Downloads: 1
| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02168361 | completed | 1 | phase 4 | ['chronic hepatitis c'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['pegylated interferon alfa-2b', 'simeprevir', 'ribavirin', 'sofosbuvir'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1', '[H]\\C1=C([H])\\[C@]2([H])C[C@]2(N=C(O)[C@]2([H])C[C@]([H])(C[C@@]2([H])C(=O)N(C)CCCC1)OC1=C2C=CC(OC)=C(C)C2=NC(=C1)C1=NC(=CS1)C(C)C)C(O)=NS(=O)(=O)C1CC1', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', '[H][C@](N=C(O)OC)(C(C)C)C(=O)N1CC2(CC2)C[C@@]1([H])C1=NC=C(N1)C1=CC2=C(C=C1)C1=C(C=C(C=C1)C1=CC3=C(C=C1)N=C(N3)[C@@]1([H])N(C(=O)[C@@]([H])(N=C(O)OC)C(C)C)[C@]3([H])CC[C@@]1([H])C3)C2(F)F'] | Inclusion Criteria: - chronic hepatitis c, - cirrhosis biopsy-proven, or via fibrotest, - CPT score less than 7, - genotype 1a, - INR 2.3 or less, - serum albumin greater than 2.7 gm/dL, - total bilirubin less than 3 gm/dL, - platelet count 50,000 per cubic milliliter or more - GFR >50 ml/min Exclusion Criteria: - non genotype 1a, - history of CPT class B or C or decompensation or history of same, - HIV or HBV coinfection, - prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent, - uncontrolled psychiatric or cardiopulmonary disorders, - planning pregnancy or unwilling/unable to practice contraception | |
| 2 | NCT02168907 | terminated | slow accruals | 0 | phase 1 | ['b-cell adult acute lymphoblastic leukemia', 'b-cell chronic lymphocytic leukemia', 'cutaneous b-cell non-hodgkin lymphoma', 'extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue', 'intraocular lymphoma', 'nodal marginal zone b-cell lymphoma', 'recurrent adult acute lymphoblastic leukemia', 'recurrent adult burkitt lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult grade iii lymphomatoid granulomatosis', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent mantle cell lymphoma', 'recurrent marginal zone lymphoma', 'recurrent mycosis fungoides/sezary syndrome', 'recurrent small lymphocytic lymphoma', 'refractory chronic lymphocytic leukemia', 'refractory hairy cell leukemia', 'small intestine lymphoma', 'splenic marginal zone lymphoma', 'testicular lymphoma', 'waldenström macroglobulinemia'] | ["['C91.11', 'C91.12', 'C91.10']", "['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']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C83.57', 'C83.50', 'C91.01', 'C91.02', 'C83.52', 'C83.56', 'C83.53']", "['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']", "['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']", "['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']", "['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']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['A87.2', 'K52.832', 'D72.111', 'C91.11', 'C91.12', 'C91.10']", "['D46.4', 'D46.1', 'D46.A', 'D46.0', 'D46.20', 'D46.21', 'D46.22']", "['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']", "['C88.0']"] | ['6,8-bis(benzylthio)octanoic acid', 'bendamustine hydrochloride'] | ['OC(=O)CCCCC(CCSCC1=CC=CC=C1)SCC1=CC=CC=C1', 'CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl'] | Inclusion Criteria: - Histologically and cytologically confirmed B-cell NHL that has relapsed from, or is refractory to, all standard therapies (including autologous transplantation) known to provide clinical benefit, but have not been treated with bendamustine for their lymphoma - Must have measurable disease (e.g., a tumor mass > 1 cm) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Expected survival > 3 months - Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation - Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists - At least 2 weeks must have elapsed from any prior surgery - Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/serum glutamate pyruvate transaminase [SGPT]) =< 3 x upper normal limit (UNL) (=< 5 x UNL if liver metastases present) - Bilirubin =< 1.5 x UNL - Serum creatinine =< 1.5 mg/dL or 133 umol/L - "International normalized ratio" or INR must be =< 1.5 - No evidence of active infection and no serious infection within the past month - Mentally competent, ability to understand and willingness to sign the informed consent form Exclusion Criteria: - Known cerebral metastases, central nervous system (CNS) or epidural tumor - Having "currently active" second malignancy unrelated to Hodgkin lymphoma (HL) or NHL, unless they have completed anti-cancer therapy, are in complete response and are considered by their physicians to be at less than 30% risk of relapse - Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs - Serious medical illness that would potentially increase patients' risk for toxicity - Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease) - History of abdominal fistula or gastrointestinal perforation =< 6 months prior to treatment with study drugs - Pregnant women, or women of child-bearing potential not using reliable means of contraception - Lactating females - Fertile men unwilling to practice contraceptive methods during the study period - Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients - Unwilling or unable to follow protocol requirements - Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction or symptomatic congestive heart failure - Patients with a history of myocardial infarction that is < 3 months prior to registration - Evidence of active infection, or serious infection within the past month - Patients with known human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C - Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment - Requirement for immediate palliative treatment of any kind including surgery |
| 3 | NCT02176005 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['moxifloxacin'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Healthy volunteers - Normal digestive transit, with usually one daily stool. - Females participating in the study : must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment. - Having given and signed the written study informed consent prior to undertaking any study-related procedure. - Covered by the French Health Insurance system. Exclusion Criteria: - Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness. - Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones. - Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded. - Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded. - Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery. - Fecal colonisation by Clostridium difficile. - Recent history of hospitalisation (within 3 months prior to inclusion). - Any antibiotic administration within 3 months before inclusion. - Any vaccination within the last 28 days. | |
| 4 | NCT02176486 | terminated | insufficient enrollment, no safety or efficacy concerns | 0 | phase 1 | ['lupus nephritis'] | ["['B26.83', 'A51.44', 'N11.8', 'N11.9', 'N12']"] | ['ixazomib', 'placebo'] | ['[H][C@@](CC(C)C)(N=C(O)CN=C(O)C1=C(Cl)C=CC(Cl)=C1)B(O)O'] | Inclusion Criteria: 1. In the opinion of the investigator, 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 female or male and aged 18 to 75 years, inclusive. 4. Has a diagnosis of systemic lupus erythematosus (SLE) defined by meeting either the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria or the American College of Rheumatology (ACR) criteria for the classification of SLE. The 4 criteria required by ACR classification are not required to be present at Screening for eligibility. 5. Has a definite diagnosis of LN based on a kidney biopsy done within 2 year of the Screening Visit which demonstrated International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV or V changes [excluding Class III (C), IV-S (C) and IV-G (C)] or World Health Organization (WHO) 1982 classification Class III,IV or V(excluding Class IIIc and IVd). 1. If no biopsy was done within 2 year of Screening Visit, biopsy can be done during the screening period as a study procedure. 2. Co-existence of classes is permitted. 6. Has a renal biopsy demonstrating either ISN/RPS or WHO class V or class V with class 2 nephritis with a UPCR of greater than (>) 3 or the participant has a renal biopsy demonstrating either active ISN/RPS or WHO class III or IV nephritis, defined by either one of the following criteria: a) A UPCR* of >=1.0 at Screening OR b) A UPCR* >0.5 at Screening and at least one of the following: i. Active urine sediment in the absence of infection or other cause within 3 months of screening, defined as at least one of the following: - >=5 red blood cells (RBC) per high power field, not due to causes other than lupus nephritis. - >=5 white blood cells (WBC) per high power field in the absence of infection. - Presence of cellular casts. ii. The participant has increased levels (above upper limit of normal [ULN]) serum dsDNA autoantibodies at screening. iii. Low complement (either C3 or C4) at Screening (>= 25 percent [%] lower than lower limit of normal [LLN]). iv. Biopsy within 3 months prior to screening visit indicating active proliferative lupus glomerulonephritis ISN/RPS class III or IV changes [excluding Class III (C), IV-S (C) and IV-G (C)] or WHO 1982 classification Class III or IV (excluding Class IIIc and IVd), with co-existing Class V permitted. - Participants may be re-screened once for urinary sediment, proteinuria or complement levels within 2 weeks of the original screening visit. - UPCR value for eligibility will be based on the average UPCR obtained from the 3 specimens collected during screening. 7. Has had an inadequate response, in the judgment of the Investigator, to at least 6 months of an immunosuppressive regimen including single or sequential use of at least one of the following: cyclophosphamide (CYC), mycophenolate mofetil (MMF), mycophenolic acid (MA), or azathioprine (AZA). 8. If the participant is on glucocorticosteroids, must be on stable dose equivalent to 20 mg/day or less of prednisone for at least 2 weeks prior to first dose of study medication. Participant who are on a stable dose equivalent to >20 mg/day and <=30 milligram per day (mg/day) of prednisone may be allowed to the study if reviewed by the adjudication committee and approved by the medical monitor; however, the steroid dose should be tapered. 9. Male participants who are sexually active with women of child bearing potential (WOCBP), even if surgically sterilized (that is, status post-vasectomy), must: a) Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug. 10. Female participants who are of child bearing potential must: a) Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug. 11. This study permits the re-enrollment of a participant that has discontinued the study as a pre- treatment failure (ie, participant has not been randomized). If re-enrolled, the participant must be re-consented. * The re-enrollment of all participants who completed Cohort A and B is permitted to subsequent cohorts (2.0 mg and 3.0 mg dose cohorts) after completion of all cycles including the follow-up period if they had no drug-related adverse events greater than Grade 1, no adverse events greater than Grade 2, continue to meet all inclusion and exclusion criteria, and the Safety Review Committee has reviewed and approved enrollment of the subject into a higher dose cohort. 12. Must be receiving Standard of Care (SOC) treatment with an immunosuppressant drug for the treatment of LN (example, MMF, MA or AZA). Exclusion Criteria: 1. Has received any investigational compound within 30 days or 5 half-lives, whichever is the longer, prior to Screening or is currently participating in another interventional clinical study. 2. Has received ixazomib, bortezomib, or another proteasome inhibitor in a previous clinical study or as a therapeutic agent. 3. Is a sponsor employee, an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (example, spouse, parent, child, sibling), or may consent under duress. 4. Has an autoimmune disease other than SLE as their main diagnosis. 5. Has drug-induced SLE. 6. Has severe, active central nervous system (CNS) lupus (British Isles Lupus Assessment Group [BILAG] A or B). 7. Has an estimated eGFR of <30 milliliter per minute per 1.73 m^2 (mL/min/1.73m^2), or is on dialysis, or is expected to have a renal transplant within 1 year of randomization, or has had a renal transplant. 8. Has a severe acute infectious disease (example, untreated active tuberculosis (TB), acute viral hepatitis, human immunodeficiency virus (HIV), untreated latent TB, or infections requiring IV anti-microbial treatment within 2 months preceding the Screening Visit. 9. Has a history of a malignant disease (except successfully treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ) within 5 years prior to Screening. 10. Has one of the following laboratory test values: 1. IgG<75% of LLN 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the central laboratory's ULN 3. Bilirubin >1.5 x ULN (participants with Gilbert Syndrome with a confirmed diagnosis and documented in the subject's medical record will not be excluded based on this criterion). 4. Platelets <75,000 per cubic millimeter (/mm^3) 5. Neutrophils <1500/ mm^3 or > 11,000/ mm^3 6. Hemoglobin <8 grams per deciliter (g/dL) 7. Positive for Hepatitis B Surface Antigen. 8. Positive for Hepatitis C antibody. 11. Has a history of drug or alcohol abuse or dependence (as defined by Diagnostic and Statistical Manual of Mental Disorders, fourth Edition [DSM-IV]) within 1 year prior to the screening visit. 12. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 3 months after participating in this study; or intending to donate ova during such time period. 13. If male, the participant intends to donate sperm during the course of this study or for 90 days after the last dose. Male participants planning to father during clinical trial conduct or within 90 days after the last planned dose of trial treatment. 14. Has moderate or severe liver disease (Child-Pugh B or C), and/or positive serological tests for hepatitis B (other than due to prior immunization) or hepatitis C. 15. Is taking excluded medications. 16. Has a history of clinically significant neuropathies of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 Grade 2 or higher. 17. Has been treated with CYC within 4 weeks of the Screening Visit. 18. Has been treated with > 3 g/day of MMF within 4 weeks of the Screening Visit. 19. Has been treated with belimumab, abatacept or tocilizumab within 3 months of the Screening Visit. 20. Has been treated with eprazutumab, alemtuzumab, rituximab or other cell depleting biological agents within 6 months of the Screening Visit. 21. Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal (including hypomotility and ulcerative/inflammatory conditions), pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study. |
| 5 | NCT02178696 | completed | 1 | phase 4 | ['depression'] | ["['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['celexa or other antidepressant as clinically indicated'] | ['CN1CCN2C(C1)C1=CC=CC=C1CC1=C2N=CC=C1'] | Inclusion Criteria: Inclusion criteria will include: - Participants diagnosed with Major Depressive Disorder and will include Hamilton Depressive Rating Scale (HDRS) scores >15 Exclusion Criteria: - Comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of hormones (including birth control) or use of psychotropic agents - We will only permit certain past anxiety disorder diagnoses, including generalized anxiety, panic, agoraphobia, social phobia - We also will exclude left-handed individuals and patients who have used any centrally acting medications or recreational drugs with the past 2 months - No history of an implant, pacemaker or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint - No metallic object in their body (such as braces) or have a history of foreign metallic object in the body such as bullets, BB's, pellets, shrapnel, or other metal fragments | |
| 6 | NCT02178995 | completed | 1 | phase 4 | ['epilepsy', 'cognitive deficits', 'attention deficits'] | ["['G40.803', 'G40.804', 'G40.911', 'G40.919', 'G40.B11', 'G40.B19', 'G40.801']", "['R41.841', 'R41.81', 'G31.84', 'I69.315', 'I69.015', 'I69.115', 'I69.815']", "['R41.840', 'Z43.0', 'Z43.1', 'Z43.2', 'Z43.3', 'Z43.5', 'F90.2']"] | ['methylphenidate'] | ['COC(=O)C(C1CCCCN1)C1=CC=CC=C1'] | Inclusion Criteria: 1. For participants with seizures: - H/o seizures of any cause - Subjective cognitive complaints - Stable antiepileptic drug doses which are not expected to change during the study - Recent normal cardiac auscultation (may be done prior to enrollment by personal physician or study staff) - Neurologist's judgement that participant is clinically appropriate for this study 2. For healthy volunteers - No history of seizures or other neurological disorders - No history of cognitive complaints for any reason (including ADHD) - Not on any medications which would interfere w/ cognitive testing 3. English fluency Exclusion Criteria: 1. IQ 2. History of an adverse reaction to methylphenidate 3. Age >65 or <18 4. Personal medical history of 1. Arrhythmias, 2. Structural cardiac disease, 3. Other cardiac abnormality 4. Uncontrolled hypertension (>150/95) during study. For those with BP >140/90 & <150/95, they will be monitored during the study and refer them for treatment if their BP remains elevated throughout the study. 5. Uncontrolled tachycardia during study 6. Progressive neurological disorders which may interfere w/ cognition for reasons other than seizures 7. Glaucoma 8. Other medical or neurological illnesses or symptoms which may interfere with cognition or medication (e.g., severe liver or renal disease, active infections, etc), or which make use of the medication inappropriate (e.g., severe agitation/anxiety). 9. Intellectual disability sufficient to render a participant unable to consent 10. Status epilepticus within the last year 11. Neurosurgery which would be expected to interfere with study tasks within the last 6 months. 5. Substance use history 1. Met criteria for substance use disorder within the past year 2. Active illicit substance use 3. Alcohol use meeting criteria for substance abuse 4. Unwillingness to abstain from alcohol w/in 24 hours of testing 6. Personal psychiatric history 1. History of a primary psychotic disorder, such as schizophrenia, or mania. 2. History of suicide attempts within the last year 3. Active suicidality 7. Severe cognitive impairments (e.g. aphasia) which render a participant unable to consent 8. Currently receiving medications which would be expected to interfere with the study tasks, if they cannot be held for study visits; 9. Pregnancy or active breastfeeding; 10. Women of childbearing potential who are sexually active and not willing or able to use a contraceptive strategy during the course of the study. 11. Any other factor which may interfere w/ a participant's ability to consent or to complete the required cognitive tasks, or may significantly interfere with their performance on the required tests 12. Concomitant use of an MAOI (if receiving methylphenidate during this study), or use of an MAOI within the last 14 days prior to receiving methylphenidate. | |
| 7 | NCT02191579 | completed | 1 | phase 4 | ['migraine disorders'] | ["['G43.B1', 'G43.D1', 'G43.B0', 'G43.D0', 'G43.A1', 'G43.411', 'G43.419']"] | ['topiramate'] | ['[H][C@@]12CO[C@@]3(COS(N)(=O)=O)OC(C)(C)O[C@@]3([H])[C@]1([H])OC(C)(C)O2'] | Inclusion Criteria: - History of chronic migraine - More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication). Exclusion Criteria: - Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period - Previous treatment with botulinum toxin of any serotype for any reason - Previous treatment with topiramate - On a ketogenic diet (high in fat, low in carbohydrates) - History of acute myopia or increased intraocular pressure - Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function - Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening. | |
| 8 | NCT02193490 | terminated | sponsor ceased sponsorship and terminated the research citing slow accrual of subjects in this clinical trial. | 1 | phase 1/phase 2 | ['dry eye'] | ["['H04.121', 'H04.122', 'H04.123', 'H04.129', 'H35.3111', 'H35.3112', 'H35.3121']"] | ['dnase', 'vehicle'] | ['[H][C@@]1(C)C[C@@]2([H])[C@]3([H])CCC4=CC(=O)C=C[C@]4(C)[C@@]3(Cl)[C@@]([H])(O)C[C@]2(C)[C@@]1(OC(=O)C1=CC=CO1)C(=O)CCl'] | Inclusion Criteria: - Aged 18 years or older. - Capable of giving informed consent and does provide informed consent. - Documented Dry Eye Disease for at least 6 months. - Schirmer I <10 - Corneal/ conjunctival (Rose Bengal) staining ≥1 - Ocular symptoms must be considered as annoying or activity limiting (OSDI ≥13; mild). - Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. Exclusion Criteria: - Allergic to Deoxyribonuclease eye drops or any similar products, or excipients of Deoxyribonuclease eye drops 0.1%. - Receiving or have received within 30 days any experimental systemic medication. - Active ocular infection or ocular allergies. - Any history of eyelid surgery or ocular surgery within the past 3 months. - Corneal epithelial defect larger than 1 mm2 in either eye. - The use of topical cyclosporine or corticosteroids within 2 weeks of enrollment - Have active drug/alcohol dependence or abuse history |
| 9 | NCT02193815 | completed | 0 | phase 1 | ['psoriasis vulgaris'] | ["['L40.0']"] | ['pf06263276', '2%tofacitinib ointment', 'daivonex', 'daivonex ointment'] | ['O[C@H](\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)C[C@H](O)C1=C)C1CC1', 'O[C@H](\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)C[C@H](O)C1=C)C1CC1'] | Inclusion Criteria: - Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests. - Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas. - The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion. Exclusion Criteria: - Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis. - Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial. - Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase. | |
| 10 | NCT02199223 | terminated | slow accrual | 0 | phase 1 | ['kras and nras wild-type colorectal cancer'] | ["['E85.82']"] | ['regorafenib + panitumumab'] | ['CNC(=O)C1=CC(OC2=CC(F)=C(NC(=O)NC3=CC=C(Cl)C(=C3)C(F)(F)F)C=C2)=CC=N1'] | Inclusion Criteria: - Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS and NRAS mutation negative (wild-type). Patients with any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146 will be excluded. Mutations of KRAS and NRAS codons not listed above are allowed. Biopsy of metastatic lesion is not required. - Patients must show signs of progression (by imaging, or tumor marker elevation) after being treated with a first line or greater treatment for their un-resectable or metastatic colorectal cancer. - Age 18 years or older. - ECOG Performance Status 0-1 - Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. - Acute toxic effects of all prior treatment have resolved to NCI-CTCAE v4.0 less than or equal to Grade 1 or baseline prior to beginning treatment. Alopecia (any grade) is allowed. Peripheral neuropathy less than or equal to Grade 2 is allowed. - Adequate bone marrow, renal and liver function as assessed by protocol laboratory requirements - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. - Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug. Highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by both sexes. - Subject must be able to swallow medication. - Measurable disease at screening by RECIST 1.1 criteria Exclusion Criteria: - Any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146. - Prior use of regorafenib. - Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of the trial. - Uncontrolled hypertension (systolic pressure greater than140 mm Hg or diastolic pressure greater than 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings despite optimal medical management. Hypertension may be corrected by adding or adjusting anti-hypertensives prior to the initiation of treatment at the discretion of the practitioner. - Active or clinically significant cardiac disease including congestive heart failure, uncontrolled cardiac arrhythmias, or unstable angina. - Evidence or history of congenital or acquired hypocoagulability disorders. - Any hemorrhage or bleeding event greater than or equal to NCI CTCAE v.4.0 Grade 3 within 4 weeks prior to start of study medication. - Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism that have initiated within 6 months of start of study treatment. Stable, persistent events under appropriate management diagnosed greater than 6 months prior to treatment are allowed at the discretion of the investigator. - Subjects who are receiving treatment for a concurrent cancer that is distinct in primary site or histology from colorectal carcinoma, except any cancer in-situ, treated basal cell or squamous cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease more than 1 year before randomization are allowed. All cancer treatments must be completed at least 1 year prior to start of study treatment. - Patients with severe hepatic impairment (Child-Pugh Class C). - Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. Baseline testing is not required. - Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections. - Symptomatic metastatic brain or meningeal tumors. Baseline brain imaging is not required. - Presence of a non-healing wound or bone fracture. - Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade 3. - Interstitial lung disease with ongoing signs and symptoms at the time of informed consent. - Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption. - Women who are pregnant or breast-feeding. - Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation. - Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results. - Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 3 weeks of starting study treatment. - Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment. - Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks before start of study medication. - Concurrent use of strong CYP3a4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) - Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole) |
| 11 | NCT02209597 | completed | 1 | phase 4 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['bupropion xl 300'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1'] | Inclusion Criteria Each subject must meet all of the following criteria: 1. Adult outpatients age 18-75 years 2. Currently on once daily bupropion HCl 300mg XL (brand or any generic), for a minimum of 4 months 3. Major depressive disorder (MDD), in partial or full remission for at least 4 months, as confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). Spontaneous relapse of depression unrelated to medication changes is less likely - about 5% chance per year - after remission has been maintained for at least 4 months.2 4. Ability to understand and willingness to comply with study procedures, and to provide written informed consent Exclusion Criteria Subjects will not be enrolled if any of the following criteria exist: 1. Remission from depression not clearly attributed to bupropion treatment 2. Current severe side effects attributable to bupropion 3. Poor adherence to bupropion treatment per patient self- report and history of refill persistence 4. History of active seizure disorder, or seizure treatment within past year 5. History of significant hepatic or renal disease, based on physician assessment 6. Currently taking drugs or natural products known to influence cytochrome P450B6 (CYP2B6) activity 7. Currently taking drugs for hepatitis C or multiple sclerosis, due to their ability to cause depression 8. Dementia or other significant cognitive impairment, per diagnosis or investigative team's assessment 9. Lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order, delusional disorder, or current psychotic symptoms diagnosed by SCID 10. Abuse of or dependence on alcohol or other substances within the past 6 months as determined by SCID, and confirmed by study physician interview 11. Current suicidal ideation | |
| 12 | NCT02212028 | completed | 1 | phase 4 | ['coronary artery disease'] | ["['I25.10', 'I25.110', 'I25.119', 'I25.111', 'I25.118']"] | ['prasugrel'] | ['CC(=O)OC1=CC2=C(CCN(C2)C(C(=O)C2CC2)C2=CC=CC=C2F)S1'] | Inclusion criteria: - Patients with ST-elevation myocardial infarction undergoing primary PCI - Age between 18 and 75 years old Exclusion criteria: - Age >75 years - Weight <60 Kg - On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 7 days - Known allergies to aspirin or prasugrel - Considered at high risk for bleeding - History of ischemic or hemorrhagic stroke or transient ischemic attack - On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban) - Treatment with IIb/IIIa glycoprotein inhibitors - Fibrinolytics within 24 hours - Known blood dyscrasia or bleeding diathesis - Known platelet count <80x106/mL - Known hemoglobin <10 g/dL - Active bleeding - Hemodynamic instability - Known creatinine clearance <30 mL/minute - Known severe hepatic dysfunction - Pregnant females* - Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study. | |
| 13 | NCT02212210 | terminated | pi permanently closed accrual for the study based on fda warning issued in april 2014. study is closed | 0 | early phase 1 | ['fever', 'labor pain', 'complication of anesthesia during pregnancy, unspecified'] | ["['A78', 'A79.0', 'A93.1', 'A96.2', 'R50.82', 'R50.83', 'R50.9']", "['O29.90', 'O29.91', 'O29.92', 'O29.93', 'O29.099', 'O29.199', 'O29.299']"] | ['methylprednisolone', 'normal saline'] | ['[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC', '[Na+].[Cl-]'] | Inclusion criteria: - Nulliparity - Age>=18 - Patient requests epidural analgesia - GA >= 37 weeks Exclusion criteria: - No prenatal care - Temperature >99.4 at decision for epidural placement - Cervical dilation >4cm - Diabetes (pre-gestational or gestational) - Autoimmune condition - Pre-eclampsia - Maternal heart disease - Current steroid use - Active infection (bacterial or viral) - Wet Tap (CSF on placement of epidural) - Pre-gestational diabetes - Known systemic infection (bacterial, viral, fungal or tubercular) - Known allergy to steroids - Heart failure - Hypertensive crisis - History of active epilepsy |
| 14 | NCT02216214 | completed | 1 | phase 4 | ['overactive bladder (oab)'] | ["['N32.81']"] | ['mirabegron', 'placebo'] | ['NC1=NC(CC(=O)NC2=CC=C(CCNC[C@H](O)C3=CC=CC=C3)C=C2)=CS1'] | Inclusion Criteria assessed at Visit 1 (Screening): - Subject is willing and able to complete the micturition diary and questionnaires correctly. - Subject has symptoms of wet overactive bladder (OAB) (urinary frequency and urgency with incontinence) for greater than or equal to 3 months prior to Screening. - Subject agrees not to participate in another interventional study from the time of screening until the final study visit. Inclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): - Subject continues to meet all inclusion criteria of Visit 1. - Subjects must experience at least one incontinence episode in the placebo run-in period based on the 3-day micturition diary. - Subject must experience at least 3 episodes of urgency (grade 3 or 4) based on the 3-day micturition diary. - Subject must experience an average of greater than or equal to 8 micturitions/day based on the 3-day micturition diary. Exclusion Criteria assessed at Visit 1 (Screening): - Subject has ongoing symptoms suggestive of bladder outlet obstruction (BOO) or history of BOO that is currently not well controlled. - Subject has Post-Void Residual Volume (PVR) greater than 150 mL. - Subject has neurogenic bladder or neurological dysfunction or injury which could affect the lower urinary tract or nerve supply. - Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by a cough provocation test). Subjects with a history of stress incontinence that is currently treated (e.g. remote history of surgery for stress incontinence) may be included as long as they pass cough provocation test. - Subject has an indwelling catheter or practices intermittent self-catheterization. - Subject has evidence of Urinary Tract Infection (UTI). Urine culture and sensitivity will be performed for positive leukocytes, or nitrites, or turbidity, or at the investigator's discretion and will be confirmed with a culture greater than 100,000 cfu/mL. If a subject has a UTI at Screening (Visit 1), the subject can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture). - Subject has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen). - Subject resides in a nursing home. - Subject is likely to enter a hospital or nursing home due to medical instability within the next 6 months in the opinion of the Investigator. - Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin. - Subject has received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]). - Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening. - Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C. - Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min determined by Estimated Glomerular Filtration Rate (eGFR, Cockroft-Gault, or MDRD formulae). A subject with end stage renal disease or undergoing dialysis is also not a candidate for the study. - Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal to 180 mmHg and/or diastolic blood pressure greater than or equal to 110 mmHg. - Subject has evidence of QT prolongation on electrocardiogram (ECG) defined as QTc greater than 450 msec for males, QTc greater than 470 msec for females or a known history of QT prolongation. - Subject has a clinically significant ECG abnormality, as determined by the Investigator. - Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant by the Investigator. - Subject has a hypersensitivity to any components of mirabegron, other β-AR agonists, or any of the inactive ingredients. - Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation. - Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening. - Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. - Subject with current history of alcohol and/or drug abuse. - Subject is using prohibited medications which cannot be stopped safely during the period. - Subject has stopped, started or changed the dose of a restricted medication within the last 30 days prior to Screening. - Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team. - Subject has previously received mirabegron. Exclusion Criteria assessed after placebo run-in period at Visit 3 (Baseline): - Subject fulfills any exclusion criteria of Visit 1 (subject does not need to repeat screening assessments [PVR, cough provocation test, chemistry/hematology/urinalysis]). - Subject was non-compliant during 2-week placebo run-in period, defined as taking less than 80% or greater than 120% of study medication. - Subject has any systolic blood pressure measurement > 180 mmHg or diastolic blood pressure measurement > 110 in the 3-day diary or during the baseline visit. | |
| 15 | NCT02217410 | completed | 0 | phase 1/phase 2 | ['kidney transplantation'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['tacrolimus (tac)', 'mycophenolate mofetil (mmf)', 'corticosteroids (cs)'] | ['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', 'COC1=C(C\\C=C(/C)CCC(=O)OCCN2CCOCC2)C(O)=C2C(=O)OCC2=C1C', '[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'] | Main Inclusion Criteria: - Written informed consent must be obtained before any assessment is performed. - Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. - Recipients of a kidney with a cold ischemia time (CIT) < 30 hours. Main Exclusion Criteria: - Recipients of an organ from a non-heart beating donor. - ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. - Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication. - Subjects at high immunological risk for rejection - Subjects at risk for tuberculosis (TB) - Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment. - Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label). | |
| 16 | NCT02220920 | completed | 1 | phase 4 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['canagliflozin (ta-7284)', 'placebo', 'insulin'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[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: - Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational dug - Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug - Patients with HbA1c of ≥7.5% and <10.5% - Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug Exclusion Criteria: - Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.) - Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) - Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria - Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg - Patients with serious renal or hepatic disease - Patients with eGFR of <45 mL/min/1.73 m2 - Patients who are the excessive alcohol addicts - Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception | |
| 17 | NCT02222246 | completed | 1 | phase 4 | ['sickle cell disease'] | ["['D57.1', 'D57.20', 'D57.212', 'D57.219', 'D57.211', 'D57.213', 'D57.218']"] | ['hydromorphone (standardized, weight-based dosing)', 'morphine sulfate (standardized, weight-based dosing)', 'hydromorphone (patient specific dosing)', 'morphine sulfate (patient specific dosing)'] | ['[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O', '[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])C=C[C@@H]2O', '[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O', '[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])C=C[C@@H]2O'] | Inclusion Criteria: - Adult SCD patients with genotypes SS, SC, SB+, or SB- Exclusion Criteria: - Patients with sickle cell trait - Allergic to both morphine sulfate and hydromorphone, - Patients who have an explicit care plan that states they cannot be admitted to the hospital for pain control, - Non-English speaking, - Patients admitted for a medical complication, - Record of >24 ED visits in the prior 12 months, - Children | |
| 18 | NCT02223065 | completed | 0 | phase 1 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['saxagliptin', 'dapagliflozin'] | ['N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', 'CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: 1. Signed Informed Consent Form - Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures. 2. Target Population - Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results. 3. Age and Reproductive Status - Males and females, ages 19 to 55 years, inclusive. To extent possible, the distribution of men and women between the sequences will be balanced - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. - Women must not be breastfeeding. d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs saxagliptin and dapagliflozin plus 5 half lives of study drug dapagliflozin (the longer half life between the 2 drugs; 3 days) for a total of 3 days following treatment completion. e) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs saxagliptin and dapagliflozin plus 5 half lives of dapagliflozin (the longer half life between the 2 drugs; 3 days) for a total of 3 days following treatment completion. f) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section Exclusion Criteria: - Any significant acute or chronic medical illness. - Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug - Any other sound medical, psychiatric, and/or social reason as determined by the investigator - Any major surgery within 4 weeks of study drug administration. - Any prior GI surgery including cholecystectomy (remote history of appendectomy will not be exclusionary). - Current, recent (within 3 months of study drug administration), or remote history of pancreatitis. - Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 4 weeks before study drug administration. - Blood transfusion within 4 weeks of study drug administration. h) Inability to tolerate oral medication. - Inability to be venipunctured performed and/or tolerate venous access. - Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, e-cigarettes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months before check-in. - Drug or alcohol abuse (within 2 years of study drug administration) as defined in the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition, Diagnostic Criteria for Drug and Alcohol Abuse History of glucose intolerance or diabetes mellitus. - For females, history of chronic or recurrent urinary tract infection (UTI) (defined as 3 occurrences per year) or UTI in the past 3 months. For males, any UTI within the previous 5 years that has not been thoroughly evaluated and for which an explanation is not clear. - History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections. - Any other sound medical, psychiatric, and/or social reason as determined by the investigator. Physical and Laboratory Test Findings 1. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population. 2. Abnormal urinalysis at screening (may repeat once). If the urinalysis is abnormal on Day -1 of Period 1, continuation in the study is up to the investigator's discretion. The CRO medical monitor should be consulted. 3. Glucosuria or hematoria at screening or Day -1 of Period 1, repeat is not permitted. d) A positive nicotine test (ie, cotinine). e) Abnormal liver function tests (alanine or aspartate aminotransferase [ALT or AST, respectively], or total bilirubin). f) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat. i) PR ≥ 210 ms ii) QRS ≥ 120 ms iii) QT ≥ 500 ms iv) QTcF ≥ 450 ms g) Positive urine screen for drugs of abuse. h) Positive urine alcohol test. i) Positive blood screen for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at screening. 4. Allergies and Adverse Drug Reaction 1. History of allergy or adverse reactions to DPP4 or SGLT inhibitors or related compounds. 2. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity). 5. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated. 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 3. Inability to comply with restrictions and prohibited activities/treatments | |
| 19 | NCT02223702 | completed | 1 | phase 4 | ['generalized aggressive periodontitis', 'aggressive periodontitis'] | ["['K05.221', 'K05.222', 'K05.223', 'K05.229']", "['K05.20', 'K05.211', 'K05.212', 'K05.213', 'K05.221', 'K05.222', 'K05.223']"] | ['amoxicillin', 'metronidazole', 'moxifloxacin'] | ['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', '[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions. - Patients were included if they were between 18 and 35 years of age and otherwise healthy. Exclusion Criteria: - if the patients had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases) - history of hepatitis or HIV infection, - immunosuppressive chemotherapy - current pregnancy, planning a pregnancy or lactation - requirement for antibiotic prophylaxis - oral diseases other than GAgP, ongoing orthodontic therapy - a history of antibiotic therapy or periodontal treatment within the preceding six months. - Subjects were excluded if they had known allergies to quinolones or penicillin or metronidazole - Not willing to participate to the study. - Not accept to sign written informed consent | |
| 20 | NCT02224599 | terminated | sponsor decision to terminate study due to poor accrual | 0 | phase 1/phase 2 | ['progressive solid malignancies', 'refractory solid malignancies', 'cancer'] | ["['A81.2', 'G12.22', 'G60.3', 'I67.3', 'M34.0', 'Q78.3', 'G12.25']", "['D46.4', 'D46.1', 'D46.A', 'D46.0', 'D46.20', 'D46.21', 'D46.22']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cyclophosphamide pill', 'imiquimod topical cream'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CC(C)CN1C=NC2=C1C1=CC=CC=C1N=C2N'] | Inclusion Criteria: 1. Ability to provide informed consent. 2. Patients with histologically proven progressive and/or refractory SM, s/p conventional salvage therapy, completed at least 3 weeks prior to study vaccination, will be eligible for enrollment. 3. Expression of one (1) or more of the following TAPAs: Sp17, AKAP-4, Ropporin, PTTG-1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1, by either RT-PCR and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood. For HER-2/neu expression, positive FISH results are acceptable. 4. Presence of measurable or evaluable disease. 5. Patients must not have any active infectious process. 6. Patients must not have a history of HIV, or active Hepatitis A, B, and C. 7. Patients must not be receiving active immunosuppressive therapy. 8. Patients must have discontinued systemic cytotoxic or radiation therapy at least three (3) weeks prior to vaccination and toxicities from previous therapies must be grade 1 or less. all other FDA approved forms of antineoplastic therapy are allowed such as immunotherapy, targeted therapies, or hormonal therapies (67, 68) 9. Patients may not have any known allergy to CYP and/or Imiquimod. 10. Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood obtained by phlebotomy and/or consent to leukapheresis for DC generation. 11. Adequate renal and hepatic function (creatinine ≤ 2.0 mg/dl, bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 4X upper limit of normal range). 12. Adequate hematologic function (Platelets ≥ 60,000/mm3, lymphocytes ≥ 1,000 mm3, neutrophils ≥ 750/mm3, hemoglobin ≥ 9.0 g/dl). 13. Karnofsky performance status ≥ 70%. 14. Expected survival ≥ 6 months. 15. Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process. Exclusion Criteria: 1. Patients without confirmed progressive and/or refractory SM using standard RECIST criteria. 2. Patients without measurable or evaluable disease. 3. Patients receiving cytotoxic therapy or radiation therapy, within three (3) weeks of vaccination. 4. Active immunosuppressive therapy, including non-physiologic systemic steroids (excluding topical, intraocular, inhaled, and intranasal steroids) for any other condition. 5. Persistent fever (>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment. 6. Active ischemic heart disease or history of myocardial infarction within six months. 7. Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA). 8. Pregnancy or breast feeding. 9. Active second invasive malignancy, other than basal cell carcinoma of the skin. 10. Life expectancy of less than 6 months. 11. Patients with contraindications to CYP and/or Imiquimod. 12. Patients who have received organ transplants. 13. Patients with psychological or geographic conditions that prevent adequate follow- up or compliance with the study protocol. |
| 21 | NCT02225574 | terminated | slow accrual - only 1 patient enrolled in phase 1 - study never went to phase ii | 0 | phase 1 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['mek-162', 'nilotinib'] | ['CN1C=NC2=C(F)C(NC3=CC=C(Br)C=C3F)=C(C=C12)C(=O)NOCCO', 'CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1'] | Inclusion Criteria: 1. Patients 18 years of age or older with advanced CML (CML-AP, CML-BP and Philadelphia chromosome-positive acute leukemia) or refractory chronic phase CML are eligible, as defined as follows: The phase I portion of the study will be conducted first in advanced phase (accelerated phase CML, blast phase CML or Philadelphia-positive acute leukemia) patients. Once MTD is identified, a cohort of 6 patients with CML chronic phase who have failed prior therapy with at least two tyrosine kinase inhibitor will be treated at the MTD to determine if this dose is also acceptable for chronic phase patients. The phase II will be conducted in two treatment arms as follows: Treatment Arm A (Advanced phase disease) and treatment Arm B (Therapy for CP-CML refractory/resistant/suboptimally responding to at least two prior TKI's) 2. (Cont - Inclusion Criteria #1) CML-AP is defined by the presence of one of the following: a. 15-29% blasts in peripheral blood (PB) or bone marrow (BM), b.>20% basophils in PB or BM, c.>30% blasts plus promyelocytes (with blasts <30%) in PB or BM, d.<100 x109/L platelets unrelated to therapy, or Clonal cytogenetics evolution (i.e., the presence of cytogenetic abnormalities other than the Philadelphia chromosome) except if only present at the time of diagnosis and not associated with other features of accelerated phase. CML-BP is defined by the presence of >/=30% blasts in the bone marrow and/or peripheral blood or the presence of extramedullary disease, with myeloid or lymphoid blast morphology. Philadelphia-chromosome acute leukemias are eligible and defined by >/=20% blasts in the peripheral blood or bone marrow at the time of diagnosis. 3. Patients with advanced phase CML or acute leukemia must have failed at least one prior TKI. Patients with chronic phase CML must have failed, have resistance or suboptimal response to at least two tyrosine kinase inhibitors, or have intolerance to two prior tyrosine kinase inhibitors. For patient with prior intolerance, they should have received at least 2 TKI and experienced intolerance to one TKI and resistance/suboptimal 4. (Cont - Inclusion Criteria #3) a. Failure to tyrosine kinase inhibitors will be defined per European-Leukemia-Net (ELN) recommendations b.Resistance or suboptimal response to at least two prior Abl-kinase inhibitor, specifically: i.Chronic-phase with resistance to imatinib, dasatinib, nilotinib, bosutinib or ponatinib defined as 1. Loss of CCyR at any time or failure to achieve CCyR after >/=18 months 2. Loss of MCyR at any time or failure to achieve PCyR after >/=12 months 3. Failure to achieve any CyR (ie, >/= 65% Ph+) after >/= 6 months 4. Hematologic relapse or failure to achieve CHR after >/=3 months ii. Chronic-phase with suboptimal response to imatinib, defined as 1. Failure to achieve PCyR after >/= 6 months 2. Failure to achieve CCyR after >/=12 months iii. Chronic-phase with suboptimal response to nilotinib, bosutinib, dasatinib or ponatinib, defined as 1. Failure to achieve PCyR after >/= 3 months 2. Failure to achieve CCyR after >/= 6 months of therapy 5. Patients with cytogenetic BCR-Abl variants and additional chromosomal abnormalities ('clonal evolution') will be eligible. Cytogenetics to be performed, but results are not required to start therapy in patients with hematologic progression 6. Patients who have failed nilotinib, including those who are refractory to nilotinib at any dose or have relapsed on nilotinib at any dose will be eligible for the study. Patients currently on nilotinib will continue on their prescribed dose of nilotinib and MEK-162 will be added based on the current cohort level in phase I or at the established MTD in phase II. In the instance the nilotinib dose is greater than the current cohort (in phase 1) or the MTD (in phase 2) patients will be dose reduced to the dosage as prescribed by protocol and then dose escalated as allowed in protocol at the PIs discretion. 7. For the phase I portion of the study, patients who had received prior therapy with nilotinib should have been able to tolerate the dose equivalent to the starting dose of nilotinib in the dose level at which the patient is being entered. Patients who previously received nilotinib but never at the dose being proposed are eligible provided they tolerated the maximum dose they were prescribed with no grade 3 or 4 toxicity not responding to optimal management. 8. Patients must have been off all prior therapy for CML for 2 weeks prior to start of study therapy and recovered from the toxic effects of that therapy. Exceptions to these are hydroxyurea and TKIs (including but not limited to imatinib, nilotinib, dasatinib, ponatinib and bosutinib), which should be discontinued ≥48 hrs prior to the start of therapy. Patients who are receiving nilotinib prior to enrollment do not have to discontinue this agent prior to start of study therapy 9. Eastern Cooperative Oncology Group (ECOG) performance status </=2 10. Men and women of childbearing potential should practice effective methods of contraception. Men and women of childbearing potential are defined as: a male that has not been surgically sterilized or female that has not been amenorrheic for at least 12 consecutive months or that has not been surgically sterilized. Patients must use birth control during the study and for 3 months after the last dose of study drug if they are sexually active. 11. Adequate organ function: Serum creatinine </=2.0 mg/dl or creatinine clearance >/=60 mL/min, Direct bilirubin </=2.0xULN (unless considered due to leukemia involvement), Alanine aminotransferase (ALT) </=2.5xULN (</=5.0xULN if considered due to leukemic involvement.) 12. Adequate cardiac function: left ventricular ejection fraction (LVEF) >/= 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram, QTc interval </= 480 ms; 13. Women of childbearing potential must have a pregnancy test at screening. 14. Signed informed consent. Exclusion Criteria: 1. Impaired cardiac function including any one of the following: a. Inability to monitor the QT interval on ECG b. Congenital long QT syndrome or a known family history of long QT syndrome. c. Clinically significant resting brachycardia (<45 beats per minute) d. QTc > 480 msec on baseline ECG. If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc e. Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) <6 months prior to screening, Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality <6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia 2. History of Gilbert's syndrome. 3. Uncontrolled arterial hypertension despite medical treatment 4. Prior therapy with a MEK- inhibitor 5. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) 6. History of retinal degenerative disease; 7. Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy 8. Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection 9. Patients who have neuromuscular disorders that are associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy) 10. Patients who are planning on embarking on a new strenuous exercise regimen after first dose of study treatment. Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on MEK162 treatment 11. Patients currently receiving treatment with strong CYP3A4 inhibitors who cannot discontinue such treatment or be switched to a different medication prior to starting study drug are excluded from study entry. Strong CYP3A4 inhibitors include the following medications: itraconazole, ketoconazole, miconazole, voriconazole; amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir; ciprofloxacin, clarithromycin, diclofenac, doxycycline, enoxacin, isoniazid, ketamine, nefazodone, nicardipine, propofol, quinidine, telithromycin. 12. Patients receiving treatment with any medications that have the potential to prolong the QT interval who cannot discontinue such treatment or be switched to a different medication prior to starting study drug are excluded from the study entry. A list of anti-arrhythmic drugs and other drugs that may prolong the QT interval is added in protocol section 8.5 (page 53). 13. Impaired gastrointestinal (GI) function or active GI disease that may significantly alter the absorption of study drug in the opinion of the treating physician (e.g., active ulcerative diseases, uncontrolled nausea, uncontrolled vomiting, uncontrolled diarrhea, active malabsorption syndrome, small bowel resection within last 1 year or gastric bypass surgery within last 1 year). 14. Another active primary malignant disease, which requires systemic treatment (chemotherapy or radiation) 15. History of significant congenital or acquired bleeding disorder unrelated to cancer 16. Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery. 17. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test 18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 3 months after study drug discontinuation. Highly effective methods of contraception are further defined. 19. Patients who are eligible, willing and able to receive an allogeneic stem cell transplant within 6 weeks are not eligible. 20. Sexually active males unless they use a condom during intercourse while taking the drug and for 3 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid; 21. History of non-compliance to medical regimens or inability to grant consent. |
| 22 | NCT02227329 | terminated | publication of guidelines advising against the use of ethanol locks. | 0 | phase 1/phase 2 | ['catheter-related bloodstream infection (crbsi) nos', 'bloodstream infection due to central venous catheter', 'bloodstream infection due to hickman catheter'] | ["['T80.211S', 'T80.211A', 'T80.211D']", "['T80.211S', 'T80.211A', 'T80.211D']", "['T80.211S', 'T80.211A', 'T80.211D']"] | ['ethanol', 'heparin lock', 'normal saline'] | ['NCCO.CCCCCCCC\\C=C/CCCCCCCC(O)=O', 'O.O.[Al+3].[Cl-].[Zr+4].NCC([O-])=O', '[Na+].[Cl-]'] | Inclusion Criteria: - Newly started on Home parenteral Nutrition and anticipated duration >3 months. - Not previously on Home Parenteral Nutrition. - Providing consent. - Patients with non-medicare insurance. - Patients with medicare insurance and a supplementary insurance. - Patients with single lumen Hickman® catheters. - No known alcohol addiction. Exclusion Criteria: - Failure to provide consent - Patients with medicare insurance and no other supplemental private insurance - Patients with a catheter type other than a single lumen Hickman® - Patients who are on HPN for less than three months - Pregnant patients - Patients who have previous proven addiction and dependence to alcohol. - Patients lacking capacity to provide consent - Patients who are not be managed by HPN team at investigator's institution |
| 23 | NCT02230995 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['metformin', 'empagliflozin/metformin', 'empagliflozin'] | ['[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', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N'] | Inclusion criteria: - Healthy male and female subjects Exclusion criteria: - Any relevant deviation from healthy condition. | |
| 24 | NCT02234037 | terminated | slow accrual | 0 | phase 1 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['decitabine'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria - Age ≥ 60 years - Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score - Provide signed written informed consent - Be able to comply with study procedures and follow-up examinations - Adequate heart function with echocardiogram demonstrating ejection fraction ≥ 45% with no evidence of systolic dysfunction - Adequate renal and hepatic function: - Total bilirubin ≤ 2x institutional Upper Limit of Normal (ULN); and - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN; and - Serum creatinine ≤ 2 times the upper limit of normal - ECOG performance < 4 - Patients with a history of carcinoma in remission (on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are included in the study. Exclusion Criteria: - Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t(15;17)(q22;q12)), (PML/retinoic acid receptor alpha [RARa] and variants) - Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML - Relapsed or refractory AML - Rapidly doubling white cell count uncontrolled with hydroxyurea - Coronary artery disease with angina limiting exercise capability - Joint disease limiting exercise capability - Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug - Psychiatric disorders that would interfere with consent, study participation, or follow-up - Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) - Any other severe concurrent disease, or serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy - No social support or inability to attend study-related visits - Carcinoma requiring systemic chemotherapy or radiation therapy |
| 25 | NCT02234427 | completed | 1 | phase 4 | ['atherosclerosis'] | ["['I67.2', 'I70.90', 'I70.91', 'I70.0', 'I70.1', 'I70.8', 'I25.83']"] | ['aspirin'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl'] | Inclusion Criteria: - 45-75 years - GeneSTAR participant - No personal History of Coronary Artery Disease - Women who are post-menopausal - Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP Exclusion Criteria: - Taking aspirin prescribed by physician - weight < 60 kg - History of recent or current bleeding - allergy to aspirin or history of adverse events to aspirin - serious comorbid conditions (such as AIDS, active cancer) - high blood pressure (>160/95) - History of gastrointestinal ulcer/bleeding - Mental incompetence to make decision to participate. | |
| 26 | NCT02238379 | completed | 1 | early phase 1 | ['social perception'] | ["['H53.33', 'F16.183', 'F16.283', 'F16.983', 'H93.291', 'H93.292', 'H93.293']"] | ['oxytocin'] | ['CC[C@H]1[C@@H](CC2=CN=CN2C)COC1=O'] | Inclusion Criteria: - Adults ages 18-64 - Good medical health - Ability to understand and speak English Exclusion Criteria: - Pregnancy - Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza). - Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic). - CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness > 3 minutes. - Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study. - A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness | |
| 27 | NCT02240680 | 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: - Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation and Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial. - Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the time of Informed Consent, who are: - 60 years of age or older at informed consent or Screen Visit, - taking stable doses of basal or biosimilar basal insulin [strictly inclusive of: insulin neutral protamine Hagedorn and isophane insulin; Humalog Basal (a suspension of insulin lispro protamine); insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed, - may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)], and - may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)]. - Patients must have an glycosylated Haemoglobin of 7.0% (53 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (Screen). - Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the Screen Visit. - In the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them. Exclusion criteria: - Impaired cognitive ability as supported by the Saint Louis University Mental Status Examination, additional assessment if necessary, and verified by the investigator at the Screen Visit. - Depressed mood as supported by a score of 10 or more on the Patient Health Questionnaire at the Screen Visit. - Type 1 Diabetes Mellitus as determined by past medical records and history. - Acute coronary syndrome (non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, and/or unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to Screen Visit. - Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. - Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or LapBand) with the objective of promoting weight loss within the past two years at Screen Visit. - Medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years. - Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia). | |
| 28 | NCT02255162 | terminated | slow accrual | 0 | phase 1 | ['acute myeloid leukemia (aml)', 'acute myelocytic leukemia', 'acute myelogenous leukemia', 'acute granulocytic leukemia', 'acute non-lymphocytic leukemia'] | ["['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']"] | ['lenalidomide', 'cytarabine'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Recipient Inclusion Criteria - Adults, aged 18 through 75 years of age, with pathologically confirmed acute myelogenous leukemia, in pathologically confirmed complete remission following anti-leukemic therapy. - AST, ALT and Alkaline Phosphatase <5x Upper Limit normal (ULN), direct bilirubin < 2.0 mg/dl. - Adequate renal function as defined by: calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Formula) or serum Cr less than institution ULN (the elderly will often have < 60 GFR) - ECOG performance status 0-2. - Have a diagnosis of high-risk AML as established by a poor-risk karyotype, adverse risk by ELN criteria, a therapy-related AML, age ≥ 60 or with antecedent hematologic disorder - LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram - Patients, or appropriate designee, must be able to provide informed consent. - Must not have received systemic anti-neoplastic therapy, including radiotherapy within 14 days of study treatment. - Female patients of childbearing age must have negative pregnancy test. - Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of lenalidomide. - All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program. - Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. If needed, patients should be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. - Donor Inclusion Criteria - Haploidentical 1st-degree relative as defined by 3/6 or 4/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age - ECOG performance status 0 or 1 - Excellent health per conventional pre-donor history (medical and psychosocial evaluation) - No positive testing for viral infection (HbsAg, HIV, HCV) - Donor ability to understand and provide informed consent - Meets standard institutional criteria for GCSF mobilized PBSC donation Exclusion Criteria: - Recipient Exclusion Criteria - Diagnosis of acute promyelocytic leukemia - Active refractory or relapsed acute leukemia - Prior use of fludarabine, as this agent has been associated with higher subsequent rates of graft versus host disease - 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. - Uncontrolled intercurrent illness that would limit compliance with study requirements. - HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drug. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. - A diagnosis of active hepatitis B or C as defined by detectable viral load assays in the blood - Known hypersensitivity to thalidomide or lenalidomide. - The development of erythema nodosum if characterized by a desquamating rash while taking lenalidomide. - Significant cardiac disease as determined by the investigator including: - Known or suspected cardiac amyloidosis - Congestive heart failure of Class III or IV of the NYHA classification - Uncontrolled angina, hypertension or arrhythmia - Myocardial infarction in past 6 months - Any uncontrolled or severe cardiovascular disease - Prior cerebrovascular event with persistent neurologic deficit - Medical conditions that, in the investigator's opinion, would impose excessive risk to the subject. - Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy. - Systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection. - Pregnant women are excluded from this study. |
| 29 | NCT02257372 | completed | 1 | phase 4 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['umec dpi', 'placebo dpi', 'ics/laba medication', 'albuterol/salbutamol metered dose inhaler (mdi)'] | ['CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1'] | Inclusion Criteria: - Type of subject: Outpatient. - Informed Consent: A signed and dated written informed consent prior to study participation. - Age: Subjects 40 years of age or older at Visit 1. - Gender: Male and female subjects are eligible to participate in the study. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS) that meets the Standard Operating Procedure (SOP) effectiveness criteria as stated in the product label; Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) - Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history. - Severity of Disease: A pre and post-albuterol/salbutamol Forced Expiratory Volume in One Second /Forced Vital Capacity (FEV1/FVC) ratio of <0.70 and post-albuterol/salbutamol FEV1 of <=70% of predicted normal values at Visit 1 (Screening) calculated using reference values provided by Quanjer. - Current clinically prescribed medication: The subject must be on the dose and frequency of one of the following ICS/LABA combinations approved for COPD at least 30 days prior screening : FSC at a dose of 500/50 mcg twice-daily (i.e. SERETIDE DISKUS™ inhaler or approved generic product such as AIRFLUSAL FORSPIRO inhaler 500/50 mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50 mcg twice daily) ; The combination of budesonide/formoterol (i.e., SYMBICORT TURBUHALER inhaler) at doses of 200/6 mcg twice-daily or 400/12 mcg twice-daily . - Dyspnea: A score of >=2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at Visit 1. Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. - Asthma: A current diagnosis of asthma. - Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. - Other Diseases/Abnormalities: The subject is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediately life-threatening illness e.g. cancer. - Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate. - Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. - Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1. - Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1. - Unstable or life threatening cardiac disease: UMEC should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV heart failure - 12-Lead Electrocardiogram (ECG): Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principle Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. Subjects with the following abnormalities are excluded from participation in the study: Atrial fibrillation with rapid ventricular rate >120 beats per minute (bpm); Sustained or nonsustained ventricular tachycardia; Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted) - Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk. - Interactions: Concomitant administration with beta-blockers and strong Cytochrome P450 3A4 (CYP3A4) inhibitors is only permitted if, in the Investigator's opinion, the likely benefit outweighs the potential risk. - Severe Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk. - Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. - Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids (12 weeks), Systemic, oral or parenteral corticosteroids (6 weeks); Antibiotics (for lower respiratory tract infection) (6 weeks); CYP3A4 strong inhibitors (6 weeks) ; ICS /LABA combination products except SERETIDE and approved FSC 500/50 generic products and SYMBICORT at approved doses and frequencies for COPD (30 days) ; SERETIDE, approved FSC 500/50 generic products, and SYMBICORT at approved doses and frequencies for COPD (12 hours prior to screening); Phosphodiesterase 4 (PDE4) Inhibitor (roflumilast) (14 days); Long-acting muscarinic antagonists (tiotropium, aclidinium, glycopyrronium, UMEC) (7 days); Inhaled long acting beta2 agonists (LABA) (salmeterol, formoterol: 48 hrs) olodaterol, indacaterol (14 days); LAMA/LABA combination products (Apply whichever mono component has the longest washout) Theophyllines (48 hours); Oral beta2-agonists (Long-acting: 48 hours) (Short-acting: 12 hours); Inhaled short acting beta2-agonists (4 hours); Inhaled short-acting anticholinergics (4 hours); Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products (4 hours); Any other investigational medication (30 days or within 5 drug half-lives, whichever is longer). Note: Use of study provided albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing. Intra-articular and epidural corticosteroid injections are permitted. Corticosteroids for short term treatment of COPD exacerbations is allowed - Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <=12 hours per day) is not exclusionary. - Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. - Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1, or who will enter the acute phase of a pulmonary rehabilitation program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. - Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator. - Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire. DISKUS is a trade mark of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners. | |
| 30 | NCT02257632 | completed | 1 | phase 4 | ['wet age-related macular degeneration'] | ["['G23.2', 'G31.85', 'I51.5', 'K04.2', 'H18.40', 'H18.49', 'H35.30']"] | ['ranibizumab 0.5 mg', 'aflibercept 2 mg'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Visual impairment predominantly due to neovascular AMD. - Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept Exclusion Criteria: - Stroke or myocardial infarction less than 3 months prior to screening. - Presence of uncontrolled systolic blood pressure or diastolic blood pressure - Type 1 or Type 2 diabetes mellitus - Use of any systemic anti-VEGF drugs - Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. - Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception For either eye: - Any active periocular or ocular infection or inflammation - Uncontrolled glaucoma - Neovascularization of the iris or neovascular glaucoma - History of treatment with any anti-angiogenic drugs For study eye: - Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline. - Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD - Irreversible structural damage within 0.5 disc diameter of the center of the macula - Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline. - Use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening. For fellow eye - Retinal or choroidal neovascularization or macula edema of any cause Other protocol-defined inclusion/exclusion criteria may apply. | |
| 31 | NCT02257970 | completed | 1 | phase 4 | ['lymphedema'] | ["['Q82.0', 'I97.2', 'I89.0']"] | ['ketoprofen', 'placebo'] | ['CC(C(O)=O)C1=CC(=CC=C1)C(=O)C1=CC=CC=C1'] | Inclusion Criteria: - a history of lymphedema of one or more limbs (unilateral or bilateral), with a duration of > 6 months. Exclusion Criteria: - Patients with active cancer, infection or bleeding tendency will be excluded. - We will also exclude patients with medical contraindications to NSAIDs, including history of allergies, know gastrointestinal intolerance, or other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate. - Minors (<18 years of age) *>90 years of age | |
| 32 | NCT02260492 | completed | 1 | phase 1 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['ot329 (combination of fluticasone propionate and salmeterol xinafoate)', 'advair diskus (combination of fluticasone propionate and salmeterol xinafoate)', 'placebo'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', 'OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1'] | Inclusion Criteria: 1. Males and females ≥ 18 years old of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control 2. Subjects with a reliable clinical history of asthma documented at least 12 weeks prior to screening 3. Subjects with a pre-bronchodilator FEV1 of > 40% and <85% of the predicted value during the screening visit and on the first day of treatment 4. Subjects who are currently non-smoking and have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had < 10 pack-years of historical use 5. Subjects with > 15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI). Note: This test may be repeated on a different day if the patient fails the first attempt; and if the patient achieves at least 10% reversibility and the Investigator thinks that a second attempt is appropriate 6. Subjects who are able to discontinue their asthma medications (inhaled corticosteroids and long-acting beta agonists) during the run-in period and for the remainder of the study 7. Subjects who are able to replace current short-acting beta agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits) 8. Subjects who are able to continue the following medications without a significant adjustment of dosage, formulation, or dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit: short-acting forms of theophylline for 12 hours, twice-a-day controlled release forms of theophylline for 24 hours, once-a-day controlled-release forms of theophylline for 36 hours 9. Subjects who are able to discontinue the following medications for the specified minimum time intervals prior to the run-in period and for the remainder of the study: oral and parenteral corticosteroids for 1 month and oral short-acting beta agonists for 12 hours 10. Subjects who are able and willing to give their written informed consent to participate in the study. ********************************************************** Exclusion Criteria: 11. Female Subjects who are pregnant or breastfeeding 12. Subjects who have life-threatening asthma in the last 10 years, as defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period 13. Subjects with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study 14. Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy 15. Subjects who are on other medications with the potential to affect the course of asthma or to interact with sympathomimetic amines (e.g. beta blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors) 16. Subjects with a viral or bacterial upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period 17. Subjects with any factors (e.g. infirmity, disability, or geographic location) that the investigator feel would likely limit the patient's compliance with the study protocol or scheduled clinic visits 18. Subjects who have used any investigational drug in any clinical trial within 1 month of receiving the first dose of OT329 Solis™ study medication 19. Subjects who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator 20. Subjects with a milk protein allergy | |
| 33 | NCT02266472 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['metformin', 'empagliflozin/metformin', 'empagliflozin'] | ['[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', 'CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N'] | Inclusion criteria: - Healthy male and female subjects - age of 18 to 55 years - body mass index (BMI) of 18.5 to 29.9 kg/m2 - additional inclusion criteria may apply Exclusion criteria: - Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator - Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 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 as 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 trial medication - Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders - additional exclusion criteria may apply | |
| 34 | NCT02269085 | terminated | slow accrual | 0 | phase 1 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['ibrutinib', 'carfilzomib'] | ['CC(C)C[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)C1=CN=CC=N1)B(O)O', '[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'] | Inclusion Criteria: 1. Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy. 2. Patients must have previously treated relapsed and/or refractory MCL with at least 2 prior lines of therapy (prior carfilzomib, ibrutinib, bortezomib, anthracycline, rituximab or stem cell transplant are acceptable). There is no upper limit for prior lines of therapy. 3. Understand and voluntarily sign an institutional review board (IRB)-approved informed consent form. 4. Age >/= 18 years at the time of signing the informed consent. 5. Patients must have bi-dimensional measurable disease (Measureable disease by CT scan defined as at least 1 lesion that measures =/>1.5 cm in single dimension.) Patient with leukemia phase (peripheral blood involvement), non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible. 6. Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less 8. Serum bilirubin <1.5 mg/dl and creatinine (Cr) Clearance >/= 30 mL/min, platelet count >75,000/mm^3 and absolute neutrophil count (ANC) > 1,500/mm^3, aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) < 3 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present. (Patients who have bone marrow infiltration by MCL are eligible if their ANC is >/= 1000/mm^3 [growth factor not allowed] or their platelet level is >/= 50,000/mm^3). 9. Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty. 10. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 30 days after the last dose of study treatment. * 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). 11. Male patients must use an effective barrier method of contraception during the study and for 30 days following the last dose of study treatment if sexually active with a female of childbearing potential. Exclusion Criteria: 1. Any serious medical condition including but not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active hemorrhage, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. 2. Pregnant or breastfeeding females. 3. Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment. 4. Prior allogeneic stem cell transplant (SCT) within 16 weeks or autologous SCT within 8 weeks of initiation of therapy. (Patients that require immunosuppressive therapy are not eligible within 60 days of therapy.) 5. Known human immunodeficiency virus (HIV) infection. Patients with active Hepatitis B infection (not including patients with prior Hepatitis B vaccination; or positive serum Hepatitis B antibody). Hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation. 6. All patients with central nervous system lymphoma. 7. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment. 8. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib). 9. Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis. 10. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of ibrutinib. 11. Major surgery within 4 weeks of initiation of therapy. 12. Requires anticoagulation with warfarin or equivalent vitamin K antagonist. 13. Requires treatment with strong CYP3A inhibitors. 14. The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient's health and survival, than of the MCL, within the subsequent 6 months at the time of consent. Investigator discretion is allowed. 15. Patients with New York Heart Association (NYHA) Class III and IV heart failure, myocardial infarction in the preceding 6 months, and significant conduction abnormalities, including but not limited to atrial fibrillation, 2nd degree AV block type II, 3rd degree block, Torsade de pointe, QT prolongation (QTc > 450 msec, sick sinus syndrome, ventricular tachycardia, symptomatic bradycardia (heart rate < 50 bpm), hypotension, light headedness and syncope. Patients with atrial fibrillation will be excluded even if they are rate-controlled. If there are any active cardiac issues, cardiology consultation will be obtained for clearance. 16. Known history of Pulmonary Hypertension 17. If the left ventricular ejection fraction (LVEF) < 40, patients will be excluded. 18. Known history of Cardiomyopathy 19. Acute infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to initiation of study. |
| 35 | NCT02278263 | completed | 1 | phase 4 | ['osteoarthritis'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['tranexamic acid', 'normal saline (0.9% nacl)'] | ['N[C@@H](CCC(N)=O)C(O)=O'] | Inclusion Criteria: - All patients at the participating sites on the waiting list for a unilateral total knee joint replacement Exclusion Criteria: - Patients with a history or risk of thrombosis - Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis - Subarachnoid haemorrhage - Hypersensitivity to tranexamic acid or any of its ingredients. - Refusal of blood products - Colour blindness - Complex hematologic disorders requiring manipulation - Coagulopathy - Pregnant and Lactating Women - Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran, heparin) - Severe renal failure (eGFR <29) | |
| 36 | NCT02288325 | completed | 1 | phase 4 | ['depressive disorder, major'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['levomilnacipran er', 'placebo'] | ['CCN(CC)C(=O)[C@]1(C[C@H]1CN)C1=CC=CC=C1'] | Inclusion Criteria - Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD) - The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months - The participant must have at least 3 lifetime episodes of MDD (including the current episode) Exclusion Criteria: - Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control - Participants who are considered a suicide risk - History of non-response to 2 or more antidepressants (after adequate treatment) - Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder - Panic disorder | |
| 37 | NCT02288507 | withdrawn | closed due to no accrual | 0 | phase 1 | ['hepatocellular cancer'] | ["['P59.20', 'P59.29']"] | ['sorafenib'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Histologically or cytologically confirmed HCC or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. m) - Barcelona Clinic Liver Cancer Stage B or C. Segmental and subsegmental portal vein thrombosis is allowed. - Metastatic disease is allowed if investigator feels liver directed therapy could offer palliative benefit (i.e., minimal extrahepatic tumor burden) - No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7. Eligibility - Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1). - Consultation with interventional radiologist and deemed an appropriate candidate for TARE. - Prior local therapy, such as surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan. - Prior yittrium-90 transarterial radioembolization (TARE) or sorafenib not allowed - Patient must be informed of the investigational nature of this study, sign and give written informed consent in accordance with institutional and federal guidelines. - Age ≥ 18 years. - Eastern Cooperative Group (ECOG) performance status ≤ 1. - Have adequate hematologic function as documented by an absolute neutrophil count (ANC) ≥ 1000/ul, platelet count ≥ 60,000/ul, and hemoglobin ≥ 8.5 mg/dl obtained within 28 days prior to registration. - Have adequate hepatic function, as determined by the following tests measured within 28 days prior to registration: serum bilirubin ≤ 2 x upper limit of normal (ULN); serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 5 x the institutional upper limit of normal (IULN). - Have adequate renal function, as determined by the following tests measured within 28 days prior to registration: serum creatinine ≤ 1.5 x ULN OR a measured creatinine clearance or calculated creatinine clearance ≥ 50 mL/min. - Have a life expectancy of ≥12 weeks - Must be able to swallow oral medications. - Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only. Exclusion Criteria: - Known or suspected allergy or hypersensitivity to sorafenib. - Any malabsorption condition. - Must not have known brain metastases. - No concurrent anticancer chemotherapy or local therapy. - No concurrent herbal or unconventional therapy (e.g., St. John's Wort) - Pregnant or nursing women - No prior radiation therapy to the liver - Inability to perform y90 TARE due to: (1) inability to catheterize the hepatic artery, (2) portal vein thrombosis/occlusion without the ability to perform selective infusion, (3) Tecnetium-99m macro-aggregated albumin hepatic artery perfusion scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary parenchyma as determined by the interventional radiologist, or (4) other contraindication to TARE identified by interventional radiologist. - Women/men of reproductive potential unwilling or unable to use an effective contraceptive method - 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 3 years. - History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months. - Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study. |
| 38 | NCT02289690 | completed | 0 | phase 1/phase 2 | ['small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['veliparib', 'carboplatin', 'etoposide', 'placebo'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'C[C@@]1(CCCN1)C1=NC2=CC=CC(C(N)=O)=C2N1', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1'] | Inclusion Criteria: 1. Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive 2. Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate. 3. Subject in Phase 2 only: must have measurable disease per RECIST 1.1. 4. Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis. 5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1. 6. Subject must have adequate hematologic, renal and hepatic function. Exclusion Criteria: 1. Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than: Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2). One line of cytotoxic chemotherapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2). Adjuvant/neoadjuvant radiotherapy (must be completed ≥ 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve). 2. Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ≥ 4 weeks prior Cycle 1 Day -2. 3. Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases. 4. Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures. 5. Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2. 6. Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must have completely recovered from any previous surgery prior Cycle 1 Day-2). 7. Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to: - Uncontrolled nausea/vomiting/diarrhea; - Active uncontrolled infection; - History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening); - History of hepatitis C (HCV) with HCV ribonucleic acid (RNA) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months it must be done at screening); - Symptomatic congestive heart failure (Yew York Heart Association [NYHA] class ≥ II); - Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation); - Psychiatric illness/social situation that would limit compliance with study requirements; - Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities. 8. The subject has a history of another active cancer within the past 3 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell carcinoma of the skin or another in situ cancer that is considered cured by the investigator (e.g., in situ prostate cancer, breast DCIS). | |
| 39 | NCT02296099 | completed | 1 | phase 4 | ['urinary incontinence, stress'] | ["['N39.41', 'N39.46', 'N39.490', 'N39.491', 'N39.492', 'R32', 'R39.81']"] | ['liposomal bupivacaine', 'placebo'] | ['CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C'] | Inclusion Criteria: - Adults greater than 18 years of age - Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia Exclusion Criteria: - Pregnant or nursing - Allergy to bupivacaine - History of drug/alcohol abuse - Severe cardiovascular, hepatic, renal disease, or neurological impairment - Long-acting opioid within 3 days or any opioid use within 24 hours before surgery - Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID) - Administration of an investigational drug within 30 days before study - Chronic pain syndromes - Daily NSAID/opioid use - Patients having concomitant procedures or not undergoing general anesthesia | |
| 40 | NCT02297230 | terminated | pi left institution prior to reaching accrual goal and analyzing data. | 0 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['capecitabine', 'trastuzumab', 'paclitaxel'] | ['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', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '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: - Biopsy proven locally advanced breast cancer: STAGE IIB (T must be > 3.0 cm, N0), IIIA (T0N2, T1N2, T2N2, T3N1), IIIB (T4N0-2). - HER-2/neu positive ( DAKO 3+ by Immunohistochemistry or FISH positive if Dako 2+) - Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes. - Measurable disease required according to the RECIST criteria (Response Evaluation Criteria in Solid Tumors) - Adequate laboratory values: - Hgb > 10 - ANC(Absolute Neutrophil Count) > 1500 - Platelets > 150,000 - Cr < 1.5 - Liver function < 3 X normal. - Patient > 18 years of age. - Medically and psychologically able to comply with all study requirements. - ECOG (Eastern cooperative Oncology group) performance score 0-1. - Signed informed consent. Exclusion Criteria: - Stage 0, Stage I, Stage IIA. - Previous XRT(Radiation therapy) or chemotherapy. - Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes. - Inflammatory breast cancer. - Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. - Exclude pregnant or lactating woman. - Woman of childbearing potential with either a positive or no pregnancy test at baseline. - Woman of childbearing potential not using a reliable and appropriate contraceptive method. - (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). - Patient will agree to continue contraception for 30 days from the date of the last study drug administration. - Serious concurrent infections. - Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months. - Patients who have had an organ allograft. - Patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockcroft and Gault43]). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min [Cockcroft and Gault43]) at baseline, a dose reduction to 75% of the XELODA starting dose is recommended. In patients with mild renal impairment (creatinine clearance 51-80 mL/min) no adjustment in starting dose is recommended. - In phase I studies, those with any abnormal renal function, since toxicity will likely be affected by the presence of any significant renal dysfunction. - Cockcroft and Gault Equation: - (140 - age [yrs]) (body wt [kg]) - Creatinine clearance for males = —————————————— - (72) (serum creatinine [mg/dL]) - Creatinine clearance for females = 0.85 x male value |
| 41 | NCT02301403 | completed | 1 | phase 4 | ['smoking cessation'] | ["['Y36.881S', 'Y36.891S', 'Y36.880S', 'Y36.881A', 'Y36.881D', 'Y36.890S', 'Y36.891A']"] | ['nicotine patch', 'preparation nicotine mini-lozenges', 'combination nrt (nicotine patch + nicotine mini-lozenges)'] | ['CC(NC(C)(C)C)C(=O)C1=CC(Cl)=CC=C1', 'CC(=O)NC1=CC=C(O)C=C1', 'CC(=O)NC1=CC=C(O)C=C1'] | Inclusion Criteria: - age >=18 years - smoking >4 cigarettes/day for the previous 6 months - able to read, write, and speak English - have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts - and if currently using NRT, agreeing to use only study medication for the duration of the study - we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses) - not currently attempting to quit smoking - not intending to quit smoking (defined as no plans to quit in the next month) - and planning to remain in the intervention catchment area for at least 12 months. Exclusion Criteria: - currently taking bupropion or varenicline - medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days - diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years - and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment. | |
| 42 | NCT02305563 | terminated | business objectives have changed, slow accrual, the standard of care for the patient population changed and we were unable to accrue any longer. | 0 | phase 1/phase 2 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['bms-936564', 'cytarabine'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Newly Diagnosed Acute Myeloid Leukemia (AML) - Considered inappropriate for intensive remission induction therapy by an investigator - Not eligible for stem cell transplantation Exclusion Criteria: - Acute promyelocytic leukemia - Current Myelodysplastic syndrome only subjects - Unstable angina or uncontrolled congestive heart failure - Any other malignancy, excluding basal or squamous cell carcinoma of the skin, in situ melanoma, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years - Respiratory disease requiring continuous supplemental oxygen Other protocol defined inclusion/exclusion criteria could apply |
| 43 | NCT02308748 | completed | 1 | phase 1 | ['drug-induced qt prolongation', 'pharmacokinetics', 'pharmacodynamics'] | ["['E06.4', 'E23.1', 'E66.1', 'G25.1', 'G25.4', 'G62.0', 'G72.0']"] | ['dofetilide', 'mexiletine', 'lidocaine', 'moxifloxacin', 'diltiazem', 'placebo'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C', 'CC(N)COC1=C(C)C=CC=C1C', 'COC1=CC=C(C=C1)[C@@H]1SC2=C(C=CC=C2)N(CCN(C)C)C(=O)[C@@H]1OC(C)=O', 'CN(CCOC1=CC=C(NS(C)(=O)=O)C=C1)CCC1=CC=C(NS(C)(=O)=O)C=C1'] | Inclusion Criteria: 1. Subject is a healthy man or woman, 18 to 35 years of age, inclusive, who weighs at least 50 kg (110 pounds), no more than 85 kg (197 pounds) and has a body mass index of 18 to 27 kg/m2, inclusive, at Screening. 2. Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12 lead 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). 3. 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. Exclusion Criteria: - 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: - QT corrected interval (QTc) using Fridericia correction (QTcF) >430 milliseconds (ms) - PR interval >220 ms or <120 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 <50 or >90 beats per minute - Pathological Q-waves (defined as Q wave >40 ms) - Ventricular pre-excitation 2. Subject has more than 12 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 activities 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, 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. | |
| 44 | NCT02321930 | completed | 1 | phase 4 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['tofacitinib 5mg po bid'] | ['[H][C@@]1(C)CCN(C[C@]1([H])N(C)C1=NC=NC2=C1C=CN2)C(=O)CC#N'] | Inclusion Criteria: 1. Patient must meet 1987 ACR criteria 2. Age > 18 years of age 3. Baseline DAS28/ESR>=3.2 4. Stable concomitant DMARDs 5. Stable prednisone <10mg or equivalent 6. Power Doppler score of >=10 7. Female subjects of childbearing potential must test negative for pregnancy 8. Male and female subjects of childbearing potential must agree to use contraception throughout the study 9. Negative QuantiFERON Gold test at screening Exclusion Criteria: 1. No active TB 2. Prednisone >10 mg 3. Pregnancy or breast feeding 4. Prior treatment with tofacitinib 5. Concomitant biologic therapy (TNF inhibitors, IL-6 inhibitors, etc.) 6. Active infection with HIV, hepatitis B or C, or herpes zoster 7. Subjects with any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities: 1. Evidence of hematopoietic disorder or hemoglobin <9 g/dL 2. Absolute lymphocyte count <0.75 x 109/L (<750/mm3) 3. Absolute neutrophil count <1.2 x 109/L (<1200/mm3) 4. Platelet count <100 x 109/L (<100,000/mm3) 5. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (x ULN) 6. Estimated GFR <40 ml/min 8. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine) 9. Subjects who require concomitant treatment with medications that are potent inhibitors of cytochrome P450 3A4 (CYP3A4), both moderate inhibitors of CYP3A4 and potent inhibitors of CYP2C19, and potent CYP inducers (See Appendix) | |
| 45 | NCT02330276 | completed | 0 | phase 1 | ['pre-diabetes'] | ["['O24.32', 'O24.82', 'O24.02', 'O24.12', 'O24.33', 'O24.83', 'O24.03']"] | ['(+)-epicatechin'] | ['O[C@@H]1CC2=C(O)C=C(O)C=C2O[C@@H]1C1=CC(O)=C(O)C=C1'] | Inclusion Criteria: - Healthy or pre-diabetic based on medical history - Male or female - Must be 21 to 75 years of age (inclusive) - Able to give informed consent to the procedures - If female, must be either postmenopausal or test negative for pregnancy at screening and on the day of the procedure. Women on estrogen therapy will be included. - If of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study - Medication use stable for 4 weeks - Body Mass Index (BMI) > 27 kg/m^2 - Definition of pre-diabetes: impaired fasting glucose (IFG, fasting glucose = 100-125 mg/dL) and elevated HbA1c (5.7-6.4%), each in the absence of other risk factors for diabetes Exclusion Criteria: - Type 2 diabetes - Pregnancy - Younger than 21 or older than 75 years of age - Clinically significant abnormalities in liver or kidney function (>3x ULN), determined in the last 6 months by a certified clinical laboratory - Recent MI or stroke (within 6 months of screening) - Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic - Medications - thiazolidinediones, any steroids, anti-depressants, weight loss drugs - Other diseases, besides type 2 diabetes, influencing carbohydrate metabolism | |
| 46 | NCT02339155 | completed | 1 | phase 4 | ['infections, bacterial'] | ["['A49.9', 'A04.9', 'A04.8', 'A49.8']"] | ['diphenhydramine'] | ['CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination and laboratory tests - Men and women between 18 to 65 years of age - Willing and able to adhere to the procedures stated in the protocol. - Female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. Reproductive potential and agrees to follow one of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP), from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit at Day 183 (at least five terminal half-lives for raxibacumab). Exclusion Criteria: - Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational study vaccine/product (pharmaceutical product or device). - Be a member of the military, a laboratory worker, first responder, health care worker, or otherwise be at higher risk of exposure to anthrax. - History of regular alcohol consumption within 1 month of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Female planning to become pregnant or planning to discontinue contraceptive precautions before the Day 183 study visit. - Pregnant (confirmed by a serum or urine hCG test) or lactating female. - Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). - Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test results at screening or within 3 months prior to first dose of study treatment. - A positive pre-study drug/alcohol screen. - A positive test for HIV antibody. - History of sensitivity to any of the study medications, or components thereof (especially latex and aluminium) or a history of other known drug allergies that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation. - Have previously been vaccinated against PA. - Have an anti-PA Ab concentration >2 times the lower limit of quantitation at screening. - Administration of immunoglobulins not included in this trial and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. - Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period. - Chronic administration (defined as more than 14 consecutive days) of systemic immunosupressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and intra-articular corticosteroids are allowed. - Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 35 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated, and subunit vaccines. Influenza vaccines are permitted after Week 8. - Subjects must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. | |
| 47 | NCT02343081 | completed | 1 | phase 4 | ['brain neoplasms, malignant, primary'] | ["['C71.7', 'C71.9', 'C79.31', 'D33.0', 'D33.1', 'D33.2', 'D49.6']"] | ['temozolomide', 'temozolomide'] | ['CN1N=NC2=C(N=CN2C1=O)C(N)=O', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion Criteria: 1. Male or female patients with primary malignant tumors of the central nervous system (CNS) excluding subjects with primary CNS lymphoma. 2. Age> 21 years. 3. There should be a gap of two weeks between the last surgery and/or radiotherapy procedure and the day of randomization. If the procedure were intrabdominal, the gap should be of four weeks. 4. Patients with neutrophils> 1.5 x 109 / L and platelets> 100 x 109 / L. 5. Signed written informed consent for participation in the trial. Exclusion Criteria: 1. Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical formulation. 2. Any situation (eg. vomiting) that may interfere with the absorption of the product under study. 3. Chemotherapy or biological therapy within four weeks prior to administering the products under study. 4. Patients who experience any symptoms of toxicity to prior antineoplastic therapies upon administration of the products under study. 5. Participation in other clinical research studies during the 90 days before the start of this study. 6. History of alcohol or drugs abuse. 7. History of severe allergic reactions to any type of antigen. 8. History of gastrointestinal surgery (except uncomplicated appendectomy, of at least three months old). 9. Patients whose clinical status would affect the safety of the products under study or interfere with the pharmacokinetic evaluation, at the discretion of the investigator. 10. Pregnant women or women planning to become pregnant during the study. | |
| 48 | NCT02344810 | withdrawn | the study did not open to accrual. no start date and no completion dates. | 0 | phase 1/phase 2 | ['adenocarcinoma of the esophagus', 'adenocarcinoma of the gastroesophageal junction', 'diffuse adenocarcinoma of the stomach', 'gastrointestinal cancer', 'intestinal adenocarcinoma of the stomach', 'mixed adenocarcinoma of the stomach', 'stage iiia esophageal cancer', 'stage iiia gastric cancer', 'stage iiib esophageal cancer', 'stage iiib gastric cancer', 'stage iiic esophageal cancer', 'stage iiic gastric cancer', 'stage iv esophageal cancer', 'stage iv gastric 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']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C49.A0', 'C49.A1', 'C49.A2', 'C49.A5', 'C49.A3', 'C49.A4', 'C49.A9']", "['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']", "['K22.2', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10', 'I85.11']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['K22.2', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10', 'I85.11']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['K22.2', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10', 'I85.11']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['K22.2', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10', 'I85.11']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['c-met inhibitor amg 337', 'oxaliplatin', 'leucovorin calcium', 'fluorouracil'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', '[H]C(=O)N1C(CNC2=CC=C(C=C2)C(=O)N[C@@H](CCC(O)=O)C(O)=O)CNC2=C1C(=O)NC(N)=N2', 'CCCCOC1=C(N)C=CC(=C1)C(=O)OCCN(CC)CC'] | Inclusion Criteria: - Patients must have a life expectancy >= 12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 48 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 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) - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of AMG 337 plus mFOLFOX6 chemotherapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; should a man impregnate or suspect that he has impregnated a woman while participating in this study, he should inform his treating physician immediately - Patients must NOT have a known immediate or delayed hypersensitivity reaction to drugs chemically related to fluorouracil, platins or their excipients nor have a known history of dihydropyrimidine dehydrogenase (DPD) deficiency - Patients must be able to swallow tablets whole - Leukocytes >= 3,000/mcL - Absolute neutrophil count >= 1,500/mcL - Hemoglobin >= 9 g/dL - Platelets >= 100,000/mcL - Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal (ULN) or =< 5 X ULN if the patient has liver metastases - Creatinine =< 1.5 X institutional ULN or creatinine clearance >= 50 mL/min for patients with creatinine levels above institutional normal - Patients must NOT be taking current medications or substances that are inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) - Patients with known human immunodeficiency virus (HIV) are not eligible if cluster of differentiation (CD)4 count is =< 200 cell/mm^3 or if receiving antiretroviral therapy - Patients must not have a pre-existing > grade 1 (Common Terminology Criteria for Adverse Events version 4 [CTCAEv4]) motor or sensory neuropathy - Patients must not have an uncontrolled infection, active hepatic, biliary disease or other uncontrolled intercurrent illnesses including, but not limited to: uncontrolled ascites, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive disorders that would limit compliance with study requirements - PHASE I: - Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria within 4 weeks prior to registration; patients must not have clinical or radiographic evidence of brain metastasis - Patients must have histologically or cytologically confirmed adenocarcinoma originating from anywhere in the gastrointestinal tract - Patients must have progression on standard therapies, for which effective therapy is not available (or patients are not a candidate for or are intolerant of such therapies) - Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: - Non-melanoma skin cancer, in situ cervical cancer, breast cancer in situ, or superficial bladder cancer (noninvasive papillary carcinoma or carcinoma in situ) - Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years from registration - Patients may have received prior surgery or radiotherapy if > 4 weeks prior to registration and patient does not have any unresolved or unstable serious toxicity - Patients must not be receiving an investigational agent concurrently and must not have received any other investigational agents within 4 weeks prior to randomization - PHASE II: - Patients must have measurable disease by RECIST 1.1 criteria within 4 weeks prior to registration to Step 0; patients must not have clinical or radiographic evidence of brain metastasis because of their poor prognosis - Patient disease status must be as follows: - Adenocarcinoma or poorly differentiated carcinoma of the stomach, esophagus or gastroesophageal (GE) junction - Histologically or cytologically confirmed Her2/neu negative cancer prior to pre-registration; Her2/neu status must be determined by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory - Locally advanced or metastatic disease that is inoperable and not amenable to curative therapy; linitis plastica is permitted - Patient must NOT have gastric carcinoid, sarcomas or squamous cell carcinoma - Patients may have received prior surgery or radiotherapy if > 4 weeks prior to registration to Step 0 and patient does not have any unresolved or unstable serious toxicity - Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions: - Non-melanoma skin cancer, in situ cervical cancer, breast cancer in situ, or superficial bladder cancer (noninvasive papillary carcinoma or carcinoma in situ) - Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years from registration to Step 0 - Patients must not be receiving an investigational agent concurrently and must not have received any other investigational agents within 4 weeks prior to registration to Step 0 - Patient may not have received prior chemotherapy for advanced disease or prior oxaliplatin or anti-MET therapy - Previous neo-adjuvant or adjuvant treatment is allowed provided that it was discontinued >= 6 months prior to registration to Step 0 - Patients must have paraffin-embedded tumor specimen available for submission for central determination of MET expression status - NOTE: it is recommended that patients not be pre-registered until the required tumor specimens are on hand and ready for submission; if submission of tissue will be submitted more than 5 working days after pre-registration, immediately notify the receiving laboratory - Patients must have had MET expression status determined by the Immunohistochemistry Laboratory and Image Analysis Laboratory in the Department of Pathology of The University of Texas MD Anderson Cancer Center in Houston: the report from the central laboratory indicates tumor tissue has MET - NOTE: for this protocol, 'MET High' will be defined as: >= 50% tumor cells with a staining intensity of 2+ or 3+ in IHC utilizing the CONFIRM anti-total MET, SP44, rabbit monoclonal primary antibody |
| 49 | NCT02348723 | completed | 1 | phase 4 | ['atrial fibrillation'] | ["['I48.0', 'I48.21', 'I48.91', 'I48.11', 'I48.19', 'I48.20']"] | ['warfarin', 'dabigatran etexilate 150mg'] | ['CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'CCCCCCOC(=O)\\N=C(\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1'] | Inclusion criteria: - Male or female patients aged >= 18 years. - Patients eligible for treatment with dabigatran etexilate 150 mg b.i.d. according to local label. - Treatment naïve patients or patients on oral anticoagulant treatment with a Vitamin K Antagonist (VKA), dabigatran etexilate, rivaroxaban, apixaban or edoxaban. - Patient with paroxysmal or persistent NVAF with a planned catheter ablation for AF unless it is performed an investigational ablation technique. - AF must have been documented at least once either by ECG, Holter monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator read outs within 24 months prior to screening (Visit 1). - The patient must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations. Exclusion criteria: - Patients with permanent AF. - Patients with AF felt to be secondary to an obvious reversible cause such as, but not limited to, an acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis. - Patients with Left Atrium (LA) size >= 60 mm - Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate - Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients - Mechanical or biological heart valve prosthesis - Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening - Stroke within 1 month prior to screening visit - Major surgery per investigator judgement within the previous month prior to screening. - Patient has received an organ transplant or is on a waiting list for an organ transplant - History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding - Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery). - Major bleeding episode (ISTH definition) one month prior to the screening visit. - Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention) - Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 10^9/L) at screening - Recent malignancy or radiation therapy (<=6 months prior to screening) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months - Active liver disease as indicated by at least one of the following: -- Prior and persistent alanine aminotransferase or Aspartate transaminase or alkaline phosphatase >3x upper limit of normal and/or -- Known active hepatitis C and/or -- Known active hepatitis B and/or -- Known active hepatitis A - Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic/myelosuppressive therapy. - Pre-menopausal (last menstruation <=1 year prior to screening) who: - Are pregnant or breast-feeding or plan to become pregnant during study or - Are not surgically sterile or - Are of child bearing potential and not practising two acceptable method of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial - Patients who have participated in another trial with an investigational drug or device within the past 30 days preceding the screening visit or are participating in another trial (patients participating in an observational study only will not be excluded) - Patients not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease and/or subjects who are institutionalised due to official or court orders and/or vulnerable subjects who are dependent on the Sponsor or the Investigator or the site, or patients who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse). | |
| 50 | NCT02349152 | completed | 1 | phase 4 | ['heart diseases', 'hyperglycemia'] | ["['I11.0', 'I11.9', 'I27.1', 'I51.9', 'I09.9', 'I27.9', 'I01.8']", "['R73.9', 'E10.65', 'E11.65', 'E13.65', 'E08.65', 'E09.65']"] | ['remifentanil', 'fentanyl'] | ['CCN(CC)CC(=O)NC1=C(C)C=CC=C1C', 'CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C'] | Inclusion Criteria: - Open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries) - Surgery with use of cardiopulmonary bypass - Patients over 18 years of age - Both female and male genders - All races Exclusion Criteria: - Minimally invasive heart surgery through thoracotomy approach - Patients receiving regional analgesia such as intrathecal morphine - Patients undergoing procedures under deep hypothermic circulatory arrest - Patients with active infections such as acute infective endocarditis - Emergency surgery - Patients undergoing transplantations and ventricular assist device insertion - Patients on any mechanical circulatory support preoperatively - Patient's refusal - Allergy to remifentanil - Positive pregnancy test - Morbid obesity - End stage liver and kidney disease | |
| 51 | NCT02350309 | completed | 1 | phase 1 | ['insomnia disorder'] | ["['F51.05']"] | ['lemborexant 5 mg', 'lemborexant 10 mg', 'lemborexant-matched placebo.', 'flurazepam 30 mg'] | ['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', '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', 'CCN(CC)CCN1C2=C(C=C(Cl)C=C2)C(=NCC1=O)C1=CC=CC=C1F'] | Inclusion Criteria: 1. Male or female, age 18 or older, at the time of informed consent. 2. Meets the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia Disorder, as follows: 1. Complains of dissatisfaction with nighttime sleep despite adequate opportunity for sleep, with complaint being one or more of the following: difficulty getting to sleep, difficulty staying asleep, or awakening earlier in the morning than desired. 2. Frequency of complaint greater than or equal to 3 times per week. 3. Duration of complaint greater than or equal to 3 months. 4. Associated with complaint of daytime impairment. 3. Insomnia Severity Index score greater than or equal to 15 at Screening. 4. Regular time in bed between 7 and 9 hours as reported at Screening. 5. Regular bedtime, defined as the time the participant attempts to fall asleep, between 21:00 and 24:00 and regular wake time between 05:00 and 09:00 as reported at Screening. 6. Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed for 7 nights during Screening, such that participant Sleep Onset Latency (sSOL) greater than or equal to 30 minutes on at least 3 nights and subjective Wake After Sleep Onset (sWASO) greater than or equal to 60 minutes on at least 3 nights. Exclusion Criteria: 1. Excessive morning sleepiness at Baseline as determined by average SOL at Baseline less than 10 minutes. 2. Females must not be lactating or pregnant at Screening or Baseline (documented by a negative beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG). (Note: A negative urine pregnancy test is required at check-in before each dose of study drug and flurazepam). 3. If females of childbearing potential: 1. Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. 2. Are currently abstinent, and do not agree to use a double barrier method (as described above) or refrain from sexual activity during the study period or for 28 days after study drug discontinuation. 3. Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). 4. A current diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia. 5. Reports experiencing within the past year confusional arousals, symptoms of REM Behavior Disorder, or sleep-related violent behavior on Munich Parasomnia Scale (MUPS), or a history of aberrant nocturnal behaviors including sleep-driving or sleep-eating. 6. Habitually naps more than 3 times per week. 7. History of drug or alcohol dependency or abuse within approximately the last 2 years. 8. Has a positive drug screen at Screening. 9. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated ECG at Screening (repeated only if initial ECG indicates a QTc interval greater than 450 ms). 10. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening or any lifetime suicidal behavior. 11. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal, psychiatric or neurological disease, or chronic pain) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments. 12. Used any prohibited prescription or over-the-counter concomitant medications within 2 weeks prior to Screening, or between Screening and Randomization. 13. Used any modality of treatment for insomnia, including cognitive behavioral therapy or marijuana within 2 weeks prior to Screening, or between Screening and Randomization. 14. Scheduled for surgery during the study. 15. Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or between Screening and Baseline, or plans to travel more than 3 times zones during the study. 16. Hypersensitivity to flurazepam, the study drug, or any of the excipients. 17. Currently enrolled in another clinical trial or used any investigational drug or device within 28 days or 5 x the half-life, whichever is longer preceding informed consent. | |
| 52 | NCT02362425 | completed | 0 | phase 1/phase 2 | ['neuromuscular disease'] | ["['M41.40', 'M41.42', 'M41.43', 'M41.44', 'M41.45', 'M41.46', 'M41.47']"] | ['n-acetylcysteine', 'placebo'] | ['CC(=O)N[C@@H](CS)C(O)=O'] | - EXCLUSION CRITERIA - PATIENTS: - Adults who cannot provide their own consent and pediatric participants who do not have a parent able to provide consent. - Patients with a history of liver disease (Liver Function Tests will be collected at baseline and at each study visit as a precautionary measure). Liver disease is defined as moderate to severe hepatic impairment based on the following: - Alanine Aminotransferase (ALT) greater than or equal to 8x upper limit of normal (ULN) with total bilirubin 2x ULN (plus >35% direct bilirubin) and/or International normalized ratio (INR) >1.5 or - Gamma-glutamyl transferase (GGT) > 2-3x ULN with bilirubin 2x ULN (plus >35% direct bilirubin) and/or INR - Patients with a history of peptic ulcers, gag reflex depression, and esophageal varices. Patients with gastrostomy tubes may be considered for participation, in the case of gag reflex depression or other swallowing or feeding difficulties. - Patients who have a severe pulmonary dysfunction (FEV1< 40% predicted) or evidence of pulmonary exacerbation. Pulmonary exacerbations refer to an acute worsening of respiratory symptoms that result from a decline in lung function. Participants may present with increased coughing, increased dyspnea, increased haemoptysis, increased fatigue, decreased pulmonary function by a min of 10%, or a change in sputum color. - Pregnant and breastfeeding women. - Consumption of antioxidants [including NAC, GSH, melatonin, Immunocal (Immunotac Research, Vandreuil-Dorion, QC, Canada), Nacystelyn (Galephar, Brussels)] in the 4 weeks before recruitment. -Daily use of acetaminophen (including Percocet, Vicodin, Oxycodone, Excedrin, and other acetaminophen-containing drugs), nitroglycerine, or carbamazepine during the past 7 days. - Current use of Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin Receptor Blockers (ARBs). - Patients who have ever used Beta2-adrenergic agonist tablets, for the purpose of increasing muscle mass (such as albuterol tablets). - For the muscle biopsy procedure only (second and third visits, if applicable): Patients who have taken Aspirin, Ibuprofen, Advil, Motrin, or Aleve within the 3 days prior to the muscle biopsy procedure, and/or patients who have taken Plavix, fresh garlic, gingko, or ginseng 5 days prior to the muscle biopsy. - Participation in trials for other therapeutic investigational drugs simultaneously or 4 weeks before recruitment. - Other clinically significant medical disease that, in the judgment of the investigators, would expose the patient to undue risk of harm or prevent the patient from completing the study. Examples include anemia (defined as Hgb < 8 gm/dl), an inability to walk safely without assistance for at least 6 minutes, and/or an inability to consume at least 6 ounces of fluid, 3 times a day, either orally or via G-tube. Patients with comorbidities (i.e. cancer, epilepsy) will be carefully assessed to determine if their comorbidity could lead to confounding or safety issues, should their participation continue. EXCLUSION CRITERIA - HEALTHY VOLUNTEERS: - Diagnosis of RYR1-related myopathy or other neurological disorder (by neurological exam, genetic testing, or muscle biopsy - Complaints of fatigue or weakness - Consumption of antioxidants [including NAC, GSH, melatonin, Immunocal (Immunotac - Research, Vandreuil-Dorion, QC, Canada), Nacystelyn (Galephar, Brussels)] in the 4 weeks before recruitment. - Use of Beta2-adrenergic agonists. | |
| 53 | NCT02363478 | completed | 1 | early phase 1 | ['systemic sclerosis'] | ["['M34.0', 'M34.89', 'M34.9', 'M34.82', 'M34.83', 'M34.81', 'M34.2']"] | ['buspirone'] | ['O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(CC1)C1=NC=CC=N1'] | Inclusion Criteria: - SSc patients with esophageal symptoms Exclusion Criteria: - none | |
| 54 | NCT02366468 | completed | 1 | phase 4 | ['diabetic retinopathy'] | ["['H35.23', 'H35.20', 'H35.21', 'H35.22', 'E10.3553', 'E11.3553', 'E13.3553']"] | ['ranibizumab 0.5 mg'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Inclusion Criteria: - Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0% - Patients with visual impairment due to DME in at least one eye - BCVA ≥ 24 and ≤ 78 letters in the study eye Exclusion Criteria: - Active intraocular inflammation - Any active infection in either eye at the - Structural damage within 0.5 disc diameter of the center of the macula in the study eye - Uncontrolled glaucoma in either eye at screening Other protocol-defined inclusion/exclusion criteria may apply. | |
| 55 | NCT02366689 | completed | 1 | phase 4 | ['dental plaque', 'gingivitis'] | ["['K05.00', 'K05.10', 'K05.01', 'K05.11']"] | ['triclosan/fluoride toothpaste', 'stannous fluoride toothpaste', 'fluoride only toothpaste', 'cetylpyridinium chloride mouthwash', 'fluoride only mouthwash'] | ['[F-].[Na+]', '[F-].[Na+]', '[F-].[Na+]', 'CC1=CC(O)=CC(C)=C1Cl', '[F-].[Na+]'] | Inclusion Criteria: 1. Male and female subjects, ages 18-70, inclusive. 2. Availability for the six-month duration of the study. 3. Good general health. 4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. 6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). 7. Signed Informed Consent Form. Exclusion Criteria: 1. Presence of orthodontic bands. 2. Presence of partial removable dentures. 3. Tumor(s) of the soft or hard tissues of the oral cavity. 4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 5. Five or more carious lesions requiring immediate restorative treatment. 6. Use of antibiotics any time during the one month prior to entry into the study. 7. Participation in any other clinical study or test panel within the one month prior to entry into the study. 8. Pregnant women or women who are breast feeding. 9. Dental prophylaxis received in the past two weeks prior to baseline examinations. 10. History of allergies to oral care/personal care consumer products or their ingredients. 11. On any prescription medicines that might interfere with the study outcome. 12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours. 13. History of alcohol or drug abuse | |
| 56 | NCT02370888 | terminated | slow accrual | 0 | phase 1 | ['leukemia, myeloid', 'myelodysplastic syndromes'] | ["['C92.Z1', 'C92.Z2', 'C92.91', 'C92.92', 'C92.Z0', 'C92.90', 'C92.11']", "['D46.9', 'D46.C', 'D46.Z']"] | ['lenalidomide'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: 1. Subjects must be at least 18 years of age; 2. Subjects must be post-allogeneic transplant from any donor source; 3. Subjects must have either: 1. High risk CD34+ AML (de novo or secondary, and any WHO 2008 classification excluding acute promyelocytic leukemia). High risk AML is defined as (a) disease status beyond complete remission (CR) #1 at transplant or (b) treatment related AML or (c) presence of adverse cytogenetics including inv(3); t(3;3); t(6;9); t(v;11); -5 or del(5q); -7; abnl(17p) or complex karyotype; or 2. High risk CD34+ MDS (WHO 2008 classification). High risk is defined as (a) blast count ≥5% at the time of transplant or (b) treatment related MD or (c) presence of adverse cytogenetics including -7/del7q or complex karyotype; 4. For AML subjects, they must have a documented CR within 45 days prior to allo-HCT; 5. For MDS subjects, they must have < 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT; 6. Subject Karnofsky performance status must be ≥ 70; 7. Subjects must be platelet transfusion independent (Platelet transfusion independence is defined as 7 days or greater without a platelet transfusion); 8. Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3; 9. Subjects must have total bilirubin ≤ 2 mg/dL; 10. Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal; 11. Subjects must have serum creatinine < 2.5 times upper limit of normal and a calculated creatinine clearance > 30 ml/min by Cockcroft-Gault formula (see Appendix I: Cockcroft-Gault Creatinine Clearance Calculation); 12. All study participants who will receive lenalidomide based on the CD34+ chimerism testing must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program; 13. Females of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) may participate, provided they meet the following conditions: a) Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; and 14. Written, voluntary informed consent, willingness, and ability to comply with all study procedures. Exclusion Criteria: 1. CD34- AML or MDS; 2. Inability to give informed consent; 3. Uncontrolled active infection(s) requiring intravenous antibiotics; 4. Known or suspected hypersensitivity to lenalidomide; 5. Grade II-IV acute GVHD or extensive GVHD; 6. Not able to swallow the lenalidomide capsule as a whole; 7. Female subjects who are pregnant or nursing. |
| 57 | NCT02371980 | completed | 1 | phase 4 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['vortioxetine', 'placebo'] | ['CC1=CC=C(SC2=CC=CC=C2N2CCNCC2)C(C)=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. Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI). 4. Reported duration of the current episode is ≥8 weeks and ≤18months. 5. Had at least 2 other major depressive episodes (MDEs) before the current episode. 6. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits. 7. Is a man or woman aged 18 to 75 years, inclusive. 8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose. Exclusion Criteria: 1. Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer. 2. Has previously or is currently participating in this study. 3. Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol. 4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 5. Has one or more of the following: 1. Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI. 2. Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. 3. Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.) 4. Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator. 5. Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc). 6. Any Axis II disorder as defined by DSM-IV-TR that might compromise the study. 6. The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. 7. Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration. 8. Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening. 9. Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed). 10. Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months. 11. Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study. 12. Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance. Note: For the purposes of this protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of > 40) are considered unstable due to the potential impact on assessment of the primary endpoint. 13. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma. 14. Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit: 1. A serum creatinine value >1.5 times the upper limits of normal (ULN). 2. A serum total bilirubin value >1.5 xULN. 3. A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN. 15. Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded. 16. Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded. 17. Has clinically significant abnormal vital signs as determined by the investigator. 18. Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator. 19. Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection. 20. Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy. 21. The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 22. Has a history of hypersensitivity or allergies to vortioxetine. 23. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 24. The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy. | |
| 58 | NCT02373098 | completed | 1 | phase 4 | ['relapsing remitting multiple sclerosis'] | ["['M94.1', 'A68.9', 'A68.0', 'A68.1', 'M35.6']"] | ['fingolimod 0.5 mg'] | ['CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1'] | Key Inclusion Criteria: 1. Written informed consent must be obtained before the beginning of te study 2. Nonresponder RRMS patients 3. Last relapse of the patient should be at least 2 months before study entry. 4. Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry. Key Exclusion Criteria: 1. Patients with secondary progressive MS. 2. Patients with known contraindications for fingolimod treatment. 3. Other coexistent autoimmune diseases 4. Pregnant or nursing (lactating) women | |
| 59 | NCT02373137 | active, not recruiting | 1 | phase 4 | ['keratoplasty', 'grafting, corneal', 'transplantation, corneal', 'transplantation, cornea', 'keratoplasty, lamellar'] | ["['Q80.2', 'H26.013', 'H26.011', 'H26.012', 'H26.019']"] | ['prednisolone', 'ofloxacin', 'tropicamide', 'phenylephrine'] | ['[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CC1COC2=C3N1C=C(C(O)=O)C(=O)C3=CC(F)=C2N1CCN(C)CC1', 'CCN(CC1=CC=NC=C1)C(=O)C(CO)C1=CC=CC=C1', 'CN[C@@H](C)[C@H](O)C1=CC=CC=C1'] | Inclusion Criteria: - Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy - Good candidates for corneal transplantation for either DMEK or DSAEK - Willingness and ability to undergo a cornea transplantation - Willingness to participate in follow-up visits Exclusion Criteria: - Participants who are decisionally and/or cognitively impaired - Participants who are not suitable for the DMEK or DSAEK surgeries - Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except uncomplicated cataract surgery - Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars) - Presence of a condition that increases the probability for failure (e.g., heavily vascularized cornea, uncontrolled uveitis) - Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy - Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or anticipated during EK - Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study at time of study EK - Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment - Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours - Hypotony (Intraocular pressure <10mmHg) - Uncontrolled (defined as intraocular pressure >25mmHg) glaucoma Visually significant optic nerve or macular pathology - Visually significant optic nerve or macular pathology | |
| 60 | NCT02375724 | completed | 1 | phase 4 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['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. Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements. 2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years 3. Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and <80% and FEV1/FVC <70%. 4. Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2) 5. Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum production for at least 3 months in each of 2 consecutive years") 6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained Exclusion Criteria: 1. History or current diagnosis of asthma. 2. Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period. 3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period. 4. Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study. 5. Patient who in the investigator's opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit. 6. Use of long-term oxygen therapy. 7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates. 8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication. 9. Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers. 10. Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening) 11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm). 12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy. 13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis 14. Current diagnosis of cancer other than basal or squamous cell skin cancer 15. Patient with any other serious or uncontrolled physical or mental dysfunction 16. Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment. 17. Patient unlikely to be cooperative or that can not comply with the study procedures 18. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening). 19. Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication. 20. Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study. | |
| 61 | NCT02382016 | completed | 1 | phase 4 | ['portopulmonary hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['macitentan'] | ['CCCNS(=O)(=O)NC1=C(C(OCCOC2=NC=C(Br)C=N2)=NC=N1)C1=CC=C(Br)C=C1'] | Main Inclusion Criteria: - Male or female of at least 18 years of age - Confirmed diagnosis of portopulmonary hypertension Main Exclusion Criteria: - Severe hepatic impairment - Severe obstructive or restrictive lung disease - Pulmonary veno-occlusive disease - Systolic blood pressure (SBP) < 90 mmHg at Screening - ALT/AST >= 3 x ULN - Bilirubin >= 3 mg/dL at Screening - Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results | |
| 62 | NCT02384746 | terminated | low accrual | 0 | phase 1 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fulvestrant', 'mln9708'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]', '[H][C@@](CC(C)C)(N=C(O)CN=C(O)C1=C(Cl)C=CC(Cl)=C1)B(O)O'] | Inclusion Criteria: 1. Female post-menopausal patients 18 years or older. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 2. Patients must have either A) histologic documentation of metastatic or locally advanced breast cancer by needle or incisional biopsy, or B) history of breast cancer with radiologic evidence of bone-only metastatic disease. 3. Patients must be post-menopausal based on either a history of an oophorectomy, or at lease one year of amenorrhea. An elevated serum gonadotropin level can be used to confirm menopausal status in a subject with one year or more of amenorrhea. 4. The invasive cancer must be HER2-negative, defined as IHC0-1+, or with a FISH ratio of <1.8 if IHC is 2+ or if IHC has not been performed. 5. Metastatic or locally advanced breast cancer for which endocrine therapy is an appropriate treatment option. 6. Patients must have been treated with Fulvestrant for at least 56 days as their most recent anti-cancer treatment, and they must be tolerating Fulvestrant with at most grade I toxicity by CTCAE v4.0. 7. Disease progression based on RECIST criteria while the subject has been taking Fulvestrant, and for which continuation of endocrine therapy would be appropriate. 8. The subject must agree to undergo pre- and post- treatment research biopsies if a non-osseous metastatic site is available for biopsy. 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 10. Life expectancy 6 months or longer. 11. Patients must meet the following clinical laboratory data: - Absolute Neutrophil Count (ANC) ≥ 1,000/mm(3) and platelet count ≥75,000/mm(3) - Total bilirubin ≤ 1.5 x the upper limit of normal range (ULN). - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN. - Calculated creatinine clearance ≥ 30 mL/min 12. Ability to give informed consent. Exclusion Criteria: 1. Failure to have fully recovered (i.e., ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy or endocrine therapy, except for Grade 2 or greater anemia. 2. Major surgery within 14 days before enrollment. 3. Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the MLN9708. 4. Central nervous system involvement. 5. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. 6. Evidence of current uncontrolled cardiovascular conditions. 7. Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 or CYP3A, or strong inducers of CYP3A. 8. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. 9. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 10. Known allergy to any of the study medication, their analogues, or excipients in the various formulations of any agent. 11. Known gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of MLN9708 including difficulty swallowing. 12. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have evidence of residual disease. 13. Patient has ≥ grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period. 14. Participation in other clinical trials within 21 days of the start of this trial or throughout the duration of this trial. 15. Visceral crisis or rapidly progressive disease for which chemotherapy would be indicated. |
| 63 | NCT02392039 | terminated | slow accrual | 0 | early phase 1 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['pegfilgrastim', 'loratadine'] | ['CN1[C@H]2CC[C@@H]1C[C@@H](C2)OC(=O)[C@H](CO)C1=CC=CC=C1', 'CCOC(=O)N1CCC(CC1)=C1C2=C(CCC3=C1N=CC=C3)C=C(Cl)C=C2'] | Inclusion Criteria: 1. Patients must have newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Grade 3B Follicular lymphoma, Burkitt Lymphoma, Peripheral T cell Lymphoma NOS, NK/T cell Lymphoma, or Transformed lymphoma. 2. Planned to receive chemotherapy for 6 cycles which the treating physician plans to utilize for pegfilgrastim to minimize risk for neutropenic fever, including but not limited to R-CHOP, R-EPOCH, and R-HyperCVAD, CHOP, and SMILE. 3. Age >= 18 years old. 4. ECOG performance status 0-3. 5. Ability to provide informed consent for participation. Exclusion Criteria: 1. Existing chronic bone pain prior to pegfilgrastim usage. 2. Creatinine clearance of <50ml/minute by Cockcroft Gault equation. 3. Allergy to filgrastim, pegfilgrastim, or Loratadine. 4. Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication. 5. Inability to swallow medications. 6. Inability to complete the survey instrumentation accurately. |
| 64 | NCT02393209 | terminated | lack of efficacy in combination. | 0 | phase 1/phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['docetaxel', 'tak-117'] | ['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 - Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous). - For Phase 2 of the study, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC. - Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions. - Has experienced failure of at least 1 prior chemotherapy regimen: - For Phase 2 of the study: - Participants must have received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease (PD). - A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen. - Participants who received prior therapy with paclitaxel as a part of the platinum-based doublet front-line regimen without PD on therapy. - Participants who, after the front-line, platinum-based, non-docetaxel containing chemotherapy, have been treated with 1 line of nivolumab or other immune-checkpoint inhibitors but progressed on or after the therapy. - For Phase 1b of the study: Participants who have experienced failure of multiple lines of prior chemotherapy are eligible. - For Phase 2, has archived or fresh tumor biopsy samples (obtained during screening) sufficient for genotyping. - Has adequate organ function, before the first dose of study drug. - Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 30 days (or longer, as mandated by local labeling) after the last dose of study drug, or agree to practice true abstinence. - Female participants must agree to not donate eggs (ova) during the course of this study and for 30 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling. - Male participants agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling, or agree to practice true abstinence. - Male participants must agree to not donate sperm during the course of the study and for 120 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling. - Has suitable venous access for the study-required blood sampling. - Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy. - In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements for the duration of the study. Exclusion Criteria: - Previous treatment with a PI3K or AKT inhibitor. - Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the participant must have documented progressive disease. - Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%. - Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug. - Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug. - Has taken proton pump inhibitors within 7 days before the first administration of study drug. - Has a condition that requires the concomitant use of any of the protocol-excluded medications, supplements, or food products during the course of the study . - Has any clinically significant co-morbidities. - Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure; evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiogram (ECG) evidence of acute ischemia or active conduction system abnormalities; Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period; or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant. - Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C. - Has brain metastasis, unless has completed definitive therapy, is not on steroids, has a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and does not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - Has active secondary malignancy that requires treatment. - Has any serious medical or psychiatric illness, including drug or alcohol abuse. - Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling. - Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before administration of the first dose of study drug. - Is unwilling or unable to abide by the requirements of the study. |
| 65 | NCT02397915 | completed | 1 | phase 4 | ['rhinitis, allergic, perennial and seasonal'] | ["['J30.0', 'J31.0', 'J30.89', 'J30.9', 'A50.05', 'J30.2', 'J30.1']"] | ['ff nasal spray', 'mf nasal spray'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)C3=CC=CO3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', '[H][C@@]12C[C@@H](C)[C@](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: - Male or female subjects who are between 18 to 65 years of age, inclusive at the time of signing the informed consent. - Severity of disease: Subjects who meet the below criteria and who may also have vasomotor rhinitis are eligible for the study. A positive skin test to perennial (for example, but not limited to, animal dander, house dust mites, cockroach, mould) and / or seasonal (for example, but not limited to, grass, tree, weed, ragweed) allergen within 12 months prior to Screening. If a subject has not been tested in the 12 months prior to Screening, a positive skin test (by prick method) is required at Screening. A positive skin test is defined as a wheal >=3 millimeters (mm) larger than the diluent control for prick testing. In vitro tests for specific Immunoglobulin E (IgE) [such as radioallergosorbent test (RAST), paper radioimmunosorbent test (PRIST)] will not be allowed as a diagnosis of AR. - A female subject is eligible to participate if she is not pregnant [as confirmed by a negative urine (preferred) or serum human chorionic gonadotrophin (hCG) test], not lactating, and at least one of the following conditions applies: (a) Non-reproductive potential defined as premenopausal females with a documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. (b) Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) modified list of highly effective methods for avoiding pregnancy in females of reproductive potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least 4 days after the last dose of study medication. The GSK modified list of highly effective methods includes: contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Oral contraceptive; either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. - A male subject is eligible to participate if (a) subjects with female partners of child bearing potential comply with the following contraception requirements from the time of first dose of study medication until at least 4 days after the last dose of study medication; (b) Vasectomy with documentation of azoospermia; (c) Male condom plus partner use of one of the contraceptive options: Contraceptive subdermal implant that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label; Oral contraceptive, either combined or progestogen alone, Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. - Understanding of questionnaires: In the opinion of the investigator, subject possesses a degree of understanding of the written questionnaires that enables the subject to complete study participation. - Informed consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. Exclusion Criteria: - Concurrent conditions / Medical History: Concomitant medical conditions defined as but not limited to a historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, uncontrolled diabetes, immunosuppression). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or compromise the scientific validity of the study; A respiratory infection at time of study participation; A condition associated with anosmia (loss of smell) and ageusia (loss of taste) within 2 weeks of study - may be self-reported condition experienced by the subject; Clinical evidence of a Candida infection of the nose or oropharynx; Acute rhinosinusitis within 60 days of screening; Current severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation or nasal trauma or nasal ulcers; History of haemorrhagic diathesis, atrophic rhinitis, or recurrent nasal bleeding which may, in the opinion of the investigator, impact on the safety of the subject or the scientific validity of the study; Nasal biopsy within 60 days of screening; Nasal jewellery or piercings which could impact nasal safety or airway resistance; Rhinitis medicamentosa within 60 days of screening; History of glaucoma, cataracts or raised intraocular pressure. - Concomitant medications: Use of intranasal corticosteroids (FF, MF or others) within 4 weeks of study participation; Recent or ongoing use of a corticosteroid by a non-nasal route which, in the opinion of the investigator, could preclude subject participation in the study; Use of intranasal medications (including intranasal antihistamines, intranasal decongestants, intranasal saline) within 1 week of study participation; Use of medications which, in the opinion of the investigator, could disturb the taste or smell faculties of the subject; Use of any medications that significantly inhibit the cytochrome P450 (CYP) sub-family CYP3A4, including but not limited to ritonavir and ketoconazole, within 4 weeks of study participation. - Relevant habits: Use of perfume or strong-smelling cosmetic products or oral rinse or similar products on the study day that could, in the opinion of the investigator, compromise participation in the study. Subjects should be notified of this criterion prior to study participation; Use of tobacco, or inhaled or oral nicotine-containing products, is not allowed for 12 hours prior to the start of dosing. - Contraindications: History of sensitivity to any of the study procedures or medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - Diagnostic assessments and other criteria: Positive pregnancy test or female who is breastfeeding; The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer), unless more stringent local guidelines need to be followed. | |
| 66 | NCT02404285 | completed | 1 | phase 1/phase 2 | ['acne vulgaris'] | ["['L70.0']"] | ['next science acne gel', 'vehicle'] | ['[H][C@@]1(C)C[C@@]2([H])[C@]3([H])CCC4=CC(=O)C=C[C@]4(C)[C@@]3(Cl)[C@@]([H])(O)C[C@]2(C)[C@@]1(OC(=O)C1=CC=CO1)C(=O)CCl'] | Inclusion Criteria: 1. Male or female ages 12 and above 2. Has 10 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment. 3. In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure 4. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation 5. Agrees to refrain from professional facial treatments during their trial participation. 6. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation. 7. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site 8. Is able to read, understand and sign the informed consent document and communicate with study staff and investigator. If the subject is a minor, the parent or documented legal guardian must meet these consent requirements and the subject must be able to understand, agree to, and sign the assent form. Exclusion Criteria: 1. Has more than 2 nodules/cystic acne lesions on the face 2. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients 3. Has any history of skin malignancy 4. Has significant facial hair that would interfere with evaluation of acne lesions or global assessment. 5. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization. 6. Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization). 7. Has had any professional facial treatments in the 14 days prior to randomization. 8. Has received any investigational treatment in the 30 days prior to randomization. 9. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial. | |
| 67 | NCT02406443 | completed | 1 | phase 4 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['sitaglitpin'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F'] | Inclusion Criteria: - Individuals of 18-70 years of age, - with Type 2 Diabetes, - with an HbA1c (6.5%-9%), - and with a systolic blood pressure (120-160 mmHg). Exclusion Criteria: - Individuals with: 1. Type 1 Diabetes, 2. eGFR <50mL/min/1.73m, 3. pregnancy or breast feeding, 4. significant cardiac, pulmonary or liver disease, 5. prior history of pancreatitis, medullary thyroid cancer, multiple endocrine neoplasia syndromes, 6. SBP >161 mmHg, 7) DBP >100 mmHg, 7. alcohol or substance abuse, 8. states of secondary hypertension. | |
| 68 | NCT02408068 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['dexamethasone', 'chronocort: fasted', 'immediate release hydrocortisone: fasted', 'chronocort: fed'] | ['[H][C@]12CC3=C(C=C(OC)C=C3)[C@@]3(CCCC[C@]13[H])CCN2C', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C'] | Inclusion Criteria: - Healthy male volunteers between 18 and 60 years of age, inclusive (at screening) - A body mass index of 21-28 (inclusive). - No clinically significant abnormal serum biochemistry, haematology and urine examination values - A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the investigator. - Negative HIV and Hepatitis b & C results - No clinically significant abnormalities in 12-lead ECG - No clinically significant deviation outside the normal ranges for blood pressure and pulse measurements - Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example: - Oral contraceptive + condom - Intra-uterine device + condom - Diaphragm with spermicide + condom - Subjects must be available to complete the study - Subjects must provide written informed consent to participate in the study Exclusion Criteria: - A clinically significant history of gastrointestinal disorder likely to influence drug absorption - Receipt of regular medication (including high dose vitamins, dietary supplements or herbal remedies) - Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction Receipt of any vaccination within the previous one month - Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections) - Current of previous history of tuberculosis - A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone - A clinically significant history of family history of psychiatric disorders/illnesses - A clinically significant history of drug or alcohol abuse - Inability to communicate well with the investigator (ie language problem, poor mental development or impaired cerebral function) - Participation in a New Chemical entity clinical study within the previous four months or a marketed drug clinical study within the previous three months - Subjects who have consumed more than two units of alcohol pre day within seven days prior to the first dose or have consumed any alcohol within the 48hr period prior to the first dose - Donation of greater than or equal to 450ml blood within the previous three months - Subjects who smoke or ex-smokers who have smoked within six months prior to first dose - Subjects who work shifts (ie regularly alternate between days, afternoons and nights) | |
| 69 | NCT02413918 | completed | 1 | phase 4 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['iloperidone'] | ['COC1=C(OCCCN2CCC(CC2)C2=NOC3=C2C=CC(F)=C3)C=CC(=C1)C(C)=O'] | Inclusion Criteria: 1. Male or female; 2. Age 18 years and older 3. Patients on: - Li at a stable dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 0.5 mEq/l OR - DIV dose for 2 weeks or longer, and a serum level at screening of greater than or equal to 45 ug/ml OR - LAM (dosage/day ≥100mg) at a stable dose for 2 weeks or longer OR - Any combination 3a, 3b, or 3c 4. Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7 5. Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 6. Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ; 7. Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 Exclusion Criteria: 1. Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic sub-type that requires hospitalization, drug induced mania or AIDS induced mania 2. Women with a positive pregnancy test or who are lactating 3. Women of child-bearing potential who are not practicing a clinically accepted method of contraception 4. Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases. 5. Patients whose clinical status requires inpatient or day hospital treatment 6. History of severe side effects associated with therapeutic doses of Li, DIV, LAM 7. Alcohol or drug dependent at time of enrollment 8. Suicidal at time of enrollment. 9. Current or previous exposure to iloperidone 10. Patients taking medication that cause QTC prolongation 11. Patients with serious cardiac disease | |
| 70 | NCT02415400 | completed | 1 | phase 4 | ['acute coronary syndromes'] | ["['I24.0']"] | ['apixaban', 'vitamin k antagonist', 'acetylsalicylic acid'] | ['COC1=CC=C(C=C1)N1N=C(C(N)=O)C2=C1C(=O)N(CC2)C1=CC=C(C=C1)N1CCCCC1=O', 'CCC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days - Planned use of antiplatelet agents for at least 1 to 6 months - Males and Females ≥ 18 years of age - Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug Exclusion Criteria: - Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve) - Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min - Patients with a history of intracranial hemorrhage - Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event - Patients with known ongoing bleeding and patients with known coagulopathies - Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin | |
| 71 | NCT02419508 | 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']"] | ['brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension', 'brinz/brim vehicle', 'prostaglandin analogue'] | ['BrC1=C(NC2=NCCN2)C=CC2=NC=CN=C12', '[H][C@@]1(C)C[C@@]2([H])[C@]3([H])CCC4=CC(=O)C=C[C@]4(C)[C@@]3(Cl)[C@@]([H])(O)C[C@]2(C)[C@@]1(OC(=O)C1=CC=CO1)C(=O)CCl', '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: - Diagnosis of either open-angle glaucoma or ocular hypertension; - Must sign an informed consent form; - Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:00. - Willing and able to attend all study visits; - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study; - Any form of glaucoma other than open-angle glaucoma or ocular hypertension; - Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol; - Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study; - Other protocol-specified exclusion criteria may apply. | |
| 72 | NCT02421575 | terminated | slow accrual | 0 | early phase 1 | ['prostate carcinoma'] | ["['D07.5']"] | ['hydroxychloroquine'] | ['CCN(CC)CCCC(C)NC1=C2C=CC(Cl)=CC2=NC=C1'] | Inclusion Criteria: - Signed written informed consent - Have abnormal digital rectal examination, or abnormal prostate specific antigen (> 4.0 ng/ml), or obstructing prostate, or biopsy proven prostate cancer - Scheduled for prostate surgery, i.e. transurethral resection of the prostate (TURP) or prostatectomy - Planned to be treated by active surveillance Exclusion Criteria: - Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus - Patients with psoriasis - Patients receiving any disease-modifying anti-rheumatic drug (DMARD) - Active clinically significant infection requiring antibiotics - Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency - Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine - Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone - Patients must not have prior visual field changes from prior 4-aminoquinoline compound use - Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria - History of hypersensitivity to 4-aminoquinoline compound |
| 73 | NCT02425306 | terminated | slow accrual to part 2 of the study. accrual to part 1 is complete. | 0 | phase 1/phase 2 | ['melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['montanide isa-51', 'polyiclc', 'cyclophosphamide'] | ['[Na+].[Cl-]', '[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: - Part 1 only: Participants with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence. Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc,;Friendswood, TX) also may be eligible. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system. - Part 2 only: Patients with a diagnosis of stage IIIB-IV melanoma with one or more tumor deposits accessible for biopsy and/or excision. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system. Patients must have adequate cutaneous, subcutaneous, soft tissue, or nodal metastases of melanoma readily accessible for biopsy - Participants will be required to have radiological studies to rule out radiologically evident disease. Required studies include: - Chest CT scan, - Abdominal and pelvic CT scan, and - Head CT scan or MRI - PET/CT fusion scan may replace scans of the chest, abdomen, and pelvis. - Participants who have had brain metastases will be eligible if all of the following are true: - Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery. - There has been no evident growth of any brain metastasis since the most recent treatment. - No brain metastasis is > 2 cm in diameter at the time of registration. - The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and for Part 1, ≤ 6 months prior to registration. - All participants must have: - ECOG performance status of 0 or 1 (Appendix 3) - Ability and willingness to give informed consent - Laboratory parameters as follows: - ANC > 1000/mm3 - Platelets > 100,000/mm3 - Hgb > 9 g/dL - HgbA1c ≤ 7.5% - Hepatic: - AST and ALT ≤ 2.5 x upper limits of normal (ULN) - Bilirubin ≤ 2.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed) - Alkaline phosphatase ≤ 2.5 x ULN - Renal - Creatinine ≤ 1.5 x ULN - Serology (within 6 months of study entry) - HIV negative - Hepatitis C negative (no evidence of active virus) - Blood is to be collected for HLA typing (Class I and Class II), which will be analyzed as part of the immunologic endpoints, but HLA type will not be an inclusion/exclusion criterion. - Age 18 years or older at registration. - Part 1 only: Participants must have at least two intact (undissected) axillary and/or inguinal lymph node basins. - Part 2 only: Participants must have at least one intact (undissected) axillary and/or inguinal lymph node basin. Exclusion Criteria: - Participants who have received the following medications or treatments at any time within 4 weeks of registration: - Chemotherapy - Interferon (e.g. Intron-A®) - Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration) - Allergy desensitization injections - High doses of systemic corticosteroids, with the following qualifications and exceptions: - In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function. - Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) (76,77). - Topical, nasal, and intra-articular corticosteroids are acceptable. - Growth factors (e.g. Procrit®, Aranesp®, Neulasta®) - Interleukins (e.g. Proleukin®) - Any investigational medication - Targeted therapies specific for mutated BRAF or for MEK - Participants who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks - Participants who are currently receiving a checkpoint molecule blockade therapy, or who have received this therapy within the preceding 12 weeks. - Participants with known or suspected allergies to any component of the vaccine. - Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol. Participants who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination. - Pregnancy. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. - Female participants must not be breastfeeding - Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator. - Participants classified according to the New York Heart Association classification as having Class III or IV heart disease (Appendix 4). - Participants with uncontrolled diabetes, defined as having a HgbA1c ≥ 7.5%. - Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary: - The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms - Clinical evidence of vitiligo - Other forms of depigmenting illness - Mild arthritis requiring NSAID medications - Participants who have another cancer diagnosis, except that the following diagnoses will be allowed: - squamous cell cancer of the skin without known metastasis - basal cell cancer of the skin without known metastasis - carcinoma in situ of the breast (DCIS or LCIS) - carcinoma in situ of the cervix - any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years - Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use. - Body weight < 110 pounds (without clothes) at registration, due to the amount and frequency with which blood will be drawn. |
| 74 | NCT02425826 | completed | 1 | phase 4 | ['parapsoriasis'] | ["['L41.5', 'L41.8', 'L41.9', 'L41.3', 'L41.4']"] | ['apremilast', 'placebo', 'placebo-apremilast'] | ['[H][C@](CS(C)(=O)=O)(N1C(=O)C2=C(C1=O)C(=CC=C2)N=C(C)O)C1=CC(OCC)=C(OC)C=C1'] | Inclusion Criteria: 1. Males or females, ≥ 18 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/procedures being conducted. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the informed consent. 5. Have moderate plaque psoriasis at screening and baseline as defined by 1. BSA (Body Surface Area)5% to 10% and 2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale 6. Must be in general good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. 7. No prior exposure to systemic treatments or biologics for the treatment of psoriatic arthritis, psoriasis, or any other indication that could impact the assessment of psoriasis. 8. Females of childbearing potential (FCBP)must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. 9. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product Exclusion Criteria: 1. Other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,immunologic disease, or other major disease that is currently uncontrolled. 2. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 3. Any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, erythrodermic, guttate, inverse, or pustular psoriasis), other than plaque psoriasis. 4. Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 5. Pregnant or breast feeding. 6. Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent. 7. Malignancy or history of malignancy, except for: 1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; 2. treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent. 8. Topical therapy within 2 weeks of randomization (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to randomization. 9. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 10. Prolonged sun exposure or use of tanning booths, which may confound the ability to interpret data from the study. 11. Prior treatment with apremilast. | |
| 75 | NCT02429258 | completed | 1 | phase 4 | ['type ii diabetes'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['farxiga', 'placebo', 'metformin', 'insulin'] | ['[Na+].[Na+].[O-]P([O-])(F)=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', 'CCOC1=CC=C(CC2=C(Cl)C=CC(=C2)[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)C=C1'] | Inclusion Criteria: - Type 2 diabetes mellitus (T2DM) - Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks - Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening - Body mass index (BMI) < or = to 45 kg/m2 Exclusion Criteria: - For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening - For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening. - Use of sulfonylureas during the 8 weeks prior to screening - Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor - Ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening - Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening | |
| 76 | NCT02429804 | terminated | accrual factor | 0 | phase 1 | ['hormone-resistant prostate cancer', 'metastatic malignant neoplasm in the bone', 'metastatic prostate carcinoma'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['fludeoxyglucose f-18', 'fluorine f 18 sodium fluoride'] | ['[H]C(=O)[C@H]([18F])[C@@H](O)[C@H](O)[C@H](O)CO', '[18F-]'] | Inclusion Criteria: - Provides written informed consent - Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride) - Able to remain still for duration of the imaging procedure (about one hour) Exclusion Criteria: - Metallic implants |
| 77 | NCT02439879 | completed | 1 | phase 4 | ['diabetic neuropathy'] | ["['E10.40', 'E11.40', 'E13.40', 'E10.43', 'E11.43', 'E13.43', 'E08.40']"] | ['alpha lipoic acid'] | ['C[C@H](N)C(O)=O'] | Inclusion Criteria: - Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria) - Symptomatic diabetic polyneuropathy - Total Symptom Score (TSS) >7 points, - HbA1c<10%, - Serum creatinine <2 mg/dl. Exclusion Criteria: - Active cardiovascular disease - Malignancy - Any other conditions causing neuropathic pain - Use of analgesic, antidepressant, or antiepileptic drugs, or any other medication aimed to relief neuropathic pain. - Child-bearing female patients not using any effective birth control method and under surveillance of a board-certified gynecologist | |
| 78 | NCT02440789 | completed | 0 | phase 1/phase 2 | ['hiv-1 infection'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['sirolimus'] | ['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'] | Inclusion Criteria: - HIV-1 infection - On continuous ART for ≥24 months prior to study entry. - CD4+ cell count ≥350 cells/mm^3 - Plasma HIV-1 RNA below the level of quantification for ≥24 months. - White blood cell (WBC) ≥3000/mm^3 - Platelet count ≥125,000/mm^3 - Absolute neutrophil count (ANC) >1300/mm^3 - Aspartate aminotransferase (AST) <1.25 x upper limit of normal (ULN) - Alanine aminotransferase (ALT) <1.25 x ULN - Calculated creatinine clearance (CrCl) ≥60 mL/min - Fasting or non-fasting triglyceride level ≤350 mg/dL - Fasting or non-fasting LDL <160 mg/dL - Urine protein to urine creatinine ratio ≤1 g/g from random urine collection Exclusion Criteria: - Serious illness requiring systemic treatment and/or hospitalization - Documentation of any CDC Category C AIDS-indicator condition or oropharyngeal candidiasis (thrush) - Intended modification of ART during the study. - Latent tuberculosis (TB) infection - TB disease within 48 weeks prior to study entry requiring treatment. - History of active hepatitis B (HBV) infection. - Hepatitis C virus (HCV) RNA-positive - Previous myelodysplasia syndrome, lymphoproliferative disease, lung disease, malignancies, congestive heart failure, life-threatening fungal infection or herpes-zoster/varicella-zoster viral infection requiring treatment. - Detectable Epstein-Barr virus (EBV) in blood - Active infection other than HIV that required receipt of systemic antibiotic therapy by intravenous infusion - History of major hypersensitivity reaction to macrolide drugs including angioedema, anaphylaxis, drug-induced dermatitis, or hypersensitivity vasculitis. - Currently pregnant or breastfeeding, or planning to become pregnant prior to or during the study. - Use of immunomodulators (eg, interleukins, interferons, and cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy. - Active drug or alcohol use or dependence - Vaccination within 14 days prior to study entry. - On or planned to change to a PI-based ART or cobicistat-boosted regimen - Anti-human papillomavirus (HPV) therapies | |
| 79 | NCT02442206 | completed | 1 | phase 4 | ['chronic obstructive pulmonary disease, copd'] | ["['G91.1', 'I42.1', 'N11.1', 'J05.0', 'G47.33', 'J44.9', 'N13.8']"] | ['qva149', 'placebo'] | ['CCC1=C(CC)C=C2CC(CC2=C1)NC[C@H](O)C1=C2C=CC(=O)NC2=C(O)C=C1'] | Inclusion Criteria: - Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the predicted normal value and a post-bronchodilator FEV1/FVC<0.7 - Current or ex-smokers who have a smoking history of at least 10 pack years. - Able and willing to give written informed consent - Hyperinflated patients with RVol>135% predicted Exclusion Criteria: - Patients on LABA or LAMA treatment at Visit 1. - History of one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2. - More than one COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2. - Patients who have clinically significant cardiovascular abnormalities, which could interfere with the assessment of the study treatment (such as but not limited to cardiac arrhythmias, heart failure with left ventricular ejection fraction <40% as determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, history of myocardial infarction 6 months prior to Visit 2) - Patients with a known history or current atrial fibrillation to be confirmed by ECG. - Patients with pacemaker, bypass or stent. - Patients whose QTcF measured at Visit 3 is >450 ms for males and >470 ms for females Additional study-specific inclusion and exclusion criteria may apply | |
| 80 | NCT02442700 | completed | 1 | phase 4 | ['hiv', 'dyslipidemia'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['pitavastatin', 'placebo'] | ['O[C@H](C[C@H](O)\\\\C=C\\\\C1=C(N=C2C=CC=CC2=C1C1=CC=C(F)C=C1)C1CC1)CC(O)=O'] | Inclusion Criteria: - aged ≥18 years - able to provide informed consent - had confirmed HIV infection - on ART including atazanavir 300 mg and ritonavir 100 mg each day in the regimens that were not changed within 12 weeks before the randomization - patients who had cholesterol level between 200 and 500 and LDL between 130 and 400 mg/dL without any lipid-lowering agent or discontinued the lipid-lowering agent at least 1 month prior to randomization Exclusion Criteria: - had the history of pitavastatin and/or the constituent of the drugs allergy - known history of myocardial infarction and/or ischemic stroke within 1 month prior to the randomization that would be endangered if we stopped the previous lipid-lowering agent before the enrollment - abnormal AST and ALT with level ≥5 times in asymptomatic patients or ≥3 times of upper normal limit (UNL) in symptomatic patients - pregnancy or breastfeeding - on cyclosporine which had major drug interactions with pitavastatin - patients who denied to join the study | |
| 81 | NCT02442739 | withdrawn | pi voluntary closure due to low accrual | 0 | early phase 1 | ['head and neck cancer', 'pancreatic cancer', 'depression'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']", "['C25.3']", "['F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['ketamine'] | ['[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. Ability to understand and the willingness to sign a written informed consent. 2. Stage -II-IV epidermoid cancer of the head and neck OR stage III-IV pancreatic cancer, with prognosis of at least three months, per oncologist. 3. Within two weeks of starting or from having started, curative intent therapy for head and neck cancer. 4. Age ≥ 18 years. 5. Adequate liver function as defined by: - ALT < 5 X institutional upper limit of normal (ULN) - AST < 5 X institutional ULN - Total bilirubin < 5 X institutional ULN 6. Both men and women of all races and ethnic groups are eligible for this trial. 7. Use of antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry if patient still DOES NOT meet exclusion criteria #3. 8. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the study team and her treating physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential. 9. Must read and understand English fluently. Exclusion Criteria: 1. Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents. 2. Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis. 3. Has moderate to severe depression according to both the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) score of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8. 4. Has Suicidal Risk Assessment (SRA) scores ≥ 6. 5. Use of monoamine oxidase inhibitors within 14 days of study entry. 6. Diagnosed with melanoma or lymphoma cancer of the head and neck. 7. Diagnosed with Stage I or II pancreatic cancer or with anticipated survival of less than three months. 8. History of allergic reactions or hypersensitivity to ketamine. 9. Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease. 10. History of significant tachyarrhythmia, severe angina, or myocardial ischemia 11. Poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood Pressure > 100 mmHG), with or without antihypertensives. 12. If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study. 13. Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT, sensitivity of 0.8). |
| 82 | NCT02444533 | completed | 1 | phase 4 | ['tonsillectomy', 'tonsillitis', 'post-operative pain'] | ["['J35.01', 'J03.90', 'J03.00', 'J03.01', 'J03.91', 'J35.03', 'J03.80']"] | ['liposomal bupivacaine'] | ['CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C'] | Inclusion Criteria: - Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy - Willing and able to understand and provide written informed consent Exclusion Criteria: - Known pregnancy - Women who are currently nursing a child - History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder - Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation - Inability to provide informed consent (patients under guardianship) - Known hypersensitivity to local anesthetics - History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record. - History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record. - Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record. - History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record. | |
| 83 | NCT02448914 | completed | 1 | phase 1 | ["parkinson's disease"] | ["['G20']"] | ['trigel', 'duodopa'] | ['C[C@@](CC1=CC(O)=C(O)C=C1)(NN)C(O)=O'] | Inclusion Criteria: 1. Willing and able to provide informed consent and judged by the Investigator to have decision-making capacity 2. Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion since minimum 30 days 3. 30 years of age or older 4. BMI between 17.0 and 31.0 kg/m2, both inclusive 5. Agreed to use adequate contraceptive measures: Female patients who have been post-menopausal for more than one year or female patients of childbearing potential using a highly efficient method of contraception during the study (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner]). Oral contraceptives in combination with other contraceptives are accepted. Male patients being vasectomised or agreeing to use condoms during the study and having a partner who is using a highly efficient method of contraception as described above. Exclusion Criteria: 1. Hypersensitivity or allergy to the investigational medicinal product (IMP) or to chemically related products 2. Contraindications for the use of levodopa or carbidopa or entacapone 3. Needing a daily total dose of Duodopa during study participation exceeding 125 mL 4. Increased fluctuation in clinical PD symptoms within 7 days prior to Screening 5. Administration of an investigational drug within 3 months prior to Screening and/or current participation in another clinical study involving a pharmaceutical or a medical device class III 6. Use of any forbidden medication as specified in Section 9.6 of the protocol 7. Known hepatitis B, hepatitis C or HIV infection 8. Donation of blood or plasma or major blood loss (≥500 mL) within 3 months prior to Screening 9. Positive urine drug test (amphetamine, benzodiazepines, tetrahydrocannabinol, cocaine or opiates) at Screening 10. Known alcohol abuse 11. Unwilling to meet the requirements of the protocol 12. Other medical or social reasons for exclusion at the discretion of the Investigator | |
| 84 | NCT02450201 | terminated | low accrual | 0 | early phase 1 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['pyruvate'] | ['CC(=O)C(O)=O'] | Inclusion Criteria: - The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5). - The subject is able and willing to comply with study procedures and provide signed and dated informed consent. - At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm). - The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Laboratory criteria for protocol entry: - Absolute neutrophil count (ANC) ≥1000 cells/µL - Hemoglobin ≥9.0 gm/dL - Platelets ≥75,000 cells/µL - Estimated creatinine clearance ≥50 mL/min - Total bilirubin ≤1.5x ULN (or if ≤4 gm/dL and direct bilirubin is WNL) - Aspartate aminotransferase (AST) ≤1.5x ULN - Alanine aminotransferase (ALT) ≤1.5x ULN - Willing to use contraception during and for 1 month after completion of the study. - For part 2 of the study: plans to initiate castrating therapy (with a GnRH antagonist, GnRH agonist, or orchiectomy). An antiandrogen may be started after initial imaging but can not be used prior to baseline imaging. An antiandrogen is allowed but not required. Exclusion Criteria: - The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study. - Current or prior androgen deprivation therapy; previous use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. - Poorly controlled hypertension, with blood pressure at study entry>160/100. - Contraindication for or inability to tolerate MRI examination. - Prostate biopsy within 12 weeks prior to study entry. - BMI of less than 18.5 or greater than 32. Subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available. - Congestive heart failure or New York Heart Association (NYHA) status≥2. - A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG. - Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year. |
| 85 | NCT02451137 | completed | 1 | phase 4 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin glargine, 300 u/ml', 'insulin glargine, 100 u/ml', 'insulin detemir', 'background therapy'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion criteria : - Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin). - Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form. Exclusion criteria: - HbA1c <8.0% or >11.0%. - Males or females <18 years of age. - Type 1 diabetes mellitus. - Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the participant's successful participation for the duration of the study. - Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization, or short-term use during acute event. - Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening. - All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products. - Pregnancy or lactation. - Women of childbearing potential with no effective contraceptive method. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. | |
| 86 | NCT02451917 | completed | 1 | phase 4 | ['type 2 diabetes mellitus', 'chronic kidney disease'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']", "['I12.9', 'N18.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5', 'I13.0']"] | ['glargine insulin', 'nph insulin'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Patients with type 2 diabetes mellitus and chronic kidney disease secondary to diabetic nephropathy in stages 3 and 4 (moderate and severe nephropathy, corresponding to glomerular filtration rate of 15-59 ml/min/1.73m²) will be included in the study. Exclusion Criteria: - Patients with systemic neoplasias, - HIV, chronic kidney disease or nephropathy from other etiologies, - severe psychiatric disorders - pregnant women. | |
| 87 | NCT02453685 | 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 30', 'insulin glargine', 'insulin aspart'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - 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 - Male or female, age at least 18 years at the time of signing informed consent - Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening - Treatment with stable daily dose (for at least 90 days prior to screening) of: - Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - Sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation - Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes - HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory - Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for 'main meal' will be according to the investigator's discretion Exclusion Criteria: - Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents) - Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit) - Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2 - Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack | |
| 88 | NCT02465983 | terminated | lack of efficacy and funding to continue investigation | 0 | phase 1 | ['pancreatic cancer'] | ["['C25.3']"] | ['cyclophosphamide'] | ['[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: - Signed informed consent - Unresectable or metastatic pancreatic cancer - Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease - 18 years of age and older - ECOG performance status of 0 or 1 - Life expectancy greater than 3 months - Satisfactory organ and bone marrow function - Meets blood coagulation parameters - Male and Female subjects of reproductive potential agree to use approved contraceptive methods Exclusion Criteria: - Participation in a therapeutic investigational study within 4 weeks prior to the screening visit - Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion - Active invasive cancer other than pancreatic cancer - HIV, HCV, or HBV infections - Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement - Ongoing or active infection - Planned concurrent treatment with systemic high dose corticosteroids - Patients requiring supplemental oxygen therapy - Prior therapy with gene modified cells - Previous experimental therapy with SS1 moiety, murine or chimeric antibodies - History of allergy to murine proteins - History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40) - Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study - Pregnant or breastfeeding women |
| 89 | NCT02471404 | completed | 1 | phase 4 | ['type 2 diabetes mellitus', 'inadequate glycaemic control'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']", "['Z59.1', 'O62.0', 'Z72.821', 'Z62.0', 'Z73.4']"] | ['dapagliflozin', 'saxagliptin', 'glimepiride', 'placebo for dapagliflozin', 'placebo for saxagliptin', 'placebo for glimepiride'] | ['CN(C)C(=N)NC(N)=N', '[H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1', 'N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2'] | Inclusion Criteria: Main Inclusion Criteria: 1. Is male or female and ≥18 and <75 years old at time of informed consent. 2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation. 3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit. 4. Has a BMI of ≤45 kg/m2 at Enrolment visit. 5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1. Main, Exclusion Criteria: 1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies. 2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data. 3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study. 4. Concomitant treatment with loop diuretics | |
| 90 | NCT02472795 | completed | 0 | phase 1/phase 2 | ['systemic lupus erythematosus'] | ["['M32.9', 'M32.0', 'M32.11', 'M32.12', 'M32.13', 'M32.14', 'M32.8']"] | ['matching placebo', 'cenerimod'] | ['[H][C@]1(CSSC[C@]2([H])NC(=O)[C@H](CC3=CC=C(O)C=C3)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H]3CSSC[C@H](NC(=O)[C@H](C)NC(=O)[C@@H]4CCCN4C(=O)[C@H](CC(N)=O)NC(=O)[C@H](CSSC[C@H](N)C(=O)N3)NC2=O)C(=O)N[C@@]([H])([C@@H](C)O)C(=O)NCC(=O)N1)C(=O)N[C@@H](CC1=CC=C(O)C=C1)C(O)=O', 'CCC1=CC(=CC(C)=C1OC[C@@H](O)CO)C1=NOC(=N1)C1=CC(=NC(OC)=C1)C1CCCC1'] | Inclusion Criteria: - Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies. - Enrolled participants must be treated with background SLE medications. Exclusion Criteria: - Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women. - Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study. | |
| 91 | NCT02478125 | terminated | low accrual | 0 | phase 1 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['burixafor hydrobromide', 'docetaxel', 'g-csf'] | ['NC1=NC(NC[C@H]2CC[C@H](CNCCCNC3CCCCC3)CC2)=NC(=C1)N1CCN(CCP(O)(O)=O)CC1', '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', 'C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1'] | Inclusion Criteria: 1. Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study 2. Be willing/able to adhere to the prohibitions and restrictions specified in this protocol 3. Male aged 18 years and above 4. Eastern cooperative group (ECOG) performance status ≤2 5. Documented histologically confirmed adenocarcinoma of the prostate 6. Metastatic prostate cancer to the bone as documented by positive bone scan imaging 7. Patient must be eligible for chemotherapy with docetaxel 8. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dL). Exclusion Criteria: 1. Have known allergies, hypersensitivity, or intolerance to docetaxel or dexamethasone or their excipients 2. Prior pelvic radiation (e.g. external beam, brachytherapy, etc) that, in the opinion of the investigator, may lead to decreased bone marrow cellularity in a marrow sample obtained from a pelvic bone marrow biopsy 3. Ongoing systemic therapy (other than a GnRH agonist/antagonist) for prostate cancer including, but not limited to: 1. CYP-17 inhibitors (e.g. ketoconazole, abiraterone) 2. Antiandrogens (e.g. bicalutamide, nilutamide) 3. Second generation antiandrogens (e.g. enzalutamide) 4. Immunotherapy (e.g. sipuleucel-T, ipilimumab) 5. Chemotherapy (e.g. docetaxel, cabazitaxel) 4. Prior radiopharmaceutical therapy (e.g. radium-223, strontium-89, samarium-153, etc) within the past year 5. Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements 6. Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated 7. Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 8. Severe hepatic impairment (Child-Pugh Class C) 9. History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study) 10. Have poorly controlled diabetes (HgB A1C ≥ 8%) 11. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. |
| 92 | NCT02491788 | completed | 1 | phase 4 | ['sleep disorder, shift-work'] | ["['G47.26']"] | ['suvorexant', 'placebo'] | ['ClC1=CC(Cl)=C(COC(CN2C=CN=C2)C2=C(Cl)C=C(Cl)C=C2)C=C1'] | Inclusion Criteria: - Aged 20-60 (older individuals excluded due to altered sleep-related circadian signaling) - Males and females - Shift worker - Minimum of three months of prior shift work - Will work minimum of four nights per week or 32 hours of night shift per week during study - "Night work" defined as having at least six hours of work occurring between 8 PM and 8 AM and no longer than 12 hours on shift - Presence of DSM-5 defined Circadian Rhythm Sleep-Wake Disorder: Shift Work Type - Insomnia (SE < 88%) during attempted daytime sleep or excessive sleepiness during nocturnal wake Exclusion Criteria: - Currently or planning to become pregnant - Currently breastfeeding - Inadequate opportunity (<7 hours) for daytime sleep after shift work - Use of sleep aids during the study period. Includes as needed or continuous use of prescription, non-prescription, and naturopathic pharmacotherapies - Diagnosis or detection (during study) of sleep disordered breathing (AHI>10) on home sleep testing; referral to clinical sleep program will be offered - Diagnosis of narcolepsy - Restless Legs Syndrome - >600 mg caffeine intake per night shift or use of prescription stimulant medication during night shift - Rotational or irregular work shifts during study - Use of digoxin for six months prior to or during study - Use of strong (e.g., etoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan) or moderate (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) CYP3A inhibitors or CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin) for six months prior to or during study - Severe hepatic impairment - Unstable or severe medical or psychiatric condition | |
| 93 | NCT02495831 | completed | 0 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['diclofenac sodium', 'diclofenac sodium and safinamide'] | ['OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl', 'OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl'] | Inclusion Criteria: 1. Signed written informed consent before inclusion in the study 2. Males and females, 25-55 years old 3. Body Mass Index (BMI): 18.5-30 kg/m2 4. Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm 5. Ability to comprehend the full nature and purpose of the study 6. Females of child-bearing potential must use at least one of the following : A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit A male sexual partner who agreed to use a male condom with spermicide A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year were admitted. Exclusion Criteria: 1. Contraindications to MAO-B inhibitors, antiepileptic drugs, or to any NSAIDs 2. Clinically significant abnormalities in ECG 3. Clinically significant abnormal physical findings 4. Clinically significant abnormal laboratory values 5. Hypersensitivity or history of anaphylaxis to drugs or allergic reactions in general 6. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases 7. Medications, including over the counter medications and herbal remedies, NSAID or anticoagulant use for 2 weeks before and during the entire study; morphine or other similar opioids, SSRIs, SNRIs, tri- or tetracyclic antidepressant, tramadol, pethidine, dextromethorphan, MAO inhibitors, meperidine derivatives and antiepileptic drugs, medicinal products that are BCRP substrates, any known enzyme inhibiting or inducing agent within 4 weeks preceding the screening visit. 8. Participation in the evaluation of any investigational product for 3 months before the study. 9. Blood donations for 3 months before the study 10. History of drug, alcohol, caffeine or tobacco abuse 11. Positive drug test at screening or day -1 12. Positive alcohol breath test at day -1 13. Abnormal diets or substantial changes in eating habits in the 4 weeks before the study; vegetarians 14. Positive or missing pregnancy test at screening or day -1, pregnant or lactating women | |
| 94 | NCT02499770 | completed | 1 | phase 1/phase 2 | ['small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'placebo', 'trilaciclib', 'etoposide'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'COC1=CC(O)=C(C=C1)C(=O)C1=CC=CC=C1'] | Inclusion Criteria: - Male or female subjects aged ≥18 years - Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry - At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 - Adequate organ function Exclusion Criteria: - Prior chemotherapy for extensive-stage SCLC - Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids. - Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure - Known history of stroke or cerebrovascular accident within 6 months prior to enrollment - Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol - Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) - Receipt of any investigational medication within 4 weeks prior to enrollment | |
| 95 | NCT02499900 | completed | 1 | phase 4 | ['multiple sclerosis'] | ["['G35', 'C81.18']"] | ['copaxone®'] | ['CCN(CC)CCOC(=O)C1(CCCCC1)C1CCCCC1'] | Inclusion Criteria: 1. Men or women at least 18 years of age or older. 2. Patients must have a confirmed and documented RRMS diagnosis 3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit. 4. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization. 5. Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth 6. Patients must be able to sign and date a written informed consent prior to entering the study. 7. Patients must be willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria 1. Patient had any contraindication to Copaxone therapy. 2. Previous use of Copaxone 40 mg/mL three times per week. 3. Patients with progressive forms of MS. 4. Patients with neuromyelitis optica. 5. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 6. Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time 7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit. 8. Pregnancy or breastfeeding. 9. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation 10. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals - other criteria may apply, please contact the investigator for more information | |
| 96 | NCT02500979 | completed | 1 | phase 1 | ['type 1 diabetes mellitus'] | ["['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['pramlintide acetate', 'placebo', 'lispro insulin u-100', 'regular insulin u-100'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[H]N[C@@H](CCCCN)C(=O)N[C@H]1CSSC[C@H](NC(=O)[C@@]([H])(NC(=O)[C@H](C)NC(=O)[C@@]([H])(NC(=O)[C@H](CC(N)=O)NC1=O)[C@@H](C)O)[C@@H](C)O)C(=O)N[C@@H](C)C(=O)N[C@@]([H])([C@@H](C)O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC1=CN=CN1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@]([H])([C@@H](C)CC)C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@]([H])([C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@]([H])([C@@H](C)O)C(=O)N[C@@H](CC1=CC=C(O)C=C1)C(N)=O'] | Inclusion Criteria: - Provision of informed consent prior to any study-specific procedures - Female and/or male aged between 18 and 70 years - Must have a prior diagnosis of T1DM - Body mass index (BMI) <30 kg/m2 - Subjects are not on current treatment with pramlintide (Symlin) and have not received pramlintide during the 6-month period prior to enrollment - Subjects should be willing to consume all of the components of the standardized meals administered during the study - Negative serum pregnancy test for female subjects of childbearing potential - Female subjects of childbearing potential must be 1 year postmenopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study - Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study Exclusion Criteria: - Recurrent severe hypoglycemia requiring assistance within 6 months before screening - A history of hypoglycemia unawareness - A confirmed diagnosis of gastroparesis - Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications: - Any oral antihyperglycemic agent or any other injectable antihyperglycemic agent that is not insulin - Drugs that directly affect GI motility (eg, anticholinergic agents such as atropine) - Drugs that slow the intestinal absorption of nutrients (eg, α-glucosidase inhibitors - A history of gastric surgery (such as gastric banding, Roux- and Y bypass) - Is expected to require or undergo treatment with acetaminophen after enrollment and at any point during the study - Has experienced diabetic ketoacidosis within the last 24 weeks - History of hospitalization within the last 6 months for glycemic control (for both hyperglycemia or hypoglycemia) - Subject has any significant disease or disorder, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate in the study - Any clinically relevant abnormal findings, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study. - Pregnancy confirmed by a positive pregnancy test, or otherwise verified. - Breast feeding - Positive hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (anti-Hbc), or human immunodeficiency virus 1/2 antibody (HIV-1/2 Ab) at Screening - History of, or current alcohol or drug abuse - Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study - Has had a major surgery or a blood transfusion within 2 months before Visit 1 (screening) - Participation in any clinical study with an investigational drug or new formulation of a marketed drug during the last 1 month prior to Visit 1 | |
| 97 | NCT02504554 | completed | 1 | phase 1/phase 2 | ['gastrointestinal problems', 'autism spectrum disorders'] | ["['A21.3', 'A22.2', 'B46.2', 'K92.2', 'K92.81', 'K91.0', 'P54.3']", "['Z16.12']"] | ['oral vancomycin', 'moviprep', 'prilosec'] | ['CN[C@H](CC(C)C)C(=O)N[C@@H]1[C@H](O)C2=CC=C(OC3=C(O[C@@H]4O[C@H](CO)[C@@H](O)[C@H](O)[C@H]4O[C@H]4C[C@](C)(N)[C@H](O)[C@H](C)O4)C4=CC(=C3)[C@@H](NC(=O)[C@H](CC(N)=O)NC1=O)C(=O)N[C@@H]1C3=CC(=C(O)C=C3)C3=C(O)C=C(O)C=C3[C@H](NC(=O)[C@@H](NC1=O)[C@H](O)C1=CC(Cl)=C(O4)C=C1)C(O)=O)C(Cl)=C2', '[Na+].[Na+].[O-]S([O-])(=O)=O', 'COC1=CC2=C(C=C1)N=C(N2)S(=O)CC1=NC=C(C)C(OC)=C1C'] | Inclusion Criteria: 1. Children ages 7-17 years 2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R) 3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items 4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial 5. General good physical health aside from gastrointestinal problems 6. Cognitive Ability to Provide Informed Assent Exclusion Criteria: 1. Antibiotics in last 6 months 2. Probiotics in last 3 months 3. Single-gene disorder (Fragile X, etc.) 4. Major brain malformation 5. Tube feeding 6. Severe gastrointestinal problems that require immediate treatment (life-threatening) 7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions 8. Severely underweight/malnourished 9. Recent or scheduled surgeries 10. Current participation in other clinical trials | |
| 98 | NCT02508259 | completed | 1 | phase 1/phase 2 | ['autism spectrum disorders'] | ["['Z16.12']"] | ['suramin', 'saline'] | ['CC1=C(NC(=O)C2=CC(NC(=O)NC3=CC=CC(=C3)C(=O)NC3=C(C)C=CC(=C3)C(=O)NC3=C4C(C=C(C=C4S(O)(=O)=O)S(O)(=O)=O)=C(C=C3)S(O)(=O)=O)=CC=C2)C=C(C=C1)C(=O)NC1=C2C(C=C(C=C2S(O)(=O)=O)S(O)(=O)=O)=C(C=C1)S(O)(=O)=O', 'COCCC1=CC=C(OCC(O)CNC(C)C)C=C1'] | Inclusion Criteria: - Autism diagnostic observation schedule (ADOS) score of ≥ 7 - Diagnosis of autism spectrum disorder by Diagnostic and Statistical Manual, 5th edition (DSM-V) - Stable treatment and diet regimen for ≥ 2 months - Resident of San Diego region Exclusion Criteria: - Any prescription medications - Hospitalization within the previous 2 months - Active medical problem such as seizures, heart, liver, kidney, or adrenal disease - Planning to start a new drug, diet, or behavioral intervention during the study - Weight under the 5th percentile for age - Unable to tolerate venipuncture, urine collection, or an indwelling intravenous catheter for 3-4 hours - Plasma creatinine ≥ 1.4 mg/dl - Liver function alanine amino transferase (ALT) or aspartate amino transferase (AST) ≥ 1.5-fold above the upper limit of normal - Known intolerance to suramin or other antipurinergic drugs - Unable to perform or cooperate with study requirements | |
| 99 | NCT02510950 | terminated | low accrual | 0 | phase 1 | ['glioblastoma multiforme', 'astrocytoma, grade iv'] | ["['L51.0', 'L51.8', 'L51.9']"] | ['poly-iclc', 'temozolomide'] | ['CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion Criteria: - Newly diagnosed histologically confirmed glioblastoma multiforme (WHO grade IV). Patients with secondary glioblastoma, in particular those who are IDH1 or IDH2 mutant, will not be excluded. - Patients who had craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted. - Consented to genome sequencing and dbGaP-based data sharing and has provided or will provide germline (PBMC) and tumor DNA/RNA samples of adequate quality for sequencing. (Acquisition of specimens for sequencing and the sequencing itself may be done under this study or as part of routine care or another research project.) - At least 18 years of age. - Karnofsky performance status ≥ 60% - Normal bone marrow and organ function as defined below: - Absolute neutrophil count ≥ 1,500/mcL - Platelets ≥ 100,000/mcL - Total bilirubin ≤ 1.5 x IULN - AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN - Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration - Bevacizumab will be allowed if given for symptomatic control of vasogenic edema and to avoid high dose of corticosteroids - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. - Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: - As this is a safety and feasibility study, prior immunotherapy will be permitted. However, any prior immunotherapy must be discontinued at least 2 weeks before peptide vaccine administration. Non-immunologic therapy may be continued. - Inadequate tissue acquisition to allow for neoantigen screening - No candidate neoantigen identified during screening - A history of other malignancy ≤ 3 years previous with the exception of non-melanoma skin cancer, any in situ cancer that has been successfully resected and cured, treated superficial bladder cancer, or any early-stage solid tumor that was successfully resected without need for adjuvant radiation or chemotherapy. - Currently receiving any other investigational agents. - Known allergy, or history of serious adverse reaction to, vaccines such as anaphylaxis, hives, or respiratory difficulty. - A history of allergic reactions attributed to compounds of similar chemical or biologic composition to poly-ICLC 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. - History of pre-existing immunodeficiency disorder including chronic infection (i.e. hepatitis B, hepatitis C, HIV), or autoimmune condition requiring immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. - Presence of clinically significant increased intracranial pressure (e.g. impending herniation) or hemorrhage, uncontrolled seizures, or requirement for immediate palliative treatment. - Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of first dose of vaccine. |
| 100 | NCT02524054 | completed | 0 | phase 1/phase 2 | ['dyspnea'] | ["['R06.00', 'R06.09']"] | ['furosemide', 'aerosolized saline'] | ['NS(=O)(=O)C1=C(Cl)C=C(NCC2=CC=CO2)C(=C1)C(O)=O'] | Inclusion Criteria: - Intractable dyspnea at rest or with minimal activity Exclusion Criteria: - Chronic congestive heart failure - Liver or kidney disease - Systemic lupus erythematosis (SLE) - Receiving potassium supplementation or other indication of hypokalemia - Major psychiatric disorders - Furosemide hypersensitivity - Not mentally competent and/or alert (unable to grant informed consent) - Under 18 years old - Not fluent in English - Inadequate birth control |