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Atrophy clinical trials

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NCT ID: NCT05916014 Recruiting - Clinical trials for Artificial Intelligence

AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis

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

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification.

NCT ID: NCT05901987 Recruiting - SMA II Clinical Trials

Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 2 Patients

Start date: August 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 2 (SMA 2) patients.

NCT ID: NCT05893537 Recruiting - Clinical trials for Age-Related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

Start date: June 16, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

NCT ID: NCT05891275 Completed - Geographic Atrophy Clinical Trials

Patients With Geographic Atrophy and Their Patient Journey in the United States (US)

Start date: May 31, 2023
Phase:
Study type: Observational

To quantify and describe patients with a Geographic Atrophy (GA) diagnosis in at least one eye, and the progression to neovascular Age-Related Macular Degeneration (including how many receive Anti-VEGF), or to GA (in the fellow eye only).

NCT ID: NCT05878418 Recruiting - Exercise Clinical Trials

The Effect of Spinal Orthosis on the Development of Scoliosis and Chest Deformity in Type I Spinal Muscular Atrophy

Start date: October 11, 2023
Phase: N/A
Study type: Interventional

Spinal muscular atrophy (SMA) is a serious neuromuscular disease characterized by the degeneration of alpha motor neurons in the spinal cord, resulting in progressive proximal muscle atrophy and denervation. The main problems are posture disorders, scoliosis, pelvic curvature, contracture, hip dislocation, foot and chest deformities. In this study, examining the effectiveness of trunk support used to alleviate the progression of scoliosis in children diagnosed with SMA Type I will contribute to the current literature.In addition to Individualized Trunk Exercises (ITE), Individualized Pulmonary Rehabilitation (IPR) and Chest Care (CC) Programme, the use of thoracolumbosacral spinal orthosis in Type I children will be used for the first time in our country and in the world literature. SMA. Our aim in the project is to examine the effectiveness of this treatment program on the motor functions, scoliosis Cobb angle, pelvic curvature and chest deformity of children with Type I SMA.The project is planned to be carried out with children diagnosed with Type I SMA who are followed up at Medipol Mega University Hospital Pediatric Chest Diseases Polyclinic.In evaluating the development of scoliosis as the primary outcome measure; Radiological evaluation (Cobb Angle) and examination of chest deformity; Lung X-ray (Basal Chest Wall Upper-Lower Ratio Measurement) will be used. As secondary outcome measures, the Children's Hospital of Philadelphia Infant Test for Neuromuscular Disorders and the Hammersmith Functional Motor Scale Expanded were used to assess motor functions and examine the level of motor development; In the World Health Organization Motor Development Scale body posture assessment; Supine Trunk Rotation Angle Test and Pelvic Curvature Test, pulse oximetry to assess oxygenation; In determining the level of satisfaction with orthosis use; Children/families' information will be questioned through the Quebec Assistive Technology User Satisfaction Evaluation Survey and Personal Information Form.The active control group will receive the ITE, IPR and CC program as a home program and once a week in the outpatient clinic for 8 weeks, 7 days a week, once a day, each session being 50-60 minutes. In the ITE-IPR-CC + spine orthosis group, in addition to the control group program, a thoracolumbosacral spine orthosis specially designed for the child will be used every day of the week and 8 hours a day for 8 weeks. Evaluations will be made at baseline and at week 8.

NCT ID: NCT05871255 Completed - Clinical trials for Genitourinary Syndrome of Menopause

Natural Topical Treatment for Vulvar and Vaginal Atrophy

Start date: January 5, 2022
Phase:
Study type: Observational

Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

NCT ID: NCT05870774 Active, not recruiting - Soft Tissue Atrophy Clinical Trials

Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results

Start date: October 28, 2021
Phase: N/A
Study type: Interventional

This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used collagen matrix Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ -20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.

NCT ID: NCT05869812 Recruiting - Atrophy Clinical Trials

Influence of β-hydroxy β-methyl Butyrate (HMB)Supplementation on Post-operative Muscle Mass and Function in Female Athletes

FAKS-HMB
Start date: May 29, 2023
Phase: Phase 2
Study type: Interventional

The proposed project will evaluate the musculoskeletal outcomes of quadriceps and hamstring muscle size and function following orthopedic knee surgery involving anterior cruciate ligament (ACL) repair or reconstruction. Currently, the research team collaborates with a team of orthopedic specialists at the University of Kansas Health System and monitor muscle size post-knee repair and follow the standard of care (SOC) practices of the licensed physical therapists (PT). The proposed project will include a randomized clinical trial to observe the muscular outcomes following the current SOC plus supplementation of calcium-β-hydroxy-β-methylbutyrate (caHMB) or placebo. CaHMB has been shown to improve rates of muscle protein synthesis while suppressing muscle protein breakdown in healthy adults. The use of caHMB has also provided evidence of muscular protection from atrophy during prolonged bed rest. This evidence supports the utility in clinically injured athletes that are subjected to disuse atrophy from the inability to bear weight or participate in typical daily physical activity. Additionally, matched for activity-related knee injuries, female athletes are more susceptible to incurring a significant injury due to a variety of genetic, hormonal, biological, anatomical, and biomechanical predispositions. Therefore, the proposed study will recruit approximately 30 females over the age of 18 that have sustained an injury to the ACL and will plan to undergo reconstructive knee surgery involving the ACL. Subjects will be monitored and measured prior to their surgical date (T0), at 2-weeks post operative (T1), and every 6-weeks until they are cleared to return to sport (T2-TRTS). Participants will be randomly assigned 1:1 in a double-blind manner to either an experimental (EXPHMB) or placebo (CONPLA) group. Doses will be provided to the participants in coded containers and will complete their dosing and a record log of intake for the duration of their rehabilitation. Three 3-day food, exercise, and health record logs will be collected to monitor nutritional intake, activity, and menstrual patterns at T0, T3, and TRTS. Participant's assessments will include body composition analysis via bioelectrical impedance analysis for total and segmental muscle and fat mass, skeletal muscle mass, and body fat percent. We will collect ultrasound images of the quadriceps and hamstrings of the operative-involved limb (OPIL) and non-operative limb (NOPL) limbs for muscle cross-sectional area (mCSA), thickness (mT), subcutaneous fat thickness (TFAT), and corrected echo intensity (EICOR) at all time points. Strength and functional assessments will occur upon entrance to the study (T0), and after loaded exercise is indicated by the practitioner (T3-TRTS) to the tolerance of the athlete. These assessments include maximal voluntary isometric contractions (MVIC) for leg extension and leg curl, standing balance tests, single-leg and double-leg jump assessment, and drop landing deviation, all on dual force plates. Data will be analyzed using multiple three-way analyses of variance [surgical leg (OPIL vs. NOPL) x treatment (EXPHMB vs. CONPLA) x time (T0 vs. T1 vs. T2 vs. T3 vs. T4 vs. T5 vs. TRTS) for the dependent variables. Significance is established at p≤0.05 and follow-up ANOVAS, T-tests, and post-hoc analyses will be conducted when significance is present. The evidence from this study will support the practitioners and coaches' abilities to maximize recovery and training outcomes, respectively, in previously injured female athletes.

NCT ID: NCT05866939 Not yet recruiting - Clinical trials for Spinal Muscular Atrophy

Development of a Multidisciplinary Network for Clinical and Laboratory Research for SMA

Start date: June 30, 2023
Phase:
Study type: Observational

The goal of this observational study is to to establish profiles of clinical progression in patients affected by the different types of SMA (type I, II and III) treated with the currently approved drugs using a structured battery of clinical tests. Another goal of the study is to assess the progression of the disease in patients identified through neonatal screening.

NCT ID: NCT05866419 Recruiting - Scoliosis Clinical Trials

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

PIERRE
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.