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NCT ID: NCT06469099 Recruiting - Ankle Sprains Clinical Trials

Ankle Injuries, Imaging and Prevention Program Effectiveness in New Army Recruits

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

infantry recruits will be examined - for the musculoskeletal system status (tendon, muscle, proprioception, agility, joints) Following, intervention program of exercises will be conducted. Another evaluation will be performed at the end of the intervention.

NCT ID: NCT06465160 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Evaluate the MNV-201 in Patients With Low Risk MDS

Start date: May 27, 2024
Phase: Phase 1
Study type: Interventional

Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood-forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. According to the American Cancer Society, in the United States, MDS occurs at a rate of 4.8 cases for every 100,000 people; MDS affects an estimated 60,000 persons in the United States, with 10,000-15,000 new cases recorded each year. MDS is defined by ineffective haematopoiesis resulting in blood cytopenias (a reduction in the number of mature blood cells), and clonal instability with a risk of evolution to acute myeloid leukaemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias and AML. MDS is generally a disease that develops with ageing; the median age at diagnosis of MDS is ~70 years, and patients frequently have comorbid conditions. The goals of therapy for patients with MDS are to reduce disease-associated symptoms and the risk of disease progression and death, thereby improving both quality and quantity of life. Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.

NCT ID: NCT06459063 Recruiting - Clinical trials for Osteoarthritis Thumb

Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

Start date: June 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).

NCT ID: NCT06457971 Active, not recruiting - Ventral Hernia Clinical Trials

Anovo Surgical System in Ventral Hernia

CLEVER
Start date: January 14, 2024
Phase: N/A
Study type: Interventional

The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.

NCT ID: NCT06457594 Completed - Clinical trials for Head and Neck Cancer

Prospective PROM and PREM Analysis Demonstrating Specification Advantage and Language Barriers

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Importance: Patient reported outcome and experience measures (PROM and PREM) constitute a cornerstone of the collective efforts to improve and personalize healthcare systems. The EORTC quality of life (QOL) group developed instruments evaluating general and disease specific oncology QOL questionnaires, and the quality of information received. Implementation of PREM and relevant PROM is essential for equity, better resources utility, accessibility and patient centered treatment. Objectives: We describe the EORTC INFO 25 translation process followed by investigation of subpopulation where action is most needed. We investigate which QOL questionnaire better reflects clinical parameters among head and neck cancer (HNC) patients. Design: A prospective cohort. Setting Tertiary, referral, head and neck dedicated surgical service. Participants: Consecutive head and neck cancer adult patients, surgically treated, recruited between January to December 2022. Exposures: We prospectively analyzed the new EORTC INFO 25 Hebrew questionnaire together with previously established Arabic translated version and the general (QLQ-C30) and specific (QLQ - H&N43) oncology QOL questionnaires. Main Outcomes and Measures: Analyzing the quality of information provided and desired in diverse HNC subgroup of patients. Analyzing which of PROM questionnaire better reflects HNC patients' disease and treatment parameters, which in turn, may predict poorer QOL. Results: We recruited 60 patients, consisting of equal female: male ratio, of which 16.66% were native Arabic speaking. Validated INFO 25 scores (median 62.6±17.5) were not associated with patients' age, sex, education status, disease, and treatment parameters. Yet, the Arabic spoken sub-population had significantly lower scores (p<0.001). In contrast to QLQ-C30, clinical imperative associations were demonstrated between QLQ - H&N43 and patients' disease stage (P<0.001), admission days (p<0.0001), free flap reconstruction (P<0.001) and adjuvant radiotherapy (P<0.001). Conclusions and relevance: The final version of the native EORTC INFO25 translation was approved by the EORTC. We demonstrate lower INFO25 scores among the Arabic speaking population, suggesting frail equity and accessibility. In order to improve patients' centered treatment and resource utilization, we reveal a strong association between disease severity and treatment aggressiveness and poor quality of life on specific, HNC oriented, EORTC QLQ - H&N43 questionnaire that was not validated on EORTC QLQ-C30, which can be omitted.

NCT ID: NCT06456177 Recruiting - Pain Relief Clinical Trials

Nociception Monitoring During Epidural Analgesia

Start date: June 30, 2021
Phase:
Study type: Observational

Introduction and aim: Nociception monitors have been used to assess pain management in anesthetized patients. The investigators set out to evaluate whether Nociception Level (NOL) monitor (PMD-200 monitor with NOL technology , (Medasense Biometrics Ltd. Ramat Gan, Israel) yields reliable readings during labor, and whether the derived NOL index will be associated with Visual analogue scale (VAS) subjective level of pain before and after the onset of epidural analgesia. Methods: Following approval by the intuitional review board No 0056-21-CMC, thirty parturients scheduled for epidural analgesia due to labor pains will be included in this prospective study, after informed consent for participation in the study will be obtained. NOL monitoring device will be connected to the subject finger. Epidural analgesia will be performed as per institutional standards. Data of VAS and NOL index will be collected once a minute. The association between VAS and NOL before and after the onset of adequate analgesia will be evaluated.

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for Polymyositis, Dermatomyositis

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06454227 Not yet recruiting - Clinical trials for Surgical Site Infection

Subcutaneous Lavage in Cesarean Section

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection. intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section. The main questions we aim to answer are: Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases? Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce Participants will: consent to participate in the trial Visit the postpartum clinic 30 days after surgery

NCT ID: NCT06453473 Not yet recruiting - Older Adults Clinical Trials

Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills

BiPerAge
Start date: September 2024
Phase: N/A
Study type: Interventional

The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.

NCT ID: NCT06452381 Active, not recruiting - Food Allergy Clinical Trials

Allergenicity Assessment of Green Marine Macroalga Ulva sp.

Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

To determine the allergenic potential in humans, we will conduct a three-stage clinical trial. In the first group, 20 healthy volunteers will be involved. All volunteers will be examined by an allergy specialist before enrolment to the study. After receiving informed consent, all volunteers will undergo an allergy skin test to the study seaweed proteins as well as to common allergens. Participants with a skin test showing sensitization will be excluded. Volunteers will be fed by 5 gram of the study seaweed 2 times a week, under supervision, for 6 weeks. After 6 weeks of feeding, skin tests will be repeated. All participants, will undergo an open oral food challenge after one month of avoidance of the study seaweed protein. Uneventful food challenge will rule out food allergy in a specific volunteer. Second, the extension clinical phase will be conducted with 100 healthy volunteers. The inclusion, exclusion and study design will be similar to the pilot study. The third phase will be conducted in a group of high-risk patients aimed to find the frequency of allergy to the study seaweed in high risk patients. Study population: 20 volunteers with high risk to seaweed food allergy. Inclusion criteria: Adults (&gt;18 years old, males and females) with at least one of the following: Active atopic dermatitis or fish or sea food allergy. Study design will be similar to the pilot study.