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NCT ID: NCT03085446 Completed - Insomnia Clinical Trials

Insomnia in Older Adults: Impact of Personalized, Diet-Induced Alterations in the Microbiota

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Insomnia is a chronic mental health condition characterized by difficulty initiating and maintaining sleep with a prevalence of over 50% in Israeli adults ages 65 and above. It is associated with increased risks for chronic illnesses (e.g., cardiovascular disease), poor mental health (e.g., anxiety and depression), functional limitations, and cognitive decline. Available pharmacological and behavioral treatments focusing on reducing nighttime hyper-arousal offer limited success, and it appears that there is no "one size fits all" treatment for late life insomnia. Mounting evidence suggests that sleep is related to metabolic status, however, studies on the associations between sleep and dietary patterns are surprisingly scarce. The ability of gut microbiota to communicate with the brain is emerging as an exciting concept in health and disease and provides the rationale for the present project. Findings demonstrate that gut microbiota modulates mental capacities such as brain plasticity and cognitive functions in older adults, as well as stress related mental illness. The composition of the intestinal microbiota in older people (>65 years) differs from the core microbiota and diversity levels of younger adults. With age, gut populations of beneficial microbes show a marked decline. As diet has been shown to markedly promote microbiota biodiversity, it is hypothesized that diet-induced changes in microbiota may provide a novel approach for the treatment of mental health. Although insomnia is strongly linked to mental health (e.g., depression and anxiety), as well as cognitive and motor performance, the effects of diet-induced microbiota alterations, based on individual microbiota composition, on late life insomnia is currently unknown. The proposed project will be the first to investigate the associations between gut microbiota and sleep, and assess the potential of a six-months personalized, diet-induced microbiota alterations intervention (PDM), aimed to improve insomnia in older adults. We will also look at cognitive, motor and mental health factors as possible mediators in this relationship. Specifically, we will test the associations between microbiota composition and sleep quality, both cross-sectionally and longitudinally, i.e., following a PDM intervention; evaluate the impact of PDM on changes in cognitive, motor and mental health functions; and identify the mediating roles of changes in cognitive, motor and mental functioning on the effects of a PDM intervention on sleep quality. Findings are expected to improve the quality of life of older adults by enhancing their sleep, functional status, mental health and overall wellbeing.

NCT ID: NCT03085394 Terminated - Tranexamic Acid Clinical Trials

Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

PHORBBS
Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

NCT ID: NCT03084445 Active, not recruiting - Clinical trials for Exposure to Environmental Pollution

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

Start date: September 2013
Phase:
Study type: Observational [Patient Registry]

Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is vast. Many of these chemicals are released into the environment where they are found in air, water, soil, house dust, and in the food supply, resulting in exposure to humans. Characterizing the extent of exposure and the effects of exposure in vulnerable populations, such as pregnant women and children, is of the utmost importance as the chemical structure of many of these compounds resembles hormones such as estrogen, testosterone and thyroid hormone, affect neurodevelopment and other health effects. Here, we focus on few classes of compounds: heavy metals, volatile organic compounds (VOCs), brominated flame retardants (PBDEs) and phthalates. We will characterize the extent of exposure to pregnant women and their infants in Israel, where biomonitoring studies in the general population are scarce. We will also examine selected outcomes in pregnant women and their offspring in relation to these compounds, and to establish a biorepository for further studies. Specific Aims: 1. To assess Heavy metals, VOCs, PBDEs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations. 2. To examine associations between exposure to heavy metals, VOCs, PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function. 3. To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children. Patients and Methods: Patients will be recruited from three delivery rooms in Israel: "Assaf Harofeh Medical Center" , "Lis (Sorasky) Medical Center" and "Rambam Medical Center", all together with around 21,000 births annually, representing all sub-populations in Israel. 500 mother-father-infant trios (for a total of 4500) will be recruited. When arriving to the delivery room, after signing the informed consent, blood and urine will be withdrawn from the mothers and fathers for Heavy metals, VOCs, PBDEs and phthalates levels. At the same time thyroid function tests will also be taken from the mothers. After delivery, cord blood will be taken, as well as meconium from the neonate. Hair, nails and Breastmilk will also be collected. From the mothers The samples will be analyzed for heavy metals, VOCs, PBDEs and phthalates. During their stay at the hospital, mothers and fathers will fill out a standardized questionnaire regarding life style factors, background information, and exposure opportunities. Detailed information on family history, previous and present pregnancy, method of delivery, perinatal complications, and pregnancy outcome will be recorded from the medical files. Expected contribution to environmental health in Israel: This will be the first data on sub-populations exposure to Heavy metals, VOCs, PBDEs and phthalates in Israel. Neonatal meconium levels will provide important information on magnitude of exposure during the last months of pregnancy, and, thus, will provide insights into the bioaccumulative nature of these Heavy metals, VOCs, PBDEs and phthalates during early stages of human development, important data for future risk assessments. Our comprehensive approach will provide detailed information on the status of each subject. Such novel knowledge would also lead to the development of preventive and counseling strategies for men and women with high BFR and phthalates exposure in order to minimize the risks of adverse outcomes. Knowledge transfer strategies are essential in order that the general public, health professionals, scientists and policy/law regulators have the appropriate knowledge on which to base their understandings and recommendations for the future. In this way, the knowledge that is generated will facilitate the development of prevention strategies to minimize health risks of Israel population.

NCT ID: NCT03083860 Not yet recruiting - Migraine Clinical Trials

Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.

Start date: September 2017
Phase: N/A
Study type: Interventional

Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.

NCT ID: NCT03083834 Recruiting - Clinical trials for Adrenal Insufficiency

Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients

Start date: March 14, 2017
Phase: N/A
Study type: Interventional

In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cortisol binding globulin levels (CBG), artificially raising total cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the free serum cortisol. In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.

NCT ID: NCT03083717 Not yet recruiting - Heart Failure Clinical Trials

Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples

Start date: April 20, 2017
Phase: N/A
Study type: Observational

Application of Nanotechnology and Chemical Sensors for Diagnosis of Decompensated Heart Failure by Respiratory Samples. Breath testing, which links specific volatile molecular biomarkers in exhaled breath to medical conditions, is becoming increasingly popular as a non-invasive and potentially inexpensive diagnostic method for various diseases. NA-NOSE performs odor detection from exhaled breath, thus producing a distinct fingerprint for each mixture of analytes. Several studies have been published, stating the advantages of these sensors, leading to promising outcomes in several fields. The NA-NOSE breath test would be fast (examination and results would be obtained within 5-10 min), inexpensive, eventually portable (smaller than desktop computer), non-invasive and free of any side effects.

NCT ID: NCT03083392 Not yet recruiting - Maxillary Sinusitis Clinical Trials

Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis

Start date: March 2017
Phase: N/A
Study type: Interventional

This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.

NCT ID: NCT03081611 Completed - Infant, Premature Clinical Trials

RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants

RAMCAN
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

NCT ID: NCT03081494 Completed - Clinical trials for Metastatic Colorectal Cancer

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Start date: June 9, 2017
Phase: Phase 1
Study type: Interventional

This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.

NCT ID: NCT03079414 Recruiting - Clinical trials for Sudden Cardiac Death

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

EPS ARREST
Start date: May 1, 2017
Phase:
Study type: Observational

Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.