Projects｜j-CCRC Japan Consortium of Clinical Research Core Hospitals

Research subjectInstitutionArea of the studyDevelopment itemsRegulatory approval

Development of Electrophysiological Determination of Uterine Receptivity (EDUR) systemOsaka University HospitalOther than cancerMedical devicesOthers

Study
outline
Approximately 1 in every 6 people of reproductive age worldwide experience infertility in their lifetime. Assisted reproductive technology (ART) includes fertility treatment in which either eggs or embryos are handled outside of a female's body to promote successful pregnancies and healthy babies. ART treatment is common worldwide.
Even though it is only the embryos which are growing normally under the severe in-vitro culture condition which are transferred, the efficiency of the treatment is not high enough. To improve efficiency of current ART treatment, we have developed the system to measure in-vivo intrauterine bioelectrical impedance for evaluating the prospect of uterine receptivity in each menstrual cycle. We are going to conduct clinical research in Taiwan to prove the efficacy and safety of the device.
DRPLA Natural History and Biomarkers StudyThe University of Tokyo HospitalOther than cancer------

Study
outline
To characterize the natural history and to identify genetic factors and biomarkers of DRPLA, we perform clinical assessments for baseline visit and two follow-up visits for twice and collect biosamples.
Explore Impacts of Head Motion on Cerebrospinal Fluid Dynamics using Simulation and Real-Time Medical ImagingJuntendo University HospitalOther than cancerMedical devices---

Study
outline
The fast-nodding head motion is found to cause the mixing of CSF in the ventricles to be more uniform and to transport the labeled CSF further into the lateral ventricles than the slow nodding and the no nodding do. The mixing of CSF and the transport in the ventricular CSF flows also occur at a faster time scale with the head in motion than at rest.
Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)Juntendo University HospitalCancerOther---

Study
outline
This prospective single arm study is aimed to evaluate efficacy and safety after low-dose (20 Gy) consolidation radiotherapy after standard chemotherapy for diffuse large B-cell lymphoma.
MEK Inhibitor (Trametinib) Treatment to Reverse Metaplasia in Gastric Mucosa After Treatment for Early Gastric Cancer or Gastric AdenomaThe University of Tokyo HospitalCancerDrugsOff-label use

Study
outline
Determine whether Trametinib treatment can significantly ameliorate the presence of metaplastic lineag es in the stomach and allow repopulation of the g astric mucosa with normal gastric lineag es in treating patients (more than 50% compared to pre-treatment). Safty evaluation of Trametinb 1 mg /day for 2 weeks treatment. For the safety evaluation, NCI-CTCAE grade will be used. For substantial safety evaluation, the emerg ence rate of rash, diarhea, cardiac functional failure, hepatic failure will be evaluate.
Longitudinal Observational Cohort Study of Autosomal Dominant Alzheimer's Disease (ADAD) (DIAN-J)The University of Tokyo HospitalOther than cancerIn vitro diagnostics
C11-PIBUnapproved

Study
outline
To study dominantly inherited AD in individuals for whom the diagnosis is certain (mutation carriers) in comparison with their non-carrier siblings, who serve as a naturally occurring control group.
Prevalence and dissemination patterns of Carbapenemase producing Enterobacteriaceae in the environment of Dhaka, BangladeshOsaka University HospitalOther than cancer---Others

Study
outline
Antimicrobial resistance (AMR) has been estimated to cause 10 million deaths each year by 2050. Speculating a higher and different distribution of resistant pathogens in Dhaka, Bangladesh- home of 166 million people, we are investigating the prevalence of Carbapenamase producing Enterobacteriaceae (CPE) spread in the local environment. Our aim is to understand the molecular epidemiology and extent of CPE dissemination from the perspective of endemicity.
Collaborating study of Prospective, MUlticenteR, Observational StUdy of the PatIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFPEF) between Japan and Cambodia Osaka University HospitalOther than cancerOtherOthers

Study
outline
Osaka University Hospital and affiliating hospitals has been conducting heart failure with preseved ejection fraction (HFpEF) registry aiming to clarify patients characteristics, treatment and long-term outcomes. We are plannning to conduct collaborating study of HFpEF registry between Japan and Cambodia
Development and industrialization of intravenous vagal nerve stimulation catheterKyushu University HospitalOther than cancerMedical devicesUnapproved

Study
outline
This study is aim to develop and industrialize the intravenous vagal nerve stimulation (iVNS) catheter system, which exerts rapid and stable bradycardia and multiple cardio-protective effects. We have developed an intravenous electrical catheter to stimulate the right vagal nerve as a clinical applicable minimally invasive technique. In the previous phase, we could produce the prototype of iVNS with control algorhythm which administrates the optimal electrical stimulation to the nerve. We formulated the regulatory strategy for obtaining the approval as “a device for inducing bradycardia”. We are now planning the First in Human clinical trial of iVNS.
Innovative diagnostic systems using Ai-nanoporeOsaka University HospitalOther than cancer---Unapproved

Study
outline
We will develop an artificial intelligent nanopore platform that provides innovative diagnostic system for bacteria, viruses, and exosomes, machine-learning their electric pulses.

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