Orthostatic Hypotension

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 evaluating a new imaging agent called 18FACI-15916 to safely and reliably measure the buildup of a protein called alpha-synuclein in the brain. This protein is involved in conditions like Parkinsons disease, Lewy body dementia, and Multiple System Atrophy, collectively known as alpha-synucleinopathies. The study includes both healthy volunteers and people with suspected alpha-synuclein-related diseases to compare protein levels and assess safety and detection accuracy. The study is an open-label, early-phase PET microdose trial involving up to 46 participants divided into four parts. Participants will receive an intravenous injection of 18FACI-15916 followed by a PET scan to detect alpha-synuclein deposits. Some will have a second PET scan to test measurement reliability, while others will undergo a whole-body PET-CT scan to estimate radiation dosage. The study includes a screening phase, scanning visits, optional spinal fluid collection, and follow-up safety calls. Participants will visit the clinic for consent, eligibility assessments including physical exams, neurological exams, questionnaires, blood and urine tests, ECG, and in some cases MRI and PET scans with a licensed tracer. During the PET scan, blood samples will be collected, and some may provide spinal fluid. Safety is monitored through follow-up phone calls. The total study duration ranges from 10 to 14 weeks depending on the part of the study the participant is in. Researchers will measure brain uptake of the tracer, adverse events, vital signs, and the reproducibility of PET scan results.

Alpha-synucleinopathies are age-related neurodegenerative disorders characterized by the build-up of alpha-synuclein in nerve cells, leading to conditions like Parkinsons disease, Multiple System Atrophy, and Dementia with Lewy Bodies. Pure Autonomic Failure is a related condition affecting the peripheral autonomic nervous system and may signal risk for developing central nervous system synucleinopathies. Researchers aim to identify biomarkers, especially changes in dopamine production in key brain areas, to predict progression from peripheral to central disease. Participants receive a radiolabeled drug called 18FF-DOPA, which is used in PET scans to study dopamine activity in the brain. Before the PET scan, patients take oral doses of carbidopa and entacapone to enhance imaging quality by reducing peripheral metabolism of 18FF-DOPA. The PET scan involves a slow injection of 18FF-DOPA followed by about 95 minutes of serial brain imaging to observe dopamine-related changes. During the study, participants undergo clinical exams to confirm diagnosis and receive the PET imaging procedure. Researchers measure differences in 18FF-DOPA uptake across patient groups 95 minutes after imaging starts to assess dopamine function. The study includes patients with autonomic failure, possible synucleinopathies, and healthy adults aged 18 and older. The study is designed to monitor safety and gather detailed imaging data over the scan period.

About 20% of adults experience recurrent fainting, leading to significant symptoms, difficulties with work and driving, injuries, and reduced quality of life. Because few treatments have been proven effective in randomized trials, researchers are conducting a phase 2, randomized, double-blind study to test if blocking serotonin 5HT3 receptors with ondansetron can prevent fainting or near fainting caused by tilt-induced vasovagal syncope VVS. This study aims to provide preliminary data for future larger trials. Participants will be randomly assigned to receive either two doses of ondansetron 8 mg by mouth one the evening before and one the morning of the study or matching placebo doses on separate days. After dosing, participants undergo a tilt table test where their heart rhythm, blood pressure, and blood samples will be monitored continuously for up to 60 minutes or until fainting occurs. Additional measurements include bioelectrical impedance to assess fluid shifts in the body during posture changes and questionnaires to evaluate quality of life, anxiety, and depression. During the study, participants will have ECG electrodes and a blood pressure cuff applied, along with an intravenous line for blood sampling. Blood samples will be collected at baseline and during the tilt test to measure catecholamine levels. Participants will also complete online surveys assessing health-related quality of life and mood symptoms. The main outcome is the time until fainting or near fainting within one hour. Secondary outcomes include stroke volume, cardiac output, vascular resistance, and psychological measures monitored during the study and within 12 months. The study lasts about one day for the tilt test and includes follow-up assessments up to one year.

Researchers are evaluating the effects of CST-3056 on symptoms and signs of neurogenic orthostatic hypotension nOH, a condition that causes a significant drop in blood pressure upon standing. This Phase 2 study focuses on people diagnosed with symptomatic orthostatic hypotension due to Parkinsons disease or pure autonomic failure. The study aims to better understand how CST-3056 impacts standing blood pressure and orthostatic symptoms in these subjects. Participants will receive single oral doses of CST-3056 once daily for five days, including an optimal dose day determined from earlier doses based on standing blood pressure and tolerability. The study also includes a placebo group receiving a single dose on one day. Subjects must discontinue other treatments using alpha-1 adrenergic receptor agonists for at least one day before key assessments and dosing. The dosing is conducted in a single-blind, sequential manner. During the study, participants will be closely monitored for changes in standing and seated blood pressure, orthostatic symptom severity using the Orthostatic Hypotension Symptom Assessment OHSA, and responses to head-up tilt table testing. Follow-up occurs 3 to 7 days after discharge via telephone to review health status and report any adverse events. The total study duration per participant includes screening, treatment over five days, and a safety follow-up call after discharge.

Researchers are studying SST001, a PET tracer labeled with 18F, which is designed to detect alpha-synuclein pathology seen in Parkinsons Disease PD and Multiple System Atrophy MSA. This phase I, non-randomized, open-label study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers as well as patients with PD and MSA. Participants in this study will receive an administration of SST001 followed by PET imaging to track its distribution and behavior in the body. The study involves a single group design without placebo or comparison arms. The focus is on collecting data on how the tracer distributes in the body, its radiation dose, and how the body processes it. Participants will be monitored for adverse events for 5 days after receiving SST001. Additionally, measurements such as whole body effective radiation dose and standardized uptake value ratio SUVR at about 80 minutes post injection will be assessed. The study includes healthy adults and patients aged 40 years or older, with monitoring of safety, imaging, and pharmacokinetic data throughout the study period.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Researchers are evaluating an investigational artificial intelligence AI software designed to estimate the severity of ejection fraction EF, which indicates how well the heart pumps blood. This prospective, multicenter, cluster-randomized controlled study compares EF severity categories determined by the AI software using continuous ECG waveform data to those measured by an FDA-cleared transthoracic echocardiogram TTE. The study aims to provide a low-burden, cost-effective alternative for EF monitoring in heart failure and related heart conditions, especially where traditional imaging access is limited. Participants will use the FDA-cleared Peerbridge COR4 ECG Wearable Monitor, a patch device worn during daily activities, to collect ECG data. During a 15-minute resting session while seated upright, 5-minute ECG segments will be recorded and analyzed by the AI software to estimate EF severity based on the American Society of Echocardiographys scale. The study includes two subprotocols one with 30 minutes of ECG recording including 15 minutes analyzed, and another allowing up to 7 days of device use with periodic sitting sessions. The EF severity from the AI software will be compared against results from echocardiography. Participants will be enrolled at multiple sites, providing paired data points consisting of simultaneous or near-simultaneous ECG recordings and echocardiograms. They will follow a standardized 15-minute seated session protocol using the wearable device, pressing an event button to mark the session start and end. Data collection includes medical histories, 12-lead ECGs, and device logs. The main outcome measures focus on agreement between the AI softwares EF severity categories and those from echocardiography over an average of 9 months. Safety and compliance will be monitored throughout the study period.

Researchers are evaluating a new method that combines an innovative motor test with perception technology and artificial intelligence to improve the diagnosis of Parkinsons disease and other similar conditions. This study aims to find clear diagnostic cut-off values, explore digital markers for early and different diagnosis, and create a diagnostic model using this combined approach alongside traditional motor tests and the acute levodopa challenge test. Participants include groups with confirmed or probable Parkinsons disease, multiple system atrophy, progressive supranuclear palsy, vascular parkinsonism, drug-induced parkinsonism, corticobasal degeneration, and dementia with Lewy bodies. The study involves recording patients motor symptoms on video and assessing them with these advanced technologies and tests to better understand diagnostic accuracy. During the study, participants will undergo examinations including the acute levodopa challenge test and video recordings of their motor symptoms. Researchers will measure outcomes such as accuracy, sensitivity, specificity, predictive values, and diagnostic odds ratios to evaluate the method. The study is observational and includes evaluations to identify useful digital biomarkers and establish a reliable diagnostic model, with participants aged 50 to 75 years involved throughout the study period.

Researchers are evaluating the use of intravenous hyperoncotic albumin compared to normal saline boluses in critically ill patients suffering from Acute Kidney Injury requiring renal replacement therapy AKI-RRT. This trial aims to determine whether albumin administration during renal replacement therapy sessions increases organ support-free days and renal replacement therapy-free days within 28 days after randomization. The study addresses the challenge that renal replacement therapy, while life-saving, may cause complications like hypotension and organ ischemia in these patients. Participants will be randomly assigned to receive either 20-25% albumin fluid or normal saline boluses during their renal replacement therapy sessions in the intensive care unit. Each treatment involves two 100 mL boluses one at the start and one halfway through each session. The renal replacement therapies include continuous renal replacement therapy CRRT, prolonged intermittent renal replacement therapy PIRRT, or intermittent hemodialysis IHD. Treatments will continue for up to 14 days in the ICU, with dosing schedules tailored to the type of renal replacement therapy. During the study, participants will be closely monitored for organ support-free days, renal replacement therapy-free days, and other health outcomes through 28 days, with extended follow-up for mortality and kidney function up to 365 days. Researchers will collect data on fluid balance, hypotension episodes during therapy, organ function scores, healthcare costs, and quality of life measures. The trial involves multiple intensive care units and includes comprehensive assessments to evaluate the impact and safety of albumin use in this critical condition.