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A study protocol for a double-blinded, randomised, placebo-controlled trial on the use of encapsulated FMT for reducing the side effects of HSCT: the HSCT-BIOME study.

BackgroundThe composition of the gut microbiota both prior to and after haematopoietic stem cell transplantation (HSCT) is increasingly implicated in the outcomes of HSCT, including infections, poor immune reconstitution and disease relapse. Faecal microbiota transplantation (FMT) offers a potential strategy of supporting the gut microbiota and improve HSCT outcomes. Although FMT has been investigated in HSCT recipients, it has largely been evaluated therapeutically for indications such as infection, or once immunocompetency is regained.MethodsPeri-HSCT FMT (i.e. before and after HSCT) will be

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… Identifiable data (consent forms, pathology reports, etc.) will be de-identified and filed with the study documents. …

Development and Implementation of an eHealth Oncohematonootric Program: Descriptive, Observational, Prospective Cohort Pilot Study.

BackgroundIn oncohematology, both the development of the disease and the side effects of antineoplastic treatment often take a toll on patients' physical and nutritional well-being. In this era of digital transformation, we launched a pioneering project for oncohematologic patients to promote adherence to a healthy lifestyle and improve their physical and nutritional well-being. We aim to achieve this goal by involving doctors and nutritionists through the Nootric app.ObjectiveThis study aims to assess the impact of the use of eHealth tools to facilitate nutrition and well-being in oncohematol

Protocol for a randomised controlled feasibility trial of an integrated psychosexual intervention for sexual difficulties in people with Multiple Sclerosis: the PIMS trial.

BACKGROUND: Multiple Sclerosis (MS) is a long-term condition that significantly diminishes quality of life (QoL). Sexual difficulties (SDs) are common, but often overlooked symptom, affecting 50-80% of people with MS (PwMS). The emergence of SDs in MS results from the intricate interplay of disease processes, treatments, and psychosocial factors, contributing to a further decline in QoL and adverse effects on body image, relationships, and psychological well-being. Despite the limited treatment options, which mainly include medications and physiotherapy, there is promise in psychological inter

Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges.

The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societ

How do study design features and participant characteristics influence willingness to participate in clinical trials? Results from a choice experiment.

BackgroundResearch about the decision to participate in a clinical study has tended to be limited to single indications and has focused on narrow sets of study and participant characteristics. This study applied stated preference methods to understand the clinical trial design attributes that most influence willingness to participate and how this varied with participant characteristics.MethodsAdults residing in the US, China, or Poland with a self-reported diagnosis of cancer, heart disease, migraine, rheumatoid arthritis, or multiple sclerosis completed an online survey. Participants were ask

Повторение повторяющихся поведенческих паттернов: серия случаев с компульсивным поведением, трicho-тillomania, ненужной саморазрушительной поведенческой активностью и синдромом жаждущего еды.

Заболевание вынужденного сексуального поведения (CSBD), трichoэпилепсия (TTM), расстройство жор (BED) и ненужное самоповреждение (NSSI) классифицируются в отдельных категориях в Межправительственной классификации болезней, 11-е издание (ICD-11). В этом серийном случае旨在 explore общие импульсивные и вынужденные черты этих расстройств, несмотря на их общую феноменологию и сопутствующие расстройства. Также обсуждается инсайт, механизмы вознаграждения и связанные нейробиологические понимания повторяющихся действий. В конце также подчеркивается потенциальная роль глиаминергических препаратов в их л

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… Declaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given her consent for her images and other clinical information to be reported in the journal. …

Pityriasis liechenoides et varioliformis acuta у пациента, лечащегося cevostamab.

Аннотация не предоставлена источником. Откройте карточку для перехода к публикации.

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… Patient consent forms were not provided to the journal but are retained by the authors. IRB approval status: Not applicable. References 1. Swan D., Murphy P., Glavey S., Quinn J. Bispecific antibodies in multiple myeloma: opportunities to enhance efficacy and improve safety. …

Церковная боль и воздействие на качество жизни пациентов с множественным склерозом.

Основная цель этого исследования заключалась в оценке воздействия шейной боли на качество жизни пациентов с множественным склерозом по сравнению с группой здоровых людей (без болезней центральной нервной системы). Материалы и методы: В период с ноября 2023 года по август 2024 года данные были собраны в специализированном госпитале Сент-Лукаша в Коньском (Польша). Критерием включения в это исследование были следующие: возраст (20-50 лет), женщины и мужчины, здоровые люди (без болезней центральной нервной системы) и люди, страдающие множественным склерозом. Лицам из исследовательской группы был

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… All participants (both study and control groups) gave informed, voluntary consent to participate in this study, which was documented on consent forms available for review from the first author. Each study participant was covered by accident insurance (certificate no. COR422153). …

Уровень рабочей способности определяет конкретный профиль обесценения комплексного основного набора МКФ для множественных склерозов.

Множественный склероз (МС) неблагоприятно влияет на трудоспособность. Комплекс комплексных международных классификаций функционирования, инвалидности и охраны здоровья для НР (КМГС-МС), опубликованный Всемирной организацией здравоохранения, еще не был расширен для оценки уровня работоспособности (ВКК). Оценить относительную значимость категорий CICF-MS в сравнении с WCL. Лица, имеющие MS (PwMS), N = 129, которые были направлены в Литовское управление по оценке инвалидности и рабочей способности для определения WCL, были разделены на три группы в зависимости от процентной доли оставшегося WCL (

The patient journey of patients with Fabry disease, Gaucher disease and Mucopolysaccharidosis type II: A German-wide telephone survey.

BACKGROUND: Lysosomal Storage Diseases (LSD) are rare and multisytemic diseases which are caused by lysosomal enzyme deficiencies leading into accumulation of waste products due to an interruption in the decomposition process. Due to the low prevalence and therefore limited disease awareness as well as the fact that LSD patients present with unspecific symptoms the final diagnosis is often made after a long delay. The aim of this German-wide survey was to characterize the period between onset of symptoms and final diagnosis regarding e.g. self-perceived health, symptom burden and false diagnos

Воздействие физических упражнений на мышечную силу и характеристики ревматических заболеваний и саркопсии: Протокол исследования по вопросам ухода за мышечными мышцами (C4M).

ЦЕЛЬ: слабость мышечных мышц характерна для ревматоидного артрита (RA), остеоартрита (OA) и саркопсии (SARC). Упражнения на выносливость могут улучшить митохондриальную функцию и окислительную способность, в то время как считается, что упражнения на прочность стимулируют синтез белка миофибрилла. Цель этого исследования заключается в сопоставлении последствий упражнений на прочность и выносливость и в изучении связи между мышечными характеристиками и результатами упражнений у пациентов с RA, OA и SARC. Мы предполагаем, что реакция на выносливость и сильные упражнения у пациентов с мышечной сла

Psychological distress, chronic conditions and quality of life in elderly hematologic cancer patients: study protocol of a prospective study.

BackgroundSimilar to most solid tumors, the incidence of hematologic malignancies has been rising. Although the median age at diagnosis is about 70 years, little is known about psychosocial aspects and comorbid conditions in elderly patients with hematologic cancers. The main objectives of our study are to assess the prevalence of psychological distress, chronic conditions, functional disabilities, and quality of life in both elderly hematologic cancer patients aged ≥70 years and an age-matched comparison sample of the general population.MethodsWe conduct a prospective study with three measuri

Пациент с вариантом множественного склероза Марбурга хорошо отреагировал на циклофосфамид.

Болезнь Марбурга — это фатальный вариант множественного склероза (MS), отличающийся своим активным, быстро прогрессирующим монофазным курсом, который часто приводит к смертности пациентов в течение нескольких недель с момента начала болезни. Из-за его редкости не существует каких-либо руководящих принципов лечения. Мы представляем 34-летнего мужчину, которому был поставлен диагноз MS, и магнитно-резонансная съемка выявила множество сверх- и инфантентных белой материи. Пульсовая стероидная терапия, иммуноглобулин внутривенно и плазменный обмен были неэффективными. После исключения других диффер

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… Declaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. …

Treatment-free survival to bortezomib combined with dexamethasone in patients with refractory/relapsed pure red cell aplasia: a prospective clinical study.

BackgroundImmunosuppressive treatments induce and maintain remissions in a majority of patients with acquired pure red cell aplasia (aPRCA); however, salvage therapy for non-responders remains unsatisfactory.MethodsIn this prospective, open-label, clinical trial (NCT04423367), patients with refractory/relapsed aPRCA were recruited and received subcutaneous bortezomib at 1.3 mg/m2 in combination with dexamethasone 40 mg weekly(BD regimen) for 12 weeks. The primary endpoint was the overall response rate at 12 weeks.ResultsIn total, 18 patients were enrolled, including 10 (55.6%) with primary aPR

A Phase Ib Investigator-Initiated Trial of Filgotinib in Patients With Idiopathic Multicentric Castleman Disease.

Background Idiopathic multicentric Castleman disease (iMCD) is a chronic systemic inflammatory disease characterized by the production of interleukin (IL)-6. The contribution of Janus kinase, downstream of IL-6 signaling, to the pathophysiology of iMCD has been suggested by several studies. Patients and methods This phase Ib single-arm trial evaluated the safety profile and efficacy of filgotinib, a JAK1 preferential inhibitor, in patients with iMCD. We recruited patients with disease activity evaluated based on their values of C-reactive protein (CRP), hemoglobin, albumin, and Eastern Coopera

Anakinra: efficacy in the management of fever during neutropenia and mucositis in autologous stem cell transplantation (AFFECT-2)-study protocol for a multicenter randomized double-blind placebo-controlled trial.

BACKGROUND: Since decades, fever and infections have been the most important complications of intensive chemotherapy and hematopoietic stem cell transplantation (HSCT) in the treatment of hematologic malignancies. Neutropenia has long been considered to be the most important risk factor for these complications. However, recent studies have shown that not neutropenia, but the development of mucositis is the most important cause of these complications. Currently, limited options for the prevention and treatment of mucositis are available, of which most are only supportive. The pro-inflammatory c

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… Risk-adjusted monitoring will be performed by personnel independent of the research team and will consist of checking informed consent forms, completeness of eCRFs, and source data verification for a random sample of patients. …

An Integrated Process and Outcome Evaluation of a Web-Based Communication Tool for Patients With Malignant Lymphoma: Randomized Controlled Trial.

BackgroundThe complex nature of the medical dialogue and the often emotional context in cancer care present challenges to health care professionals (HCPs) and patients. Patients are increasingly expected to be informed participants and to be able to make conscious decisions, which they often find very difficult. In an attempt to support patients with malignant lymphoma in clinical communication, we developed a stand-alone, Web-based intervention called "PatientTIME." The development of PatientTIME was based on a participatory intervention mapping framework. Its primary aim is to boost patients

CARBOMETASPINE: protocol for a multicenter, prospective, randomized controlled trial of carbonfiber spinal fixation in metastatic disease.

BACKGROUND: Spinal metastases frequently cause neurological compromise and mechanical instability. Titanium fixation limits postoperative imaging and hinders stereotactic body radiotherapy (SBRT) planning because of artefacts. METHODS: CARBOMETASPINE is a multicentre, prospective, randomised controlled trial. A total of 226 adults with unstable or epidurally infiltrating spinal metastases will be randomised 1 : 1 : 1 to: (I) carbonfibre/PEEK fixation + postoperative SBRT (5 × 5 Gy); (II) titanium fixation + postoperative SBRT; (III) preoperative SBRT + titanium fixation. The primary endpoint i

Risk and response adapted therapy following autologous stem cell transplant in patients with newly diagnosed multiple myeloma (RADAR (UK-MRA Myeloma XV Trial): study protocol for a phase II/III randomised controlled trial.

IntroductionMultiple myeloma is a plasma cell malignancy that accounts for 1%-2% of newly diagnosed cancers.At diagnosis, approximately 20% of patients can be identified, using cytogenetics, to have inferior survival (high-risk). Additionally, standard-risk patients, with detectable disease (minimal residual disease (MRD)-positive) postautologus stem cell transplant (ASCT), fare worse compared with those who do not (MRD-negative). Research is required to determine whether a risk-adapted approach post-ASCT could further improve patient outcomes.MethodsRADAR is a UK, multicentre, risk-adapted, r

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… Agree to practise true abstinence when this is in line with the preferred and usual lifestyle of the subject from the time of signing the informed consent form until 5 months after the last dose of study drug. … Consent forms are included in online supplemental material . Trial registration Following initial consent, participant eligibility for trial registration will be assessed. …

Adaptation of Coping Together - a self-directed coping skills intervention for patients and caregivers in an outpatient hematopoietic stem cell transplantation setting: a study protocol.

BackgroundDespite numerous reports of significant distress and burden for hematopoietic stem cell transplantation (HSCT) patients and caregivers (CGs), HSCT-specific coping interventions remain rare. The few in use lack specificity and are often not easily accessible or cost-effective. Whereas the development of new interventions is resource-intensive, theory-informed adaptation of existing evidence-based interventions is promising. To date, no HSCT-specific intervention has relied on a formal adaptation approach.MethodsUsing the Center for Disease Control and Prevention's Map of Adaptation, t

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… Amenable participants will sign the consent form and complete a socio-demographic questionnaire. Each participant will be provided a copy of the signed consent form. … All HSCT participants (patients, CGs) have signed consent forms. Consent for publication This manuscript does not contain data from any individual person, therefore consent for publication is not applicable. Competing interests The authors declare they have no competing interests. …