ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00580801
Conditions: Hepatitis C
Keywords: Hepatitis C Telaprevir Pegylated-interferon-alfa-2a Pegasys Ribavirin Copegus
Sponsor: Tibotec BVBA
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

Detailed description:
This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.

Arms: arm 1: Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50. arm 2: Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48. arm 3: Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
Interventions: intervention 1: Telaprevir intervention 2: Pegylated-interferon-alfa-2a intervention 3: Placebo intervention 4: Ribavirin
Intervention descriptions: intervention 1: Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks. intervention 2: Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50. intervention 3: Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks. intervention 4: Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

Protocol documents:
Clinical trial NCT00582738
Conditions: Recurrent Hepatitis C
Keywords: Fibrosis progression recurrent hepatitis C viral infection liver transplant recipients everolimus Hepatitis C recurrence after orthotopic liver transplantation (OLT)
Sponsor: Novartis Pharmaceuticals
Start date: 2007-12-01; Completion date: 2010-01-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant

Detailed description:

Arms: arm 1: Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor \[CNI\] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)\[MPA\], with or without steroids) / no everolimus introduction. arm 2: Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
Interventions: intervention 1: CsA-TAC (standard Treatment) intervention 2: Everolimus
Intervention descriptions: intervention 1: Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction. intervention 2: Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Protocol documents:
Clinical trial NCT00587483
Conditions: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery
Keywords: cardiopulmonary bypass reperfusion ventricular fibrillation ventricular fibrillation amiodarone lidocaine cardiac surgery
Sponsor: Mayo Clinic
Start date: 2007-11-01; Completion date: 2010-01-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.

Detailed description:
This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone administration decreases the incidence of ventricular fibrillation, the number of defibrillation attempts and the total energy and current required for defibrillation should ventricular fibrillation occur.

Arms: arm 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug. arm 2: Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm) when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles. arm 3: None
Interventions: intervention 1: Lidocaine intervention 2: Amiodarone intervention 3: Placebo
Intervention descriptions: intervention 1: Lidocaine is a class I (sodium channel block) antiarrhythmic drug intervention 2: 300 mg intervention 3: Saline

Protocol documents:
Clinical trial NCT00597116
Conditions: Mesothelioma
Keywords: Mesothelioma inoperable relapsed
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-12-01; Completion date: 2010-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.

Detailed description:

Arms: arm 1: Vinorelbine arm 2: Vandetanib
Interventions: intervention 1: Vinorelbine intervention 2: Vandetanib
Intervention descriptions: intervention 1: None intervention 2: once daily oral dose

Protocol documents:
Clinical trial NCT00604890
Conditions: Superficial Basal Cell Carcinoma
Keywords: Double-Blind Placebo Topical Treatment Dose-Ranging sBCC
Sponsor: BPGbio
Start date: 2008-03-01; Completion date: 2010-01-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.

Detailed description:

Arms: arm 1: Active cream, 3% AM \& PM arm 2: Placebo cream AM ; 3% active cream PM arm 3: Placebo cream AM; 1.5% active cream PM arm 4: Placebo AM and PM
Interventions: intervention 1: API 31510 3% Topical Cream intervention 2: API 31510 1.5% Topical Cream intervention 3: Placebo
Intervention descriptions: intervention 1: Topical treatment 3% active cream applied to the lesion intervention 2: Topical treatment 1.5% active cream applied to the lesion intervention 3: Topical treatment placebo applied to the lesion

Protocol documents:
Clinical trial NCT00605293
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Detailed description:

Arms: arm 1: Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1. arm 2: Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta intervention 2: Epoetin alfa
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms iv/month (starting dose) intervention 2: As prescribed

Protocol documents:
Clinical trial NCT00608842
Conditions: Lipoma
Sponsor: Kythera Biopharmaceuticals
Start date: 2007-11-01; Completion date: 2010-01-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.

Detailed description:
A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Arms: arm 1: Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. arm 2: Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. arm 3: Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments. arm 4: Participants received matching vehicle placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
Interventions: intervention 1: Deoxycholic Acid Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Administered via intralipomal injection. intervention 2: Matching vehicle placebo administered via intralipomal injection.

Protocol documents:
Clinical trial NCT00610129
Conditions: Neuroendocrine Tumors Metastatic Neuroendocrine Tumors
Keywords: MK-0646
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor.

MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.

Detailed description:

Arms: arm 1: MK-0646
Interventions: intervention 1: MK-0646
Intervention descriptions: intervention 1: MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.

Protocol documents:
Clinical trial NCT00611247
Conditions: Leukemia, Myeloid
Sponsor: Bruno C. Medeiros
Start date: 2007-12-01; Completion date: 2010-01-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis

Detailed description:
This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML) and poor risk features.

Patients will be assigned to 1 of 2 parallel treatment groups based on their AGAT promoter region methylation status, as determined by PCR.

Patients achieving a complete remission after 1 to 2 cycles of chemotherapy will be eligible to receive up to an additional 5 cycles of temozolomide of 5 or 19 days, depending on the methylation status of the AGAT promoter (consolidation phase).

Arms: arm 1: Induction: 200 mg/m2/day oral Temozolomide x 7 days arm 2: Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: Priming, Group 2 only, 100 mg/m2/day temozolomide.

Induction (both arms) 200 mg/m2/day temozolomide

Protocol documents:
Clinical trial NCT00615433
Conditions: Schizophrenia
Keywords: Schizophrenia Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-01-01; Completion date: 2010-01-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Lurasidone intervention 2: Olanzapine intervention 3: Placebo comparator intervention 4: Lurasidone 40 mg tablets
Intervention descriptions: intervention 1: 120mg/day intervention 2: 15mg/day intervention 3: Placebor Comparator intervention 4: Lurasidone 40 mg tablets

Protocol documents:
Clinical trial NCT00621179
Conditions: Endometriosis Infertility
Keywords: Endometriosis,infertility,in vitro fertilization
Sponsor: Colorado Center for Reproductive Medicine
Start date: 2003-03-01; Completion date: 2010-01-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio

Detailed description:
See summary

Arms: arm 1: Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention arm 2: Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization arm 3: Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation arm 4: Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
Interventions: intervention 1: Leuprolide acetate in depot suspension intervention 2: No intervention
Intervention descriptions: intervention 1: Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3 intervention 2: None

Protocol documents:
Clinical trial NCT00629525
Conditions: Hormone Refractory Prostate Cancer
Sponsor: Daniel George, MD
Start date: 2005-08-01; Completion date: 2010-01-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).

Detailed description:
This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.

Arms: arm 1: RAD001 at a dose of 10 mg PO daily
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: RAD001 at a dose of 10 mg PO daily

Protocol documents:
Clinical trial NCT00630396
Conditions: Stroke, Acute
Keywords: stroke ischemic neuroprotection minocycline tissue plasminogen activator (tPA) biomarkers pharmacokinetics antiapoptotic anti-inflammatory treatment matrix metalloproteinase-9 (MMP-9) thrombolysis Minocycline to Improve Neurologic Outcome in Stroke (MINOS) cerebrovascular stroke cerebrovascular accident cerebral stroke cerebrovascular accident (CVA)
Sponsor: David Hess, MD
Start date: 2008-05-01; Completion date: 2010-01-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

Detailed description:
Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Interventions: intervention 1: Minocycline
Intervention descriptions: intervention 1: Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.

Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.

Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.

Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses

Protocol documents: