ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00627679
Conditions: Asthma
Keywords: Pediatric asthma
Sponsor: Allergan
Start date: 2005-12-01; Completion date: 2006-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Detailed description:

Arms: arm 1: Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5 arm 2: Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5 arm 3: Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5 arm 4: Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
Interventions: intervention 1: Budesonide Inhalation Suspension intervention 2: MAP0010 low dose intervention 3: MAP0010 intermediate dose intervention 4: MAP0010 high dose
Intervention descriptions: intervention 1: Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 2: Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 3: Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 4: Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Protocol documents:
Clinical trial NCT00697203
Conditions: Dyslipidemia
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2006-05-01
Enrollment: 292 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Pravastatin intervention 3: Dalcetrapib intervention 4: Dalcetrapib intervention 5: Dalcetrapib
Intervention descriptions: intervention 1: po daily for 12 weeks intervention 2: 40mg po daily for 12 weeks intervention 3: 300mg po daily for 12 weeks intervention 4: 600mg po daily for 12 weeks intervention 5: 900mg po daily for 12 weeks

Protocol documents:
Clinical trial NCT00740246
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2005-07-01; Completion date: 2006-05-01
Enrollment: 594 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Detailed description:
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Arms: arm 1: Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.

Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. arm 2: Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.

Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
Interventions: intervention 1: VIT-45 intervention 2: Placebo
Intervention descriptions: intervention 1: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously intervention 2: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

Protocol documents:
Clinical trial NCT01260922
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-04-01; Completion date: 2006-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study investigated the relative bioavailability (rate and extent of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under fasting conditions.

Detailed description:

Arms: arm 1: Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets arm 2: Aricept® 10 mg Orally Disintegrating Tablets
Interventions: intervention 1: Donepezil Hydrochloride intervention 2: Aricept®
Intervention descriptions: intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet

Protocol documents:
Clinical trial NCT01260948
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-04-01; Completion date: 2006-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally disintegrating tablet) in healthy adult subjects administered under non-fasting conditions.

Detailed description:

Arms: arm 1: Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg arm 2: Aricept® Orally Disintegrating Tablets, 10 mg
Interventions: intervention 1: Donepezil Hydrochloride intervention 2: Aricept®
Intervention descriptions: intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet

Protocol documents:
Clinical trial NCT01490294
Conditions: Myocardial Perfusion Imaging Magnetic Resonance Imaging
Keywords: Cardiac MRI gadobutrol
Sponsor: Bayer
Start date: 2004-03-01; Completion date: 2006-05-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.

For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.

The total imaging time is about 45 min.

Detailed description:

Arms: arm 1: Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 2: Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 3: Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI. arm 4: Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Interventions: intervention 1: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 3: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 4: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Intervention descriptions: intervention 1: 0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg) intervention 2: 0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg) intervention 3: 0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg) intervention 4: 0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)

Protocol documents:
Clinical trial NCT01634243
Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2005-01-01; Completion date: 2006-05-01
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.

Detailed description:

Arms: arm 1: SPM 962 transdermal patch
Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day

Protocol documents:
Clinical trial NCT00152451
Conditions: Epilepsy, Partial
Keywords: Epilepsy Partial onset seizures Seletracetam
Sponsor: UCB S.A. - Pharma Sector
Start date: 2005-05-19; Completion date: 2006-05-03
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

Detailed description:

Arms: arm 1: Escalating doses twice daily were to be administered.
Interventions: intervention 1: Seletracetam (ucb 44212)
Intervention descriptions: intervention 1: * Pharmaceutical form: oral capsules
* Concentration: 10 and 50 mg
* Route of administration: oral administration

Protocol documents:
Clinical trial NCT00152503
Conditions: Epilepsy, Partial
Keywords: Epilepsy Partial Onset Seizures Seletracetam Levetiracetam
Sponsor: UCB Pharma SA
Start date: 2005-08-31; Completion date: 2006-05-12
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.

Detailed description:

Arms: arm 1: Escalating doses twice daily were to be administered.
Interventions: intervention 1: Seletracetam (UCB44212)
Intervention descriptions: intervention 1: * Pharmaceutical form: oral capsules
* Concentration: 2, 10 and 50 mg
* Route of administration: oral administration

Protocol documents:
Clinical trial NCT00298831
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-10-27; Completion date: 2006-05-22
Enrollment: 224 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Detailed description:

Arms: arm 1: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
Interventions: intervention 1: Sugammadex intervention 2: Rocuronium
Intervention descriptions: intervention 1: At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered. intervention 2: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Protocol documents:
Clinical trial NCT00287118
Conditions: Candidates for Systemic Therapy for Psoriasis Psoriasis
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-10-27; Completion date: 2006-05-30
Enrollment: 189 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Efalizumab
Intervention descriptions: intervention 1: Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.

Protocol documents:
Clinical trial NCT00152971
Conditions: Arthroplasty, Replacement, Knee Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2004-11-01; Completion date: 2006-06-01
Enrollment: 2615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Detailed description:

Arms: arm 1: low dose regimen taken once daily arm 2: high dose regimen taken once daily arm 3: 30 mg subcutaneously twice daily
Interventions: intervention 1: Dabigatran Dose 1 - day 2 to completion intervention 2: Dabigatran Dose 1 - day 1 intervention 3: Dabigatran Dose 2 - day 2 to completion intervention 4: Dabigatran Dose 2 - day 1 intervention 5: Enoxaparin
Intervention descriptions: intervention 1: low dose regimen taken once daily intervention 2: low dose regimen taken once daily intervention 3: high dose regimen taken once daily intervention 4: high dose regimen taken once daily intervention 5: 30 mg subcutaneously twice daily

Protocol documents:
Clinical trial NCT00266409
Conditions: Generalized Anxiety Disorder Panic Disorder
Sponsor: UCB Pharma
Start date: 2005-10-01; Completion date: 2006-06-01
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

Detailed description:

Arms: arm 1: Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 2: Panic Disorder: Newly prescribed SSRI or SNRI alone arm 3: Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 4: Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
Interventions: intervention 1: Niravam intervention 2: SSRI/SNRI
Intervention descriptions: intervention 1: None intervention 2: Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

Protocol documents:
Clinical trial NCT00071487
Conditions: Lupus Erythematosus, Systemic
Keywords: SLE
Sponsor: Human Genome Sciences Inc.
Start date: 2003-10-01; Completion date: 2006-06-01
Enrollment: 449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

Detailed description:
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg
Intervention descriptions: intervention 1: Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks. intervention 2: Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 3: Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks. intervention 4: Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.

Protocol documents:
Clinical trial NCT00091819
Conditions: Staphylococcal Skin Infection
Keywords: staph MRSA cSSSI
Sponsor: Cumberland Pharmaceuticals
Start date: 2005-01-01; Completion date: 2006-06-01
Enrollment: 862 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Telavancin intervention 2: Vancomycin
Intervention descriptions: intervention 1: Telavancin 10 mg/kg/day, IV for up to 14 days. intervention 2: Vancomycin 1 Gm IV q 12 hrs for up to 14 days.

Protocol documents:
Clinical trial NCT00123604
Conditions: Hypertension Type 2 Diabetes Mellitus
Keywords: beta-blockers endothelial function
Sponsor: St. Paul Heart Clinic
Start date: 2004-06-01; Completion date: 2006-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Detailed description:
Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Arms: arm 1: Carvedilol, orally, 25 mg, twice daily for five months arm 2: Metoprolol, orally, 200 mg, twice daily for five months.
Interventions: intervention 1: Carvedilol intervention 2: Metoprolol
Intervention descriptions: intervention 1: 25 mg twice daily for five months. intervention 2: 200 mg twice daily for five months.

Protocol documents: