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NCT ID: NCT01238497 Completed - Clinical trials for Severe Aortic Stenosis

SOURCE XT REGISTRY

Start date: September 2010
Phase:
Study type: Observational

This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XTâ„¢ Valve, and delivery devices.

NCT ID: NCT01237899 Completed - Clinical trials for Chronic Kidney Disease

Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of 16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind for LY2623091 and placebo (negative control), and open label for eplerenone (positive control).

NCT ID: NCT01237236 Completed - Clinical trials for Advanced Solid Tumor

A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.

Start date: December 21, 2010
Phase: Phase 1
Study type: Interventional

LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6. CDK4/6 is involved in the process that allows both normal and cancer cells to divide and multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor models in animals. Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease the ability of the bone marrow to make white blood cells, platelets, and red blood cells. Although these effects are expected to be reversible, they can increase the risk of infection, bleeding and fatigue. The primary purpose of this study is to find the highest dose of LEE011 that can be safely given to adult patients with advanced solid tumors or lymphomas for which no further effective standard treatment is available. It will provide information about the side effects that may occur following treatment. The study will also possibly provide early evidence for LEE011's anti-tumor activity.

NCT ID: NCT01237145 Completed - Clinical trials for Extrinsic Allergic Alveolitis

Bronchoalveolar Immune Response Determination

BIRD
Start date: September 2011
Phase: N/A
Study type: Observational

The purpose of this study is to establish if cells present in lung tissue during extrinsic allergic alveolitis (EAA) are able to elicit an immune response against specific antigens. The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to specific antigens and this response can be measured using ELISPOT.

NCT ID: NCT01236625 Completed - Tissue Adhesions Clinical Trials

The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs

LAPAD
Start date: June 2008
Phase: N/A
Study type: Observational

Official title: LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs Background: With improved surgical technology and ageing of the population the number of reoperations in the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is required to gain access to the abdominal cavity and operation area. Adhesiolysis significantly increases the risk for inadvertent organ damage, such as enterotomies, leading to higher morbidity, mortality and socioeconomic costs. Purpose: To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs. Design: Prospective observational study. Primary outcomes: - adhesiolysis time - inadvertent enterotomy - seromuscular injury - miscellaneous organ damage - Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death) Secondary outcomes: - Hospital stay - Intensive care admission - Reinterventions - In-hospital costs - Parenteral feeding - Short term readmissions (30 days) - Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke Activity Score Index(DASI) ) Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010 Estimated study completion date: 1 february 2011

NCT ID: NCT01236612 Completed - Clinical trials for Plasmodium Falciparum Malaria

Experimental Human Malaria Infection After Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

EHMI9
Start date: April 2011
Phase: N/A
Study type: Interventional

Malaria is one of the major infectious diseases in the world with a tremendous impact on the quality of life significantly contributing to the ongoing poverty in endemic countries. It causes almost one million deaths per year, the majority of which are children under the age of five. The malaria parasite enters the human body through the skin, by the bite of an infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the blood stream, causing the clinical phase of the disease. As a unique opportunity to study malaria immunology and efficacy of immunisation strategies, a protocol has been developed in the past to conduct experimental human malaria infections (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially serious or even lethal, Plasmodium falciparum (P.falciparum) malaria can be radically cured at the earliest stages of blood infection where risks of complications are virtually absent. The investigators have shown previously, that healthy human volunteers can be protected from a malaria mosquito challenge by immunization with mosquito-bites under chloroquine prophylaxis (CPS immunization). However, it is unknown whether this protection is based on immunity directed towards the liver- or the blood stage of the disease. For future development of vaccines and understanding of protective immunity to malaria, it is important to investigate at which level protective immunity is generated by CPS immunization. Therefore, we aim to investigate whether CPS immunization confers protection to a blood-stage challenge.

NCT ID: NCT01235598 Completed - Clinical trials for Rheumatoid Arthritis

Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

MARVELOUS
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.

NCT ID: NCT01235585 Completed - Schizophrenia Clinical Trials

A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25306)

Start date: December 2010
Phase: Phase 3
Study type: Interventional

This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

NCT ID: NCT01234727 Completed - Diabetes Mellitus Clinical Trials

Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes

Start date: December 2010
Phase: N/A
Study type: Observational

A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany & Holland.

NCT ID: NCT01234350 Completed - Prostate Cancer Clinical Trials

A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Start date: January 2011
Phase:
Study type: Observational

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.