Hypothalamic Disorder

Researchers are evaluating a combined sleep promotion and cognitive training intervention to help improve cognitive function in older survivors of intensive care units ICU. This study focuses on adults aged 60 and older who are at high risk for delirium and cognitive decline similar to mild Alzheimers disease after ICU discharge. The study aims to assess whether these interventions can reduce the risk of developing Alzheimers disease and related dementias by addressing sleep deficiency, inactivity, and circadian rhythm disturbances common in ICU survivors. Participants will be randomly assigned to one of four groups a combination of nighttime sleep promotion using earplugs and eye masks plus daily 30-minute computerized cognitive training sessions cognitive training alone sleep promotion alone or an active control group receiving educational modules on brain health. The interventions last up to seven days following ICU discharge, with cognitive training sessions scheduled based on individual circadian rhythms measured by a wearable sensor. During the study, participants will be monitored using body temperature sensors to optimize the timing of cognitive training. Researchers will assess cognitive function, including executive function and working memory, at several time points within seven days after hospital discharge, and at one, six, and twelve months follow-up. The study also examines how sleep and activity may influence cognitive outcomes, with safety and ongoing care monitored throughout the study period, which concludes in May 2027.

Researchers are evaluating the safety and effectiveness of a monthly Leuprorelin treatment given for 24 months in children diagnosed with central precocious puberty CPP. This phase 4, single-arm, open-label study focuses on children with early puberty signs, primarily girls younger than 9 years and boys younger than 10 years, who have reached Tanner stage 2 or higher. The study aims to understand how this treatment impacts hormone levels and puberty progression over two years. Participants will receive Leuprorelin injections every four weeks for up to 24 months. This treatment is designed to influence hormone levels by suppressing luteinizing hormone LH after stimulation with gonadotropin-releasing hormone GnRH. The study tracks changes in hormone levels, pubertal development, growth parameters like height and weight, and monitors for any treatment-related adverse events during this period. During the trial, children will undergo regular assessments including hormone tests to measure LH, follicle-stimulating hormone FSH, testosterone, and estradiol levels, as well as evaluations of their pubertal stage and growth. Safety is closely monitored by recording any side effects related to the treatment. The primary outcome is the suppression of peak LH levels 24 weeks after starting treatment, with ongoing follow-ups up to 96 weeks to observe longer-term effects and safety.

Researchers are studying RM-718 to assess its safety, tolerability, and how the body processes it in healthy individuals with obesity and in patients with impairments in the MC4R pathway. This study includes people aged 12 to 65 years and focuses on those with hypothalamic obesity and Prader-Willi Syndrome, conditions related to obesity caused by specific brain or genetic issues. The study has four parts Part A tests single weekly doses of RM-718 or placebo in healthy obese adults aged 18 to 55 Part B tests multiple weekly doses in a similar group Part C involves multiple weekly doses in patients aged 12 to 65 with hypothalamic obesity and Part D gives multiple weekly doses to patients with Prader-Willi Syndrome aged 12 to 65. Doses are administered by weekly injections under the skin, and parts A and B are randomized, placebo-controlled, and double-blind, while parts C and D are open-label dose escalations. Participants will receive various weekly doses of RM-718 or placebo depending on their study part, with monitoring for side effects throughout. Researchers will assess safety by tracking adverse events during and after treatment, as well as measure how the drug behaves in the body over time. They will also monitor changes in body mass index, weight, waist size, and hunger symptoms in patients with hypothalamic obesity and Prader-Willi Syndrome. The study includes safety follow-up calls extending up to 210 days after dosing in some parts, with total participation lasting up to 26 weeks depending on the group.

Researchers are evaluating the effects of traditional Chinese medicine combined with intradermal acupuncture on girls with idiopathic precocious puberty, a condition characterized by early onset of puberty without an identifiable cause. This phase 3 randomized controlled trial aims to determine if combining acupuncture point stimulation with herbal treatment can improve symptoms and prevent the condition from worsening. The study focuses on girls with mild to moderate precocious puberty and explores whether this combined approach offers benefits beyond traditional herbal medicine alone. Participants will be randomly assigned to one of two groups. One group will receive Ziyin-Xiehuo traditional Chinese medicine granules twice daily along with intradermal acupuncture point stimulation targeting specific points, applied three times daily with needles changed every two days, for a duration of six months. The other group will receive only the traditional Chinese medicine granules twice daily for the same six-month period. This design allows comparison between combined therapy and herbal medicine alone. During the study, researchers will monitor participants breast development changes, particularly the reduction or disappearance of mammary nucleus size at three months. They will also assess bone age changes compared to chronological age over six months. Various evaluations such as ultrasound measurements of uterus and ovary size, Tanner staging, and hormone treatment history will be collected. Safety and efficacy will be carefully observed throughout the six-month treatment period.

Researchers are studying how well setmelanotide works to reduce weight, hunger, and improve quality of life in patients aged 4 years and older with congenital Hypothalamic Obesity cHO. This phase 3 trial evaluates the safety and effectiveness of setmelanotide compared to placebo in this population. Participants have specific diagnoses related to hypothalamic injury and hormone deficiencies, with elevated body mass index BMI or BMI percentiles as criteria. Participants will receive a daily subcutaneous injection of either setmelanotide or a placebo in a randomized 21 ratio. The treatment period lasts for 26 weeks on a therapeutic regimen. The study is double-blind and placebo-controlled to objectively assess the effects of setmelanotide on weight and hunger measures. During the trial, participants will complete assessments measuring changes in BMI, hunger scores, weight, and quality of life related to weight impact. Safety will be monitored by tracking adverse events throughout the 26-week period. Additional evaluations include changes in BMI z-scores for pediatric patients and physical functioning scores. The trial is sponsored by Rhythm Pharmaceuticals, Inc. and will follow participants from baseline through the 26-week treatment duration.

The trial investigates whether the perfusion index PI can reliably predict changes in systolic blood pressure SBP in adults with spinal cord injury SCI during a controlled cool temperature challenge. The study involves participants aged 18 to 75 years with SCI at neurological levels C4-T12 graded as ASIA Impairment Scale A or B motor complete, along with healthy age- and gender-matched able-bodied controls. Researchers aim to understand the relationship between PI and SBP changes, which may help clarify blood pressure instability after SCI and contribute to developing wearable monitoring devices. Participants in both groups undergo a non-invasive cool thermal challenge in a climate-controlled chamber at 18C 64.4F for up to 90 minutes, after a 10-minute baseline period at 27C 80F. They wear shorts and a T-shirt while seated in a wheelchair. Continuous measurements of PI, blood pressure, and other vital signs are recorded using sensors attached to the skin throughout the warm baseline and cool challenge phases. During the study, participants will have temperature sensors taped to their forehead and pulse oximeters placed on their ear, finger, and toe to measure PI and beat-to-beat blood pressure. Measurements are taken while seated in a wheelchair for 10 minutes in a warm room and then up to 90 minutes in a cool room. The primary outcomes are continuous recordings of PI and SBP during these phases. This research may support the development of wearable devices for early detection and management of blood pressure fluctuations in persons with SCI.

This research aims to evaluate the Antimfcllerian Hormone AMH as a predictor of infertility risk in children with cancer or benign diseases treated with chemotherapy andor pelvic irradiation. It focuses on girls aged 3 to 14 years, including prepubertal and pubertal patients, who are classified into high, moderatelow, and no risk groups based on their treatments potential impact on ovarian reserve. The study addresses the challenge of assessing ovarian reserve and fertility preservation needs in young patients who progress normally through puberty but may have impaired ovarian function due to treatment. Participants are observed over several years with no intervention administered as part of the study. They are grouped by their risk category high risk those receiving conditioning therapy for bone marrow transplantation or pelvic irradiation, moderatelow risk patients treated with chemotherapy regimens associated with varying risks, and no risk patients with benign or malignancies not involving gonadotoxic treatment. Assessments include measuring AMH levels and other hormones before and after treatment and during follow-up visits up to 18 years old. During the study, participants undergo evaluations at inclusion, end of treatment, annually for the first three years, and then every two years until age 18. These include blood tests for ovarian reserve hormones AMH, FSH, estradiol, testosterone, LH, pubertal stage assessments using TANNER criteria, menstrual cycle monitoring, and bone age evaluation via X-rays. Researchers will use these measurements to identify patients at risk of premature ovarian failure and to better understand how chemotherapy affects ovarian function in relation to pubertal status.

This research aims to compare the thickness of the endometrial lining in adolescent and young adult females on estrogen replacement therapy using two types of progesterone treatments daily oral micronized progesterone and the etonogestrel implant. The study focuses on patients aged 12 to 25 years with specific diagnoses requiring estrogen therapy, addressing gaps in knowledge about endometrial protection and bleeding patterns in this group. Participants will choose between two progesterone therapies oral micronized progesterone taken daily at 100mg or the etonogestrel implant placed in a clinic. The study will last six months, during which participants will continue their estrogen therapy and start their selected progesterone treatment. Two pelvic ultrasounds will be performed, one at the start and one after six months of progesterone use, to measure changes in endometrial thickness. Throughout the study, participants will complete surveys about bleeding patterns, side effects, satisfaction, and adherence to their progesterone treatment. The study team will track medication use through pill counts or photos for those on oral progesterone. All ultrasound and survey data will be securely stored and analyzed to assess the mean change in endometrial thickness and other patient-reported outcomes over six months.

This research aims to understand the nutritional knowledge and dietary habits of athletic women and how these factors might affect their menstrual health. It focuses on women diagnosed with functional hypothalamic amenorrhea FHA and those experiencing other menstrual irregularities like oligomenorrhea or polymenorrhea without organic causes. The study is observational and investigates the connection between nutrition and menstrual function in this specific group. Participants are athletic women aged 16 to 30 who engage in physical activity more than two days a week. The study collects data using validated questionnaires to assess nutritional knowledge, eating habits, and eating behaviors. It compares women with FHA to those with other menstrual dysfunctions to evaluate differences in nutrition and behavior. There are no interventions or treatments the study observes existing conditions and habits at baseline. Participants will complete questionnaires that evaluate their nutritional knowledge and eating behaviors related to menstrual health. Researchers will analyze the data to understand any correlations between diet and menstrual irregularities. The primary outcome is the assessment of nutritional knowledge in women with FHA, while secondary outcomes include comparisons of eating habits and behaviors across different menstrual dysfunctions. The study is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia and runs through January 2026.

This research investigates how abnormalities in body fat amount, distribution, and function relate to female gonadal dysfunctions, including hypothalamic amenorrhea and polycystic ovary syndrome PCOS. The study aims to better understand how fat tissue communicates with the female reproductive system and to identify new biomarkers that could help diagnose and treat these conditions. Participants include women with different types of PCOS, exercise-related amenorrhea, and healthy controls. Women in five groups will be studied, including those with exercise-associated hypothalamic amenorrhea, hyperandrogenic and non-hyperandrogenic PCOS both lean and with weight excess, women who exercise but have normal ovulation, and healthy women with no regular exercise. Researchers will collect samples and data from fat tissue, muscle, blood, and microbiome to analyze proteins, gene expression, hormones, body composition, cardiovascular health, and inflammatory markers. Participants will undergo detailed physical exams, body composition scans, blood tests, glucose tolerance tests, ultrasound imaging, blood pressure monitoring, biopsies, and microbiome sampling. Researchers will measure adipokine and myokine signals over up to five years and assess their associations with reproductive hormones and cardiovascular risk factors. The study includes comprehensive monitoring of metabolism, inflammation, oxidative stress, and the microbiome to explore their links to reproductive health.