ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00888654
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2009-08-01; Completion date: 2014-04-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: The use of diindolylmethane, a substance found in cruciferous vegetables, may slow the growth of tumor cells.

PURPOSE: This phase II trial is studying how well diindolylmethane works in treating patients with stage I or stage II prostate cancer undergoing radical prostatectomy.

Detailed description:
OBJECTIVES:

Primary

* To measure the level of diindolylmethane in prostate tissue after treatment with oral microencapsulated diindolylmethane (B-DIM) in patients with stage I or II adenocarcinoma of the prostate undergoing radical prostatectomy.

Secondary

* To measure serum biomarkers (e.g., total PSA, serum testosterone, and diindolylmethane levels) pre- and post-treatment with B-DIM.
* To measure tissue biomarkers (e.g., androgen receptor, NF-κB, and PSA) pre- and post-treatment with B-DIM.

OUTLINE: This is a multicenter study.

Patients receive oral microencapsulated diindolylmethane (B-DIM) twice daily for 14-72 days in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy 1 day after the last dose of B-DIM.

Patients undergo blood and tissue sample collection for correlative laboratory studies. Blood samples are analyzed for serum PSA, testosterone, and diindolylmethane levels by high performance liquid chromatography and tandem mass spectrometry (LC-MS/MS). Tissue samples are analyzed for diindolylmethane concentration by LC-MS/MS and for androgen receptor, activated NF-κB (p65 antibody), and PSA expression by IHC.

Arms: arm 1: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)

Radical Prostatectomy
Interventions: intervention 1: B-Dim intervention 2: Radical Prosatectomy
Intervention descriptions: intervention 1: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery) intervention 2: None

Protocol documents:
Clinical trial NCT00888979
Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation during Pregnancy Nicotrol Inhaler
Sponsor: Hartford Hospital
Start date: 2009-04-01; Completion date: 2014-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.

Detailed description:
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.

Arms: arm 1: Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Interventions: intervention 1: Nicotrol Inhaler
Intervention descriptions: intervention 1: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern

Protocol documents:
Clinical trial NCT00917150
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease COPD emphysema
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-03-01; Completion date: 2014-04-01
Enrollment: 771 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: tetomilast (OPC-6535) intervention 2: tetomilast (OPC-6535) intervention 3: tetomilast (OPC-6535) intervention 4: placebo
Intervention descriptions: intervention 1: oral administration of 12.5mg OPC-6535, once daily for 24months intervention 2: oral administration of 25mg OPC-6535, once daily for 24months intervention 3: oral administration of 50 mg OPC-6535, once daily for 24months intervention 4: oral administration of placebo, once daily for 24months

Protocol documents:
Clinical trial NCT00939874
Conditions: HIV Osteopenia Osteoporosis HIV Infections
Keywords: HIV+ Raltegravir Tenofovir osteopenia osteoporosis bone markers treatment experienced
Sponsor: St Vincent's Hospital, Sydney
Start date: 2009-10-01; Completion date: 2014-04-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir to another HIV medication raltegravir.

Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Protocol documents:
Clinical trial NCT00964353
Conditions: Blood Coagulation Disorders
Keywords: coumadine genotype genes Warfarin
Sponsor: University of Chicago
Start date: 2009-08-01; Completion date: 2014-04-01
Enrollment: 359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

Detailed description:
The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.

Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.

Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.

Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Arms: arm 1: Estimated Effective Warfarin dosing calculations are based on clinical data algorithms arm 2: Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Interventions: intervention 1: Warfarin
Intervention descriptions: intervention 1: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Protocol documents:
Clinical trial NCT01012089
Conditions: Chronic Kidney Disease Bacterial Infection
Keywords: Hemodialysis Peritoneal dialysis Daptomycin Pharmacokinetics
Sponsor: University of Oklahoma
Start date: 2009-11-01; Completion date: 2014-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to:

1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
2. Determine urine, HD and PD clearance of daptomycin.

Detailed description:
Infectious and sepsis events are one of the most common complications in children with chronic kidney disease. The incidence is highest in children with an access for dialysis, especially in those with catheters. Staphylococcal species account for more than 50% of access infections (ranging from 58-77%). Failure to clear the infection results in loss of dialysis access.

Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus, and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown.

Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.

Arms: arm 1: Pediatric patients on hemodialysis or peritoneal dialysis with suspected or confirmed infection and who were receiving standard of care antibiotics were also eligible to receive a single dose of daptomycin 5mg/kg IV. Serial blood draws were obtained to assess daptomycin pharmacokinetics
Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: Daptomycin IV 5 mg/kg one time dose

Protocol documents:
Clinical trial NCT01027884
Conditions: Muscular Dystrophy, Duchenne Ambulatory Care
Keywords: Idebenone Duchenne Muscular Dystrophy (DMD) Respiratory function Ambulatory and non-ambulatory patients Subjects not using glucocorticoids
Sponsor: Santhera Pharmaceuticals
Start date: 2009-07-01; Completion date: 2014-04-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.

Detailed description:
This study was a Phase III, multicenter, randomized, double-blind, placebo-controlled efficacy and safety study. DMD patients (ambulatory and non-ambulatory) at age 10-18 years were enrolled at sites in Europe and North America. Study subjects were randomized in a 1:1 ratio to receive either idebenone (900 mg/day) or placebo 3 times a day with meals for 52 weeks. The primary endpoint was the difference between Catena®/Raxone® and placebo in the change from Baseline to week 52 in Peak Expiratory Flow (PEF as percent predicted, PEF%p, a measure of respiratory muscle strength) as measured by hospital-based spirometry. PEF was also measured by the patient at home using the hand-held ASMA-1 device (secondary endpoint). Other respiratory endpoints included Forced Expiratory Volume in 1 second (as percent predicted, FEV1%p, an additional measure of respiratory muscle strength) and Forced Vital Capacity (as percent predicted, FVC%p, a measure of restrictive lung disease predictive of morbidity and mortality in DMD).

Arms: arm 1: Placebo 900 mg/day arm 2: Idebenone 900 mg/day
Interventions: intervention 1: Placebo intervention 2: Idebenone
Intervention descriptions: intervention 1: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals intervention 2: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals

Protocol documents:
Clinical trial NCT01045421
Conditions: Advanced Nonhematological Malignancies Non-Small Cell Lung Cancer Small Cell Lung Cancer Metastatic Breast Cancer Head and Neck Squamous Cell Carcinoma Gastroesophageal Adenocarcinoma
Keywords: NSCLC SCLC HNSCC
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2010-02-01; Completion date: 2014-04-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced nonhematological malignancies.

Detailed description:
Following the determination of the Recommended Phase 2 Dose (RP2D) and schedule (Phase 1), 20 response-evaluable patients in each of the 5 tumor indications will be enrolled (Phase 2-Stage 1). An interim analysis will determine which tumor indications will proceed to enroll an additional 25 patients (Phase 2-Stage 2) to further evaluate Overall Response Rate (ORR) and other secondary endpoints.

Arms: arm 1: MLN8237 administered as an enteric-coated tablet (ECT)
Interventions: intervention 1: MLN8237 (Alisertib)
Intervention descriptions: intervention 1: Phase 1:

MLN8237 will be administered orally twice a day on a 7-day dosing schedule

Phase 2:

MLN8237 will be administered orally at the maximum tolerated dose determined in Phase 1 for 7-days followed by a minimum 14-day rest period.

Protocol documents:
Clinical trial NCT01069003
Conditions: Coronary Artery Disease
Keywords: Heart Disease Cardiovascular Disease Platelet Aggregation Inhibitors Dual Antiplatelet Therapy Clopidogrel Prasugrel Vascular Disease Myocardial Ischemia
Sponsor: Medtronic Vascular
Start date: 2010-04-01; Completion date: 2014-04-01
Enrollment: 2272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.

Detailed description:
To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Arms: arm 1: Subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization. arm 2: Subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Eligible subjects are without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization. arm 3: Non randomized subjects followed through 24 months
Interventions: intervention 1: Placebo Arm intervention 2: Thienopyridine Therapy intervention 3: Surveillance Arm
Intervention descriptions: intervention 1: Placebo and ASA (75 mg - 325 mg) intervention 2: Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg) intervention 3: Non randomized arm to understand clinical outcomes in a commercial setting

Protocol documents:
Clinical trial NCT01070888
Conditions: Exercise Induced Asthma
Keywords: Asthma Exercise Induced Asthma
Sponsor: Boston Children's Hospital
Start date: 2010-02-01; Completion date: 2014-04-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

Detailed description:
The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

Arms: arm 1: This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler. arm 2: This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.
Interventions: intervention 1: Budesonide/Formoterol intervention 2: Budesonide
Intervention descriptions: intervention 1: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks intervention 2: Budesonide 180mcg, 2 puffs twice daily for 2 weeks

Protocol documents:
Clinical trial NCT01088906
Conditions: Carcinoma, Non Small Cell Lung
Keywords: Phalcis BRCA1 RAP80 TS First line Non-squamous
Sponsor: Spanish Lung Cancer Group
Start date: 2010-01-01; Completion date: 2014-04-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial.

Detailed description:
This is a non-randomized, phase IIA pharmacogenomic, open label, uncontrolled, efficacy study in patients with advanced non-squamous cell lung cancer as a first line therapy.

Arms: arm 1: pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
Interventions: intervention 1: Pemetrexed/Cisplatin
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day.

Protocol documents:
Clinical trial NCT01095887
Conditions: Kidney Transplant
Keywords: ABO incompatibility living donor kidney transplant kidney transplant ABO blood type incompatible
Sponsor: Mayo Clinic
Start date: 2010-05-01; Completion date: 2014-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to try to determine if the drug eculizumab can help prevent antibody-mediated rejection in patients undergoing a kidney transplant from a living donor with a different blood type than their own.

Detailed description:
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. In some instances, the only suitable living kidney donor is ABO blood group incompatible. This usually presents a barrier to successful transplantation because most recipients have circulating serum antibodies that bind to incompatible blood groups that will bind and damage the kidney allograft early after transplantation. Fortunately, over the past decade, we and others have developed protocols involving the pretransplant removal of anti-blood group antibodies using multiple plasmapheresis treatments that allow for the successful transplantation of ABOi LDKTx. Thus, this therapy enables patients to receive a living donor with its advantages rather than having to wait \>5 years for a deceased donor kidney.

Arms: arm 1: Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.

Protocol documents:
Clinical trial NCT01122381
Conditions: Headache, Migraine
Keywords: headache, migraine depression disability evaluation weight gain
Sponsor: US Department of Veterans Affairs
Start date: 2011-12-01; Completion date: 2014-04-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ethosuximide works better than placebo in the prevention of episodic migraine among veterans.

Detailed description:
Chronic and episodic headaches in veteran populations include migraine, transformed migraine, and post-traumatic headache with migrainous features. More and better prophylactic drugs with fewer side effects (such as weight gain) are needed to treat these disabling, refractory conditions which generally have less than a 50% response rate to preventative treatments.

Rare forms of severe familial hemiplegic migraine (FHM) are considered channelopathies and can be caused by mutations in a calcium channel gene. Serotonin is also known to be a critical neurotransmitter in migraine based on the pharmacology of acute and preventative treatments. We previously identified a "migraine" signaling pathway in an invertebrate C. elegans "hemiplegic migraine" model of a mutant calcium channel upstream from transforming growth factor-beta (TGF-beta) and showed that low serotonin levels can be rescued by treatment with the childhood antiepileptic drug ethosuximide (ESX).

Objective: We propose to test our findings from this invertebrate migraine model to determine its relevance to humans in the prevention of episodic migraine.

Primary Aim: Determine whether ethosuximide (ESX) will be significantly more effective than placebo in reducing migraine headache days. We propose a 3 year, double blind, phase 1/2 randomized, 2:1 ESX:placebo controlled parallel trial in episodic migraineurs comparing migraine headache days during the last 4 weeks of treatment to a pre-treatment 4 week baseline.

Arms: arm 1: ethosuximide blinded capsules of 250mg ESX; titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability arm 2: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed "30mg"/kg/d) vs maximum tolerability
Interventions: intervention 1: ethosuximide intervention 2: placebo comparator
Intervention descriptions: intervention 1: ethosuximide (ESX) intervention 2: placebo

Protocol documents: