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NCT ID: NCT00741429 Completed - Type 2 Diabetes Clinical Trials

A 2-Month Safety Follow-Up Trial

Start date: May 2007
Phase: Phase 3
Study type: Observational

The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

NCT ID: NCT00741338 Completed - Clinical trials for Mucopolysaccharidosis I

Immune Tolerance Study With Aldurazyme® (Laronidase)

Start date: September 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.

NCT ID: NCT00741260 Completed - Breast Cancer Clinical Trials

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

Start date: December 9, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group of the combination of neratinib and capecitabine. Each subject will participate in only 1 dose group. Additional subjects may be included at any dose level to further assess the safety and tolerability at that dose level. In Part 2, up to 60 subjects with erbB-2 positive metastatic breast cancer will receive treatment with the combination of neratinib and capecitabine at the maximum tolerated dose level, as determined in Part 1. In addition 20 subjects with prior lapatinib exposure will be enrolled in Part 2. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted, if appropriate. In case one test article of the combination is discontinued due to intolerance the other test article can be administered alone. The primary objectives of Part 1 are to assess the safety and tolerability, and to define the maximum tolerated dose (MTD) of neratinib in combination with capecitabine in subjects with advanced solid tumors. The primary objective of Part 2 of this study is to confirm the MTD determined in Part 1. The secondary objective of Part 1 is to collect information on preliminary anti-tumor activity of the combination of neratinib and capecitabine. Secondary objectives for Part 2 are to collect pharmacokinetic information and to obtain additional efficacy data, such as Objective Response Rate, for subjects with erbB-2 positive breast cancer treated at the MTD of neratinib + capecitabine.

NCT ID: NCT00740428 Completed - Clinical trials for Pelvic Floor Abnormalities

Pelvic Floor Exercises During Gestation in the Prevention of Urinary Incontinence and Pelvic Floor Muscle Dysfunction

Start date: March 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Urinary incontinence is any involuntary loss of urine. During gestation, hormonal and mechanical factors favor the incidence of urinary loss that may persist after delivery in up to 50% of women. Gestational urine loss can be prevented or treated during pregnancy with physical therapy. Pregnancy and delivery have been widely deemed important risk factors that should be assessed while developing preventive and curative treatments for both female urinary incontinence and pelvic floor muscle dysfunction. Pelvic floor muscle exercises, led by skilled physical therapists, can prevent, reduce, or even cure involuntary urine loss as well as pelvic floor muscle dysfunction. Within this framework, developing a low-cost, easy-to-perform method for the treatment of urinary incontinence and pelvic floor muscle dysfunction, with a preventive or curative approach, is considered necessary. The overall objective of this study is to assess the effects of pelvic floor exercises during pregnancy on pelvic floor muscles and urinary continence. Secondary aims include determining whether exercises change pelvic floor muscle function; if changing pelvic floor muscle function reduces the occurrence of urinary incontinence; developing and applying a manual guide; and determining whether the physical therapy guide is well accepted, easily understandable and reproducible.

NCT ID: NCT00740402 Completed - Stroke Clinical Trials

Motor Learning of a Planning Task in Stroke Patients: the Maze Paradigm Measured Through Time and Error as Variables

Start date: January 2008
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the process of acquiring a motor skill subject in post-stroke, comparing them with healthy subjects.

NCT ID: NCT00740285 Completed - Scleroderma Clinical Trials

Effectiveness and Safety of Lidocaine for Scleroderma

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.

NCT ID: NCT00740259 Completed - Schizophrenia Clinical Trials

Efficacy and Tolerability of Flunarizine for the Treatment of Schizophrenia: Comparison With Haloperidol

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

Flunarizine is a calcium channel blocker traditionally used for the treatment of vertigo and migraine. It also has the mechanism of action associated with antipsychotic activity (D2 receptor blockade), but has never been tested as such. The investigators hypothesis is that flunarizine can be an atypical antipsychotic.

NCT ID: NCT00738504 Completed - Injury Clinical Trials

Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.

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

The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.

NCT ID: NCT00737971 Completed - Clinical trials for Diabetic Macular Edema

Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

ATEMD
Start date: August 2008
Phase: Phase 4
Study type: Interventional

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

NCT ID: NCT00736866 Completed - Clinical trials for Acute Kidney Failure

The Acetylcysteine for Contrast-Induced Nephropathy Trial

ACT
Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast. Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.