Trajectory for the Regulatory Approval of a Combination of Pertuzumab Plus Trastuzumab for Pre-treated HER2-positive Metastatic Colorectal Cancer Using Real-world Data.

Utilizing real-world data (RWD) for effective clinical implementation is becoming more and more appealing as the cost of drug development rises, especially for patients with rare diseases and rare molecular subtypes for whom conducting randomized controlled trials is challenging. If a regulatory approval methodology based on RWD as an external control group can be established, drug development for rarer fractions can be accelerated by lowering costs and time, as well as reducing physical and emotional burdens on both patients and healthcare professionals. Since 2017, we have been prospectively collecting the clinical data of standard therapies in patients with rare molecular fractions under the SCRUM-Japan Registry platform, which is a qualified registry utilized as external control data for regulatory submission.

Stabilometric analysis of neck orientations during mealtime by a wearable device for dysphagia patients.

Postural changes are commonly used treatment to prevent the elderly from the risk of aspiration pneumonia. However, the evidence-based studies regarding effectiveness of this treatment remains unclear since no systematic method exists to measure constantly changing postures without disturbing usual eating behaviors. In this paper, using IMU system attached to a smart-phone based wearable technology, we analyzed data of the neck orientation angles obtained from the dysphagia patients and healthy adults during their mealtime and attempted to see if the obtained data can show differences regarding the dynamics of the angles.

Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial.

The applicability of circulating tumor DNA (ctDNA) genotyping to inform enrollment of patients with cancer in clinical trials has not been established. We conducted a phase 2 trial to evaluate the efficacy of pertuzumab plus trastuzumab for metastatic colorectal cancer (mCRC), with human epidermal growth factor receptor 2 (HER2) amplification prospectively confirmed by tumor tissue or ctDNA analysis ( UMIN000027887 ). HER2 amplification was confirmed in tissue and/or ctDNA in 30 patients with mCRC.

Deep Learning-Based Swallowing Monitor for Realtime Detection of Swallow Duration.

Aspiration pneumonia is a life-threatening disease for the elderly. To prevent its risk, regular swallowing assessment is necessary; however, current screening tools for swallow assessment are not widely available and medical experts are insufficient. As a portable assessment tool, we have been developing a smartphone-based realtime monitoring device (GOKURI) which can evaluate swallowing ability based on swallow sounds.

Automatic Measurements of Neck Angles toward the Bedside Treatment for the Dysphagia Patients at the Community-Based Health Care.

For the elderly with dysphagiais, postural changes are a popular method to reduce the risk of aspiration pneumonia. Among them, the reclining position, a postural change set by the bed angles, has been widely used in practical settings. However, setting the reclining positions is difficult since all beds do not have a system to measure angles especially at the nursing facilities and patient's homes.

Robot-assisted voluntary initiation reduces control-related difficulties of initiating joint movement: A phenomenal questionnaire study on shaping and compensation of forward gait.

Humans employ various control strategies to initiate and maintain bodily movement. In case that the normal gait function is impaired, exoskeleton robots provide motor assistance during therapy. While the robotic control system builds on kinematic gait functions, the patient's voluntary efforts to initiate motion also contribute to the effectiveness of the therapy process.

Smartphone-based swallowing monitoring and feedback device for mealtime assistance in nursing homes.

As many of the elderly are prone to dysphagia, preventing aspirations during mealtime assistance is a huge concern, especially for institutions operated with limited staff. Two of the main course of actions that are taken usually to prevent aspiration are the altering of bolus consistency and altering of the swallowing posture. To assist prevention of pneumonia, we have been developing a smartphone-based wearable technology that can evaluate swallowing ability in real-time.