Kornimate/medical-research-clean huggingface dataset:
development of tcb nomogram to identify neonatal hyperbilirubinemia in term and late-preterm infants

Conditions: Hyperbilirubinemia, Neonatal

Summary: thirteen hospitals in china will participate in the study, which aims to provide data on transcutaneous bilirubin (tcb) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific tcb nomogram. the investigators hypothesize that the hour-specific tcb nomogram can predict neonatal hyperbilirubinemia in term and late-preterm chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

neonatal hyperbilirubinemia is very common; it is not always a benign condition. if left untreated, it can have devastating consequences including cerebral palsy and hearing loss. it is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.

Eligibility criteria:
inclusion criteria: term or late-preterm newborn infants with gas of ≥35 weeks and birth weights of ≥2,000 g were included. exclusion criteria: all sick newborn infants who were admitted to the intensive care unit.

Keywords: hyperbilirubinemia neonatal transcutaneous bilirubin
pharmacokinetics (pk) and safety of zanzalintinib in participants with moderate hepatic impairment (hi)

Conditions: Hepatic Impairment; Moderate Hepatic Impairment

Summary: the primary purpose of this study is to evaluate the plasma pk of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.


Eligibility criteria:
key inclusion criteria: * all participants: * no clinically significant medical history (aside from the hi for participants in the hi group only), physical examination findings, or vital signs, as deemed by the investigator. * a continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last pk sample collection. * has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing. * participants with moderate hi only: * adequate bone marrow function, at the screening and dosing visit. * is classified as having moderate hi by the child-pugh classification system (class b, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \> 1.5\* upper limit of normal (uln) and ≤ 3\* uln at the screening and dosing visit. * has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at the screening visit with features of cirrhosis due to any etiology. * healthy control participants only: * age must be within ± 10 years of the mean age of participants with moderate hi. the sex ratio (male/female ratio), and smoking status ratio (smokers/non-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate hi. key exclusion criteria: * all participants: * • history of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs. * has or is at risk for major cardiac events or dysfunction. * participants with moderate hi only: * history of liver or other solid organ transplant. * fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 child-pugh point) within 30 days prior to day 1, in the opinion of the investigator and sponsor. * symptoms or history of grade 3 or worse degree of encephalopathy within 3 months of dosing. * clinical evidence of severe ascites at the screening visit or at check in. * healthy control participants only: * history or presence of alcohol or drug abuse within the past 2 years prior to dosing. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: zanzalintinib pharmacokinetics
thiamine supplementation in high risk cardiac surgery patients

Conditions: Cardiac Surgery

Summary: this pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients

thiamine has a pivotal role and is an essential cofactor for pyruvate dehydrogenase activity. widely known wet beri-beri is developed due to thiamine deficiency and characterized by vasodilatory shock and despaired oxygen extraction leading to kidney, heart and central nervous system dysfunction. thiamine deficiency is often underestimated and even in primary absence of vitamin b1 deficiency, high-consumptive state of many critical illness and cardiac surgery itself can lead to its lack. reported that in patients on chronic dialysis and patients with aki requiring rrt thiamine deficiency is a usual finding. in cross-sectional observational study it has been shown that up to 33% of patients with a diagnosis of congestive heart failure (chf) had thiamine deficiency due to chronic loop diuretic use. also reported that 96% of patients (21 of 23) with heart failure receiving loop diuretic therapy (daily dose: 80-240 mg furosemide) developed thiamine deficiency. in prospective observational trial it has been shown that plasma thiamine levels were decreased after cabg surgery. in a secondary analysis of a randomized, double-blind, placebo-controlled trial conducted in septic patients, thiamine supplementation showed highly-promising renal protective effect. need for rrt was 8 patients (21%) in placebo group and 1 patient (3%) in thiamine group (p=0.04). on the other hand it was unable to show any benefit of thiamine supplementation in patients undergoing cabg surgery. although, postoperative oxygen consumption was significantly increased among patients receiving thiamine. nevertheless, existing evidence suggests that thiamine supplementation might be an attractive strategy in counteracting organ dysfunction and thus morbidity and mortality in high-risk cardiac surgical patients.

Eligibility criteria:
inclusion criteria: * valve surgery + cabg that required cardiac surgery with cpb * aged 18 years or older * signed informed consent exclusion criteria: * emergency surgery * chronic kidney disease of g4-g5 categories according to kdigo criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 29 ml/min/1.73 m2, history of kidney transplantation) * known allergy to thiamine * pregnancy * current enrollment into another rct (in the last 30 days) * previous enrollment and randomisation into the apply trial * administration of thiamine in the previous 30 day

Keywords: thiamine thiamine supplementation vasoplegia syndrome inotropic support cardiac surgery renal failure
safety, tolerability, and efficacy of etrasimod (apd334) in participants with primary biliary cholangitis

Conditions: Primary Biliary Cholangitis

Summary: the purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (apd334) in participants with primary biliary cholangitis (pbc).


Eligibility criteria:
key inclusion criteria: * males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed primary biliary cholangitis (pbc) diagnosis based upon at least 2 of 3 criteria: * anti-mitochondrial antibodies (ama) titer \>1:40 on immunofluorescence or m2 positive by enzyme-linked immunosorbent assay (elisa) or positive pbc-specific antinuclear antibodies (anti-gp210 and/or anti-sp100) * alkaline phosphatase (alp) \>1.5 x upper limit of normal (uln) for at least 6 months * liver biopsy findings consistent with pbc * use of ursodeoxycholic acid (udca) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening) * participants must have alp \>1.5 x uln but \<10 x uln, alanine aminotransferase (alt) and aspartate aminotransferase (ast) \<5 x uln, and total bilirubin \<uln, at all screening visits * ast, alt, alp, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other key exclusion criteria: * chronic liver disease of a non-pbc etiology. however, pbc participants accompanied with primary sjögren's syndrome (pss) are eligible to be enrolled. * history or evidence of clinically significant hepatic decompensation * medical conditions that may cause non-hepatic increases in alp (e.g., paget's disease) * clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis c virus anytime in the past * immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start * treatment with obeticholic acid (oca) within 30 days prior to day 1 note: other protocol defined inclusion/exclusion criteria may apply
self-assessment tuberculin skin test

Conditions: Tuberculin Skin Test

Summary: the research team/investigator/nurse/professional health care workers will teach the participants how to read the results for tst test. the investigator will compare the reading results done by the participants to the results read by the nurses.

this is a cross-sectional study of hiv-infected patients from 2 hiv clinics in bangkok: hiv-nat, thai red cross aids research centre and taksin hospital. research team/investigator/nurse/professional health care workers will assess whether the reading of tst test between the participants and the nurses are the same or not. the investigator and team believe that the readings of the tst tests between the participants and the nurses will be the same. if the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. this is a pilot study to test this innovative method to teach the participants to read the tst results by themselves. if this technique is successful, then the investigator and team can expand the method to other hospitals in thailand as well as in the region.

Eligibility criteria:
inclusion criteria: 1. documented hiv-1 infection 2. aged ≥18 years old 3. no sign and symptom of active tb exclusion criteria: 1. refuse to read tst by themselves

Keywords: tuberculin skin test latent tb infection hiv/tb co-infected participants sensitivity specificity positive predictive value (ppv) negative predictive value (npv)
a study of hypoxia imaging in advanced pancreatic cancer patients being treated with gemcitabine and th-302 or th-302 placebo

Conditions: Pancreatic Adenocarcinoma; Advanced Disease; Metastatic Disease

Summary: researchers are looking for better ways of diagnosing and treating pancreatic cancer. it is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. this study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and th-302/placebo in the emr 200592-001 clinical research study. this study will use positron emission tomography (pet) scans to look at hypoxia in tumours. pet is an imaging test that can be used to measure hypoxia in tumours. for this study, a radioactive tracer called fluoroazomycin arabinoside (faza) will be used to "label" areas of hypoxia in tumours. determining the levels of hypoxia in tumour tissue using faza-pet scans and comparing these levels with the patient's response to treatment with gemcitabine and th-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment. the main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.


Eligibility criteria:
inclusion criteria: * have consented to participating on the first-line gemcitabine + th-302/placebo (study number emr200592-001) study * age 18 years or older * cytologic/histologic diagnosis of pancreatic adenocarcinoma * advanced stage pancreatic cancer: locally advanced or metastatic. * no prior chemotherapy for advanced/metastatic disease. adjuvant chemotherapy allowed if completed \> 6mths from study entry. prior radio-sensitizing doses of 5-fu or gemcitabine also allowed. * ecog performance status 1 or less * adequate end organ and marrow function * measureable or non-measureable disease by recist 1.1 * female patients of child-bearing potential must have a negative serum pregnancy test (bhcg) and must agree to abstinence or use adequate contraception for the duration of the study * disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (dcis) breast disease). * ability to provide written informed consent * must be able to lie flat comfortably for 30 to 60 min to complete imaging study exclusion criteria: * inability to lie supine for 30 to 60 minutes * concurrent second primary * life expectancy of less than 12 weeks * on treatment with disulfiram (antabuse) due to \[18f\]faza injection containing up to 10% (v/v) ethanol in pbs (phosphate-buffered saline)

Keywords: hypoxia 18f-faza 18f-fluoroazomycin arabinoside positron emission tomography pet participating in study emr200592-001
a confirmatory study of tau-284 in pediatric patients with perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: the objectives of this study are: to confirm the superiority of tau-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and plasma concentrations of tau-284.

this is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of tau-284 over placebo after two weeks of administration of tau-284 (10 mg/day or 20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with "the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\])" as the primary endpoint; and to investigate the dose response, safety, and plasma concentrations of tau-284.

Eligibility criteria:
inclusion criteria: * patients aged between 7 and 15 years * patients with a weight of at least 20 kg * patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria * patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period exclusion criteria: * patients with vasomotor rhinitis or eosinophilic rhinitis * patients who have concurrent nasal disease that may affect the efficacy of tau-284 * patients with a history of any of the nasal surgical procedures * patients who have a positive result for pollen antigens which are dispersed during the study period * patients who have a positive result for dog dander or cat dander antigen * patients with current or previous history of drug allergy * patients who concurrently have renal function abnormalities that may cause safety problems

Keywords: tau-284 bepotastine besilate histamine h1 receptor antagonists
polk covid-19 and flu response

Conditions: Covid19

Summary: study objectives: to perform covid-19 diagnostic and serologic testing on emergency medical personnel in polk county to determine: 1. covid-19 prevalence 2. rate of convalesced personnel (+antibodies) 3. rate of asymptomatic carriers

this observational study involves a community wide program offering free covid-19 testing to county front line workers, including ems personnel, board of county commissioners and sheriffs' office personnel. these personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. the survey is voluntary and written informed consent is obtained . ems personnel can still get the free testing even if they do not want to fill out the survey. the primary objective of the study is to describe the prevalence of covid-19 antigen and igm and igg markers amongst our county/ems workers. the secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities.

Eligibility criteria:
inclusion criteria: polk county (fl) emergency personnel including ems, fire rescue, board of county commissioners, and sheriff's office exclusion criteria: age \< 18
part-time patch therapy for treatment of intermittent exotropia

Conditions: Intermittent Exotropia

Summary: intermittent exotropia is the most common type of exotropia in children. treatment options are surgical and non surgical. nonsurgical management include correction of refractive errors, active orthoptic treatments, prisms and occlusion therapy. benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. according to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.


Eligibility criteria:
inclusion criteria: * intermittent distance exotropia or constant distance exotropia at least 15δ and intermittent near exotropia or exophoria exclusion criteria: * no child's cooperation in evaluation of deviation control and regular visits for follow-up examinations * anisometropia more than 1.50 d, hypermetropia more than 3.50 d, and myopia more than 4.50 d on cyclorefraction * history of previous treatments including eye occlusion, minus therapy, and strabismus surgery * any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
prospective analysis of morbi-mortality of patients with cancers in active phase of treatment suspected or diagnosed of a sars-cov-2 infection

Conditions: Sars-CoV2; Cancer

Summary: national multicentre epidemiological study to describe retrospectively and prospectively the clinical outcomes of patients with a suspected coronavirus infection (either confirmed or not) while receiving a medical treatment for the underlying cancer


Eligibility criteria:
inclusion criteria: i1. confirmed diagnosis of any type of solid or hematologic tumor; i2. ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ; i3. patient with suspicion of covid-19 (clinical symptoms of covid-19 including fever (\>38°c) and/or respiratory tract symptoms), either confirmed or not. note 1: patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging. note 2: patients will be eligible regardless of the presence of a neutropenia (either febrile or not) ; i4. patient and/or family did not decline data collection after complete information.

Keywords: covid-19 oncology epidemiology predictive factors
safety and effectiveness of monovisc® injection for osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether intra-articular injection of monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

this randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (oa) of the knee as compared to a placebo comparator injection of sterile saline.

Eligibility criteria:
main inclusion criteria: * male or female * age 35 to 75 years * body mass index (bmi) 20 to 40 kg/m2 * willing and able to provide informed consent * willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection * not pregnant or lactating * previous conservative treatment regimen for osteoarthritis (oa) * diagnosis of idiopathic oa of the index knee * oa symptoms for \>= 6 months * index knee kellgren-lawrence (k-l) grade of ii or iii * index knee baseline summed womac pain score \>= 200mm and \< 400mm after nsaid washout * contralateral knee k-l grade 0, i or ii * contralateral knee baseline womac pain score \< 150mm after nsaid washout main exclusion criteria: * joint disorders which could interfere with treatment effectiveness * joint disorders which could interfere with study assessments * arthroscopy of either knee within 3 months of screening * open surgery of index knee within 12 months of screening * open surgery of contralateral knee within 3 months of screening * injection of hyaluronic acid (ha) in either knee within 6 months of screening * injection of steroid in index knee within 3 months of screening * any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection * synovial fluid aspirate volume \> 20 milliliters (ml) * visual appearance of synovial fluid that contraindicates injection * index knee range of motion \< 90 degrees * subject participation in other research study within 30 days of screening * subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study * unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable * other medication or treatments that could interfere with study injection or assessments * allergy to gram positive bacterial products or intolerance of acetaminophen * active fibromyalgia * peripheral neuropathy severe enough to interfere with evaluation of either knee * vascular insufficiency severe enough to interfere with evaluation of the subject * hemiparesis involving either lower extremity * systemic bleeding disorder * other conditions which may adversely affect the success of the procedure

Keywords: monovisc® hyaluronic acid gel injection knee