ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00059215
Conditions: Cardiovascular Diseases Heart Diseases
Sponsor: Eli Lilly and Company
Start date: 2003-04-01; Completion date: 2004-01-01
Enrollment: 905 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.

Detailed description:

Arms: arm 1: Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days arm 2: Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days arm 3: Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days arm 4: Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
Interventions: intervention 1: Prasugrel (CS-747) intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT00061633
Conditions: Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections
Sponsor: Cumberland Pharmaceuticals
Start date: 2003-06-01; Completion date: 2004-01-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

Detailed description:

Arms: arm 1: None arm 2: cSSSI - complicated skin and skin structure infections
Interventions: intervention 1: Telavancin intervention 2: Vancomycin or antistaphylococcal penicillin
Intervention descriptions: intervention 1: Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days intervention 2: Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.

Protocol documents:
Clinical trial NCT00790270
Conditions: Cervical Strain
Keywords: Cervical strain whiplash ibuprofen cyclobenzaprine
Sponsor: Stony Brook University
Start date: 2003-01-01; Completion date: 2004-01-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Detailed description:
Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cyclobenzaprine intervention 2: Ibuprofen intervention 3: Ibuprofen plus Cyclobenzaprine
Intervention descriptions: intervention 1: 5 mg orally every 8 hours as needed intervention 2: Ibuprofen 400 mg every 8 hours as needed intervention 3: Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Protocol documents:
Clinical trial NCT00806416
Conditions: Osteoporosis
Sponsor: Organon and Co
Start date: 2003-05-01; Completion date: 2004-01-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.

Detailed description:

Arms: arm 1: alendronate/vitamin D combination then alendronate arm 2: alendronate then alendronate/vitamin D combination arm 3: alendronate/vitamin D combination then vitamin D arm 4: vitamin D then alendronate/vitamin D combination
Interventions: intervention 1: alendronate sodium (+) cholecalciferol intervention 2: Comparator: alendronate intervention 3: Comparator: cholecalciferol (Vitamin D)
Intervention descriptions: intervention 1: A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. intervention 2: A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period. intervention 3: A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period.

Protocol documents:
Clinical trial NCT00971633
Conditions: Chemotherapy-Induced Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2003-11-01; Completion date: 2004-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Detailed description:

Arms: arm 1: Treatment Sequence A-B-C arm 2: Treatment Sequence B-C-A arm 3: Treatment Sequence C-A-B arm 4: Treatment Sequence A-C-B arm 5: Treatment Sequence B-A-C arm 6: Treatment Sequence C-B-A
Interventions: intervention 1: Comparator: Treatment A (Zofran, ondansetron) intervention 2: Comparator: Treatment B (Zofran, ondansetron) intervention 3: Comparator: Treatment C (Zofran, ondansetron)
Intervention descriptions: intervention 1: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) intervention 2: a single 8 mg tablet of Zofran marketed in the U.K., taken PO intervention 3: a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

Protocol documents:
Clinical trial NCT01046253
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-01-01; Completion date: 2004-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by applesauce-sprinkle method.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Lansoprazole 30 mg Delayed-Release Capsule arm 2: Prevacid® 30 mg Delayed-Release Capsule
Interventions: intervention 1: Lansoprazole intervention 2: Prevacid®
Intervention descriptions: intervention 1: 30 mg Delayed-Release Capsules intervention 2: 30 mg Delayed-Release Capsule

Protocol documents:
Clinical trial NCT01683838
Conditions: Spinal Cord Injury Muscle Spasticity
Keywords: spinal cord injury muscle spasticity
Sponsor: Acorda Therapeutics
Start date: 2002-06-01; Completion date: 2004-02-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fampridine-SR intervention 2: Placebo
Intervention descriptions: intervention 1: 25mg bid (twice daily) intervention 2: Placebo

Protocol documents:
Clinical trial NCT00041756
Conditions: Osteoarthritis, Knee
Keywords: Primary Disease: Knee Primary Osteoarthritis
Sponsor: Procter and Gamble
Start date: 2002-07-01; Completion date: 2004-02-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Detailed description:
Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Arms: arm 1: Placebo tablet arm 2: 25 mg PG-530742 arm 3: 50 mg PG-530742 arm 4: 100 mg PG-530742 arm 5: 200 mg PG-530742
Interventions: intervention 1: PG-530742 intervention 2: Placebo intervention 3: 50 mg PG-530742 intervention 4: 100 mg PG-530742 intervention 5: 200 mg PG-530742
Intervention descriptions: intervention 1: One 25 mg PG-530742 tablet, twice daily for for one year intervention 2: One placebo tablet, twice daily for for one year intervention 3: One 50 mg PG-530742 tablet, twice daily for for one year intervention 4: 100 mg PG-530742 tablet, twice a day for one year intervention 5: 200 mg PG-530742 tablet, twice a day for one year

Protocol documents:
Clinical trial NCT00102440
Conditions: Gout
Keywords: uric Acid xanthine oxidase tophi Drug Therapy
Sponsor: Takeda
Start date: 2002-07-01; Completion date: 2004-02-01
Enrollment: 760 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

Detailed description:
This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol
Intervention descriptions: intervention 1: Febuxostat 80 mg, orally, once daily for up to 52 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 52 weeks. intervention 3: Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Protocol documents:
Clinical trial NCT01149486
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-01-01; Completion date: 2004-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 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: Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets arm 2: Hyzaar® 100/25 mg Tablets
Interventions: intervention 1: Losartan potassium/Hydrochlorothiazide intervention 2: Hyzaar®
Intervention descriptions: intervention 1: 100/25 mg Tablets intervention 2: 100/25 mg Tablets

Protocol documents:
Clinical trial NCT00003483
Conditions: Meningioma
Keywords: adult meningioma recurrent adult meningioma
Sponsor: Burzynski Research Institute
Start date: 1998-06-01; Completion date: 2004-03-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with meningioma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with meningioma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with meningioma.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with meningima as measured by an objective response to therapy (complete response, partial response) or stable disease.
* To determine the safety and tolerance of Antineoplaston therapy in adults with meningima.

OVERVIEW: This is a single arm, open-label study in which adults with meningioma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00067470
Conditions: Mucopolysaccharidosis VI
Sponsor: BioMarin Pharmaceutical
Start date: 2003-09-01; Completion date: 2004-03-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.

Detailed description:

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

Protocol documents:
Clinical trial NCT00674609
Conditions: Palliative Care Pain Cancer
Keywords: Palliative Care Pain Cancer
Sponsor: Jazz Pharmaceuticals
Start date: 2002-02-01; Completion date: 2004-03-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

Detailed description:
This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).

Arms: arm 1: Placebo control arm 2: Active treatment arm 3: Active treatment
Interventions: intervention 1: Placebo intervention 2: Sativex® intervention 3: THC Alone
Intervention descriptions: intervention 1: Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours. intervention 2: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours. intervention 3: Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

Protocol documents:
Clinical trial NCT00684762
Conditions: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-03-01; Completion date: 2004-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.

Detailed description:
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (1 x 100 mg tablet), or a single oral dose of the reference formulation, Pletal® (1 x 100 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Arms: arm 1: A single dose of cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours. arm 2: A single dose of cilostazol (Pletal® 1 x 100 mg tablet) administered after an overnight fast of at least 10 hours.
Interventions: intervention 1: Cilostazol 100 mg Tablets intervention 2: Cilostazol (Pletal®) 100 mg Tablets
Intervention descriptions: intervention 1: Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours intervention 2: Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.

Protocol documents:
Clinical trial NCT00711646
Conditions: Spasticity Multiple Sclerosis
Keywords: Spasticity Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2002-06-01; Completion date: 2004-03-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.

Detailed description:
This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal.

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: