ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00532779
Conditions: Obesity Overweight
Keywords: Obesity Antiobesity agents Antiobesity drugs Overweight drug therapy Obese drug therapy Weight loss drug effects Bupropion administration and dosage Naltrexone administration and dosage Double blind method Combination drug therapy Delayed action preparations
Sponsor: Orexigen Therapeutics, Inc
Start date: 2007-10-01; Completion date: 2009-05-01
Enrollment: 1742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.

Detailed description:
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Arms: arm 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy arm 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy arm 3: Placebo with ancillary therapy
Interventions: intervention 1: Naltrexone SR 16 mg/Bupropion SR 360 mg /day intervention 2: Naltrexone SR 32 mg/Bupropion SR 360 mg /day intervention 3: Placebo intervention 4: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol documents:
Clinical trial NCT00543400
Conditions: Coronary Artery Disease (CAD)
Keywords: Percutaneous Coronary Intervention (PCI)
Sponsor: Momenta Pharmaceuticals, Inc.
Start date: 2007-09-01; Completion date: 2009-05-01
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).

The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.

Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI.

Detailed description:

Arms: arm 1: Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 2: Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 3: Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given. arm 4: Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
Interventions: intervention 1: M118 intervention 2: Unfractionated Heparin
Intervention descriptions: intervention 1: intravenous (IV) infusion intervention 2: IV infusion

Protocol documents:
Clinical trial NCT00545051
Conditions: Postmenopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2009-05-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months. arm 2: Participants received monthly oral placebo for 12 months.
Interventions: intervention 1: Placebo intervention 2: ibandronate
Intervention descriptions: intervention 1: po monthly for 12 months intervention 2: 150mg po monthly for 12 months

Protocol documents:
Clinical trial NCT00546910
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-10-01; Completion date: 2009-05-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.

Detailed description:

Arms: arm 1: 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. arm 2: Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food. intervention 2: 3 capsules of placebo have to be taken once daily in the morning, with or without food.

Protocol documents:
Clinical trial NCT00548431
Conditions: Leukemia, Lymphocytic, Acute
Keywords: Leukemia, Lymphocytic, Acute [C04.557.337.428.511] 6-mercaptopurine methotrexate asparaginase
Sponsor: Rigshospitalet, Denmark
Start date: 2007-12-01; Completion date: 2009-05-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

Detailed description:
In addition to the details above we will also explore

* the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
* the early development of anti-ASP antibodies during continuous PEG-ASP therapy.

The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.

Arms: arm 1: All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m\^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 increments since the study stopped 2 weeks after the last HDM
Interventions: intervention 1: 6-mercaptopurine
Intervention descriptions: intervention 1: Standard dose 25 mg/m\^2/day. Can be increased up to 75 mg/m\^2/day if the myelosuppression is acceptable (ANC\>0.5 T-count \>50)

Protocol documents:
Clinical trial NCT00554216
Conditions: Obesity
Keywords: Obesity, morbid obesity
Sponsor: VIVUS LLC
Start date: 2007-11-01; Completion date: 2009-05-01
Enrollment: 1267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Detailed description:

Arms: arm 1: VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg) arm 2: Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate. arm 3: Placebo to match
Interventions: intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: Placebo matched phentermine/topiramate
Intervention descriptions: intervention 1: 3.75 mg phentermine/23 mg topiramate intervention 2: 15 mg phentermine/92 mg topiramate intervention 3: Placebo matched phentermine/topiramate

Protocol documents:
Clinical trial NCT00557284
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis (Eczema) associated with food allergies
Sponsor: 1st Allergy & Clinical Research Center
Start date: 2008-03-01; Completion date: 2009-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
AD is a disease found in children; the focus of the study is the mechanisms associated in children with AD induced by food allergies.

This study will be a randomized, double-blind, placebo-controlled, parallel group trial conducted in participants diagnosed with atopic dermatitis and food allergies. The study duration for participants will be approximately 9 weeks. A total of 20 participants will be recruited for the entire study. Each arm will consist of 10 participants.The study will enroll 20 children, male or female, 1 - 8 years of age with atopic dermatitis (AD) associated with food allergens, previously documented by skin or RAST test, before enrollment. Atopic dermatitis and gastrointestinal (GI) symptoms will be scored and followed throughout the study.

Detailed description:

Arms: arm 1: Montelukast arm 2: None
Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age intervention 2: Oral granules or chewable tablet, PO QD (given oral daily)

Protocol documents:
Clinical trial NCT00566631
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended Release (ER) Invega
Sponsor: Janssen-Cilag International NV
Start date: 2007-07-01; Completion date: 2009-05-01
Enrollment: 294 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label (all people know the identity of the intervention), single-arm (getting one dose of medicine), multi-center (conducted in more than 1 center) study to evaluate tolerability, safety and efficacy of flexible daily doses of paliperidone ER in participants with acute schizophrenia. All participants will be given paliperidone ER once daily at a dose of 3, 6, 9, or 12 milligram (mg) tablets orally depending on Investigator's discretion, based on participant's clinical response and tolerability towards paliperidone ER. The duration of the core phase of the treatment will be 6 weeks and the participants who will complete this phase, respond well and would like to continue, will be eligible to be enrolled in an extension phase, which is no longer than 12 months. Efficacy will primarily be evaluated by treatment response evaluated through total Positive and Negative Syndrome Scale (PANSS) score. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone
Intervention descriptions: intervention 1: Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.

Protocol documents:
Clinical trial NCT00571194
Conditions: End Stage Renal Disease
Keywords: pravastatin, peritoneal dialysis, pediatric patients
Sponsor: Arkansas Children's Hospital Research Institute
Start date: 2007-09-01; Completion date: 2009-05-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.

Detailed description:
This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.

Arms: arm 1: PK profile of pravastatin
Interventions: intervention 1: pravastatin
Intervention descriptions: intervention 1: A single 10 mg dose of pravastatin will be administered 3 mL blood samples for pravastatin Pharmacokinetic evaluations will be collected at 0.5, 1, 2, 3, 4, 6, and 8 hours. 5 mL blood samples for pravastatin PK and laboratory evaluations will be drawn at pre-dose and 24 hours.

Vital Signs and Physical Exams will also be done throughout the study

Protocol documents:
Clinical trial NCT00582036
Conditions: Hyperglycemia Hematopoietic Stem Cell Transplantation
Keywords: Hyperglycemia Hematopoietic stem cell transplantation Bone marrow transplant High blood sugar
Sponsor: University of Oklahoma
Start date: 2007-02-01; Completion date: 2009-05-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

Detailed description:
TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.

Arms: arm 1: Regular Sliding Scale Insulin administration for hyperglycemia arm 2: MiniMed Paradigm monitoring device for hyperglycemia
Interventions: intervention 1: Regular Insulin intervention 2: Deployment of the MiniMed Paradigm monitoring device
Intervention descriptions: intervention 1: Use of sliding scale insulin as per Appendix 1 intervention 2: Automated insulin delivery system

Protocol documents:
Clinical trial NCT00582608
Conditions: CNS Cancer Neuroblastoma Sarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2001-10-01; Completion date: 2009-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.

Detailed description:
To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.

Arms: arm 1: This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m\^2 dose \[intended specific activity of '20mCi/mg protein\] preceded by administration of 50mg/1.73m2 of unlabeled -8H9.
Interventions: intervention 1: 131I-8H9 intervention 2: 8H9
Intervention descriptions: intervention 1: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\] intervention 2: administration of 50mg/1.73m\^2 of unlabeled 8H9.

Protocol documents:
Clinical trial NCT00593112
Conditions: ADHD
Keywords: HMRS Scanning ADHD Child Adolescent HMRS Scans
Sponsor: Massachusetts General Hospital
Start date: 2006-11-01; Completion date: 2009-05-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows:

Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS.

Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.

Detailed description:
The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children with ADHD between the ages of 12-17 years old, before and after a six-week open treatment trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20 controls matched by age and gender. We also will scan 20 children with ADHD between the ages of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of Concerta. These 20 children will be scanned once while on medication and once while off medication

Arms: arm 1: None arm 2: Healthy Volunteer Control group
Interventions: intervention 1: OROS methylphenidate intervention 2: No intervention
Intervention descriptions: intervention 1: Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks. intervention 2: No intervention

Protocol documents:
Clinical trial NCT00593567
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Sponsor: Innocoll
Start date: 2007-12-01; Completion date: 2009-05-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.

Detailed description:
Infected skin ulcers in patients with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

In this study, all subjects will be given the necessary supplies and taught how to take care of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.

Arms: arm 1: Daily topical gentamicin sponge and standard daily wound care arm 2: Daily oral levofloxacin 750 mg and standard daily wound care
Interventions: intervention 1: gentamicin-collagen sponge intervention 2: Levofloxacin
Intervention descriptions: intervention 1: Inserted daily into open ulcer intervention 2: 750mg oral levofloxacin daily

Protocol documents: