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NCT ID: NCT01379261 Completed - Clinical trials for Myocardial Infarction

Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction

CHILL-MI
Start date: June 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether treatment of patients suffering from ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous coronary intervention (PCI) result in a reduction in infarct size.

NCT ID: NCT01376804 Completed - Clinical trials for Kidney Transplantation, Cytomegalovirus Infections

A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Start date: July 2011
Phase: Phase 4
Study type: Interventional

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

NCT ID: NCT01375764 Completed - Hyperlipidemia Clinical Trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

GAUSS
Start date: July 28, 2011
Phase: Phase 2
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

NCT ID: NCT01374451 Completed - Islet Cell Tumor Clinical Trials

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

COOPERATE-1
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET

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: NCT01373983 Completed - Clinical trials for Peripheral Neuropathy

Intrathecal Bolus Doses of Ziconotide

ZicBol
Start date: August 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate if the effect of ziconotide can be tested by intrathecal bolus doses.

NCT ID: NCT01372709 Completed - Clinical trials for Abdominal Aortic Aneurysm

TriVascular Post-Market Registry

Start date: May 2011
Phase:
Study type: Observational

This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

NCT ID: NCT01372059 Completed - Stroke Clinical Trials

The Effects of a Rhythm and Music-based Therapy Program and Therapeutic Riding in Late Recovery Phase Following Stroke

Start date: January 2010
Phase: N/A
Study type: Interventional

The initiative to the study is based on the fact that various forms of enriched environments and multimodal stimulation are found to have positive influences on motivation and psychosocial well-being and have been shown to facilitate multiple processes in the brain leading to structural regeneration and functional recovery. Since there is a lack of rehabilitation programs that encompass all dimensions of a stroke survivor's life researchers agree upon the need for a rehabilitation program that addresses both the social and physical needs of the patients. The aim with the project is to investigate whether it is possible to improve the life situation among patients with a history of stroke through a rhythm and music method and therapeutic riding. To get insights in the underlying mechanisms our research also focuses on relevant physiological, neurobiological and psychosocial mechanisms induced by the interventions. The hypothesis is that both treatment methods will mainly enhance participants' degree of participation. The study is a randomized controlled trial where about 123 participants (50-75 years old) who had their stroke incident 1 - 5 years ago will be consecutively included and randomly allocated to the following three groups: a) Ronnie Gardiner Rhythm Music Method (RGRM) b) therapeutic riding c) a control group receiving RGRM after 9 months. Treatment proceeds during 12 weeks and evaluation takes place pre- and post intervention, and 12 and 24 weeks after the treatment is finalized. The evaluation consists of a thorough neuropsychological assessment, a physiotherapeutic assessment, sampling of blood and questionnaires covering mental, psychosocial, physical and psychological well-being. Interviews are also conducted in order to map the participants' experiences from the two treatment programs. Specially designed interviews are also planned to be carried through with participants having aphasia. So far, there is only empirical support suggesting that RGRM has positive effects for individuals with a history of stroke making it significant to carry out research with the aim to contribute to strengthening the evidence of the method. A positive outcome would increase the scientific basis for this alternative treatment thus facilitating further research and implementation in everyday clinical practice.

NCT ID: NCT01370629 Completed - Atrial Fibrillation Clinical Trials

Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)

Start date: August 2011
Phase:
Study type: Observational

This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.

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