Kaifu Gun, Japan

A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)

Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Adult cohort: The trial includes a maximum of 5 visits and the record of patient's diagnosis as standard of truth: - One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 can be done on the same day as V2 if all the inclusion/non-inclusion criteria are met). - Two sequential imaging visits (V2 and V4, minimum interval 2 days and up to 14 days): each visit will consist of gadopiclenol injection or comparator injection and MRI procedure. - Two safety visits (V3 and V5): 1 day after each injection and MRI examination. Pediatric cohort: The inclusions will be divided into 4 age groups: patients from birth to 23 months of age inclusive, patients from 2 to 6 years, patients from 7 to 11 years and patients from 12 to 17 years. The recruitment in the 3 older groups of pediatric patients can be conducted in parallel with adult patients' enrolment. The decision to start the inclusion in the group of patients aged from birth to 23 months will be taken by the Trial Safety Review Board (TSRB). The trial includes a maximum of 3 visits and the record of patient's diagnosis as standard of truth: - One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 can be done on the same day as V2 if all the inclusion/non-inclusion criteria are met). - One imaging visit (V2): will consist of gadopiclenol injection and MRI procedure. - pharmacokinetics (PK) group: Blood sampling for PK will start after gadopiclenol injection according to defined blood sampling schedule and will take up to 8 hours. - One safety visit (V3): 1 day after gadopiclenol injection and MRI examination. All Patients: Images will be assessed off-site in a centralized manner. Pediatric group : 24 patients of the pediatric cohort will be included in gadopiclenol PK profile assessment. The approach implemented for pharmacokinetics (PK) analyses allows sparse blood sampling only and is selected to minimize the clinical burden to children. All cohorts : During the trial, the safety of the patients will be monitored and assessed based on the reporting of adverse events (AEs), including vital signs, ECG for pediatric patients and clinical laboratory parameters (blood samples).

Effect of Respiratory Virus Infection on EmeRgencY Admission Study (EVERY Study)

The investigators register consecutive patients who meet the eligibility criteria at 3 participating hospitals from electronic medical records. As a routine clinical practice, presence of respiratory symptoms using standard electronic medical record (EMR) format are universally assessed at the emergency room when the patients are determined to be admitted. Patients are registered if they meet the eligibility criteria and information of medical history, baseline characteristics, living status, physical findings, laboratory tests, chest X-ray, electrocardiogram, on admission are retrieved from the EMRs. The nasopharyngeal swab is obtained within 24 hours after admission as a standard practice, which will be sampled at either emergency rooms or hospital wards. The swab is transferred to the onsite laboratory office to measure the FilmArray 2.1 by trained technicians or physicians in charge. Serum antibodies for RS virus are obtained from patients with suspected lower respiratory infection (bronchitis and pneumonia) who provided their written informed consent, at the timing of admission and 4 weeks after the admission.

Early Treatment With a Sodium-glucose Co-transporter 2 Inhibitor in High-risk Patients With Acute Heart Failure

TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)

This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions. 1. Detection of unknown adverse drug reactions 2. Incidence of adverse drug reactions under actual use conditions of the drug 3. Factors that may affect the safety or effectiveness "Safety specification" Thrombotic events, Infusion reaction, re-bleeding

A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer

Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

This is a mandatory Post-Marketing Surveillance (PMS) requested by Pharmaceuticals and Medical Devices Agency (PMDA) as a part of the Japan-Risk Management Plan (J-RMP).

Product Surveillance Registry