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Syndrome clinical trials

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NCT ID: NCT00971789 Completed - Clinical trials for Hamartoma Syndrome, Multiple

Sirolimus to Treat Cowden Syndrome and Other PTEN Hamartomatous Tumor Syndromes

Start date: July 2008
Phase: Phase 2
Study type: Interventional

Background: People with phosphatase and tensin homolog deleted on chromosome 10 (PTEN) hamartomatous tumor syndromes (PHTS) have a mutation in one of their genes called PTEN that can lead to benign tumors called hamartomas throughout the body. This puts them at increased risk for breast, thyroid and endometrial cancer. People with a PTEN mutation have increased activity of proteins such as protein kinase B (AKT) and mammalian target of rapamycin (mTOR), which may be responsible for tumor growth and their increased risk of these cancers. Experiments show that a drug called sirolimus, which is used to prevent the immune system from rejecting transplanted organs, can inhibit cancer cell growth by blocking the mTOR protein. Objectives: To test the ability of sirolimus to decrease the activity of proteins that are regulated by mTOR in both benign and cancerous tumor tissue. Eligibility: People 18 years of age and older with Cowden syndrome or other PHTS. Design: Sirolimus treatment. Patients take sirolimus once a day in 28-day treatment cycles. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects. Evaluations. Patients come to the clinic for a history and physical examination on day 1 of every treatment cycle, then every month for the first two months off therapy, and then at 6 and 12 months. In addition, they have the following procedures: - Positron emission tomography (PET) scan and neuropsychological testing before starting treatment. - Clinical photography (photographic documentation of skin lesions) before starting treatment. Patients who do not have cancer have repeat photography at 2 and 8 weeks and then, if the lesions shrink or go away while on therapy, again every month for the first 2 months off sirolimus, then at 6 months and 1 year. Patients who have cancer and continue treatment beyond 8 weeks have repeat photography every 8 weeks while on the study. - Digital dermoscopy (skin lesion examination using a high resolution camera). This is done at the same intervals as clinical photography. - Multiple biopsies of the skin and lower intestine, and possibly the tumor in patients with cancer, before starting treatment, at 2 weeks of treatment and at 8 weeks of treatment. - Blood and urine tests every week while on treatment for the first two cycles, then every 4 weeks for patients who continue treatment beyond two cycles. - Imaging studies, such as computerized tomography (CT), ultrasound or magnetic resonance imaging (MRI) in patients with cancer before starting treatment and again every two cycles to monitor the tumor size and location.

NCT ID: NCT00971711 Completed - Clinical trials for Irritable Bowel Syndrome

Safety Study of Probiotics in Adults With Irritable Bowel Syndrome

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

Determine the safety and preliminary effectiveness of VSL#3 in adults with IBS.

NCT ID: NCT00971685 Recruiting - POEMS Syndrome Clinical Trials

The Treatment of Lenalidomide in Patients With POEMS Syndrome

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

Lenalidomide is a immunomodulatory drug derived from thalidomide, without neurotoxicity. Lenalidomide blocks the increased secretion of interleukin-6, tumor necrosis factor alpha and vascular endothelial growth factor (VEGF). The association with dexamethasone increased Lenalidomide response rate. More recently the efficacy of Lenalidomide has been reported in a patient with POEMS (POEMS:polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome with improvement of clinical condition and reduction of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) level.

NCT ID: NCT00971334 Completed - Pregnancy Clinical Trials

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

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

The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.

NCT ID: NCT00970541 Terminated - Insulin Resistance Clinical Trials

Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

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

The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.

NCT ID: NCT00969631 Completed - Clinical trials for Polycystic Ovary Syndrome

Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)

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

The purpose of this study is to compare and determine the efficacy of combined metformin and Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.

NCT ID: NCT00969280 Completed - Dry Eye Syndromes Clinical Trials

Acupuncture for Dry Eye Syndrome

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

This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.

NCT ID: NCT00968708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

EXAMINE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

NCT ID: NCT00968071 Completed - Clinical trials for Myelodysplastic Syndrome

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.

NCT ID: NCT00966628 Active, not recruiting - Clinical trials for Dengue Shock Syndrome

Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients (DSS)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in fluid resuscitation, to upto 44% in established shock.The mainstay of DSS treatment is prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma or colloid solutions for profound or continuing shock. However, this administration is often associated with fluid overload and induces edema in these patients. Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety of solution containing half molar sodium lactate (Totilacâ„¢) with standard treatment(isotonic crystalloid Ringer's Lactate) in pediatric Dengue Shock Syndrome patients, using plasma soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator. Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance and improved tissue perfusion. This is obtained with much smaller volumes.We plan to assess the efficacy and safety of hypertonic sodium lactate in resuscitation of DHF/DSS patients.