Clinical trials: Validation Studies
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD)
Validation of the CIDI 5.0 Against the SCID-5 for Lifetime Mental Disorders
The World Health Organization Composite International Diagnostic Interview (CIDI) is a fully structured diagnostic tool designed for lay interviewers to assess the prevalence of mental and substance use disorders.
- Conditions
- Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Posttraumatic Stress Disorder (PTSD)
- Trial name
- NCT07604753
- Testing
- CIDI-5
- Where
- Hong Kong
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
MEDICATION RELATED OSTEONECROSIS OF THE JAW
Infiltration of Medical Ozone for the Treatment of Medication-Related Osteonecrosis of the Jaws (MRONJ)
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents; it is also a potentially painful and debilitating condition.
- Trial name
- OZOPROMAF (NCT05036837)
- Testing
- OZOPROMAF_SEQ1
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Palermo
Athletic Injuries
Validity of an Upper Extremity Physical Performance Test Battery in Healthy Athletes
This project comprises two studies; a cross-sectional study and a prospective study. 1. The cross-sectional study aims to develop and validate a new sport-specific test battery (PROMs, analytical and physical performance tests)…
- Trial name
- VAL_PPT_H (NCT06153121)
- Testing
- Physical performance test - Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Physical performance test - modified Closed Kinetic Chain Upper Extremity Stability Test (m-CKCUEST), Physical performance test - Seated Seated Single Arm Shot Put Test (SSASPT)
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University Ghent
Affective; Reaction, Pregnancy Related
Developing and Validating Digital Affective Patient Experience/Outcome Measure
The aim of the research project is to develop and validate a new digital measure of affective patient experience in maternal care.
- Conditions
- Affective; Reaction, Pregnancy Related, Validation Studies
- Trial name
- ETVa (NCT03337321)
- Where
- Finland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Breast Neoplasms
CT-AI Breast Cancer Opportunistic Screening Health Examination Study
This study evaluates the clinical utility of a locked chest CT artificial intelligence model for opportunistic breast cancer screening among women undergoing health examinations.
- Trial name
- NCT07809698
- Testing
- CT-AI-assisted breast cancer screening
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Alzheimer Disease, Mild Cognitive Impairment
Software Validation Study-Cognitive Status Indicator
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Trial name
- REMIND-V (NCT06809725)
- Testing
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Spark Neuro Inc.
Parkinson Disease
AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD).
- Trial name
- dBM-DEV (NCT06444789)
- Testing
- connected smartwatch
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Healthy
Competition With Striatal [11C]ORM-13070 Binding by Atipamezole and Endogenous Noradrenaline
The purpose of this study is to validate [11C]ORM-13070 as an alpha2C-adrenoceptor imaging agent for human positron emission tomography (PET) studies of brain alpha2C-adrenoceptor occupancy.
- Trial name
- AIMI (NCT01435213)
- Testing
- Atipamezole, Atomoxetine, Ketamine
- Where
- 2 sites in Finland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Turku
In Utero Drug Exposure
Validation of the In-utero Transmission of Probiotics
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study.
- Trial name
- PROBIO (NCT04050189)
- Testing
- Natural products: Probiotics
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Endothelial Dysfunction, Acute Myocardial Infarction (AMI)
Validation of Cor-IS Impedance Spectroscopy Against Ultrasound Flow-Mediated Dilation
This prospective observational study evaluated the Cor-IS bioelectrical impedance spectroscopy technique for the assessment of endothelial function by comparison with ultrasound-based brachial artery flow-mediated dilation (FMD).
- Conditions
- Endothelial Dysfunction, Acute Myocardial Infarction (AMI), Cardiovascular Risk Factors (e.g., Hypertension), Flow Mediated Dilation
- Trial name
- NCT07882550
- Testing
- Cor-IS FMD, Ultrasound FMD
- Where
- Greece
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Aristotle University Of Thessaloniki
COVID-19
Bioaerosol Sampling Device (BSD) Clinical Study
The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be…
- Trial name
- NCT06047067
- Where
- 6 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Cantor BioConnect, Inc.
Respiratory Rate
ChroniSense Polso Wrist Worn Respiration Rate Validation Study
20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system
- Trial name
- NCT03750344
- Testing
- Diagnostic test
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Cancer
Development and Validation of a Health-related Quality of Life Instrument
This study aims to develop a health related quality of life (HRQOL) patient reported outcome (PRO) for patients receiving immune checkpoint modulator (ICM) therapy.
- Trial name
- FACT-ICM (NCT02651831)
- Testing
- Focus groups and individual interviews, Questionnaire
- Where
- Canada
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Validation Study
Validity and Reproducibility of Dietary Assessment Against Objective Measures
A cross-sectional study with repeated measurements among healthy Danish adults to assess the validity and reproducibility of a self-administered 7-day web-based dietary assessment tool, myfood24® tested against objective…
- Trial name
- VALID (NCT05600530)
- Where
- Denmark
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Inge Tetens
Family Satisfaction
The Reliability And Validity Of Family Satisfaction In Intensive Care Unit 24 (FS-ICU 24) Scale In Turkish Language
Purpose of this study was to investigate the validity and reliability of Family Satisfaction in the Intensive Care Unit-24 (FC-ICU 24) survey in Turkish language, evaluation the satisfaction of intensive care unit patients'…
- Trial name
- NCT03733977
- Where
- Turkey (Türkiye)
- Volunteers
- 369 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
Pre-diabetes
ELFI Health (e-Health for Empowerment by Lifestyle, Food Advice and Interaction)
In the present study the investigators will examine whether people living with prediabetes benefit from an e-health lifestyle intervention of three months.
- Trial name
- ELFI (NCT06236334)
- Testing
- ELFI lifestyle intervention
- Where
- Netherlands
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- TNO
Sleep Apnea
Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
- Trial name
- NCT03385187
- Testing
- NightOwl HSAT
- Where
- Belgium
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Aortic Aneurysm
Validation of a Software and the Follow-up of Anteropoterior Migration of Stent
The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure.
- Trial name
- ASMOT (NCT05287828)
- Testing
- Surgeons CT scan analysis, PRAEVAorta CT scan analysis
- Where
- France
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Nurea
Cardiovascular Diseases
VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators
ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs.
- Trial name
- LOCAL-ECG (NCT05324111)
- Testing
- Kardia 6L
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- The Leeds Teaching Hospitals NHS Trust