Clinical trials: Validity and Safety
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
Cartilage Damage
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care")…
- Trial name
- ACTIVE (NCT05186935)
- Testing
- Injectable Hydrogel treatment
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Hy2Care BV
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
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
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
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
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
Surgery
Validation of a User Questionnaire to Assess Surgeon Satisfaction and Perspectives on Robotic Surgical Systems
Robotic surgery represents a cornerstone for surgical treatment of different diseases. Since the Da Vinci patent expiry, several new robotic systems entered the market in the effort to spread to a greater extent the benefits of…
- Trial name
- RSSQ (NCT07051941)
- Testing
- Validation of a satisfaction questionnaire for robotic surgeon
- Volunteers
- 100 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Triple Negative Breast Cancer, Breast Cancer
TA(E)C-GP Versus A(E)C-T for the High Risk TNBC Patients and Validation of the mRNA-lncRNA Signature
The purpose of this study is to compare the efficacy and safety between docetaxel combined with doxorubicin (epirubicin) and cyclophosphamide followed by gemcitabine combined with cisplatin and doxorubicin (epirubicin) combined…
- Trial name
- NCT02641847
- Testing
- docetaxel, doxorubicin or epirubicin, cyclophosphamide
- Where
- China
- Volunteers
- 503 people
- Sponsor
- Fudan University
Coronary Artery Disease, Acute Myocardial Infarction
Heart Cycle Prestudy
In this Prestudy which will be followed by the multicentral GEx- main-trial, the feasibility of a new cardiac rehabilitation device (GEx system) is proved with coronary heart disease patients who participate in cardiac…
- Trial name
- PreGEx (NCT01627457)
- Testing
- Guided Exercise (GEx) system
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- RWTH Aachen University
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.
Cancer
Validation of an Adjusted Dosing Algorithm of Carboplatin
An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function.
- Trial name
- NCT02103244
- Testing
- Carboplatin
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Rijnstate Hospital
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
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
Deglutition Disorders, Deglutition
Translation and Validation of the Visual Analysis of Swallowing Efficiency and Safety Into European Portuguese
The goal of this observational study is to translate and validate to European Portuguese "Visual Analysis of Swallowing Efficiency and Safety - VASES".
- Trial name
- VASES (NCT06742034)
- Where
- Portugal
- Volunteers
- 34 people
- Sponsor
- Centro Hospitalar de Entre o Douro e Vouga
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
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
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
ICU Acquired Weakness (ICUAW)
Feasibility and Safety of Digital Rehab Platform for Bedridden Patients
Study Title Rehabilitation Program for Bedridden Patients Using Digital Devices Study Purpose This study aims to evaluate the effectiveness of a rehabilitation program using digital devices and apps for bedridden patients in a…
- Trial name
- NCT06849765
- Testing
- Rehabilitation
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Asan Medical Center