Clinical trials: Validation Studies
Neuron Disease, Motor
Technical and Clinical Validation of the WPM-SEMG Prototype
Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy.
- Trial name
- NCT06584084
- Testing
- WPM-SEMG prototype
- Where
- Switzerland
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Alain Kaelin
Brain Injuries, Traumatic
Brain Oximeter Calibration and Validation Study
The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein blood oxygen saturations.
- Trial name
- TPOT (NCT05397704)
- Testing
- brain pulse oximeter
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Cyban Pty Ltd
ICU Patients, ICU Acquired Weakness
The Validity and Reliability Study of the Chelsea Critical Care Physical Assesment Tool
This study is aimed at providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity.
- Trial name
- NCT04811638
- Testing
- Validation of the Chelsea Critical Care Physical Assesment Tools
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Saglik Bilimleri Universitesi
Eosinophilic Esophagitis
Monocentric Retrospective Observational Study for Validation of Meta-analysis of the Metatrascryptome and Transcriptome of Eosynophyl Esophagitis
This is a retrospective monocentric observational study involving patients with Eosinophilic esophagitis (EoE), gastroesophageal reflux disease (GERD), and controls (patients without EoE and GERD).
- Trial name
- NCT06071585
- Testing
- Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis
- Where
- Italy
- Volunteers
- 105 people
- Sponsor
- IRCCS San Raffaele
Dialysis
Clinical Validation Study for Optimization of Anemia MAnagement in Hemodialysis Patients With End Stage Kidney Disease Using the Dialysis Anemia TReatmenT Model
This is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at Intermountain Utah Dialysis and Intermountain Medical Center Dialysis Services.
- Trial name
- SMART (NCT05936021)
- Testing
- Algorithm model-based Aranesp doses, Standard of care
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Intermountain Health Care, Inc.
Vascular Malformations, Vascular Anomaly
Vascular Anomaly Pathology and Genomics Biopsy Study
The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.
- Conditions
- Vascular Malformations, Vascular Anomaly, Hemangioma, Arteriovenous Malformations
- Trial name
- NCT04836884
- Testing
- Percutaneous Vascular Anomaly/Malformation Biopsy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Mayo Clinic
Vitreoretinal Lymphoma
Multicentre Implementation and Validation of a Molecular Diagnostic for VitreoRetinal Lymphoma
The goal of this observational study is to gain new insights into the changes in proteins, genes and other molecular biological substances in the aqueous humour, vitreous humour, blood serum and, in rare cases, retina/choroid…
- Trial name
- DecodeVRL (NCT05841914)
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- Vinodh Kakkassery, MD
Infant Nutrition Disorders, Weight Loss
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge.
- Conditions
- Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth
- Trial name
- NCT07718516
- Testing
- Woddle Smart Changing Pad
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Stan Kachnowski
Chronic Liver Disease and Cirrhosis
Real-World Validation of a Prognostic Prediction Model for Patients With Acute Exacerbations of Chronic Liver Disease
Our study is a multi-site, prospective, observational study including patients with acute exacerbations of CLD. Approximately 1500 patients from 24 hospitals in diverse regions in China will be enrolled and followed for 3 months.
- Trial name
- NCT06181448
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Stable Angina, Coronary Artery Disease
Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)
Imaging the inside of coronary arteries (intravascular imaging) offers great insight into the assessment and treatment of coronary artery disease.
- Trial name
- VALID-PET-CT (NCT04205110)
- Testing
- PET-CT
- Where
- United Kingdom
- Volunteers
- 7 people
- Sponsor
- Barts & The London NHS Trust
Parkinson's Disease
The CloudUPDRS Smartphone Software in Parkinson's Study.
This study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical gold standard - the Unified Parkinsons Disease Rating…
- Trial name
- CUSSP (NCT02937324)
- Testing
- CloudUPDRS smartphone software assessment, Clinical assessment
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- University College, London
Pregnant Individuals, Aneuploidy
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of…
- Conditions
- Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome
- Trial name
- ADVANCE (NCT07643896)
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- BillionToOne Inc.
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer…
- Trial name
- NCT04842123
- Testing
- Electrocardiogram
- Where
- 6 sites in United States
- Volunteers
- 568 people, healthy volunteers welcome
- Sponsor
- Garmin International
Gambling, Pathological
Screening for Excessive Gambling Behaviors on the Internet
The Internet medium is particularly vector for gambling problems. Since the opening of the online gambling sector in France, no screening for excessive gambling behaviours is provided for by the law, although it is known that…
- Trial name
- EDEIN (NCT02415296)
- Testing
- stage 1, stage 2, stage 3
- Where
- France
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Necrotizing Enterocolitis
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies.
- Trial name
- NEC (NCT00588718)
- Where
- United States
- Volunteers
- 740 people
- Sponsor
- R. Lawrence Moss
Disorder of Consciousness
SECONDs' Italian Translation and Transcultural Validation
The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness.
- Trial name
- IT-SECONDs (NCT05714215)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
Haemophilia A
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical…
- Trial name
- OPTIMS (NCT01436825)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in France, Italy
- Volunteers
- 69 people
- Sponsor
- Bayer
Body Temperature
Temporal Artery Thermometer in Patient Transport: Reliability and Validity.
Evaluate the reliability and validity of temperature measurements using an existing, Health Canada-approved, non-invasive temporal artery thermometer, and comparing results to an established, invasive gold standard (esophageal…
- Trial name
- TAT (NCT03920943)
- Testing
- Measurement of temperature using non-invasive means
- Where
- Canada
- Sponsor
- Ornge Transport Medicine
Healthy
A Study to Validate Treadmill Parameters
The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.
- Trial name
- NCT05333263
- Testing
- Treadmetrix
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Infections in Acute Myocardial Infarction Patients
Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
Prospective biomedical research study
- Trial name
- NCT05412732
- Testing
- prospective biomedical research study
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz