ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01410565
Conditions: Bladder Cancer
Keywords: Bladder Cancer Non-Muscle Invasive Bladder Cancer NMIBC Apaziquone EOquin GU Cancer TURBT
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2011-07-01; Completion date: 2014-03-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Detailed description:

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: Apaziquone intervention 2: Placebo
Intervention descriptions: intervention 1: Apaziquone 4 mg in 40 mL diluent intervention 2: Placebo for Double Blind Phase

Protocol documents:
Clinical trial NCT01439009
Conditions: Heart Failure
Keywords: Heart failure Volume overload Tolvaptan loop diuretics
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-09-01; Completion date: 2014-03-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Detailed description:

Arms: arm 1: 15 mg arm 2: Placebo
Interventions: intervention 1: Tolvaptan intervention 2: Placebo of tolvaptan
Intervention descriptions: intervention 1: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning intervention 2: Once-daily oral administration of one placebo tablet in the morning

Protocol documents:
Clinical trial NCT01441440
Conditions: Major Depressive Disorder
Keywords: venlafaxine ER Major depressive disorder Japan placebo-controlled
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-11-01; Completion date: 2014-03-01
Enrollment: 538 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: venlafaxine ER 75 mg/day (fixed dose) intervention 2: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) intervention 3: Placebo
Intervention descriptions: intervention 1: Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration intervention 2: Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration intervention 3: Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration

Protocol documents:
Clinical trial NCT01460290
Conditions: Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2011-10-01; Completion date: 2014-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives: The investigators propose a first-ever, prospective trial of asenapine in older adults with bipolar disorder (BD) to evaluate effects on mood symptoms, tolerability and functional/general health status. Given the dearth of treatment data on older adults with BD, findings are likely to be of substantial clinical interest, may inform larger future studies and will assist in refining bipolar treatment recommendations.

Hypotheses:

Primary: Asenapine therapy will be associated with reduced bipolar manic and depressive symptoms in older adults with BD.

Secondary: Asenapine therapy will be associated with improved functional and general health status, improved global psychopathology, and good tolerability in older adults with BD.

Detailed description:

Arms: arm 1: 12-weeks of open-label asenapine treatment
Interventions: intervention 1: Asenapine
Intervention descriptions: intervention 1: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.

Protocol documents:
Clinical trial NCT01462877
Conditions: Dyslipidemias Cardiovascular Diseases Hypertriglyceridemia
Keywords: Lipid Regulating Agents Drug Therapy cardiovascular diseases hypertriglyceridemia Hydroxymethylglutaryl-CoA Reductase Inhibitors fenofibrate Dyslipidemias Combination
Sponsor: Abbott
Start date: 2011-10-01; Completion date: 2014-03-01
Enrollment: 506 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

Detailed description:
It is an open-label , single group, multi-center study. At around 30 investigate sites, 500 dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose TG ≥1.70 mmol/L (150mg/dl) and \<5.65mmol/L (500mg/dl) after at least 2 month statin monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG will be recruited and given statin-fenofibrate combination therapy for 8 weeks. Several lipid parameters and safety parameters will be compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment. Secondary endpoints on efficacy are the absolute change and the percent of change on TC, LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN and Cr before and after treatment and the number of clinical meaningful abnormal change defined as ALT or AST \>3ULN, or CK \>10ULN, or BUN \>1.5ULN or Cr \>1.5ULN. Other Arm type is a self comparator

Arms: arm 1: None
Interventions: intervention 1: fenofibrate
Intervention descriptions: intervention 1: Fenofibrate Capsule 200mg qd orally

Protocol documents:
Clinical trial NCT01469039
Conditions: Schizophrenia
Keywords: Alkermes schizophrenia ALKS 9072 ALKS 9070 aripiprazole lauroxil
Sponsor: Alkermes, Inc.
Start date: 2011-12-01; Completion date: 2014-03-01
Enrollment: 623 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALKS 9072 intervention 2: Placebo
Intervention descriptions: intervention 1: Intramuscular (IM) injection, 441 mg or 882 mg given monthly intervention 2: Placebo for IM injection, given monthly

Protocol documents:
Clinical trial NCT01472692
Conditions: Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure
Keywords: Prehypertension Gout Puls Wave Velocity Hypertension 24 hour blood pressure
Sponsor: University of California, San Diego
Start date: 2011-10-01; Completion date: 2014-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Febuxostat
Intervention descriptions: intervention 1: 80mg PO daily for 8 weeks

Protocol documents:
Clinical trial NCT01473758
Conditions: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Keywords: COPD Chronic obstructive pulmonary disease Roflumilast
Sponsor: AstraZeneca
Start date: 2012-02-01; Completion date: 2014-03-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD exacerbations will be assessed using patient diaries and questionnaires.

Detailed description:
Participants will be asked whether they agree to participate in the measurements of arterial stiffness. Participants who agree will be included in the substudy, with the target of 60 patients with arterial stiffness measurements to complete the trial.

Study was terminated due to difficulty in identifying further eligible patients for this exploratory study within a reasonable time.

Arms: arm 1: added on to standard therapy for acute COPD exacerbations arm 2: added on to standard therapy for acute COPD exacerbations
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 µg tablet, od, oral administration in the morning after breakfast intervention 2: tablet, od, oral administration in the morning after breakfast

Protocol documents:
Clinical trial NCT01521559
Conditions: Branch Retinal Vein Occlusion
Sponsor: Regeneron Pharmaceuticals
Start date: 2012-04-01; Completion date: 2014-03-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.

Detailed description:

Arms: arm 1: Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. arm 2: Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36.
Interventions: intervention 1: Macular Laser Photocoagulation intervention 2: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01531673
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-02-01; Completion date: 2014-03-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.

Detailed description:
This is a Phase 2, randomized, multicenter, double-blinded, placebo-controlled, study of VX-661 monotherapy, and VX-661/ivacaftor co-therapy in participants with CF who are homozygous or heterozygous for the F508del CFTR mutation.

This study is separated into seven groups: Group 1-7, respectively. Approximately 180 participants were randomized in a ratio of 4:1; active drug to matching placebo in each group.

Arms: arm 1: All participants in group 1, 2a, 2b, 3a, 3b, 4, 5a, 5b, 6a and 6d who received placebo matched to VX-661 tablet and/or placebo matched to ivacaftor tablet for up to 28 days. arm 2: All participants in group 1 who received VX-661 10 milligram (mg) tablet orally once daily (qd) for up to 28 days. arm 3: All participants in group 2a who received VX-661 30 mg tablet orally qd and placebo matched to Ivacaftor tablet every 12 hours (q12h) for up to 28 days. arm 4: All participants in group 2b who received VX-661 10 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days. arm 5: All participants in group 3a who received VX-661 100 mg tablet orally qd and placebo matched to Ivacaftor tablet q12h for up to 28 days. arm 6: All participants in group 3b who received VX-661 30 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days. arm 7: All participants in group 4 who received VX-661 100 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days. arm 8: All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days. arm 9: All participants in group 5b who received VX-661 150 mg tablet qd and Ivacaftor 150 mg tablet q12h orally for up to 28 days. arm 10: All participants in group 6a who received VX-661 100 mg tablet qd and Ivacaftor 50 mg tablet q12h orally for up to 28 days. arm 11: All participants in group 6d who received VX-661 50 mg tablet and Ivacaftor 150 mg tablet q12h orally for up to 28 days. arm 12: All participants in group 7 who received placebo matched to VX-661 tablet orally qd in combination with physician-prescribed Kalydeco (Ivacaftor) for up to 28 days. arm 13: All participants in group 7 who received VX-661 100 mg tablet orally qd in combination with physician-prescribed Kalydeco (Ivacaftor) for up to 28 days.
Interventions: intervention 1: VX-661 intervention 2: Ivacaftor intervention 3: Placebo matched to VX-661 intervention 4: Placebo matched to ivacaftor
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01534494
Conditions: Alcohol Dependence
Keywords: alcohol dependence psilocybin clinical trial motivational enhancement therapy
Sponsor: University of New Mexico
Start date: 2012-01-01; Completion date: 2014-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data. Participants will receive psilocybin orally in two all-day administration sessions, conducted in a secure outpatient psychiatric setting, in a dose range that has been well-tolerated in recent studies. Psilocybin administration will occur in the context of a behavioral intervention including a total of 12 sessions over 12 weeks, incorporating Motivational Enhancement Therapy (MET (Miller, Zweben et al. 1992; Miller 1995), based on Motivational Interviewing (Miller and Rollnick 2002)) with booster sessions, as well as preparation before and debriefing after the psilocybin administration sessions. The MET will incorporate attention to spirituality as well as drinking behavior as a primary subject of change. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured during treatment and for 24 weeks after the end of treatment. The investigators hypothesize that drinking will decrease following the psilocybin sessions, and that increases in motivation, self-efficacy, and spirituality (primary contrast 12 weeks vs. baseline) will be observed among study participants.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Psilocybin
Intervention descriptions: intervention 1: two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy.

Protocol documents:
Clinical trial NCT01534962
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation Ranolazine Arrhythmias, Cardiac Antiarrhythmic Agents Cardiac Electroversion Ranexa
Sponsor: Menarini Group
Start date: 2012-01-01; Completion date: 2014-03-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).

After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility.

Maximum treatment duration is 112 days (16 weeks).

Detailed description:
Patients with persistent AFib are screened for eligibility and undergo direct current cardioversion (DCC). If DCC is successful (defined as persistence of sinus rhythm 2 h post-DCC) patients meeting all the inclusion criteria and none of the exclusion criteria are randomly assigned to the treatment arms (Ranolazine low, intermediate, high dose or placebo, given BID).

Transtelephonic ECG devices (TT-ECG) are used for recording of AFib recurrence to be read by a Central ECG Core Laboratory. Any symptoms indicative of AFib have to be recorded by the patient in a diary.

Study Visits are held for screening (Visit 1), at DCC and randomisation (Visit 2), one week post DCC (Visit 3), after 8 weeks of treatment (Visit 4), and at end of treatment (Visit 5). A safety follow-up telephone call is held 2 weeks after end of treatment.

12-Lead ECGs are performed at every visit.

Safety evaluations include regular safety laboratory blood and urine tests, 12-lead ECGs and the continuous recording of adverse events.

A double-dummy technique is used to ensure double-blind conditions.

Arms: arm 1: Ranolazine, low dose, oral, BID arm 2: Ranolazine, intermediate dose, oral, BID arm 3: Ranolazine, high dose, oral, BID arm 4: Placebo (sugar pill), oral, BID.
Interventions: intervention 1: Ranolazine intervention 2: Ranolazine intervention 3: Ranolazine intervention 4: Placebo
Intervention descriptions: intervention 1: Oral administration, BID; for a maximum of 112 days. intervention 2: Oral administration, BID; for a maximum of 112 days. intervention 3: Oral administration, BID; for a maximum of 112 days. intervention 4: Oral administration, BID; for a maximum of 112 days.

Protocol documents:
Clinical trial NCT01542372
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: PTSD Cognitive behavioral therapy (CBT) Medication augmentation Treatment-resistant PTSD Cambodian refugees Culturally sensitive treatment
Sponsor: Massachusetts General Hospital
Start date: 2012-04-01; Completion date: 2014-03-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project aims to investigate the efficacy of two models to treat Posttraumatic Stress Disorder (PTSD) for Cambodian refugees in primary care. The first step in both models is giving a medication, which is a serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SSRN), with paroxetine being the first-line agent. For those patients who still have PTSD, the second step is either another medication or a culturally sensitive cognitive behavioral therapy (CBT). The investigators hypothesize that patients will improve in both models, but more so in the the CBT model.

Detailed description:
This project aims to investigate the efficacy of two models to treat PTSD for Cambodian refugees in primary care. The first step in both models is giving a medication (an SSRI/SSRN, e.g., paroxetine). For those who still have PTSD, the second step is either adding another medication (e.g., prazosin) or providing culturally sensitive cognitive behavioral therapy (CBT). We hypothesize that patients will improve in both models, but more so in the the CBT model. The primary outcome measure is PTSD severity as assessed by the PTSD Checklist (PCL). Eligibility requirements include having PTSD and having been old enough to remember the Khmer Rouge period.

Arms: arm 1: In one arm, the patients will be given a medication augmentation for SSRI/SSRN-resistant PTSD arm 2: In this arm, patients will receive CBT to treat SSRI/SSRN-resistant PTSD.
Interventions: intervention 1: Medication augmentation intervention 2: CBT
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01565902
Conditions: Hepatic Impairment
Keywords: BAF312 Pharmacokinetics Hepatic impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2014-03-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.

Detailed description:

Arms: arm 1: Treatment with a single oral dose of 0.25 mg BAF312 arm 2: Treatment with a single oral dose of 0.25 mg BAF312 arm 3: Treatment with a single oral dose of 0.25 mg BAF312 arm 4: Treatment with a single oral dose of 0.25 mg BAF312
Interventions: intervention 1: BAF312
Intervention descriptions: intervention 1: Treatment with a single oral dose of 0.25 mg BAF312

Protocol documents: