ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00408902
Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-11-01; Completion date: 2008-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.

SECONDARY OBJECTIVES:

I. To evaluate the effect of MLN518 on progression-free survival and overall survival in patients with metastatic clear cell renal carcinoma.

II. To evaluate the toxicity of MLN518 in patients with metastatic clear cell renal carcinoma.

III. To evaluate the effects of MLN518 on serum VEGF-A, VEGF-R2, PIGF, and PDGF levels of patients with metastatic renal cell carcinoma receiving MLN518.

IV. To determine the VHL gene status, methylation, and pVHL in archived material from the primary nephrectomy specimen of patients receiving MLN518.

V. To evaluate tumor blood flow and vessel permeability based on functional imaging with dynamic contrast enhanced magnetic resonance imaging (dceMRI) in metastatic renal cell carcinoma patients treated with MLN518.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Arms: arm 1: Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: tandutinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally, 500 mg bid daily intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00413153
Conditions: HIV Infections
Keywords: HIV Kaletra Reyataz Insulin sensitivity Lipids Body Composition Receiving Kaletra Treatment Experienced
Sponsor: Massachusetts General Hospital
Start date: 2006-05-01; Completion date: 2008-12-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

Detailed description:
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

Arms: arm 1: Boosted Reyataz (300mg atazanavir + 100mg ritonavir) arm 2: Kaletra (pre-study dose)
Interventions: intervention 1: atazanavir/ritonavir intervention 2: lopinavir/ritonavir
Intervention descriptions: intervention 1: atazanavir 300mg + ritonavir 100mg once daily intervention 2: patient remains on their pre-study dose of lopinavir/ritonavir

Protocol documents:
Clinical trial NCT00413335
Conditions: Obesity Impaired Glucose Tolerance Type 2 Diabetes Mellitus
Keywords: Childhood and Adolescent Obesity Metabolic phenotype Impaired Glucose Tolerance Type 2 Diabetes Mellitus Insulin Sensitivity Insulin Resistance Abdominal fat partitioning Impaired Glucose Tolerance (IGT) Type 2 Diabetes Mellitus (T2DM)
Sponsor: Yale University
Start date: 2005-11-01; Completion date: 2008-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.

Detailed description:
Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.

The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.

Arms: arm 1: Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months. arm 2: Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: 2mg to begin then 4mg, twice daily for 4 months intervention 2: Subject receives placebo.

Protocol documents:
Clinical trial NCT00421928
Conditions: Osteoarthritis, Knee Pain
Keywords: Chronic Pain Osteoarthritis, Knee tapentadol Pain Assessment
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2007-01-01; Completion date: 2008-12-01
Enrollment: 1030 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Detailed description:
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US. The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.

Arms: arm 1: tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks arm 2: oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks arm 3: placebo matching placebo twice a day (BID) during 15 weeks
Interventions: intervention 1: oxycodone intervention 2: placebo intervention 3: tapentadol (CG5503)
Intervention descriptions: intervention 1: 10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks intervention 2: matching placebo twice a day (BID) during 15 weeks intervention 3: 50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks

Protocol documents:
Clinical trial NCT00435487
Conditions: Angina, Unstable Myocardial Infarction
Keywords: Non-ST Elevation Acute Coronary Syndromes coronary interventions
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2008-12-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)

Detailed description:
The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalteparin ( Fragmin) intervention 2: Unfractionated heparin
Intervention descriptions: intervention 1: Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours. intervention 2: Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg \[units per kilogram\] and initial infusion of 12 U/kg/h \[units per kilogram per hour\]).

Protocol documents:
Clinical trial NCT00440830
Conditions: Pain
Keywords: acute pain nicotine nausea sedation
Sponsor: Columbia University
Start date: 2005-12-01; Completion date: 2008-12-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Effect of nicotine patch as an adjutant for acute pain after surgery.

Detailed description:
This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Arms: arm 1: Smokers who were treated with nicotine arm 2: Nonsmokers who were treated with nicotine arm 3: Smokers who were treated with placebo arm 4: Nonsmokers who were treated with placebo
Interventions: intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: placebo intervention 4: placebo
Intervention descriptions: intervention 1: nicotine patch (0,5,10 or 15mg/day) applied to smokers intervention 2: nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers intervention 3: placebo patch applied to smokers intervention 4: placebo patch applied to nonsmokers

Protocol documents:
Clinical trial NCT00442546
Conditions: Osteoarthritis Postoperative Pain
Keywords: opioid
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: pregabalin intervention 2: pregabalin intervention 3: Placebo
Intervention descriptions: intervention 1: 150 milligram (mg)/ day (double blind) intervention 2: 300 mg/day (double blind) intervention 3: Placebo

Protocol documents:
Clinical trial NCT00447499
Conditions: Acromegaly
Keywords: Acromegaly Somatostatin Analogs Somatuline® Autogel® lanreotide growth hormone IGF-1 Inappropriate Growth Hormone Secretion Syndrome Somatotropin Hypersecretion Syndrome Inappropriate GH Secretion Syndrome
Sponsor: Ipsen
Start date: 2007-04-01; Completion date: 2008-12-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

Detailed description:
Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option.

Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection.

Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic. If Somatuline Autogel can be safely administered unsupervised, while maintaining disease control, this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic.

This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control. Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values.

Arms: arm 1: Somatuline Autogel (lanreotide acetate) Injection
Interventions: intervention 1: Somatuline Autogel (lanreotide acetate) intervention 2: Home administration
Intervention descriptions: intervention 1: Injections intervention 2: Questionnaire

Protocol documents:
Clinical trial NCT00455455
Conditions: Myopia Hyperopia
Sponsor: University of Waterloo
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

Detailed description:
The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Optifree RepleniSH Multipurpose Disinfecting Solution intervention 2: ReNu Multiplus Multipurpose Solution
Intervention descriptions: intervention 1: lens care system intervention 2: lens care system

Protocol documents:
Clinical trial NCT00456521
Conditions: Obesity Overweight
Keywords: Obesity Behavior Modification
Sponsor: Orexigen Therapeutics, Inc
Start date: 2007-03-01; Completion date: 2008-12-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Detailed description:
The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.

Arms: arm 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling arm 2: Placebo with intensive group lifestyle modification counseling
Interventions: intervention 1: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Intensive group lifestyle modification counseling
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00459381
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the therapeutic efficacy of pazopanib hydrochloride, as measured by 6-month progression-free survival (PFS), in patients with recurrent glioblastoma.

II. Determine the safety profile of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the efficacy of this drug, as measured by radiographic response, time to progression, and overall survival, in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for at least 2 years.

Arms: arm 1: Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis
Interventions: intervention 1: pazopanib hydrochloride intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00460564
Conditions: Post-Stroke Spasticity Cerebrovascular Accident
Keywords: Spasticity Post-Stroke botulinum toxin type A Upper Limb
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.

Detailed description:
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: GSK1358820 intervention 2: Placebo
Intervention descriptions: intervention 1: botulinum toxin type A intervention 2: Placebo

Protocol documents:
Clinical trial NCT00460655
Conditions: Post-Stroke Spasticity Cerebrovascular Accident
Keywords: Post-Stroke Lower Limb botulinum toxin type A Spasticity
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.

Detailed description:
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GSK1358820 intervention 2: Placebo
Intervention descriptions: intervention 1: botulinum toxin type A intervention 2: Placebo

Protocol documents: