Kornimate/medical-research-clean huggingface dataset:
the school spit study - elementary schools in high covid-19 incidence regions

Conditions: SARS-CoV2 Infection

Summary: this study will conduct an evaluation of a program that is being implemented sickkids / toronto public health that provides take-home saliva testing kits in schools. operationally, there is a planned randomization so that all schools have an equitable chance to receive the intervention at various time periods during the planned operational roll-out, which will require a staggered implementation consistent with the stepped-wedge study design. this study will leverage this chance implementation to do a robust evaluation of the public health intervention. schools that are not being rolled out to week one, will begin in the "control phase" (testing at an assessment center, primary care or acute care center) and transition to the program "intervention phase" (take home saliva kits available at schools) at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study. the investigators will evaluate the impact of the program on sars-cov-2 case identification in schools.

this is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design. eligible elementary public schools high sars-cov-2 incidence regions (quintiles 4 and 5) in toronto will be randomized. the study will occur over a 7-week period with a minimum of one-week of baseline data (control phase - testing at an assessment center, primary care or acute care center) and then schools will start the program in a stepwise manner (20 crossovers per week) with take-home saliva being available to all 120 schools by the end of the study period. the primary objective of the study is to assess whether the availability of take home saliva kits at schools for symptomatic testing leads to increased diagnosis of sars-cov-2 cases in the school.

Eligibility criteria:
elementary schools will be included in the evaluation if they are: * considered an elementary school by the school board * open for in-person learning during the study period * they have at least 200 students * offer at least 4 grades exclusion criteria: schools that are middle schools only, that are not open for in-person learning, have fewer than 200 students or are not a complete elementary school (i.e. schools offering independent courses, prep schools with 1-2 grades, elementary schools with \< 4 grades) will be excluded.

Keywords: school testing
adjuvant mfolfirinox for high-risk stage iii colon cancer

Conditions: Colon Cancer Stage III

Summary: a multicenter, open labeled randomized, phase ii trial comparing mfolfirinox and mfolfox6 as adjuvant treatment for high risk stage iii (pt4n1/2 or ptanyn2) colon cancer

after inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mfolfirinox or mfolfox 6 with a 1:1 ratio. arm a: mfolfirinox arm b: mfolfox

Eligibility criteria:
inclusion criteria: 1. age of 20-70 years with an ecog ≤ 2 2. age of 71-75 years with an ecog = 0 3. pathologically confirmed high-risk stage iii colon adenocarcinoma (pt4n1 or ptanyn2) 4. curative radical resection (successful r0 resection) within 60 days before randomization 5. adequate organ functions * anc ≥ 2×106 cells/ml * hemoglobin ≥ 9.0 g/dl * platelets ≥ 100×106 cells/ml * alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (uln) * serum total bilirubin ≤ 1.5 uln * alkaline phosphatase ≤ 2.5 × uln * serum creatinine ≤1.5 × uln or creatinine clearance \> 50 ml/min (cockcroft-gault formula) 6. able to understand and willing to sign and date written voluntary informed consent form 7. life expectancy ≥ 5 years exclusion criteria: 1. distant metastasis 2. middle or lower rectal cancer of need for radiotherapy 3. postoperative complication of 3 or more grades of clavien-dindo classification 4. underlying disease or postoperative condition which is contraindication for chemotherapy 5. known hypersensitivity reaction to any study treatment component 6. familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer 7. inflammatory bowel disease 8. previous other malignancy which cannot be curatively treated 9. pregnancy or breast feeding 10. any other situation would exclude the patient from study based on the investigator's opinion

Keywords: high risk stage iii (pt4n1/2 or ptanyn2) colon cancer
evaluation of the efficacy and safety of rosuvastatin 5 mg versus pravastatin 40 mg and atorvastatin 10 mg in type iia and iib hypercholesterolaemic patients

Conditions: Type IIa and IIb Hypercholesterolaemia

Summary: the purpose of this study is to evaluate the efficacy and safety of rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: pravastatin 40 mg and atorvastatin 10 mg. treatment efficacy will be evaluated by the percentage of ldl-c variation after 8 weeks of treatment.


Eligibility criteria:
inclusion criteria: * subjects presenting type iia or iib primary hypercholesterolaemia diagnosed for at least 3 months, in a context of primary prevention with at least two associated cardiovascular risk factors and: (i)either "naive" to all lipid-lowering therapy, (ii)or treated with a statin (treatment ongoing or stopped during the previous 8 weeks) exclusion criteria: * homozygous or heterozygous familial hypercholesterolaemia * hypertriglyceridaemia (tg ≥ 4 g/l) * subjects at high cardiovascular risk according to the afssaps 2005 definition (coronary artery disease or history of documented vascular disease, high cardiovascular risk type 2 diabetes, subject in primary prevention with a 10-year chd risk \> 20%) * history of adverse events or hypersensitivity to an hmg co-a reductase inhibitor (particularly a history of myopathy) * concomitant use of any drugs not authorized during the study * active liver disease with elevation of serum transaminases (asat, alat) more than twice the upper limit of normal * cpk more than 3 times the upper limit of normal * moderate or severe renal failure (creatinine clearance \< 6 ml/min) * poorly controlled hypothyroidism; poorly controlled hypertension (dbp \> 95 mm hg and/or sbp \> 180 mm hg)

Keywords: dyslipidemia
the effect of reading fairy tales and coloring on children's fear level in children who are administered inhaler medication with a mask.

Conditions: Fear Anxiety; Satisfaction

Summary: this thesis study was conducted as an unblinded, randomized controlled experiment to examine the effects of reading and coloring fairy tales, which can be used during inhaler medication administration with a mask, on children's fear level and parental health care satisfaction.

data were collected at edirne sultan 1. murat state hospital pediatrics clinic between september 2023 and january 2024. children aged 3-6 were included in the study. in the research, the sample was divided into three groups. 99 children participated in the study, 33 children in each group. using the randomization program, it was determined which sample group the children would be included in. in the study, reading fairy tales and coloring were used as distraction methods for the experimental group. inhaler medication was administered via mask to the control group without any application. the implementation period of the research lasted an average of four months. necessary ethical permissions were obtained before the research. in the study, the child fear scale was used to measure the level of fear, the pedsql health care satisfaction scale was used to measure parental satisfaction, and the children's emotional indicators scale was used to measure emotional indicators. explanatory information about the application was given to the children and their parents by the researcher, and they were voluntarily informed and signed a consent form. research data were collected by the researcher by meeting children and parents face to face.

Eligibility criteria:
inclusion criteria: 1. parent and child volunteering to participate in the study, 2. the child is between the ages of 3-6, 3. being admitted due to respiratory system disease, 4. inhaler treatment with a mask will be applied. exclusion criteria: 1. parent and child not voluntarily participating in the study, 2. the child has any genetic, congenital, chronic or metabolic disease, 3. the child has vision, hearing and speech problems, 4. the child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.

Keywords: inhaler medicine fear readin fairy tales coloring satisfaction
the food effect on pk characteristics and safety profiles of pa-111

Conditions: Mixed Dyslipidemia

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of pa-111 in healthy subjects.

the purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of pa-111 in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg (female 45kg) and body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit exclusion criteria: * participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * other exclusions applied
telmisartan in mild to moderate hypertensive patients

Conditions: Hypertension

Summary: to evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with abpm


Eligibility criteria:
inclusion criteria: * patients with blood pressure levels of 140/90 mm hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex exclusion criteria: * suspected or known diagnosis of arterial hypertension with a secondary cause * women who were not using an effective method of contraception, or who were pregnant, or breast-feeding * systolic blood pressure \> 200 mm hg or diastolic blood pressure \> 115 mm hg * laboratory test values two fold above the upper normal limit * previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin ii blocker (aiiar) * new york heart association class iii or iv heart failure * history of stroke in the 6 months prior to entry into the study * uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels \> 140 mg/dl on 3 consecutive assessments * patients who were included in another investigational drug study in the past 30 days
comparison of a tissue perfusion guided hemodynamic protocol with a standard hemodynamic protocol in septic shock patients

Conditions: Septic Shock

Summary: the surviving sepsis campaign (ssc) published 2008 revised guidelines to improve survival of septic shock patients. for hemodynamic stabilization the ssc recommends distinct treatment goals. the study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.

background septic shock is a frequent and severe entity with a mortality of 55%. the surviving sepsis campaign (ssc) published 2008 revised guidelines to improve survival of septic shock patients. for hemodynamic stabilization the ssc recommends as treatment goals a mean arterial blood pressure \> 65mmhg (map), a central venous blood pressure of 8-12 mmhg, a mixed venous oxygen saturation \>65%, a central venous oxygen saturation \> 70% and a diuresis \> 0.5 ml/kg/h (1). according to the ssc guidelines a map \> 65 mmhg should be aimed because at this blood pressure level tissue perfusion is preserved. this is based on a study in ten septic shock patients where norepinephrine was titrated to three levels (65, 75 and 85 mmhg) and the authors concluded that parameters of tissue perfusion did not differ between the each level (2). objective to evaluate if a hemodynamic protocol guided by parameters of tissue perfusion could reduce the duration of vasopressor treatment in septic shock patients. methods patients suffering from septic shock requiring vasopressor support are randomly assigned to a control group (usual care) and an intervention group (tissue perfusion guided protocol). in the intervention group parameters of tissue perfusion are used to guide hemodynamic therapy.

Eligibility criteria:
inclusion criteria: * 2 or more sirs criteria according to accp/sccm definition * documented infection or strong suspicion of infection with adequate antibiotic treatment * shock according to accp/sccm definition with the necessity of vasopressor treatment exclusion criteria * patients admitted with central nervous diseases * st elevation myocardial infarction * pulmonary embolism * out of hospital cardiac arrest patients * patients with therapy limitations * known pregnancy * inclusion in other interventional trials
effect of prebiotics on blood glucose management

Conditions: Hyperglycemia; Insulin Sensitivity

Summary: this survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.

highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. however, its protective role in subjects with hyperglycemia are remain unclear. this study aims to examine the effect of 8-week prebiotics supplementation on glucose management in subjects with hyperglycemia. by understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hyperglycemia, which is a major risk factor for cardiovascular diseases.

Eligibility criteria:
inclusion criteria: 1. age: 30-65 years old 2. fasting venous plasma glucose ≥5.6mmol/l or plasma glucose 2 h after an oral glucose load ≥7.8mmol/l or glycosylated hemoglobin ≥5.7% or newly diagnosed diabetes without hypoglycemic drugs using 3. bmi≥18 kg/ m2 exclusion criteria: 1. receiving or have been treated with hypoglycemic drugs or insulin. 2. complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. 3. severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal or gfr\<30ml/min/1.73m2). 4. autoimmune diseases or thyroid diseases. 5. women who are pregnant, nursing, or prepare to give birth during the trail. 6. malignant disease, infectious disease, inflammatory disease and advanced liver disease. 7. mental or intellectual abnormalities, unable to sign informed consent. 8. complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit. 9. received antibiotics, probiotics within 3 months before screening visit or throughout the trail. 10. major operations were performed within six months of screening visit, or will be made during the trial. 11. alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)

Keywords: hyperglycemia prebiotics
clinical study to evaluate the safety, immunogenicity and efficacy of investigational flu vaccine compared to approved flu vaccine in children.

Conditions: Influenza Virus

Summary: safety, immunogenicity and efficacy of an adjuvanted quadrivalent subunit influenza virus vaccine compared to non-adjuvanted comparator influenza vaccine in children ≥6 to \<72 months of age. the study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.


Eligibility criteria:
inclusion criteria: * children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to \<72 months of age * documented consent provided by the subject's parent(s)/legal guardian(s) * subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures. exclusion criteria: * children with history of allergy to vaccine components. * additional eligibility criteria may be discussed by contacting the site

Keywords: influenza children
cbd cannabis extract: pharmacokinetic studies

Conditions: Epilepsy

Summary: the initial goal is to ascertain the pharmacokinetic (pk) profile of cbd (cannabidiol) after a single dose of cbde (cannabidiol extract), although the plan is to extend these studies to multiple dose administrations in the future, since it is likely that (cannabidiol) and/or its metabolites will show some accumulation. these studies will provide detailed information that will inform the continuation and expansion of cbde in other research projects.

the objective is to determine the pk profile of cbd(cannabidiol) , its metabolites, and minor phytocannabinoids after single dose administration of cbde (at 2.5 mg/kg cbd). attainment of this goal will provide essential information on phytocannabinoid disposition and dosing regimen optimization. to accomplish this objective, the working hypothesis that complex phytochemical mixtures present in full spectrum hemp extracts (fshes), as exemplified by cbde, differ from purified cbd-containing products with regard to pk, will be tested. the approach to testing this working hypothesis will be to use liquid chromatography-mass spectrometry (lc/ms) to both characterize the phytocannabinoid concentration-time profiles following cbde administration (single and multiple dosing).

Eligibility criteria:
inclusion criteria: * normal, healthy adults aged 21 to 55 years exclusion criteria: * allergy to sesame oil/products * obese: bmi is 35 or higher * smoker (tobacco \& marijuana use \[smoking or use of oral hemp/cbd products\]) * currently any taking prescriptions medication(s) \[with exception of oral contraceptives\] or over-the-counter medications/supplements * consuming botanical/non-botanical dietary supplements (3 days prior to study) * known history of cardiac, liver, kidney or hematological disease, diabetes * autoimmune disorders * known history of neurologic/psychiatric disorders * report of an active infection * subject is pregnant or breast-feeding, or is expecting to conceive during the study * subjects of child bearing potential will use (or is currently using) during the study, one of the following acceptable methods of contraception: male sterilization (vasectomy) female sterilization (tubal ligation, hysterectomy) intrauterine service intrauterine device (iud) or other implant oral contraceptive, injectable contraceptive contraceptive patch/ring diaphragm male condom sponge/spermicide

Keywords: cbd cannabidiol extract cannabidiol cbde pharmacokinetics
deep neural network approaches for closed-loop deep brain stimulation

Conditions: Parkinson Disease

Summary: in this research study the researchers want to learn more about brain activity related to speech perception and production in patients with parkinson's disease who are undergoing deep brain stimulation (dbs).

deep brain stimulation (dbs) is the gold-standard treatment for patients with medication resistant motor complications of parkinson's disease (pd) and provides the only opportunity to record and stimulate in the human basal ganglia. most recently, the concurrent use of research electrocorticography (ecog) during dbs surgery, including pioneering work from pittsburgh, has further enabled basic neuroscience investigation of human cortical-subcortical network dynamics. the discovery that aberrant synchronization of rhythmic neuronal activity recorded in pd patients is suppressed by dbs has advanced the concept that measures associated with pathological activity may be used as biomarkers to control the delivery of dbs therapy. pilot studies of adbs in pd have reported promising clinical results from triggering dbs stimulation when the signal recorded from the dbs electrode showed a high level of oscillatory power in the beta frequency range (13 - 35 hz). that approach, however, has important limitations. most importantly, beta power recorded from the dbs lead is suppressed by movement including pd tremor, its detection is highly dependent on lead location and the recording montage needed to record during stimulation is incompatible with directional current steering, a recent innovation employing segmented stimulation contacts. the inherent complexity of the increased parameter space through dbs innovations also overwhelms standard programming techniques. finally, use of additional biomarker signals (e.g., recorded from cortex) is likely to improve the ability to adaptively control dbs for disorders marked by complex multidimensional symptomatologies such as pd. the current proposal will establish methods for overcoming these limitations by developing techniques for multi-feature classification from ecog recordings, using advanced machine learning algorithms.

Eligibility criteria:
inclusion criteria: 1. subjects scheduled for dbs implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of parkinson's disease 2. subjects able to provide informed consent and comply with task instructions. 3. subjects 18-85 years old exclusion criteria: 1. non-english-speaking subjects
family support weaning from mechanical ventilation in cardiovascular surgery

Conditions: Patient Comfort; Anxiety; Patient Satisfaction

Summary: mechanical ventilation support is used to ensure airway clarity in patients after surgery.if patients are not informed about mechanical ventilation treatment in the pre -operation period, panic, anxiety and comfort may be experienced when they wake up from anesthesia and find them in intensive care under mechanical ventilation with various tubes and equipment. the separation from the mechanical ventilator (mv) covers the patient's mechanical support and the entire process of separation of endotrakeal tube.during the separation of the mechanical ventilator, the support of one of the patient members of the patient may increase the stress and comfort of the patient. therefore, this research is planned

intensive care nurses spend a long time with patients and observe them closely. intensive care nurses in the mv separation process; plays a special and important role. recently, family support has been used in patient care. an increase in anxiety and comfort levels is observed in patients receiving family support. this study was planned with the aim of supporting the patient by the family member during the separation of the patient from the mechanical ventilator after cardiac surgery and to evaluate the comfort and anxiety level of the patients.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * to agree to participate in the research verbally and in writing * to be over the age of 18 * knowing turkish * not having any psychiatric disease * no vision, hearing and perception problems * receiving mechanical ventilator support after cardiac surgery and being followed in the intensive care unit. exclusion criteria: * patients who do not meet the inclusion criteria * other patients receiving mechanical ventilator support after surgery in the intensive care unit other than cardiac surgery

Keywords: weaning patient satisfaction anxiety family support cardiac surgery