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Digestive System Diseases clinical trials

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NCT ID: NCT00210249 Completed - Lymphoma Clinical Trials

Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment

PHRC2003
Start date: September 2002
Phase:
Study type: Observational

Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.

NCT ID: NCT00195975 Completed - Abdominal Pain Clinical Trials

Heart Rate Variability in Children With a Functional Gastrointestinal Disorder

Start date: June 2005
Phase: N/A
Study type: Observational

The current study is designed to assess relationships between anxiety/stress, autonomic nervous system balance, and electrical activity in the stomach before and after eating/drinking in children with abdominal pain.

NCT ID: NCT00164775 Completed - Clinical trials for Functional Gastrointestinal Disorder

The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia

Start date: June 2005
Phase: Phase 3
Study type: Interventional

The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in treatment of functional dyspepsia. This is a double blind randomised placebo controlled trial in which consecutive patients with diagnosis of functional dyspepsia will be studied. After exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be evaluated for treatment response, which is defined as satisfactory relief of dyspeptic symptoms at the end of 12-week treatment.

NCT ID: NCT00128284 Completed - Gastroparesis Clinical Trials

A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time

Start date: February 2005
Phase: N/A
Study type: Observational

The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy.

NCT ID: NCT00110708 Active, not recruiting - Autism Clinical Trials

Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

Start date: April 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in children with autism.

NCT ID: NCT00101725 Completed - Clinical trials for Irritable Bowel Syndrome

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Start date: December 2004
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).

NCT ID: NCT00073047 Completed - Ulcerative Colitis Clinical Trials

Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

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

The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.

NCT ID: NCT00072943 Completed - Crohn's Disease Clinical Trials

A Humanized Anti-Interferon-γ Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease

Start date: March 2002
Phase: Phase 2
Study type: Interventional

The purpose of the HARMONY study is to assess the safety and efficacy of an investigational drug called HuZAF, in patients with moderate to severe Crohn's disease (CD). HuZAF is a humanized anti-Interferon-gamma (anti-IFN-γ) monoclonal antibody, which binds and blocks IFN-γ, a protein in the immune system that is involved in inflammation. Antibodies are proteins normally produced by our immune system to help fight off foreign substances. Scientists have been able to make therapeutic humanized monoclonal antibodies, similar to the antibodies in our bodies, to target diseases.

NCT ID: NCT00058942 Completed - Diarrhea Clinical Trials

A Trial of Tap Water Treatment in the Elderly

Start date: January 2000
Phase: N/A
Study type: Interventional

This study is being conducted in Sonoma County, California. Gastrointestinal illness and diarrhea are recognized as a significant cause of morbidity and mortality in the elderly. One study showed that 51% of deaths caused by diarrhea over a 9-year period occurred in individuals over the age of 74 years. Although many infectious diseases are more problematic in the elderly because of a decline in immune function and a higher incidence of pre-existing malnutrition and dehydration, it is still not known what the principal modes of transmission are and which infectious agents are responsible. The principal objective of this study is to evaluate the ability of in-home treatment of tapwater to reduce gastrointestinal illness in non-institutionalized elderly individuals. The trial will test household-level treatment of drinking water by joint use of ultraviolet light and filtration devices. A secondary objective is an estimate of the incidence of specific bacterial, viral, and protozoan agents in stool specimens collected from elderly individuals with gastrointestinal symptoms that might be related to water consumption.

NCT ID: NCT00035334 Completed - Clinical trials for Rheumatoid Arthritis

Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis

Start date: October 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.