Adrenal Insufficiency

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

Researchers are studying patients with endogenous Cushing syndrome to understand how often adrenal insufficiency occurs when treated with osilodrostat combined with glucocorticoid replacement. The study also examines new steroid biomarkers to monitor osilodrostat dosing, and assesses treatment durability, safety, and clinical improvement. This observational study aims to provide important insights into managing this condition with a block-and-replace approach. The study has two phases. In Phase 1 (Titration), participants start with a low dose of osilodrostat and add methylprednisolone replacement. Doses are adjusted to reach specific cortisol level goals, with frequent monitoring and communication. Once these goals are met, participants enter Phase 2 (Maintenance), where they continue treatment for 48 weeks with periodic cortisol tests to track treatment effects. Participants will regularly provide blood and saliva samples for cortisol and steroid profiling, and report symptoms related to adrenal insufficiency. Researchers will track clinical measures such as blood pressure, weight, and quality of life over about 48 weeks. The main outcome is the percentage of participants experiencing adrenal insufficiency during Phase 1, along with various secondary health and hormone measures throughout the study.

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.

Glucocorticoids are hormones that help control inflammation and regulate the immune system. In children with blood cancers like acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), these hormones are given as medications to quickly reduce cancer cells. However, this treatment can suppress the body's natural glucocorticoid production, leading to a deficiency that increases infection risks and is hard to detect due to overlapping chemotherapy side effects. This study aims to understand how often and for how long this deficiency occurs in children with these cancers and to identify those at higher risk. The study observes children diagnosed with ALL or LBL who are treated with glucocorticoids for at least 21 consecutive days. Regular low-dose ACTH tests will be performed during and after treatment to assess the body's natural glucocorticoid production. These tests are done only when children already have venous access and are hospitalized for treatment, minimizing extra burden. The study follows participants from enrollment until three months after their last glucocorticoid dose. Participants will be monitored through these ACTH tests to detect adrenal insufficiency and its duration. The main outcome measured is the occurrence of adrenal insufficiency, with a secondary focus on how long it lasts. The study involves children up to 18 years old and takes place at two children's hospitals. The goal is to improve understanding and management of glucocorticoid deficiency during and after cancer treatment, with careful attention to the safety and comfort of the children involved.

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 compare advanced hemodynamic monitoring with standard monitoring during propofol sedation for ERCP procedures, focusing on whether advanced monitoring better detects hemodynamic events needing intervention. ERCP is used mainly for therapeutic treatment of biliary and pancreatic duct disorders, especially in elderly patients who often face hemodynamic challenges during sedation due to comorbidities. Maintaining adequate organ blood flow and oxygen is crucial, and standard monitoring may miss some important hemodynamic changes. The study has two groups: one group receives standard monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS without arterial cannulation. The other group receives advanced monitoring using the MostCare system via radial arterial cannulation, capturing detailed parameters like cardiac output, stroke volume, systemic vascular resistance, and cardiac power output. Both groups undergo ERCP under propofol sedation, with advanced monitoring aimed at providing more detailed data to guide interventions. Participants will be adults aged 18 or older with certain physical health status undergoing ERCP while breathing on their own. They will be monitored from the start of sedation until the end of the procedure for hemodynamic events requiring clinical intervention. The study will record the number of such events and compare findings between the two monitoring methods. Consent and continuous monitoring ensure participant safety throughout the procedure.

Researchers are investigating tumors affecting the hypothalamic-pituitary unit in children and adults aged 2 to 70 years. The study aims to identify genetic factors involved in the development of these pituitary tumors and related disorders, as well as to develop new clinical studies for their recognition and treatment. It also explores the psychological effects of cortisol secretion in children with Cushing disease and seeks to understand inheritance patterns and associations with other family conditions. Participants undergo procedures including tissue specimen collection and MRI scans to study the molecular genetics of tumors and related developmental pathways. This observational protocol serves as a screening and training platform for medical fellows and students and supports the development of future clinical trials focused on diagnosis and therapy of pituitary tumors. During the study, participants provide peripheral blood and tumor tissue samples for molecular genetic testing. Researchers assess cognitive, psychological, and patient-reported health outcomes related to hypercortisolemia and adrenal insufficiency. The study also monitors clinical and genetic features of pituitary tumors and collects data on mental and social well-being. Participation involves ongoing assessments and follow-up to support future research and clinical care improvements.

Researchers are investigating the risk of low blood pressure (hypotension) after anesthesia induction in high-risk patients with serious health conditions, classified as American Society of Anesthesiologists (ASA) physical status 3 or 4. This study compares a new method called target-controlled infusion (TCI) of propofol to the standard manual anesthesia induction. Previous research showed TCI may cause less hypotension in general patients, and this trial continues that work focusing on patients at higher risk. The study involves two groups of patients undergoing major elective surgery. One group receives manual anesthesia induction where propofol is given at a fixed dose based on weight over 1-2 minutes, aiming for a hypnosis level measured by bispectral index (BIS) of 35-60. The other group receives TCI induction where the propofol concentration is computer-controlled and adjusted to maintain a hypnosis level measured by BIS of 35-55. Both groups are monitored using a pressure recording analytical method (PRAM) device to track heart and blood vessel function during and after anesthesia induction. Participants will be monitored closely from one minute before induction to ten minutes after to measure blood pressure and heart function parameters including systolic, diastolic, and mean arterial pressures. Additional heart and circulation data such as arterial elastance, stroke volume variation, and cardiac output are recorded to predict and understand hypotension. This detailed monitoring aims to compare the effects of TCI and manual induction on blood pressure stability in these high-risk patients during anesthesia.

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.