Kornimate/medical-research-clean huggingface dataset:
cyclosporine and prognosis in acute myocardial infarction (mi) patients

Conditions: ST Elevation Acute Myocardial Infarction

Summary: infarct size is a major determinant of prognosis after acute myocardial infarction (ami). the investigators recently reported that cyclosporine a, when administered immediately prior to percutaneous coronary intervention (pci), can significantly reduce infarct size in stemi (st elevation acute myocardial infarction) patients. the objective of the present study is to determine whether cyclosporine can improve stemi patient clinical outcome. nine-hundred and seventy two patients with st elevation mi will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. they will receive one single injection of cyclosporine a (ciclomulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by pci. the incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (lv) remodeling) will be assessed at one year and three years after treatment.


Eligibility criteria:
inclusion criteria: eligibility criteria (for screening before hospital admission): 1. all (male and female) patients, aged over 18, without any legal protection measure, 2. having a health coverage, 3. presenting within 12 hours of the onset of chest pain, 4. who have st segment elevation ≥0.2 mv in two contiguous leads, 5. for whom the clinical decision was made to treat with percutaneous coronary intervention (pci). and (further inclusion criteria to be confirmed by the admission coronary-angiography): 6. the culprit coronary artery has to be the lad 7. the lad artery has to be occluded (timi flow grade 0-1) at the time of admission coronary angiography. 8. preliminary oral informed consent followed by signed informed consent as soon as possible. patients undergoing either primary pci or rescue pci are eligible for the study. patients with previous ami, pci or coronary artery bypass surgery (cabg) are eligible for the study. exclusion criteria: 1. patients with loss of consciousness or confused 2. patients with cardiogenic shock 3. patients with the left circumflex or the right coronary artery (rca) as the culprit artery, or with evidence of coronary collaterals to the risk region 4. patients with an opened (timi \> 1) lad coronary artery at admission on initial (admission) coronary angiography 5. patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance \ 180/110 mmhg) 6. patients treated with any compound containing hypericum perforatum (st.-john's-worth) or stiripentol or aliskiren or bosentan or rosuvastatine 7. female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). 8. patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for hiv, or hepatitis

Keywords: stemi cyclosporine reperfusion injury
motor control in chronic fatigue syndrome and fibromyalgia

Conditions: Fibromyalgia; Chronic Fatigue Syndrome

Summary: this project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (cfs/me) and/or fibromyalgia syndrome (fms). focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. investigations will also comprise muscle activity, reaction time and fine motor control.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic fatigue syndrome or fibromyalgia exclusion criteria: * patients who already had been treated.

Keywords: motor control walking physical activity muscle activity
post anaesthesia care hypotension prevention

Conditions: Hypotension During Surgery

Summary: the goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. the main question this trial aims to answer is: • does the use of the hypertension prediction index (hpi) decrease hypotension during surgery and in the post-operative period? during and after their surgery, participants in the intervention group will be treated according to the hpi-algorithm. participants in the control group will be treated following the standard of care.

rationale: hypotension during and after surgery is associated with serious complications. using a machine learning algorithm, hypotension can be accurately predicted. edwards lifesciences developed this algorithm, called "hypotension prediction index" and integrated this in their hemodynamical monitors. recent studies have shown a decrease in intraoperative hypotension when using the hypotension prediction index. objective: to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension (time weighted average) both during and after surgery (24 hrs). intervention: patients in the intervention group will be treated using the hypotension prediction index algorithm to prevent hypotension. in case of actual hypotension the treatment thereof is at the discretion of the anaesthesiologist. main study parameters/endpoints: the decrease in time weighted average of hypotension in the peri- and post-operative period.

Eligibility criteria:
inclusion criteria: * patients \> 18 years old * patients planned to undergo laparotomy surgery * patients that will receive an invasive arterial catheter as part of their procedure * patients that are planned to go to the post anaesthetic care unit (pacu) post-operatively exclusion criteria: * patients with known arrythmias * patients with known severe heart valve disease * patients with the need for dialysis * clamping of the aorta or pringle's manoeuvre during surgery * emergency procedures

Keywords: laparotomy hypotension goal directed therapy post-operative prediction artificial intelligence
study of energy requirements in critically ill newborns

Conditions: Respiratory Distress Syndrome

Summary: objectives: i. determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.

protocol outline: patients are assigned to one of three groups according to gestational age (24-28 weeks estimated gestational age (ega) vs 29-34 weeks ega vs 35 weeks ega and over) and severity of respiratory illness (need for high frequency ventilation vs stable conventional ventilator settings or extubated within past 24 hours vs no need for mechanical ventilation). patients receive water labeled with deuterium and oxygen o 18 by mouth or by gastrostomy tube on days 1 and 7. urine samples are collected prior to the first dose, 4-6 hours after the first dose, and then every 24 hours until the second dose. all urine is collected for 4-6 hours after the second dose. samples are analyzed by dual inlet isotope ratio mass spectrometry.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- infants with estimated gestational age (ega) of at least 24 weeks with respiratory illness who are on high frequency ventilation (hfov) and meet the following conditions: appropriate size for gestational age (aga) no congenital anomalies no medical complications, including seizures and necrotizing enterocolitis or control infants with ega of at least 24 weeks must meet 1 of the following conditions: requirement for stable conventional ventilator settings with respiratory index score of less than 2.5 and/or extubated within past 24 hours no requirement for mechanical ventilation must meet all of the following conditions: aga no congenital anomalies no medical complications, including seizures and necrotizing enterocolitis no documented sepsis by positive blood culture no supplemental oxygen use (infants 35 weeks ega and over only) --prior/concurrent therapy-- hfov group: concurrent surfactant, theophylline, or inotrope (vasopressor) therapy allowed control group: no concurrent inotrope (vasopressor) therapy

Keywords: cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome
a study to determine the safety, tolerability and efficacy of kp-413 in subjects with atopic dermatitis(ad)

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of kp-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * has a clear diagnosis of ad meeting the hanifin and rajka criteria for ad that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total bsa as determined using the rule of nines * has a baseline igss of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a baseline igss of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck. * female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study. exclusion criteria: * female who is pregnant, nursing an infant, or planning a pregnancy during the study period. * has a baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs. * presence of a concurrent skin condition that could interfere with assessment of treatment. * treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.

Keywords: atopic dermatitis
the influence of desensitizing agent on postoperative sensitivity in posterior composite restoration

Conditions: Dentin Hypersensitivity

Summary: this study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.


Eligibility criteria:
inclusion criteria: * patients having active primary class i carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients. * teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment. * preoperative radiographic record of the carious lesions. * buccolingual width is no more than half the inter-cuspal distance exclusion criteria: * excessive tooth wear due to clenching or abnormal habits. * patients with direct occlusal contact by antagonist cusp (traumatic occlusion). * patients with periodontal or gingival disease. * patients using analgesics and/or anti-inflammatory medicine.
safety and efficacy between the distal and proximal radial vascular access technique

Conditions: Coronary Artery Disease

Summary: the investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. as a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.

randomised clinical trial / equivalence model permutted block asignation 1:1 statistical power 90% and significance 2.5%. sample loss estimation - 15% chi-square to categorical and t student to numerical variables. logistic regression binomial for adverse outcomes. if needed, an intention to treat analysis will be performed.

Eligibility criteria:
inclusion criteria: * patients over 18 years * clinical indication for coronary angiography / angioplasty * palpable radial and distal radial pulse * previous clinical barbeau test * radial and distal radial patency via vascular ultrasound * 24-hour and 30-day follow-up feasibility exclusion criteria: * previous vascular punctions in the studied anatomic site * artery introductor relationship * arteriovenous fistula * current treatment with oral anticoagulants * contraindication for heparin * incomplete medical records * vascular access sheath - radial artery mismatch * distal radial or ulnar fracture history

Keywords: radial artery distal radial artery vascular access radial artery occlusion
mindfulness-based stress reduction and cognitive function in stress and aging

Conditions: Anxiety Disorders; Depression

Summary: the investigators are developing and then testing whether mindfulness-based stress reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.


Eligibility criteria:
inclusion criteria: * aged 65+ * current depressive and/or anxiety symptoms * current depressive and/or anxiety disorder * able to participate in behavioral study exclusion criteria: * unable to participate in study

Keywords: anxiety depression cognition mbsr mindfulness stress elderly
hemodynamic instability prevented with polaramine® infusion before extracorporeal circulation

Conditions: Hemodynamic Instability; Vasoplegic Syndrome

Summary: this single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. the objective of the present investigation is to determine the role of polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (cpb) during cardiac surgery. our hypothesis is that polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from cpb.

vasoplegic syndrome is recognized as a common complication after cpb. its incidence ranges from 5% to 25% after cardiac surgery requiring cpb. such syndrome is related to an inflammatory reaction, which is attributed to the cpb. this syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs. investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. according to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances. the hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. this study aims to determine the effect of an antihistamine (dexchlorpheniramine (polaramine®)) administered intravenously before cpb, on the vasoplegic syndrome incidence after separation from cpb.

Eligibility criteria:
inclusion criteria: * men aged 18 and older * post menopausal women * patients scheduled for an aortic valve replacement with a traditional sternotomy and cpb exclusion criteria: * patients with a left ventricular ejection fraction lower than 40% * patients with pulmonary arterial hypertension higher than 50mm of hg, * redo cardiac surgery, * atrioventricular and intraventricular conduction disturbances * epilepsy or convulsions * atopic disease * women of childbearing potential * patients at risk of glaucoma * patients with therapy interacting with dexchlorpheniramine (polaramine®). * patients unable to provide a signed informed consent

Keywords: cardiac surgery cardiopulmonary bypass dexchlorpheniramine h1 blockers norepinephrine histamine release
effects of dexmetomidine and remifentanil used for controlled hypotension in septorhinoplasty surgery on cardiac electrophysiology: prospective randomized study

Conditions: Rhinoplasty Surgery

Summary: our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. we planned to compare the patients by recording preoperative and postoperative ecgs. we also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.


Eligibility criteria:
inclusion criteria: * patients with an asa score of i and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study. exclusion criteria: patients aged \ 45 years, patients with liver and/or kidney failure, obese patients (bmi \>30), trauma patients, asa ii-iii-iv patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study. -
association between subtypes of anti citrullinated peptide antibodies and lung damage in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. according to the literature review, the prevalence of pid on thoracic ct scan is one-third of patients. diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. the lung seems to have a central role in the genesis of rheumatoid arthritis. it also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs. the hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways. currently, there are no data on interstitial pneumopathy in black and afro-caribbean subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * patient with rheumatoid arthritis acr/eular 2010 * patient with a higher age or equal to 18 * patient receiving social security * patient giving his free and informed written consent exclusion criteria: * patient with overlap syndrome with another autoimmune disease * patients with known severe cardiopulmonary pathology * woman who is pregnant and breast feeding * patient with language difficulties or understanding
analysis of the intestinal microbiome in patients with wet age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: analysis of the intestinal microbiome in patients with wet age-related macular degeneration


Eligibility criteria:
inclusion criteria: * newly diagnosed neovascular age-related macular degeneration. exclusion criteria: * chronic gastrointestinal disorders
observational study on metabolism and psychopathology in transsexual patients

Conditions: Transsexualism

Summary: gender identity disorders (also known as transsexualism) is defined as a condition in which a person with apparently normal somatic sexual differentiation is convinced that he or she is actually a member of the other sex. most patients therefore undergo so called cross-sex hormone treatment. treatment protocols follow international consensus statements but vary considerably between different centres and countries since no prospective and controlled trials are available on this subject and recommendations are mainly based on retrospective data analysis and experience of the individual centres. applying high doses of testosterone to biological females and vice versa high doses of estradiol to biological males definitely impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. especially in male-to-female-transsexuals there seems to be an increased risk for the development of mood disorders and cardiometabolic comorbidities. in this multi-center observational study we want to investigate, if there is any difference with regard to these outcomes, according to the varying standards of cross-sex hormone treatment between the different centers. different outcome measures described below will be assessed each time during routine visits at the different centers.


Eligibility criteria:
inclusion criteria * patients with the diagnosis gender identity disorder (icd-10: f64.0), who have given written informed consent following adequate oral and written information. general exclusion criteria * patients below the age of 18 * legally incompetent patients * prior intake of cross-sex hormones * missing written informed consent * intersexuality

Keywords: transsexualism cross-sex hormone treatment sex hormones mood stress cortisol cardiovascular metabolome
measurement of distinct biological pools of hydrogen sulfide in women with cardiovascular disease

Conditions: Cardiovascular Disease

Summary: cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the united states. the impact of cardiovascular in women was not recognized by clinicians for a long time. it is now evident that, women suffer the consequences of cardiovascular at rates at least as high as those observed in men but there are still major gaps in our understanding this disease in women. hydrogen sulfide (h2s), a gaseous mediator plays an important role in the cardiovascular system. research has demonstrated it's critical role in animal ischemia reperfusion models. hydrogen sulfide exists in distinct biological pools in blood. recently, the kevil lab has pioneered the development of new analytical techniques for accurate measurement of all biological pools of h2s. by measuring these distinct pools of h2s in women with and without cardiovascular disease the investigators hope to further understanding of role of h2s in pathophysiology of cardiovascular disease. this research will help to assess the ability of h2s and its distinct biological pools to potentially be a diagnostic marker or a therapeutic target for cardiovascular disease.


Eligibility criteria:
inclusion criteria: 1. patients presenting to the cardiac catheterization laboratory for coronary or peripheral angiography. 2. females,age\>40years exclusion criteria: 1. inability to provide informed consent. 2. stelevationmyocardialinfarction. 3. cardiogenicshock. 3. abi \>1.4 (indicative of non-compressible vessel needing further evaluation to diagnose pad), unless documented known pad. 4. non-atheroscleroticpad(e.g.buerger'sdisease). 5. enrolment in another clinical trial with use of experimental therapeutic agents.

Keywords: hydrogen sulfide pools,