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NCT ID: NCT04153292 Recruiting - Clinical trials for Mitral Regurgitation

The ENCIRCLE Trial

ENCIRCLE
Start date: November 12, 2020
Phase: N/A
Study type: Interventional

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

NCT ID: NCT04148859 Recruiting - Clinical trials for Pregnant With Complication

Feto-Fetal Transfusion Syndrome in Multiple Pregnancies

Start date: November 2004
Phase: N/A
Study type: Interventional

Objectives: Twin-to-twin transfusion syndrome (TTTS) generates high risk for one of the twins, may lead to preterm delivery and is also associated with neurodevelopmental deficits. The aim of this study was to explore a controlled amnioreduction (AR) procedure in which the amniotic pressure is simultaneously measured with the removed volume of amniotic pressure. Methods: Eleven patients with severe TTTS at stages II and III of Quintero classification were enrolled to the study. The amniotic pressure was measured along with the removed volume of the amniotic pressure between 17-34 weeks of gestation. The umbilical artery S/D ratio for each twin was measured at the beginning and after every 500cc of removed amniotic fluid. Long-term neurodevelopmental outcome of infants with TTTS was evaluated from a questionnaire for assessing the overall health of the surviving twins.

NCT ID: NCT04148612 Recruiting - Clinical trials for Depressive Disorder, Major

A Study to Evaluate the Benefit of Opti-Me Application to Different Treatments of MDD

Start date: October 6, 2020
Phase: N/A
Study type: Interventional

Major depressive disorder (MDD) is a debilitating disease characterized by depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD affects one in six adults in their lifetime. To date, decisions regarding specific treatment protocols for MDD are based on clinical experience and risk factors with limited data on outcome prediction. In addition, since it takes 8 weeks to assess if a treatment is successful, the long and often unsuccessful search for an effective antidepressant is accompanied by significant decrease in patients' quality of life, an increased risk of suicidal action, and decreased chance of response and remission with each attempt. This has led to examination of various markers (e.g., neuroimaging, electrophysiological, genetic and behavioral) in an attempt to predict the response to various forms of treatments, including pharmacotherapies and TMS (Transcranial Magnetic Stimulation) for depression. Elminda had developed a novel, non-invasive imaging EEG-based technology, Brain Network Analytics (BNA), for visualization and quantification of specific brain functions. The rationale of the study is to develop a reliable marker for MDD treatment outcome based on the BNA.

NCT ID: NCT04146480 Recruiting - Cardiac Amyloidosis Clinical Trials

The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis

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

Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1): A. AL - Light chain sunset. B. ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes: 1. Hereditary / familial - due to genetic mutation 2. Senile / Wild-type (WT) - Acquired with age The main goal of this study is to evaluate cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantification of absorption [in standard uptake value SUVs]. and to compare cardiac amyloidosis imaging using 18F-NaF PET / CT and gamma camera imaging with 99mTc-PYP.

NCT ID: NCT04143685 Recruiting - Clinical trials for Premature Rupture of Membrane

Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

NCT ID: NCT04142931 Recruiting - Clinical trials for Triple Negative Breast Cancer

Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

Start date: February 24, 2020
Phase: Phase 1
Study type: Interventional

Sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions: - Safety, tolerability and effectiveness of the device. - Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.

NCT ID: NCT04140500 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

Start date: November 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.

NCT ID: NCT04138368 Recruiting - Clinical trials for Postpartum Depression

The Effect of Early Dyadic Psychotherapy for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional Development

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD , these interventions have failed to show a significant improvement in mother-child interaction quality and infant development. The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. Among the central influences of OXT on human social behavior are increased trust, empathy and eye contact. Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction . Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . A recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions. Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. The aims of this study are: 1. To assess the relationship between levels of oxytocin in mothers suffering from postpartum depression and their babies, before and after psychological dyadic treatment compered to supportive treatment. 2. To study the added value of dyadic treatment over conventional supportive treatment for PPD that does not focus specifically on the mother's relationship with her baby. 3. To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development. Methods: Subjects: 50 Mothers will be interviewed and diagnosed as suffering from PPD according to DSM-IV-TR, will be enrolled within 2-8 months postpartum.

NCT ID: NCT04136301 Recruiting - Anxiety Clinical Trials

The Effect of Exposure to an Informative Video on Maternal Anxiety

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.

NCT ID: NCT04129892 Recruiting - Preventive Therapy Clinical Trials

In Favor of My Resilient Self- Effects of an Academic Course on the Emotional Resilience of Students.

Start date: August 3, 2019
Phase: N/A
Study type: Interventional

The course " In Favor of My Resilient Self" will guide participants to develop their strength sources, as well as practice self-calming and self-controlling exercises. The main goals of the course are to: 1. Measure the effects on the emotional resilience and confidence of participants. 2. Assess differences in the course's affect on students from the faculty of sciences compared with students from the faculty of social studies. 3. Understand the mechanisms of the effects. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the course.