ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00431964
Conditions: Cystic Fibrosis
Keywords: azithromycin, Zithromax
Sponsor: CF Therapeutics Development Network Coordinating Center
Start date: 2007-02-01; Completion date: 2009-11-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.

Detailed description:
Azithromycin is an antibiotic that has been shown to improve lung function in patients with cystic fibrosis (CF) whose lungs are infected with a bacterium called Pseudomonas aeruginosa. Scientists are not sure how azithromycin works in cystic fibrosis. It does not appear to work by killing the bacteria Pseudomonas aeruginosa, but it may make these bacteria and other bacteria less damaging to the lungs by reducing their ability to attach to the lining of the lung, or by reducing the bacteria's ability to make substances that damage the lungs of patients with cystic fibrosis. Azithromycin may also work directly on the cells in the lungs to improve lung function. This could occur by reducing inflammation (swelling) in the lungs, and/or making the mucus less sticky, or by affecting the salt channel that doesn't function correctly in CF. If azithromycin works in one or more of these ways; it may also be effective in improving lung function in cystic fibrosis patients who are not infected with Pseudomonas aeruginosa.

We are conducting this research study to examine the safety, effect on lung function and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin. This study is designed to determine if patients with cystic fibrosis whose lungs are not infected with the bacteria Pseudomonas aeruginosa will benefit from 24 weeks of treatment with the antibiotic azithromycin. Benefit will be determined as having better pulmonary function tests and getting sick less often compared to a placebo (sugar pill). This study is also designed to determine if azithromycin is safe when administered for 24 weeks to cystic fibrosis patients not infected with Pseudomonas aeruginosa. By doing this study, we hope to learn more about CF and improve the way in which we treat it.

Comparison: Three times weekly azithromycin tablets added to standard care, compared to three times weekly placebo tablets added to standard care.

Arms: arm 1: azithromycin 250 mg tablets arm 2: placebo tablets (matched to active drug in appearance)
Interventions: intervention 1: azithromycin 250 mg tablets intervention 2: placebo tablets
Intervention descriptions: intervention 1: * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs intervention 2: * One (1) tablet three times weekly for patients who weigh 40-79 lbs
* Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs

Protocol documents:
Clinical trial NCT00435929
Conditions: HIV Infections
Keywords: Treatment Naive
Sponsor: Hoffmann-La Roche
Start date: 2006-09-01; Completion date: 2009-11-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ritonavir intervention 2: saquinavir [Invirase]
Intervention descriptions: intervention 1: 100mg po bid intervention 2: 1000mg po bid

Protocol documents:
Clinical trial NCT00436475
Conditions: Glucose Intolerance Type 2 Diabetes Mellitus Metabolic Syndrome
Keywords: Glucose intolerance Type 2 diabetes mellitus Metabolic syndrome
Sponsor: Tufts Medical Center
Start date: 2007-09-01; Completion date: 2009-11-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.

Detailed description:
There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.

Arms: arm 1: Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily arm 2: Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily arm 3: Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily arm 4: Vitamin D3-Placebo plus Calcium-Placebo
Interventions: intervention 1: Vitamin D3 2,000 IU orally once daily intervention 2: Calcium Carbonate 400 mg orally twice daily intervention 3: Vitamin D3-Placebo intervention 4: Calcium-Placebo
Intervention descriptions: intervention 1: Vitamin D3 2,000 IU orally once daily intervention 2: Calcium Carbonate 400 mg orally twice daily intervention 3: Vitamin D3-Placebo intervention 4: Calcium-Placebo

Protocol documents:
Clinical trial NCT00447694
Conditions: Beta-thalassemia Iron Overload
Keywords: Iron Chelation Deferasirox Chelator Desferal beta-thalassemia Iron overload
Sponsor: Novartis
Start date: 2006-02-01; Completion date: 2009-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2\* in beta-thalassemia patients with deferasirox treatment.

Detailed description:

Arms: arm 1: Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Oral deferasirox 30mg/kg/day once per day for 77 weeks.

Protocol documents:
Clinical trial NCT00453180
Conditions: Autistic Disorder Asperger Syndrome Child Development Disorders, Pervasive
Keywords: Autistic Disorder Asperger's PDD NOS Pervasive Developmental Disorder Autism N-acetylcysteine acetylcysteine NAC antioxidant treatment core symptoms Autism Spectrum Disorders Asperger's Disorder Pervasive Developmental Disorder Not Otherwise Specified Pervasive Developmental Disorders
Sponsor: Indiana University School of Medicine
Start date: 2007-03-01; Completion date: 2009-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.

Detailed description:
Autism is increasingly being recognized as a common disorder with enormous public health significance. The core symptoms of autism include severe deficits in social relatedness and communication, and interfering repetitive behavior. No medications have been shown to consistently improve any of these symptoms.

The central hypothesis of this study is that NAC will improve behavioral manifestations of autism which may include core or associated symptoms. We plan to test our hypothesis and complete the objectives of this project by pursuing the following specific aims:

* Evaluate the efficacy of oral NAC in a 12-week, double-blind, placebo-controlled study involving 32 children and adolescents with autism spectrum disorders.
* Evaluate the safety and tolerability of oral NAC in 32 children and adolescents with autism spectrum disorders.

Arms: arm 1: Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths. arm 2: Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Interventions: intervention 1: N-acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day. intervention 2: Subjects randomized to placebo arm will receive placebo pill for duration of study.

Protocol documents:
Clinical trial NCT00454116
Conditions: Colorectal Cancer
Keywords: Colon Cancer Rectal Cancer
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-03-01; Completion date: 2009-11-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Detailed description:

Arms: arm 1: FOLFIRI + placebo vandetanib arm 2: FOLFIRI + low dose vandetanib arm 3: FOLFIRI + high dose vandetanib
Interventions: intervention 1: Vandetanib intervention 2: FOLFIRI
Intervention descriptions: intervention 1: once daily oral tablet two doses intervention 2: Intravenous infusion

Protocol documents:
Clinical trial NCT00473590
Conditions: Multiple Myeloma
Keywords: Avastin AMBER Myeloma Velcade
Sponsor: Genentech, Inc.
Start date: 2007-06-01; Completion date: 2009-11-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma.

Detailed description:

Arms: arm 1: Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression. arm 2: Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
Interventions: intervention 1: Bevacizumab intervention 2: Bortezomib intervention 3: placebo
Intervention descriptions: intervention 1: 15 mg/kg administered by intravenous infusion intervention 2: 1.3 mg/m\^2 administered by intravenous bolus injection intervention 3: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00486018
Conditions: Macular Edema Retinal Vein Occlusion
Keywords: Lucentis RVO BRVO Edema
Sponsor: Genentech, Inc.
Start date: 2007-07-01; Completion date: 2009-11-01
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ranibizumab injection 0.3 mg intervention 2: Ranibizumab injection 0.5 mg intervention 3: Sham injection
Intervention descriptions: intervention 1: Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 2: Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. intervention 3: Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.

Protocol documents:
Clinical trial NCT00487669
Conditions: Advanced Non-small Cell Lung Cancer
Keywords: paclitaxel poliglumex xyotax alimta advanced non-small cell lung cancer
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2006-10-01; Completion date: 2009-11-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.

Detailed description:
Primary objective

To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

Secondary Objectives

To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

To evaluate the duration of response, time to progression, and overall survival of advanced NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.

To compare the overall response rate using three-dimensional reconstruction of target lesions by Medical Metrx Solutions (MMS) and RECIST criteria.

Arms: arm 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
Interventions: intervention 1: paclitaxel poliglumex, pemetrexed
Intervention descriptions: intervention 1: The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued

Protocol documents:
Clinical trial NCT00501891
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma Multiforme Brain and Central Nervous System Tumors Recurrent Malignant Glioma Recurrent Glioblastoma Multiforme Avastin Bevacizumab Temodar Temozolomide
Sponsor: Duke University
Start date: 2007-07-01; Completion date: 2009-11-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.

Detailed description:
This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.

Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.

Arms: arm 1: Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
Interventions: intervention 1: Bevacizumab intervention 2: Metronomic Temozolomide
Intervention descriptions: intervention 1: Bevacizumab administered intravenously 10mg/kg every other week. intervention 2: Temozolomide 50mg/m2 given orally on a daily basis.

Protocol documents:
Clinical trial NCT00517881
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-06-01; Completion date: 2009-11-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intervention descriptions: intervention 1: Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.

Protocol documents:
Clinical trial NCT00519831
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2007-08-01; Completion date: 2009-11-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and help kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving vinflunine together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vinflunine together with cetuximab works as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Estimate the objective response rate in patients receiving vinflunine and cetuximab as second-line therapy for stage IIIB or IV non-small cell lung cancer.

Secondary

* Determine the progression-free survival of patients treated with this regimen.
* Determine the safety of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.
* Determine the duration of overall response in these patients.

OUTLINE: This is a multicenter study.

Patients receive vinflunine IV over 15-20 minutes on day 1 and cetuximab IV over 60-120 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive additional courses beyond 4 courses at the discretion of the principal investigator.

After completion of study therapy, patients are followed periodically for 6 months.

Arms: arm 1: Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.
Interventions: intervention 1: cetuximab intervention 2: vinflunine
Intervention descriptions: intervention 1: 400 mg/m² week 1,then 250 mg/m² weekly intervention 2: Vinflunine 320 mg/m² every 21 days

Protocol documents: