Kornimate/medical-research-clean huggingface dataset:
leukocytes and perioperative cardio vascular events

Conditions: Elective Non-cardiac Surgery

Summary: to analyze whether non-cardiac surgery in high-risk cardio-vascular patients induces a quantitative change in one or several leukocyte subpopulations and whether such changes are associated with perioperative cardio-vascular events.

annually, there are more than 200 million surgeries worldwide (weiser et al., 2016; weiser et al., 2008). the poise study revealed 5% of patients undergoing a non-cardiac surgery suffer perioperative myocardial infarcts going along with a perioperative mortality rate of about 11,6% (devereaux et al., 2011). possibilities to preoperatively identify patients at risk are limited (devereaux und sessler, 2015; gillmann et al., 2014) and prophylactic interventions are not yet established or controversial (devereaux und sessler, 2015). selected leukocyte subpopulations have been demonstrated to be associated with higher risk for cardiovascular events (berg et al., 2012; cheng et al., 2008; engelbertsen et al., 2012; kotfis et al., 2015; rogacev et al., 2011; rogacev et al., 2012).the aim of this study is to analyze whether surgical stress (non-cardiac surgery) induces a quantitative change in one or several of these leukocyte subpopulations and whether quantitative changes are associated with perioperative cardiovascular events. therefore, high-risk cardio-vascular patients scheduled for non-cardiac surgery will be recruited. blood will be drawn at predefined time points before surgery and up to three days postoperatively. leukocytes will be analyzed by flow cytometry. during 30 day follow up adverse cardiovascular events will be recorded. ecgs will be recorded preoperatively and on post-op day 3. high-sensitive cardiac troponin t will be measured prior to the operation and on post-op day one to three. the patient chart will be screened for cardio vascular events up to day 30. a telephone interview will be performed to detect cardiovascular events after discharge until post-op day 30.

Eligibility criteria:
inclusion criteria: * 18 years or older * coronary heart disease * non-cardiac surgery * inpatient treatment * informed consent exclusion criteria: * 17 years of age or younger * known pregnancy or breastfeeding * missing informed consent * ambulatory or day-case surgery * emergency surgery * acute or chronic leukemia * current leukocytosis * current aplasia or leukopenia * current gm-csf treatment * carotid artery surgery * history of splenectomy or indications of splenectomy * cortisone treatment within past 14 days * history of organ transplantation * current immunosuppressive medication * chemotherapy completed less than 14 days ago * intraoperative dexamethasone application * entity which is part of the composite endpoint diagnosed within past 28 days

Keywords: leukocyte subpopulations perioperative myocardial infarction non-cardiac surgery perioperative cardiovascular risk
real-time accurate pathology inspection and decompression study

Conditions: Spine Injuries and Disorders; Pain, Chronic; Pain, Back; Pain, Neck; Radiculopathy

Summary: the primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (land) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.

objectives the primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (land) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes. design and outcomes this is a prospective observational study to determine the degree to which a laser-assisted neural decompression (land) procedure relieves spine and extremity pain. subjects will have elected to have the procedure are part of their standard of care in treating their spine and/or leg pain. subjects will complete a baseline survey and two follow-up surveys at 3-months and 12-months after their procedure date. interventions and duration there will be no study intervention. subjects will only be monitored and evaluated for pre- and post-operative pain, quality of life, satisfaction, and medication use. subjects will be followed for 12 months following their land procedure. sample size and population this study will last for 4 years starting february 10, 2020. there will be no maximum subject population size. we aim for a minimum population size of 1,500 in order to give statistical significance with results.

Eligibility criteria:
inclusion criteria: * prescribed spinal decompression procedure by their healthcare provider. * previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief. * willing and able to adhere to the protocol of the study including the survey timeline. * between the ages of 18-85 years. exclusion criteria: * inability or unwillingness to give written informed consent. * not a candidate for the land procedure
retrospective review of mechanically ventilated patients using a continuous data collection system.

Conditions: Mechanical Ventilation; Acute Respiratory Distress Syndrome; Hypoxic Respiratory Failure

Summary: today, the electronic medical record, microprocessor mechanical ventilators, and physiologic monitoring are under-utilized when translating research into decision support. current medical informatic capabilities can be leveraged to calculate trends in measured parameters to initiate a paradigm shift in critical care from reaction-based treatment to proactive and plausibly preventative care. therefore, the purpose of this study is to develop baseline understanding of our practice and how data collection utilizing a newly implemented system called t3. we would like to retrospectively review mechanically ventilated patients in which we have collected continuous data to test a newly developed analytic platform. additionally we would like to compare these results to our standards of practice established by clinical practice guidelines.


Eligibility criteria:
inclusion criteria: * patient selection will be determined by available data collected in the t3 system. we estimate 50 patients in which mechanical ventilator data has been collected utilizing the limited intellibridge modules (4 systems currently available to collect ventilator data). exclusion criteria: * patient not connected to t3 data collection system.

Keywords: ards ali mechanical ventilation
a study of nivolumab-relatlimab fixed-dose combination versus regorafenib or tas-102 in participants with later-lines of metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab fdc, also referred to as bms-986213) for the treatment of non-microsatellite instability high (msi-h)/deficient mismatch repair (dmmr) metastatic colorectal cancer (mcrc) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.


Eligibility criteria:
inclusion criteria * histological confirmed previously treated colorectal cancer with adenocarcinoma histology with metastatic or recurrent unresectable disease at study entry. * participants must have:. i) progressed during or within approximately 3 months following the last administration of approved standard therapies (at least 1, but not more than 4 prior lines of therapies in the metastatic setting), which must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-vegf therapy, and anti-egfr therapy (if ras wild-type), if available in the respective country, or;. ii) been intolerant to prior systemic chemotherapy regimens if there is documented evidence of clinically significant intolerance despite adequate supportive measures. * must have sufficient tumor tissue \& evaluable pd-l1 expression to meet the study requirements. * must have measurable disease per recist v1.1. participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately. exclusion criteria * prior treatment with either an immunotherapy or with regorafenib or with tas-102. * untreated central nervous system (cns) metastases, participants are eligible if cns metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the cns treatment). * history of refractory hypertension not controlled with anti-hypertensive therapy, myocarditis (regardless of etiology), uncontrolled arrhythmias, acute coronary syndrome within 6 months prior to dosing, class ii congestive heart failure (as per the new york heart association functional classification), interstitial lung disease/pneumonitis or an active, known or suspected autoimmune disease. * confirmed tumor microsatellite instable high/deficient mismatch repair (msi-h/dmmr) status as per local standard testing; msi/mmr test results from initial diagnosis are acceptable. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: micro-satellite stable (mss) metastatic colorectal cancer (mcrc) relatlimab nivolumab bms-986213 regorafenib stivarga lonsurf
cbcr for executive functions in patients with abi in the chronic phase

Conditions: Acquired Brain Injury; Cognitive Symptom; Executive Dysfunction

Summary: this study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury

this study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. furthermore, the study consists of groups that receives the computerized training both with and witouth support from a professional.

Eligibility criteria:
inclusion criteria: * persons who are able to give an informed consent both verbally and in writing * persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset) * persons who score less than the 30. percentile in one or more of the primary outcome measures outlined above. exclusion criteria: * persons with neurodegenerative diseases * persons with diseases which can influence executive functions such as adhd * persons who are motorically or cognitively unable to use a tablet and complete the cbcr-training
herbal supplements for improvement of liver function in participants with alcoholic liver disease

Conditions: Alcoholic Liver Disease

Summary: alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. there is a paucity of data to support the allopathic intervention among these group of patients. livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. the aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.


Eligibility criteria:
inclusion criteria: adults aged over 18 years with the evidence of alcoholic liver disease (ald) based on a thorough history, physical examination, and laboratory tests and all of the following: * chronic alcohol intake, identified with audit(alcohol use disorder inventory test) questionnaire * active alcohol use until 4 weeks prior to presentation * alt and ast elevated \>1.5 times the upper limit of normal * over 1.5 ratio of ast to alt * maddrey discriminant function(df) less than 30 exclusion criteria: * severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months * severe renal impairment (glomerular filtration rate below 60 ml/min per 1.73m2) * hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and wilson's disease * participants with active viral hepatitis * under going active treatment for alcohol withdrawal syndrome(aws) at the study entry * participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc. * pregnant, attempting to conceive, or lactating women * participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
psychological characteristics of patients with severe asthma

Conditions: Asthma; Attachment; Coping Skills; Personality Trait

Summary: like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. these patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. the scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. a better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years and followed in the respiratory department of the besançon university hospital for an asthmatic disease diagnosed for more than 12 months. will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (gina levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (\>50% in the previous year) (ats-ers 2014 criteria). * patient able to understand the objectives of the research * patient who has signed a research consent form * patient affiliated to a french social security system or beneficiary of such a system exclusion criteria: * patient with reading and comprehension difficulties that prevent them from completing the questionnaires * motor disability that prevents the patient from completing the questionnaires * legal incapacity or limited legal capacity * subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator * subject without health insurance * subject under court protection, guardianship, conservatorship, or protective supervision. protection.
multimodal imaging of subchondral bone in knee osteoarthritis : predictive model

Conditions: Knee Osteoarthritis; Joint Disease; Arthritis; Musculoskeletal Disease

Summary: predictive factors of osteoarthritis progression are not yet well understood. however, a growing role attaches importance to the subchondral bone. the aim of the present project is to determine predictive factors of progression of osteoarthritis at the knee by a multimodal characterization of subchondral bone by medical resonnance imaging, direct high resolution digitization radiographs and bone texture analysis. at the end of the project, an innovative imaging device, combining semi-automatic softwares for texture analysis, control detection and image registration would be supplied. this will enable on the one hand a more accurate and reproducible way to measure the joint space width of the affected compartment and on the other hand, an assistance to better detect patients at risk of progression of their knee osteoarthritis. identifying these "progressors" patients might permit their selection in clinical trials at baseline adapted to their severe disease, using for example biologic treatments targeting knee osteoarthritis. the main objective of this study is to analyze the predictive capacities of bone texture parameters measured on the high-resolution radiography of the knee on the structural evolution of the knee osteoarthritis at 3 years.


Eligibility criteria:
inclusion criteria: * knee osteoarthritis according to the criteria of knee osteoarthritis of american college of rheumatology. * having felt a painful push in the last 6 months. * visual analogic scale pain \> 4 on a 0 to 10 scale. * having a radiographic score of oarsi (osteoarthritis research society international score) from 2 to 3 whether it is for the presence of a joint space narrowing or the presence of an osteophyte exclusion criteria: * patello-femoral degenerative osteoarthritis isolated. * incapacitated to consider the position in schuss for the realization of the radiography. * valgus \> in 5 ° * secondary degenerative osteoarthritis

Keywords: fractal analysis trabecular bone texture knee osteoarthritis subchondral bone medical resonnance imaging
probiotic in dry eye syndromes

Conditions: Dry Eye Syndrome

Summary: this study will evaluate efficacy and safety of systemic and ophthalmic probiotic from bacterial lysate of lactobacillus sakei on microbiota, immunological and clinical outcomes of patients with dry eye syndrome.

the ocular surface is comprised of the cornea and its overlying tissue, the conjunctiva. the ocular surface is continuously exposed to the external environment and, therefore, to different microbial species. a resident ocular surface microbiota has been found in various studies. although little is known so far, some elements of this microbiota and/or its metabolites could represent protective cofactosr in the pathogenesis of common ocular diseases. on the other hand, the gut microbiota is known to influence host homeostasis in distal tissues, such as brain (gut-barin axis), lungs (gut-lungs axis) and skin (gut-skin axis). however, little is known about distal effects of the gut microbiota on the ocular surface. in this study we sought to evaluate the efficacy and safety aspects of l.sakei as both ophtalmic probiotic lysate and oral live probiotic on dry eye syndrome, using a factorial design, against placebo.

Eligibility criteria:
inclusion criteria: * male or female * 18\<age\<60 * bcva (best corrected visual acuity) \>=9/10 * at least 2 subjective complaints compatible with dry eye * tbut (tear break-up time) \<= 10 sec, schirmer's test \<= 10mm * signed informed consent, voluntary adherence to treatment exclusion criteria: * pregnancy/breastfeeding * conjunctivitis * thyroid disease * diabetes * rheumatologic diseases including sjogren's syndrome * neurologic conditions, including stroke, bell's palsy, parkinson's, trigeminal nerve problem * refractive surgery (lasik or prk) * other eye surgeries * hsv keratitis * medication/supplement use, including psychiatric medicines, otc cold medicines, anti-histamines, beta-blockers, pain relievers, sleeping pills, diuretics, hormones replacement, and oral contraceptives * chemical splashes / injuries to the eyes * contact lens use * environmental (dusty, windy, hot/dry) * any treatment for dry eye in previous 4 weeks (including lubricants, steroids, cyclosporine)
lean body mass response to higher-protein diets during winter military training

Conditions: Body Weight

Summary: the objectives of this study are to: 1) determine effects of a prototype recovery food product providing supplemental energy on whole-body protein balance, skeletal muscle mass, and biomarkers of physiological status and strain during winter military training, and 2) determine the extent to which varying macronutrient composition (protein-based \[pro\] versus carbohydrate-based \[cho\]) of the food product modulates the physiological consequences to strenuous military training.

up to 120 norwegian soldiers from the 2nd battalion, brigade north, norwegian army stationed at skjold garrison will be enrolled in a 9-day, randomized controlled study. using dietary analysis, body composition assessments, stable isotope methodologies, basic biochemical techniques, and measures of physiological strain, the effects of supplemental energy in the form of carbohydrate and protein on indices of muscle mass and physiological status will be assessed. we hypothesize that consuming supplemental energy will attenuate the effects of severe energy deficit on inflammation, androgenic hormones, and whole-body protein retention, thereby protecting skeletal muscle mass. we expect that consuming pro will promote a more favorable recovery than consuming cho, as indicated by measures of increased whole-body protein synthesis and greater conservation of skeletal muscle mass.

Eligibility criteria:
inclusion criteria: * male and female norwegian soldiers aged 18 years or older participating in the 4-day training program. exclusion criteria: * history of skin irritation (e.g., nickel or adhesive allergy), difficulty swallowing large pills, and allergies to dairy products

Keywords: military training whey protein body composition
assessment of infection activity in travelers and migrants diagnosed with chronic schistosomiasis

Conditions: Schistosomiasis

Summary: the primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, pcr (where available), poc-cca (where available), and serum caa results). all subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome pcr where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and schistosome pcr (where available), and urine strip testing poc-cca (where available); and stool sampling for microscopy and pcr, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity. composite reference standards will be used to assess and classify the activity of the infection. organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected. serum (at least 1 ml remaining from routine diagnostics) will be sent to lumc, the netherlands, where caa will be determined with the ucp-lf caa test designed for routine use. participants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at lumc for 15 years, to allow secondary research.


Eligibility criteria:
inclusion criteria 1. diagnosis of chronic schistosomiasis (\>3 months after last potential exposure) according to site-specific diagnostic practice 2. signed informed consent (and assent for minors). exclusion criteria 1. age below 5 years; 2. exposure to praziquantel after the last potential exposure to schistosomes 3. acute infection, i.e. likely infection \<3 months before presentation

Keywords: schistosomiasis chronic diagnosis