ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00640315
Conditions: Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease COPD Pulmonary hypertension
Sponsor: Bayer
Start date: 2008-08-01; Completion date: 2009-09-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).

Detailed description:
In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed:

* Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood cell (WBC), partial thromboplastin time (PTT), prothrombin time (Quick), international normalized ratio (INR) (prothrombin time expressed in relation to normal value) ;
* Clinical chemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), gamma glutamyl transpeptidase (GGT), creatine phosphokinase (CK), lipase, cholinesterase (CHE), glucose, creatinine, urea, uric acid, bilirubin, total protein, serum albumin, sodium, potassium, calcium, chloride.

And due to the small number of subjects analyzed at several local labs, no summary statistics were provided.

Arms: arm 1: Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3. arm 2: Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) 1.0 mg intervention 2: Riociguat (Adempas, BAY63-2521) 2.5 mg
Intervention descriptions: intervention 1: 1.0 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3). intervention 2: 2.5 mg BAY63-2521 will be given twice per subject, as single dose administration during the hemodynamic investigation (on study day 1) and during the lung function testing (on study day 3).

Protocol documents:
Clinical trial NCT00642902
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis Atacicept
Sponsor: EMD Serono
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept
Intervention descriptions: intervention 1: Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks. intervention 2: Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks. intervention 3: Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks. intervention 4: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.

Protocol documents:
Clinical trial NCT00654355
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis eczema
Sponsor: Wake Forest University
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.

Detailed description:
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.

Arms: arm 1: tacrolimus ointment
Interventions: intervention 1: tacrolimus ointment
Intervention descriptions: intervention 1: tacrolimus ointment to be applied twice daily to affected areas during duration of study

Protocol documents:
Clinical trial NCT00655551
Conditions: Partial Epilepsies Partial Onset Seizures
Keywords: epilepsy seizures Lacosamide Vimpat intravenous
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

Detailed description:
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.

Arms: arm 1: Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily arm 2: Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily arm 3: Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Interventions: intervention 1: lacosamide intervention 2: lacosamide intervention 3: lacosamide
Intervention descriptions: intervention 1: Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days intervention 2: Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days intervention 3: Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days

Protocol documents:
Clinical trial NCT00657150
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2008-03-01; Completion date: 2009-09-01
Enrollment: 2055 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.

Detailed description:

Arms: arm 1: 220 mg once daily arm 2: 40 mg once daily
Interventions: intervention 1: Enoxaparin intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: 40 mg once daily intervention 2: 220 mg once daily

Protocol documents:
Clinical trial NCT00658632
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD erosive GERD erosive esophagitis
Sponsor: Eisai Inc.
Start date: 2008-02-01; Completion date: 2009-09-01
Enrollment: 1397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with 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 mild to moderate erosive Gastroesophageal Reflux Disease (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, once daily for 4-8 weeks. intervention 2: Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

Protocol documents:
Clinical trial NCT00661362
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors HbA1c Incretins
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2009-09-01
Enrollment: 570 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 patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Detailed description:

Arms: arm 1: Metformin + Saxagliptin arm 2: Metformin + Placebo
Interventions: intervention 1: Saxagliptin intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: Oral tablet, once daily for 24 weeks intervention 2: oral tablet, once daily for 24 weeks intervention 3: oral tablet, once daily for 24 weeks

Protocol documents:
Clinical trial NCT00662259
Conditions: Generalized Anxiety Disorder
Keywords: Anxiety disorders Generalized anxiety
Sponsor: University of California, San Diego
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.

Detailed description:
This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to measure the response to a known, FDA approved marketed anxiolytic. As such, this is not a study testing safety and efficacy of an approved medicine; it is a study to evaluate the usefulness of fMRI (a non-significant risk device procedure) to correlate the clinical/behavioral effects of a marketed anxiolytic with brain activity assessed by magnetic resonance imaging. fMRI is a more direct measure of brain function than behavior, outcomes are quantitative and objective. As such, it may be more specific, i.e., may be more sensitive to drug effects or show them earlier than clinical endpoints and enable determination of efficacy in smaller or shorter studies than those required to show effects on clinical endpoints. Finally, imaging may allow differentiation of placebo responders from true drug responders.

Arms: arm 1: Alprazolam, an FDA-approved drug, will be administered to 24 patients with generalized anxiety disorder. arm 2: A placebo comparator will be administered to 12 patients with generalized anxiety disorder
Interventions: intervention 1: Alprazolam (Xanax) intervention 2: Placebo
Intervention descriptions: intervention 1: Drug dose will be fixed across patients: alprazolam 0.5 mg b.i.d escalating to 1.0 mg b.i.d. The treatment duration will be approximately 28 days (4 weeks). intervention 2: Placebo, bid, p.o. for 28 +/- 2 days.

Protocol documents:
Clinical trial NCT00673075
Conditions: Hypertension Coronary Artery Disease
Keywords: carvedilol Coreg (TM) hypertension blood pressure coronary artery disease Nebivolol BYSTOLIC (TM)
Sponsor: Forest Laboratories
Start date: 2008-05-01; Completion date: 2009-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.

Detailed description:

Arms: arm 1: Encapsulated Nebivolol arm 2: Encapsulated Carvedilol
Interventions: intervention 1: Nebivolol intervention 2: Carvedilol
Intervention descriptions: intervention 1: Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily intervention 2: Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Protocol documents:
Clinical trial NCT00678743
Conditions: Dyslipidemias
Keywords: cholesterol dyslipidemia omega 3
Sponsor: Provident Clinical Research
Start date: 2007-08-01; Completion date: 2009-09-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.

Detailed description:
The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits.

The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:

* Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.
* Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.

Arms: arm 1: Subjects who had successfully completed a 12-wk double-blind crossover study of P-OM3 plus simvastatin 20 mg/d were eligible for the open-label extension study. Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.
Interventions: intervention 1: Omacor + simvastatin
Intervention descriptions: intervention 1: Omacor 4 grams/day plus simvastatin 80 mg/day. Simvastatin dose adjusted at Investigator discretion after week 6.

Protocol documents:
Clinical trial NCT00683852
Conditions: Major Depressive Disorder
Keywords: Depression
Sponsor: Massachusetts General Hospital
Start date: 2008-09-01; Completion date: 2009-09-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder

Detailed description:
This is a 60-day, multi-center, double-blind, placebo-controlled study on the efficacy of aripiprazole (Abilify) augmentation of selective serotonin reuptake inhibitors (SSRIs) or selective serotonin norepinephrine uptake inhibitors (SNRIs) venlafaxine in patients with MDD who have responded inadequately to treatment with ADTs. The purpose of our study is to evaluate the efficacy and tolerability of low-dose (2 mg/day) aripiprazole (Abilify) as an augmentation strategy in MDD non-responding to ADT with SSRIs or the SNRI venlafaxine.

Arms: arm 1: patients randomly assigned to the drug/drug sequence, the dose of aripiprazole will be 2 mg/day during the first phase of the study, and 5 mg/day in the second phase. arm 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study. arm 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study.
Interventions: intervention 1: Aripiprazole 5mg intervention 2: Aripiprazole 2mg intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days) intervention 2: For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days) intervention 3: for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)

Protocol documents:
Clinical trial NCT00683904
Conditions: Non-small Cell Lung Cancer (NSCLC)
Sponsor: R-Pharm
Start date: 2008-06-01; Completion date: 2009-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL intervention 2: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
Intervention descriptions: intervention 1: On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. intervention 2: After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.

Protocol documents:
Clinical trial NCT00687531
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-11-01; Completion date: 2009-09-01
Enrollment: 385 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent mild-moderate asthmatic patients at least 12 years old.

Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.

Detailed description:

Arms: arm 1: Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
Interventions: intervention 1: Mometasone Furoate
Intervention descriptions: intervention 1: Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.

Protocol documents:
Clinical trial NCT00690612
Conditions: Hypertension
Keywords: pediatric renal disease high blood pressure
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2009-09-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.

Detailed description:

Arms: arm 1: investigator determines efficacious dose based on child's BP response.
Interventions: intervention 1: candesartan cilexetil
Intervention descriptions: intervention 1: 0.05, 0.2, 0.4 mg/kg, oral solution, single daily dose

Protocol documents:
Clinical trial NCT00694603
Conditions: Non-small Cell Lung Cancer
Keywords: cetuximab tyrosine kinase inhibitor
Sponsor: Lecia V. Sequist
Start date: 2006-09-01; Completion date: 2009-09-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.

Detailed description:
* Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
* The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.

Arms: arm 1: 400mg/m2 IV x 1 and then 250mg/m2 IV weekly
Interventions: intervention 1: Cetuximab
Intervention descriptions: intervention 1: Given intravenously once per week.

Protocol documents:
Clinical trial NCT00697619
Conditions: Nasopharyngeal Cancer
Sponsor: Sun Yat-sen University
Start date: 2005-09-01; Completion date: 2009-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.

Detailed description:

Arms: arm 1: Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. arm 2: Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Interventions: intervention 1: Zometa (zoledronic acid)
Intervention descriptions: intervention 1: Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Protocol documents: