ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01020123
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus metformin glipizide
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2011-02-01
Enrollment: 530 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients

Detailed description:

Arms: arm 1: AZD1656 arm 2: AZD1656 arm 3: AZD1656 arm 4: AZD1656 arm 5: AZD1656 arm 6: None arm 7: Glipizide administered to 1 group of patients
Interventions: intervention 1: AZD1656 intervention 2: Placebo intervention 3: Glipizide
Intervention descriptions: intervention 1: Different doses of AZD1656 administered to 5 groups of patients intervention 2: AZD1656 placebo and glipizide placebo administered to 1 group of patients intervention 3: Glipizide administered to 1 group of patients

Protocol documents:
Clinical trial NCT01030952
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 Nateglinide Acarbose glucose fluctuation
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2011-02-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.

Detailed description:

Arms: arm 1: Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. arm 2: Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
Interventions: intervention 1: Nateglinide intervention 2: Acarbose
Intervention descriptions: intervention 1: Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. intervention 2: Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.

Protocol documents:
Clinical trial NCT01033019
Conditions: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Keywords: Basal cell carcinomas, sporadic, superficial and nodular, skin
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2011-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).

Detailed description:

Arms: arm 1: Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. arm 2: Participants topically applied matching placebo cream twice daily for 6 weeks.
Interventions: intervention 1: LDE225 0.75% intervention 2: Vehicle
Intervention descriptions: intervention 1: 0.75% cream intervention 2: matching placebo cream to 0.75% LDE225 cream

Protocol documents:
Clinical trial NCT01034540
Conditions: Hypertriglyceridemia
Sponsor: Provident Clinical Research
Start date: 2010-03-01; Completion date: 2011-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.

Detailed description:
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.

Arms: arm 1: POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment arm 2: Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
Interventions: intervention 1: POM3 intervention 2: Placebo
Intervention descriptions: intervention 1: 4 g/day intervention 2: matching placebo capsule, 4 g/day

Protocol documents:
Clinical trial NCT01040403
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-01-01; Completion date: 2011-02-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.

Detailed description:

Arms: arm 1: low dose inhaled olodaterol orally once daily from the Respimat inhaler arm 2: low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 3: low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 4: low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 5: high dose inhaled olodaterol orally once daily from the Respimat inhaler arm 6: high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 7: high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily arm 8: high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily
Interventions: intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat
Intervention descriptions: intervention 1: olodaterol (BI 1744) low intervention 2: low tiotropium bromide intervention 3: olodaterol (BI 1744) high intervention 4: medium tiotropium bromide intervention 5: high tiotropium bromide intervention 6: Placebo intervention 7: Respimat inhaler

Protocol documents:
Clinical trial NCT01044212
Conditions: Functional Disorder of Intestine
Keywords: Urogynecology
Sponsor: University of Rochester
Start date: 2009-11-01; Completion date: 2011-02-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.

Detailed description:
See above

Arms: arm 1: Docusate is the standard of care regimen arm 2: Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Interventions: intervention 1: Docusate intervention 2: Bowel medications
Intervention descriptions: intervention 1: Docusate 100mg BID intervention 2: Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Protocol documents:
Clinical trial NCT01045096
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux Erosive Esophagitis Pharmacokinetics Pediatrics Drug Therapy
Sponsor: Takeda
Start date: 2010-03-01; Completion date: 2011-02-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.

Detailed description:
Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the backward flow of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of GERD in the pediatric population is increasingly becoming recognized and documented. It is a disease that may persist through adulthood, with symptoms in older children and adolescents similar to those seen in adults.

Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type GERD symptoms of heartburn and regurgitation. Treatment for GERD is aimed at improving symptoms and healing esophageal inflammation.

Takeda Global Research \& Development Center, Inc. (TGRD) developed dexlansoprazole delayed release capsules as a new therapy for treating acid related disorders including symptomatic non-erosive GERD, healing of erosive esophagitis (EE) and maintenance of healed EE.

Dexlansoprazole delayed release capsules have not been studied in subjects younger than 12 years of age. This study is designed to evaluate the safety of dexlansoprazole delayed release capsules in the pediatric population (1 to 11 years old) and to determine if the PK profile of dexlansoprazole in subjects 1 to 11 years of age is similar to that in adults given a similar dose.

Subjects who satisfy the screening evaluation and Inclusion/Exclusion Criteria may be enrolled in the study. Eligible subjects will be assigned to one of three treatment groups. Attempts will be made to enroll an equal number of male and female subjects in each treatment group.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole intervention 3: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days. intervention 2: Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days intervention 3: Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Protocol documents:
Clinical trial NCT01047501
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids EPA docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin Lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin Trilipix Vytorin Simcor Niaspan ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor LDL HDL cholesterol dyslipidemia VASCEPA icosapent ethyl
Sponsor: Amarin Pharma Inc.
Start date: 2009-12-01; Completion date: 2011-02-01
Enrollment: 702 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AMR101 (ethyl icosapentate) - 4 g/day intervention 2: AMR101 (ethyl icosapentate) - 2 g/day intervention 3: Placebo
Intervention descriptions: intervention 1: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks intervention 2: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks intervention 3: Placebo 4 capsules/day for 12 weeks

Protocol documents:
Clinical trial NCT01056289
Conditions: Major Depressive Disorder
Sponsor: Pfizer
Start date: 2010-03-01; Completion date: 2011-02-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg intervention 2: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg intervention 3: Placebo
Intervention descriptions: intervention 1: DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. intervention 2: DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. intervention 3: DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.

Protocol documents:
Clinical trial NCT01056601
Conditions: Pancreatic Cancer
Keywords: insulinoma cancer of pancreas neoplasms, pancreas alpha-cell tumor glucagonoma beta-cell tumor somatostatinoma
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2010-09-01; Completion date: 2011-02-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer cells but the mechanism is not well defined but has been determined to be cytostatic. Combining these two drugs may work together in the treatment of pancreatic cancer.

Detailed description:

Arms: arm 1: Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.
Interventions: intervention 1: Bortezomib intervention 2: Panobinostat
Intervention descriptions: intervention 1: 1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period intervention 2: 20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period

Protocol documents:
Clinical trial NCT01063049
Conditions: Preparation for Colonoscopy
Sponsor: Gastroenterology Services, Ltd.
Start date: 2010-02-01; Completion date: 2011-02-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.

Detailed description:

Arms: arm 1: Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. arm 2: Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. arm 3: Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
Interventions: intervention 1: Gatorade/Miralax intervention 2: NuLytely intervention 3: Bisacodyl intervention 4: Placebo
Intervention descriptions: intervention 1: Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM. intervention 2: Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy. intervention 3: Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon. intervention 4: Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy

Protocol documents:
Clinical trial NCT01071252
Conditions: Chronic Plaque-type Psoriasis
Keywords: Moderate to severe chronic plaque-type psoriasis AIN457 dermatology
Sponsor: Novartis Pharmaceuticals
Start date: 2010-03-01; Completion date: 2011-02-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01074554
Conditions: Sarcoidosis
Keywords: sarcoidosis mycobacteria cutaneous lesions
Sponsor: Vanderbilt University
Start date: 2010-02-01; Completion date: 2011-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Growing research from independent laboratories provide an association between mycobacteria and sarcoidosis. More recent immunologic and molecular studies demonstrate immune responses to mycobacteria virulence factors. The purpose of this study is to assess if administration of anti-mycobacterial drug therapy will aid in resolution of cutaneous sarcoidosis lesions.

Detailed description:
Independent molecular and immunologic investigations strengthen the association between mycobacterial antigens and sarcoidosis pathogenesis. Molecular analysis of sarcoidosis granulomas reveals the presence of Mycobacterium tuberculosis complex (MTB) DNA and proteins that are significantly absent from granulomatous controls. Mycobacterial DNA has been detected in cutaneous sarcoidosis lesions, in addition to systemic immune responses against mycobacterial antigens. Due to the association between sarcoidosis and mycobacterial antigens, we postulated that broad spectrum antimycobacterial therapy could lead to restoration of T cell function and clinical improvement of chronic cutaneous sarcoidosis lesions. We investigated the safety and efficacy of Concomitant Levofloxacin, Ethambutol, Azithromycin, and Rifampin (CLEAR) therapy among chronic cutaneous sarcoidosis subjects, with change in lesion diameter from baseline to completion of 8 weeks of therapy as the primary endpoint; we assessed for decreases in granuloma burden, if granulomas were evident upon histologic examination. Change in modified Sarcoidosis Activity Severity Index (SASI) was the secondary endpoint.

Arms: arm 1: The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.

All four drugs are given concomitantly. arm 2: The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
Interventions: intervention 1: Antibiotic Regimen intervention 2: Placebo Regimen
Intervention descriptions: intervention 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg QD Azithromycin 500mg on day 1, then 250 mg po QD Rifampin 5-10 mg/kg for a maximum of 300mg po QD All four drugs are given concomitanly intervention 2: lactose control tablets; one for each antibiotic with equivalent pills

Protocol documents:
Clinical trial NCT01093976
Conditions: Trichotillomania Obsessive Compulsive Disorder
Keywords: Skin Picking OCD Trichotillomania Pathological Skin Picking
Sponsor: University of Chicago
Start date: 2010-04-01; Completion date: 2011-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with these disorders. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed description:
The study consists of twelve weeks of open-label dronabinol. All eligible study subjects will be started on open-label dronabinol 2.5mg/day for 3 weeks. The dose will be increased to 5mg/day at visit 2 (Week 3), to10mg/day at visit 3 (Week 6), and to 15mg/day at Visit 4 (Week 9) unless clinical improvement is attained at a lower dose (clinical improvement will be assessed by the investigator with respect to obsessive thoughts, urges and compulsive behaviors). Subjects will be seen every three weeks during the 12-week, open-label study. All efficacy and safety assessments will be performed at each visit. Subjects who are not compliant with their use of study medication (i.e. failing to take medication for three or more consecutive days) will be discontinued from the study.

Laboratory testing, including liver function tests, a blood chemistry panel, and urine toxicology will be completed for subjects at baseline if in the opinion of the study physician the medical history of the subject warrants such tests for their safety. All females, regardless of age, will undergo a urine pregnancy test at screening and all subjects will be required to do a urine drug screen at the screening visit to test for drugs of abuse.

At study conclusion, subjects will be given the option to continue on medication (via prescription) if covered by insurance, and will then be followed in our clinic or referred to another psychiatrist. All study subjects will be offered follow-up care with CBT and/or medication in our outpatient clinic (if covered by insurance) or be given a list of appropriate referrals in the community.

Arms: arm 1: Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Interventions: intervention 1: Dronabinol
Intervention descriptions: intervention 1: 2.5mg-15mg by mouth once a day for twelve-weeks

Protocol documents:
Clinical trial NCT01113541
Conditions: Bipolar Disorder
Keywords: Ziprasidone Bipolar Disorder Metabolic Syndrome
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-07-01; Completion date: 2011-02-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Detailed description:
The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone HCL (oral)
Intervention descriptions: intervention 1: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.

Protocol documents: