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NCT ID: NCT03512613 Recruiting - Clinical trials for Congenital Heart Defect

A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects

Start date: May 29, 2018
Phase:
Study type: Observational

Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury. There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery. The previous modal of the study device has been cleared for marketing by the FDA (k150268). The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.

NCT ID: NCT03512197 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

Start date: July 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off). This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR<0.05) AML.

NCT ID: NCT03511833 Not yet recruiting - Clinical trials for Acute Traumatic Pain

Comparison of Treatment by IN Ketamine to IV Morphine in Acute Pain

Start date: December 2019
Phase: Phase 3
Study type: Interventional

Patients who present with acute traumatic injuries in the pre-hospital setting or to the emergency department (ED) are treated with opioids, the current gold standard for severe acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory depression- which necessitates post medication administration continuous monitoring of patients. IV administration may be difficult or impossible to provide in a number of extreme circumstances. For these reasons, there is a constant search for alternate treatment options for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in our department in adults, in an open, prospective study (Shimonovich at al 2016), and warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and efficacious analgesic and is overall well received both by patients and physicians. Side effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic potential for pain reduction in trauma patients, pre-hospital patients, and battlefield injuries. The study we are conducting is designed to test and analyze the safety and efficacy of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when both medications are administered by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.

NCT ID: NCT03510377 Completed - Aging Clinical Trials

Effects of Aquatic Intervention on Fall Risk, Hazard Perception, Calendar Planning and Brain Activity During Elderly

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

Normal aging is associated with balance, mobility and executive functions decline that increase fall risk and influence Activity of Daily Living (ADL) and Instrumental ADL (IADL) functions such as safe road-crossing, planning and organizing everyday activities. Changes in cerebellar functional plasticity may mediate between the decline in balance, mobility and executive functions during elderly. Fortunately, mounting evidence suggests that physical activity is beneficial for decreasing aging effects and optimize brain structure and function. According to the dynamic systems theory, the environment in which the physical activity occurs influences the results of the activity. We propose an aquatic physical intervention program as a tool to decrease aging effects that in turn might lower fall risk, increase safety of road-crossing and improve planning and organizing everyday activities among community-dwelling older individuals.

NCT ID: NCT03510078 Recruiting - Diabetes Mellitus Clinical Trials

Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients

Start date: April 17, 2018
Phase: N/A
Study type: Interventional

Hyperglycemia is a common condition among hospitalized patients. The occurrence of severe hyperglycemia is associated with increased morbidity and mortality in several populations. Several trials assessed the benefits of aggressive versus conventional glucose control. These studies evaluated different patient populations, glucose targets and treatment protocols and as a result reported conflicting results. To date there are no clear guidelines regarding to the preferred glucose target range in hospitalized non-critically ill patients. The common practice is to maintain glucose level lower than 180 mg/dl however there are no evidence based regarding to the outcomes of hospitalized patients treated with intensive compared to conventional glycemic control. This prospective randomized controlled study will compare intensive vs. standard glycemic control in hospitalized non-critically ill patients. Within 24 hours of hospitalization in the internal medical or geriatric departments, patients who are expected to require hospitalization for at least three consecutive days will be randomly assigned into one of the two study groups - intensive with a target blood glucose range of 130 mg per deciliter or less, or conventional glucose control, with a target of 130-180 mg per deciliter. The investigators defined the primary end point as a composite outcome of mortality in 30 days, severe hypoglycemia, severe infections within 30 days, CVA and cardiac ischemic events within 30 days.

NCT ID: NCT03508063 Completed - Healthy Subjects Clinical Trials

Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)

Start date: December 20, 2017
Phase:
Study type: Observational

A clinical trial to validate the MCPM (Multi-parameter Combined Physiological Signal-based Monitoring), in estimating physiological activity level, at rest, previous and following stimuli.

NCT ID: NCT03507699 Completed - Liver Metastases Clinical Trials

Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer

Start date: December 15, 2018
Phase: Phase 1
Study type: Interventional

A single institution study to evaluate the safety and tolerability of the combination treatment of nivolumab, ipilimumab, CMP-001 and radiosurgery in patients with metastatic colorectal cancer with liver metastases.

NCT ID: NCT03507660 Completed - Clinical trials for Pelvic Floor Muscle Weakness

Verbal Instruction for Contraction Pelvic Floor Muscles Among Males

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

The aim of this study is to compare the effectiveness of different verbal instruction on pelvic floor muscle contraction among males. Pelvic floor contraction will be measured via ultrasound.

NCT ID: NCT03506230 Recruiting - Clinical trials for Type2 Diabetes Mellitus

Financial Incentives for Low Socioeconomic Diabetic Patients

Start date: November 25, 2018
Phase: N/A
Study type: Interventional

Patients with uncontrolled diabetes [glycated hemoglobin (Hba1c)>8.5%] from low socioeconomic status neighborhoods in Jerusalem will be recruited. They will be randomly assigned to an intervention group and a control group. The intervention group will be offered a bonus to buy their medications, 100 Israeli Shekels (ILS) (30$) each month for 3 months, if they reduce their HBA1c by 0.7% or if their HbA1c level reaches 7.5%. After 6 months they will be eligible for another bonus for one month if they improve their HbA1c by 0.3% from the previous test. The control group will buy medications as usual. All participants will be contacted by phone and will be encouraged to contact their doctor, to perform blood tests and to maintain a healthy lifestyle.

NCT ID: NCT03505801 Active, not recruiting - Atrial Fibrillation Clinical Trials

Confirm Rx Insertable Cardiac Monitor SMART Registry

Start date: April 24, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.