Kornimate/medical-research-clean huggingface dataset:
validation of a german translation and cultural adaptation of the addenbrooke's cognitive examination iii

Conditions: Neurocognitive Dysfunction

Summary: the aim of the entire project was to perform a translation and cultural adaptation of the addenbrooke's cognitive examination - iii (ace-iii), adhering to the translation and cultural adaptation of patient reported outcomes measures-principles of good practice, in order to make it available to german clinicians. part of the translation process is the cognitive debriefing which will be performed as a survey which rates the applicability of every single item as well as of the entire addenbrooke's cognitive examination - iii tool.

the recent demographic developments have drastically increased the importance of developing applicable approaches to the diagnostics of dementia and the general evaluation of cognitive function. many different tests were developed to thoroughly evaluate neurocognitive function. the addenbrooke's cognitive examination, developed in 2000, was one such tests and has served as an open source neurocognitive examination tool ever since. the current version is the addenbrooke's cognitive examination iii (ace-iii). the aim was to develop a tool that would be able to identify dementia in its early stages and also to differentiate between the different types of dementia. in order to achieve reliable results, cognitive tests should be conducted in a familiar language and draw from the cultural background a participant is familiar with. the ace-iii and all its predecessors were developed in english and for an english-speaking cultural background, not directly applicable to the typical german patient. this made it necessary to perform not only a verbatim translation of test contents, but also to appropriately adapt the test content to reflect the cultural background of the typical german patient. the international society for pharmacoeconomics and outcomes research (ispor) - task force for translation and cultural adaptation has developed the "translation and cultural adaptation of patient reported outcomes measures-principles of good practice", to ensure a consistent and rigorous methodology in the process of translating and adapting patient-reported outcomes measures. the principles of good practice consist of ten steps: 1. preparation 2. forward translation 3. reconciliation 4. back translation 5. back translation review 6. harmonization 7. cognitive debriefing 8. review of cognitive debriefing results and finalization 9. proofreading 10. final report

Eligibility criteria:
inclusion criteria: * male and female employees of the department of anesthesiology and operative intensive care medicine (ccm, cvk), charité universitätsmedizin berlin (residents, specialist physician for anesthesiology, senior physicians, medical students engaged in research projects) .- ≥ 18 years of age * experience in the field of neurocognitive testing exclusion criteria: * insufficient knowledge of the german language
study to investigate effects of antiischemic drug therapy in silent ischemia

Conditions: Myocardial Ischemia

Summary: there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (cad), and, particularly, on a possible benefit of medical therapy in such patients. swissi 1 therefore recruits totally asymptomatic subjects older than 40 years of age without any history of cad but one cardiovascular risk factor with documented silent ischemia. participants are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

although there is still controversy regarding why ischemic episodes are symptomatic in some patients and completely asymptomatic in others, it is now widely accepted that silent ischemia, like symptomatic episodes, negatively affects prognosis. silent ischemia may occur in totally asymptomatic patients without (type i) or with a history (type ii) of an ischemic cardiac event and coexists with symptomatic episodes in many patients (type iii). however, there is a lack of data on the prognostic importance of silent ischemia in totally asymptomatic subjects without history of coronary artery disease (cad), i.e. silent ischemia type i, and, particularly, on a possible benefit of medical therapy in such patients. reasons lie in the difficulty to identify such patients and their expected low event rates implying that large patient populations and/or long follow-up periods would be necessary to come to definite conclusions. still, to address this problem, we perform swissi 1 which includes totally asymptomatic subjects older than 40 years of age without any history of cad but one cardiovascular risk factor with documented silent ischemia. they are randomized to open antianginal drug therapy and risk factor control versus only risk factor management and followed up for ≥ 10 years.

Eligibility criteria:
inclusion criteria: * documented silent myocardial ischemia type i * at least one cardiovascular risk factor exclusion criteria: * history of cardiovascular disease

Keywords: myocardial ischemia randomized controlled trials drug therapy
early identification of pathogens in children with respiratory tract infection by mechanical ventilation using mngs

Conditions: VAP - Ventilator Associated Pneumonia

Summary: vap（ventilator-associated pneumonia）is the most common complication of mechanical ventilation in severely ill patients. vap is defined as pneumonia occurring 48 hours after patients receive mechanical ventilation, including pneumonia occurring within 48 hours after extubation. it is one of the important causes of hospital-acquired infection, and the incidence of vap in children on mechanical ventilation is about 10%, or 7/1000 days of mechanical ventilation, and the overall mortality is 10-24%.research has so far explained the relationship between bacteria isolated from human biological samples and vap pathogens. most studies are limited to the level of bacterial species, and there are few reports on bacterial genotyping, and there is a lack of scientific basis for the pathogenesis of vap caused by bacteria in ventilator pipeline. the aim of the study is to investigate pathogen of the sputum in deep respiratory tract of patients with mechanical ventilation in picu by the means of second generation sequencing (ngs).

children receiving invasive mechanical ventilation in the intensive care unit (picu) of the pediatric hospital of fudan university will be included. deep sputum samples were collected within 24 h and on day 5 of mechanical ventilation, respectively, and sent for ngs at the same time. sputum etiology examination is performed with sputum culture blood free dna test. the basic clinical data of the children (age, sex, weight, picu diagnosis and other basic information, as well as the time of start and end of invasive mechanical ventilation for basic diseases, glasgow coma score (gcs score), 3rd generation pediatric mortality risk score iii(prism iii score), crp, pct, white blood cell count and body temperature will be recorded。 clinical data related to the use of glucocorticoids, antibiotics and other drugs as well as life support such as renal replacement therapy, extracorporeal membrane, lung oxygenation and other life support were collected. time and method of diagnosis of vap pathogens were collected. by comparing sensitivity and specificity of ngs and conventional sputum specimens for detection of vap, the clinical value of mngs in vap will be studied.

Eligibility criteria:
inclusion criteria: * the time of invasive mechanical ventilation was less than 24 h when admitted to picu total duration of invasive mechanical ventilation is over 5 days exclusion criteria: * participants in other clinical trials in the same period no informed consent signed
evaluation of a non-invasive brain compliance measurement device

Conditions: Diabetes; Diabetic Ketoacidosis

Summary: this is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. the investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from jan medical: the nautilus neurowave system™ (nns), learning, talking, behavior, or development. the investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old or do not have diabetes and are between the ages of 10 to less than 17 years old.

at enrollment, 1 week, 1 month, 3 month, 12 month computerized neurocognitive testing wear nns mri of the brain at 3 month and 12 months formal neurocognitive testing at 3 months and 12 months

Eligibility criteria:
inclusion criteria: to be eligible for the study, all subjects must meet the following criteria: 1. healthy control or 2. clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the pediatric endocrine society consensus statement guidelines 3. age 10 years to less than 17 years 4. parent/guardian understand the study protocol and agrees to comply with it. 5. primary care giver (i.e parent/guardian) comprehends written english. this is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in spanish or other language. subject comprehends and speaks english. exclusion criteria: subjects who meet any of the following criteria are not eligible for the study: 1. history of head trauma with any loss of consciousness 2. history of premature birth (less than 30 weeks of gestation) 3. history of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age 4. history of neurologic disease independent of diabetes (seizure disorder)
use of intravenous ferric carboxymaltose in treatment of anemia in cancer patients undergoing chemotherapy

Conditions: Anemia; Cancer

Summary: this study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

the study aims to investigate the effect of fcm (without esas) on anemic cancer patients undergoing chemotherapy (with or without radiotherapy); stratified by status of iron deficiency (i.e. non-iron deficient vs. iron deficient patients ). the study will also try to find out whether serum level of hepcidin and c reactive protein can correlate with response patients will receive one or two doses of fcm, based on the body weight and hb level. patients will be followed-up for a total of twelve weeks. the study is divided into a screening, treatment and follow-up phases and is expected to be completed in 12 months.

Eligibility criteria:
inclusion criteria: * patient is an adult more than or equal 18 years old at the time of informed consent. * patient has pathologic diagnosis of solid tumor (breast cancer, colorectal, lung, sarcoma, head and neck, sarcoma, genitourinary or gynecological cancer). * patients who started chemotherapy (with or without radiotherapy) or planned to receive chemotherapy for at least 12 weeks. * patient has an eastern cooperative oncology group performance status between 0 and 2. * patient with hb ≤11 g/dl. * patient has a life expectancy at least 6 months. * adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum creatinine level of less than 2 mg per deciliter. * patient is able to understand and provide informed consent to participate in the study. exclusion criteria: * patient has hb \< 8.0 g/dl * patient presenting with hematologic malignancy including * prior gastric surgery. * patients on definitive radiotherapy alone. * patients with relevant history (within six weeks) or clinical evidence of hemolysis or active bleeding that could, in the investigator's judgment, be a potential cause for the anemia (no gross hematuria, hemoptysis, hematochezia or melena and negative stool for hemoccult) * presence of other nutritional anemia; deficiency of vitamin b12 less than 187 pg/ml and deficiency of folate less than 3.1 ng/ml according to the local laboratory normal ranges * patient has iron overload (serum ferritin more than 800 ng/ml or transferrin saturation (tsat) more than 40%) * patient is pregnant or lactating. * patient has a personal or family history of hemochromatosis. * patient has hypersensitivity to any form of iv iron. * patient has received red blood cells transfusion or used erythropoietin within 2 weeks of enrollment into the study. * patient has received any form of intravenous iron within the last 12 weeks * patient has received oral iron supplements within 1 month of enrollment to the study, except for multivitamin supplements containing less than 30 mg iron.
pain and safety of restylane with and without lidocaine for correction of moderate and severe nasolabial folds

Conditions: Nasolabial Fold

Summary: the purpose of this study is to evaluate the pain and safety associated with injections of restylane lidocaine compared to restylane using a visual analogue scale.


Eligibility criteria:
inclusion criteria: * signed informed consent * men or women aged 18 years or older of chinese origin * subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study * intent to undergo correction of both nasolabial folds(nlf) with a wrinkle severity in wrinkle severity rating scale(wsrs) of either 3 on both sides or 4 on both sides exclusion criteria: * previous use of any permanent (non-biodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat below the level of the lower orbital rim * previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment * previous tissue revitalisation treatment with laser or light, mesotherapy radiofrequency, chemical peeling or dermabrasion in the midface within 6 months before treatment * scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated * other condition preventing the subject from entering the study in the investigator's opinion

Keywords: hyaluronic acid, nasolabial fold, lidocaine
the altitude inflammatory bowel disease study

Conditions: Inflammatory Bowel Disease

Summary: this is a prospective, controlled and observational study. participants underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 meters above sea level (m.a.s.l.) in a hypobaric pressure chamber. clinical parameters, as well as blood and stool samples and biopsies from the sigmoid colon (by sigmoidoscopy) are collected at subsequent time points. the investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000 m) can alter disease activity and can modulate a pro inflammatory reaction.

to evaluate the potential influence of hypoxia on the course of ibd on a biomolecular level, and to test the effects of hypoxia under standardized conditions, the investigators initiated a prospective and controlled investigation in healthy controls and ibd patients in stable remission. the investigators primary aim is to show that a 3-hour stay at high altitude can alter disease activity of ibd. ten healthy volunteers, 11 crohn's disease (cd) patients and 9 ulcerative colitis (uc) patients underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l. in a hypobaric low-pressure chamber situated at the swiss aeromedical center, dubendorf, switzerland. stool samples for the analysis of calprotectin and microbiotal composition, biopsy samples from the rectosigmoid region, and blood samples were repetitively collected and analysed in conjunction with detailed records of clinical symptoms over a subsequent interval of 4 weeks.

Eligibility criteria:
inclusion criteria: * had a diagnosis of crohn's disease or ulcerative colitis at least 6 months prior to inclusion * gave written consent * were in clinical remission (measured by harvey bradshaw activity index (hbi) in cd and the partial mayo score for uc) exclusion criteria: * had contraindications for a sigmoidoscopy * had intercurrent bacterial or viral intestinal disease (by culture or serology) * were pregnant or breast feeding * had a severe concomitant disease which excluded from participating in the study by means of the study physician * were likely to or showed no cooperation for the study procedures * had active infection or systemic antibiotic, antiviral or antifungal treatment 3 weeks before baseline * were suffering from short-bowel syndrome * were receiving parenteral nutrition * had a clinical condition which did not allow a stay at heights of 4,000 m.a.s.l. * were claustrophobic
prospective study of the prosigna assay on neoadjuvant clinical decision-making in women with hr+/her2- breast cancer

Conditions: Breast Cancer

Summary: this research study is evaluating a genomic analysis called predictor analysis of microarray 50 (pam50, by prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.

as the investigators understanding of how er-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. national medical guidelines now include the routine use of tumor profiling tests, like the prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery. currently, the prosigna® assay (also called pam-50) is fda approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. in these cases, physicians run this test using tumor tissue from a patient's breast surgery. however, the prosigna® assay is not approved for use preoperatively, or before surgery. previous studies showed that the prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). in this study, the investigators will use tumor tissue from the participant's biopsy to run the prosigna® assay. the test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery. this study is being done to determine how prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.

Eligibility criteria:
inclusion criteria: * patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer * er or pr ≥ 1% by immunohistochemistry (ihc) * her2-negative status, according to guidelines by asco cap guidelines: https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751 * tumor size ≥ 0.5cm (clinical or radiographic measurements) * any nodal status allowed * age \> 18 years old * felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician exclusion criteria: * er-negative and pr-negative invasive breast cancer (\< 1% by ihc) * known metastatic disease

Keywords: breast cancer
neoadjuvant adebrelimab with dalpiciclib for resectable esophageal squamous cell carcinomas

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(pd-l1) immunotherapy, adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies. * the primary tumor should be located in the thorax. * the patients should be evaluated to be able to have surgical resection before the surgery according to the examinations . 2. the patients should be at the range of 18-75 years old, eastern cooperative oncology group (ecog) 0-1. 3. the patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent. exclusion criteria: 1. the stage of tumor is t4b (ajcc/international union against cancer (uicc) 8th edition) and cannot be resected. 2. currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy. 3. history of other malignancies. 4. have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease. 5. any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components. 6. presence of serious medical diseases, such as grade ii and above cardiac dysfunction (nyha criteria), ischemic heart diseases, etc. 7. the patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy, are excluded from the study. 8. female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded. 9. received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial. 10. any other factors that are not suitable for inclusion in this study judged by investigators.

Keywords: esophageal squamous cell carcinoma neoadjuvant therapy immunotherapy cdk4/6 inhibitor
fkbp51s: a new molecular biomarker for glioblastoma? pre- and post-operative blood levels evaluation of fkbp51s protein and correlation with mri phenotype

Conditions: Glioblastoma

Summary: the aim of this interventional study is to investigate the correlation between magnetic resonance phenotype and levels of fkbp51s protein pre and post surgery in adult patients affected by glioblastoma


Eligibility criteria:
inclusion criteria: * age \>= 18 years * diagnosis of glioblastoma with surgery criteria * brain mri with contrast both pre and post surgery exclusion criteria: * no availability of radiological documentation * glioblastoma diagnosis not confirmed by histological examination * withdrawal of icf