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NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01775917 Recruiting - Missed Abortion Clinical Trials

The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception.

Start date: January 2013
Phase: N/A
Study type: Observational [Patient Registry]

During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned. It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections. it has been shown that misoprostol - prostaglandin E1 given for missed abortions is successful in emptying the uterus in 85% of cases without any need for surgical intervention. and during recent years many women prefer this approach than the surgical one . Many have tried using sonographic signs such as endometrial thickness, the presence of a gestational sac, and color doppler to differ between blood clots and a gestational residua in uterus, and to decide according to these signs wether there is a need for surgical evacuation or an expectant management could be used. but none of these methods have been proven to be completely efficient as predictors. In this study the investigators will examine whether the doppler indices in the uterine arteries can help to predict which gestational residua needs surgical evacuation of the uterus and which could be managed expectantly. The study hypothesis is that the resistance in uterine artery doppler will be lower in cases with intrauterine residua as opposed to high resistance in cases without residua.

NCT ID: NCT01775618 Completed - Hemophilia A Clinical Trials

Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A

Start date: May 29, 2013
Phase: Phase 3
Study type: Interventional

Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. The current standard treatment for severe hemophilia A is infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary. Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.

NCT ID: NCT01774890 Completed - Clinical trials for Congenital Heart Disease

ST2, a Novel Biomarker for Cardiac Remodeling in Adults With Congenital Heart Disease

Start date: March 2013
Phase: N/A
Study type: Observational

The remarkable improvement in survival of children with congenital disease has led to a continuously growing number of adults with congenital heart disease in the developed world. Many of these patients had had cardiac surgery at early age, the may live for many years with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any combination of the above. These past and ongoing cardiac insults often result in significant cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and prognostic value for these patients. Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as markers for heart disease in infants and children. This resulted in many studies and more than 25 publications in the medical literature. We believe that the newly discovered cardiac marker, ST2, will emerge as an important addition to cardiac evaluation in the coming years.The aim of this study is to measure ST2 levels in patients with congenital right heart disease and correlate ST2 levels to clinical status, imaging and prognosis.

NCT ID: NCT01772576 Completed - Tachycardia Clinical Trials

Safety and Performance Study of the Reliance 4-Front Lead

Start date: October 2012
Phase: N/A
Study type: Interventional

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONTâ„¢ Active Fixation Defibrillation Leads.

NCT ID: NCT01772472 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Start date: April 3, 2013
Phase: Phase 3
Study type: Interventional

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

NCT ID: NCT01772303 Recruiting - Hard to Heal Wounds Clinical Trials

Safety and Efficacy Study of HO/03/03 10-40 Micro Grams to Treat Hard to Heal Wounds

H2H
Start date: January 2013
Phase: Phase 0
Study type: Interventional

This multicenter, prospective, open-label, outpatient study will assess the safety and efficacy of HO/03/03 10µg applied topically once daily for up to 24 weeks in up to 100 subjects with Hard to Heal documented chronic wounds of various etiologies (pressure ulcers, diabetic ulcers, post operational wounds surgical incisions ulcers of rheumatoid arthritis and trauma wounds) of at least 4 weeks documentation.

NCT ID: NCT01772251 Completed - Clinical trials for Diabetes Mellitus, Insulin-Dependent, 1

Safety and Tolerability of Oshadi Icp In Patients With Type 1 Diabetes Mellitus - Phase Ib Clinical Study

Start date: February 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Diabetes mellitus (DM) is a chronic disease of carbohydrate, fat, and protein metabolism caused by an absolute or relative deficiency of insulin, an anabolic hormone. The current methods of insulin therapy for diabetic patients are multiple daily injection therapy and continuous subcutaneous insulin infusion with an external pump. This rout of administration may lead to hyperinsulinemia as insulin is administered in a non physiological way, targeting mainly extra hepatic tissues (muscle, fat). A method of providing insulin without the need for injections has been a goal in drug delivery. Oshadi Drug Administration Ltd. has developed oral carrier for proteins based on biochemistry and quantum theory of biochemical reactions. The carrier enables the absorption of proteins from the gastrointestinal tract in their full structure. Oshadi has also developed the Oshadi Icp - insulin, proinsulin and C-peptide in Oshadi carrier, administrated orally. This study was design in order to evaluate the safety and feasibility of multiple administration of Oshadi Icp

NCT ID: NCT01771809 Completed - Ulcerative Colitis Clinical Trials

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

TURANDOT II
Start date: March 18, 2013
Phase: Phase 2
Study type: Interventional

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

NCT ID: NCT01770691 Completed - Clinical trials for Stress Urinary Incontinence

Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Start date: September 2007
Phase: N/A
Study type: Interventional

Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life. The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.