Clinical Research Directory

Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.

Estradiol Supplementation and Rotator Cuff Repair

Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.

Targeting Insomnia to Prevent Depression in the Menopause Transition

This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period. The two main questions the study aims to answer are: 1. Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation? 2. Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?

Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

Participants are being invited to a research study. This research aims to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal/perimenopausal symptoms including hot flashes effects, depression/anxiety, memory-problems, and muscular problems. This study will assess what types of electrical brain stimulation affect different menopausal related symptoms. This study will help guide the development of electrical stimulation to be used for improving women's health during menopause transition.

Polyphenol Metabolism and Personalized Nutrition in Menopause (PolyPause).

The study aims to evaluate the role of the gut microbiome and phageome in explaining interindividual variability in the metabolic response to polyphenol-rich nutraceuticals among menopausal women. Insights from this research will support the development of personalized nutrition strategies to improve quality of life and reduce cardiovascular disease (CVD) risk during menopause.

Progressive Relaxation Exercise, Menopausal Symptoms and Working Performance

Women typically enter menopause between the ages of 40 and 47, and they spend approximately one-third of their lives in this phase. During menopause, many experience hot flashes due to decreased estrogen levels, along with vasomotor changes such as altered heart rhythms and sleep disturbances. These issues may accompany or occur independently of hot flashes. Additionally, psychological changes can arise, including tension, sudden mood swings, anxiety, stress, and depression. Physiological concerns may include vaginal atrophy and stress incontinence.

Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia

This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

Affect of Duavive on Mood & Anxiety Symptoms

This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial

Selecting theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing Risk-reducing salpingo-oophorectomy (RRSO) and developing a 3D bioprinted hormone-producing bioprosthetic model. If efficacy and tolerability are confirmed in vivo, this bioprosthetic model might be used to replace hormones' production in BRCA mutated patients undergoing prophylactic surgery.

Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life

The study will be conducted as a randomized controlled experimental study to determine the effects of the Emotional Freedom Technique (EFT) applied to women in menopause on sleep quality and quality of life. It will be conducted with 80 women between the ages of 45-64, registered in a family health center in a city in the east of Turkey, who have been in menopause for at least one year and volunteer to participate in the study. EFT will be applied to the women to be included in the experimental group in the study once a week, a total of four times in a month. The "Participant Information Form", "Utian Quality of Life Scale" and "Pittsburgh Sleep Quality Scale" prepared by the researchers in line with the literature information will be used in the collection of research data.

Virtual perI-/Menopause Registry of AusTrALia

13 million (50.7%) Australians are born with ovaries, 14% (\~3 million) are currently aged 40-59 yrs, \& all such who live to midlife will experience menopause, defined as \>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression/anxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \& urinary urgency. These symptoms are linked with lower quality of life \& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \& dementia are also associated with menopause, yet it remains disconcertingly poorly studied. The investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-/menopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \& mental health symptoms, \& to direct priorities for research, education, \& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \& impact. The participating consumers, researchers, clinical specialists, policy makers, \& modern virtual data infrastructure enable this unique \& innovative registry design, future translation to improved community health, \& promote awareness \& collaborative synergies. Leveraging the investigators' critical range of expertise \& ongoing feedback opportunities for both participants \& stakeholder partnerships, the investigators will create a ground-breaking platform that: * empowers the consumer voice and priorities, * enables peri-/menopause research to extend beyond existing niche focuses, * evidences the true impact of peri-/menopause across the nation, * evolves healthcare services and outcomes, \& * educates community, clinicians, \& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \& apply the best aspects of care from across the world.

Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity

The goal of this randomized controlled trial\] is to investigate the effects of a 12-week time restricted eating (TRE) and exercise combined intervention, as compared to (i) TRE alone, and to (ii) Caloric Restriction (CR) plus the same exercise intervention elicited by the TRE group, on Skeletal muscle tissue (SMT) quantity, quality and function (primary outcome), Resting energy expenditure (REE) and cardiometabolic health (secondary outcomes), and miRNA biomarkers in postmenopausal women with overweight or obesity.