Kornimate/medical-research-clean huggingface dataset:
hemodynamic optimalization in pediatric patients

Conditions: Hemodynamic Instability

Summary: hemodynamic unstability, defined by macrocirculation and/or microcirculation dysfunction or alteration is common in critically ill pediatric patients. the initial treatment of hemodynamically unstable patient is the fluid resuscitation (fluid challenge therapy). however, the stabilization of hemodynamics only with fluid resuscitation can be achieved in less than 50% pediatric patients. in case of persistent hypotension (defined as mean arterial pressure below 65 mmhg, or by the formula - 55 + 1,5 x age in years), or in case of persistent lactate levels and base deficit elevation is the catecholamine therapy method of choice in case of sufficiently restored intravascular volume. in adult patients, the drug of choice (the first line therapy of persistent hypotension) is considered norepinephrine (based on evidence-based data). the norepinephrine is administered intravenously in form of continuous infusion, with the dose adjusted to the target level of mean arterial pressure (map). it should be preferably administered through the central venous catheter to minimize the complications associated with the damage of the peripheral vein wall damage in case of administered into the peripheral vein. due to lack of evidence-based data (ebm) for pediatric population, there is still significant heterogenity of clinical practice and dobutamin, dopamine, norepinephrine and epinephrine are being used for hemodynamically unstable pediatric patient.

after ethics committee approval, pediatric patients admitted to the departement of pediatric anesthesiology and intensive care with the need of vasopressor and/or inotrope therapy in the selected study period will be included. the primary aim of the trial is the describe the therapy effect on the vital signs (heart rate, blood pressure), level of lactate and base deficit in 1,3,6,12,24,48 and every other 24th hours. the secondary aim of the trial is the incidence of complications: arrythmias, hypertension, defects of peripheral perfusion, mortality, renal failure, the pelod-2 and psofa score at admission and every next 24 hours. the cumulative overall dose and the cumulative 24 hours dose of vasopressors/inotropes will be recorded.

Eligibility criteria:
inclusion criteria: * pediatric patients in selected age interval * admitted to the pediatric intensive care unit * hemodynamic instability with the need for vasopressor and/or inotrope therapy exclusion criteria: * patients with no hemodynamic instability * patients with achieved hemodynamic stability after fluid resuscitation

Keywords: hemodynamic instability vasopressor therapy pediatric patient norepinephrine epinephrine dobutamine
delivering emt via telehealth to children and families

Conditions: Language Impairment

Summary: in the u.s., approximately 12% of children under 36 months have language impairments, yet less than 2% receive early language intervention. early language intervention is underutilized nationally, with pronounced service gaps in rural communities. this gap is a significant issue because children with language impairments are at increased risk for learning and reading disabilities that can persist into adulthood. telehealth has the potential to mitigate service gaps by improving access to treatments, increasing the availability of clinicians with expertise in language intervention, and reducing healthcare costs. telehealth can alleviate logistic and geographic barriers to treatment facing children with disabilities and their families in rural communities. however, there is insufficient evidence on the effects of telehealth interventions for children with language impairments under 36 months. consequently, there is an urgent need to explore innovative telehealth interventions with potential to improve the quality and efficiency of language treatments. the investigators will conduct a feasibility trial (small randomized control trial) to evaluate a telehealth intervention for children with language impairments and their caregivers.

aim 1: explore stakeholders' preferences, experiences, and information needs regarding the delivery of language interventions via telehealth. ethnographic interviews will be conducted with 16 stakeholders (n= 8 caregivers, 8 clinicians) to explore their preferences, experiences, and needs. aim 2: determine the effect of telehealth enhanced milieu teaching on caregiver language strategy use. caregiver language strategy use will be compared between the intervention and control groups (n = 28 families, 14 intervention,14 control) during semi-structured caregiver-child interactions.

Eligibility criteria:
inclusion criteria: * (a) child age between 18 and 36 months * (b) developmental age of 9 months as measured on the visual reception scale of the mullen scales of early learning (msel; 1995) * (c) language delay as measured by a score of at least 1.33 sd below the mean on the preschool language sclaes-5th edition (pls-5; zimmerman, steiner, \& evatt-pond, 2011), and * (d) hearing (with or without amplification) reported at 25db hl or better confirmed by audiological testing, or medical record. exclusion criteria: * (a) primary diagnosis of any specific disability other than a language impairment including severe motor impairment * (b) concomitant sensory impairments (e.g., hearing impairment, blindness), and * (c) symptoms of autism spectrum disorder as measured by a result indicating "high risk" for autism (e.g., scores of 8 or higher) on the modified checklist for autism in toddlers-revised with follow-up (mchat-r/f robins, fein \& barton, 2009).

Keywords: language impairment telehealth rural enhanced milieu teaching
effects of ondansetron dose and timing on post-operative nausea and vomiting

Conditions: Post-operative Nausea and Vomiting

Summary: the aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. primary outcome will be incidence of ponv in the pacu prior to discharge.

Eligibility criteria:
inclusion criteria: * asa i, ii, iii presenting for ambulatory surgery to be performed under general anesthesia exclusion criteria: * patients with allergies or contraindications to study medications

Keywords: ambulatory surgery post-operative nausea and vomiting general anesthesia
analytical performance evaluation of blood glucose monitoring systems- investigator sponsored contour® xt comparator study - ulm germany

Conditions: Diabetes

Summary: in this clinical trial, accuracy evaluation of bayer contour xt blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * male or female subjects with type 1 or type 2 diabetes or healthy subjects * for bg adjustment people with type 1 diabetes exclusion criteria: * severe acute illness that, in the opinion of the investigator, might pose additional risk to the patient * chronic illness that, in the opinion of the investigator, might pose additional risk to the patient * current condition that, in the opinion of the investigator, doesn't enable subject to participate in the study * for bg adjustment people with type 1 diabetes without chd, condition after myocardial infarction, paod, cerebral events or hypoglycaemia unawareness * legal incompetence or limited legal competence * age \< 18 years * dependency from the sponsor or the clinical investigator * mental incapacity or language barriers precluding adequate compliance with the study procedures

Keywords: blood glucose monitoring systems iso 15197 system accuracy
ovulation triggering 2 vs 3 follicles

Conditions: Infertility

Summary: poor responders in in-vitro fertilization (ivf) cycles represent a major challenge for fertility specialists. although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one ivf cycle. traditionally, ivf cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (iui) due to the low pregnancy rates associated with these cycles. the minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. this retrospective quality control study aims to compare pregnancy rates in ivf cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles.


Eligibility criteria:
inclusion criteria: * stimulated ivf cycle at clinique ovo * patients with a maximum of 3 mature follicles (≥14mm) on the day of ovulation trigger exclusion criteria: * cycle cancelation due to no follicles * history of recurrent implantation failure * contraindication of ovulation induction medication
genetic epidemiology of cvd risk factors

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine the role of genetic factors influencing risk factors for cardiovascular disease, ultimately identifying specific genes influencing the age-related progression of cardiovascular disease risks.

background: understanding the genetic basis of common multifactorial diseases such as cardiovascular disease (cvd) remains an elusive goal, but the great advances in molecular genetic technology, statistical genetic methods, and phenotypic assessment of cvd risk factors in recent years have facilitated more sophisticated genetic studies of risks for heart disease. the study is a follow-up to one conducted in the 1970's and 1980's. the availability of 5 large kindreds first identified and recruited as part of the "high blood pressure in the young" program is an important resource. the investigators have an extensive array of baseline data that was collected in the late 1970s and early 1980s on 750 participants stemming from that project, although some data are available only on a subset of participants. the present study population centers on 764 individuals in five large, multigenerational, extended families (four white and one african-american) originally examined 25 years ago. data collected from the original participants include hundreds of biochemical, medical, physiological, behavioral, physical, psychological, genetic and demographic traits. design narrative: the study consists of four specific aims: 1) collect 25-year follow-up data from approximately 500 of the original participants, and new data from approximately 500 of their relatives not examined in the original study. the cardiovascular disease risk factor phenotypes to be collected include hemodynamic measures, carotid intima-media thickness, and measures of cardiopulmonary function. 2) obtain dna samples from these 1,000 individuals and use modern high-throughput molecular genotyping methods to create a 10 cm genetic marker map. 3) quantify and characterize the nature of genetic influences on cvd risk factors using quantitative genetic methods suited for cross-sectional and serial (follow-up) data from relatives in large extended families. 4) conduct linkage analyses to identify chromosomal regions (qtls) harboring genes that influence individual variation in cardiovascular disease risk factors. following these linkage analyses, the investigators will examine more closely the strongest linkage signals with fine mapping linkage analysis in order to narrow chromosomal regions of interest. the study is a collaboration between wright state university and the southwest foundation for biomedical research.

Eligibility criteria:
no eligibility criteria
impact of best practice alerts in cardiology outpatient clinics

Conditions: Hypertension; Atrial Fibrillation

Summary: this quality improvement intervention seeks to implement two best practice alerts (bpas) for use in cardiology clinics while simultaneously evaluating the impact of each bpa- one for patients with uncontrolled blood pressure and one for patients with atrial fibrillation not on anticoagulation.

best practice alerts based will be created for hypertension and atrial fibrillation. outpatient cardiology providers will be randomly allocated into one of three groups. the first group will receive the bpa for hypertension alone. the second group will receive the bpa for atrial fibrillation alone. the final group will receive both bpas. the rate of blood pressure control for all patients and anticoagulation in patients with atrial fibrillation in each group will be evaluated prior to and after the implementation of the bpas to determine the effect of the bpa.

Eligibility criteria:
inclusion criteria: * all patients seen routinely by cardiologists at duke exclusion criteria: * none
open label extension study of [s,s]-reboxetine in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this is a study to investigate the long-term safety and effectiveness \[s,s\]-reboxetine in relieving the symptoms of fibromyalgia in patients.


Eligibility criteria:
inclusion criteria: * male or female of any race, at least 18 years of age * patients must meet the acr criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) * completed preceding double-blind randomized, controlled trial exclusion criteria: * patients with other severe pain (eg, diabetic peripheral neuropathy and postherpetic neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia * patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder * a current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression * history of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

Keywords: phase 3, safety study, [s,s]-reboxetine, fibromyalgia
azp-3601 sad and mad study in healthy subjects and patients with hypoparathyroidism

Conditions: Chronic Hypoparathyroidism

Summary: this study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics of azp-3601 following single and repeated administration in both healthy volunteers and patients with chronic hypoparathyroidism (chp) the protocol includes 3 parts: * part a: first-in-human single ascending dose (sad) study in healthy volunteers * part b: multiple ascending dose (mad) study with 2 weeks of treatment in healthy volunteers * part c: open-label mad study with a total treatment duration of 3 months in patients with chp.


Eligibility criteria:
main inclusion criteria * part a: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2 * part b: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a body mass index of 19 to 28 kg/m2 * part c: 1. male and female patients aged 18 to 75 years inclusive 2. history of chp for ≥12 months at the time of screening with documentation of two measurements of serum calcium and parathyroid hormone (pth). 3. requirement for therapy with calcitriol ≥0.25 μg per day or alphacalcidol ≥0.50 μg per day (both are active vitamin d supplements), and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above normal dietary calcium intake at baseline assessments. main exclusion criteria * parts a and b: 1. clinically significant abnormal lab values, as judged by the investigator 2. using tobacco products with 3 months prior to first drug administration 3. history of alcohol abuse or drug addiction * part c: 1. known history of autosomal-dominant hypocalcemia (adh resulting from gain-of-function calcium-sensing receptor \[casr\] or gna11 mutations) or pseudohypoparathyroidism (impaired responsiveness to pth) 2. any current disease that might affect calcium metabolism or calcium phosphate homeostasis other than hp 3. use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides (e.g., digoxin or digitoxin) or systemic corticosteroids within 4 weeks prior to start of treatment. 4. previous treatment with pth-like drugs, including pth(1-84), pth(1-34), or abaloparatide, within 3 months prior to screening.
clinical study on neoadjuvant therapy of homoharringtonine combined with androgen deprivation for prostate cancer

Conditions: Prostate CA

Summary: the high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (psa). at the same time, few trials reported pathological complete response (pcr) and minimal residual lesion (mrd). the purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

this study will divide patients into two sections, and eligible patients will be enrolled. patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into two groups, homoharringtonine combined with androgen deprivation and placebo combined with androgen deprivation, according to a computer-generated random sequence. treatment group was given 1mg intravenous infusion of homoharringtonine + 250ml 5% glucose injection, once a day for two consecutive days, and repeated medication after three weeks of intermittent treatment for two cycles + continuous androgen deprivation therapy; in the placebo group, the same size, color, and dosage form of 5% glucose injection were used, and the administration was the same as in the treatment group. after starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood psa and other indicators. at the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Eligibility criteria:
inclusion criteria: * ① age ≥18 years and ≤85 years; * histologically confirmed prostate cancer without small cell features; * metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or ct3-4 stages; ④the score of ecog (eastern cooperative oncology group) was 0-1; ⑤ all patients voluntarily sign informed consent, and can adhere to treatment and follow-up; exclusion criteria: * ①any previous or ongoing pca treatment, including radiotherapy, chemotherapy, adt, etc. * previous prostatectomy; * any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient * allergic to the drugs used; ⑤ refuse to undergo radical prostatectomy; ⑥ according to the investigator's judgment, it is not suitable to participate in this clinical trial;
increasing hepatitis b screening among korean church attendees

Conditions: Hepatitis B

Summary: the purpose of this study is to design an intervention to increase hepatitis b (hbv) screening among korean americans. the investigators will design a culturally specific intervention (educational sessions) and test the effect of the intervention on 1200 korean americans. all subjects will be interviewed before the intervention/control sessions and 6 months after the sessions to assess hbv screening levels in the two groups. self-reported hbv screening will be verified by a review of subjects' medical records. the primary study hypothesis is that the intervention group will have a higher rate of hbv serologic testing at follow-up compared to the control group.

the purpose of this study is to design an intervention to increase hepatitis b (hbv) screening among korean americans. the investigators will design a culturally specific intervention; an educational small group discussion led by a trained korean leader. the effect of the intervention will be tested on 1200 korean americans. subjects will be recruited at korean churches and invited to join a one-hour discussion of health issues with other members of their church. one half of the subjects will participate in the intervention group. these subjects will discuss hbv and will receive resources related to hbv and where to obtain screening. the other half of the subjects will participate in the control group. these subjects will discuss nutrition and physical activity and will receive resources related to these topics, but not related to hbv and where to obtain screening. all subjects will be interviewed before the sessions and 6 months after the sessions to assess hbv screening levels in the two groups. self-reported hbv screening will be verified by a review of subjects' medical records. the primary study hypothesis is that the intervention group will have a higher rate of hbv serologic testing at follow-up compared to the control group. secondary hypotheses are: the intervention group will have a higher level of knowledge of hepatitis b and liver cancer at follow-up compared to the control group. the effect of the intervention on hepatitis b serologic testing will be mediated by knowledge of hepatitis b and liver cancer.

Eligibility criteria:
inclusion criteria: * korean ancestry * have not previously received hbv screening or do not know the results of previous hbv screening test * no history of liver cancer or liver disease * current resident of the los angeles area exclusion criteria: * younger than 18 years of age or older than 64 years of age * not of korean ancestry * previously screened for hbv * history of liver disease or liver cancer * not a current resident of the los angeles area

Keywords: hepatitis b screening korean americans