ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00771173
Conditions: Catheter-related Bladder Discomfort
Keywords: Phenazopyrdine post operative bladder catheritization VAS scores Bladder pain related to indwelling foley catheters. Bladder irritaion related to indwelling foley catheters.
Sponsor: Loyola University
Start date: 2008-08-01; Completion date: 2010-01-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.

Detailed description:
This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery.

Hypothesis and Aims:

We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a Foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo.

The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurements.

Arms: arm 1: Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first arm 2: For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.
Interventions: intervention 1: phenazopyridine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Phenazopyrdine HCl 200 mg q8h x 24 intervention 2: Placebo tablet administered q8 hours for 24 hours postop.

Protocol documents:
Clinical trial NCT00787605
Conditions: Hypertension Diabetes Mellitus
Keywords: Hypertension, diabetes mellitus, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2
Sponsor: Novartis
Start date: 2008-11-01; Completion date: 2010-01-01
Enrollment: 860 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) given to diabetic patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and \< 200 mm Hg).

Detailed description:

Arms: arm 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks arm 2: Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
Interventions: intervention 1: Amlodipine intervention 2: Hydrochlorothiazide (HCTZ) intervention 3: Aliskiren
Intervention descriptions: intervention 1: Amlodipine 5 mg for 1 week followed by Amlodipine 10 mg for 7 weeks intervention 2: Hydrochlorothiazide 12.5 mg for 1 week followed by Hydrochlorothiazide 25 mg for 7 weeks intervention 3: Aliskiren 150 mg for 1 week followed by Aliskiren 300 mg for 7 weeks

Protocol documents:
Clinical trial NCT00790790
Conditions: Osteoarthritis Knee Pain
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2010-01-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To gather data on whether a new drug for osteoarthritis knee pain will be safe and have an effect on pain levels.

Detailed description:

Arms: arm 1: Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks. arm 2: Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment. arm 3: Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
Interventions: intervention 1: Placebo intervention 2: LY545694 49 mg intervention 3: LY545694 105 mg
Intervention descriptions: intervention 1: LY545694 placebo BID po for 5 weeks intervention 2: LY545694 49 mg BID po for 5 weeks. intervention 3: LY545694 105 mg BID po for 5 weeks.

Protocol documents:
Clinical trial NCT00791921
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2008-11-01; Completion date: 2010-01-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Detailed description:

Arms: arm 1: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks arm 2: Placebo of CDP870
Interventions: intervention 1: CDP870 intervention 2: Placebo of CDP870
Intervention descriptions: intervention 1: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC) intervention 2: Placebo given every 2 weeks until Week22 (SC)

Protocol documents:
Clinical trial NCT00792688
Conditions: Wounds
Keywords: burn wounds wound healing
Sponsor: TR Therapeutics
Start date: 2008-10-01; Completion date: 2010-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.

Detailed description:

Arms: arm 1: GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid arm 2: GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid arm 3: GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid
Interventions: intervention 1: GLYC-101 Gel (0.1%) intervention 2: GLYC-101 Gel (1.0%) intervention 3: GLYC-101 Placebo
Intervention descriptions: intervention 1: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. intervention 2: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5. intervention 3: Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

Protocol documents:
Clinical trial NCT00797797
Conditions: Fibromyalgia
Keywords: fibromyalgia milnacipran pregabalin treatment Forest Research Institute
Sponsor: Forest Laboratories
Start date: 2008-11-01; Completion date: 2010-01-01
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: No Treatment Added intervention 2: Milnacipran Added
Intervention descriptions: intervention 1: No added treatment intervention 2: Milnacipran 100 mg/d added

Protocol documents:
Clinical trial NCT00803244
Conditions: Primary Disease
Keywords: allergic rhinoconjunctivitis
Sponsor: Stallergenes Greer
Start date: 2009-01-01; Completion date: 2010-01-01
Enrollment: 381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Detailed description:
To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:

\- The Average Adjusted Symptom Score (AASS).

To document the safety of the treatment.

Arms: arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet
Interventions: intervention 1: 300 IR intervention 2: Placebo
Intervention descriptions: intervention 1: 300 IR grass pollen allergen extract tablet starting 2 months before the grass pollen season and during the grass pollen season intervention 2: Placebo sublingual tablet starting 2 months before the grass pollen season and during the grass pollen season

Protocol documents:
Clinical trial NCT00803361
Conditions: Generalized Anxiety Disorder
Keywords: anxiety
Sponsor: Eli Lilly and Company
Start date: 2008-12-01; Completion date: 2010-01-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 60 to 120 mg, capsules, oral, once a day for 15 weeks intervention 2: placebo capsules, oral, once a day for 15 weeks

Protocol documents:
Clinical trial NCT00804986
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2008-12-01; Completion date: 2010-01-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.

Detailed description:

Arms: arm 1: Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 2: Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 3: Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 4: Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 5: Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. arm 6: Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Interventions: intervention 1: LY2428757 intervention 2: Placebo
Intervention descriptions: intervention 1: Once weekly for 12 weeks as a subcutaneous injection. intervention 2: 1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.

Protocol documents:
Clinical trial NCT00806494
Conditions: Urinary Bladder, Overactive
Keywords: Fesoterodine Open Label Flexible Dose OAB
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2010-01-01
Enrollment: 331 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To explore the effects of fesoterodine when used in a flexible dose manner

Detailed description:

Arms: arm 1: Fesoterodine 4mg, escalating to 8mg as required
Interventions: intervention 1: Fesoterodine
Intervention descriptions: intervention 1: Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated

Protocol documents:
Clinical trial NCT00811564
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2008-12-01; Completion date: 2010-01-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

Detailed description:

Arms: arm 1: Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution arm 2: Latanoprost 0.005% ophthalmic solution
Interventions: intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution intervention 2: latanoprost 0.005%
Intervention descriptions: intervention 1: 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day intervention 2: 1 drop of study medication taken once daily

Protocol documents:
Clinical trial NCT00813488
Conditions: Chronic Pain
Keywords: Breakthrough Pain Opioid-tolerant Chronic Pain
Sponsor: Cephalon
Start date: 2008-12-01; Completion date: 2010-01-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.

Detailed description:

Arms: arm 1: This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid. arm 2: This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.
Interventions: intervention 1: Fentanyl Buccal Tablet intervention 2: Immediate release oxycodone
Intervention descriptions: intervention 1: FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.

The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).

For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician. intervention 2: Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.

The maximum single dose would be 60 mg (4 capsules).

Protocol documents:
Clinical trial NCT00816023
Conditions: Bloodloss Surgical Procedures, Operative
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.

Detailed description:

Arms: arm 1: target steady state concentration of 0.15 mg/L arm 2: target steady state concentration of 0.75 mg/L arm 3: target steady state concentration of 2.25 mg/L arm 4: placebo
Interventions: intervention 1: ecallantide intervention 2: placebo
Intervention descriptions: intervention 1: infusion administered IV over the duration of the surgical procedure intervention 2: solution for IV infusion over the duration of the surgical\>\> procedure

Protocol documents:
Clinical trial NCT00819091
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2010-01-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Detailed description:

Arms: arm 1: 5 mg orally (po) once daily arm 2: one tablet once daily
Interventions: intervention 1: BI 1356 intervention 2: Placebo
Intervention descriptions: intervention 1: 5mg orally (po) tablet qd intervention 2: Placebo matching BI 1356 5mg one tablet daily

Protocol documents:
Clinical trial NCT00829244
Conditions: Infertility
Keywords: Infertility Assisted reproductive technology
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-08-01; Completion date: 2010-01-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.

Detailed description:

Arms: arm 1: GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator arm 2: GONAL-f® at a standard dose of 150 IU per day
Interventions: intervention 1: GONAL f® prefilled pen intervention 2: GONAL f® prefilled pen
Intervention descriptions: intervention 1: GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only intervention 2: GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to Day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the center's standard practice.

Protocol documents:
Clinical trial NCT00834041
Conditions: Hypertension
Keywords: aliskiren pediatric hypertension pharmacokinetics (PK) pharmacodynamics (PD) plasma renin activity mini-tablet formulation
Sponsor: Novartis
Start date: 2009-04-01; Completion date: 2010-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.

Detailed description:

Arms: arm 1: Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning arm 2: Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning
Interventions: intervention 1: Aliskiren 3.125 mini-tablets
Intervention descriptions: intervention 1: Oral mini-tablets (3.125 mg) of aliskiren once each morning

Protocol documents:
Clinical trial NCT00836355
Conditions: Acute Ischemic Stroke
Keywords: stroke magnetic resonance imaging enoxaparin minocycline NIH stroke scale modified Rankin scale neuroprotection
Sponsor: NYU Langone Health
Start date: 2009-04-01; Completion date: 2010-01-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether enoxaparin, minocycline, or both medications in combination may help in recovery from acute stroke.

Enoxaparin (brand name Lovenox®) is a medication approved for use in humans to prevent and to treat blood clots in deep veins in certain specific medical situations. Minocycline (brand name Minocin®) is a tetracycline antibiotic approved to treat a number of bacterial infections in humans. The investigators are studying these medications in acute human stroke because they have each been separately shown to reduce the amount of injured brain tissue in rats made to have acute ischemic stroke experimentally. In a human trial comparing minocycline with placebo (a sugar pill) acute ischemic stroke patients who took minocycline had better recovery after 1 week, 1 month and 3 months than patients who took placebo.

Detailed description:
Enoxaparin is a low molecular weight heparin (average molecular weight 4,500 daltons, vs. 12,000 to 15,000 daltons for unfractionated heparin) administered subcutaneously and intravenously. It is a marketed drug FDA-approved in various clinical situations for: the prevention and treatment of deep vein thrombosis; and in the treatment of acute myocardial infarction. Minocycline is an orally administered antibiotic of the tetracycline class. It is a marketed drug FDA-approved for the treatment of various bacterial and rickettsial infections. Both medications have been found to be neuroprotective in experimental stroke models. Minocycline has shown promise in a human acute stroke study.

This study is designed to investigate two logistically simple treatment regimens, singly or in combination, employing these medications for acute ischemic stroke:

1. pulsed intravenous (iv) administration of enoxaparin initiated within 6 hours and completed by 24 hours after stroke onset; and
2. oral minocycline treatment once daily for five days.

The goal of treatment is neuroprotection: the limitation of the loss of brain tissue that follows ischemic stroke.

Arms: arm 1: None arm 2: Minocycline 200 mg orally once daily for 5 days arm 3: None arm 4: None
Interventions: intervention 1: Enoxaparin intervention 2: Minocycline
Intervention descriptions: intervention 1: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later intervention 2: 200 mg orally once daily for 5 days

Protocol documents:
Clinical trial NCT00836693
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2009-01-01; Completion date: 2010-01-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tadalafil intervention 2: placebo
Intervention descriptions: intervention 1: 5 milligrams (mg) administered orally once a day for 12 weeks intervention 2: tablet administered orally once a day for 12 weeks.

Protocol documents: