Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents. Objective: To monitor the effects of HRT on adolescents with POI. Eligibility: Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed. Design: All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include: Blood and urine tests. A test of their heart function. A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates. A test of their grip strength. Participants will squeeze a handheld device as hard as they can. Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner. A test to measure skin pigmentation. Participants' skin will be touched lightly with a device. An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush. Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.

Type: Interventional

Start Date: Jul 2025

open study

This study will evaluate the feasibility and potential effects of a six-week, music-based binaural beats stimulation program in adults with attention-deficit/hyperactivity disorder (ADHD). Forty adults with ADHD will be randomly assigned to either a binaural beat stimulation group or a control group. Both groups will attend 12 supervised listening sessions over six weeks and listen to similar music for 20 minutes per session; however, only the intervention group's music will contain embedded binaural beats. Cognitive assessments will be completed before and after the intervention to evaluate changes in attention and memory. Session attendance and participant retention will also be examined to assess the feasibility and acceptability of the program.

Type: Interventional

Start Date: Mar 2026

open study

Approximately 70 subjects (35 subjects per light and dark group) will be enrolled in this clinical study (to complete with a minimum of 10 subjects per skin type (I-VI) to assess the effects of known UV Radiation dosage on light and dark skin, assess the protective effect of two SPF test materials, placebo product, and standard sunscreen ('Pad O') on skin, before and after a known UV Radiation dosage and collect the interstitial dermal fluid from approximately 60 subjects and send to Eurofins Discovery for analysis. The following study evaluations will be obtained: SPF Determination, Visual Assessment of Erythema, Chromameter and Mexameter measurements, Digital photography, Thermometer readings and Collection of Dermal Interstitial Fluid (IDF).

Type: Interventional

Start Date: Sep 2026

open study

The goal of this observational study is to see if ribonucleic acid (RNA) sequencing can improve the diagnostic yield and accuracy of genetic testing compared to gene sequencing alone. Participants will be asked to share their medical history and prior genetic testing results, and to donate a blood sample for testing.

Type: Observational

Start Date: Aug 2025

open study

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating weakness, which can worsen suddenly without a clear predictor. The hypothesis is that continuous monitoring of key aspects of patient physiology and activity coupled to rigorous telemedicine-performed examination has the potential to detect MG worsening which requires change in treatment with the benefit of avoiding need for hospitalization or emergent therapy. This study is to evaluate the reliability of the technology and patient compliance to the monitoring program

Type: Observational

Start Date: Aug 2026

open study

The goal of this study is to develop and test KABAWIL, a culturally tailored intervention designed to reduce HIV-related and intersectional stigmas experienced by Indigenous communities in Guatemala and improve engagement across the HIV Continuum of Care. The study will also assess the feasibility, acceptability, and implementation of the intervention. The main questions it aims to answer are: Can a culturally adapted version of the FRESH intervention reduce HIV-related and intersectional stigmas among Indigenous men and Indigenous healers? Does participation in KABAWIL improve outcomes related to HIV prevention, testing, treatment, and care using a status-neutral approach? Is KABAWIL feasible, acceptable, and appropriate for implementation in Indigenous communities in Guatemala? Researchers will first adapt the existing FRESH intervention through interviews and focus groups with Indigenous men, Indigenous healers, healthcare providers, stigma experts, and Maya knowledge keepers. Researchers will then compare participants who receive KABAWIL immediately with participants assigned to a 3-month wait-list control group. Participants will: Participate in interviews or focus groups to help adapt the intervention (Aim 1). Attend one of three KABAWIL workshops or be assigned to a 3-month wait-list control group (Aim 2). Complete surveys and assessments measuring HIV-related intersectional stigma and HIV Continuum of Care outcomes before and after the intervention (Aim 2). Participate in post-intervention interviews to provide feedback on the intervention's feasibility, acceptability, and implementation (Aim 3).

Type: Interventional

Start Date: Sep 2026

open study

This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed "Beef+", that will emphasize the incorporation of unprocessed, lean beef (<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life

Type: Interventional

Start Date: Sep 2026

open study

The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.

Type: Interventional

Start Date: Aug 2026

open study

The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.

Type: Interventional

Start Date: Aug 2026

open study

To evaluate the efficacy and safety of subcutaneous nomlabofusp in adult and pediatric subjects with Friedreich's ataxia

Type: Interventional

Start Date: Aug 2026

open study

The purpose of the present study is to assess prospectively the abuse potential of gabapentin compared to placebo and alprazolam in healthy non-drug-dependent recreational sedative drug users under fasted condition.

Type: Interventional

Start Date: Jun 2026

open study

The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The primary aim of the study is to quantify volume change of the lower face rea over time after injection of filler. The secondary aim is to collect patient related outcomes (PROs) via FACE-Q. Participants will receive hyaluronic acid filler injections (Restylane Lyft(for contouring of the chin. Each patient will receive FDA approved dosages of filler to the lower face region to treat chin regression or chin contouring, as per FDA approved indications. Prior to injections patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 moths for re-imaging.

Type: Interventional

Start Date: Sep 2026

open study

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered with Concomitant Infliximab in Healthy Participants

Type: Interventional

Start Date: Jul 2026

open study

This study compares two methods of prescribing parenteral nutrition (PN) in adults with cancer who are unable to meet nutritional needs by oral or enteral intake.

Type: Interventional

Start Date: Aug 2025

open study

The primary purpose of this study overall is to validate a modified version of a commercially available ankle brace. Inertial measurement unit sensors will be incorporated into an existing ankle brace ("sXAB") by TayCo Brace, Inc. In two consecutive studies, gait metrics data collected from the sensor enabled ankle brace will be compared to data collected by the gold-standard equipment that is used in research and clinical settings to determine whether the sXAB performs adequately in terms of measurement or technical feasibility prior to further clinical evaluation. In the Phase 2 protocol, the sXAB will be validated on healthy subjects wearing combat boots performing walking, running, jumping, and stair climbing activities. These movements were selected because they simulate key movements performed during operational activities. All participants experience both conditions: with an ankle brace and without an ankle brace. Comparisons are made within-subject between brace and no-brace conditions. It is hypothesized that the sensor-enabled ankle brace will measure gait metrics with a high degree of accuracy (within 5%) when compared against the gold-standard lab equipment (i.e., motion capture and research-grade inertial measurement units).

Type: Interventional

Start Date: May 2026

open study

This study will evaluate the safety and efficacy of GIA632 in participants with moderate to severe cutaneous lichen planus (cLP).

Type: Interventional

Start Date: Sep 2026

open study

Studies proposed in this application will image mitochondrial Complex-I in cocaine use disorder (CUD) and matched healthy controls

Type: Interventional

Start Date: Sep 2026

open study

The purpose of this study is to learn about the effectiveness of different pain control options after hand and wrist surgery, specifically Ketorolac, Tylenol, and a regional nerve block. Ketorolac (Toradol) is a nonsteroidal anti-inflammatory drug (NSAID) that is similar to ibuprofen (Motrin or Advil). Tylenol (acetaminophen) is a commonly used over the counter drug. A nerve block is pain medication that is applied directly to the nerves around the surgical site before the surgery and keeps working to reduce pain in the area for several hours after the surgery. All of these medicines and procedures are approved by the Food and Drug Administration (FDA) for patient care. This study aims to understand if using these medicines in combination helps patients having hand and wrist surgery avoid the need for opioid pain medications.

Type: Interventional

Start Date: Mar 2025

open study

The proposed study will enroll healthy older adult participants to examine the effectiveness of music listening activities to promote hearing and cognition. Participants will be randomized into one of four experimental groups and can expect to participate for up to 21 hours of research distributed over 20 weeks.

Type: Interventional

Start Date: Aug 2026

open study

The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.

Type: Interventional

Start Date: Aug 2026

open study

The goal of this clinical trial is to learn how to increase the usage and acceptability of Food Is Medicine programs among families with young children experiencing food insecurity who receive Medicaid benefits. Food Is Medicine programs connect food and nutrition programs to the healthcare system to address health issues. Food Is Medicine programs include food prescription programs that are recommended to patients by healthcare providers. These programs are designed to increase the amount of fruit and vegetables people eat to improve their health. The program described here works with pediatric practices serving a high Medicaid population in Buffalo, NY to recruit families with children aged 2-6 who are experiencing food insecurity-not having reliable access to the food they need. The main questions it aims to answer are: - What food prescription program is used most completely and consistently by food insecure families with children aged 2-6? - How do the programs being tested impact the amount of fruits and vegetables children eat and the household's food and nutrition security status? Researchers will compare 2 experimental delivery Food Is Medicine programs, a meal kit program and a produce prescription program, to each other and a standard of care mobile market voucher program to understand which program works the best for families with young children. Participants will: - Receive 1 of 3 food prescription programs for 24 weeks (6 months) - Complete a short survey at different times throughout the program reporting how much of the food in the food prescription their family ate and why they didn't eat it all (if applicable). - Complete a phone survey about their family, their eating and shopping habits, and other health questions before they start the program, at the end of the program, and 6 months after the program ended. - Complete an online diet recall survey recording what their child aged 2-6 ate for a 24-hour period before they start the program, at the end of the program, and 6 months after the program ended.

Type: Interventional

Start Date: Jul 2026

open study

ACPMP's first-ever patient-powered global patient registry/natural history study collects patient and caregiver information and data to fuel clinical trials and drive breakthroughs for appendix cancer and PMP. We've invested the time and resources to make our Registry regulatory grade. Our Registry operates under active, ongoing Institutional Review Board (IRB) oversight by independent ethicists. It is powered by NORD's IAMRARE®, an industry gold standard platform built to be consistent with FDA's best thinking on natural history studies.

Type: Observational

Start Date: Feb 2026

open study

This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the last menstrual period (the first day of your last period). Because this vaccine has not been studied in pregnant individuals, the registry collects information on pregnancy outcomes and infant health during the first year of life. People may join the registry if they: - are pregnant now (or recently pregnant), - are 10 to 25 years old, and - received at least one dose of study vaccine during pregnancy or within 30 days before their last period. The registry collects information from participants and their doctors at different times: - at enrollment, - around 27 weeks of pregnancy, - at the end of pregnancy, and - for infants, at 4 months and 12 months of age. All the information is collected remotely (phone, online forms, email, fax, or mail) by a coordinating center. No new medical tests or office visits are required beyond routine care.

Type: Observational

Start Date: May 2024

open study

This prospective observational study will investigate the relationship between the gut microbiome and adverse effects following stereotactic radiosurgery (SRS). Patients undergoing SRS as part of their standard clinical care will provide blood and stool samples before treatment and during follow-up. Samples will be analyzed to characterize fecal and blood metabolomic profiles and changes in the gut microbiome over time. The study has two primary objectives: to determine how stereotactic radiosurgery affects the gut microbiome and associated metabolomic profiles, and to evaluate whether microbiome- and metabolite-associated features are related to the development of adverse effects following SRS. Clinical data and standard-of-care neuroimaging will be collected longitudinally to identify outcomes including radiation necrosis and other adverse radiation effects. Biological profiles from patients who develop these outcomes will be compared with those from patients who do not, as well as within individual patients over time. The study aims to identify microbiome and metabolic signatures associated with susceptibility to adverse effects of stereotactic radiosurgery, with the long-term goal of improving risk stratification and informing future approaches to monitoring and treatment.

Type: Observational [Patient Registry]

Start Date: Aug 2025

open study

This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day [mg/day]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).

Type: Interventional

Start Date: Aug 2026

open study