitabine). - Anti-cancer agents used for pleurodesis are not counted as a line of therapy. - Prior radiation therapy is allowed provided the patient has recovered from any toxic effects and >/= 7 days have elapsed between the last session and randomization. - Patients must use effective contraception throughout the trial and until 3 months after the last dose. Exclusion Criteria: - More than 30 days expsoure to an EGFR inhibitor or a known EGFR-toxicity resulting in dose modifications. - Prior exposure to agents targeting either the HGF or MET pathway, including but not limited to crizotinib, cabozantinib, ficlatuzumab, rilotumumab, and tivantinib. - Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently. - Brain metastases or spinal cord compression that were not definitively treated with surgery and/or radiation or that were previously diagnosed and treated without evidence of clinically stable disease for >/= 14 days. Patients with treated central nervous system (CNS) metastases who are asymptomatic and on a stable dose of corticosteroid for >/= 14 days prior to randomization are eligible. - History of another cancer in the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, stage I uterine cancer, or other cancers that are curable. - Life expectancy < 12 weeks. - Radiographically visible interstitial lung disease (ILD) or a history of it. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Inadequate hematologic, biological, or organ function. - Significant history of cardiac disease. - Serious active infection at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment, including positive HIV or active hepatitis B or C infections, significant gastrointestinal abnormalities, uncontrolled diabetes. - Any inflammatory changes to the surface of the eye. - Inability to take oral medication, need for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. - Pregnant or breast-feeding women. - Any major surgery within 2 weeks prior to randomization. - Inability to understand the language(s) in which the HRQOL questionnaires are available. | |
| 62 | NCT02032277 | completed | 0.4980318248271942 | phase 3 | ['triple negative breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['cyclophosphamide', 'placebo', 'doxorubicin', 'paclitaxel', 'carboplatin', 'veliparib', 'placebo'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'C[C@@]1(CCCN1)C1=NC2=CC=CC(C(N)=O)=C2N1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Histologically confirmed invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed). Clinical stage T2-3 N0-2 or T1 N1-2 by physical exam or radiologic studies. 2. Documented Breast Cancer Gene (BRCA) germline mutation testing. 3. Estrogen Receptor (ER)-, Progesterone Receptor (PR)-, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast. 4. ECOG Performance status of 0 to 1. 5. Women must be determined to be not of childbearing potential (surgically sterile, or postmenopausal defined as amenorrheic for at least 12 months) by the Investigator OR they must have a negative serum pregnancy test prior to randomization. Exclusion Criteria: 1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy radiotherapy or investigational agents) with therapeutic intent for current breast cancer. 2. Previous treatment with carboplatin, paclitaxel, doxorubicin, cyclophosphamide and a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor. 3. Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Subjects must have discontinued use of such agents prior to beginning study treatment. 4. A history of seizure within 12 months prior to study entry. 5. Pre-existing neuropathy from any cause in excess of Grade 1. | |
| 63 | NCT02032875 | completed | 0.9076943397521973 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['daclatasvir', 'sofosbuvir', 'ribavirin'] | ['COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C', 'CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications - Participants chronically infected with hepatitis C virus (HCV) Genotype 1, 2, 3, 4, 5, or 6 with HCV RNA viral load of ≥10,000 IU/mL at screening - Participants may be treatment-naïve or treatment-experienced - Cirrhotic participants must have cirrhosis confirmed by biopsy, Fibroscan or fibrotest and Aspartate aminotransferase platelet ratio index (APRI) criteria as outlined in the protocol - Post-transplant participants must be at least 3 months post-transplant with no evidence of moderate or severe rejection Exclusion Criteria: - History of multi-organ transplant, with the exception of dual transplantation of the liver/kidney, is prohibited - Current or known history of cancer (with the following exceptions: In situ carcinoma of the cervix, adequately treated basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma within Milan criteria for transplantation) within 5 years prior to screening - Evidence of an ongoing medical condition contributing to chronic liver disease other than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, or toxin exposures) - History of HIV infection or chronic hepatitis B virus (HBV) as documented by HBV serologies (e.g., HBsAg-seropositive). Participants with resolved HBV infection may participate (e.g., HBcAb-seropositive with concurrent HBsAg-seronegative) - Active hospitalization for decompensated liver disease | |
| 64 | NCT02032888 | completed | 0.9123498797416687 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['daclatasvir', 'sofosbuvir'] | ['COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C', 'CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: - Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications - Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening - Patients who are HCV treatment-naive - Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening - Patients with HCV RNA ≥10,000 IU/mL at screening - Patients with HIV-1 infection Key Exclusion Criteria: - Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry - Patients infected with HIV-2 - Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair - Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening - Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed - Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy | |
| 65 | NCT02032901 | completed | 0.9121630191802979 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['daclatasvir', 'sofosbuvir'] | ['COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C', 'CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: - Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications - Subjects chronically infected with hepatitis C virus (HCV) genotype 3 - Subjects who are HCV treatment-naive - Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited) - HCV RNA ≥10,000 IU/mL at screening Key Exclusion Criteria: - HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted - Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair - Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening - Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed) - Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy | |
| 66 | NCT02034513 | completed | 0.7890797853469849 | phase 3 | ['diabetes', 'diabetes mellitus, type 1'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['insulin degludec', 'insulin glargine', 'insulin aspart'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypo episode within the last year (according to the ADA (American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Male or female, age at least 18 years at the time of signing informed consent - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 - Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH) insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin) for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening) - Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1 | |
| 67 | NCT02036515 | completed | 0.8735105395317078 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ertugliflozin 5 mg', 'ertugliflozin 15 mg', 'placebo for ertugliflozin 5 mg', 'metformin', 'sitagliptin', 'glimepiride', 'placebo for ertugliflozin 10 mg'] | ['CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CSCC[C@H](N)C(O)=O', 'N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', '[H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus (T2DM) - On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin - Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2 - Male, postmenopausal female or surgically sterile female - If a female of reproductive potential, agrees to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis - History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug- or chemical-induced, and post-organ transplant) - A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) or DPP-4 inhibitor - On a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable - Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable - Has been treated with insulin (except for short-term use [<= 7 days]), injectable antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2) inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™), colesevelam (Welchol™), or any other non-protocol approved AHAs within 12 weeks of study participation - Has active, obstructive uropathy or indwelling urinary catheter - History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation - A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer - Known history of Human Immunodeficiency Virus (HIV) - Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - A medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease - Has any clinically significant malabsorption condition - If taking thyroid replacement therapy, has not been on a stable dose for at least 6 weeks prior to study participation - Has been previously randomized in a study with ertugliflozin - Has participated in other studies involving an investigational drug within 30 days prior or during study participation - Has undergone a surgical procedure within 6 weeks prior to or planned major surgery during study participation - Has a positive urine pregnancy test - Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of study medication - Planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of study medication - Excessive consumption of alcoholic beverages or binge drinking - Has donated blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial | |
| 68 | NCT02037503 | recruiting | 0.5761823058128357 | phase 3 | ['suicidal ideation', 'major depressive disorder', 'healthy participants'] | ["['R45.851']", "['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['ketamine', 'saline'] | ['CC1=CC(O)=CC(C)=C1Cl', 'COCCC1=CC=C(OCC(O)CNC(C)C)C=C1'] | Inclusion Criteria: Suicidal Ideation group: 1. Any person admitted to the emergency room department after a suicide attempt , defined as requiring medical intervention - not just a psychiatrist ( surgical or pharmacological treatment but also the need for observation ) . 2. The need for medical intervention will be defined by the ER ED physician 3. Ages 18-65 For the depression group: 1. Diagnosed with major depression according to DSM VI. 2. Ongoing depression (according to DSM criteria) despite treatment with at least two antidepressants in adequate dosages and for longer than three weeks. 3. Ages 18-65 For the romantic relationship breakup: 1. Participants that have experienced a meaningful romantic relationship break-up within the past 12 months - Exclusion Criteria for all groups: 1. Psychotic state instate in the examination 2. Diagnosis of schizophrenia / schizoaffective disorder 3. Drug or alcohol abuse as is revealed in by blood/urine tests 4. Patient in which, according to the examiner, there is primary or secondary gain. 5. Patient , which, at the time of his admission , is without any pharmacological treatment. | |
| 69 | NCT02038036 | completed | 0.40814387798309326 | phase 3 | ['polycythemia vera'] | ["['D45']"] | ['best available therapy', 'ruxolitinib'] | ['N#CC[C@H](C1CCCC1)N1C=C(C=N1)C1=C2C=CNC2=NC=N1'] | Inclusion Criteria: Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2. Exclusion Criteria: Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, excluding specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated with any investigational agent, Women who are pregnant or nursing. Other inclusion/exclusion criteria apply. | |
| 70 | NCT02038179 | completed | 0.8146594166755676 | phase 2/phase 3 | ['pre-hypertension', 'jnc 7 stage i hypertension'] | ["['O11.1', 'O11.2', 'O11.3', 'O11.4', 'O11.9', 'O11.5', 'O10.02']", "['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['allopurinol', 'placebo'] | ['O=C1N=CN=C2NNC=C12', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements: - Systolic blood pressure (SBP) ≥ 120 and <160 or; - Diastolic blood pressure (DBP) ≥ 80 and < 100 - Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women - Age 18-40 Exclusion Criteria: - Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed) - Estimated glomerular filtration rate < 60 mL/min/1.73m2 - Current use of any urate-lowering therapy or statins - Prior diagnosis of gout or past use of urate-lowering therapy for gout - Prior diagnosis of diabetes - Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months - Active smokers - Immune-suppressed individuals including transplant recipients or current use of azathioprine. - Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL - Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype - Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol | |
| 71 | NCT02038920 | completed | 0.3738822638988495 | phase 3 | ["crohn's disease"] | ["['K50.90', 'K50.913', 'K50.914', 'K50.911', 'K50.912', 'K50.918', 'K50.919']"] | ['vedolizumab', 'vedolizumab placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements 2. Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures 3. Participants aged 15 to 80 years (inclusive) at the time of consent 4. A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug 5. A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug 6. Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohn's disease (CD) established based on the Revised Diagnostic Criteria for Crohn's disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug 7. Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings: - C-reactive protein (CRP) at screening test is above 0.30 mg/dL - Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs - Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs 8. In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available) 9. Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent 1. Corticosteroids - Resistance - Dependence - Intolerance 2. Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate) - Refractory - Intolerance 3. Anti-tumor necrosis factor alpha (TNFα) antibodies - Inadequate response - Loss of response - Intolerance Exclusion Criteria: 1. Participants with an evidence of or suspected abdominal abscess 2. Participants with a history of subtotal or total colectomy 3. Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome 4. Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis 5. Participants who have a treatment history with natalizumab, efalizumab or rituximab 6. Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration 7. Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohn's disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration 8. Participants who had received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration 9. Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration 10. Participants who had received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed 11. Participants who had received any live vaccinations within 27 days before initiation of study drug administration 12. Participants who had undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study 13. Participants who had received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration 14. Participants who had received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration or participants who are fasted 15. Participants who had received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration 16. Participants who had been infected with Clostridium difficile, cytomegalovirus, or any other intestinal pathogen within 27 days before the first dose of the study drug 17. Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration 18. Participants with a history or an complication of dysplasia of the small or large intestine 19. Participants who were suspected to have enteritis other than CD 20. Participants who were hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive at the screening. Or participants who are hepatitis B core (HBc) antibodypositive or HBs antibody positive, even though HBs antigen-negative. However, this does not apply to participants who are only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative, or HCV-RNA-negative 21. Participants who had an evidence of history of tuberculosis or a suspected history of tuberculosis (including those who have findings suggesting previous tuberculosis on chest imaging procedure at the screening). However, this does not apply to participants who had completed prophylactic isoniazid, or participants who had been receiving prophylactic isoniazid for more than 21 days before the first dose of the study drug (in the latter case, the screening period are allowed to extend up to 28 days to ensure at least 21-day prophylactic isoniazid and then the study treatment is allowed to start) 22. Participants who had positive T-SPOT test or QuantiFERON test at the screening 23. Participants who had a history or complication of identified congenital or acquire immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus [HIV] infection or organ transplantation) 24. Participants who had been affected by extraintestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug 25. Participants who had a treatment history with MLN0002 26. Female participants who are lactating at the screening, or have positive urine pregnancy test either at the screening or baseline 27. Participants who had serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood 28. Participants who had a history of a surgery requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of a surgery requiring hospitalization during the study period 29. Participants who had a complication or a history of malignancy. However, this does not apply to the following participants: - Participants who had a curative resection of localized skin basal cell carcinoma or have completed curative radiotherapy - Participants who had not experienced recurrence for more than 1 year since completion of a curative resection or curative radiotherapy for skin squamous cell carcinoma - Participants who had not experienced recurrence for more than 3 years since completion of a curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix For participants who had a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the investigator and the sponsor had a discussion to decide eligibility on the basis of type of malignancy and treatment applied 30. Participants who had a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease. 31. Participants who had any subjective symptoms in the subjective PML checklist at the screening or baseline 32. Participants who had any of the following laboratory abnormalities at the screening; - Hemoglobin ≤8 g/dL - White blood cells ≤3,000/μL - Lymphocytes ≤500/μL - Platelets ≤100,000/μL or ≥1,200,000/μL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN) - Alkaline phosphatase (ALP) ≥3×ULN - Creatinine ≥2×ULN 33. Participants who had a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug 34. Participants who had a history or a complication of psychotic disorder that could obstruct compliance with the study procedures | |
| 72 | NCT02039505 | completed | 0.7326525449752808 | phase 3 | ['ulcerative colitis'] | ["['K51.80', 'K51.813', 'K51.814', 'K51.90', 'K51.913', 'K51.914', 'K51.811']"] | ['vedolizumab', 'vedolizumab placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. In the opinion of the investigator, a participant is capable of understanding and complying with protocol requirements. 2. A participant who is capable of entering the signature and the date on the informed consent by himself/herself or by the participant's legally acceptable representative, if applicable, prior to initiation of study procedures. 3. A participant aged 15 to 80 (inclusive) at the time of signing the informed consent (regardless of sexes). 4. A male participant, who has no sterilization history and whose female partner has child-bearing potential, who agreed with taking proper contraception during the period from the time of signing the informed consent form through 6 months after the last dose of study drug. 5. A female participant with child-bearing potential (having no history of sterilization or whose last menstruation was within 2 years) whose male partner is not receiving contraceptive treatment, and agreed to take proper contraception during the period from the time of signing on the informed consent form through 6 months after the last dose of the study drug. 6. Participants with diagnosis of total or left-sided ulcerative colitis (UC) based on the Revised Diagnostic Criteria for UC issued by "Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease" by the Ministry of Health, Labor and Welfare (MHLW) of Japan (2012) at least 6 months before the start of administration of the study drug. 7. A participant with moderately or severely active UC as determined by baseline complete Mayo score of 6 to 12 (inclusive) with an endoscopic subscore of ≥2. 8. Participants whose complication of colon cancer or dysplasia had to be ruled out by total colonoscopy at the start of the study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available), if participants met any of the following criteria; participants with ≥8-year history of total or left-sided colitis, participants aged ≥50 years, or participants with a first-degree family history of colon cancer. 9. Participants meeting the following treatment failure criteria with at least one of the following agents within 5 years before signing on the informed consent: 1. Corticosteroids - Resistance: Participants whose response was inadequate after treatment of ≥40 mg/day for ≥1 week (oral or IV) or 30 to 40 mg/day for ≥2 weeks (oral or IV). - Dependence: Participants for which it is difficult to reduce the dosage to <10 mg/day due to recurrence during gradual dose reduction (oral or IV). - Intolerance: Participants who were unable to receive continuous treatment due to adverse reactions (e.g., Cushing's syndrome, osteopenia/osteoporosis, hyperglycaemia, insomnia, infection). 2. Immunomodulators (azathioprine [AZA] or 6- mercaptopurine [6-MP]) - Refractory: Participants whose response was inadequate after treatment for ≥12 weeks. - Intolerance: Participants who were unable to receive continuous treatment due to adverse reactions (e.g., nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase genetic mutation, infection). 3. Tumor necrosis factor-alpha (TNFα) antagonist - Inadequate response: Participants whose response was inadequate after the induction therapy in the dosage described in the package insert. - Loss of response: Participants who had recurrence during the scheduled maintenance therapy after achievement of clinical response (those who withdrew for other reasons than relapse are not applicable here). - Intolerance: Participants who were unable to receive continuous treatment due to adverse reactions (eg, infusion-related reaction, demyelination, congestive heart failure, infection). Exclusion Criteria: 1. Participants whose partial Mayo score decrease by 3 points or more between screening and the start of study drug administration. 2. Participants having or suspected to have abdominal abscess or toxic megacolon. 3. Participants with a history of subtotal or total colectomy. 4. Participants with ileostomy, colostomy, fistula or severe intestinal stenosis. 5. Participants having a treatment history with natalizumab, efalizumab or rituximab. 6. Participants who started oral 5-ASA, probiotics, or oral corticosteroids (≤30 mg/day) within 13 days before the first dose of the study drug. Participants who have used these drugs for at least 14 days before the first dose of the study drug, and who changed dosage of or discontinued these drugs within 13 days before the first dose of the study drug. 7. Participants who have received 5-ASA, corticosteroid enemas/suppositories, corticosteroid IV infusion, oral corticosteroid at >30 mg/day, drugs for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the UC treatment (eg, Daikenchuto) within 13 days before the first dose of the study drug. 8. Participants who have used an antidiarrheal drug for 4 or more consecutive days within 13 days before the first dose of the study drug or within 7 days before the first dose of the study drug. 9. Participants who have received AZA or 6-MP within 27 days before the first dose of the study drug However, this will not apply to participants who have used these drugs for 83 or more days before the first dose of the study drug and continued the steady dose administration of the drugs for 27 or more days before the first dose of the study drug. 10. Participants who have received cyclosporine, tacrolimus, methotrexate, tofacitinib or any study drugs of low-molecular compound for UC treatment within 27 days before the first dose of the study drug. 11. Participants who have received adalimumab within 27 days before the first dose of the study drug or any biologic agents other than adalimumab within 55 days before the first dose of the study drug. However, this will not apply to participants who have topically received these drugs (eg., intraocular injection for treatment of age-related macular degeneration). 12. Participants who have received any live-vaccinations within 27 days before the first dose of the study drug. 13. Participants who underwent the enterectomy within 27 days before the first dose of the study drug or those anticipated to require an enterectomy during the study. 14. Participants who have received leukocytapheresis or granulocyte apheresis within 27 days before the first dose of the study drug. 15. Participants who have been infected with an intestinal pathogen including clostridium difficile or cytomegalovirus within 27 days before the first dose of the study drug. 16. Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration. 17. Participants with a history or a complication of colonic mucosal dysplasia. 18. Participants suspected to have enteritis other than UC. 19. Participants indicated in the screening test as hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive. Participants indicated as hepatitis B core (HBc) antibody-positive or HBs antibody positive even though HBs antigen-negative However, the criteria will not apply to those with only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative or HCV-RNA-negative. 20. Participants who have or are suspected to have a history of tuberculosis (including those whose findings in the chest imaging procedure at screening showing anamnesis of tuberculosis). However, the criteria will not apply to those who had completed prophylactic treatment with isoniazid, and who have been receiving prophylactic isoniazid for 21 days or longer before the first dose of the study drug (the latter may initiate study drug administration with screening phase extended to 28 days at maximum for prophylactic treatment to become 21 days or more). 21. Participants indicated as positive in T-SPOT or QuantiFERON at screening test. 22. Participants who have a history or complication of identified congenital or acquired immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus [HIV] infection or organ transplantation). 23. Participants who were affected by extra-intestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug. 24. Participants who have treatment history with MLN0002. 25. Nursing mothers during the screening phase, or female participants indicated positive in urine pregnancy test either at the screening or baseline. 26. Participants having serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood. 27. Participants with a history of an operation requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of an operation requiring hospitalization during the study period. 28. Participants having a complication or a history of malignancy However, it will not apply to the following participants; - Participants who had a curative resection of localized skin basal cell carcinoma or had completed curative radiotherapy. - Participants who have not experienced recurrence for 1 year or longer since completion of curative resection or curative radiotherapy for skin squamous cell carcinoma. - Participants who have not experienced recurrence for 3 year or longer since completion of curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix. For participants having a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the Investigator and the sponsor will discuss to decide eligibility on the basis of type of malignancy and treatment applied. 29. Participants having a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease. 30. Participants for which any subjective symptoms in the Subjective PML checklist were found at the screening or baseline. 31. Participants for which any of the following laboratory abnormalities were found at the screening; - Hemoglobin ≤8 g/dL - White blood cells ≤3,000/μL - Lymphocytes ≤500/μL - Platelets ≤100,000/μL, or ≥1,200,000/μL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN) - Alkaline phosphatase (ALP) ≥3×ULN - Creatinine ≥2×ULN 32. Participants having a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug. 33. Participants having a history or a complication of psychotic disorder that may obstruct compliance with the study procedures. | |
| 73 | NCT02041533 | active, not recruiting | 0.3532359302043915 | phase 3 | ['stage iv or recurrent non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['gemcitabine', 'cisplatin', 'carboplatin', 'paclitaxel', 'pemetrexed'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 - Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria - PD-L1+ on immunohistochemistry testing performed by central lab - Men and women, ages ≥ 18 years of age Exclusion Criteria: - Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy - Known anaplastic lymphoma kinase (ALK) translocations - Untreated central nervous system (CNS) metastases - Previous malignancies - Active, known or suspected autoimmune disease | |
| 74 | NCT02042690 | completed | 0.8465459942817688 | phase 3 | ['acute lymphoblastic leukemia'] | ["['C91.01', 'C91.02', 'C91.00']"] | ['chemotherapy'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - acute lymphoblastic leukemia - 18-39 years old - in first complete remission -Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤2.5 times the institutional ULN - - Adequate renal function defined as creatinine ≤3 times the institutional ULN - No uncontrollable infection - Performance Status(PS)score 0-2(WHO) - Subjects able to provide written informed consent Exclusion Criteria: - having HLA-matched donor - high-risk ALL: (1)Ph+ALL (2)Hypodiploidy (3)t(v;11q23) (4) complex karyotype（≥5 chromosome abnormalities）（5）high white blood cell (WBC) count (B-ALL≥30×109/L;T-ALL ≥100×109/L). - pregnancy - Loss of ability to freely provide consent due to psychiatric or physical illness | |
| 75 | NCT02043678 | active, not recruiting | 0.44510966539382935 | phase 3 | ['prostatic neoplasms'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['radium-223 dichloride (xofigo, bay88-8223)', 'matching placebo (normal saline)', 'abiraterone', 'prednisone/prednisolone'] | ['Cl[223Ra]Cl', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Male subjects of age ≥ 18 years - Prostate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 - Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis - Asymptomatic or mildly symptomatic prostate cancer - Subjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment - Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L) - Eastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1 Exclusion Criteria: - Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine - Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily - Pathological finding consistent with small cell carcinoma of the prostate - History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations - History of or known brain metastasis - Malignant lymphadenopathy exceeding 3 cm in short-axis diameter - Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization - Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered - Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization. | |
| 76 | NCT02044146 | completed | 0.6411874890327454 | phase 2/phase 3 | ['acute coronary syndrome', 'percutaneous coronary intervention'] | ["['I24.0']", "['Y35.312S', 'Y35.313S', 'Y35.412S', 'Y35.413S', 'Y35.812S', 'Y35.813S', 'Y35.92XS']"] | ['ticagrelor, prasugrel, clopidogrel'] | ['CC(=O)OC1=CC2=C(CCN(C2)C(C(=O)C2CC2)C2=CC=CC=C2F)S1'] | Inclusion Criteria: - Patients: age >18 yrs, < 75yrs -> 60 kg ( since March 2015 age >75 and < 60 kg eligible - but prasugrel reduced to 5mg daily if randomized to personalized therapy arm) - NSTEMI undergoing PCI will be eligible Exclusion Criteria: - Patients will be excluded if they have: i) a contra-indication for clopidogrel or prasugrel or ticagrelor (as per monograph), ii) have an intolerance to aspirin, iii) have absolute requirement for ticagrelor or prasugrel (e.g. stent thrombosis, allergic reaction to clopidogrel), iv) requirement for anti-coagulation treatment, v) a history of stroke, TIA or intracranial hemorrhage , vi) a platelet count < 100,000/μl, vii) a known bleeding diathesis, viii) hematocrit <30% or >52%, ix) severe liver dysfunction, x) renal insufficiency (creatinine clearance < 30ml/min), xi) adjuvant therapy with a glycoprotein IIbIIIa inhibitor. | |
| 77 | NCT02044354 | unknown status | 0.4841625392436981 | phase 3 | ['metastatic castration-resistant prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['taxotere', 'jevtana'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', '[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C4=CC=CC=C4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@H](C[C@H]1OC[C@@]21OC(C)=O)OC)C3(C)C'] | Inclusion Criteria: - Affiliated to a social security regimen ; - Male patients older than 18 years ; - Histologically confirmed adenocarcinoma of the prostate ; - Continued androgen deprivation therapy either by LHRH agonists/antagonists or orchidectomy ; - Serum testosterone <0.50 ng/ml (1.7 nmol/L) ; - Progressive disease (PSA progression or radiological progression or clinical progression) ; - ECOG 0-2 ; - Information delivered to patient and informed consent form signed by the patient or his legal representative ; - Adequate organ or bone marrow function as evidenced by: - Hemoglobin >/= 10 g/dL - Absolute neutrophil count >/=1.5 x 109/L, - Platelet count >/=100 x 109/L, - AST/SGOT and/or ALT/SGPT </=1.5 x ULN; - Total bilirubin </=1.5 x ULN, - Serum creatinine </=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded Exclusion Criteria: - Patients having received an investigational drug and/or prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior enrolment in the study, excepted radiotherapy directed to a single bone lesions which is nonacceptable if within 2 weeks ; - Prior treatment with Taxotere or Jevtana ; - Pre-existing symptomatic peripheral neuropathy grade > 2 (CTCAE V4) ; - Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed ; - History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs ; - Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus), active infection including HIV infection, active Hepatitis B or C infection that would preclude participation in the trial ; - Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) ; | |
| 78 | NCT02044510 | terminated | slow recruitment and small observed effect size | 0.4420241415500641 | phase 2/phase 3 | ['urinary bladder, neurogenic'] | ["['G98.0', 'K59.2', 'M48.061', 'M48.062']"] | ['mirabegron', 'placebo'] | ['NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Diagnosis of traumatic or nontraumatic suprasacral spinal cord injury (SCI) or multiple sclerosis (MS, based on a neurologist assessment and/or the McDonald criteria)(28) - Age >18 years - Stable method of bladder management for >3months (either spontaneous or provoked voiding, or intermittent catheterization). - Bothersome urinary symptoms (urinary frequency, urgency, or urgency incontinence based on standard ICS definitions(29)) and completed 3 day voiding diary demonstrating at least 1 episode of non-stress based urinary incontinence over the 72hr period (this may be urgency based incontinence or unaware incontinence). - Patient is able to read and speak English Exclusion criteria: Based on Screening visit history: - Participation in another drug or device study in the 60 days prior to the screening visit. - Previous urologic surgery: Transurethral prostatectomy, bladder augmentation, sphincterotomy, bladder neck sling, artificial urinary sphincter, catheterizable channel, implantable electrostimulator/neuromodulator - Current use of suprapubic catheter/foley catheter - Unstable cardiac disease (uncontrolled hypertension, myocardial infarction, unstable angina, severe congestive heart failure (NYHA 3 or 4), ventricular arrhythmia (such as torsades de pointes), or stroke within the last 6 months) - Clinically significant abnormal ECG - The investigator believes the patient has an increased risk of QT prolongation (based on review of the screening ECG and patients concurrent medications) - History of significant renal dysfunction within 1 year, or serum creatinine >150umol/L at screening visit (visit 1). - History of significant liver disease within 1 year, or serum AST/ALT >2 times upper limit of normal, GGT >3 times upper limit of normal, total bilirubin >2 times upper limit of normal at screening visit (visit 1). - History of pelvic radiation - History of bladder cancer - History of a concurrent malignancy or cancer (except noninvasive skin cancer) within the last 5 years. Subjects with a history of cancer are considered eligible if the subject has undergone potentially curative therapy and the subject has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin). - Patient has a history of interstitial cystitis/pelvic pain syndrome - Patient has a history of acute or chronic urinary retention within the last 3 months, and is currently not using intermittent catheters - Patient has a history of a tachyarrhythmia - Patient has a history of glaucoma - Patient has a medical condition that may cause noncompliance with the study protocol - In the opinion of the Investigator the patient has a history of significant stress urinary incontinence - Patient has signs and symptoms of an active urinary tract infection (symptoms of dysuria, foul smelling urine, cloudy urine, increased spasticity, increased autonomic dysreflexia, self reported fever, increased incontinence, back/suprapubic pain). o Patient will submit urine for culture and sensitivity, undergo treatment, and will be eligible for rescreening after treatment. - Female patient who is pregnant or breastfeeding, or plans to become pregnant. - Male patient who is planning on fathering a child during the study or for 28 days after the last dose of study drug, or who is planning to donate sperm - Patient refuses to provide written consent - Patient will be unable or unwilling to complete the questionnaires and study visits - In the opinion of the study investigator, it is not in the patient's best interest to be enrolled in this study. Based on medication and allergy review - The new addition of an anticholinergic medication, or a change to anticholinergic dose, within the last 30 days, (bladder specific anticholinergics include oxybutynin, tolterodine, fesoterodine, solifenacin, darifenacin, trospium, hyoscine, oxybutynin gel or patch, atropine, benzatropine). If previously used and discontinued, these medications must have been stopped for >2 weeks - Newly added bladder active medication (or dose change) within the last 2 months (Tamsulosin, Silodosin, Terazosin, Baclofen, Diazepam, amitriptyline, Finasteride, Dutasteride, DDAVP/desmopressin) - Use of flecainide, propafenone, donepezil, thioridazine, tramadol, aripiprazole, desipramine, imipramine, venlafaxine or digoxin - Intravesical onabotulinum toxin use within the last 1 year - Intravesical oxybutynin within the last 3 months - Patient has a previous history of treatment with mirabegron - Patient has a known allergy to mirabegron or a previous adverse reaction to a beta 3 agonist. Based on physical exam - Patient has a postvoid residual > 250mL at study enrollment after repeated tested (1 attempt to re-void to ensure complete emptying of the bladder) and is not using intermittent catheters - Patient has a resting BP >180 mmHg systolic and/or >110 mmHg diastolic after 2 minutes of sitting quietly - Patient has a resting heart rate >100bpm after 2 minutes of sitting quietly - In the opinion of the study investigator, it is not in the patient's best interest to be enrolled in this study based on a clinically significant abnormality on physical exam. |
| 79 | NCT02045290 | completed | 0.7677441835403442 | phase 3 | ['type 1 diabetes'] | ["['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['metformin', 'placebo'] | ['CSCC[C@H](N)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). Exclusion Criteria: 1. Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit <30% or hemoglobin <10 gm/dL | |
| 80 | NCT02045862 | completed | 0.6959934234619141 | phase 3 | ['urinary bladder overactive', 'overactive bladder', 'urgency incontinence', 'urinary bladder diseases\\urologic diseases'] | ["['N32.81']", "['N32.81']", "['N39.41', 'N39.46', 'N39.490', 'N39.491', 'N39.492', 'R32', 'R39.81']"] | ['solifenacin succinate', 'mirabegron', 'placebo to match solifenacin', 'placebo to match mirabegron'] | ['O=C(O[C@H]1CN2CCC1CC2)N1CCC2=CC=CC=C2[C@@H]1C1=CC=CC=C1', 'NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Main Inclusion at Screening (Visit 1): - Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months); - Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; Main Inclusion at Randomization (Visit 2): - Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition). - Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period. - Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period. Exclusion Criteria: Main Exclusion at Screening (Visit 1): - Subject had clinically significant bladder outflow obstruction at risk of urinary retention; - Subject had significant PVR volume (> 150 mL); - Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor; - Subject has an indwelling catheter or practices intermittent self-catheterization; - Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; - Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; Main Exclusion at Randomization (Visit 2): - Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite). - Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period. | |
| 81 | NCT02046369 | completed | 0.6675702929496765 | phase 3 | ['bipolar i depression'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['lurasidone', 'placebo'] | ['[H][C@@]12[C@H]3CC[C@H](C3)[C@]1([H])C(=O)N(C[C@@H]1CCCC[C@H]1CN1CCN(CC1)C1=NSC3=CC=CC=C13)C2=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated. If emancipated, subjects must provide written informed consent. In accordance with Institutional Review Board (IRB) requirements, the subject will complete an informed assent prior to study participation. - Male or female subjects 10 to 17 years of age, inclusive with bipolar I disorder, most recent episode depressed, with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-V criteria, and confirmation of the bipolar I disorder diagnosis by an adequately trained clinician at the time of screening, by means of the Schedule for Affective Disorders and Schizophrenia for School-age Children [K-SADS-PL]). Note: The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records. - Subject has a lifetime history of at least one manic episode. A reliable informant (eg, family member or caregiver) or medical records must be able to confirm this history. - Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration. - CDRS-R score ≥ 45 at screening and Baseline. - YMRS score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at screening and Baseline. - Within 3rd to 97th percentile for gender specific BMI-for-age growth charts from the World Health Organization (WHO) growth charts - In good physical health on the basis of medical history, physical examination, and laboratory screening. - Females who participate in this study: - are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR- - practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR- - are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. - Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken. - In the judgment of the investigator, the subject is able to swallow the size and number of study drug tablets specified per protocol - Willing and able to adhere to protocol-specified meal requirements during dosing. - Subjects may have a lifetime diagnosis of ADHD. If a subject is taking psychostimulants for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the investigator and noted in the source records. Exclusion Criteria: - Has an Axis I or Axis II (DSM-IV or any DSM-5) diagnosis other than bipolar I disorder that has been the primary focus of treatment within 3 months of screening. - Subject has been hospitalized for a bipolar manic or mixed episode within the 30 days prior to randomization. - Has a history or current diagnosis of intellectual disability, autism spectrum disorder, neuroleptic malignant syndrome, or any neurologic disorder, or severe head trauma. - Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C. - Any of the following: - Documented history of chromosomal disorder with developmental impairment (ie, trisomy chromosome 21; 22q11 deletion syndrome). - Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood - eg, Duchenne muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders. In addition, subjects must not have a history of persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary. - CDRS-R total score > 85 at screening or Baseline - Demonstrates a decrease (improvement) of ≥ 25% in the CDRS-R adjusted total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline. - Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator. - Lifetime history of electroconvulsive therapy (ECT). - Resistant to antipsychotic treatment based on at least two prior adequate trials (ie, adequate dose and duration) of an antipsychotic agent within the current episode of depression, or subject has a history of non-response to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode. - Clinically significant neurological, metabolic (including Type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study. - Has a history of malignancy < 5 years prior to signing the informed consent. - Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study. - Clinically relevant abnormal laboratory values or abnormal vital sign values/findings. - A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Abnormal screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read. - Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone. - Clinically significant substance abuse disorder (with the exception of caffeine or tobacco) based on DSM-5 criteria within the last 6 months prior to screening. - Positive test results at screening or Baseline for: 1. Urine drugs of abuse (including amphetamines/methamphetamines, barbiturates, benzodiazepines, cocaine, opioids, phencyclidine, and cannabinoids). A positive test for amphetamines/methamphetamines, barbiturates, opioids, or benzodiazepines may not result in exclusion of subjects if the investigator determines that the positive test is as a result of taking prescription medicine(s) as prescribed. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the investigator will evaluate the subject's ability to abstain from prohibited substances during the study. If in the investigator's clinical judgment the subject will abstain, the subject may be enrolled after consultation with the Medical Monitor. 2. Pregnancy test. - Females who are pregnant, lactating, or likely to become pregnant during the study. - Participated in another interventional clinical trial or receiving an investigational product within 30 days prior to screening. - Donation of whole blood within 60 days prior to randomization. - Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes. - Clinically relevant history of drug hypersensitivity to lurasidone or any components in the formulation. - Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to randomization. - Received depot neuroleptics unless the last injection was at least 1 month or 1 treatment cycle prior to screening, whichever is longer. - Received treatment with antidepressants, atomoxetine or alpha 2 agonists (eg, guanfacine) within 3 days prior to randomization, fluoxetine hydrochloride within 21 days of randomization, monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine within 120 days of randomization. - Use of all psychotropic medications prior to randomization with the exception of those medications explicitly permitted within 3 days prior to randomization (7 days prior to randomization for aripiprazole). - Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma. - At screening or Baseline the subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS or has a score of 7 on item 13, Suicidal Ideation, on the CDRS-R. - Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property during the study. Subject has a history of one or more serious suicide attempts (based on the investigator's judgment) in the 3 months prior to screening. Subjects determined to be at risk of suicide or injury, as assessed by the investigator at screening, will be referred for further psychiatric evaluation. - Adhering to a special diet for the 28 days prior to drug administration (eg, liquid, protein, raw food diet). - Subject is planning to move during the study, is chronically homeless, or is unable to attend all planned study visits. The Medical Monitor will be consulted for individual cases, as needed. - Subject with newly diagnosed Type 2 diabetes during screening or subject is on injectable medication for the treatment of Type 2 diabetes. A subject with Type 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as: - Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126 mg/dL. - HbA1c ≤ 6.5%; and - If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated. - Subject has required hospitalization for diabetes or related complications in the past 12 months. - The use of concomitant medications that are potent inducers or inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system during the trial (from signing informed consent until follow-up). - Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 4 minutes of standing up). | |
| 82 | NCT02046564 | completed | 0.6342792510986328 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['asc-01', 'placebo'] | ['CN[C@H]1CC[C@@H](C2=CC(Cl)=C(Cl)C=C2)C2=CC=CC=C12', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients who are either inpatients or outpatients. - Patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial. - Patients who have been given a diagnosis of "Major Depressive Disorder, Single Episode" or "Major Depressive Disorder, Recurrent" according to the DSM-5 and who have a current episode of major depression that has been continuing for at least 8 weeks - Patients with a HAM-D 17 total score of 18 or more at the Screening Period evaluation Exclusion Criteria: - Female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial - Pregnant or breast-feeding female patients, or female patients who may be pregnant - Patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history - Patients who have had electroconvulsive therapy - Patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent - Patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms) - Patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic - fasting blood glucose level ≥ 126 mg/dL - 2-hour glucose level in 75-g oral glucose tolerance test (OGTT) ≥ 200 mg/dL - non-fasting blood glucose level ≥ 200 mg/dL - HbA1c [NGSP level] ≥ 6.5% - Patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent) - Patients who have a history of neuroleptic malignant syndrome or serotonin syndrome - Patients who have a history of seizure disorder (eg, epilepsy) | |
| 83 | NCT02046603 | completed | 0.8740190863609314 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['tocilizumab', 'dmards', 'oral corticosteroids', 'methotrexate'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O'] | Inclusion Criteria: - Active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria - Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines - Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to [≥] 4 weeks prior to baseline - Permitted non-biologic DMARDs are allowed if on stable dose for at least 4 weeks prior to baseline - Receiving treatment on an outpatient basis, not including tocilizumab - Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol during the study and for at least 3 months following the last dose of tocilizumab Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline - Rheumatic autoimmune disease other than RA - Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis - Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 - Prior history of or current inflammatory joint disease other than RA - Exposure to tocilizumab either intravenous or SC at any time prior to baseline - Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening - Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline - History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies - Known active current or history of recurrent infections - Major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening - Active tuberculosis (TB) requiring treatment within the previous 3 years - Positive for hepatitis B or hepatitis C virus infection - Primary or secondary immunodeficiency (history of or currently active) - Pregnant or lactating women - Inadequate hematologic, renal or liver function | |
| 84 | NCT02048813 | active, not recruiting | 0.4792689383029938 | phase 3 | ['anemia', 'chronic lymphocytic leukemia', 'small lymphocytic lymphoma'] | ["['D53.2', 'D64.9', 'D46.4', 'D53.0', 'D53.9', 'D61.3', 'D61.9']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide', 'fludarabine phosphate', 'ibrutinib'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O', 'NC1=NC=NC2=C1C(=NN2[C@@H]1CCCN(C1)C(=O)C=C)C1=CC=C(OC2=CC=CC=C2)C=C1'] | Inclusion Criteria: - Diagnosis of CLL according to the National Cancer Institute (NCI)/Internal Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria; this includes previous documentation of: - Biopsy-proven small lymphocytic lymphoma or - Diagnosis of CLL according to the NCI/IWCLL criteria as evidenced by all of the following: - Peripheral blood lymphocyte count of greater than 5 x 10^9/L - Immunophenotype consistent with CLL defined as: - The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc) - Clonality as evidenced by kappa or lambda light chain restriction (typically dim immunoglobulin expression) - Negative FISH analysis for t(11;14)(immunoglobulin heavy locus [IgH]/cyclin D1 [CCND1]) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D1 staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy) - No prior chemotherapy, Bruton's tyrosine kinase (BTK) inhibitor therapy, or monoclonal anti-body therapy for treatment of CLL or SLL - Has met at least one of the following indications for treatment: - Evidence of progressive marrow failure as manifested by the development of worsening anemia (hemoglobin [Hg] < 11 g/dl) and/or thrombocytopenia (platelets < 100 x 10^9/L) - Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly - One or more of the following disease-related symptoms: - Weight loss >= 10% within the previous 6 months - Grade 2 or 3 fatigue attributed to CLL - Fevers > 100.5 Fahrenheit (F) for 2 weeks without evidence of infection - Clinically significant night sweats without evidence of infection - Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a two-month period or an anticipated doubling time of less than six months - ECOG performance status between 0-2 - Life expectancy of >= 12 months - Ability to tolerate FCR based therapy - No deletion of 17p13 on cytogenetic analysis by FISH - Glomerular filtration rate (GFR) > 40 mL/minute as calculated by the Cockcroft-Gault formula - Total bilirubin =< 2.5 x upper limit of normal (ULN) unless due to Gilbert's disease; for those with a total bilirubin > 2.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed; if value is higher due to hepatic involvement by CLL, patient is eligible - Serum glutamic oxaloacetic transaminase (SGOT) aspartate transaminase (AST)/serum glutamate-pyruvate transaminase (SGPT) alanine transaminase (ALT) =< 3.0 x the institutional ULN; if value is higher due to hepatic involvement by CLL, patient is eligible - Prothrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligible - No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation - No current use of corticosteroids; EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted - No previous use of corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL; prior use of corticosteroids for reasons other than treatment of autoimmune complications is allowed - No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer) - Able to adhere to the study visit schedule and other protocol requirements - No major surgery within the last 4 weeks (28 days) of first dose of study drug or minor surgery within 3 days of first dose of study drug - No radiation therapy =< 4 weeks prior to registration - Patients with human immunodeficiency virus (HIV) infection may be eligible provided they meet the following criteria: - CD4-positive cell count >= lower limit of institutional normal - HIV viral load < 10,000 copies HIV ribonucleic acid (RNA)/mL (if not on anti-HIV therapy) OR < 50 copies HIV RNA/mL (if on anti-HIV therapy) - No evidence of hepatitis B or C infection - No evidence of resistant strains of HIV - No history of acquired immune deficiency syndrome (AIDS)-defining condition - Patients must not have any of the following conditions: - Congestive heart failure or New York Heart Association Functional Classification III or IV congestive heart failure - History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration - Recent infections requiring systemic treatment; need to have completed anti-biotic therapy > 14 days before the first dose of study drug - Cerebral vascular accident or intracranial bleed within the last 6 months - Infection with known chronic, active hepatitis C - Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment (PCR positive patients will be excluded) - Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) family 3, subfamily A (3A) inhibitor - Patients may not be on any other investigational agents - Patients may not have received warfarin or another vitamin K antagonist in the preceding 30 days - Women must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to registration to rule out pregnancy; female patients who are of non-reproductive potential are those who are post-menopausal by history (i.e. no menses for >= 1 year); OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for 90 days after the last dose of study drug - Patient must be able to swallow capsules and not have the following conditions: - Disease significantly affecting gastrointestinal function - Resection of the stomach or small bowel - Symptomatic inflammatory bowel disease - Ulcerative colitis - Partial or complete bowel obstruction - Patient must not be on any other systemic immunosuppressant therapy other than corticosteroids within 28 days of the first dose of study drug - Patient must not be vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug - Patient must not have any known bleeding disorders (e.g., von Willebrand's disease) or hemophilia - Patient must not have currently active, clinically significant hepatic impairment (>= moderate hepatic impairment according to the NCI/Child Pugh) | |
| 85 | NCT02051608 | active, not recruiting | 0.39542487263679504 | phase 3 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['gantenerumab', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not receiving AD approved medication - Cerebral spinal fluid (CSF) result consistent with the presence of amyloid pathology - Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities - Fluency in the language of the tests used at the study site - Willingness and ability to complete all aspects of the study - Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted) - If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening - Agreement not to participate in other research studies for the duration of this trial and its associated substudies PART 2 - All participants who have been randomized and are actively participating in the study are eligible for Part 2 Exclusion Criteria: - Dementia or neurocognitive disorder (NCD) due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia - History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function - History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months - History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits - History of schizophrenia, schizoaffective disorder, or bipolar disorder - Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed) - History or presence of atrial fibrillation - Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher) - Uncontrolled hypertension - Chronic kidney disease - Impaired hepatic function PET imaging substudy, in addition to above: - Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits Part 2 Participants who have been discontinued from the study | |
| 86 | NCT02054156 | completed | 0.7536871433258057 | phase 3 | ['cystic fibrosis'] | ["['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']"] | ['azithromycin', 'placebo', 'tobramycin solution for inhalation'] | ['[H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=CC=C1)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O'] | Inclusion Criteria: - Age ≥ 6 months to ≤ 18 years - Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype or positive CF Newborn Screening result for immunoreactive trypsinogen (IRT) IRT/DNA or IRT/IRT and one or more of the following criteria: - sweat chloride ≥ 60 milliequivalent (mEq)/liter by quantitative by pilocarpine iontophoresis test (QPIT) - two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene - Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproteronol of less than - 5 mV) - Documented new positive oropharyngeal, sputum or lower respiratory tract culture for Pa within 30 days of the Baseline Visit (Visit 1), defined as: a) first lifetime documented Pa positive culture; or b) Pa recovered after at least a two-year history of Pa negative respiratory cultures (≥ 1 culture/ year) - Clinically stable with no evidence of any significant respiratory symptoms at the Baseline Visit that would require administration of intravenous anti- pseudomonal antibiotics, oxygen supplementation, and/or hospitalization as determined by the study physician - Written informed consent obtained from participant or participant's legal representative (and assent when applicable) and ability for participant to comply with the requirements of the study Exclusion Criteria: - Macrolide antibiotic use within 30 days of the Baseline Visit - Initiation of current course of treatment with TIS >14 days prior to Baseline Visit - Weight <6.0 kg at the Baseline Visit - History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside - History of azithromycin hypersensitivity or adverse reaction to azithromycin or allergy to macrolide antibiotics - History of positive respiratory culture for Non-tuberculous mycobacteria (NTM) or Burkholderia cepacia complex within 2 years of the Baseline Visit - History of unresolved, abnormal renal function (defined as serum creatinine greater than 1.5 times the upper limit of normal for age). - History of unresolved, abnormal liver function tests (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 4 times the upper limit of normal range) or history of portal hypertension - History of unresolved, abnormal neutropenia (ANC ≤ 1000) - Abnormal ECG test at the Baseline Visit defined as a QT interval corrected (QTc) (B) of ≥460 msec or history of ventricular arrhythmia - History of abnormal hearing sensitivity defined as hearing threshold levels >25 dB HL (decibels Hearing Level) for visual reinforcement audiometry (VRA) at any frequency (500-4000Hz) or >20 Decibels Hearing Level (dBHL) for play or standard audiometry at any two frequencies (500-8000Hz) in either ear, not associated with middle ear disease (including infection) or a flat (Type B) tympanogram - New initiation of chronic therapy (greater than 21 days) with drugs known to prolong QT interval (refer to Appendix III) within 30 days prior to the Baseline Visit or coadministration of nelfinavir or oral anticoagulants - Positive serum or urine pregnancy test at the Baseline Visit (to be performed on all females of child-bearing potential) or for females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception during participation in the study - Administration of any investigational drug within 30 days prior to the Baseline Visit - Presence of a condition or abnormality (e.g., pre-existing heart disease) that in the opinion of the site investigator would compromise the safety of the participant or the quality of the data | |
| 87 | NCT02054702 | completed | 0.7304414510726929 | phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['brexpiprazole', 'aripiprazole'] | ['O=C1NC2=CC(OCCCCN3CCN(CC3)C3=C4C=CSC4=CC=C3)=CC=C2C=C1', 'ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies - Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry - Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following: - Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80 - Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness - Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill) Exclusion Criteria: - Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator - Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit - Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation. - Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments. | |
| 88 | NCT02054897 | completed | 0.8453925848007202 | phase 3 | ['diabetes', 'diabetes mellitus, type 2'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['semaglutide', 'placebo'] | ['CC[C@H](C)[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC1=CNC=N1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association class IV | |
| 89 | NCT02058108 | terminated | study terminated on the recommendation of an independent data monitoring committee (dmc) subsequent to an interim efficacy analysis for futility.] | 0.7273520827293396 | phase 3 | ['chronic hepatitis b'] | ["['B18.0', 'B18.1', 'B18.2', 'B18.8', 'B18.9']"] | ['telbivudine', 'placebo'] | ['CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Key Inclusion Criteria: - Clinical history compatible with compensated chronic hepatitis B - Documented compensated chronic hepatitis B defined by the following: 1. Positive serum HBsAg at screening and at least one other documentation of HBsAg positive at least 6 months prior to screening 2. For HBeAg positive patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 5 log10 copies/mL (or 20 000 IU/mL) (COBAS Taqman®) at screening ; serum ALT ≥ 1.5×ULN and < 10×ULN (pediatric ULN) for two times during the screening period or within 6 months prior to screening 3. For HBeAg negative patients at screening, significant biologic and/or histologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (serum HBV DNA level ≥ 4 log10 copies/mL (or 2 000 IU/mL) (COBAS Taqman®) at screening) ; serum ALT ≥ 1.0 ×ULN and < 10×ULN (pediatric ULN) for two times during the screening period or within 12 months prior to screening) Key Exclusion Criteria: - Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of HAV, HEV, CMV, EBV, or HSV. - Patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-CHB treatment (approved or investigational) at any time before screening - Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy - Patient has one or more additional known primary or secondary causes of liver disease, other than CHB; has a decompensated liver disease ; is a Liver transplant recipient or organ or bone marrow transplant recipient. - History of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study. - Patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum CK levels (≥7×ULN), any muscular disease - Patient receiving any drugs potentially associated with myopathy within 3 months prior to screening - Any other clinical significant disease, condition or abnormality, unrelated to their HBV infection at screening, as assessed by the investigator |
| 90 | NCT02058147 | completed | 0.858642578125 | phase 3 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin glargine/lixisenatide fixed ratio combination', 'insulin glargine (hoe901)', 'lixisenatide (ave0010)', 'metformin'] | ['[V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O', '[Na+].[Na+].[O-]P([O-])(F)=O', '[V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O', 'CSCC[C@H](N)C(O)=O'] | Inclusion criteria: - Participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (DPP-4) inhibitors, and who were not adequately controlled with this treatment. - Signed written informed consent. Exclusion criteria: - HbA1c at screening visit: - less than 7.5% or more than 10% for participants previously treated with metformin alone, - less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment. - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. - Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening. - Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician). - History of discontinuation of a previous treatment with a glucagon-like peptide (GLP-1) receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. - Participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide. - Any contraindication to metformin use, according to local labeling. - Use of weight loss drugs within 3 months prior to screening visit. - Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. - History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g, multiple endocrine neoplasia syndromes). - Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit. - At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2. - At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range. - At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN. - At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). Exclusion Criteria for randomization at the end of the screening period: - HbA1c less than 7% or above 10%; - Fasting Plasma glucose above 250 mg/dL (13.9 mmol/L); - Metformin maximal tolerated dose less than 1500 mg/day; - Amylase and/or lipase more than 3 ULN. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. | |
| 91 | NCT02058160 | completed | 0.8595892786979675 | phase 3 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin glargine/lixisenatide (hoe901/ave0010)', 'insulin glargine (hoe901)', 'metformin (background drug)'] | ['[V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O', '[Na+].[Na+].[O-]P([O-])(F)=O', 'CN(C)C(=N)NC(N)=N'] | Inclusion criteria : - Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. - Treatment with basal insulin for at least 6 months before the screening visit. - Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. - Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit. - For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of: - metformin (more than or equal to 1500 mg/day or maximal tolerated dose), - a sulfonylurea, - a glinide, - a dipeptidyl-peptidase-4 inhibitor, - a sodium glucose co-transporter 2 inhibitor, - Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit. - Signed written informed consent. Exclusion criteria: - Age under legal age of adulthood at screening visit. - HbA1c at screening visit less than 7.5% or above 10%. - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. - Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. - Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed. - History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy. - Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide. - Use of weight loss drugs within 3 months prior to screening visit. - Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. - History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). - Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit. - At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2. - At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range. - At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN. - At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). - Any contraindication to metformin use, according to local labeling, if the participant was taking metformin. - Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin. Exclusion criteria for randomization: - HbA1c less than 7% or above 10% . - Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L). - Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit). - Amylase and/or lipase more than 3 ULN . The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. | |
| 92 | NCT02058368 | completed | 0.8271979093551636 | phase 3 | ['prostatic hyperplasia'] | ["['N40.0', 'N40.1']"] | ['dutasteride 0.5mg capsules', 'dutasteride placebo capsules', 'tamsulosin 0.2mg tablets', 'disintegrating placebo tamsulosin tablet'] | ['[H][C@@]1(CC[C@@]2([H])[C@]3([H])CC[C@@]4([H])NC(=O)C=C[C@]4(C)[C@@]3([H])CC[C@]12C)C(=O)NC1=CC(=CC=C1C(F)(F)F)C(F)(F)F', '[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C', 'CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC(=C(OC)C=C1)S(N)(=O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Males, aged >=50 years - Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) - International Prostate Symptom Score (IPSS) >=12 points at Screening - Prostate volume >=30cc (by TRUS) - Total serum Prostate Specific Antigen (PSA) >=1.5ng/mL and <= 10 ng/mL at Screening - Maximum urinary flow rate (Qmax) >5mL/sec and 15mL/sec and minimum voided volume of >=125 milliliter (mL) at Screening - Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) - Fluent and literate in local language with the ability to comprehend and record information on the IPSS, BPH-related Health Status (BHS), BPH Impact Index (BII), and Problem Assessment Scale Sexual Function Inventory (PAS- SFI) questionnaires - Men with a female partner of childbearing potential must agree to use a condom up to 6 months after the last dose (applies only to countries where the local product monograph for dutasteride mandates condom use for men with a female partner of childbearing potential) Exclusion Criteria: - History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious Digital Rectal Examination [DRE]). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy. - Previous prostatic surgery (including TURP, laser, transrectal high intensity focused ultrasounds(HIFU), thermotherapy, transurethral needle ablation (TUNA), balloon dilatation, and stent replacement) or other invasive procedures to treat BPH. - History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Catheterisation (<10F) is acceptable with no time restriction. - History of AUR within 3 months prior to Screening Visit. - Post-void residual volume >250mL (suprapubic ultrasound) at Screening. - Any conditions other than BPH, which may in the judgment of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). - Unstable liver disease (chronic stable hepatitis B and C are acceptable if subject meets entry criteria). - History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at Screening. - Any unstable, serious co-existing medical condition(s) including, but not limited to: 1. Myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. 2. Postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. 3. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to study procedures in the opinion of the investigator or GSK medical monitor. Investigator may consult with GSK Medical Monitor if condition could interfere with subject's safety 4. History of breast cancer or clinical breast examination finding suggestive of malignancy. 5. History of malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a priori malignancy who have had no evidence of disease for at least the past 5 years are eligible. - Current or Previous Use of the following medications: 1. Use of any 5-alpha-reductase inhibitor (e.g. finasteride), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), or other drugs noted for gynaecomastia effects, or that could affect prostate volume, within the 6 months preceding the historical TRUS or Screening Visit and throughout the study (other than as study medication). Previous use of dutasteride should not be within 6 months of the baseline or historical TRUS. 2. Anabolic steroids (subject must discontinue for 6 months prior to study entry to be eligible) and agree not to take them for the duration of the study. 3. Phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study. 4. Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening Visit (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin, silodosin) and/or predicted to need any alpha blockers other than the study prescribed tamsulosin. 5. Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephedrine, ephedrine) or anticholinergics (e.g. oxybutynin,tolterodine, darifenacin, solifenacin,propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments. - Hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs. - Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives of drug, whichever is the longer) preceding the Screening Visit and/or plans to participate in such a trial during the course of this study. | |
| 93 | NCT02058589 | completed | 0.7943830490112305 | phase 3 | ['herpes zoster'] | ["['B02.39']"] | ['placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female, aged 18 years or older and having reached the age of legal consent, on the date the informed consent is signed. - Written informed consent obtained from the subject. - Subject who has received an ABO compatible allogeneic renal transplant. - Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to the first vaccination. - Subject without an episode of allograft rejection over the previous three months (90 days) prior to the first vaccination. - Subject with stable renal function, stability defined as: - less than 20% variability between last two creatinine measurements or calculated GFR - or in the opinion of the investigator after investigator review of more than the last two creatinine measurements or calculated GFRs. - Subject not less than 4 months (120 days) and not more than 18 months (547 days) after allograft transplantation at the time of the first vaccination. - Subjects with multiple dialysis options (peritoneal and/or more than one anatomical access site for haemodialysis) in the event acute or chronic dialysis is needed. - Female subjects of non-childbearing potential may be enrolled in the study. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of the first vaccination, and - has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: - Any primary kidney disease with a high incidence of recurrent primary kidney disease. - Evidence of recurrent primary kidney disease within the current allograft. - Previous allograft loss secondary to recurrent primary kidney disease. - Multiple kidney transplants are allowed if the reason for a previous allograft's loss is not recurrent primary kidney disease. - More than one organ transplanted (i.e. kidney-liver, double kidney or kidney-other organ(s) transplanted). - History of events that, in the opinion of the investigator, may put subject at increased risk for chronic allograft dysfunction (e.g. delayed graft function, peri-operative complications). - Histologic reports of chronic allograft injury (e.g. transplant glomerulopathy, arteriopathy, C4d deposition). - Evidence of significant proteinuria in the opinion of the investigator. - Panel reactive antibody score (PRA or cPRA) that is unknown at the time of transplant. - Any autoimmune or potential immune-mediated disease including primary kidney disease. - Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine/placebo. - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. - Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered product - Administration or planned administration of a live vaccine within 30 days prior to the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. - Planned administration during the study of a varicella or HZ vaccine other than the study vaccine. - Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. - Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo. - Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit. - Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies. - Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment. - Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe. - Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. - Acute disease and/or fever at the time of vaccination. - Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3. | |
| 94 | NCT02059187 | completed | 0.8832576870918274 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['mk-1293', 'lantus™', 'prandial insulin'] | ['[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD) - hemoglobin A1C of ≤11.0% and requires insulin for glycemic control - Body mass index (BMI) <45 kg/m^2 Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis, or has type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L) - One or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months - History of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients based on the label of the country of the investigational site - On a weight loss program within the last 8 weeks - Received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior 8 weeks - Bariatric surgery within 12 months prior to signing the informed consent - Likely to require treatment for ≥2 consecutive weeks or repeated courses of corticosteroids - Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study - New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months - Presence of any of the following during the last 3 months: acute coronary syndrome, coronary artery intervention, and/or stroke or transient ischemic neurological disorder - Severe peripheral vascular disease - Systolic blood pressure ≥ 160 mm Hg or a diastolic ≥95 mm Hg and blood pressure is not considered likely to be under these limits with an adjustment in antihypertensive medication - Chronic myopathy or a progressive neurological or neuromuscular disorder - Active nephropathy - History of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Human immunodeficiency virus (HIV) - Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - History of melanoma, leukemia, lymphoma, or renal cell carcinoma - Hyperthyroidism - On a stable dose of thyroid hormone replacement therapy for <6 weeks - Uses recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence - Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug - Donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the study - Poor mental function or any other reason to expect that the participant may have difficulty in complying with the requirements of the study - Clinically significant ECG abnormality which exposes the participant to risk by enrolling in the study - Positive urine pregnancy test - Participant is a night shift worker which causes difficulty complying with the overnight fast requirement and has potential for confounding the 7-point SMBG analysis - Participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L] - Has used a formulation of glargine insulin other than Lantus™ | |
| 95 | NCT02059642 | completed | 0.9838618636131287 | phase 2/phase 3 | ['adhd', 'attention-deficit/hyperactivity disorder, predominantly inattentive type'] | ["['F90.0']"] | ['mg01ci (1400 mg)', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening Visit. - Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5. - Subject has ADHD with at least moderate clinical severity (Clinical Global Impression-Severity [CGI-S]) score of 4 or greater). - Subject has a score on the total ADHD symptom score with adult prompts of the CAARS-Inv of at least 22. - Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study - Subject is able to attend the clinic regularly and reliably. - Subject is able to swallow tablets and capsules. - Subject is able to understand, read, write, and speak English fluently to complete the study-related materials (or Hebrew for Israeli subjects). - Subject is able to understand and sign an informed consent form to participate in the study. Exclusion Criteria: - Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1 adequate trial of atomoxetine treatment (in the investigator's judgment). - Subject has any psychiatric condition clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator . - Subject has a known or suspected human immune deficiency virus-positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis. - Subject has a history of an allergy or sensitivity to B-complex vitamins. - Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder. - Subject has a current Axis I diagnosis (other than ADHD) according to the Structured Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of bipolar disorder or psychosis. - Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Screening Visit. - Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day or folic acid supplements during the 2 weeks before the Screening Visit. - Subject has used an investigational medication/treatment in the 30 days before the Screening Visit - Subject has used any medication or food supplement that the investigator or the medical monitor considers unacceptable during the 14-day period before randomization. - Subject has a current drug or alcohol dependence or substance abuse disorder according to DSM-IV. Subject should also agree to keep their caffeine intake consistent and refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce servings of coffee) during the study. - Subject has suicidality, defined as active ideation, an intent or plan, or any significant lifetime suicidal behavior. Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded. - Subject has taken any prescription or non-prescription ADHD medications during the 14 days (for all psychotropic medications other than fluoxetine) or 28 days (for fluoxetine) before the randomization visit. - Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses - Subject is related to the sponsor, investigator, or study staff. - Subject has any condition that, in the principal investigator's opinion, would place the subject at risk or influence the conduct of the study or interpretation of results, - Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason. - Subject is pregnant, lactating, or using an inadequate contraceptive method. - If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. | |
| 96 | NCT02063854 | completed | 0.7955322861671448 | phase 2/phase 3 | ['involutional osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['ne-58095 ir', 'ne-58095 ir placebo', 'ne-58095 dr', 'ne-58095 dr placebo'] | ['OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O', 'OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O', 'OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O', 'OC(CC1=CN=CC=C1)(P(O)(O)=O)P(O)(O)=O'] | Inclusion Criteria: 1. Patients with a diagnosis of involutional osteoporosis 2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent 3. Women for whom at least 2 years have passed since the last natural menstruation Exclusion Criteria: 1. Patients with secondary osteoporosis 2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass 3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA) 4. Patients with a history of radiotherapy to the lumbar spine or the pelvis 5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period 6. Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period 7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period 8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period 9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding 10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus) 11. Patients with hypocalcemia 12. Patients with hypercalcemia 13. Patients with a diagnosis of renal calculus 14. Patients with serious renal, hepatic, or cardiac disease 15. Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period. | |
| 97 | NCT02064439 | completed | 0.805010974407196 | phase 3 | ['pulmonary embolism', 'thromboembolism', 'thrombosis', 'venous thrombosis', 'venous thromboembolism'] | ["['I27.82', 'Z86.711', 'I26.01', 'I26.09', 'I26.90', 'I26.99', 'I26.93']", "['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']", "['I81', 'K64.5', 'I51.3', 'I67.6', 'I74.11', 'I74.5', 'I74.8']", "['K64.5', 'I67.6', 'O87.3', 'O22.50', 'O22.51', 'O22.52', 'O22.53']", "['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['bay 59-7939', 'bay 59-7939', 'asa'] | ['ClC1=CC=C(S1)C(=O)NC[C@H]1CN(C(=O)O1)C1=CC=C(C=C1)N1CCOCC1=O', 'ClC1=CC=C(S1)C(=O)NC[C@H]1CN(C(=O)O1)C1=CC=C(C=C1)N1CCOCC1=O', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week Exclusion Criteria: - Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min | |
| 98 | NCT02065791 | completed | 0.8201426267623901 | phase 3 | ['diabetes mellitus, type 2', 'diabetic nephropathy'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']", "['E10.21', 'E11.21', 'E13.21', 'E08.21', 'E09.21']"] | ['canagliflozin', 'placebo'] | ['[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than (<) 90 mL/min/1.73 m^2 - Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization - Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g Exclusion Criteria: - History of diabetic ketoacidosis or type 1 diabetes mellitus - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Renal disease that required treatment with immunosuppressive therapy - Known significant liver disease - Current or history of New York Heart Association (NYHA) Class IV heart failure - Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening | |
| 99 | NCT02066129 | completed | 0.8102834224700928 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['fluticasone 44 mcg', 'fluticasone 220 mcg'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', '[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Physician-diagnosed asthma - At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in the past 12 months - Able to perform reproducible spirometry - Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS + long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1 second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist (SABA) use > 2 days per week or night-time awakenings due to asthma > 2 nights per month] - Prebronchodilator FEV1 ≥ 60% predicted - Ability and willingness to provide informed assent - For females of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method. - History of clinical varicella or varicella vaccine Exclusion Criteria: - Systemic (oral or injectable) corticosteroids within previous 2-week period - Current or recent (previous 2-weeks) use of medications known to significantly interact with corticosteroid disposition, including but not limited to carbamazepine, erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole - Presence of chronic or active lung disease other than asthma - Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study - A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids - History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure - More than 5 prednisone treated exacerbations in the past 12 months - More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months - History of adverse reactions to ICS preparations or any of their ingredients - Receiving hyposensitization therapy other than an established maintenance regimen (On maintenance regimen for ≥ 3 months) - History of premature birth before 35 weeks gestation | |
| 100 | NCT02066181 | active, not recruiting | 0.5954812169075012 | phase 3 | ['desmoid-type fibromatosis'] | ["['M72.4', 'M72.2', 'M72.0']"] | ['sorafenib tosylate'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Patients must have confirmation of DT/DF by local pathologist prior to registration - Patients may have been treated with locoregional therapies such as major surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2 - Patients may have been treated with cytotoxic, biologic (antibody), immune or experimental therapy, tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration (6 weeks for mitomycin and nitrosoureas) and recovered from any therapy related toxicity to less than CTCAE grade 2 - Patients with prior or current treatment of sorafenib are excluded - No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with sorafenib: - Boceprevir - Indinavir - Nelfinavir - Lopinavir/ritonavir - Saquinavir - Telaprevir - Ritonavir - Clarithromycin - Conivaptan - Itraconazole - Ketoconazole - Mibefradil - Nefazodone - Posaconazole - Voriconazole - Telithromycin - Drugs with possible or conditional risk of torsades should be used with caution knowing that sorafenib could prolong the QT interval - Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >= 3 days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis) - Patients must have measurable disease - Patients have to meet one of the following criteria to be eligible: - Disease determined unresectable or entailing unacceptably morbid surgery based on 1 or more of the following characteristics: - Multifocal disease - Disease in which there is involvement or inadequate plane from: neurovascular bundle, bone, skin, or viscera - Large size in relationship to location OR multi-compartment involvement - Progression by radiographic imaging (10% increase in size by RECIST v1.1 within 6 months of registration) - Patients with symptomatic disease which meets the following criteria Brief Pain Inventory (BPI) score greater than or equal to 3 AND one of the following: - Inability to control pain with NSAIDs and considering addition of narcotics OR - > 30% increase in current use of narcotics OR - Addition of a new opioid narcotic - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Patients who are pregnant or nursing are not eligible - No patients with a history of cardiac disease: congestive heart failure > class II New York Heart Association (NYHA); active coronary artery disease (CAD) (myocardial infarction or unstable angina within 6 months prior to study entry) - No patients with inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy - No patients with clinically significant gastrointestinal (GI) bleeding or bleeding diathesis within 30 days prior to registration - Absolute neutrophil count >= 1,500/mm^3 - Hemoglobin >= 8 g/dl - Platelets >= 75,000/mm^3 - Total bilirubin =< 1.5 x upper limits of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamate pyruvate transaminase (SGPT) (aspartate aminotransferase [ALT]) =< 1.5 x ULN - Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation |