Kornimate/medical-research-clean huggingface dataset:
quality of life and psychological well-being in patients with malignant melanoma

Conditions: Malignant Melanoma

Summary: the purpose of this study is to analyse the physical and psychological side-effects in the course of treatment with ifn-alpha. the effectiveness of a specific intervention for the management of these side-effects is evaluated.

today, the consideration of the side effects of intensive treatment measures and their influence on quality of life are regarded as standard procedures in oncology. quality of life measurements have found their way into clinical studies as patient-reported outcomes. in comparison to other tumor types, the field of dermato-oncology has had less research activity concerning quality of life. however, in recent years more attention has been paid to health related quality of life in malignant melanoma patients, especially under adjuvant treatment with interferon-alpha. data about high dose ifn-α treatment, especially from the usa, show that there are significant physical and psychological side effects, such as fatigue and depression, which often lead to dosage reduction or termination of treatment. as yet, there are very few systematic studies about low dose ifn-α treatment, especially in regard to the side effects during the course of the disease. concerning treatment side-effects it is known throughout various areas of oncology that specific psycho-oncological interventions assist in the patients' adaptation to the illness and handling of the side effects of therapy.

Eligibility criteria:
inclusion criteria: * documented and proven stage ib up to stage iiic malignant melanoma * no clinical and radiological evidence or suspicion of persistent disease * treatment with ifn-α within a study or analog treatment schedule with ifn-α * ecog performance status \< 2 * constant after care * informed consent to participate in the study * melanoma diagnosis within the last 5 years or therapy, recurrence or progression within this period of time. exclusion criteria: * inoperable lymph nodes- or distant metastases * tumors of other origins or localisations within the past 10 years * severe and permanent infectious diseases, e. g. hiv or hepatitis * participation in other treatment studies apart from ifn-α * insufficient knowledge of german language

Keywords: melanoma interferon-a quality of life psychological distress depressive symptoms side effects
18f-fapi pet/mri imaging in myelofibrosis: a prospective observational study.

Conditions: Myelofibrosis

Summary: this study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18f-fdg pet/ct and 18f-fapi pet/mri imaging for the evaluation of systemic fibrosis in mf patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.

myelofibrosis (mf) is a pathological process characterized by dysplasia of bone marrow fibrous tissue, clonal proliferation of potential stem cells, inflammatory changes in the bone marrow microenvironment, and extramedullary hematopoiesis. bone marrow histopathology is the gold standard for diagnosis, but because of the invasive nature of the puncture, repeated examination is not possible to dynamically monitor the disease process. in addition, due to the focal nature of puncture biopsy, it can not accurately reflect the systemic disease. 18f-fdg pet/ct provides visual assessment of mf, but its diagnostic effectiveness decreases as mf progresses. 18f-fapi pet/mri characterizes fiber activation processes in a variety of diseases. this study intends to use a prospective, observational, self-controlled, multi-center study design to evaluate the feasibility and diagnostic efficacy of 18f-fdg pet/ct and 18f-fapi pet/mri imaging for the evaluation of systemic fibrosis in mf patients based on the results of bone marrow pathological biopsy, and to analyze the relationship between imaging results and clinical prognosis.

Eligibility criteria:
inclusion criteria: * patients with primary myelofibrosis or myelofibrosis secondary to myeloid tumors were diagnosed according to the diagnostic criteria of who 2022. * stable vital signs, ecog score ≥ 2 points, tolerate and cooperate to complete 18f-fdg pet/ct and 18f-fapi pet/mri examination. * the interval between imaging ,hematologic, cytogenetic and pathology was \< 2 weeks. * willing to accept 18f-fdg pet/ct and 18f-fapi pet/mri , sign the informed consent. exclusion criteria: * inability or unwillingness to provide informed consent. * other malignancies, autoimmune diseases, or chronic active infections were diagnosed within 1 year before the diagnosis of myelofibrosis. * current infection was present within 1 week before pet examination. * pregnant or lactation. * unable to follow protocol to complete follow-up. * have received glucocorticoid therapy within 2 weeks before pet imaging examination. * using granulocyte colony-stimulating factor (g-csf) within 4 weeks prior to pet imaging.
resistance exercise for the prevention of age-related sarcopenia

Conditions: Sarcopenia

Summary: the purpose of this study is to determine the benefits of negative work progressive resistance exercise (pre) for the conservative management of sarcopenia in older male veterans at the dc vamc. efficacy will be assessed by examining post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

the chief aim of this protocol is to determine the efficacy of negative work progressive resistance exercise (pre) in the management of sarcopenia in older male veterans at the dc vamc. this proposed study is a randomized clinical trial using a single-arm, delayed cross-over design with repeated measures. this method is a patient-first approach to clinical research that permits all participants to receive the intervention while allowing the investigators to conduct both within subjects and between subjects comparisons with a modest study enrollment. during the "pre-treatment period" we will recruit, screen, and consent 30 older men with sarcopenia. the participants will be randomized into two groups: active treatment and delayed treatment. the initial "active treatment" and "delayed treatment" periods will last 12 weeks. after 12 weeks, the participants in the delayed treatment group will crossover (without a washout period) and start 12 weeks of intervention. all participants will detrain and be monitored for follow up during their respective 12-week "post treatment" period. outcome measures include post-exercise changes in metabolic and inflammatory markers, muscle morphology, strength, and functional status.

Eligibility criteria:
inclusion criteria: adult, ambulatory males \> 60 years old (n=30) will be recruited for this proposed study. participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an alm that is \< 2 sd below the mean values of a young adult reference group using dexa scanning. exclusion criteria: exclusion criteria include bmi scores \> 30 or a mini-mental status exam score of \ 110 mg/dl), triglyceride levels \> 200 mg/dl, and/or known dm, or abnormalities of other routine blood tests (i.e., \> 2 sd beyond normal) will be excluded from the study. uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.

Keywords: sarcopenia aging rehabilitation exercise
wound assessment using spectral imaging us

Conditions: Diabetes; Diabetic Foot; Diabetic Foot Ulcer

Summary: during the observational, non-interventional study, at baseline study visit (bsv) subjects will be screened and consented. eligible subjects will undergo imaging with the deepview device. pre- and post-debridement images will be obtained (if debridement performed per soc), as well as reviewing medical history and physical assessments. additional study visits (svs) will be performed when patient returns to the clinic for routine clinic visit for up to 12 weeks or wound closure. during these visits deepview imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.


Eligibility criteria:
inclusion criteria: * at least 18 years old. * subject has an ulcer, or slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of diabetes. * the target ulcer will be the largest ulcer if two or more eligible dfus are present and will be the only one evaluated in the study. * the target ulcer is planned to undergo standard wound care (swc) therapy (see 8.6 standard wound care (swc) therapy). * subject understands and is willing to participate in the clinical study and can comply with required visits. exclusion criteria: * target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes. * target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. * eligible dfu has associated untreated acute osteomyelitis or active infection * subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy. * subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
navelbine and radiotherapy in locally advanced lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study is an open label randomized multi-centre phase ii trial in patients with inoperable locally advanced stage iib-iiib non small cell lung cancer who fulfils the general criteria for curatively intended irradiation. the treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. the patients will be included in the study after completing the induction chemotherapy. randomization will take place only if an acceptable dose plan can be obtained.

this study was an open label randomized multi-centre phase ii trial in patients with inoperable locally advanced stage iib-iiib non small cell lung cancer who fulfils the general criteria for curatively intended irradiation. the treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. the patients was included in the study after completing the induction chemotherapy. randomization took place only if an acceptable dose plan could be obtained. primary endpoint: local recurrence free interval

Eligibility criteria:
inclusion criteria: * age ≥18 years * patients with histologically or cytologically documented diagnosis of locally advanced nsclc stage iib to iiib without pleural effusion * performance status 0-1 on the ecog scale * weight loss ≤10% during the last 6 months * adequate lung function measured as fev1 ≥1.0 * neutrophile count ≥1.5 x 109/l and platelet count ≥100 x 109/l * serum bilirubin ≤1.5 upper limit of normal (uln) * alat ≤2 x uln * able to comply with study and follow-up procedures * patients with reproductive potential must use effective contraception * written (signed) informed consent to participate in the study exclusion criteria: * any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease) * any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) * prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy * inability to take oral medication, or requirement of intravenous alimentation * active peptic ulcer disease * nursing mothers

Keywords: induction chemotherapy non-small cell lung cancer randomized phase ii study navelbine oral (r) 3d-conformal radiotherapy chemo-radiotherapy local-regionally advanced non-small cell lung cancer
statins in the elderly

Conditions: Mortality

Summary: in patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent us recommendations consider statins in people only between 40 and 75 years. moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the french healthcare system. the aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.

statins in primary prevention are associated with a 1.2% decreased absolute risk of cardiovascular events in large randomized studies. anyway, in patients ≥ 75 years, the impact of statins on mortality have not been demonstrated and large observational studies have shown an increased risk of mortality in people with low cholesterol. moreover, statins are associated with numerous side effects, particularly in the elderly including myalgia and myositis, diabetes, cognitive disorders, fatigue and loss of energy and of physical activities, treatment interactions. at last, the cost of statins for the french national health insurance is 800 million euros per year (including around 200 million euros for people ≥ 75 years). the benefit/risk ratio of statins is not established in primary prevention in people ≥ 75 years, leading to numerous and discordant expert advices since no specific randomized trial have been conducted in this population. thus, in patients ≥ 75 years treated with statins in primary prevention, the studied strategy will be to stop statin therapy. the comparison strategy will be represented by the group of patient who will continue their statin at the same dose. patients will be followed up every three months, according to general recommendations, during 36 months. clinical events will be prospectively registered

Eligibility criteria:
inclusion criteria: * people aged ≥ 75 years * treated with any statin from at least one year, in primary prevention * having replied to a standardized questionnaire allowing to screen any history of cardiovascular event * consent form signed exclusion criteria: * life prognosis below 6 months * patient with known homozygous or double heterozygous familial hypercholesterolemia * dementia

Keywords: statins elderly mortality quality of life randomized trial cost effectiveness study primary care
concurrent assessment of skeletal muscle mass and synthesis/breakdown in old age

Conditions: Sarcopenia; Muscle Atrophy

Summary: this study involves minimally-invasive techniques to measure muscle mass, muscle protein breakdown and synthesis simultaneously in older age.

most people will have noticed that with age people become frail. this is principally due to wasting of skeletal muscle known as "sarcopenia". crucially, sarcopenia is more than just a symptom of weakness and poor functional capacity; it exposes people to an increased risk of falls and fractures, impacting quality of life, independence, health status and ultimately lifespan. muscles represent the largest organ in the body, making up over 50% of total body weight. most people know that skeletal muscles are important for movement and to support the skeleton, but not everyone is aware of how important muscles are for whole-body health. for example, muscles represent a vast protein store containing amino acids (the building blocks of protein) which can be broken down in times of fasting, infection and disease in order to provide energy to help other vital organs. because of the detrimental effects on health, and the associated health costs, sarcopenia is of grave concern. therefore, there is a significant clinical need to pre-identify at-risk older individuals who have low muscle mass so that they can be offered an intervention (of diet, exercise or drug-based) before they suffer any of the potential problems outlined above. current techniques for measuring whole-body muscle mass, including mri and ct are time-consuming, expensive and in huge demand in hospital settings, meaning that muscle wasting conditions such as sarcopenia often go undiagnosed. in this project we propose a potential solution to this problem by developing a diagnostic of sarcopenia that requires only a single drink and subsequent urine collection. in addition, throughout this project we aim to explore the mechanisms underlying muscle wasting by assessing the muscle of those with low and 'normal' muscle mass.

Eligibility criteria:
inclusion criteria: - healthy volunteers of normal body mass index (bmi \<35 kg/m2), aged 65-85 years exclusion criteria: * a bmi \> 35 kg/m2 * active cardiovascular disease: o angina, heart failure (class iii/iv), arrhythmia, right to left cardiac shunt, recent cardiac event * cerebrovascular disease: o previous stroke, aneurysm (large vessel or intracranial), epilepsy * respiratory disease including: o pulmonary hypertension, copd * metabolic disease: o hyper and hypo parathyroidism, untreated hyper and hypothyroidism, cushing's disease, type 1 or 2 diabetes * active inflammatory bowel or renal disease * malignancy * recent steroid treatment (within 6 months) or hormone replacement therapy * clotting dysfunction
observational study to evaluate the safety and efficacy of zepzelca™ injection

Conditions: SCLC

Summary: the purpose of this study is to evaluate the safety and efficacy of zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.


Eligibility criteria:
inclusion criteria: * patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study * patients who have received or are scheduled to receive zepzelca™ inj., according to domestic approval indications * patients with metastatic sclc who have failed first-line platinum-based chemotherapy exclusion criteria: * patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment * patients with a history of hypersensitivity reactions to this drug or its components * pregnant, potentially pregnant, or lactating women * patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining) * patients who are judged by the principle investigator or sub-investigator to be ineligible to participate in the study.
von willebrand disease in the netherlands

Conditions: Von Willebrand Disease

Summary: the primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with vwd.

von willebrand disease (vwd) is the most common inherited bleeding disorder, and is characterized by a defective platelet adhesion and aggregation. vwd is caused by a reduced (type 1), an abnormal function (type 2) or a complete absence (type 3) of von willebrand factor (vwf). in recent years, large retrospective cohort studies have provided valuable insights on the clinical presentation, bleeding phenotype, quality of life, diagnostics, genetics and treatment of patients with vwd. one of these large studies is the von willebrand in the netherlands (win) study, which is a nationwide cross sectional study of moderate and severe von willebrand disease patients, that was initiated in 2007. over 800 vwd patients were included in the win study, which was about 80% of all known vwd patients in the netherlands. although the win study and large retrospective studies in other countries provided important insights in understanding vwd, some significant challenges remain and large prospective studies are lacking to provide answers. all large retrospective cohort studies have assessed the bleeding phenotype of patients with vwd using bleeding scores or retrospective questionnaires. bleeding scores calculate the sum of all bleeding episodes during lifetime. therefore, they provide useful information on the bleeding tendency during lifetime. however, bleeding scores do not provide information on the change of bleeding tendency. if a patient had a period in his or her lifetime in which he or she had many bleeding episodes, then the bleeding score is high. though, the patient could have had those bleeds 30 years ago and did not have a bleeding episode since then. therefore, bleeding scores do not provide information on the current bleeding phenotype of vwd patients. furthermore, previous studies provided limited information on the frequency of mild bleedings, like gum bleeding or epistaxis, that occur in daily life but do not require therapy. nevertheless, these bleeding episodes can cause a major impairment in quality of life. this is especially important in children, because school-going children with vwd have a lower quality of life and have a different bleeding tendency, characterized by more cutaneous bleeding (81%), oropharyngeal bleeding (64%) and epistaxis (56%). therefore, the primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with vwd.

Eligibility criteria:
inclusion criteria: * historically lowest vwf:ag and/or vwf:rco and/or vwf:cb ≤ 0.30 iu/ml and/or fviii:c ≤ 0.40 iu/ml * treatment at a hemophilia treatment center in the netherlands * all types of vwd * all ages exclusion criteria: - other known bleeding disorders present.

Keywords: von willebrand disease von willebrand factor nationwide study prospective study