ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00608465
Conditions: Metabolic Syndrome X
Keywords: Fibrolytic Dysfunction Obesity PAI-1
Sponsor: Vanderbilt University
Start date: 2006-05-01; Completion date: 2011-05-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The combination of high blood pressure and having central obesity is an increasing important factor for heart disease in men and women. It can also lead to the early development of hardening of the arteries and increased risk of a stroke. This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity.

Detailed description:
Obesity is an increasingly important risk factor for cardiovascular disease in men and women and is associated with the premature development of atherosclerosis, and increased risk of stroke. A classical perspective of cardiovascular risk does not adequately explain all of the cardiovascular events associated with obesity. Elevated plasma levels of plasminogen activator inhibitor type I (PAI-1) are one of the biochemical hallmarks for obesity and likely contribute the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that vascular PAI-1 excess promotes the development of intravascular thrombosis. We will test the hypothesis that secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release. From a public health perspective, there is no greater threat to America's cardiovascular health than the epidemic of obesity. It is anticipated that this study will provide new insights nto the molecular mechanisms that contribute to the development of fibrinolytic dysfunction and cardiovascular disease in obesity.

Arms: arm 1: Eplerenone (study drug) arm 2: Ramipril
Interventions: intervention 1: Eplerenone intervention 2: Ramipril
Intervention descriptions: intervention 1: 5 mg x 1 week followed by 10 mg x 9 weeks. intervention 2: Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.

Protocol documents:
Clinical trial NCT00616603
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty. Sciatic nerve Blocks. Dexamethasone.
Sponsor: Loma Linda University
Start date: 2007-08-01; Completion date: 2011-05-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Dexamethasone is a commonly used steroid. This medication has been used for many years by physicians for many different indications. Recent articles, multiple case reports, and experience at this institution have indicated that dexamethasone successfully prolongs the effective duration of local anesthetics for regional blocks. This can cause a significant reduction in postoperative pain and the decreased need for postoperative narcotics. Although other adjuncts can be used for prolonging nerve blocks, epinephrine causes local vasoconstriction which can cause ischemia and nerve damage in a large nerve such as the sciatic nerve.Dexamethasone will not cause this problem and yet could prolong the duration of a sciatic nerve block. Therefore, the goal of this study is to prospectively evaluate the effectiveness of dexamethasone, both locally through the nerve block and systemically via IV administration, in prolonging the effective duration of local anesthetics when used in sciatic nerve blocks.

Detailed description:

Arms: arm 1: This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline. arm 2: Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline. arm 3: Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
Interventions: intervention 1: Ropivacaine intervention 2: Dexamethasone intervention 3: Dexamethasone intervention 4: Normal Saline
Intervention descriptions: intervention 1: 20 ml of 0.2% ropivacaine injected locally as regional anesthesia given once. intervention 2: 8mg Dexamethasone injected locally along with ropivacaine for regional anesthesia given once. intervention 3: 2ml(8mg)Dexamethasone given once intravenously. intervention 4: 2ml of normal saline given once intravenously.

Protocol documents:
Clinical trial NCT00625703
Conditions: Cystic Fibrosis
Keywords: Pharmacokinetic
Sponsor: University of Texas Southwestern Medical Center
Start date: 2010-12-01; Completion date: 2011-05-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.

Detailed description:
Patients with cystic fibrosis who have pulmonary exacerbations associated with the isolation of Methicillin-resistant Staphylococcus aureus (MRSA) in their sputum will be identified by their primary physicians and by laboratory record review. If they meet the inclusion criteria, they will be invited to participate in the study. The primary outcome variables include pharmacokinetic and pharmacodynamic indices. The study end points include completion of the sputum and blood sampling for pharmacokinetic studies of both intravenous and oral formulations of linezolid and collection of microbiologic specimen (sputum and anterior nares cultures) one month after discharge. Additionally, pharmacokinetic data will be analyzed for effects of age and cystic fibrosis transmembrane conductance regulator (CFTR) mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome

Arms: arm 1: None
Interventions: intervention 1: Linezolid
Intervention descriptions: intervention 1: Pharmacokinetics

daily dose of linezolid at 15 mg/kg/dose Intravenously (IV) based on subject's weight at study entry, over half an hour period, every 8 hours for a minimum of 7 days to a maximum of 28 days total. The primary doctor may change the route of administration of linezolid from IV to oral (by mouth)after 72 hours on IV formulation and demonstrated clinical improvement based on the clinical evaluation by the primary doctor and comparison of cystic fibrosis exacerbation criteria scores before and after initiating treatment with linezolid.

Protocol documents:
Clinical trial NCT00626548
Conditions: Prostate Cancer
Keywords: Hormone Resistant Prostate Cancer Endothelin A Receptor Antagonist Endothelin A Endothelin A antagonist
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2011-05-01
Enrollment: 2577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

Detailed description:

Arms: arm 1: Matching Placebo arm 2: ZD4054 (Zibotentan)
Interventions: intervention 1: ZD4054 intervention 2: Palcebo
Intervention descriptions: intervention 1: 10 mg once daily oral dose intervention 2: Matching Plcebo oral tablet once daily

Protocol documents:
Clinical trial NCT00633360
Conditions: Premenstrual Syndrome Depression
Keywords: Women PMS Depression
Sponsor: Massachusetts General Hospital
Start date: 2008-02-01; Completion date: 2011-05-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Drospirenone and ethinyl estradiol intervention 2: Placebo
Intervention descriptions: intervention 1: Once daily by mouth intervention 2: Once daily by mouth

Protocol documents:
Clinical trial NCT00635648
Conditions: Fungal Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-01; Completion date: 2011-05-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: caspofungin acetate
Intervention descriptions: intervention 1: Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy.

Protocol documents:
Clinical trial NCT00646399
Conditions: Staphylococcal Sepsis
Keywords: Staphylococcal Coagulase Negative Staphylococcus Monoclonal antibodies Very Low Birth Weight Infants Prophylaxis
Sponsor: Biosynexus Incorporated
Start date: 2009-03-01; Completion date: 2011-05-01
Enrollment: 1579 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety, PK and efficacy comparing Pagibaximab Injection to placebo in preventing staphylococcal sepsis in very low birth weight infants. 1550 infants will be enrolled prior to 48 hours of life and will be randomized 1:1 to receive active drug or placebo on study days 0, 1, 2, 9, 16, and 23.

Detailed description:
Phase 2b/3, randomized, double-blind, multicenter, placebo-controlled study evaluating the safety, efficacy and pharmacokinetics (PK) of pagibaximab (100 mg/kg/dose) in comparison to placebo for the prevention of staphylococcal sepsis in VLBW infants (600 -1200 grams). Subjects monitored for treatment related adverse events and tolerability to infusion of study drug. Neonatal sepsis will be assessed in the presence of clinical signs and symptoms and one blood culture positive for S. aureus or two blood cultures positive for Coagulase Negative Staphylococci (CoNS). The study period will be 35 days after the first dose or until, death, discharge, or transfer, whichever occurs first.

Arms: arm 1: Phosphate Buffered Saline arm 2: Pagibaximab at 100 mg/kg intravenously at Days 0, 1, 2, 9, 16 and 23.
Interventions: intervention 1: Placebo intervention 2: Pagibaximab 50 mg/mL
Intervention descriptions: intervention 1: Phosphate Buffered Saline on Days 0, 1, 2, 9, 16 and 23. intervention 2: Pagibaximab 100 mg/kg dosed on Days 0, 1, 2, 9, 16 and 23

Protocol documents:
Clinical trial NCT00652834
Conditions: Gastrointestinal Lesions Signs and Symptoms, Digestive
Keywords: Renal transplant recipients Gastrointestinal findings in small bowel capsule endoscopy Mycophenolic acid Mycophenolate Mofetil Mycophenolate Sodium
Sponsor: University of California, Los Angeles
Start date: 2009-04-01; Completion date: 2011-05-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn more about symptoms and gastrointestinal lesions associated with taking myfortic® by switching patients to a delayed release formulation that is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule Endoscopy (SBCE).

Detailed description:
Myfortic® recently introduced to the market has shown to be similar to MMF in how effectively it works and how well it is tolerated. Both drugs have the same active ingredient, but they are different in the way that they deliver them to the body. Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA. MPA has more potent effects on the lymphocytes than other cells. This makes for improved GI tolerability of the MPA therapy.

Arms: arm 1: This was a four-week study designed to investigate GI mucosal lesions by SBCE in kidney transplant recipients who were using MMF, and to examine the changes in clinical symptoms and intestinal mucosa lesions 30 days after switching over from MMF to EC-MPS. The patient was switched from MMF to EC-MPS (Myfortic) on the equimola basis.
Interventions: intervention 1: Small bowel capsule endoscopy (SBCE) intervention 2: myfortic
Intervention descriptions: intervention 1: SBCE will be performed at Day 2 and Day 30. intervention 2: switching from mycophenolate mofetil to mycophenolic acid on equimolar basis

Protocol documents:
Clinical trial NCT00667875
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence Alcoholism Naltrexone Aripiprazole Substance Abuse
Sponsor: Medical University of South Carolina
Start date: 2008-04-01; Completion date: 2011-05-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.

Detailed description:

Arms: arm 1: None arm 2: Naltrexone arm 3: Naltrexone + Aripiprazole
Interventions: intervention 1: Placebo intervention 2: Naltrexone intervention 3: Naltrexone + Aripiprazole
Intervention descriptions: intervention 1: placebo intervention 2: Naltrexone (25mg or 50 mg per titration schedule) intervention 3: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Protocol documents:
Clinical trial NCT00679926
Conditions: HIV Infections
Keywords: HIV AIDS HIV/AIDS Treatment Naive
Sponsor: Oklahoma State University Center for Health Sciences
Start date: 2008-05-01; Completion date: 2011-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to \<50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.

Detailed description:
This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves \>700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.

Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.

Arms: arm 1: Patients taking 4 (four) lopinavir/ritonavir (200mg/50mg tablets) and 1 (one) tenofovir (300mg tablet) every 24 (twenty four) hours.
Interventions: intervention 1: Once daily
Intervention descriptions: intervention 1: Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily

Protocol documents:
Clinical trial NCT00687713
Conditions: Methamphetamine Dependence
Sponsor: National Institute on Drug Abuse (NIDA)
Start date: 2008-05-01; Completion date: 2011-05-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.

Detailed description:
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.

It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.

Arms: arm 1: Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day. arm 2: Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.
Interventions: intervention 1: Bupropion intervention 2: Placebo
Intervention descriptions: intervention 1: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00709826
Conditions: Pancreatic Cancer Metastatic Pancreatic Cancer
Sponsor: Tragara Pharmaceuticals, Inc.
Start date: 2008-08-01; Completion date: 2011-05-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

Detailed description:
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.

Arms: arm 1: 400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib arm 2: placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
Interventions: intervention 1: gemcitabine intervention 2: placebo intervention 3: Erlotinib intervention 4: apricoxib
Intervention descriptions: intervention 1: Gemcitabine: per package insert. intervention 2: placebo: 100 mg tablets, 400 mg/day intervention 3: Erlotinib - per package insert. intervention 4: apricoxib: 100mg tablets, given orally

Protocol documents: