Kornimate/medical-research-clean huggingface dataset:
study to assess the effect of co-administration of azd9833 on the pharmacokinetics of midazolam, of omeprazole, of celecoxib and of dabigatran etexilate in healthy postmenopausal female volunteers

Conditions: Healthy Volunteers

Summary: this study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites

participants will be randomized to one of 3 treatment arms on day 1 prior to investigational medicinal product (imp) administration: * arm a: single oral doses of midazolam and omeprazole administered together + repeated doses of azd9833 . * arm b: single oral doses of dabigatran etexilate + single oral dose of azd9833 . * arm c: single oral doses of celecoxib + repeated oral doses of azd9833. each participant will be involved in the study for up to 7 to 8 weeks

Eligibility criteria:
inclusion criteria: * healthy postmenopausal female participants aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture. * participants must be postmenopausal by fulfilling the following criterion: * have a body mass index (bmi) between 19 and 35 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive as measured at screening. * must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin k antagonist anticoagulants) during study, and for 2 weeks after last administration of imp. exclusion criteria: * history of any clinically significant disease or disorder as described by the investigator. * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * use of systemic estrogen-containing hormone replacement therapy within 6 months prior to first dose in the study. * have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc.) within 14 days of beginning study treatment (ie, first administration of omeprazole in arm a. * have taken any drug with enzyme-inducing properties such as st john's wort within 3 weeks of screening. * presence of any contraindication to the probe substrates omeprazole, midazolam, dabigatran or celecoxib per the united states package insert. * any of the following signs or confirmation of covid-19 infection: * subject has a positive rt-pcr test for sars-cov-2 prior to randomization. * clinical signs and symptoms consistent with covid-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at randomization. * subject has been previously hospitalized with covid-19 infection within the last 12 months.

Keywords: drug-drug interaction midazolam omeprazole dabigatran etexilate celecoxib postmenopausal breast cancer
metabolic and therapeutic effects of american and korean red ginseng in the treatment of type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: the study is a 2 phase double blind randomized placebo control trial. the objective is to asses the metabolic and therapeutic effects of american ginseng (panax quinquefolius l.) extract and korean red ginseng (steamed panax c.a. meyer) extract in the management of type 2 diabetes in a 12 week period. one hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: hbalc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).


Eligibility criteria:
inclusion criteria: * presence of type 2 diabetes (at least 1 year) as defined by a1c between ≥6.5% and ≤8.1%, at recruitment, * treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8) * between the age of 40 and 75 years * systolic blood pressure \<140 and diastolic blood pressure \<90 * clinically euthyroid (measuring t3 and t4) * normal renal and liver functions * post-menopausal or non-pregnant women (post-menopausal includes: those females with more than a year of cessation of menstruation) * a negative result on a pregnancy test administered at screening * subjects taking an effective form of birth control (example: condom, abstinence, etc.) * willing to comply with the study protocol and sign a consent form exclusion criteria: * individuals with bleeding disorders * individuals with allergies to nitroglycerin * planned surgery, pregnancy or breastfeeding * taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/l * increased a1c level of more than 2% from baseline during the study * history of angina or heart attack * use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months * bmi \> 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods * smoke cigarettes; alcohol intake \> 2 drinks/day * the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study * subjects taking warfarin or coumadin, prescription nsaids, chronic use of high-dose (\>81mg) non-prescription nsaids, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.
reduced antithrombotic strategy for high bleeding risk patients with myocardial infarction

Conditions: Myocardial Infarction

Summary: rationale: heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. these drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. however, the newer drugs introduce a significant risk of serious bleeding. aim: the aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely. hypothesis: significantly reduced bleeding with a similar preventive effect are expected. design: the dan-dapt trial include high bleeding risk patients with heart attacks from danish hospitals (rigshospitalet, aarhus, odense, aalborg, roskilde, and gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.


Eligibility criteria:
inclusion criteria: 1. mi caused by atherothrombotic cad (type 1 mi) according to "the fourth universal definition of mi", which has been treated with pci with contemporary drug-eluting stents. this definition of type 1 mi requires the detection of a rise and/or fall of cardiac troponin values with at least one value \>99th percentile and at least one of the following criteria assessed by the treating physician: * symptoms indicating acute myocardial ischemia * new ischemic changes on the electrocardiogram * development of pathological q-waves * imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology * visible coronary thrombus by angiography 2. precise-dapt score ≥25 3. age ≥18 years exclusion criteria: 1. contraindications including allergies to asa or p2y12 inhibitors 2. indication for oral anticoagulation 3. previous stent thrombosis 4. life expectancy \<1 year 5. resuscitated cardiac arrest with glasgow coma scale \<8 and/or need of intubation 6. prior intracranial hemorrhage 7. active bleeding (barc ≥2) at randomization 8. women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception 9. hypertensive crisis (systolic blood pressure \>180 mmhg and/or diastolic blood pressure \>120 mmhg) 10. unable to understand and follow study-related instructions or to comply with study protocol

Keywords: high bleeding risk cyp2c19 genotyping dual antiplatelet therapy percutaneous coronary intervention
diagnostic values of urothelial carcinomas: single-bolus versus split-bolus computed tomography urography

Conditions: Urothelial Carcinoma

Summary: single-bolus computed tomography urography (ctu)is a recently developed one-stop imaging examination for diagnosis of urinary tract diseases, including urinary malignancies. however, single-bolus ctu uses two post- contrast phases (i.e.: nephrographic and excretory phases) for diagnosis of urinary tract diseases. a further-developed split-bolus ctu uses solitary post-contrast phase containing mixed information of nephrographic and excretory phases for diagnosis of urinary tract disease; however, whether split-bolus ctu has similar high diagnostic values for urinary malignancies remains unaddressed. thus, the aim of this study is to compare the diagnostic performance between single-bolus and split-bolus ctu for diagnosing urinary malignancies. this study will enroll 352 patients from two hospitals if they fit the including criteria including aged \> 40 years old, presenting with gross hematuria or having urinary malignancies histories, normal renal function (i.e.: estimated glomerular filtration rate \> 60 ml/min/1.73 m2, no allergic history to iodinated contrast medium and no pregnancy). all enrolled patients will be randomized to undergo split-bolus and single-bolus ctu in 1: 1 manner. two radiologists will read ctu images independently using a standardized recording sheet with likert scales 1-5 representing higher probabilities of presence of urinary malignancies for larger number). the diagnostic values of split-bolus and single-bolus ctu will analyzed using reference standards by final diagnoses of urinary malignancies (i.e.: presence of urinary malignancies based on histological examinations of cytology examinations, biopsies or surgical specimens). the diagnostic performance of split-bolus ctu and single- bolus ctu for urinary malignancies will be compared using areas under receiver operating curve (roc) to determine whether there is presence of significant difference .

this study will enroll 352 patients. the calculation of sample size is according to the following equation: n2=〖(z∝+zβ/2)〗\^2/〖(δ-\|ε\|)〗\^2 \[p1(1-p1)/k+p1(1-p2)\] ∝=0.05, β=0.2, δ=0.05, p1=0.96, p2=0.80 then, the number of each arm patient should be ≥ 141 patients. however, if 20 % of the enrolled patients by fitting inclusion criteria are excluded by fitting exclusion criteria, the number of each arem should be ≥ 176 patients. thus, this study plans to enroll 352 patients (for two arms). the enrolled patients are randomized to two groups (using single-bolus ctu versus using split-bolus ctu) using permuted block method.

Eligibility criteria:
inclusion criteria: fitting all of the followings 1. age ≥ 40 years old 2. presenting with gross hematuria or having a history of urothelial carcinomas 3. normal renal function (i.e.: estimated glomerular filtration rate ≧ 60 ml/min/1.73 m2) 4. no allergy history of iodinated contrast medium exclusion criteria: fitting any of the followings 1. pregnant or lactating woman 2. withdrawal of informed consent
a study of the bronchodilator effect of formoterol fumarate used in combination with mometasone furoate metered dose inhaler in children with persistent asthma (p06476 am2)

Conditions: Asthma

Summary: a study to compare the bronchodilatory effect of a single dose of mometasone furoate/formoterol fumarate (mf/f) pressurized metered dose inhaler (mdi) delivered with and without an aerochamber plus® with flow-vu® anti-static valved holding chamber (spacer) versus placebo mdi (combined with and without spacer) and formoterol fumarate (f) dry powder inhaler (dpi). participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. each treatment period was separated by a 5 to 7 day washout period. it assumed that a single dose mf/f mdi 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (fev1) area under the curve from 0 to 12 hours (auc\[0-12 hr\]) when compared to placebo.


Eligibility criteria:
inclusion criteria: * must have a diagnosis of asthma of at least 6 months duration * must have taken an inhaled corticosteroid (\[ics\]; alone or in combination with a long-acting beta-2 agonist \[laba\]) for at least 3 months prior to the screening visit and must have been on a stable daily dose for at least 2 weeks prior to the screening visit * fev1 must be at least 70% predicted after all restricted medications have been withheld for the appropriate intervals * must demonstrate an increase in absolute fev1 of at least 12% within 30 minutes after administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of nebulized albuterol (2.5 mg), if confirmed as standard office practice exclusion criteria: * has been treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalized for management of airway obstruction within 3 months prior to the screening visit * has required ventilator support for respiratory failure secondary to asthma * demonstrates a decrease in absolute fev1 of \>20% at any time from the screening visit up to and including the baseline visit * requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists (saba) mdi, or 2 or more nebulized treatments per day of 2.5 mg saba on any 2 consecutive days from the screening visit up to and including the baseline visit * experiences a clinical deterioration in asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing saba) as judged by the investigator, at any time from the screening visit up to and including the baseline visit

Keywords: asthma children persistent
effect of omega-3 fatty acids on the perioperative immune response and erythrocyte function

Conditions: Colon Cancer

Summary: ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. an exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. when omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. they modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. they also have a strong anti-inflammatory effect by mediating resolution of the inflammation. furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing. the investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.


Eligibility criteria:
inclusion criteria: * patients (male or female) undergoing elective laparoscopic surgery for colon cancer * age between 60 and 80 years * bmi between 20 kg/m2 and below 30 kg/m2 * written informed consent exclusion criteria: * participation in or having participated in another clinical trial within the previous 3 months * indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve * pre-operative hemoglobin\<5.0 mmol/l * metastatic disease * very poor peripheral venous access * current history of inflammatory or infectious disease * the use of anti-inflammatory drugs * the use of thyroid medication * the use of fish oil products or fish consumption more than 2 times a week * contra-indication for the use of omegaven-fresenius, including: * general contra-indications for parenteral nutrition * allergy to fish or egg protein.

Keywords: fish oil omega-3 fatty acids postoperative inflammatory response erythrocyte function
ghrelin in patients with a rare disease associated with intellectual disability, and hyperphagia, and/or overweight, and/or obesity

Conditions: Angelman Syndrome; Smith-Magenis Syndrome; X Fragile Syndrome; Epilepsy; Prader-Willi Syndrome

Summary: a significantly higher proportion of patients with rare diseases (rd) with intellectual disability (id), present hyperphagia, overweight or obesity, compared to the general population. prader-willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity. the aim of the study is to find out whether the levels of ghrelin, which are abnormally high in pws throughout life, are also high in these rd when people have hyperphagia and/or overweight.

a significantly higher proportion of patients with rare diseases (rd) with intellectual disability (id), present hyperphagia, overweight or obesity, compared to the general population. prader-willi syndrome (pws) and related syndromes (pws-like) represent the most well-known causes of eating disorders with early and severe obesity. other known rd with id have been described as being associated with eating disorders with overweight or obesity, which appear later in adolescence : angelman's syndrome (approximately 40% of patients are overweight or obese, and 32% of children have hyperphagia), fragile x syndrome (over 30% are obese), smith-magenis syndrome (50 to 60% are obese). prader-willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity. the aim of the study is to find out whether the levels of ghrelin, which are abnormally high in pws throughout life, are also high in these pathologies when people have hyperphagia and/or overweight. the study involves a single visit carried out during a routine follow-up in the crmr, in which the blood sample will allow the dosage of the ghrelin hormon. the visit will also involves a data collection and some questionnaires.

Eligibility criteria:
inclusion criteria: * patients with one of the following rare diseases associated with : angelman syndrome, smith-magenis syndrome, x fragile syndrome, rare diseases of the cerebellum, rare epilepsies, pw-like syndromes or other rare diseases with eating disorders * patients aged minimum 3 years and maximum 50 years. * patients with overweight (or obesity) and/or hyperphagic behavior. exclusion criteria: * administrative problems: impossibility of giving parents or legal guardians informed information ; no coverage by a social security scheme.
effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

Conditions: Lumbar Radiculopathy

Summary: purposes of the study to investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. patients will receive the intervention for six weeks. outcomes will be assessed at baseline and post-intervention.

Eligibility criteria:
inclusion criteria: * patient age ranges from 20 -45 * unilateral chronic lumbosacral radiculopathy * intervertebral disc herniation confirmed by mri * one of the following : 1. h- reflex amplitude side to side difference 0.67 in absence of latency difference. 2. h- reflex amplitude side to side difference smaller than 0.5 in p of latency difference. 3 - side to side h- reflex latency difference more than 1 msec. 4- prolonged h-reflex latency more than 30 msec. exclusion criteria: * systematic disease * lumbar canal stenosis * pervious surgeries * scoliosis * kyphosis * spinal fracture * bilateral symptoms * steroid injection
investigating immune escape by sars-cov-2 variants

Conditions: COVID-19; Immunity

Summary: the purpose of this protocol is to investigate the ability of pre-existing immunity by natural infection or vaccination to prevent infections by emerging sars-cov-2 variants.

several variants of the sars-cov-2 virus were identified in 2020 including the united kingdom variant (known as 20i/501y.v1, voc 202012/01, or b.1.1.7), south africa variant (known as 20h/501y.v2 or b.1.35), and brazil variant (known as p.1), with more variants still being discovered. there is concern that these variants, due to mutations in spike protein and receptor-binding domain of the spike protein, can be more infectious, lethal, and potentially escape the immune responses from vaccination or prior infection. research is needed to understand the risks associated with currently known variants of sars-cov-2 as well as investigate if there is potential for new mutations to form that would allow sars-cov-2 variants to partially or entirely escape the immune mechanisms developed from vaccination and/or prior infection from the wild-type strain of sars-cov-2.

Eligibility criteria:
inclusion criteria: * people who have been fully vaccinated for covid-19 2-12 weeks prior to enrollment or individuals \<3 months post-covid-19 infection. * collection of samples for blood samples will be done only from healthy, nonpregnant adults who weigh at least 110 pounds. * participants must be able to provide informed consent. exclusion criteria: -subjects considered vulnerable including children, pregnant women, nursing home residents, or other institutionalized persons, fetuses, prisoners, and persons without decisional capacity.
fluid responsiveness in post-cardiac surgery

Conditions: Fluid Overload; Cardiac Surgery; Postoperative Complications

Summary: the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (ppv) and stroke volume (sv) variation. furthermore, passive leg raising (plr), end-expiratory occlusion test, and tidal volume challenge test, "mini"-fluid challenge are currently available to assess fluid responsiveness.

Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation * patients ≥18 years of age * patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery) * patients with normal systolic function of the left and right ventricle * patient is mechanically ventilated with a protective lung strategy exclusion criteria: * patients with spontaneously breathing activity * patients undergoing emergent cardiac surgery. * patient with severe peripheral arterial occlusive disease * pregnant women * contraindication of passive leg raising test * unstable post-operative course * post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications; * presence of residual severe tricuspid or any valvular regurgitations * low cardiac output, low ejection fractions (ef ≤45%) * open chest,pao2/fio2 ≤ 200