HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema

Introduction Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. Methods and analysis This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with 99mTc lymphoscintigraphy—one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. Ethics and dissemination The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020

Proposal Of Propulsion Unit Based On Earthworm Setae For Underwater Excavation Robot

In this paper, we developed a propulsion unit with bristles imitating the setae of earthworm. This propulsion unit is installed in SEAVO: sub-seafloor excavation robot. To realize underwater excavation by SEAVO, it is necessary to move the soft and fluid sedimentary layer of seafloor surface. As a solution, we focused on the setae of earthworm which live in mud and soft soil. Then, we developed the propulsion unit with bristles imitating the earthworm's setae and measured the performance of the bristlesattached propulsion unit. Comparing the measurement result of the bristles-attached propulsion unit with the previous propulsion unit, we confirmed the usefulness of the bristles-attached propulsion unit

Distributed Driving System For The Excavation Unit Of A Lunar Earthwarm-Type “Leavo” Excavation Robot

The authors have developed a small excavation robot called the “LEAVO” for lunar exploration, and they have confirmed its usefulness as an excavation robot. They then attempted to add a curved excavation function in order for the LEAVO to increase its exploration field. To achieve this goal, it was necessary for the LEAVO’s excavation unit to transmit the motor output torque to the excavation head without any losses. In this paper, therefore, the authors proposed a new driving system called the “distributed driving system,” which reduced the transmission losses by distributing the actuators and arranging them in the frontal part of the robot. Moreover, the authors developed the prototype of this system and measured its output torque as an operational check

Phase I study of combined therapy with vorinostat and gefitinib to treat BIM deletion polymorphism-associated resistance in EGFR-mutant lung cancer (VICTROY-J) : a study protocol

The BIM deletion polymorphism is reported to be associated with poor outcomes of epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) treated with EGFR-TKIs, including gefitinib. We have shown that a histone deacetylase inhibitor, vorinostat, can epigenetically restore BIM function and apoptosis sensitivity to EGFR-TKIs in EGFR-mutant NSCLC cells with BIM deletion polymorphisms. The purpose of this study is to determine the feasibility of combined treatment of vorinostat with gefitinib in BIM deletion polymorphism positive EGFR-mutant NSCLC patients. BIM deletion polymorphism positive EGFR mutant NSCLC patients treated with at least one EGFR-TKI and one regimen of chemotherapy are being recruited to this study. Vorinostat (200-400mg) will be administered orally once daily on days 1-7, and gefitinib 250 mg orally once daily on days 1-14. With a fixed dose of gefitinib, the dose of vorinostat will be escalated following a conventional 3+3 design. The primary endpoint is to define the maximum tolerated dose (MTD) of vorinostat combined with 250 mg of gefitinib. This is the first phase I study of combined therapy with vorinostat and gefitinib for NSCLC patients double selected for an EGFR mutation and BIM deletion polymorphism

Proposal Of Propulsion Unit Based On Earthworm Setae For Underwater Excavation Robot

In this paper, we developed a propulsion unit with bristles imitating the setae of earthworm. This propulsion unit is installed in SEAVO: sub-seafloor excavation robot. To realize underwater excavation by SEAVO, it is necessary to move the soft and fluid sedimentary layer of seafloor surface. As a solution, we focused on the setae of earthworm which live in mud and soft soil. Then, we developed the propulsion unit with bristles imitating the earthworm's setae and measured the performance of the bristlesattached propulsion unit. Comparing the measurement result of the bristles-attached propulsion unit with the previous propulsion unit, we confirmed the usefulness of the bristles-attached propulsion unit

Distributed Driving System For The Excavation Unit Of A Lunar Earthwarm-Type “Leavo” Excavation Robot

The authors have developed a small excavation robot called the “LEAVO” for lunar exploration, and they have confirmed its usefulness as an excavation robot. They then attempted to add a curved excavation function in order for the LEAVO to increase its exploration field. To achieve this goal, it was necessary for the LEAVO’s excavation unit to transmit the motor output torque to the excavation head without any losses. In this paper, therefore, the authors proposed a new driving system called the “distributed driving system,” which reduced the transmission losses by distributing the actuators and arranging them in the frontal part of the robot. Moreover, the authors developed the prototype of this system and measured its output torque as an operational check