Kornimate/medical-research-clean huggingface dataset:
cough-generated aerosols of ntm in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: non-tuberculous mycobacteria (ntm) are opportunistic pathogens normally found in soil and water that are being cultured from cystic fibrosis (cf) airways at an increasing frequency. they have been demonstrated to cause clinically significant lung disease in some cases and the transmission of ntm, from person to person has been proposed. there are currently no standardized guidelines for isolation of those colonized or infected with ntm. the investigators will measure particle droplet size from patients with cf who have positive sputum cultures for ntm with the hypothesis that they will be in a range that can spread infection.

patients with a positive ntm sputum culture will be asked to participate in the study. if they agree to participate they will sign an informed consent and will be scheduled to come to the university of florida clinical research center for the testing. the test will consist of the following: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. there can be a break inbetween the coughing if needed. patients maybe asked to come back a second time if they develop a different type of ntm or start treatment for ntm.

Eligibility criteria:
inclusion criteria: * age greater than or equal to age 8 years * confirmed diagnosis of cf * sputum/throat/bronchoscopic culture positive for ntm within the last 12 months exclusion criteria: * pregnancy * pneumothorax within the last 6 months * forced expiratory volume at one second \<30% predicted * hemoptysis greater than 1 tablespoon within the last 7 days

Keywords: positive nontuberculous mycobacteria
high-intensity exercise training or multidisciplinary treatment in extremely obese adolescents

Conditions: Obesity; Cardiovascular Diseases

Summary: the aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents


Eligibility criteria:
inclusion criteria: * bmi \>+ 2sd (age adjusted) * fitted for group treatment * at least one parent attending the treatment exclusion criteria: * not able to join treatment * not able to walk

Keywords: adolescent overweight exercise multidisciplinary approach oxygen uptake flow mediated dilatation cardiovascular risk factors
influenza vaccine dose-response in infants and toddlers: immunogenicity and reactogenicity

Conditions: Influenza

Summary: the purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.


Eligibility criteria:
inclusion criteria: * child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination * child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age) * child is available and can complete all relevant procedures during the entire study period * parent or legal guardian is available and can be reached by phone during the entire study period * parent/guardian provides written informed consent * parent/guardian is fluent in english exclusion criteria: * child has history of laboratory-confirmed influenza * child has history of any prior influenza immunization * child has history of anaphylactic reaction to any component of the vaccine (i.e. egg) * child has received immune globulin or other blood products within the prior six weeks * child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed) * child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy) * child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period * child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period * child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child

Keywords: influenza vaccines infant dose-response relationship, immunologic
ebus-gs-tblb with or without fluoroscopy for the diagnosis of ppls

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(ebus-gs) for the diagnosis of peripheral pulmonary lesions (ppls) without radiographic fluoroscopy.

the investigators evaluated the efficacy and safety of transbronchial biopsy (tbb) and bronchial brushing by endobronchial ultrasonography (ebus) with a guide sheath (gs) as a guide for diagnosing peripheral pulmonary lesions (ppls) without radiographic fluoroscopy.the study is designed as a two-center prospective randomized controlled trial. the participating centers are department of pulmonary medicine and endoscope center, shanghai chest hospital affiliated to shanghai jiaotong university school, china. department of pulmonary medicine, fukushima medical university, japan.patients are divided into two groups, ebus-gs-x-ray group and ebus-gs group.each subject will be randomized to each group.the study is expected to enroll 100 patients at 2 centers (china:75, fukushima:25).

Eligibility criteria:
inclusion criteria: 1. individuals eligible for inclusion are patients that the ct scan appearance of the ppls showed the longest diameter was more than 2 cm and solid lesions. exclusion criteria: 1. the lesion is close to the pleural membrane 2. refusal of participation 3. severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy

Keywords: endobronchial ultrasonography with a guide sheath peripheral pulmonary lesions transbronchial biopsy
anti pd-l1 antibody + anti ctla-4 antibody in combination with hormone therapy in patients with hormone receptor positive her2-negative recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate the safety and efficacy of anti pd-l1 antibody + anti ctla-4 antibody in combination with hormone therapy in patients with hormone receptor positive her2-negative recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. patients aged \>= 20 years at informed consent. 2. patients who have provided written informed consent themselves. 3. patients who have metastatic and/or advanced lesion 4. documentation of er-positive and/or pr-positive tumor (\>=1% positive stained cells). 5. patients with cancer confirmed to be her2-negative. 6. patients with confirmed menopause 7. patients who have plans of 2nd hormone therapy. 8. patients with a measurable lesion based on recist 1.1 9. patients with ecog ps of 0 to 1. 10. patients without any severe disorder in the major organs. exclusion criteria: - exclusion criteria: 1. active or prior documented autoimmune disease within the past 2 years. 2. current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab 3. patients with central nervous system metastasis 4. patients with life-threatening disease. 5. patients with a history of treatment with anti-pd-1, anti-pd-l1, anti-pd-l2 or anti-ctla-4 antibody drug. 6. patients who have received live vaccination within 30 days before start of the investigational products. 7. patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia. 8. patients considered ineligible for participation in this study by their attending physicians.
clinical evaluation of the "nicu clinical decision support dashboard" - chmco

Conditions: Preterm Birth; Low; Birthweight, Extremely (999 Grams or Less); Neonatal Infection; Satisfaction; Stress; Chronic Lung Disease; Growth Acceleration; Adverse Event

Summary: this study evaluates the use of a nicu clinical integration system (dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction. clinicians will be asked to follow their current standard of care practices with the aid of this technology. about half of participants will receive care in nicu rooms with the dashboard installed while the other half will receive standard care without the dashboard.

the current nicu environment can be stressful and overwhelming for parents of babies admitted and for clinicians caring for the babies. there is a wide range of monitors in a very clinical environment that does not take into account the comfort of neonates. the dashboard works in parallel with ehr and systems of record, and provides a cohesive view of the patient's status and planned clinical workflow in a single location for both parents and staff. accessories such as environmental sensors and cameras are used to ensure that the environment is comfortable and promotes optimal development of the baby. caregivers can educate and coach parents to facilitate integrating them into their infant's care. the nicu dashboard also supports a family view to facilitate education and assist the family in tracking core measures and developmental milestones.

Eligibility criteria:
neonates and their parents inclusion criteria: * admission to the nicu * at least one parent (biological, guardian, or adoptive) involved * one parent can understand and speak the english language * parent aged 14 years or older * parent with sufficient mental capacity to provide written informed consent as determined by a rn * signed informed consent * aged 19+ yrs: signed by parent of nicu baby * aged \<19 yrs (minor): signed by both parent of nicu baby and parent/guardian of parent exclusion criteria: * expected discharge from the nicu in \<48 hours clinicians interacting with the nicu dashboard inclusion criteria: * employee of institution with direct patient care in the nicu (e.g. physician, np, rn, therapist) * aged 19 years or older * expected interaction with the nicu dashboard * signed informed consent exclusion criteria: * no interaction with the nicu dashboard

Keywords: nicu developmental care neuroprotective technology
quadratus lumborum block for post-cesarean analgesia

Conditions: Postoperative Pain

Summary: most women having planned cesarean section receive spinal anesthetic for the procedure. typically, spinal opioids are administered during the same time as a component of multimodal analgesia to provide pain relief in the 16-24 hr period postoperatively. however, spinal opioids are frequently associated with adverse effects such as nausea, pruritus, sedation and occasionally respiratory depression. the quadratus lumborum (ql) block is a regional analgesic technique which blocks t5-l1 nerve branches and has an evolving role in postoperative analgesia for lower abdominal surgeries and is a potential alternative to spinal opioids. there is some evidence that it may provide visceral along with somatic pain relief. it is a simple and safe technique that has been studied in lower abdominal surgeries, but has not been studied for pain relief after cesarean section. if found effective, it will have the advantage of a reduction in opioid associated adverse effects while providing similar quality of analgesia. this block has evolved from the previously known transversus abdominis plane block. we propose to undertake a study that will compare the relative efficacy of ql block with local anesthetic to spinal morphine. we will also study if it provides any incremental benefit when administered in addition to spinal morphine.

this will be a randomized controlled double blinded trial. seventy five female patients belonging to american society of anesthesiologists status 1-3, age 18-45 yrs undergoing elective caesarean delivery will be included in this prospective study. after obtaining informed consent, they will be randomized to one of the three groups by a computer-generated randomization. all patients will receive standard spinal anesthetic. they will be randomized to one of the three groups (n=25 per group). groups 1 and 3 will receive intrathecal morphine in addition to the spinal anesthestic. group 2 will receive equal volume of saline added to the intrathecal mixture. ultrasound guided quadratus lumborum block will be done. following negative aspiration, 25 ml of ropivacaine 0.5% (groups 2 and 3), or the same amount of saline (group 1) will be injected in each side. all patients will receive routine postoperative analgesia, including analgesics and oral morphine. all patients will be assessed postoperatively by a blinded investigator at 6, 12 and 24h post-operatively.

Eligibility criteria:
inclusion criteria: * elective cesarean delivery * american society of anesthesiologists physical status 1-3 * suitable for procedure to be carried out under spinal anesthesia exclusion criteria: * inability to give informed consent or to co-operate with post-operative evaluation * allergy to local anesthetics, morphine, fentanyl, ropivacaine * ongoing major medical or psychiatric problems * chronic opioid use * major coagulopathy * bmi\>35 on first ante natal visit * pre-eclampsia * contraindication to neuraxial anesthesia

Keywords: cesarean quadratus lumborum block analgesia ultrasonography
investigating the link between type 2 immunity and nafld in human obesity

Conditions: Obesity, Morbid; NASH - Nonalcoholic Steatohepatitis; Chronic Inflammation

Summary: this study is being done to better understand the relationship between inflammation in adipose tissue (at), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.


Eligibility criteria:
inclusion criteria: * undergoing gastric bypass surgery * confirmed auroc f=0 or f\>2 liver fibrosis * age 30-70 years * bmi greater than 40 kg/m2 * negative pregnancy test (female only) * lab values: normal tsh exclusion criteria: * autoimmune diseases * hepatitis b or c positive * heavy alcohol use * active smoking history * active cancer history * history of asthma * history of copd * taking plavix or coumadin * blood donation within past 2 months * glucocorticoid therapy * taking antihistamine on regular basis

Keywords: obesity nash adipose tissue inflammation insulin resistance
a study of ocrelizumab in children and adolescents with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (pd) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (rrms). the data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent phase iii study in children and adolescents.


Eligibility criteria:
inclusion criteria: * body weight \>/= 25 kg * children and adolescents must have received all childhood required vaccinations * female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception * diagnosis of relapsing-remitting multiple sclerosis (rrms) * expanded disability status scale (edss) at screening: 0-5.5, inclusive * neurologic stability for \>/= 30 days prior to screening, and between screening and baseline * participants naive to prior disease-modifying therapy (dmt) * participants who have had at least 6 contiguous months of dmt within the past 1 year must have evidence of disease activity occurring after the full 6-month course of treatment, that is, at least one relapse or \>/= 1 gd-enhancing lesion(s) on a t1-weighted brain mri exclusion criteria: * known presence or suspicion of other neurologic disorders that may mimic ms, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development * patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (mog) antibody positive are not eligible to participate in the study. * in case of an adem-like appearance of the first ms attack, a second attack with clear ms-like features is required. * infection requiring hospitalization or treatment with iv anti-infective agents * history or known presence of recurrent or chronic infection (e.g., hiv, syphilis, tuberculosis) * receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation * history or laboratory evidence of coagulation disorders * peripheral venous access that precludes iv administration and venous blood sampling * inability to complete a magnetic resonance imaging (mri) scan * history of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ * history of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mabs) or known hypersensitivity to any component of ocrelizumab solution * previous treatment with b-cell-targeted therapies * percentage of cd4 \< 30% * absolute neutrophil count \< 1.5x1000/microliter * lymphocyte count below the lower limit of normal (lln) for age- and sex-specific reference range
a study evaluating abi-h0731 as adjunctive therapy in participants with chronic hepatitis b infection

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine if abi-h0731 given in combination with a standard of care (soc) hepatitis b virus (hbv) nucleos(t)ide reverse transcriptase inhibitor (nuc) medication is safe and effective in participants with chronic hepatitis b virus infection (chbv).

this is a phase 2a, multi-center, double-blind, placebo-controlled study evaluating abi-h0731 as adjunctive therapy in virally-suppressed participants with chbv.

Eligibility criteria:
key inclusion criteria: * male or female between ages 18 and 70 years * virologically-suppressed (defined as hbv dna ≤limit of quantitation (loq) for at least 6 months before screening on soc nuc therapy * hbeag-positive or hbeag-negative at screening * in good general health except for chbv key exclusion criteria: * co-infection with hiv, hepatitis c virus (hcv), hepatitis e virus (hev) or hepatitis d virus (hdv) * history or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening * clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than hbv, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the investigator or the sponsor makes the participant unsuitable for the study * previous treatment with an investigational agent for hbv other than abi-h0731 in the last 6 months before screening * history of hepatocellular carcinoma (hcc) * females who are lactating or pregnant or wish to become pregnant are excluded from the study * exclusionary laboratory parameters at screening include: * platelet count \<100,000/mm3 * albumin \<lower limit of normal (lln) * direct bilirubin \>1.2×upper limit of normal (uln) * alanine aminotransferase (alt) \>5×uln at screening * international normalized ratio (inr) \>1.5×uln * glomerular filtration rate (gfr) \<60 ml/min/1.73 m2 by chronic kidney disease epidemiology collaboration (ckd-epi) equation

Keywords: chronic hepatitis b hbv hbeag-positive hepatitis b hbeag-negative vebicorvir vbr
clinical significance and optimal treatment of community-onset urinary tract infections caused by extended-spectrum β-lactamase and/or ampc β-lactamase producing enterobacteriaceae

Conditions: Urinary Tract Infections

Summary: the purposes of this study are: 1. to estimate the prevalence of extended spectrum β-lactamase (esbl) and/or ampc among enterobacteriaceae which cause community-onset urinary tract infections (utis) 2. to collect the background, risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to enterobacteriaceae (both esbl, ampc- and non esbl and/or ampc producing) after receive different antibiotic regimens. 3. to develop a scoring system to early identify patients at risk of being infected with esbl- and/or ampc-producing enterobacteriaceae by comparing the risk factors for community-onset utis caused by esbl- and/or ampc-positive against non esbl -and/or ampc enterobacteriaceae 4. to demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset utis in patients at risk for esbl- and/or ampc-producing organism. the study hypothesis (i) patients infected with community-acquired uropathogenic esbl- and/or ampc-producing enterobacteriaceae who receive regimens other than carbapenems have a worse outcome. (ii) there are certain risk factors predicting the acquisition of community-onset utis caused by esbl- and/or ampc-producing enterobacteriaceae. (iii) the use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset utis caused by esbl- and/or ampc-producing enterobacteriaceae.


Eligibility criteria:
inclusion criteria: * adult patients who admitted to the taipei veterans general hospital with the diagnosis of community-onset uti caused by enterobacteriaceae will be eligible for inclusion in this study if hospitalization for parental antimicrobial therapy is required exclusion criteria: * pregnancy or lactation in women, * history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled), * complete obstruction of the urinary tract, * peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness, * immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy, * a baseline pathogen resistant to study drug, * treatment with a systemic antimicrobial agent for \>24 h within 72 h prior to enrolment, or absolute neutrophil count \<1000/mm3. * men with a history or physical findings suggestive of acute or chronic prostatitis will also excluded.

Keywords: community-onset urinary tract infections caused by enterobacteriaceae