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NCT ID: NCT00654212 Completed - Colonic Neoplasms Clinical Trials

Endo-Laparoscopic Approach Versus Conventional Open Surgery in Obstructing Left-sided Colon Cancer: RCT

Start date: January 2002
Phase: Phase 4
Study type: Interventional

Objective: Whether temporary endoscopic decompression by Self-expanding metal stents (SEMS) could allow these patients to undergo successful laparoscopic resection (endo-laparoscopic approach) has never been previously studied. This randomized trial aims to compare this approach with emergency open surgery in the management of obstructing left-sided colon cancer.

NCT ID: NCT00652743 Completed - Influenza Clinical Trials

Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules

Start date: March 23, 2008
Phase: Phase 3
Study type: Interventional

Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule. The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).

NCT ID: NCT00652366 Completed - Pancreatic Cancer Clinical Trials

A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Start date: May 2008
Phase: Phase 2
Study type: Interventional

This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

NCT ID: NCT00650598 Completed - Pain, Postoperative Clinical Trials

A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

Start date: March 2004
Phase: Phase 4
Study type: Interventional

To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.

NCT ID: NCT00644605 Completed - Clinical trials for Hypertension, Pulmonary

A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

Start date: October 2002
Phase: Phase 3
Study type: Interventional

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

NCT ID: NCT00643929 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

LENS - Long-term Eltrombopag Observational Study

LENS
Start date: February 2007
Phase: N/A
Study type: Observational

A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.

NCT ID: NCT00643201 Completed - Venous Thrombosis Clinical Trials

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

NCT ID: NCT00640601 Completed - Schizophrenia Clinical Trials

Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia

SPECTRUM
Start date: March 2008
Phase: Phase 3
Study type: Interventional

A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects with Schizophrenia.

NCT ID: NCT00637819 Completed - Clinical trials for Systemic Lupus Eythematosus (SLE)

Leflunomide in Systemic Lupus Erythematosus

Start date: January 2003
Phase: Phase 2
Study type: Interventional

A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide

NCT ID: NCT00636103 Completed - Asthma Clinical Trials

Efficacy Study of Herbal Formula CUF2 to Treat Childhood Asthma

Start date: July 2002
Phase: Phase 1/Phase 2
Study type: Interventional

Asthma is a long-term disease process with genetic, allergic, environmental, infectious, emotional and dietary influences. The symptoms control are mainly using an inhaled drug, avoiding triggers or taking preventive medicine. Although side effects are unlikely at low dose of the asthma treatment, they have become apparent at the higher dose. Due to safety concern, parents often turn to complementary and alternative medicine which they believe is natural and safe and may help to reduce the conventional medication dosage. There are number of reports that treatment with traditional Chinese herbs or formulas resulted in significant improvement in lung function and reduction in the airway hyper-reactivity reaction. Our study drug CUF2, was based on a classical formulae and had been proven to have anti-inflammatory and immunomodulatory activities in laboratory and animal studies. With the pre-clinical evidence, this study aims to determine the effect of CUF2 on improving the clinical symptoms, biochemical markers, and requirement of steroid dosage among children with asthma.