Active clinical trials for "Atrophy"

Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy. Primary objective: • To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment. Secondary objectives: To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment. To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks. To evaluate the safety of 0.005% Estriol vaginal gel To evaluate the acceptability of 0.005% Estriol vaginal gel

This study will comprise of two phases, an observational phase and a treatment phase. In the observational phase the specific aims are: 1. To determine the presence and regional distribution of microglial activation, as assessed by 18F-PBR06 PET, in subjects with MSA as compared to healthy controls, at baseline and at 6-9 months' follow-up. 2. To assess the relationship between microglial activation and clinical progression at baseline and follow-up. In the treatment phase the specific aims of the study are: The specific aims of the study are: To assess whether verdiperstat (BHV-3241) reduces 18F-PBR06 PET signal, and thus microglial activation and inflammation, in well-characterized MSA patients. To assess the relationship between PET changes and clinical progression at baseline and follow-up in patients treated with verdiperstat. To assess the relationship between PET changes and volumetric brain MRI at baseline and follow-up in patients treated with verdiperstat. Currently there is no known disease modifying therapy for MSA. Recently, the drug verdiperstat (BHV-3241) has appeared in the investigational arena specifically for the indication of Multiple System Atrophy. Verdiperstat (BHV-3241) is currently being used in a phase 3 active drug trial at Massachusetts Hospital. Verdiperstat (BHV-3241) is known to target Myeloperoxidase, an enzyme implicated in neuroinflammation, a major driver in disease pathogenesis. Our previous study (IRB protocol #2016P002373) demonstrated that applying TSPO (translator protein) PET imaging enabled us to track changes in neuroinflammation and thus provide a viable biomarker for disease progression. In this pilot study, the investigators aim to assess the effect of an investigational drug, verdiperstat (BHV-3241) on microglial activation in MSA patients using [F-18]PBR06 and to link it with clinical and morphometric MRI brain changes following treatment.

Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Balance and falling losses can also affect occupation. Our study was conducted to examine the relationship between physical performance and occupational balance in elderly individuals. According to the power analysis, it is planned to include the individual in the study. Individuals will only be evaluated and the relationship between scale results will be analyzed statistically.

This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.

This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.

Because of its iron-chelating and antioxidant properties, alpha lipoic acid may be a treatment for geographic atrophy (GA) secondary to age-related macular degeneration. There is ample published data about the safety and pharmacokinetics of alpha lipoic acid in adults. However, there is not much data on the safety and tolerability of higher doses of alpha lipoic acid in the elderly population. The purpose of Phase I of this protocol is to determine if there are safety/tolerability concerns seen when higher doses of alpha lipoic acid are taken by subjects 65 years of age or older. The objective of Phase 2 of this protocol is to determine the effects of ALA on the progression of GA in subjects with AMD. The central hypothesis, based on the existing literature, is that oral ALA reduces the rate of enlargement of GA in AMD subjects. The rationale is that the antioxidant and iron chelating effects of ALA will slow down one of the major pathways responsible for GA progression.

The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

The goal of this clinical trial is to assess the effectiveness of GS010, a gene therapy, in improving the visual outcome in participants with Leber Hereditary Optic Neuropathy (LHON) due to the G11778A ND4 mitochondrial mutation when vision loss is present for six months or less.