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Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024.

The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of

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… Both Class 1 and 2 CTGTPs must comply with advertising restrictions, serious adverse events, product defects, recall reporting, and traceability system maintenance. Class 2 CTGTPs also require environmental risk assessment if they contain genetically modified organisms. …

Cellular Therapy for Systemic Autoimmune Diseases: New Opportunities for Future Research and Interdisciplinary Collaboration.

Systemic autoimmune diseases (sAIDs) affect 1 in 10 people and represent a leading cause of death in women under the age of 65 years. Despite the emergence of targeted-biologic therapies, mortality rates for sAIDs have not improved. Emerging cellular therapies represent a promising therapeutic strategy for patients living with sAIDs given their potential to induce sustained remission and limit long-term exposure to glucocorticoids. Encouraging outcomes from a case series of patients with systemic lupus erythematosus, idiopathic inflammatory myopathy, and systemic sclerosis (SSc) have ignited c

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… Simple but effective strategies can include having an updated list of trial names and locations on the patient organization's website, advertising for trials within patient‐ and caregiver‐directed newsletters, and offering webinars on the potential benefits and risks of cellular therapies. …

Understanding In-Person and Online Exercise Oncology Programme Delivery: A Mixed-Methods Approach to Participant Perspectives.

Alberta Cancer Exercise (ACE) is an exercise oncology programme that transitioned from in-person to online delivery during COVID-19. The purpose of this work was to understand participants' experiences in both delivery modes. Specifically, survivors' exercise facilitators and barriers, delivery mode preference, and experience with programme elements targeting behaviour change were gathered. A retrospective cohort design using explanatory sequential mixed methods was used. Briefly, 57 participants completed a survey, and 19 subsequent, optional interviews were conducted. Most participants indic

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… The programme is delivered across cancer centres in Alberta using established relationships with healthcare workers, print advertising material, and by word of mouth. ACE baseline evaluation has been reported [ 41 ]. …

Cancer Burden in China during 1990-2019: Analysis of the Global Burden of Disease.

This study reports the risk factors, trends, and burden of cancer in China from 1990 to 2019 from the Global Burden of Diseases. The incidence, mortality, and DALY of all cancers in China for the past 30 years were analyzed. In 2019, the age-standardized rates (ASRs) of cancer incidence, mortality, and DALY in China were 232.42/100 000, 136.72/100 000, and 3288.22/100 000, respectively. The five cancers with the highest age-standardized incidence rates were lung, stomach, colorectal, breast, and prostate cancers. From 1990 to 2019, the number of new cancer cases, deaths, and DALY increased by

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review.

The drug thalidomide has resurged in the world market under restrictive conditions for marketing and use. In Brazil, there are still cases of pregnant women using thalidomide even after the implementation of laws that regulate the control of use (Law No. 10.651/2003 and Collegiate Board Resolution No. 11/2011). The objective of this study was to discuss the control of thalidomide use in Brazil, based on a scoping review of the scientific literature, documents, and data from the Ministry of Health. A total of 51 studies and documents related to the following subthemes were selected: (1) organiz

Development and Preliminary Psychometric Evaluation of the ACRIS-CS: A Theory-Based Measure of Prospective Acceptability of Cognitive Rehabilitation in Cancer Survivors.

Background/Objectives: Cancer-related cognitive impairment (CRCI) is a prevalent survivorship concern associated with functional limitations and reduced quality of life. Although cognitive rehabilitation shows beneficial effects, implementation depends not only on efficacy but also on survivors' anticipated willingness to engage. No psychometrically validated instrument currently exists to assess prospective acceptability of cognitive rehabilitation among cancer survivors. This study aimed to: (1) develop the Acceptability of Cognitive Rehabilitation Interventions Survey-Cancer Survivors (ACRI

First-in-human Study of AZD5153, A Small-molecule Inhibitor of Bromodomain Protein 4, in Patients with Relapsed/Refractory Malignant Solid Tumors and Lymphoma.

AZD5153, a reversible, bivalent inhibitor of the bromodomain and extraterminal family protein BRD4, has preclinical activity in multiple tumors. This first-in-human, phase I study investigated AZD5153 alone or with olaparib in patients with relapsed/refractory solid tumors or lymphoma. Adults with relapsed tumors intolerant of, or refractory to, prior therapies received escalating doses of oral AZD5153 once daily or twice daily continuously (21-day cycles), or AZD5153 once daily/twice daily continuously or intermittently plus olaparib 300 mg twice daily, until disease progression or unacceptab

Выдержка гемпта (Extractum Cannabis) в деле " Лечение кишечных расстройств и диспепсии: исторические сведения из Барселоны, Испания " .

В этом исследовании изучается траектория интереса и использования экстракта каннабиса (выдержка канабиса сативы L.) для симптоматического лечения легких желудочно-кишечных расстройств и диспепсии в Барселоне XIX и начала XX века (Каталония, Испания) 1939, на основе обзора первичных источников. Цель настоящего документа заключается в том, чтобы представить исторический фармацевтический и прикладный обзор использования гематома (Cannabis L.) в медицинских целях до его запрещения, способствуя тем самым его признанию в качестве медицинского продукта. Представленная информация свидетельствует об ис

Novel Augmentation Strategies in Major Depression.

Hypothesis The hypotheses of all the four included studies share the common idea that it is possible to augment the effect of antidepressant drug treatment by applying different interventions and with each intervention attain a clinically meaningful better effect compared to a control condition, and with minor side effects, thus improving the short- and medium-term outcome in major depression. Procedures Study design The basic study design has been the double blind randomised controlled trial (RCT). In the light therapy study, all patients were treated with sertraline for the whole of the stud

Abstracts from the 37th Annual Meeting of the Society of General Internal Medicine, 2014, San Diego, CA, USA.

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… Recommendations from Breakout Sessions Community strategies to address stroke disparities Commnity strategies to increase diversity in stroke research studies ● Culturally sensitive advertising on risk factor reduction ● Investigators should partner with community organizations to increase trust in research … markets) ● Provide non-monetary incentives (e.g., blood pressure monitors) ● Recognize the family’s role in prevention ● Research takes place in the community Community strategies to address stroke disparities | Commnity strategies to increase diversity in stroke research studies ● Culturally sensitive advertising …

Haematological and Oncological Training Therapy With Stationary Strength and Cardio Machines (HOT) in Routine Cancer Care: A 3-Year Real-World Evaluation of Acceptance, Feasibility, Safety, and Effects.

BackgroundExercise improves physical function and health-related quality of life (HRQoL) in patients with cancer; however, nationwide structured programmes remain limited. A hospital in Germany implemented a donation-funded Haematological and Oncological Training Therapy with Stationary Strength and Cardio Machines (HOT), and a 3-year real-world data analysis aimed to evaluate its acceptance, feasibility, safety, and effects.MethodsHOT comprised 24 sessions of combined resistance and aerobic training, complemented by a sensorimotor module for patients with chemotherapy-induced peripheral neuro

Stem cell revolution: bridging the gap between research and clinical application.

Stem cells are characterized by their capacity for self-renewal and their potential for multi-directional differentiation, enabling them to develop into various functional tissues and organs under specific conditions. Their applications hold considerable promise, and the market for stem cell products is progressively expanding. Internationally, several stem cell products have received approval for market release; however, in China, the field remains largely undeveloped, presenting substantial opportunities for growth. Recent years have witnessed significant advancements in stem cell research,

Exploring the characteristics of conversational agents in chronic disease management interventions: A scoping review.

ObjectiveWith the increasing global burden of chronic diseases, there is the potential for conversational agents (CAs) to assist people in actively managing their conditions. This paper reviews different types of CAs used for chronic condition management, delving into their characteristics and the chosen study designs. This paper also discusses the potential of these CAs to enhance the health and well-being of people with chronic conditions.MethodsA search was performed in February 2023 on PubMed, ACM Digital Library, Scopus, and IEEE Xplore. Studies were included if they focused on chronic di

Cancer survivorship: understanding the patients' journey and perspectives on post-treatment needs.

BackgroundCancer treatments have many adverse effects on patient's health leading to poor cardiorespiratory capacity, muscular- degeneration, fatigue, loss of strength and physical function, altered body-composition, compromised immune-function, peripheral neuropathy, and reduced quality of life (QOL). Exercise programs can significantly increase functional capacity when tailored to individual needs, thus improving health. Exercise interventions in cancer rehabilitation, when supported by appropriate nutrition can be effective in attaining a healthy weight and body-composition. The successful

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… PPI input included review, feedback and suggestions on the study flyers advertising the study, on the questionnaire and focus group topics guide designed for the focus groups and the lay summary describing the research. …

Cancer Prevalence Projections in Japan and Decomposition Analysis of Changes in Cancer Burden, 2020-2050: A Statistical Modeling Study.

BACKGROUND: We provide comprehensive sex-stratified projections of cancer prevalence for 22 cancer sites in Japan from 2020 to 2050. METHODS: Using a scenario-based approach, we projected cancer prevalence by combining projected incidence cases and survival probabilities. Age-specific incidences were forecasted using age-period-cohort models, while survival rates were estimated using a period-analysis approach and multiple parametric survival models. To understand changes in cancer prevalence, decomposition analysis was conducted, assessing the contributions of incidence, survival, and popula

CRISPR/Cas9: A revolutionary genome editing tool for human cancers treatment.

Cancer is a genetic disease stemming from genetic and epigenetic mutations and is the second most common cause of death across the globe. Clustered regularly interspaced short palindromic repeats (CRISPR) is an emerging gene-editing tool, acting as a defense system in bacteria and archaea. CRISPR/Cas9 technology holds immense potential in cancer diagnosis and treatment and has been utilized to develop cancer disease models such as medulloblastoma and glioblastoma mice models. In diagnostics, CRISPR can be used to quickly and efficiently detect genes involved in various cancer development, prol

Cancer prevention programmes in Mexico: are we doing enough?

Cancer has increased in all the countries of the world and Mexico is no exception. The recognised risk factors for the main types of cancer are reviewed and searched through the Mexican government web pages and cancer prevention programmes to tackle the risk factors in the population. The Mexican government, a member of the World Health Organization, shows that the main approach is an early diagnosis rather than prevention, forgetting that an ounce of prevention is better than a pound of cure. Effective public programmes should be promoted to reduce preventable risk factors in the population (

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… Creating smoke-free spaces, the total prohibition of advertising, sponsorship and promotion of tobacco products, combined with those already mentioned in the pictographs and warnings, as well as the tax increase on tobacco products, are the public policies to which the Mexican government has committed …

A comprehensive economic assessment of the burden of obesity in Kuwait.

BackgroundObesity is a complex public health issue that has risen to epidemic proportions globally. The aim of this study was to estimate the economic costs associated with obesity from governmental and societal perspectives in the State of Kuwait in 2024.MethodsA disease-specific prevalence-based cost-of-illness framework was applied. Key parameters include prevalence of obesity and its related comorbidities, relative risks, healthcare resources, income rate and growth, and lost workdays for patients and relatives, all were derived from literature. The outcomes measured were total healthcare

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… An evaluation of Chile’s Law of Food Labeling and Advertising on sugar-sweetened beverage purchases from 2015 to 2017: A before-and-after study . PLoS Med . 2020 ; 17 ( 2 ):e1003015. doi: 10.1371/journal.pmed.1003015 32045424 PMC7012389 55 Tham KW , Lim AYL , Baur LA . …

Health literacy, eHealth literacy and their association with burden, distress, and self-efficacy among cancer caregivers.

PurposeHealth literacy skills are vital for cancer caregivers in helping cancer survivors to navigate their diagnosis, treatment, and recovery but little is known. This study explored health literacy and eHealth literacy among cancer caregivers and the relationship between health literacy/eHealth literacy and potential associated factors.MethodsInformal caregivers who had cared for an individual with cancer completed a survey which collected demographic data and measured caregiver health literacy, eHealth literacy, self-efficacy, burden, and distress.ResultsSeven percent of caregivers had inad

Catgut embedding in acupoints combined with repetitive transcranial magnetic stimulation for the treatment of postmenopausal osteoporosis: study protocol for a randomized clinical trial.

BACKGROUND: To date, the clinical modulation for bone metabolism based on the neuro-bone mass regulation theory is still not popular. The stimulation of nerve systems to explore novel treatments for Postmenopausal osteoporosis (PMOP) is urgent and significant. Preliminary research results suggested that changes brain function and structure may play a crucial role in bone metabolism with PMOP. Thus, we set up a clinical trial to investigate the effect of the combination of repetitive transcranial magnetic stimulation (rTMS) and catgut embedding in acupoints (CEA) for PMOP and to elucidate the c