Clinical trials: Consent
MELAS Syndrome, Mitochondrial Diseases
Ketones & Mitochondrial Heteroplasmy
The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA at position 3243 (A>G).
- Trial name
- NCT01252979
- Testing
- Medium-Chain Triglycerides
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- The University of Texas Health Science Center, Houston
Informed Consent, Awareness
Patients' Readings of Pre-operative Informed Consent Forms
Patient informed consent is a form which contains the patient's probable outcome of the procedure to be performed, and the probable risk and benefit of the patient's knowledge of the illness.
- Trial name
- NCT03555760
- Testing
- Observation of informed consent form readings of all patients who are scheduled for surgery
- Where
- Turkey (Türkiye)
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Ankara University
Pediatric Crohn's Disease
Trial of Enhanced Pre-Consent Discussion
Nested within the COMBINE pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with Crohn's Disease) or patients > 18 years old being…
- Trial name
- NCT02869880
- Testing
- Enhanced Pre-Consent Discussion, Standard Pre-consent Discussion
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Sexual and Reproductive Health and Rights, Violence Against Women and Girls
Right to Health and Freedom From Violence
Bangladesh has the earliest patterns of marriage in the current developing world, high adolescent fertility and high rates of spousal violence against women and girls.
- Trial name
- SAFE (NCT03280680)
- Testing
- Female+male group sessions, Female group sessions, No group sessions
- Volunteers
- 11,340 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Maternal Anxiety, Prenatal Diagnosis
Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
This prospective study evaluates the impact of video-based patient education compared to standard verbal informed consent on state anxiety levels and procedure acceptance rates in pregnant women undergoing invasive prenatal…
- Conditions
- Maternal Anxiety, Prenatal Diagnosis, Amniocentesis, Chorionic Villus Sampling
- Trial name
- NCT07876726
- Testing
- Multilingual Video-Based Patient Education, Standard Verbal Informed Consent
- Where
- Turkey (Türkiye)
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Ankara City Hospital Bilkent
Surgery, Cholecystectomy, Laparoscopic
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip…
- Conditions
- Surgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip
- Trial name
- NCT00288899
- Testing
- Enhanced surgical iMedConsent process (with "repeat back"), standard surgical iMedConsent process
- Where
- 7 sites in United States
- Volunteers
- 575 people
- Sponsor
- VA Office of Research and Development
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
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
Inguinal Hernia
The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial
The use of electronic media in informed consent giving has become increasingly important in recent years. Due to the easy access to information via electronical media, patients are primed in a heterogeneous manner concerning…
- Trial name
- NCT04494087
- Testing
- Explanatory video, Informed consent form
- Where
- 2 sites in Switzerland
- Volunteers
- 183 people
- Sponsor
- Kantonsspital Winterthur KSW
Malocclusion, Dentofacial Deformities
Augmented Reality for Orthognatic Surgery Patient Education
To evaluate whether the use of augmented reality (AR) for visualizing 3D models can be a valuable addition to patient education regarding orthognathic procedures compared to using only 2D visualization (on a computer screen).
- Conditions
- Malocclusion, Dentofacial Deformities, Patient Satisfaction, Informed Consent
- Trial name
- NARRATE (NCT06140043)
- Testing
- Patient consultation
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 60 people
- Sponsor
- University Medical Center Groningen
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
Understanding of Consent in Clinical Research, Implementation of Consent in Clinical Research
Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants
The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the…
- Trial name
- NCT05541536
- Testing
- Consultation meeting, Pamphlet, Usual Care
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Informed Consent
Capacity to Consent in Acutely Intoxicated Emergency Department Patients
The ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population.
- Trial name
- NCT02885532
- Testing
- University of California, San Diego Brief Assessment of Capacity to Consent Tool
- Where
- United States
- Volunteers
- 417 people
- Sponsor
- Hennepin Healthcare Research Institute
Informed Consent
Informed Consent and Clinical Trials
To understand the patients' meaning of the informed consent process in clinical trials. Objective of the study is: to assess, in a cohort of subjects included in clinical trials, whether the information and the informed Consent…
- Trial name
- NCT01635842
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Azienda Usl di Bologna
Endometrium Cancer, Sentinel Lymph Node
Multimedia Aid Gynecologic Counseling and Consent
This is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently.
- Conditions
- Endometrium Cancer, Sentinel Lymph Node, Perioperative/Postoperative Complications
- Trial name
- NCT03899441
- Testing
- Video
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
Osteosarcoma, Ewing's Sarcoma
Informed Consent in Pediatric Cancer Trials
Background: Informed consent is the process by which prospective participants in clinical trials learn about clinical research in order to decide whether they want to enroll in the study.
- Conditions
- Osteosarcoma, Ewing's Sarcoma, Neuroblastoma, Brain Tumors
- Trial name
- NCT00923650
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC)
Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.
- Trial name
- OTT15-04 (NCT02688803)
- Testing
- Dose dense AC-P, Dose dense AC, FEC-D
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Ottawa Hospital Research Institute
Cancer, Metastasis
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like…
- Conditions
- Cancer, Metastasis, Pain
- Trial name
- NCT00374751
- Testing
- Samarium (153SM)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- New York Presbyterian Brooklyn Methodist Hospital
Adolescents
Parental Permission and Adolescent Assent and Decision-Making in Clinical Research
This study will evaluate how adolescents enrolled in clinical research and their parents: Understood the study information presented before they agreed to participate Made decisions about enrolling in the study Experienced the…
- Trial name
- NCT00571311
- Where
- United States
- Volunteers
- 356 people
- Sponsor
- National Institutes of Health Clinical Center (CC)