Clinical trials: Informed Consent
VR-based Informed Consent, Cataract and Intraocular Lens Surgery
VR for Cataract Anxiety Lowering Management
Cataract is currently the leading cause of blindness globally, and surgery is the only effective treatment. With the advancement of medical technology, cataract surgery is usually performed under topical anesthesia, which means…
- Trial name
- VR-CALM (NCT07586280)
- Testing
- Virtual reality simulation of intraoperative audiovisual experience
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Basal Cell Carcinoma
Video-Based Treatment Options for Basal Cell Carcinoma
The purpose of this study is to determine if presenting treatment options to basal cell carcinoma patients in video format will improve efficiency and allow patients to receive consistent, comprehensive, visually-depicted…
- Trial name
- NCT02158650
- Testing
- Video-Based Informed Consent
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Emory University
Coronary Artery Perforation
Investigation of the Ringer Perfusion Balloon Catheter
The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion under the conditions of…
- Trial name
- NCT04849169
- Testing
- Experimental
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vascular Solutions LLC
Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery
Communicating Risks: Consent for Lumbar Puncture
The goal of this randomized control trial is to compare the effect of visual aids on the recall of probabilistic risks in healthy participants.
- Trial name
- NCT05717465
- Testing
- Anatomy diagrams, Standard informed consent
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University College London Hospitals
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
Cleft Palate, Jaw Abnormalities
Improving Informed Consent for Cleft Palate Repair
To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has…
- Conditions
- Cleft Palate, Jaw Abnormalities, Maxillofacial Abnormalities, Mouth Abnormalities
- Trial name
- NCT02595307
- Testing
- Pamphlet
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- IWK Health Centre
Improve the Informed Consent Process
Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.
- Trial name
- NCT02081248
- Testing
- Consent Form Specific Format 1, Consent Form Specific Format 2
- Where
- 23 sites in United States
- Volunteers
- 198 people
- Sponsor
- Medical College of Wisconsin
Shared Decision Making, Cesarean Section
Shared Decision-Making During Anesthesia Consent for Elective Cesarean Delivery
Shared decision-making (SDM) is the accepted ethical and legal standard for informed consent, but it is not known how it operates in anesthesia consent for cesarean delivery.
- Conditions
- Shared Decision Making, Cesarean Section, Anesthesia, Obstetrical, Informed Consent
- Trial name
- SDM-Consent (NCT07858084)
- Testing
- Observation of anesthesia consent encounter and postpartum questionnaire
- Where
- Canada
- Volunteers
- 105 people
- Sponsor
- University of British Columbia
Stroke
Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC
This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a telemedicine system for performing research in a remote hospital system.
- Trial name
- NCT00390286
- Where
- United States
- Sponsor
- University of California, San Diego
Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred, Parturient Who Develop a Postdural Puncture Headache
Chronic Headache and Chronic Backache Following Unintentional Dural Puncture at Delivery Room.
he study is a telephone questionnaire. The study will include 400 women, 100 in each group. OBJECTIVE: To investigate the prevalence of chronic and chronic back pain following PDPH accidental dural puncture during epidyral…
- Conditions
- Parturient Who Underwent Epidural Anesthesia During Which an Unintentional Dural Punctur Occurred, Parturient Who Develop a Postdural Puncture Headache, Parturient Who Gave Informed Consent to Participation in the Study
- Trial name
- NCT03908424
- Testing
- Epidural Blood patch.
- Where
- Israel
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
Aneuploidy, Genetic Counseling
GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients
The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing.
- Conditions
- Aneuploidy, Genetic Counseling, Informed Consent, Decisional Conflict
- Trial name
- GEM (NCT06771453)
- Testing
- Video Educational Tool Regarding Prenatal Genetics
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Hysterectomy, Informed Consent
Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
To determine whether the addition of audio-visual presentations to standard physician interaction improves patient comprehension as it relates to the information provided during the informed consent process in patients undergoing…
- Trial name
- NCT01933139
- Testing
- Audio-visual presentation
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Brooke Army Medical Center
Preoperative Anxiety, Anesthesia
QR Code-Based Video-Supported Anesthesia Information and Preoperative Anxiety
This study aims to evaluate the effects of QR code-based video-supported anesthesia information on preoperative anxiety, comprehensibility of information, and patient satisfaction in adult patients undergoing elective surgery.
- Conditions
- Preoperative Anxiety, Anesthesia, Informed Consent, Patient Education
- Trial name
- QR-AID (NCT07647588)
- Testing
- QR Code-Based Video-Supported Anesthesia Information
- Where
- Turkey (Türkiye)
- Volunteers
- 284 people
- Sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
HIV Infected Individuals, Informed Consent
Analysis of the Persistence, Reservoir and HIV Latency
The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored.
- Trial name
- APRIL (NCT05752318)
- Volunteers
- 500 people
- Sponsor
- University Hospital, Strasbourg, France
Attitude to Computers, Attitude of Health Personnel
An Interactive Patient-Centered Consent for Research Using Medical Records
The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data.
- Conditions
- Attitude to Computers, Attitude of Health Personnel, Researcher-Subject Relations, Trust
- Trial name
- NCT03063268
- Testing
- Trust-Enhanced Messaging on E-Consent, Interactive features on E-Consent, Standard E-Consent
- Where
- United States
- Volunteers
- 734 people, healthy volunteers welcome
- Sponsor
- University of Florida
Consent Form
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial.
- Trial name
- NCT07122960
- Testing
- Visual ICF, Text-only ICF
- Where
- South Africa
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Columbia University
Upper Extremity Problem
Interactive Informed Consent and Decision Conflict
Informed consent for surgery can address the legal aspects while also being simple, informative, and empathic. It can help people confirm that the potential harms are acceptable in light of the potential benefits.
- Trial name
- NCT05980078
- Testing
- Interactive consent, Standard consent
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- University of Texas at Austin
HIV Infections
Consent for Use of Stored Patient Specimens for Future Testing
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.
- Trial name
- NCT00031408
- Where
- 63 sites in United States, Puerto Rico
- Volunteers
- 17,444 people, healthy volunteers welcome
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Colorectal Cancer, Shared Decision Making
Preoperative 3D Models and Shared Decision-making
The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.
- Conditions
- Colorectal Cancer, Shared Decision Making, Anxiety, Informed Consent
- Trial name
- NCT06625008
- Testing
- 3D-printed model
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Vanderbilt University Medical Center
Recurrent Diffuse Pontine Gliomas
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG)…
- Trial name
- NCT00600054
- Testing
- nimotuzumab (anti EGFR humanized monoclonal antibody)
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 44 people
- Sponsor
- YM BioSciences