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NCT ID: NCT00773058 Unknown status - Clinical trials for Acute Respiratory Distress Syndrome

Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if stress doses of hydrocortisone improve early outcome in patients who are in early stage of ARDS and with relative adrenal insufficiency.

NCT ID: NCT00770601 Terminated - NOMID Clinical Trials

Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease

Start date: January 26, 2009
Phase: Phase 3
Study type: Interventional

This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, problems with the eyes and learning difficulties. Canakinumab is an experimental drug that inhibits the action of a protein produced by the body called human IL-1beta, which is responsible for the symptoms in NOMID and also contributes to many other kinds of inflammatory diseases. Patients 2 years of age and older with NOMID / CINCA may be eligible for this study. Participants undergo the following procedures: Screening Phase - Medical history and review of medical records - Blood tests - Daily diary of symptoms and medicines take Washout/Lead-in Phase - Discontinuation of anakinra or other medications, a 6 to 48-hour run-in period (only for patients who discontinued anakinra or other IL-1 blocking therapy). Treatment Phase - Injection of canakinumab under the skin every 8 weeks for 6 months - Monitoring and evaluations during treatment, including: - Quality-of-life questionnaires and daily diary - Vital signs measurements (heartbeat, blood pressure, temperature) - Blood tests - Electrocardiogram - Tuberculosis skin test - Neurological, eye and skin examinations at beginning and end of study - Cognitive evaluation at beginning and end of study - Lumbar puncture (spinal tap) at the beginning of the study, 2 weeks after the second dosing of canakinumab and at the end of the study - X-rays and bone density scan at beginning and end of study - Magnetic resonance imaging (MRI) of the head at beginning and end of study Follow-up Phase - Monthly clinic visits after the last dose of canakinumab for a minimum of 60 days End-of-Study Evaluation - Series of tests 8 weeks after last dose of canakinumab to evaluate treatment response and side effects

NCT ID: NCT00770458 Completed - Turner Syndrome Clinical Trials

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

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

Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

NCT ID: NCT00769574 Completed - Coronary Syndrome Clinical Trials

Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.

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

To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).

NCT ID: NCT00769288 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

FAU in Treating Patients With Advanced Solid Tumors or Lymphoma

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

Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. This phase I trial is studying the side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma.

NCT ID: NCT00768820 Recruiting - Fragile X Syndrome Clinical Trials

The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome

VCFS
Start date: May 2001
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors

NCT ID: NCT00767689 Terminated - Clinical trials for Hand and Foot Syndrome

Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy

Start date: March 21, 2006
Phase: N/A
Study type: Interventional

Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

NCT ID: NCT00767364 Completed - Clinical trials for Short Bowel Syndrome

Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome

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

Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of 2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it was causing an increase in a gastrointestinal (GI) disease called intussusception. However, the new rotavirus vaccine was studied by the manufacturer and was not found to cause an increase in the cases of intussusception. Intussusception is a disease in which a portion of the GI tract folds back on itself leading to GI tract obstruction or back-up. The manufacturer of the vaccine noted on package insert information that the vaccine was not studied, originally, in infants with a history of GI disorders or in infants who have had surgery on their abdomen. Currently, there is no information available in the scientific literature about the use of the oral rotavirus vaccine in infants with GI diseases or those who have had GI surgeries. The objective of the study is the assessment of safety and tolerability of the oral RotaTeq® vaccine for all infants participating in the study. All infants will be followed for clinical adverse events with active safety surveillance for the first 42 days after each dose and also monthly afterward for a total of 12 months from the first vaccination date. The secondary objective of the study is to quantify the immunologic response will occur in all of the infants in the study. Assessment of percentage of the number of infants who have a good immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A (IgA) level in infants with short bowel syndrome compared to normal infants will occur. Infants, meeting eligibility criteria and whose parents have signed informed consent will have their study information collected. These infants will be tested for the presence of pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is obtained, participants will receive their first oral rotavirus vaccine dose between the ages of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine may be administered with other routine pediatric vaccines at the participant primary care provider's office. The date of the rotavirus vaccine and lot number would be recorded on vaccine administration date cards. Most participants will have their vaccines given through the Infectious Disease clinic staff at the Children's Hospital of Michigan. Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of life. Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event Reporting System and MedWatch forms. Finally, two weeks after the participants have had all three oral rotavirus vaccine doses, the second and final blood draw will take place for measuring the post-vaccine level of anti-rotavirus antibody, IgA. Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding any serious adverse events. Each infant will also be assessed in the clinical setting each week after a vaccine dose has been given. As above, parents of participants will be asked to fill out the vaccine report card and record the child's temperature, and any episodes of vomiting, diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be asked to record any other events from day 8 through 42 after each vaccine is administered such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly phone call safety follow-ups during the 12 month period following the first vaccination. A Data Safety and Monitoring Board will oversee the study and it's progress and will have the ability to vote to stop the study.

NCT ID: NCT00765999 Completed - Clinical trials for Chronic Constipation

An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Start date: October 31, 2008
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

NCT ID: NCT00764218 Recruiting - Hypertension Clinical Trials

Cardiovascular Phenotype Study in Patients With Obstructive Sleep Apnea Syndrome

SAS-HTA
Start date: March 2001
Phase: Phase 0
Study type: Interventional

Patients with obstructive sleep apnea syndrome have permanent variations of their hemodynamic parameters during the night : heart rate, arterial blood pressure, cardiac output. This is due to the repetition of respiratory events (obstructive apnea and hypopnea) leading to frequent micro-arousals. These disorders have several consequences : hypertension, NO-dependent vasodilatation impairment, baroreceptor reflex impairment, insulin resistance and other cardiovascular impairments.