Clinical trials: Consent
Cancer, Oncology Problem
Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
The purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.
- Trial name
- NCT01772511
- Testing
- Questionnaire
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Andrew Sch umacher
Biopsy
Use of Portable Technology in Patient Education of Shave/Punch Biopsies
The investigators investigated the use of portable MP3 technology in patient education and informed consent of shave and punch biopsies. Eighty patients were divided randomly into a control and experimental group.
- Trial name
- NCT01110148
- Testing
- video-based informed consent for skin biopsies, traditional informed consent
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of California, Davis
Breast Cancer, Ovarian Cancer
Methods in Education for Breast Cancer Genetics
In 1997, the Genetics Department of the NCI Medicine Branch helped establish a breast cancer genetics program at the National Naval Medical Center s Breast Care Center.
- Trial name
- NCT00001806
- Testing
- Genetic Education and Counseling
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- National Cancer Institute (NCI)
Benign Prostatic Hyperplasia
Effectiveness of Smartconsent in Improving Understanding of Informed Consent
The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.
- Trial name
- SMARTCONSENT (NCT04856943)
- Testing
- Smartconsent application, Control group
- Where
- 2 sites in Spain
- Volunteers
- 52 people
- Sponsor
- Bioaraba Health Research Institute
Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy
A Pilot Study of Metabolic Effects of Omentectomy
PROTOCOL SUMMARY Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of…
- Conditions
- Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2, Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy, Age 18-64 Years
- Trial name
- OMT (NCT00565799)
- Testing
- Omentectomy, No intervention
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- NYU Langone Health
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
Pregnancy, Informed Consent
Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean…
- Trial name
- NCT07117708
- Testing
- Early Surgical Consent, Surgical Consent if Clinically Indicated
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Duke University
Outcome Assessments (Health Care), Comprehension
Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent.
- Conditions
- Outcome Assessments (Health Care), Comprehension, Language
- Trial name
- NCT03105752
- Testing
- Questionnaire of understanding
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
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
Cancer
Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists'Communication Styles
The purpose of this study is to examine doctor-patient communication about treatment options which may include an experimental, new treatment for cancer.
- Trial name
- NCT00582192
- Testing
- Consult visit
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Data Sharing
Ethical Challenges of Consent in Data Sharing
In recent years, Mahidol Oxford Tropical Medicine Research Unit (MORU) has coordinated some of the largest international studies involving many sites in low-income and hard-to-reach settings.
- Trial name
- Data Sharing (NCT03346720)
- Testing
- Semi-structured interviews, Focus group discussions (FGDs)
- Where
- 3 sites in Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Endodontic Diseases, Clinical Communication
Generative AI-Based Immersive Training for Endodontic Risk Disclosure and Informed Consent Among Dental Students
The objective of this prospective, parallel-group, 1:1 randomized controlled trial is to evaluate the effectiveness of a generative artificial intelligence (AI)-based immersive training program, utilizing the Gemini platform, in…
- Conditions
- Endodontic Diseases, Clinical Communication, Informed Consent
- Trial name
- GAI-ENDORDIC (NCT07731867)
- Testing
- Generative AI-Based Immersive Training, Conventional Case-Based Learning
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Breast Cancer
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death.
- Trial name
- OTT 15-05 (NCT02696707)
- Testing
- LVEF 3 month, LVEF 4 month
- Where
- 4 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Ottawa Hospital Research Institute
Informed Consent, Procedural State Anxiety
Improving Informed Consent in Pediatric Endoscopy
Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction.
- Conditions
- Informed Consent, Procedural State Anxiety, Subject's Satisfaction
- Trial name
- NCT00899392
- Testing
- Emmi Pediatric Upper Endoscopy Patient Education Module
- Where
- United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Dysphagia
Evaluation of Two Different Thickening Products in Patients With Dysphagia
Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care.
- Trial name
- NCT01651975
- Testing
- Thickenup, Thickenup Advance
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Davis
Patient Satisfaction
The Use of an Online Learning and Consent Platform in Infertility Treatment
The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online…
- Trial name
- NCT03962257
- Testing
- EngagedMD online learning platform
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Rheumatoid Arthritis
Consortium of Early Arthritis Cohorts USA
Rheumatoid arthritis (RA) is the most common form of inflammatory arthritis. In the US, it is estimated that as many as 3 million adults may suffer from the disease.
- Trial name
- CATCH-US (NCT02386527)
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Anxiety
Educational Video to Improve Understanding and Reduce Anxiety in Heart Attack Patients
Patients who are diagnosed with a heart attack are often confronted with an unexpected hospital admission and an urgent heart catheterization.
- Conditions
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Anxiety, Patient Education Materials
- Trial name
- VID-ACS (NCT07424482)
- Testing
- Educational Video
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Tobias Schreiber
Patient Satisfaction
Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study
Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the…
- Trial name
- NCT04024189
- Testing
- Survey
- Where
- United Kingdom
- Volunteers
- 39 people
- Sponsor
- The Christie NHS Foundation Trust