ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00646282
Conditions: Hyperparathyroidism, Secondary
Sponsor: Emory University
Start date: 2008-04-01; Completion date: 2010-01-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation. As a consequence, they can develop an endocrine disorder called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures. In spite of the known bone disease and hyperparathyroidism, there is no well defined treatment for these patients.

Moreover, kidney transplant recipients present a higher mortality rate compared to the general population, and the principal cause of death is cardiovascular disease. Dialysis patients are known to have extensive cardiovascular calcifications and increased vascular stiffness, and these factors have been closely associated with cardiovascular mortality.

The effect of vitamin D on bone health is well known in the general population. Many studies showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin D and calcium supplements. Vitamin D analogues are also commonly used to treat hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients.

Hectorol® is a vitamin D analog which has been demonstrated to effectively treat hyperparathyroidism in dialysis and pre-dialysis patients.

The effects of vitamin D supplementation on bone disease, hyperparathyroidism and cardiovascular function in kidney transplant recipients have not been properly studied.

Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular function in kidney transplant recipients is still unknown.

Detailed description:
The investigators plan to study the cardiovascular and bone effects of Hectorol® in 100 kidney transplant recipients. The kidney transplant patients will be screened for kidney transplant dysfunction and hyperparathyroidism. The study medication will be given to 50 patients. The other 50 patients will continue to be treated with the actual standard of care at the transplant clinic. Subjects will be followed for 18 months and their laboratory values, bone density, vascular calcification and stiffness will be collected to see if there is an effect of Hectorol® compared to the actual standard of care.

Arms: arm 1: Stable kidney transplant recipients will receive Doxercalciferol arm 2: Stable kidney transplant recipients will not receive any drug
Interventions: intervention 1: doxercalciferol
Intervention descriptions: intervention 1: The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.

Protocol documents:
Clinical trial NCT00646581
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Memory Concentration Insulin
Sponsor: University of Massachusetts, Worcester
Start date: 2006-10-01; Completion date: 2010-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:

1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory.
2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level

Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.

Detailed description:
Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning in this patient with schizophrenia.

Arms: arm 1: Subjects are given a one-time, single dose of placebo intranasal spray arm 2: Subjects are given a one-time, single dose of intranasal insulin
Interventions: intervention 1: Placebo intervention 2: Insulin (Humulin)
Intervention descriptions: intervention 1: Placebo intervention 2: 40 IU Intranasal Insulin will be administered once

Protocol documents:
Clinical trial NCT00647556
Conditions: Photoaging
Sponsor: Galderma R&D
Start date: 2008-04-01; Completion date: 2010-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Detailed description:
Same as above.

Arms: arm 1: adapalene arm 2: Tretinoin
Interventions: intervention 1: adapalene gel, 0.3% intervention 2: tretinoin 0.05% emollient cream
Intervention descriptions: intervention 1: applied topically once daily in the evening intervention 2: applied topically once daily in the evening

Protocol documents:
Clinical trial NCT00652080
Conditions: Squamous Cell Carcinoma
Sponsor: BPGbio
Start date: 2008-06-01; Completion date: 2010-01-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound 31510 in a topical cream when applied to in situ cutaneous squamous cell carcinoma and to obtain preliminary efficacy data for the treatment of in situ cutaneous squamous cell carcinoma by Compound 31510 topical cream.

Detailed description:

Arms: arm 1: Active Cream 3%; AM \& PM
Interventions: intervention 1: API 31510
Intervention descriptions: intervention 1: Topical Cream; 3% active; AM \& PM application

Protocol documents:
Clinical trial NCT00654381
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-04-01; Completion date: 2010-01-01
Enrollment: 561 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Detailed description:

Arms: arm 1: patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356 arm 2: patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose arm 3: patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose arm 4: patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Interventions: intervention 1: BI 1356 intervention 2: BI 1356 intervention 3: voglibose placebo intervention 4: BI 1356 placebo intervention 5: voglibose
Intervention descriptions: intervention 1: 5 mg/daily intervention 2: 10 mg/daily intervention 3: three times daily intervention 4: once daily intervention 5: 0.6 mg/daily

Protocol documents:
Clinical trial NCT00655564
Conditions: Psoriasis
Sponsor: Wake Forest University
Start date: 2008-05-01; Completion date: 2010-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.

Detailed description:
To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).

Arms: arm 1: Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
Interventions: intervention 1: Alefacept
Intervention descriptions: intervention 1: Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.

Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).

Protocol documents:
Clinical trial NCT00656630
Conditions: Alcoholism
Sponsor: The Scripps Research Institute
Start date: 2007-12-01; Completion date: 2010-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.

Detailed description:
This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.

Arms: arm 1: Acamprosate arm 2: Naltrexone arm 3: None
Interventions: intervention 1: Acamprosate intervention 2: Naltrexone intervention 3: Placebo
Intervention descriptions: intervention 1: Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration intervention 2: 50mg capsule, Once daily, 1 week duration intervention 3: Matched placebo capsule, 1 week duration

Protocol documents:
Clinical trial NCT00658528
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD erosive GERD erosive esophagitis
Sponsor: Eisai Inc.
Start date: 2008-02-01; Completion date: 2010-01-01
Enrollment: 1061 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

Detailed description:
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rabeprazole sodium intervention 2: Esomeprazole
Intervention descriptions: intervention 1: Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.

Protocol documents:
Clinical trial NCT00658775
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD erosive GERD erosive esophagitis
Sponsor: Eisai Inc.
Start date: 2008-02-01; Completion date: 2010-01-01
Enrollment: 1069 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Detailed description:
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rabeprazole sodium intervention 2: Esomeprazole
Intervention descriptions: intervention 1: Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

Protocol documents:
Clinical trial NCT00663052
Conditions: Plaque Psoriasis Psoriasis
Keywords: Enbrel Psoriasis Topical Psoriasis Wyeth Psoriasis Active Psoriasis
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2010-01-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Detailed description:

Arms: arm 1: A arm 2: B
Interventions: intervention 1: Etanercept intervention 2: Etanercept
Intervention descriptions: intervention 1: ETN 50 mg QW + PBO QW for 12 weeks followed by ETN 50 mg QW for 12 weeks. intervention 2: ETN 50 mg BIW for 12 weeks folowed ETN 50 mg QW for 12 weeks.

Protocol documents:
Clinical trial NCT00663858
Conditions: Benign Prostatic Hypertrophy
Sponsor: AEterna Zentaris
Start date: 2008-03-01; Completion date: 2010-01-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cetrorelix 78+78 intervention 2: Cetrorelix 78 + Placebo intervention 3: Placebo
Intervention descriptions: intervention 1: Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) intervention 2: Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28 intervention 3: Placebo on Week 0, Week 2, Week 26 and Week 28

Protocol documents:
Clinical trial NCT00666848
Conditions: Metabolic Syndrome Hypertension
Keywords: Metabolic syndrome Hypertension Sitagliptin Enalapril
Sponsor: Vanderbilt University
Start date: 2008-03-01; Completion date: 2010-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on blood pressure in people already taking a blood pressure medication called an ACE inhibitor.

Detailed description:
The prevalence of metabolic syndrome and Type 2 diabetes mellitus (T2DM) has reached epidemic proportions in developed countries and is closely associated with hypertension. As new oral hypoglycemic agents become available for clinical use, practitioners wishing to treat both hyperglycemia and hypertension will use varieties of combinations of medications. In this setting, understanding interactions and additive effects of these medications becomes essential. Sitagliptin, a selective dipeptidyl peptidase-IV (DPP-4) inhibitor, improves glycemic control in patients with T2DM by decreasing the degradation of the incretin hormones. The incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) augment nutrient mediated insulin release. To date there have been two reports of a blood pressure lowering effect of the DPP-4 inhibitor vildagliptin, but no mechanism for this effect has been proposed.

Specific Aim 1: To test the hypothesis that the DPP-4 inhibitor sitagliptin lowers blood pressure compared to placebo therapy in subjects with the metabolic syndrome.

Specific Aim 2: To test the hypothesis that the DPP-4 inhibitor sitagliptin potentiates the blood pressure response to acute ACE-inhibition.

Arms: arm 1: Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior . arm 2: Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior. arm 3: Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
Interventions: intervention 1: Placebo intervention 2: Enalapril 5mg intervention 3: Enalapril 10mg intervention 4: Sitagliptin
Intervention descriptions: intervention 1: Enalapril 0mg after 5 days of placebo versus after 5 days sitagliptin 100mg/d intervention 2: Enalapril 5 mg after 5 days placebo versus after 5 days sitagliptin 100mg/d intervention 3: Enalapril 10mg after 5 days placebo versus after 5 days sitagliptin 100 mg/d intervention 4: Sitagliptin 100mg/day for 5 days crossed over to placebo daily for 5 days prior to arms.

Protocol documents:
Clinical trial NCT00668317
Conditions: Cough
Keywords: Hyper-responsiveness, reflux cough
Sponsor: Hull University Teaching Hospitals NHS Trust
Start date: 2006-09-01; Completion date: 2010-01-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.

Detailed description:

Arms: arm 1: 20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte
Interventions: intervention 1: Omeprazole intervention 2: Ranitidine
Intervention descriptions: intervention 1: 20 mg BD tablet 8 weeks duration intervention 2: 300 mg od nocte tablet 8weeks duration

Protocol documents:
Clinical trial NCT00682890
Conditions: Polycystic Ovary Syndrome PCOS Insulin Sensitivity
Sponsor: Virginia Commonwealth University
Start date: 2005-11-01; Completion date: 2010-01-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS

Detailed description:
Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.

Arms: arm 1: Placebo tablet and birth control pill daily arm 2: metformin 2000 mg and birth control pill daily
Interventions: intervention 1: placebo intervention 2: metformin
Intervention descriptions: intervention 1: placebo birth control pill daily intervention 2: 2000 mg per day for 3 months daily birth control pill

Protocol documents:
Clinical trial NCT00688740
Conditions: Breast Cancer
Keywords: adjuvant treatment
Sponsor: Sanofi
Start date: 1997-06-01; Completion date: 2010-01-01
Enrollment: 1491 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.

Detailed description:
In addition to the 5-year analysis conducted in September 2003, two other analyses were planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis at 10 years was considered more appropriate than an event-based (700 Disease Free Survival events) analysis.

Arms: arm 1: docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment arm 2: 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment
Interventions: intervention 1: Docetaxel intervention 2: 5-fluorouracil intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: intravenous intervention 2: intravenous intervention 3: intravenous intervention 4: intravenous

Protocol documents:
Clinical trial NCT00691002
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2008-05-01; Completion date: 2010-01-01
Enrollment: 1245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).

Detailed description:

Arms: arm 1: Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) arm 2: Ointment Vehicle arm 3: Calcipotriol 25 mcg/g in the ointment vehicle arm 4: Hydrocortisone 10 mg/g in the ointment vehicle
Interventions: intervention 1: Calcipotriol plus hydrocortisone (LEO 80190) intervention 2: LEO 80190 Vehicle intervention 3: Hydrocortisone intervention 4: Calcipotriol
Intervention descriptions: intervention 1: Once daily application intervention 2: None intervention 3: None intervention 4: None

Protocol documents: