Autonomic Dysfunction

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are evaluating how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. This study aims to assess abdominal massage's impact on bowel movement frequency, gastric residual volume, and abdominal distension. The trial is designed as a prospective, single-blind randomized controlled trial to provide scientific evidence for abdominal massage use in this patient group. Participants are randomly assigned to either an intervention group receiving abdominal massage or a control group receiving standard care without massage. Abdominal massage is performed twice daily for 15 minutes over three days using specific techniques like effleurage, petrissage, and vibration. The massage is given at the bedside in a semi-Fowler position before enteral feeding, with routine nursing care provided to all patients. Throughout the study, researchers monitor bowel movements, gastric residual volume, abdominal distension, and stool consistency using specialized forms and scales twice daily. Data collection includes clinical assessments such as Glasgow Coma Scale and APACHE II scoring. The study lasts three days for each patient, with detailed recording of gastrointestinal function parameters to evaluate the effects of abdominal massage compared to standard care.

Researchers are evaluating the use of [18F]-MFBG PET scans to assess heart nerve activity in people with Parkinson's disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB), and Alzheimer's disease (AD). The study compares this method with the current standard [123I]-MIBG SPECT scans, focusing on distinguishing between PD and MSA as well as DLB and AD. This is a prospective study conducted at two centers, aiming to validate the accuracy and feasibility of [18F]-MFBG PET for these neurological conditions. Participants will undergo several imaging tests including dynamic cardiac [18F]-MFBG PET, [123I]-MIBG SPECT, and cerebral [18F]-PE2I PET scans. Healthy volunteers and patients with confirmed diagnoses will be included, with groups divided by age and disease duration. A dosimetry study will also be conducted for healthy volunteers to measure radiation exposure from [18F]-MFBG. Multiple visits to the hospital are required for scans and assessments. During the study, participants will have thorough neurological assessments, brain MRI scans, and blood sampling alongside PET and SPECT imaging. Researchers will evaluate diagnostic accuracy, effect size of tracer uptake changes, and relationships between heart nerve imaging and brain dopamine transporter changes and autonomic dysfunction. The study includes monitoring for safety and will analyze regional heart uptake patterns. Participants can expect 3 to 4 hospital visits with detailed imaging and clinical evaluations over the study period.

Researchers are evaluating a new imaging agent called [18F]ACI-15916 to safely and reliably measure the buildup of a protein called alpha-synuclein in the brain. This protein is involved in conditions like Parkinson's 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 [18F]ACI-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 Parkinson's 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 [18F]F-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 [18F]F-DOPA. The PET scan involves a slow injection of [18F]F-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 [18F]F-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.

Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.

Researchers are evaluating a fruit and vegetable prescription (F&V Rx) program designed to improve diabetes management among low-income Hispanic adults with type 2 diabetes. The study aims to test how F&V prescriptions affect participation in diabetes self-management education and support (DSME/S), fruit and vegetable intake, diet quality, blood sugar control measured by hemoglobin A1c, and the program's acceptability and sustainability. This pilot randomized controlled trial addresses gaps in understanding the role of F&V prescriptions combined with DSME/S attendance in diabetes care. The study includes three groups: one receiving usual care, one receiving usual care plus four monthly F&V Rx vouchers regardless of DSME/S attendance, and one receiving usual care plus F&V Rx vouchers contingent on monthly DSME/S group attendance over 16 weeks. Participants in the intervention groups receive vouchers to purchase fruits and vegetables at local stores. The trial tests the impact of these approaches on education uptake and retention as well as health and dietary outcomes. Participants will attend study visits at the beginning and end of the 16-week period for assessments including blood samples for A1c and plasma carotenoids, dietary intake surveys, and diabetes self-management questionnaires. Researchers will monitor voucher use, DSME/S attendance, and collect feedback from both participants and care providers to evaluate program implementation. The study is conducted with cultural adaptations and community involvement to support relevance for Hispanic adults with type 2 diabetes.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and potential effectiveness of YA-101 in people with multiple system atrophy (MSA), a rare neurological condition. This Phase 2, double-blind, placebo-controlled, multi-center study aims to compare two doses of YA-101 against a placebo. The study is designed to gather important information on how the drug behaves in the body and its impact on symptoms of MSA. Participants will be randomly assigned to receive either YA-101 or a placebo, both taken twice daily. The study includes a dose escalation approach to assess the effects of different doses. The treatment period lasts up to 112 days, during which safety and response to the drug will be closely monitored. During the trial, participants will have regular assessments including evaluations of adverse events, drug concentration in the blood, and changes in MSA symptoms using scales such as the Unified Multiple System Atrophy Rating Scale and a 10-meter walking test. Safety tests will also be conducted to track any side effects. The total study participation spans from baseline through Day 112, with careful monitoring to understand the drug's effects and tolerability.

This research aims to evaluate the safety, clinical effects, and microglial activation in patients with Multiple System Atrophy (MSA) using Foralumab Nasal. The study is a Phase 2a trial sponsored by Tiziana Life Sciences LTD, focusing on patients aged 30 to 85 years with a diagnosis of clinically established or probable MSA. It measures changes in motor symptoms and brain activity over the course of the study. Participants will first enter a 6-month observational phase without treatment, followed by a 6-month open-label phase where they receive Foralumab Nasal. This drug is an anti-CD3 monoclonal antibody given as a nasal spray. Treatment involves eight 3-week dosing cycles, each with three doses per week for two weeks, followed by a week without dosing. During the study, participants will undergo various assessments including motor function tests, brain scans to measure TSPO activity and brain volume changes, and quality of life questionnaires. Safety and clinical effects will be closely monitored, with the total study duration lasting 12 months. The primary outcomes focus on changes in MDS-UMSARS scores and TSPO activity from screening to month 6.

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.