Kornimate/medical-research-clean huggingface dataset:
testosterone and cortisol levels in infants

Conditions: Infant, Premature; Infant, Very Low Birth Weight

Summary: very low birth weight (vlbw) infants have more health and developmental problems than normal birth weight full-term infants. these problems are more common in males than female vlbw preterm infants. male vlbw infants also experience less positive mother-infant interactions than females, especially when mothers are emotionally distressed. this is a significant problem because positive mother-infant interactions function as an important protective factor against the negative health and developmental outcomes associated with prematurity. the source of the vulnerability of male vlbw infants to health problems, suboptimal mother-infant interactions, and poor development goes beyond gender socialization differences and includes biological factors. identification of infant and maternal biological markers/predictors of infant health and developmental outcomes could ultimately lead to interventions for vlbw preterm infants. the purpose of this study is to confirm that testosterone rather than cortisol is a more reliable marker/predictor of complications affecting infants' health outcomes, mother-infant interactions, and infant cognitive/motor/language developmental outcomes; and that male infants exhibit a higher sensitivity to testosterone levels than female infants. this longitudinal study will examine the associations of the steroid hormones, testosterone and cortisol, levels with infant health, mother-infant interactions, and infant cognitive/motor/language development ('infant development') in very low birthweight (vlbw, bw \< 1,500 g) preterm (gestational age \< 32 weeks gestation) infants after adjusting for maternal physical and mental health state, infant socioemotional and behavioral development, and characteristics of infants and mothers. concurrent and repeated measurement of testosterone and cortisol levels both in infants and mothers will be conducted through infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected age).


Eligibility criteria:
inclusion criteria: * neonates will be included if they are less than or equal to 32/0 weeks gestational age at birth and have a birth weight \< 1500 grams. * mothers will be included if they are (1) older than 15 years, (2) able to communicate in english or spanish, (3) primary caregivers of the newborn. exclusion criteria: * neonates will be excluded if they (1) are born \> 32/0 weeks ga, (2) weigh more than 1,500 grams at birth, (3) have congenital abnormalities, (2) will be discharged before day 7 of life, (3) have a positive urine drug screen, or (4) are being placed for adoption after discharge from the hospital. * mothers will be excluded if they have (1) narcotic or injection drug dependence or (2) a documented serious health (e.g., cancer or hiv positive) or psychological (e.g., schizophrenia) problem.
study of lm-108 as a single agent or in combination with toripalimab in subjects with advanced solid tumours

Conditions: Advanced Solid Tumor

Summary: this is a phase i/ii, open-label, dose-escalation and dose-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lm-108 (an anti-ccr8 mab) as a single agent or in combination with toripalimab in advanced solid tumours.


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0-1. 2. histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 3. at least one measurable disease for expansion cohorts per response evaluation criteria in solid tumours (recist) v1.1. 4. subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. exclusion criteria: 1. have received anti-ccr8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose. 2. subjects with anti-tumor treatment within 21 days prior to 1st dosing of lm-108, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. 3. any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of ctcae v5.0. 4. subjects with uncontrolled tumor-related pain. 5. subjects with known brain metastases. 6. uncontrollable clinical third luminal effusion. 7. known history of autoimmune disease. 8. use of any live attenuated vaccines within 28 days. 9. have severe cardiovascular disease. 10. uncontrolled or severe illness. 11. history of immunodeficiency disease. 12. active malignancies which are likely to require the treatment. 13. child-bearing potential female. 14. have psychiatric illness or disorders.
fenofibrate role in breast cancer patients

Conditions: Breast Cancer

Summary: the aim of the study is to assess the efficacy of fenofibrate in either reversing and/or preventing the development of pipn in breast cancer patients treated with paclitaxel-based regimen. the primary outcome :clinical improvement of neuropathic pain and grade by 1-ct-ctcae -version-4 \& fact/gog-nt-12 questionnaire and its effect on quality of life (qol). the secondary outcome : the efficacy of fenofibrate in either reversing and/or preventing the development of pipn via alteration of either nerve growth factor (ngf) or/ and/( nfl).

ethical committee approval will be obtained from ethics committee of faculty of pharmacy, damanhur university. 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. fifty female patients with diagnosed breast cancer, who are candidates for will be recruited from damanhur oncology center. 4. all enrolled patients will be randomly assigned into two arms: group 1 ( arm a) (n=25: will receive four cycle of ac followed by paclitaxel 80 mg/m2 weekly for 12 week. group 2 ( arm b) (n=25): will receive the same regimen as group1 in addition to 160mg (17 ,18 ) fenofibrate once daily for 3 month. 5. all patients will be submitted to: * full patient history and clinical examination. * routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests). * serum samples will be collected from patients at the time of admission for measuring the neuropathy biomarkers nerve growth factor (ngf) and (nfl) to lipid profile . * clinical assessment of neuropathic pain using fact/gog ntx 12 questionnaire and nct-ctcae -version-4 . 6. all patients will be followed up during paclitaxel treatment period (12 weeks). at the end of paclitaxel treatment, serum samples will be collected from patients for measuring the biomarkers . 7. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 8. results, conclusion, discussion, and recommendations will be given.

Eligibility criteria:
inclusion criteria: 1. included a diagnosis breast cancer with age \> 18 years. 2. naïve to chemotherapy exclusion criteria: 1. concurrent administration (statins , cyclosporine) . 2. advanced liver disease (defined as liver enzyme elevation \>3-fold upper limit of normality, or cirrhosis); chronic kidney disease (ckd, defined as an egfr \<60 ml min-1 1.73 m-2); acute or chronic pancreatitis and diabetes. 3. patients with a history of allergy to fenofibrate. 4. concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. 5. pregnancy or breast feeding.
albuterol integrated adherence monitoring in children with asthma

Conditions: Asthma in Children

Summary: the investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the children's hospital of los angeles

this study is designed to (1) determine whether an integrated eam albuterol rescue inhaler can increase proper use (2) determine if the monitoring capabilities of the device (flow rate, warnings) and/or increased proper use from having the device correlate with better outcomes. the investigators will also have patients perform at-home gamified spirometry (aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change outcomes.

Eligibility criteria:
inclusion criteria: * patients 8 to \<19 years of age with a diagnosis of asthma as icd-9 code 493 or icd-10 code j45 seen in the allergy clinic at chla who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment. exclusion criteria: * patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or age \< 4 (proair® digihaler only approved for subjects 4 years and older). patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc).
transpyloric feeding for prevention of micro-aspiration

Conditions: Microaspiration; Gastro Esophageal Reflux

Summary: to determine the effect of transpyloric (tp) feeding on microaspiration and lung inflammation in ventilated preterm infants.

specific aim 1): to determine the effect of tp feeding on microaspiration and lung inflammation. hypothesis: tp feeding will reduce the microaspiration and pulmonary inflammation in ventilated preterm infants. evaluate markers of microaspiration (pepsin a) and lung inflammation \[total cell counts, nuclear factor-kb (nf-kb) activation, tumor necrosis factor-α (tnf-α), il-1β, il-6, il-8, angiopoietin 2 (ang2), high-mobility group box-1 protein (hmgb1), macrophage migration inhibitory factor (mif) and interferon-γ (ifn-γ)\] in ta samples obtained from preterm ventilated infants with and without tp feeding. specific aim 2): to determine the effect of tp feeding on respiratory support. hypothesis: tp feeding will decrease the respiratory severity score (rss) \[fraction of inspired oxygen (fio2) x mean airway pressure (map)\] and number of infants requiring ventilator support. evaluate respiratory support in preterm ventilated infants with and without tp feeding.

Eligibility criteria:
inclusion criteria: * preterm infants with birth weight \<1500 grams * requiring ventilatory support exclusion criteria: * culture-proven sepsis * ventilator associated pneumonia (vap).
special lower back pillow examination

Conditions: Low Back Pain

Summary: low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. it should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.

we plan to examine the use of a special lower back pillow and the time period of the sitting position. we would like to know how it helps to prevent and treat low back pain. we would like to know more about the people's pillow usage habits. we are planning a questionnaire survey. we combine our own questions with validated, official questionnaires. validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.

Eligibility criteria:
inclusion criteria: * in case of patients with low back pain: chronic pain * in case of asymptomatic individuals: no symptomes exclusion criteria: * serious neurologycal symptomes * serious scoliosis * previous surgery which affected the local stabilizers * serious pulmonar disease

Keywords: lbp special pillow lower back pillow
different spinal needles sizes and dural puncture epidural for labor analgesia

Conditions: Labor Pain; Epidural Analgesia

Summary: the rationale behind the dural puncture epidural (dpe) technique lies in the fact that a dural perforation with a spinal needle purportedly creates a conduit for accelerated translocation of local anesthetics from the epidural to the subarachnoid space. when compared with conventional epidural block, it provides improved sacral block and onset of analgesia. despite the benefits associated, the supportive literature remains scarce. no trial has determined if similar results could be obtained with a smaller needle. in this trial, dpe using 25- and 27-gauge (g) spinal needles are compared. the main outcome will be the time required to obtain a pain score ≤ 1 using a 0-10 numeric rating scale (nrs). the hypothesis is that that both needle sizes will result in similar onset times and therefore designing the current study as an equivalence trial.


Eligibility criteria:
inclusion criteria: * healthy pregnant woman * singleton and vertex presentation * 37-42 weeks of gestational age * active labor with cervical dilation \< 5cm * body mass index between 20 and 35 kg/m2 * desired labor epidural analgesia exclusion criteria: * adults who are unable to give their own consent * presence of any pregnancy-related disease (e.g., gestational hypertension, preeclampsia, gestational diabetes) * known fetal anomalies * increased risk of cesarean delivery (e.g., previous uterine rupture, previous cesarean delivery) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, international normalized ratio ≥ 1.4 or partial prothrombin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to la * prior sacral or lumbar spine surgery

Keywords: labor analgesia dural puncture epidural postdural puncture headache neuraxial analgesia
semaglutide for the treatment of cognitive dysfunction in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will examine whether semaglutide may improve cognitive function in individuals with major depressive disorder (mdd).

this is a 16-week, placebo-controlled, randomized, double-blind, clinical trial, involving 60 overweight individuals with mdd and pre-treatment cognitive dysfunction. study participants will receive one of the following study interventions in addition to 'standard of care' treatment: once-daily semaglutide, initiated at 3 mg/day for 4 weeks, increased to 7 mg/day for 4 more weeks and titrated to 14 mg/day for the subsequent 8 weeks; or matching placebo. participants will be assessed to examine the effect of semaglutide on their cognitive function.

Eligibility criteria:
inclusion criteria: 1. informed consent before study-related activity 2. individuals between the ages of 18 and 60 who meet diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) criteria for mdd 3. overweight (i.e. bmi ≥ 25 kg/m2) 4. below-average (i.e. \>1 sd below norm) performance in the trail making test-b (tmtb) exclusion criteria: 1. current, or in the past 4 weeks, treatment with other oral hypoglycemic agents and/or insulin 2. diagnosis of possible or probable alzheimer's disease, mild cognitive impairment, or any other dementia 3. history of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration 4. severe mood episode, defined as a hamilton depression rating scale (hamd-17) score of \>23 5. actively suicidal or evaluated as being a suicide risk (operationalized as a score of ≥3 on hamd-17 suicide item and/or by clinical assessment). 6. substance use disorder within 3 months before screening or a positive baseline toxicology screen 7. dsm-5 diagnosis of obsessive compulsive disorder, posttraumatic stress disorder (current or within the last year), or borderline personality disorder as assessed by a study investigator 8. presence of absolute or relative contraindication to semaglutide (e.g. hypersensitivity to semaglutide, hepatic impairment, renal impairment with chronic kidney disease stage 3 and above, personal or familial history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2) 9. history of diabetic retinopathy 10. history of pancreatitis or pancreatic cancer 11. presence of clinically unstable general medical illness 12. pregnancy or breastfeeding women
lactobacillus reuteri dsm 17938 in functional constipation

Conditions: Functional Constipation

Summary: the diffusion of gastrointestinal (gi) chronic diseases is significantly increased during the last century in western countries. in the usa and northern europe, constipation is twofold the prevalence found in the east and southern europe. in italy, constipation affects up to 15-17% of the whole adult population. of them, more than half (about 10%) treats this disorder by assuming laxatives, while the remaining does not even assume drugs. a close relationship between intestinal environment and bacterial flora has been found. as a matter of fact changes in the intestinal physiology can modify the composition of bacterial flora as well as modifications in the intestinal microbiota can modify the physiology of the gut. the probiotic effects on the gi motility can be due to substances released by bacteria and/or products of their fermentation. also, probiotic may indirectly act by the release of neuroendocrine factors and/or substances released by the immune system. clinically, it has already been demonstrated that probiotics exert a positive effect on symptoms and intestinal habit in constipated ibs patients. in this framework, the idea to perform a long lasting intervention study in patients with functional constipation treated with probiotics sounds convincing. the present study is a randomized, double blind, placebo controlled, monocentric study, concerning the evaluation of efficacy of 3 months administration of lactobacillus reuteri dsm 17938 in patients with functional constipation, as defined by the rome criteria. clinical, physiological, hematological and immunologic variables will be evaluated.


Eligibility criteria:
inclusion criteria: * fulfilment of the rome criteria iii for functional constipation * availability of at least one gi imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema) * commitment to availability for the whole study period exclusion criteria: * major abdominal surgery * presence of any concomitant diseases such as organic gi diseases and/or lactose and gluten intolerance; medical or psychiatric illness * alarming symptoms (rectal bleeding, weight loss, etc) * family history of peptic ulcer, colorectal cancer, or ibd * abnormal laboratory data or thyroid function.

Keywords: functional constipation functional foods probiotics lactobacillus reuteri
assessment of sensitivity of the hypothalamic gnrh pulse generator to estradiol and progesterone inhibition

Conditions: Hyperandrogenemia; Polycystic Ovary Syndrome

Summary: gonadotropin-releasing hormone (gnrh) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (lh) and follicle-stimulating hormone (fsh). lh and fsh control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. progesterone and estrogen then decrease the number of gnrh pulses produced by the brain (and therefore the number of lh pulses from the pituitary). the ability to decrease gnrh pulses seems to be very important for normal menstrual function in adult women. the purpose of this study is to learn more about how gnrh and lh pulses are controlled during puberty. the information gathered in this study will hopefully allow us to learn more about how menstrual cycles are normally established in girls during puberty.

in this study, the investigators will aim to discover the effect of 7 days of estrogen and progesterone on gnrh pulses in girls in early and mid puberty. ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

Eligibility criteria:
inclusion criteria: * girls ages 8 to 14 * tanner 1-3 pubertal stage * pre-menarchal * normal screening labs exclusion criteria: * abnormal screening labs * congenital adrenal hyperplasia * hyperandrogenism (e.g., hirsutism, elevated free testosterone level) * hemoglobin \<12 mg/dl or hematocrit \< 36% (subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit.) * weight \< 31 kg * history of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer * on hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study * pregnant or breast feeding * participation in a research study within the past 30 days that involved taking a study drug. * participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days. * cigarette smoking * history of surgery that required bedrest within the past 30 days * family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy) * in order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be tanner stage 3
improving health outcomes and equity by targeting postpartum mothers at highest risk

Conditions: Maternal Behavior; Postpartum Depression

Summary: the goal of this educational clinical trial is to identify black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. the main question\[s\] it aims to answer are: * how can the investigators help postpartum black people who have poor outcomes by decreasing the number of ed visits/readmissions for postpartum people within the first 30 days postpartum? * how can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ed visits? participants will be put into the study group or control group. the study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum.


Eligibility criteria:
inclusion criteria: * postpartum patients who have delivered a baby at the hospital of university of pennsylvania * ages 18 or older * self-identify as black (listed on chart) * speak english * able to read * other characteristics defined by our risk prediction model (algorithm) exclusion criteria: * unable to provide informed consent * speaks a language other than english

Keywords: postpartum