ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00236938
Conditions: Anemia
Keywords: iron peritoneal dialysis anemia
Sponsor: American Regent, Inc.
Start date: 2002-07-01; Completion date: 2004-10-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Detailed description:
This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Arms: arm 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. arm 2: Stable erythropoietin (EPO) dose and no supplemental iron.
Interventions: intervention 1: Venofer and stable erythropoietin (EPO) regimen intervention 2: stable erythropoietin (EPO) regimen
Intervention descriptions: intervention 1: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. intervention 2: Stable erythropoietin (EPO) dose and no supplemental iron.

Protocol documents:
Clinical trial NCT00236977
Conditions: Anemia
Keywords: CKD iron anemia
Sponsor: American Regent, Inc.
Start date: 2003-08-01; Completion date: 2004-10-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Detailed description:
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Arms: arm 1: iron sucrose injection arm 2: oral iron
Interventions: intervention 1: Venofer intervention 2: Ferrous Sulfate
Intervention descriptions: intervention 1: iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. intervention 2: oral iron tablets; 325 mg three times a day orally for 56 days

Protocol documents:
Clinical trial NCT00610727
Conditions: Migraine
Keywords: Migraine, Prochlorperazine aerosol
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2004-08-01; Completion date: 2004-10-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

Detailed description:
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.

Arms: arm 1: Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg arm 2: Inhaled Staccato prochlorperazine 1.25 mg arm 3: Inhaled Staccato prochlorperazine 2.5 mg arm 4: Inhaled Staccato prochlorperazine 5 mg arm 5: Inhaled Staccato prochlorperazine 10 mg arm 6: inhaled Staccato Placebo (0 mg)
Interventions: intervention 1: Prochlorperazine 0.5 mg IV over 5 sec intervention 2: Inhaled prochlorperazine 0.625 mg intervention 3: Inhaled prochlorperazine 1.25 mg intervention 4: Inhaled prochlorperazine 2.5 mg intervention 5: Inhaled prochlorperazine 5 mg intervention 6: Inhaled prochlorperazine 10 mg intervention 7: Inhaled placebo intervention 8: Prochlorperazine 10 mg IV over 5 sec
Intervention descriptions: intervention 1: IV Prochlorperazine for bioavailability intervention 2: Inhaled Staccato Prochlorperazine 0.625 mg intervention 3: Inhaled Staccato Prochlorperazine 1.25 mg intervention 4: Inhaled Staccato Prochlorperazine 2.5 mg intervention 5: InhaledStaccato Prochlorperazine 5 mg intervention 6: InhaledStaccato Prochlorperazine 10 mg intervention 7: Inhaled Staccato Placebo (0 mg) intervention 8: Prochlorperazine 10 mg IV over 5 sec for patient qualification

Protocol documents:
Clinical trial NCT00685685
Conditions: Healthy
Keywords: Therapeutic Equivalency
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2004-09-01; Completion date: 2004-10-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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

Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two lovastatin 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, lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 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 lovastatin. 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. Vital signs will be monitored if judged necessary by the physician in charge. 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 Lovastatin 40 mg administered after an overnight fast of at least 10 hours. arm 2: A single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours.
Interventions: intervention 1: Lovastatin 40 mg tablets intervention 2: Lovastatin (Mevacor®) 40 mg Tablets
Intervention descriptions: intervention 1: 40 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 40 mg tablet administered after an overnight fast of at least 10 hours

Protocol documents:
Clinical trial NCT00150618
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Start date: 2004-03-30; Completion date: 2004-10-07
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: SPD503 (1 mg) intervention 2: SPD503 (2 mg) intervention 3: SPD503 (3 mg) intervention 4: SPD503 (4 mg) intervention 5: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00004500
Conditions: Meconium Aspiration
Keywords: cardiovascular and respiratory diseases meconium aspiration syndrome rare disease
Sponsor: Windtree Therapeutics
Start date: 2000-03-01; Completion date: 2004-11-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
OBJECTIVES:

Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

Detailed description:
PROTOCOL OUTLINE:

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.

Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.

Patients are followed for 12 months.

Arms: arm 1: Lucinactant via bronchoaveolar lavage arm 2: Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Interventions: intervention 1: Lucinactant intervention 2: Standard Care
Intervention descriptions: intervention 1: Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other. intervention 2: The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC

Protocol documents:
Clinical trial NCT00066170
Conditions: Narcolepsy
Keywords: Narcolepsy Daytime Sleepiness Daytime sleepiness in narcolepsy
Sponsor: Jazz Pharmaceuticals
Start date: 2003-04-01; Completion date: 2004-11-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Detailed description:

Arms: arm 1: Xyrem + Modafinil Placebo arm 2: Xyrem Placebo + Modafinil Placebo arm 3: Xyrem Placebo + Modafinil at established dose arm 4: Xyrem + Modafinil at established dose
Interventions: intervention 1: Xyrem intervention 2: Xyrem Placebo intervention 3: Modafinil at established dose intervention 4: Modafinil (Placebo)
Intervention descriptions: intervention 1: Xyrem oral solution at 6 g/day for 4 weeks and 9 g/day for another 4 weeks. intervention 2: Xyrem Placebo oral solution 12 ml per day for 4 weeks and 18 ml per day for another 4 weeks. intervention 3: Modafinil oral capsules at 200 to 600 mg per day for 8 weeks. intervention 4: Modafinil Placebo oral capsules 1 to 3 capsules per day for 8 weeks.

Protocol documents:
Clinical trial NCT00078325
Conditions: Obstructive Sleep Apnea Hypopnea
Keywords: Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc NUVIGIL
Sponsor: Cephalon
Start date: 2004-02-01; Completion date: 2004-11-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.

Detailed description:

Arms: arm 1: Armodafinil 250 mg/day arm 2: Armodafinil 150 mg/day arm 3: Placebo
Interventions: intervention 1: Armodafinil 250 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Placebo
Intervention descriptions: intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily in the morning

Protocol documents:
Clinical trial NCT00932321
Conditions: Prevention of Pregnancy
Keywords: Contraception
Sponsor: Warner Chilcott
Start date: 2004-01-01; Completion date: 2004-11-01
Enrollment: 938 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Detailed description:

Arms: arm 1: Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle arm 2: Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle
Interventions: intervention 1: Norethindrone Acetate/Ethinyl Estradiol 24 Days intervention 2: Norethindrone Acetate /Ethinyl Estradiol 21 Days
Intervention descriptions: intervention 1: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets intervention 2: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Protocol documents:
Clinical trial NCT00944450
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-08-01; Completion date: 2004-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.

Detailed description:

Arms: arm 1: Sitagliptin anhydrous formulation arm 2: Sitagliptin monohydrate FMI formulation
Interventions: intervention 1: Sitagliptin phosphate anhydrous formulation intervention 2: Comparator: sitagliptin phosphate monohydrate form
Intervention descriptions: intervention 1: Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods. intervention 2: Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.

Protocol documents:
Clinical trial NCT01149733
Conditions: Healthy
Sponsor: Teva Pharmaceuticals USA
Start date: 2004-11-01; Completion date: 2004-11-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.

Detailed description:

Arms: arm 1: 0.4 mg Capsule arm 2: 0.4 mg Capsule
Interventions: intervention 1: Tamsulosin intervention 2: Tamsulosin
Intervention descriptions: intervention 1: Test 0.4 mg Capsule intervention 2: Reference Listed 0.4 Capsule

Protocol documents:
Clinical trial NCT01227629
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim
Start date: 2003-09-01; Completion date: 2004-11-01
Enrollment: 502 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events.

A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.

Detailed description:

Arms: arm 1: Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). arm 2: Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. arm 3: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 4: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 5: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 6: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 7: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 8: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 9: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 10: once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0
Interventions: intervention 1: dabigatran with ASA intervention 2: dabigatran with ASA intervention 3: dabigatran with ASA intervention 4: dabigatran with ASA intervention 5: dabigatran with ASA intervention 6: dabigatran with ASA intervention 7: warfarin intervention 8: dabigatran without ASA intervention 9: dabigatran without ASA intervention 10: dabigatran without ASA
Intervention descriptions: intervention 1: dose comparison in combination intervention 2: dose comparison in combination intervention 3: dose comparison in combination intervention 4: dose comparison in combination intervention 5: dose comparison in combination intervention 6: dose comparison in combination intervention 7: comparator intervention 8: dose comparison intervention 9: dose comparison intervention 10: dose comparison

Protocol documents:
Clinical trial NCT00321919
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2000-07-01; Completion date: 2004-12-01
Enrollment: 605 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether anemia prevention with NeoRecormon has an additional impact on reducing cardiovascular risk over conventional anemia treatment in patients mostly with stage IV chronic kidney disease and renal anemia. The anticipated time on study treatment is 2+ years and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months. arm 2: Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
Interventions: intervention 1: epoetin beta [NeoRecormon] intervention 2: epoetin beta [NeoRecormon]
Intervention descriptions: intervention 1: Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase. intervention 2: Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.

Protocol documents:
Clinical trial NCT00022763
Conditions: HIV Infections
Keywords: Anti-HIV Agents pentafuside
Sponsor: Hoffmann-La Roche
Start date: 2001-08-01; Completion date: 2004-12-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate T-20 in children.

Detailed description:
Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

Interventions: intervention 1: Enfuvirtide
Intervention descriptions: intervention 1: None

Protocol documents: