ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00207727
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Sponsor: Centocor, Inc.
Start date: 2004-07-01; Completion date: 2006-08-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Detailed description:
Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS

Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Interventions: intervention 1: CNTO 1275
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00214539
Conditions: Asthma
Keywords: Asthma Bronchial Thermoplasty
Sponsor: Boston Scientific Corporation
Start date: 2004-04-01; Completion date: 2006-08-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma.

This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).

Detailed description:
Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries.

Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks. All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase.

Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean Phase) during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral steroids. If a subject cannot tolerate the steroid reduction at a particular level (as evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of steroid.

All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the Reduced Steroid Phase). All subjects will be exited from the study following completion of the 52 week evaluations.

Arms: arm 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. arm 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
Interventions: intervention 1: Bronchial Thermoplasty with the Alair System intervention 2: Control
Intervention descriptions: intervention 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. intervention 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.

Protocol documents:
Clinical trial NCT00224107
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker
Sponsor: Watson Pharmaceuticals
Start date: 2005-05-01; Completion date: 2006-08-01
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed description:
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Arms: arm 1: Silodosin 8 mg once daily with food arm 2: Matching Placebo capsule once daily with food
Interventions: intervention 1: Silodosin intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg daily for 12 weeks intervention 2: 1 capsule daily for 12 weeks

Protocol documents:
Clinical trial NCT00280384
Conditions: Spasmodic Torticollis
Sponsor: Eisai Limited
Start date: 2006-01-01; Completion date: 2006-08-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: E2014 (Botulinum toxin type B) intervention 2: E2014 (Botulinum toxin type B) Placebo
Intervention descriptions: intervention 1: A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12. intervention 2: A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.

Protocol documents:
Clinical trial NCT00291187
Conditions: Insomnia
Sponsor: Vanda Pharmaceuticals
Start date: 2006-02-01; Completion date: 2006-08-01
Enrollment: 411 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Detailed description:

Arms: arm 1: Take orally 30 minutes prior to bedtime. arm 2: 20 mg taken orally 30 minutes prior to bedtime. arm 3: 50 mg taken orally 30 minutes prior to bedtime. arm 4: 100 mg taken orally 30 minutes prior to bedtime.
Interventions: intervention 1: 20 mg VEC-162 intervention 2: 50 mg VEC-162 intervention 3: 100 mg VEC-162 intervention 4: Placebo
Intervention descriptions: intervention 1: 20 mg VEC-162 intervention 2: 50 mg VEC-162 intervention 3: 100 mg VEC-162 intervention 4: Placebo

Protocol documents:
Clinical trial NCT00363038
Conditions: Ecchymosis
Keywords: Bruising Topical 20% arnica
Sponsor: Northwestern University
Start date: 2006-07-01; Completion date: 2006-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.

Detailed description:

Arms: arm 1: Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Interventions: intervention 1: Petrolatum United States Pharmacopeia (USP) intervention 2: Vitamin K and retinol ointment intervention 3: Arnica ointment intervention 4: Vitamin K ointment
Intervention descriptions: intervention 1: Topical formation applied to bruise twice daily for 2 weeks. intervention 2: Topical formation applied to bruise twice daily for 2 weeks. intervention 3: Topical formation applied to bruise twice daily for 2 weeks. intervention 4: Topical formation applied to bruise twice daily for 2 weeks.

Protocol documents:
Clinical trial NCT00779285
Conditions: Breast Neoplasm
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-02-01; Completion date: 2006-08-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.

Detailed description:

Arms: arm 1: Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Interventions: intervention 1: Pegylated Liposomal Doxorubicin
Intervention descriptions: intervention 1: Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.

Protocol documents:
Clinical trial NCT01182194
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-06-01; Completion date: 2006-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg
Interventions: intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®
Intervention descriptions: intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets

Protocol documents:
Clinical trial NCT01182207
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-07-01; Completion date: 2006-08-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult subjects under non-fasting conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg
Interventions: intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®
Intervention descriptions: intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets

Protocol documents:
Clinical trial NCT00356603
Conditions: Migraine Disorders
Keywords: Migraine Sumatriptan Succinate Injection Kit Cluster Headache self-injection
Sponsor: GlaxoSmithKline
Start date: 2006-06-20; Completion date: 2006-08-07
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.

Detailed description:

Arms: arm 1: Sumatriptan
Interventions: intervention 1: Sumatriptan Succinate
Intervention descriptions: intervention 1: Sumatriptan Succinate

Protocol documents:
Clinical trial NCT00089973
Conditions: Neoplasms, Breast
Keywords: breast cancer
Sponsor: GlaxoSmithKline
Start date: 2004-06-30; Completion date: 2006-08-25
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the following research questions:

1. Does breast cancer respond to Ispinesib?
2. What are the side effects of Ispinesib?
3. How much Ispinesib is in the blood at specific times after it is taken?

Detailed description:

Arms: arm 1: Females with advanced or metastatic breast cancer were administered Ispinesib
Interventions: intervention 1: Ispinesib
Intervention descriptions: intervention 1: Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).

Protocol documents:
Clinical trial NCT00244725
Conditions: Deep Vein Thrombosis Fibrillation, Atrial Venous Thromboembolism Pulmonary Embolism
Keywords: deep vein thrombosis total knee replacement PE Venous thromboembolism DVT pulmonary embolism VTE
Sponsor: GlaxoSmithKline
Start date: 2005-09-01; Completion date: 2006-09-01
Enrollment: 961 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Detailed description:

Interventions: intervention 1: Odiparcil intervention 2: Warfarin intervention 3: Coumadin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00016354
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2001-03-01; Completion date: 2006-09-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors.
* Evaluate the acute and chronic toxicity profile of this regimen in these patients.
* Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects in these patients.
* Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral benzoylphenylurea (BPU) once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BPU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated with BPU as above to confirm the MTD.

Patients are followed for 30 days.

PROJECTED ACCRUAL: Approximately 18-24 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: benzoylphenylurea
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00051025
Conditions: Non-Hodgkin's Lymphoma Lymphoma, B-cell Lymphoma, Low-grade
Sponsor: Eisai Inc.
Start date: 2000-05-01; Completion date: 2006-09-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

Detailed description:

Interventions: intervention 1: ONTAK
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00104520
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis
Sponsor: Gilead Sciences
Start date: 2005-02-01; Completion date: 2006-09-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Detailed description:
Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called PA. Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI), an investigational formulation of the antibiotic administered using the eFlow® Electronic Nebulizer by PARI GmbH, in CF patients with PA.

In this study, participants were screened for eligibility at Visit 1 (Day -42) and returned to the center for Visit 2 after a 14-day evaluation period. At Visit 2 (Day -28), participants began a 28-day course of open-label Tobramycin Inhalation Solution (TIS). At Visit 3 (Day 0), following completion of the 28-day course of TIS, participants began randomized, blinded treatment with either AZLI twice a day (BID) or three times a day (TID) or placebo BID or TID, and continued treatment for a total of 28 days, with a clinic visit at Day 14 (Visit 4) and at the end of treatment (Visit 5 \[Day 28\]). Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment (Visits 6 to 9 \[Days 42 to 84\]).

Two hundred and forty-seven participants were treated in the TIS phase of this study. Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug (AZLI or placebo).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZLI 75 mg two times a day (BID)/three times a day (TID) intervention 2: Placebo two times a day (BID)/three times a day (TID)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00108433
Conditions: Bacteremia Gram-Positive Bacterial Infections
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2006-09-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).

Detailed description:
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.

Interventions: intervention 1: Cefazolin IV intervention 2: Linezolid IV intervention 3: Vancomycin (IV)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00127530
Conditions: Multiple Sclerosis
Keywords: Walking Ability
Sponsor: Acorda Therapeutics
Start date: 2005-05-01; Completion date: 2006-09-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

Detailed description:
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Arms: arm 1: Placebo control arm 2: 10 milligram (mg) tablet b.i.d.
Interventions: intervention 1: Fampridine-SR intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, 10 mg, twice daily, 14 weeks intervention 2: sugar pill, twice a day (b.i.d.)

Protocol documents:
Clinical trial NCT00165789
Conditions: Parkinson's Disease
Sponsor: Eisai Inc.
Start date: 2005-09-01; Completion date: 2006-09-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

Detailed description:

Interventions: intervention 1: E2007
Intervention descriptions: intervention 1: None

Protocol documents: