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Roxadustat in treating anemia in dialysis patients (ROAD): protocol and rationale of a multicenter prospective observational cohort study.

BackgroundRoxadustat has been shown effective in treating patients with anemia due to chronic kidney disease. However, its long-term effect on clinical outcomes and socioeconomic burden and safety remains unclear.Methods/designThis is a multicenter, prospective, longitudinal observational cohort study assessing if Roxadustat improves prognosis in dialysis patients. Primary outcomes will be major adverse cardiovascular events (MACE), defined as composites of cardiovascular death, myocardial infarction, cerebral infarction, hospitalization because of heart failure; all-cause mortality, and annua

Ход работы сессии 31st Европейский педиатрический конгресс по педиатрии: часть 2.

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Take the reins: a study protocol of a randomized controlled trial testing the effects of time-restricted eating vs. nutrition control on cancer-related fatigue among survivors of hematological malignancies.

BACKGROUND: Cancer-related fatigue is one of the most common and debilitating side effects of cancer and its treatments. Fatigue may stem from disruptions in circadian rhythms and dysregulation of glucose metabolism, which can be improved through time-restricted eating. Time-restricted eating is a daily eating pattern that entails consuming food within a defined, consistent window (e.g., 10 h) every day. When the eating window aligns with the daylight hours, it can entrain circadian processes and modulate physiological regulation of whole-body metabolism. It is hypothesized that time-restricte

Protocol of the optimal study: Optimization of polypharmacy in geriatric oncology - A randomized controlled trial.

BackgroundPolypharmacy is very common in older cancer patients and these patients are particularly vulnerable to drug-drug interactions and adverse drug reactions because they often receive chemotherapy and symptom-relieving agents.MethodsThe primary aim of the randomized, controlled Optimization of Polypharmacy in Geriatric Oncology (OPTIMAL) trial is to test whether an advisory letter with the results of a comprehensive medication review conducted with the Fit fOR The Aged (FORTA) list to the caring physician in rehabilitation clinics improves the quality of life (QoL) of older cancer patien

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… Towards the end of rehabilitation week 1, the study nurse/physician will mail the screening checklist, the signed informed consent form, and the patient’s questionnaire to the coordinating center. … The study participant’s IDs are used to label the informed consent forms, questionnaires, and all other study materials for a specific patient. The study materials will be packed for each study participant’s ID in the coordinating center and shipped to the rehabilitation clinics. …

Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA).

IntroductionDigital patient monitoring (DPM) tools can enable more effective clinical care and improved patient outcomes in cancer. However, their broad adoption requires ease of use and demonstration of real-world clinical utility/impact. ORIGAMA (MO42720) is an interventional, open-label, multicountry platform study investigating the clinical utility of DPM tools and specific treatments. ORIGAMA will begin with two cohorts that aim to assess the impact of the atezolizumab-specific Roche DPM Module (hosted on the Kaiku Health DPM platform (Helsinki, Finland)) on health outcomes and healthcare

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… Participants will provide written informed consent in a face-to-face setting (examples of the informed consent forms are provided as online supplemental materials ) and will be enrolled and randomised (if applicable) through an interactive web-based response system. … Ethics committees reviewed the protocol, the patient informed consent forms (Cohort A and B), the Roche modules and their content and the additional patient-facing material shared within the DPM solution. …

Family caregiver ambassador support for caregivers of patients with newly diagnosed hematological cancer: a feasibility study.

PurposeThis study investigated the feasibility of a one-on-one peer support intervention in family caregivers of newly diagnosed patients with a hematological cancer during initial treatment.MethodsThe study was a one-arm feasibility study including family caregivers of newly diagnosed patients with hematological cancer (n = 26) and caregiver ambassadors who were family caregivers of previously treated patients as peer supporters (n = 17). The one-on-one peer support intervention consisted of three components: a caregiver ambassador preparatory course; 12 weeks of one-on-one peer support, and

The patient reported transformation of identity and voice in life-limiting illness.

BackgroundIndividuals facing life-limiting illnesses undergo a profound transformation that encompasses significant physiological changes, in the level of medical care received, and a shift in overall goals of care. This transformation is irreversible and involuntary. However, individuals living with mental health conditions and life-limiting illnesses are not able to go through transformation due to diagnostic overshadowing. Previous research has examined the transformations experienced by caregivers in the context of spinal cord injuries, as well as by professional caregivers in palliative c

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… A consent form detailing the study, including confidentiality measures and the right to withdraw, was sent to participants 1 week before their interviews. Participants signed the forms and sent screenshots of signed forms to the chief investigator (CI). … Interviews were scheduled for those who wished to proceed, and consent forms were sent to all participants prior to the interviews, reminding them of their right to withdraw at any time. …

The impact of experiential avoidance on anxiety and depressive disorders in hematological cancer patients.

Anxiety disorders and/or depressive disorders co-occurring with hematological cancer are an additional burden for patients. Experiential avoidance (EA; efforts to avoid negative emotions, thoughts, or memories) is an empirically evident transdiagnostic factor for the onset and maintenance of anxiety and depressive disorders in non-cancer populations. There is lack of evidence on the impact of EA in predicting anxiety and depression in cancer patients. A total of 291 patients with hematological cancer (60% male, mean age 55 years) were included in this cross-sectional observational study. Parti

Spinal cord Compression Outcomes Of Treatment (SCOOT) Delphi study.

BackgroundEarlier diagnosis, advances in medical oncology and radiation modalities continue to improve cancer patients' survival length, leading to a rise in metastatic disease and metastatic spinal cord compression (MSCC). Treatment approaches need a high level of individualisation, making management decisions for these patients challenging.MethodsA modified Delphi study with quantitative and qualitative analysis to identify thresholds for surgical intervention for MSCC patients and the factors underpinning those thresholds. A predefined expert panel was sent rounds of decision-making questio

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… Consent Invitation letters and informed consent forms were sent electronically. All non-responders were removed from the list after 2 weeks ( Appendix 1 ). Anonymity was maintained throughout ( Appendix 2 ). …

Study protocol: Close Assessment and Testing for Chronic Graft-vs.-Host disease (CATCH).

Chronic graft-versus-host disease (GVHD) is an immune-mediated disorder that causes significant late morbidity and mortality following allogeneic hematopoietic cell transplantation. The "Close Assessment and Testing for Chronic GVHD (CATCH)" study is a multi-center Chronic GVHD Consortium prospective, longitudinal cohort study designed to enroll patients before hematopoietic cell transplantation and follow them closely to capture the development of chronic GVHD and to identify clinical and biologic biomarkers of chronic GVHD onset. Data are collected pre-transplant and every two months through

Evaluation of advanced platelet-rich fibrin (PRF) as a bio-carrier for ampicillin/sulbactam.

OBJECTIVES: Mechanisms of wound healing are often impaired in patients with osteonecrosis of the jaw (ONJ). According to the guidelines for the treatment of this disease, early surgical intervention is indicated. However, surgery often faces complications such as wound healing disorders. The application of platelet-rich fibrin (PRF) after necrosectomy between bone and mucosa may constitute a promising approach to improve surgical results. An aspect that was not investigated until now is that PRF acts as a "bio-carrier" for antibiotics previously applied intravenously. MATERIALS AND METHODS: W

Внутренний ядерный слой в педиатрическом множестве склерозов.

ЦЕЛИ: Множественный склероз педиатрии (POMS) приводит к повреждениям зрительного нерва и сетчатки вследствие оптического неврита (ON) и потенциальной субклинической активности. Нейроаксональные повреждения сетчатки проявляются в разбавлении перипиллярного слоя сетчатки (PRNFL), а также в мешковой ганглионной клетке и внутреннем плексиформном слое (GCIP). Была высказана мысль о том, что толщина внутреннего ядерного слоя (ИНЛ) будет увеличиваться в результате провокационной деятельности или после острого ВН и уменьшится от хронического нейродегенерации. Макулярные микроциклы в INL были описаны у

Prevalence of low alkaline phosphatase activity in laboratory assessment: Is hypophosphatasia an underdiagnosed disease?

BackgroundTissue-nonspecific alkaline phosphatase (TNSALP) encoded by the ALPL gene is of particular importance for bone mineralization. Mutation in the ALPL gene can lead to persistent low ALP activity resulting in the rare disease Hypophosphatasia (HPP) that is characterized by disturbed bone and dental mineralization. While severe forms are extremely rare with an estimated prevalence of 1/100.000, recent studies suggest that moderate form caused by heterozygous mutations are much more frequent with an estimated prevalence of 1/508. The purpose of this study was to estimate the prevalence of

The Survivor Unmet Needs Survey (SUNS) for haematological cancer survivors: a cross-sectional study assessing the relevance and psychometric properties.

BackgroundRelevant and psychometrically sound needs assessment tools are necessary for accurate assessment of haematological cancer survivors unmet needs. No previous study has developed nor psychometrically evaluated a comprehensive needs assessment tool for use with population-based samples of haematological cancer survivors. This study aimed to assess the validity and reliability of the Survivor Unmet Needs Survey (SUNS) with haematological cancer survivors.MethodsThe relevance, content and face validity of the SUNS to haematological cancer survivors was assessed using qualitative interview

High serum level of interleukin-6 is linked with dyslipidemia in oral lichen planus.

Oral lichen planus (OLP) is a complex chronic inflammatory disorder in which autocytotoxic CD8+ T cells, locally present in the affected tissue, induce basal keratinocyte apoptosis, through the release of several cytokines, such as interleukin-6 (IL-6). IL-6 is a proinflammatory cytokine that is related to alterations in lipid metabolism in psoriasis patients. Impaired lipid metabolism together with high serum levels of triglycerides have been found in association with OLP. However, the correlation between serum levels of IL-6 and dyslipidemia has not yet been studied in this disorder. The pre

Deciding to Enrol in a Cancer Trial: A Systematic Review of Qualitative Studies.

BackgroundClinical trials are essential for the advancement of cancer treatments; however, participation by patients is suboptimal. Currently, there is a lack of synthesized qualitative review evidence on the patient experience of trial entry from which to further develop decision support. The aim of this review is to synthesise literature reporting experiences of participants when deciding to enrol in a cancer clinical trial in order to inform practice.MethodsA systematic review and meta-synthesis of qualitative studies were conducted to describe the experiences of adult cancer patients who d

Microangiopathy in multiple myeloma: a case of carfilzomib-induced secondary thrombotic microangiopathy successfully treated with plasma exchange and complement inhibition.

BACKGROUND: Thrombotic microangiopathy (TMA) is a potentially organ and life-threatening condition affecting patients with multiple myeloma (MM). Cases of proteasome inhibitor-induced TMA and specifically carfilzomib-induced TMA have been rarely reported and standards for diagnostic workup and treatment are not available. CASE PRESENTATION: We describe a case of a male MM patient under salvage therapy including proteasome inhibitor carfilzomib following chemotherapy and autologous stem cell transplantation. The patient then developed acute kidney injury with clinical and laboratory signs of T

Palliative patients who may benefit from intranasal delivery of symptomatic drugs: a two-center observational study evaluated the administration of morphine and dexamethasone in Polish hospices.

IntroductionPatients receiving hospice care at the end of life often suffer from a variety of ailments. They may need medication to alleviate symptoms for the rest of their lives. The most common and recommended way to take opioids and steroids is orally. Less frequently, the subcutaneous or intravenous routes are used. The intranasal route is a relatively uncommon but interesting alternative for administering drugs.AimThe study aims to identify hospice patients who may benefit from changing the standard opioid and steroid administration route to intranasal delivery.Material and methodsThe ele

Lifestyle in Multiple Myeloma - a longitudinal cohort study protocol.

BACKGROUND: Deterioration in bone health is one of the presenting symptoms of Multiple Myeloma (MM), a cancer of plasma cells. As a consequence of this condition, patients suffer bone pain and bone damage and report cancer-related fatigue, resulting in deterioration in their quality of life. Evidence in patients with solid tumours shows promise for the positive effects of physical activity on quality of life. However, in the case of patients with MM a better understanding of the association between physical fitness and quality of life factors is still required. Therefore, this cohort study aim

Rationale and design of platelet transfusions in haematopoietic stem cell transplantation: the PATH pilot study.

IntroductionIn patients with transient thrombocytopenia being treated with high-dose chemotherapy followed by stem cell rescue-haematopoietic stem cell transplantation (HSCT), prophylactic transfusions are standard therapy to prevent bleeding. However, a recent multicentre trial suggests that prophylactic platelet transfusions in HSCT may not be necessary. Additionally, the potential overuse of platelet products places a burden on a scarce healthcare resource. Moreover, the benefit of prophylactic platelet transfusions to prevent clinically relevant haemorrhage is debatable. Current randomised