Kornimate/medical-research-clean huggingface dataset:
hypersensitive troponin performance to identify syncope at risk of serious adverse events in the short term

Conditions: Syncope

Summary: syncope, a frequent reason for emergency room visits and hospitalization, is a symptom of three major etiological entities: cardiac causes, vaso-reflex causes and orthostatic hypotension. the etiological diagnosis is often uncertain and the prognostic assessment orients the outcome of the patient. the vast majority of syncope management costs are related to hospitalizations. hospitalization in the immediate aftermath of emergency care is justified by a short-term prognosis. the current relevance of hospitalizations and the prognostic assessment of syncope is questioned.

the improvement of cardiac troponin assay techniques has increased its sensitivity to detect myocardial ischemic conditions, even at the expense of a loss of specificity. myocardial infarction type 2 is due to an imbalance between needs and oxygen supply to cardiomyocytes at the time of an increase of the first and / or a decrease of the second and is favored by an underlying cardiovascular field fragile. syncope, because of the low flow that they imply, can be the cause of a type ii myocardial infarction on fragile cardiovascular ground. the study is prospectively conducted in all patients admitted for syncope to assess the actual diagnostic performance of hypersensitive troponin in the syncope risk stratification. the primary benefit is to identify patients at risk of serious cardiac events in the short term. the secondary benefits expected from the study are a decrease in unjustified hospitalizations of patients admitted to the emergency for syncope and thus a decrease in the cost of care. the validation of the indication of the troponin assay in the stratification of the risk after a syncope passes by its prospective evaluation in a prognostic study.

Eligibility criteria:
inclusion criteria: * patients admitted to the emergency department for syncope as defined by european society of cardiology (esc) recommendations. exclusion criteria: * patient under guardianship or safeguard of justice * refusal to participate * inability to contact the patient again at m1, m3, m6 * malaise without loss of consciousness (lipothymia) * loss of post-traumatic knowledge (after head trauma) * loss of consciousness of toxic origin * loss of consciousness of confirmed epileptic origin (known epileptic or strongly evocative history with post-critical state) * diagnosis performed during the initial emergency assessment of a major adverse cardiovascular event.

Keywords: hypersensitive troponin risk of serious adverse events emergency
effects of lactobacillus plantarum kabp-51 probiotic on body composition, microbiome and mood in healthy overweight adults

Conditions: Weight Loss; Mood

Summary: the objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (lactobacillus plantarum kabp-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass). our subjects will be measured 4 times over the course of a 12-week supplementation period - at baseline, week 4, week 8, and week 12. we will have 2 groups (n=30 per group): * probiotic lactobacillus plantarum kabp-51 * placebo (maltodextrin/corn starch) subjects will be recruited from local fitness/wellness centers and businesses (e.g. plymouth fitness; planet fitness; marathon sports, etc) using a simple flyer. if volunteers meet the inclusion/exclusion criteria, they will review/sign the informed consent form (icf) before any baseline measurements are collected. participants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. this periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts. our expectation is that this fairly simple 12-week design will show that the kabp-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).


Eligibility criteria:
inclusion criteria: * healthy moderately overweight exclusion criteria: * pregnant women * inability to complete prescribed supplement regimen * current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)

Keywords: microbiome probiotic psychobiotic weight loss body composition obesity depression dysbiosis
efficacy of moxibustion in diabetes peripheral neuropathy

Conditions: Peripheral Neuropathy; Diabetic Neuropathies

Summary: this pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on diabetes peripheral neuropathy.

background: the purpose of this study is to investigate the clinical effects of moxibustion for treating diabetes peripheral neuropathy. hypothesis: subjects who have participated in the moxibustion treatment will have greater improvement in people with diabetes with signs and symptoms of peripheral neuropathy than the control group after 8 weeks. design and subjects: a pilot randomized controlled trial. subjects with diabetes peripheral neuropathy will be recruited from the community. 30 subjects will be randomized to moxibustion groups and control groups in a 1:1 ratio. interventions: subjects in the moxibustion group will receive three times per week for 12 weeks; control groups will be allocated to the waitlist will receive no moxibustion treatments throughout the 8 weeks.

Eligibility criteria:
inclusion criteria: * all patients between 18 and 75 years with diagnosed diabetes mellitus, according to who criteria. * proven peripheral neuropathy. * written consent with documentation that all participants received relevant information about this study is given to the patient. * the participants must be willing and able to meet the planned visit and meet the planned schedule, including participation in the experimental investigations. exclusion criteria: * health professionals' assessment makes the patient have medical or surgical diseases unsuitable to participate in the study. * pregnancy or breastfeeding for female patients. * competitive conditions that can cause peripheral neuropathy. * participants involved in the planning or execution of the study.

Keywords: moxibustion peripheral neuropathy
heartmate 3 ce mark study long term follow-up

Conditions: Advanced Refractory Left Ventricular Heart Failure

Summary: the purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with hm3 in the ce mark study and continue to be ongoing with the heartmate 3 lvas after the ce mark study 2 year follow-up. the study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the heartmate 3 lvas in those patients that completed the 2-year follow-up in the heartmate 3 ce mark study.


Eligibility criteria:
inclusion criteria: 1. patient or legal representative has signed informed consent form (icf). 2. patient was enrolled in the heartmate 3 ce mark study and continues to be supported with the heartmate 3 lvas after the 2 year ce mark study follow-up. exclusion criteria: 1. patient does not consent to the continued data collection.

Keywords: heart failure ventricular dysfunction cardiomyopathies heart disease cardiovascular disease heart-assist devices thoratec corporation
effect of treatment with fingolimod on the immune response following seasonal flu vaccination and tetanus booster injection in patients with relapsing multiple sclerosis (ms)

Conditions: Relapsing Multiple Sclerosis

Summary: this study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing ms.


Eligibility criteria:
inclusion criteria: * must have relapsing ms * must have lifetime tetanus vaccination * agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection exclusion criteria: * patients with a type of ms that is not relapsing * patients with history of chronic immune disease * certain cancers * diabetic patients with certain eye disorders * patients who are on certain immunosuppressive medications or heart medications * patients with certain heart conditions * patients with certain lung conditions * patients who have already received the 2010/2011 seasonal influenza vaccine other protocol-defined inclusion/exclusion criteria may apply

Keywords: relapsing multiple sclerosis ms immune response
to assess the level of adherence of subjects receiving saizen® via easypod™ in italy

Conditions: Growth Disorders

Summary: this is an italian, multicentre, observational study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents or guardian and subjects (when applicable) will provide their informed consent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the summary of product characteristics (smpc) * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
prevalence of nafld in t1dm patients

Conditions: NAFLD; Type 1 Diabetes; Fatty Liver, Nonalcoholic

Summary: to determine the prevalence of nafld in t1dm patients.


Eligibility criteria:
inclusion criteria: * t1dm * ≥ 18 years of age * written informed consent obtained exclusion criteria: * excessive alcohol use * exclusion of other causes of liver disease and secondary causes of liver steatosis
clinical evaluation of proclear toric and biofinity toric

Conditions: Astigmatism

Summary: the aim of this study is to compare the short-term clinical performance of two toric contact lenses.

the aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

Eligibility criteria:
inclusion criteria: 1. are at least 17 years of age and has full legal capacity to volunteer. 2. have understood and signed an information consent letter. 3. are willing and able to follow instructions and maintain the appointment schedule. 4. are an adapted soft toric contact lens wearer. 5. do not habitually wear either of the two study lens types. 6. have a vertex-corrected contact lens prescription with a spherical component of +4.00d to -9.00d in combination with astigmatism of no less than -0.75d and no more than -2.25d in each eye. 7. can achieve best corrected distance visual acuity of +0.10 logmar (subjective refraction) or better in each eye. 8. can be fitted with and achieve a distance visual acuity of +0.18 logmar or better in each eye with the study contact lenses. exclusion criteria: 1. are participating in any concurrent clinical or research study. 2. have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use. 3. have a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. 5. have known sensitivity to the diagnostic pharmaceuticals to be used in the study. 6. have a history of not achieving comfortable cl use (5 days per week; \> 8 hours/day) 7. are an employee of the centre for ocular research \& education directly involved in the study (i.e. on the delegation log).
a study of adavosertib (mk-1775) in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone for participants with platinum-sensitive ovarian tumors with the p53 gene mutation (mk-1775-004)

Conditions: Ovarian Cancer

Summary: this is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the p53 mutation. in part 1, a small group of participants will receive adavosertib along with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this combination. in part 2, participants will be randomly assigned to receive either adavosertib plus paclitaxel and carboplatin or placebo plus paclitaxel and carboplatin to assess efficacy of adavosertib compared to placebo. the primary hypothesis of the study (part 2) is that administration of adavosertib in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (pfs) per enhanced response evaluation criteria in solid tumors version 1.1 (enhanced recist 1.1) compared to participants treated with paclitaxel plus carboplatin alone.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer which has progressed after paclitaxel / platinum-based therapy. * platinum-sensitive disease. radiological progression must have occurred 6 months or more after the completion of the most recent platinum-based treatment. * measurable disease. * available tumor sample(s). * performance status of ≤1 on the eastern cooperative oncology group (ecog) performance scale. * adequate organ function. exclusion criteria: * pregnancy or the intention to become pregnant during the course of the study. * participation in a study with an investigational compound or device within 28 days of receiving first dose of study medication. * active central nervous system (cns) metastases and/or carcinomatous meningitis. * primary cns tumor. * known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, adavosertib) or its analogs (i.e., cremophor, mannitol, etc.). * participant requires the use of medications or products that are metabolized by, or inhibit, or induce cytochrome p450 3a (cyp3a4). * ongoing peripheral neuropathies ≥grade 2 and related to previous treatment. * known psychiatric or substance abuse disorders. * regular use (including "recreational use") of any illicit drugs or recent history (within the last year) of drug or alcohol abuse. * hiv positive. * active hepatitis b or c. * symptomatic ascites or pleural effusion. * clinical history suggestive of li fraumeni syndrome.
a phase 1 single/multiple dose study of pf-06293620 to assess safety, tolerability and pharmacokinetics in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: a first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of pf-06293620 in subjects with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * men and women of non-childbearing potential with type 2 diabetes mellitus * subjects on stable doses of metformin \>/= 1500 mg daily (sad cohorts) or \>/= 1000 mg daily (mad cohorts) x 30 days prior to screening * hba1c 7-10% (sad cohorts) or 6.5-10% (mad cohorts) inclusive at screening * fasting c-peptide \>1.12 ng/ml (sad cohorts) or \>/= 0.8 mg/ml (mad cohorts) at screening exclusion criteria: * history of type 1 diabetes mellitus * evidence of diabetic complications with significant end-organ damage * history of chronic pancreatitis or at high risk for pancreatitis * poorly controlled hypertension * history of cardiovascular or cerebrovascular event or procedure

Keywords: first in human single dose multiple dose escalation safety study type 2 diabetes mellitus
normothermia versus hypothermia for valvular surgery patients

Conditions: Valvular Heart Disease

Summary: cardiopulmonary bypass (cpb) has been used successfully for cardiac surgery for over half a century. hypothermia became a ubiquitous practice for adult patients undergoing cpb. to date, most studies have been conducted in coronary artery bypass graft (cabg) patients with conflicting results. current evidence does not support one temperature management strategy for all patients. the purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic cpb in valvular surgery patients.


Eligibility criteria:
inclusion criteria: * isolated heart valve surgery * heart valve surgery plus cabg * age 20-80 exclusion criteria: * urgent operation * left ventricle ejection fraction \< 35% * decompensated congestive heart failure * chronic renal failure (glomerular filtration rate \< 60 ml/min) * severe hepatic and pulmonary disease * bleeding diathesis or history of coagulopathy * planed deep hypothermic circulatory arrest * history of acute myocardial infarction in the last 3 month * preoperative core temperature \>37oc

Keywords: cardiopulmonary bypass hypothermia normothermia troponin i bleeding
the effects of map and etco2 on venous sinus pressures

Conditions: Idiopathic Intracranial Hypertension

Summary: the purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.

to prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.

Eligibility criteria:
inclusion criteria: * adults determined to be candidates for venous sinus stenting

Keywords: end-tidal carbon dioxide venous sinus stenting venous sinus caliber and pressures
predictors of treatment failure pain among patients gunshot wounds

Conditions: Chronic Pain

Summary: in patients with gunshot wounds during hostilities in ukraine, 76.9% have negative results of pain treatment, which leads to its chronicity. identifying predictors of negative pain outcomes in these patients may improve their treatment outcomes.

one of the strongest factors that has a psychological impact on a person is war and conditions in which injury occurs, conditions in which pain occurs. a gunshot wound received during the war in the conditions of hostilities becomes the reason for the indisputable association of pain sensations with the events in which the patient was injured. it is pain and memories, memories and pain that cause the development of states with self-destructive behavior. according to statistics, gunshot wounds account for 54-70%. gunshot wounds to the chest during anti-terrorist operations/oos make up 7.4-11.7%, shrapnel wounds prevail here - 72.2%, explosive wounds - 17.5%, bullet wounds - 10.3%, and lethality - 12.2 -25%. according to the data of the command of the medical forces of the armed forces of ukraine, in the structure of gunshot injuries, 64% are injuries to the limbs: of them, 74.8% are soft tissues, 25.2% are gunshot fractures, bone defects are noted in 11.6% of patients, and wounded. the study of predictors of negative results of pain treatment in patients with gunshot wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. since in 76.9% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria:
inclusion criteria: * presence of gunshot wounds during hostilities, male gender exclusion criteria: * absence of gunshot wounds during hostilities, other sex
influence of central nervous insulin sensitivity on insulin secretion

Conditions: Insulin Secretion

Summary: insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. the tissue in which it manifests are mainly muscle, liver, and adipose tissue. since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. in animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. this finding of insulin action in the brain could also be confirmed in human studies. the investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. for this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.


Eligibility criteria:
inclusion criteria: * hba1c ≤6.0% * normal glucose tolerance during 75g oral glucose tolerance test (ogtt) exclusion criteria: * not removable metal parts in or on the body * manifest cardiovascular disease * claustrophobia * recent surgery (less than 3 months) * simultaneous participation in other studies * acute disease or infection within the last 4 weeks * neurological and psychiatric disorders * treatment with centrally acting drugs * hemoglobin hb \<13g / dl * hypersensitivity to any of the substances used