Clinical trials: Validity and Safety
Functional Dyspepsia
Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients
The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia
- Trial name
- NCT03971383
- Testing
- Aolanti Weipang Tablets
- Where
- China
- Volunteers
- 236 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Metastatic Colorectal Cancer, RAS Wild-type
Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix® and FOLFIRI or FOLFOX in First Line (VALIDATE)
A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting…
- Trial name
- VALIDATE (NCT03043950)
- Testing
- Panitumumab
- Where
- Germany
- Volunteers
- 647 people
- Sponsor
- iOMEDICO AG
High-Risk Multidisciplinary Care, Clinical Decision Support
ANCHOR Validation Trial in High-Risk Multidisciplinary Care
This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the…
- Conditions
- High-Risk Multidisciplinary Care, Clinical Decision Support, Artificial Intelligence-Assisted Care, Telemedicine
- Trial name
- NCT07597499
- Testing
- Gemini 3.1 Pro with Safety Prompt, ANCHOR Clinical AI Verification Layer (with Gemini 3.1 Pro)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Refractive Errors
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health…
- Trial name
- NCT05049070
- Testing
- Mobile medical application to self administer a subjective refraction test, Standard of care refraction test
- Where
- 12 sites in United States
- Volunteers
- 349 people
- Sponsor
- 1800 Contacts, Inc.
Performance and Safety
Clinical Study of CT 5400 RT for System Validation
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Trial name
- NCT06466577
- Testing
- CT 5400 RT System
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Ovarian Cancer
Safety in Ovarian Cancer for Average-Risk Women - Analysis
This study is designed to evaluate the safety, specificity, and downstream diagnostic burden of the Evident™ Ovarian Cancer Screening Test in average-risk postmenopausal women.
- Trial name
- SOARA (NCT07872644)
- Testing
- Blood-Based Ovarian Cancer Screening Test
- Where
- 2 sites in United States
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- Mercy BioAnalytics, Inc.
Diabetes Mellitus, Type 2
Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)
This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel treatment groups, with active control, will be performed only in brazilian sites under the sponsorship of Eurofarma Laboratórios S.A..
- Trial name
- EVOLUTION (NCT02689362)
- Testing
- Evogliptin, Sitagliptin
- Where
- 10 sites in Brazil
- Volunteers
- 146 people
- Sponsor
- Eurofarma Laboratorios S.A.
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Chronic Kidney Diseases, Protein-Energy Malnutrition
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
- Trial name
- NCT06576479
- Testing
- Nutritious Shake, Nutritional counseling
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- NIN Institute
Eyes Dry Chronic, Chronic Conjunctivitis of Both Eyes
CDL Validation Study
Ocular surface photography is significantly limited in standardization and reproducibility. This reduces its applicability for clinical monitoring of acute or chronic disease.
- Conditions
- Eyes Dry Chronic, Chronic Conjunctivitis of Both Eyes, Limbal Stem-cell Deficiency, Eye Lesion
- Trial name
- NCT05461469
- Where
- Austria
- Volunteers
- 104 people
- Sponsor
- Occyo GmbH
Drug Interactions
Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation
The purpose of this study is to identify and validate a probe cocktail for use in future drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important roles in the disposition of drugs.
- Trial name
- NCT00964106
- Testing
- Caffeine, Rosiglitazone, Flurbiprofen
- Where
- 2 sites in South Korea
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Norovirus, Healthy Participants
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM)…
- Trial name
- NCT02475278
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Takeda
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
Healthy Subjects, Chronic Conditions, Multiple
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.
- Trial name
- NCT04796181
- Testing
- Neteera 130H
- Where
- 2 sites in United States, Israel
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Neteera Technologies Ltd.
Magnetic Resonance Imaging
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.
- Trial name
- NCT03407495
- Testing
- IOP Injection (MPB-1523)
- Where
- 5 sites in Taiwan
- Volunteers
- 52 people
- Sponsor
- MegaPro Biomedical Co. Ltd.
To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment
- Conditions
- To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, Allow Researchers to Sub-classify Valve Morphology in Relation, to Treatment Success. This Will be Evidenced by Venous Patency
- Trial name
- Resrch_Reg_2 (NCT01593891)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Synergy Health Concepts, Inc.
Alzheimer Disease, Dementia
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over…
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases
- Trial name
- NCT04640077
- Testing
- No Intervention, donanemab
- Where
- 27 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Eli Lilly and Company
HIV Infections
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
- Trial name
- NCT00504452
- Testing
- KP-1461
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Koronis Pharmaceuticals.
Pre-surgical Anxiety, Blood Glucose Concentration
Vis Pre Surgery Medical Food Validation Study
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications…
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels
- Trial name
- NCT07359222
- Testing
- Pre-surgical medical food
- Where
- India
- Volunteers
- 67 people
- Sponsor
- TM Nutrition LLC