Kornimate/medical-research-clean huggingface dataset:
remote ischaemic postconditioning in the clinical setting of nsteacs and urgent pci

Conditions: Post Procedural Myocardial Infarction

Summary: this study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a nstemi/unstable angina undergoing pci.

patients presenting with non st elevation acute coronary syndromes (nsteacs) - nstemi and unstable angina patients are enrolled in this study. eligible patients are approached, with patient information sheets and are consented for involvement into the study. patients are randomised to intervention or control. patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmhg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography. this protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection. prior to the intervention, a blood sample will be taken to measure serum troponin t and ck-mb (baseline level). following pci patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. troponin t and ck-mb levels will be measured for the 24 hours after pci, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups. primary end point myocardial injury (peri-procedural myocardial infarction and injury) measured by ctnt and ck-mb release over 24 hours after primary pci.

Eligibility criteria:
inclusion criteria: * patients admitted with nstemi/ unstable angina undergoing percutaneous intervention exclusion criteria: * known renal failure * known liver disease * peripheral vascular disease involving upper limbs * inability to consent
treatment of chronic mountain sickness

Conditions: Hypoxia, Altitude

Summary: this study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

about 100 million individuals reside at high altitude (\>2500m) worldwide, with the largest populations of highlanders being found in south america (andean), central asia (tibetan and sherpa) and east africa (ethiopian). despite unique adaptations to hypoxia in these populations, chronic mountain sickness (cms) is a clinical syndrome which is observed in 5-33% of individuals residing permanently at high altitude.several pharmacological approaches have been proposed in the treatment of ee and cms. however, few studies show sufficient clinical evidence for safety and efficacy in cms treatment and most highlanders with cms remain untreated. the present project aims to better characterize chronic hypoxic responses in highlanders and to evaluate the interest of acetazolamide and statins as potential treatments for chronic mountain sickness.

Eligibility criteria:
inclusion criteria: * male * age between 18 and 55 yrs * body mass index \<30kg/m² * born at \>3500 m, living for \>3 years at the local high altitude * no diagnosis of cardiorespiratory, metabolic or neurological diseases * no drug intake * no smoker * chronic mountain sickness score ≥6 exclusion criteria: * diagnosis of cardiorespiratory, metabolic and neurological diseases * systolic \> 130 mmhg and/or diastolic \> 85 mmhg blood pressure * drug intake * smoker * chronic mountain sickness score \<6
fecal microbiota therapy versus standard therapy in decompensated nash related cirrhosis: a randomized controlled trial.

Conditions: NASH Related Decompensated Cirrhosis

Summary: the study will be conducted in the department of hepatology, institute of liver \& biliary sciences, new delhi. as a part of this study history will be taken and clinical examination will be done. subjects will be screened for diagnosis of nash (non alcoholic steatohepatitis) cirrhosis. if subjects are found to have nash (non alcoholic steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. the prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. this administration of sample, 50 ml daily will occur once a month every month for 6 months. the liver function parameters will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.


Eligibility criteria:
inclusion criteria: 1. age more than 18 years. 2. all patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis. 3. histological evidence of definite or probable nash (non alcoholic steatohepatitis) based upon a liver biopsy prior to enrollment and a nafld (non alcoholic fatty liver disease) activity score (nas) ≥5 with ≥1 in each component of the nas score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3). 4. no history of recent spontaneous bacterial peritonitis.(1 month) 5. child pugh score of 6 - 10 exclusion criteria: 1. diagnosis of liver disease other than nash (non alcoholic steatohepatitis) cirrhosis 2. ongoing bacterial infection requiring antibiotic treatment. 3. current or history of significant alcohol consumption for a period of more than 3 4. consecutive months within 1 year prior to screening 5. treatment with antibiotics or probiotics in the preceding 3 months. 6. inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper gastrointestinal endoscopy 7. pregnant patients
dengue vaccine hesitancy and acceptance in endemic regions of argentina: impact of communication strategies

Conditions: Dengue

Summary: among all arboviruses, dengue (den) is the vector borne disease with the highest burden worldwide. around 390 million infections per year are estimated, of which around 96 million are clinically apparent. since its re-emergence in 1998 in argentina, den has shown an epidemic behavior affecting mainly the northern and central regions in which the circulation of serotypes has been heterogeneous. the last significant outbreak was registered between the end of 2019 and the beginning of 2020.. vaccine development for den prevention has been a long and challenging journey. the only vaccine that has reached registration to date is a recombinant attenuated tetravalent vaccine (dengvaxia, sanofi pasteur) showing an efficacy against virological confirmed den infection of 36.6% (4.2-61.4) in seronegative subjects at baseline and 77.9% (65.1-86.0) in seropositive. however, this vaccine has not been pre qualified by the world health organization. new dengue vaccines are in advanced stages of development worldwide. at least three vaccines are in advanced stages of development including one produced by takeda, the butantan institute and the merck, sharp \& dohme development. the implementation of a vaccination strategy in argentina could be a health-relevant approach. however, the best way to implement this requires prior information describing and investigating numerous aspects of vaccination including acceptability. a systematic review of two acceptability surveys showed an acceptability of 77% to 86% but in countries with endemic den at time of the surveys. it is possible that in argentina, the introduction to the regular calendar, for use in specific regions with a high and periodic burden of disease, of highly effective and safe den vaccines will be considered. however, to our knowledge, we do not have available evidence of the potential acceptability of these vaccines. the main objectives of this research will be: to evaluate the acceptability of a den vaccine in potential target populations in regions of high burden of disease in argentina. describe main determinants of and barriers to den vaccine acceptability in regions of high burden of disease in argentina. identify information and intervention needs to design and implement communication strategies that have a positive impact on the acceptability of a den vaccine.


Eligibility criteria:
inclusion criteria: * people who express willingness to participate and who are residents of communes with a high burden of dengue disease. exclusion criteria: * persons who do not give informed consent.

Keywords: vaccine hesitancy
effect of anesthetic conditions on stapling thickness and quality

Conditions: Gastrectomy

Summary: the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. during stapling it is common to reduce systolic arterial blood pressure (sap) below 100 mmhg to reduce peritoneal perfusion and have better compression. higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.

patients are randomized to two groups: group standard perfusion means that the sap is kept between 100 and 140 mmhg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction. low perfusion group means that 1. systolic blood pressure is kept below 100 mmhg from the first linear staple till the last by using a clevidipine infusion to regulate the blood pressure accurate just below 100 mmhg for a short time while needed. 2. goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation \> 20 % 3. increase intra abdominal pressure (iap) up to 20 mmhg inly during stapling and return to minimum iap needed to achieve 3 liter workspace. the resected stomach is removed and analyzed outside the body before throwing away:

Eligibility criteria:
inclusion criteria: * primary sleeve gastrectomy exclusion criteria: * allergy to one of the drugs used intra operative * liver, renal, cardiac or lung disease with limited function
rapid diagnostic tests for assessment of initial clearance and detection of recurrent malaria infections

Conditions: Plasmodium Falciparum Malaria

Summary: the aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in tanzanian children. for this purpose the investigators used five diagnostic tools, 2 rapid diagnostic tests based on histidine rich protein 2(hrp2) and lactate dehydrogenase(ldh), 2 microscopical methods and one polymerase chain reaction (pcr). the investigators followed the 53 enrolled children during 42 days.


Eligibility criteria:
inclusion criteria: * children between 6-59 months * fever (≤37.5 c) or history of fever during the preceding 24 hours * confirmed p.falciparum monoinfection * uncomplicated malaria * parasite density between 2000-250.000/µl * willing/able to comply with the 42 day follow up * informed concent from patient/guardian exclusion criteria: * children with history of antimalaria drug intake within the last two weeks * symptoms / signs of severe disease

Keywords: rdt malaria treatment follow up diagnosis
assessment of pain with insertion of the foley catheter for induction of labour

Conditions: Pain

Summary: the purpose of this study is to assess pain in women randomised to digital or speculum placement of a foley catheter. pain during cervical ripening with the foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.

the most common method described for placing the foley catheter is under direct visualisation of the cervix during a sterile speculum examination. another method is to place the catheter during a digital cervical examination. maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking. the visual analogue scale is used to subjectively assess pain. with a skin conductance algesimeter an objective assessment of pain is possible.

Eligibility criteria:
inclusion criteria: * singleton fetus in cephalic presentation with a bishop score of 3-5 and * indication for induction of labour exclusion criteria: * low-lying placenta, * undiagnosed vaginal bleeding, * more than one previous caesarean section, * previous use of an induction or pre-induction agent during the same pregnancy, * signs of infection (maternal fever) * non- proficiency in the swedish language.

Keywords: foley catheter induction labour skin conductance visual analogue scale mechanical method
validation of brief computerized cognitive assessment in multiple sclerosis (bccams)

Conditions: Multiple Sclerosis

Summary: cognitive disorders are common in early stage of multiple sclerosis (ms) and concern mainly information processing speed (ips) which also influences with other cognitive functions such as attention, working memory and executive functions. the investigators validated a computerized test of ips, the computerized speed cognitive test (csct), which can detect disorders of ips in ms. a short battery was proposed, the brief cognitive assessment for multiple sclerosis (bicams) battery, which combines the symbol-digit modalities-test (sdmt), a test of the ips, and two measures of episodic memory. on the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (bccams)) combining the csct and a computerized test of visual episodic memory. purpose: to establish the screening value of a brief computerized cognitive assessment (bccams) combining the computerized speed cognitive test (csct) and a new computerized episodic visual memory test (cevmt) in french-speaking patients with multiple sclerosis as compared to a reference battery (macfims).


Eligibility criteria:
inclusion criteria: patients : * aged 18-64 years * francophone * ms relapsing-remitting under interferon beta-1b treatment in inclusion, secondary progressive and primary progressive ms forms * having signed an informed consent (later than the day of inclusion and before any examination required by research) * being affiliated to health insurance controls: * aged 18-64 years * francophone * having signed an informed consent (later than the day of inclusion and before any examination required by research) * being affiliated to health insurance exclusion criteria: patients: * other neurological diseases with impact on cognitive functions. * severe psychiatric disease or severe depression. * current dependence on alcohol or drugs. * modification or stop of psychotropic treatment in less than a month. * modification of ms treatment in less than a month. * visual, visual-motor and / or motor impairments excluding the ability to perform cognitive tests. * pregnant controls: * neurologic disease and known chronic systemic with impact on cognitive functions. * severe psychiatric disease or severe depression. * current dependence on alcohol or drugs. * psychotropic treatment * cognitive complaint * prior cognitive testing with the same tests less than one year. * pregnant

Keywords: cognition brief computerized cognitive assessment impairment prediction
safety and efficacy of mipomersen in patients with severe hypercholesterolemia on a maximally tolerated lipid-lowering regimen and who are not on apheresis

Conditions: Hypercholesterolemia; Coronary Heart Disease

Summary: the purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

hypercholesterolemia is characterized by markedly elevated low density lipoproteins (ldl). elevated ldl is a major risk factor for coronary heart disease (chd). mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein b (apo-b). apo-b plays a role in producing low density lipoprotein cholesterol (ldl-c) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. high ldl-c is an independent risk factor for the development of coronary heart disease (chd) or other diseases of blood vessels. it has been shown that lowering ldl-c reduces the risk of heart attacks and other major adverse cardiovascular events. the purpose of this study is to determine whether mipomersen safely and effectively lowers ldl-c in severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

Eligibility criteria:
inclusion criteria: * fasting ldl-c ≥200 mg/dl (5.1 mmol/l) at screening and the presence of at least 1 of the following criteria: * myocardial infarction (mi) * percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) * coronary artery disease documented by angiography or any other accepted imaging technique * positive exercise test (≥1 mm st-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography) * other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm * or, if alternative above were not met, fasting ldl-c ≥300 mg/dl (7.8 mmol/l) * on stable, maximally tolerated statin therapy for 8 weeks * on stable, medication from an additional class of hypolipidemic agents for 8 weeks. * on stable, low fat diet for 12 weeks * stable weight for 6 weeks exclusion criteria: * significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, type i diabetes, or uncontrolled type ii diabetes * apheresis within 3 months prior to screening or expected to start apheresis during the treatment phase
biomarkers of fatigue related to adjuvant chemotherapy for breast cancer

Conditions: Fatigue; Breast Cancer

Summary: fatigue is common in cancer patients receiving adjuvant chemotherapy. to further understand the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective study with breast cancer patients receiving adjuvant chemotherapy.

patients with breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of chemotherapy. patients whose scores on the brief fatigue inventory (bfi) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue. the patients whose fatigue won't worse following the first cycle of chemotherapy will be used as controls. we will collect blood samples of both groups before and 21 days after the start of chemotherapy. we will analyze the following biomarkers: il2, il10, tnf and tgfb-1 measured by amplification reaction; fsh, lh, estradiol, dhea, dheas and cortisol hormones measured by chemiluminescent enzyme immunometric assay

Eligibility criteria:
inclusion criteria: * non metastatic breast cancer; * patients undergoing adjuvant chemotherapy exclusion criteria: * hypothyroidism; * depression; * anemia; * heart disease or decompensated hypertension

Keywords: fatigue biomarkers breast cancer
a long term study of gk530g in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: this open label study is to determine the safety profile of gk530g in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of gk530g in a long-term treatment.


Eligibility criteria:
inclusion criteria: * men and women at the age of 12 or older at the screening visit. * those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin). exclusion criteria: * those with more than two nodular acne lesions or any cyst. * those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne. * those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to investigator's judgment

Keywords: acne vulgaris
bundle evaluation in extra renal epuration, incidence of thrombosis

Conditions: Adults Receiving Renal Replacement Therapy

Summary: this is a prospective observational clinical multicentric study in icu with acute renal failure requiring renal replacement therapy.

prospective before / after observational clinical multicentric study on icu acute kidney injury during renal replacement therapy. evaluation of incidence and exposure to hemofilter clotting. the after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).

Eligibility criteria:
inclusion criteria: * adult (age \> 18 years) * renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration) * consent of patients exclusion criteria: * use citrate anticoagulation * age below 18 years

Keywords: renal replacement therapy hemofilter clotting clotting risk factor hemofilter clotting prevention