Kornimate/medical-research-clean huggingface dataset:
blood lactate level for pre-hospital orientation of septic shock

Conditions: Sepsis; Lactate Blood Increase

Summary: in the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. as clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (icu) or in the emergency department (ed). point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making. the aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.

this trial is a prospective, observational, non-randomized controlled study. a total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ed or icu admission. in the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.

Eligibility criteria:
inclusion criteria: * age \> 18 years either sex * severe sepsis according to the french anesthesiology and intensive care society (sfar) and intensive care society (srlf) conference 2005 defined by the existence of an infectious disease and at least one the following: * low blood pressure prior to volume expansion * glasgow coma scale \< 13 * skin mottling score \> 2 * septic shock according to the french anesthesiology and intensive care society (sfar) and intensive care society (srlf) conference 2005 definition exclusion criteria: * age \< 18 years * pregnancy * serious comorbid conditions with a not to be reanimated status known since pre-hospital setting * patients with guardianship or curator

Keywords: sepsis lactate prehospital prediction mortality
cortisol secretion, sensitivity and activity and hypertension

Conditions: Hypercortisolism; Arterial Hypertension

Summary: the goal of this observational study is to evaluate, between patients with arterial hypertension and non hypertensive control group, * the prevalence of hidden hypercortisolism * the relationship between organ damage and oxidative stress level, cortisol secretion degree, sensitivity and peripheral activity


Eligibility criteria:
inclusion criteria: * hypertension group: arterial hypertension * no hypertension group: absence of arterial hypertension exclusion criteria: * body mass index (bmi) \>30 kg/m2 * active smoking (\>20 cigarettes/day) * pregnancy/lactation * hypertension associated with family history of hypertension and cerebrovascular events before 40 years of age * sleep apnea * hypertension appearance in pre-pubertal age * hypokalemia * hypertension in the setting of an incidental adrenal mass * classic signs and symptoms of hypercortisolism (lunar facies, striae, hypertrichosis, skin atrophy, hump) * proven endocrine hypertension (pheochromocytoma, hyperaldosteronism, hyperparathyroidism, acromegaly, hyperthyroidism) * renovascular hypertension * diseases or conditions associated with increased activity of the hypothalamic-pituitary- adrenal axis and/or oxidative stress, such as type 2 diabetes, rheumatoid arthritis, severe rheumatic/autoimmune diseases, severe hematological diseases, alcoholism, depressive syndrome, chronic renal failure (gfr \<45 ml/min), severe hypovitaminosis d (25ohvitamind \<10 ng/dl) * therapies that interfere with the activity of the hpa axis (i.e. glucocorticoids, antidepressants).

Keywords: hypertension hidden hypercortisolism hypercortisolism cortisol sensitivity
the feasibility of using the pulsepoint to facilitate overdose education and naloxone distribution

Conditions: Carrying Naloxone/Narcan on Their Person or in Their Vehicle; Being Trained to Respond to an Opioid Overdose

Summary: this study is a feasibility trial to assess whether, in a random sample of 180 agencies where pulsepoint is already active, revised procedures (hereinafter pulsepoint-od) to facilitate opioid overdose and naloxone distribution (oend) can successfully recruit first responder agencies and layperson responders. for this study, agency refers to a single implementation site where pulsepoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with pulsepoint. the study will test the following hypotheses: h1: more first responder agencies will be successfully recruited by arm 2 than by arm 1. h2: more layperson responders will report engaging with oend programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 \[only this hypothesis is covered by the irb, hypothesis 1 is not human subjects research\].

a full, detailed description of the study protocol and preregistered procedures is located in our formal protocol paper (https://doi.org/10.2196/57280) which is also cited at the end of this specific registration. all specific language throughout this document is derived directly (verbatim) from the protocol paper, which is our controlling, planned preregistration document for this project.

Eligibility criteria:
layperson responders who are part of the pulsepoint system register with a local first responder agency using their smartphone. anyone who is registered with a pulsepoint agency randomly selected for this project is included. most layperson responders (eg, those who are not also off-duty first responders themselves) are only alerted to incidents in public spaces. no identifying information is collected from these users except the unique id of the device.
high-sensitivity troponin t plasma levels in patients with aortic stenosis (tyrolean aortic stenosis study-2)

Conditions: Aortic Stenosis; Heart Failure; Syncope; Angina Pectoris

Summary: tass-2 (tyrolean aortic stenosis study-2) aims to characterize the clinical value of minimally elevated troponin t plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.

development of symptoms such as heart failure, syncope or angina pectoris is the well-established indication for valve operation in patients with severe aortic stenosis. however, many patients tend to misinterpretate or even ignore symptom onset, and irreversible myocardial dysfunction may occur. measurement of aortic valve area by transthoracic echocardiography using the continuity equation is prone to methological mistakes, whereas transvalvular gradients are usually easy to quantify but may underestimate hemodynamic effects in the presence of low flow (stroke volume index below 35 ml/m2). all these shortcomings in clinical routine may be overcome by objectively and easily assessable parameters indicating advanced aortic stenosis. severe aortic valve calcification is such a risk factor for worse prognosis. however, assessment of valve calcification by echocardiography is a subjective measurement and highly operator-dependent. quantification of valve calcification by multi detector computed tomography is limited by exposure to radiation, availibilty and cost. a laboratory parameter already used in clinical routine would fullfill the requirements for such a risk stratification much better. natriuretic peptides may be of interest in this context, but their plasma levels are strongly influenced by age, sex, concomitant arterial hypertension and/or renal dysfunction and volume status. recently, high-sensitivity troponin plasma levels have been suggested to indicate ongoing myocardial fibrosis in aortic stenosis. a small study with 60 patients suggested that hs-tnt predicte the operative outcome of as. we therefore set out to characterize the clinical value of minimally elevated troponin t plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.

Eligibility criteria:
inclusion criteria: * aortic stenosis detected by echocardiography / invasively exclusion criteria: * acute coronary syndrome * endocarditis
long-versus short-axis ultrasound guidance for subclavian vein cannulation

Conditions: Vascular Access Complication; Perioperative/Postoperative Complications

Summary: central venous catheterization is commonly applied in patients undergoing cardiac surgery. the subclavian vein has lower risk of infection and provides more patients comfort. however central venous catheterization may results in complications such as pneumothorax, hemothorax or arterial puncture. it has been suggested that ultrasound (us) guidance could improve the success rate, reduce the number of needle passes and decrease complications. two different real-time 2-dimensional us techniques can be employed in the insertion of central venous catheters. the first technique involves real-time us-guided cannulation of subclavian vein using a long axis/in-plane approach. the second one involves real-time us-guided using a short axis/out-off-plane approach. however to date no studies have compared their efficacy and safety. the purpose of this study was to compare the us-guided long-axis versus short-axis approach for the scv catheterization in adult critical care patients.

the two techniques used for vessel visualization are far different: the short-axis (sa) approach attempts to view the vessel in cross-section while venous access is obtained. the strength of the sa approach is that the vein is centered under the transducer and that the midpoint of the transducer becomes a reference point for the insertion of the needle, and that at the same time is possible to visualize sc artery and the pleural line. sa approach is easy to learn by novice sonologists. the long-axis (la) approach employs a technique that views the length of the vessel during cannulation.for this reason, with la approach is possible to visualize the needle advance during the entire procedure from the soft tissues until the lumen of the vein, but sc artery and pleural line are not visualized in the same scan. for la approach, practice is required to keep the needle precisely within the image and care must be taken to avoid the probe inadvertently moving away from the target structure.

Eligibility criteria:
inclusion criteria: * aged =\>18 years * patients who needed central venous catheter for clinical reasons exclusion criteria: * aged \<18a years

Keywords: central venous access ultrasonography subclavian vein pneumothorax vessel view
ondansetron effect on pain relief after laparoscopic cholecystectomy

Conditions: Cholecystitis

Summary: laparoscopic cholecystectomy (lc) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. however, patients who have undergone lc still complain of postoperative pain. it has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. it possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-ht3 receptor antagonist, a na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. the study aimed to demonstrate the effectiveness of ip administration of ondansetron on pain management post lc.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo elective lc exclusion criteria: * patients undergoing chronic pain treatment * previous allergic response to local anesthetics or 5-ht3 receptor antagonists * patients who received analgesics or sedatives 24 h before scheduled surgery
ublituximab in combination with tgr-1202 +/- ibrutinib or bendamustine in patients with b-cell malignancies

Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of ublituximab in combination with tgr-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies


Eligibility criteria:
inclusion criteria: * confirmed b-cell non-hodgkin lymphoma (nhl), chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll), and other b-cell lymphoproliferative disorders as approved by the medical monitor or study chair * refractory to or relapsed after at least 1 prior treatment regimen * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * known hepatitis b virus, hepatitis c virus or hiv infection * autologous hematologic stem cell transplant within 3 months of study entry or allogeneic hematologic stem cell transplant within 12 months * primary central nervous system lymphoma or known intracranial involvement
effect of follicle flushing on oocyte fertilization rate

Conditions: Infertility

Summary: the purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing ivf treatment

this will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing ivf treatment. oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from: group i= egg retrieved in the follicular fluid of the first aspirate (no flushing) group ii= egg retrieved in the 1st-2nd flush group iii= egg retrieved in the 3rd-5th flush development and utilization. pregnancy rates will be reported as a surrogate outcome.

Eligibility criteria:
inclusion criteria: * up to 40 years old * both ovaries present * triggering final oocyte maturation using hcg or gnrh agonist exclusion criteria: * egg donation * pgd cases
study of dietary additive phosphorus on proteinuria and fibroblast growth factor-23

Conditions: Albuminuria

Summary: phosphorus-based food additives are commonly used by food manufacturers for many applications, such as enhancing flavor, in ready-to-eat foods and beverages. while these additives can significantly increase an individual's daily phosphorus intake, little is known about the effect of dietary phosphorus on kidney health. in this study, the investigators will first lower baseline phosphorus intake to about 1000mg/d by educating participants to avoid foods with phosphorus additives. then, participants will be randomized to a higher phosphorus period (\~2gm/d) and a lower phosphorus period (\~1gm/d) by providing unaltered, commercially-available food/beverage products with and without phosphorus additives. the investigators hypothesize that participants will have higher urine albumin excretion and fibroblast growth factor-23 (fgf-23) during the higher phosphorus period compared to the lower phosphorus period.

the study of dietary additive phosphorus on proteinuria and fgf-23 (soda-pop) was a single-center, randomized, double-blind, two-period cross-over study that examined the effect of higher vs. lower phosphorus intake for 3 week periods, achieved by addition of commercially available diet beverages and breakfast bars to diet on albuminuria and fibroblast growth factor 23, in adults with presumed early chronic kidney disease (estimated glomerular filtration rate \>= 45 ml/min/1.73m2; and urine albumin/creatinine ratio \>=17 mg/g for men or \>=25 mg/g for women).

Eligibility criteria:
inclusion criteria: adults at least 21 years of age with at least microalbuminuria exclusion criteria: estimated glomerular filtration rate \<45ml/min/1.73m2, poorly controlled diabetes or hypertension, nephrotic syndrome, hyperparathyroidism, paget's disease, multiple myeloma, uncontrolled thyroid disease, chronic antacid use, use of phosphorus binders, phosphorus supplements, or high-dose vitamin d, inability to complete feeding study, investigator discretion

Keywords: proteinuria
developing the probability algorithm for pulmonary hypertension echocardiography

Conditions: Pulmonary Hypertension

Summary: the goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (rv) function in echocardiography, and ecg have in detecting pulmonary hypertension. the main questions it aims to answer are: can novel markers in ecg and echocardiography suggest the presence of ph? can existing screening guidelines be improved with the addition of these markers?

pulmonary hypertension (ph) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. it can cause severe breathlessness and failure of the right side of the heart. sadly it is often fatal. ph can be caused by a number of different conditions and life expectancy varies with the underlying cause, ranging from months to years. for some subtypes of ph, effective treatments exist which can significantly improve life expectancy and quality of life. accurate tools for the assessment of ph are therefore essential, so that we can better understand and predict life expectancy and so that life-saving medications can be started earlier. once doctors suspect that somebody has ph, they refer them to a specialist ph centre for assessment and a procedure called right heart catheterisation (rhc), which will confirm the diagnosis. however, evidence for the suspicion of ph is frequently overlooked, leading to an average delay to diagnosis from onset of symptoms of two years. this late presentation negatively impacts survival for these patients and prevents them promptly starting the effective treatments which are available. an electrocardiogram (ecg) is a recording of the heart's electrical signals, printed in waveforms. it is a painless, low-cost, and readily-available test used in ph assessment. echocardiography (echo) is a quick, safe and well-tolerated test often requested to investigate breathless patients and can provide useful information about the suspicion of ph. echo has however been shown to lack accuracy in milder forms of the disease. it has been hypothesised that subtle markers of right ventricular function by echo, such as free wall strain (rvfws) begin to deteriorate before the more established findings. a large, cross-population study of ecg features and echo markers such as rvfws both in isolation and in combination, in patients referred for ph assessment may help identify these markers, and improve detection of the disease.

Eligibility criteria:
inclusion criteria: * patients 18+ who have undergone tte, ecg and rhc as part of their clinical care exclusion criteria: * patients \<18 years old * known or suspected congenital heart disease * patient has opted-out of allowing their data to be used for research and planning (via the national data opt-out choice in england, or equivalent data protection scheme in scotland)
biomarkers in vascular ehlers-danlos syndrome

Conditions: Vascular Ehlers-Danlos Syndrome

Summary: the purpose of this study is to determine whether patients with vascular ehlers-danlos syndrome present significant and specific changes of arterial endothelial and smooth muscular cell signalling/secretion, in comparison to matched healthy volunteers and patients with spontaneous arterial dissections.

vascular ehlers-danlos syndrome is a rare inherited disease which confers exceptional organ fragility in seamingly healthy young adults. the disease is caused by a mutation in the col3a1 gene encoding type iii collagen, critical to ensure physical resistance to mechanical stress of hollow organs. the disease results in increased tissular fragility, responsible of spontaneous arterial ruptures and dissections and spontaneous bowel perforations. the life-expectancy of patients with vascular ehlers-danlos syndrome is reduced by these recurring accidents. the exact mechanisms that trigger arterial accidents are unknown. recent findings suggest a possible deleterious effect of inflammation and a possible dysregulation of the tgf-beta pathway. thus, the purpose of this study is to identify further alterations in vascular endothelial and smooth muscular cell signalling/secretion, and to confirm previously suggested mechanisms of arterial accidents in veds patients.

Eligibility criteria:
inclusion criteria: * patients with vascular ehlers-danlos syndrome must have been positively tested for a pathogenic mutation within the col3a1 gene. * in patients with arterial dissection(s) any associated systemic arterial disease must have been ruled out, especially vascular ehers-danlos syndrome exclusion criteria: -all subjects must not present any chronic systemic disease, any acute disease within seven days prior to enrollment, diabetes mellitus and arterial hypertension.

Keywords: biomarkers ehlers-danlos syndrome, vascular type pathophysiology
the efficacy and safety of scta01 in hospitalized patients with severe covid-19

Conditions: Covid19

Summary: the study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled phase ii/iii trial, and will be conducted globally. the study is comprised of two parts: dose selection (phase ii) and pivotal treatment effect (phase iii).

in this study, phase ii part will evaluate the efficacy, safety and pk of scta01 low dose+bsc, high dose+bsc and placebo+bsc in patients with severe covid-19. in phase ii part, subjects will be randomized at 1:1:1 ratio. at the end of phase ii part, a dose for the phase iii will be determined. the phase iii part will evaluate the efficacy, safety, and immunogenicity of scta01 at the recommended dose recommended. subjects in phase iii part will be randomized at 1:1 ratio to scta01+bsc and placebo+bsc groups.

Eligibility criteria:
inclusion criteria: * hospitalized patients with severe covid-19 (5 point on nih 8-point ordinal scale). * male or female adult ≥18 years of age at time of enrollment; * biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as sars-cov-2 infection (pcr or antigen-based diagnostic tests); * ≤ 10 days since symptoms of covid-19 onset. exclusion criteria: * patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale); * patients with critical covid-19; * patients with severe covid-19 who received convalescent plasma or covid-19 vaccine, or anti-sars-cov-2 spike (s) protein targeted therapy; * alanine-amino transferase (alt) or aspartate transaminase (ast) is 5 times higher than the upper limit of the normal value; * estimated glomerular filtration rate (egfr) \<30 ml/min or on dialysis {egfr calculated by cockcroft-gault formula (cockcroft dw, 1976), male: crcl (ml/min) = \[(140 - age) × weight (kg)\] × 1/ \[scr (mg/dl) × 72\]; female: crcl (ml/min) = \[(140 - age) × weight (kg)\] × 0.85/ \[scr (mg/dl) × 72\]}.
gycabiane and glycemic control of prediabetic subjects

Conditions: Hyperglycemia

Summary: the purpose of this study is to examine the effects of supplementation glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

cinnamon's effects on blood glucose have been the subject of many clinical and animal studies; however, the issue of cinnamon intake's effect on fasting blood glucose (fbg) in people with prediabetes still remains unclear. the main purpose of this study is to examine the effects of supplementation with glycabiane, a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight prediabetic subjects in a randomized, placebo-controlled, clinical trial.

Eligibility criteria:
inclusion criteria: * male or female from 25 to 65 years old * 1.0g/l ≤ fast blood glucose \< 1.26g/l * overweight (imc \> 25) exclusion criteria: * thyroid disease * hypogonadism * history of musculoskeletal, autoimmune or neurological disease * treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant * pregnant or lactating women

Keywords: cinnamon chromium prediabete overweight