Adrenal Hyperplasia

This clinical trial investigates the safety and recovery benefits of tubeless laparoscopic adrenalectomy in patients undergoing adrenal gland removal surgery. The study aims to answer whether avoiding drainage tubes after surgery helps patients recover more quickly, focusing on pain, the time to first get out of bed, and the recovery of intestinal function. It is a prospective, single-center, randomized controlled study enrolling 200 patients who need laparoscopic adrenalectomy. Participants are randomly assigned to one of two groups: one group receives surgery without drainage tubes (tubeless group), and the other group has drainage tubes placed after surgery (drainage group). The study compares outcomes such as pain scores, blood tests, and recovery indicators between these groups. Follow-up includes adrenal ultrasounds at one and six months post-surgery to monitor recovery and safety. During the study, participants will have blood tests and assessments of pain, time to mobilization, and intestinal function for the first three days after surgery. Researchers will also monitor for complications like fever and wound infections. Follow-up ultrasound exams at one and six months will help evaluate longer-term recovery. The trial uses block randomization and collects data to assess whether tubeless surgery promotes faster and safer recovery after adrenalectomy.

Researchers are evaluating CRN04894, an adrenocorticotropic hormone (ACTH) receptor antagonist, in adults with ACTH-dependent Cushing's syndrome, including Cushing's disease and Ectopic ACTH Syndrome (EAS). This Phase 1b/2a open-label study aims to explore the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses of CRN04894 in this patient population. The study is a first-in-disease, multiple-ascending dose exploratory trial to better understand how the drug behaves and affects the condition. Participants will receive oral doses of atumelnant (CRN04894) once daily for either 10 or 14 days in a sequential, open-label format. The treatment periods are followed by a 4-day washout phase after the 10-day dosing group. The study includes fixed-dose cohorts and monitors participants throughout these periods to assess the drug's impact on the disease and the body. During the study, participants will undergo monitoring for safety, including treatment-emergent adverse events, adrenal insufficiency, and laboratory test findings, all assessed up to Day 15. Pharmacokinetic measures include maximum plasma concentration, time to reach this concentration, and plasma exposure over time. Additionally, early morning serum cortisol levels will be tracked to evaluate changes from baseline. The total participation involves dosing and follow-up assessments to collect this comprehensive data.

Researchers are evaluating the effectiveness of acupuncture compared to metformin, both combined with lifestyle management, in improving glucose control in women with insulin resistance and polycystic ovary syndrome (PCOS). The study aims to see if these treatments improve ovulation, hormone balance, quality of life, and symptoms of anxiety and depression, while also investigating if acupuncture has fewer side effects. They also explore whether these treatments can reverse molecular changes that may help prevent type 2 diabetes. Participants will be randomly assigned to one of three groups: lifestyle management alone, lifestyle management plus acupuncture, or lifestyle management plus metformin. Acupuncture treatments involve inserting sterile needles into specific abdominal and leg acupuncture points related to ovarian and pancreatic function, administered three times weekly for four weeks, then twice weekly for twelve weeks. Metformin is taken orally, starting at a low dose and gradually increasing to 1500 mg daily over 16 weeks. All women receive lifestyle advice on weight management, diet, and exercise at the start. During the study, participants undergo assessments at the start, after 4 months of treatment, and again 4 months post-treatment. These include blood tests measuring insulin sensitivity, glucose levels, hormone levels, and molecular markers from tissue samples. Researchers will also monitor menstrual patterns, ovulation, quality of life, mental health symptoms, eating habits, and treatment side effects. The study lasts 8 months with ongoing evaluations to determine the cost-effectiveness and overall impact of each treatment approach.

Researchers are investigating how progesterone affects luteinizing hormone (LH) pulse frequency during waking and sleep periods in mid- to late pubertal girls, both with and without hyperandrogenism (HA). The study aims to find out if progesterone reduces waking LH pulse frequency more than sleep-associated LH pulse frequency in girls without HA, and whether this effect is less in girls with HA. The study is a randomized, placebo-controlled, double-blind crossover trial involving mid- to late pubertal girls at Tanner breast stage 3 or higher but no more than 2 years after menarche. Participants will attend two 18-hour clinical research unit admissions across separate menstrual cycles, receiving either oral micronized progesterone (0.8 mg/kg at 7 AM, 3 PM, 11 PM, and 7 AM) or placebo. Blood samples will be collected every 10 minutes overnight to measure LH pulses and other hormones. After at least two months, participants will switch treatments for the second admission. Participants will be closely monitored throughout the study with frequent blood tests to characterize LH secretion patterns. The main measure is LH pulse frequency while awake, with sleep LH pulse frequency as a secondary measure. The study includes detailed hormone analysis and statistical modeling to compare effects between girls with and without HA. The total participation includes two inpatient admissions separated by at least two months.

Researchers are investigating the causes and development of adrenal tumors, which include adrenocortical carcinoma, Cushing syndrome, Conn syndrome, and pheochromocytoma. The study aims to better understand how these tumors form and to evaluate new treatment options for patients with malignant adrenal tumors, addressing the limited current therapies available. This observational research is sponsored by the University of Wuerzburg and has been ongoing since 2002. Participants in the study may provide tumor material and related biological samples if they have adrenal tumors. Additionally, biological samples are collected from patients without adrenal tumors to serve as comparison controls. The research does not involve experimental treatments but focuses on collecting and analyzing biospecimens to explore tumor biology and potential therapies. Throughout the study, participants contribute by providing tumor and biosample materials. Researchers analyze these samples to study tumor characteristics and evaluate possible new treatments. There are no specific outcome measures listed. The study is observational, with no assigned treatments, and aims to gather information to support future therapeutic developments. Participants' involvement duration varies, and the study is expected to continue until December 2032.

This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the model's ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patient's B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.

Researchers are studying women with Polycystic Ovary Syndrome (PCOS) to investigate markers related to blood vessel, heart muscle, and inner vessel lining function. The study looks at these markers both before and during a glucose tolerance test, as well as changes after treatment. It explores how metabolic and hormonal abnormalities in PCOS affect these markers and evaluates the impact of different treatments over time. Participants will be divided into four groups: one group will receive lifestyle changes combined with a GLP-1 receptor agonist drug, another will receive lifestyle changes with an oral contraceptive, a third group will receive lifestyle changes with metformin, and the last group will receive lifestyle changes alone. After six months of treatment, the same tests will be repeated to observe changes. Tests include glucose and insulin levels, arterial stiffness, heart function using echocardiography, blood vessel dilation, and hormone levels. During the study, women will undergo detailed measurements at baseline, during the oral glucose tolerance test at multiple time points, and after six months of treatment. These assessments include blood tests, heart ultrasound scans, and blood vessel function tests. Researchers will track changes in heart strain, arterial stiffness, and blood vessel lining thickness as primary outcomes. Secondary outcomes include changes in coronary flow and blood vessel dilation. The study will last over a year with follow-up assessments at six and twelve months.

Researchers are studying acute coronary syndrome (ACS), a condition caused by reduced blood flow to the heart, leading to heart tissue damage. This research focuses on understanding how stress and inflammation responses, shown by increased cortisol and C-reactive protein (CRP) levels, relate to changes in immune cells in the blood. The study aims to see how these factors predict clinical outcomes during hospital stays and after discharge in ACS patients. This is a prospective, observational study involving patients admitted with ACS to a coronary care unit over two years. Blood samples will be collected at admission to measure cortisol and CRP levels, along with counts of immune cells like leukocytes, neutrophils, lymphocytes, and eosinophils. Patients will receive usual medical care, and their clinical progress will be monitored through laboratory markers and medical records. After hospital discharge, participants will be followed up by telephone for six months. Participants will undergo baseline physical exams and electrocardiograms at admission, with regular blood tests to track heart damage markers and immune cell counts. Researchers will analyze these data to find links between immune responses, stress, inflammation, and patient outcomes. The primary outcome is cardiovascular death within one year, with secondary outcomes including heart attacks, strokes, revascularization procedures, and hospitalizations for unstable angina. The total study period includes two years of enrollment and six months of follow-up for each patient.

Researchers are following participants with Cushing's syndrome to collect data during their routine care and to create a registry for studying long-term outcomes. This observational study focuses on patients aged 14 and older with active or treated overt Cushing's syndrome, mild adrenal Cushing's syndrome (MACS), or silent corticotroph tumors. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to gather information up to 10 years after various treatments. Participants undergo data collection before and over time after receiving surgical, medication, and/or radiation therapies. Various questionnaires are used to assess quality of life, general health, anxiety, depression, stress, impulsivity, food cravings, and related symptoms. These tools include the Cushing's QoL, Nottingham Health Profile, Hospital Anxiety and Depression Scale, Perceived Stress Scale, Barratt's Impulsivity Scale, Beck Depression Inventory, State-Trait Anxiety Inventory, Food Craving Questionnaires, Visual Analogue Scale, and the STRAP-R food variant. During the study, participants will complete these questionnaires and provide ongoing data related to their condition and treatments. Researchers monitor outcomes up to 10 years following treatment, focusing on changes in health, quality of life, and psychological symptoms. This long-term observation helps improve understanding of Cushing's syndrome outcomes under regular medical care.

Researchers are studying patients with Cushing's syndrome to understand how the condition affects physical function, quality of life, and circadian rhythms both before and after treatment. The study aims to evaluate the negative impacts of Cushing's syndrome on health-related quality of life and physical abilities, as well as how the condition alters circadian rhythms in the body and peripheral tissues. The research also explores how some of these complications may improve after the disease is controlled. This observational study does not involve any interventions or treatments assigned by the researchers. Instead, it follows patients diagnosed with endogenous Cushing's syndrome, including both ACTH-dependent and ACTH-independent types, over time to monitor changes related to their condition and treatment. Assessments occur at baseline, then again at 3 months and 1 year after treatment to observe changes in various health measures. Participants will undergo evaluations including quality of life questionnaires, blood pressure checks, tests of arterial stiffness and endothelial function, insulin resistance, body composition, bone density, physical performance tests, and sleep and activity monitoring. Researchers will also analyze gene expression in blood and tissue samples and measure hormone and metabolite levels in urine. Safety and mental health are assessed with standardized scales. The total follow-up period for each participant is approximately one year after treatment initiation.