ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00407030
Conditions: Cervical Dystonia
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2006-07-01; Completion date: 2009-06-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Detailed description:

Arms: arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection arm 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection arm 3: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection
Interventions: intervention 1: incobotulinumtoxinA (Xeomin) (240 Units) intervention 2: incobotulinumtoxinA (Xeomin) (120 Units) intervention 3: Placebo
Intervention descriptions: intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units) intervention 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units) intervention 3: Placebo

Protocol documents:
Clinical trial NCT00414726
Conditions: Ischemic Stroke
Keywords: ischemic stroke normobaric oxygen therapy
Sponsor: Massachusetts General Hospital
Start date: 2007-01-01; Completion date: 2009-06-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onset), to standard medical treatment.

Detailed description:
Stroke is the third leading cause of death and the leading cause of disability in the United States. Ischemic stroke is caused by a blockage of blood flow to one or more brain arteries, usually due to a blood clot. As a result there is a reduced supply of oxygen and other nutrients leading to permanent brain damage. Normobaric oxygen therapy (NBO, or high-flow oxygen delivered via a facemask) shows promise as a simple, widely accessible, low-cost therapy that can prevent stroke-related brain damage and extend the time window for administering the clot-busting drug t-PA (tissue plasminogen activator), which is the only acute stroke treatment approved by the Food and Drug Administration.

The primary goal of this trial is to compare the safety and therapeutic efficacy of NBO (started within 9 hours of symptom onset) to standard medical treatment with Room Air. We aim to enroll a total of 240 individuals with acute ischemic stroke less than 9 hours after symptom onset, at the Massachusetts General and Brigham and Women's Hospitals in Boston. Participants will be randomly selected to receive either room air (RA, control) or NBO (active treatment) at flow rates of 30-45L/min administered via a face mask for 8 hours. Neurological function scores and neuroimaging \[magnetic resonance imaging (MRI) or computed tomography (CT) scans\] will be obtained before, during, and after therapy until 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit individuals with stroke.

Arms: arm 1: Oxygen, inhaled at 30-45L/min via a facemask for 8 hours arm 2: Room Air, inhaled at 30-45L/min via a facemask for 8 hours
Interventions: intervention 1: NBO (Normobaric Oxygen) intervention 2: Room Air
Intervention descriptions: intervention 1: High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. intervention 2: Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.

Protocol documents:
Clinical trial NCT00419926
Conditions: Kidney Transplantation
Keywords: Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant
Sponsor: Novartis
Start date: 2006-12-01; Completion date: 2009-06-01
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.

Detailed description:

Arms: arm 1: In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. arm 2: In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study.
Interventions: intervention 1: Enteric-coated mycophenolate sodium (Myfortic) intervention 2: Cyclosporine (Neoral) intervention 3: Prednisone
Intervention descriptions: intervention 1: 1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. intervention 2: cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels intervention 3: 20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Protocol documents:
Clinical trial NCT00420628
Conditions: Chalazion Hordeolum
Sponsor: Bausch & Lomb Incorporated
Start date: 2006-11-01; Completion date: 2009-06-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Detailed description:

Arms: arm 1: 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension arm 2: Vehicle
Interventions: intervention 1: loteprednol etabonate/tobramycin opthalmic suspension intervention 2: vehicle
Intervention descriptions: intervention 1: Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. intervention 2: topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

Protocol documents:
Clinical trial NCT00421733
Conditions: Diabetic Nephropathy Chronic Kidney Disease
Keywords: Type 2 Diabetic Nephropathy
Sponsor: Abbott
Start date: 2006-12-01; Completion date: 2009-06-01
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.

Detailed description:

Arms: arm 1: One paricalcitol 1 mcg capsule and one matching placebo capsule per dose arm 2: Two paricalcitol 1 mcg capsules per dose arm 3: Two placebo capsules per dose
Interventions: intervention 1: Zemplar (paricalcitol ) capsules intervention 2: Zemplar (paricalcitol) capsules intervention 3: Placebo
Intervention descriptions: intervention 1: Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily) intervention 2: Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily) intervention 3: Group 1 - Placebo once daily (two placebo capsules once daily)

Protocol documents:
Clinical trial NCT00423813
Conditions: Fibromyalgia
Keywords: FMS Fibro pain Body pain tenderness stiffness muscular pain joint pain
Sponsor: Jazz Pharmaceuticals
Start date: 2006-12-01; Completion date: 2009-06-01
Enrollment: 573 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

Detailed description:
The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: Xyrem®
Intervention descriptions: intervention 1: Oral Solution intervention 2: two doses

Protocol documents:
Clinical trial NCT00424632
Conditions: Solid Tumors
Sponsor: Pfizer
Start date: 2006-11-01; Completion date: 2009-06-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-03814735
Intervention descriptions: intervention 1: 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00426855
Conditions: Lymphoma, Non-Hodgkin
Keywords: Lymphoma, Non-Hodgkin, Low-Grade
Sponsor: Peter Moosmann
Start date: 2007-01-01; Completion date: 2009-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.

Detailed description:
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.

Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.

Arms: arm 1: Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
Interventions: intervention 1: Bendamustine intervention 2: Bortezomib
Intervention descriptions: intervention 1: starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w intervention 2: weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w

Protocol documents:
Clinical trial NCT00430573
Conditions: Substance-Related Disorders
Keywords: cognitive-behavior therapy d-cycloserine cognitive enhancer drug dependence opiate dependence exposure isolated doses of d-cycloserine isolated doses of matching pill placebo DCS
Sponsor: Boston University Charles River Campus
Start date: 2007-02-01; Completion date: 2009-06-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

Detailed description:
This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Arms: arm 1: D-cycloserine-augmented CBT-IC arm 2: Placebo-augmented CBT-IC
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) intervention 2: Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Protocol documents:
Clinical trial NCT00434434
Conditions: Allergic Asthma
Keywords: AQUA anti-CD11 CD11a Asthma Allergy
Sponsor: Genentech, Inc.
Start date: 2007-10-01; Completion date: 2009-06-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: omalizumab intervention 2: omalizumab intervention 3: placebo
Intervention descriptions: intervention 1: Aged Liquid; subcutaneous repeating dose intervention 2: Lyophilized; subcutaneous repeating dose intervention 3: Subcutaneous repeating dose

Protocol documents:
Clinical trial NCT00434954
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide Byetta Amylin Lilly
Sponsor: AstraZeneca
Start date: 2007-02-01; Completion date: 2009-06-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide twice daily (BID) intervention 2: premixed insulin aspart twice daily (BID)
Intervention descriptions: intervention 1: subcutaneous injection (5 mcg or 10 mcg), twice a day intervention 2: subcutaneous injection (titrated appropriately), twice a day

Protocol documents:
Clinical trial NCT00441090
Conditions: Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic
Keywords: Chronic Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP
Sponsor: Eisai Inc.
Start date: 2007-02-01; Completion date: 2009-06-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).

Detailed description:
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants. All study participants will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).

At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based on this visit.

Arms: arm 1: 2.5, 5, 10 or 20 mg tablets

1 tablet taken orally once daily for 28 days arm 2: 2.5, 5, 10, or 20 mg tablets

1 tablet taken orally once daily for 28 days
Interventions: intervention 1: Placebo intervention 2: Avatrombopag tablets
Intervention descriptions: intervention 1: Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. intervention 2: Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.

Protocol documents:
Clinical trial NCT00445978
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease SCD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO
Sponsor: BioMarin Pharmaceutical
Start date: 2007-05-01; Completion date: 2009-06-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SEQUENTIAL

Brief summary:
This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the safety and biologic activity of daily oral administration of 4 escalating doses of sapropterin dihydrochloride over 16 weeks in subjects with sickle cell disease. During an optional extension phase, the study will assess the safety, tolerability, and efficacy of extended treatment with sapropterin dihydrochloride, for a total of up to 2 years; The extension phase of this study was terminated.

Detailed description:
This Phase 2a, multicenter, open-label, dose-escalation study was designed to assess the safety and biological activity of once-daily (or twice-daily \[BID\], only for the highest dose level) oral administration of 4 escalating doses of sapropterin dihydrochloride to subjects with Sickle Cell Disease (SCD); 32 subjects were enrolled in the dose-escalation phase of this study. Subjects received oral, once daily (for 2.5, 5, and 10 mg/kg/day) or BID (for 20 mg/kg/day) doses of sapropterin dihydrochloride during a 16-week, dose-escalation period, with dose levels increasing within subjects every 4 weeks, as follows: 2.5, 5, 10, and 20 mg/kg/day. At the highest dose level (20 mg/kg/day), the total dose of sapropterin dihydrochloride was divided, half of the tablets taken in the morning within 1 hour after a meal, and half approximately 12 hours later (or BID) within 1 hour after a meal. The extension phase of this study was terminated.

Arms: arm 1: 2.5, 5, 10, 20 mg/kg/day of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks, with an optional extension phase at the highest tolerated dose for up to a total of 2 years.
Interventions: intervention 1: Sapropterin Dihydrochloride
Intervention descriptions: intervention 1: Subjects will receive oral, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Dosing was with 100 mg tablets and rounded to the nearest whole tablet. Each dose was taken within 1 hour after the morning meal. Subjects may continue in an optional extension phase at the highest tolerated dose for up to a total of 2 years.

Protocol documents:
Clinical trial NCT00446511
Conditions: Hypertension
Keywords: children pediatrics high blood pressure hypertension valsartan enalapril
Sponsor: Novartis Pharmaceuticals
Start date: 2007-06-01; Completion date: 2009-06-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Valsartan intervention 2: Enalapril intervention 3: placebo matched to enalapril intervention 4: placebo matched to valsartan
Intervention descriptions: intervention 1: Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 2: Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 3: Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 4: placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Protocol documents: