Conectar
by Masatsugu Ishii, Osamu Itano, Hideki Iwamoto, Yuko Takami, Naomi Okada, Tetsuya Inoue, Satoshi Itano
We identified an effective chemotherapy regimen in patients refractory to standard chemotherapy. We included patients with unresectable colorectal liver metastases who underwent hepatic artery infusion chemotherapy and systemic chemotherapy between January 2015 and December 2022. This study was a retrospective analysis conducted at a single center. The patients received either biweekly oxaliplatin and 5-fluorouracil through hepatic artery infusion chemotherapy as well as bevacizumab and leucovorin injected intravenously (HAIC-FOLFOX-B) or biweekly irinotecan and 5-fluorouracil by hepatic artery infusion chemotherapy and bevacizumab and leucovorin injected intravenously (HAIC-FOLFIRI-B). Of the 42 patients, 20 underwent HAIC-FOLFOX-B while 22 underwent HAIC-FOLFIRI-B treatment with response rates of 25% and 4.5%, respectively. The median overall survival and progression-free survival were 12.9 and 4.7 months and 17.4 and 7.7 months in patients undergoing HAIC-FOLFOX-B and HAIC-FOLFIRI-B, respectively. The overall incidence of grade 3/4 toxicity was 23.8%. However, no treatment-related deaths occurred. Functional catheter-associated problems occurred in 9.5% of the patients. Hepatic arterial occlusion occurred in three patients (7.1%); catheter-associated infection occurred in one (2.4%) patient. However, these occurrences were not life-threatening complications. HAIC-FOLFOX-B and HAIC-FOLFIRI-B might improve survival in patients with unresectable colorectal liver metastases and in those who underwent both systemic oxaliplatin-based and irinotecan-based chemotherapies and were refractory to them. HAIC FOLFOX-B and FOLFIRI-B regimens might be effective therapeutic options in patients with unresectable colorectal liver metastases refractory to standard systemic chemotherapy.The intestinal microbiota of people with Parkinson’s disease (PwP) differs significantly from that of healthy individuals. Given that altered microbiota may play a role in the pathogenesis of Parkinson’s disease, faecal microbiota transplantation (FMT) has been proposed as a potential therapeutic approach. However, the efficacy of FMT in improving motor symptoms in PwP has been inconclusive in some pilot randomised controlled trials (RCT). Previous RCTs on PwP employed simple FMT, but our modified approach—pretreatment with antibiotics before FMT (A-FMT)—has been shown to improve the engraftment rate of given species and the beneficial effects of FMT. This study aims to evaluate the efficacy and safety of A-FMT for PwP, particularly in those with motor fluctuations.
This study is a randomised, double-blind, placebo-controlled, parallel-group study with an 8-week observation period following a single A-FMT. Thirty clinically established PwP with prominent motor fluctuation episodes will be randomised 1:1 to FMT or placebo. Participants in both groups will receive antibiotic treatment prior to colonoscopy for FMT or placebo treatment. Primary and secondary endpoints will include subjective and objective evaluations of motor and non-motor symptoms and will be evaluated before and after antibiotic treatment and at 4 and 8 weeks after the procedure. Exploratory endpoints will include blood and faecal sample analyses, advanced brain MRI and pharmacokinetic assessment of levodopa concentrations during a levodopa challenge test.
This study has been approved by the ethical committee of Juntendo University in August 2024 (J24-005) and will be conducted in accordance with the Declaration of Helsinki, the Japan Ministry of Health, Labour and Welfare Clinical Trials Act and related laws and regulations. All patient data will be anonymised to protect privacy and used solely for study purposes. Results will be published in academic journals and presented at conferences.
jRCTs031240344.
Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.
This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.
The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.
28 October 2024, V.8.0.
jRCT1091220353.
Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.
The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.
This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.
jRCT1062220035.
Pain is under-assessed and under-treated among people living with dementia. This study aims to explore the perspectives of people with dementia, family carers, and healthcare professionals regarding their experiences and needs for pain assessment and management.
A qualitative descriptive approach.
Between May and August 2023, people with early-stage dementia (n = 6), their family carers (n = 7), and healthcare professionals (n = 10) from four Australian states participated in semi-structured interviews, online or by telephone. Most of the participants were female. Work experience of healthcare professionals and caring experience of carers ranged from 3–40 and 2–8 years, respectively. Following transcription, the data were analysed using inductive thematic analysis.
Four main themes and 10 subthemes were identified. Main themes were (1) communications to identify pain in people with dementia, (2) pain assessment in people with dementia, (3) pain management strategies, and (4) training in pain and dementia care. Healthcare professionals and family carers reported challenges in pain identification. People with dementia also mentioned their pain being unrecognised by carers. Facilitators included familiarity and communication with people with dementia and family carers. Non-verbal cues and unusual behaviours were commonly used to identify pain, and a personalised pain assessment approach was highlighted. Non-pharmacological strategies were used as the first-line therapy to manage pain. However, a lack of knowledge and training in pain and dementia care indicated the need for a training program (e.g., a self-paced online short course).
Pain assessment and management in people with dementia is challenging, primarily due to communication barriers and a lack of skill training. Formal pain assessment and management training and efficient, easy-to-use pain assessment tools are needed to address this.
Limited communication capacity in people with dementia and lack of training in carers are key challenges regarding pain assessment and management in people with dementia. Improved training in communication, pain assessment, and management skills may help to address these challenges.
This study addressed a lack of knowledge and skills for healthcare professionals and family carers in effective pain assessment and management in people with dementia. Collaborative communication among different stakeholders and skills training may overcome the challenges and barriers.
COREQ guidelines were followed when reporting this study.
Healthcare professionals, people with dementia, and family carers contributed to the design of interview questions and data collection.
FreshRSS 