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NCT ID: NCT01422876 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

NCT ID: NCT01421992 Completed - Clinical trials for Dystrophia Myotonica 1

Methylphenidate in Myotonic Dystrophy Type 1

Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether methylphenidate is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1).

NCT ID: NCT01421966 Completed - Clinical trials for Lower Extremity Chronic Ulcers in Diabetics

Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

Start date: August 2011
Phase: Phase 3
Study type: Interventional

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.

NCT ID: NCT01421667 Completed - Clinical trials for Lymphoma, Non-Hodgkin

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

NCT ID: NCT01421537 Completed - Skin Burn Extensive Clinical Trials

Evaluation Of Enoxaparin Pharmacokinetic For Thromboprophylaxis In Burn Care Patients

Start date: January 2011
Phase:
Study type: Observational

OVERVIEW: - Thromboembolisms represent a serious and feared complication in hospitalized patients. - Several factors make the ICU patient population at increased risk of venous thromboembolism. - A high incidence of thromboembolic events is starting to emerge from recent medical literature in the burn patient. - Actual guidelines for thromboprophylaxis in burn care patients are based on multiple non-burn patient trials. - Burn patient physiology is radically different than that of general ward hospitalized patients - Since the actual chemical thromboprophylaxis have not been evaluated in the burn patient, it is of interest to assess their efficacy in patients with severe burns. - Hence, the pharmacokinetic characterization of heparins (a well accepted mode of thromboprophylaxis) in burn patients could guide future quality of care for this subclass of patients. Our proposal is based on the conviction that anti-Xa activity of low-molecular-weight heparins in the burn patients do not correlate with levels described to prevent thromboembolic events in the general hospitalized population. The investigators aim to: 1. To evaluate pharmacokinetics and pharmacodynamics of low-molecular-weight heparins (enoxaparin), with anti-Xa levels in severely burned patients receiving thromboprophylaxis. 2. To determine the correlation between antithrombotic activity of heparins and the different metabolic phases of the thermally injured patient.

NCT ID: NCT01421381 Completed - Clinical trials for Leber's Hereditary Optic Neuropathy

RHODOS Follow-up Single-visit Study

RHODOS-OFU
Start date: September 2011
Phase: N/A
Study type: Observational

This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.

NCT ID: NCT01420783 Completed - Clinical trials for Hematopoietic Neoplasm

Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: - Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for : - Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and - Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia. - PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for: - Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and - Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET. Secondary Objectives: - To evaluate the safety of SAR302503. - To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility. - To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts. - To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8. - To evaluate splenic response as measured by spleen volume using MRI or CT. - To evaluate the pharmacokinetics of SAR302503 after single and repeat doses. - To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition. - To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life. - To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.

NCT ID: NCT01420471 Completed - Sinusitis Clinical Trials

Medicated Punctured-Glove-Finger Spacer Study

FISHNET
Start date: September 2011
Phase: Phase 4
Study type: Interventional

All adult patients undergoing sinus surgery for chronic rhinosinusitis (CRS) that satisfy the inclusion/exclusion criteria will be included in the study. All patients enrolled in this study will have spacers (impregnated with saline or Triamcinolone) inserted into their middle meati after sinus surgery. Patients will serve as their own controls. Nostril's will be randomized to either the experimental treatment (Triamcinolone-impregnated spacer) or the control treatment (Saline-impregnated spacer). These spacers will be removed after 6-days post-op. Participants will undergo the standard post-operative endoscopic sinus surgery follow-up appointments plus one additional research visit (not standard of care). This includes follow-up appointments at 6 days, 14 days, 5 weeks, 3 months, and 6 months of the post-operative period. During these appointments, the surgeon will assess the post-operative mucosal appearance (Philpott-Javer Sinus Rating System). SNOT-22 surveys will be administered, as per standard protocol, at each post-op follow up visit. Sinus tissue biopsies will be taken from both meati on 28-day and 3-month post-op follow-up appointments for analysis. Our objective is to determine if triamcinolone soaked Merocel middle meatus spacers (MMS) in a perforated glove finger improves patient outcomes, wound healing and reduces inflammation compared to a standard saline-soaked merocel sponge within a perforated glove finger in CRS patients receiving FESS. Our hypothesis is that triamcinolone-medicated Merocel MMS are not inferior to standard saline-soaked spacers, when both are enclosed in a perforated surgical glove finger.

NCT ID: NCT01420419 Completed - Pain Clinical Trials

Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

LanP
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.

NCT ID: NCT01420393 Completed - Heart Failure Clinical Trials

Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation

RAFT-AF
Start date: September 2011
Phase: N/A
Study type: Interventional

Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure. This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.