ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00646204
Conditions: Parkinson's Disease
Keywords: Parkinson's disease non-motor symptoms
Sponsor: Baylor College of Medicine
Start date: 2006-04-01; Completion date: 2009-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's disease.

Parkinson's disease (PD) affects about one million people in the United States. It is a common neurological condition that is clinically defined by rigidity (muscle stiffness), bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals numerous non-motor symptoms that have been underemphasized. Problematic symptoms include varying degrees of dementia, psychosis, diminished assertiveness and confidence, general fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder, and a common yet difficult to define sense of "not feeling well".

Detailed description:
Patients were enrolled over 11 months from the Parkinson Disease Center and Movement Disorder Clinic at Baylor College of Medicine. PD was diagnosed using standard criteria. Specific inclusion criteria were intentionally broad and included both fluctuating and non-fluctuating patients with a UPDRS "motivation" (#4) score of greater or equal to 2. Patients with dementia (MMSE\<24) or taking amantadine were excluded.

The patients signed an informed consent approved by the Baylor College of Medicine Institutional Review Board and the study was registered on Clinical Trials.gov #NCT00646204. The study was funded by a grant from the Forest Research Institute.

After baseline assessments, patients (N=40) were randomized equally to drug (N=20) and placebo (N=20) groups. This was done by a computerized random number generator by a coordinator not otherwise involved in the study.

Patients completed medical and medication histories, a Unified Parkinson's Disease Rating Scale (UPDRS), a battery of neuropsychiatric assessments (see Table 2), global impressions, and adverse events. Patients were not allowed to change other PD medications. The drug/placebo dosing began at 5 mg/day and increased to 5 mg 2x/day, 10 mg / 5 mg, and finally 10 mg 2x/day, in weekly increments. After a safety call (2 weeks after initiation) they returned for identical assessments at week 8. Drug accountability was documented at each visit. An 8-week open label extension was started if desired using the same protocol and assessments.

Tabulations and univariate statistics on difference scores between visits were run using Intercooled Stata V8.0 for windows (Stata Corporation, College Station, Texas 77845), and included Student's t-test with equal variances and contingency table analysis using Pearson's Chi-square test. Statistics were done using LOCF. Corrections for multiple comparisons were not done.

Arms: arm 1: memantine 10 mg bid arm 2: 2 tabs bid
Interventions: intervention 1: Memantine intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg bid intervention 2: 2 tabs bid

Protocol documents:
Clinical trial NCT00653328
Conditions: Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2003-05-01; Completion date: 2009-03-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy.

PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the median time to tumor progression in patients with recurrent ovarian epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary adenocarcinoma treated with Doxil and atrasentan hydrochloride.

Secondary

* To determine the objective response rate and survival of patients treated with this regimen.
* To determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with platinum-taxane (sensitive vs resistant).

Patients will be administered Doxil 50 mg/m2 intravenous every 28 days and take atrasentan 10 mg orally everyday continuously beginning on Day 1. Patients will continue Doxil + atrasentan in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and every 2 months thereafter.

Arms: arm 1: None
Interventions: intervention 1: atrasentan hydrochloride intervention 2: doxil
Intervention descriptions: intervention 1: Atrasentan 10 mg orally everyday continuously beginning on Day 1. intervention 2: 50 mg/m2 intravenously every 28 days

Protocol documents:
Clinical trial NCT00658333
Conditions: Renal Transplantation
Keywords: Renal Transplantation Immunosuppression Renal transplant recipients Gastrointestinal symptoms associated with MMF therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2008-03-01; Completion date: 2009-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

Detailed description:

Arms: arm 1: Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B. arm 2: Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
Interventions: intervention 1: Enteric-coated Mycophenolate Acid (EC-MPA) intervention 2: Mycophenolate Mofetil (MMF) intervention 3: Placebo MMF intervention 4: Placebo EC-MPA
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00666458
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes metformin
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2009-03-01
Enrollment: 822 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Detailed description:

Arms: arm 1: saxagliptin add-on to metformin arm 2: sitagliptin add-on to metformin
Interventions: intervention 1: saxagliptin intervention 2: sitagliptin
Intervention descriptions: intervention 1: tablet, per oral, once daily intervention 2: capsule, per oral, once daily

Protocol documents:
Clinical trial NCT00666757
Conditions: Depression
Keywords: Severe Depressive Episode
Sponsor: Eli Lilly and Company
Start date: 2008-05-01; Completion date: 2009-03-01
Enrollment: 750 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.

Detailed description:

Arms: arm 1: study drug arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: duloxetine intervention 2: fluoxetine intervention 3: citalopram intervention 4: paroxetine intervention 5: sertraline
Intervention descriptions: intervention 1: 30-120 milligrams (mgs) orally daily for 12 weeks intervention 2: 20-80 mgs orally daily for 12 weeks intervention 3: 20-40 mgs orally daily for 12 weeks intervention 4: 20-50 mgs orally daily for 12 weeks intervention 5: 50-200 mgs orally daily for 12 weeks

Protocol documents:
Clinical trial NCT00671879
Conditions: Lower Back Pain
Sponsor: Meda Pharmaceuticals
Start date: 2008-04-01; Completion date: 2009-03-01
Enrollment: 830 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.

Detailed description:
Methodology:

This will be a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg tablets, or placebo.

Subjects will be evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remain symptomatic on Study Day 7 will be allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects will be contacted by telephone for a safety follow-up 7 days after the last dose of study medication.

A pharmacokinetic (PK) substudy will be conducted at selected sites. These sites will obtain blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.

Arms: arm 1: Carisoprodol 700 mg twice daily arm 2: Carisoprodol SR 500 mg twice daily arm 3: Placebo
Interventions: intervention 1: Carisoprodol SR 700 mg intervention 2: Carisoprodol SR 500 mg intervention 3: Placebo
Intervention descriptions: intervention 1: 700 mg twice daily tablet intervention 2: carisoprodol SR 500 mg tablet intervention 3: placebo tablet

Protocol documents:
Clinical trial NCT00682565
Conditions: Heart Failure Myocardial Ischemia Angina Pectoris
Sponsor: Cytokinetics
Start date: 2008-04-01; Completion date: 2009-03-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.

Detailed description:
The primary objective of this study is to assess the effect of intravenous (i.v.) CK-1827452 on symptom-limited exercise tolerance in patients with ischemic cardiomyopathy and angina. The secondary objectives are to assess the tolerability of CK-1827452 administered three times daily (tid) to steady state in an immediate-release (IR), blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina and to assess CK-1827452 plasma concentrations at trough and 1 hour after dosing with CK-1827452 administered tid to steady state in an IR, blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina.

Arms: arm 1: CK-1827452 I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose arm 2: CK-1827452 I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr or placebo, followed by 6 days three times a day oral dose and a final single oral dose
Interventions: intervention 1: CK-1827452 24mg and 6 mg iv infusion intervention 2: CK-1827452 12.5mg capsule intervention 3: CK-1827452 48 mg and 11 mg iv infusion intervention 4: CK-1827452 25mg capsule intervention 5: Placebo iv infusion intervention 6: Placebo capsule
Intervention descriptions: intervention 1: I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr intervention 2: 12.5mg oral immediate release capsule intervention 3: I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr intervention 4: 25mg oral immediate release capsule intervention 5: Matching placebo iv infusion intervention 6: Matching placebo oral immediate release capsule

Protocol documents:
Clinical trial NCT00683592
Conditions: Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2008-03-01; Completion date: 2009-03-01
Enrollment: 481 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.

Detailed description:
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 470 patients at approximately 10 clinical sites. Safety and efficacy will be assessed at each visit. A DNA sample will be collected and analyzed for response to vilazodone.

Arms: arm 1: vilazodone arm 2: None
Interventions: intervention 1: vilazodone intervention 2: placebo
Intervention descriptions: intervention 1: titration to 40 mg tablets qd (once a day) for 8 weeks intervention 2: placebo

Protocol documents:
Clinical trial NCT00686998
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2009-03-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the effects of AZD 2624 in patients with schizophrenia

Detailed description:

Arms: arm 1: AZD2624 40 mg arm 2: Olanzapine 15 mg arm 3: Matching Placebo
Interventions: intervention 1: AZD2624 intervention 2: Olanzapine intervention 3: Placebo
Intervention descriptions: intervention 1: Oral Suspension intervention 2: PO BID intervention 3: None

Protocol documents:
Clinical trial NCT00688467
Conditions: Asthma
Keywords: Neutrophilic Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-01; Completion date: 2009-03-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluation of treatment in participants with mild asthma.

Detailed description:
To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced late asthmatic response (LAR) in participants with mild asthma.

Arms: arm 1: Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2 arm 2: Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
Interventions: intervention 1: Navarixin intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2 intervention 2: Matching capsule to be taken once daily in the morning for 10 days during Treatment Period 1 or Treatment Period 2

Protocol documents:
Clinical trial NCT00701727
Conditions: Hypercholesterolemia
Keywords: metabolic diseases metabolic disorder dyslipidemias lipid metabolism disorders
Sponsor: Radiant Research
Start date: 2008-06-01; Completion date: 2009-03-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a prospective, placebo-controlled, cross-over trial comparing the the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) treatment on several parameters of reverse cholesterol transport (RCT) in men and post-menopausal women diagnosed with hypercholesterolemia. The primary hypothesis is that the ezetimibe treatment will increase the excretion of endogenous (plasma-derived) cholesterol as fecal sterols, with secondary hypotheses that there will be a significant increase in de novo cholesterol synthesis, treatment will increase cholesterol efflux from tissues into the bloodstream, and increase global RCT.

Detailed description:
The study will compare the effects of approximately 7 weeks of placebo treatment to 7 weeks of ezetimibe (10mg/day) on: 1) the efficiency of endogenous (plasma-derived) cholesterol excretion (%/day) 2) de novo cholesterol (DNC) synthesis ((%/day) 3) cholesterol efflux from tissues into blood (Ra), and 4) global RCT (efflux from tissues that is excreted as fecal sterols). Subjects will receive 7 weeks of either treatment or placebo, undergo RCT and DNC measurements, taking 10 days, then cross-over to the alternate placebo or treatment for an additional 7 weeks, followed by a second set of RCT and DNC measurements.

Arms: arm 1: ezetimibe (10mg/day)for 7 weeks arm 2: Placebo control
Interventions: intervention 1: ezetimibe intervention 2: Placebo
Intervention descriptions: intervention 1: 1 tablet,10mg, once a day, for 7 weeks intervention 2: 1 tablet, once a day, for 7 weeks

Protocol documents:
Clinical trial NCT00713609
Conditions: Acne Vulgaris
Keywords: Acne Acne Vulgaris Pimples
Sponsor: Stiefel, a GSK Company
Start date: 2008-06-01; Completion date: 2009-03-01
Enrollment: 591 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed description:
The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Arms: arm 1: Benzoyl peroxide/clindamycin gel + tazarotene cream arm 2: Benzoyl peroxide/clindamycin gel + vehicle cream arm 3: Benzoyl peroxide gel + tazarotene cream arm 4: Clindamycin gel + tazarotene cream arm 5: Vehicle gel+ tazarotene cream arm 6: Vehicle gel + vehicle cream
Interventions: intervention 1: Benzoyl peroxide gel intervention 2: Clindamycin gel intervention 3: Tazarotene cream intervention 4: Vehicle gel intervention 5: Vehicle cream
Intervention descriptions: intervention 1: 5% benzoyl peroxide in a gel applied topically once a day intervention 2: 1% clindamycin phosphate applied topically once a day intervention 3: 0.1 % tazarotene in a cream applied topically once a day intervention 4: Vehicle gel is an identical gel without the active ingredients intervention 5: Vehicle cream is an identical cream without the active ingredients

Protocol documents:
Clinical trial NCT00718081
Conditions: Major Upper or Lower Abdominal Surgery
Sponsor: Talphera, Inc
Start date: 2008-08-01; Completion date: 2009-03-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01 treated subjects.

Detailed description:

Arms: arm 1: Oral Sufentanil arm 2: Oral sufentanil arm 3: Oral dosage of placebo
Interventions: intervention 1: Oral sufentanil intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dosage of sufentanil intervention 2: Oral dosage of placebo

Protocol documents:
Clinical trial NCT00737594
Conditions: Portal Hypertension
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2008-07-01; Completion date: 2009-03-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.

Detailed description:

Arms: arm 1: Participants receive matching placebo capsules three times daily (TID) arm 2: Participants receive 12 mcg Cobiprostone TID arm 3: Participants receive 18 mcg Cobiprostone TID
Interventions: intervention 1: Placebo intervention 2: Cobiprostone
Intervention descriptions: intervention 1: Matching placebo capsules for oral administration intervention 2: Cobiprostone capsules for oral administration

Protocol documents:
Clinical trial NCT00739596
Conditions: Hypertension
Keywords: Hypertension African American aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure amlodipine stage 2
Sponsor: Novartis Pharmaceuticals
Start date: 2008-07-01; Completion date: 2009-03-01
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of a fixed dose combination of aliskiren HCTZ versus amlodipine in African American patients with Stage 2 hypertension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aliskiren Hydrochlorothiazide (HCTZ): 8 weeks intervention 2: Amlodipine: 8 weeks
Intervention descriptions: intervention 1: Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks intervention 2: Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks

Protocol documents:
Clinical trial NCT00740584
Conditions: HIV Infections HSV-2 Genital Herpes
Keywords: Prevention
Sponsor: Starpharma Pty Ltd
Start date: 2008-08-01; Completion date: 2009-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.

Detailed description:

Arms: arm 1: 3%w/w SPL7013 vaginal gel (VivaGel)
Interventions: intervention 1: 3% SPL7013 Gel (VivaGel)
Intervention descriptions: intervention 1: A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

Protocol documents: