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NCT ID: NCT00439517 Completed - Clinical trials for Previously Untreated Metastatic Colorectal Cancer

Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.

FUTURE
Start date: February 2007
Phase: Phase 2
Study type: Interventional

This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)

NCT ID: NCT00438607 Completed - Parkinson's Disease Clinical Trials

Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease

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

The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with moderate to late-stage Parkinson's Disease who are also taking the Parkinson's medication, levodopa (L-DOPA). This study will also explore: 1. the pharmacokinetics of BIIB014 in Parkinson's patients who are also taking L-DOPA (this will be done by measuring the levels of BIIB014 in the blood at several different times during the study), and 2. the activity of BIIB014 when given to Parkinson's patients who are also taking L-DOPA (this will be done by performing different Parkinson's Disease assessments during the study to examine change in waking OFF time, change in time with troublesome dyskinesia, change in Unified PD Rating Scale (UPDRS) scores, and Clinical Global Improvement). Patients who enter this study will be randomly assigned to receive either BIIB014 or a placebo but because the study is blinded, neither they nor their study doctor will know which study treatment they are taking. The study will be divided into 2 parts: - Part A: a, rapid, sequential cohort, dose escalation to establish MTD, followed by - Part B: a parallel-group exploration of the two highest tolerated doses versus placebo. Note: As Part A of the study is now concluded, some of the study design information presented below (e.g., number of study arms) pertains only to Part B.

NCT ID: NCT00438555 Completed - Obesity Clinical Trials

Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children

4055obesityprv
Start date: October 2006
Phase: N/A
Study type: Interventional

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.

NCT ID: NCT00437983 Completed - Clinical trials for Age Associated Memory Impairment

The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment

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

The primary objective of this trial is to assess the ability of an oral administration of Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.

NCT ID: NCT00437931 Completed - Hyperthyroidism Clinical Trials

Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction

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

Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction

NCT ID: NCT00437814 Recruiting - Clinical trials for Traumatic Brain Injury

Effect of Ketamine (Ketalar) on Intracranial Pressure

Start date: September 2005
Phase: N/A
Study type: Interventional

Objectives: Ketamine is an effective, short-acting anesthetic drug, which does not decrease blood pressure. It is widely stated that Ketamine increases intracranial pressure (ICP), which prevents its use in many emergency situations, specifically in patients with traumatic brain injury (TBI) and with increased ICP. Based on previous clinical experience, we hypothesized that Ketamine decreases – rather than increases – ICP. Methods: Prospective, controlled, clinical trial. Children with ICP monitoring will receive a single Ketamine dose (1-1.5 mg/kg) either for increased ICP and/or before a potentially distressing activity. Hemodynamic variables, ICP and cerebral perfusion pressure (CPP) will be recorded 1 minute before and every minute for 10 minutes following Ketamine administration (Before/after design).

NCT ID: NCT00437775 Recruiting - Clinical trials for Diabetes Mellitus Type 2

ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects

Start date: January 2007
Phase: Phase 4
Study type: Observational

Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. Hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.

NCT ID: NCT00437567 Recruiting - Clinical trials for Necrotizing Enterocolitis

Prebiotics in the Prevention of Necrotizing Enterocolitis

Start date: July 2009
Phase: Phase 2
Study type: Interventional

Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of <1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

NCT ID: NCT00437528 Recruiting - Overactive Bladder Clinical Trials

Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity

Start date: November 2006
Phase: Phase 1
Study type: Observational

A novel sensor (a device named sensurine)was developed in the aim of real- time measurement of bladder volume. The sensurine device is a wearable, fully passive, non-invasive and compact heat flow sensor (patent pending) and electronic control unit. The device will serve as a tool for managing and treating bladder dysfunction (by behavioral treatment), such as overactive bladder without incontinence, urge incontinence and voiding difficulties. In this phase I of the clinical trial the sensor unit will be tested for technological feasibility demonstration and for collecting design data.

NCT ID: NCT00437073 Terminated - Neoplasms, Breast Clinical Trials

Brain Metastases In ErbB2-Positive Breast Cancer

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

This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.