ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00601458
Conditions: Acute Pain
Keywords: Primary, unilateral, first metatarsal bunionectomy with osteotomy
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2008-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: pregabalin intervention 2: naproxen sodium intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0. intervention 2: Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0. intervention 3: Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

Protocol documents:
Clinical trial NCT00611442
Conditions: Bowel Preparation for Colonoscopy
Sponsor: Brooke Army Medical Center
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.

Detailed description:

Arms: arm 1: split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment arm 2: split-dose PEG solution without dietary restrictions plus placebo pretreatment
Interventions: intervention 1: lubiprostone intervention 2: placebo
Intervention descriptions: intervention 1: lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy intervention 2: placebo gelcap, taken at noon the day prior to the colonoscopy

Protocol documents:
Clinical trial NCT00616018
Conditions: Drug Induced Liver Injury
Keywords: acetaminophen protein adducts hepatic function drug safety non drinkers
Sponsor: Kennon Heard
Start date: 2007-08-01; Completion date: 2008-01-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

Detailed description:

Arms: arm 1: all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Interventions: intervention 1: acetaminophen
Intervention descriptions: intervention 1: 4 g/day for 10 consecutive days

Protocol documents:
Clinical trial NCT00656084
Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Sponsor: US Oncology Research
Start date: 2004-12-01; Completion date: 2008-01-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL

Detailed description:

Arms: arm 1: Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
Interventions: intervention 1: gemcitabine intervention 2: mitoxantrone intervention 3: rituximab
Intervention descriptions: intervention 1: 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan. intervention 2: Novantrone 10 mg/m2on Day 1. The order of administration will be:

Gemzar--\>Novantrone--\>Rituxan. intervention 3: Rituxan 375 mg/m2 on Day 1. The order of administration will be:

Gemzar--\>Novantrone--\>Rituxan.

Protocol documents:
Clinical trial NCT00674219
Conditions: Obsessive-Compulsive Disorder Generalized Anxiety Disorder
Keywords: Obsessive-compulsive disorder Generalized anxiety disorder Memantine Namenda
Sponsor: University of California, Los Angeles
Start date: 2005-05-01; Completion date: 2008-01-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to obtain preliminary open-label data on the efficacy and tolerability of memantine, an anti-glutamatergic medication with a unique pharmacodynamic profile, in individuals with OCD and individuals with GAD. Because glutamatergic hyperactivity in frontal and frontal-subcortical circuits may play a role in the symptomatic expression of OCD, and possibly GAD, agents that reduce glutamatergic neurotransmission should provide unique anti-stress and anti-obsessional benefits. Memantine is a specific, uncompetitive antagonist at the NMDA receptor that blocks sustained activation of the NMDA receptor by high concentrations of glutamate under pathological conditions but rapidly leaves the NMDA channel upon transient physiological activation by low concentrations of glutamate.

Detailed description:
Several case reports and an open-label trial have reported efficacy of anti-glutamatergic medications for the treatment of OCD. In an open-label trial of riluzole, a glutamate release inhibitor, seven of 13 adult patients with OCD improved, and five were categorized as treatment responders. Another open trial found riluzole to be effective for four of six children with treatment-refractory OCD. N-acetylcysteine, an agent that likely attenuates glutamate neurotransmission, was effective as an augmentation in one patient with OCD. Two case reports described memantine treatment of OCD. Poyurovsky et al. reported improvement with memantine augmentation in one patient with treatment resistant OCD, while Pasquini and Biondi noted improvement in one OCD patient with checking compulsions but not in one with contamination obsessions. There have been no controlled or open-label trials of memantine in OCD reported thus far.

Few studies have examined the efficacy of anti-glutamatergic agents in GAD. In an open-label trial of riluzole treatment in 18 patients with GAD, twelve patients responded and eight achieved remission. A double-blind, controlled study found that LY354740, a metabotropic glutamate receptor 2/3 (mGlu2/3) agonist, was significantly more effective than placebo for GAD. No studies of memantine in GAD have been reported thus far. We hypothesized that treatment with memantine would result in significant symptom reduction in both OCD and GAD.

Arms: arm 1: OCD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication. arm 2: GAD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: Namenda 10mg BID for 12 weeks

Protocol documents:
Clinical trial NCT00752089
Conditions: Dental Erosion
Keywords: enamel fluoride uptake erosion enamel remineralization
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2008-01-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Detailed description:
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

Arms: arm 1: Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. arm 2: Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. arm 3: Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. arm 4: Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Interventions: intervention 1: NaF/ KNO3/isopentane Dentifrice intervention 2: NaF/KNO3 Dentifrice intervention 3: NaF Dentifrice intervention 4: Placebo Dentifrice
Intervention descriptions: intervention 1: Experimental toothpaste intervention 2: Experimental toothpaste intervention 3: Active comparator intervention 4: Placebo comparator

Protocol documents:
Clinical trial NCT00761462
Conditions: Infectious Diseases
Keywords: Pediatrics Safety Musculoskeletal System Neurologic Manifestations Joint Diseases Joint Deformities, Acquired
Sponsor: Bayer
Start date: 1999-10-01; Completion date: 2008-01-01
Enrollment: 1029 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.

Detailed description:
This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.

Arms: arm 1: Subjects receiving Ciprofloxacin (group followed-up for 5 years) arm 2: Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Interventions: intervention 1: Ciprofloxacin intervention 2: Non-quinolone antibiotic
Intervention descriptions: intervention 1: Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label intervention 2: Common used dose and route

Protocol documents:
Clinical trial NCT00770432
Conditions: Constipation
Keywords: Human Experimentation
Sponsor: Bayer
Start date: 2007-11-01; Completion date: 2008-01-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days.

Detailed description:

Arms: arm 1: MiraLAX® (polyethylene glycol 3350 powder for solution) arm 2: MALTRIN 500® M500 (maltodextrin 500)
Interventions: intervention 1: Polyethylene glycol 3350 intervention 2: Placebo, maltodextrin 500 powder for solution
Intervention descriptions: intervention 1: Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days. intervention 2: Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.

Protocol documents:
Clinical trial NCT00842153
Conditions: Psoriasis
Keywords: Psoriasis Plaque Type Psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2007-11-01; Completion date: 2008-01-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.

Detailed description:
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.

Arms: arm 1: Topical foam formulation that includes clobetasol propionate (Steroid) arm 2: Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
Interventions: intervention 1: Clobetasol propionate foam intervention 2: Vehicle foam
Intervention descriptions: intervention 1: Topical Clobetasol propionate foam intervention 2: Vehicle foam does not include the active drug.

Protocol documents:
Clinical trial NCT00848965
Conditions: Rhinitis, Allergic, Perennial Allergic Rhinitis
Keywords: fluticasone propionate Vienna Challenge Chamber glucocorticosteroids allergic rhinitis
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug) and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Fluticasone propionate intervention 2: Placebo
Intervention descriptions: intervention 1: Corticosteriod, with anti-inflammatory effects intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT00857961
Conditions: Hypogonadism
Sponsor: Eli Lilly and Company
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.

Detailed description:

Arms: arm 1: Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments. arm 2: Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments. arm 3: Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments. arm 4: Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments.
Interventions: intervention 1: Testosterone MD-Lotion
Intervention descriptions: intervention 1: Administered Topically

Protocol documents:
Clinical trial NCT01018420
Conditions: Pharmacokinetics
Keywords: healthy
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2007-11-01; Completion date: 2008-01-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive control for the corrected QT interval (QTc) prolongation.

Detailed description:
This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen of 4.8 mg over 6 hours. In addition, it will determine whether or not there is a trend toward effect of this high dose regimen on the electrocardiogram (ECG), mainly the corrected QT interval (QTc), via comparison to a 400 mg dose of moxifloxacin, a positive control for QTc prolongation. Eighteen healthy, non-smoking, non-obese, non-pregnant adults between the ages of 18 to 55 years of age will be randomized in a double blind fashion to either the colchicine or moxifloxacin treatment groups. On the day prior to the study (Day -1), subjects will receive colchicine and moxifloxacin placebos according to the same schedule and conditions as will be present during the study, and baseline ECG's will be determined by 24 hour 12-lead Holter monitoring. On Day 1, after a minimum 10 hour overnight fast, subjects enrolled in the colchicine treatment group (N=15) will receive two 0.6 mg capsules (plus one dose moxifloxacin placebo) followed by an additional 0.6 mg colchicine dose (plus one dose moxifloxacin placebo) every hour for 6 additional doses; subjects in the moxifloxacin treatment group will receive placebo doses matching the colchicine treatment group over the first 5 hours, then 400 mg moxifloxacin (plus one dose colchicine placebo) at the 6 hour point. Fasting will continue for 4 hours after the first dose at which time a standardized meal will be served. Blood will be drawn from all participants at times sufficient to adequately define the pharmacokinetics of colchicine. During the study, continuous 24-hour ECG monitoring via 12-lead Holter monitor will be performed. Triplicate ECG records will be extracted from 5 minute observation periods throughout the 24 hours post dose. Finally, all study subjects will be monitored for adverse effects throughout the entire study period.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Colchicine intervention 2: Moxifloxacin
Intervention descriptions: intervention 1: two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses intervention 2: 400 mg capsule at the 6 hour point

Protocol documents:
Clinical trial NCT01033747
Conditions: Liver Iron Overload
Keywords: iron overload iron chelation therapy B-thalassemia
Sponsor: Novartis Pharmaceuticals
Start date: 2003-02-01; Completion date: 2008-01-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.

Detailed description:

Arms: arm 1: Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study arm 2: Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5mg/kg/day to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
Interventions: intervention 1: Deferasirox intervention 2: Deferasirox
Intervention descriptions: intervention 1: 10 mg/kg or 30 mg/kg orally daily intervention 2: 5 mg/kg or 30 mg/kg orally daily

Protocol documents:
Clinical trial NCT01101191
Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Sponsor: Purdue Pharma LP
Start date: 2007-08-01; Completion date: 2008-01-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms: arm 1: Reformulated OXY 80 mg x 1 dose arm 2: Original OxyContin® (OXY) 80 mg x 1 dose
Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 80-mg tablet x 1 dose taken without food. intervention 2: Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.

Protocol documents:
Clinical trial NCT01125917
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2004-06-01; Completion date: 2008-01-01
Enrollment: 354 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal patch
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. intervention 3: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Protocol documents: