Clinical trials: BIS, open to volunteers
Dilated Cardiomyopathy (DCM)
A Phase 1 AAV Gene Therapy Trial Evaluating Safety and Preliminary Efficacy of RP-A701 in Subjects With BAG3 Dilated Cardiomyopathy
This is a Phase 1, open-label, dose-escalation trial to characterize the safety, tolerability, and preliminary efficacy of RP-A701 following a single IV administration in high-risk adult patients with BAG3-DCM.
- Trial name
- NCT07137338
- Testing
- RP-A701 is a recombinant viral vector composed of an AAV serotype rh.74 (AAVrh.74) capsid encapsulating the transgene, BCL2-associated Athanogene 3 (BAG3)
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Short Bowel Syndrome
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
- Trial name
- EASE SBS 5 (NCT07197944)
- Testing
- Glepaglutide
- Where
- 33 sites in United States, Austria and 12 more
- Volunteers
- 90 people
- Sponsor
- Zealand Pharma
Depression - Major Depressive Disorder, Cognitive Behavior Therapy
Mechanisms Of Change in Psychotherapy: The Effects of Cognitive Behavioral Therapy and Psychodynamic Therapy in Once - Versus Twice - Weekly Sessions on Outcomes in Depression.
The MOP II study examines how to improve therapy for people struggling with a depressive disorder. Cognitive Behavioral Therapy (CBT) and Short-Term Psychodynamic Psychotherapy (STPP) are two evidence-based treatments for…
- Conditions
- Depression - Major Depressive Disorder, Cognitive Behavior Therapy, Psychodynamic Therapy
- Trial name
- MOP II (NCT07408687)
- Testing
- Cognitive behavior therapy, Psychodynamic therapy
- Where
- Norway
- Volunteers
- 200 people
- Sponsor
- University of Oslo
Stroke, Spinal Cord Injuries (SCI)
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training.
- Conditions
- Stroke, Spinal Cord Injuries (SCI), Chronic Disease
- Trial name
- INTeRAcT-bis (NCT07912320)
- Testing
- Intensive rehabilitation programme
- Where
- 2 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- KU Leuven
Dilated Cardiomyopathy (DCM), Cardiovascular Diseases
BAG3-DCM Natural History Study
The goal of this international observational study is to learn about the natural history of Dilated Cardiomyopathy (DCM) arising from pathogenic BAG3 variants in adult patients ≥18 years of age.
- Conditions
- Dilated Cardiomyopathy (DCM), Cardiovascular Diseases, Heart Diseases, Genetic Diseases
- Trial name
- NCT07486752
- Volunteers
- 30 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD).
- Conditions
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload
- Trial name
- EU-PHASE-HD (NCT07676786)
- Testing
- Observational Assessment
- Where
- 2 sites in Romania
- Volunteers
- 30 people
- Sponsor
- Stefan Lujinschi
Lymphoedema
Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)
Lymphoedema, a chronic condition caused by the accumulation of protein-rich fluid in the intercellular spaces due to impaired lymphatic function, is a common complication in cancer patients.
- Trial name
- ONCOLYMPH (NCT07011316)
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- The Greater Poland Cancer Centre
Critically Ill Patients
BIS in Critically Ill Patients in ICU
The Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced…
- Trial name
- NCT07583732
- Testing
- Processed EEG monitoring
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University
Age Problem, Dialysis; Complications
Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
As Korea is becoming a super-aged society, the number of elderly patients with end-stage kidney disease (ESKD) is expected to increase rapidly. Therefore, the burden on Korean society will also increase.
- Conditions
- Age Problem, Dialysis; Complications, Frailty, Quality of Life
- Trial name
- NCT06141798
- Testing
- Hemodialysis
- Where
- 7 sites in South Korea
- Volunteers
- 428 people
- Sponsor
- Soonchunhyang University Hospital
Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG).
- Conditions
- Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
- Trial name
- IBIS (NCT07585643)
- Testing
- Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.
- Where
- 2 sites in Australia, Brazil
- Volunteers
- 40 people
- Sponsor
- Telethon Kids Institute
Extubation Success, Extubation Failure
Combined RSBI, TOF, and BIS for Prediction of Extubation Success
This prospective observational study aims to evaluate the predictive value of the combined use of the rapid shallow breathing index, train-of-four ratio, and bispectral index for extubation success after general anesthesia.
- Conditions
- Extubation Success, Extubation Failure, Postoperative Respiratory Complications
- Trial name
- NCT07577453
- Testing
- Combined pre-extubation assessment using RSBI, TOF ratio, and BIS
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Gaziantep City Hospital
Anesthesia , Analgesia, Breast Surgery
Intraoperative Music and Propofol Consumption in Breast Surgery
The goal of this study is to find out whether listening to music during surgery can reduce the amount of propofol, an anesthesia medicine, needed in patients having elective breast surgery.
- Trial name
- NCT07687095
- Testing
- Intraoperative Music
- Where
- Turkey (Türkiye)
- Volunteers
- 74 people
- Sponsor
- Uludag University
Acute Myeloid Leukemia
Twice-per-weekSelinexor, 2 Days Melphalan
Twice-per-week Selinexor, 2 days Melphalan plus BU2FLU3 compared with BU3FLU5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial
- Trial name
- NCT06613035
- Testing
- Selinexor, Melphalan, Intravenous Busulfan
- Where
- 4 sites in China
- Volunteers
- 126 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Dilated Cardiomyopathy
Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults
This is a multicentre, prospective cohort study designed to elucidate the natural history of dilated cardiomyopathy (DCM) associated with specific gene mutations in Chinese patients.
- Trial name
- NCT07646600
- Testing
- Observational, None intervention
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
This is a Phase 1/2, open-label, dose-exploration and dose-expansion, clinical trial evaluating the safety, tolerability, pharmacodynamics, and preliminary efficacy of a single intravenous infusion of AFTX-201 in adults with…
- Trial name
- UPBEAT (NCT07426419)
- Testing
- AFTX-201
- Where
- 5 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Affinia Therapeutics
Cardiac Surgical Procedures (Postoperative Population), Critical Illness
BIS in ICU Interventional Study
This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery.
- Conditions
- Cardiac Surgical Procedures (Postoperative Population), Critical Illness, Postoperative Complications (Cardiopulmonary), Delirium - Postoperative
- Trial name
- NCT07350122
- Testing
- Device-guided sedation, standard sedation practice
- Volunteers
- 144 people
- Sponsor
- Medical University of Graz
Chronic Kidney Disease Associated Pruritus, End Stage Renal Disease on Dialysis
Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.
- Trial name
- NCT07769073
- Testing
- Nalfurafine Hydrochloride, plasebo
- Volunteers
- 36 people
- Sponsor
- Universitas Indonesia
Kidney Failure, Chronic, Quality of Life
Twice vs Thrice Weekly Hemodialysis: Clinical Outcomes and Quality of Life
This prospective cohort study aims to compare clinical outcomes and health-related quality of life between adults receiving established twice-weekly versus thrice-weekly maintenance hemodialysis at Assiut University Hospitals.
- Trial name
- NCT07821788
- Volunteers
- 130 people
- Sponsor
- Assiut University
Intensive Care Unit Sedation, Sedation
A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients
This prospective observational study aims to compare the clinical performance of two target-controlled infusion (TCI) models, Eleveld and Schnider, for propofol sedation in mechanically ventilated intensive care unit (ICU)…
- Conditions
- Intensive Care Unit Sedation, Sedation, Target Controlled Infusion of Propofol
- Trial name
- NCT07239687
- Testing
- propofol, TCI Propofol Injection
- Where
- Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Hacettepe University
General Anesthesia With Propofol, Closed-Loop
Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine
The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing.
- Trial name
- NCT06729892
- Testing
- Esketamine at low dose, new BIS baseline, an equivalent dose of saline
- Volunteers
- 120 people
- Sponsor
- bo xu