Kornimate/medical-research-clean huggingface dataset:
influence of probiotics on prevention of atopy, atopic disease and immunological responses

Conditions: Eczema; Asthma; Allergic Rhinitis

Summary: this will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with bifidobacterium longum and lactobacillus rhamnosus gg. the primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.

one of the most important early influences on the immune system is the intestinal microflora. the gastrointestinal tract, being the largest body area interacting with the environment, is one of the earliest to be colonized and is quantitatively the most important source of microbial stimulation for the immature immune system. probiotics are helpful bacteria from healthy intestinal tract, and have shown potential in reducing allergy. this is extremely important as allergic diseases are on the rise worldwide. probiotics are safe, easy to administer and can be used early for intervention as allergic sensitization, once established, is difficult to reverse. this double-blind, randomized placebo-controlled study has recruited 253 children from birth. these babies, with a family history of atopic disease, will be randomly assigned into one of 2 groups to receive either normal infant formula or formula with bifidobacterium longum and lactobacillus rhamnosus gg. the formula will be consumed postnatally for 6 months, after which the child will continue with normal follow-on milk. children will be examined at the neonatal period and at 1, 3, 6, 12 and 24 months. blood samples will be collected at birth (cord blood) and at 1 year of age. blood will be analyzed for cytokines, total ige and specific ige. skin prick test for common allergens will also be performed at 1 year of age. stools will be collected at 5 days, 1, 3, 12 months and analyzed for the pattern of stool colonization.

Eligibility criteria:
inclusion criteria: * parents agree to the subject's participation in the study and informed consent has been obtained. * either parent or sibling (i.e. first degree relative) has a history of atopy. this will be evidenced by a doctor-diagnosis of asthma, allergic rhinitis or eczema and a positive skin prick test to any of a panel of common allergens. * the subject is born at above 35 weeks of gestation and weighs above 2 kg. * the subject does not have major congenital malformations/major illness. * family appears to be able to successfully complete this trial. exclusion criteria: * mother has a medical illness, which in the opinion of the investigator, will interfere with the results of the study. * the parent is unable/unwilling to comply with procedures. * the parents choose to totally breast-feed the child.

Keywords: probiotics eczema asthma allergic rhinitis prevention immunological responses
cooperative huntington's observational research trial

Conditions: Huntington Disease

Summary: the purpose of this study is to collect prospective data from individuals who are part of a huntington disease (hd) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about hd, develop potential treatments for hd, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of hd.

cohort (cooperative huntington observational research trial) is a coordinated research effort by huntington study group research centers worldwide to prospectively collect data from consenting individuals who are affected by huntington's disease (hd) and who are part of an hd family. the systematically accrued data from annual prospective assessments will relate clinical characteristics (phenotypes) between families with genetic and environmental factors. the knowledge from these relationships will better inform us about the onset and progression of hd, help identify potential interventions for hd, and aid in planning research studies of experimental treatments aimed at slowing or postponing the onset of hd. the consented collection of biological samples will further provide research material and correlative data for scientists to identify biomarkers that parallel the development and progression of hd. identification of biomarkers will in turn contribute to our understanding of hd and enhance the efficiency and power of disease-modifying therapeutic trials.

Eligibility criteria:
inclusion criteria: * (1) manifest/pre-manifest hd: individuals of any age who are affected by hd or an individual 18 years or older who - has tested positive for the hd gene. * (2) individuals at risk: an individual 18 years or older who has not undergone dna testing for the mutation responsible for hd and who is a first degree relative (parent, sibling, child) of an individual with manifest or pre-manifest hd or an older adolescent 15 to 17 years of age who has a parent with manifest hd or pre-manifest hd enrolled in cohort. * (3) adults at secondary risk: an individual 18 years of age or older who has not undergone dna testing for the mutation responsible for hd and is a grandparent or grandchild of an individual enrolled in cohort who has manifest hd or pre-manifest hd * (4) control: a spouse or caregiver, 18 years of age or older, of an individual enrolled in cohort who has manifest hd or pre-manifest hd * (5) adult gene negative: an individual, 18 years of age or older, with a family history of hd who has undergone dna testing and does not carry the genetic mutation responsible for hd. exclusion criteria: * (1) anyone who does not fit the inclusion criteria

Keywords: huntington disease, observational, family members, biomarker
transition from donor milk: a feasibility study

Conditions: Preterm Birth; Nutrition, Healthy

Summary: preterm and very low birth weight (vlbw, \< 1,500g) infants who receive donor human milk (dhm) often experience slow postnatal growth and no clinical data is available to guide the duration of dhm for preterm infants. we hypothesize that transitioning from dhm to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.


Eligibility criteria:
inclusion criteria: 1. greater than 1,250 grams 2. at least 28 days of life 3. diet consisting of donor human milk with/without mother's own milk exclusion criteria: 1. birth weight below the 5th percentile 2. history of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder 3. congenital anomalies 4. care team discretion

Keywords: newborn human milk
in vivo effects of c1-esterase inhibitor on the innate immune response during human endotoxemia - vector ii

Conditions: Innate Immune Response; Endotoxemia; Inflammation; Sepsis

Summary: excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. this can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (mods) and acute respiratory distress (ards). in marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs. the investigators hypothesize that pre-treatment with c1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response. in this study, human endotoxemia will be used as a model for inflammation. subjects will, prior to endotoxin administration, receive c1 esterase inhibitor or placebo. blood will be sampled to determine the levels of markers of the innate immune response.


Eligibility criteria:
inclusion criteria: * healthy male volunteers (18-35 years old) exclusion criteria: * relevant medical history * drug-, nicotine-abuses * tendency towards fainting * hyper- or hypotension * use of any medication
polyethyleneglycol3350 laxative vs placebo in constipated children

Conditions: Constipation

Summary: assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.


Eligibility criteria:
inclusion criteria: * male or female outpatients between the ages of 4 to 16 years. * adolescent female patients must not be pregnant or lactating. * constipated according to rome i definition * two or fewer bowel movements during the initial observation week. * absence of a stool impaction * bowel movement after receiving enema * are otherwise in good health, as judged by a physical examination. * parent or guardian is mentally competent to sign an instrument of informed consent exclusion criteria: * patients with heme positive stool at baseline exam. * patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam * patients with known or suspected perforation or obstruction other than fecal impaction. * patients who are breastfeeding, pregnant or intend to become pregnant during the study. * female patients of childbearing potential who refuse a pregnancy test. * patients with a known history of organic cause for their constipation. * patients with congenital malformations that produce constipation (hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases). * history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. * use of concomitant medications that cause constipation * patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures. * patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications. * patients with clinically significant elevations of tsh or abnormal plasma electrolytes. * patients who, within the past 30 days have participated in an investigational clinical study
embolization of pelvic veins in treatment of pelvic congestion syndrome

Conditions: Pelvic Congestive Syndrome

Summary: chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to the international association for the study of pain. in other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition


Eligibility criteria:
inclusion criteria: * clinical symptoms of pelvic congestion syndrome documented by doppler ultrasound * failed medical treatment. exclusion criteria: * endometriosis. * uterine fibroids. * previous pelvic operations. * urological diseases.
radial extracorporeal shockwave therapy (reswt) for coccydynia: a quasi-experimental case series

Conditions: Coccyx Injury

Summary: the aim of this study was to assess whether a pain-adapted protocol of reswt is effective in treating coccydynia.


Eligibility criteria:
inclusion criteria: * age ≥18 years * vas pain level ≥6 * diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia) exclusion criteria: * age \<18 years * local or systemic neurological disease * rheumatological disease * malignant disease * previous spinal surgery or spinal disease * coagulopathies * pregnancy * vas pain level \<6 * recent (≤6 weeks) trauma to the coccyx
safety and efficacy of fentanyl citrate in children

Conditions: Children

Summary: title: safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation objective: to evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation. design: double-blind randomized controlled study patients: patients age 2 months through 18 years who are admitted in seoul national university hospital pediatric intensive care unit, and applied with mechanical ventilation. interventions: after enrollment of patient, blind reagent (fentanyl citrate or normal saline) is prepared by assigned pharmacist. investigators, caregivers, patient, and parents of the patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing pharmacist knows that. protocol: all enrolled patients receive continuous infusion of midazolam and blind reagent. the start time of study is when the continuous infusion of midazolam and blind reagent are begun. assigned research nurse check comfort behavior scale of the patient every hour regularly, and whenever the patient seem to be overactive. endpoint of the study is 48 hours after begining. if there is any adverse effect or unexpected event, however, the study can be early terminated.

comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'. adverse effect of fentanyl include hypotension, coma, and ileus. unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.

Eligibility criteria:
inclusion criteria: * children mechanically ventilated * age : from 2 months to 18 years exclusion criteria: * children with neurologic disease * children with drugs which can affect the level of consciousness * children with renal disease * children with hypotension (systolic blood pressure \< 70 + (2 x age in year) mmhg)

Keywords: mechanical ventilation sedation fentanyl midazolam comfort behavior scale
the impact of citrus products on cardiovascular health

Conditions: Healthy; Overweight and Obesity

Summary: epidemiological studies have indicated that the consumption of citrus fruit is inversely associated with the risk of cardiovascular disease. however, clinical data regarding the effects of blood orange juice upon endothelial function is scarce. this randomised, crossover study investigates whether blood orange juice compared to a control drink improves blood vessel function and other cardiovascular health indicators (such as blood pressure and blood lipids). all the subjects will be asked to consume blood orange juice and a control drink in a randomised order, each over a 2-week period, divided by a 1-week wash out period.

endothelial function measured via flow mediated dilation (fmd), blood pressure, anthropometric measures, lipid profile, high-sensitivity c-reactive protein (hscrp) and endothelin 1 (et-1), cyclic guanosine monophosphate (cgmp) will be evaluated in healthy overweight/obese caucasians prior to and following 2-week consumption of blood orange juice and a control drink. evaluation of endothelial function as measured by fmd will be conducted on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in premenopausal women, which will be monitored in serum samples.

Eligibility criteria:
inclusion criteria: * generally healthy * caucasians (of european origin) * bmi \> 25 kg/m2 exclusion criteria: * presence of cardiovascular diseases * smoking * use of medications or dietary supplements (vitamins, antioxidants) * on a special diet and/or a training program to change weight

Keywords: endothelial function flow mediated dilation lipid profile blood pressure flavanones caucasian
pemf and pec blocks in mastectomy reconstruction patients

Conditions: Breast Cancer Female

Summary: this is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (pemf), pectoral interfascial block (pib), and placebo on postoperative pain control. this study has the interdisciplinary cooperation of the regional anesthesia group, and the breast and plastic surgery divisions. all female patients with breast cancer evaluated at columbia university medical center (cumc) who are undergoing unilateral or bilateral mastectomy with tissue expander reconstruction will be offered enrollment in this prospective study.

chronic pain after mastectomy, or breast tissue removal, is very common with almost half of women experiencing some type of residual pain and even 13% characterizing it as severe. poor acute postoperative pain control is not only associated with development of chronic pain, but has also been shown to be associated with delayed wound healing. therefore, optimization of postoperative pain control is paramount not just for patient comfort, but to decrease immediate and long-term postoperative complications. there are two adjunctive modes of perioperative pain control currently in use at columbia university medical center (cumc). the first mode uses pulsed electromagnetic fields (pemf) and consists of a noninvasive device placed over dressings around the surgical site. the second is a regional anesthetic and -the pectoral interfascial block (pib) in which a long-lasting local anesthetic (bupivacaine/ropivacaine) is injected into the surgical dissection area. both of these techniques for postoperative analgesia have been shown to be effective in different types of breast surgery, but there is no current literature comparing the two modalities in their efficacy in reducing postoperative pain. there is also no current literature in their efficacy in the mastectomy and tissue expander patient population. the proposed trial is a prospective, randomized, controlled, double-blind trial to evaluate the efficacy of these two modalities of postoperative analgesia in patients undergoing mastectomy and tissue expander reconstruction.

Eligibility criteria:
inclusion criteria: * subjects must be female * subjects must be 18 years or older * subjects must be undergoing unilateral or bilateral mastectomy with tissue expander reconstruction exclusion criteria: * allergy to all narcotic medications * intake of any chronic opioids or pain medications preoperatively for a chronic condition or chronic use.

Keywords: mastectomy tissue expander pemf pib
medical management of sleep disturbance during opioid tapering

Conditions: Opioid Dependence; Opioid Withdrawal; Sleep Disturbance

Summary: this study will evaluate whether a dual orexin-receptor antagonist approved by the fda for sleep disturbance, suvorexant (suvo; belsomra), will increase total sleep time in patients with opioid use disorder (oud) undergoing supervised withdrawal. this study is designed as a dose-finding study of suvo compared to placebo. briefly, oud patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. all participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. participants will be randomized to receive either placebo, low dose suvo, or high dose suvo and the investigators hypothesize that one or both doses of suvo will improve total sleep time relative to placebo. patients will attend a single follow-up session, 5-10 days following discharge.


Eligibility criteria:
inclusion criteria: * aged 18 years old and above * meets diagnostic and statistical manual of mental disorders (dsm)-5 criteria for oud with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids. * provides a urine sample that tests positive for opioids. * willing to comply with the study protocol. * have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation. exclusion criteria: * seeking or currently enrolled in methadone or buprenorphine maintenance treatment for oud * pregnant or breast feeding * have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification * have a known allergy to the study medications * past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia * current use of a selective serotonin reuptake inhibitor (ssri) or monoamine oxidase (mao) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant * current narcolepsy, restless leg syndrome or sleep paralysis * high risk for current sleep apnea * current major depressive disorder * past year suicidal behavior * severe hepatic or renal impairment * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>3x uln * total bilirubin \>2x upper limit of normal (uln) * creatinine \>1.5x uln * have circumstances that would interfere with study participation (e.g., impending jail)
neurocognitive impairment in patients with covid-19

Conditions: Critical Illness; COVID-19; Central Nervous System Injury; Delirium; Encephalopathy

Summary: delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with covid-19. prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for covid-19. the value of biomarkers of neuroaxonal injury was proven in preliminary studies. these biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with covid-19. due to worldwide increasing numbers of hospitalized patients with covid-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with covid-19.

this is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with covid-19. all study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. a panel of biomarkers (among others nse, s100b and neurofilament proteins) will be measured. clinical assessment will be performed using validated delirium tests (among others cam-icu, icdsc) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others short blessed test). a group of patients with a comparable severity of disease but without the detection of sars-cov-2 will serve as control group and will undergo the same clinical and laboratory examinations. we hypothesize, that: * patients with covid-19 are more likely to develop delirium and neurocognitive impairment than patients without covid-19 * patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of covid-19 than patients without a preexisting neurocognitive deficit * specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with covid-19

Eligibility criteria:
inclusion criteria: * adult patients of every age * admission to hospital with suspected covid-19 disease * confirmed sars-cov-2 infection within 48 hours after admission exclusion criteria: * transferral from another hospital * other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage) * confirmed sars-cov-2 infection later than 48 hours after hospital admission * participation in another interventional study * no written informed consent from patient or legal representative