ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00878878
Conditions: Pulmonary Hypertension
Keywords: Pulmonary artery systolic pressure (PASP) Pulmonary Vascular Resistance (PVR) Right Heart Catheterization Pulmonary hemodynamics
Sponsor: GE Healthcare
Start date: 2009-03-01; Completion date: 2010-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) intervention 2: Dextrose
Intervention descriptions: intervention 1: Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison. intervention 2: Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose.

Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Protocol documents:
Clinical trial NCT00882518
Conditions: Schizophrenia
Keywords: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) qualified PANSS assessment
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2010-07-01
Enrollment: 388 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Detailed description:

Arms: arm 1: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day) arm 2: Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)
Interventions: intervention 1: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) intervention 2: Chlorpromazine
Intervention descriptions: intervention 1: 200 mg or 300 mg, oral, single dose intervention 2: 50 mg, oral, double dose

Protocol documents:
Clinical trial NCT00889720
Conditions: Smoking Cessation
Keywords: smoking cessation varenicline elective surgery wound infections post-operative complications
Sponsor: Pfizer
Start date: 2009-11-01; Completion date: 2010-07-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

Detailed description:
Recruitment to this study was terminated (on February 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. The decision to end recruitment to the trial was not based on any safety concerns.

Arms: arm 1: None
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd

Protocol documents:
Clinical trial NCT00895752
Conditions: Fragile X Syndrome
Sponsor: Indiana University
Start date: 2009-04-01; Completion date: 2010-07-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effectiveness and tolerability of riluzole in adults with Fragile X Syndrome.

Detailed description:
Fragile X Syndrome (FXS) represents the most common inherited form of intellectual disability. FXS is more common in males and the symptoms associated with the disorder are more marked in males. FXS is associated with characteristic physical features, behaviors, and comorbidities. Those with FXS often suffer from behavioral difficulties that include anxiety-related symptoms (shyness, social phobia, obsessive-compulsive disorder (OCD) symptoms), attention deficit hyperactivity symptoms (overarousal, hyperactivity, distractibility, impulsivity) and aggressive/self-injurious behaviors.

Riluzole is approved by the FDA for use in treating amyotrophic lateral sclerosis (ALS) in adults. Recently, riluzole has been the subject of several open-label studies describing the use of the drug in treatment-resistant depression and OCD.

Given the overlap between repetitive behavior in FXS and symptoms of OCD, it is logical to study riluzole in FXS given the compound's promise in ameliorating treatment-refractory symptoms of OCD.

Arms: arm 1: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
Interventions: intervention 1: Riluzole
Intervention descriptions: intervention 1: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.

Protocol documents:
Clinical trial NCT00902486
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Sponsor: Incyte Corporation
Start date: 2009-05-01; Completion date: 2010-07-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.

Detailed description:

Arms: arm 1: INCB028050 4mg Once daily (QD) arm 2: INCB028050 7mg QD arm 3: INCB028050 10mg QD arm 4: Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
Interventions: intervention 1: INCB028050 intervention 2: INCB028050 intervention 3: INCB028050 intervention 4: Placebo
Intervention descriptions: intervention 1: 4 mg capsules QD intervention 2: 7 mg capsules QD intervention 3: 10 mg capsule QD intervention 4: Placebo matching INCB028050 QD

Protocol documents:
Clinical trial NCT00918879
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors HbA1c Incretins
Sponsor: AstraZeneca
Start date: 2009-05-01; Completion date: 2010-07-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.

Detailed description:

Arms: arm 1: Saxagliptin arm 2: None
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet, once daily for 24 weeks intervention 2: Oral tablet, once daily for 24 weeks

Protocol documents:
Clinical trial NCT00920309
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal Dominant Polycystic Kidney Disease rapamycin ADPKD
Sponsor: Yale University
Start date: 2009-06-01; Completion date: 2010-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation.

This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment.

Detailed description:
This is a 2 year, open label trial to evaluate the role of rapamycin as treatment for ADPKD. Patients will be randomized 2:1 to the rapamycin arm or to standard therapy. The dose of rapamycin will be adjusted so that patients obtain 24 trough levels of 4-6ng/ml. There will be a volumetric MRI measurement at the start and end of the treatment period. Patients will be monitored every 4 months throughout the study.

Arms: arm 1: Drug: Rapamycin

Other Names:

sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml. arm 2: Standard of Care
Interventions: intervention 1: Rapamycin intervention 2: Standard of Care-Placebo
Intervention descriptions: intervention 1: The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml. intervention 2: None

Protocol documents:
Clinical trial NCT00924612
Conditions: Male Hypogonadism
Keywords: Primary hypogonadism Secondary hypogonadism
Sponsor: Clarus Therapeutics, Inc.
Start date: 2009-07-01; Completion date: 2010-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Detailed description:
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Arms: arm 1: Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state arm 2: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with very low fat (6-10% fat). arm 3: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with low fat (20% fat). arm 4: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with normal fat (30% fat). arm 5: Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \~800 calories with high fat (50% fat).
Interventions: intervention 1: Oral testosterone undecanoate (containing 300 mg T)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00925990
Conditions: Hepatitis C
Keywords: HCV interferon-naive
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2009-06-01; Completion date: 2010-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.

Detailed description:
There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.

This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.

Arms: arm 1: Study drug plus ribavirin arm 2: Study drug plus placebo for ribavirin
Interventions: intervention 1: ribavirin intervention 2: CTS-1027 intervention 3: Placebo for ribavirin
Intervention descriptions: intervention 1: 200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks intervention 2: 5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks intervention 3: Capsules identical to ribavirin in appearance containing inactive ingredients

Protocol documents:
Clinical trial NCT00933686
Conditions: Fibromyalgia
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2007-12-01; Completion date: 2010-07-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saizen® intervention 2: Placebo and Saizen®
Intervention descriptions: intervention 1: Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9. intervention 2: Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9.

Protocol documents:
Clinical trial NCT00937859
Conditions: Nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2009-06-01; Completion date: 2010-07-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Detailed description:

Arms: arm 1: SER120 arm 2: None
Interventions: intervention 1: SER120 intervention 2: Placebo
Intervention descriptions: intervention 1: SER120 intervention 2: Placebo

Protocol documents:
Clinical trial NCT00984659
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive Dyspnea
Sponsor: GlaxoSmithKline
Start date: 2009-10-29; Completion date: 2010-07-01
Enrollment: 366 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

Detailed description:
Dyspnea, referred to by patients as "shortness of breath" or "breathlessness," is frequently associated with decreases in functional status, quality of life, and disabilities. Currently available questionnaires do not specifically address the shortness of breath component of COPD. The development of a patient reported outcome questionnaire that will specifically assess Shortness of Breath with Daily Activities (SOBDA) in patients with COPD is needed.

Arms: arm 1: Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day arm 2: Salmeterol 50mcg DISKUS twice a day arm 3: Placebo DISKUS twice a day
Interventions: intervention 1: Fluticasone propionate/salmeterol combination product intervention 2: Salmeterol intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks intervention 2: Salmeterol 50mcg DISKUS twice a day for 8 weeks intervention 3: Placebo DISKUS twice a day for 8 weeks

Protocol documents:
Clinical trial NCT00986583
Conditions: Pain
Keywords: Succinylcholine Statins myalgias statins with succinylcholine and pain
Sponsor: The Cleveland Clinic
Start date: 2009-09-01; Completion date: 2010-07-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.

Detailed description:

Arms: arm 1: Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months. arm 2: Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.
Interventions: intervention 1: Succinylcholine
Intervention descriptions: intervention 1: Succinylcholine will be administered pre-induction over a period of 5 seconds

Protocol documents:
Clinical trial NCT00989833
Conditions: Exercise Induced Asthma
Keywords: Exercise induced asthma Mild intermittent asthma Exercise induced bronchoconstriction
Sponsor: AstraZeneca
Start date: 2009-09-01; Completion date: 2010-07-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1. The primary objective of this study is:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
2. The secondary objectives of this study are:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
   * To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event

Detailed description:

Arms: arm 1: budesonide 400yg + terbutaline 0.4 mg as-needed arm 2: placebo + terbutaline 0.4 mg as-needed arm 3: placebo + budesonide/formoterol 160/4.5 yg as-needed
Interventions: intervention 1: budesonide intervention 2: terbutaline intervention 3: budesonide/formoterol
Intervention descriptions: intervention 1: 400 yg x 1 intervention 2: 0.4 mg as-needed intervention 3: 160/4.5 yg as-needed

Protocol documents:
Clinical trial NCT00993226
Conditions: Postoperative Pain
Keywords: Postoperative pain Local anaesthesia Postoperative pain after open abdominal hysterectomy surgery
Sponsor: Durect
Start date: 2009-05-01; Completion date: 2010-07-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.

Detailed description:

Arms: arm 1: double-blind arm 2: double-blind arm 3: double-blind arm 4: double-blind arm 5: double-blind arm 6: double-blind
Interventions: intervention 1: SABER-Bupivacaine Treatment 1a intervention 2: Placebo SABER-Bupivacaine Treatment 1b intervention 3: Bupivacaine HCl Treatment 1c intervention 4: SABER-Bupivacaine Treatment 2a intervention 5: Placebo SABER-Bupivacaine Treatment 2b intervention 6: Bupivacaine HCl Treatment 2c
Intervention descriptions: intervention 1: 5.0 ml intervention 2: 5.0 ml intervention 3: 40 ml intervention 4: 7.5 ml intervention 5: 7.5 ml intervention 6: 40 ml

Protocol documents:
Clinical trial NCT00995709
Conditions: Behcet Disease
Keywords: Behçet's disease, intermediate uveitis panuveitis posterior uveitis uveitis
Sponsor: Novartis Pharmaceuticals
Start date: 2009-10-01; Completion date: 2010-07-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.

Detailed description:

Arms: arm 1: AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. every 2 weeks arm 2: AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg e arm 3: Placebo was administered in 2 s.c. injections every 2 weeks
Interventions: intervention 1: AIN457 intervention 2: AIN457 intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01024244
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2009-12-01; Completion date: 2010-07-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help answer the following questions:

* To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo for 12 weeks.
* To evaluate the safety of LY2599506 in participants with diabetes.
* To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
* To determine how much LY2599506 should be given to participants.
* To determine if LY2599506 has an effect on a participant's weight.

The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow-up period.

Detailed description:

Arms: arm 1: Participants received 2 placebo capsules by mouth (po), twice daily (BID), prior to morning and evening meals for 12 weeks. arm 2: Participants received 50-mg capsules of LY2599506 po BID (One 50 mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. arm 3: Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. arm 4: Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. arm 5: Participants received 200-mg of LY2599506 po once daily (QD) (Two 100 mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Interventions: intervention 1: Placebo intervention 2: LY2599506
Intervention descriptions: intervention 1: Administered po BID, prior to morning and evening meals for 12 weeks. intervention 2: Administered po for 12 weeks

Protocol documents: