ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01211730
Conditions: Evidence of Liver Transplantation Hyperglycemia Rejection
Keywords: Liver transplantation Glucose Hyperglycemia Insulin Rejection Hypoglycemia
Sponsor: Northwestern University
Start date: 2009-04-01; Completion date: 2016-05-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.

Detailed description:
Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.

In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.

Arms: arm 1: Insulin treatment to target blood glucose at 140 mg/dl arm 2: Insulin treatment to target blood glucose at 180 mg/dl
Interventions: intervention 1: Insulin
Intervention descriptions: intervention 1: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

Protocol documents:
Clinical trial NCT01253421
Conditions: Major Depressive Disorder (MDD)
Keywords: MDD Major Depressive Disorder Amisulpride
Sponsor: Mclean Hospital
Start date: 2012-02-01; Completion date: 2016-05-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of a single low dose of the D2/D3 antagonist amisulpride on reward processing. More generally, this study will test the role of dopamine (a naturally occurring brain chemical) in depression.

Hypotheses:

Administration of a single low dose of the D2/D3 antagonist amisulpride will (1) improve performance in a behavioral task assessing learning from feedback and (2) boost activation in reward-related brain regions.

Detailed description:
Through an integration of a functional magnetic resonance imaging (fMRI) approach coupled with a pharmacological challenge, the goal of the current study will be to investigate the role of dopamine in MDD. Participants in this research will include 36 MDD subjects and 36 demographically matched healthy participants recruited from the community by Dr. Pizzagalli's laboratory at McLean Hospital's Center for Depression, Anxiety and Stress Research. This study will include two sessions:

* The first session will involve a diagnostic interview, and a series of questionnaires and assessments.
* The second session will take place at the McLean Hospital's Neuroimaging Center, and include the administration of a low-dose of amisulpride (50 mg capsule) or placebo, followed by an fMRI brain scan and administration of two behavioral tasks.

Arms: arm 1: Subjects experiencing a current episode of major depression who are randomized to receive amisulpride arm 2: Subjects experiencing a current episode of major depression who are randomized to receive placebo arm 3: Subjects having no history of mental disorder (healthy controls, HC) who are randomized to receive amisulpride arm 4: Subjects having no history of mental disorder who are randomized to receive placebo
Interventions: intervention 1: amisulpride intervention 2: placebo
Intervention descriptions: intervention 1: single low-dose pharmacological challenge, 50 mg amisulpride intervention 2: single-dose placebo capsule

Protocol documents:
Clinical trial NCT01269346
Conditions: Breast Cancer
Keywords: Locally recurrent metastatic HER2Positive breast cancer
Sponsor: Eisai Inc.
Start date: 2010-12-01; Completion date: 2016-05-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

Protocol documents:
Clinical trial NCT01282073
Conditions: Glomerulonephritis, Membranous
Keywords: Idiopathic membranous nephropathy Mycophenolate mofetil Proteinuria Renal function
Sponsor: Kyungpook National University Hospital
Start date: 2011-03-01; Completion date: 2016-05-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.

Detailed description:
Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mycophenolate mofetil, low dose steroid intervention 2: Cyclosporin, low dose steroid
Intervention descriptions: intervention 1: Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg)

Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day

Duration: 48 weeks intervention 2: Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)

Steroid: same dosage with active comparator goup

Duration: 48 weeks

Protocol documents:
Clinical trial NCT01282242
Conditions: Acute Stroke
Keywords: acute stroke, IV rt-PA, Activase, Alteplase
Sponsor: Lee Schwamm
Start date: 2011-01-01; Completion date: 2016-05-01
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was jointly developed and is jointly led by investigators at Massachusetts General Hospital and the intramural division of NINDS. We are doing this research study to find out if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute ischemic stroke when their stroke onset was not witnessed making them ineligible for standard thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people recover better from their stroke.

The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if rt-PA is effective if given to people who are selected for treatment based on MRI evidence of an early stroke, and 3) get information about this new MRI diagnostic methods for guiding stroke treatment.

Detailed description:
This study was jointly developed and is jointly led by Massachusetts General Hospital and the NINDS. This is a multi-center, open-label, Phase IIa safety study in adult acute ischemic stroke patients to determine if it is safe to extend intravenous thrombolytic treatment to subjects who are evaluated within 24 hours from last known well ("stroke onset") and eligible to receive thrombolytic treatment within 4.5 hours from symptom discovery with the assistance of an MRI-based "witness" when no human witness of stroke onset is available. The study is designed to investigate the safety in using standard diagnostic MRI in selecting patients for thrombolytic therapy when the last known well time places the patient beyond the current IV thrombolytic time-window.

Arms: arm 1: open-label
Interventions: intervention 1: IV rt-PA
Intervention descriptions: intervention 1: open-label

Protocol documents:
Clinical trial NCT01324570
Conditions: Pain
Keywords: Pain Opioid Analgesia Moderate to severe pain
Sponsor: Purdue Pharma LP
Start date: 2011-07-01; Completion date: 2016-05-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

Detailed description:
A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Arms: arm 1: Buprenorphine transdermal system
Interventions: intervention 1: Buprenorphine transdermal system
Intervention descriptions: intervention 1: Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.

Protocol documents:
Clinical trial NCT01338636
Conditions: Exercise-induced Pulmonary Arterial Hypertension
Keywords: Exercise-induced pulmonary arterial hypertension (EIPAH) Pulmonary arterial hypertension (PAH) ambrisentan Advanced cardiopulmonary exercise test (CPET)
Sponsor: Brigham and Women's Hospital
Start date: 2008-09-01; Completion date: 2016-05-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is assess whether ambrisentan can help people with exercise- induced pulmonary arterial hypertension (EIPAH). The investigators also want to find out if ambrisentan is safe to take without causing excessive side effects.

Detailed description:
EIPAH population: These participants may provide a unique window into the pathogenesis of PAH. Our data suggest that these participants may represent an early phase of PAH with an abnormal vascular response.

The study includes an assessment of the potential impact of ambrisentan on the exercise capacity Advanced Level-3 cardiopulmonary exercise test (CPET) and the World Health Organization functional class (WHO FC).

Arms: arm 1: Open-label ambrisentan
Interventions: intervention 1: Ambrisentan
Intervention descriptions: intervention 1: 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.

Protocol documents:
Clinical trial NCT01396070
Conditions: Non-Hodgkin Lymphoma (NHL) Cutaneous Lymphoma Cutaneous T-cell Lymphoma (CTCL) Mycosis Fungoides Sezary Syndrome
Sponsor: Youn Kim
Start date: 2011-05-01; Completion date: 2016-05-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.

Detailed description:
This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.

The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.

Arms: arm 1: Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
Interventions: intervention 1: Brentuximab vedotin
Intervention descriptions: intervention 1: 1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).

Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10.

Protocol documents:
Clinical trial NCT01499953
Conditions: Superficial Vein Thrombosis
Keywords: superficial vein thrombosis thrombosis SVT
Sponsor: GWT-TUD GmbH
Start date: 2012-04-01; Completion date: 2016-05-01
Enrollment: 472 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Detailed description:
Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment

Arms: arm 1: Rivaroxaban for 45 days oral dose: 10 mg OD arm 2: Fondaparinux for 45 days subcutaneous application: 2,5 mg OD
Interventions: intervention 1: Rivaroxaban intervention 2: Fondaparinux
Intervention descriptions: intervention 1: Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral intervention 2: Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous

Protocol documents:
Clinical trial NCT01502761
Conditions: Acute Stroke
Keywords: stroke Magnesium endovascular
Sponsor: University of Southern California
Start date: 2012-03-01; Completion date: 2016-05-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to "at risk" tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique

Detailed description:

Arms: arm 1: Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients arm 2: Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients arm 3: Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients arm 4: Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Interventions: intervention 1: Magnesium Sulfate
Intervention descriptions: intervention 1: Intra-arterial

Protocol documents:
Clinical trial NCT01553136
Conditions: Alcoholism Alcohol Abuse Smoking Alcohol Drinking
Keywords: alcohol-related disorders Cholinergic Drugs varenicline Chantix
Sponsor: Yale University
Start date: 2012-09-01; Completion date: 2016-05-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.

Detailed description:
Building upon knowledge about the role of nicotinic acetylcholine receptors in alcohol drinking and smoking, varenicline, a smoking cessation treatment that targets these receptors, will be tested as a potential treatment for alcohol dependent smokers seeking alcohol treatment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day

Protocol documents:
Clinical trial NCT01583166
Conditions: Stress Urinary Incontinence
Sponsor: University of Massachusetts, Worcester
Start date: 2012-03-01; Completion date: 2016-05-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bupivacaine intervention 2: Saline intervention 3: Epinephrine
Intervention descriptions: intervention 1: 10ml 0.5% bupivacaine intervention 2: 10ml 0.9% sodium chloride intervention 3: 1:200,000 epinephrine

Protocol documents:
Clinical trial NCT01632904
Conditions: Polycythemia Vera
Keywords: Polycythemia Vera PV
Sponsor: Incyte Corporation
Start date: 2012-06-01; Completion date: 2016-05-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

Detailed description:
This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to PV will be enrolled.

Subjects will be randomized (1:1) to 1 of 2 treatment arms:

A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo

Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ruxolitinib intervention 2: Hydroxyurea (HU) intervention 3: HU-placebo intervention 4: Ruxolitinib-placebo
Intervention descriptions: intervention 1: Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy. intervention 2: Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria. intervention 3: All placebo will be self-administered, and dosing will be the same as with the blinded dose.

When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently. intervention 4: All placebo will be self-administered, and dosing will be the same as with the blinded dose.

When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.

Protocol documents:
Clinical trial NCT01721967
Conditions: Hypertrophic Cardiomyopathy
Keywords: chest pain dyspnea
Sponsor: Duke University
Start date: 2012-11-01; Completion date: 2016-05-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).

Detailed description:

Arms: arm 1: Ranolazine, 500 mg for 60 days
Interventions: intervention 1: Ranolazine
Intervention descriptions: intervention 1: None

Protocol documents: