Kornimate/medical-research-clean huggingface dataset:
testosterone regulation of the natriuretic peptide system

Conditions: Hypertension

Summary: the proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. the hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. the entire protocol is 8 weeks in duration.


Eligibility criteria:
inclusion criteria: * men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and bmi between 18.5 and 25. * women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, bmi between 18.5 and 25. exclusion criteria: * antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.

Keywords: natriuretic peptide
b-type natriuretic peptide (bnp) in human hypertension

Conditions: Hypertension Stage 1

Summary: the investigators working hypothesis is that human hypertension is in part due to a derangement in the endocrine function of the heart - a primary or secondary mechanism - resulting in a relative deficiency of the natriuretic peptides (np). the remodeled hypertensive heart could result in altered processing and degradation of b-type np resulting in altered molecular forms with decreased biological activity. the investigators further hypothesized the chronic administration of bnp in subjects with hypertension, is feasible, safe and will induce a sustained reduction in blood pressure.

ongoing investigations by our laboratory group and others have established that the heart is an endocrine organ as well as a pump. the heart synthesizes and secretes two peptide hormones - atrial natriuretic peptide (anp) and b-type natriuretic peptide (bnp) - that are endogenous ligands for a particulate guanylyl cyclase receptor (npr-a). following receptor binding and generation of its second messenger cgmp, the natriuretic peptides (nps) mediate biological actions which include natriuresis, inhibition of the renin-angiotensin system and vasodilatation with local autocrine and paracrine actions in the heart to include inhibition of fibrosis and enhancement of diastolic function. hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction and heart failure. its myocardial complications result from increased mechanical load on the heart. under physiological conditions of increased myocardial load and resulting myocardial stretch, anp and bnp synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * subjects with stage 1 hypertension (sbp: 140-159 mm hg or dbp 90-99 mm hg) if on therapy, it must be stable for at least 1 month. exclusion criteria: * congestive heart failure (any nyha class). * ef \< 50%. * myocardial infarction within 3 months of screening. * unstable angina within 14 days of screening, or any evidence of myocardial ischemia. * moderate to severe pulmonary hypertension. * valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis. * sustained vt or v-fib within 14 days of screening. * sustained atrial fibrillation. * second or third degree av block without a permanent cardiac pacemaker. * cva within 3 months of screening, or other evidence of significantly compromised cns perfusion. * total bilirubin of \>1.5 mg/dl or ast and alt 1.5 times the upper limit of normal range. * renal insufficiency assessed by calculated gfr \< 60 ml/min (cockroft-gault equation). * serum sodium of \ 160 meq/dl. * serum potassium of \ 5.0 meq/dl. * women taking hormonal contraceptives. * body mass index (bmi) \> 35.

Keywords: hypertension treatment
intracerebral electrical stimulation and the optimisation of presurgical planning in drug-refractory partial epilepsy

Conditions: Epilepsy

Summary: patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. during this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. this study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. during this procedure, direct brain electrical stimulations is a standard clinical practice to assess seizure sensitivity and for functional mapping. however the efficiency of these stimulations can be questioned and could potentially be improved. indeed, only two typical frequencies are commonly used in our epilepsy centre, 1hz and 50hz, without clear clinical or scientific justification for these specific frequencies. this study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies could improve the definition of the seizure onset zone and hence the presurgical planning. we will maintain the usual stimulation frequencies (standard clinical stimulations condition) and add new frequencies to the protocol (research stimulations condition). the choice of these new frequencies will be based either on the spontaneous frequency of the onset of the patients' typical seizures or on physiological frequencies depending on the brain structures stimulated (i.e., theta in the medial temporal lobe). the protocol will be proposed to all patients undergoing a stereo-electro-encephalography (seeg) in our epilepsy center and the efficiency of the two conditions (standard clinical stimulations condition vs research stimulations condition) will be compared. the efficiency will be assessed as any epileptic event, recorded in the intracerebral eeg or symptom induced by the stimulations. this project will last 36 months. 20 patients will be included.

Eligibility criteria:
inclusion criteria: * all patients undergoing a stereo-electro-encephalography (seeg), age 12 to 65 years old. exclusion criteria: * usual excluding criteria for a seeg.

Keywords: epilepsy electrical brain stimulation neurosurgery stereo-electro-encephalography (seeg)
def-314 better accuracy in ejection fraction (ef) assessment with definity

Conditions: Cardiac Disease

Summary: this is a phase 3, prospective, open-label, multicenter study to evaluate left ventricular ejection fraction (lvef) measurement accuracy and reproducibility of definity® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (cmr) used as the truth standard.


Eligibility criteria:
inclusion criteria: 1. men and women ≥ 18 years of age in sinus rhythm 2. able to communicate effectively with trial personnel 3. has undergone a 2d echo with or without contrast obtained within 6 months prior to enrollment (day 0) 4. has provided signed informed consent after receiving a verbal and written explanation of this clinical trial - exclusion criteria: 1. female subjects who are pregnant or lactating. all women of child bearing potential \[wocbp\] must have a negative urine pregnancy test at screening regardless of contraceptive use history. 2. women of child-bearing potential are excluded unless they: 1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, or 2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or 3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to definity® dose administration and be willing to continue using the same method for the duration of the study. 3. current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient. 4. uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmhg or diastolic blood pressure ≥ 110 mmhg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmhg). 5. unstable cardiovascular status defined as: 1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/definity® dose administration day 2. transient ischemic attack or stroke within 3 months prior to definity® dose administration 3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease 4. clinically significant congenital heart defects 5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise 6. acute pulmonary embolus or pulmonary infarction 7. acute myocarditis or pericarditis 8. acute aortic dissection 9. atrial fibrillation 6. any major surgery within 4 weeks prior to screening 7. known contraindications to undergoing cmr or claustrophobia 8. participation in any investigational drug, device, or placebo study within 30 days prior to screening 9. known hypersensitivity to perflutren, or any of the excipients in definity® 10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -

Keywords: left ventricular ejection fraction definity enhanced echocardiogram cardiac magnetic resonance
lifestyle intervention in obese arab women

Conditions: Metabolic Syndrome; Diabetes

Summary: the study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic arab women

200 obese non-diabetic arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (ncep-iii criteria) will be randomized to either conventional or intensive treatment. the intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). the targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. duration of the intervention: 12 month.

Eligibility criteria:
inclusion criteria: * obesity (bmi: 30-40 kg/squared meter) * female gender * being 35-54 years old exclusion criteria: * diabetic a contraindication for physical activity

Keywords: obesity women arab metabolic syndrome lifestyle intervention quality of life
fasting versus non-fasting on outcomes and satisfaction prior to cardiac catheterization

Conditions: Heart Diseases

Summary: moderate sedation is used in the catheterization laboratory relieve the anxiety and discomfort associated with access and other aspects of the procedure. whether being in a fasting state (nothing per os, npo) at the time of the procedure is beneficial or harmful is not well known, but patients are typically required to be fasting at the time of elective procedures, guidance derived from procedures that require general anesthesia. whereas the typical thinking was that fasting prior to procedures would minimize the risk of aspiration in the event of intubation, or nausea and other symptoms generally, several studies have shown that prolonged fasting prior to procedures is associated with increased nausea, vomiting, aspiration and procedure recovery time. we aim to evaluate patient satisfaction, nausea and immediate outcomes of patients who are not kept npo prior to cardiac catheterization.


Eligibility criteria:
inclusion criteria: * \>18 years of age * requiring a cardiac catheterization as per standard of care * elective procedure with planned moderate sedation exclusion criteria: * bmi \>45 * all emergent procedures * all mechanical circulatory support-assisted procedures * other high risk procedures (as identified by the operator) * pregnant women * hemodynamically unstable patients * active gi illness, including nausea at the time of screening * taking chronic pain medications at home or on current brief course of narcotics * dementia * encephalopathy * patients scheduled for deep sedation * severe gerd (if the patient requires more than one medication for adequate control of gerd symptoms or has required medical intervention within the past year)
hypertension dash diet and salt free diet

Conditions: Hypertension; Nutritional Status; Diet, Healthy; Blood Pressure; Salt; Deficit (or Low)

Summary: background: in the management of hypertension lifestyle changes are recommended along with pharmacological treatment. aims: this randomized controlled intervention study aimed to compare the effects of a dietary approaches to stop hypertension (dash) diet and a salt-free diet on blood pressure in hypertension patients. methods: this study was conducted with 60 patients with primary hypertension. one group (n=30) was given an individualized dash diet, the other group was given a salt-free diet (n=30), and the participants were followed for two months. the patients' blood pressures were monitored daily throughout the study, and their biochemical parameters were monitored at the beginning of the study, in the first and second months.

this study, which was planned as a randomized controlled intervention study, was conducted to compare the effects of the dietary approaches to stop hypertension (dash) and salt-free diet on blood pressure in patients with hypertension. the study was complited with the participation of 60 hypertensive individuals (46 females, 14 males) who applied to between july 2019 and march 2020. patients with hypertension who were living in kayseri province, at least elementary school graduate, in the 20-65 age group, able to communicate with the researcher face to face and by phone, diagnosed with hypertension at least 4 weeks ago, and whose medication did not change were included in the study. one group (n = 30) received the dash diet and the other group received a salt-free diet (n = 30) and was followed for 2 months. research data was repeated during application with the face-to-face interview method. research data was collected through a questionnaire containing questions about the sociodemographic characteristics, nutritional habits, chronic diseases, and medications of the individuals. anthropometric measurements of the patients were made and blood and urine samples were taken. food consumption frequency was noted, dash diet compliance scale and international physical activity questionnaire (ipaq) short form were applied.

Eligibility criteria:
inclusion criteria: * hypertension at least four weeks prior and had not changed their drug regimen in the previous four weeks * 20-65 age group * at least primary school graduate * able to express himself verbally * volunteer to participate in the dietary intervention * able to communicate with the researcher face to face and by phone exclusion criteria: * those with chronic diseases other than cardiovascular diseases (such as type ii diabetes, kidney disease, cancer disease) * using alcohol or smoking
changes in attention level due to isometric exercises and level three progression eccentric movements

Conditions: Therapy, Exercise

Summary: determine the changes in attention level due to isometric exercises and level three progression eccentric movements. the attention level will be measured using a mental speed test (how quickly a subject can process information and make decisions based upon that information). another outcome measure will be the ability of the subject to maintain balance

on day 1, subjects will complete the mental speed test and will undergo cdp testing using the modified clinical testing of sensory integration in balance (mctsib) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. these will constitute the baseline information. subjects will be divided into two groups: a isometric group (performing the isometric exercises) and an eccentric group (performing the eccentric exercises). at the end of day 1, the isometric group will perform the isometric exercises while the eccentric group will act as control (no exercise). on day 2, subjects will complete the mental speed test and will undergo the cdp testing a second time. these will constitute the first follow-up information. at the end of day 2, the eccentric group will perform the eccentric exercises while the isometric group will act as control (no exercise). throughout day 3, subjects will complete the mental speed test and undergo the cdp testing a third time. this will constitute the second and last follow-up information.

Eligibility criteria:
inclusion criteria: * healthy individuals exclusion criteria: * any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)

Keywords: balance, postural postural equilibrium mental speed isometric exercise eccentric exercise
evaluation of the potential impact of an artificial intelligence solution in second reading of organized screening.

Conditions: Breast Cancer Female

Summary: based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. the main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an ai system (here the mammoscreen™ system).

this is a retrospective multicenter study of mammography imaging data contained in the pacs (picture archiving and communication system) of six radiology centers located in the rhône, puy de dôme, cantal and haute-loire départements. in order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. more recent mammograms will be excluded.

Eligibility criteria:
inclusion criteria: * women aged 50 to 74 participating in the organized screening campaign. * having had a screening mammogram with a final l1 result of "normal" (acr 1/ bi-rads 1) or "benign" (acr 2/ bi-rads 2). * for which a second reading interpretation is available * screening mammograms performed during the years 2015 to2019 (in order to have follow-up data (subsequent mammogram or information on the person's future) exclusion criteria: - mammography not performed as part of organized screening
acute glycemic effects of crackers made by different flours

Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Summary: this study investigated the acute effects of cracker consumption made by different flours on glycemic responses.

this study aimed to determine the glycemic index and glycemic load of crackers made by different flours (wheat, whole wheat, and 30% sunflower seed flour substitution) and to investigate the effects of these types of crackers on postprandial glycemic responses in healthy humans. moreover, blood pressure levels and subjective appetite were evaluated.

Eligibility criteria:
inclusion criteria: * healthy * non-smoking * non-diabetic men and women * body mass index between 18 and 25 kg/m2 exclusion criteria: * severe chronic diseases (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions) * gastrointestinal disorders * pregnancy * lactation * competitive sports * alcohol abuse * drug dependency

Keywords: blood glucose crackers glycemic index glycemic load
brown seaweeds effect on glucose tolerance and appetite response

Conditions: High Blood Glucose

Summary: the project is a randomized, 3-way, blinded crossover trial in which 20 healthy, fasted participants consume meals with 30 g of a linear corn starch and 5 g of one of the seaweeds, laminara digitata or undaria pinnatifida or a pea protein control. the primary aim is to investigate whether the brown seaweeds affect the postprandial glucose area under the curve (auc). stomach emptying, insulin, c-peptide, appetite-regulating hormones (oxyntomodulin, glucagon, glp-1 and pyy), and specific metabolites from the seaweeds in the urine and plasma as well as subjective satiety are also analyzed.

brown seaweeds may contain bioactive compounds as they contain secondary plant metabolites, including flavonoids and other phenolic compounds as well as carotenoids. dietary fibre is the major component of brown seaweeds, mainly composed from laminarans, alginates, fucans and cellulose. several dietary fibers and secondary plant metabolites have been shown to have an impact on health and more specifically on glycemic control. therefore, the aim of this study was to investigate whether two selected brown seaweeds have an effect on the postprandial glucose response to a starch load as well as several secondary measures, including appetite responses. in a controlled crossover trial, 20 healthy fasted participants consumed 5 g of either laminaria digitata (ld) or undaria pinnatifida (up) or 1 g of pea protein (ctr). the volunteers concomitantly ingested 200 ml of a drink with corn starch. blood samples were drawn at baseline, as well as 20, 40, 60, 90, 120 and 180 min after the meal. differences in glucose, insulin, c-peptide, plasma incretin concentrations, and insulin sensitivity index (isi) were analyzed and appetite was scored by a visual analogue scale and a subsequent ad libitum test meal.

Eligibility criteria:
inclusion criteria: bmi 20-25 kg/m2. waist circumference \< 102 cm. non-smoking. like (can tolerate) seaweed, pasta, meat sauce as these foods are part of the test meal. can tolerate paracetamol (pinex, actavis, denmark). exclusion criteria: systemic infections, psychiatric or metabolic diseases, and any clinical condition, chronic or frequent use of medication (including blood thinners, excluding contraceptives), smoking (throughout the trial and 12 months before the start of the experiment), blood donations during or in the month leading up to the study period, elite athletes (\> 10 hours of hard exercise / week, self-reported), high intake of alcohol (defined as a weekly intake of \> 7 units for women and \> 14 units for men), have or have had a drug addiction, participation in other scientific studies during the study period, lactating, pregnancy or ongoing planning of pregnancy, and vegetarianism or veganism.

Keywords: seaweed insulin glucose tolerance c-peptide appetide metabolomics