ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00183625
Conditions: Schizophrenia
Keywords: Antipsychotic Agents Employment
Sponsor: University of California, Los Angeles
Start date: 2000-06-01; Completion date: 2006-09-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.

Detailed description:
Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support may be effective in helping people with schizophrenia maintain a stable job. Risperidone and olanzapine are antipsychotic drugs; participants in this study will be taking either risperidone or olanzapine for the duration of the study. This study will provide schizophrenia patients with employment support alone or with behavioral skills training to determine which combination is more effective in helping patients obtain and maintain a job.

At study entry, participants will undergo a clinical and diagnostic evaluation to determine the severity of their schizophrenia. Participants will be tapered off their regular medication for schizophrenia over 4 weeks. At the end of Week 4, they will be randomly assigned to receive either risperidone or olanzapine. Participants will then be assigned an Individual Placement and Support (IPS) specialist to assist them in finding a job. After participants secure a job, they will be randomly assigned to receive IPS either alone or with the Workplace Fundamentals Skills Training Module for 2 years. Participants' risperidone or olanzapine treatment will continue during this 2-year period. Participants will have clinic visits at study entry and Months 7, 12, and 24. At each visit, participants will complete questionnaires and will be interviewed about their schizophrenia symptoms and occupational functioning.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Individual Placement and Support (Supported Employment) intervention 2: Social Skills Training intervention 3: Olanzapine intervention 4: Risperidone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00194129
Conditions: Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 1997-11-01; Completion date: 2006-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.

Detailed description:
Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients are initially stabilized on dual therapy of lithium and depakote and then randomly assigned to double-blind treatment with either lithium monotherapy or continued dual therapy. Patients remain in the study for six months or until they experience a relapse. Patients in this study are required to bring a friend or family member to all study visits as well as attend chemical dependency services. This study is sponsored by the NIMH. Subjects receive study-related care at no cost.

Arms: arm 1: Patients assigned to the combination group were continued on lithium and blinded divalproex. arm 2: Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.
Interventions: intervention 1: Lithium intervention 2: Divalproex intervention 3: Placebo
Intervention descriptions: intervention 1: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. intervention 2: Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml. intervention 3: Placebo pills that looked exact to divaloproex were provided to subjects and take twice daily.

Protocol documents:
Clinical trial NCT00245570
Conditions: Asthma, Exercise-Induced
Sponsor: Organon and Co
Start date: 2005-12-01; Completion date: 2006-09-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

Detailed description:

Arms: arm 1: Montelukast - Salmeterol - Placebo arm 2: Montelukast - Placebo - Salmeterol arm 3: Salmeterol - Montelukast - Placebo arm 4: Salmeterol - Placebo - Montelukast arm 5: Placebo - Montelukast - Salmeterol arm 6: Placebo - Salmeterol - Montelukast
Interventions: intervention 1: Comparator: Montelukast intervention 2: Comparator: Salmeterol intervention 3: Comparator: Placebo (montelukast) intervention 4: Comparator: Placebo (salmeterol)
Intervention descriptions: intervention 1: 1 dose montelukast 10 mg tablet given orally in one of three treatment periods intervention 2: 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods intervention 3: 1 dose matching-image placebo to montelukast tablet in two of three treatment periods intervention 4: 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods

Protocol documents:
Clinical trial NCT00257660
Conditions: Cervical Dystonia
Sponsor: Ipsen
Start date: 2005-10-10; Completion date: 2006-09-01
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Detailed description:

Arms: arm 1: Drug: abobotulinumtoxinA (Dysport®) arm 2: Placebo
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: 500 units intervention 2: 500 units

Protocol documents:
Clinical trial NCT00260962
Conditions: Anorexia Nervosa
Keywords: Pilot Project, Clinical Trial, Treatment Outcome, Psychopharmacology
Sponsor: Ottawa Hospital Research Institute
Start date: 2000-09-01; Completion date: 2006-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Detailed description:
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.

Arms: arm 1: Placebo and Treatment as usual (Day Hospital Program). After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy. arm 2: After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Interventions: intervention 1: Olanzapine intervention 2: Day Hospital
Intervention descriptions: intervention 1: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day. intervention 2: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.

Protocol documents:
Clinical trial NCT00462644
Conditions: Adrenal Insufficiency
Keywords: adrenal insufficiency etomidate rapid sequence induction
Sponsor: University of Tennessee
Start date: 2006-02-01; Completion date: 2006-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in trauma patients.

Detailed description:
The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholine for RSI. Both drug regimens have a rapid onset, short duration and short half-life.

Patients will be randomly assigned to one arm of the study. The trauma nurse emergency room responders, intensive care unit staff, or helicopter crew will pull a study envelope which will contain a randomization to either the etomidate arm or standard therapy arm. The numbers will correspond to a log, delineating which medication is given. The nurse will document the medication as RSI Study Drug - etomidate or RSI Study Drug - standard and the randomization packet number (ie, RSI Study Drug, etomidate, #1, RSI Study Drug, standard, #2, etc.) and will document the patient's name and medical record number on the study log in either the helicopter or the ER Resuscitation Bay.

Baseline cortisol level will be drawn prior to RSI. An additional cortisol level will be drawn 4-6 hours later. Following this level, a cortrosyn stimulation test will be performed by giving 0.25 mg cortrosyn IV and rechecking a cortisol level in 60 minutes. Adrenal insufficiency will be defined as a baseline cortisol level of \<15 or an increase in cortisol of \<9 after cortrosyn administration. Patients will be monitored for 24 hours for hemodynamics, IV fluid administration , and use of vasopressors. Patient will be resuscitated to adequate mean arterial blood pressure and urine output. Any patient found to be adrenal insufficient will be treated with hydrocortisone 50 mg IV every 6 hours.

Arms: arm 1: Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications arm 2: Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
Interventions: intervention 1: RSI sedation with etomidate/succinylcholine intervention 2: RSI sedation with fentanyl/midazolam/succinylcholine
Intervention descriptions: intervention 1: etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV intervention 2: 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV

Protocol documents:
Clinical trial NCT00637728
Conditions: Anorexia Cachexia Weight Loss
Keywords: Megestrol acetate Anorexia Cachexia Lung cancer Pancreatic cancer Unintended weight loss Body weight Appetite Megace ES
Sponsor: Par Pharmaceutical, Inc.
Start date: 2006-06-01; Completion date: 2006-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

Detailed description:

Arms: arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Placebo suspension
Interventions: intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Placebo
Intervention descriptions: intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Placebo oral suspension, 5 mL once daily

Protocol documents:
Clinical trial NCT00637806
Conditions: Anorexia Cachexia Weight Loss
Keywords: Megestrol acetate Anorexia Cachexia Cancer Unintended weight loss Body weight Appetite Megace ES
Sponsor: Par Pharmaceutical, Inc.
Start date: 2006-06-01; Completion date: 2006-09-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Detailed description:

Arms: arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Megestrol acetate concentrated suspension 60 mg/mL arm 3: None
Interventions: intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Megestrol acetate concentrated suspension 60 mg/mL intervention 3: Placebo
Intervention descriptions: intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 3: Placebo oral suspension, 5 mL once daily

Protocol documents:
Clinical trial NCT00675948
Conditions: Pain Cancer
Keywords: Palliative Care Pain Cancer
Sponsor: Jazz Pharmaceuticals
Start date: 2002-04-01; Completion date: 2006-09-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

Detailed description:
Subjects who have previously participated in GWCA0101, a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® (containing delta-9-tetrahydrocannabinol \[THC\] and cannabidiol \[CBD\]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.

Arms: arm 1: Active treatment arm 2: Active treatment
Interventions: intervention 1: Sativex intervention 2: GW-2000-02
Intervention descriptions: intervention 1: Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both as extract of Cannabis sativa L.

Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours. intervention 2: Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

Protocol documents:
Clinical trial NCT00685334
Conditions: Eating Disorders
Keywords: Atypical Antipsychotics Anorexia Nervosa
Sponsor: New York State Psychiatric Institute
Start date: 2003-11-01; Completion date: 2006-09-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.

Detailed description:
Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to extreme weight loss and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in treating people with AN. Specifically, the atypical antipsychotic medications olanzapine and aripiprazole may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of olanzapine and aripiprazole in treating people with AN.

Participation in this study will last 12 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 12 weeks of treatment with daily olanzapine or aripiprazole. Participants will meet with a study doctor weekly over the 12 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. In addition, participants will undergo repeat blood draws every 4 weeks and repeat questionnaires every month of the treatment period. Upon completing the 12 weeks of treatment, participants will repeat most baseline assessments.

Arms: arm 1: Participants will take olanzapine arm 2: Participants will take aripiprazole
Interventions: intervention 1: Olanzapine intervention 2: Aripiprazole
Intervention descriptions: intervention 1: Participants will take olanzapine daily for 12 weeks. intervention 2: Participants will take aripiprazole daily for 12 weeks.

Protocol documents:
Clinical trial NCT00945750
Conditions: Heartburn
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-08-01; Completion date: 2006-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg FCT with water.

Detailed description:

Arms: arm 1: Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). arm 2: Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3). arm 3: Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). arm 4: Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 3). arm 5: Participants received famotidine 20 mg CT as a single dose without water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Period 3). arm 6: Participants received famotidine 20 mg CT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water (Period 3).
Interventions: intervention 1: Famotidine FCT intervention 2: Famotidine CT
Intervention descriptions: intervention 1: Famotidine 20 mg oral film-coated tablet taken once daily intervention 2: Famotidine 20 mg oral chewable tablet taken once daily

Protocol documents:
Clinical trial NCT00981214
Conditions: Cystic Fibrosis Exocrine Pancreatic Insufficiency
Keywords: Cystic fibrosis Exocrine Pancreatic Insufficiency Zenpep-1009
Sponsor: Forest Laboratories
Start date: 2006-05-01; Completion date: 2006-09-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Detailed description:
The study sample will consist of evaluable participants, all of whom will be children younger than 7 years of age. Participants will receive EUR-1008 (APT-1008) Microtabs formulation. The study design involves a 4-day screening period, a 7-day dose stabilization period, and a 7-day treatment period (excluding an end-of-study evaluation).

The optimal dose of EUR-1008 (APT-1008) Microtabs, determined during the dose stabilization period, will be used during the treatment period. Participants are instructed to consume a predefined diet.

Arms: arm 1: None
Interventions: intervention 1: EUR-1008 (APT-1008)
Intervention descriptions: intervention 1: EUR-1008 (APT-1008) Microtabs contained in a capsule will be administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule will be allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).

Protocol documents: