Clinical trials: Validity and Safety
Patient Safety, Intraoperative Complications
Validation Study of ClassIntra®
Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications.
- Conditions
- Patient Safety, Intraoperative Complications, Postoperative Complications, Risk Management
- Trial name
- ClassIntra® (NCT03009929)
- Testing
- Observational study
- Where
- 18 sites in United States, Australia and 10 more
- Volunteers
- 2,500 people
- Sponsor
- University Hospital, Basel, Switzerland
Cystic Fibrosis, Fibrosis
The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis.
Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk…
- Conditions
- Cystic Fibrosis, Fibrosis, Lung Diseases, Respiratory Diseases
- Trial name
- A-STEP (NCT02717650)
- Testing
- A-STEP, A-STEP (New Protocol), Comparator: CPET cycle ergometer (Gold Standard)
- Where
- Australia
- Volunteers
- 7 people
- Sponsor
- The Alfred
Chronic Myeloid Leukemia
Radotinib as 3rd or Later Line Therapy in CP-CML
The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.
- Trial name
- REVITAL (NCT02422719)
- Testing
- Radotinib
- Where
- South Korea
- Volunteers
- 73 people
- Sponsor
- Ulsan University Hospital
Stroke, Balance
The Validity and Reliability of an Improved Paper Grasping Test for Stroke
The study included volunteer patients diagnosed with stroke who applied to the Neurology Outpatient Clinic at SANKO University Sani Konukoğlu Application and Research Hospital.
- Conditions
- Stroke, Balance, Validity and Safety
- Trial name
- NCT07181005
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people
- Sponsor
- Sanko University
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.
Healthy Volunteers
Pharmacokinetics, Safety, and Lung Deposition of 99mTc-DTPA Delivered Via the EDDIS System in Healthy Volunteers
Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) - a portable, breath-actuated, digitally monitored system for precision delivery of inhaled agents with automated recording of inspiratory volume, flow…
- Trial name
- EDDIS-PK (NCT07053696)
- Testing
- Technetium-99m Diethylenetriaminepentaacetic Acid, EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)
- Where
- Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- Andrey Petrov
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
Clostridium Difficile-Associated Diarrhea
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease…
- Trial name
- NCT00747071
- Testing
- Colostrum
- Where
- Israel
- Sponsor
- Hadassah Medical Organization
IgA Nephropathy (IgAN), Henoch Schönlein Purpura Nephritis
To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies
The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients…
- Trial name
- NCT07822100
- Testing
- Gd-IgA1 monitoring
- Where
- China
- Volunteers
- 374 people
- Sponsor
- Hong Zhang
Perioperative Care Process Adherence
Development and Validation of the Perioperative Care Process Adherence Scale
This study aims to develop a new measurement instrument, the Perioperative Care Process Adherence Scale (PBSUO), and to evaluate its psychometric properties.
- Trial name
- PCPAS (NCT07833111)
- Where
- Turkey (Türkiye)
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Volkan Gokmen
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.
Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
ID-JPL934 for Abnormal Bowel Movement
Probiotics, which are part of the human body, are microorganisms, which are known to have beneficial effects when consumed in a certain amount, and have the function of controlling intestinal flora and inhibiting inflammation.
- Trial name
- NCT03395626
- Testing
- ID-JPL934
- Where
- South Korea
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Cervical Intraepithelial Neoplasia, Cervical Cancer
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women.
- Conditions
- Cervical Intraepithelial Neoplasia, Cervical Cancer, HIV
- Trial name
- SAVE (NCT02237326)
- Testing
- Visual Inspection with Acetic Acid, Visual Inspection with Lugol's Iodine
- Where
- Kenya
- Volunteers
- 654 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Gastrointestinal Disease, Endoscopy
Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP
In this study, the investigators proposed an artificial intelligence-based biliary stricture navigation system in MRCP-based ERCP, which can instruct the direction of guide wire and the position of stent placement in real time.
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Endoscopic Retrograde Cholangiopancreatography
- Trial name
- NCT04903444
- Testing
- Artificial intelligence assistant system
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Renmin Hospital of Wuhan University
Healthy Subject
Validation and Standardization of Test Methods and Evaluators for Testing of Hair Care Range of Products
An exploratory approach for validation and standardization of test methods and evaluators to conduct In-Vivo clinical safety and efficacy testing of hair care range of products. A total of 40 subjects will be enrolled.
- Trial name
- NCT05763888
- Testing
- No drug will given
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NovoBliss Research Pvt Ltd
Atopic Eczema/Dermatitis (Non-Specific)
Skin bioMARkers for Atopic Eczema Therapy Evaluation
The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the…
- Trial name
- SMART (NCT04194814)
- Testing
- crisaborole (2%) ointment, betamethasone valerate 0.1% cream
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
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
Parkinson's Disease (PD), Functional Capacity
Validity and Reliability of the Six-Minute Pegboard Ring Test in Individuals With Parkinson's Disease
Parkinson's patients who volunteer to participate in the study will be included. Parkinson's patients participating in the study will be referred from the SANKO University Hospital Neurology Outpatient Clinic.
- Conditions
- Parkinson's Disease (PD), Functional Capacity, Upper Extremity Function, Validity and Safety
- Trial name
- NCT07422064
- Where
- Turkey (Türkiye)
- Volunteers
- 47 people
- Sponsor
- Sanko University
Glioma : Oligodendroglioma or Astrocytoma
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
- Trial name
- ProTool (NCT02077543)
- Testing
- Brain Tissue Imprint - Medical Device (ProTool)
- Where
- 5 sites in France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Grenoble