Clinical trials: Consent Forms
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
Scleroderma
Empirical Comparative Study of Variation Blood Level Antibody Vitamin D at Scleroderma (SSc) Patients Compared Healthy Peoples
The aim is to find the presence of anti vitamin D antibodies in scleroderma patients and compare with control. A second goal is anti vitamin D levels in serum of scleroderma patients in relation to the clinical manifestations of…
- Trial name
- SSc (NCT01553890)
- Testing
- Blood sample
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meir Medical Center
Advanced Renal Cell Carcinoma (aRCC)
Envafolimab Combined With Axitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
Introduction: This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunotherapy) and Axitinib (a targeted…
- Trial name
- NCT07159191
- Testing
- Envafolimab Injection, Axitinib Tablets
- Volunteers
- 30 people
- Sponsor
- Peking Union Medical College Hospital
Informed Consent
Patients' Comprehension and Internalization of Operative Consent Form
This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016.
- Trial name
- NCT04627597
- Volunteers
- 22 people
- Sponsor
- Singapore General Hospital
Depression
Reboxetine Treatment in Depressed Children and Adolescents an 8-Week, Open Study
The aim of the present study is to prospectively assess the anti-depressant effectiveness of reboxetine in children and adolescents, as compared with fluoxetine, in a randomized controlled open-label trial.
- Trial name
- NCT00426946
- Testing
- Reboxetine
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Geha Mental Health Center
Consent Forms, Asthma
Informed Consent Formats by Information Preference and Priority
This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.
- Trial name
- NCT03416907
- Testing
- Original consent form, Shortened consent form, Reordered, shortened consent form
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Carnegie Mellon 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
Multiple Sclerosis (MS)
The Effect of Aerobic Exercise on an Elliptical Trainer Versus a Treadmill, in People With Multiple Sclerosis
The aim of this study is to examine the effects of aerobic exercise training using an elliptical trainer compared to a treadmill on gait and walking abilities, expressed in dynamic stability, balance, and walking speed, in people…
- Trial name
- MS (NCT06583967)
- Testing
- Physical Training
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Soroka University Medical Center
Cancer
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
- Trial name
- NCT04548063
- Testing
- 6,000 word consent form, 4,000 word consent form, 2,000 word consent form
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Mayo Clinic
Age 3 to 16 Years (Inclusive), Male or Female, Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye
The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical Trial
Objective: To study the effectiveness and safety of low-intensity single wavelength red light in controlling high myopia in children and adolescents. Methods: Subject population: Children aged 3-16 years who have high myopia.
- Conditions
- Age 3 to 16 Years (Inclusive), Male or Female, Clinical Diagnosis Confirming That Myopia Has Occurred in at Least One Eye, The Guardian Voluntarily Signed the Subject's Informed Consent Form
- Trial name
- NCT05184621
- Testing
- Eyesing Redlight Instrument
- Where
- China
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Shanghai Eye Disease Prevention and Treatment Center
Comprehension, Informed Consent
The New Executive and Appendix Template (NEAT) Study
There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants…
- Trial name
- NCT03419832
- Testing
- NEAT Form, Standard Form
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Wake Forest University Health Sciences
Early Detection of Cancer
Evidence-informed Choice for Women Participating in Mammography Screening
Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.
- Trial name
- NCT01335906
- Testing
- Information
- Where
- Spain
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- Andaluz Health Service
Alzheimer Disease, Early Onset, Mild Cognitive Impairment
Engagement 2.0 Forms of Consent for Data (re-)Use
The objective of this qualitative study is to create a better understanding of patients' mental model of health data engagement interfaces and tools (such as Dynamic Consent).
- Trial name
- ENGAGE (NCT05229978)
- Testing
- Showing an existing Dynamic Consent (computer interface) as prompt
- Where
- Belgium
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
Consent Forms
Clinical Informed Consent Format Evaluation
This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ).
- Trial name
- NCT02489682
- Testing
- Long-form written Informed consent information, Short-form written Informed consent information, Video Informed consent information
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Carnegie Mellon University
Whole Genome Sequencing
A Study of Consent Forms for Whole Exome and Whole Genome Sequencing
Background: The purpose of this study is to investigate the process of consenting participants to whole exome/genome sequencing and its outcomes. It is unknown how best to consent people to this new technology.
- Trial name
- NCT01927770
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Informed Consent, Comprehension
AI-Driven Consent Simplification Study
The overarching goal of this pilot is to explore how generative artificial intelligence (genAI) can be used to improve the accessibility and understandability of informed consent materials in clinical research.
- Conditions
- Informed Consent, Comprehension, Communication, Disclosure
- Trial name
- ACCESS (NCT07303517)
- Testing
- Original ICF, AI Simplified ICF, Podcast - Original ICF
- Where
- United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
Scoliosis Neuromuscular, Scoliosis Idiopathic
Post-market Clinical Follow-up Study of NEMOST V2
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children. As part of post-market surveillance, EUROS is conducting a retrospective and prospective study to collect…
- Conditions
- Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms
- Trial name
- NEMOST V2 (NCT07403084)
- Testing
- NEMOST V2 growing domino
- Where
- 5 sites in France
- Volunteers
- 140 people
- Sponsor
- EUROS
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