Clinical trials: Validity and Safety
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
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
Validity and Safety
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia
The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or…
- Trial name
- NCT04591197
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Nanfang Hospital, Southern Medical University
Renal Insufficiency, Chronic, Kidney Failure, Chronic
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis).
- Conditions
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Chronic Kidney Diseases
- Trial name
- CORDIAL (NCT06314503)
- Testing
- WEAKID
- Where
- 3 sites in Italy, Netherlands and 1 more
- Volunteers
- 12 people
- Sponsor
- UMC Utrecht
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
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
Gastrointestinal Disease, Endoscopy
Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
In this study, the investigators proposed a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups.
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Cholangiopancreatography, Endoscopic Retrograde
- Trial name
- NCT04719117
- Where
- 3 sites in China
- Volunteers
- 150 people
- Sponsor
- Renmin Hospital of Wuhan University
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.
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
Healthy Male Adults Participants, Vasectomy
Plan A Novel Delivery Device Study
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
- Trial name
- NCT06891729
- Testing
- Delivery Lumen Access Device, DLAD
- Where
- 2 sites in Australia, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
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.
Validity and Safety
Monitor Orthopaedic Footwear Questionnaire (MOS) Validity and Reliability Study
The aim of the study is to adapt the MOS questionnaire into Turkish and to investigate the validity and reliability of the questionnaire.
- Trial name
- MOS (NCT07033390)
- Testing
- survey
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Medipol University
Penicillin Allergy
Amoxicillin Challenge for Penicillin Allergy Diagnosis
False diagnosis of penicillin allergy are frequently reported, and have been proven detrimental to patients. Current guidelines for the assessment of drug allergies recommend that penicillin allergy be evaluated first with prick…
- Trial name
- Pen-VIE (NCT03757052)
- Testing
- Penicillin Skin Testing
- Where
- Canada
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
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
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
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.
Healthy Volunteers, Drug Delivery Systems
Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems
This is a crossover study to evaluate real-time performance, airflow control, user-device interaction, and safety systems of three portable inhalation systems from the EDDIS platform.
- Conditions
- Healthy Volunteers, Drug Delivery Systems, Inhalation of Liquid Air, Administration Site Injury
- Trial name
- EDDIS-ENG (NCT06902129)
- Testing
- EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)
- Where
- Switzerland
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Petrov, Andrey
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
Arrhythmia
Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)
AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets.
- Trial name
- NCT05617001
- Testing
- Kardia 12L
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
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.