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Atrophy clinical trials

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NCT ID: NCT04851873 Completed - Clinical trials for Spinal Muscular Atrophy

Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)

SMART
Start date: September 8, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.

NCT ID: NCT04834050 Completed - Knee Osteoarthritis Clinical Trials

Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis

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

Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA) patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on QF muscle parts thickness and pennation angle measurements of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12 patients with knee OA as positive control group and 13 volunteers as healthy control group. All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness and pennation angle measurements of QF muscle parts were evaluated by ultrasonography.

NCT ID: NCT04794634 Completed - Alzheimer Disease Clinical Trials

Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers

RETEVAL
Start date: March 9, 2021
Phase: N/A
Study type: Interventional

Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.

NCT ID: NCT04766957 Completed - Clinical trials for Vulvovaginal Atrophy

Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy

IDRA
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.

NCT ID: NCT04744662 Completed - Geographic Atrophy Clinical Trials

ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of intravitreal injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability. It is a progressive disease with no approved therapy to slow or arrest the process of continual photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in development for to reduce rates of vision in patients with GA associated with AMD. ONL1204 has demonstrated protection of multiple retinal cell types in several preclinical models of acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is currently in a Phase 1 clinical study in patients with macula-off retinal detachment to evaluate safety and tolerability of a single-dose of ONL1204 Ophthalmic Solution. The study is ongoing and uses the same doses and route of administration as this Phase 1b study in patients with GA.

NCT ID: NCT04740268 Completed - Atrophic Acne Scar Clinical Trials

Straberi Microneedling For Atrophic Acne

SAA
Start date: December 23, 2022
Phase: N/A
Study type: Interventional

This pilot study will expand knowledge and application needling using the Straberi microneedling device for the improvement of Atrophic Acne Scarring

NCT ID: NCT04735549 Completed - Vaginal Atrophy Clinical Trials

Vulvovaginal Atrophy Correction Using Neodymium Laser

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: vaginal health index, perineometry, elastography of vulva, cytological methods. Female Sexual Function Index (FSFI), The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Vulvovaginal Symptoms Questionnaire (VSQ), Visual Analogue Scale (VAS) will be used to collect feedback on changes in the participants life quality. Total up to 120 participants with postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment group, topical hormones treatment group, and both laser treatment with topical hormones application group, by 40 participants in each. The time intervals between tests will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment and combine laser and topical hormones therapy of the vaginal atrophy will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment and laser treatment with hormones application compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the hormones only therapy group.

NCT ID: NCT04717245 Completed - Vaginal Atrophy Clinical Trials

Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment

Start date: October 25, 2018
Phase: N/A
Study type: Interventional

Postmenopausal hypoestrogenism may determine genital atrophy, which may be accompanied by a non-specific inflammatory process and may hinder or even prevent sexual intercourse. In more severe cases, the patient may have local pain that interferes with their daily activities. The best treatment for increasing genital trophism is still estrogen. However, there are women who can not use this therapy or do not want it. Therefore, there is a need for alternatives, such as ablation techniques: use of CO2 LASER and fractional radiofrequency. The study was carried out at the outpatient clinic of Lower Genital Tract ambulatory of the Discipline of Gynecology, Department of Obstetrics and Gynecology, Clinical Hospital, Faculty of Medicine, University of São Paulo, involving 75 women who were divided after randomization in three groups: Group 1 - treatment with topical vaginal promestriene (n = 25 patients); Group 2 - treatment with fractional CO2 LASER (n = 25 patients); Group 3 - fractional microablative radiofrequency treatment (n = 25 patients). An evaluation of the complaints were be performed through questionnaires on sexuality, quality of life and urinary incontinence, as well as biopsies of the vaginal wall for histomorphometric, immunohistochemical and molecular biology study before and after six months of treatment. The duration of the study were fifteen months.

NCT ID: NCT04708847 Completed - Healthy Volunteers Clinical Trials

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer

Start date: February 10, 2021
Phase: Phase 1
Study type: Interventional

This study will induce disuse atrophy through unilateral immobilization of the thigh and lower leg in healthy male volunteers to evaluate the PD of a single subcutaneous dose of GYM329 prior to or after unilateral thigh and lower leg immobilization. Healthy male volunteers will receive either GYM329 or placebo by subcutaneous injection at two time points, before and after 2 weeks of unilateral thigh and lower leg immobilization, in an investigator- and subject-blinded, randomized, placebo-controlled, parallel-group design. At enrollment, all subjects will be randomized in a 1:2 ratio to either the pre-immobilization active drug group receiving a single subcutaneous dose of GYM329 before unilateral thigh and lower leg immobilization (Group A) or the pre-immobilization placebo group receiving a single subcutaneous dose of placebo before unilateral thigh and lower leg immobilization (Group B). On Day 15, subjects assigned to Group B and who completed the muscle strength assessment at Day15 will be further randomized in a 1:1 ratio to either the post-immobilization active drug group (Group B-1) or the post-immobilization placebo group (Group B-2). Group A will receive GYM329 on Day 1 and placebo on Day 15. Group B will receive placebo on Day 1. Subsequently, Group B-1 will receive GYM329 on Day 15 and Group B-2 will receive placebo on Day 15. Muscle strength will be measured at pre-immobilization of unilateral thigh and lower leg, post-immobilization of unilateral thigh and lower leg (Day 15), Day 29, and Day 43. Subjects will be observed for 252 days after the second study treatment administration (266 days after the first study treatment administration).

NCT ID: NCT04705883 Completed - Breast Cancer Clinical Trials

Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

VIBRA
Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)