Clinical trials: Human Factors
Virus Diseases, RNA Virus Infections
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults
A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02233816
- Testing
- Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine, High dose of quadrivalent VLP vaccine
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Medicago
Hepatitis B, Hepatitis A
Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
- Trial name
- NCT00603252
- Testing
- Twinrix, Engerix-B, Havrix
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Virus Diseases, RNA Virus Infections
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine in the Elderly Population
This is a multiple sites phase II trial, randomized, observer-blind, dose ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-based Seasonal VLP…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02236052
- Testing
- Non-adjuvanted low dose of quadrivalent VLP vaccine, Non-adjuvanted medium dose of quadrivalent VLP vaccine, Non-adjuvanted high dose of quadrivalent VLP vaccine
- Where
- 3 sites in Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Medicago
Rheumatoid Arthritis
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially…
- Trial name
- NCT02682823
- Testing
- AI-1000 G2, Tocilizumab
- Where
- 8 sites in United States
- Volunteers
- 91 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Hepatitis C, Chronic
Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)
The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard…
- Trial name
- RE-CHUT (NCT00725842)
- Testing
- Peg-IFN alfa-2b, Ribavirin
- Volunteers
- 97 people
- Sponsor
- Merck Sharp & Dohme LLC
Supplemental Oxygen
Usability Evaluation of a Portable Oxygen Concentrator
This study evaluates how well an individual can put together and use a Portable Oxygen Concentrator (POC) by following the instructions in the User Manual.
- Trial name
- NCT04299178
- Testing
- X-PLO2R POC
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Belluscura LLC
Cervical Cap Insemination
Human Factors Usability Study of Ib2C Conception System
The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use.
- Trial name
- NCT01564940
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Rinovum Women's Health, Inc.
Hepatitis C, Chronic
An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin.
- Trial name
- NCT01392742
- Where
- 9 sites in Bulgaria
- Volunteers
- 443 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Solid Tumors
ADC-1013 First-in-Human Study
The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or…
- Trial name
- NCT02379741
- Testing
- ADC-1013
- Where
- 5 sites in Denmark, Sweden and 1 more
- Volunteers
- 24 people
- Sponsor
- Alligator Bioscience AB
Leukemia, Leukemia, Myeloid
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type
- Trial name
- CYNK001AML01 (NCT04310592)
- Testing
- CYNK-001
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celularity Incorporated
Virus Diseases, RNA Virus Infections
Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies.
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02768805
- Testing
- 15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine, 15 µg/strain of the licensed quadrivalent vaccine
- Where
- 9 sites in United States, Canada
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Medicago
Xerostomia
SaliPen Human Factors Study for OTC Labeling
This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information…
- Trial name
- SaliPen (NCT05058430)
- Testing
- Electrical salivary stimulator system assigned to subjects with xerostomia, No Electrical salivary stimulator system assigned to subjects without xerostomia
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Saliwell Ltd.
Onychomycosis
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to…
- Trial name
- NCT05626270
- Testing
- LunulaLaser OTC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Erchonia Corporation
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Juvenile Idiopathic Arthritis
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label…
- Trial name
- NCT02052167
- Testing
- methotrexate prefilled pen
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- medac GmbH
Acute Myelogenous Leukemia, Acute Myeloid Leukemia
MCLA-117 in Acute Myelogenous Leukemia
This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.
- Trial name
- NCT03038230
- Testing
- MCLA-117 bispecific antibody
- Where
- 9 sites in United States, Belgium and 3 more
- Volunteers
- 80 people
- Sponsor
- Merus B.V.
Virus Diseases, RNA Virus Infections
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT01991587
- Testing
- Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine, High dose of quadrivalent VLP vaccine
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medicago
Tinnitus
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by…
- Trial name
- NCT05374421
- Testing
- Erchonia® THL™
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Erchonia Corporation
Advanced/Metastatic Solid Tumors, Colorectal Cancer
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.
- Conditions
- Advanced/Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Gastroesophageal-junction Cancer
- Trial name
- NCT03526835
- Testing
- MCLA-158, MCLA-158 + Pembrolizumab, MCLA-158 + FOLFIRI
- Where
- 54 sites in United States, Belgium and 5 more
- Volunteers
- 560 people
- Sponsor
- Merus B.V.