A multicenter retrospective observational NAPOLEON2 study of nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable pancreatic cancer.

Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer. However, there are limited clinical data on its efficacy and safety in the real-world. We therefore initiated a retrospective and prospective observational study (NAPOLEON-2).

Calcium evaluation using coronary computed tomography in combination with optical coherence tomography.

Optical coherence tomography (OCT) can assess calcium thickness, a key factor for predicting good stent expansion; however, it underestimates coronary calcium severity due to its penetration limitation. This study aimed to evaluate computed tomography (CT) and OCT images to assess calcification. We investigated 25 left anterior descending arteries of 25 patients, using coronary CT and OCT, and assessed their calcification.

Two weeks administration of tranexamic acid for acute intracerebral hemorrhage: A hospital-based pilot study.

Background: A previous report suggested that functional status does not differ between patients who received tranexamic acid and those who received placebo within the early hours of intracerebral hemorrhage (ICH). Our pilot study tested the hypothesis that 2 weeks administration of tranexamic acid would contribute to functional improvement.

Methods: Consecutive patients with ICH were administered 250 mg tranexamic acid 3 times a day continuously for 2 weeks.

Study Design of the Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) - Protocol for a Prospective, Multicenter, Open Registry.

Guidelines for the prevention and management of cardiovascular disease (CVD) highly recommend cardiac rehabilitation (CR) on the basis of abundant evidence of its effectiveness. However, the current understanding and dissemination of CR in Japan are far from sufficient. The Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) is an academic society-led prospective multicenter observational registry conducted by the Registration and Facility Accreditation System Committee of the Japanese Association of Cardiac Rehabilitation.

Incidence, clinical characteristics, and diagnostic approach in transthyretin amyloid cardiomyopathy: The Kumamoto Cardiac Amyloidosis Survey.

Background: In recent years, transthyretin amyloid cardiomyopathy (ATTR-CM) has received increasing attention; however, the epidemiology of ATTR-CM in Japan is not yet understood. In the Kumamoto Cardiac Amyloid Survey, we evaluated the current incidence, clinical characteristics, diagnostic approaches, and treatment strategies for ATTR-CM and compared tafamidis-prescription hospitals with regional hospitals.

Methods: We conducted a retrospective multicenter observational cohort study.

Impact of cerebrovascular comorbidity on prognosis in Japanese patients undergoing PCI: 1-year data from Japanese multicenter registry (KICS).

Cardiovascular and cerebrovascular diseases are considered the principal cause of morbidity and mortality worldwide; the effect of stroke-induced cardiac manifestations is well recognized; however, not enough clinical data have been found about the impact of stroke with underlying cardiac disease. This study's objective is to assess the impact of stroke on the prognosis of patients with underlying IHD, who underwent PCI treatment. This was a multicenter, 1-year observational study in patients undergoing PCI in one of the 17 participating centers across Japan.

Palliative radiotherapy for painful lymph node metastases.

Background: There is limited evidence concerning radiotherapy for painful lymph node metastases (PLM). We evaluated the effectiveness of radiotherapy for PLM using the International Consensus Endpoint in a subgroup analysis of a prospective observational study.

Methods: In the primary study, 302 patients received radiotherapy for painful tumors.

Influence of pain duration on pain outcomes following palliative radiotherapy for painful tumors: the sooner the irradiation, the better?

Purpose: The influence of pre-radiotherapy pain duration on post-treatment outcomes was assessed.

Methods: Patients that received palliative radiotherapy were analyzed in a prospective observational study investigating curative and palliative radiotherapy. Brief Pain Inventory data were acquired at baseline and 1, 2, and 3 months after commencing irradiation.

Temporal trends in coronary intervention strategies and the impact on one-year clinical events: data from a Japanese multi-center real-world cohort study.

Percutaneous coronary intervention (PCI) has significantly advanced over the last 40 years, but it is not clear whether there have been any changes in prognosis in recent years. The Kumamoto Intervention Conference Study Real-World Registry is a multi-center registry that enrolls consecutive patients undergoing PCI in 17 centers in Kyushu, Japan. To elucidate the clinical impact of recent changes in treatment strategies, 8841 consecutive participants (historical PCI: n = 4038, enrolled between January 2013 and December 2014, and current PCI: n = 4803, between January 2015 and March 2017) with 1-year follow-up data were analyzed.

Dose-Dependent Inhibitory Effect of Rosuvastatin in Japanese Patients with Acute Myocardial Infarction on Serum Concentration of Matrix Metalloproteinases-INVITATION Trial.

Aim: Matrix metalloproteinases (MMPs) play critical roles in acute myocardial infarction (AMI). This trial was conducted to determine the potential effects of higher-dose rosuvastatin on circulating MMP levels in patients with AMI.

Methods: This was a multicenter, open-label, 1:1 randomized, parallel-group study.

Index and Nonindex Pain Endpoints in Radiation Therapy for Painful Tumors: A Secondary Analysis of a Prospective Observational Study.

Purpose: Improving pain interference in daily activities, rather than mere pain reduction, is a desirable endpoint for palliative radiation therapy. The association between pain response and pain interference has been studied almost exclusively in patients with painful bone metastases (PBMs), whereas nonindex pain has scarcely been explored in palliative radiation therapy. We investigated whether index and nonindex pain endpoints are associated with pain interference changes in patients with both PBMs and painful non-bone-metastasis tumors (PNTs).

Imaging-guided PCI for event suppression in Japanese acute coronary syndrome patients: community-based observational cohort registry.

Although there is accumulating evidence for the usefulness of imaging-guided percutaneous coronary intervention (PCI), there are few studies for acute coronary syndrome (ACS), and the impact of the frequency of use has not been well addressed. From the Kumamoto Intervention Conference Study; a Japanese registry comprising 17 institutions, consecutive patients undergoing successful PCI from April 2008 through March 2014 were enrolled. Subjects were divided into two groups: imaging-guided PCI and angiography-guided PCI.

Endovascular Treatment of Long Superficial Femoral Artery-Chronic Total Occlusions Using the Gogo Catheter With IVUS Via a Popliteal Puncture Method Is Effective, Safe, and Useful.

Objectives: We aimed to investigate the usefulness of inserting a 6Fr sheath guided by duplex ultrasonography via a popliteal artery puncture. We also aimed to demonstrate endoluminal tracking using a retrograde approach using the Gogo catheter with intravascular ultrasound (IVUS).

Background: The bidirectional approach is useful for increasing the success rate of the procedure for long superficial femoral artery-chronic total occlusions (SFA-CTOs).

Possible Dose-Response Relationship in Palliative Radiotherapy for Non-bone Painful Lesions.

Aims: Total radiation dose does not predict pain response in conventionally fractionated radiotherapy for bone metastases. By contrast, in radiotherapy for solid painful tumours other than bone metastases, it is unknown whether there is a dose-response relationship. We sought to determine whether a higher total radiation dose predicted a higher pain response rate in palliative radiotherapy for non-bone painful lesions.

Predictors of the Predominance of NonIndex Pain After Palliative Radiation Therapy for Painful Tumors.

Purpose: Even when index pain (pain caused by the irradiated tumor) is palliated after radiation therapy (RT), patients may not derive the full benefits of RT in the presence of another, more intense pain. In this case-control study with prospectively collected data, we sought to identify predictors of the predominance of nonindex pain after palliative RT.

Methods And Materials: Brief Pain Inventory data were collected from patients who received RT for painful tumors.

Modified frailty index predicts postoperative outcomes of spontaneous intracerebral hemorrhage.

Objectives: Frailty is an indispensable concept among elderly. The purpose of this study was to determine the association between modified frailty index (mFI) and the postoperative outcome of surgery for spontaneous intracerebral hemorrhage (sICH).

Patients And Methods: Outcome measures included an unfavorable outcome (modified Rankin Scale score of 4-6) or mortality at 6-8 months after hemorrhage.

Lung cancer risk stratification using methylation profile in the oral epithelium.

Background: Assuming that the entire airway is affected by the same inhaled carcinogen, similar molecular alterations may occur in the lung and oral cavity. Thus, we hypothesized that DNA methylation profiles in the oral epithelium may be a promising biomarker for lung cancer risk stratification.

Methods: A methylation-specific polymerase chain reaction was performed on oral epithelium from 16 patients with lung cancer and 32 controls without lung cancer.

A phase II study of NK012, a polymeric micelle formulation of SN-38, in unresectable, metastatic or recurrent colorectal cancer patients.

Purpose: NK012 is a polymeric micelle formulation of SN-38, the active metabolite of irinotecan. We evaluated the efficacy and safety of NK012 in Japanese patients with unresectable metastatic colorectal cancer.

Methods: We conducted a multicenter open-label phase II trial of NK012 monotherapy in 58 patients who had been treated with an oxaliplatin-based chemotherapy regimen (group A: 53 patients with UGT1A1 genotype -/-, *6/-, or *28/-; group B: 5 patients with UGT1A1 genotype *6/*28 or *6/*6).

Improvement in pain interference after palliative radiotherapy for solid and hematologic painful tumors: a secondary analysis of a prospective observational study.

Background: We previously demonstrated that patients with painful hematologic tumors were more likely to experience pain response after palliative radiotherapy (RT) than those with painful solid tumors. However, it is unknown whether change in pain interference differs between these two tumor types. In the present study, we carried out a secondary analysis of our previous prospective observational study to investigate this matter.