Clinical trials: Validation Study
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Dementia, Pain
PainChek® US Validation Nursing Home Study
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities.
- Trial name
- NCT06049732
- Testing
- PainChek®
- Where
- 5 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- PainChek Ltd
Diffuse Midline Glioma (DMG), Glioblastoma
ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors
This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other…
- Conditions
- Diffuse Midline Glioma (DMG), Glioblastoma, Recurrent Ependymoma, Recurrent Malignant Central Nervous System Neoplasm
- Trial name
- PNOC023 (NCT04732065)
- Testing
- ONC206, Standard of Care Radiation Therapy, Optional Proton (1H) MR spectroscopy (MRS)
- Where
- 7 sites in United States, Netherlands and 1 more
- Volunteers
- 208 people
- Sponsor
- Sabine Mueller, MD, PhD
Cerebral Palsy (CP)
Feasibility and Discriminant Validity of Monitoring Movement Behavior of Adolescents With Cerebral Palsy
A new artificial intelligence network has been developed to monitor real-world daytime and nighttime movement behavior of adolescents with cerebral palsy (CP).
- Trial name
- NCT06090383
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Type 1 Diabetes (T1D)
Development and Preclinical Validation of DiaBuddy, a Point-of-Care Decision Support Tool for Children With Type 1 Diabetes: A Pilot Clinical Study
Type 1 Diabetes Mellitus (T1DM) in children requires precise insulin dose adjustments and reliable sick-day decision-making on a daily basis.
- Trial name
- DiaBuddy (NCT07470905)
- Testing
- Access to DiaBuddy tool
- Where
- India
- Volunteers
- 25 people
- Sponsor
- Regency Hospital Kanpur
Sedation
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children.
- Trial name
- NCT01957566
- Testing
- APS
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of Wisconsin, Madison
Keratoconus
Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)
KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors.
- Trial name
- QFK (NCT04517903)
- Testing
- eye rubbing questionnaire
- Where
- 8 sites in France
- Volunteers
- 292 people
- Sponsor
- University Hospital, Bordeaux
Idiopathic Parkinson Disease, Dyskinesias
Reliability and Validity Study of the Turkish Version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)
The aim of this methodological study was to investigate the Turkish validity and reliability of the Parkinson's Disease Dyskinesia Scale (PDYS-26).The scale evaluates choreic dyskinesia.Measures the impact of dyskinesia on…
- Conditions
- Idiopathic Parkinson Disease, Dyskinesias, Quality of Life
- Trial name
- NCT07023224
- Testing
- Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 130 people
- Sponsor
- Izmir Bakircay University
Blood Glucose, Executive Function
MOReS Freestyle Libre Validation Study
To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.
- Conditions
- Blood Glucose, Executive Function, Cognitive Change
- Trial name
- NCT04989712
- Testing
- Exposure
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Oxford Brookes University
Fluid Status, Peritoneal Dialysis
Bioimpedance as a Tool for Fluid Management in Peritoneal Dialysis (PD) Patients
Hypothesis: The investigators hypothesize that regular monitoring of BIA adds value to the management of fluid status in PD patients Objectives of the study: The objective is to show that in patients where the additional…
- Trial name
- NCT00801112
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- University Hospital of North Staffordshire
Liver Cancer
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called "phase correction algorithm") in…
- Trial name
- NCT00543777
- Testing
- Magnetic Resonance Elastogram, 2-Point Dixon Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- M.D. Anderson Cancer Center
Fibula / Surgery, Surgical Flaps
Novel Application of a Low-cost Alternative to Patient Specific Implants (PSI) in Mandibular Free Fibula Flap Reconstruction by Reverse Engineering of Stock Plates: A Pilot Validation Study
Stock reconstruction plates have been used for decades and represent a tried-and-true alternative to custom plating. Stock plates are readily available, are cost effective, and can be accurately bent before surgery, particularly…
- Conditions
- Fibula / Surgery, Surgical Flaps, Computer-Aided Design, Mandibular Reconstruction* / Methods
- Trial name
- NCT05672056
- Testing
- Computer guided placement of a stock plate pre-bent on a 3D printed model
- Where
- Egypt
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cairo University
Difficult Biliary Cannulation
A Convolutional Neural Network for Difficult Biliary Cannulation
The main purpose of the study is to train a convolutional neural network (CNN) to predict difficult biliary canulation (DBC) following the European Society of Gastrointestinal Endoscopy Society (ESGE).
- Trial name
- PRECABIDO2 (NCT07389915)
- Testing
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Volunteers
- 600 people
- Sponsor
- University of La Laguna
Quality of Life, Spinal Deformity
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with…
- Conditions
- Quality of Life, Spinal Deformity, Scoliosis
- Trial name
- NCT04846296
- Testing
- Questionnaire
- Where
- Turkey (Türkiye)
- Volunteers
- 125 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Establish Normative pH Values in Neonates
Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
Objectives: 1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor 2.
- Trial name
- NCT02279264
- Testing
- RightSpot Infant pH Indicator
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- RightBio Metrics
Validation Study
The Aims of the Study Are to Translate the Index of Professional Governance (IPG 3.0) Into Italian and Validate It and to Assess the State of Professional Governance in an Italian Hospital (ISMETT)
Professional Governance (PG) is a way to actualize better work environments and structural empowerment. PG has a history over many years in the healthcare industry and has been defined as multidimensional organizational…
- Trial name
- NCT06814639
- Volunteers
- 75 people
- Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Developmental Disability, Intellectual Disability
Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system.
- Conditions
- Developmental Disability, Intellectual Disability, Autism Spectrum Disorder, Congenital Anomaly
- Trial name
- NCT05295277
- Testing
- Standard of care genetic testing group
- Where
- 8 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Bionano Genomics
Covid19
Detection of COVID-19 Using Breath Analysis - Validation Study
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
- Trial name
- COVID-19 (NCT04602949)
- Testing
- Breath Biopsy Analysis
- Where
- Israel
- Volunteers
- 2,558 people, healthy volunteers welcome
- Sponsor
- Scentech Medical Technologies Ltd
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
Rejection Acute Renal, Rejection Chronic Renal
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
This is a multinational, multi-center, observational cohort study. Kidney allograft rejection is poorly detected by standard-of-care biomarkers.
- Conditions
- Rejection Acute Renal, Rejection Chronic Renal, Transplantation, Kidney Rejection Transplant
- Trial name
- VALiDATE (NCT07805343)
- Testing
- Donor-derived cell-free DNA
- Where
- 25 sites in United States, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Paris Translational Research Center for Organ Transplantation