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NCT ID: NCT06373159 Active, not recruiting - Sepsis Clinical Trials

An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan

Start date: April 10, 2024
Phase:
Study type: Observational

This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied. In observational studies, only observations are made without participants receiving any advice or changes to their healthcare. DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC. To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting. In this study, researchers will assess patient data from a hospital database in Japan. The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year. To learn about this, researchers will collect the following information: - The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis - The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores) - The number of days between diagnosis of sepsis and the beginning of DIC Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan. In this study, only available data from routine care are collected.

NCT ID: NCT06298643 Active, not recruiting - Clinical trials for Lower-risk Myelodysplastic Syndromes

Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan

Start date: December 22, 2023
Phase:
Study type: Observational

The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.

NCT ID: NCT06224907 Active, not recruiting - Hemophilia A Clinical Trials

Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A

GENEr8-JPN
Start date: December 25, 2023
Phase: Phase 3
Study type: Interventional

This Phase III clinical study will evaluate the safety and effectiveness of valoctocogene roxaparvovec in Japanese patients with severe hemophilia A.

NCT ID: NCT06212752 Active, not recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

Start date: June 13, 2023
Phase: Phase 3
Study type: Interventional

This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

NCT ID: NCT06212089 Active, not recruiting - Parkinson Disease Clinical Trials

Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study to evaluate the safety and pharmacokinetics of TR-012001 in patients with Parkinson's disease when TR-012001 or placebo is administered.

NCT ID: NCT06153966 Active, not recruiting - Prion Disease Clinical Trials

PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.

Start date: January 4, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.

NCT ID: NCT06149104 Active, not recruiting - Heart Failure Clinical Trials

A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study

Start date: December 4, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this open-label study is to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1 study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.

NCT ID: NCT06130410 Active, not recruiting - COVID-19 Clinical Trials

Special Investigation for Booster Dose of Comirnaty in Children Ages 6 Months Though 4 Years

Start date: March 6, 2024
Phase:
Study type: Observational

The purpose of this post-marketing study is to assess the safety of Comirnaty monovalent XBB.1.5. for booster vaccination children ages 6 months though 4 years under actual use medical practice.

NCT ID: NCT06106568 Active, not recruiting - Liver Metastases Clinical Trials

An Observational Study to Learn More About the Impact of Gadoxetate Sodium-Enhanced Magnetic Resonance Imaging (EOB-MRI) When Used to Diagnose the Spread of Cancer From the Pancreas to the Liver in Japanese People Under Real-World Conditions

Start date: November 20, 2023
Phase:
Study type: Observational

This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer. Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver. Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results. Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions. The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs. The main information that researchers will collect in this study: participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy the length of time: from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival) from the date of first treatment for pancreatic cancer until the cancer spreads of other organs from the date of diagnosis of pancreatic cancer to starting the first treatment from the date of first treatment for pancreatic cancer to starting the second treatment option treatments that the participants have received, including anti-cancer drugs, radiation, and surgery the number of hospital visits, use of healthcare facilities, and related costs. The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI. The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022. Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study. In this study, only available data from health records are collected. No visits or tests are required as part of this study.

NCT ID: NCT06095115 Active, not recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

ICONIC-LEAD
Start date: October 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.