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NCT ID: NCT05590403 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

Start date: October 28, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA

NCT ID: NCT05572567 Completed - Clinical trials for Arthritis, Rheumatoid

Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

Start date: October 10, 2022
Phase:
Study type: Observational

This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry. The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.

NCT ID: NCT05568615 Completed - ALS Clinical Trials

Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Start date: October 26, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

NCT ID: NCT05563454 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How Safe the Study Treatment BAY2395840 is, How it Affects the Body and How it Moves Into, Through, and Out of the Body if Given in Single and in Repetitive Doses to Japanese Healthy Male Participants

Start date: October 11, 2022
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP). DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar levels being too high for too long. BAY2395840 works by blocking specific receptors. A receptor is a protein inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell. BAY2395840 specifically blocks so-called bradykinin B1 receptor, whose activation is involved in inflammatory responses. This blockage may help to relieve pain and inflammation. BAY2395840 has already been studied in clinical studies with European people. However, data for Japanese people are still missing. The participants of this study do not benefit from this study. However, the study will provide information on how to use BAY2395840 in later studies with Japanese people. The main purpose of this study is to learn how safe the study drug BAY2395840 is and how it affects the body if given in single and in repetitive doses to Japanese healthy male participants. To answer this question, the researchers will collect and analyze the medical problems the participants have after taking BAY2395840 and that may or may not be related to the study treatments. These medical problems are also known as "adverse events". In addition, the study team will learn how BAY2395840 moves into, through and out of the body if given in single and in repetitive doses to Japanese healthy male participants. For this, the researchers will collect data on: - the (average) highest level of BAY2395840 in the blood (also referred to as Cmax) - the (average) total level of BAY2395840 in the blood (also referred to as AUC) during the treatment period with the study drug on day 1 and for the repetitive dose group only (see below), on day 7. Subsequently, the study team will compare the data between those participants who received the study drug BAY2395840 (from different dosing groups) and those participants who received placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. All study participants will be randomly (by chance) assigned to 1 of 5 treatment groups. Dependent on the treatment group, the participants will either take: - a single dose of the lowest, middle and highest BAY2395840 dose (treatment groups 1 to 3) - repetitive doses of the highest BAY2395840 dose (treatment group 4) or - placebo (treatment group 5). The participants will take their treatments as dosage form 1 after diet 1. The treatment period with repetitive doses of BAY2395840 will be 7 subsequent days. The participants from treatment groups 1 to 3 will have an in house-period of 8 days including 7 overnight stays. The participants from treatment group 4 will have an in house-period of 12 days including 11 overnight stays. The study duration will be approximately 6 weeks per participant for dose groups 1 to 3 and approximately 7 weeks per participant for dose group 4. During the study, the study team will: - take blood and urine samples - do physical examinations - check the vital signs such as blood pressure, heart rate, body temperature - examine heart health using electrocardiogram (ECG). About 10 to 14 days after the participants take their last treatment, the study doctors and their team will check the participants' health.

NCT ID: NCT05563246 Completed - Clinical trials for Lipoprotein Disorder

A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

KRAKEN
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.

NCT ID: NCT05559229 Completed - Gallbladder Cancer Clinical Trials

Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report

Start date: January 15, 2021
Phase:
Study type: Observational

Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.

NCT ID: NCT05547087 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Dose Finding Study of VN-0200

Start date: October 13, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

NCT ID: NCT05495581 Completed - Healthy Volunteers Clinical Trials

A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well

Start date: August 25, 2022
Phase: Phase 1
Study type: Interventional

The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. ASP5354 is a potential new medical dye to help surgeons clearly see the ureter during surgery. ASP5354 is injected into the body and is detected by a type of camera called near infrared fluoroscopy, or NIR-F for short. Together they show live images of the ureter during surgery. Before ASP5354 is available as a medical dye, the researchers need to understand how it affects the body. In this study, the researchers will check how ASP5354 affects the body in adults up to 75 years old. The main aim is to learn how ASP5354 is processed by the body in people whose kidneys do not work well compared to healthy people. There will be 4 groups of people with different levels of how well their kidneys work. This study will include a 3-night stay in a clinical research unit. People will be admitted to the clinic the day before they receive the ASP5354 injection. The study doctor will take their medical history. People will have an ECG to measure their heart rhythm, a medical examination, and will have their vital signs checked (pulse rate, body temperature and blood pressure). They will also give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. People will need to fast for several hours before receiving the injection. The next day, people will receive 1 injection of ASP5354. They will continue to fast for a few hours afterwards. They will have an ECG and will have their vital signs checked. They will also give blood and urine samples for laboratory tests and the study doctors will check for medical problems. During the next 2 days, people will give more blood and urine samples and the study doctors will check for medical problems. On the last day, people will also have their vital signs checked. If there are no medical problems on the last day, people can return home. People will return to the clinic about 1 week later for a final check-up. They will have an ECG, a medical examination and have their vital signs checked. They will give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. The study doctors will also check for medical problems.

NCT ID: NCT05495061 Completed - Clinical trials for Primary Open Angle Glaucoma, Ocular Hypertension

A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Start date: August 9, 2022
Phase: Phase 3
Study type: Interventional

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

NCT ID: NCT05480553 Completed - Clinical trials for Acute Pain in Herpes Zoster

NPC-06 to Pain Associated With Acute Herpes Zoster

Start date: August 5, 2022
Phase: Phase 3
Study type: Interventional

To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.