Kornimate/medical-research-clean huggingface dataset:
isolation 2.0: a multicenter clinical care and research platform

Conditions: Atrial Fibrillation

Summary: treatment recommendations and guidelines for patients with atrial fibrillation (af) are continuously changing. the role of catheter ablation in the treatment of af increases and the techniques of the procedures are improving unceasingly. responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. the aim is to create a clinical characterization platform for patients scheduled for af ablations with the purpose to optimize health care processes and related translational research.

study design: prospective cohort study and research platform of patients referred for af ablation. clinical characteristics and results of routine tests and procedures before, during and after af ablation are collected. in addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extecg), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. in subgroups of patients transesophageal electrocardiogram (te-ecg), epicardial electroanatomical mapping and/or left atrial appendage (laa) biopsy is performed.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * documented atrial fibrillation; * referred for any type of af ablation: catheter ablation, stand-alone surgical af ablation, surgical af ablation concomitant with cardiac surgery, hybrid af ablation, or redo af ablation; * able and willing to provide written informed consent. exclusion criteria: * conditions preventing the patient from adhering from the study protocol; * emergency procedures. a subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ecg-imaging is asked: * severe allergic reaction against contrast agents used in the ct- or mri-protocol * severe allergic reaction against body surface electrodes a subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ecg (te-ecg) is asked: • status after esophageal or gastric surgery a subject who meets any of the following criteria will be excluded from the subset in whom additional consent for cardiovascular magnetic resonance (isolation cmr) is asked: • contraindication to mri a subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (combat-af) is asked: • prior catheter or surgical af ablation. specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical af ablation): * chronic obstructive pulmonary disease (copd) gold 11, 111, or iv; * heart failure, currently in new york heart association (nyha) class ill or iv; * any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.

Keywords: ablation pulmonary vein isolation
mechanisms of chronic kidney disease (ckd)-induced foam cell formation

Conditions: Chronic Kidney Disease; Cardiovascular Disease

Summary: there is currently little understanding of macrophage cholesterol homeostasis and foam cell formation across the spectrum of ckd. we hypothesize that an inverse relationship exist between the severity of ckd and processes underlying foam cell formation, and that the relationship becomes independent of serum lipoprotein levels as renal function declines. we propose to systematically examine scavenger receptors and cholesterol uptake as well as cholesterol transporters and efflux mechanisms in individuals with normal renal function, patients with moderate ckd. we further propose to determine if processed contributing to foam cell formation are related to the plasma lipid profile and if the relationship is modified by co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this population and directly influence vascular integrity. these data will be critically important to understand when the abnormality starts and will provide crucial information.


Eligibility criteria:
inclusion criteria: patients with moderate degree of ckd, or patients with advanced ckd or control subjects with intact kidney function male or female all ethnic groups ≥ 18 years and have signed informed consent exclusion criteria: pregnancy and current smoking bmi \> 45 rheumatoid arthritis and systemic lupus erythematosus history of active or chronic hepatitis b, history of active or chronic hepatitis c, human immunodeficiency virus (hiv) for moderate ckd subjects: nephrotic syndrome for control subjects: nephrotic syndrome, patients with estimated gfr \< 60 ml/min/1.73 m\^2, or proteinuria
ivus assessment of atheroma burden after acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. intravascular ultrasound (ivus) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

according to current guidelines, patients with coronary lesions with stenosis \<70% should receive optimal secondary prevention drug treatment without angioplasty, even after an acute coronary syndrome (acs). nevertheless, coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. intravascular ultrasound (ivus) enables a precise description of coronary atheroma, better than the one provided by coronary angiography. the first objective is to assess by endo-coronary ultrasound, under optimal medical treatment, the evolution of atheromatous plaque (with stenosis \<70%). the evolution will be appreciated after 12 months of treatment the percentage of atheromatous volume (pva). the aim of the first secondary objective to evaluate, after 12 months of treatment, the evolution of the total atheromatous volume (vat) and the standardized total atheromatous volume (standardized vat). the second secondary objective is to evaluate by endo-coronary ultrasound, the evolution of a stable atheromatous plaque. this analysis will be performed in patients with a second coronary lesion (atheroma plaque), resulting in less than 70% stenosis, and not being responsible for acute coronary syndrome. the evolution of the stable plate will be compared to the evolution of the unstable plate. finally, the third secondary objective is to estimate the incidence of clinical events (death, acute coronary syndromes, ischemic stroke, revascularization, hospitalization for heart failure) within 12 months of the occurrence of an acute coronary syndrome managed by medical treatment optimal secondary prevention (without performing angioplasty).

Eligibility criteria:
inclusion criteria: * adult patients hospitalized for acs, for whom the target lesion has less than 70% stenosis and not treated with coronary angioplasty. exclusion criteria: * patients presenting with a target lesion with ≥70% stenosis ; patients for whom the target lesion is treated with coronary angioplasty ; interventions: a first ivus will be performed after the acute coronary event (baseline) and will be done again one-year after to assess changes in the atherosclerotic plaques.

Keywords: acute coronary syndrome ivus atherosclerotic plaque
intravenous propofol and fentanyl vs propofol for sedation in trus biopsy

Conditions: Pain

Summary: nowadays, trus biopsy become one of the most popular tests for diagnosis of prostate cancer. this procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. there are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. in siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. so, this study is to find out whether opioids is need for trus biopsy.


Eligibility criteria:
inclusion criteria: * age over 18 year * patient american society of anesthesiology physical status i-iii. * scheduled for transrectal ultrasound-guided prostate biopsy * bmi equal to or less than 30 kg/cm2 exclusion criteria: * known hypersensitivity to propofol or fentanyl * history of bleeding tendency * known case of active anal or rectal disease * unable to rate pain score * history of drug abuse * chronic opioid use

Keywords: pain trus biopsy
ischemic conditioning during air transport save penumbral tissue

Conditions: Acute Stroke

Summary: the purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (rlic) using the doctormate device, a special blood pressure device used to perform rlic, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.

in this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive rlic using the doctormate device. the rlic treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. blood pressure will be 200 mm hg with 5 minutes of reperfusion between each inflation. subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects. the study will be conducted at one site ( university of iowa hospitals and clinics)

Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤ 80 years 2. suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference). 3. patient screened for rtpa, and rtpa administered if eligible 4. subject or legally authorized representative able to provide consent at the time of the assessment 5. nihss 6-20 exclusion criteria: 1. any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on ct scan at the community hospital 2. history of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment 3. history of diabetes mellitus 4. enrollment in another clinical trial 5. patient incarcerated 6. pregnancy. patients ages 18-55 will need to have a negative urine or blood based pregnancy test. 7. agitation deemed unsafe for ischemic preconditioning testing. 8. arteriovenous fistula in upper limb

Keywords: remote limb ischemic conditioning large vessel occlusion helicopter transport
real world app-based ccaap management of children with asthma

Conditions: Asthma

Summary: this study is a multi-center randomized controlled trial of children with asthma. the objective of the study is to compare the app-based efficacy of china children asthma action plan (ccaap) and written ccaap used in management of children with asthma. the main questions are:1. is the app-based ccaap effective/feasible in management of children with asthma? 2. is the app-based ccaap better than written ccaap in management of children with asthma?

the study is a multi-center randomized control study.the enrollment period is 3 months. patients who is in 6-17 years of age will be randomized recruited into two groups: the app-based asthma action plan group and the written ccaap group. patients in app group will receive written ccaap and mobile phone-based asthma self-management app (youran respiratory) which includes an electronic asthma action plan, peak expiratory flow monitor system and peak expiratory flow meter. patients in written ccaap management group will write down the symptoms and pef in asthma diary. the data of the number of asthma episodes, the improvement of fev1 , the number of unscheduled medical visits, the score of children's quality of life, the questionnaire of asthma knowledge, act / c-act score, the absent days of parental work, the absent days of children study, and the cost of health economics will be collected regularly in a year with the interval of 3 months to assess the efficacy of ccaap in asthma management. the study will recruit 400 cases for each group from ten children's hospitals. the study will be completed in a year.

Eligibility criteria:
inclusion criteria: * did not receive control treatment or did not reach well-control; * can perform spirometry pulmonary function tests; * parents are skilled in using smartphones and app apps (android or ios); exclusion criteria: * reach the level of asthma well control; * can not use the smartphone app software; * can not cooperate the test of peak expiratory flow; * did not treatment coexist respiratory disease effectively (such as sinusitis, obstructive sleep apnea-hypopnea syndrome, etc.); * combined with other systemic diseases outside the respiratory system (such as leukemia, rheumatoid arthritis, etc.). * receiving allergen-specific immunotherapy. * undergoing trial for other medications or instruments.

Keywords: asthma children action plan app-based
bioequivalency study of montelukast chewable 5 mg tablets under fasted conditions

Conditions: Asthma

Summary: the objective of this study was to prove the bioequivalence of montelukast chewable tablet under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to montelukast or any comparable or similar product.
physio pci: impact of coronary angioplasty on non-hyperaemic pressure ratio in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the use of intra coronary physiological assessment with fractional flow reserve (ffr) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. further, ffr has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. a lower value of ffr after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all ffr values. among 750 patients in the fractional flow reserve post-stent registry, the event rate was 29.5% in patients with ffr\ 0.95 (p\<0.001). however, ffr remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. this leads to the validation of resting indices (instantaneous wave-free ratio (ifr), diastolic pressure ratio (dpr), and resting full-cycle ratio (rfr) among others). those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to ffr (≤0.89 vs 0.80, for ifr and rfr, and ffr 16 respectively).in the validate rfr study, a head-to-head comparison of rfr and ifr from a retrospective analysis, diagnostic accuracy of rfr was 97.4% with an area under the curve 1 (auc) of 99.6%. in the more recent re-validate rfr study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of rfr in all-comers patients. compared to ifr, rfr achieved high diagnostic accuracy, sensitivity and specificity. these are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of rfr before and after pci in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the middle east region..


Eligibility criteria:
inclusion criteria: * patient is ≥ 21 years * the patient is deemed eligible for pci of at least one coronary stenosis (rfrpre ≤0.89 or ffr≤0.80) * the patient is able and is willing to comply with all study procedures and process. exclusion criteria: * the patient is in cardiogenic shock * the patient has a bifurcation lesion that requires a planned two stents technique * the patient refuses to participate. * the patient suffers acute coronary syndrome and should be treated by pci in the culprit lesion (non-culprit lesions in non-culprit vessel could be included) * the patient has an ostial stenosis to be treated by pci

Keywords: percutaneous coronary intervention fractional flow reserve resting full cycle ratio
effect of the scl16a11 risk haplotype on treatments to prevent type 2 diabetes

Conditions: PreDiabetes

Summary: the goal of this randomized clinical trial is to determine the impact of the risk haplotype on slc16a11 on early therapeutic responses in treatments to prevent t2d in mexican mestizos with prediabetes. the main question\[s\] it aims to answer are: * evaluate the effect of the risk haplotype on weigth loss \>3% * evualuate the differences in lipid profiles and glycemic parameters (fasting glucose, hba1c). participants will be randomized into two groups: lifestyle intervention (lsi): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week), or lsi + met (750 mg metformin twice a day). researchers will compare carriers and non carriers of the risk haplotype of slc16a11 to see if there are diferent treatment responses.

objectives: dietary modification and/or metformin remain the most cost-effective treatment to prevent type 2 diabetes (t2d). yet, there is an important variation in receiving the benefit among individuals. a haplotype in slc16a11 is associated with decreased insulin action and risk for t2d in mexicans. we aim to determine the impact of the risk haplotype on slc16a11 on early therapeutic responses in treatments to prevent t2d. methods: we recrute individuals with at least one prediabetes criteria according to the american diabetes association with a body mass index (bmi) between 25 and 45 kg/m2. participants are randomized into two groups: lifestyle intervention (lsi): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week), or lsi + met (750 mg metformin twice a day). standardized dietitians delivere the lsi. the treatment goal is to achieve \>3% weight loss during the 12-week follow-up. participants are genotyped for the risk allele rs13342232 and rs75493593. the effects of the risk haplotype are evaluated with linear and logistic regressions adjusted by age, sex, five genetic principal components, bmi, and prediabetes criteria at baseline. primary outcome is a significant interaction between the treatment arm and genotype in weight loss goal \>3% after the treatment. secondary outcome are differences in lipid levels and third outcome is differences in glycemic parameters (fasting glucose, hba1c).

Eligibility criteria:
inclusion criteria: * mexican mestizos * at least one prediabetes criteria according to the american diabetes association: fasting glucose between 100-124 mg/dl, glycosylated hemoglobin (hba1c) between 5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g of glucose) (1); * age ranged between 18-65 years * overweight or obesity (bmi between 25.0 - 40 kg/m2). exclusion criteria: * chronic diseases * pregnancy * chronic use of medications that altered plasma glucose levels.

Keywords: prediabetes metformin precision nutrition slc16a11 mexican mestizos
an observational study of xeloda (capecitabine) monotherapy in patients with colorectal cancer (axel)

Conditions: Colorectal Cancer

Summary: this observational study will evaluate xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage iii (duke c) after surgical resection. data will be collected for 3 years.


Eligibility criteria:
inclusion criteria: * adult patients, over the age of 18 years * presence of colon adenocarcinoma * surgical resection for colon cancer stage iii (duke c) * prior adjuvant therapy with xeloda monotherapy exclusion criteria: * contraindications for xeloda
evaluation of convenience and compliance of the easypod™ electronic self-injector

Conditions: Growth Hormone Deficiency; Turner Syndrome; Chronic Renal Failure; Small for Gestational Age

Summary: this is an international, multicenter study involving children treated with saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use. both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.

an international, multicenter cross-sectional study (observatoire des pratiques médicales®) involving a cohort of children treated with saizen®, a growth hormone. the study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. no specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.

Eligibility criteria:
inclusion criteria: * already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, turner's syndrome, chronic renal failure, small-for-gestational age \[sga\] patients, based on rcp) exclusion criteria: * cases in which saizen® is contra-indicated (based on local rcp) * children returning for consultation, who have not brought back their easypod™ electronic self-injector. * children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study

Keywords: electronic device growth hormone treatment
clinical evaluation of the interlace medical hysteroscopic morcellator

Conditions: Abnormal Uterine Bleeding; Infertility

Summary: this study assesses the effectiveness of intrauterine fibroid and polyp removal using the interlace medical 1st generation hysteroscopic morcellator device based on a retrospective review of medical records of women who have been treated with the device.

a retrospective review of medical records for eleven (11) premenopausal women who had been treated with the new hysteroscopic morcellator was conducted at four hospital or ambulatory surgical center sites. four physicians performed hysteroscopic operative procedures to remove intrauterine polyps, type 0 (completely within the uterine cavity), type i (mostly within the cavity) and type ii (\< 40% within the cavity) submucous myomas. percent pathology removed, total morcellation time, total fluid used, fluid deficit and treatment-related adverse events were assessed. each of the four treating physicians also evaluated device performance using a 10 point scale (1 = "poor" and 10 = "excellent").

Eligibility criteria:
inclusion criteria: * female * at least 18 years old * treated for intra-uterine submucosal fibroids (type 0 or 1 myomas and/or polyps using the interlace 1st generation morcellator device. exclusion criteria: * none

Keywords: morcellator hysteroscope myomectomy polypectomy uterine fibroids