ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01336296
Conditions: Kidney Transplant Recipients
Sponsor: University of Cincinnati
Start date: 2010-09-01; Completion date: 2014-04-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction starting at the time of transplant in kidney transplant recipients.

Detailed description:

Arms: arm 1: Initiation of mycophenolic acid (Myfortic) 2 weeks prior to transplantation (with Simulect induction at time of transplant) arm 2: mycophenolic acid (Myfortic) at time of transplant with Thymoglobulin induction
Interventions: intervention 1: mycophenolic acid
Intervention descriptions: intervention 1: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.

Protocol documents:
Clinical trial NCT01342965
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2014-04-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m\^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m\^2 iv on Day 1.

Detailed description:

Arms: arm 1: Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. arm 2: Participants received gemcitabine 1250 mg/m\^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m\^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Interventions: intervention 1: Erlotinib intervention 2: Chemotherapy
Intervention descriptions: intervention 1: Erlotinib was supplied as tablets. intervention 2: Cisplatin and gemcitabine were locally sourced with commercial products.

Protocol documents:
Clinical trial NCT01344876
Conditions: Multiple Myeloma Non-Hodgkin Lymphoma Acute Myeloid Leukemia Acute Lymphoid Leukemia Chronic Myeloid Leukemia
Keywords: multiple myeloma [MM] non-Hodgkin lymphoma [NHL] acute myeloid leukemia [AML] acute lymphoid leukemia [ALL] chronic myeloid leukemia [CML]
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2011-04-01; Completion date: 2014-04-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the maximum tolerated dose (MTD) of OPB-51602

Detailed description:

Arms: arm 1: OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
Interventions: intervention 1: OPB-51602
Intervention descriptions: intervention 1: once daily during the treatment period

Protocol documents:
Clinical trial NCT01345188
Conditions: Cardiomyopathy Chest Pain Dyspnea
Sponsor: Midwest Cardiovascular Research Foundation
Start date: 2011-04-01; Completion date: 2014-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.

Detailed description:

Arms: arm 1: 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. arm 2: 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Interventions: intervention 1: Ranexa intervention 2: Placebo
Intervention descriptions: intervention 1: 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. intervention 2: 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Protocol documents:
Clinical trial NCT01395784
Conditions: Opioid Abuse
Keywords: Oxycodone Opioid abuse
Sponsor: New York State Psychiatric Institute
Start date: 2010-08-01; Completion date: 2014-04-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.

Detailed description:
This 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.

Arms: arm 1: Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB). arm 2: Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg. arm 3: Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.
Interventions: intervention 1: pioglitazone
Intervention descriptions: intervention 1: A PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.

Protocol documents:
Clinical trial NCT01433263
Conditions: Cachexia
Keywords: Wasting syndrome emaciation lung cancer adenocarcinoma pancreatic cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2014-04-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A safety \& efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BYM338 active drug intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01433913
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2011-11-01; Completion date: 2014-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention on cell proliferation in the prostatectomy tissue.

SECONDARY OBJECTIVES:

I. To determine the effect of metformin intervention on prostate tissue bioavailability of metformin.

II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the prostatectomy tissue.

III. To determine the effect of metformin intervention on potential molecular targets of metformin including activated protein kinase (AMPK) activation, mammalian target of rapamycin (mTOR) regulation, and cell cycle regulation in the prostatectomy tissue.

IV. To determine the effect of metformin intervention on changes in systemic hormones and growth factors that have been shown to be modulated by metformin in other patient populations including fasting glucose, fasting insulin, insulin-like growth factor axis, testosterone, and sex hormone binding globulin (SHBG).

V. To determine the effect of metformin intervention on changes in prostate-specific antigen (PSA) levels.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) for 4-12 weeks.

ARM II: Patients receive placebo PO QD for 4-12 weeks.

Patients in both arms undergo surgery one day after completion of treatment.

After completion of study treatment, patients are followed up within 30 days of surgery.

Arms: arm 1: Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks. arm 2: Patients receive placebo PO QD for 4-12 weeks.
Interventions: intervention 1: metformin hydrochloride intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01453595
Conditions: Renal Cancer
Keywords: Kidney renal cell carcinoma BEZ235 11-080
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-10-01; Completion date: 2014-04-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study tests a new medication for treatment of kidney cancer, called BEZ235. This medication works by blocking several mechanisms that the cancer needs to grow and survive. By blocking these mechanisms, the medication can thus suppress further growth of the cancer, possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus \[Torisel®\] or everolimus \[Afinitor®\]) typically only block one mechanism in cancer cells, so the investigators think that BEZ235 may work even better against kidney cancer.

The purpose of the first part of this study is to test the safety of giving BEZ235 at different doses. The investigators are trying to find a safe dose of BEZ235 and want to find out what effects, good and/or bad, it has on the patient and the cancer.

Detailed description:

Arms: arm 1: This is a single-institution, open label, single-arm Phase 1b/2 trial of BEZ235 in patients with advanced RCC. The study will be conducted in two phases:

Phase 1b: dose-escalation will be performed to determine the maximally tolerated dose (MTD) of twice daily BEZ235 to use in Phase 2 (RP2 dose).

Phase 2: subjects with clear cell who have experienced disease progression on prior first or second-line mTOR targeted therapy will be treated on the MTD of twice daily BEZ235.
Interventions: intervention 1: BEZ235
Intervention descriptions: intervention 1: BEZ235 will be taken orally twice daily starting on Day 1, Cycle 1, self-administration will continue twice daily on a continuous schedule with cycle length defined as 28 days. Increasing dosing levels of BEZ235 will be studied sequentially (beginning with Dose Level 1, BEZ235 400mg by mouth twice daily) as per the treatment noted below.

Cohort-1a BEZ235 300 mg by mouth twice daily Cohort 1 BEZ235 400 mg by mouth twice daily Cohort 2 BEZ235 600 mg by mouth twice daily Cohort 3 BEZ235 800 mg by mouth twice daily

Protocol documents:
Clinical trial NCT01457430
Conditions: Hereditary Angioedema
Sponsor: Massachusetts General Hospital
Start date: 2011-12-01; Completion date: 2014-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.

Detailed description:

Arms: arm 1: Open-label study
Interventions: intervention 1: Icatibant
Intervention descriptions: intervention 1: 30 mg subcutaneous dose of Icatibant

Protocol documents:
Clinical trial NCT01467505
Conditions: Hepatitis C
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-02-01; Completion date: 2014-04-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.

Detailed description:

Arms: arm 1: Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion. arm 2: Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa-2a intervention 4: Immunosuppressant Regimen
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Subcutaneous Injection intervention 4: Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.

Protocol documents:
Clinical trial NCT01483209
Conditions: Ischemia Vasopressor
Keywords: Digital ischemia Vasopressor
Sponsor: Duke University
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this project is to determine if performing a "chemical sympathectomy" by injecting botulinum toxin A in critically ill patients on vasopressors can treat digital ischemia. This is a prospective, non-randomized pilot study designed to demonstrate proof of concept. We propose to study patients in the intensive care units of Duke Hospital who, secondary to exposure to vasoactive medications used to maintain acceptable blood pressures, have developed signs and symptoms of digital ischemia. A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. There were no major adverse events reported by the product information sheet or in other related studies of Botox for digital ischemia.

Detailed description:

Arms: arm 1: Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia
Interventions: intervention 1: Injection of botulinum toxin A
Intervention descriptions: intervention 1: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy

Protocol documents:
Clinical trial NCT01485991
Conditions: Hepatitis C
Keywords: Hepatitis C TMC435HPC3001 TMC435 Hepatitis C Virus (HCV) HEP C Genotype 1 Treatment experienced Null responders Partial responders
Sponsor: Janssen R&D Ireland
Start date: 2012-02-01; Completion date: 2014-04-01
Enrollment: 771 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Detailed description:
This study is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), double-dummy (patients receive both active and inactive pills also called placebo), 2-arm, multicenter Phase III clinical study in adult treatment experienced Chronic Hepatitis C (CHC) genotype-1 infected patients who failed to respond during at least 1 previous course of PegINFα-2a/ RBV therapy. The purpose of the trial is to study the efficacy of TMC435 in combination with PegINFα-2a and RBV for 48 weeks of treatment compared to the approved regimen of telaprevir in combination with PegINFα-2a and RBV for 48 weeks of treatment. The study will consist of a screening period (maximum 6 weeks), treatment period (48 weeks) and post-treatment period (until 72 weeks after the start of treatment). For the first 12 weeks one group of patients will take TMC435 and TVR placebo, plus PegINFα-2a and RBV. The other group will take TMC435 placebo and TVR, plus PegINFα-2a and RBV. After 12 weeks, patients in both arms will only take PegINFα-2a and RBV up to week 48. After patients stop taking study medication, they will continue to go to the doctor's office for study visits until a total of 72 weeks after they start study treatment. Patients will be monitored for safety throughout the study. Study assessments at each study visit may include, but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TMC435 intervention 2: TVR
Intervention descriptions: intervention 1: TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks. intervention 2: TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Protocol documents:
Clinical trial NCT01497262
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing-Remitting
Sponsor: Novartis Pharmaceuticals
Start date: 2012-02-01; Completion date: 2014-04-01
Enrollment: 162 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.

Detailed description:

Arms: arm 1: Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Interventions: intervention 1: Fingolimod
Intervention descriptions: intervention 1: Fingolimod will be supplied as 0.5mg capsules in bottles of 35.

Protocol documents:
Clinical trial NCT01499290
Conditions: Complicated Intra-Abdominal Infection
Keywords: Ceftazidime Meropenem Metronidazole Anti-Bacterial Agents Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents cIAI, Complicated Intra-Abdominal Infection
Sponsor: Pfizer
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Detailed description:
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Arms: arm 1: IV treatment arm 2: IV treatment
Interventions: intervention 1: CAZ-AVI intervention 2: Metronidazole intervention 3: Meropenem
Intervention descriptions: intervention 1: Ceftazidime 2000 mg and 500 mg of avibactam intervention 2: 500 mg of Metronidazole intervention 3: 1 gram of Meropenem

Protocol documents:
Clinical trial NCT01500720
Conditions: Small Cell Lung Cancer
Sponsor: Sanofi
Start date: 2012-03-01; Completion date: 2014-04-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

* To assess disease progression free rate at 12 weeks
* To assess Response Rate (Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1) and duration of response
* To assess Overall Survival (OS)
* To assess the Safety (National Cancer Institute - Common Toxicity Criteria \[NCI-CTC\] version 4.03)
* To assess the Health-Related Quality of Life (HRQoL)

Detailed description:
Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cabazitaxel intervention 2: Topotecan
Intervention descriptions: intervention 1: Cabazitaxel 25 milligram per square meter (mg/m\^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent. intervention 2: Topotecan 1.5 mg/m\^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

Protocol documents: