ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00391846
Conditions: Heart Failure Ventricular Dysfunction, Left
Keywords: Heart Failure Ventricular Dysfunction NTproBNP
Sponsor: AstraZeneca
Start date: 2006-10-01; Completion date: 2009-01-01
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

Detailed description:

Arms: arm 1: Treatment guided by clinical symptoms and signs + NTproBNP arm 2: Treatment guided by clinical symptoms and signs
Interventions: intervention 1: Captopril intervention 2: Enalapril intervention 3: Lisinopril intervention 4: Ramipril intervention 5: Trandolapril intervention 6: Bisoprolol intervention 7: Carvedilol intervention 8: Metoprolol succinate intervention 9: Candesartan intervention 10: Valsartan intervention 11: Eplerenone intervention 12: Spironolactone intervention 13: Diuretics intervention 14: HF treatment according to Swedish guidelines intervention 15: Blood samples intervention 16: The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None intervention 16: None

Protocol documents:
Clinical trial NCT00403494
Conditions: Intermittent Claudication
Keywords: Intermittent Claudication IC Symptomatic Peripheral Arterial Disease Peripheral Arterial Disease PAD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO
Sponsor: BioMarin Pharmaceutical
Start date: 2006-12-01; Completion date: 2009-01-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether sapropterin dihydrochloride is safe and effective in the treatment of intermittent claudication (IC) caused by peripheral arterial disease (PAD).

Detailed description:
This was a Phase 2, multicenter, multinational, prospective, randomized, double-blind, placebo-controlled, parallel study designed to assess the efficacy and safety of sapropterin dihydrochloride in subjects with intermittent claudication (IC) caused by peripheral arterial disease (PAD). Subjects who met initial screening criteria were monitored criteria and that dosages of permitted concomitant medications were stable.

Arms: arm 1: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks. arm 2: Subjects receive matching oral Placebo twice daily for 24 weeks.
Interventions: intervention 1: Placebo intervention 2: Sapropterin Dihydrochloride
Intervention descriptions: intervention 1: Subjects receive matching oral Placebo twice daily for 24 weeks. intervention 2: Subjects receive 400 mg oral sapropterin dihydrochloride twice daily for 24 weeks.

Protocol documents:
Clinical trial NCT00406354
Conditions: Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2009-01-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.

Detailed description:

Arms: arm 1: 0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks arm 2: 0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks arm 3: matching placebo daily dose taken orally
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks. intervention 2: Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.

Protocol documents:
Clinical trial NCT00423189
Conditions: Age-Related Macular Degeneration
Keywords: LUV Lucentis Visudyne PDT AMD ARMD Age Related Macular Degeneration
Sponsor: David M. Brown, M.D.
Start date: 2007-01-01; Completion date: 2009-01-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD.

Detailed description:
The PDT/Lucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD. Patients will be randomized to one of three groups. All patients will receive three consecutive monthly treatments with ITV ranibizumab. Patients randomized to group I will receive only ITV ranibizumab. Patients randomized to group II will also receive one treatment with reduced fluence (20% fluence) verteporfin PDT at day 0. Patients randomized to group III will also receive one treatment with reduced fluence (40% fluence) vPDT. All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria. Thirty patients (ten per group) will be recruited from one U.S. sites in a 6-month period. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Arms: arm 1: drug - intravitreal ranibizumab arm 2: 40% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab arm 3: 20% fluence photodynamic therapy-PDT therapy with 0.5mg ranibizumab
Interventions: intervention 1: Ranibizumab (Lucentis) intervention 2: 0.5mg ranibizumab
Intervention descriptions: intervention 1: as needed, one intravitreal injection of 0.50mg ranibizumab intervention 2: as needed, one intravitreal injection of 0.50mg ranibizumab

Protocol documents:
Clinical trial NCT00435162
Conditions: Hypertension
Keywords: Children pediatrics High Blood Pressure Hypertension Valsartan
Sponsor: Novartis Pharmaceuticals
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Valsartan 0.25 mg/kg intervention 2: Valsartan 1.0 mg/kg intervention 3: Valsartan 4.0 mg/kg
Intervention descriptions: intervention 1: once daily intervention 2: once daily intervention 3: once daily

Protocol documents:
Clinical trial NCT00438971
Conditions: Panic Disorder
Keywords: Panic Disorder Anxiety Disorder Duloxetine
Sponsor: Massachusetts General Hospital
Start date: 2006-08-01; Completion date: 2009-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether duloxetine is effective in the treatment of panic disorder.

Detailed description:
Panic Disorder is relatively common, with a lifetime prevalence of 3.5 % (Kessler, et al 1994) and characterized by a typically chronic course (Marzol \& Pollack, 2000). Affected individuals tend to be high utilizers of general health care services, frequently receiving extensive and unrevealing medical work-ups (Katon, 1997); while the panic disorder itself often goes unrecognized (Sartorious, et al 1993). Panic disorder has a significant negative impact on work, family, and social life (Rubin, et al 2000), and is associated with increased rates of negative life events and diminished overall quality of life (Cramer, et al 2005). Research indicates that the quality of life and well-being of patients with panic disorder is similarly or more impaired than that of patients with serious medical illnesses, such as type II diabetes (Rubin, et al 2000).

Treatment of panic disorder is focused on the reduction of panic attacks, avoidance behavior, and anticipatory anxiety, as well as the resolution of comorbid conditions. The overarching goal of panic disorder treatment is reduction in symptoms to allow improvement in overall quality of life (Pollack, 2005).

Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that has greater initial noradrenergic effects than venlafaxine (Goldstein, et al 2004). Recent data from a placebo controlled fixed dose study, suggested that venlafaxine at 225 mg/d (a dose at which noradrenergic effects are likely to be relevant), was more efficacious on a number of measures of panic disorder than the SSRI, paroxetine (Pollack, et al 2003). This data, combined with our clinical experience with duloxetine to date, support the assertion that duloxetine is likely to prove an effective agent for panic disorder.

Thus, we propose to perform the first systematic examination of the efficacy of duloxetine for panic disorder in a study in which 15 patients with panic disorder will receive duloxetine flexibly dosed from 30 to 120 mg/d in open treatment for 8 weeks. Information learned in this study will help guide treatment selection for panic disorder by providing initial open efficacy data for duloxetine in panic disorder.

Arms: arm 1: None
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: Treatment will be initiated at 30mg/day in the first week (week 0), and then increased to 60mg/day at week 1, with the option to increase to 90mg at week 4, and 120mg at week 6.

Protocol documents:
Clinical trial NCT00439413
Conditions: Nicotine Dependence
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2007-06-01; Completion date: 2009-01-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.

Detailed description:

Arms: arm 1: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.

During treatment, subjects received Selegiline Transdermal System, 6mg -20cm(2) patch, one time per day for 9 weeks

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks arm 2: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -4 week Screening/Baseline Phase.

During treatment, subjects received matched placebo 20cm(2) patch transdermal patch one time per day for 9 weeks

Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks
Interventions: intervention 1: Selegiline Transdermal Patch intervention 2: Placebo intervention 3: Smoking Cessation Counseling
Intervention descriptions: intervention 1: Selegiline cm(2) via transdermal system intervention 2: Matching placebo via transdermal system intervention 3: Subjects were provided with on-site, individual smoking cessation counseling sessions 1x per week for 9 weeks

Protocol documents:
Clinical trial NCT00442507
Conditions: Esophageal Neoplasms Esophageal Diseases
Keywords: Esophagus Esophagogastric Junction Avastin Bevacizumab Erlotinib
Sponsor: Washington University School of Medicine
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Determine the time to progression for the combination of erlotinib and bevacizumab in patients with previously treated metastatic cancer of the esophagus or gastroesophageal junction

Detailed description:
We postulate that the addition of bevacizumab may increase the efficacy of erlotinib in patients with metastatic esophageal cancer, without adding significant toxicity. The non-overlapping toxicity profiles may allow the administration of the maximum tolerated doses for both agents without additive toxicities with the goal of demonstrating synergistic clinical activity. This combination has been previously tested in two studies for other malignancies with good tolerance and encouraging results.

Arms: arm 1: Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
Interventions: intervention 1: Erlotinib intervention 2: Avastin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00459537
Conditions: Onychomycosis
Keywords: Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses
Sponsor: Novartis
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 1029 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

Detailed description:

Arms: arm 1: 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. arm 2: 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Interventions: intervention 1: terbinafine hydrogen chloride intervention 2: amorolfine nail lacquer
Intervention descriptions: intervention 1: 10 % terbinafine hydrogen chloride (HCL) intervention 2: 5 % amorolfine nail lacquer

Protocol documents:
Clinical trial NCT00464269
Conditions: Epilepsy
Keywords: Epilepsy Brivaracetam Partial Onset Seizures, Adolescents & Adults
Sponsor: UCB Pharma
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Detailed description:

Arms: arm 1: Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period. arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period. arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period. arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.
Interventions: intervention 1: Placebo intervention 2: Brivaracetam 2.5 mg intervention 3: Brivaracetam 10 mg intervention 4: Brivaracetam 25 mg
Intervention descriptions: intervention 1: * Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg, 10 mg and 25 mg
* Route of Administration: Oral use intervention 2: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use intervention 3: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg
* Route of Administration: Oral use intervention 4: * Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 25 mg
* Route of Administration: Oral use

Protocol documents:
Clinical trial NCT00467259
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Natural Menopause
Sponsor: Warner Chilcott
Start date: 2007-04-01; Completion date: 2009-01-01
Enrollment: 1271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

Detailed description:
Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Arms: arm 1: 28 cm² Placebo patch arm 2: Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
Interventions: intervention 1: Testosterone Transdermal System intervention 2: Placebo patch
Intervention descriptions: intervention 1: Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks intervention 2: placebo patch, changed twice a week for 52 weeks

Protocol documents:
Clinical trial NCT00479336
Conditions: Cirrhosis
Keywords: OPC-41061 Tolvaptan ascites Cirrhosis
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-06-01; Completion date: 2009-01-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the dose response for changes from baseline in body weight as a primary endpoint and to investigate improvement in ascites, abdominal circumference, lower-limb edema, and pleural effusion as secondary endpoints in seven-day repeated oral administration of OPC-41061 at 7.5, 15, and 30 mg/day or placebo in cirrhosis patients with ascites despite taking conventional diuretics.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: OPC-41061 7.5mg intervention 2: OPC-41061 placebo intervention 3: OPC-41061 15mg intervention 4: OPC-41601 30mg
Intervention descriptions: intervention 1: 7.5mg, 1 tablet a day intervention 2: placebo, 1 tablet a day intervention 3: 15mg, 1 tablet a day intervention 4: 30mg, 1 tablet a day

Protocol documents:
Clinical trial NCT00491387
Conditions: Hypertension
Keywords: hypertension sympathetic nervous system
Sponsor: University of Cincinnati
Start date: 2007-08-01; Completion date: 2009-01-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. The hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

Detailed description:
Patients were to receive sympathetic cardiac innervation testing with I-123 MIBG at baseline and again after receiving a titrate dose of beta-blocker. Data were to be assesses by repeated measures testing.

Arms: arm 1: Subjects will undergo I-123 MIBG testing before and after sustained-release beta-adrenergic blockade.
Interventions: intervention 1: Metoprolol Succinate
Intervention descriptions: intervention 1: Once daily, oral, 12.5 mg to 200 mg, dose titrated to reduce heart rate by 20% or to less than 65 beats per minute.

Protocol documents:
Clinical trial NCT00494481
Conditions: Advanced Breast Cancer
Keywords: Zactima
Sponsor: Genzyme, a Sanofi Company
Start date: 2006-01-01; Completion date: 2009-01-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Detailed description:

Arms: arm 1: Docetaxel + placebo vandetanib arm 2: Vandetanib + Docetaxel
Interventions: intervention 1: Vandetanib (ZD6474) intervention 2: Docetaxel
Intervention descriptions: intervention 1: once daily oral dose intervention 2: intravenous infusion

Protocol documents:
Clinical trial NCT00504309
Conditions: Hypertriglyceridemia
Keywords: triglycerides hypertriglyceridemia omega-3 n-3 eicosapentaenoic acid EPA docosahexaenoic acid DHA flow mediated dilation fish Moderate hypertriglyceridemia
Sponsor: Penn State University
Start date: 2007-07-01; Completion date: 2009-01-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.

Detailed description:

Arms: arm 1: 4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks). arm 2: 1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks. arm 3: Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks. arm 4: 4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks. arm 5: 1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks. arm 6: Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
Interventions: intervention 1: 4/day of 4g P-OM3 capsules intervention 2: 4/day of 1g P-OM3 capsules intervention 3: Corn Oil Placebo, 4 capsules/day for 8 weeks
Intervention descriptions: intervention 1: 4/day of 4g P-OM3 capsules for 8 weeks intervention 2: 4/day of 1g P-OM3 capsules for 8 weeks intervention 3: 4 capsules per day of corn oil placebo for 8 weeks

Protocol documents: