Kornimate/medical-research-clean huggingface dataset:
venous excess ultrasound for personalized resuscitation in septic shock

Conditions: Septic Shock; Sepsis; Shock; Critical Care, Intensive Care; Resuscitation

Summary: the goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (vexus) to guide fluid management in patients with septic shock is feasible. septic shock is a life-threatening condition where infection causes dangerously low blood pressure. while fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. the main questions it aims to answer are: 1. is it feasible to recruit patients, obtain consent, and follow the vexus-guided management protocol? 2. does vexus-guided management, compared with usual care, improve the health and well-being of patients with septic shock? researchers will compare two groups: one receiving vexus-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether vexus prevents fluid overload and kidney problems. participants in the vexus group will: 1. undergo vexus scans every 24 hours for 3 days 2. receive fluid management guided by vexus findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion 3. be monitored for 28 days to track kidney function, need for dialysis, and survival.


Eligibility criteria:
inclusion criteria: 1. adult patients (≥18 years) 2. within 12 hours of meeting septic shock diagnosis based on following sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate \> 2 mmol/l, and suspected or confirmed infection) 3. within 48 hours of intensive care unit admission. exclusion criteria: 1. already receiving renal replacement therapy 2. patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment 3. patients who have limitations on medical therapy or restrictions on goals of care 4. active bleeding causing hemodynamic instability 5. veno-venous or veno-arterial extracorporeal membrane oxygenation 6. previously enrolment in study 7. 10% or more of body surface area acute burn injury 8. suspected or confirmed liver cirrhosis 9. established allergy to sulfa drugs; 10. patients receiving treatments that require continuous iv fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus) 11. unable to measure fluid balance accurately 12. contra-indication to study recommended interventions (e.g., diuretics, inotropes) 13. unable to perform vexus due to anatomical barriers (e.g., surgical dressings); 14. unable to complete vexus scan during the 6-hour resuscitation window 15. moderate to severe tricuspid regurgitation 16. untreated metabolic/biochemical findings (hypokalemia \[k+\]\ 40 mmol/l and/or ph \> 7.55\], hypomagnesemia \[mg2+\] \ 155 mmol/l)

Keywords: randomized controlled trial ultrasound venous congestion septic shock pilot study resuscitation
bioequivalence study of fixed-dose combinations and coadministered individual tablets of saxagliptin/metformin-brazil

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (xr), 500-mg, fixed-dose combination (fdc) tablet with saxagliptin, 5-mg and metformin, 500-mg xr tablets administered together in both the fasted and fed states. in addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin xr, 1000-mg, fdc tablet with saxagliptin, 5-mg and metformin, 1000-mg xr tablets administered together in both the fasted and fed states.


Eligibility criteria:
key inclusion criteria: * healthy men and women * women of childbearing potential who are using acceptable method of contraception * women who are not pregnant or nursing * body mass index (bmi) of 18 to 29.9 kg/m\^2, inclusive. bmi=weight(kg)/height(m)\^2. key exclusion criteria: * any significant acute or chronic medical illness. * history of gastrointestinal (gi) disease * major surgery within 4 weeks of study drug administration * any gi surgery that could impact study drug absorption * donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration. * blood transfusion within 3 months of study drug administration for women and within 2 months for men * inability to be venipunctured and/or tolerate venous access * current smoker or recent (within 1 month) history of regular tobacco use * recent (within 6 months of study drug administration) drug or alcohol abuse * participation in a bioequivalence study within the last 6 months of study drug administration * estimated creatinine clearance of \<80 ml/min using cockcroft-gault formula * history of allergy to drug class or related compounds * history of allergy to metformin or other similar acting agents * history of any significant drug allergy
phase i drug trial for s/e of marimastat in disabling malformations when no other options.

Conditions: Vascular Anomalies

Summary: 3 patients were enrolled in each of 3 study cohorts. there three cohorts were given differing, incrementally larger doses of this phase i drug. the same safety measures are being obtained on all patients. efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly. the study is structured to include a 24 month drug-phase and a 24 month follow-up phase. the study is now closed to enrollment.


Eligibility criteria:
inclusion criteria: * patient with vascular malformation causing risk of one or more of the following based on unanimous assessment of designated physicians in the multidisciplinary vascular anomalies team. * airway/respiratory/visual/auditory/neurologic compromise; * high output cardiac failure; * life-threatening or disabling hemorrhage(cutaneous/gi/intracranial/ parenchymal/cavitary); * skeletal distortion/destruction/erosion; * life-threatening or disabling soft tissue distortion or destruction * patient must be felt to have failed, be unable to significantly benefit from, or be at risk for other available therapies, including surgeries, embolization, and sclerotherapy based on unanimous assessment of designated physicians in the multidisciplinary vascular anomalies team. * patient must be felt to have one or more physical, imaging, photographic, physiologic or other measurable features that can be measured on a regular basis for preliminary evaluation of efficacy. the feature(s) must be agreed on by the designated physicians in the multidisciplinary vascular anomalies team). * signed patient informed consent. exclusion criteria: * pregnancy * patient nursing child. * female patient of childbearing potential unwilling to receive contraceptive counseling and use reliable contraceptive method. * patient enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) * parent or guardian or child unwilling to provide consent or assent.

Keywords: arteriovenous malformation lymphatic malformation gorham
pet imaging of giant cell and takayasu arteritis

Conditions: Giant Cell Arteritis; Takayasu Arteritis

Summary: while 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) imaging is often included in the diagnostic work-up of patients with large-vessel vasculitis (lvv), 18f-fdg lacks specificity for inflammatory cells and has limited ability to track therapy response. moreover, high background 18f-fdg uptake in the brain and myocardium largely precludes imaging temporal arteritis in giant-cell arteritis (gca) and coronary artery involvement in takayasu arteritis respectively. these limitations of 18f-fdg for imaging lvv highlight important unmet clinical needs, which might be overcome by using a somatostatin receptor subtype-2 (sst2) pet tracer.

up-regulation of sst2 in activated macrophages represents a novel imaging target for measuring vascular inflammation, which has been previously examined in atherosclerosis using 68ga-dotatate. to test the hypothesis that sst2 pet imaging can accurately identify lvv, patients with active gca or takayasu arteritis will undergo vascular 68ga-dotatate or 18f-fluoroethyltriazole-(tyr3)-octreotate (feto) pet-mri at baseline, with repeat imaging after 6 months of treatment. a group of individuals with lvv in clinical remission will also undergo sst2 pet imaging. data from patients with clinically inactive disease will serve to confirm tracer specificity for active disease, as well as signal reproducibility. 18f-feto is an alternative sst2 tracer to 68ga-dotatate; the longer half-life and shorter positron range of 18f compared to 68ga may offer several advantages, including wider tracer availability and improved spatial resolution when imaging small arteries. all patients will also undergo 18f-fdg imaging before treatment, where clinically indicated.

Eligibility criteria:
inclusion criteria: * male or female participants \>18 years old * able to give written, informed consent and to lie flat * either: 1. new clinical diagnosis or acute flare of lvv (giant-cell arteritis or takayasu's arteritis) within \~1 week of treatment initiation, and 2. clinical indication for 18f-fdg pet-ct scan determined by the referring physician, or 3. undergoing surgery for lvv, or 4. diagnosis of lvv in remission exclusion criteria: * women of child bearing potential not using adequate contraception * contra-indication to mri scanning * contrast allergy or contrast-nephropathy * chronic kidney disease (egfr \<30 ml/min/1.73 m2) * any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study * history of recent malignancy deemed relevant to the study by the investigator
isolated liver perfusion with oxaliplatin

Conditions: Unresectable Colorectal Liver Metastases

Summary: the primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. the second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (hai) therapy with floxuridine (fudr)/leucovorin.


Eligibility criteria:
inclusion criteria: * patients will be included that are scheduled to undergo surgery for placement of hepatic arterial infusion pump for hai therapy and * histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. limited resectable extrahepatic disease is acceptable. * no chemotherapy, radiotherapy, or biologic therapy for their malignancy in the 4 weeks prior to the liver perfusion and must have recovered from all side effects. * an ecog performance standard of 0, 1 or 2 for 24 hours prior to surgery. * adequate hepatic function as evidenced by bilirubin \< 2.0 mg/dl and a pt \< 2 seconds greater than the upper limit of normal. * age equal to 18 years or older and greater than 30 kg. * platelet counts greater than 100,000, a hematocrit \> 27.0, a white blood count \> 3000/microliter, and a creatinine less than or equal to 1.5 mg/dl or a creatinine clearance of \> 60 ml/min. patients with elevations in hepatic transaminases secondary to the presence of metastatic disease in the liver are eligible. * aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks and willing to sign an informed consent. * the disease in the liver must be considered unresectable as defined by greater than three sites of disease in the liver, bilobar disease, and tumor abutting major vascular or ductal structures making anatomic resection with preservation of liver function impossible. exclusion criteria: * pregnant patients and nursing mothers will be excluded due to the unknown effects of oxaliplatin on the fetus or newborn * patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible. * patients with active infections are not eligible. * patients with biopsy proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system will be excluded. * patients with ischemic cardiac disease or history of congestive heart failure with an lvef \< 40% will be excluded. * patients with copd or other chronic pulmonary disease with pft's indicating an fev\< 50% predicted for age will be excluded. * patients with a history of veno-occlusive disease of the liver are ineligible.
effect of red yeast rice, phytosterols and l-tyrosol on lipid profile and endothelial function

Conditions: Hypercholesterolemia

Summary: a large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and l-tyrosol. because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) ldl cholesterolemia reduction.

european food safety authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and l-tyrosol. in a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity. preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids. no data are available on the combined effects of these dietary supplement in humans.

Eligibility criteria:
inclusion criteria: * suboptimal ldl level (115-160 mg/dl) * tg\<400 mg/dl * signed informed consent form exclusion criteria: * patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 10 years * ldl-c\ 160 mg/dl, tg\>400 mg/dl * obesity (bmi\>30 kg/m2) or diabetes mellitus * assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism * antihypertensive treatment not stabilized since at least 3 months * known current thyroid, gastrointestinal or liver diseases * any medical or surgical condition that would limit the patient adhesion to the study protocol

Keywords: red yeast rice phytosterols l-tyrosol lipids ldl-cholesterol endothelial function
a multicenter registry to study the characteristics and outcomes of jordanian heart failure patients.

Conditions: Heart Failure; Chronic Heart Failure; Acute Heart Failure

Summary: heart failure research registry is a collection of computerized information about individuals with heart failure. the database in this registry is obtained from several jordanian medical centers which will represent an extremely valuable resource for epidemiological research on heart failure patients.

understanding the cause of heart failure (hf) and how the body will respond to it, is critical for an effective treatment. hf is a global problem with significant morbidity and mortality, despite improved understanding of the pathophysiology and a growing range of therapeutic options. jordanian heart failure registry (johfr) will be the first research project of heart failure prevalence in jordan. it is undertaken by primary healthcare professionals with main aim to improve knowledge about the care of patients with hf. the investigators responsible for conducting this research are physicians and their teams who deal with heart failure patients in their outpatient and inpatient clinic centers including the public and private medical sectors in jordan's medical community. standards in the hashemite kingdom of jordan complies with the recognized good guideline directed medical practices internationally

Eligibility criteria:
inclusion criteria: 1. patients who are 18 years or older with heart failure diagnosis as defined by internationally recognized guidelines. 2. current residents of the hashemite kingdom of jordan exclusion criteria: 1. patients who refuse or unable to sign a consent form. 2. patient inability to follow up with provider
comparison of anti-xa activity of enoxa ® versus lovenox ® in acute coronary syndrome

Conditions: Acute Coronary Syndrome; Factor X

Summary: this study is a clinical trial monocentric, open, randomized enoxa ® versus lovenox ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.

the patients included in this study with an acute coronary syndrome be admitted to the emergency room and receive treatment with enoxaparin. low molecular weight heparin (lmwh) treatment in this indication is usually spread over a week. the experience of the study intends to focus only on the first injection administered in selected patients. two assays are carried out, including an assessment of the anti-xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe. clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home) tolerance assessment (clinical and biological) is performed during follow-up.

Eligibility criteria:
inclusion criteria: * male or female over the age of 20 years * acute coronary syndrome * admission to the emergency department exclusion criteria: * patient participating in another study * pregnant or lactating or of childbearing potential not using medically accepted method of contraception * taking an anticoagulant in the last three months * patient with known haemostatic disorder * contraindication absolute and / or relative to the use of enoxaparin * nobody wishing to participate in this study or not having the ability to understand its objectives

Keywords: enoxaparin acute coronary syndrome factor x
sensorimotor integration underlying balance control in individuals with incomplete spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.

after obtaining their consent, participants will undertake evaluations at different times: 1. assessment 1 week prior to training 2. training over 4 weeks (nature of the training depends on the group) 3. assessment 1 week after training 4. assessment 1 month after training (follow-up) each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. days can be consecutive or non-consecutive but will be within a given week. the assessment consists of: * session 1 (s1; duration: 3h) will include presentation of the study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment. * session 2 (s2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of h reflex. after the initial assessment, isci participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. the training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).

Eligibility criteria:
for participants with spinal cord injury inclusion criteria: * have an incomplete lesion of spinal cord * level of spinal cord lesion between c5 and t12 * at least, 6 months post-injury * be considered as ais c or d * be able to stand without support for 15 seconds * be able to provide informed consent in english or in french exclusion criteria: * to have cognitive deficits * to have personal or family history of epilepsy * to have suffered moderate or severe traumatic brain injury * to have cochlear implant for control participants exclusion criteria: * to have orthopedics problems * to have cognitive deficits * to have neurological problems

Keywords: combined explosive strength and balance training balance control corticospinal tract intracortical mechanisms vestibular system
effects of ketamine on mentalizing and metacognition in healthy volunteers

Conditions: Ketamine-Induced Psychotic Disorder; Social Cognition; Theory of Mind

Summary: antipsychotic medication shows generally good effect sizes when looking at reduction of positive psychotic symptoms of schizophrenia, such as paranoia or delusion. however, social functioning often remains deficient in patients, meaning dopamine-receptor antagonists are not sufficient in treatment of people with schizophrenia. a naturalistic video-based paradigm, named masc has been used in the past to model over- and undermentalizing in patients with autism spectrum disorder and schizophrenia, since deficits in mentalizing can be explained by either overinterpreting a social situation (e.g. paranoid thoughts about intentions of others towards self) or by lacking the skill to read intentions of others. to find out whether experimental manipulation via a non-competetive n-methyl-d-aspartate antagonist can induce difficulties with social cognition similar to those observed in people with schizophrenia, the investigators will conduct a rct applying either ketamine or a placebo intravenously while participants are completing the above mentioned mentalizing task in the fmri-scanner.


Eligibility criteria:
potential participants are excluded based on the following criteria: * history of psychiatric/neurological disorder (self and first-degree relatives) * learning disabilities, or loss of consciousness for more than 5 minutes * history of alcohol or drug abuse within the last 12 months * history of ketamine abuse * history of complications during anesthesia (self and first-degree relatives) * serious physical illness * claustrophobia * color-blindness * metalliferous implant * visual impairments other than corrective lenses * injury or disease of the inner ear with loss of hearing * consumption of any prescription or over-the-counter medication 3 days previous to the examination * pregnancy * currently breastfeeding a baby * hypotension (blood pressure \< 100/60) * hypertension (blood pressure \> 140/90) * underweight (bmi \<17) * overweight (bmi ≥30) recruited participants are required to meet the following criteria: * height between 150 and 195 cm * bodyweight between 50 and 99kg * male or female * right-handed * physically, neurologically and psychiatrically healthy * non-smoker * normal or corrected-to-normal eye-sight * good command of german language

Keywords: ketamine fmri psychosis mentalizing social cognition metacognition