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NCT ID: NCT01379456 Completed - Hip Fracture Clinical Trials

Eva-Hip, Evaluation of Rehabilitation After Hip-fracture

Eva-Hip
Start date: February 2011
Phase: N/A
Study type: Interventional

To evaluate the effect on gait and activity of a home based physiotherapy intervention 4-6 months after the fracture. The investigators hypothesis is that exercises performed after the initial rehabilitation, which focuses on specific components of gait control will improve gait and increase level of activity.

NCT ID: NCT01377402 Completed - Clinical trials for Coronary Artery Disease

ARgentinean Risk Assessment Registry in ACS; the ARRA-RACS Study

ARRA-RACS
Start date: November 2005
Phase: N/A
Study type: Observational

The first aim of this trial is to assess the long-term prognostic value of Omega-3 index, which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other fatty acids in the erythrocyte membrane, in an unselected, regional multicenter observational study of 982 chest pain patients admitted to the emergency unit, employing blood samples collected at admission. The second purpose of this study is to evaluate the prognostic utility of vitamin D in the same population. The third purpose of this study is to assess the incremental prognostic value of B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP).

NCT ID: NCT01377090 Completed - Systemic Sclerosis Clinical Trials

Digital Ulceration

CAP
Start date: January 2011
Phase: N/A
Study type: Observational

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

NCT ID: NCT01375127 Completed - Clinical trials for Kidney Transplantation

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Start date: August 2011
Phase: N/A
Study type: Observational

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

NCT ID: NCT01374425 Completed - Colorectal Cancer Clinical Trials

Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer

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

This will be a randomized, open-label, multicenter, phase II study. The study population will consist of participants with first-line metastatic colorectal cancer.

NCT ID: NCT01374321 Completed - Clinical trials for Acute Myocardial Infarctus

Safety and Efficacy Study of TRO40303 for Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction

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

Objectives of the phase 2 prospective, multicenter, randomized, double-blind, placebo-controlled study is to assess safety and efficacy of TRO40303 administered just before balloon inflation during percutaneous coronary intervention (PCI) for limitation of infarct size in patients treated for acute myocardial infarction (AMI). The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred eighty patients will be included. It will last one month per patient and its overall duration will be 11 months. The efficacy will be assessed by infarct size expressed as area under the curve for creatine kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac Magnetic Resonance. Safety will be assessed by - clinic evaluation, - blood samples (hematology, biochemistry, renal and hepatic function), - Recording and follow-up of major adverse events occurring during the first 48h after reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat revascularization, renal or hepatic, vascular complication and bleeding). - ECG - Recording cardiac events during one month after AMI - Follow-up of global left ventricular function by Echocardiography at D3 and D30. Demographic and medical history at inclusion and non-cardiac events occurring during the first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min, 6h, and 12h post the end of administration. Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a statistical power of 85% and a probability of type I error of 0.05. Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be performed using O'Brien's method for multiple endpoints testing. Secondary analysis: comparisons of the CMR criteria described above will be performed using mixed model of ANCOVA. All analyses will be performed on the Full Analysis Set and Per protocol populations. Safety analysis: A comparison of the incidence of cumulative adverse clinical events between the groups will be performed by Fisher's exact tests. Subjects will undergo primary PCI and receive concomitant medications according to current standard of care. After coronary angiography is performed but just before balloon inflation is performed, patients who meet the enrollment criteria will be randomly assigned to either the control group or the TRO40303 group. Randomization is ensured by taking the treatment units in ascending and consecutive order in each strata (anterior/posterior as determined on ECG). Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes before balloon inflation and stenting, the patients in the TRO40303 group will receive an intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral IV. The patients in the control group will receive an equivalent volume of the placebo. Patients will be hospitalized for as long as there is a medical indication. CMR and echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and 5. A follow-up visit will be conducted one month after PCI.

NCT ID: NCT01374035 Withdrawn - Mental Disorders Clinical Trials

The Western Norway Mental Health Interface Study on Referral Letters

Start date: August 1, 2010
Phase: N/A
Study type: Interventional

The main object to this trial is to study the function of referral letters as a mean to coordinate the care process for adult people when referred from Primary Care to Specialised Mental Health Care. The study will explore if and to what degree the quality of these referral letters can be improved, and the potential improvement's impact on defined patient-, professional and organisational related outcomes. According to Medical Research Council guidelines for evaluating complex interventions, a stepwise design with the use of both qualitative and quantitative methods will be used to conduct a controlled intervention study.

NCT ID: NCT01370928 Completed - Colorectal Cancer Clinical Trials

Colonoscopy Screening Using a Novel Slim Colonoscope - a Randomized Controlled Trial

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

The purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. The prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. The hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. Both colonoscopes are manufactured by the same company.

NCT ID: NCT01370005 Completed - Hypertension Clinical Trials

12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

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

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

NCT ID: NCT01369368 Recruiting - Clinical trials for Acute Myeloid Leukemia

Treatment of Acute Leukemia Relapse After Allotransplantation

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

Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.