ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00918866
Conditions: Pulmonary Heart Disease
Keywords: Phase 4 DEFINITY® hemodynamics pulmonary artery pressure
Sponsor: Lantheus Medical Imaging
Start date: 2009-07-01; Completion date: 2009-12-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.

Detailed description:
This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure \< 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.

The inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.

Arms: arm 1: Subjects with pulmonary arterial pressure (PAP) of \< or = to 35 mmHg. arm 2: Subjects with a PAP of \> or = to 35 mmHg.
Interventions: intervention 1: Definity
Intervention descriptions: intervention 1: one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight

Protocol documents:
Clinical trial NCT00928083
Conditions: Malaria Falciparum Malaria Vivax Healthy Volunteers
Keywords: Phase I Safety and tolerability Pharmacokinetic synthetic peroxide trioxolane treatment of erythrocytic stages of malaria
Sponsor: Medicines for Malaria Venture
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.

This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts:

* Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality.
* Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way crossover design.
* Part C investigated the safety, tolerability and PK profile of multiple oral doses of OZ439.

The starting oral dose was 50 mg and the maximum single dose to be administered did not exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.

Detailed description:

Arms: arm 1: OZ439 Single doses of 50mg (capsules) arm 2: OZ439 Single doses of 100mg (capsules) arm 3: OZ439 Single doses of 200mg (capsules) arm 4: OZ439 Single doses of 400mg (capsules) arm 5: OZ439 Single doses of 400mg (capsules) administered with food. arm 6: OZ439 Single doses of 400mg (aqueous dispersion) arm 7: OZ439 Single doses of 800mg (capsules) arm 8: OZ439 Single doses of 800mg (aqueous dispersion) arm 9: OZ439 Single doses of 1200mg (capsules) arm 10: OZ439 Single doses of 800mg (aqueous dispersion) arm 11: Placebo control for Single rising Part A arm 12: Single dose of OZ439 800mg aqueous dispersion administered under fed conditions arm 13: Single dose of OZ439 800mg aqueous dispersion administered under fast conditions arm 14: 200mg aqueous solution OZ439 or placebo once daily for 3 days fasted arm 15: 400mg aqueous solution OZ439 or placebo once daily for 3 days fasted arm 16: 800mg aqueous solution OZ439 or placebo once daily for 3 days fasted arm 17: Placebo control for Multiple rising Part C
Interventions: intervention 1: OZ439 50mg API capsules intervention 2: OZ439 200mg API capsules intervention 3: OZ439 400mg aqueous dispersion intervention 4: OZ439 800mg aqueous dispersion intervention 5: OZ439 100mg API capsules intervention 6: OZ439 400mg API capsules intervention 7: OZ439 1600mg aqueous dispersion intervention 8: OZ439 800mg API capsules intervention 9: OZ439 1200mg API capsules intervention 10: Placebo intervention 11: OZ439 200mg aqueous dispersion
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: OZ439 100mg (2x50mg API capsules) intervention 6: OZ439 400mg (2x200mg API capsules) intervention 7: None intervention 8: OZ439 800mg (4x200 API capsules) intervention 9: OZ439 1200mg (6x200mg API capsules) intervention 10: None intervention 11: None

Protocol documents:
Clinical trial NCT00954356
Conditions: Dental Pain
Keywords: Pain following 3rd molar/wisdom tooth extraction
Sponsor: Xenon Pharmaceuticals Inc.
Start date: 2009-09-01; Completion date: 2009-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: XPF-001 intervention 2: placebo
Intervention descriptions: intervention 1: Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules) intervention 2: Single oral administration of 5 x 100 mg Placebo capsules.

Protocol documents:
Clinical trial NCT00955513
Conditions: Grade I/II Ankle Sprain
Keywords: Ankle sprain soft tissue injury
Sponsor: Novartis
Start date: 2009-07-01; Completion date: 2009-12-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

Detailed description:

Arms: arm 1: drug arm 2: drug arm 3: placebo
Interventions: intervention 1: diclofenac diethylamine gel 2.32% intervention 2: diclofenac diethylamine gel 2.32% intervention 3: Placebo
Intervention descriptions: intervention 1: diclofenac diethylamine gel 2.32% twice a day intervention 2: diclofenac diethylamine gel 2.32% three times a day intervention 3: Placebo

Protocol documents:
Clinical trial NCT00962065
Conditions: Type 2 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2009-08-01; Completion date: 2009-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: A low dose of LX4211; daily oral intake for 28 days arm 2: A high dose of LX4211; daily oral intake for 28 days arm 3: Matching placebo dosing with daily oral intake for 28 days
Interventions: intervention 1: LX4211 Low Dose intervention 2: LX4211 High Dose intervention 3: Placebo
Intervention descriptions: intervention 1: A low dose of LX4211; daily oral intake for 28 days intervention 2: A high dose of LX4211; daily oral intake for 28 days intervention 3: Matching placebo dosing with daily oral intake for 28 days

Protocol documents:
Clinical trial NCT00964431
Conditions: Dental Pain
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2009-08-01; Completion date: 2009-12-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.

Detailed description:

Arms: arm 1: None arm 2: Single dose arm 3: None arm 4: None
Interventions: intervention 1: Celecoxib 400 mg intervention 2: Placebo intervention 3: Indomethacin Test (lower dose) intervention 4: Indomethacin Test (upper dose)
Intervention descriptions: intervention 1: Capsules 2 x 200 mg Single-Dose intervention 2: Capsules 2 Single-Dose intervention 3: 20-mg single dose intervention 4: 40-mg single dose

Protocol documents:
Clinical trial NCT00979459
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-09-01; Completion date: 2009-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the pharmacokinetics of two formulations of MK-1006. The primary hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and film coated tablet (FCT) formulations of MK-1006 will be similar.

Detailed description:

Arms: arm 1: Participants received a single dose of four 20 mg dry filled capsules of MK-1006 arm 2: Participants received a single dose of two 40 mg film coated tablets of MK-1006
Interventions: intervention 1: MK-1006 DFC intervention 2: MK-1006 FCT
Intervention descriptions: intervention 1: Each dry filled capsule contains 20 mg MK-1006 intervention 2: Each film coated tablet contains 40 mg of MK-1006

Protocol documents:
Clinical trial NCT00982553
Conditions: HIV Infections
Keywords: Healthy Volunteers
Sponsor: Imperial College London
Start date: 2009-09-01; Completion date: 2009-12-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels of each other when given separately and together. This is a phase I, open-label, prospective, three phase, pharmacokinetic study.

Detailed description:
Phase I (study day 1 - 14):

* 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled.
* On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.
* This will be followed by a wash-out period.
* As steady state pharmacokinetics of ribavirin are not reached for several weeks, single dosing pharmacokinetics will be assessed in this study

Phase II (study days 15 - 19):

* On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend for safety visits and witnessed dosing during this phase.
* Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached, subjects will attend for a 12 hour detailed pharmacokinetic visit where following witnessed administration of raltegravir 400 mg without food, blood sampling will be drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment of raltegravir plasma exposure.

Phase III (study day 20):

• Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.

Arms: arm 1: Treatment with Single dose ribavirin (800 mg) administered on day 1 arm 2: Treatment with Raltegravir (400 mg twice daily) administered from days 15-19 arm 3: Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20
Interventions: intervention 1: Ribavirin intervention 2: Raltegravir
Intervention descriptions: intervention 1: 800mg once daily intervention 2: 400mg twice daily

Protocol documents:
Clinical trial NCT00985439
Conditions: Dental Pain
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2009-09-01; Completion date: 2009-12-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.

Detailed description:

Arms: arm 1: One 18-mg Diclofenac Test Capsule and 1 placebo capsule arm 2: One 35-mg Diclofenac Test Capsule and 1 placebo capsule arm 3: None arm 4: None
Interventions: intervention 1: Diclofenac Test (lower dose) intervention 2: Diclofenac Test (upper dose) intervention 3: Celecoxib 400 mg intervention 4: Placebo
Intervention descriptions: intervention 1: 18-mg Single dose intervention 2: 35-mg Single dose intervention 3: Capsules 2 x 200 mg Single-dose intervention 4: Capsules 2 Single-dose

Protocol documents:
Clinical trial NCT00989014
Conditions: Erythematotelangiectatic Rosacea
Keywords: Erythematotelangiectatic Rosacea
Sponsor: Galderma R&D
Start date: 2009-09-01; Completion date: 2009-12-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

Detailed description:

Arms: arm 1: 0.5% Topical Gel arm 2: 0.18% Topical Gel arm 3: 0.07% Topical Gel arm 4: Vehicle Topical Gel
Interventions: intervention 1: CD07805/47 intervention 2: CD07805/47 intervention 3: CD07805/47 intervention 4: CD07805/47 placebo
Intervention descriptions: intervention 1: 0.5% Topical Gel intervention 2: 0.18% Topical Gel intervention 3: 0.07% Topical Gel intervention 4: Vehicle Topical Gel

Protocol documents:
Clinical trial NCT00994422
Conditions: Head Lice
Keywords: PEDICULUS HUMANUS CAPITIS Head Lice
Sponsor: Topaz Pharmaceuticals Inc
Start date: 2009-10-01; Completion date: 2009-12-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivermectin cream intervention 2: vehicle control
Intervention descriptions: intervention 1: Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1. intervention 2: Up to 4 ounces of vehicle control applied to the hair and scalp on day 1

Protocol documents:
Clinical trial NCT00996931
Conditions: Autism
Keywords: autistic spectrum disorder lenalidomide
Sponsor: Sutter Medical Foundation
Start date: 2009-02-01; Completion date: 2009-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory cytokines including TNF-alpha and may actually alter the clinical course of autism for some children.

Detailed description:
Autism currently affects 1:142 births and has no definite cause. Recent research has shown possible identifying markers in neuroglial inflammation with elevated cytokines IL-1, Il-6, and MCP-1 and elevated ratios of CSF/serum levels of TNF-alpha in patients with regressive autism.

Lenalidomide (Revlimid®) is an analogue of thalidomide. Based on the improved clinical efficacy predicted for Revlimid® in its effects on TNF-alpha and other immunomodulatory cytokines, this oral compound may prove efficacious with less toxicity compared with thalidomide.

The study will evaluate the efficacy of lenalidomide by measurement of changes in EEG, clinical global impression, Childhood Autism Rating Scale, and serum and CSF (if available) TNF-alpha at the end of the study compared with the same measurements at baseline.

Arms: arm 1: None
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: 2.5 mgs per day orally for 12 weeks

Protocol documents:
Clinical trial NCT01004614
Conditions: Healthy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-11-01; Completion date: 2009-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

Detailed description:

Arms: arm 1: 24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water. arm 2: 24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water
Interventions: intervention 1: Amlodipine intervention 2: Amlodipine intervention 3: Amlodipine intervention 4: Amlodipine
Intervention descriptions: intervention 1: 3rd OD 5 mg tablet single oral dose administered with water intervention 2: 2nd OD 5 mg tablet single oral dose administered with water intervention 3: 3rd OD 5 mg tablet single oral dose administered without water intervention 4: 2nd OD 5 mg tablet single oral dose administered without water

Protocol documents:
Clinical trial NCT01009554
Conditions: Dental Health
Keywords: Mouthwashes
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Start date: 2009-10-01; Completion date: 2009-12-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is 8 weeks long. People participating in this study will be asked to brush their teeth two times a day. Some people will get a mouthwash. People with a mouthwash will rinse two times a day after brushing their teeth. The mouth, teeth, tongue and gums will be looked at by a dentist. The dentist will look at the mouth to make sure the mouthwash does not irritate the mouth. The dentist will also look at the color of the teeth and amount of stain on the front teeth.

Detailed description:
This is an 8-week, randomized, observer-blind, controlled, parallel group clinical study design to assess the oral tissue tolerance of a potassium oxalate containing mouthrinse. Subjects will have their oral soft/hard tissues assessed and will be evaluated for stain levels and tooth color shades at Screening/Baseline (Visit 1), Week 4 (Visit 2), Week 6 (Visit 3) and Week 8 (Visit 4). Subjects will be instructed to brush their teeth two times daily in their usual manner using the provided sodium fluoride toothpaste. Subjects assigned to the mouthrinse group will be instructed to rinse twice daily after brushing.

Arms: arm 1: 1.5% potassium oxalate sensitive mouthwash arm 2: Sodium Fluoride Dentifrice
Interventions: intervention 1: Potassium Oxylate Mouthwash intervention 2: Sodium Fluoride Dentifrice
Intervention descriptions: intervention 1: Rinse with 10 mL for 60 seconds, twice daily after brushing in usual manner with a sodium fluoride dentifrice intervention 2: Brush in usual manner, twice daily, with a sodium fluoride dentifrice

Protocol documents:
Clinical trial NCT01009619
Conditions: Bronchiolitis Obliterans Syndrome Graft Rejection Lymphocytic Bronchiolitis Respiratory Infection
Keywords: Bronchiolitis Obliterans Syndrome Acute allograft Rejection Lymphocytic bronchiolitis Respiratory infection Survival Mortality Pulmonary function FEV1 Broncho-alveolar lavage Neutrophils Interleukin Culture Azithromycin
Sponsor: KU Leuven
Start date: 2005-09-01; Completion date: 2009-12-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preventive treatment with azithromycin reduces the prevalence fo Bronchiolitis Obliterans Syndrome after lung transplantation.

Detailed description:
* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or azithromycin) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
* 1:1 inclusion ratio (placebo:azithromycin).
* Randomisation at discharge after informed consent.

Arms: arm 1: 250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study arm 2: PLacebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
Interventions: intervention 1: Azithromycin intervention 2: Placebo
Intervention descriptions: intervention 1: Azithromycin 250 mg daily during 5 days followed by 250 mg three times a week on Mon., Wed. and Fri. during study-period. intervention 2: Placebo once daily during 5 days, followed by one placebo three times a week on Mon., Wed. and Fri during rest of study-period.

Protocol documents:
Clinical trial NCT01010776
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone
Sponsor: Janssen-Cilag Farmaceutica Ltda.
Start date: 2008-02-01; Completion date: 2009-12-01
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are not satisfied with their treatment.

Detailed description:
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), non-randomized, single-arm study of paliperidone ER in participants previously treated with risperidone with poor response. The study will consist of 2 phases: a main phase of 6 months and an extension phase of another 6 months. The total duration of the study will be 12 months. All participants will receive an oral (having to do with the mouth) daily dose of paliperidone ER in flexible dosage (in the range of 3-12 milligram \[mg\]: 3 mg, 6 mg, 9 mg, or 12 mg) according to Investigator's discretion. Efficacy and safety of participants will primarily be evaluated by Positive and Negative Syndrome Scale (PANSS) and Extrapyramidal Symptoms Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Interventions: intervention 1: Paliperidone Extended Release (ER)
Intervention descriptions: intervention 1: Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.

Protocol documents: