ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00905450
Conditions: Cataract Inflammation
Keywords: Surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2009-06-01; Completion date: 2010-05-01
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.

Detailed description:

Arms: arm 1: BOL-303242-X (Mapracorat) arm 2: Vehicle for BOL-303242-X (Mapracorat)
Interventions: intervention 1: BOL-303242-X intervention 2: Vehicle for BOL-303242-X
Intervention descriptions: intervention 1: Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules. intervention 2: Medication instilled into the study eye, subjects randomized to various drug dose schedules.

Protocol documents:
Clinical trial NCT00907218
Conditions: Attention Deficit/Hyperactivity Disorder Smoking Cessation
Keywords: ADHD Attention Deficit Hyperactivity Disorder ADHD medication Chantix varenicline smoking smoking cessation quit smoking
Sponsor: Massachusetts General Hospital
Start date: 2009-04-01; Completion date: 2010-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to learn about the efficacy of a medication called varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be improved with varenicline treatment. The investigators also hypothesize that varenicline treatment will result in significant reductions in cigarette smoking. Another objective of this study is to more fully evaluate the response and tolerability to varenicline in this group of cigarette smoking adults with ADHD.

Detailed description:

Arms: arm 1: Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.
Interventions: intervention 1: Varenicline (Chantix)
Intervention descriptions: intervention 1: Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.

Protocol documents:
Clinical trial NCT00918138
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Detailed description:

Arms: arm 1: (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) arm 2: (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo)
Interventions: intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Placebo matching Metformin XR intervention 4: Metformin XR intervention 5: Placebo matching Saxagliptin
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, 4 weeks intervention 2: Tablets, Oral, 1500 mg, once daily, 4 weeks intervention 3: Tablets, Oral, 0 mg, once daily, 4 weeks intervention 4: Tablets, Oral, 500 mg, once daily, 4 weeks intervention 5: Tablets, Oral, 0 mg, once daily, 4 weeks

Protocol documents:
Clinical trial NCT00918684
Conditions: Depression
Keywords: Depression
Sponsor: Weill Medical College of Cornell University
Start date: 2002-12-01; Completion date: 2010-05-01
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram.

Detailed description:
Age-related brain changes have been associated with development of late-life depression. Prominent among aging-related changes is decline in white matter disproportionately affecting frontal structures.Based on previous findings, we conceptualized treatment resistance, disability, and executive dysfunction as clinical phenomena contributed, at least in part, by compromised integrity of frontal neural systems. The study focuses on frontal white matter abnormalities in geriatric depression and their relationship to treatment response, disability,and executive dysfunction.

Arms: arm 1: 12-week open label with 2 week placebo period (14 weeks total)
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 10mg tab daily

Protocol documents:
Clinical trial NCT00932646
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2010-05-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Detailed description:

Arms: arm 1: Medium Dose once Daily arm 2: Low Dose once Daily arm 3: Placebo once Daily arm 4: 12 mcg twice daily
Interventions: intervention 1: BI 1744 (Olodaterol) Low Dose intervention 2: BI 1744 (Olodaterol) Medium Dose intervention 3: Placebo intervention 4: Foradil
Intervention descriptions: intervention 1: BI1744 Respimat low dose once daily and placebo Foradil intervention 2: BI1744 Respimat medium dose once daily and placebo Foradil intervention 3: Placebo Respimat once daily and placebo Foradil intervention 4: 12 mcg twice daily and placebo Respimat

Protocol documents:
Clinical trial NCT00943098
Conditions: Dental Pain
Sponsor: IBSA Institut Biochimique SA
Start date: 2009-09-01; Completion date: 2010-05-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Diclofenac HPBCD s.c. 75mg/ml intervention 2: Voltarol 75mg/3ml i.m.
Intervention descriptions: intervention 1: 1 single injection at day of dental surgical extraction intervention 2: 1 single injection at day of dental surgical extraction

Protocol documents:
Clinical trial NCT00944021
Conditions: Pulmonary Tuberculosis
Keywords: Early Bactericidal Activity EBA Pulmonary Tuberculosis PA-824 pretomanid
Sponsor: Global Alliance for TB Drug Development
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

Detailed description:
The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: PA-824 intervention 2: PA-824 intervention 3: PA-824 intervention 4: Rifafour e-275 mg intervention 5: PA-824
Intervention descriptions: intervention 1: 50mg intervention 2: 100mg intervention 3: 150 mg intervention 4: 275 mg intervention 5: 200 mg

Protocol documents:
Clinical trial NCT00945945
Conditions: Osteoarthritis Knee Pain
Keywords: Osteoarthritis, Knee Pain
Sponsor: Eli Lilly and Company
Start date: 2009-07-01; Completion date: 2010-05-01
Enrollment: 424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine if duloxetine 60 mg once daily (QD) reduces pain severity in patients with osteoarthritis (OA) knee pain compared with placebo.

Detailed description:

Arms: arm 1: Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol. arm 2: Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
Interventions: intervention 1: Duloxetine (DLX) intervention 2: Placebo (PLA)
Intervention descriptions: intervention 1: dose daily by mouth intervention 2: Placebo Comparator daily by mouth

Protocol documents:
Clinical trial NCT00947167
Conditions: Neuroendocrine Tumors Carcinoid Tumors Adrenal Gland Tumors Neuroblastoma Pancreatic Neuroendocrine Tumors Multiple Endocrine Neoplasia
Sponsor: Pamela L. Kunz
Start date: 2009-03-01; Completion date: 2010-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine objective response rates (RR) by RECIST guideline version 1.1 for all patients treated with this strategy consisting of initial therapy with pertuzumab as a single agent and then addition of erlotinib for those who have stable disease or progressive disease at three months (Simon design).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pertuzumab intervention 2: erlotinib
Intervention descriptions: intervention 1: 840 mg, 420 mg, iv intervention 2: 150 mg, PO

Protocol documents:
Clinical trial NCT00953017
Conditions: Colonoscopy
Keywords: Efficacy of bowel cleansing Patient tolerability Amitiza Dulcolax Miralax Colonoscopy preparation Bowel preparation Screening colonoscopy
Sponsor: Brooke Army Medical Center
Start date: 2009-07-01; Completion date: 2010-05-01
Enrollment: 425 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Detailed description:

Arms: arm 1: 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 2: 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 3: 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy. arm 4: 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Interventions: intervention 1: Miralax (PEG 3350) intervention 2: Amitiza (Lubiprostone) intervention 3: Dulcolax (Bisacodyl) intervention 4: Golytely (polyethylene glycol)
Intervention descriptions: intervention 1: Miralax 255gm bottle intervention 2: Amitiza 24mcg gelcap intervention 3: Bisacodyl 5mg tab x2 intervention 4: Golytely 1 gallon

Protocol documents:
Clinical trial NCT00957034
Conditions: Heart Failure
Sponsor: Warner Chilcott
Start date: 2009-07-01; Completion date: 2010-05-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Heart failure (HF) is a complex condition resulting from structural or functional heart diseases that impair the ability of the heart to fill with or pump out blood. The main manifestations of HF are shortness of breath and tiredness which may limit the ability to exercise or perform simple daily physical activities such as walking. Heart disease leading to HF is associated with reduced muscle mass and reduced strength and low blood levels of testosterone; a hormone normally produced by the human (male and female) body. Recent studies have shown improvements of symptoms and ability to exercise in patients with heart failure receiving testosterone.

This is a placebo controlled study to determine the efficacy and safety of low dose testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women with significant HF.

Detailed description:

Arms: arm 1: placebo patch arm 2: 300 micrograms/day transdermal testosterone patch arm 3: 450 micrograms/day transdermal testosterone patch
Interventions: intervention 1: placebo intervention 2: testosterone
Intervention descriptions: intervention 1: placebo patch intervention 2: 300 or 450 micrograms/day transdermal testosterone patch

Protocol documents:
Clinical trial NCT00966355
Conditions: Variceal Bleeding, Cirrhosis
Keywords: Cirrhosis, Esophagus Disorders, Varicose Veins
Sponsor: Korea University
Start date: 2006-09-01; Completion date: 2010-05-01
Enrollment: 1034 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Detailed description:
In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Arms: arm 1: treat with terlipressin IV for 5 days and endoscopic treatment arm 2: treat with somatostatin IV for 5 days and endoscopic treatment arm 3: treat with octreotide IV for 5 days and endoscopic treatment
Interventions: intervention 1: Terlipressin intervention 2: Somatostatin intervention 3: Octreotide
Intervention descriptions: intervention 1: loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days intervention 2: loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days intervention 3: loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days

Protocol documents:
Clinical trial NCT00972244
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus Japanese phase 2 efficacy safety dapagliflozin
Sponsor: AstraZeneca
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.

Detailed description:

Arms: arm 1: 1mg dapagliflozin arm 2: 2.5mg dapagliflozin arm 3: 5mg dapagliflozin arm 4: 10mg dapagliflozin arm 5: Placebo
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: once daily, 12 weeks intervention 2: once daily, 12 weeks

Protocol documents:
Clinical trial NCT00975650
Conditions: Hypogonadism
Keywords: Primary Hypogonadism Secondary Hypogonadism
Sponsor: Acerus Pharmaceuticals Corporation
Start date: 2009-08-01; Completion date: 2010-05-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.

Detailed description:
Primary Objective:

The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®.

Secondary Objective:

To establish a safety profile for Nasobol.

Arms: arm 1: Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; arm 2: Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days arm 3: Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; arm 4: Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
Interventions: intervention 1: Nasobol® intervention 2: Androderm® (Positive Control)
Intervention descriptions: intervention 1: Intra-nasal Testosterone (2 syringes), b.i.d. intervention 2: QD administration

Protocol documents:
Clinical trial NCT00979875
Conditions: Healthy
Keywords: insulin recombinant human hyaluronidase Healthy volunteers
Sponsor: Halozyme Therapeutics
Start date: 2009-09-01; Completion date: 2010-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

Detailed description:

Arms: arm 1: All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.

Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.

Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.

Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart.
Interventions: intervention 1: Recombinant human hyaluronidase PH20 (rHuPH20) intervention 2: Insulin lispro intervention 3: Insulin glulisine intervention 4: Insulin aspart
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: