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NCT ID: NCT00941746 Completed - Clinical trials for Osteoarthritis, Knee

Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain

Start date: August 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (NGF).

NCT ID: NCT00941733 Completed - Clinical trials for Critical Lower Limb Ischemia

Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

INPACT-DEEP
Start date: September 2009
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion™ drug eluting balloon or with a standard (Percutaneous Transluminal Angioplasty) PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.

NCT ID: NCT00941018 Completed - Healthy Clinical Trials

Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers

Start date: June 2009
Phase: Phase 1
Study type: Interventional

This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.

NCT ID: NCT00940849 Completed - Gastric Emptying Clinical Trials

Gastric Emptying and Gallbladder Motility Study

Start date: October 2009
Phase: N/A
Study type: Interventional

Background of the study: Plant sterols can play an important role in lowering plasma cholesterol. The extent to which plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest that the difference in these effects depends on gastric emptying and bile secretion. Objective of the study: The aim of this study is to gain insight in the mechanisms that may be involved in the effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test this, we compare the different effects of the consumption of a plant sterol containing drink prior to, during and after a standardized meal.

NCT ID: NCT00940719 Completed - Multiple Sclerosis Clinical Trials

Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)

Start date: August 2009
Phase: N/A
Study type: Interventional

In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.

NCT ID: NCT00940355 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

The purpose of this study is to determine the effectiveness of an intervention conducted by a pulmonary nurse in patients with COPD. The hypothesis is that in a sample of COPD patients with clinically relevant problems in health status (physiological functioning, symptoms, functional impairment and quality of life), a motivational intervention conducted by a pulmonary nurse will lead to patient-tailored treatment and an improved health status.

NCT ID: NCT00940004 Completed - Melanoma Clinical Trials

Toll-like Receptor (TLR) Ligand Matured Dendritic Cell Vaccination in Melanoma Patients

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives: This is an exploratory study, consisting of two parts. In part I a dose escalation is performed and the primary objective is the safety of different doses of TLR-dendritic cell (TLR-DC). In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination and the primary objective of this part is the immunological response to TLR-DC vaccination, with toxicity and clinical efficacy being secondary objectives. These studies will provide important data on the safety and immunological effects of TLR-matured DC. Study design: This study is an open label prospective exploratory intervention study. Study population: The investigators' study population consists of HLA-A2.1 positive melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is planned or performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.

NCT ID: NCT00939666 Completed - Clinical trials for Locally Advanced Rectal Cancer

Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer

Start date: July 1, 2009
Phase: N/A
Study type: Interventional

The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed.

NCT ID: NCT00939406 Completed - Clinical trials for Degenerative Spinal Stenosis

Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Hyalospine
Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.

NCT ID: NCT00939003 Completed - Clinical trials for Axial Spondyloarthritis

Study of Adalimumab in Patients With Axial Spondyloarthritis

Start date: July 2009
Phase: Phase 3
Study type: Interventional

This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.