Kornimate/medical-research-clean huggingface dataset:
comparing standard of care biopsy system to a novel biopsy needle system by computational pathologic analysis

Conditions: Prostate Cancer Screening

Summary: prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. a novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. this study will compare quality and quantity of tissue retrieved by both systems. further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and gleason scores in terms of tissue area, tissue length, and tissue tortuosity.

prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). the objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. tissue analyses will be completed by pathologists blinded to the biopsy system used.

Eligibility criteria:
inclusion criteria: * adult males with psa density greater than or equal to 0.15 * lesions are visible under mri * pirads score is greater than or equal to 3 * able to and willing to provide consent exclusion criteria: * subject has had previous local prostate therapy, focal therapy, brachytherapy, adt, surgery, or chemotherapy for prostate cancer * history of dementia, cognitive impairment, or deep vein thrombosis (dvt) * is a prisoner currently or has a history of incarceration * unable to understand english * has metastatic prostate cancer or a tumor stage of t2c, t3, or t4 * has concurrent malignancies * is positive for hiv, hbv, and/or hcv infection * has low-performance status
effect of anthocyanins on metabolic profiles in subjects with pre-diabetes

Conditions: Insulin Resistance; Glucose Metabolism Disorders; Type 2 Diabetes; Lipid Metabolism Disorders

Summary: metabolic problems represent one of the major health concerns which are attractive for being addressed by nutritional interventions, as these are directly connected to dietary habits.anthocyans possess cardiovascular disease prevention, obesity control, and diabetes alleviation properties, but association between anthocyans and prediabetes need to be more firmly understood and established from robust clinical data. however, there is little human research that has reported on the efficacy of increased anthocyans bioactive consumption on insulin sensitivity in pre-diabetes.

the investigators plan to conduct a randomized double-blind, placebo-controlled trial to characterize the potential effects of anthocyans, purified from bilberries and blackcurrants, on metabolic abnormalities commonly associated with type 2 pre-diabetes.

Eligibility criteria:
inclusion criteria: * fpg 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l) (ifg) or 2-h plasma glucose in the 75gogtt 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)(igt) or hba1c 5.7-6.4%. * newly diagnosed t2dm who exceed the upper limit of the range but has not yet accepted hypoglycemic therapy. exclusion criteria: patients with cardiac, renal, or hepatic diseases or with hyperthyroidism or who had concomitant infections, or who use of anti-diabetic drug or potential affect plasma glucose drugs, pregnant and breast-feeding women, and with polycystic ovarian syndrome.
acalabrutinib in patients with chronic lymphocytic leukemia with direct oral anticoagulation (cicero)

Conditions: CLL

Summary: the goal of cicero is to investigate the clinical outcome with a particular focus on prospective data on safety using acalabrutinib (+/- obinutuzumab) in cll patients receiving co-medication with doacs (edoxaban, rivaroxaban, dabigatran, apixaban) irrespective of treatment line.

the non-interventional study (nis) cicero will collect real-world data to explore acalabrutinib (+/- obinutuzumab) in adult cll patients (irrespective of treatment line) who receive co-medication with doacs. the primary focus of the study is to investigate the incidence proportion of bleeding events. due to the mostly elderly cll patient population, cll patients often suffer from multiple cardiovascular comorbidities including atrial fibrillation (af), deep vein thrombosis (dvt) or pulmonary embolism (pe) which make anticoagulation mandatory. up to now, no systematic and prospective evaluation on interactions of btkis and doacs has been conducted. in order to assess bleeding events, a questionnaire will be used to document if bleeding events occurred in-between visits in routine care. patients will be asked at each visit if distinct events occurred in the time between the last visit until the current visit and discuss the questionnaire with the physician to determine of any (s)ae occurred until end of acalabrutinib treatment.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patients with chronic lymphocytic leukemia (cll) and decision for treatment with acalabrutinib (+/- obinutuzumab) according to current smpc as assessed by the treating physician or already started treatment with acalabrutinib (+/- obinutuzumab) according to current smpc no longer than 6 weeks ago * other concomitant disease resulting in medical need of or already under treatment with direct oral anticoagulant (doac) treatment with edoxaban (lixiana®) or rivaroxaban (xarelto®) or dabigatran (pradaxa®) or apixaban (eliquis®) according to the respective current smpc. * eastern cooperative oncology group (ecog) performance status 0-2 * signed, written informed consent. exclusion criteria: * combination of acalabrutinib with other substances than obinutuzumab for cll treatment * participation in an interventional clinical trial with acalabrutinib

Keywords: cll acalabrutinib (+/- obinutuzumab) doac
clinical pharmacist intervention on medication adherence and clinical outcomes in chronic kidney disease patients

Conditions: Chronic Kidney Disease

Summary: the purpose of this research study is to evaluate the impact of clinical pharmacist interventions on treatment outcomes, health-related quality of life (hrqol),and medication adherence among chronic kidney disease patients. pharmacist's intervention aim to answer: 1. how a clinical pharmacist intervention program impact medication adherence in chronic kidney disease? 2. to assess how patients' counseling and medication adherence impact patient health-related quality of life? 3. how a clinical pharmacist intervention program improves clinical outcomes of chronic kidney disease patients?

this is a randomized, pharmacist-led, two-group, longitudinal descriptive intervention study performed at a private hospital nephrology department. the study included the introduction of clinical pharmacist interventions to improve adherence to prescribed medications, health-related quality of life, and clinical outcomes in patients with chronic kidney disease(ckd). recruited patients were randomly divided into two groups; the basic intervention group and the advanced intervention group. the basic intervention group received routine counseling. an advance intervention group was provided in addition to the usual counseling, education about chronic kidney disease, hypertension or other comorbidity and management, as well as medication adherence, and renal diet (educational infographic for chronic kidney disease patients) at three follow-up intervals after every 2 months. both groups were followed up for a period of 6 months. pre-validated questionnaires will be used for the assessment 1. medication adherence rating scale (mars): to evaluate medication adherence 2. mos 36-item short form survey instrument (sf-36): for evaluation of health related quality of life. for evaluation of clinical outcome blood pressure, serum creatinine, and hemoglobin will be obtained from medical records (from hospital software or from patient who had done their labs from out sources)during the baseline visit. the same laboratory tests will also be assessed at patients three-time intervals at admission or first visit at the start of treatment, week 8, and week 16.

Eligibility criteria:
inclusion criteria: * all male and female inpatients and outpatients with chronic kidney disease defined as a creatinine clearance (crcl) less than 60 ml/min/l, 73 m2 * over the age of 18 years , will be included in study. * patient who are on maintenance hemodialysis also included. exclusion criteria: * patients with acute renal failure * patients who are receiving renal transplants will not be included. * patients who will refuse to participate in study will not be included.

Keywords: clinical pharmacist intervention medication adherence clinical outcomes health related quality of life
lacidipine in mild to moderate essential hypertension patients with type 2 diabetes in korea

Conditions: Diabetes Mellitus, Type 2; Essential Hypertension

Summary: this study was designed to evaluate the anti-hypertensive efficacy of lacidipine in hypertensives with type 2 diabetes and effectiveness on endothelial cell function in korean population.


Eligibility criteria:
inclusion criteria: * newly diagnosed as essential hypertension or not treated in the past 2 weeks(if the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments) * mean seated sbp at screen visit = 130mmhg (as measured by a mercury sphygmomanometer) * type 2 diabetes (american diabetes association criteria 2004) and hba1c \<11% * agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential * provide written informed consent exclusion criteria: * mean seated sbp of \> 180 mmhg * known or suspected secondary hypertension * anemia defined by haemoglobin concentration \< 10.0 g/dl * hemoglobinopathy or peripheral vascular disease * clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dl; alanine aminotransferase, aspartate aminotransferase, total bilirubin, or alkaline phosphatase \> 2.5 times the upper limit of the normal reference range) * unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment * chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible) * female who is lactating, pregnant, or planning to become pregnant * clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.) * acute or chronic metabolic acidosis or a history of diabetic ketoacidosis

Keywords: korean patients type 2 diabetes endothelial function lacidipine essential hypertension
a real world study evaluating the clinical application of peg-rhg-csf during chemotherapy in patients with solid tumors

Conditions: Neutropenia

Summary: prospective, multicenter, non-interventional registration studies were used in this project . eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in sichuan province, sichuan province, were selected from the first chemotherapy cycle using peg-rhg-csf (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. the use of peg-rhg-csf and related patient outcomes until the end of chemotherapy. analyze the clinical practice of using peg-rhg-csf in the real world.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients; 3. the first use of peg-rhg-csf during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient); 4. subjects volunteered to participate in this clinical trial and signed informed consent. exclusion criteria: 1. peg-rhg-csf was used in the current chemotherapy cycle; 2. have received hematopoietic stem cell transplantation or bone marrow transplantation; 3. other drug clinical trials are currently underway.
evaluating the cardiovascular effects of tourniquet application

Conditions: Orthopedic Disorder; Hemodynamic Instability

Summary: the goal of this prospective observational study is to investigate the impact of tourniquet application on cardiac efficiency through the cardiac cycle efficiency parameter and to explore how central regional technique alters this effect compared to general anesthesia. we aim to answer the following main questions: 1) does the use of a tourniquet reduce cardiac efficiency? 2) does the impact of tourniquet use on cardiac efficiency vary with general anesthesia or central regional technique? the patients included in the study will be divided into two groups based on whether they receive general anesthesia or combined spinal epidural anesthesia.the patients' cardiac cycle efficiency and advanced hemodynamic monitoring parameters will be recorded during procedure.

after obtaining ethical committee approval (atadek; 2022-14/12), 43 patients undergoing elective unilateral total knee arthroplasty under tourniquet were enrolled in our prospective observational study. patients were divided into two groups: general anesthesia (group ga: 22 patients) or combined spinal epidural anesthesia (group csea: 21 patients). cardiac and vascular parameters were recorded using the new algorithmic application of arterial wave analysis called pressure recording analytical method (pram) at 9 time points: (t1) pre-anesthesia, (t2) post-anesthesia before tourniquet inflation, (t3-8) during tourniquet inflation, and (t9) after tourniquet deflation.

Eligibility criteria:
inclusion criteria: * planned for elective unilateral total knee arthroplasty under tourniquet application * aged 18 and over * either general anesthesia (ga) or combined spinal-epidural anesthesia (csea) will be administered exclusion criteria: * patients under 18 years of age * patients with heart failure * patients with valve disease * patients with rhythm disorders * patients with a history of myocardial infarction in the last 3 months * patients unwilling to provide consent

Keywords: cardiac cycle efficiency arterial elastance dp/dtmax cardiac power output tourniquet
study of affective forecasting skills in post-traumatic stress disorder

Conditions: Post-traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is associated with a marked tendency to have exaggerated and persistent negative beliefs and expectations about oneself or the world . although posttraumatic stress symptoms have been shown to be associated with a tendency to negatively anticipate the future, affective forecasting skills (i.e., the ability to predict one's own emotional reactions in response to a future event) have never been explored in ptsd . the hypothesis that the ptsd is associated with a negative affective forecasting bias, characterized by a tendency to predict more intense emotional responses to future negative events.


Eligibility criteria:
inclusion criteria: * understanding and being able to express themselves in french * understanding of informed consent and signature of the study participation form * giving informed, dated and signed consent * benefiting from health insurance coverage * normal or corrected visual and auditory acuity to achieve normality * group 1 : dsm-5 ptsd criteria, assessed using caps and ptsd checklist for dsm-5 (pcl-5, weathers \& al., 2013) * group 2: ptsd criteria a only exclusion criteria: refusal of participation after clear and fair information on the study. * visual or auditory sensory disability to participate in the study. * personal history of neurological disease or current neurological disease. * personal history of current psychiatric disorder or psychiatric disorder (excluding ptsd in patients in the experimental group), assessed via the mini. * pregnant or breastfeeding women * consumption of toxic substances other than tobacco and alcohol. * minors or adults under guardianship, under judicial protection, persons deprived of liberty. * groups 2 and 3: personal history of psychiatric disorder or current psychiatric disorder and taking psychotropic drugs * group 1: personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, trauma and stress-related disorders and treatment with psychotropic drugs not stabilized

Keywords: emotion post-traumatic stress disorder affective forecasting virtual reality autonomic nervous system electrodermal activity
antidiabetic effects on intrahepatic fat

Conditions: Non-Alcoholic Fatty Liver Disease; Type2 Diabetes

Summary: this was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (glucophage, bristol-myers squibb), liraglutide (victoza, novo nordisk), or gliclazide (diamicron, servier) groups. all patients were informed about a proper diet and exercise. for the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. for the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/l. for the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.at the end of the study, data will be collected and analyzed.

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years; 2. type 2 diabetes mellitus; 3. not used antidiabetic drugs within 3 months; 4. hba1c(7-10%); 5. presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography); 6. female subjects：post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period; 7. body mass index (bmi) 20-35kg/m2, and stable weight 3 months(less than 10% volatility); 8. patients signed the informed consent. exclusion criteria: 1. used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months; 2. suffering from pancreatitis or other pancreatic diseases or have other similar history; 3. glp-1 analogs or sulfonylurea allergy history; 4. liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit); 5. moderate to severe renal insufficiency (egfr\<60ml/min/1.73m2,calculated according to mdrd); 6. female subjects drinking\> 14 units / week; male subjects drinking\> 21 units/week; 7. a history of metabolic or autoimmune liver diseases or viral hepatitis diseases; 8. a history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history; 9. congestive heart failure (nyha grade ⅲ - ⅳ grade); 10. severe gastrointestinal diseases; 11. other serious concomitant diseases; 12. pregnant or planning pregnancy; 13. the researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment; 14. subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional chinese medicines can not be adjusted or disabled.

Keywords: liraglutide metformin gliclazide
patient derived vascularized microtumor model of gastrointestinal peritoneal carcinomatosis

Conditions: Peritoneal Carcinomatosis; Gastrointestinal Peritoneal Carcinomatosis

Summary: this is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.


Eligibility criteria:
inclusion criteria: * patients must have a gi tumor * must have planned standard of care surgical procedure * age ≥ 18 years. * ability to understand and the willingness to sign a written informed consent exclusion criteria: - pattens who are unable to comply with the study protocol

Keywords: peritoneal carcinomatosis gastrointestinal peritoneal carcinomatosis
outcomes and prognostic factors in covid-19

Conditions: COVID-19; Elderly Patients; Critical Illness; Survival; Old Age

Summary: the primary aim is to study the short-term outcome of elderly icu patients (≥ 70 years) suffering from covid-19 using a multicenter and multi-national approach. the secondary aim is to investigate the properties of a simple frailty scale in this cohort, and in particular if this is an instrument that can be used for outcome prediction in this group. in addition, various other parameters of potential relevance for older critically ill patients will be studied.

the study started in march 2020 and included until summer 2021 nearly 4000 patients. several comprehensive analyses were conducted and published. subsequently, in december 2021 the protocol was slightly changed and recruitment continues in 2022. data are collected regarding: pre-admission life conditions with frailty (clinical frailty scale, cfsf.r.a.i.l score); vaccination status; icu-admission (e.g. sofa), icu-treatment, survival (30 day and 3 months). data are collected electronically through an e-crf and with baseline documentation of the icu. the database is located in denmark, at the department of epidemiology, university of aarhus. each icu will only have access through the database of their own patients, and patient id is not registered (names, birth-date or social security numbers) so it is in that sense anonymous. the goal is to recruit at up to 400 icus that will continuously collect data. the covip study had two different previous recruitment periods. period 1 (march to may 2020) finished representing the first wave of the pandemic in most countries. the second recruitment period has been defined being from september 1st to december 31st 2020 representing the second wave in most countries. recruitment in 2021 also continued until the summer without allocating a specific recruitment period. however, the third recruitment period opened january 1st 2022 and is still ongoing.

Eligibility criteria:
inclusion criteria: 1. age \> 70 years 2. icu-admission 3. infection with sars-cov-2 exclusion criteria: 1. age \<70 years

Keywords: covid-19 elderly patients