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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01833897 | completed | 1 | phase 4 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['standard of care', 'ketamine', 'd-cycloserine'] | ['CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O', '[H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3', 'N[C@@H]1CONC1=O'] | Inclusion Criteria: - Male and female patients with Diagnostic and Statistical Manual, Version 4 (DSM-IV) diagnosis of bipolar disorder I or II, current major depressive episode without psychotic features, 18-60 - Insufficient therapeutic response during the current episode - Medically stable for study participation - Judged clinically not to be at significant suicide or violence risk - Subject is off all psychotropic and other types of drugs likely to interact with glutamate for at least 14 days before starting the study. One exception is chloral hydrate or short acting benzodiazepines for distressing anxiety or insomnia (up to 72 hours prior to each MRI scan). In addition, subjects will be off antipsychotics for 1 month and off fluoxetine for 6 weeks prior to the study. - Subject is likely to be able to tolerate a medication washout. Only subjects who have failed their current medication regiment will be washed off medications. Exclusion Criteria: - History of chronic psychosis or drug induced psychosis of any kind - Current DSM-IV diagnosis of drug abuse/dependence in the last six months. Subjects must have a negative drug screen at baseline. - Women will be excluded if they are pregnant lactating, or not either surgically-sterile or using appropriate methods of birth control. Women must agree to continue using applicable birth control throughout the trial. All women of child-bearing potential must have a negative urine pregnancy test - Taking any medication contraindicated with ketamine or DCS (ethionamide, isoniazid) - History of seizures, renal insufficiency or congestive heart failure - History of clinically significant violence - History of ketamine abuse/dependence or prior clinically significant adverse reaction to ketamine - Current alcohol abuse or dependence - Untreated hypertension - Clinically abnormal liver function tests (LFTs), thyroid, renal function or anemia - Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan. - Medicinal patch, unless removed prior to the MR scan | |
| 2 | NCT01842581 | completed | 1 | phase 4 | ['hepatic encephalopathy', 'cirrhosis'] | ["['E51.2', 'G92', 'G93.40', 'G93.41', 'G93.49', 'I67.4', 'P91.819']", "['K74.3', 'K74.4', 'K74.5', 'K74.60', 'K74.69', 'P78.81', 'K70.30']"] | ['rifaximin', 'lactulose'] | ['CC[C@H](C)[C@H](N)C1=N[C@@H](CS1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@H]1CCCCNC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](CC(O)=O)NC(=O)[C@H](CC2=CNC=N2)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](NC(=O)[C@@H](CCCN)NC1=O)[C@@H](C)CC', 'OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O'] | Inclusion Criteria: - Male or non-pregnant, non-lactating females greater than or equal to (≥) 18 years old. - In remission from demonstrated overt HE (Conn score 0 or 1). - Have had one or more episodes of overt HE associated with cirrhosis within 6 months prior to screening visit (Day -7 to -1). - Participant has a close family member or other personal contact who is familiar with the participant's HE and can provide continuing oversight to the participant and is willing to perform as caregiver for the participant during the conduct of the trial. Exclusion Criteria: - Participant has been diagnosed with human immunodeficiency virus (HIV) as determined by medical history. - History of tuberculosis infection. - Participant has been diagnosed with chronic respiratory insufficiency. - Participant has been diagnosed with a current infection for which they are currently taking oral or parenteral antibiotics. - Renal insufficiency requiring routine dialysis. - Participant has an active spontaneous bacterial peritonitis(SBP) infection. - Intestinal obstruction or inflammatory bowel disease. - Participant has active malignancy within the last 5 years prior to screening visit, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised. - Current gastrointestinal (GI) bleeding or has a history of a GI hemorrhage of sufficient severity to require hospitalization and a transfusion of ≥2 units of blood within 3 months prior to screening visit. - Participant is anemic, as defined by a hemoglobin of less than (<) 8 grams/deciliter (g/dL). - Scheduled to receive a liver transplant within 1 month of screening. | |
| 3 | NCT01844531 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['empagliflozin', 'metformin (glucophage®)', 'metformin (glucophage®)', 'empagliflozin', 'empagliflozin and metformin', 'empagliflozin and metformin'] | ['CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N'] | Inclusion criteria: 1. Healthy male and female subjects 2. Subjects must be able to understand and comply with study requirements 3. Age 18 to 50 years 4. Body mass index (BMI) 18.5 to 29.9 kg/m2 Exclusion criteria: 1. Any relevant deviation from healthy conditions | |
| 4 | NCT01846273 | completed | 1 | phase 4 | ['age-related macular degeneration', 'polypoidal choroidal vasculopathy'] | ["['H35.3130', 'H35.3230', 'H35.3110', 'H35.3120', 'H35.3131', 'H35.3132', 'H35.3190']", "['M31.9', 'T86.290']"] | ['ranibizumab', 'verteporfin pdt', 'sham pdt'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O', 'COC(=O)CCC1=C2NC(\\C=C3/N=C(/C=C4\\N\\C(=C/C5=N/C(=C\\2)/C(CCC(O)=O)=C5C)C(C=C)=C4C)C2=CC=C([C@@H](C(=O)OC)[C@@]32C)C(=O)OC)=C1C'] | Inclusion Criteria: - Confirmed diagnosis of symptomatic macular PCV in the study eye - A qualifying vision score at study entry - A qualifying lesion size in the study eye at study entry Exclusion Criteria: - Active inflammation or infection in the study eye - Uncontrolled intraocular pressure in the stuy eye - Ocular condition in the study eye which may impact vision and confound study outcomes - Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids | |
| 5 | NCT01849276 | terminated | slow accrual | 0 | phase 1 | ['adult acute megakaryoblastic leukemia (m7)', 'adult acute minimally differentiated myeloid leukemia (m0)', 'adult acute monoblastic leukemia (m5a)', 'adult acute monocytic leukemia (m5b)', 'adult acute myeloblastic leukemia with maturation (m2)', 'adult acute myeloblastic leukemia without maturation (m1)', 'adult acute myeloid leukemia with 11q23 (mll) abnormalities', 'adult acute myeloid leukemia with del(5q)', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'adult acute myelomonocytic leukemia (m4)', 'adult erythroleukemia (m6a)', 'adult pure erythroid leukemia (m6b)', 'blastic phase chronic myelogenous leukemia', 'recurrent adult acute myeloid leukemia', 'untreated adult acute myeloid leukemia'] | ["['C94.21', 'C94.22', 'C94.20']", "['C7A.1']", "['C93.01', 'C93.02', 'C93.00']", "['C93.Z1', 'C93.Z2', 'C93.91', 'C93.92', 'C93.01', 'C93.02', 'C93.Z0']", "['C92.01', 'C92.02', 'C92.00']", "['C92.01', 'C92.02', 'C92.00']", "['R19.5', 'H35.09', 'M26.50', 'M26.59', 'Q99.8', 'R06.89', 'R06.9']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C92.51', 'C92.52', 'C93.11', 'C93.12', 'C93.31', 'C93.32', 'C92.50']", "['C94.01', 'C94.02', 'C94.00']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['metformin hydrochloride', 'cytarabine'] | ['CN(C)C(=N)NC(N)=N', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Patients with relapsed/refractory disease must have morphologic proof (from bone marrow aspirate, smears or touch preps of bone marrow biopsy) of AML with >= 10% blasts within two weeks (14 days) prior to initiation of therapy - All immunophenotype and cytogenetic/molecular groups are eligible for participation except for acute promyelocytic leukemia (APL) (as proven by the presence of promyelocytic leukemia/retinoic acid receptor alpha [PML-RARα]) - Patients must demonstrate one of the following: - Relapse after first complete remission - Refractory to conventional induction chemotherapy (failure to respond to 1 or more cycles of daunorubicin and cytarabine) or to re-induction - Patients with previously untreated AML are candidates if they are unable to receive anthracyclines, and have documented AML with >= 20% blasts within one week prior to enrollment - Patients with chronic myelogenous leukemia (CML) in myeloid blast crisis are eligible if their disease has failed to respond, and/or they are intolerant, to the available tyrosine kinase inhibitors (TKIs) - Serum total and direct bilirubin =< upper limit of normal (ULN) - Serum creatinine < 1.4 mg/dl in females and < 1.5 mg/dl in males, and creatinine clearance > 60 mL/min - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])/serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< ULN - Bicarbonate within the normal range of the hospital lab (24-32 mmol/L) - Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Females of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception while on study - Childbearing potential is defined as any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has NOT undergone a hysterectomy or bilateral oophorectomy; OR - Has NOT been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months) - Patients with a history of central nervous system (CNS) leukemia are eligible if they are not symptomatic from current CNS involvement - If there is CNS involvement that is known prior to enrollment or identified subsequently, it will be treated accordingly - Patients may have received therapy for other malignancies, as long as they have completed therapy at least 6 months prior to study entry and be deemed to have a life expectancy of at least 2 years with regard to that malignancy - All patients must have given signed, informed consent prior to registration on study Exclusion Criteria: - Patients who have received chemotherapy or radiotherapy within 4 weeks prior to enrollment are NOT eligible for participation - The exception to this is patients who are refractory to conventional initial induction chemotherapy (=< 2 courses) or to first radiation (1 course); patients must have morphologic proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of AML with > 10% blasts within 2 weeks prior to initiation of study therapy; the last dose of cytotoxic therapy (NOT including hydrea, which is allowed) must have been given >= 14 days prior to initiation of study therapy - Patients with a history of diabetes mellitus (DM) treated with metformin are NOT eligible for participation - Patients who are pregnant or breast feeding are NOT eligible for participation due to the lack of knowledge regarding the effects of the drugs on the fetus and during breast feeding - Patients with any intercurrent organ damage or medical problems that would prohibit therapy are NOT eligible for participation - Patients with any active, uncontrolled infection are NOT eligible for participation - Patients who are receiving therapy for another active malignancy are NOT eligible for participation - The exception to this is squamous cell carcinoma or basal cell carcinoma of the skin |
| 6 | NCT01850446 | completed | 1 | phase 4 | ['influenza'] | ["['J11.81', 'J11.82', 'J10.01', 'J10.81', 'J10.82', 'J11.08', 'J11.2']"] | ['ergoferon', 'oseltamivir'] | ['CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1'] | Inclusion Criteria: 1. Patients aged 18 to 70 years. 2. Patients who were admitted to hospital within 48 hours from the onset of influenza signs. 3. Patients with body temperature ≥37,8°C when visiting a doctor + severity of influenza symptoms ≥4 scores (presence of at least 1 non-specific flu symptom ≥2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the severity ≥1 score). 4. Diagnosed influenza confirmed by rapid diagnostic test (OSOM Influenza A&B Test). 5. The possibility to start therapy within 48 hours after the onset of the first symptoms of influenza. 6. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial. 7. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial. Exclusion Criteria: 1. Suspected pneumonia, bacterial infection or the presence of a severe disease requiring usage of antibacterial drugs (including sulphanilamides) starting from Day 1 of the disease. 2. Severe influenza with indications for hospitalization. 3. Suspected early manifestations of diseases that have symptoms similar to influenza symptoms (other acute respiratory and infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, hematologic neoplasms and other pathology). 4. Patients requiring concurrent antiviral products forbidden by the study. 5. Medical history of primary and secondary immunodeficiencies. а) lymphoid immunodeficiencies (Т-cell and/or В-cell, immunodeficiencies with predominant antibody deficit); b) phagocytic deficits; c) complement factor deficit; d) combined immunodeficiencies including AIDS secondary to HIV infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; total lymphocytopenic syndrome; polyclonal lymphocyte activation syndrome; postsplenectomic syndrome; congenital asplenia; abnormal immune complex syndrome associated with infectious, autoimmune and allergic diseases. 6. Medical history of sarcoidosis 7. An oncological disease/suspected oncological disease. 8. Exacerbated or decompensated chronic diseases affecting a patient's ability to participate in the clinical trial. 9. Medical history of polyvalent allergy. 10. Allergy/intolerance to any of the components of the product used for influenza therapy. 11. Impaired glucose tolerance, type 1 and type 2 diabetes mellitus. 12. Malabsorption syndrome, including congenital or acquired lactose deficiency or another disaccharide deficiency. 13. Pregnancy, breast-feeding. 14. Consumption of narcotics, alcohol > 2 alcohol units per day, mental diseases. 15. Use of any medicine listed in the section "Prohibited concomitant treatment" within 30 days preceding the inclusion in this study. 16. Patients who, from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the regimen of the study drugs. 17. Participation in other clinical studies within 1 month prior to enrollment in the current trial. 18. Patients related to the research staff of the clinical trial site who are directly involved in the trial or are the immediate family member of the researcher. The immediate family members include husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted. 19. Patients employed with OOO "NPF "MATERIA MEDICA HOLDING" (i.e., the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family). | |
| 7 | NCT01852383 | completed | 1 | phase 4 | ['depression', 'dysthymic disorder'] | ["['F53.0', 'P91.4', 'Z13.31', 'Z13.32']", "['F34.1']"] | ['duloxetine'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Diagnosis of dysthymic disorder (SCID and DSM-IV) - Age 60 - 95 - Mini-Mental State Score ≥ 24 - 24-item Hamilton Rating Scale for Depression score 12-25 - Willing and capable of giving informed consent Exclusion Criteria: - Current major depressive episode (SCID and DSM-IV) - Alcohol or substance dependence during the last year (SCID and DSM-IV) - Bipolar disorder, schizophrenia and other psychotic disorders(SCID and DSM-IV) - Clinical stroke, dementia, Huntington's disease, epilepsy or other major neurological disease - Acute unstable medical conditions - Active suicidal ideation or plan - Non-response to duloxetine (minimum 90 mg/day for 6 weeks) during the past year - A positive urine drug screen for substances of abuse or dependence - Sensitivity with intolerability to duloxetine - Use of other medications that may interact with duloxetine, including inhibitors of cytochrome P450 1A2 (CYP1A2) and cytochrome P450 2D6 (CYP2D6), e.g., quinolone antibiotics and type 1-C anti-arrhythmics. Several antidepressant medications, including most SSRIs, are inhibitors of CYP2D6 but these medications are not permitted during this antidepressant treatment trial. - Patients with hypertension (BP >140/90 mm Hg on 2 consecutive measurements). For patients with treated hypertension and BP >140/90, written approval must be obtained from patient's internist allowing them to participate in this study. - Known liver damage or disease | |
| 8 | NCT01854593 | completed | 1 | phase 4 | ['proliferative diabetic retinopathy', 'diabetic traction retinal detachment', 'vitreous hemorrhage'] | ["['H35.23', 'H35.20', 'H35.21', 'H35.22', 'E10.3553', 'E11.3553', 'E13.3553']", "['E10.3543', 'E11.3543', 'E13.3543', 'E10.3541', 'E10.3542', 'E10.3549', 'E11.3541']", "['H43.13', 'H43.10', 'H43.11', 'H43.12']"] | ['bevacizumab'] | ['[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'] | Inclusion Criteria: - Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR) - Indicated for vitrectomy Exclusion Criteria: - History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months | |
| 9 | NCT01856790 | completed | 0 | early phase 1 | ['type 1 diabetes'] | ["['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['liraglutide'] | ['CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: 1. age 18-40 years 2. clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required) 3. duration of T1D ≥ 1 year 4. HbA1c ≤ 9 % 5. Treated with CSII for at least 3 months 6. Body weight > 50 kg (to accommodate phlebotomy) 7. Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct Exclusion Criteria: 1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment) 2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct 3. Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control 4. History of hypoglycemic seizure within last 3 months 5. Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests. 6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy 7. History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility 8. Taking a medication known to affect gastric motility 9. History of pancreatitis, gallstones, alcoholism or high triglyceride levels 10. Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2) 11. Subjects unable to give consent | |
| 10 | NCT01856907 | completed | 1 | phase 4 | ['disorder of glucose regulation'] | ["['P81.9', 'P81.8']"] | ['sitagliptin-metformin', 'metformin', 'placebo pill'] | ['CN(C)C(=N)NC(N)=N', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1'] | Inclusion Criteria: - Females 18 years to 42 years of age who experienced gestational diabetes mellitus (GDM) during recent (within 12 months) pregnancy with prediabetic hyperglycemia determined by an oral glucose tolerance test (OGTT) with 75 g glucose postpartum. Study subjects will be inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum. - Written consent for participation in the study Exclusion Criteria: - Cholestasis during the past pregnancy - Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) - Serum aspartate transaminase (AST) and/or alanine aminotransferase (ALT) level exceeding more than twice normal lab values - Presence of hypersensitivity to sitagliptin or other DPP-4 inhibitor - Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or over the counter [OTC]) - Prior use of medication to treat diabetes except gestational diabetes - Use of drugs known to exacerbate glucose tolerance - History of diabetes or prior use of medications to treat diabetes except GDM - Creatinine clearance less than 60 ml/min - Pregnancy planned during the coming two years - Currently lactating - Patient not willing to use adequate contraception during study period (unless sterilized) | |
| 11 | NCT01859793 | completed | 1 | phase 4 | ['diabetes', 'atherosclerosis'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['I67.2', 'I70.90', 'I70.91', 'I70.0', 'I70.1', 'I70.8', 'I25.83']"] | ['sitagliptin', 'placebo'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F'] | Inclusion Criteria: 1. Adult age 21-70 years of age. 2. Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%. 3. On stable metformin therapy for at least 6 weeks prior to enrollment. 4. Glycosylated Hemoglobin ≥6.2% and ≤ 9.5%. Exclusion Criteria: 1. History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 50% on angiography or by confirmed history of myocardial infarction by standard criteria.) 2. Evidence of other evident major illness including chronic renal insufficiency (creatinine clearance less than 60 mL/min),chronic liver disease (AST or ALT greater than 2.5 x normal), or cancer currently undergoing systemic therapy or had systemic therapy for cancer within 1 year of enrollment. 3. Pregnancy as determined by urinary beta-HCG test 4. Illicit drug use (heroin, cocaine etc) in the past 1 year. 5. Alcohol abuse, defined as the equivalent of 14 beers/week for a man or 7 beers/week for a woman 6. History of allergy to DPP-4 inhibitors at the time of screening/enrollment 7. Prior history of pancreatitis 8. Patients currently on insulin or sulfonylurea therapy. 9. Patients currently on digoxin. - | |
| 12 | NCT01864005 | completed | 1 | phase 4 | ['non-st or st elevation acute coronary syndromes'] | ["['I21.4', 'I22.2', 'R74.01', 'I21.29', 'I21.3', 'R74.02', 'I21.11']"] | ['ticagrelor', 'clopidogrel'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - 1. Provision of informed consent prior to any study specific procedures - 2. Female or male aged at least 18 years - 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception - 4. Index event of non-ST or ST segment elevation ACS. Exclusion Criteria: - 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days) - 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped - 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation - 4. Requires dialysis - 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped | |
| 13 | NCT01864525 | completed | 1 | phase 1/phase 2 | ['essential voice tremor', 'vocal tremor', 'voice tremor', 'essential tremor of voice'] | ["['E74.11', 'G25.0', 'D47.3', 'I10', 'R31.1', 'E63.0', 'H21.263']", "['E74.11', 'G25.0', 'D47.3', 'I10', 'R31.1', 'E63.0', 'H21.263']"] | ['octanoic acid', 'inactive capsule'] | ['CCCCCCCC(O)=O'] | Inclusion Criteria: - Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment - Participants show measurable voice tremor from recordings of the voice during screening appointment Exclusion Criteria: - Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder - Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder) - Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer - Participants have a diagnosis of diabetes mellitus - Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study - Participants have a dependence on alcohol or allergy to alcohol - Participants are pregnant or lactating - Participants have an allergy to soy - Participants have Irritable Bowel Syndrome | |
| 14 | NCT01866826 | completed | 0 | phase 1/phase 2 | ['hiv'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['rifaximin'] | ['CC[C@H](C)[C@H](N)C1=N[C@@H](CS1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@H]1CCCCNC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](CC(O)=O)NC(=O)[C@H](CC2=CNC=N2)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](NC(=O)[C@@H](CCCN)NC1=O)[C@@H](C)CC'] | - PARTICIPANT INCLUSION CRITERIA: Patients who have agreed in the course of other research studies to have their records reviewed will have the following elements evaluated from their existing records: age, history of human immunodeficiency virus (HIV) infection, antiretroviral therapy (ART) history and viral loads prior to informed consent, or else these elements will be assessed after informed consent. All blood draws to assess eligibility will be completed after obtaining informed consent. To participate in this study the criteria listed below will need to be met. 1. Subjects must be 18 years of age or older. 2. Able and willing to provide written informed consent 3. Must have a history of documented HIV infection. 4. HIV infection if not previously documented at host institutions will need to be documented by a plasma human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load, rapid HIV test or any other licensed enzyme-linked immunosorbent assay (ELISA) test and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, HIV pro-viral deoxyribonucleic acid (DNA) at any time prior to study entry. 5. ART- treated subjects who are virologically suppressed for greater than or equal to 3 years (1095 days). To meet this criteria all documented viral loads in the 3 years (1095 days) prior to the screening visit must be below the lower limit of detection [LLD] using Food and Drug Administration (FDA)-approved standard assays (i.e. <50 copies/mL) with the following clarification: In each of the three prior years, subjects experiencing a single blip [i.e. viral loads above the lower limit of detection, LLD] may be included provided they satisfy the following criteria: the blips are below 200 copies/ml, and the blip is surrounded (i.e the preceding and succeeding viral loads) by undetectable HIV-1 RNA level measurements. That is all viral loads must be below LLD EXCEPT for up to one blip. In any 12 month period. 6. Viral RNA level < 50 c/ml at Screen 1. 7. A minimum of 2 HIV-1 RNA levels that are below the lower limit of detection using standard assays will be required during the 12 month period prior to their screening visit. As assay characteristics across the sites can vary, LLD for the assay will be used to define whether or not a subject is suppressed. 8. Stable dose of statin therapy for 6 months if receiving statin therapy. 9. No known allergy or contraindication to the use of rifamycin compounds such as rifampin, rifabutin or rifaximin. . 10. The effect of rifaximin on the developing human fetus are unknown, therefore subjects must be willing to use two methods of contraception (one of which must be a barrier method) during the study period. Adequate methods of birth control include: tubal ligation, hysterectomy, condoms (male or female) with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; any of the methods that require a prescription (such as contraceptive pills or patch, Norplant, Depo-Provera, and others) or a male partner who has previously undergone a vasectomy. The following elements will be assessed with a blood draw and after obtaining informed consent. 1. Absolute Neutrophil count (ANC) greater than or equal to 750/mm(3) 2. Hemoglobin greater than or equal to 10.0 g/dL for women and Hemoglobin 11.0 g/dl for men 3. Platelet count greater than or equal to 75,000/mm(3) 4. Estimated Glomerular Filtration Rate (eGFR) >60 mL/min, eGFR will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 5. Confirmed serum glutamate pyruvate transaminase (SGPT)/serum glutamate oxaloacetate transferase (SGOT) less than or equal to 3 times the upper limit of normal (ULN) 6. International Normalized Ratio (INR) less than or equal to the upper limit of normal (ULN) for the assay 7. Negative urine pregnancy test of child bearing potential at randomization 8. No evidence of active hepatitis B or hepatitis C (active hepatitis B will be defined as a positive hepatitis B surface antigen present on a single determination, whereas a positive result on hepatitis C RNA will be considered as evidence of active hepatitis C) All routine laboratory testing used to determine safety will be completed within the 70 days prior to randomization. EXCLUSION CRITERIA: 1. Known bleeding diathesis (for example a diagnosis of hemophilia or Von Willebrand disease) 2. Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patients ability to participate in the study 3. Serious illness requiring systemic treatment and/or hospitalization within 30 days of screening into the study 4. Evidence of active opportunistic infections or neoplasms (excluding cutaneous basal cell carcinoma and squamous cell carcinoma) in the 6 months prior to randomization 5. History of inflammatory bowel disease (Crohn's Disease, ulcerative colitis) 6. Positive urine pregnancy test at screening (of child bearing potential). 7. Breastfeeding 8. Current imprisonment 9. Concurrent immunomodulatory agents, including systemic corticosteroids in the 12 weeks prior to randomization. Topical, nasal or inhaled corticosteroid use is allowed 10. Concomitant use of probiotics except yogurt 11. Chronic antibiotic use such as tetracyclines for acne 12. Vaccinations within 6 weeks of randomization 13. Concomitant use of anticoagulants (other than aspirin and nonsteroidal anti-inflammatory drugs (NSAIDS)) is an exclusion criterion for subjects opting in for the colonoscopy. Aspirin and NSAIDs will be discontinued per each institutions requirement before the procedure. 14. Child-Pugh Class C disease 15. A prior history of Clostridium difficile colitis 16. Any condition that precludes the safe administration of conscious sedation for endoscopy (such as decompensated lung or heart disease) will not be able to participate in the colonoscopy aspect of the protocol. | |
| 15 | NCT01869634 | completed | 1 | phase 4 | ['human immunodeficiency virus infection'] | ["['Z21']"] | ['darunavir with ritonavir and fixed-dose viread+emtricitabine daily'] | ['CC(C)C1=NC(CN(C)C(=O)N[C@@H](CCN2CCOCC2)C(=O)N[C@H](CC[C@H](CC2=CC=CC=C2)NC(=O)OCC2=CN=CS2)CC2=CC=CC=C2)=CS1'] | Inclusion Criteria: - Willing to sign consent form - Naïve to ART (remote ART use >5 years will be considered on a case by case basis) - No known GI or cardiovascular disease - Between the ages of 18 and 60 - No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness. - All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures. - Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease - There are no CD4+ T-cell count or HIV plasma viral load restrictions. Exclusion Criteria: - Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN)) - Thrombocytopenia (platelet count <50.000 within 6 weeks) - Contra-indications to upper endoscopy or conscious sedation - Anemia (>grade 1 [appendix 1]) - Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy. - Renal insufficiency (serum Creatinine >1.2 ULN) - History of chronic proteinuria that could impact viread use. - Allergy to contrast used for CT angiography - Requirement to take medications that are contraindicated with study ART regimen. | |
| 16 | NCT01869699 | completed | 1 | phase 4 | ['fever', 'critical illness'] | ["['A78', 'A79.0', 'A93.1', 'A96.2', 'R50.82', 'R50.83', 'R50.9']", "['G62.81', 'G72.81']"] | ['acetaminophen', 'placebo'] | ['NCC(CC(O)=O)C1=CC=C(Cl)C=C1'] | Inclusion Criteria: - 18 years of age and older - Patient in an intensive care unit - Weight greater or equal to 50 kgs - Fever: core body temperature greater than or equal to 38.3 degrees Celsius - Clinically stable: no active resuscitation with fluids, blood products, or dose increases of vasoactive medications within 1 hour of study drug administration Exclusion Criteria: - Acetaminophen hypersensitivity - Acute liver failure or acute liver injury - Heat stroke, malignant hyperthermia, neuroleptic malignant syndrome - Therapeutic cooling, physical cooling, extracorporeal blood circuit therapies - Administration of acetaminophen-containing medications, non-steroidal anti-inflammatory drugs, or aspirin greater than 81 mg within specified times per drug prior to fever presentation | |
| 17 | NCT01871805 | completed | 1 | phase 1/phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['alectinib'] | ['CCC1=CC2=C(C=C1N1CCC(CC1)N1CCOCC1)C(C)(C)C1=C(C3=C(N1)C=C(C=C3)C#N)C2=O'] | Inclusion Criteria: - Histologically confirmed, locally advanced, not amenable to curative therapy, or metastatic NSCLC - ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test - NSCLC that has failed crizotinib treatment - Measurable disease as defined by RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2 - Adequate hematologic, hepatic and renal function Exclusion Criteria: - Prior therapy with ALK inhibitor other than crizotinib - Brain or leptomeningeal metastases that are symptomatic and/or requiring treatment - History of serious cardiac dysfunction - History of or current active infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) - Clinically significant gastrointestinal abnormality that would affect absorption of the drug - Pregnant or lactating women | |
| 18 | NCT01873950 | completed | 1 | phase 1 | ['drug-induced surface ecg changes'] | ["['E06.4', 'E23.1', 'E66.1', 'G25.1', 'G25.4', 'G62.0', 'G72.0']"] | ['ranolazine', 'dofetilide', 'verapamil', 'quinidine sulfate', 'placebo'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12CCN(C[C@@H]1C=C)[C@]([H])(C2)[C@@H](O)C1=C2C=C(OC)C=CC2=NC=C1', 'COC1=C(OC)C=C(CCN(C)CCCC(C#N)(C(C)C)C2=CC(OC)=C(OC)C=C2)C=C1', 'CN(CCOC1=CC=C(NS(C)(=O)=O)C=C1)CCC1=CC=C(NS(C)(=O)=O)C=C1'] | Inclusion Criteria: Subjects who meet all of the following inclusion criteria will be eligible to participate in the study: 1. Subject signs an IRB approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for sites in the United States) before any study related procedures are performed. 2. Subject is a healthy man or woman, 18 to 35 years of age, inclusive, who weighs at least 50 kg (110 pounds) and has a body mass index of 18 to 27 kg/m2, inclusive, at Screening. 3. Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee). 4. Female subjects must be at least 2 years postmenopausal, surgically sterile or practicing 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique), and not pregnant or lactating before enrollment in the study. 5. Male or female subjects must agree to practice 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from Screening until 30 days after the last dose of study drug. 6. Subject is highly likely (as determined by the investigator) to comply with the protocol defined procedures and to complete the study. Exclusion Criteria: - Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study: 1. Subject has a 12 lead safety ECG result at Screening or Check in of Period 1 with evidence of any of the following abnormalities: - QTc using Fridericia correction (QTcF) >450 milliseconds (ms) for men and >470 ms for women - PR interval >220 ms - QRS duration >110 ms - Second- or third-degree atrioventricular block - Complete left or right bundle branch block or incomplete right bundle branch block - Heart rate <40 or >90 beats per minute - Pathological Q-waves (defined as Q wave >40 ms) - Ventricular pre-excitation 2. Subject has more than 12 to 20 ectopic beats during the 3 hour Holter ECG at Screening. 3. Subject has a history of unexplained syncope, structural heart disease, long QT syndrome, heart failure, myocardial infarction, angina, unexplained cardiac arrhythmia, torsades de pointes, ventricular tachycardia, or placement of a pacemaker or implantable defibrillator. Subjects will also be excluded if there is a family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome. 4. Subject has a history or current evidence of any clinically significant (as determined by the investigator) cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, urologic, and/or other major disease or malignancy (excluding nonmelanoma skin cancer). The investigator may allow exceptions to these criteria (e.g., stable mild joint disease [that will not interfere with or influence the leg raises/exercises required by the protocol, in the opinion of the investigator], cholecystectomy, childhood asthma) following discussion with the medical monitor. 5. Subject has a history of thoracic surgery. 6. Subject has any condition possibly affecting study drug absorption (e.g., gastrectomy, Crohn's disease, irritable bowel syndrome). 7. Subject has a skin condition likely to compromise ECG electrode placement. 8. Subject is a female with breast implants. 9. Subject's laboratory test results at Screening or Check in of Period 1 are outside the reference ranges provided by the clinical laboratory and considered clinically significant (as determined and documented by the investigator or designee). 10. Subject's laboratory test results at Screening or Check in of Period 1 indicate hypokalemia, hypocalcemia, or hypomagnesemia according to lower limits of the reference ranges provided by the clinical laboratory. 11. Subject's laboratory test results at Screening or Check in of Period 1 are >2 × the upper limit of normal (ULN) for alanine aminotransferase or aspartate aminotransferase, >1.5 × ULN for bilirubin, or >1.5 × ULN for creatinine. 12. Subject has a positive test result at Screening for human immunodeficiency virus antibody, hepatitis C antibodies, or hepatitis B surface antigen. 13. Subject has a mean systolic blood pressure <90 or >140 mmHg or a mean diastolic blood pressure <50 or >90 mmHg at either Screening or Check in of Period 1. Blood pressure will be measured in triplicate after the subject has been resting in a supine position for a minimum of 5 minutes. 14. Subject has a known hypersensitivity to ranolazine, dofetilide, verapamil, or quinidine or related compounds. 15. Subject has consumed alcohol, xanthine containing products (e.g., tea, coffee, chocolate, cola), caffeine, grapefruit, or grapefruit juice within 48 hours before dosing or anticipates an inability to abstain from these products throughout the duration of the study. 16. Subject has used nicotine containing products (e.g., cigarettes, cigars, chewing tobacco, snuff) within 6 weeks before Screening (self reported). 17. Subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance of music, television, movies, games, and activities that may cause excitement, emotional tension, or arousal during the prespecified time points (e.g., before and during ECG extraction windows). 18. Subject is unwilling to comply with study rules, including the study specific diet, attempting to void at specified times (e.g., before ECG extraction windows), remaining quiet, awake, undistracted, motionless, and supine during specified times, and avoiding vigorous exercise as directed. 19. Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months before Screening, has a history of alcoholism or drug/chemical/substance abuse within 2 years before Screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor), or has a positive test result for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates) at Screening or Check in of each period. 20. Subject has used any prescription or nonprescription drugs within 14 days or 5 half lives (whichever is longer), or complementary and alternative medicines within 28 days before the first dose of study drug (excluding oral contraceptives, hormone replacement therapy, aspirin, ibuprofen, and acetaminophen). 21. Subject is currently participating in another clinical study of an investigational drug or has been treated with any investigational drug within 30 days or 5 half lives (whichever is longer) of the compound. 22. Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days before Check in of Period 1. 23. Subject has any other condition that precludes his or her participation in the study (as determined by the investigator). | |
| 19 | NCT01874535 | completed | 1 | phase 4 | ['erosive esophagitis'] | ["['B37.81', 'K20.0', 'K20.80', 'K20.81', 'K20.90', 'K20.91', 'K21.9']"] | ['esomeprazole 40 mg'] | ['COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1'] | Inclusion Criteria: - patients between the ages of 15 and 80 years - with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, - who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Exclusion Criteria: 1. coexistence of peptic ulcer or gastrointestinal malignancies, 2. pregnancy, 3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), 4. previous gastric surgery, 5. allergy to esomeprazole, 6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and 7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis. | |
| 20 | NCT01876251 | terminated | the study was terminated on june 24th, 2015 due to change in strategy of pf-03084014 development. there were no safety/efficacy concerns behind the decision. | 0 | phase 1 | ['breast cancer metastatic'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['pf-03084014', 'pf-03084014', 'pf-03084014', 'docetaxel', 'docetaxel'] | ['CCC[C@H](N[C@H]1CCC2=CC(F)=CC(F)=C2C1)C(=O)NC1=CN(C=N1)C(C)(C)CNCC(C)(C)C', 'CCC[C@H](N[C@H]1CCC2=CC(F)=CC(F)=C2C1)C(=O)NC1=CN(C=N1)C(C)(C)CNCC(C)(C)C', 'CCC[C@H](N[C@H]1CCC2=CC(F)=CC(F)=C2C1)C(=O)NC1=CN(C=N1)C(C)(C)CNCC(C)(C)C', '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', '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'] | Inclusion Criteria: - Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease. Exclusion Criteria: - Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors. |
| 21 | NCT01878708 | terminated | slow accrual | 0 | early phase 1 | ['t-cell lymphoma', 'relapsed t-cell lymphoma', 'refractory t-cell lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['peg-l-asparaginase', 'dexamethasone acetate'] | ['[H][C@@]12C[C@@H](C)[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: - Patients must meet the following criteria on screening examination to be eligible to participate in the study: - Patients must have histologically confirmed peripheral T-cell lymphoma, with the diagnostic specimen reviewed at one of the DFHCC hematopathology laboratories. Eligible histologies include: - PTCL-NOS - Systemic T cell/null anaplastic large cell lymphoma (ALCL), regardless of Alk status - Angioimmunoblastic T-cell lymphoma (AITL) - Hepatosplenic (alpha-beta or gamma-delta) lymphoma (HSL) - Enteropathy-associated T-cell lymphoma (EATL) - Adult T-cell leukemia/lymphoma (ATLL), lymphomatous subtype - Subcutaneous panniculitis-like T-cell lymphoma - T-cell Prolymphocytic Leukemia (T-PLL) - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan - Patients must have relapsed or progressed after at least 1 prior course of anti-lymphoma therapy. - Age 18-65 years. - ECOG performance status <2 (see Appendix A). - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study. - Patients with cutaneous disease only are not eligible. - Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier to grade 1 or below (unless approved by the Study Chair). - Patients may not be receiving any other study agents at the time of first treatment. - History of treatment with an asparaginase agent. - Patients with a history of alcohol abuse, or patients unwilling or unable to remain completely abstinent of alcohol during the study period. - Hepatitis B or C seropositivity (except for hepatitis B with negative surface antigen and hepatitis B viral load). - Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis or Gilbert's disease). - AST/ALT ≥ 3 x ULN. - History of pancreatitis, or amylase > ULN or lipase > ULN. - History of thromboembolic disease. - Grade 2 or above neuropathy. - Diabetes mellitus, unless it is type II diabetes adequately controlled with anti-diabetic agents (A1c < 7). - History of CNS hemorrhage or thrombosis. Patients with a history of CNS lymphomatous involvement are eligible only if their CNS disease is in remission at the time of study entry. - Uncontrolled intercurrent illness including, but not limited to uncontrolled active infection, symptomatic congestive heart failure (New York Hospital Association (NYHA) class II-IV, resulting in at least slight limitation of activity), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Inability to provide informed consent - Pregnancy or lactation. - Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. - HIV-positive individuals on combination antiretroviral therapy are ineligible. |
| 22 | NCT01885910 | completed | 1 | phase 4 | ['acne vulgaris'] | ["['L70.0']"] | ['doxycycline 100mg', 'aczone 5% gel'] | ['[H][C@@]12[C@@H](C)C3=C(C(O)=CC=C3)C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])[C@H]2O', 'NC1=CC=C(C=C1)S(=O)(=O)C1=CC=C(N)C=C1'] | Inclusion Criteria: - Outpatient, male or female subjects of any race, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study; - Facial acne vulgaris characterized by the following: IGA Score >3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones) - Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms Exclusion Criteria: - Female subjects who are pregnant (positive urine pregnancy test), breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control. - Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites. - Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)> - History of clinically significant anemia or hemolysis. - History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis). - Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris - Evidence of recent alcohol or drug abuse - Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study - History of poor cooperation, non-compliance with medical treatment or unreliability - Participation in an investigational drug study within 30 days of the baseline visit. | |
| 23 | NCT01886781 | completed | 1 | phase 4 | ['irritable bowel syndrome'] | ["['K58.2', 'K58.8', 'K58.0', 'K58.1', 'K58.9']"] | ['lactobacillus plantarum 299v', 'placebo comparator'] | ['CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1'] | Inclusion Criteria: - fulfillment of the Rome II criteria for IBS, - availability of at least one colonoscopy within the last three years, - aged 18 or older at the time of screening, - provision of written informed consent, - commitment of availability throughout the 12 week study period. Exclusion Criteria: - major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy, - current use of antibiotics, - history of organic intestinal disease, - pregnant or breastfeeding mothers, - chronic infectious disease like HIV or tuberculosis, and - unable to understand English or Afrikaans. | |
| 24 | NCT01889420 | terminated | low accrual | 0 | phase 1 | ['multiple myeloma in relapse'] | ["['C90.02']"] | ['combination therapy'] | ['CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1'] | Inclusion Criteria: Age > 18 years Relapsed or progressive multiple myeloma (MM) (Progressive Disease), defined as a 25% increase from the lowest response value in ANY of the following: Serum M-protein (absolute increase ≥0.5 g/dL) Urine M-protein (absolute increase of ≥200 mg/24 hours) Bone marrow plasma cell percentage (≥ 10% absolute increase) in absence of measurable M-protein Difference in kappa & lambda free light chain levels (ratio must be abnormal; absolute change must be >10 mg/dL) Patients are also considered to have progressive disease when: New bone or soft tissue lesions (e.g. plasmacytomas) are identified; or There is an unequivocal increase in the size of previously existing lesions; or The development of an otherwise unexplained serum calcium >11.5 mg/dL Have received 1, but no more than 4 prior treatment regimens or lines of therapy for MM (Induction therapy followed by stem cell transplant & consolidation/maintenance therapy will be considered as one line of therapy) ECOG Performance status 0 - 2 Life expectancy of at least 12 weeks Evaluable MM with, at least one of the following, assessed within 21 days prior to randomization: Serum M-protein ≥ 0.5 g/dL, or Urine M-protein ≥ 200 mg/24 hour, or In absence of detectable serum or urine M-protein, serum FLC (SFLC) > 100 mg/L (involved light chain) and/or an abnormal kappa/lamda ratio (>4:1 or <2:1), or Monoclonal plasma cells in a bone marrow biopsy/aspirate of >5% Adequate organ and marrow function as defined below: - Leukocytes ≥ 2,500/mcL - Absolute neutrophil count ≥ 1,500/mcL - Platelets ≥ 100,000/mcL - Total bilirubin < 2 X ULN - AST(SGOT)/ALT(SPGT) ≤ 2.5 X ULN - Creatinine < 1.5 X ULN Contraception Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for duration of study, and for 90 days after completion of therapy. A female of child-bearing potential is considered to be any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - No hysterectomy or bilateral oophorectomy; or - Not naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a female of child-bearing potential. No prior therapy with pomalidomide or everolimus. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Receiving any other investigational agents. Minimum 4 week "washout" period is required. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide, everolimus, or other agents used in the study. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or nursing (due to the rick for congenital abnormalities and the potential of this regimen to harm nursing infants). Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). Plasma cell leukemia or circulating plasma cells ≥ 2 × 10^9/L. Waldenstrom's Macroglobulinemia. Patients with known amyloidosis. Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow). Immunotherapy within 21 days prior to randomization. Myelodysplastic syndrome Major surgery (excluding kyphoplasty) within 28 days Known cirrhosis. Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days Ongoing graft-vs-host disease. Using CYP3A4 inhibitors such as Ketoconazole, Ritonavir, Itraconazole, Erythromycin, Clarithromycin, Nelfinavir, Fluconazole, Amiodarone, Cyclosporine, Diltiazem, nefazadone,fluvoxamine, verapamil, chloramphenicol, Indinavir or saquinavir within 7 days of treatment. |
| 25 | NCT01892020 | completed | 1 | phase 4 | ['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']"] | ['biphasic insulin aspart 50', 'biphasic human insulin 50'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months - Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1) - Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit - Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory) Exclusion Criteria: - Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening - Previous use of any insulin other than premixed human insulin 50 BID within 3 months prior to Visit 1 - Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days | |
| 26 | NCT01892189 | completed | 0 | phase 1 | ['ketamine-induced brain activity changes', 'psychotic-like symptoms'] | ["['Y93.81', 'Y93.02', 'Y93.11', 'Y93.32', 'Y93.41', 'Y93.42', 'Y93.43']", "['F43.29', 'P24.00', 'P24.01', 'R68.89', 'F30.10', 'F30.11', 'F30.12']"] | ['ketamine', 'tak-063', 'tak-063 placebo'] | ['[H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3'] | Inclusion Criteria: 1. In the opinion of the investigator, participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is a healthy adult male. 4. Speaks English as their first language. 5. Is aged 18 to 45 years, inclusive, at the time of informed consent and first dose of study drug. 6. Weighs at least 50 kg and has a body mass index (BMI) between 18 and 32 kilogram per metre square (kg/m^2), inclusive at Screening. 7. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 8. Has a normal magnetic resonance imaging (MRI) scan and electroencephalogram (EEG) measurement at Screening. Exclusion Criteria: 1. Has received any investigational compound or ketamine within 30 days prior to Day 1 of Period 1. 2. Has received TAK-063 in a previous clinical study or as a therapeutic agent. 3. Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress. 4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality (including MRI or EEG), which may impact the ability of the participant to participate or potentially confound the study results. 5. Has a known hypersensitivity to any component of the formulation of TAK-063 or ketamine. 6. Has a contraindication for ketamine. 7. Has a positive result for drugs or alcohol at Screening or Check-in (Day -1 of Period 1). 8. Has a history of drug or alcohol abuse or dependence (as defined by Diagnostic & Statistical Manual of Mental Disorders, fourth Edition [DSM-IV]) within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 9. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products. 10. Has evidence of current cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-063 or ketamine or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias. 11. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]). 12. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of Period 1. 13. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or a known history of human immunodeficiency virus infection at Screening. 14. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1 of Period 1) or cotinine test is positive at Screening or Check-in (Day -1 of Period 1). 15. Has poor peripheral arterial/venous access or recent wrist trauma. 16. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 3 months prior to Day 1 of Period 1. 17. Has a Screening and/or Check-in (Day -1 of Period 1) abnormal (clinically significant) electrocardiogram (ECG). Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 50 to 90 mm Hg for diastolic, if out of range may be repeated once for eligibility determination at the Screening Visit or Check-in (Day -1 of Period 1). 18. Has a resting heart rate outside the range 50 to 90 beats per minute (bpm), if out of range may be repeated once for eligibility determination at the Screening Visit and/or Check-in (Day -1 of Period 1). 19. Has a QT interval with Fridericia correction method (QTcF) greater than (>) 430 milliseconds (ms) or PR outside the range 120 to 220 ms, if out of range may be repeated once for eligibility determination within a maximum of 5 minutes, at the Screening Visit and/or Check-in (Day -1 of Period 1). 20. Has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 upper limit of normal (ULN). 21. Has a history of Axis I/II mental disorders according to DSM-IV Axis I/II such as depression, anxiety disorders, bipolar disorder, attention deficit/hyperactivity disorder (ADHD), autism spectrum disorders, anorexia nervosa, bulimia nervosa, and schizophrenia. 22. Has a history of head injury or trauma. 23. Has any condition that would prevent an MRI from accurately or safely being performed (e.g., claustrophobia, cardiac pacemaker, metallic implants or clips), as verified per study site's standard MRI assessment questionnaire. 24. Has a risk of suicide according to the Investigator's clinical judgment (e.g., per Columbia-Suicide Severity Rating Scale [C-SSRS]) or has made a suicide attempt in the previous 6 months prior to Screening. | |
| 27 | NCT01895270 | completed | 0 | phase 1/phase 2 | ['opioid dependence'] | ["['F11.20', 'F11.24', 'F11.281', 'F11.282', 'F11.288', 'F11.29', 'F11.21']"] | ['isradipine', 'placebo'] | ['COC(=O)C1=C(C)NC(C)=C(C1C1=CC=CC2=NON=C12)C(=O)OC(C)C'] | Inclusion Criteria: 1. Availability to attend clinic 6 days a week for approximately 30-60 minutes per day. 2. Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant. 3. Participants must submit a urine sample negative for drugs of abuse other than opioids or marijuana prior to starting the study. Exclusion Criteria: 1. Unstable medical condition or stable medical condition that would interact with study medications or participation. 2. History of major psychiatric disorder (psychosis, schizophrenia, bipolar) 3. Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc). 4. Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or any drug that would have major interaction with drugs to be tested. 5. Liver function tests greater than 3 times normal; BUN and Creatinine outside normal range. 6. EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block. 7. Physical dependence on alcohol or drugs other than opioids, marijuana or tobacco (as determined by physician assessment). 8. Pre-existing severe gastrointestinal narrowing. | |
| 28 | NCT01897532 | completed | 1 | phase 4 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'linagliptin'] | ['[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1'] | Inclusion criteria: 1. Documented diagnosis of T2DM before visit 1(screening). 2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with Glucagon-like Peptide 1 (GLP-1) receptor agonists, Dipeptidyl-peptidase 4 (DPP-4) inhibitors or Sodium Glucose Linked Transporter 2 (SGLT-2) inhibitors if => consecutive 7 days. 3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization. 4. HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening) 5. Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1 6. Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening) 7. Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure 8. High risk of cardiovascular (CV) events defined by: 1) albuminuria (micro or macro) and previous macrovascular disease and/or 2) impaired renal function with predefined Urine Albumin Creatinine Ratio (UACR) Exclusion criteria: 1. Type 1 diabetes mellitus. 2. Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient. 3. Active liver disease or impaired hepatic function, defined by serum levels of either Alanine Transaminase (ALT) (SGPT), Aspartate transaminase (AST) (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1. 4. Estimated Glomerular filtration Rate (eGFR) <15 ml/min/1.73 m2 (severe renal impairment or End Stage Renal Disease (ESRD), Modification of Diet in Renal Disease (MDRD) formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis. 5. Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve). 6. Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent. 7. Known hypersensitivity or allergy to the investigational products or its excipients. 8. Any previous or current alcohol or drug abuse that would interfere with trial participation in the opinion of the investigator. 9. Participation in another trial with an investigational drug ongoing or within 2 months prior to visit 1 (screening). 10. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control (acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local authorities), double barrier method and vasectomised partner) or do not plan to continue using acceptable method of birth control throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. 11. Patients considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration, have a life expectancy less than 5 years for non-CV causes, or have cancer other than non-melanoma skin cancer within last 3 years, or has any other condition than mentioned which in the opinion of the investigator, would not allow safe participation in the study. 12. Acute coronary syndrome (ACS), diagnosed <= 2 months prior to visit 1 (screening). 13. Stroke or Transient Ischemic Attack (TIA) <= 3 months prior to visit 1 (screening). | |
| 29 | NCT01901809 | completed | 1 | phase 4 | ['heart failure, diastolic'] | ["['I50.30', 'I50.31', 'I50.32', 'I50.33', 'I50.40', 'I50.41', 'I50.42']"] | ['furosemide', 'dopamine'] | ['NS(=O)(=O)C1=C(Cl)C=C(NCC2=CC=CO2)C(=C1)C(O)=O', 'NCCC1=CC(O)=C(O)C=C1'] | Inclusion Criteria: - Admission to Johns Hopkins Hospital for acute decompensated heart failure. - Patient ≥18 years of age - Estimated GFR of > 15 milliliters/min/1.73m2 determined by the Modification of Diet in Renal Disease (MDRD) equation - Willingness to provide informed consent - Known ejection fraction by noninvasive testing of > 50% within 12 months of admission to the hospital with no interval myocardial infarction since inclusion transthoracic echo, by history, or by ECG. - Negative pregnancy test in a female of child bearing potential - Willingness of primary attending physician for patient to participate. Exclusion Criteria: - Systolic BP <90 mmHg on admission - Hemoglobin (Hgb) < 8 g/dl - Known allergy or intolerance to furosemide or low dose dopamine. - Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks - Acute coronary syndrome within 4 weeks - Cardiac diagnoses in addition to or other than HFpEF: i. Active myocarditis ii. Hypertrophic obstructive cardiomyopathy iii. Severe valvular disease iv. Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemachromatosis v. Complex congenital heart disease vi. Constrictive pericarditis vii. Severe pulmonary hypertension (RVSP ≥ 60), not secondary to HFpEF - Non-cardiac pulmonary edema - Clinical evidence of digoxin toxicity - Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation - Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization - History of temporary or permanent renal replacement therapy or ultrafiltration - History of renal artery stenosis > 50% - Need for mechanical hemodynamic support - Sepsis - Terminal illness (other than HF) with expected survival of less than 1 year - Previous adverse reaction to the study drugs - Use of IV iodinated contrast material/dye in last 72 hours or planned during hospitalization - Enrollment or planned enrollment in another randomized clinical trial during this hospitalization - Inability to comply with planned study procedures - Pregnancy or nursing mothers | |
| 30 | NCT01904071 | completed | 1 | phase 4 | ['hip fracture'] | ["['M84.359S', 'M84.459S', 'M84.359A', 'M84.459A', 'M84.359K', 'M84.359P', 'M84.459K']"] | ['ivms (iv morphine)'] | ['[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])C=C[C@@H]2O'] | Inclusion Criteria: 1. English speaking patients 2. ≥18 years of age 3. radiographic evidence of hip fracture 4. Patients must be awake, alert and oriented to time, place and person. 5. pain score of ≥ 5 in 10 point scale. Exclusion Criteria: 1. cognitive deficits 2. allergic to amide-type local anesthetic or morphine 3. more injuries than just hip fracture. | |
| 31 | NCT01904643 | terminated | accrual factor | 0 | phase 1 | ['adult acute megakaryoblastic leukemia (m7)', 'adult acute minimally differentiated myeloid leukemia (m0)', 'adult acute monoblastic leukemia (m5a)', 'adult acute monocytic leukemia (m5b)', 'adult acute myeloblastic leukemia with maturation (m2)', 'adult acute myeloblastic leukemia without maturation (m1)', 'adult acute myeloid leukemia with 11q23 (mll) abnormalities', 'adult acute myeloid leukemia with del(5q)', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'adult acute myelomonocytic leukemia (m4)', 'adult erythroleukemia (m6a)', 'adult pure erythroid leukemia (m6b)', 'recurrent adult acute myeloid leukemia'] | ["['C94.21', 'C94.22', 'C94.20']", "['C7A.1']", "['C93.01', 'C93.02', 'C93.00']", "['C93.Z1', 'C93.Z2', 'C93.91', 'C93.92', 'C93.01', 'C93.02', 'C93.Z0']", "['C92.01', 'C92.02', 'C92.00']", "['C92.01', 'C92.02', 'C92.00']", "['R19.5', 'H35.09', 'M26.50', 'M26.59', 'Q99.8', 'R06.89', 'R06.9']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C92.51', 'C92.52', 'C93.11', 'C93.12', 'C93.31', 'C93.32', 'C92.50']", "['C94.01', 'C94.02', 'C94.00']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']"] | ['lenalidomide', 'mitoxantrone hydrochloride', 'etoposide', 'cytarabine'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O', 'OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Patients eligible include those with diagnosis of AML other than acute promyelocytic leukemia by World Health Organization (WHO) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Serum creatinine =< 1.5 mg/dL; if serum creatinine > 1.5 mg/dL, then the estimated glomerular filtrate rate (GFR) must be > 60ml/min/1.73m^2 as calculated by the Modification of Diet in Renal Disease equation - Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is considered to be secondary to Gilbert's syndrome, hemolysis, or hepatic infiltration by AML - Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x ULN - Alkaline phosphatase =< 2.5 x ULN - All study participants must be registered into the mandatory Revlimid assistance (RevAssist) program, and be willing and able to comply with the requirements of RevAssist - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy Exclusion Criteria: - Patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents - Patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient's last prior therapy before initiation of treatment on clinical trial - Have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment - Have significant, uncontrolled active infection - Pregnant or nursing patients will be excluded from the study - Known human immunodeficiency virus (HIV) infection |
| 32 | NCT01904864 | completed | 1 | phase 4 | ['iron deficiency anemia'] | ["['D50.9', 'D50.0', 'D50.8']"] | ['elemental iron (novaferrum®)', 'elemental iron (ferrous sulfate)'] | ['CC1=CC(OCCCC(C)(C)C(O)=O)=C(C)C=C1', '[Ca]'] | Inclusion Criteria: 1. Age ≥ 9 to < 48 months 2. IDA documented by hematologic indices (hemoglobin, MCV, RDW, reticulocyte count, reticulocyte hemoglobin content), serum ferritin, serum iron and total iron binding capacity Exclusion Criteria: 1. Iron deficiency likely or definitely due to blood loss from the intestine or other sites. 2. Evidence of response to recent/current oral iron therapy, as determined by increase in hemoglobin by > 1.0 gm/dL and MCV by 5 fL above measurements prior to iron therapy 3. History or evidence of intestinal malabsorption 4. History of prior intravenous iron therapy 5. Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination, or laboratory tests 6. Other causes of anemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests. 7. High likelihood of suboptimal adherence by parents with study requirements (previous missed clinic visits) 8. Inability to tolerate oral medications 9. History of birth at < 30 weeks gestation 10. Other medical or social factors at discretion of treating physician | |
| 33 | NCT01907217 | completed | 1 | phase 4 | ['depression'] | ["['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['methohexitone', 'suxamethonium'] | ['CCC#CC(C)C1(CC=C)C(=O)NC(=O)N(C)C1=O', 'C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C'] | Inclusion Criteria: - Patients ≥18 years diagnosed with major depressive episode (DSM-IV) and referred for ECT Exclusion Criteria: - Any condition rendering patients medically unfit for general anaesthesia or ECT; treatment with ECT in previous six months; dementia or other Axis 1 diagnosis; alcohol/other substance abuse in previous six months; inability/refusal to consent. | |
| 34 | NCT01907321 | completed | 1 | phase 1/phase 2 | ['ischemic stroke'] | ["['I25.5', 'H47.013', 'H93.013', 'G45.9', 'H47.011', 'H47.012', 'H47.019']"] | ['measures performed on all subjects'] | ['COC1=C(O)C=CC(CNC(=O)CCCC\\C=C\\C(C)C)=C1'] | Inclusion Criteria: 1. Acute (0-14 days) and subacute (14 days - 6 months) ischemic stroke 2. Neurologic status permits participation. 3. Medical status permits participation. Exclusion Criteria: 1. Dysphagia secondary to something other than stroke. 2. Refuses consent. 3. Incapable of informed consent and has no representative. 4. Multiple strokes and previous history of dysphagia secondary to stroke. 5. Longer than 6 months post-stroke 6. Known cardiac valve thrombosis 7. Stroke etiology of dissection 8. Unstable / evolving stroke lesion. 9. History of cancer in the head or neck 10. History of radiation to the head or neck 11. History of degenerative disease | |
| 35 | NCT01907854 | completed | 1 | phase 4 | ['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']"] | ['liraglutide', 'sitagliptin', 'placebo', 'placebo'] | ['CN(C)C(=N)NC(N)=N', 'N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F'] | Inclusion Criteria: - - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - - Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose - - HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive) - - Body mass index equal to or above 20 kg/m^2 Exclusion Criteria: - - Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol - - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness - - Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice) - - History of chronic pancreatitis or idiopathic acute pancreatitis - - Screening calcitonin value equal to or above 50 ng/L - - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) - - Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit - - Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m^2 per modification of diet in renal disease formula - - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening - - Heart failure, New York Heart Association class IV - - Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg) | |
| 36 | NCT01908387 | terminated | due to slow accrual study was terminated. | 0 | phase 1 | ['myelodysplastic syndromes', 'chronic myelomonocytic leukemia', 'acute myeloid leukemia', 'multiple myeloma', 'non-hodgkin lymphoma', 'hodgkin lymphoma'] | ["['D46.9', 'D46.C', 'D46.Z']", "['C93.11', 'C93.12', 'C93.10']", "['C92.A1', 'C92.A2', 'C92.61', 'C92.62', 'C92.A0', 'C92.60']", "['C90.01', 'C90.02', 'C90.00']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['oral azacitidine'] | ['NC1=NC(=O)N(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - 1. Eighteen years of age to 80 years of age at the time of signing the informed consent document; 2. Understand and voluntarily sign an informed consent document prior to any study related assessments and/or procedures being conducted; 3. Able to adhere to the study visit schedule and other protocol requirements; 4. Have a documented diagnosis of one of the following: - Myelodysplastic syndromes or Chronic myelomonocytic leukemia (based on a bone marrow aspirate or bone marrow biopsy) or; - Acute myeloid leukemia (based on a bone marrow aspirate or bone marrow biopsy), limited to those subjects for whom standard curative or palliative measures do not exist or are no longer effective or; - Multiple myeloma, limited to those subjects for whom standard curative or palliative measures do not exist or are no longer effective or; - Non-Hodgkin lymphoma or Hodgkin lymphoma, limited to those subjects for whom standard curative or palliative measures do not exist or are no longer effective; 5. For subjects with myelodysplastic syndromes only, have at least one of the following: - Hemoglobin level ≤ 9.0 g/dL; - Platelet count ≤ 75,000 /μL; - Red blood cell transfusion-dependent as defined by: - Average red blood cell transfusion requirement of ≥ 4 units per 28 days confirmed for a minimum of 84 days prior to starting study treatment. Hemoglobin levels within 7 days prior to administration of an red blood cell transfusion must be ≤ 9.0 g/dL in order for the transfusion to be counted towards red blood cell transfusion-dependent status. Red blood cell transfusions administered when hemoglobin levels were > 9.0 g/dL and/or red blood cell transfusions administered for elective surgery will not qualify as a required transfusion for the purpose of providing evidence of red blood cell transfusion-dependent status. Note that 4 units of red blood cell in Japan is equivalent to 2 units of red blood cell outside of Japan; - No consecutive 42 days that are red blood cell -transfusion-free during the 84 days prior to starting study treatment; • Platelet transfusion-dependent as defined by: - Have at least two separate platelet transfusion episodes during 56 days prior to starting study treatment. Platelet transfusions administered for elective surgery will not qualify as a required transfusion for the purpose of providing evidence of platelet transfusion-dependent status; - No consecutive 28 days that are platelet-transfusion-free during the 56 days prior to starting study treatment; 6. Eastern Cooperative Oncology Group performance status of 0 or 1; 7. Females of childbearing potential (FCBP: a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal [ie, amenorrhea following cancer therapy does not rule out childbearing potential] for at least 24 consecutive months [ie, has had menses at any time in the preceding 24 consecutive months]) must: - Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner; injectable and implantable hormonal contraceptive have not been approved in Japan as of March 2013) throughout the study, and for 3 months following the last dose of oral azacitidine and; - Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at screening and; - Have a negative urine pregnancy test within 72 hours prior to starting study treatment (note that the screening serum pregnancy test can be used as the test prior to starting study treatment if it is performed within the 72 hour timeframe); 8. Male subjects with a female partner of childbearing potential must agree to use at least 2 physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study and for 3 months following the last dose of study drug. Exclusion Criteria: 1. Hypoplastic myelodysplastic syndromes defined as bone marrow cellularity of < 20%; 2. Atypical chronic myeloid leukemia and unclassifiable myeloproliferative neoplasms. Subjects with white blood cell counts ≥ 12,000/μL must be excluded (for subjects with acute myeloid leukemia: subjects with white blood cell counts ≥ 15,000/μL must be excluded, and for subjects with chronic myelomonocytic leukemia: subjects with white blood cell counts ≥ 20,000/μL must be excluded); 3. Active central nerve system lymphoma unless the subject has been previously treated and remains asymptomatic for 3 months; 4. Dry tap bone marrow aspirate due to myelofibrosis, and/or myelofibrosis accompanied by splenomegaly; 5. Percentage of neoplasm cells in bone marrow more than 50%; 6. Prior treatment with azacitidine or other hypomethylating agent that was discontinued due to adverse event related to that therapy except adverse events related to topical reactions related to injection of azacitidine; 7. Prior allogeneic or autologous stem cell transplant; 8. History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity; 9. Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s) (eg, idiopathic thrombocytopenic purpura [ITP]), or microvascular disorder(s) (eg, disseminated intravascular coagulation, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura); 10. Treatment with any anticancer therapy (standard or investigational) within the previous 21 days prior to the first dose of study drug or less than full recovery (CTCAE grade 1) from the clinically significant toxic effects of that treatment. Treatment with hydroxyurea within the previous 28 days prior to the first dose of study drug must be excluded; 11. Concurrent use of corticosteroids, except for subjects on a stable or decreasing dose for at least 1 week prior to starting study treatment for medical conditions other than primary diseases. Topical use of corticosteroids is permitted regardless of dose 12. Prior history of malignancies, other than myelodysplastic syndromes, chronic myelomonocytic leukemia, acute myeloid leukemia, multiple myeloma, non-hodgkin lymphoma, or hodgkin lymphoma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: - Basal or squamous cell carcinoma of the skin; - Carcinoma in situ of the cervix or breast; - Incidental histological finding of prostate cancer (Tumor nodes metastasis [TNM] stage of T1a N0M0 or T1b N0M0); - Early-stage gastric cancer suitable for endoscopic mucosal resection or endoscopic submucosal dissection; 13. Significant active cardiac disease within the previous 6 months, including: - New York Heart Association (NYHA) class III-IV congestive heart failure; - Unstable angina or angina requiring surgical or medical intervention; - Myocardial infarction; 14. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment); 15. Known human immunodeficiency virus (HIV) positivity (eg, subjects who are receiving antiretroviral therapy for HIV disease); 16. Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded; 17. Any of the following laboratory abnormalities: - Absolute neutrophil count < 1,000/μL (except for subjects with acute myeloid leukemia); - Serum glutamic oxaloacetic transaminase/aspartate transaminase or serum glutamic pyruvate transaminase/alanine transaminase > 2.5 ×upper limit of normal; - Serum bilirubin > 1.5 × upper limit of normal. High levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs' test or over 50% of indirect bilirubin; - Serum creatinine > 1.5 × upper limit of normal; - Bicarbonate (venous blood) < 22 mEq/L; - Abnormal coagulation parameters (Prothrombin time-international normalized ratio > 1.5 or activated partial thromboplastin time > 40 seconds); - Hemoglobin level < 8.0 g/dL (for multiple myeloma, non-hodgkin lymphoma, or hodgkin lymphoma only); - Platelet count < 25,000 /μL (for multiple myeloma, non-hodgkin lymphoma, or hodgkin lymphoma only); 18. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding; 19. History of cerebrovascular accident or transient cerebral ischemic attack within 6 months prior to starting study treatment; 20. Interstitial lung disease, pulmonary fibrosis, or other severe respiratory disease; 21. Hepatic cirrhosis, or other moderate to severe hepatic disease; 22. Known or suspected hypersensitivity to azacitidine or mannitol; 23. Pregnant or breastfeeding females; 24. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study; 25. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study; 26. Any condition that confounds the ability to interpret data from the study. |
| 37 | NCT01914926 | completed | 1 | phase 4 | ['heart rate and rhythm disorders'] | ["['O76']"] | ['metoprolol', 'diltiazem'] | ['COCCC1=CC=C(OCC(O)CNC(C)C)C=C1', 'COC1=CC=C(C=C1)[C@@H]1SC2=C(C=CC=C2)N(CCN(C)C)C(=O)[C@@H]1OC(C)=O'] | Inclusion Criteria: Eligible patients had to have a 12-lead electrocardiogram (ECG) showing atrial fibrillation or atrial flutter with a ventricular rate of greater than or equal to 120 beats per minute and a systolic blood pressure of greater than or equal to 90 mmHg. Exclusion Criteria: Patients were excluded if they had any of the following: - a systolic blood pressure <90 mmHg, ventricular rate greater than or equal to 220 beats per minute, - QRS >0.100 seconds, 2nd or 3rd degree atrioventricular (AV) block, - temperature >38.0 ˚C, - acute ST elevation myocardial infarction, - known history of New York Heart Association Class IV heart failure or - active wheezing with a history of bronchial asthma or COPD. In addition, patients were excluded if there was: - prehospital administration of diltiazem or any other AV nodal blockading agent, - a history of cocaine or methamphetamine use in the previous 24 hours prior to arrival, - a history of allergic reaction to diltiazem or metoprolol, - a history of sick sinus or pre-excitation syndromes, - a history of anemia with hemoglobin <11.0 g/dl, - pregnancy or breastfeeding. | |
| 38 | NCT01915914 | completed | 1 | phase 4 | ['skin diseases'] | ["['L99', 'O99.711', 'O99.712', 'O99.713', 'O99.719', 'O99.72', 'O99.73']"] | ['fluticasone propionate'] | ['COC1=CC=CC(=C1)N=C1C(=CNC2=C1C=C(C=C2C)S(=O)(=O)C1=CC=CC(=C1)C(=O)N(C)C)C(O)=N'] | Inclusion Criteria: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the package insert of CUTIVATE and PHYSIOGEL Lotion. Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects eligible for enrolment in the study must meet all of the following criteria: 1. male or female patients age between 1 to 18 years old (including 1 year and excluding 18 years old); 2. Diagnose atopic dermatitis according to criteria of Williams; 3. Mild to moderate AD on the head/neck, trunk, upper limbs or lower limbs and PSGA scores 2-3; 4. The informed consent must be signed before any study specific tests or procedures are initiated; Subjects eligible for enrolment in the MAINTENANCE phase of the study must meet all of the following criteria: 5. Achieve treatment success after receiving Fluticasone propionate 0.05% cream twice daily up to 4 weeks in ACUTE phase Exclusion Criteria: Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects meeting any of the following criteria must not be enrolled in the study: Acute phase: 1. Dermatitis of only the face, feet or hands; 2. The involved area has exceeded 10% of the whole body area; 3. Diagnosed contact dermatitis at predilection sites of AD; 4. Atrophy, telangiectasia, extensive scarring lesions in the area or areas to be treated; 5. Had topical therapies including but not limit to calcineurin inhibitors (topical tacrolimus or topical pimecrolimus), corticosteroids, antihistamines within 14 days prior to screening; 6. Has accepted nonsteroidal immunosuppressants (eg cyclosporine, methotrexate), or ultraviolet light treatments including ultraviolet-A and ultraviolet-B, or systemic corticosteroids regardless administration by oral, intramuscular, or intravenous within 4 weeks prior to screening; 7. Pregnant or breast-feeding. Women of Childbearing Potential (WOCBP) with a positive urine pregnancy test performed within 7 days before the start of treatment; 8. Has immunocompromised disease (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or have a history of malignancy (including basal cell carcinoma, squamous cell carcinoma, melanoma); 9. Has open skin infections (bacterial, viral or fungal) if at the application site; 10. Has head lice or scabies; 11. Present with clinical conditions other than AD that may interfere with the valuation (e.g. generalized erythrodema, toxicoderma, acne, Netherton's Syndrome, psoriasis); 12. Require systemic therapy for the treatment of atopic dermatitis, or had systemic therapy including but not limit to antihistamines within 14 days prior to screening; 13. Has accepted any experimental or investigational drug or therapy within 6 weeks prior to screening; 14. Has known hypersensitivity to Fluticasone Propionate 0.05% cream, or PHYSIOGEL lotion, or relate drugs; 15. Non-compliance with general medical treatment, or are known to miss appointments, or don't intend to comply with the protocol for the duration of the study; 16. Drug abuse, mental dysfunction, or other factors limiting the subject's ability to cooperate fully with study-related procedures; 17. Know to be unreliable or may be unable to complete the study; 18. Any condition or prior/present treatment that would render the subject not eligible for the study; Maintenance phase: 19. Accepted topic therapies other than Fluticasone propionate 0.05% cream and emollients during the ACUTE phase; 20. Has active skin infection (bacterial, viral or fungal). | |
| 39 | NCT01918306 | terminated | company stopped production of study drug due to excessive toxicities, lack of efficacy | 0 | phase 1/phase 2 | ['estrogen receptor negative breast cancer', 'human epidermal growth factor 2 negative carcinoma of breast', 'triple negative breast cancer', 'recurrent breast cancer', 'stage iv breast cancer', 'triple-negative breast cancer'] | ["['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']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['cisplatin', 'gdc -0941'] | ['CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - Patients must provide informed written consent. - Patients must be <18 years of age. - ECOG performance status 0-1. - Clinical stage IV invasive mammary carcinoma, ER negative (defined as expression of ER in < 5% cells), PR negative (defined as expression of PR in < 5% cells), HER2 negative [acceptable FDA approved methods of HER2 analysis include IHC (0, 1+), fluorescence in situ hybridization (FISH) with HER2/CEN-17 ratio <2, and/or chromogenic in situ hybridization (CISH)] with HER2/CEN-17 ratio <2, as previously documented by histological analysis. - Androgen receptor negativity, defined as < 10% of tumor cell nuclei with immunoreactivity for AR in a CLIA certified laboratory. See section 5.1. - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension by RECIST criteria 1.1, with radiologic scans within 21 days of day 1, cycle 1. - Up to one prior chemotherapy regimens for metastatic disease. - No prior treatment with cisplatin in the metastatic setting. - Biopsy of a metastatic lesion in patients with reasonably accessible metastatic lesions (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases). If a reasonably accessible site is available for biopsy, the patient must agree to biopsy. - Life expectancy ≥ 6 months in the opinion of the investigator - Patients must have adequate hematologic, hepatic, and renal function. All tests must be obtained less than 21 days from day 1 of study treatment. This includes: - ANC >/=1500/mm3 - Platelet count >/=100,000/mm3 - Hemoglobin ≥ 9 g/dL - Creatinine </=1.5X upper limits of normal (ULN) - INR ≤ 2 - Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN) - AST and ALT ≤ 3 x ULN (or ≤ 5.0 x ULN if hepatic metastases are present) - For patients without known Type II diabetes, the following is required at screening: o -Fasting blood glucose </= 135 mg/dL (7.49 mmol/L) and glycosylated hemoglobin (HbA1c) <7.0 % or International Federation of Clinical Chemistry (IFCC) < 53 mmol/mol - For patients with Type II diabetes receiving only oral anti-hyperglycemic therapy (patients receiving insulin are not eligible), the following are required at screening: - -HbA1c < 8.5 % or IFCC < 69.4 mmol/mol - -Stable regimen of oral anti-hyperglycemic therapy without insulin usage for at least 3 weeks prior to first study treatment - -Fasting blood glucose levels </= 160 mg/dL (8.88 mmol/L) and no hypoglycemia (BS <60) during home monitoring for at least 1 week prior to study entry - Patients must be able to swallow and retain oral medication. - For patients who are not postmenopausal or surgically sterile (absence of ovaries and/or uterus), agreement to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year (e.g., hormonal implants, combined oral contraceptives, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of GDC-0941 or 6 months after the last dose of cisplatin, whichever is longer; postmenopausal is defined as: - Age >/= 60 years - Age </= 60 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; and follicle stimulating hormone and estradiol in the postmenopausal range - Patients may have received radiation therapy to painful bone metastases or areas of impending bone fracture as long as radiation therapy is completed ≥ 2 weeks prior to day 1 of cycle 1 of treatment. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment. Baseline radiologic scans must be obtained after completion of radiation. - Patients must complete all screening assessments as outlined in the protocol. Exclusion Criteria: - Any kind of malabsorption syndrome significantly affecting gastrointestinal function. - Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biologic therapy) other than the ones specified in the protocol. Patients must have discontinued the above cancer therapies for 1 week prior to the first dose of study medication, as well as recovered from toxicity (to ≤ than grade 1, except for alopecia) induced by previous treatments. Any investigational drugs should be discontinued 2 weeks prior to the first dose of study medication and radiotherapy must have been completed ≥ 2 weeks prior to initiation of study drug (Cycle 1, Day 1). - Prior use of PI3K, or Akt inhibitors in the neoadjuvant, adjuvant, and metastatic setting for the treatment of cancer. These include, but are not limited to: GDC-0941, GDC-0980, GDC-0032, BEZ235, BKM120, LY294002, PIK-75, TGX-221, XL147, XL765, SF1126, PX-866, D-87503, D-106669, GSK615, CAL101. Patients who have received PI3K/Akt inhibitors previously for <4 weeks will be eligible. - Pregnant or lactating women. - Insulin-dependent diabetes. Patients with Type II diabetes must meet criteria outlined in Inclusion Criteria. - Uncontrolled intercurrent illness including, but not limited to: - -Ongoing or active infection requiring parenteral antibiotics - -Impairment of lung function (COPD > grade 2, lung conditions requiring oxygen therapy) or current dyspnea at rest - -Symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease) - -Known Left Ventricular Ejection Fraction (LVEF) < 50%. - -Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months - -Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg, found on two consecutive measurements separated by a 1 or 2 week period despite adequate medical support) - -Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.0, grade 3] - -QTcF ≥ 480 msec on screening EKG - -Known history of QT/QTc prolongation or Torsades de Pointes (TdP) - -ST depression or elevation of ≥ 1.5 mm in 2 or more leads - -Diarrhea of any cause ≥ CTCAE grade 2 - -Active autoimmune disease that is not controlled by nonsteroidal or steroidal (<10 mg of prednisone per day) anti inflammatory drugs or active inflammatory disease, including small or large intestine inflammation such as active Crohn's disease or ulcerative colitis, which requires immunosuppressive therapy - -Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary - -Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for at least 2 weeks from completion of radiation treatment, on a dose of steroids equivalent to <10 mg prednisone daily for at least one week, and on a stable dose of therapeutic anticonvulsants) - -Known history of chronic liver disease, including cirrhosis, current alcohol abuse, or infection with hepatitis B virus or hepatitis C virus (active or carrier), or renal failure - -Known history of chronic pancreatitis - -Conditions that affect lymphocyte counts, such as HIV infection or immunosuppressive therapy - Use of prohibited drugs |
| 40 | NCT01918761 | terminated | poor accrual | 0 | phase 1 | ['non small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['dacomitinib, pemetrexed'] | ['[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O'] | Inclusion criteria: - Written informed consent - Histologically or cytologically confirmed stage IV non-squamous NSCLC - Patients who are candidates to receive pemetrexed monotherapy - If pemetrexed has been administered as first line therapy there must be a treatment free interval of at least one cycle (21 days) - Measurable disease by RECIST criteria version 1.1. - ≥18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - Adequate left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA) - Adequate organ function, including: 1. Adequate bone marrow reserve: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm3, platelets should be ≥ 100.000 cells/mm3 2. Creatinine clearance ≥ 45 mL/min 3. Total bilirubin ≤ 1.5 x upper normal limit (ULN) 4. Aspartate Aminotransferase (AST) (SGOT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases) 5. Alanine Aminotransferase (ALT) (SGPT) ≤ 3 x ULN (≤ 5.0 x ULN if hepatic metastases) - Female patients or their partners must be postmenopausal (defined as 12 months of amenorrhea following last menses), surgically sterile or must agree to use effective contraception while receiving trial treatment and for at least 3 months thereafter (the definition of effective contraception will be based on the judgment of the investigator). Male patients or their partners must be surgically sterile or must agree to use a barrier method of contraception while receiving trial treatment and for at least 3 months thereafter. (In all cases the definition of effective contraception will be based on the judgment of the investigator). - Able to comply with required protocol procedures and able to receive oral medications Exclusion criteria: - Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer - Predominantly squamous cell histology - Patients with symptomatic brain metastases - Chemotherapy, radiotherapy, biological or investigational agents within two weeks of baseline disease assessments - Patients with uncontrolled or significant cardiovascular disease, including: 1. Myocardial infarction within 12 months 2. Uncontrolled angina within 6 months 3. Congestive heart failure within 6 months 4. Diagnosed or suspected congenital long QT syndrome 5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) 6. Prolonged QTc interval on pre-entry electrocardiogram. QTc must be less than CTC Grade 2 (≤480 msec) using appropriate correction formula with manual read by investigator if required. The echocardiogram (ECG) may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation 7. Any history of second or third degree heart block (may be eligible if currently have a pacemaker) 8. Heart rate <50/minute on baseline electrocardiogram 9. Uncontrolled hypertension - Prior malignancy: Patients will not be eligible if they have evidence of other malignancy (other than non-melanoma skin cancer or in situ cervical cancer, or localized and presumed cured prostate cancer with prostate specific antigen (PSA) < ULN) within the last 3 years. - Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start. Known hypersensitivity to pemetrexed and/or dacomitinib - Patients with exposure to other investigational drug therapy - Previous therapy with an oral tyrosine kinase inhibitor (TKI) |
| 41 | NCT01922934 | completed | 1 | phase 4 | ['obesity'] | ["['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']"] | ['obesity pharmacotherapy'] | ['CC(C)(N)CC1=CC=CC=C1'] | Inclusion Criteria: 1. BMI > 30 kg/m2 and < 45 kg/m2 2. Any one of the following (weight-related) diagnoses: type 2 diabetes or pre-diabetes, including those treated with glucose lowering medications; hypertension, including patients treated with anti-hypertensive medications; hyperlipidemia, including those treated with lipid lowering agents; atherosclerotic cardiovascular disease, including coronary heart disease, cerebrovascular disease, or peripheral vascular disease; obstructive sleep apnea 3. Visited their primary care provider (PCP) at least twice during the past 12 months, including once in the last 6 months Exclusion Criteria: Heart attack or stroke within the past 6 months; cancer treated within the past 5 years, except for non-melanoma skin cancer or localized prostate cancer; other medical contraindications to weight loss (e.g., end-stage renal disease, cirrhosis); active substance abuse; current treatment for bipolar disorder or schizophrenia; discretion of PCP (see below) | |
| 42 | NCT01924767 | completed | 1 | phase 1 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['bi 10773 placebo', 'bi 10773', 'bi 10773 placebo', 'bi 10773', 'bi 10773 placebo', 'bi 10773 placebo', 'bi 10773', 'bi 10773'] | ['[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1'] | Inclusion criteria: 1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less. 2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening. 3. Age >21 and Age <70 years (male and hysterectomised female patients) Age >60 and Age <70 years (postmenopausal female patients) 4. Body Mass Index (BMI) >18.5 and <40 kg/m2 5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation Exclusion criteria: 1. Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose) 2. Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during washout. 3. Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening 4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as: - Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot) - Renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²) - Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack) - Neurological disorders (such as epilepsy) or psychiatric disorders - Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections) - Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder 5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms) 7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50) | |
| 43 | NCT01926496 | completed | 1 | phase 4 | ['actinic keratosis (ak)'] | ["['L57.0', 'L11.0', 'L82.0', 'L82.1', 'L85.2', 'L85.1', 'L87.0']"] | ['ingenol mebutate gel, 0.015%', 'imiquimod cream, 5%'] | ['[H][C@@]12C[C@@H](C)[C@]34C=C(C)[C@H](OC(=O)C(\\C)=C/C)[C@@]3(O)[C@H](O)C(CO)=C[C@@]([H])(C4=O)[C@]1([H])C2(C)C', 'CC(C)CN1C=NC2=C1C1=CC=CC=C1N=C2N'] | Inclusion Criteria: 1. Signed Informed Consent Form (ICF) prior to any trial-related procedures 2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp. 3. Subject at least 18 years of age 4. Female subjects must be of either: 1. Non-childbearing potential, or, 2. Childbearing potential, provided there is a confirmed negative urine pregnancy test 5. Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%) Exclusion Criteria: 1. Location of the selected treatment area: - on the periorbital skin - on the perioral skin/around the nostrils - within 5 cm of an incompletely healed wound - within 10 cm of a suspected BCC or SCC or other neoplasia 2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn). 3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area. 4. History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area 5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1) 6. Organ transplant recipients 7. Immunosuppressed subjects (for example HIV patients) 8. Female subjects who are breastfeeding. 9. Subjects who are institutionalised by court order or by the local authority 10. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state) | |
| 44 | NCT01928394 | active, not recruiting | 1 | phase 1/phase 2 | ['advanced or metastatic solid tumors'] | ["['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']"] | ['cobimetinib'] | ['OC1(CN(C1)C(=O)C1=C(NC2=C(F)C=C(I)C=C2)C(F)=C(F)C=C1)[C@@H]1CCCCN1'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types: - Triple Negative Breast Cancer - Gastric Cancer - Pancreatic Cancer - Small Cell Lung Cancer - Bladder Cancer - Ovarian Cancer - Subjects must have measurable disease - Eastern Cooperative Oncology Group (ECOG) of 0 or 1 - Adequate hematological and organ function as confirmed by laboratory values Exclusion Criteria: - Active brain metastases or leptomeningeal metastases - Subjects with active, known or suspected autoimmune disease - Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment - Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited | |
| 45 | NCT01930045 | completed | 0 | phase 1 | ['hiv infections'] | ["['Z21']"] | ['raltegravir (isentress™)', 'maalox (mal)'] | ['CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1', 'OC(=O)C1=CC=CC=C1O'] | Inclusion Criteria: - On a stable raltegravir dose as part of a stable antiretroviral regimen for ≥1 month before the study - If female, is not pregnant or breast feeding - Body mass index ≤32 kg/m^2 Exclusion Criteria: - Mentally or physically incapacitated, has significant emotional problems, or history of clinically significant psychiatric disorder within ≤10 years - History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease (excluding HIV) - History of gastric bypass surgery - History of cancer, except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated ≥10 years before the study - History of chronic diarrhea within ≤3 months before the study - History of significant multiple and/or severe allergies (food, drug, latex), or had an anaphylactic reaction or significant intolerability to drugs or food - Had major surgery or donated or lost ≥1 unit of blood (500 mL) ≤4 weeks before the study - Participated in another investigational trial ≤4 weeks before the study - Taking rifampin or is unable to refrain from the use of 1) any proton pump inhibitor from 2 weeks before and throughout the study, or 2) any histamine H2-blockers, antacids, calcium supplements, or multivitamins from 2 weeks before and throughout the study - Consumes >3 glasses of alcoholic beverages per day - Consumes excessive amounts of caffeine beverages (coffee, tea, cola, energy drinks, or other caffeinated drinks) per day - Currently uses or has a history of drug abuse within ≤6 months before the study | |
| 46 | NCT01933425 | completed | 1 | phase 4 | ['neuromuscular blockade'] | ["['M41.40', 'M41.42', 'M41.43', 'M41.44', 'M41.45', 'M41.46', 'M41.47']"] | ['rocuronium', 'sugammadex', 'placebo'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - patients > 18 years old - elective laparoscopic operation - can read and understand Danish - informed consent Exclusion Criteria: - BMI > 30 kg/cm2 - known allergy to medications that are included in the project, - severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis), - neuromuscular disease that may interfere with neuromuscular data, - lactating or pregnant, - impaired liver function, - converting to laparotomy, - perioperative use of neuromuscular blocking agents before randomization, - pneumoperitoneum set to >12 mmHg on the insufflator | |
| 47 | NCT01933594 | completed | 0 | phase 1/phase 2 | ['hiv infections'] | ["['Z21']"] | ['romidepsin', 'placebo for romidepsin'] | ['C\\\\C=C1/NC(=O)[C@H]2CSSCC\\\\C=C\\\\[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@@H](NC1=O)C(C)C'] | Inclusion Criteria: Cohorts 1, 2, & 3 - HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA - Receiving 2 (or more) nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir, dolutegravir, or efavirenz for at least 90 days prior to study entry with no intention to change for the duration of the study - Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the 1st measurement must be from a result obtained between 365-91 days, inclusive, prior to study entry. Documentation of the 2nd measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry. - CD4 cell count ≥300 cells/mm^3 obtained within 90-50 days prior to study entry at any US laboratory that has a CLIA certification or equivalent - HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay within 90-50 days prior to study entry - HIV-1 RNA level of ≥0.4 copies/mL obtained by SCA within 90-50 days prior to study entry. This result must be available prior to the pre-entry visit - The following laboratory values obtained within 21-0 days prior to study entry by any laboratory that has a CLIA certification or equivalent - ANC ≥1500 cells/mm^3 - Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women - Platelet count ≥120,000/mm^3 - The following laboratory values obtained within 21-7 days prior to study entry by any laboratory that has a CLIA certification or equivalent - CrCl ≥60 mL/min - Potassium & magnesium within normal limits - AST (SGOT) <2.0 x ULN - ALT (SGPT) <2.0 x ULN - Alkaline phosphatase <2.0 x ULN - Total bilirubin <2.5 x ULN - HCV antibody negative result within 90-50 days prior to study entry or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained within 90-50 days prior to study entry - Negative HBsAg result obtained within 90-50 days prior to study entry or a positive HBsAb result at any time prior to study entry - For females of reproductive potential, negative serum or urine pregnancy test (latter with sensitivity of ≤25 mIU/mL) at the screening visit, pre-entry visit within 21-7 days prior to study entry, & at entry prior to romidepsin infusion, by any US laboratory that has a CLIA certification or equivalent - Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All female participants of reproductive potential must be instructed to use contraceptives for 6 months/180 days after completing RMD or placebo infusion - Karnofsky performance score ≥80 within 21-7 days prior to study entry - Men and women age ≥ 18 years - Ability & willingness to provide written informed consent - Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen Exclusion Criteria: Cohorts 1, 2, & 3 - History of or current malignancy requiring cytotoxic therapy - Bacterial, fungal, or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry - History of or current CMV end organ disease (eg, retinitis) - History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator - Chronic, acute, or recurrent infections that are current & serious in the opinion of the investigator & for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable - Active autoimmune disorders including but not limited to: inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis & optic neuritis - History of seizure disorders - History of anticonvulsant use within 60 days prior to study entry - History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome - Breastfeeding - Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry - Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study - Intent to use cytokines (e.g., IL-2 or IL-12) during the course of the study. Prior administration of cytokines is not an exclusion criterion; however, at least 60 days between the most recent cycle of any cytokine and study entry is required - Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole); dexamethasone; macrolide antibiotics (azithromycin, clarithromycin, erythromycin); ARVs that are inhibitors of, or are metabolized by, CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc); cobicistat; warfarin; nefazodone; rifamycins (rifabutin, rifampin, rifapentine); St. John's Wort; carbamazepine; phenytoin; phenobarbital; amiodarone; dofetilide; pimozide; procainamide; quinidine; sotalol; & birth control products containing estrogen; drugs that are p-glycoprotein inhibitors; & drugs that prolong the QTc interval with a risk of Torsades de Pointes - Known allergy, sensitivity, or any hypersensitivity to components of RMD or its formulation - Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry - Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements - Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry - Psychosocial conditions that would prevent study compliance and follow-up, as determined by the investigator - Documented opportunistic infections within 60 days prior to entry Inclusion Criteria: Cohort 4, Step 1 - HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA - Receiving 2 or more nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir or dolutegravir for at least 90 days prior to study entry with no intention to change for the duration of the study - Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the first measurement must be from a result obtained between 365-61 days, inclusive, prior to study entry. Documentation of the second measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry - CD4 cell count ≥300 cells/mm^3 obtained between 36-60 days prior to study entry (screening visit) at any US laboratory that has a CLIA certification or equivalent - HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay at screening (between 36-60 days prior to study entry) - The following laboratory values obtained at pre-entry (between 3-14 days prior to study entry) by any laboratory that has a CLIA certification or equivalent - ANC ≥1500 cells/mm^3 - Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women - Platelet count ≥120,000/mm^3 - CrCl ≥60 mL/min - Potassium & magnesium within normal limits - AST (SGOT) <2.0 x ULN - ALT (SGPT) <2.0 x ULN - Alkaline phosphatase <2.0 x ULN - Total bilirubin <2.5 x ULN - HCV antibody negative result at screening (between 36-60 days prior to study entry) or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained at screening - Negative HBsAg result obtained at screening (between 36-60 days prior to study entry) or a positive HBsAb result at any time prior to study entry - For females of reproductive potential, negative urine pregnancy test (with a sensitivity of ≤25 mIU/mL) at screening (between 36-60 days prior to study entry), at pre-entry (between 3-14 days prior to study entry), & at entry prior to infusion, by any US laboratory that has a CLIA certification or equivalent - Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All participants of reproductive potential will be instructed to use contraceptives for 6 months or 180 days after completing RMD/placebo infusion - Karnofsky performance score ≥80 at pre-entry (between 3-14 days prior to study entry) - Men and women age ≥ 18 years - Ability & willingness to provide written informed consent - Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen Exclusion Criteria: Cohort 4, Step 1 - History of or current malignancy requiring cytotoxic therapy - Bacterial, fungal or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry - History of or current CMV end organ disease (eg, retinitis) - History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator - Chronic, acute, or recurrent infections that are current & serious, in the opinion of the investigator, for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable - Active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis, & optic neuritis - History of seizure disorders - History of anticonvulsant use within 60 days prior to study entry - History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome - Breastfeeding - Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry - Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study - Intent to use cytokines (eg, IL-2 or IL-12) during the course of the study - Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (azithromycin, clarithromycin, erythromycin), antiretrovirals that are inhibitors of, or are metabolized by CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc), cobicistat, warfarin, nefazodone, rifamycins (rifabutin, rifampin, rifapentine), St. John's Wort, carbamazepine, phenytoin, phenobarbital, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, & birth control products containing estrogen, drugs that are p-glycoprotein inhibitors, & drugs that prolong the QTc interval with a risk of Torsades de Pointes - Known allergy/sensitivity or any hypersensitivity to components of RMD or its formulation - Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry - Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements - Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry - Psychosocial conditions that would prevent study compliance & follow-up as determined by the investigator - Documented opportunistic infections within 60 days prior to entry - Use of any of the medications listed in the Prohibited Medications table in the protocol See the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4. | |
| 48 | NCT01933880 | completed | 1 | phase 4 | ['attention deficit hyperactivity disorder (adhd)'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['osmotic release oral system methylphenidate hydrochloride (oros-mph)'] | ['COC(=O)C(C1CCCCN1)C1=CC=CC=C1'] | Inclusion Criteria: - ADHD children must sign the consent form in person, and their parents or guardian must endorse, in the consent form, participation of the child in the designated research program - Through personal interaction and assessment questionnaire, examine to determine compliance of DSM-IV ADHD diagnostic criteria - According to the judgment of researchers, the ADHD children should have normal intelligence. Normal intelligence is defined as no obvious evidence of mental retardation in general (specific learning disabilities will not be considered mental retardation in general), formal IQ test to be conducted and 85 marks or above ought to be scored - ADHD children should not have been subjected to psychotropic drug treatment within 6 months. Those ADHD children on whom methylphenidate immediate-release tablets treatment is effective (with maximum daily dosage of 60 mg), may be admitted - Normal children with IQ greater than or equal to 85 Exclusion Criteria: - Unable to fully comply with the cognitive function test in the laboratory - Known to be allergic to methylphenidate - Consumption of psychoactive drugs currently or in the past 30 days, including use of monoamine oxidase inhibitors, clonidine, other alpha 2 adrenergic receptor agonists, tricyclic antidepressants, theophylline, bishydroxycoumarin etc - History of alcohol, drugs or substances abuse - Have medical history of type I or II bipolar affective disorder, anxiety disorder, schizophrenia or pervasive developmental disorder | |
| 49 | NCT01938040 | completed | 1 | phase 4 | ['gallbladder disease'] | ["['K82.9', 'K82.8', 'K87']"] | ['ibuprofen'] | ['[H][C@@]12OC3=C(OC)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O'] | Inclusion Criteria: - undergoing laparoscopic cholecystectomy under general anesthesia - American Society of Anesthesiologists status of 1, 2 or 3 (as determined by the anesthesiologists) - not pregnant of breast feeding Exclusion Criteria: - cognitively impaired - using antipsychotic drugs - chronic use of steroids or opioids - subject has received COX inhibitors within 3 days if surgery - subjects for whom opiates, benzodiazepines and COX inhibitors are contraindicated - subjects with a history of bleeding disorders or peptic ulcer disease | |
| 50 | NCT01939977 | completed | 1 | phase 4 | ['secondary hyperparathyroidism due to renal causes'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['paricalcitol', 'calcifediol'] | ['CC(C)[C@@H](C)\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)CCC1=C', 'CC(C)[C@@H](C)\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)CCC1=C'] | Inclusion Criteria: - Patient that have willingly signed and dated the ICD (Informed Consent Document) approved by the EC (Ethics Committee) before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it. - Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor. - 24 hours previous to the transplantation, patient must have a significant grade of secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels between 110 and 600 pg/mL as per central laboratory results. - Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central). - Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results. - Patients that are to be treated with immunosuppression based on tacrolimus, mofetil mycofenolate or mycophenolic acid and with steroids and that are not going to be treated with mTOR (mammalian target of rapamycin) inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation. - Patients that are able to take oral capsules on the first week post-transplantation. Exclusion Criteria: - Third or subsequent renal transplantation. - Positive cross-match assay or ABO (A-B-0) incompatibility - Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation. - Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D). - Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsorption. - Patient with hypo or hyperthyroidism not controlled based on investigators criteria. - Patient with uncontrolled hypertension based on investigators criteria. - Patients that, 48 hours previous to transplantation, have been receiving calcimimetics. - Patients with VIH (human immunodeficiency virus)infection of positive serology for HBV (hepatitis B virus) and/or HCV (hepatitis C virus) - Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC) - Patients that are participating on other clinical trial with investigational drugs. - Women of childbearing potential (defined as those whose last menstruation was <2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment. - Patient with other diseases or conditions that based on investigators criteria are not suitable for the study. - Treatment will not be started if the Calcium-Phosphorus product (CAxP)is >55 mg2/dL2 or in case of hyperphosphatemia considered significant as per investigator criteria | |
| 51 | NCT01942590 | completed | 0 | phase 1/phase 2 | ['pompe disease'] | ["['E74.02']"] | ['clenbuterol', 'placebo'] | ['CC(C)(C)NCC(O)C1=CC(Cl)=C(N)C(Cl)=C1'] | Inclusion Criteria: 1. Diagnosis of Pompe disease by blood acid alpha-glucosidase assay and acid alpha-glucosidase gene sequencing, 2. Age: 18+ years at enrollment, 3. Receiving ERT at standard dose (20 mg/kg every 2 weeks) for at least 52 weeks, 4. Subjects are capable of giving written consent. Exclusion Criteria: 1. Continuous invasive ventilation (via tracheostomy or endotracheal tube) 2. Clinically relevant illness within two weeks of enrollment including fever > 38.2 C, vomiting more than once in 24 hours, seizure, or other symptom deemed contraindicative to new therapy. 3. Chronic heart disease (Myocardial infarction, arrythmia, cardiomyopathy) 4. Tachycardia 5. History of seizure disorder 6. Hyperthyroidism 7. Pheochromocytoma 8. Pregnancy 9. History of diabetes 10. History of hypersensitivity to beta 2-agonist drugs such as albuterol, levalbuterol (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline, salmeterol (Serevent), 11. Patients on a non-standard schedule for ERT; for example, weekly infusions as opposed to infusions every two weeks. 12. Treatment for asthma in the previous 12 months. 13. The use of the following concommitant meds is prohibited during the study: - diuretics (water pill); - digoxin (digitalis, Lanoxin); - beta-blockers such as atenolol (Tenormin), metoprolol (Lopressor), and propranolol (Inderal); - tricyclic antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), and nortriptyline (Pamelor); - Monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or - other bronchodilators such as albuterol, levalbuterol (Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol (Serevent), isoetherine (Bronkometer), metaproterenol (Alupent, Metaprel), or isoproterenol (Isuprel Mistometer). | |
| 52 | NCT01943552 | completed | 1 | phase 4 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['placebo', 'ipratropium bromide'] | ['[H][C@]12CC[C@]([H])(C[C@@H](C1)OC(=O)C(CO)C1=CC=CC=C1)[N+]2(C)C(C)C'] | Inclusion criteria: - All patients must sign an informed consent. - Male or female patients aged >= 40 years and <= 80 years - All patients must be diagnosed with COPD and must meet the following spirometric criterion: post-bronchodilator forced expiratory volume in 1 second (FEV1) < 70% of forced vital capacity (FVC) at Screening Visit (Visit 1). - All patients have relatively stable COPD (i.e. have no COPD exacerbation within 4 weeks prior to Screening Visit). - All patients are about to receive selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia, whilst the estimated time of surgical procedures lasts for not less than 2 hours, and the estimated time of general anaesthesia lasts for not less than 3 hours and not longer than 5 hours. - Patients must be able to perform all study related procedures including technically acceptable pulmonary function tests (PFTs). Exclusion criteria: - Patients who need maintenance treatment of bronchodilators (including anticholinergics, ß-agonists, xanthines). - Patients with a recent history (i.e. six months or less) of myocardial infarction - Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year - Patients with symptomatic chronic heart failure (i.e. New York Heart Association functional class III-IV) - Known narrow angle glaucoma - Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms - Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count >= 600 / mm3 (0.6×10^9/L). A repeat eosinophil count will not be conducted in these patients | |
| 53 | NCT01947153 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['metformin', 'linagliptin', 'metformin', 'linagliptin'] | ['[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', '[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', '[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1'] | Inclusion criteria: - Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation - Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and urinalysis). - Age 18 to 45 years (incl.) - Body mass index by Quetelet between 18.50 to 24.99 kg/m2 (incl.) - Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If a female is postmenopausal (no menses for at least 2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing. - Male subjects who agree on using effective contraception during the study (barrier contraceptive methods) Exclusion criteria: - Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance - Any laboratory value outside the reference range that is of clinical relevance - Any evidence of a clinically relevant concomitant disease - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C) - A positive urine drug screening test at screening and on admission to the trial site in each treatment period. - A positive alcohol breath test at screening and on admission to the trial site in each treatment period. - Surgery of the gastrointestinal tract (except appendectomy) | |
| 54 | NCT01948791 | completed | 1 | phase 4 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['ena713'] | ['CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C'] | Key Inclusion Criteria: - Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria - MMSE score of ≥ 10 and ≤ 26 - The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks - Be in stable medical condition - Have signed off informed consent form by patients or his/her legal guardian Key Exclusion Criteria: - Severe AD - Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition - Attending other clinical trials or taking other clinical trial drugs - A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS); - Patients who is using any AChEI or memantine | |
| 55 | NCT01949545 | completed | 1 | phase 1 | ['solid tumors', 'hematologic malignancies', 'hepatic impairment'] | ["['E70.338', 'E70.339', 'O28.0', 'P61.8', 'P61.9', 'T45.8X1A', 'T45.8X1D']", "['Z73.82', 'G31.84', 'M10.38', 'M10.30', 'M10.311', 'M10.312', 'M10.319']"] | ['carfilzomib'] | ['[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Key Inclusion Criteria: 1. Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies) 2. At least ≥ 2 prior treatment regimens for the underlying malignancy 3. Confirmed advanced solid tumor or hematologic malignancy 4. Measurable or evaluable disease 5. Clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. Hepatic impairment will be assessed as per National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema and will fall into one of the following three categories: - Cohort 2 (mild): Bilirubin > 1-1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) > ULN, but bilirubin ≤ ULN - Cohort 3 (moderate): ≥ 1.6-3 × ULN; any AST - Cohort 4 (severe): Bilirubin > 3 × ULN; any AST Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function: All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion #5, which should be substituted with the following criterion to be enrolled into the study: - Cohort 1 (normal hepatic function): Bilirubin ≤ ULN; AST ≤ ULN 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 7. Left ventricular ejection fraction (LVEF) ≥ 40% 8. Adequate renal function (calculated creatinine clearance ≥ 30 mL/min) 9. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment Key Exclusion Criteria: 1. Subjects with symptomatic brain metastasis or central nervous system (CNS) disease 2. Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrolment 3. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests [bilirubin, AST] will be allowed) | |
| 56 | NCT01950819 | completed | 1 | phase 4 | ['end stage renal disease (esrd)', 'chronic kidney disease (ckd)', 'hemodialysis', 'renal replacement therapy', 'renal transplantation'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']", "['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']", "['I95.3', 'R88.0', 'Z49.31']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['corticosteroids', 'evr+rcni', 'mpa+scni'] | ['[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C', 'CO[C@@H]1C[C@@H](CC[C@H]1O)\\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC', '[H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)CC[C@]12C'] | Inclusion Criteria: 1. Written informed consent obtained. 2. Subject randomized within 24 hr of completion of transplant surgery. 3. Recipient of a kidney with a cold ischemia time < 30 hours. 4. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor. Exclusion Criteria: 1. Subject unable to tolerate oral medication at time of randomization. 2. Use of other investigational drugs at the time of enrollment. 3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 4. Multi-organ transplant recipient. 5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. 6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA. 7. Subject who is HIV-positive. 8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable. 9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV). 10. Subject with a BMI greater than 35. 11. Subject with severe systemic infections, current or within the two weeks prior to randomization. 12. Subject requiring systemic anticoagulation. 13. History of malignancy of any organ system. 14. Subject with severe restrictive or obstructive pulmonary disorders. 15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. 16. Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3. 17. Pregnant or nursing (lactating) women. 18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. | |
| 57 | NCT01954732 | withdrawn | slow accrual | 0 | phase 1 | ['stage ia pancreatic cancer', 'stage ib pancreatic cancer', 'stage iia pancreatic cancer', 'stage iib pancreatic cancer'] | ["['C25.3']", "['C25.3']", "['C25.3']", "['C25.3']"] | ['metformin hydrochloride'] | ['CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed resectable pancreatic carcinoma; patients with pancreatic neuroendocrine tumors are not eligible - Patients must be previously untreated with chemotherapy or radiation therapy - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Patients must have surgical resection of the pancreas planned, with enrollment at least 7 days prior to surgery; patients with surgery scheduled > 15 days will not be excluded - Hemoglobin (Hg)A1C must be below 7% - Total bilirubin less than 1.5 X institutional upper limit of normal - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 X institutional upper limit of normal - Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal - Serum creatinine within normal institutional limits - Alkaline phosphatase < 1.5 X institutional upper limit of normal - Subjects must have the ability to understand and be willing to provide written informed consent Exclusion Criteria: - History of metformin use in the previous 3 months - Treatment with neoadjuvant chemotherapy or radiation therapy - History of allergic reactions attributed to metformin - Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Metabolic acidosis, acute or chronic, including ketoacidosis - Metastatic disease |
| 58 | NCT01957215 | completed | 1 | phase 4 | ['ankle sprain'] | ["['S93.401S', 'S93.402S', 'S93.409S', 'S93.411S', 'S93.412S', 'S93.419S', 'S93.421S']"] | ['indomethacin', 'placebo'] | ['COC1=CC2=C(C=C1)N(C(=O)C1=CC=C(Cl)C=C1)C(C)=C2CC(O)=O'] | Inclusion Criteria: - Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit - Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating. - Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle) Exclusion Criteria: - Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. - Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain. - Pregnancy , Breast Feeding and Substance Abuse | |
| 59 | NCT01959139 | active, not recruiting | 1 | phase 1/phase 2 | ['metastatic pancreatic adenocarcinoma'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['pegph20', 'oxaliplatin', 'leucovorin', 'irinotecan', '5-fluorouracil'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O', 'FC1=CNC(=O)NC1=O'] | - Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases - Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) - Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3 years prior to registration; patients must not have had prior chemotherapy in metastatic setting; prior abdominal radiation therapy is not allowed - Patients must have a Zubrod performance status of 0-1 - Absolute neutrophil count (ANC) >= 1,500/mcL - Platelets >= 100,000/mcL - Hemoglobin >= 9 g/dL - Total bilirubin =< institutional upper limit of normal (IULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 X IULN in the absence of liver metastases or =< 5.0 x IULN with liver metastasis - Serum albumin >= 3 g/dL - Serum creatinine =< ULN within 14 days prior to registration OR calculated creatinine clearance > 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration - Patients must have international normalized ratio (INR) =< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration) - Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent - Patients must not have liver disease such a cirrhosis, chronic active hepatitis or chronic persistent hepatitis - Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding - Patients with a known history of human immunodeficiency virus (HIV) must not be on active treatment for HIV - Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples - Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation | |
| 60 | NCT01964547 | completed | 1 | phase 4 | ['multiple sclerosis', 'spasticity'] | ["['G35', 'C81.18']"] | ['sativex', 'placebo'] | ['[H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)OC1=C2C(O)=CC(CCCCC)=C1'] | Inclusion Criteria (ALL to be fulfilled): - Patient is willing and able to give informed consent for participation in the study. - Patient is aged 18 years or above. - Diagnosed with any disease sub-type of multiple sclerosis. - Diagnosed with symptomatic spasticity due to multiple sclerosis. - Patient has at least moderate spasticity in the opinion of the investigator. - Patient fulfils at least one of the two criteria below. Subject must be either: - Currently established on a regular dose of anti-spasticity therapy, or - Previously tried and failed anti-spasticity therapy. - Stable medication regimen for at least four weeks prior to study entry, for all medications which may have an effect on spasticity and/or cognition. - If the patient is taking disease modifying medication this must be at a stable dose for three months prior to the initial visit. - Willing and able to comply with all study requirements. - Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable. - Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study. Exclusion Criteria (if ANY apply): - Any history or immediate family of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. - Any concomitant disease or disorder (such as poorly controlled epilepsy or seizures) that may influence the patient's level of cognition or mood. - Currently using or has used cannabis or cannabinoid-based medications within 30 days of study entry and unwilling to abstain for the duration of the study. - Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption (more than 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug. - Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products. - Female patients of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. - Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. - Patients who have received an investigational medicinal product within the 12 weeks prior to the initial visit. - Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study may influence the result of the study, or the patient's ability to participate in the study. - Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study. - Previously randomised to this study. | |
| 61 | NCT01966107 | completed | 1 | phase 4 | ['copd', 'chronic obstructive pulmonary disease', 'moderate to very severe copd'] | ["['J44.9', 'J44.1', 'J44.0']", "['F71', 'N87.1', 'N89.1', 'N90.1', 'E44.0', 'J45.40', 'K05.212']"] | ['aclidinium bromide', 'placebo'] | ['OC(C(=O)O[C@H]1C[N+]2(CCCOC3=CC=CC=C3)CCC1CC2)(C1=CC=CS1)C1=CC=CS1'] | Inclusion Criteria: - 1. Male or female outpatients ≥ 40 years of age - 2. Current or former cigarette smokers with a smoking history of at least 10 pack-years - 3. A diagnosis of stable, moderate to very severe COPD (GOLD, 2015) with a post-bronchodilator FEV < 80% FEV1/forced vital capacity (FVC) ratio < 70% - 4. Must have at least one of the following 4 criteria: 1. Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis) 2. Documented coronary artery disease (angina, MI, angioplasty/stent/bypass) 3. Documented peripheral vascular disease or history of claudication 4. At least 2 of the following atherothrombotic risk factors as determined by the PI: 1. Male ≥ 65 years or female ≥ 70 years 2. Diabetes 3. Dyslipidemia 4. Hypertension 5. Waist circumference inches males ≥ 40 in or in females ≥ 38 inches 6. Evidence of renal dysfunction (eGFR < 60) and microalbuminuria (eGFR is based on modification of diet in renal disease [MDRD] equation, microalbuminuria is defined as ≥ 30-300 mcg/mg creatinine on a spot urine or ≥30 mg creatinine on a 24hr urine test) - 5. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II) - 6. Able to perform pulmonary function test (PFT) maneuvers and follow study procedures - 7. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test at Visit 1A and be practicing medically acceptable method of contraception. Otherwise, female patients should be at least 1 year postmenopausal, surgically sterile (defined as having a hysterectomy or tubal ligation). - 8. Should understand study procedures and be willing to participate in the study as indicated by signing the ICF Exclusion Criteria: - 1. Significant diseases other than COPD or cardiovascular disease (e.g., metastatic cancer) which, in the opinion of the PI, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study - 2. Unstable or life threatening cardiovascular disease or COPD as determined by the PI - 3. Patients with comorbid lung disease such as asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease - 4. Planned lung transplant or lung volume reduction surgery - 5. Currently treated with a combination of LAMA and LABA/ICS therapy. - 6. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within 5 years prior to screening. Patients with treated basal cell and squamous cell (skin) carcinoma are allowed - 7. Respiratory infection or COPD exacerbation at Screening and/or within 4 weeks prior to screening - 8. Uncontrolled infection resulting from human immunodeficiency virus (HIV) and/or active hepatitis - 9. Reported history of drug or alcohol abuse within the past 12 months - 10. History of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) - 11. History of acute urinary retention, treatment refractory benign prostatic hyperplasia (BPH), bladder neck obstruction, or narrow-angle glaucoma (Note: Patients with controlled, stable BPH are not excluded) - 12. Patients unable to use a multidose DPI or a pressurized metered-dose inhaler - 13. Treatment with any other investigational drug within 30 days (or 6 half-lives, whichever is longer) before Visit 1A - 14. Women who are pregnant or breastfeeding - 15. Use of any prohibited medication listed in Appendix II - 16. Employee or immediate relative of an employee of AstraZeneca, any of its affiliates or partners, or the study center | |
| 62 | NCT01968434 | completed | 1 | phase 4 | ['cough', 'upper respiratory tract infection'] | ["['R05', 'G44.83', 'J45.991', 'A37.90', 'A37.91', 'A37.00', 'A37.01']", "['R09.2', 'A15.7', 'A15.8', 'A15.9', 'J98.9', 'R06.03', 'J12.1']"] | ['carbocisteine cough syrup'] | ['N[C@@H](CSCC(O)=O)C(O)=O'] | Inclusion Criteria: - cough attributed to URTI such as the common cold - 2-5 years of age - moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment. - moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent) - signature of informed consent Exclusion Criteria: - Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease. - Children who received cough medicines or drugs containing antihistamines the day prior to study entry. - Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring - Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry ) - Known sensitivity to carbocysteine specifically to the comparator Mucolit - gastric ulcer | |
| 63 | NCT01970176 | completed | 0 | phase 1/phase 2 | ['cardiomyopathy', 'renal impairment'] | ["['A36.81', 'B33.24', 'I25.5', 'I42.0', 'I42.6', 'I42.9', 'O90.3']", "['M10.38', 'M10.30', 'M10.311', 'M10.312', 'M10.319', 'M10.321', 'M10.322']"] | ['tadalafil', 'placebo'] | ['[H][C@]12CC3=C(NC4=CC=CC=C34)[C@H](N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1'] | Inclusion Criteria: - A total of 39 patients with PSD as defined by an ejection fraction of less than 40%, no clinical signs or symptoms of congestive heart failure, a minimal distance on 6-minute walk of equal or >450 meters will be recruited and calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the (MDRD-measurement of renal dysfunction, formula) assessed within the past 24 months. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath than they will still qualify for the protocol. Exclusion Criteria: - Current or anticipated future need for nitrate therapy - Systolic blood pressure < 90 mmHg or > 180 mm Hg - Diastolic blood pressure < 40 mmHg or > 100 mmHg - Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum proteases inhibitors for HIV) who cannot be taken off these medications for the duration of the study. - Patients taking the following selective alpha blockers and who are unable to stop for the duration of the study; - Alfuzosin - Prazosin - Doxazosin - Tamsulosin - Terazosin - Silodosin - Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance - Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease) - Patients with an allergy to iodine. - Patients on PDEV inhibition for pulmonary hypertension - Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study - Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation) - Obstructive Hypertrophic cardiomyopathy - Infiltrative or inflammatory myocardial disease (amyloid, sarcoid) - Pericardial disease - Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent - Severe congenital heart diseases - Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening - Second or third degree heart block without a permanent cardiac pacemaker - Stroke within 3 months of screening or other evidence of significantly compromised Central Nervous System (CNS) perfusion - Hemoglobin <9 g/dL - Patients with severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal) - Serum sodium of < 125 mEq/dL or > 150 mEq/dL - Serum potassium of < 3.2 mEq/dL or > 5.9 mEq/dL - Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50% - Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period - Less than 21 years of age - Pregnant or nursing women. - Women of child bearing potential who do not have a negative pregnancy test at study entry and who are not using effective contraception - Non-cardiac condition limiting life expectancy to less than one year, per physician judgment - Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data - Received an investigational drug within 1 month prior to dosing - In the opinion of the investigator is unlikely to comply with the study protocol or is unsuitable for any reasons | |
| 64 | NCT01975220 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['empagliflozin/metformin xr, fdc', 'empagliflozin/metformin xr fdc', '25 mg empagliflozin/1000 mg metformin xr, fdc', '1 tablet empagliflozin/2 tablets metformin xr', '1 tablet empagliflozin/3 tablets metformin xr', '1 tablet empagliflozin/2 tablets metformin xr'] | ['CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1'] | Inclusion criteria: 1. Healthy males or females 2. Age 18-50 years (incl) 3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl) 4. Subjects must be able to understand and comply with study requirements Exclusion criteria: Any deviation from healthy condition | |
| 65 | NCT01980940 | completed | 0 | phase 1/phase 2 | ['osteoarthritis pain'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['etoricoxib 75 mg 4% dmso gel', 'etoricoxib 75 mg 4% pg gel', 'etoricoxib 150 mg 4% dmso gel', 'etoricoxib 150 mg 4% pg gel', 'etoricoxib 163 mg 4% dmso gel', 'placebo', 'etoricoxib 50 mg 4% dmso', 'matching placebo to etoricoxib 50 mg 4% dmso gel'] | ['CC1=NC=C(C=C1)C1=C(C=C(Cl)C=N1)C1=CC=C(C=C1)S(C)(=O)=O'] | Inclusion Criteria - Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for >6 months based on clinical and radiographic criteria; - Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or III; - The knee designated as the "study joint" must be the participant's primary source of pain/disability in the lower extremity. If both knees are affected, the most painful joint will be selected for evaluation for inclusion and clinical response; - Female participants of childbearing potential must demonstrate a serum beta human chorionic gonadotropin (β-hCG) level consistent with a non-gravid state at the screening visit and urine β-hCG at Day -1 prior to first dosing and agree to use adequate oral or barrier contraception or abstain from sexual contact at least 7 days prior to treatment and continuing through the treatment period or a discontinuation visit; - Willing to limit alcohol intake (beer 8 ounces, wine 4 ounces, liquor 1 ounce) to no more than 14 drinks a week (no more than 2 in a day) and to avoid unaccustomed strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical therapy) for the duration of the study; - Judged to be in general good health with the exception of osteoarthritis based on medical history, physical examination, and routine laboratory tests. - For Part 2, if the participant is a regular user of non-steroidal anti-inflammatory drugs (NSAIDs) including coxibs he/she must report a history of positive therapeutic benefit in osteoarthritis of the knee with NSAID/coxibs in the past; - For Part 2, participants must be taking a single NSAID on a regular basis and at a prescription strength for at least 30 days prior to study screening ("regular basis" is defined as at least 25 of the previous 30 days) for treatment of symptoms of osteoarthritis. Exclusion Criteria: - Has a concurrent medical/arthritic disease; - History of acute ligamentous or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected knee within 6 months prior to study entry; - Is a candidate for imminent joint replacement; - Has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (apart from migraine), or other systemic disease that in the opinion of the investigator contraindicates the use of etoricoxib; - Has congestive heart failure with symptoms that occur at rest or minimal activity; - Has unstable angina that occurs at rest or with minimal activity; - Has uncontrolled hypertension (sitting diastolic blood pressure >95 mm Hg, or sitting systolic blood pressure >165 mm Hg); - Has a history of stroke or transient ischemic attack (TIA) within the previous 6 months; - Has a history of hepatitis/hepatic disease that has been active within the previous 2 years; - Has a history of neoplastic disease; - Is currently a user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years; - Is allergic of has hypersensitivity to aspirin, ibuprofen, rofecoxib, celecoxib, valdecoxib, other NSAIDs, acetaminophen, or sulfa drugs; - Has used intravenous, intramuscular, or oral corticosteroids within 1 month of study entry; - Has used glucosamine and/or chondroitin sulfate for <6 months prior to study start; - Has used intra-articular steroids, HYALGAN™ (sodium hyaluronate, Sanofi Pharmaceuticals), or SYNVISC™ (hylan G-F 20, Wyeth-Ayerst Pharmaceuticals) to the study joint within 3 months of entry into the study or intra-articular steroids, HYALGAN™, or SYNVISC™ to any other joint within 1 month of study entry; - Has used topical, oral or systemic analgesic medications within 2 weeks of study entry and for the duration of the study; - Requires treatment with warfarin, heparin, high-dose aspirin (>325 mg), or digoxin; - Has used Arcoxia® within 2 weeks of study entry. | |
| 66 | NCT01982435 | completed | 1 | phase 1/phase 2 | ['diabetic macular edema'] | ["['E10.311', 'E10.319', 'E11.311', 'E11.319', 'E13.311', 'E13.319', 'E10.3513']"] | ['ranibizumab', 'ranibizumab'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O', 'CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Inclusion Criteria: - Subjects will be eligible if the following criteria are met: - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age > 18 years - ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye - Willing, committed, and able to return for ALL clinic visits and complete all study related procedures - At least 6 previous bevacizumab injections for diabetic macular edema in the last 12 months in the study eye. - At least 2 bevacizumab injections within 10 weeks and the most recent bevacizumab injection within 6 weeks of baseline study visits in the study eye. - Persistent foveal-involving diabetic macular edema based on presence of intraretinal and/or subretinal fluid by SDOCT in the foveal center at study entry in the study eye. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from this study: - Pregnancy (positive pregnancy test) or lactation - Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD (intrauterine device), or contraceptive hormone implant or patch. - Intravitreal steroid or periocular steroid treatment within 3 months of study entry in the study eye. - Focal/grid laser photocoagulation treatment within 3 months of study entry in the study eye. - Panretinal photocoagulation treatment within 3 months of study entry in the study eye. - Prior vitrectomy in the study eye - History of retinal detachment in the study eye - Prior trabeculectomy or other filtration surgery in the study eye - Active intraocular inflammation in either eye - Active ocular or periocular infection in either eye - Active scleritis or episcleritis in either eye - History of any other retinal vascular disease (e.g., retinal vein occlusion, retinal artery occlusion) in the study eye. - Coexistent retinal disease other than diabetic retinopathy (e.g., AMD (age related macular degeneration), inherited retinal disease) in the study eye. - Intraocular surgery within 3 months of study entry in the study eye. - History of corneal transplant or corneal dystrophy in the study eye. - Significant media opacities in study eye which may interfere with visual acuity in the study eye. - Participation as a subject in any clinical study within 3 months of study entry. - History of allergy to topical iodine - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated - Participation in another simultaneous medical investigation or trial | |
| 67 | NCT01983566 | terminated | 0 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['bi 207127 high fat', 'bi 207127 with omeprazole', 'bi 207127', 'bi 207127 low fat'] | ['[Na+].OC([O-])=O'] | Inclusion criteria: - Healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Subjects will be either Caucasian or Japanese (first generation Japanese: born in Japan with parents of Japanese descent, and not more than 5 years out of Japan, documented by medical interview and by appropriate materials - e.g. passport, birth certificate, etc) - Age 20 to 35 years (incl.) - BMI 18.5 to 25 kg/m2 (incl.) Exclusion criteria: - Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator - Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged clinically relevant by the investigator - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders - Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) - Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders | |
| 68 | NCT01985477 | terminated | terminated phase i due to slow accrual without progression to phase ii. | 0 | phase 1 | ['myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['lenalidomide', 'dexamethasone', 'all-trans retinoic acid (atra)'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O', '[H][C@]12CC3=C(C=C(OC)C=C3)[C@@]3(CCCC[C@]13[H])CCN2C', 'C\\C(\\C=C\\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(O)=O'] | Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form 2. Age >/= 18 years at the time of signing the informed consent form 3. Serum creatinine </= 2.5 mg/dl OR Creatine clearance > 30 ml/min 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 5. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional affective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. 6. Continuation from Inclusion #5: *A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 7. Able to take prophylactic antiplatelet/anticoagulation, warfarin or equivalent agent 8. Patient is able to understand and comply with the terms and conditions of the Lenalidomide Counseling Program. 9. Phase I Specific Inclusion Criteria: Multiple myeloma that has progressed on lenalidomide and dexamethasone combination therapy at a dose of 25 mg daily on lenalidomide and 40 mg weekly of dexamethasone with measurable levels of myeloma paraprotein in serum ( >/= 0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (FLC) ratio. 10. Phase I Specific Inclusion Criteria: Laboratory test results within these ranges: Absolute neutrophil count > 1000 cells/mm^3; Platelet count > 100,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 50,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells; Total bilirubin </= 2.0 mg/dL; AST (SGOT) and ALT (AGPT) < 3 x upper limits of normal (ULN) 11. Phase II Specific Inclusion Criteria: Cohort A: Multiple myeloma that has progressed on lenalidomide and dexamethasone combination therapy with measurable levels of myeloma paraprotein in serum ( >/= 0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or involved FLC level by more than 10 mg/dL and abnormal free light chain (FLC) ratio. Cohort B: Multiple myeloma that has progressed on single agent lenalidomide therapy with measurable disease defined as: doubling of the M-component in 2 consecutive measurements in less than or equal to 2 months OR increase in serum M-protein levels by >/= .5g or urine protein by 200mg/24 hours, or involved FLC level by more than 10 mg/dL (with an abnormal FLC ratio). 12. Phase II Specific Inclusion Criteria: Laboratory test results within these ranges: Absolute neutrophil count > 1000 cells/mm^3; Platelet count > 75,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 50,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells; Total bilirubin </= 2.0 mg/dL; AST (SGOT) and ALT (AGPT) < 3 x ULN Exclusion Criteria: 1. Any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 3. Use of any cancer therapy within 14 days prior to beginning cycle 1 day 1 of therapy with the exception of lenalidomide and dexamethasone (radiation therapy allowed within 5 days of completion of radiation therapy) 4. Known hypersensitivity to lenalidomide or ATRA. |
| 69 | NCT01985581 | completed | 1 | phase 4 | ['attention deficit hyperactivity disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['guanfacine extended release', 'placebo', 'stimulant therapy'] | ['C[C@H](N)CC1=CC=CC=C1', 'NC(=N)NC(=O)CC1=C(Cl)C=CC=C1Cl'] | Inclusion Criteria: 1. Male or female patient aged 6 to 12 years at the time of consent/assent and to then of study. A patient who would turn 13 before the end of the study cannot be enrolled 2. Patient's parent or legally authorized representative (LAR) must provide signed informed consent before any study-related procedures are completed. 3. Patient meets the diagnostic standard manual-5 criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type 4. Patient is currently on a stable stimulant regimen but whose EF is suboptimal. Suboptimal EF is defined as a global executive composite t-score greater than 65 (>1.5 SD from mean) on the BRIEF-P questionnaire at screening. 5. Patient who is currently and is expected to remain on a stable stimulant regimen throughout the study. A stable stimulant regimen is defined as: •No significant change in dose or dosing frequency within the past 30 days prior to screening and stimulant is felt to be optimized by the investigator. 6. Patient is functioning at an age-appropriate level intellectually, as judged by the Investigator. 7. Patient is able to swallow intact tablets. 8. Patient has sitting blood pressure (BP) measurement within the 95th percentile for age, sex, and height (see Blood Pressure Levels for Boys and Girls by Age and Height Percentile 9. Patient and parent/LAR understand, are willing, able, and likely to fully comply with the study procedures and restrictions defined in this protocol. Exclusion Criteria: 1. Patient has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis [except oppositional defiant disorder (ODD)], including any severe co-morbid Axis II disorders or severe Axis I disorders such as post-traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder. 2. Patient has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the patient and/or could confound the interpretation of the study. Mild stable asthma treated without the use of beta-2 agonist is not exclusionary. 3. Patient has a known personal history, or presence, of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (e.g., clinically significant heart block or QT interval prolongation: QTc >0.44 seconds), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia. 4. Patient has a known family history (in siblings, parents, and/or grand-parents) of sudden cardiac death, ventricular arrhythmia, or QT prolongation (QTc >0.44 seconds). 5. Patient has a known history of hypertension (see Blood Pressure Levels for Boys and Girls by Age and Height Percentile 6. Patient has glaucoma. 7. Patient has a history of a seizure disorder (other than a simple childhood febrile seizure). 8. Patient has renal or hepatic insufficiency 9. Patient is currently using prohibited medication. 10. Patient has taken another investigational product within 30 days prior to the Enrolment Visit. 11. Patient has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any of its active ingredients or patient is taking other products containing guanfacine. 12. History of adverse event or failure to respond (lack of efficacy) to an adequate trial of an alpha-agonist. 13. Patient is female and is pregnant or currently lactating. 14. Patient is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicide ideation. Patients with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. | |
| 70 | NCT01986062 | completed | 1 | phase 4 | ['attention deficit hyperactivity disorder (adhd)'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['ar11', 'placebo'] | ['CC(N)CC1=CC=CC=C1'] | Inclusion Criteria: 1. Male or female between 6 and 12 years of age, inclusive, at the time of Screening. 2. Diagnosed as meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for ADHD. 3. A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. 4. An ADHD Rating Scale (ADHD-RS) score at Screening and Baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: hyperactive-impulsive subscale, inattentive subscale, or total score. Exclusion Criteria: 1. Secondary or co-morbid diagnoses other than ADHD, with the exception of simple phobias, oppositional defiant disorder, elimination disorders, motor skills disorders, communication disorders, learning disorders, adjustment disorders, and sleep disorders if, in the opinion of the investigator, the associated symptoms do not confound assessment of safety or efficacy. 2. Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. 3. History of any of the following medical disorders: seizure disorder (excluding a history of febrile seizures), structural cardiac disorders, serious cardiac conditions, hypertension, untreated thyroid disease, glaucoma, Tourette's disorder, or chronic tics. 4. Clinically significant abnormal ECG finding or abnormal cardiac finding on physical exam (including presence of a pathologic murmur) at Screening. 5. Use of any psychotropic medication (sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to Baseline, at bedtime only, are allowed during the study). 6. A history of hypersensitivity or intolerance to any formulation of amphetamine or lisdexamfetamine. | |
| 71 | NCT01988493 | active, not recruiting | 1 | phase 1/phase 2 | ['carcinoma, hepatocellular'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['tepotinib 300 mg', 'tepotinib 500 mg', 'tepotinib 1000 mg', 'tepotinib', 'sorafenib'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Histologically or cytologically confirmed HCC - Participants were either intermediate HCC of BCLC Stage B, who were not eligible for surgical and/or local-regional therapies or who had progressive disease (PD) after surgical and/or local-regional therapies (note: the local-regional therapy must not contain sorafenib), or advanced HCC of BCLC Stage C - Participants who had disease progression on or were intolerant to the prior standard treatment for advanced HCC (phase Ib Korean subjects only) - A tumor biopsy was required for determining MET status - MET+ status (Phase 2 only), as determined by the central laboratory (Phase 1b retrospectively, Phase 2 for participant selection) were defined in the protocol - Child-Pugh class A with no encephalopathy according to the screening assessment - Asian male or female, 18 years of age or older - Measurable disease in accordance with RECIST v1.1 (Phase 2 only) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 - Eligible for treatment with sorafenib, was assessed by investigators according to the Package Insert and clinical judgment (Phase 2 only) - Signed and dated informed consent indicating that the participants had been informed of all the pertinent aspects of the trial prior to enrollment - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures - Life expectancy was judged by the investigator of at least 3 months Exclusion Criteria: - Prior systemic anticancer treatment for advanced HCC, included targeted therapy (for example, sorafenib), chemotherapy, or any other investigational agent (Phase 2 only) - Prior treatment with any agent targeting the hepatocyte growth factor (HGF)/c-Met pathway - Prior local-regional therapy within 4 weeks prior to Day 1 of trial treatment - Prior history of liver transplant - Laboratory index at baseline were defined in the protocol - Past or current history of neoplasm other than HCC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years - Known central nervous system (CNS) or brain metastasis that is either symptomatic or untreated - Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested products - Clinically significant gastrointestinal bleeding within 4 weeks before trial entry - Peripheral neuropathy Grade greater than or equal to 2 (Common Terminology Criteria for Adverse Events [CTCAE] v4.0) - Impaired cardiac function was defined in the protocol - Hypertension uncontrolled by standard therapies - Participants with a family history of long QT syndrome or who take any agent that is known to prolong QT/QTc interval - Known human immunodeficiency virus (HIV) infection - Particpants who had acute pancreatitis and/or chronic pancreatitis, with elevated lipase and/or amylase, clinical symptoms, and/or imaging studies that are indicative of the diagnosis (Mainland Chinese participants only) - Known or suspected drug hypersensitivity to any ingredients of sorafenib (Phase 2 only) and MSC2156119J - Female participants who were pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug - Concurrent treatment with a non-permitted drug - Substance abuse, other acute or chronic medical or psychiatric condition, or laboratory abnormalities that may increase the risk associated with trial participation in the opinion of the investigator - Participation in another clinical trial within the past 28 days - Previous anticancer treatment-related toxicities not recovered to baseline or Grade 0-1 (except alopecia and peripheral neuropathy) - Participants with any concurrent medical condition or disease that will potentially compromise the conduct of the study at the discretion of the investigators | |
| 72 | NCT01989195 | completed | 1 | phase 1/phase 2 | ['ischemic cardiomyopathy'] | ["['I25.5']"] | ["'seemore' - manganese-enhanced mri contrast reagent"] | ['OC[C@H](O)[C@H](CO)[N+]12CC[N+]3(CC([O-])=O)CC[N+]4(CC([O-])=O)CC[N+](CC([O-])=O)(CC1)[Gd-]234'] | Inclusion Criteria: - All subjects to be entered must: - be at least 18 years of age. - if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile - provide written informed consent after having received oral and written information about the study - be in stable health based on medical history, examination and tests Exclusion Criteria: - have a positive pregnancy test (females) - received an investigational drug or device within 30 days prior to administration of SeeMore? - have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers - have a history of drug abuse or alcoholism - are taking a digitalis preparation or calcium channel blocker - have a history of torsades or prolonged QT/QTc interval - have NYHA Grade IV heart failure - have abnormal liver function tests or a history of liver disease - have uncontrolled hypertension (Systolic Blood Pressure > 140 or Diastolic BP > 90 consistently at baseline) - have abnormal baseline potassium or calcium values or hemoglobin less than 10 g/dl - are noncompliant or otherwise unlikely to perform as required by the protocol - have pretest likelihood of CAD for which the requisite number of subjects have been entered - develop an arrhythmia prior to or during either of the exercise tests; SeeMore? should not be administered. | |
| 73 | NCT01989754 | completed | 1 | phase 4 | ['diabetes mellitus, type 2', 'albuminuria'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'canagliflozin, 100 mg', 'canagliflozin, 300 mg'] | ['[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'] | Inclusion Criteria: - Must have a diagnosis of type 2 diabetes mellitus - Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening) - Greater than or equal to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with high risk of CV events - Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels. Exclusion Criteria - History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - History of one or more severe hypoglycemic episode within 6 months before screening - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Ongoing, inadequately controlled thyroid disorder - Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant - Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening. | |
| 74 | NCT01993108 | completed | 1 | phase 4 | ['healthy', 'attention deficit hyperactivity disorder'] | ["['Z76.3', 'Z76.2']", "['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['methylphenidate', 'naltrexone', 'placebo'] | ['COC(=O)C(C1CCCCN1)C1=CC=CC=C1', 'OC1=CC=C2C[C@H]3N(CC=C)CC[C@@]45[C@@H](OC1=C24)C(=O)CC[C@@]35O'] | Inclusion Criteria for all study participants: - Right-Handedness Exclusion Criteria for all study participants: - Any clinically significant history of cardiac problems - Any current Axis I psychiatric diagnosis as verified by the Structured Clinical Interview for DSM-IV (other than participants with ADHD or history of alcohol dependence) - A previous adequate trial with methylphenidate (Ritalin) or naltrexone (ReVia) - Currently taking any psychoactive medications - Any clinically significant medical condition - Any clinically significant neurological problem (seizures, tics, serious head injury) - Contraindications to MRI (metal objects in body or claustrophobia) - Currently pregnant or lactating - Alcohol or substance abuse (current or in the past 2 years) - Left-handedness or ambidextrous - Liver or kidney disease Inclusion Criteria for the participants with ADHD: - Currently un-medicated adults with ADHD - Has met full DSM-IV-R criteria (at least six of nine symptoms)for inattentive or hyperactive/impulsive subtypes (or both) by age 7 as well within the past month - Has described a chronic course of ADHD symptomatology from childhood to adulthood - Has endorsed a moderate or severe level of impairment attributed to the ADHD symptoms | |
| 75 | NCT01996826 | completed | 0 | phase 1/phase 2 | ['corneal neovascularization', 'corneal graft failure'] | ["['H16.403', 'H16.401', 'H16.402', 'H16.409']"] | ['avastin® (bevacizumab)', '0.9% nacl & refresh liquigel'] | ['[Na+].[Cl-]'] | Inclusion Criteria: - Age > 18 years - Participant willing and able to provide written informed consent - Willing and able to comply with study assessments for the full duration of the study - High-risk characteristics for penetrating keratoplasty: 1. Presence of corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR 2. Extension of corneal NV to graft-host junction in a previous failed graft - In generally good stable overall health Exclusion Criteria: - History of Stevens-Johnson syndrome or ocular pemphigoid - Ocular or periocular malignancy - Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively - Uncontrolled glaucoma - Currently on dialysis - Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry - Concurrent use of systemic anti-VEGF agents - Change in topical corticosteroid regimen within 14 days of transplantation - Use of systemic immunosuppressive for indication other than corneal graft rejection - Pregnancy (positive pregnancy test) or lactating - Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method) - Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg - History of thromboembolic event within 12 months prior to study entry - Participation in another simultaneous medical investigation or trial | |
| 76 | NCT02002221 | completed | 1 | phase 4 | ['type 2 diabetes mellitus (t2dm)'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['vildagliptin (laf237)', 'placebo', 'insulin', 'metformin'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', 'OC12CC3CC(C1)CC(C3)(C2)NCC(=O)N1CCC[C@H]1C#N', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1'] | Inclusion Criteria: - Confirmed diagnosis of T2DM by standard criteria. - HbA1c ≥ 7.0 to ≤ 10% at Visit 1. - Age: ≥ 20 to < 75 years old at Visit 1. - BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1. Exclusion Criteria: - FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1. - Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. - Significant heart diseases - Hepatic disorder Other protocol defined inclusion/exclusion criteria may apply | |
| 77 | NCT02003391 | completed | 1 | phase 4 | ['open angle glaucoma', 'ocular hypertension'] | ["['H40.10X0', 'H40.10X1', 'H40.10X2', 'H40.10X3', 'H40.10X4', 'H40.1130', 'H40.1131']", "['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['beta-blocker monotherapy', 'travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution'] | ['CC(C)OC(=O)CCC\\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\\C=C\\[C@@H](O)COC1=CC=CC(=C1)C(F)(F)F'] | Inclusion Criteria: - Have a clinical diagnosis of either open angle glaucoma or ocular hypertension. - Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further intraocular pressure (lOP) reduction. - Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye. - Must be able to understand and sign an Informed Consent form. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Use of medication excluded by the protocol. - Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol. - Ocular surgeries or procedures excluded by the protocol. - Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal). - Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator. - Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. - Other protocol-specified exclusion criteria may apply. | |
| 78 | NCT02016625 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['faldaprevir', 'faldaprevir', 'cyclosporine', 'tacrolimus'] | ['[H][C@@](N=C(O)OC1CCCC1)(C(=O)N1C[C@@]([H])(C[C@@]1([H])C(O)=N[C@@]1(C[C@@]1([H])C=C)C(O)=O)OC1=C2C=CC(OC)=C(Br)C2=NC(=C1)C1=CSC(N=C(O)C(C)C)=N1)C(C)(C)C', '[H][C@@](N=C(O)OC1CCCC1)(C(=O)N1C[C@@]([H])(C[C@@]1([H])C(O)=N[C@@]1(C[C@@]1([H])C=C)C(O)=O)OC1=C2C=CC(OC)=C(Br)C2=NC(=C1)C1=CSC(N=C(O)C(C)C)=N1)C(C)(C)C', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion criteria: - Healthy males or females subjects - Age 18 to 50 years (incl.) - Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.) - Signed and dated written informed consent prior to admission to the study Exclusion criteria: - Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged clinically relevant by the investigator. - Systolic blood pressure (BP) less than 100 mmHg and more than 140 mmHg. - Diastolic BP less than 60 mmHg and more than 90 mmHg. - Pulse rate (PR) less than 50 bpm and more than 90 bpm. - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Any evidence of a concomitant disease judged clinically relevant by the investigator - Positive QuantiFERON-TB Gold In-Tube | |
| 79 | NCT02017327 | completed | 1 | phase 4 | ['primary open angle glaucoma', 'ocular hypertension'] | ["['H40.1130', 'H40.1131', 'H40.1132', 'H40.1133', 'H40.1134', 'H40.1110', 'H40.1111']", "['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['monoprost', 'lumigan 0.01%', 'lumigan 0.03% unit dose'] | ['CC(C)OC(=O)CCC\\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1CC[C@@H](O)CCC1=CC=CC=C1', 'CCNC(=O)CCC\\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\\C=C\\[C@@H](O)CCC1=CC=CC=C1', 'CCNC(=O)CCC\\C=C/C[C@H]1[C@@H](O)C[C@@H](O)[C@@H]1\\C=C\\[C@@H](O)CCC1=CC=CC=C1'] | Inclusion Criteria: - Male or female aged ≥18 years old. - Written informed consent. - Association of the 3 following criteria: 1. Both eyes have primary open angle glaucoma or ocular hypertension already treated and controlled by mono-therapy of Lumigan® 0.01% since at least 3 months (according to European Glaucoma Society guidelines). 2. Intra Ocular Pressure ≤ 18 mm Hg in both eyes. 3. With local intolerance signs in at least one eye defined by the association of: 3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale. And 3.2.1 Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 5 symptoms: irritation/burning, itching, tearing, eye dryness sensation, foreign body sensation. And/Or 3.2.2 Presence of at least 2 signs with a level of severity ≥ 1 (= mild or moderate or severe) among the following 3 signs: superficial punctate keratitis, blepharitis, eyelid skin darkness. Exclusion Criteria: - - Presence of at least one severe objective sign among the following: - Global ocular staining with Oxford (0-15) grading scheme >12. - Blepharitis (Grade 4: Very severe, i.e. eczematiform lesion). - Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma). - Visual field not performed or not available within the 6 months before inclusion visit. - Fundus not performed or not available within the 6 months before inclusion visit. - Advanced stage of glaucoma: - Absolute defect in the ten degrees central point of the visual field. - Severe visual field loss according to the investigator's best judgement. - Risk of visual field worsening as a consequence of participation in the trial according to the investigator's best judgement. - Best far corrected visual acuity ≤ 1/10. - History of trauma, infection, inflammation within the 3 months before inclusion visit. - Ongoing or known history of ocular allergy and/or uveitis and/or viral infection. - Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day). - Corneal ulceration. - Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation. - Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination. Systemic/non ophthalmic/ exclusion criteria - Non-controlled diabetic patient. - Known or suspected hypersensitivity to one of the components of the study product. - Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study. Specific exclusion criteria for women - Pregnancy, lactation. - Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) and is not surgically sterilised. | |
| 80 | NCT02019264 | completed | 1 | phase 4 | ['cardiovascular disease', 'high cardiovascular risk', 'obesity', 'overweight', 'type 2 diabetes'] | ["['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']", "['Q93.81', 'B33.4', 'A36.81', 'A50.54', 'A52.00', 'A52.09', 'B33.24']", "['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']", "['E66.3']", "['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['lorcaserin hydrochloride', 'placebo'] | ['C[C@H]1CNCCC2=CC=C(Cl)C=C12'] | Inclusion Criteria 1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2) 2. Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program 3. Age >= to 40 years with established CV disease as defined by one of the following: 1. History of documented MI or ischemic stroke 2. History of peripheral artery disease 3. History of revascularization (coronary, carotid, or peripheral artery) 4. Significant unrevascularized coronary arterial stenosis OR Age >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus (T2DM) without established CV disease plus at least one of the following CV risk factors: 1. Hypertension, or currently receiving therapy for documented hypertension 2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia 3. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 4. High high sensitivity C-reactive protein (hsCRP) 5. Urinary albumin-to-creatinine ratio (ACR) >= 30 ug/mg Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes Association (ADA) guidelines. All T2DM subjects must have an HbA[1c] less (<) than 10% at Screening. If subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months prior to randomization. Exclusion Criteria 1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV) 2. Known left ventricular (LV) ejection fraction < than 20% 3. Moderate or greater symptoms of pulmonary hypertension (PH) 4. Known severe valvular disease 5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end stage renal disease (ESRD) 6. Severe hepatic impairment 7. Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations 8. Use of more than one other serotonergic drug 9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior to Screening including, but not limited to: pergolide, ergotamine, methysergide, cabergoline 10. History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease) 11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients 12. Planned bariatric surgery 13. Females must not be breastfeeding or pregnant | |
| 81 | NCT02020616 | terminated | lack of efficacy | 0 | phase 1/phase 2 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ly3053102', 'exenatide er', 'placebo', 'metformin'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1'] | Inclusion Criteria - Participants with type 2 diabetes mellitus for at least 6 months before entering the trial based on the disease diagnostic criteria (World Health Organization [WHO]) classification managed with diet or exercise alone or with a stable dose of metformin of at least 1000 mg/day for at least 60 days before screening or on metformin and an eligible second oral anti-hyperglycemic medication after a 60-day washout of the second oral anti-hyperglycemic medication - Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause - Have a hemoglobin A1c value of ≥7.0% and ≤10.5%, if on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days), or have a hemoglobin A1c value of ≥7.0% and ≤9.5%, and are on an appropriate diet and exercise regimen, a stable dose of metformin and willing to discontinue a second oral anti-hyperglycemic medication - Have a body mass index ≥23 and ≤45 kilograms per square meter (kg/m^2) Exclusion Criteria - Have used insulin for diabetic control for more than 6 consecutive days within 1 year prior to screening - Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 2 months, prior to the first week of the study - Have hepatitis B and/or positive hepatitis B surface antigen. hepatitis C or human immunodeficiency virus (HIV) and/or positive HIV antibodies - Have known or suspected cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing - Have cardiac disease with functional status that is New York Heart Association Class II, III, or IV or in the last 6 months have had any of the following: a history of myocardial infarction , unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, or cerebrovascular accident (for example, stroke) - Have poorly controlled hypertension, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days prior to the first week of the study - Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase or aspartate aminotransferase levels >2 times the upper limit of the reference range - Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone which, in the opinion of the investigator, would pose a risk to participant safety. Participants on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria - Have clinically significant peripheral vascular disease, or clinical evidence of active diabetic proliferative retinopathy, (known significant autonomic neuropathy) as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis - Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years - Have impaired renal function - Have fasting triglycerides >500 milligrams per deciliter (mg/dL) at screening - Have experienced a keto-acidotic episode requiring hospitalization in the last 6 months - Have an electrocardiogram (ECG) considered to be indicative of cardiac disease - Have personal or family history of long QT syndrome, family history of sudden death in a first-degree relative before age 40, or personal history of unexplained syncope within the last year. Use of prescription or over-the-counter medications known to prolong the QT or QTc interval - Have a history of bone disease (including osteoporosis or unhealed fractures), evidence of osteoporosis (femoral neck or lumbar spine T-score <-2.5) determined by dual X-ray absorptometry (DXA) scan at screening, evidence of osteopenia (T-score between -1.0 and -2.5 at the femoral neck or lumbar spine) with a high risk of fracture based on risk factors or current active treatment of periodontal disease |
| 82 | NCT02028767 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['empagliflozin 2.5 mg', 'empagliflozin 10 mg', 'metformin 500 mg', 'empagliflozin/metformin fdc'] | ['[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1', '[H][C@@]1(CCOC1)OC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@]2([H])O[C@]([H])(CO)[C@@]([H])(O)[C@]([H])(O)[C@@]2([H])O)C=C1', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N'] | Inclusion criteria: 1. Healthy males or females according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests. 2. Age 18 to 50 years (inclusive) 3. BMI 18.5 to 29.9 kg/m2 (inclusive) 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation. Exclusion criteria: 1. Any finding in the medical examination (Including blood pressure [BP], pulse rate [PR], or electrocardiogram [ECG]) deviating from normal and judged clinically relevant by the investigator. 2. Any evidence of a concomitant disease judged clinically relevant by the investigator. 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. 4. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) 5. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders. 6. History of relevant orthostatic hypotension, fainting spells, or blackouts. 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to the trial medication or it's excipients) 9. Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication. 10. Within 14 days prior to the administration of trial medication, use of drugs that might reasonably influence the results of the trial, based on current knowledge 11. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication. 12. Smoker (has used tobacco or nicotine-containing products within 6 months prior to administration of trial medication) 13. Inability to refrain from smoking on specified trial days 14. Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or > 7 alcohol-containing drinks per week) 15. Drug abuse or positive drug screen 16. Blood donation (more than 100 ml wihtin 30 days prior to administration of trial medication or intended during the trial) 17. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial 18. Inability to comply with dietary regimen of trial site 19. Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study. For female subjects: 20. Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion. 21. No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent, surgically sterile, or post menopausal will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide). Post-menopausal is defined as at least 1 year of spontaneous amenorrhea and deemed post menopausal by a physician based on screening clinical laboratory tests (follicle stimulating hormone and luteinizing hormone). 22. Lactation | |
| 83 | NCT02030821 | completed | 1 | phase 4 | ['blood loss', 'hip arthritis', 'knee arthritis'] | ["['P61.3', 'D50.0', 'P50.8', 'P50.9', 'P50.2', 'P50.0', 'P50.1']", "['M00.051', 'M00.052', 'M00.059', 'M00.151', 'M00.152', 'M00.159', 'M00.251']", "['M00.061', 'M00.062', 'M00.069', 'M00.161', 'M00.162', 'M00.169', 'M00.261']"] | ['amicar', 'txa'] | ['NCCCCCC(O)=O', 'NC[C@H]1CC[C@@H](CC1)C(O)=O'] | Inclusion Criteria: - Patients electing to undergo primary total hip or knee arthroplasty Exclusion Criteria: - History of stents - Myocardial infarction, - Cerebrovascular accident or stroke - Deep venous thrombus - Pulmonary embolus - Late onset color blindness - Hypercoagulable state | |
| 84 | NCT02038153 | terminated | low accrual | 0 | phase 1/phase 2 | ['acute myeloid leukemia arising from previous myelodysplastic syndrome', 'adult acute myeloid leukemia in remission'] | ["['D46.Z', 'D46.9', 'C94.6', 'D46.C']", "['C90.01', 'C90.21', 'C90.31', 'C92.31', 'C95.91', 'F10.11', 'F10.21']"] | ['lenalidomide'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: - Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable - Post autologous stem cell transplant bone marrow biopsy core that is consistent with morphologic remission - Must have received induction and consolidation chemotherapy, and autologous stem cell transplant for AML - Life expectancy of greater than 12 months - Karnofsky performance status 70 or greater - Leukocytes >= 2,000/mcL - Absolute neutrophil count >= 1,000/mcL - Platelets >= 75,000/mcL - Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert's disease - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 4 X institutional upper limit of normal - Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation - Ability to understand and the willingness to sign a written informed consent document - Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirement of RevAssist® Exclusion Criteria: - Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier - Patient received another investigational agent after post autologous stem cell transplant - Patient who will be receiving another investigational product during the study - Patient who is growth factor or transfusion dependent - Patient has central nervous system leukemia - History of allergic reactions attributed to thalidomide or lenalidomide - History of erythema nodosum, characterized by a desquamating rash while taking thalidomide or similar drugs - Prior history of metastatic malignancy - Uncontrolled illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have suffered recent (< 6 months) myocardial infarction, unstable angina, uncontrolled hypertension, or difficult to control cardiac arrhythmias - Evidence of uncontrolled congestive heart failure - Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy - Patients who are positive for hepatitis B core antibody, but negative for the hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3 months post-transplant - Patient is positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus-1 (HTLV-1) - Women of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months) - Men who did not agree not to father a child and who refused to use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy |
| 85 | NCT02039674 | active, not recruiting | 1 | phase 1/phase 2 | ['non-small cell lung carcinoma'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['paclitaxel', 'carboplatin', 'pemetrexed', 'erlotinib', 'gefitinib'] | ['CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', 'COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | Inclusion Criteria: - Stage IIIb/IV NSCLC - Disease progression >1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease - Resolution of any toxic effects (excepting alopecia) of the most recent therapy - At least one radiographically measurable lesion - Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale - Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start) - Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors Exclusion Criteria: - Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab - Expected to require any other form of antineoplastic therapy while on study - Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication - Has received a live-virus vaccination within 30 days of planned treatment start - Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation) - History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years - Active central nervous system (CNS) metastases and/or carcinomatous meningitis - Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) - Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed) - Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms - Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication - Radiation therapy to lung >30 Gy within 6 months of first dose of study medication - Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication - Active infection requiring therapy - History of Human Immunodeficiency Virus (HIV) - Active Hepatitis B or C - Symptomatic ascites or pleural effusion - Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids - Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study - Psychiatric disorders and substance (drug/alcohol) abuse | |
| 86 | NCT02043860 | terminated | low accrual | 0 | phase 1 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['melphalan', 'filgrastim (g-csf)'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: 1. Patients meeting criteria for symptomatic myeloma 2. Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy 3. Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months 4. Patient age 18-75 years at time of enrollment 5. Karnofsky performance status of ≥70 6. Cardiac function: LVEF >40% 7. Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal 8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated 9. Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin) Exclusion Criteria: 1. Patients with diagnosis of plasma cell leukemia 2. Patients with myeloma who have had any disease progression prior to enrollment 3. Patients with truly non secretory myeloma (patients with light chain disease are eligible) 4. Pregnant or breast-feeding 5. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis. 6. Patients who have undergone prior allograft or autologous transplant 7. Prior solid organ transplant 8. Patients receiving prior radiation to more than 20% of bone marrow containing areas |
| 87 | NCT02045875 | completed | 1 | phase 4 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['dulera'] | ['[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: 1. Physician diagnosis of asthma of moderate severity 2. Subjects ≥ 18 years of age 3. Currently receiving an inhaled corticosteroid medication and being prescribed Dulera 100/5 as part of standard of care based upon asthma severity and dosing guidelines 4. Asthma Control Questionnaire (ACQ) result > 1.0 at entry 5. Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs) 6. History of reversible airway obstruction documented by treating physician Exclusion Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease; chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with Dulera Exclusion Criteria 1. Intermittent asthma (asthma exacerbations or symptoms < 3 days/week) 2. Diagnosis of emphysema in prior year 3. Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis, pulmonary hypertension or lung cancer 4. On any medication documented to have a drug interaction with Dulera | |
| 88 | NCT02046200 | completed | 0 | phase 1/phase 2 | ['alcohol use disorder'] | ["['F10.94', 'F10.980', 'F10.982', 'F10.988', 'F10.99', 'F10.959', 'F10.96']"] | ['ivermectin', 'placebo', 'alcohol'] | ['CO[C@H]1C[C@@H](O[C@@H](C)[C@@H]1O)O[C@H]1[C@H](C)O[C@H](C[C@@H]1OC)O[C@H]1[C@@H](C)\\\\C=C\\\\C=C2/CO[C@@H]3[C@H](O)C(C)=C[C@@H](C(=O)O[C@H]4C[C@@H](C\\\\C=C1/C)O[C@@]1(CC[C@H](C)[C@@H](C(C)C)O1)C4)[C@]23O.CC[C@@H](C)[C@H]1O[C@@]2(CC[C@@H]1C)O[C@@H]1C\\\\C=C(C)\\\\[C@@H](O[C@@H]3O[C@@H](C)[C@H](O[C@@H]4O[C@@H](C)[C@H](O)[C@@H](OC)C4)[C@@H](OC)C3)[C@@H](C)\\\\C=C\\\\C=C3/CO[C@@H]4[C@H](O)C(C)=C[C@@H](C(=O)O[C@@H](C1)C2)[C@]34O', 'CC1=NC(C)=C(OC[C@]2(C[C@H]2C(=O)NC2=CC=C(F)C=N2)C2=CC=CC(F)=C2)C=N1'] | Inclusion Criteria: - age between 21 and 65; - meet current DSM-V diagnostic criteria for an alcohol use disorder Exclusion Criteria: - current treatment for alcohol problems, a history of treatment in the 30 days before enrollment or current treatment seeking; - a current (last 12 months) DSM-V diagnosis of dependence on any psychoactive substances other than alcohol and nicotine; - a lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder; - positive urine screen for narcotics, amphetamines, or sedative hypnotics; - serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R); - pregnancy, nursing, or refusal to use reliable method of birth control (if female); - a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes); - AST, ALT, or GGT ≥ 3 times upper normal limit; - currently on prescription medication that contraindicates use of IVN; - any other circumstances that, in the opinion of the investigators, compromises participant safety. | |
| 89 | NCT02047149 | terminated | low accrual | 0 | phase 1 | ['chronic myelogenous leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['zileuton (zyflo®) dasatinib (sprycel®)', 'dosing with zileuton/dasatinib in cml', 'daily dosing of zileuton/dasatinib', 'daily dosing with zileuton/dasatinib for cml'] | ['CC(N(O)C(N)=O)C1=CC2=CC=CC=C2S1', 'CC(N(O)C(N)=O)C1=CC2=CC=CC=C2S1', 'CC(N(O)C(N)=O)C1=CC2=CC=CC=C2S1', 'CC(N(O)C(N)=O)C1=CC2=CC=CC=C2S1'] | Inclusion Criteria: Target Population: 1. Patients with CML with known inadequate response (as appropriate for their CML status) to TKIs or known resistance will be considered for this study - Patients who are resistant or not responding adequately to dasatinib as a first line therapy, but are not able or eligible to receive other effective second line treatment can be considered for participation in the study. - Age > 18 years - ECOG performance status ≤ 2 - Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN) - Hepatic enzymes (AST, ALT ) ≤ 1.5 times the institutional ULN - Serum Na, K+, Mg2+, Phosphate and Ca2+>= Lower Limit of Normal (LLN) - Serum Creatinine < 2.3 mg/dL - PT, PTT all Grade 0-1 3) Ability to take oral medication 4) Concomitant Medications - Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy 5) Age and Sex - Women of childbearing potential and men of fathering potential must use an adequate method of contraception to avoid pregnancy throughout the study to minimize the risk of pregnancy Exclusion Criteria: 1. Sex and Reproductive Status - Women of childbearing potential and men of fathering potential unable or unwilling to use an adequate method of contraception to avoid pregnancy throughout the study to minimize the risk of pregnancy 2. Target Population - Patients intolerant of dasatinib. 3. Medical History and Concurrent Diseases - History of active malignancy during the past 5 years with the exception of nonmetastatic treated skin cancer (e.g. basal or squamous cell carcinoma ) or stage 0 cervical carcinoma - Patients known to be HIV-positive - Patients with active, uncontrolled infections - Concurrent medical condition which may increase the risk of toxicity, including: - Pleural or pericardial effusion of any grade - Cardiac Conditions: - Uncontrolled angina, congestive heart failure or MI within (6 months) - Diagnosed congenital long QT syndrome - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) - Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) - Severe cardiac dysfunction (NYHA classification III-IV) - Severe pulmonary disease - History of significant bleeding disorder unrelated to cancer 4. Physical and Laboratory Test Findings - Hepatic dysfunction (serum bilirubin ≥ 2 x ULN, and/or ALT ≥ 3 x ULN, and/or AST ≥ 3 x ULN) - Renal dysfunction (creatinine ≥ 200 μmol/l or 2.3 mg/dl) - Subjects with hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration 5. Allergies and Adverse Drug Reactions - Patients with known allergic reaction or intolerance to either dasatinib or zileuton 6. Prohibited Treatments and/or Therapies - Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: - quinidine, procainamide, disopyramide - amiodarone, sotalol, ibutilide, dofetilide - erythromycin, clarithromycin - chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide - cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. - Patients requiring anticoagulation with Coumadin 7. Other Exclusion Criteria - Prisoners or subjects who are involuntarily incarcerated. - Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness. |
| 90 | NCT02048072 | completed | 1 | phase 4 | ['multiple sclerosis', 'autonomic nervous system dysfunction'] | ["['G35', 'C81.18']", "['E28.8', 'E28.9', 'E29.8', 'E29.9', 'E31.8', 'E31.9', 'H83.2X3']"] | ['gilenya'] | ['CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1'] | Inclusion Criteria: - indication for treatment with Gilenya according label - treatment with Gilenya intended - no contraindications for the treatment with Gilanya - all safety-aspects have been fullfilled - age between 18 and 60 years - written consent is given Exclusion Criteria: - relapse during the last 30 days befor randomization - steroids within 30 days before randomization - heart rhythm disturbance - new or currently changed dose (last 4 weeks) of bata-blockers, calcium antagonists, antidepressants or antiarrhythmics - diabetes mellitus - polyneuropathy - missing consent - pregnancy - lactation period | |
| 91 | NCT02049814 | completed | 1 | phase 4 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['metformin', 'voglibose', 'acarbose'] | ['[H][C@]12CC[C@]3([H])[C@]([H])(C[C@@H](O)[C@]4(C)[C@H](CC[C@]34O)C3=CC(=O)OC3)[C@@]1(C)CC[C@@H](C2)O[C@H]1C[C@H](O)[C@H](O[C@H]2C[C@H](O)[C@H](O[C@H]3C[C@H](O)[C@H](O)[C@@H](C)O3)[C@@H](C)O2)[C@@H](C)O1', 'OCC(CO)N[C@H]1C[C@](O)(CO)[C@@H](O)[C@H](O)[C@H]1O', 'COC1=C(C=C(Cl)C=C1)C(=O)NCCC1=CC=C(C=C1)S(=O)(=O)NC(=O)NC1CCCCC1'] | Inclusion Criteria: 1. Has a historical diagnosis of type 2 diabetes mellitus (T2DM) for at least 6 months prior to the screening visit (V1). 2. Is male or female and aged from 18 to 75 years, inclusively. 3. Has a body mass index (BMI) between 20 and 45 kg/m^2, inclusively. 4. Is experiencing inadequate glycemic control with a glycosylated hemoglobin (HbA1c) concentration between 7.0% and 10.0%, inclusively. 5. Has been treated with Metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to Screening, unless there is documentation that the participant's current dose is his or her maximum tolerated dose (MTD) and MTD is ≤1000 mg/day. 6. Keeps constant body weight with fluctuation range no more than 10% over for at least 3 months before screening. 7. Hemoglobin levels of the participant are ≥12 g/dL (≥120 g/L) in male and≥ 10 g/dL (≥100 g/L) in female at screening visit. 8. Male serum creatinine <1.5 mg/dL and female serum creatinine <1.4 mg/dL, or estimated glomerular filtration rate (eGFR) >60 ml/min/1.73m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) approximation at Screening. 9. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 10. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: 1. Type 1 diabetes mellitus. 2. Has received insulin, voglibose, acarbose or other oral hypoglycemic drugs (except Metformin) for accumulative total of more than 7 days within the latest 3 months prior to Visit 1. 3. Has a history of cardiovascular disease: acute myocardial infarction, class III or IV heart failure, or cerebrovascular accident (stroke) within the latest 3 months prior to Visit 1. 4. The participant's liver function is damaged and has a significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, or the value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times more than the upper limit of normal level at Visit 1. 5. Has an active proliferative retinopathy or macular degeneration that need to have an urgent treatment in the opinion of investigators. 6. Has a frequent attack of hypoglycemia or loses consciousness due to hypoglycemia in the opinion of investigators. 7. Has one or more times ketoacidosis or hyperosmotic status/coma. 8. Is receiving long-term (>14days) systemic glucocorticoid treatment (except the medicine: local, intraocular, inhalation or via the nose) or has received such treatment for 4 weeks at Visit 1. 9. Has a hematopathy (e.g. hemolytic anemia, drepanocytosis) that may interfere with the HbA1c test. 10. Has other liabilities (e.g. drug abuse, alcoholism or mental disorder) that may hinder the participant to follow and complete the study. 11. Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization. 12. Is unsuitable for this study in the opinion of investigators. 13. Has a disease need to use other taboo or caution drugs that is not listed in this study. 14. If female, is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study. | |
| 92 | NCT02050009 | withdrawn | study was never opened to accrual | 0 | phase 1 | ['ovarian papillary serous carcinoma', 'ovarian serous cystadenocarcinoma', 'recurrent fallopian tube cancer', 'recurrent ovarian epithelial cancer', 'recurrent ovarian germ cell tumor', 'recurrent primary peritoneal cavity cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C57.00', 'C57.01', 'C57.02', 'D28.2']", "['H18.523', 'H18.521', 'H18.522', 'H18.529']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['metformin hydrochloride', 'carboplatin', 'paclitaxel'] | ['CN(C)C(=N)NC(N)=N', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1', 'CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v.) 1.1; for those patients in the Phase 1a portion that are agreeable, disease must be amenable to ultrasound or computed tomography (CT) guided biopsy of a lesion outside of the target lesion; patients must have histologically or cytologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer - No antineoplastic therapy (eg, drugs, biologicals, monoclonal antibodies, etc) or radiotherapy within 6 months before enrollment; patients previously treated with antineoplastic therapy in the past must have recovered (ie, grade =< 1 toxicity or patient's baseline status, except alopecia) from all treatment-related toxicities - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Absolute neutrophil count >= 1,500 cells/mm^3 - Platelets >= 100,000 cells/mm^3 - Hemoglobin >= 9 g/dL - Total bilirubin =< 1.5 times the upper limit of normal - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic oxaloacetic transaminase [SGOT]/serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional normal limits - Creatinine =< 1.5 for men and 1.4 for women - Fasting blood sugar =< 126 - Hemoglobin A1C =< 6.5 - Patients in the Phase 1a portion of the clinical trial must have a tumor that is deemed safe to biopsy and must consent to serial biopsies and or surgical resection after treatment with metformin - Patients must be minimally, status post bilateral salpingo-oophorectomy - Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document - Willing and able to comply with all appointments for treatment, lab testing, biopsies, imaging and any other testing - Suitable venous access for infusion of chemotherapy and phlebotomy Exclusion Criteria: - Patients may not be receiving any other investigational agents - Patients must not have evidence of disease recurrence within 6 months of completing the last dose of platinum based therapy - Patient with current diagnosis of diabetes, or currently taking insulin, metformin, sulfonylureas, or other medications used for the treatment of elevated blood sugar - Conditions leading to increased risk of metformin induced lactic acidosis, including congestive heart failure (New York Heart Association [NYHA] class III or IV), history of acidosis, or daily intake of 3 or more alcoholic drinks - Use of metformin in the past 6 months - History of allergic reactions/hypersensitivity reactions to metformin - History of allergic or hypersensitivity reaction to carboplatin, paclitaxel, or Cremophor® EL - Baseline nausea > grade 1 - Baseline evidence of metabolic acidosis, with total carbon dioxide (TCO2) of less than 20 - Patients with history of >= grade 2 neurotoxicity or any toxicity requiring discontinuation from taxanes chemotherapy that is not resolved to =< grade 1 - Any condition that would prohibit patient from being able to take and digest metformin, such as gastroparesis, history of malabsorption, history of baseline diarrhea, current symptoms of small bowel obstruction, current symptoms of an ileus, history of a resection of the stomach or small bowel, or history of Crohn's disease/colitis - Current alcohol abuse: patients using more than 1 standard unit of alcohol per day for the past 30 days; a standard unit of alcohol is defined as a 12 oz beer (350 mL), 1.5 oz (45 mL) of 80-proof alcohol, or one 6-oz (175 mL) glass of wine - Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or breast feeding - Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of metformin, or other severe infection - Diagnosis of or treated for another malignancy within 2 years of enrollment; patient with non-melanoma skin cancer or carcinoma in situ of any type, are not excluded if they have undergone complete resection; patients with a history of stage IA endometrial endometrioid carcinomas are also not excluded - Diagnosis of primary central nervous system (CNS) disease or carcinomatous meningitis - Patient has symptomatic brain metastasis; if patient has asymptomatic brain metastasis, must have: - Stable brain metastasis for 2 years documented radiographically. - Be without any neurological dysfunction that would confound evaluation of adverse events - Women of child-bearing potential (WOCBP) are not eligible for the study; since the standard of care for ovarian cancer treatment is total abdominal hysterectomy and bilateral salpingo-oophorectomy this is not thought to exclude patients who otherwise might want to participate |
| 93 | NCT02051335 | completed | 0 | phase 1 | ['memory impairment', "alzheimer's disease"] | ["['Z73.82', 'G31.84', 'M10.38', 'M10.30', 'M10.311', 'M10.312', 'M10.319']", "['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['roflumilast', 'roflumilast placebo', 'donepezil', 'donepezil placebo', 'scopolamine'] | ['FC(F)OC1=C(OCC2CC2)C=C(C=C1)C(=O)NC1=C(Cl)C=NC=C1Cl', 'FC(F)OC1=C(OCC2CC2)C=C(C=C1)C(=O)NC1=C(Cl)C=NC=C1Cl', 'O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1', 'O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1', 'CN1[C@H]2C[C@@H](C[C@@H]1[C@H]1O[C@@H]21)OC(=O)[C@H](CO)C1=CC=CC=C1'] | Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is a healthy adult male. 4. Is aged 18 to 45 years, inclusive, at the time of informed consent. 5. Weighs at least 60 kg and has a body mass index (BMI) between 18 and 32 kg/m^2 inclusive at Screening. 6. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. 7. Has clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant (CS) by the investigator at screening and Day -1 (Check-in) of Period 1. Exclusion Criteria: 1. Has received any investigational compound within 3 months prior to the first dose of study medication. 2. Has received roflumilast, donepezil, or scopolamine in a previous clinical study or as a therapeutic agent. 3. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results. 5. Contraindications to scopolamine: hypersensitivity to scopolamine and other belladonna alkaloids, and/or any component of the formulation, serious allergic reactions, wide and narrow angle glaucoma, gastrointestinal motility disorders (such as constipation, gastroesophageal reflux disease, irritable bowel syndrome), benign prostatic hyperplasia with urinary retention, asthma, chronic obstructive pulmonary disease (COPD), seizures, coronary artery disease, hypertension, and congestive heart failure. 6. Participants with existing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, as assessed by the Mini International Neuropsychiatric Interview (MINI) or acute psychiatric episode within 6 months of Screening. 7. Has a known hypersensitivity to any component of the formulation of roflumilast, donepezil, scopolamine, or related compounds. 8. Has a positive urine drug result for drugs of abuse at Screening or Day -1 (Check-in) of each Period. 9. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from drug use or excessive alcohol use throughout the study. 10. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products. 11. Intends to donate sperm during the course of this study or for 12 weeks thereafter. 12. Any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking roflumilast, donepezil, scopolamine, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias. 13. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, or erosive esophagitis, frequent [more than once per week] occurrence of heartburn. 14. Has had any surgical intervention within 6 months that may impact the bioavailability of the compound (eg, cholecystectomy, bariatric surgery). 15. Has a history of cancer within the past 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin who are eligible. 16. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen at Screening. 17. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in on Day -1 (Check-in of Period 1). 18. Cotinine test is positive at Screening or Check-in (Day -1 of each Period). 19. Has poor peripheral venous access. 20. Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 3 months prior to Day 1 of Period 1. 21. Has a Screening or Day -1 (Check-in) of Period 1 abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or qualified delegate. 22. Has abnormal Screening or Day -1 (Check-in) of Period 1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal. 23. Has a current diagnosis or history of glaucoma or had a first-degree relative diagnosed with glaucoma. 24. Has a risk of suicide according to the investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months). 25. Has a history of depression associated with suicidal thinking and/or behavior. 26. 26. In the opinion of the investigator or sponsor, the participant is unsuitable for inclusion in the study. | |
| 94 | NCT02055352 | completed | 1 | phase 4 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['budesonide', 'fluticasone', 'indacaterol', 'salmeterol'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'C[C@@H]1C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]2(C)[C@@]1(O)C(=O)SCF', 'CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1', 'OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1'] | Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed - Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines. - Current or ex-smokers who have a smoking history of at least 10 pack years - Patients with a history of at least one exacerbation. - Patients able to read and complete Exclusion Criteria: - Use of other investigational drugs within 30 days - Patients with a history of hypersensitivity to any of the study drugs - History or current diagnosis of ECG abnormalities - Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range - Patients who have not achieved an acceptable spirometry result at Visit 1 - Patients with a body mass index (BMI) of more than 40 kg/m2 - Patients with lung cancer or a history of lung cancer - Patients with a history of malignancy of any organ system - Pregnant or nursing (lactating) women - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment - Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers) - Patients that are uncontrolled or unstable on permitted therapy, who in the opinion of the investigator, have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment - Patients requiring oxygen therapy for chronic hypoxemia - Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 - Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension - Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency. - Patients with history of lung surgery - Patients who are participating in the active phase of a supervised pulmonary rehabilitation program. - Patients with a history of asthma Other protocol-defined inclusion/exclusion criteria may apply | |
| 95 | NCT02057770 | terminated | low accrual rate | 0 | phase 1 | ['leukemia, myeloid, acute'] | ["['C92.A1', 'C92.A2', 'C92.61', 'C92.62', 'C92.A0', 'C92.60']"] | ['busulfan', 'fludarabine phosphate', 'cyclophosphamide', 'tocilizumab'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12C[C@H](C)[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: - AML without complete remission (CR/CRc/CRi) after at least 2 induction therapies OR - AML that has relapsed within 6 months after obtaining a CR OR - AML that has relapsed more than 6 months after obtaining a CR, and has treatment failure (TF) or progressive disease (PD) following at least 1 re-induction regimen OR - AML that has relapsed post Allogeneic transplantation - Active AML (bone marrow blasts ≥ 5% by morphology, staining, or flow) and/or presence of estramedullary disease - Available HLA-haploidentical donor that meets the following criteria: - Blood-related family member (sibling (full or half), offspring, or parent, cousin, niece or nephew, aunt or uncle, or grandparent) - At least 18 years of age - HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards - In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting HSC - No active hepatitis - Negative for HTLV and HIV - Not pregnant NOTE: there were HLA-matched sibling and HLA-matched unrelated donor cohorts, but those closed without completion of accrual with Amendment 11 - Karnofsky performance status ≥ 50 % - Adequate organ function as defined below: - Total bilirubin ≤ 2.5 mg/dl (unless the patient has a history of Gilbert's syndrome) - AST(SGOT) and ALT(SGPT) ≤ 3.0 x IULN - Creatinine ≤ 2.0 x IULN OR estimated creatinine clearance ≥ 30 mL/min/1.73 m2 by Cockcroft-Gault Formula - Oxygen saturation ≥ 90% on room air - LVEF ≥ 40% - FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is < 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation. - At least 18 years of age at the time of study registration - Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable) Exclusion Criteria: - Circulating blast count ≥ 10,000/uL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed) - Known HIV or Active hepatitis B or C infection - Known hypersensitivity to one or more of the study agents - Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -7) - Currently receiving or has received any intensive chemotherapy within the 14 days prior to the first dose of study drug (Day -7) (hydrea or other non-intensive regimens such as decitabine may be used but must stop at least one day prior to the first dose of study drug) - Pregnant and/or breastfeeding - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements. |
| 96 | NCT02058095 | completed | 1 | phase 1/phase 2 | ['cardiomyopathy', 'renal impairment'] | ["['A36.81', 'B33.24', 'I25.5', 'I42.0', 'I42.6', 'I42.9', 'O90.3']", "['M10.38', 'M10.30', 'M10.311', 'M10.312', 'M10.319', 'M10.321', 'M10.322']"] | ['tadalafil', 'placebo'] | ['[H][C@]12CC3=C(NC4=CC=CC=C34)[C@H](N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1'] | Inclusion Criteria: - - Inclusion Criteria: - A total of 39 patients with PDD as defined by an ejection fraction of greater than 50%, no clinical signs or symptoms of congestive heart failure, a minimal distance on 6-minute walk of equal or >450 meters will be recruited and calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the (MDRD-measurement of renal dysfunction, formula) assessed within the past 36 months. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath than they will still qualify for the protocol. Exclusion Criteria: • Current or anticipated future need for nitrate therapy - Systolic blood pressure < 90 mmHg or > 180 mm Hg - Diastolic blood pressure < 40 mmHg or > 100 mmHg - Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum proteases inhibitors for HIV) who cannot be taken off these medications for the duration of the study. - Patients taking the following selective alpha blockers and who are unable to stop for the duration of the study; - Alfuzosin - Prazosin - Doxazosin - Tamsulosin - Terazosin - Silodosin - Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance - Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease) - Patients with an allergy to iodine. - Patients on PDEV inhibition for pulmonary hypertension - Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study - Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation) - Obstructive Hypertrophic cardiomyopathy - Infiltrative or inflammatory myocardial disease (amyloid, sarcoid) - Pericardial disease - Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent - Severe congenital heart diseases - Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening - Second or third degree heart block without a permanent cardiac pacemaker - Stroke within 3 months of screening or other evidence of significantly compromised Central Nervous System (CNS) perfusion - Hemoglobin <9 g/dL - Patients with severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal) - Serum sodium of < 125 mEq/dL or > 150 mEq/dL - Serum potassium of < 3.2 mEq/dL or > 5.9 mEq/dL - Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50% - Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period - Less than 21 years of age - Pregnant or nursing women. - Women of child bearing potential who do not have a negative pregnancy test at study entry and who are not using effective contraception - Non-cardiac condition limiting life expectancy to less than one year, per physician judgment - Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data - Received an investigational drug within 1 month prior to dosing - In the opinion of the investigator is unlikely to comply with the study protocol or is unsuitable for any reasons | |
| 97 | NCT02058290 | terminated | slower than expected enrollment | 1 | phase 4 | ['bowel obstruction'] | ["['K22.2', 'K31.5', 'K82.0', 'N32.0', 'K56.609', 'K56.699', 'J04.10']"] | ['iv morphine sulfate or sponsor-approved equivalent', 'exparel'] | ['OC[C@H]1O[C@@](CO)(OC[C@@]2(OC[C@@]3(OC[C@@]4(OC[C@@]5(OC[C@@]6(OC[C@@]7(OC[C@@]8(OC[C@@]9(OC[C@@]%10(OC[C@@]%11(OC[C@@]%12(OC[C@@]%13(OC[C@@]%14(OC[C@@]%15(OC[C@@]%16(OC[C@@]%17(OC[C@@]%18(OC[C@@]%19(OC[C@@]%20(OC[C@@]%21(OC[C@@]%22(OC[C@@]%23(OC[C@@]%24(OC[C@@]%25(OC[C@@]%26(OC[C@@]%27(OC[C@@]%28(OC[C@@]%29(OC[C@@]%30(OC[C@@]%31(OC[C@@]%32(OC[C@@]%33(OC[C@@]%34(OC[C@@]%35(OC[C@@]%36(OC[C@@]%37(O[C@H]%38O[C@H](CO)[C@@H](O)[C@H](O)[C@H]%38O)O[C@H](CO)[C@@H](O)[C@@H]%37O)O[C@H](CO)[C@@H](O)[C@@H]%36O)O[C@H](CO)[C@@H](O)[C@@H]%35O)O[C@H](CO)[C@@H](O)[C@@H]%34O)O[C@H](CO)[C@@H](O)[C@@H]%33O)O[C@H](CO)[C@@H](O)[C@@H]%32O)O[C@H](CO)[C@@H](O)[C@@H]%31O)O[C@H](CO)[C@@H](O)[C@@H]%30O)O[C@H](CO)[C@@H](O)[C@@H]%29O)O[C@H](CO)[C@@H](O)[C@@H]%28O)O[C@H](CO)[C@@H](O)[C@@H]%27O)O[C@H](CO)[C@@H](O)[C@@H]%26O)O[C@H](CO)[C@@H](O)[C@@H]%25O)O[C@H](CO)[C@@H](O)[C@@H]%24O)O[C@H](CO)[C@@H](O)[C@@H]%23O)O[C@H](CO)[C@@H](O)[C@@H]%22O)O[C@H](CO)[C@@H](O)[C@@H]%21O)O[C@H](CO)[C@@H](O)[C@@H]%20O)O[C@H](CO)[C@@H](O)[C@@H]%19O)O[C@H](CO)[C@@H](O)[C@@H]%18O)O[C@H](CO)[C@@H](O)[C@@H]%17O)O[C@H](CO)[C@@H](O)[C@@H]%16O)O[C@H](CO)[C@@H](O)[C@@H]%15O)O[C@H](CO)[C@@H](O)[C@@H]%14O)O[C@H](CO)[C@@H](O)[C@@H]%13O)O[C@H](CO)[C@@H](O)[C@@H]%12O)O[C@H](CO)[C@@H](O)[C@@H]%11O)O[C@H](CO)[C@@H](O)[C@@H]%10O)O[C@H](CO)[C@@H](O)[C@@H]9O)O[C@H](CO)[C@@H](O)[C@@H]8O)O[C@H](CO)[C@@H](O)[C@@H]7O)O[C@H](CO)[C@@H](O)[C@@H]6O)O[C@H](CO)[C@@H](O)[C@@H]5O)O[C@H](CO)[C@@H](O)[C@@H]4O)O[C@H](CO)[C@@H](O)[C@@H]3O)O[C@H](CO)[C@@H](O)[C@@H]2O)[C@@H](O)[C@@H]1O', 'O=[Zn]'] | Inclusion Criteria: - Male or female, at least 18 years of age. - Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.) - Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments. Exclusion Criteria: - Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol. - Patients who abuse alcohol or other drug substance. - Patients with severe hepatic impairment. - Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy. - Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study. - Participation in an EXPAREL study within the last 30 days. - Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study. In addition, a patient was ineligible if he or she met the following criteria during surgery: - Patients who had any concurrent surgical procedure. - Patients with unplanned multiple segmental resections of large intestine. - Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy. - Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed. - Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents. - Patients who received Entereg. |
| 98 | NCT02058628 | completed | 1 | phase 4 | ['acne vulgaris'] | ["['L70.0']"] | ['clindamycin + bpo', 'azelaic acid'] | ['O=C(OOC(=O)C1=CC=CC=C1)C1=CC=CC=C1', 'OC(=O)CCCCCCCC(O)=O'] | Inclusion Criteria: - Subjects who are males or females 12 to 45 years of age, inclusive. - Subjects with acne vulgaris who have: a minimum of 17 to a maximum of 60 inflammatory facial lesions (papules and pustules), including the nose, and no more than 1 facial nodular cystic lesions and a minimum of 20 to a maximum of 125 non-inflammatory facial lesions (open and closed comedones) and an ISGA score of 2 or 3. - Subjects agreeing not to use sun-beds or undergo any ultraviolet (UV) light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study. - Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. Subjects under the legal age of consent must provide assent and have the written, informed consent of both parents or legal guardians. Exclusion Criteria: - Unable to comply with the requirement of the study. - Female subjects who are pregnant, breast-feeding, or sexually active and not using reliable contraception and/or not prepared to do so for the duration of the trial (a negative pregnancy test must be confirmed at Visit 1, 3, 4 and 5, for all females if menarche has occurred). - Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris. - Subjects who have facial hair that may obscure the accurate assessment of acne grade. - Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. - Prior Therapy: Have received treatment with the following therapies at the times specified prior to Baseline: systemic retinoids [6 months]; systemic antibiotics, investigational therapy, facial procedure (chemical or laser peel, microdermabrasion, artificial UV therapy), topical corticosteroids on the face or systemic corticosteroids [4 weeks]; topical antibiotics on the face, topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) [2 weeks]; medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments, neuromuscular blocking agents (Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents), drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity [1 day]. - Subjects who are unwilling to stop using the following types of facial products during the study: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids. - Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components (azaleic acid, lincomycin, clindamycin, BPO), or excipients of the study medication. - Use of estrogens, including oral, implanted, and topical contraceptives, androgens, or anti-androgenic agents of less than 12 consecutive weeks prior to start of study dosing (change of the dose or drug is not permitted between 12 weeks prior study dosing until end of the study). | |
| 99 | NCT02059434 | completed | 1 | phase 1 | ['chronic obstructive pulmonary disease (copd)', 'asthma'] | ["['G91.1', 'I42.1', 'N11.1', 'J05.0', 'G47.33', 'J44.9', 'N13.8']", "['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['las190792 dose 1', 'las190792 dose 2', 'las190792 dose 3', 'las190792 dose 4', 'las190792 dose 5', 'las190792 dose 6', 'las190792 dose 1 (part 2)', 'las190792 dose 2 (part 2)', 'tiotropium 18 μg', 'indacaterol 150 μg', 'placebo'] | ['[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', 'CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1'] | Inclusion Criteria (PART 1): - Adult male subjects aged 18 to 70 years - Body mass index (BMI) 18.5 to 30 kg/m2 at screening - Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening - Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods - Screening FEV1 value of ≥70% of the predicted normal value after a washout of at least 5 h for short-acting beta2-agonists and 72 h for long-acting beta2-agonists - FEV1 reversibility of ≥12% and an absolute increase of at least 200 mL over the baseline value within 30 min after inhalation of 400 µg of salbutamol - Subjects using intermittent salbutamol and / or subjects on a stable dose or regimen of low dose ICS (as defined by the GINA guidelines) at least 4 weeks prior to screening - Predose FEV1 value of first treatment period within the range of ±20% of the FEV1 measured at screening prior to salbutamol inhalation - Subjects who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings - Normal blood pressure (defined as SBP between 100 and 140 mmHg, and DBP between 50 and 90 mmHg) at screening, measured after resting in supine position for 5 minutes. - Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator - Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at screening - Subjects who are able and willing to provide written informed consent - Subjects able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005 criteria at screening Inclusion Criteria (PART 2): - Adult male and non-childbearing potential women subjects aged ≥40 years with a clinical diagnosis of stable moderate to severe COPD according to GOLD guidelines at screening - Females must be of non-childbearing potential, confirmed at screening - Post-salbutamol FEV1 <80% and ≥30% of the predicted normal value and post-salbutamol FEV1 / forced vital capacity (FVC) <70% - Ability to change current COPD therapy, to discontinue previous prescribed medications after signature of informed consent - No evidence of clinically significant respiratory and / or cardiovascular conditions or laboratory abnormalities - No other relevant pulmonary disease or history of thoracic surgery - No contraindication to the use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction, narrow-angle glaucoma, or beta2-agonists usage - Subjects who are negative for HBsAg, HBc IgM, hepatitis C antibody and HIV I and II antibodies at screening - Subjects who are able and willing to provide written informed consent - Subjects able to perform repeatable pulmonary function testing for FEV1 according to the ATS / ERS 2005 criteria at screening Exclusion Criteria (PART 1 and 2): - Subjects who do not conform to the above inclusion criteria - Current smokers, subjects with a smoking history during the last 12 months or subjects with a smoking history of more than 10 pack-years - Other relevant pulmonary disease or history of thoracic surgery - Subjects with a BMI ≥40 kg/m2 (only applicable for Part 2) - Subjects with any clinically relevant history or presence of abnormality from the medical history and/or physical examination (only applicable for Part 1) - Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality that could put the subject at risk or could confound the results of the study (only applicable for Part 2) - Subjects with a surgical history clinically relevant for the purpose of the study - History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin - Subjects with serious adverse reaction or serious hypersensitivity to Spiriva (for Part 2 only), indacaterol (for Part 2 only), or the formulation excipients (eg, lactose) or other drugs in the same pharmacologic class (for Part 1 and Part 2) - Current diagnosis of COPD (for Part 1 only) or history of / or current diagnosis for asthma (for Part 2 only) - Recent history of asthma / COPD exacerbation requiring hospitalisation or need for increased maintenance treatments for asthma / COPD within 6 weeks prior to screening or randomisation - Use of daily oxygen therapy >10 h per day (for Part 2 only) - Use of systemic steroids for respiratory reasons within 3 months prior to screening - Lower respiratory tract infection within 6 weeks prior to screening or randomisation - Upper respiratory tract infection requiring antibiotics within 4 weeks prior to screening or randomisation - Current history of tuberculosis, bronchiectasis or other non-specific pulmonary disease - QTcF interval >430 ms at screening or prior to randomisation, or history of long QT syndrome (for Part 1 only) - QTcF interval, >450 ms for males and >470 ms for females at screening or prior to randomisation, or history of long QT syndrome (for Part 2 only) - Subjects with a history of excessive use or abuse of alcohol or with a history of drug abuse within the past 2 years - Subjects who are positive for drugs of abuse and alcohol tests at screening and prior to randomisation - Donation or loss >400 ml of blood and plasma within the previous 3 months prior to screening - Subjects consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week - Subjects with a significant infection or known inflammatory process at screening or prior to randomisation - Subjects with acute gastrointestinal symptoms at the time of screening or prior to randomisation - Subjects with an acute infection such as influenza at the time of screening or prior to randomisation - Male subjects who do not agree to follow instructions to avoid pregnancies - Subjects who are not able to adhere to the restrictions on prior and concomitant medications - Subjects who intend to use any concomitant medication not permitted by the protocol or who have not undergone the required washout period for a particular prohibited medication - Subjects who have used any investigational drug within 3 months prior to screening or within the equivalent time of 6 half-lives of receiving the last administration, whichever is longer - Subjects who have received the last dose of investigational product more than 3 months ago but who are on an extended follow-up - Subjects who are vegans or who have medical dietary restrictions - Subjects unable to communicate reliably with the Investigator - Subjects who are unlikely to co-operate with the requirements of the study | |
| 100 | NCT02059967 | withdrawn | due to no accrual. | 0 | phase 1 | ['adenocarcinoma of the lung', 'large cell lung cancer', 'squamous cell lung cancer', 'stage iia non-small cell lung cancer', 'stage iib non-small cell lung cancer', 'stage iiia non-small cell lung cancer', 'stage iiib non-small cell lung cancer'] | ["['D02.20', 'D02.21', 'D02.22']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['paclitaxel', 'carboplatin'] | ['CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1'] | Inclusion Criteria: - Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma not otherwise specified. - The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung 2.gif for staging. - All detectable tumor must be encompassed by radiation therapy fields. - 18-fluorodeoxyglucose PET is required for staging and treatment planning. - Atelectasis, if present, must involve less than a complete lung. - Laboratory values: - Neutrophils >1500/µL - Platelets >100,000/µL - Bilirubin < 1.5 mg/dL - Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase [SGOT]) < 2x upper limit normal - Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase [SGPT]) < 2x upper limit normal - Serum creatinine < 2.0 mg/dL - Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days must be ≥ 59 mL/min - Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec - Plan of curative radiotherapy with or without concurrent chemotherapy. - Karnofsky Performance Scale score of ≥ 70%. - Age ≥ 18 years old. - Measurable disease on the planning CT. - Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the PTV covered by the prescription dose, and the attending physician must have reviewed and approved the DVHs as follows: - total lung V20 Gy ≤ 30% - mean esophageal dose ≤ 34 Gy - esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30% - heart V40 Gy ≤ 50% - maximum brachial plexus dose ≤ 66 Gy - maximum spinal cord PRV dose ≤ 50 Gy - maximum aorta dose ≤ 66 Gy - maximum main bronchus dose ≤ 66 Gy - maximum dose ≥ 66 Gy allowed in only one lobar bronchus. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery. - Prior radiation therapy to the thorax. - Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past 5 years. - Clinically significant pleural effusions, pericardial effusions, or superior vena cava syndrome. - Oxygen supplementation required during therapy. - Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus. - Tumors that affect more than one lobar bronchus, except the second involved bronchus in the right middle lobe bronchus. - Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm. - Myocardial infarction within the last 6 months, symptomatic heart disease, uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled bronchospasms. - History of a prior malignancy from which the patient has not been disease free for a minimum of 2 years, other than adequately treated basal/squamous skin cancer or in situ cervix cancer or other in situ malignancy. - Pregnant or lactating women. |