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NCT ID: NCT04289870 Active, not recruiting - Clinical trials for Tricuspid Regurgitation

Innoventric Trilliumâ„¢ Stent Graft First-in-Human (FIH) Study

Start date: June 24, 2020
Phase: N/A
Study type: Interventional

A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trilliumâ„¢ Stent Graft System. Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.

NCT ID: NCT04288843 Completed - Endometrium Clinical Trials

Endometrial Dating by Ex-vivo Imaging of Endometrial Biopsies of In-vitro Fertilization Candidate Participants

Start date: June 16, 2019
Phase:
Study type: Observational

To evaluate the correlation between cycle day determination by clinical signs, study participant testimony, endometrium histopathology biopsy and ex-vivo imaging of the uterus endometrium.

NCT ID: NCT04288648 Completed - Clinical trials for Urinary Stress Incontinence

Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence

Start date: May 17, 2020
Phase:
Study type: Observational [Patient Registry]

Examination of pelvic floor contraction in different positions among women with and without stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will enable clinicians and researchers to establish an appropriate protocol for pelvic floor muscle examination and treatment.

NCT ID: NCT04287283 Active, not recruiting - Stroke Clinical Trials

Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research

Start date: January 2008
Phase:
Study type: Observational

In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment. The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.

NCT ID: NCT04284683 Completed - Obesity Clinical Trials

Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults

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

Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Therefore, persons who are physically active maintain higher RMR and less body fat than do sedentary controls. It is well known that high energy intake stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age (RMR tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of RMR). However, the research regarding the effect of a specific combination of macronutrients and exercise on RMR is scarce. Therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on RMR in normal weight and overweight children, adolescents and adults.

NCT ID: NCT04284670 Recruiting - Childhood Obesity Clinical Trials

The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.

NCT ID: NCT04284501 Recruiting - Headache Clinical Trials

Comparing Sensory Modulation, Anxiety and Quality of Life Between Children With Primary Headaches and Healthy Peers

Start date: August 1, 2014
Phase:
Study type: Observational

Study hypotheses: 1. Children with headaches will show significantly higher sensory reactivity, higher anxiety level and lower quality of life that health controls. 2. Among children with headaches, sensory reactivity will significantly correlate with higher anxiety level and lower quality of life. 3. Among children with headaches quality of life will be predicted by sensory reactivity and anxiety level. Study significance: This is one of the first studies to explore the role of sensory reactivity and its relation to the psychological (anxiety) aspects among children and youth with headaches. Moreover, by using an elaborated point of view this study also measures the interaction between these factors and the child's quality of life. Referring to this interaction is critical for the intervention process in the meaning of: (a) helping determine whether pediatric headaches is best conceptualized as a CNS disorder, an emotional disorder, or some hybrid (b) increasing physicians' recognition of headaches pathogenesis and related outcomes, encouraging physicians to refer in the intake and intervention to both children and parents and when needed - to consider mental health services for child/parents. (c) to illuminate the physiological/psychological factors that have the most significant impact on QOL of children with headaches. Methods: Participants: The sample will include 60 children aged 8-18 years. The study group will include 30 children diagnosed with Primary headache - Migraine or TTH. They will be recruited from the pediatric neurological clinic in Bnai-Zion Health Center. The control group will include 30 children from the community with typical development and no history of chronic headaches or another chronic disease, no ADHD or learning disabilities, matched by age, gender and socio-economic status to the study group. Inclusion criteria for the study group: Children with Primary headaches diagnosed as Migraine or TTH between 8-18 years of age. Exclusion criteria for the sample group Evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms.

NCT ID: NCT04283968 Recruiting - Atopic Dermatitis Clinical Trials

Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis

Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

Prospective double-blinded placebo-controlled study, among adult patients suffering from moderate-to-severe atopic dermatitis (AD), insufficiently responsive to topical and systemic treatment. In the first group all patients will receive 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. In the second group all patients will receive 4 placebo transplantations each 2 weeks apart. Patients will be allowed to continue with their baseline medical topical treatment, including moisturizers and glucocorticoids, during the study period, but no new therapy should be commenced. The patients of the second group, who received the placebo treatment will have the possibility to enter an open label phase in which they will receive 4 fecal microbial transplantations (FMTs) from healthy donors each 2 weeks apart. The severity of AD and the fecal microbiome profile will be evaluated by the Scoring Atopic Dermatitis Score (SCORAD score), Investigator Global Assessment scale for Atopic Dermatitis (IGA) and the weekly use of topical corticosteroids, at the beginning of the study, before every FMT, and 1-6 months after the last FMT.

NCT ID: NCT04283864 Recruiting - Crohn Disease Clinical Trials

Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease

Start date: November 29, 2020
Phase:
Study type: Observational

The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children. 150 children newly diagnosed with Crohn's disease will participate in the study and their data will be used to create an algorithm about their microbiome, disease, diet, etc. 100 other children newly diagnosed will participate in the study and their data will be use to validate the algorithm. The investigators will be recruiting 50 healthy participants: 20 that are undergoing an endoscopy for abdominal pain and 30 that comes to the physician for different reasons. After parental consent, the participants will receive an explanation of the study and sign a consent form for colonoscopy. Before colonoscopy, participants will bring fecal samples, give blood samples, biopsies and biopsy brushes (superficial scraping of the tissue) will be taken during the operation. These samples will be retained until further consent is obtained for further study. After receiving the results of the colonoscopy, children who have been diagnosed with Crohn's disease will be offered to participate in the second part of the study, they will receive an explanation about the app, collection of fecal samples at home, diet logs and anthropometric measurements, demographic information, medical and family history will be registered. During the first 3 months: the participants will be asked to log data in the app and collect fecal samples at home. They will be asked to come for a follow up visit where anthropomorphic measurements and blood samples will be taken. Participants will be asked to log in every day to report in the app daily activity and food intake throughout the study period. Each week, the research coordinator will call on participants to make sure the app is correctly filled in, collect the stool samples correctly and answer questions. During the entire study participants will collect fecal samples, every first week of the month participants will enter information in the app. For children who have not been diagnosed with Crohn's disease by the colonoscopy, or children who visit the institute for reasons other than inflammatory bowel disease without a clear finding will participate in the study control group. If consent is given, fecal samples will be collected at the entrance of the study and after one year, blood samples, a food questionnaire and anthropometric indices, demographic information, medical and family history will be completed.

NCT ID: NCT04283604 Recruiting - ADHD Clinical Trials

The Effects of a Single Dose of Methylphenidate on Motor Performance

Start date: May 27, 2021
Phase: Phase 4
Study type: Interventional

Aim: To evaluate the effects of MPH on young adults diagnosed with ADHD on different exercise performance tests. Hypothesis: MPH will have positive effects on motor tests requiring concentration. Methods: 200 healthy physical education students, 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group. The study will be divided into two sub studies (100 participants each), in which, two motor tests will be evaluated (two agility tests, two motor accuracy tests and balance). All participants will arrive for two sessions, and will perform two motor tests in each session. In the second session, half of the participants with ADHD (25 participants) will undergo another session of the same motor tests with their usual treatment (treatment group) and another half (25 participants) without their treatment (ADHD control group). The non-ADHD control group (50 participants) will perform the second session without medications - to assess a learning effect. Note, the investigators are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self. Control treatment for ADHD participants will consist of not taking their medication before the motor test. For evaluation of physiological responses and perception of effort, heart rate, temperature, blood pressure and RPE before and after motor tests, will be measured.