ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00826943
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Sponsor: Vanderbilt University
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.

Detailed description:
Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.

Arms: arm 1: 5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) arm 2: 10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. arm 3: one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo
Interventions: intervention 1: Cetirizine intervention 2: Levocetirizine intervention 3: Placebo
Intervention descriptions: intervention 1: Cetirizine 10 mg tab daily x 7 days intervention 2: 5 mg tab daily x 7 days intervention 3: Placebo tablet daily x 7 days

Protocol documents:
Clinical trial NCT00828568
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2008-06-01; Completion date: 2009-05-01
Enrollment: 425 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK.

The secondary objective is to compare the adverse event (AE) profiles of the two creams.

Detailed description:

Arms: arm 1: Imiquimod 5% manufactured by Taro applied for 16 weeks arm 2: Aldara, Imiquimod 5% applied for 16 weeks arm 3: Imiquimod vehicle applied for 16 weeks
Interventions: intervention 1: Imiquimod 5% manufactured by Taro intervention 2: Aldara - Imiquimod 5% intervention 3: Imiquimod Vehicle manufactured by Taro
Intervention descriptions: intervention 1: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 2: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks intervention 3: Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Protocol documents:
Clinical trial NCT00841087
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart
Intervention descriptions: intervention 1: The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime intervention 2: Injection subcutaneously at bedtime intervention 3: Injection subcutaneously immediately before each meal.

Protocol documents:
Clinical trial NCT00845195
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinitis Allergy Nasal Spray Antihistamine Intranasal Corticosteroid
Sponsor: Alcon Research
Start date: 2009-03-01; Completion date: 2009-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Olopatadine HCl Nasal Spray, 0.6% intervention 2: Azelastine HCl Nasal Spray, 0.1%
Intervention descriptions: intervention 1: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days intervention 2: 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days

Protocol documents:
Clinical trial NCT00845481
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Daivobet® ointment intervention 2: Betnovat® ointment intervention 3: Diprosalic ointment intervention 4: Dermovat ointment intervention 5: Elocon ointment intervention 6: Daivobet® ointment vehicle
Intervention descriptions: intervention 1: Once daily application 6 days a week for 3 weeks intervention 2: Once daily application 6 days a week for 3 weeks intervention 3: Once daily application 6 days a week for 3 weeks intervention 4: Once daily application 6 days a week for 3 weeks intervention 5: Once daily application 6 days a week for 3 weeks intervention 6: Once daily application 6 days a week for 3 weeks

Protocol documents:
Clinical trial NCT00854360
Conditions: Seasonal Allergic Rhinitis Hayfever
Keywords: Seasonal Allergic Rhinitis Hayfever
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-03-01; Completion date: 2009-05-01
Enrollment: 487 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Detailed description:

Arms: arm 1: During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily. arm 3: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. arm 4: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Interventions: intervention 1: Beclomethasone dipropionate HFA Nasal Aerosol intervention 2: Placebo
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol

Protocol documents:
Clinical trial NCT00856193
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Bronchodilator
Sponsor: Novartis
Start date: 2009-02-01; Completion date: 2009-05-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.

Detailed description:

Arms: arm 1: Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. arm 2: NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
Interventions: intervention 1: Placebo intervention 2: NVA237
Intervention descriptions: intervention 1: Matching placebo capsules were supplied for inhalation once daily with Concept 1 device. intervention 2: NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.

Protocol documents:
Clinical trial NCT00856843
Conditions: Colonoscopy
Keywords: colonoscopy bowel preparation
Sponsor: Braintree Laboratories
Start date: 2009-02-01; Completion date: 2009-05-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Detailed description:

Arms: arm 1: Polyethylene glycol 3350 based bowel preparation arm 2: BLI800
Interventions: intervention 1: BLI800 intervention 2: Polyethylene glycol 3350 based bowel preparation
Intervention descriptions: intervention 1: Solution for oral administration prior to colonoscopy intervention 2: Solution for oral administration prior to colonoscopy

Protocol documents:
Clinical trial NCT00857272
Conditions: Colonoscopy
Keywords: colonoscopy bowel preparation
Sponsor: Braintree Laboratories
Start date: 2009-02-01; Completion date: 2009-05-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

Detailed description:

Arms: arm 1: Active control arm 2: Investigational dose
Interventions: intervention 1: PEG electrolyte lavage solution + bisacodyl - reformulation intervention 2: PEG electrolyte lavage solution + bisacodyl
Intervention descriptions: intervention 1: multi dose formulation (tablet/solution) for oral administration prior to colonoscopy intervention 2: multi dose preparation (tablet/solution) for oral administration prior to colonoscopy

Protocol documents:
Clinical trial NCT00873821
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2009-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.

Detailed description:

Arms: arm 1: MK-0941 arm 2: Placebo Comparator
Interventions: intervention 1: MK-0941 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water. intervention 2: Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.

Protocol documents:
Clinical trial NCT00888459
Conditions: Smokeless Tobacco Use
Keywords: tobacco chew nrt nicotine lozenges self-help
Sponsor: Mayo Clinic
Start date: 2008-04-01; Completion date: 2009-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Detailed description:
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Arms: arm 1: Self-help counseling material and 4 mg nicotine lozenges arm 2: self help counseling material and placebo nicotine lozenges
Interventions: intervention 1: nicotine replacement therapy intervention 2: placebo NRT
Intervention descriptions: intervention 1: 4 mg nicotine lozenges, ad lib, for 12 weeks. intervention 2: Placebo nicotine lozenges

Protocol documents:
Clinical trial NCT00889330
Conditions: Allergic Conjunctivitis
Sponsor: Vistakon Pharmaceuticals
Start date: 2009-04-01; Completion date: 2009-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Detailed description:

Arms: arm 1: active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). arm 2: Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
Interventions: intervention 1: alcaftadine intervention 2: Placebo
Intervention descriptions: intervention 1: 0.25% Ophthalmic Solution, one drop in each eye at each of two visits. intervention 2: Vehicle without active, one drop in each eye at each of two visits.

Protocol documents:
Clinical trial NCT00910858
Conditions: Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)
Sponsor: Celgene Corporation
Start date: 2005-01-01; Completion date: 2009-05-01
Enrollment: 40 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).

Detailed description:

Arms: arm 1: Participants in the Pharmacokinetic Phase received a single 10 mg oral dose of lenalidomide on Day -7. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.

During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment. arm 2: Following the enrollment of the first 25 patients into the Monotherapy Phase, a second group of 15 patients with low- or intermediate-1-risk MDS not associated with a del 5q (non-del 5q) cytogenetic abnormality were enrolled to receive 15 mg of lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure. During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment.
Interventions: intervention 1: Lenalidomide intervention 2: Recombinant human erythropoietin
Intervention descriptions: intervention 1: Lenalidomide 5-mg capsules for oral administration intervention 2: Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.

Protocol documents:
Clinical trial NCT00911612
Conditions: Irritable Bowel Syndrome Diarrhea
Keywords: bile acid malabsorption permeability diarrhea IBS stool
Sponsor: Mayo Clinic
Start date: 2009-01-01; Completion date: 2009-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome.

This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.

Detailed description:
Background:

Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to side effects or insufficient benefit. Bile acid malabsorption (BAM) is recognized as a cause of chronic diarrhea and has been investigated as a mechanism for the phenotype of diarrhea predominant IBS (D-IBS). Increased exposure of the colon to bile acids which may result from accelerated small bowel transit or abnormal function of the apical sodium bile acid transporter (ASBT) has been postulated to cause functional diarrhea or symptoms of D-IBS by a number of mechanisms, such as increase colonic secretion, and mucosal permeability. Recent preliminary data suggest that doses of chenodeoxycholate (CDC) that are approved for the dissolution of gall stones are associated with accelerated colonic emptying and looser stool consistency.

Hypothesis:

The bile acid binding agent, Colesevelam HCl, decreases colonic transit and permeability in patients with D-IBS.

Specific Aim:

To investigate the effect of Colesevelam, which binds bile acids in the small intestine and reduces the concentration of bile acids in the colon, on colonic transit, permeability and the bowel function of patients with D-IBS.

Methods:

Twenty-four D-IBS participants will be randomized to placebo or treatment with Welchol (Colesevelam HCL) 1.875 gram b.i.d. for 12-14 days. A baseline colon transit, 24 hour urine for colon permeability, and blood for serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO) will be measured and venous blood DNA will be collected and stored. The measurement of serum 7 alpha-hydroxy-4-cholesten-3-one (7 alpha-HCO), which is a measurement of hepatic cholesterol synthesis, is closely related to the fecal loss of bile acids, and is a validated method for screening for BAM. Following treatment for 12 days, transit and permeability studies will be repeated. Bowel function symptoms will be recorded for the duration of the study.

Arms: arm 1: Participants received colesevelam 1.875 g twice daily arm 2: Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
Interventions: intervention 1: Colesevelam intervention 2: Placebo
Intervention descriptions: intervention 1: Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days intervention 2: Inert capsule matching the study drug, given twice daily

Protocol documents:
Clinical trial NCT00919191
Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-04-01; Completion date: 2009-05-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Detailed description:
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.

Arms: arm 1: Once daily use in a split face model:

1. Tretinoin gel
2. Adapalene Benzoyl peroxide
Interventions: intervention 1: Tretinoin gel intervention 2: Adapalene and Benzoyl peroxide
Intervention descriptions: intervention 1: Tretinoin gel 0.04% used once daily in a split-face model intervention 2: Adapalene .1% and Benzoyl peroxide 2.5%

Protocol documents:
Clinical trial NCT00928954
Conditions: Nystagmus
Keywords: gabapentin memantine nystagmus Drug treatment
Sponsor: Case Western Reserve University
Start date: 2005-02-01; Completion date: 2009-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.

Detailed description:
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.

Arms: arm 1: Increasing dose to 300 mg four times per day (total of 1200 mg/day) arm 2: Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
Interventions: intervention 1: gabapentin intervention 2: memantine
Intervention descriptions: intervention 1: increasing to 1200 mg/day intervention 2: increasing to 40 mg/day

Protocol documents: