ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00740857
Conditions: Pain
Keywords: Dental pain analgesia
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: placebo intervention 2: ibuprofen Formulation 1 intervention 3: ibuprofen Formulation 2
Intervention descriptions: intervention 1: 2 placebo gels capsules delivered as a single dose. intervention 2: 2 marketed ibuprofen gels intervention 3: 2 marketed ibuprofen gels

Protocol documents:
Clinical trial NCT00751400
Conditions: Pain
Keywords: Non-prescription
Sponsor: Bayer
Start date: 2008-07-01; Completion date: 2008-11-01
Enrollment: 497 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Detailed description:
Issues on adverse event data are addressed in the Adverse Event section.

The following acronyms and abbreviations were used in the results section.

\- General Educational Development (GED)

Arms: arm 1: subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
Interventions: intervention 1: Naproxen Sodium ER (BAYH6689)
Intervention descriptions: intervention 1: Consumer use of Extended Release Naproxen Sodium

Protocol documents:
Clinical trial NCT00756548
Conditions: Colon Cancer
Keywords: colonoscopy screening
Sponsor: Braintree Laboratories
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 386 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Detailed description:

Arms: arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy
Interventions: intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation
Intervention descriptions: intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy

Protocol documents:
Clinical trial NCT00756977
Conditions: Colon Cancer
Keywords: Colonoscopy screening
Sponsor: Braintree Laboratories
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Detailed description:

Arms: arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy
Interventions: intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation
Intervention descriptions: intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy

Protocol documents:
Clinical trial NCT00759811
Conditions: Heart Failure Myocardial Ischemia
Keywords: Heart Failure Myocardial Ischemia Methotrexate Inflammation Anti-Inflammatory Agents Inflammation Mediators
Sponsor: Instituto de Cardiologia do Rio Grande do Sul
Start date: 2007-12-01; Completion date: 2008-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.

Detailed description:
Recent studies have showed the importance of proinflammatory mediators in the heart failure. However, there is a lack of benefit of therapies that tried to neutralize these mediators.

Methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. Methotrexate limits infarct size via this adenosine-dependent mechanisms in heart of dogs (J Cardiovasc Pharmacol. 2004 Apr;43(4):574-9). A recent trial showed that this drug reduced proinflammatory mediators in patients with heart failure (Am Heart J. 2006 Jan;151(1):62-8).

These data suggest that methotrexate may improve physical capacity in patients ischemic heart failure reducing inflammation, but a randomized clinical trial is necessary to prove it.

Arms: arm 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks. arm 2: Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
Interventions: intervention 1: Methotrexate intervention 2: Placebo
Intervention descriptions: intervention 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.

All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks. intervention 2: Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.

All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.

Protocol documents:
Clinical trial NCT00762359
Conditions: Stomach Ulcer Duodenal Ulcer
Keywords: Curling Ulcer Gastric Ulcer Aspirin Acetylsalicylic Acid Drug Therapy
Sponsor: Takeda
Start date: 2007-05-01; Completion date: 2008-11-01
Enrollment: 461 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

Detailed description:
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lansoprazole intervention 2: Gefarnate
Intervention descriptions: intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Protocol documents:
Clinical trial NCT00762476
Conditions: Common Cold
Keywords: cold, common rhinovirus
Sponsor: The Dial Corporation
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 411 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.

Detailed description:
Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.

Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.

The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 3804-250A intervention 2: 3804-291
Intervention descriptions: intervention 1: * topical product
* apply 2 pumps
* apply at least every 4 hours or after hand washing intervention 2: * topical
* apply 2 pumps
* apply at least every 4 hours or after hand washing

Protocol documents:
Clinical trial NCT00772304
Conditions: Allergic Rhinitis
Keywords: rhinitis
Sponsor: Alcon Research
Start date: 2008-10-01; Completion date: 2008-11-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.

Detailed description:

Arms: arm 1: Olopatadine 0.6% / Azelastine 137 mcg
Interventions: intervention 1: Olopatadine 0.6% / Azelastine 137 mcg
Intervention descriptions: intervention 1: single dose; 2 sprays per nostril

Protocol documents:
Clinical trial NCT00772967
Conditions: Osteoarthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-01; Completion date: 2008-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.

Detailed description:

Arms: arm 1: Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 2: Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 3: Participants were treated with Ultracet for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 4: Participants were treated with Placebo for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 5: Participants were treated with Naproxen for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 6: Participants were treated with Ultracet for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.
Interventions: intervention 1: Naproxen intervention 2: Placebo intervention 3: Ultracet
Intervention descriptions: intervention 1: Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. intervention 2: Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. intervention 3: Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.

Protocol documents:
Clinical trial NCT00795275
Conditions: Obesity
Keywords: pre-diabetes isotopes insulin secretion insulin action GLP-1 simple obesity impaired fasting glucose
Sponsor: University of Colorado, Denver
Start date: 2008-01-01; Completion date: 2008-11-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.

Detailed description:

Arms: arm 1: Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) arm 2: Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)
Interventions: intervention 1: Sitagliptin Phosphate
Intervention descriptions: intervention 1: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Protocol documents:
Clinical trial NCT00831701
Conditions: Ureteral Calculi
Keywords: Adrenergic alpha antagonists drug therapy tamsulosin ureter
Sponsor: University of Zurich
Start date: 2006-09-01; Completion date: 2008-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.

The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.

Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.

Detailed description:

Arms: arm 1: Tamsulosin treatment arm 2: Placebo treatment
Interventions: intervention 1: Tamsulosin intervention 2: Placebo
Intervention descriptions: intervention 1: 0.4 mg Tamsulosin once daily for 21 days intervention 2: One placebo pill per day for 21 days or until stone expulsion

Protocol documents:
Clinical trial NCT00898560
Conditions: Partial Epilepsy
Keywords: Partial Epilepsy Eslicarbazepine acetate Combined oral contraceptive Pharmacokinetics Tolerability
Sponsor: Bial - Portela C S.A.
Start date: 2008-09-01; Completion date: 2008-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).

Detailed description:

Arms: arm 1: A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). arm 2: 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
Interventions: intervention 1: eslicarbazepine acetate and Microginon® intervention 2: Microginon®
Intervention descriptions: intervention 1: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.

Microginon®: single oral dose on day 14 of treatment period intervention 2: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)

Protocol documents:
Clinical trial NCT00972439
Conditions: Oral Contraceptive
Keywords: Oral Contraceptives Breast Tissue
Sponsor: University of Southern California
Start date: 2007-08-01; Completion date: 2008-11-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.

Detailed description:

Arms: arm 1: Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. arm 2: Ovcon Fe® is an oral contraceptive that contains less progestin.
Interventions: intervention 1: Oral Contraceptive: Ortho-Novum® 1/35 intervention 2: Oral Contraceptive: Ovcon Fe®
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00980746
Conditions: Painful Diabetic Neuropathy
Keywords: pain diabetes neuropathy
Sponsor: Bial - Portela C S.A.
Start date: 2007-11-01; Completion date: 2008-11-01
Enrollment: 557 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.

Detailed description:

Arms: arm 1: ESL 400 mg twice daily (BID) arm 2: ESL 800 mg once-daily (QD) arm 3: Eslicarbazepine 600 mg twice daily arm 4: Eslicarbazepine acetate 1200 mg once daily arm 5: Eslicarbazepine acetate 800 mg twice daily arm 6: Placebo
Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Placebo
Intervention descriptions: intervention 1: Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. intervention 2: oral route

Protocol documents:
Clinical trial NCT00995475
Conditions: COPD
Sponsor: University of Dundee
Start date: 2006-10-01; Completion date: 2008-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.

Detailed description:

Arms: arm 1: FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. arm 2: FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.
Interventions: intervention 1: Fluticasone propionate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01101321
Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Sponsor: Purdue Pharma LP
Start date: 2008-06-01; Completion date: 2008-11-01
Enrollment: 58 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) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility 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 (Totowa) x 1 dose arm 2: Reformulated OXY 80 mg (Wilson) x 1 dose
Interventions: intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food. intervention 2: Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.

Protocol documents: