ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01164644
Conditions: Ecchymosis
Keywords: ecchymosis bruising rhinoplasty nose job arnica arnica montana
Sponsor: University of Wisconsin, Madison
Start date: 2010-06-01; Completion date: 2012-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surgeons throughout the world, although there is no study proving its benefit after rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the amount of bruising and the intensity of the bruising after surgery. Photographs of the subject's face will be taken and used to analyze bruising after rhinoplasty surgery in subjects who receive Arnica montana and compare them to photographs of subjects who take a placebo (sugar pill).

Detailed description:
Subjects will receive either oral arnica montana or placebo without any identifying labels or markers on the drugs.

During the post-operative period, the patients will be seen back in surgery clinic on post-operative days 3, 7 and 10. During the first two visits, the subject will receive routine post-operative care with no difference from patients not enrolled in the study. This includes routine sets of photographs. The participant will then return for a third post-operative visit lasting under ten minutes only for study photos using the left and right "three-quarters" view. Again, the subject will hold a measurement marker so length measurements can be made, and this marker will be held under the ear to not interfere with the routine cosmetic analysis of the photographs. The digital photographs will be used to analyze the bruising for the study. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.

Arms: arm 1: The subject will take twelve pills by mouth three times a day over four days. arm 2: The subject will take twelve pills by mouth three times a day over four days.
Interventions: intervention 1: Arnica montana intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will take twelve pills by mouth three times a day over four days. intervention 2: Subjects will take twelve pills by mouth three times a day over four days.

Protocol documents:
Clinical trial NCT01164891
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2010-07-01; Completion date: 2012-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RO5185426
Intervention descriptions: intervention 1: Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered

Protocol documents:
Clinical trial NCT01169519
Conditions: Heart Disease
Keywords: Hypoplastic left heart syndrome Hypoplastic right heart syndrome Superior cavopulmonary anastomosis Total cavopulmonary anastomosis Children with single ventricle anatomy
Sponsor: Duke University
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with single ventricle anatomy undergo staged surgical palliation. The result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. While surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. Elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation.

Sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle.

The investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage II and III surgical palliation.

Detailed description:

Arms: arm 1: Pharmacokinetic and hemodynamic evaluation following sildenafil administration
Interventions: intervention 1: Sildenafil by injection intervention 2: Sildenafil by injection intervention 3: Sildenafil by injection intervention 4: Sildenafil by injection
Intervention descriptions: intervention 1: Sildenafil 0.125mg/kg injection over 20min intervention 2: Sildenafil 0.25mg/kg injection over 20min intervention 3: Sildenafil 0.35mg/kg by injection over 20min intervention 4: Sildenafil 0.45mg/kg by injection over 20min

Protocol documents:
Clinical trial NCT01170962
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2010-08-01; Completion date: 2012-12-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Detailed description:

Arms: arm 1: (prior null responders) arm 2: (prior null responders) arm 3: (prior partial responders) arm 4: (prior partial responders) arm 5: (prior partial responders only)
Interventions: intervention 1: BMS-790052 intervention 2: BMS-790052 intervention 3: Placebo intervention 4: peginterferon alfa-2a intervention 5: ribavirin
Intervention descriptions: intervention 1: Film coated tablet, Oral, 20 mg, once daily, 24 weeks intervention 2: Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks intervention 3: Film coated tablet, Oral, 0mg, Once daily, 24 weeks intervention 4: Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks intervention 5: Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks

Protocol documents:
Clinical trial NCT01197833
Conditions: Great Saphenous Vein Incompetence Visible Varicosities
Keywords: varicose veins Great saphenous vein varicosities
Sponsor: Boston Scientific Corporation
Start date: 2010-09-01; Completion date: 2012-12-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

Detailed description:

Arms: arm 1: Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein arm 2: Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein arm 3: endovenous ablation followed by injection of vehicle (placebo) to target vein
Interventions: intervention 1: endovenous ablation+polidocanol injectable microfoam 0.125% intervention 2: Endovenous ablation+polidocanol injectable microfoam 1.0% intervention 3: Endovenous ablation+polidocanol injectable foam 2.0%
Intervention descriptions: intervention 1: All components except API intervention 2: endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0% intervention 3: Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Protocol documents:
Clinical trial NCT01198327
Conditions: Retinal Vein Occlusion
Keywords: RVO CRVO BRVO Horizon Bravo Cruise
Sponsor: Peter A Campochiaro, MD
Start date: 2010-08-01; Completion date: 2012-12-01
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO \& CRUISE trials and subsequently followed in the HORIZON extension trial.

Detailed description:
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.

Arms: arm 1: Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
Interventions: intervention 1: ranibizumab intervention 2: Peripheral Laser
Intervention descriptions: intervention 1: Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart. intervention 2: Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.

Protocol documents:
Clinical trial NCT01227902
Conditions: Epilepsy
Keywords: Seizures retigabine IR GW582892 Epilepsy Open label, flexible dose Partial-onset seizures
Sponsor: GlaxoSmithKline
Start date: 2010-07-01; Completion date: 2012-12-01
Enrollment: 203 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.

Detailed description:
This is an open-label, multi-centre, flexible dose study of retigabine immediate release (IR). The study will enroll male and female outpatients (≥ 18 years of age) with partial-onset seizures (POS) who are inadequately controlled on their current monotherapy Antiepileptic Drug (AED). Following a Screening Period of up to 2 weeks, subjects will enter an 8-week Baseline Phase to determine baseline seizure frequency. At the end of the Baseline Phase, subjects who meet or exceed the minimum seizure frequency of 4 partial seizures per 56 days, will enter the Treatment Period (4 weeks Titration, 16 weeks Flexible Dose Evaluation Phase). All subjects will receive retigabine IR starting at 150 mg/day and will be titrated to 600 mg/day by Week 4. From Week 5 onwards, subjects' doses will be maintained between 300 to 1200 mg/day using a flexible dosing regimen to optimise response and tolerability. The maximum duration of the study is approximately 33 weeks (inclusive of a 3 week Taper/Follow-up Phase).

Arms: arm 1: Open Label flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).
Interventions: intervention 1: Retigabine IR
Intervention descriptions: intervention 1: Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).

Protocol documents:
Clinical trial NCT01235507
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-02-01; Completion date: 2012-12-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methotrexate intervention 2: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: stable dose as prescribed intervention 2: 8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions

Protocol documents:
Clinical trial NCT01235910
Conditions: Hypertension Cardiac Transplantation
Keywords: Hypertension Cardiac transplantation Aliskiren Cyclosporine
Sponsor: University of Colorado, Denver
Start date: 2011-05-01; Completion date: 2012-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.

Detailed description:
Hypertension is a major complication following cardiac transplantation, with a prevalence of 93% at 5 years post-transplant. Post-cardiac transplant hypertension is due to multiple factors such as use of cyclosporine, chronic kidney disease, and denervation. Hypertension in this population is difficult to treat, and most patients require therapy with multiple antihypertensive agents in order to achieve adequate blood pressure control. Aliskiren, a direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action and potent blood pressure-lowering effects. As such, aliskiren is an attractive treatment option for post-cardiac transplant hypertension. This study will characterize the pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75 mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac transplant patients.

Arms: arm 1: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Interventions: intervention 1: Aliskiren
Intervention descriptions: intervention 1: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows

Protocol documents:
Clinical trial NCT01240200
Conditions: Diabetes Mellitus
Keywords: diabetes elderly insulin injections
Sponsor: Emory University
Start date: 2011-01-01; Completion date: 2012-12-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by diabetes. Controlling the glucose may prevent these complications. As people age, their bodies become unable to make enough insulin to control the blood sugars. Pills used to treat diabetes may help for a while, but many times this does not last. When the blood sugar is too high, insulin is frequently recommended and used to treat diabetes. Insulin is often started by adding a long-acting insulin to the medicines a patient already takes. In this study, glargine insulin will be taken together with the diabetes pills currently being used. Glargine is a long-acting insulin which is given under the skin once a day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).

Currently, insulin delivery is only available as a shot. The purpose of this study is to compare how satisfied patients are when using two different types of insulin shots. Specifically, this study aims to determine if people over 65 years old are more satisfied taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance to use the insulin syringes and the insulin pens.

The ability of patients to give themselves shots can affect how well the sugar is controlled. As people age, medical and other problems may develop that affect their ability to do certain things. Another aim of this study is to determine if the ability to use an insulin pen and insulin syringe is affected by age or some other problem.

During this study, participants will be treated with insulin given by a syringe for 12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction with treatment throughout the study. The investigators hypothesize that among elderly patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal insulin via a pen device results in higher treatment satisfaction scores and more accurate dosing than treatment with basal insulin via conventional vial and syringe methods.

A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for the study is Grady Memorial Hospital clinics in Atlanta, Georgia.

Detailed description:

Arms: arm 1: Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2. arm 2: Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
Interventions: intervention 1: Glargine intervention 2: glargine via insulin pen
Intervention descriptions: intervention 1: oral antidiabetic agents plus once daily insulin glargine via an insulin syringe intervention 2: oral antidiabetic agents plus insulin glargine in a pre-filled pen

Protocol documents:
Clinical trial NCT01240785
Conditions: Gestational Diabetes
Keywords: gestational diabetes metformin insulin
Sponsor: Turku University Hospital
Start date: 2006-06-01; Completion date: 2012-12-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Detailed description:
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Arms: arm 1: Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values arm 2: NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values
Interventions: intervention 1: metformin intervention 2: insulin
Intervention descriptions: intervention 1: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily intervention 2: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Protocol documents:
Clinical trial NCT01252238
Conditions: Insulin Sensitivity Aortic Compliance Diastolic Function
Sponsor: Brigham and Women's Hospital
Start date: 2010-06-01; Completion date: 2012-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is an investigation of the effect of commonly prescribed anti-hypertensive agents on insulin sensitivity, diastolic function and aortic compliance. The aims of the study are as follows:

Specific Aim 1: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies glucose homeostasis and insulin sensitivity.

To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed basally and after twelve weeks of treatment with either a calcium channel blocker with placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with a renin inhibitor and an angiotensin receptor antagonist.

Specific Aim 2: To determine in insulin resistant, hypertensive subjects if renin inhibition for 12 weeks modifies diastolic function and aortic compliance response to dietary sodium intake.

The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance (characteristic aortic impedance) will be measured at baseline and then after acute and chronic renin inhibition:

1. Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high and low dietary sodium intake conditions (\~1 week each) before and after a single dose of a renin inhibitor.
2. Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at baseline and after 12 weeks of each of the three drug treatment arms above.

The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.

Detailed description:

Arms: arm 1: Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg) arm 2: None arm 3: Only taking Amlodipine
Interventions: intervention 1: Aliskiren intervention 2: Valsartan and Aliskiren intervention 3: Amlodipine
Intervention descriptions: intervention 1: Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks. intervention 2: Subject taking combination of valsartan and aliskiren. intervention 3: Taking Amlodipine as prescribed by MD for management of high blood pressure.

Protocol documents:
Clinical trial NCT01252810
Conditions: Chronic Renal Insufficiency Diabete Mellitus Congestive Heart Failure
Keywords: CATH Catheterization CI-AKI Contrast-induced acute kidney injury DM Diabetes mellitus eGFR Estimated glomerular filtration rate MDRD Modification of Diet in Renal Disease NYHA New York Heart Association PCI Percutaneous coronary intervention SCr Serum creatinine
Sponsor: GE Healthcare
Start date: 2010-11-01; Completion date: 2012-12-01
Enrollment: 284 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GE-145
Intervention descriptions: intervention 1: GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.

Protocol documents: