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Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration.

Randomised controlled trials often use surrogate endpoints to substitute for a target outcome (an outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve efficiency (through shortened duration of follow-up, reduced sample size, and lower research costs), and for ethical or practical reasons. However, their use has a fundamental limitation in terms of uncertainty of the intervention effect on the target outcome and limited information on potential intervention harms. There have been increasing calls for improved repo

Experiences and Perspectives of Patients with Non-HIV-Associated Lipodystrophies and Their Caregivers: A Qualitative Study.

BackgroundLipodystrophy comprises a group of conditions characterized by loss of functional adipose tissue, resulting in severe metabolic complications and a complex range of symptoms.ObjectiveThis study sought to gain a holistic understanding of the impact of congenital or non-human immunodeficiency virus acquired lipodystrophies on the quality of life of patients and their caregivers and to capture the impact of lipodystrophy on quality of life using a standard instrument.MethodsTen patients with lipodystrophies and five caregivers from the USA and UK were recruited through convenience sampl

BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study.

BackgroundThe approval of epoetin biosimilars in the European Union requires extensive scientific evaluation and stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar epoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting.MethodsPatients >18 years with CIA (haemoglobin [Hb] ResultsOverall, 2333

Оценка эффективности, безопасности и соблюдения оральной терапии лекарств у пациентов с повторным множественным склерозом.

Предыстория и цели: Отбор соответствующих лекарственных средств для борьбы с изменением болезней (ДМР) имеет решающее значение для оптимизации лечения и замедления развития заболеваний в условиях множественного склероза (МС). Исследования в реальном мире позволяют оценить эффективность наркотиков и их использование в обычной клинической практике. Поэтому цель этого исследования состояла в том, чтобы определить эффективность и безопасность пероральной терапии для пациентов с повторно излучающимся множественным склерозом и особенностями участия в терапии. Материалы и методы: Ретроспективное и пе

Rituximab-Associated Flare of Cryoglobulinemic Vasculitis.

BackgroundPatients with cryoglobulinemic vasculitis (CV) can develop disease flare after rituximab administration. The objective of our study was to describe the prevalence, clinical characteristics, predisposing factors, and outcomes of patients with rituximab-associated flare of CV.MethodsWe conducted a retrospective study in a tertiary referral center until March 25, 2020.ResultsAmong 64 patients with CV who received rituximab therapy in our center, 14 (22%) developed disease flare. Median age was 67.5 years. Seven patients (50%) had type II CV and the other half had either type I (n = 6) o

Показатели объема мозга у взрослых, страдающих болезнями MOG-Antibody-Associated: Продольное многоцентральное исследование.

Фон/задачи: мало что известно о воздействии болезни, связанной с антителами (МОГАД), на атрофию мозга миэлина олигодендроцита. В этом многоцентровом продольном исследовании сопоставляются объемы MRI и T2 повреждения мозга между пациентами MOGAD, пациентами, повторно выделяющими MS (RRMS), и группой по здоровому контролю (HC) с помощью сканирования МRI мозга, доступного в онлайновом хранилище. Методы: В общей сложности 16 взрослых пациентов MOGAD (9 F) имели возрастную и половую связь с 44 пациентами RRMS (17 F), нанятыми в Центре MS в Вероне, и 14 ОВ. Для каждого пациента было необходимо прове

Clinical features and pathological analysis of primary rib Langerhans cell histiocytosis: case series and literature review.

BackgroundLangerhans cell histiocytosis (LCH) is a rare histiocytic neoplasm characterized by the abnormal proliferation of Langerhans cells, which can infiltrate various tissues throughout the body, leading to a spectrum of organ damage. This study aims to explore the clinical characteristics, imaging manifestations, and pathological features of the disease to enhance clinical diagnosis and understanding of such conditions.Case descriptionThis study reviews the clinical data of four patients diagnosed with LCH at The First Affiliated Hospital of Hunan University of Traditional Chinese Medicin

A diagnostic challenge of mysterious bone pain caused by tumor-induced osteomalacia with multiple tumors: a case report.

BACKGROUND: Tumor-induced osteomalacia (TIO) is a rare, tumor-induced, metabolic bone disorder, the exact incidence of which is unknown. The most common cause of TIO is hypersecretion of tumor-derived fibroblast growth factor 23 (FGF23). Surgical resection can cure TIO in most cases, while for patients with TIO who are ineligible for surgery, biologic antibodies targeting FGF23 can be used as treatment. However, the diagnosis of TIO is more difficult than its treatment as the initial presentation can be misleading or nonspecific; thus, diagnosing TIO remains a clinical challenge. CASE DESCRIP

Канадский совместный проект по генетической восприимчивости к многочисленным склерозовым группам населения и этиологии болезней.

В предыдущих генетических и эпидемиологических исследованиях анализировались подгруппы канадского Совместного проекта по генетической приемлемости для группы пациентов с множественным склерозом (CCPGSMS), однако всеобъемлющий анализ населения, охваченного исследованиями, еще не проведен. ЦЕЛЬ: В этом ретроспективном исследовании рассматриваются модели множественного склероза (МС) 13,663 Члены групп, включая 4,821 лиц с НР или подозреваемых НР и 8,842 Члены семьи.Мы сгруппировали участников в эпидемиологические подгруппы по возрасту MSshore, клинической стадии диагностики, типу симптомов при на

Immunotherapy with check-point inhibitors (CPI) in adult malignancies: a protocol for the systematic review of the quality of economic analyses.

BackgroundImmuno-oncology, and in particular, check-point inhibitors (CPIs), have led to a paradigm shift in the field of cancer care. The cost of new drug development is high, and many novel agents in oncology are significantly more expensive than older agents. Therefore, healthcare funders have factored measures of cost-effectiveness into decisions concerning drug reimbursement and incorporation of new agents into treatment algorithms. The methodology of cost-effectiveness evaluations, however, is less rigorously applied than those evaluating clinical efficacy and safety data. Thus, in spite

Effects of Aerobic Exercise Therapy through Nordic Walking Program in Lactate Concentrations, Fatigue and Quality-of-Life in Patients with Long-COVID Syndrome: A Non-Randomized Parallel Controlled Trial.

BackgroundLong-COVID syndrome comprises a variety of signs and symptoms that develop during or after infection with COVID-19 which may affect the physical capabilities. However, there is a lack of studies investigating the effects of Long-COVID syndrome in sport capabilities after suffering from COVID-19 infection. The purpose of the study was to evaluate and compare lactate concentration and quality of life (QoL) in patients with Long-COVID with those who have not developed non-Long-COVID during Nordic walking exercise therapy.MethodsTwenty-nine patients (25.5 ± 7.1 years) took part in a non-

"Let him die. He caused it": A qualitative study on cancer stigma in Tanzania.

Cancer stigma presents a critical barrier to care seeking, contributing to delayed presentation and poor cancer outcomes worldwide. The burden of cancer in Tanzania is on the rise, with cancer being the third-leading cause of death in the country. Despite rising incidence and poor outcomes of cancer, cancer-related stigma interventions have received low prioritization. There is a need for sound research that focuses on understanding attitudes driving stigma, its impact on care-seeking and treatment adherence, and intervention models to reduce stigma. We used a cross-sectional qualitative study

Seventeen-year reassessment of diagnostic transitions, biologic therapy initiation and mortality in spondyloarthritis: results from the REGISPON-3 study.

OBJECTIVES: To evaluate disease evolution, diagnostic transitions, time to biologic treatment initiation and mortality in patients with spondyloarthritis (SpA) after 17 years from the original Spanish Registry of Spondyloarthritis (REGISPONSER). METHODS: Spondyloarthritis Registry 3 (REGISPON-3) is a two-timepoint longitudinal study with patients fulfilling the European Spondyloarthropathy Study Group criteria participating in the REGISPONSER study and re-evaluated after 17 years. Clinical, laboratory, radiological and treatment data were collected and compared with baseline. Diagnostic chang

Symptom burden survey and symptom clusters in patients with cervical cancer: a cross-sectional survey.

Abstract Purpose The purpose of this study is to determine the incidence and severity of symptoms of patients with cervical cancer within 6 months after radiotherapy and chemotherapy, form a symptom burden report, evaluate the distribution characteristics of symptoms, identify symptom clusters, and provide a basis for clinical doctors and nurses to improve the symptom management of patients with cervical cancer after radiotherapy and chemotherapy. Methods The patients with cervical cancer within 6 months after radiotherapy and chemotherapy were recruited to investigate their symptom burden. Ex

Patient Perceptions Regarding Multiple Myeloma and Its Treatment: Qualitative Evidence from Interviews with Patients in the United Kingdom, France, and Germany.

BACKGROUND: The current standard of care for multiple myeloma requires several regimens of treatment, with patients experiencing high symptom burden and side effects, which negatively impact health-related quality of life (HRQoL). Thus, it is crucial to understand patient perceptions of multiple myeloma and how patients value different treatment options. OBJECTIVE: The purpose of this study was to conduct an exploratory investigation into concepts that could form attributes that influence treatment choices for patients with multiple myeloma and to identify trade-offs that patients are willing

Совпадение в полном тексте источника
… The study protocol and the informed consent forms received ethical approval from a central institutional review board. The original approval was received on 5 March 2019 (approval number 18200). … Ethics approval The study protocol and the informed consent forms received ethical approval from a central institutional review board (Ethical and Independent Review Services, Independence, MO, USA). Consent All patients provided informed written consent prior to being interviewed. …

Кровеносный барьер проницаемость в зависимости от степени заболевания и времени многократного склерозового диагноза в оптическом неврите.

Динамическая магнитная резонансная визуализация, усиливающаяся контрастом, является перспективным биомаркером, позволяющим в vivo количественно определить проницаемость кровеносного барьера. ЦЕЛИ: Изучение взаимосвязи между проницаемостью мозга и кровеносным барьером, остротой оптического неврита и множественным преобразованием склероза в оптический неюрит. МЕТОДЫ: Модели Gjedde-Patlak, полученные с помощью динамических контрастно усиленных магнитных резонансных изображений, использовались для оценки проницаемости кровеносного барьера (Ki) в 78 Пациенты оптического неврита. :: 2017 Критерии Mc

Совпадение в полном тексте источника
… Study consent forms were approved by Copenhagen's Regional Committee on Health Research Ethics. Consent for publication: Not applicable. …

Multidisciplinary Approach to Older Adults with Hematologic Malignancies-a Paradigm Shift.

Hematologic malignancies are most likely to present in the seventh and eighth decades of life. Continued population growth will lead to increasing numbers of older adults with hematologic malignancies. Oncology care for older adults is complex and must account for the effect of aging on disease biology and treatment tolerance. Multidisciplinary oncology care has been utilized in solid tumor oncology for decades, initially driven by the need for multi-modality treatment. In this review, we make the case for multidisciplinary oncogeriatric care for older adults with hematologic malignancies in o

Кинесиофобия у больных строкой, множественный склероз и болезнь Паркинсонаса

Фон: Строке (S), множественный склероз (MS), болезнь Паркинсона (PD) являются хроническими неврологическими заболеваниями, которые являются коллангом для общественного здравоохранения и представляют собой реальную социальную проблему. Физическая активность (ПА) улучшает функциональные характеристики, снижает различные симптомы в ПД и MS, уменьшает неврологические расстройства инсульта у пациентов и дает им шанс на независимость. One Среди основных препятствий на пути успешной реабилитации - пассивность пациентов. Причина может заключаться в психологических аспектах, в частности в боязни передв

Risk factor analysis of pulmonary cement embolism during percutaneous vertebroplasty or kyphoplasty for osteoporotic vertebral compression fractures.

OBJECTIVE: The purpose of this research is to evaluate the risk factors and incidence of pulmonary cement embolism (PCE) during percutaneous vertebroplasty (PVP) or kyphoplasty (PKP) for osteoporotic vertebral compression fractures (OVCFs) based on postoperative computed tomography (CT). METHODS: A total of 2344 patients who underwent PVP or PKP due to OVCFs in our spine center were analyzed retrospectively. According to the detection of postoperative pulmonary CT, the patients were divided into two groups: pulmonary cement embolism group (PCE group) and non-pulmonary cement embolism group (N

Current models, challenges and best practices for work conducted between European academic cooperative groups and industry.

BackgroundThe academia-industry interface is important, and, despite challenges that inevitably occur, bears the potential for positive synergies to emerge. Perceived barriers to wider collaboration in academia-industry oncology research in Europe need to be addressed, current academic cooperative group and industry models for collaboration need to be discussed, and a common terminology to facilitate understanding of both sectors' concerns needs to be established with an eye towards improving academia-industry partnerships on clinical trials for the benefit of patients with cancer.MethodologyC