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NCT ID: NCT01261858 Not yet recruiting - Sternal Closure Clinical Trials

Sternal Closure With Biologic Bone Cement in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

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

Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG) in patients undergoing surgery for coronary artery disease. Given the increasing risk profile of contemporary cardiac surgery patients, sternal complications are subject to increase concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in sternal closure technique has been lacking and postoperative complications remain. In this study, the investigators aim to assess the effectiveness of using a novel osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to conventional sternal closure in post CABG patients having median sternotomy. The outcomes of interest for this study will include: pain, discomfort, lung function, wound healing and analgesic use. The investigators assume that the use of KryptoniteTM will decrease postoperative pain leading to improvement in postoperative lung function. This may also lead to improvement in patient recovery and decrease in postoperative complications. The investigators will undertake a single-blinded randomized, controlled study consisting of patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to either Group A (usual closure with stainless steel wires) or Group B (usual closure with stainless steel wires plus application of bone cement). Each group will consist of 64 patients in a total of 128 patients. Lung function data using a spirometer will be collected preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data will be collected on the 1st to 5th postoperative days.

NCT ID: NCT01259492 Completed - Clinical trials for Attention Deficit/Hyperactivity Disorder

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

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

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).

NCT ID: NCT01257711 Completed - Gastric Cancer Clinical Trials

A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer

SCAR
Start date: October 9, 2008
Phase: N/A
Study type: Interventional

Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal gastrectomy, however the debate one which is better remains unanswered. The aim of this study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms and reflux problems when compared to Billroth II reconstruction. Patients with resectable gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected. They will be randomized after completion of distal subtotal gastrectomy to under go either Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively. At 6 months follow up a repeat nutritional assessment using clinical and biochemical parameters will be carried out. The biochemical markers are part of routine follow up. The final assessment will be at the one year post surgery visit when by interview using EORTC 30 questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and surgery data for recurrence will be repeated. At one year patients will also have upper gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis will be graded and esophageal reflux assessed as per Los Angeles classification. It is postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for mortality and lost to follow up, a total of 160 subjects to be randomized equally will be recruited.

NCT ID: NCT01254396 Completed - Clinical trials for Erectile Dysfunction

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.

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

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.

NCT ID: NCT01254383 Completed - Clinical trials for Erectile Dysfunction

Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

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

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

NCT ID: NCT01254279 Completed - Clinical trials for Prostate Cancer Metastatic

Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

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

The purpose of this study is to allow patients similar to that evaluated in the TROPIC trial (NCT00417079), and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in those patients who have progressed during or after docetaxel and to document the overall safety of cabazitaxel in these patients. Please note that in each country, patient recruitment will end when cabazitaxel becomes commercially available.

NCT ID: NCT01252654 Completed - Myopia Clinical Trials

Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis

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

Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery for refractive error). Their use has decreased the incidence of serious complications when compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available and differs from the Intralase in that it does not interfere with the curvature of the cornea when creating the flap. The Intralase applanates the cornea flat during flap creation which causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the two lasers in a randomization of left and right eyes in the same patient. The investigators want to measure any difference that the lower intraocular pressure may have during the creation of the flap. This will be measured with a questionaire on patient experience during the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness measured with anterior segment OCT during the post-operative follow up period. To date no-one has compared the use of these two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.

NCT ID: NCT01249664 Completed - Clinical trials for Myopia, Pathological

VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

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

VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment. Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment. Total duration of the study will be 48 weeks.

NCT ID: NCT01249365 Completed - Clinical trials for Infections, Papillomavirus

The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Start date: January 24, 2011
Phase: Phase 3
Study type: Interventional

This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

NCT ID: NCT01248897 Completed - Clinical trials for Neoplasms, Metastasis

Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

BioPATH
Start date: August 17, 2010
Phase:
Study type: Observational

The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.