ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00737282
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Detailed description:
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Arms: arm 1: Proellex 25 mg once daily arm 2: Proellex 50 mg once daily
Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg
Intervention descriptions: intervention 1: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle intervention 2: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Protocol documents:
Clinical trial NCT00747149
Conditions: Type 2 Diabetes
Keywords: diabetes type 2
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 598 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.

Detailed description:

Arms: arm 1: titrated arm 2: Non-titrated
Interventions: intervention 1: Rosuvastatin
Intervention descriptions: intervention 1: Oral

Protocol documents:
Clinical trial NCT00749944
Conditions: Smoking Cessation
Keywords: nicotine withdrawal, smoking cessation, varenicline
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days) intervention 2: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)

Protocol documents:
Clinical trial NCT00756678
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.

Detailed description:

Arms: arm 1: Carboxymethylcellulose and Glycerin arm 2: Polyethylene glycol 400
Interventions: intervention 1: Lubricant Eye Drops (Optive™) intervention 2: Lubricating Eye Drops (blink® Tears)
Intervention descriptions: intervention 1: 1 drop in both eyes as needed for 7 days' intervention 2: 1 drop in both eyes as needed for 7 days

Protocol documents:
Clinical trial NCT00757848
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Sponsor: AstraZeneca
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD9668 intervention 2: AZD9668 Placebo equivalent
Intervention descriptions: intervention 1: 60 mg, oral tablet, twice daily for 28 days intervention 2: Match placebo to 60 mg, oral tablet, twice daily for 28 days

Protocol documents:
Clinical trial NCT00758420
Conditions: Varicose Veins
Keywords: Varicose Veins
Sponsor: Boston Scientific Corporation
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

Detailed description:
The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.

Arms: arm 1: Varisolve (polidocanol endovenous mircofoam) arm 2: Agitated saline
Interventions: intervention 1: Varisolve (Polidocanol Endovenous Microfoam) intervention 2: Agitated Saline
Intervention descriptions: intervention 1: 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) intervention 2: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

Protocol documents:
Clinical trial NCT00763256
Conditions: Periodontal Disease
Sponsor: Colgate Palmolive
Start date: 2006-05-01; Completion date: 2009-08-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test effectiveness of dentifrice in maintaining periodontal health.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Triclosan, Fluoride intervention 2: Fluoride
Intervention descriptions: intervention 1: subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period. intervention 2: subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Protocol documents:
Clinical trial NCT00765674
Conditions: Hypertension
Keywords: aliskiren antihypertensive hypertension renin inhibitor moderate-severe hypertension
Sponsor: Novartis
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 1191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.

Detailed description:

Arms: arm 1: Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 2: Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 3: Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 4: Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide (HCTZ) intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: 150 and 300 mg tablets intervention 2: 5 and 10 mg capsules intervention 3: 12.5 and 25 mg capsules intervention 4: tablet intervention 5: capsules

Protocol documents:
Clinical trial NCT00765882
Conditions: Chronic Constipation
Keywords: Constipation Chronic Constipation Linaclotide
Sponsor: Forest Laboratories
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 633 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Detailed description:

Arms: arm 1: Linaclotide 290 micrograms arm 2: Linaclotide 145 micrograms arm 3: Matching placebo
Interventions: intervention 1: Linaclotide 290 micrograms intervention 2: Linaclotide 145 micrograms intervention 3: Placebo
Intervention descriptions: intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 3: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Protocol documents:
Clinical trial NCT00765947
Conditions: Essential Hypertension ( Mild to Moderate)
Keywords: Essential Hypertension ( mild to moderate)
Sponsor: Novartis
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 256 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).

Detailed description:

Arms: arm 1: All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Interventions: intervention 1: Aliskiren intervention 2: Hydrochlorothiazide intervention 3: Amlodipine
Intervention descriptions: intervention 1: Aliskiren 150 or 300 mg intervention 2: Hydrochlorothiazide 12.5 or 25 mg intervention 3: Amlodipine 5 or 10 mg

Protocol documents:
Clinical trial NCT00769314
Conditions: Herpes Labialis
Sponsor: Valerio Therapeutics
Start date: 2007-05-01; Completion date: 2009-08-01
Enrollment: 1727 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

Detailed description:

Arms: arm 1: Acyclovir Lauriad 50mg arm 2: None
Interventions: intervention 1: Acyclovir Lauriad intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg muco-adhesive buccal tablets, single application on the gum intervention 2: 50 mg muco-adhesive buccal tablets, single application on the gum

Protocol documents:
Clinical trial NCT00785356
Conditions: Uterine Fibroids Anemia
Keywords: Uterine fibroids Anemia
Sponsor: Repros Therapeutics Inc.
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Detailed description:
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Arms: arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Placebo
Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months

Protocol documents:
Clinical trial NCT00785512
Conditions: Hypertension
Keywords: nebivolol Bystolic® Hypertension blood pressure withdrawal
Sponsor: Forest Laboratories
Start date: 2008-11-01; Completion date: 2009-08-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Detailed description:

Arms: arm 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration arm 2: Matching placebo tablets, oral administration
Interventions: intervention 1: Nebivolol intervention 2: Placebo
Intervention descriptions: intervention 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration intervention 2: Matching placebo tablets, oral administration

Protocol documents:
Clinical trial NCT00789724
Conditions: ST Segment Elevation Acute Myocardial Infarction
Keywords: acute myocardial infarction
Sponsor: Virginia Commonwealth University
Start date: 2008-11-01; Completion date: 2009-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart).

Current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin II, norepinephrine and aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients continue to develop heart failure within 1 year of AMI. These patients are at very high risk of death.

Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling. Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1) production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death).

In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after AMI.

We hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after AMI.

Detailed description:

Arms: arm 1: Anakinra 100 mg given daily by subcutaneous injection for 14 days arm 2: 0.67 ml of NaCl 0.9% solution
Interventions: intervention 1: Anakinra intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg daily subcutaneous injection for 14 days intervention 2: 0.67 ml of NaCl 0.9% subcutaneously daily for 14 days

Protocol documents:
Clinical trial NCT00790751
Conditions: Erectile Dysfunction
Keywords: ED Erectile Dysfunction Dysfunction Erectile
Sponsor: VIVUS LLC
Start date: 2008-11-01; Completion date: 2009-08-01
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: avanafil intervention 3: avanafil intervention 4: avanafil
Intervention descriptions: intervention 1: 30 minutes orally prior to initiation of sexual activity intervention 2: 30 minutes orally prior to initiation of sexual activity intervention 3: 30 minutes orally prior to initiation of sexual activity intervention 4: 30 minutes orally prior to initiation of sexual activity

Protocol documents:
Clinical trial NCT00791323
Conditions: Inflammation
Sponsor: Allergan
Start date: 2008-11-01; Completion date: 2009-08-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy

Detailed description:

Arms: arm 1: Ketorolac 0.4% arm 2: Mineral Oil Emollient
Interventions: intervention 1: Ketorolac 0.4% intervention 2: Lubricating Eye Drop
Intervention descriptions: intervention 1: One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days intervention 2: One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation

Protocol documents:
Clinical trial NCT00824070
Conditions: Cataract Extraction
Keywords: Bioavailability
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-02-01; Completion date: 2009-08-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.

Detailed description:

Arms: arm 1: Besifloxacin ophthalmic suspension arm 2: Vigamox (moxifloxacin ophthalmic solution, 0.5%) arm 3: Zymar (gatifloxacin ophthalmic solution, 0.3%)
Interventions: intervention 1: Besifloxacin hydrochloride intervention 2: moxifloxacin hydrochloride intervention 3: gatifloxacin
Intervention descriptions: intervention 1: Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 2: Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 3: Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Protocol documents:
Clinical trial NCT00825500
Conditions: Migraine Headache
Keywords: Migraine headache Loxapine Staccato
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2009-01-01; Completion date: 2009-08-01
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.

Detailed description:
This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.

Arms: arm 1: Inhaled Staccato Placebo (0 mg) arm 2: Inhaled Staccato Loxapine 1.25 mg, single dose arm 3: Inhaled Staccato Loxapine 2.5 mg, single dose
Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 1.25 mg intervention 3: Inhaled Loxapine 2.5 mg
Intervention descriptions: intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Inhaled Staccato Loxapine 1.25 mg, single dose intervention 3: Inhaled Staccato Loxapine 1.25 mg, single dose

Protocol documents:
Clinical trial NCT00828412
Conditions: Atopic Dermatitis
Sponsor: Promius Pharma, LLC
Start date: 2009-03-01; Completion date: 2009-08-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.

Detailed description:

Arms: arm 1: EpiCeram Skin Barrier Emulsion arm 2: Desonide Cream 0.05%
Interventions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Desonide Cream 0.05%
Intervention descriptions: intervention 1: topical cream, twice daily, 6 weeks intervention 2: topical cream, twice daily, 6 weeks

Protocol documents: