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NCT ID: NCT06155162 Completed - Clinical trials for Stress Related Disorder

The HuggyPuppy Intervention for War-related Distress

Start date: November 8, 2023
Phase: N/A
Study type: Interventional

This clinical trial will test the efficacy of parent-delivered HuggyPuppy Intervention in alleviating war-related stress in children aged 3-8 during the Gaza-Israel war. Moreover, it will test whether the type of doll provided moderates the efficacy of the intervention. Children will be provided a doll ('Huggy') of to their homes or places of shelter, and asked to take care of it. Five different types of dolls will be randomly assigned to children. Pre-intervention, parents will complete a brief questionnaire asking about the child's past week stress symptoms, and exposure to traumatic war-experiences. Three weeks following the intervention, parents will be asked to complete a post-intervention questionnaire, asking about the child's symptoms, their own anxiety, depression, and stress, as well as their use of the intervention.

NCT ID: NCT06138756 Completed - Migraine Clinical Trials

Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

Start date: October 1, 2023
Phase:
Study type: Observational

Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, prescribed, wearable device, FDA-cleared for acute and/or preventive treatment of migraine with or without aura in patients 12 years or older. Multiple studies have shown that REN has high safety, tolerability, and efficacy in adults and adolescents. This study aims to evaluate REN's real-world safety and efficacy in pre-adolescents, 9-11 years old.

NCT ID: NCT06088407 Completed - Clinical trials for Heterotopic Ossification

Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery

Start date: February 21, 2016
Phase: N/A
Study type: Interventional

Heterotopic ossification (HO) following elbow fracture-dislocation is a well-recognized condition that can lead to reduced range of motion, increased pain, and the necessity for repeat surgeries. Inflammation serves as a pivotal initiating factor in the formation of (HO) following a traumatic event. The inflammatory cascade triggered can lead to the dysregulation of tissue homeostasis, thereby promoting the aberrant formation of ectopic bone. Tranexamic acid (TXA), a Food and Drug Administration (FDA) approved synthetic antifibrinolytic agent, has garnered significant attention for its potential to mitigate the inflammatory response in the context of orthopaedic surgical procedures. This study aims to investigate the hypothesis that reducing soft tissue hematoma during elbow fracture-dislocation surgery through the intraoperative administration of TXA, can alleviate the occurrence or severity of ectopic bone formation. Methods: A prospective randomized study was conducted on patients with elbow fracture-dislocation who underwent surgery between 2016 and 2022. A total of 50 patients were enrolled and randomly assigned to two groups. The first group received 1 gram of intravenous tranexamic acid before the operation, followed by an additional 1 gram intravenously during wound closure. The second group did not receive any anti-bleeding medication. Patients were followed up at intervals of 2 weeks, 6 weeks, 3 months, and as needed after the surgery. At the end of the follow-up period, there were 23 patients in the first group and 24 in the second group, with a median follow-up duration of 12.7 months. All patients did not receive any other form of HO prophylaxis. Postoperative radiographs and clinical outcomes were assessed and recorded.

NCT ID: NCT06081725 Completed - Aging Clinical Trials

Playfulness in Online and Face-to-face Interactions, From Adulthood to Aging

Play
Start date: January 20, 2023
Phase: N/A
Study type: Interventional

Playful interactions have an important role in human sociality. During playful interactions, two individuals continuously co-create an imaginary world together, such as playing roles in an imaginary scene or co-creating synchronized movements together. Playful interactions are characterized by an enhanced sense of flow and joy and have been associated with physical and psychological well-being across the lifespan. This research team and others have shown that playful interactions are particularly beneficial for the older population, which are at higher risk of cognitive decline and social isolation. The overarching aim of this proposal is to conduct an in-depth investigation of the effects of playful interactions, in older population. Specifically the investigators will test the effect of short playful interaction on cognitive measures, as well as social and affective indices, and compare them to a non-playful interaction (such exercise class, or personal conversation).

NCT ID: NCT06077006 Completed - Migraine Disorders Clinical Trials

The Impact of nCoV-2019 on Children With Migraine

Start date: April 1, 2021
Phase:
Study type: Observational

Executive functions, anxiety and their relation to social participation and quality of life among children with Migraine during COVID-19 Backgrounds: Among children, especially adolescents, migraine stands out as one of the most prevalent headache disorders. It is susceptible to stress and has the potential to affect children's emotional and cognitive status and therefore, affect their function, and notably amid the COVID-19 pandemic. Study Objective: To compare executive functions (EF), anxiety, social participation and quality of life (QoL) between children with migraine and healthy controls, and to examine the differences of these factors between children who were infected by COVID-19 and those who were not. Study Population: The research will include 75 children between the ages of 6 and 18 years, diagnosed with Migraine, who are under follow-up at the Pediatric Neurology Clinic in Bnei Zion. A control group of 75 children without chronic diseases, assessed during routine visits at the Pediatric Neurology Clinic or for other reasons, will also be included. Research Methods: Participants will complete questionnaires related to demographic details, quality of life, sleep, and emotional status. Inclusion Criteria: Children between the ages of 6 and 18 years with Migraine. Exclusion Criteria: Children unable or unwilling to complete the questionnaires, and those with secondary headaches or other chronic illness. Informed Consent: Participants aged 11 and older will provide informed consent, while younger children will receive oral explanations, and their paren

NCT ID: NCT06053034 Completed - Low Back Pain Clinical Trials

Effectiveness of the Solio Alfa Care Plus Device in Treating Low Back Pain

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Objectives: This double-blind, randomized, prospective, single-centre study evaluated the effectiveness of radiofrequency therapy by the SOLIO Alfa Cure Plus in the treatment of a non-specific low back pain (LBP) Methods: Thirty-seven patients completed pain, disability, and lower back flexibility scales. Randomization was obtained by having an equal amount of sham and real devices and distributing them randomly to patients out of a box where the devices were.

NCT ID: NCT06050967 Completed - Clinical trials for Gaucher Disease Type 1

A Second-generation AI Based Therapeutic Regimen in Patients With Gaucher Disease Treated With Enzyme Replacement Therapy.

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

An open-labeled, prospective, single-center proof-of-concept study. Patients with Gaucher Disease aged 18-75 who received intravenous Enzyme Replacement Therapy once every two weeks were enrolled. The study utilized the Altus Careā„¢ cellular phone-based application, which integrated an algorithm-based approach to provide random dosing regimens within a pre-defined range determined by the physician. The app allowed personalized therapeutic regimens with variations in dosages and administration times.

NCT ID: NCT06046534 Completed - Clinical trials for Systemic Lupus Erythematosus

Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

ERYTHRO
Start date: October 27, 2023
Phase:
Study type: Observational

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

NCT ID: NCT06044467 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects

Start date: December 11, 2018
Phase: Phase 1
Study type: Interventional

A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal liver functions to be treated with CM-101.

NCT ID: NCT06037577 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.