Kornimate/medical-research-clean huggingface dataset:
point-of-care system for determination of bilirubin capacity in neonates

Conditions: Jaundice, Neonatal; Hyperbilirubinemia; Bilirubin-Induced Neurological Dysfunction (BIND)

Summary: the aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates.

the status of bilirubin binding to albumin (alb) is central to personalized management of unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced neurologic dysfunction (bind) (1). our objectives were to validate the aviv bili-4 hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical studies and surveys of end-users. in addition, we continued our efforts to validate the bili-4 device in order to facilitate aviv, inc. in their development of claims of the most appropriate use of bilirubin binding capacity (bbc) information in the management of neonates. neonatal blood samples were obtained from newborns born at stanford university's lpch with gestational ages (ga) ranging from 22-40 wks. total bilirubin (tb), alb and apparent serum unbound bilirubin (ub) concentrations were measured or calculated. ratios of bound bilirubin (bb) to reserve alb binding capacity for bilirubin (rabc) were also determined. bilirubin binding capacity (bbc) by hematofluorometry (hmf) was compared to the calculated bbc (or 8.8 × alb) using alb levels as measured by the clinical laboratory. we report the progress of this inquiry at the stanford university (1).

Eligibility criteria:
inclusion criteria are in vitro testing of blood samples obtained from eligible babies: * subjects must meet all of the following inclusion criteria to be considered eligible for study enrollment soon after birth or re-admission (for phototherapy): * parental informed consent * male and female newborns with a ga ≥ 24 wks with a birthweight ≥ 500 g as well as sick or unstable late preterm newborns infants with ga ≥ 35 wks with a birthweight ≥ 2500 g. * enrollment at age less than 14 days and more than 6h exclusion criteria: * none.

Keywords: bilirubin binding capacity preterm neonates and jaundice
safety and efficacy of edoxaban and rivaroxaban to cerebral venous thrombosis in chinese patients

Conditions: Cerebral Venous Thrombosis; Anticoagulants and Thrombotic Disorders; Anticoagulation Treatment; Anticoagulant Therapy; Anticoagulant Drugs; NOACs; Anticoagulant Prophylaxis/Therapy; Anticoagulation With NOAC; Anticoagulation With Direct Oral Anticoagulants

Summary: the goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (cvt). the main question it aims to answer are: * do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban? * do the bleeding events occur during the treatment period of edoxaban and rivaroxaban? the main tasks participants will be asked to do: * participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage. * participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.


Eligibility criteria:
inclusion criteria: 1. patient aged from 18 to 80 years and no gender preference; 2. diagnosis of cvt as confirmed on mrbti/mrv or ct/ctv or dsa; 3. acute or subacute cvt from onset to door within 4 weeks; 4. the treating clinician irrelevant to the study is of the opinion that the patient is appropriate for edoxaban or rivaroxaban; 5. patient or legally authorized representative is able to give written informed consent. exclusion criteria: 1. patient refuse to take edoxaban or rivaroxaban to treat cvt; 2. pregnancy or breastfeeding women at the time of enrollment, or women who plan to get pregnant during study; 3. patient is anticipated to require invasive procedure (e.g. thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation; 4. cvt secondary to central nervous system infection or severe head trauma; 5. it is in the proliferative stage of malignant tumors currently or within 6 months of diagnosis; 6. bleeding diathesis or other contraindication to anticoagulation; 7. any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use; 8. concomitant use of strong cyp3a4 or p-gp inhibitors; 9. impaired renal function (crcl\<30 ml/min using cockcroft-gault equation) or investigator anticipate the crcl lower than 30 ml/min during study; 10. impaired liver function (alt or ast exceeds twice the normal upper limit) or diagnosed as acute hepatitis currently; 11. patient is unable to swallow due to depressed level of consciousness or other reasons; 12. patient has a severe or fatal comorbid illness with life expectancy less than 6 months; 13. patient with severe hypertension (sbp≥180mmhg and/or dbp≥110mmhg); 14. patient is known to be allergic to edoxaban or rivaroxaban.
study to evaluate the efficacy and safety of larazotide acetate for the relief of ced symptoms

Conditions: Celiac Disease

Summary: to assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

this is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Eligibility criteria:
inclusion criteria: * male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months * on a gluten-free diet for at least 6 months * experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea) * willing to maintain current gluten-free diet throughout participation in the study exclusion criteria: * refractory celiac disease or severe complications of celiac disease * chronic active gi disease other than celiac disease
study comparing efficacy and safety of defibrotide vs best supportive care in the prevention of hepatic veno-occlusive disease in adult and pediatric patients

Conditions: Veno-occlusive Disease

Summary: this study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (vod) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing vod.


Eligibility criteria:
inclusion criteria: 1. patient must be above the age of 1 month as of the start date of study treatment. 2. patient must be scheduled to undergo allogeneic hematopoietic stem cell transplant (hsct) (adults or pediatric patients) or autologous hsct (pediatric patients only) and be at high risk or very high risk of developing veno-occlusive disease (vod). 3. female patients (and female partners of male patients) of childbearing potential who are sexually active must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 1 week after the last dose of defibrotide. 4. adult patients must be able to understand and sign a written informed consent. for minor patients, the parent/legal guardian or representative must be able to understand and sign a written informed consent. assent, when appropriate, will be obtained according to institutional guidelines. exclusion criteria: 1. patient has hemodynamic instability within 24 hours before the start of study treatment. 2. patient has acute bleeding that is clinically significant within 24 hours before the start of study treatment. 3. patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment. 4. patient is using or plans to use an investigational agent for the prevention or treatment of vod. 5. patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 6. patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent. 7. patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study. 8. patient is pregnant or lactating and does not agree to stop breastfeeding. 9. patient has a known history of hypersensitivity to defibrotide or any of the excipients. 10. patient or parent/legal guardian or representative lacks the full mental capacity to understand and sign a written informed consent. 11. patient is receiving or plans to receive other investigational therapy during study.

Keywords: stem cell transplant hematopoietic stem cell transplant (hsct) veno-occlusive disease (vod) sinusoidal obstruction syndrome (sos)
comparison on succinylcholine onset time assessed by train of four stimulation versus clinical judgment during rapid sequence induction of anesthesia

Conditions: Suxamethonium Sensitivity; Aspiration of Gastric Contents Into Respiratory Tract, Part Unspecified

Summary: succinylcholine is a myorelaxant agent often used during rapid sequence induction for patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration of gastric content. whereas other myorelaxant agents are monitored with train of four stimulation to assess onset and duration, few anesthesiologists use train of four stimulation for onset of succinylcholine, as the anesthesiologists evaluate the effect with the time from injection (usually one minute) and the muscle fasciculation due to the release of acetylcholine. the data available on onset duration of this drug are old and bases on only few studies, but the succinylcholine if sometime harmful (anaphylaxis , cardiac arrest, bronchospasm). the investigators want to assess the onset time of succinylcholine with an objective toll , the train of four stimulation, and evaluate if the clinical judgment of the anesthesiologist is reliable to predict an adequate moment for endotracheal intubation.


Eligibility criteria:
inclusion criteria: * every patient undergoing general anesthesia with the use of suxamethonium for induction as assessed by the anesthesiologist exclusion criteria: * patient under 18 years old * pregnant woman * nasotracheal intubation * monitoring of train of four at the adductor pollis impossible (such as patient with no arm )
the anti-inflammatory effects of high-fat nutrition; towards a clinical application

Conditions: Trauma

Summary: patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. high fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. the activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor. in this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.


Eligibility criteria:
inclusion criteria: * healthy males and females * 45 \> age \<55 exclusion criteria: * gastrointestinal diseases * inflammatory conditions

Keywords: cck release
effect of escitalopram vs. reboxetine on gastro-intestinal sensitivity of patients with major depressive disorder

Conditions: Major Depression; Pain; Abdominal Pain

Summary: patients with major depressive disorder (mdd) commonly have many gastrointestinal complaints. gastrointestinal pain is classified into 2 categories: visceral and somatic pain. the main aim of this study is to compare somatic and visceral sensitivity between healthy people and pateints with mdd. these two sensitivities will be assessed by the 2 following tests: standardized rectal distension and transdermal transcutaneous electric nerve stimulation. thereafter, patients with mdd will be randomly allocated to escitalopram or reboxetine. after 6 weeks of treatment, somatic and visceral sensitivity will be reassessed.


Eligibility criteria:
inclusion criteria: * mdd according with dsm-iv-tr * hamilton depression scale \> 21 exclusion criteria: * history of gastrointestinal illness * history of escitalopram, citalopram or reboxetine allergy. * history of escitalopram, citalopram or reboxetine resistant depression. * other axis i psychiatric disorder. * a punctuation \> 2 on the suicide item of the ham-d. * history of ect during the past 6 months. * pharmacological failure of the present depressive episode. * pregnancy or nursing. * treatment with drugs that may interact with study medication.

Keywords: major depression pain escitalopram reboxetine visceral sensitivity somatic sensitivity
cerebral edema in pediatric diabetic ketoacidosis

Conditions: Diabetic Ketoacidosis

Summary: the purpose of this trial is to compare two different rates of fluid administration during diabetic ketoacidosis (dka) treatment in children to determine which fluid administration rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling during dka.

cerebral edema (swelling of the brain) is the most frequent serious complication of diabetic ketoacidosis (dka) in children. the cause of cerebral edema during dka is not well understood. recent studies suggest that it may result from lack of adequate blood flow to the brain during dka, before treatment starts. brain injury, resulting in edema, may occur before treatment because of lack of adequate blood flow to the brain and additional injury may occur when adequate blood flow is re-established during treatment (called reperfusion injury). because additional injury may occur during treatment, it is important to understand whether the rate of administration of intravenous fluids, and, therefore, the speed of reperfusion of the brain, is related to the degree of brain swelling and injury. most current treatment protocols indicate that intravenous fluids should be administered slowly, but it may be possible that brain injury and swelling might be lessened if adequate blood flow is established more quickly. in this study, researchers will use magnetic resonance (mr) imaging to compare two different rates of fluid administration during dka treatment in children. the investigators will use mr imaging to measure brain swelling and metabolism at three time points-twice during treatment and once after recovery from dka-and will compare these measurements to determine which fluid administration rate has more beneficial effects on brain metabolism and brain swelling. the study's researchers hypothesize that more rapid re-establishment of blood flow to the brain (via more rapid administration of intravenous fluids) will result in less brain swelling and injury than slower rehydration with delayed re-establishment of adequate brain blood flow will.

Eligibility criteria:
inclusion criteria: * age 8-18 years * diagnosis of diabetic ketoacidosis * able to cooperate with mr scanning exclusion criteria: * pre-existing cerebral injury or brain structural abnormality * dental hardware or other metal devices which would interfere with mr imaging

Keywords: diabetic ketoacidosis dka cerebral edema brain edema
a new treatment for primary smear-positive pulmonary tuberculosis with interleukin-2

Conditions: Tuberculosis, Pulmonary

Summary: the purpose of the study is to compare the efficacy and safety of standard chemotherapy regimen 2hrze/4hr plus il-2 and standard regimen 2hrze/4hr for newly diagnosed smear positive pulmonary tuberculosis.

1. design:the study is a multi-center, randomized, controlled, open clinical trial. 2. population:initial smear positive pulmonary tuberculosis patients who fulfill the inclusion and exclusion criteria. 3. investigational regimens: experimental group regimen:2hrze/4hr+interleukin-2 （500000 units daily, subcutaneous injection in the first month） the control group regimen: 2hrze/4hr dosage: isoniazid 300mg(given once daily),rifampin 450mg(less than 50kg,given once daily) or 600mg(more than 50kg,given once daily),pyrazinamide 1500mg(less than 50kg,given once daily) or 30mg/kg(more than 50kg,given once daily),ethambutol 750mg(less than 50kg,given once daily) or 1000mg(more than 50kg,given once daily). 4. primary and secondary outcome measures: primary efficacy outcome measures:(a)negative conversion rate of sputum bacteria. (b)sputum smear conversion proportion at the treatment completion . secondary efficacy outcome measure:recurrence rate after treatment.

Eligibility criteria:
inclusion criteria: 1. is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate). 2. is aged 18-65 years. 3. chest x-ray showed that there were active tuberculosis foci in the lungs with one of the following cases: (1) sputum specimens (or sputum and bronchial lavage fluid) were 2+ once or 1+ twice ; (2) sputum smear positive and sputum x-pert positive. 4. newly diagnosed cases receiving anti-tb treatment for less than one month. 5. no other immune preparations （such as: thymosin，ifn-y，bcg-psn，mycobacterium vaccae，utilins，lentinan ）were used in the past 3 months. 6. the urine analysis of women of childbearing age are negative and agree to use the efficient contraception during the study period. exclusion criteria: 1. has a known allergy to any drug of treatment regimens. 2. there are serious complications or impaired renal function (serum creatinine is 1.5 times higher than the normal limit) or impaired liver function (alt or ast levels are 3 times higher than the normal limit); hemoglobin is less than 7.0g/dl. platelets less than 50x109/l. 3. complication with diabetic. 4. the screening diagnosis was isoniazid resistance or rifampin resistance 5. there are serious cardiovascular diseases, such as heart failure, hypertension, arrhythmia or post myocardial infarction state. 6. is known to be pregnant or breast-feeding. 7. karnofsky score is less than 50%. 8. is taking any clinical trial in the past 3 months. 9. is critically ill, and in the judgment of the investigator, not fit for the study or unlikely to complete the full course of study. 10. hiv is positive or aids patients. 11. has non tuberculous mycobacterial lung disease. 12. merge with extra pulmonary tuberculosis.

Keywords: pulmonary tuberculosis interleukin-2 clinical trial
active surveillance for adverse events following immunization with the butantan trivalent influenza vaccine (2018)

Conditions: Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Infections; Virus Diseases; Vaccines; Physiological Effects of Drugs

Summary: rationale and background: since 2013, butantan institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (ib tiv). objetive: to conduct an active surveillance study focusing on the elderly and health care professionals as part of butantan pharmacovigilance plan, while passive surveillance activities will continue. the pharmacovigilance plan, via active surveillance, is being implemented in response to who requirements for pre-qualification of ib tiv.

study design: this is a prospective cohort study. population: target groups for vaccination defined by the national immunization program of brazil: healthcare workers and elderly (people over 60 years old). study size: a total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with ib tiv, and who agree to participate after providing informed consent.

Eligibility criteria:
inclusion criteria: * health care professional; or * elderly (age 60 or more); and * to have indication to be vaccinated against influenza, according the the brazilian national immunazition programme; and * to be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and * to demonstrates interest to participate in the study as registered in the informed consent form (icf). exclusion criteria: * known systemic hypersensitivity to eggs or to any component of the vaccine; * suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° c on the day of vaccination; * history of severe adverse reaction after previous administration of an influenza vaccine within 6 weeks following vaccination; * history of guillain-barre syndrome or other demyelinating disease; * behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements; * any other condition in the opinion of the investigator that justifies exclusion from participation.