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NCT ID: NCT00480025 Terminated - Clinical trials for Lung Cancer, Non-Small Cell

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

Start date: October 4, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00479960 Not yet recruiting - Oligospermia Clinical Trials

A Preliminary Study on Effect of Omega-3 on Human Sperm

Start date: June 2007
Phase: Phase 0
Study type: Interventional

The phospholipids of mammalian spermatozoa possess a distinctive fatty acid composition with high proportion of long chain polyunsaturated fatty acids. The lipid composition is a major determinant of the membrane flexibility and sperm motility required for proper fertilization. It also influences the sperm plasma membrane's fluidity, chilling sensitivity and thermotropic lipid phase transition (LPT) and these parameters determine our ability to cryopreserve these cells. Our hypotheses is that by providing dietary supplementation of omega-3 polyunsaturated fatty acids an improvement of sperm parameters (number, motility, viability) can be achieved. We also expect alteration spermatozoal plasma membrane fatty acid composition, making it more chilling resistant. Experimental methodology: 1) Characterize fatty acid composition of the spermatozoa of normal and abnormal spermatozoa by gas chromatography. 2) Characterize sperm plasma membrane LPT by FTIR spectrometer. 3) Run a randomized double-blind, placebo controlled, crossed-over dietary fatty acid supplementation pilot trial in human sub-fertile patients. Large scale trial will follow, if justified. In both trials sperm characterization of each participant will be conducted before, during and following the trial. Subfertile males will benefit greatly if their sperm parameters can be improved and cryopreserved while ensuring enhanced post-thawing survival. We believe that changing the fatty acid composition of sperm plasma membrane by simple dietary means will open the way to improve the fertility of those that needs it the most.

NCT ID: NCT00479752 Completed - Colorectal Cancer Clinical Trials

Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

CORE 2
Start date: January 2008
Phase: Phase 2
Study type: Interventional

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

NCT ID: NCT00479102 Not yet recruiting - Anemia Clinical Trials

Prevention of Iron Deficiency in 2nd Year of Life

Start date: May 2007
Phase: Phase 4
Study type: Interventional

Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.

NCT ID: NCT00478998 Not yet recruiting - Clinical trials for Upper Tract Ureterolithiasis

Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .

NCT ID: NCT00478881 Completed - Overactive Bladder Clinical Trials

A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

Start date: August 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

NCT ID: NCT00478647 Completed - Gaucher Disease Clinical Trials

Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With Imiglucerase

Start date: July 25, 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this study is to evaluate the safety and efficacy of every other week dosing of GA-GCB (velaglucerase alfa) in participants with type 1 Gaucher disease who were previously treated with imiglucerase.

NCT ID: NCT00478530 Completed - Clinical trials for Macular Degeneration

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

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

To evaluate the scotopic and photopic ERG responses before and after one month of intravitreal avastin injection in patients with choroidal neovascularization. A positive finding that will reveal a toxic effect of intravitreal avastin injection on any component of the retina will have a significant important clinical impact regarding the decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.

NCT ID: NCT00477555 Completed - Clinical trials for Coronary Artery Bypass Grafting

Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position

Start date: April 2006
Phase: N/A
Study type: Observational

The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic performance and a potential for increased durability. This study will document the hemodynamic performance, as assessed by echocardiographic recordings, at six months post implantation.

NCT ID: NCT00476996 Terminated - Clinical trials for Rheumatoid Arthritis

A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

SCRIPT
Start date: May 15, 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.