Clinical trials: Human Factors
Healthy Volunteers
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the…
- Trial name
- NCT06395350
- Testing
- Spire Health Monitor
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Spire, Inc.
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)
This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B.
- Trial name
- NCT01283074
- Where
- 16 sites in Greece
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
Coronavirus, Coronavirus Infection
Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate…
- Conditions
- Coronavirus, Coronavirus Infection, Severe Acute Respiratory Syndrome Coronavirus 2, Pneumonia
- Trial name
- CYNKCOVID (NCT04365101)
- Testing
- CYNK-001
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Celularity Incorporated
Spinal Cord Injuries, Tetraplegia
Human Factors Validation Testing of the Wandercraft Personal Exoskeleton
The goal of this interventional, national, prospective, open and monocentric study is to demonstrate that a personal exoskeleton can be used by the intended users without serious use errors or problems, for the intended uses and…
- Conditions
- Spinal Cord Injuries, Tetraplegia, Paraplegia
- Trial name
- ExoUser (NCT06715631)
- Testing
- Hands-free exoskeleton
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Wandercraft
Human Immunodeficiency Virus, Ischemic Heart Disease
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)
- Trial name
- NCT00296153
- Testing
- Omega-3-acid ethyl esters 90
- Where
- Denmark
- Volunteers
- 51 people
- Sponsor
- Pronova BioPharma
Smoking, Tobacco
Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit
Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)
- Trial name
- NCT03148613
- Testing
- Carbon Monoxide Breath Sensor System (COBSS), Bedfont - Micro+™ Smokerlyzer®
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- David Utley, MD
Low Birth Weight Infants
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO)…
- Trial name
- NCT05203900
- Testing
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Meiji Co., Ltd.
Ovarian Neoplasms, Pancreatic Neoplasms
A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors
The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab…
- Conditions
- Ovarian Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms
- Trial name
- NCT00841191
- Testing
- CNTO 328; Anti-interleukin-6 monoclonal antibody
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 84 people
- Sponsor
- Centocor, Inc.
Cancer
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
- Trial name
- NCT00816361
- Testing
- MEDI-573
- Where
- 6 sites in United States
- Volunteers
- 43 people
- Sponsor
- MedImmune LLC
Hepatitis B, Hepatitis A
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis…
- Trial name
- NCT00289731
- Testing
- TWINRIX™, Engerix™-B, HAVRIX™
- Where
- 9 sites in Belgium, Czechia and 1 more
- Volunteers
- 596 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Virus Diseases, RNA Virus Infections
Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.
A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT01991561
- Testing
- Low dose of H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel, High dose of H5 VLP vaccine + Alhydrogel
- Where
- 2 sites in Canada
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Medicago
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Gout
Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
There is a mounting and clear association between hyperuricaemia, gout and the presence of traditional cardiovascular (CV) risk factors and CV event-equivalent conditions such as chronic kidney disease, metabolic syndrome, and…
- Trial name
- FORWARD (NCT02500641)
- Testing
- Febuxostat 80/120mg/day, Allopurinol 100 up to 600mg/day, Colchicine
- Where
- 26 sites in Germany, Italy and 4 more
- Volunteers
- 196 people
- Sponsor
- Menarini International Operations Luxembourg SA
Diabetes Mellitus
Human Factors and Home Use Study of the Vigilant Diabetes Management Application
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether…
- Trial name
- NCT02276131
- Testing
- Vigilant Diabetes Management Application
- Volunteers
- 61 people
- Sponsor
- InSpark Technologies, Inc.
SARS-CoV-2 Infection, Influenza A
Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT07430410
- Testing
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Volunteers
- 200 people
- Sponsor
- CorDx, Inc.
Virus Diseases, RNA Virus Infections
Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.
A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02022163
- Testing
- Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel, High dose of H7 VLP vaccine + Alhydrogel
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medicago
Supplemental Oxygen
Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator
This study was a follow-up evaluation of modifications made to the instructions in the User Manual following the initial study evaluating how well an individual can put together and use a Portable Oxygen Concentrator (POC).
- Trial name
- NCT04358848
- Testing
- X-PLO2R
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Belluscura LLC
Chronic Obstructive Pulmonary Disease (COPD)
WearME-Pro Phase II: Remote Use Usability and Longitudinal Validation Study (Patch Form Factor).
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with COPD in a home-use environment.
- Trial name
- WearME-Pro (NCT07430605)
- Testing
- WearME-Pro Patch System, FDA-cleared handheld spirometer (reference comparator), Cardea SOLO ECG patch (optional subset; exploratory HR reference)
- Where
- 3 sites in United States
- Volunteers
- 82 people
- Sponsor
- LASARRUS Clinic and Research Center
Neuropathy, Diabetic, Neuropathy;Peripheral
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic…
- Conditions
- Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful
- Trial name
- NCT05291975
- Testing
- Erchonia® EVRL™
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Erchonia Corporation
COVID-19
Home Usability Study of the SARS-CoV-2 (COVID-19) Test
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.
- Trial name
- NCT04395391
- Testing
- SARS-CoV-2
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation