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NCT ID: NCT01643031 Not yet recruiting - Diabetes Mellitus Clinical Trials

Effect of Modifying Anti-platelet Treatment to Ticagrelor in Patients With Diabetes and Low Response to Clopidogrel

MATTIS-D
Start date: August 2012
Phase: Phase 4
Study type: Interventional

In recent years numerous studies have shown that the response of patients to the anti-platelet drug clopidogrel is widely variable. Furthermore, patients who do not respond well to the drug ("resistant") have been shown to be at increased risk to develop cardiac events, including myocardial infarction and mortality. It thus seems reasonable to test the efficacy of the drug (by platelet function tests) and modify treatment accordingly. However, a large study that examined a strategy of routine testing of clopidogrel response in thousands of patients (GRAVITAS study) did not show any clinical benefit. This study was limited, however, by a very low event rate (2.3%), and by the strategy employed to treat patients with low response (increasing the clopidogrel dose), which is currently known to be ineffective in many patients with low response. To overcome these limitations the investigators plan to examine a high risk population - patients with diabetes planned to undergo coronary angiography - and to treat clopidogrel low responders by switching their treatment to the potent anti-platelet drug ticagrelor, which has been shown to overcome clopidogrel low response. The investigators hypothesize that patients with diabetes and low response to clopidogrel will benefit clinically from switching therapy to ticagrelor. The main endpoint of the study will be the risk of myocardial enzyme elevation following percutaneous coronary intervention (PCI); a marker which has been strongly associated with poor clinical outcome. The aim of the study is, therefore, to assess whether a strategy of monitoring platelet function during clopidogrel treatment in patients with diabetes undergoing PCI, and modifying treatment to ticagrelor in patients with low response, will be associated with reduced risk of myocardial enzyme release. The investigators plan to enroll patients with treated diabetes, planned to undergo coronary angiography. Patients with acute or recent myocardial infarction will be excluded. They will be tested for response to clopidogrel by the VerifyNow P2Y12 assay (either on chronic clopidogrel treatment or 12-24 hours after receiving 300 mg clopidogrel). Patients with low response to clopidogrel (≥ 208 PRU) will be randomized to either continued treatment with clopidogrel (75 mg/day), or switching of treatment to ticagrelor (90 mg twice a day) for 30 days (followed by continued clopidogrel therapy). The primary endpoint will be the rate of troponin of CK-MB (cardiac enzymes) measured 20-24 hours after the PCI. Secondary endpoints will be the occurrence of adverse clinical endpoints - myocardial infarction, need for urgent revascularization or mortality at 30 days. The investigators aim to enroll 100 patients in each study group (ticagrelor vs. continued clopidogrel). Assuming a clopidogrel low response rate of 40% among patients with diabetes, about 500 patients would have to be screened to identify 200 patients with low response.

NCT ID: NCT01641003 Not yet recruiting - Pancreatic Cancer Clinical Trials

Isolation and Characterization of Cancer Stem Cells Using iFP Technique

Start date: July 2012
Phase: N/A
Study type: Observational

1. to evaluate insoluble fibrinogen particles (iFP), as a tool for harvesting, growing and transferring attachment-dependent cancer stem cells and comparing it to the standard method ( coated plate) . 2. to evaluate whether using iFP for growing CSC can yield better results of isolating and enriching CSCs from fresh tumors than other conventional methods

NCT ID: NCT01639989 Not yet recruiting - Early Pregnancy Clinical Trials

Doppler Assesment of Blood Flow in the Spiral Arteries

Start date: September 2012
Phase: N/A
Study type: Observational

In this study we will try to show that performing Doppler of the Spiral arteries is doable. No outcome will be followed at this stage

NCT ID: NCT01639976 Not yet recruiting - Missed Abortion Clinical Trials

Doppler Flow Measurements in Patients With Misoprostol Treatment for Arrested Pregnancy

Start date: September 2012
Phase: N/A
Study type: Observational

Testing the whether Doppler studies after cytotec treatment can predict success of treatment.

NCT ID: NCT01638039 Not yet recruiting - Dysentery Clinical Trials

Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections

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

The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.

NCT ID: NCT01637727 Not yet recruiting - Clinical trials for Gestational Diabetes Mellitus

Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women

GDM
Start date: September 2012
Phase: N/A
Study type: Observational

The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM. In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.

NCT ID: NCT01637428 Not yet recruiting - Clinical trials for Post Thrombotic Syndrome

The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome

Start date: July 2012
Phase: Phase 2
Study type: Interventional

The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.

NCT ID: NCT01633983 Not yet recruiting - Clinical trials for Central Serous Chorioretinopathy

Methotrexate for Central Serous Chorioretinopathy Treatment Trial

MTX4CSC
Start date: August 2012
Phase: Phase 2
Study type: Interventional

Central serous chorioretinopathy (CSC) is a disease of unknown origin however multiple reports have indicated correlation of appearance of CSC with exposure to exogenous or elevated levels of endogenous corticosteroid. Since the level of endogenous corticosteroids is upregulated in many inflammatory conditions, control of the inflammation may be beneficial in reducing this level thus eliminating the stimulus for CSC. Methotrexate (MTX) is widely used to control different types of inflammation. The investigators are going to try an escalating doses of MTX to treat CSC under full medical supervision.

NCT ID: NCT01632410 Not yet recruiting - Stroke Clinical Trials

The Autonomic Nervous System State and Response to Different Stimuli Among Patients Post Stroke: A Follow-up Study

Start date: July 2012
Phase: N/A
Study type: Observational

The study describes the autonomic control system function in subjects post stroke in comparison with healthy subjects. Aims: To describe the Autonomic hart rate control system function in post stroke subjects in different rehabilitation levels in comparison with healthy subjects. To examine the reflective reaction of the autonomic control system as reflected in the heart rate variability to stimulations subjects in different rehabilitation levels in comparison with healthy subjects. To examine the autonomic control system reaction as reflected in the heart rate variability to physical and cognitive action subjects in different rehabilitation levels in comparison with healthy subjects.

NCT ID: NCT01629628 Not yet recruiting - Crohn Disease Clinical Trials

Adalimumab for the Management of Post-operative Crohn's Disease (CD)

POPART
Start date: July 2012
Phase: Phase 3
Study type: Interventional

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence. Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks. Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks. The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.