Clinical Trials Logo

Filter by:
NCT ID: NCT01657981 Completed - Pharmacokinetics Clinical Trials

A Study to Find Out How YM150 is Absorbed Into and Eliminated From the Body in Healthy Male Subjects

Start date: February 2007
Phase: Phase 1
Study type: Interventional

The study aims to observe how YM150 was absorbed, distributed and excreted after dosing with a radio labeled drinking solution.

NCT ID: NCT01657123 Not yet recruiting - Addison's Disease Clinical Trials

Exercise Capacity and Recovery in Addison's Disease

Start date: January 2013
Phase: N/A
Study type: Interventional

Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. Physical exercise represents a stress condition influencing many systems in the body. Given a workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's disease are not able to meet the increased demand of adrenal steroids in case of physical exercise, which may result in an impaired exercise capacity and a prolonged post-exercise recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and improves post-exercise recovery in patients with Addison's disease.

NCT ID: NCT01656915 Completed - Healthy Clinical Trials

Ex Vivo LPS Stimulation in Healthy and Compromised Subjects

Start date: June 2012
Phase: N/A
Study type: Observational

Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects. The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased). Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.

NCT ID: NCT01655212 Terminated - Clinical trials for Sensorineural Hearing Loss

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

CONCERT
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The objective of the trial is to investigate whether early treatment with oral valganciclovir of infants with both congenital cytomegalovirus infection and sensorineural hearing loss can prevent progression of hearing loss.

NCT ID: NCT01654328 Terminated - Clinical trials for Radiographic Contrast Agent Nephropathy

Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy

INOVATIO
Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients.

NCT ID: NCT01654211 Completed - Healthy Volunteer Clinical Trials

A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.

NCT ID: NCT01652469 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

EMPHASIS
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

NCT ID: NCT01652105 Not yet recruiting - Morbid Obesity Clinical Trials

Randomized Trial of Preoperative Diets Before Bariatric Surgery

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

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

NCT ID: NCT01652027 Completed - Hemophilia A Clinical Trials

Hemophilia Inhibitor Previously Untreated Patient Study

HIPS
Start date: July 2011
Phase:
Study type: Observational

Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII) and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which interfere with the function of FVIII concentrates. The reason that some, but not all, people with severe hemophilia A develop inhibitors is incompletely understood. Understanding individual and environmental risk factors is important to be able to prevent and possibly treat inhibitors. This study will look at individual and treatment characteristics in babies with severe hemophilia A who have not yet received treatment with FVIII (called Previously Untreated Patients, or PUPS). Subjects in the study will be asked to provide diaries of treatments, medications, and illnesses. Treatment will be directed by the subjects' physician, but all subjects will receive Advate, a third-generation recombinant FVIII product. Subjects will have blood drawn for laboratory tests, which include studies of the immune system and genetic studies of the FVIII mutation, before and 7-9 days after the first treatment with FVIII, and 5 days (+/-2 days) after the 5th, 10th, 20th, 30th, 40th, and 50th days of treatment with FVIII (exposure days). The duration of the study will be first 50 treatments or 3 years, whichever comes first.

NCT ID: NCT01651780 Completed - Clinical trials for Aortic Valve Insufficiency

Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

BRAVO-2/3
Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively