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NCT ID: NCT03254758 Recruiting - Clinical trials for Decompensated Liver Cirrhosis

A Study of ADR-001 in Patients With Liver Cirrhosis

Start date: July 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs) manufatured in our company. The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.

NCT ID: NCT03254134 Not yet recruiting - Atrial Fibrillation Clinical Trials

Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Start date: August 30, 2017
Phase: N/A
Study type: Observational

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

NCT ID: NCT03254108 Recruiting - Clinical trials for Congestive Heart Failure

Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Start date: August 2017
Phase: N/A
Study type: Interventional

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

NCT ID: NCT03253991 Recruiting - Essential Tremor Clinical Trials

A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Escential Tremor

Start date: November 17, 2014
Phase: N/A
Study type: Interventional

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

NCT ID: NCT03252808 Not yet recruiting - Clinical trials for Pancreatic Cancer Stage IV

Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Japanese Patients With Unresectable Pancreatic Cancer.

Start date: August 18, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the recommended dose of TBI-1401(HF10) treatment in combination with chemotherapy (Gemcitabine + Nab-paclitaxel) in Japanese patients with stage III or IV unresectable pancreatic cancer.

NCT ID: NCT03252587 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus

Start date: September 12, 2017
Phase: Phase 2
Study type: Interventional

This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

NCT ID: NCT03251482 Not yet recruiting - Clinical trials for VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

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Start date: September 30, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).

NCT ID: NCT03251430 Recruiting - Osteoporosis Clinical Trials

Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy

Start date: August 20, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

NCT ID: NCT03250325 Not yet recruiting - Synovial Sarcoma Clinical Trials

Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma

Start date: August 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.

NCT ID: NCT03248232 Recruiting - Clinical trials for Aortic Valve Stenosis

Assessments of Thrombus Formation in TAVI

Start date: August 1, 2017
Phase: N/A
Study type: Observational

Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established. To establish the antithrombotic regimen in patients undergoing TAVI, 1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS). 2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.