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NCT ID: NCT01810718 Completed - Clinical trials for Chronic Graft Versus Host Disease

Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD

Nilo-cGVHD
Start date: November 2011
Phase: Phase 1
Study type: Interventional

Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a standard satisfactory treatment for these patients does not exist. cGVHD is an immune-mediated disease, resulting from a complex interaction between donor and recipient adaptive immunity, but its exact pathogenesis is still incompletely defined. The purpose of this study is to determine safety and efficacy of Nilotinib in a population with steroid-refractory/or steroid-dependent cGvHD with a phase I study. In phase II the MTD will be used to define the efficacy of Nilotinib in a cGvHD steroid- refractory or steroid dependent population, with the same characteristics of the previously Imatinib-treated population.

NCT ID: NCT01809574 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease

Start date: May 2013
Phase: N/A
Study type: Observational

We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.

NCT ID: NCT01809561 Not yet recruiting - Endometriosis Clinical Trials

Telomeres Evaluation in Endometriosis

Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women. Our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis.

NCT ID: NCT01809418 Completed - Clinical trials for Obstructive Sleep Apnea

keePAP Device for Treatment of Obstructive Sleep Apnea

Start date: July 2013
Phase: N/A
Study type: Interventional

The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.

NCT ID: NCT01809366 Completed - Clinical trials for Effect on Implantation and Pregnancy Rates

Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET

Start date: January 2012
Phase: N/A
Study type: Interventional

Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.

NCT ID: NCT01809145 Recruiting - Sarcoidosis Clinical Trials

Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.

NCT ID: NCT01808625 Terminated - Clinical trials for BRAIN MALIGNANCIES AFTER RADIATION THERAPY

Hyperbaric Oxygen Stimulation for Patients With Brain Malignancies After Radiation Therapy.

Start date: March 2013
Phase: N/A
Study type: Interventional

Radiotherapy is the mainstay of treatment for brain malignancies and is associated with significant neurotoxicity. Due to continuous increase in patient's survival, the long term risk for radiation-induced brain inflammation and necrosis inducing secondary cognitive impairments are increasing concerns. Currently there is no effective treatment for preventing long term radiation-induced brain damage. Hyperbaric oxygen therapy (HBOT) is the administration of high oxygen concentrations within a pressurized chamber to increase the cellular/mitochondrial delivery of oxygen. Oxygen stimulation by HBOT has become the definitive therapy for radiation-induced damage to soft tissues and bone due to its ability to stimulate healing processes by supplying the energy/oxygen needed while down-regulating genes involved in inflammation. Oxygen stimulation by HBOT is currently indicated for patients with overt radiation-induced neurotoxicity and was proven to reduce further development of radiation damage while stimulating "idling" neurons to return to function. Since HBOT is considered safe, we hypothesize that its application following radiation, before the manifestation of neurological side effects, may help avert development of early/delayed onset radiation-induced neurotoxicity. In the proposed study, for the first time, HBOT will be applied early after radiation to prevent the expected decrease in patients neurocognitive functions (NCF) and improve their quality of life (QOL). The study is designed to provide statistically significant assessment, in a prospective randomized clinical trial, of the effect of oxygen stimulation applied soon after brain radiotherapy, for patients with primary and secondary brain tumors, on patients QOL and NCF. In addition, advanced imaging methodologies will be applied to study the feasibility of quantifying oxygen stimulation effects on the tumor and surrounding brain tissue.

NCT ID: NCT01808573 Completed - Clinical trials for HER2+ Metastatic Breast Cancer (MBC)

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NALA
Start date: March 29, 2013
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

NCT ID: NCT01807845 Recruiting - Clinical trials for Vitamin D Deficiency

Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment.

VD
Start date: January 2013
Phase: N/A
Study type: Interventional

Background: Vitamin D3 (VD) is an oil soluble vitamin formed in the skin during exposure to UV light. It is essential for bone and calcium metabolism, insulin reactivity, immune system etc. The dietary sources of VD are scarce, and insufficient. Epidemiological studies link proper VD status with lower risks of bone fracture, hypertension, diabetes, cancer and more. VD deficiency is widespread, mainly due to avoidance of sun exposure due to fear of melanoma. Therefore there is an urgent need to enrich staple foods & beverages with VD, to prevent deficiency. A novel technology was developed , for nanoencapsulating VD within casein micelles (CM) (natural milk protein nanoparticles). Previously we have found that the bioavailability of VD in CM in 1% fat milk was similar to that in an aqueous dietary supplement based on a synthetic emulsifier- Tween 80- which is sometimes used by the industry to add VD into milk. The main research question studied in the current project is: how will the bioavailability of VD be affected by its delivery in CM compared to its delivery using Tween 80 in a fat free milk product, like nonfat yogurt. Hypothesis: The open molecular structure of caseins, which evolved to be easily digestible, may facilitate the bioavailability of VD nanoencapsulated in CM, so that it will not be less than that in Tween 80, which is considered to be good. CM are particularly useful for oil-soluble micronutrient delivery in non-fat products. The most widely consumed nonfat milk product is 0% fat yoghurt, chosen it for this study. Methods: Yoghurts will be made from 3 milk formulations: 1. Skim milk (0% fat) enriched with 50,000 international units (IU) VD in 150 gr product, in CM. 2. Skim milk with same dosage of VD, emulsified with Tween 80. 3. Placebo: skim milk without added VD. 90 healthy adults, aged 18-65, having passed a medical qualification examination, will be randomly assigned to 3 groups. Following over-night fasting they will each consume a 150 gr yoghurt sample as detailed above, and be requested to fast 2 more hours. Blood will be sampled before yoghurt consumption, and after 1, 7 and 14 days following consumption. Blood-serum level of 25(OH)D (the form of VD used as a status indicator in routine blood tests), by chemiluminescence immunoassay (CMIA). Expected findings: The bioavailability of VD in CM will not be lower than that in Tween 80, in 0% fat yoghurt. Significance of the study: With the widespread VD deficiency, decreased fat consumption and rising demand for using only natural ingredients there is great importance in delivery of VD and other fat-soluble micronutrients in protein-based delivery systems, like CM, instead of using synthetic emulsifiers, and it is imperative to assure the bioavailability is not compromised by this dramatic change. CM solubilize VD and help uniformly distribute it in aqueous products and protect it against heat, oxidation and UV.

NCT ID: NCT01807221 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.