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NCT ID: NCT03577795 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Prospective Cohort Study of Asthma and COPD Overlap in Japanese COPD Patients Using the Diagnostic Criteria of The Japanese Respiratory Society

ACO-Registry
Start date: June 19, 2018
Phase:
Study type: Observational [Patient Registry]

This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria.

NCT ID: NCT03575871 Completed - Dermatitis, Atopic Clinical Trials

Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

JADE Mono-2
Start date: June 29, 2018
Phase: Phase 3
Study type: Interventional

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

NCT ID: NCT03575351 Completed - Clinical trials for Lymphoma, Non-Hodgkin

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

TRANSFORM
Start date: October 23, 2018
Phase: Phase 3
Study type: Interventional

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

NCT ID: NCT03574597 Completed - Obesity Clinical Trials

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

SELECT
Start date: October 24, 2018
Phase: Phase 3
Study type: Interventional

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

NCT ID: NCT03572985 Completed - Clinical trials for Healthy Participants

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to collect alcohol calibration data for the driving simulator.

NCT ID: NCT03571607 Completed - Clinical trials for Pneumococcal Infections

A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

Start date: July 12, 2018
Phase: Phase 3
Study type: Interventional

This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.

NCT ID: NCT03570957 Completed - Clinical trials for Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Start date: July 17, 2018
Phase: Phase 1
Study type: Interventional

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.

NCT ID: NCT03570047 Completed - Clinical trials for Non-valvular Atrial Fibrillation

Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

CER3
Start date: May 8, 2018
Phase:
Study type: Observational

An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan

NCT ID: NCT03569436 Completed - Clinical trials for Cancer of Head and Neck

Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread

Start date: February 14, 2018
Phase:
Study type: Observational

Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab

NCT ID: NCT03568435 Completed - Kidney Cancer Clinical Trials

Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

Start date: February 14, 2018
Phase:
Study type: Observational

A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer