ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01136408
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim
Start date: 2005-11-01; Completion date: 2006-09-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.

Detailed description:

Arms: arm 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration arm 3: Dose-adjusted warfarin based on target INR values
Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Warfarin
Intervention descriptions: intervention 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration intervention 3: Dose-adjusted warfarin based on target INR values

Protocol documents:
Clinical trial NCT01363050
Conditions: Healthy Volunteers
Sponsor: Egalet Ltd
Start date: 2006-01-01; Completion date: 2006-09-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a phase 1, open label, multiple dose study in healthy male and female volunteers. Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.

The objective of this study in healthy volunteers was to determine the safety, tolerability, and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ketorolac tromethamine
Intervention descriptions: intervention 1: Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.

Protocol documents:
Clinical trial NCT00474253
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-02-10; Completion date: 2006-09-09
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Detailed description:

Arms: arm 1: Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex. arm 2: Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.
Interventions: intervention 1: Sugammadex intervention 2: Succinylcholine intervention 3: Rocuronium
Intervention descriptions: intervention 1: Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex intervention 2: Single bolus IV dose of 1.0 mg/kg succinylcholine intervention 3: Single bolus IV dose of 1.2 mg/kg rocuronium

Protocol documents:
Clinical trial NCT00475215
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-10-27; Completion date: 2006-09-09
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

Detailed description:

Arms: arm 1: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg. arm 2: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg.
Interventions: intervention 1: Sugammadex intervention 2: Rocuronium
Intervention descriptions: intervention 1: Sugammadex solution for injection. intervention 2: Rocuronium bromide solution for injection.

Protocol documents:
Clinical trial NCT00087594
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-11-01; Completion date: 2006-10-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1. arm 2: Participants will receive the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin
Intervention descriptions: intervention 1: 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1) intervention 2: 1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)

Protocol documents:
Clinical trial NCT00091832
Conditions: Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer
Keywords: Breast Cancer Cancer
Sponsor: Amgen
Start date: 2004-09-01; Completion date: 2006-10-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Detailed description:

Arms: arm 1: Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 2: Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 3: Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 4: Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks. arm 5: Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 6: Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.
Interventions: intervention 1: Denosumab intervention 2: IV Bisphosphonates
Intervention descriptions: intervention 1: Denosumab administered by subcutaneous injection intervention 2: Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid

Protocol documents:
Clinical trial NCT00104234
Conditions: Mucopolysaccharidosis VI
Sponsor: BioMarin Pharmaceutical
Start date: 2004-02-01; Completion date: 2006-10-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.

Detailed description:

Arms: arm 1: N-acetylgalactosamine 4-sulfatase arm 2: None
Interventions: intervention 1: N-acetylgalactosamine 4-sulfatase intervention 2: Placebo/rhASB
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00129974
Conditions: Carcinoma, Small Cell
Keywords: Lung cancer Phase II Drug Therapy
Sponsor: Tufts Medical Center
Start date: 2005-08-01; Completion date: 2006-10-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour shrinkage when given to patients with previously untreated extensive-stage small cell lung cancer. The second purpose is to see if the side effects appear better than what is expected with standard chemotherapy.

Detailed description:
Extensive-stage small cell lung carcinoma is incurable. Present therapies are toxic and responses are short lived. This phase II, single arm, window of opportunity study will assess the response rate and toxicity of pemetrexed and gemcitabine in this cohort.

Interventions: intervention 1: pemetrexed and gemcitabine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00162981
Conditions: Epilepsy Epilepsy, Generalized Seizures
Sponsor: Lundbeck LLC
Start date: 2005-10-01; Completion date: 2006-10-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Detailed description:
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.

More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Clobazam Low Dose intervention 2: Clobazam High Dose
Intervention descriptions: intervention 1: 5 to 10 mg/day with doses in the morning and at bedtime; orally intervention 2: 5 to 40 mg/day with doses in the morning and at bedtime; orally

Protocol documents:
Clinical trial NCT00200356
Conditions: Cerebral Infarction
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2004-08-01; Completion date: 2006-10-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Edaravone intervention 2: Sodium Ozagrel
Intervention descriptions: intervention 1: Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. intervention 2: Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.

Protocol documents:
Clinical trial NCT00250458
Conditions: Migraine
Sponsor: Organon and Co
Start date: 2006-03-01; Completion date: 2006-10-01
Enrollment: 346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Detailed description:

Arms: arm 1: Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate arm 2: matching placebo
Interventions: intervention 1: Comparator: Rizatriptan intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack. intervention 2: One dose matching placebo to Rizatriptan to treat one migraine attack.

Protocol documents:
Clinical trial NCT00271570
Conditions: Kawasaki Disease
Sponsor: University of California, San Diego
Start date: 2004-04-01; Completion date: 2006-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.

Detailed description:
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.

Arms: arm 1: Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg) arm 2: Remicade (5mg/kg) single dose
Interventions: intervention 1: Infliximab (Remicade) intervention 2: Intravenous immunoglobulin (IVIG)
Intervention descriptions: intervention 1: Remicade was 5 mg/kg IV (single dose) intervention 2: 2nd dose of IVIG (2g/kg)

Protocol documents:
Clinical trial NCT00292227
Conditions: Parkinson's Disease
Keywords: advanced-stage idiopathic Parkinson's disease
Sponsor: UCB Pharma
Start date: 2006-01-01; Completion date: 2006-10-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.

Detailed description:

Arms: arm 1: Rotigotine Patch arm 2: Placebo patch
Interventions: intervention 1: Rotigotine intervention 2: Placebo intervention 3: Moxifloxacin infusion intervention 4: Placebo infusion intervention 5: Placebo infusion
Intervention descriptions: intervention 1: Rotigotine patch applied once daily for a 24-hour period.

Rotigotine dose schedule (patch application days):

Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day; intervention 2: Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days):

Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day; intervention 3: Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39 intervention 4: Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39 intervention 5: Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39

Protocol documents:
Clinical trial NCT00295022
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed
Sponsor: UCB S.A. - Pharma Sector
Start date: 2006-07-29; Completion date: 2006-10-01
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Detailed description:

Arms: arm 1: Placebo was administered orally on Days 1 and 2. arm 2: 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. arm 3: 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
Interventions: intervention 1: Placebo intervention 2: Montelukast intervention 3: Levocetirizine
Intervention descriptions: intervention 1: * Pharmaceutical form: Over-encapsulated tablet
* Route of administration: Oral use intervention 2: * Pharmaceutical form: Over-encapsulated tablet
* Concentration: 10 mg
* Route of administration: Oral use intervention 3: * Pharmaceutical form: Over-encapsulated tablet
* Concentration: 5 mg
* Route of administration: Oral use

Protocol documents:
Clinical trial NCT00295854
Conditions: Interstitial Cystitis
Keywords: Interstitial Cystitis urgency frequency MN-001 Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index
Sponsor: MediciNova
Start date: 2005-05-01; Completion date: 2006-10-01
Enrollment: 296 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.

Detailed description:
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in a 1:1:1 ratio to receive either 500 mg MN-001 bid, 500 mg MN-001 once daily or placebo. Patients will be dispensed study drug beginning at Baseline (Visit 2) and will return to the study center for Visit 3 (28 days ± 2 days after Baseline), and Visit 4 (56 days ± 2 days after Baseline), at end of study for safety and efficacy assessments. The patient will be contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up. Study drug will be dispensed at Visits 2 and 3. Safety assessments will include adverse events, physical examinations, clinical laboratory testing, and changes in vital signs. Efficacy assessments include percentage of patients at least "moderately improved" for each treatment group using the patient reported Global Response Assessment (GRA) (see Appendix 1). Secondary assessments include a decrease in bladder pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.

Arms: arm 1: None arm 2: placebo tablets
Interventions: intervention 1: MN-001 BID intervention 2: MN-001 intervention 3: Placebo
Intervention descriptions: intervention 1: Eligible patients received 500 mg MN-001 bid intervention 2: Eligible patients received 500 mg MN-001 once daily (qd) intervention 3: Eligible patients received placebo

Protocol documents:
Clinical trial NCT00309777
Conditions: Hypercholesterolemia Dyslipidemia
Keywords: hypercholesterolemia kowa dyslipidemia pitavastatin NK-104 Primary Hypercholesterolemia or Combined Dyslipidemia
Sponsor: Kowa Research Europe
Start date: 2005-09-01; Completion date: 2006-10-01
Enrollment: 857 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Detailed description:

Arms: arm 1: Pitavastatin 2 mg once daily arm 2: Simvastatin 20 mg once daily arm 3: Pitavastatin 4 mg once daily arm 4: Simvastatn 40 mg once daily
Interventions: intervention 1: Pitavastatin intervention 2: Simvastatin
Intervention descriptions: intervention 1: Pitavastatin once daily intervention 2: Simvastatin once daily

Protocol documents:
Clinical trial NCT00319449
Conditions: Hypercholesterolemia Coronary Arteriosclerosis
Sponsor: Organon and Co
Start date: 2005-09-01; Completion date: 2006-10-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.

Detailed description:

Arms: arm 1: Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. arm 2: Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
Interventions: intervention 1: Ezetimibe intervention 2: Placebo intervention 3: Atorvastatin 10 mg
Intervention descriptions: intervention 1: 10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin intervention 2: 10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin intervention 3: 10 mg/day atorvastatin, orally, (ongoing treatment in participants)

Protocol documents:
Clinical trial NCT00366444
Conditions: Pain, Postoperative
Keywords: Bunionectomy Bunion surgery Post-operative pain
Sponsor: Xanodyne Pharmaceuticals
Start date: 2006-08-01; Completion date: 2006-10-01
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg every 6 hours intervention 2: Placebo every 6 hours

Protocol documents:
Clinical trial NCT00387153
Conditions: Cancer
Keywords: Oncology Cancer Blood Cancers
Sponsor: Myriad Therapeutics, Inc.
Start date: 2005-08-01; Completion date: 2006-10-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

Detailed description:
MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.

Interventions: intervention 1: MPC-2130
Intervention descriptions: intervention 1: MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours

Protocol documents: