ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00508924
Conditions: Coronary Artery Disease Angina, Unstable
Keywords: Argatroban Direct thrombin inhibitor Percutaneous coronary intervention Activated clotting time PCI ACT
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2005-08-01; Completion date: 2006-10-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.

Detailed description:
This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Argatroban intervention 2: Argatroban intervention 3: Argatroban intervention 4: Heparin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00573066
Conditions: Hypoplastic Left Heart Tetralogy of Fallot Tricuspid Atresia
Keywords: Postoperative from cardiac surgery Dexmedetomidine
Sponsor: Athena Zuppa
Start date: 2004-05-01; Completion date: 2006-10-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

Detailed description:
This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and infusion doses will be administered to a total of 36 evaluable patients.

Arms: arm 1: A predetermined dose of Dexmedetomidine
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.

Protocol documents:
Clinical trial NCT00710554
Conditions: Pain Peripheral Neuropathy
Keywords: Pain Peripheral Neuropathy Allodynia
Sponsor: Jazz Pharmaceuticals
Start date: 2005-08-01; Completion date: 2006-10-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

Detailed description:
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.

Protocol documents:
Clinical trial NCT00928668
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2006-01-01; Completion date: 2006-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.

Detailed description:

Arms: arm 1: Single dosing of low dose Olodaterol inhaled orally from Respimat Device arm 2: Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device arm 3: Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device arm 4: Single dosing of high dose Olodaterol inhaled orally from Respimat Device arm 5: Single dosing of Olodaterol placebo inhaled orally from Respimat Device
Interventions: intervention 1: Placebo intervention 2: Olodaterol (BI1744CL) intervention 3: Olodaterol (BI1744CL) intervention 4: Olodaterol (BI1744CL) intervention 5: Olodaterol (BI1744CL)
Intervention descriptions: intervention 1: Placebo device for comparison intervention 2: Olodaterol comparison of low, medium low, medium high and high doses intervention 3: Olodaterol comparison of low, medium low, medium high and high doses intervention 4: Olodaterol comparison of low, medium low, medium high and high doses intervention 5: Olodaterol comparison of low, medium low, medium high and high doses

Protocol documents:
Clinical trial NCT02767765
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2003-06-01; Completion date: 2006-10-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Detailed description:

Arms: arm 1: Anemic cancer participants will receive r-HuEPO for 4 weeks.
Interventions: intervention 1: r-HuEPO
Intervention descriptions: intervention 1: All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.

Protocol documents:
Clinical trial NCT00474617
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-12-29; Completion date: 2006-10-20
Enrollment: 162 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Detailed description:

Arms: arm 1: Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. arm 2: Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex. arm 3: Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
Interventions: intervention 1: Sugammadex intervention 2: Rocurium
Intervention descriptions: intervention 1: None intervention 2: intravenous (IV) single bolus dose of 0.6 mg.kg-1

Protocol documents:
Clinical trial NCT00269087
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Bronchitis COPD Emphysema
Sponsor: GlaxoSmithKline
Start date: 2005-01-28; Completion date: 2006-10-25
Enrollment: 122 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Detailed description:

Interventions: intervention 1: fluticasone propionate/salmeterol combination DISKUS
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00320424
Conditions: Thromboembolism
Keywords: Xa factor VTE MOSLL pentasaccharide
Sponsor: GlaxoSmithKline
Start date: 2006-02-16; Completion date: 2006-10-26
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Detailed description:

Interventions: intervention 1: Fondaparinux
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00353873
Conditions: Asthma
Keywords: FLIXOTIDE asthmatics children 4-11 years SERETIDE asthma-control
Sponsor: GlaxoSmithKline
Start date: 2005-11-18; Completion date: 2006-10-26
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

Detailed description:
A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

Arms: arm 1: Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily arm 2: Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily
Interventions: intervention 1: Fluticasone propionate intervention 2: Fluticasone propionate/salmeterol
Intervention descriptions: intervention 1: 200μg twice daily intervention 2: 50/100μg twice daily

Protocol documents:
Clinical trial NCT00256867
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes Type II
Sponsor: GlaxoSmithKline
Start date: 2005-08-18; Completion date: 2006-10-31
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.

Detailed description:

Interventions: intervention 1: GSK523338
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01824602
Conditions: BIPOLAR I DISORDER
Keywords: BIPOLAR I DISORDER, Eslicarbazepine acetate
Sponsor: Bial - Portela C S.A.
Start date: 2006-02-01; Completion date: 2006-11-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093) administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration to onset of action in the different dose groups, and c) monitor the appearance of depressive symptoms.

Detailed description:
This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks. On Day 10, patients who showed no improvement were switched to open-label escape therapy with an established antimanic therapy. Patients could have been hospitalized at screening or at any time during the study at the investigator's discretion. Following randomisation (V2, Day 1), patients were assessed on Days 3, 7, 10, 14, 21, 28, and 56, after which they could either enter a recurrence prevention study, or the study drug could be tapered off and they could undergo follow-up assessments.

Arms: arm 1: Eslicarbazepine acetate 1800 mg arm 2: Eslicarbazepine acetate 1200 mg arm 3: Eslicarbazepine acetate 600 mg arm 4: Placebo pills
Interventions: intervention 1: Eslicarbazepine acetate 1800 mg intervention 2: Eslicarbazepine acetate 1200 mg intervention 3: Eslicarbazepine acetate 600 mg intervention 4: Placebo
Intervention descriptions: intervention 1: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 2: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 3: Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets. intervention 4: Placebo sugar pills

Protocol documents:
Clinical trial NCT00097721
Conditions: Breast Neoplasms
Keywords: breast neoplasm breast cancer breast tumor
Sponsor: Eisai Inc.
Start date: 2004-09-01; Completion date: 2006-11-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Detailed description:
The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m\^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy.

The secondary objectives are to evaluate:

* The safety and tolerability of E7389 monotherapy in this patient population;
* The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival;
* Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS);
* Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form

Arms: arm 1: None
Interventions: intervention 1: E7389
Intervention descriptions: intervention 1: The first cohort of subjects were to receive E7389 1.4 mg/m\^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m\^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.

Protocol documents:
Clinical trial NCT00116753
Conditions: Prostate Cancer
Keywords: Prostate Cancer Androgen ablation therapy
Sponsor: Ferring Pharmaceuticals
Start date: 2005-01-01; Completion date: 2006-11-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

Detailed description:

Arms: arm 1: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9. arm 2: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9. arm 3: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
Interventions: intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix
Intervention descriptions: intervention 1: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9 intervention 2: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9 intervention 3: Drug: Degarelix subcutaneous 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10

Protocol documents:
Clinical trial NCT00159263
Conditions: Asthma
Keywords: Asthma Glucocorticoid Long-acting beta2-adrenoceptor Inhaled corticosteroids
Sponsor: Imperial College London
Start date: 2004-11-01; Completion date: 2006-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate a possible interaction between formoterol and budesonide on GR-translocation and to compare the effect of different doses of Symbicort (80/4.5 and 2x80/4.5 mcg) with the effect of budesonide (200 mcg and 800 mcg) on GR translocation, and to investigate the effect of the study drugs on exhaled NO (bronchial and alveolar fraction.

Detailed description:
Combination therapy with inhaled corticosteroids (ICS) and long-acting β(2)-adrenergic agonists (LABA) is reported to have superior effects on controlling asthma symptoms to ICS alone; however, there is no molecular-based evidence to explain the clinical effects. Here, the effect of the ICS/LABA combination was compared with ICS on glucocorticoid receptor (GR) activation in sputum macrophage.

In a randomised, double-blind cross-over placebo-controlled 6-visit study, 10 patients with mild asthma were given placebo, formoterol (Oxis(®) 12 μg), budesonide (Pulmicort(®) 200 μg :BUD200, or 800 μg :BUD800), or budesonide/formoterol combination (Symbicort(®)) as a single 100/6 μg (SYM100) or double 200/12 μg (SYM200) dose. Sputum macrophages were separated by plate adhesion from induced sputum. GR binding to the glucocorticoid-response elements on oligonucleotides (GR-GRE binding) was evaluated by ELISA. mRNA expression of MAP-kinase phosphatase (MKP)-1 and IL-8 were measured by quantitative RT-PCR.

Arms: arm 1: placebo arm 2: Oxis(®) 12 μg arm 3: Pulmicort(®) 200 μg arm 4: Pulmicort(®) 800 μg arm 5: single 100/6 μg SYM100 arm 6: double 200/12 μg SYM200
Interventions: intervention 1: Placebos intervention 2: Formoterol Inhalant Powder intervention 3: Budesonide Powder intervention 4: Budesonide and Formoterol Product
Intervention descriptions: intervention 1: Dry powder inhaler intervention 2: 12ug intervention 3: Inhaler intervention 4: Combination Inhaler, Symbicort

Protocol documents:
Clinical trial NCT00165776
Conditions: Cervical Dystonia Spasmodic Torticollis
Sponsor: Eisai Co., Ltd.
Start date: 2004-06-01; Completion date: 2006-11-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose will be examined with Williams multiple comparison. For safety evaluation, an inter group comparison (active drug and placebo) will be performed mainly focusing on incidence of adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.

Detailed description:

Interventions: intervention 1: BOTULINUM TOXIN TYPE B
Intervention descriptions: intervention 1: None

Protocol documents: