Kornimate/medical-research-clean huggingface dataset:
left atrial appendage closure for the prevention of thromboembolisms in patients undergoing aortic bioprosthesis surgery

Conditions: Aortic Stenosis

Summary: the primary purpose of the laa-closure trial is to assess the efficacy and safety of surgical closure of laa in patients undergoing aortic valve replacement. this randomized, prospective, open-label international multicenter trial will enroll 1040 patients undergoing aortic valve replacement with cha2ds2-vasc score ≥2 but without an indication for anticoagulation at the time of enrollment. patients will be randomized in 1:1 fashion to standard therapy + surgical closure of laa vs. standard therapy alone. the duration of the study is five years (plus additional 10 years).

previous studies have concluded that ≥90% of af related left atrial thrombi are located in the left atrial appendage (laa). surgical closure of laa can be performed using ligation, stapler or other devices designed for this purpose during cardiac surgery. however, current evidence for surgical closure of laa is scarce and no large scale randomized prospective clinical trials addressing this issue have been published. american college of cardiology (acc)/ american heart association (aha) guidelines state that laa exclusion should be considered in patients with recurrent and persistent af who remain symptomatic with heart rate control and where antiarrhythmic medication is not tolerated or no longer effective. current european association of cardiothoracic surgery (eacts) guidelines conclude that there is no proven benefit of surgical laa exclusion in terms of stroke reduction or mortality benefit (level of evidence 2a b), and if exclusion is contemplated, devices designed for appendage exclusion should be used rather than a cut-and-sew or stapling technique. these guidelines are based on small poorly designed descriptive trials and only one small randomized trial. laa-closure trial aims to assess efficacy and safety of prophylactic surgical closure of laa in patients undergoing aortic valve replacement.

Eligibility criteria:
inclusion criteria: 1. patients undergoing aortic valve replacement (+/- coronary bypass and/or mitral valve surgery) according to clinical indications (esc guidelines for the management of valvular heart disease) 2. age ≥18 years 3. no indication for long term anticoagulation at the time of enrollment. 4. patients with chads-vasc score ≥2 5. patient is willing to comply with specified follow-up evaluations 6. patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate medical ethics committee or institutional review board. exclusion criteria: * age \< 18 years * expected survival \< 1 year * chronic atrial fibrillation * indication for long term anticoagulation therapy before the index procedure * mechanical valve implantation previously or at the index procedure * any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.
coronary atherosclerosis disease early identification and risk stratification by noninvasive imaging

Conditions: Coronary Artery Disease

Summary: the investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (cad) and underwent cardiac computed tomography angiography (cta). the endpoint was major adverse cardiac events (mace).the investigator aim to evaluate the prognostic value of cta, risk factors and bio-markers for mace.

the investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (cad) and underwent cardiac computed tomography (ct). cardiac ct was assessed for coronary artery calcification score (cacs) and the extent, the location, the stenosis severity, and the composition of the plaque in cta. the base line information was recorded, including risk factors, drugs, bio-markers, and psychological. the endpoint was mace, defined as composite cardiac death, nonfatal myocardial infarction (mi).we aim to evaluate the prognostic value of cta, risk factors and bio-markers for major adverse cardiac events (mace).

Eligibility criteria:
inclusion criteria: 1. suspected of coronary heart disease, coronary cta has been completed. 2. age \> 18 years old. 3. have biochemical test results. 4. signed informed consent. exclusion criteria: 1. malignant tumor, severe liver and kidney diseases. 2. combination of cardiomyopathy, valvular disease, congenital heart disease, a variety of reasons the left cardiac insufficiency.

Keywords: coronary artery disease ct mace
multiple grain in type 2 diabetes

Conditions: Diabetes Mellitus

Summary: we aim to investigate the beneficial effect of adding grain fiber to daily rice meal in type 2 diabetic patients. we anticipate this intervention will improve glycemia and lipid profile in these patients.

resistance of insulin-mediated glucose transport is a fundamental early defect in the pathogenesis of type 2 diabetes mellitus (dm). it has been found that high fiber concentration in meal is frequently associated with low gi. in many single-blind cross-over study, short term consumption of high fiber meal has been shown to enhance postprandial insulin sensitivity in healthy subjects. we presume that increasing daily consumption of fiber would improve the insulin resistance and therefor glycemic parameters patients with dm. patients with type 2 diabetes with stable dose of hypoglycemic medication control will be recruited, two types of meals will be given, type a is a general asian rice-meal and type b consists of the same rice with multiple-grain-fiber added. both type of meals will be consumed for 3 months by each patients.

Eligibility criteria:
inclusion criteria: * mentally competent adults of either sex with age 30-75 years old * patients have type 2 diabetes mellitus diagnosed after 25 years of age * patients have been in inadequate but stable glycemic control by diet. inadequate glycemic control isdefined as: hba1c 7.1-11.0% * patients have signed the written informed consent. exclusion criteria: * patients with type 1 diabetes mellitus * patients with alcohol, drugs or medications abuse considered by the investigator * patients with impaired liver function (ast, alt\>2.5× upper limit of normal) * patients with impaired kidney function (serum creatinine\>3.0 mg/dl) * patients with emphysema or chronic bronchitis * patients with hepatic cirrhosis * patients with chronic intestinal diseases related to marked disorders of digestion or absorption * patients participated investigational drug trial within 1 month before entering this study * patients with any other serious diseases considered by the investigator not in the condition to enter the trial

Keywords: diabetes rice fiber
validity and reliability of the short physical performance battery in patients undergoing total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: objectives: practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with total knee arthroplasty(tka) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. therefore, the aim of this study is to evaluate the validity and reliability of the short physical performance battery (sppb) among patients with tka. methods: we included patients who underwent tka surgery. the sppb, timed up and go(tug) test and, hospital for special surgery (hss) knee score were administered to the patients. sppb was performed twice on the same day with 1 h rest.


Eligibility criteria:
inclusion criteria: * patients who had primary tka surgery at six months ago, were diagnosed with preoperative knee oa, and were willing to participate in the research exclusion criteria: * a previous orthopedic, neurological, or systemic disease that effected walking or standing, body mass index of 40 kg / m2 and over and having any other surgery on the same limb that effected walking.

Keywords: total knee arthroplasty, knee, short physical performance battery, validity, reliability
a clinical trial of chazhu xiaozhi decoction against non-alcoholic fatty liver disease

Conditions: Hepatic Steatosis; Symptoms and Signs

Summary: the goal of this clinical trial is to learn if drug chazhu xiaozhi decoction works to treat non-alcoholic fatty liver disease in adults. it will also learn about the safety of drug chazhu xiaozhi decoction. the main questions it aims to answer are: does drug chazhu xiaozhi decoction improve the degree of hepatic steatosis in patients with non-alcoholic fatty liver disease? what medical problems do participants have when taking drug chazhu xiaozhi decoction? researchers will compare drug chazhu xiaozhi decoction to a placebo (a look-alike substance that contains no drug) to see if drug chazhu xiaozhi decoction works to treat non-alcoholic fatty liver disease. participants will: take drug chazhu xiaozhi decoction or a placebo every day for eight weeks keep a record of their symptoms and the degree of hepatic steatosis before and after the treatment


Eligibility criteria:
inclusion criteria: according to the diagnostic criteria, patients with nafld and spleen deficiency and damp-heat syndrome are selected. the specific criteria are as follows: 1. age 18-50 years, both genders eligible; 2. meets the diagnostic criteria for nafld; 3. meets the diagnostic criteria for traditional chinese medicine spleen deficiency and damp-heat syndrome; 4. has significant risk factors: cap≥238db/m, body mass index (bmi) ≥23 kg/m²; 5. has not received any anti-nafld medication treatment in the past month; 6. normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels; 7. has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits; 8. voluntarily participates in the study and signs an informed consent form. exclusion criteria: 1. has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis b, hepatitis c, etc.); 2. has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, wilson's disease, etc.; 3. has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (nyha functional classification iii or above), renal failure (glomerular filtration rate egfr \< 30 ml/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.; 4. has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.; 5. known allergy or intolerance to any component of the study medication; 6. has participated in another clinical trial within the last three months; 7. pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial; 8. has severe mental illness or behavioral disorders that may affect adherence to the study protocol; 9. other conditions that the researcher considers unsuitable for participation in this study.
assessment of medication optimization in rural kentucky appalachian patients with mild cognitive impairment or dementia

Conditions: Dementia; Mild Cognitive Impairment

Summary: the amor-kentucky study will examine the impact of a pharmacist-physician patient-centered medication therapy management deprescribing intervention to address inappropriate medication use in patients with cognitive impairment in underserved, lower socioeconomic populations in rural appalachian kentucky. the results of this study will provide valuable insights on how to expand and implement deprescribing interventions using telemedicine to reduce the prevalence and the associated healthcare costs of medication-related problems in patients with mild cognitive impairment, alzheimer's disease and other dementias in rural areas throughout the us. the investigators will assess the potential use of telemedicine in this population by performing an initial single arm, unblinded study of the medication therapy management (mtm) describing intervention in rural/underserved kentucky appalachian populations with cognitive impairment and/or dementia using potentially inappropriate medications (n=50). following initial recruitment and clinical evaluation, engaged participants will have their medication list reviewed by a pharmacist-clinician team to identify targets for deprescribing intervention. the intervention will be engaged remotely with the participant and their caregiver, and the mtm team at 4 weeks post initial evaluation, and then reinforced at a 3-month timepoint. this approach will be carried forward through a telemedicine practice at university of kentucky that is comprised of approximately 500 patient-caregiver dyads throughout rural areas of appalachian kentucky.


Eligibility criteria:
1. 60 years or older, 2. diagnosed with mild cognitive impairment or dementia, 3. using at least one potentially inappropriate medications, 4. living in the community, 5. willing to participate in the study (both the patient and the caregiver)

Keywords: medication optimization rural population dementia alzheimer's disease telemedicine
quantifying systemic immunosuppression to personalize cancer therapy

Conditions: Melanoma; Breast Cancer; Renal Cell Carcinoma; Urinary Bladder Cancer; Squamous Cell Carcinoma of Head and Neck; Small Cell Carcinoma; NSCLC

Summary: the serpentine (stratify cancer patients by immunosuppression) project, represents the most consistent effort so far attempted to translate mdsc into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.

the study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. the project will also take advantage of innovative and high-throughput techniques to define additional mdsc related biomarkers and, most importantly, to identify novel drugs for myeloid-derived suppressor cells (mdsc) blocking in predisposed patients. finally,it will perform the first survey assessing the link between mdsc and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. globally, the serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of mdsc quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.

Eligibility criteria:
inclusion criteria * histologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, rcc and uc, scchn, scc or nsclc, stage iii resectable nsclc will also be included * will and ability to comply with the protocol * willingness and ability to provide an adequate archival formalin-fixed paraffin-embedded (ffpe) tumor sample available for exploratory biomarker analysis * age from 18 to 90 years at the time of recruitment * ecog performance status \<= 2 * understanding and signature of the informed consent * consenting to participate to the socio-economical-psychological survey exclusion criteria * known history of hiv infection * serious neurological or psychiatric disorders * pregnancy or lactation * inability or unwillingness of participant to give written informed consent * inability or unwillingness to be regularly followed up at the same center
comparison of compounded topical anesthetics

Conditions: Procedural Pain

Summary: the primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic benzocaine 20%/ lidocaine 8%/tetracaine 4% (blt) compared to 4% lidocaine topical in providing relief of pain during ipl, pdl, and microneedling procedures.


Eligibility criteria:
inclusion criteria: * men and women over 18, but not more than 75 years of age. * patients who have a regularly scheduled dermatology appointment for intense pulse light (ipl), pulse dye laser (pdl), or microneedling. exclusion criteria: * any subject who has a previous history of allergy, sensitivity, and contraindication to benzocaine, lidocaine, or tetracaine. * patients with cardiac/respiratory disease, seizure disorder, or neuropathies. * patients who are under treatment for a dermatologic condition that may interfere with the evaluation of the study. * pregnant women and women who are breastfeeding. * patients who report concurrent use of anxiolytics or opiates, which may interfere with the interpretation of results.
correlation between oxidative stress status and covid-19 severity

Conditions: Oxidative Stress

Summary: during the new covid-19 pandemic physicians all over the world have faced different challenges .oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in covid-19 infection to the best of knowledge.present study aimed to evaluate oxidative stress marker and redox system status in different covid-19 patients regarding the severity of involvement.

oxidative stress is a probable cause of multi organ failure in this setting which never has been evaluated in covid-19 infection to the best of knowledge.present study aimed to evaluate oxidative stress marker and redox system status in different covid-19 patients regarding the severity of involvement. demographic and lab data of 60 covid-19 confirmed positive cases gathered .these patients divided in to two arms: 1- severe covid-19 which were intubated or admitted in intensive care unit due to severe hypoxia 2- non-severe covid-19 patients which were not hypoxic and admitted in ward with no need to invasive oxygenation. all patients had positive rt-pcr positive nasopharyngeal swab results for covid-19 or lung ct scan compatible with covid-19. malondialdehyde(mda) , biopterin, neopterin, sod, glutathione levels would be checked by elisa tests and compared between these two groups and healthy controls.

Eligibility criteria:
inclusion criteria: * more than 18 years old * positive rt-pcr covid-19 * compatible lung ct with covid-19 exclusion criteria: * not signing informed consent * using antioxidants * using statins
target versus standard human milk fortification in very low birth weight preterm infants

Conditions: Postnatal Growth Failure of Preterm Infants; Human Milk Fortification

Summary: the prevention of postnatal growth failure in very low birth weight (vlbw) preterm infants is of utmost importance. standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. data on efficacy and safety of prolonged target fortification are scarce. the investigators performed a prospective interventional study in vlbw preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.

the prevention of postnatal growth failure in very low birth weight (vlbw) preterm infants is of utmost importance. fortified human milk is the goal for preterm infants' nutrition. standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. data on efficacy and safety of prolonged target fortification are scarce. prospective interventional study was conducted in vlbw preterm infants, exclusively fed with human milk. twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. weekly growth and daily growth velocity were compared with that of an historical group of vlbw preterm infants that had received standard fortified human milk. osmolality, metabolic and gastrointestinal tolerance were monitored.

Eligibility criteria:
inclusion criteria: * birth weight \< 1500 grams * gestational age \< 32 weeks * birth weight \> 10th percentile according to fenton' growth chart * exclusively breast feeding during the entire hospital stay exclusion criteria: - presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)

Keywords: human milk target fortification
a study comparing the safety and efficacy of risankizumab to methotrexate in subjects with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug * have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both screening and baseline visits * be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator * be a candidate for treatment with methotrexate (mtx) according to local label exclusion criteria: * subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment * previous exposure to risankizumab * previous exposure to mtx * use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator * subject has a history of clinically significant hematologic, renal, or liver disease

Keywords: abbv-066 bi 655066