Kornimate/medical-research-clean huggingface dataset:
an evaluation of simvastatin plus omacor compared to simvastatin plus placebo in subjects with mixed dyslipidemia

Conditions: Mixed Dyslipidemia

Summary: the primary objective of this study is to compare the effect of simvastatin plus omacor to simvastatin plus placebo for lowering non-high density lipoprotein cholesterol in subjects with mixed dyslipidemia.

this trial will utilize a randomized, double-blind, two-period crossover design. at visit 4 (week 0), after a 5-week diet lead-in/baseline period, subjects meeting all entry criteria will be randomized to one of two double-blind treatment sequences, simvastatin/omacor first or simvastatin/placebo first. each treatment period consists of 6 weeks. after randomization, subjects will self-administer the study drugs once a day in the evening.

Eligibility criteria:
inclusion criteria: * men and women, ages 18-79 inclusive * fasting, untreated non-high-density lipoprotein cholesterol (non-hdl-c level above atp iii goals * fasting, untreated triglyceride (tg) level in the high to very high range * provide written informed consent and authorization for protected health information exclusion criteria: * pregnancy * use of lipid-altering drugs which cannot be stopped * history of certain cardiovascular conditions or cardiac surgery within the prior 6 months * body mass index above 40 kg per square meter * allergy or sensitivity to omega-3 fatty acids or to statin drugs * poorly-controlled conditions including diabetes, hypertension, or thyroid disease * certain muscle, liver, kidney, lung or gastrointestinal conditions * certain medications * active cancers treated within prior 2 years (except non-melanoma skin cancer)

Keywords: cholesterol dyslipidemia omega 3
early evaluation of left ventricular systolic function impairment in patients with chronic kidney disease by multimodal ultrasonography

Conditions: Chronic Kidney Diseases; Left Ventricular Systolic Dysfunction

Summary: the goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(ckd). the main questions it aims to answer are: 1. if first-phase ejection fraction（ef1）could early detect the left ventricular systolic dysfunction in patients with ckd. 2. whether ef1 can detect left ventricular systolic dysfunction in patients with ckd more sensitively than speckle-tracking echocardiography and myocardial work. participants will need to cooperate to do an echocardiography. researchers will compare healthy volunteers and patients with ckd to see if ef1 could early detect the left ventricular systolic dysfunction.


Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease who are hospitalized in the fifth affiliated hospital of sun yat-sen university. * lvef≥50%. exclusion criteria: * patients with primary hypertension, diabetes and congenital heart disease. * patients who are pregnant or lactating. * patients with the blurry ultrasound images.

Keywords: first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease
infectious etiology of vomiting in children with presumed acute gastroenteritis

Conditions: Acute Gastroenteritis; Vomiting

Summary: in children with acute gastroenteritis (age), vomiting often precedes diarrhea. to establish the diagnosis of age, enteropathogen detection typically relies on diarrheal stool samples. however, testing requires sufficient stool sample, which may not be easily available. recent studies suggest that in children presenting to emergency departments with presumed age with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. the rate of enteropathogen detection in children with isolated vomiting due to age may differ in various populations. using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed age in whom an enteropathogen can be identified. this will be a prospective cohort study. children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed age, lasting no longer than 7 days before enrolment, will be recruited. a total of 198 participants will be recruited and a rectal swab will be collected. the participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.


Eligibility criteria:
inclusion criteria: * age 0-5-year-old * presence of ≥3 episodes of vomiting due to presumed age at inclusion * \<7 days of symptoms at the time of inclusion * signed written informed consent exclusion criteria: * anticipated inability to complete 14 days follow-up * history of neutropenia (as rectal swabs are contraindicated) * critically ill status requiring urgent medical intervention * inability to provide a rectal swab for testing * chronic gastrointestinal tract disorders such as inflammatory bowel disease, cystic fibrosis, coeliac disease * immunodeficiency

Keywords: acute gastroenteritis children vomiting enteropathogens
characterization of rhythmicity profiles of bradykinin-mediated angioedema attacks using a tracking smartphone application.

Conditions: Bradykinin-mediated Angioedema

Summary: bradykinin-mediated angioedema is a rare and disabling disease, characterized by the occurrence of attacks marked by localized swelling of skin, but also of the airways, which can be life-threatening. the unpredictable nature of attacks is a key feature of angioedema, placing patients under constant threat. it seems that there are different patterns of yearly distribution for these attacks, but this is poorly described in the literature. the objectives of the study are to establish different rhythmicity profiles of patients according to the frequency of the attacks; and to identify factors potentially triggering the attacks. for this purpose, patients with bradykinin-mediated angioedema will be monitored daily using a smartphone application. each day, the application will ask the patient if he or she is having an attack and, if so, the characteristics of the attack and the events preceding it


Eligibility criteria:
inclusion criteria: * diagnosis of bradykinin-mediated angioedema * age \> 18 * having a smartphone * non opposition to answer the questionnaire exclusion criteria: * patients with other type (histaminergic) angioedema * patient unable or unwilling to use a smartphone application * opposition to the research * minor or protected adult * person deprived of liberty

Keywords: bradykinin angioedema smartphone application attack hereditary angioedema
effect of empagliflozin on quality of life in chronic heart failure patients with diabetes mellitus type ii

Conditions: Chronic Heart Failure

Summary: effect of empagliflozin on quality of life in patient of chronic heart failure with diabetes mellitus type ii. as per esc guidelines empagliflozin is recommended as part of the first-line treatment for hfref, irrespective of diabetes status. as per american college of cardiology (acc)/american heart association (aha) empagliflozin is recommended in both diabetic and non-diabetic hf (especially beneficial in patients with hfref and hfpef). the aim of my study is to assess the impact of empagliflozin on quality of life in pakistani patients, considering the genetic, environmental and cultural factors. the study will also explore whether empagliflozin can offer cost-effective option for managing chronic heart failure and diabetes, potentially reducing the economic burden on both patients and health care system.

effect of empagliflozin on quality of life in patient of chronic heart failure with diabetes mellitus type ii. as per esc guidelines empagliflozin is recommended as part of the first-line treatment for hfref, irrespective of diabetes status. this is a comparative clinical study with randomized groups. participants will be allocated to either the empagliflozin group or the placebo group alongside standard therapy. blinding will be done by assigning drug to participants according to computer generated numbers in 2 groups in 1:1 ratio. empagliflozin group: taking empagliflozin 10mg once daily per oral along with standard treatment. their quality of life assessed by using kansas city cardiomyopathy questionnaire. placebo group: identical placebo tablets, following the same dose and schedule as the empagliflozin group along with standard treatment of chronic heart failure. duration is of18 months. will take place in fazaia ruth pfau medical college and hospital and nicvd hospital karachi.

Eligibility criteria:
inclusion criteria: 1. age 40-70 years at time of screening. 2. both men and women are included in study. 3. patients with chronic heart failure and currently categorized in class ii-iv heart failure as per nhya classification having ejection fraction less than 40%. 4. patients having nt- probnp levels greater than 25pg/ml. 5. diabetic patient diagnosed (hba1c \> 6.5mg/dl) and currently taking antidiabetic medicine. exclusion criteria: 1. pregnant female. 2. patient with end stage renal disease (esrd). 3. patient with acute decompensated heart failure. 4. acute coronary syndrome patients.

Keywords: chf dm type ii
clinical significance of platelet reactivity on clopidogrel during off-pump coronary artery bypass

Conditions: Coronary Artery Disease

Summary: objective: to evaluate the early and late prognoses of patients according to platelet reactivity after clopidogrel administration and determine whether the measurement of platelet inhibition predicted 1-year clinical outcomes after off-pump coronary bypass (opcab) study design * prospective, observational, single-center study * subjects with opcab surgery who meet all inclusion and exclusion criteria will be enrolled. * platelet reactivity after 7-days clopidogrel treatment from the day of surgery will be measured by verifynow system. * dual antiplatelet therapy including aspirin and clopidogrel will be administered for 1 year after surgery and subjects will be followed-up for 1 year about primary endpoint. * cutoff value of p2y12 reactivity units (prus) for primary endpoint will be assessed and the cohort will be divided by the pru cutoff value (low/high platelet reactivity groups). * the primary and secondary endpoints will be compared between two groups


Eligibility criteria:
inclusion criteria: * patients with indications for surgical myocardial revascularization * patients who undergo off-pump coronary artery bypass * age between 19\~80 years * patients with signed informed consent exclusion criteria: * patients with combined surgery with coronary bypass grafting * on-pump conversion * patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis * patients with chronic treatment with proton pump inhibitors * patients with preoperative bleeding * thrombocytopenia (platelet count 70,000/ml) * re-do surgery * early death before the measurement of platelet reactivity

Keywords: platelet activity, cabg, off-pump surgery
evaluation of healing process after laser asissted gingivectomy techniques

Conditions: Gingival Enlargement

Summary: objective: the aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including er:yag laser, diod laser, and conventional techniques. method: this study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. clinical periodontal parameters, gingival crevicular fluid (gcf) kgf-2 and vegf-a levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. gingival temperature and epithelization levels in 3, 7, 14 and 21 days; gcf kgf-2 and vegf-a levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. preoperative anxiety and postoperative satisfaction were evaluated through questionnaires

objective: the aim of this study was to evaluate and determine clinical and biochemical comparison of 3 different methods including er:yag laser, diod laser, and conventional techniques commonly used in resective gingival surgeries in terms of preoperative anxiety, postoperative satisfaction, epithelization, gingival temperature, inflammation and pain levels in post-operative healing process. method: this study was conducted on 32 female, 13 male, a total of 45 individuals (study group patients) with an indication of resective gingival surgery in the anterior region of the maxillar anterior regions and 11 female, 4 men, a total of 15 individuals (negative control group patients) with a healthy gingiva. clinical periodontal parameters, gingival crevicular fluid (gcf) kgf-2 and vegf-a levels and gingival temperature levels were recorded before the investigation and during operations with 3 different techniques, gingival temperature was measured. gingival temperature and epithelization levels in 3, 7, 14 and 21 days; gcf kgf-2 and vegf-a levels in 14 and 21 days and pain levels between 1-7 days of post-operative healing process were evaluated. preoperative anxiety and postoperative satisfaction were evaluated through questionnaires

Eligibility criteria:
inclusion criteria: * systemically healthy individuals * the existence of at least 20 functioning teeth, * the existence of chronic inflammatory gingival enlargement exclusion criteria: * pregnancy/lactation, * drug use, * previous periodontal therapy within 6 months
validation of a genetic signature to predict the development of sarcomas

Conditions: Genetic Signature in Development of Sarcomas

Summary: the aim of the sari study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. this study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma. following the sequencing of the exomes of all these patients, the sari study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. this signature is the subject of a patent (bff 170286 / vf, filed on june 22, 2017). a final validation step with samples that have not been used to optimize this signature is now required. moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones. the objective of the predisarc study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.

a total of 60 patients will be included in this pilot study: * group 1: 20 patients with induced radio sarcoma * group 2: 20 patients without primary sarcoma or induced radio sarcoma * group 3: 20 patients with primary sarcoma these numbers will make it possible to have preliminary data making it possible to judge the interest of the genetic signature in the prediction of the radiation-induced sarcomas.

Eligibility criteria:
inclusion criteria: 1. major patient at the time of initial radiotherapy or diagnosis of primary sarcoma. 2. patient belonging to one of these 3 groups : group 1: patient treated with radiotherapy for cancer other than primary sarcoma and who developed sarcoma (other than osteosarcoma) in the irradiated area. or group 2: patient who received radiotherapy for more than 5 years and did not develop sarcoma or other secondary cancers or group 3: patient who developed primary sarcoma and who had never been treated with radiotherapy 3. patient who have signed informed consent to participate in the study. 4. affiliation to the social security system. exclusion criteria: 1. patient unable to understand, read and / or sign informed consent. 2. person benefiting from a protection system for adults (including guardianship and trusteeship) 3. pregnant or lactating woman. 4. patient who participated in the sari study "predictive study of sarcomas developed in irradiated territory from the gsf-geto database (id-rcb no .: 2011-a01102-39)"

Keywords: sarcoma genetic
brain and abdominal aneurysm study

Conditions: Aneurysm

Summary: aneurysmal subarachnoid hemorrhage (asah) is the most deadly kind of stroke. each year, 40,000 americans have sah. case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. most commonly, sah results from rupture of an intracranial aneurysm. screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of sah. aortic aneurysm also constitutes a major public health problem with high lethality. current estimates are that ruptured aortic aneurysm kills 13,000 americans each year. screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those who die did not have a diagnosis of aortic aneurysm prior to rupture. the relationship between intracranial and aortic aneurysm has long been recognized, but poorly quantified. recent genome-wide association studies (gwas) provide a molecular biological evidence for a shared pathophysiology. the chromosome 9p21 locus confers increased risk for both intracranial aneurysms and aortic aneurysms. these gwas data, along with linkage data for other susceptibility loci, indicate that individuals and families harboring one type of aneurysm may be at especially increased risk of the other. the rationale for this project is that opportunistic screening for abdominal aortic aneurysms (aaa) may be warranted in patients who present with aneurysmal subarachnoid hemorrhage. this study is meant to see if the yield of screening in this population is too low to justify its routine use. the investigators plan to systematically screen for aaa in all cases of asah presenting to mch for treatment. if no individual out of 81 consecutively screened cases of asah has evidence of aaa, then the investigators can have strong confidence that there is a less than 5% chance of finding an aaa in the patient population.


Eligibility criteria:
1. men and women age ≥ 18 years. 2. diagnosis of intracranial aneurysm secured by magnetic resonance angiography (mra), computed tomographic angiography (cta), or catheter-based cerebral angiography. 3. diagnosis of subarachnoid hemorrhage diagnosed by head ct, brain mri or lumbar puncture. 4. provides written informed consent. 5. no know diagnosis of aortic aneurysm 6. no history of prior screening for aortic aneurysm 7. no condition like recent abdominal surgical scar that would preclude abdominal ultrasonography 8. no therapy like abdominal hypothermia pads that would preclude abdominal ultrasonography
validation of software for assessment of sleep apnea from data acquired by a wearable smartwatch

Conditions: Sleep Apnea

Summary: this clinical validation study aims to evaluate the utility of fitbit's sleep apnea alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. the sleep apnea alert software analyses data from a fitbit commercially available wrist photoplethysmogram (ppg) device. the sleep apnea alert software is an investigational software as medical device (samd) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (ahi) of 15 or greater. this clinical validation study will be used to validate fitbit's ppg-based sleep apnea algorithm. the outputs of the fitbit sleep apnea alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.


Eligibility criteria:
inclusion criteria: * capable of giving informed consent * comfortable reading the provided written study instructions in english (and/or local language) and using a smartphone in english (and/or local language). * have medical insurance either in the form of private insurance or a national health program. exclusion criteria: * no implanted cardiac devices * not pregnant. pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle. * no medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
exercise treatment of dental anxiety

Conditions: Dental Anxiety

Summary: a single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.

the primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure. primary efficacy endpoint: change in the visual analogue scale (vas) for anxiety before and after the intervention prior to the elective minor dental procedure

Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years of age or older * a total score of 12 points or more on the dental anxiety scale at screening and baseline evaluations * scheduled appointment for an elective minor dental procedure * informed consent exclusion criteria: * pregnant or lactating women * current diagnosis of any other dsm-iv, with the exception of other phobic disorders, social anxiety disorder or dysthymia * serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% vo2max

Keywords: dental anxiety, physical activity, dental phobia cortisol, amylase
effect of nicardipine on renal function in deliberate hypotension

Conditions: Spinal Stenosis

Summary: the aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin c, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

to induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. nicardipine expands the renal artery and increases glomerular filtration rate. previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery. the aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin c, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing anterior or posterior spine interbody fusion exclusion criteria: * patients with american society of anesthesiologists physical status iii or iv * liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 iu/l * cerebrovascular disease * anemia of less than hematocrit 24% * diabetes mellitus * severe malnutrition * those diuretics or antihypertensive drugs