ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00474058
Conditions: Parkinson's Disease
Keywords: rotigotine Neupro® Parkinson's Disease
Sponsor: UCB Pharma
Start date: 2007-05-01; Completion date: 2009-03-01
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

Detailed description:
The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Arms: arm 1: Rotigotine transdermal patch arm 2: Placebo transdermal patch
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Rotigotine transdermal patches:

10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)

Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h intervention 2: Placebo transdermal patches

Protocol documents:
Clinical trial NCT00477334
Conditions: Genital Herpes
Keywords: Recurrent genital herpes Black population
Sponsor: Novartis
Start date: 2007-06-01; Completion date: 2009-03-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

Detailed description:

Arms: arm 1: Famciclovir 1000 mg; twice a day for one day. arm 2: Placebo; twice a day for one day.
Interventions: intervention 1: Famciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: oral; two 500 mg tablets twice a day; single day treatment intervention 2: oral; two tablets twice a day; single day treatment

Protocol documents:
Clinical trial NCT00491829
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2007-06-01; Completion date: 2009-03-01
Enrollment: 945 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

Detailed description:

Arms: arm 1: 50 mg qhs arm 2: 100 mg qhs arm 3: placebo qhs
Interventions: intervention 1: 50 mg qhs intervention 2: 100 mg intervention 3: placebo
Intervention descriptions: intervention 1: flibanserin 50 mg intervention 2: flibanserin 100mg intervention 3: placebo

Protocol documents:
Clinical trial NCT00506519
Conditions: Disseminated Intravascular Coagulation
Keywords: DIC associated with severe sepsis
Sponsor: LEO Pharma
Start date: 2007-07-01; Completion date: 2009-03-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.

Detailed description:

Arms: arm 1: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% arm 2: Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275% arm 3: The best standard treatment for the underlying condition only
Interventions: intervention 1: Antithrombin alfa (INN name) intervention 2: Control (Standard treatment)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00508157
Conditions: Metabolic Syndrome Schizophrenia
Sponsor: Bristol-Myers Squibb
Start date: 2007-11-01; Completion date: 2009-03-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole intervention 2: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
Intervention descriptions: intervention 1: Tablets, Oral, 5 to 30 mg, once daily, 16 weeks intervention 2: Tablets, Oral, According to summary of product characteristics (SmPC)

Protocol documents:
Clinical trial NCT00511706
Conditions: Choroidal Neovascularization Age-Related Maculopathy
Sponsor: Allergan
Start date: 2007-11-01; Completion date: 2009-03-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Detailed description:

Arms: arm 1: Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. arm 2: Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
Interventions: intervention 1: dexamethasone intervention 2: ranibizumab intervention 3: sham
Intervention descriptions: intervention 1: Intravitreal injection of dexamethasone 700 µg at Day 1. intervention 2: Ranibizumab 500 µg at day -30 and Day 7-14. intervention 3: Sham needle-less injection administered in the study eye at Day 1.

Protocol documents:
Clinical trial NCT00517699
Conditions: Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2007-09-01; Completion date: 2009-03-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate intervention 3: Cytarabine
Intervention descriptions: intervention 1: 750mg/m2 iv intervention 2: 8g/m2 iv intervention 3: 2g/m2 iv

Protocol documents:
Clinical trial NCT00518986
Conditions: Sleep Disorders Obstructive Sleep Apnea Major Depressive Disorder Dysthymic Disorder
Keywords: Obstructive Sleep Apnea/Hypopnea Syndrome Excessive Sleepiness
Sponsor: Cephalon
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.

Detailed description:

Arms: arm 1: armodafinil 200 mg/day arm 2: Placebo
Interventions: intervention 1: armodafinil intervention 2: placebo
Intervention descriptions: intervention 1: 200 mg/day intervention 2: placebo

Protocol documents:
Clinical trial NCT00521599
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2007-05-01; Completion date: 2009-03-01
Enrollment: 672 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a placebo-controlled study with 8-weeks of double-blind treatment of mometasone furoate dry powder inhaler (MF DPI) 200 mcg twice daily (BID) using two different inhalers, preceded by the Screening Period and by 2 weeks of open-label treatment with one inhalation of MF DPI 200 mcg twice daily in corticosteroid-dependent asthmatic subjects. The objective of this study is to evaluate the therapeutic equivalency of the 100 mcg and 200 mcg MF DPIs when providing the same total daily dose (400 mcg/day).

Detailed description:

Arms: arm 1: 2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks arm 2: 1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks arm 3: 2 inhalations of placebo matching mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
Interventions: intervention 1: Mometasone furoate dry powder inhaler intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00525135
Conditions: Head and Neck Cancer
Sponsor: University of California, San Francisco
Start date: 2007-08-01; Completion date: 2009-03-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive, which will allow for detection of tumor and make further ablation treatment effective.

Detailed description:
PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Arms: arm 1: If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation. arm 2: If no increased uptake is seen, patients will continue on valproic acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well.
Interventions: intervention 1: Valproic Acid
Intervention descriptions: intervention 1: OUTLINE: This is a pilot study.

Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment.

Quality of life is assessed at the end of every week through a study diary.

Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

Protocol documents:
Clinical trial NCT00527605
Conditions: Benign Prostatic Hyperplasia Prostatic Hyperplasia
Keywords: placebo control Chinese Dutasteride Randomized Benign Prostatic Hyperplasia Double blind
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Detailed description:

Arms: arm 1: dutasteride 0.5mg once daily orally arm 2: Placebo matched once daily orally
Interventions: intervention 1: Dutasteride 0.5mg capsule intervention 2: Dutasteride matched placebo
Intervention descriptions: intervention 1: Dutasteride 0.5mg once daily orally intervention 2: Dutasteride matched placebo once daily orally

Protocol documents:
Clinical trial NCT00527904
Conditions: Gastric Ulcer
Keywords: osteoarthritis rheumatoid arthritis ankylosing spondylisit NSAIDS
Sponsor: POZEN
Start date: 2007-03-01; Completion date: 2009-03-01
Enrollment: 239 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).

Detailed description:
PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population.

Arms: arm 1: 500 mg delayed release naproxen/20 mg immediate release esomeprazole
Interventions: intervention 1: PN400 (VIMOVO) intervention 2: PN 400 (VIMOVO)
Intervention descriptions: intervention 1: Subjects are instructed to take 2 tablets a day, one in the morning and one in the afternoon/evening. The morning tablet should be taken with water, on an empty stomach 30 to 60 minutes before breakfast, or the first meal. The afternoon/evening tablet should be taken with water, on an empty stomach 30 to 60 minutes before dinner. Tablets should be swallowed whole and not broken, crushed or chewed. intervention 2: 500 mg delayed-release naproxen/20 mg immediate release esomperazole dosed twice daily for 12 months

Protocol documents:
Clinical trial NCT00528411
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease CAD heart attack stable angina Stable coronary artery disease
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2009-03-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.

Detailed description:

Arms: arm 1: Aspirin + Placebo arm 2: Aspirin + clopidogrel arm 3: Aspirin + Ticagrelor
Interventions: intervention 1: Ticagrelor Tablets intervention 2: Clopidogrel (over encapsulated) capsule intervention 3: Aspirin Tablets
Intervention descriptions: intervention 1: Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD) intervention 2: Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD) intervention 3: Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.

Protocol documents:
Clinical trial NCT00532844
Conditions: Endothelial Dysfunction
Keywords: 6R-BH4 BH4 BH4 deficiency sapropterin dihydrochloride endothelial dysfunction NO Hypertension Nitric Oxide Vitamin C
Sponsor: BioMarin Pharmaceutical
Start date: 2007-09-01; Completion date: 2009-03-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study will compare plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone.

Detailed description:
This was a Phase 2, randomized, open-label, 2-treatment, 2-sequence, 2-period crossover, pharmacokinetic (PK) study designed to compare the plasma concentrations of BH4 in subjects with endothelial dysfunction following 14 days of treatment by each of 2 regimens: sapropterin dihydrochloride with vitamin C and sapropterin dihydrochloride alone. Each subject received each regimen; the 2 treatment groups varied only in the sequence of the 2 regimens. The washout period between treatment regimens comprised the 1 day period between the last dose of study drug under the first regimen and the first dose of study drug under the second regimen (Day 14 morning to Day 15 morning).

Arms: arm 1: Sapropterin dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28. arm 2: Sapropterin dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.
Interventions: intervention 1: Sapropterin Dihydrochloride intervention 2: Sapropterin Dihydrochloride and Vitamin C
Intervention descriptions: intervention 1: Sapropterin Dihydrochloride 5 mg/kg twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28. intervention 2: Sapropterin Dihydrochloride 5 mg/kg and 500 mg Vitamin C twice a day administered as whole tablets orally within 1 hour after morning and evening meals for 13 days and the last dose within 1 hour after a morning meal on Day 14 and Day 28.

Protocol documents:
Clinical trial NCT00535405
Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Sponsor: Organon and Co
Start date: 2007-11-01; Completion date: 2009-03-01
Enrollment: 1289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Detailed description:

Arms: arm 1: Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 2: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 3: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 4: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 5: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
Interventions: intervention 1: Atorvastatin 10 mg intervention 2: Ezetimibe 10 mg/simvastatin 20 mg intervention 3: Atorvastatin 20 mg intervention 4: Ezetimibe 10 mg/simvastatin 40 mg intervention 5: Atorvastatin 40 mg
Intervention descriptions: intervention 1: Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks intervention 2: Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks intervention 3: Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks intervention 4: Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks intervention 5: Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Protocol documents:
Clinical trial NCT00537329
Conditions: Candidemia
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2009-03-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

Detailed description:

Arms: arm 1: This is an open-label, multi-center, non-comparative 12 week study evaluating the efficacy and safety of anidulafungin in subjects with candidemia.
Interventions: intervention 1: Anidulafungin
Intervention descriptions: intervention 1: Eligible subjects will be initiated on a single loading dose of 200 mg IV anidulafungin, followed by 100 mg IV anidulafungin once daily for a minimum of 5 days but not more than 42 days.

Protocol documents:
Clinical trial NCT00542620
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2007-09-01; Completion date: 2009-03-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin detemir intervention 2: insulin aspart intervention 3: insulin detemir intervention 4: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart intervention 2: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir intervention 3: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart intervention 4: Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir

Protocol documents: