Clinical trials: Consent, open to volunteers
ADHD
Testing a New Method to Improve Informed Consent in Prison Research
Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures.
- Trial name
- Spark BATIR (NCT06378281)
- Testing
- Modified teach-to-goal informed consent
- Where
- 2 sites in Switzerland
- Volunteers
- 100 people
- Sponsor
- Stéphanie Baggio
Pancreas Cancer
SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent
Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed…
- Trial name
- SURGIMEDIA (NCT07494994)
- Testing
- Standard Informed Consent, Multimedia Video - Based Informed Consent
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Anaesthesia Complication
Patients Gender Influence on Communication of Anaesthesia Risk
In Anaesthesia Practice, an Informed consent involves discussing the risks and benefits involved with a certain procedure and its alternatives.
- Trial name
- NCT06814236
- Testing
- Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Sir Ganga Ram Hospital
Labour Pain
Spoken Animation for Labour Epidural
The purpose of this study is to evaluate a new animated information film as a tool for introducing the concept of epidural as a method of labour pain relief to expectant women.
- Trial name
- SALE (NCT07202221)
- Testing
- Participant views Epidural animation before reading gold standard written information, Participant receives current gold standard written information alone
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
Cardiac Arrest, Pulseless Electrical Activity
Surviving PEA in Roanoke (SPEAR) Study
The Carilion Clinic and Virginia Tech Carilion School of Medicine, in conjunction with Roanoke Fire-EMS, Botetourt County Department of Fire \& EMS and Salem Fire-EMS, are studying the outcomes of patients experiencing Pulseless…
- Trial name
- SPEAR (NCT05283850)
- Testing
- High Calcium, Low Sodium (HCLS) Crystalloid Therapy, High Calcium, High Sodium (HCHS) Crystalloid Therapy
- Where
- United States
- Volunteers
- 342 people
- Sponsor
- Carol Bernier
Diabetes
Achieving Chronic Care equiTy by leVeraging the Telehealth Ecosystem
This study examines the impact of a multi-level intervention aiming to improve telehealth access for low-income patients managing chronic health conditions, such as hypertension and diabetes.
- Trial name
- ACCTiVATE (NCT06598436)
- Testing
- Digital Health Coaching (Patient-Level Intervention), Practice Facilitation (Clinic-Level Intervention)
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- University of California, San Francisco
Urolithiasis, Kidney Calculi
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Before kidney stone surgery with a flexible or semirigid ureteroscope, patients must read and sign a written consent form, but many patients find these forms long and hard to understand.
- Conditions
- Urolithiasis, Kidney Calculi, Ureteral Calculi, Informed Consent
- Trial name
- AUDIO-CONSENT (NCT07859436)
- Testing
- Standard written informed consent, Human-voice audio consent recording, AI-cloned-voice audio consent recording
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 240 people
- Sponsor
- Aydin Adnan Menderes University
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Undescended Testis, Anxiety State
The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.
- Trial name
- NCT06698081
- Testing
- Video Multimedia
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Marmara University
Premalignant Conditions, Malignant Lesions
To Evaluate the Best Metric for Inspection Time During a Diagnostic and/or Surveillance Upper Gastrointestinal Endoscopy (Age ≥ 18 Years, Informed Consent), Between Total Inspection Time Versus Withdrawal Time, for the Identification of Malignant Lesions
Gastric cancer is the fifth cause of cancer-related mortality worldwide. Gastric carcinogenesis involves the progression from premalignant conditions such as atrophic gastritis and intestinal metaplasia to premalignant lesions…
- Conditions
- Premalignant Conditions, Malignant Lesions, Gastric, Esophageal
- Trial name
- NCT06696209
- Testing
- Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy, Analysis of the total time of the Upper Gastrointestinal Endoscopy, Upper gastrointestinal endoscopy: Common Practices
- Where
- Portugal
- Volunteers
- 1,290 people, healthy volunteers welcome
- Sponsor
- Portuguese Oncology Institute, Coimbra
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Procedural Sedation and Analgesia
Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
The goal of this observational study is to learn whether a participant's understanding of the informed consent information is related to the amount of propofol needed during endobronchial ultrasound (EBUS).
- Conditions
- ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Procedural Sedation and Analgesia, Informed Consent
- Trial name
- NCT07677982
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Uludag University
Rare Disorders
Implementing Dynamic Consent for Rare Disease Patients
The study aims to test on a cohort of rare patients a digital innovative tool to support patients/parents in the informed consent and assent process and to keep up-to-date a lawful informed and dynamic consent and to use samples…
- Trial name
- ConsDinamico (NCT06656247)
- Testing
- Online consenting
- Volunteers
- 50 people
- Sponsor
- Istituto Ortopedico Rizzoli
Skeletal Deformities, Orthognathic Surgical Procedures
Impact of 3D-Printed Anatomical Model on Patient Understanding in Orthognathic Surgery
The goal of this clinical trial is to learn whether using three dimensional (3D)-printed anatomical models improves the informed consent process for participants undergoing orthognathic surgery.
- Conditions
- Skeletal Deformities, Orthognathic Surgical Procedures, Anxiety, Patient Education
- Trial name
- NCT07068412
- Testing
- 3D-printed Orthognathic Surgical Simulation, 2D Visual Representations of Skeletal Movements in Orthognathic Surgery
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 60 people
- Sponsor
- King Abdulaziz University
Breast Cancer, Complication of Surgical Procedure
Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this…
- Trial name
- PRC (NCT06351865)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Portsmouth Hospitals NHS Trust
Anesthesia, Surgical Patients
Effect of Visual Aids Added to Informed Consent on Patient Understanding and Anesthesia Awareness
This prospective cluster-randomized controlled study aims to evaluate whether visual support material provided in addition to the standard written informed consent form improves patients' comprehension of informed consent and…
- Trial name
- NCT07461480
- Testing
- Standard Informed Consent, Visual Support Supplemented Informed Consent
- Volunteers
- 236 people
- Sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
Objective: To evaluate the effects of the postbiotic preparation JK-5G on gastrointestinal function recovery (GI-2 time), gastrointestinal dysfunction, nutritional status, and safety in patients after surgery for malignant bowel…
- Conditions
- Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief, Hemodynamically Stable Within 24h Post-op, Per Investigator, Informed Consent Obtained Before Surgery or Randomization
- Trial name
- NCT07850089
- Testing
- High-Concentration Compound Lactic Acid Bacteria Metabolite JK-5G
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Informed Consent, Patient Education
Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy
This study will evaluate whether a digital-supported informed consent process improves patient understanding before advanced therapeutic endoscopy procedures.
- Conditions
- Informed Consent, Patient Education, Patient Comprehension, Therapeutic Endoscopy
- Trial name
- DIGI-CONSENT (NCT07723105)
- Testing
- Digital-Supported Informed Consent Pathway, Standard Physician-Led Informed Consent
- Where
- Canada
- Volunteers
- 180 people
- Sponsor
- Unity Health Toronto
VR-based Informed Consent
Virtual Reality for Patient Informed Consent in Neurosurgery
The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.
- Trial name
- NCT06627426
- Testing
- VR-based patient informed consent
- Where
- Switzerland
- Volunteers
- 34 people
- Sponsor
- University Hospital, Basel, Switzerland
Communication, Surgery
Redesigning Surgical Care for Patients in Wisconsin
This study evaluates strategies to train surgeons to use Better Conversations, an evidence-based communication framework designed to improve informed consent by helping patients understand the goals of surgery, the downsides of…
- Conditions
- Communication, Surgery, Shared Decision Making
- Trial name
- NCT07475104
- Testing
- Education Specialist Delivered Training, Automated Training
- Where
- 2 sites in United States
- Volunteers
- 660 people
- Sponsor
- University of Wisconsin, Madison
Surgeons, Surgical Procedure, Unspecified
Improving Surgical Communication for Patients in Wisconsin
The purpose of this study is to evaluate a new training program to support communication between surgeons and their patients. The goal of the training program is to help patients get the information they need to make treatment…
- Trial name
- NCT06647303
- Testing
- Training on communication framework, Focus Group, Surveys
- Where
- United States
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison