Kornimate/medical-research-clean huggingface dataset:
longitudinal analysis of spirometry in black children

Conditions: Lung Diseases

Summary: to conduct a longitudinal investigation of early childhood lower respiratory illness (lri) and patterns of lung growth using an existing electronic dataset generated by an 18-year study (1972-1990) of a population of 102 black children followed from birth at the frank porter graham child development center.

background: the study should improve knowledge of the patterns of functional lung development during childhood and factors that influence both relative level and growth rate of lung function in black children and should offer new understanding of the predictive value of spirometric tests of lung function performed at an early age. design narrative: the study used a previously existing database which was of unique value because it included comprehensive respiratory illness data collected on-site during the children's tenure in the frank porter graham child development center's daycare facility and spirometric data collected longitudinally from three to 13 years of age. furthermore, the measurements were for children in a racial group for whom limited cross-sectional or longitudinal spirometric data were available. the longitudinal analyses had two primary objectives. the first was to characterize patterns of functional lung development in black children from three to 13 years of age and relate these patterns to potentially influential factors such as (a) wheezing and non-wheezing associated lri experience during the infant (ages 0 to two) and preschool (ages two to five) years, (b) ages of occurrence of first and subsequent lri episodes, and (c) respiratory syncytial virus etiology of lri. potentially confounding factors included prenatal and childhood exposure to environmental tobacco smoke and allergies. the second objective was to determine the degree to which spirometric parameters 'track' for individual children and for populations of children over the interval from three to 13 years of age. this objective required assessment of the degree to which spirometric evaluations during the preschool years were predictive of later lung function. the statistical analyses for achieving these objectives used recently developed statistical methods based on the general linear mixed model. by design, these methods for longitudinal data handled unbalanced data with missing values, incorporated time-varying covariates, and provided more exactly the extent to which the level of lung function of individual children was maintained relative to that of other study children and determined the value of preschool spirometric measurements as predictors of levels of spirometric performance during later childhood and adolescence. these analyses utilized methods developed by stewart, pekow, burchinal, and helms in 1991 that were unique in that they were designed to handle incomplete, inconsistently-timed data as well as complete, balanced data. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
study of eribulin in combination with anti-pd-1 antibody in patients with metastatic triple-negative breast cancer

Conditions: TNBC - Triple-Negative Breast Cancer

Summary: to evaluate the efficacy of eribulin in combination with anti-pd-1 antibody in patients with metastatic triple-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. the patients sign the written informed consent. 2. women aged 18-75. 3. the pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［er-negative(ihc\<1%), pr-negative(ihc\<1%), her2-negative（ihc-/+ or ihc++ and fish/cish-）］. patients with at least one measuring lesion that was conformed to recist v1.1 standard. 4. pd-1/pd-l1positive or tmb≥5. 5. prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient. 6. eastern cooperative oncology group (ecog) performance status of ≤ 1. 7. the results of patient's blood tests are as follows: • hb≥90g/l; • plt≥100\^9/l; • serum albumin ≥3g/dl;• neutrophils≥1.5\^9/l; tsh≤ normal upper limit (uln);• alt and ast ≤1.5 uln (liver metastases ≤3 uln); • tbil ≤uln (total bilirubin ≤1.5 uln in gilbert's syndrome or liver metastasis subjects);• alt and ast ≤1.5 uln (liver metastases ≤3 uln);• akp≤ 2.5 uln; • renal function within 7 days before the first administration: serum creatinine ≤1.5 uln or creatinine clearance ≥60ml/min 8. female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment. exclusion criteria: 1. the subjects had a central nervous system metastases with clinical symptoms. 2. subjects with treatment history of pd-1 / pd-l1 inhibitors; 3. peripheral neuropathy ≥ grade 2; cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease. 4. pregnant or lactating women. 5. other clinical trials of drugs were used in the first four weeks before the first dose. 6. the subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications. 7. hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.). 8. congenital or acquired immune deficiency (such as hiv infection); 9. receive live vaccine within 4 weeks before or during the study period; 10. patients who are allergic to or contraindicated to the experimental drugs. 11. other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease. 12. subjects with any other diseases that are unfit for the treatment.

Keywords: tnbc eribulin anti-pd-1 antibody
stent implantation of polyurethane expandable valve, by catheter, in patients with pulmonary valve dysfunction

Conditions: Valvulopathy

Summary: prospective study, single arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to severe impairment of right ventricular function. during throughout the study, safety parameters related to valve operation will be evaluated (patient's functional class), in addition to the occurrence of serious adverse events. after the procedure, the patient must be hospitalized in the intensive care unit until the complete hemodynamic stabilization and normalization of lung function and in good general condition (2 to 3 days of stay) and then transferred to the ward (2 to 3 days and stay) before hospital discharge. a formal statistical analysis plan (sap) will be developed and finalized before closing the database. full details of data presentations and analysis will be provided in sap. additional statistical analyses, other than those described in this section, may be performed if deemed appropriate and included in sap. any deviations from the final analysis plan or what is presented in the protocol will be discussed in the final study report. no formal inferential statistics will be applied to the data collected in the study.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older; * pulmonary valve dysfunction and moderate to severe impairment of right ventricle function; * functional class ii to iv new york heart association (nyha) classification of heart failure. exclusion criteria: * impairment of cardiovascular function; * neurological impairment; * syndromes without prognosis or survival of less than 1 year; * carriers of infection undergoing medical treatment; * patients undergoing artificial life support; * known hypersensitivity to aspirin or heparin; * positive urine or serum test for pregnancy in female patients of reproductive age.

Keywords: pulmonary valve dysfunction pulmonary valvulopathy stent implant pulmonary valve disorders polyurethane expandable valve stent tetralogy of fallot cardiac insufficiency right ventricular dysfunction pulmonary valve insufficiency heart diseases prosthesis
vancomycin or trimethoprim/sulfamethoxazole for methicillin-resistant staphylococcus aureus osteomyelitis

Conditions: Osteomyelitis; Methicillin-resistant Staphylococcus Aureus

Summary: the primary question of this study is to understand if trimethoprim-sulfamethoxazole (tmp-smx) is as effective as vancomycin for treating methicillin-resistant staphylococcus aureus (mrsa) osteomyelitis.

treatment of osteomyelitis is hampered by a paucity of evidence from prospective clinical trials with randomized treatment arms. furthermore, previous randomized or observational trials have enrolled small numbers of subjects and thus often had non-definitive findings. one of the most common causes of osteomyelitis is staphylococcus aureus. over the past 10 years, rates of methicillin-resistant s. aureus (mrsa) have risen dramatically. vancomycin is currently the treatment of choice for treating mrsa. while vancomycin is effective, it is only available in intravenous formulation and has renal and bone marrow toxicities. there is a critical need for effective, oral, cheap drugs for the treatment of mrsa. trimethoprim-sulfamethoxazole (tmp-smx) is a drug with several advantageous properties for the treatment of mrsa osteomyelitis. to address this question regarding optimal treatment of mrsa osteomyelitis, we designed a prospective, randomized trial comparing tmp-smx with vancomycin for the treatment of mrsa osteomyelitis.

Eligibility criteria:
inclusion criteria: 1. culture-proven mrsa, obtained in operating room or sterile biopsy procedure from bone site. the infection and sampling site can either be within bone or a deep soft-tissue site that is contiguous with bone; or radiographic abnormality consistent with osteomyelitis in conjunction with a positive blood culture for mrsa. 2. surgical debridement of infection site, as needed. 3. subject is capable of providing written informed consent. 4. subject is at least 18 years of age. 5. subject capable of receiving outpatient parenteral therapy for 12 weeks. exclusion criteria: 1. hypersensitivity to tmp-smx or vancomycin. 2. s. aureus resistant to tmp-smx or vancomycin. 3. osteomyelitis that develops directly from a chronic, open wound. 4. polymicrobial culture(the only exception is if coagulase-negative staphylococcus is present in the culture and the clinical assessment is that it is a contaminant). 5. subject has a positive pregnancy test at study enrollment. 6. convicted felon currently in prison. 7. baseline renal or hepatic insufficiency that would preclude administration of study drugs. 8. active injection drug use without safe conditions to administer intravenous antibiotics for 3 months. 9. anticipated use of antibiotics for greater than 14 days for an infection other than osteomyelitis.

Keywords: vancomycin trimethoprim-sulfamethoxazole combination
evaluation of corneal epithelial thickness mapping

Conditions: Dry Eye and Contact Lens Wear

Summary: optovue has developed a new feature for mapping corneal epithelial thickness. the purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. consented subjects will undergo a series of cornea measurements using optical coherence tomography (oct) that will be used for analysis.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * able and willing to provide consent * able and willing to complete the required examinations * dry eye group only: clinical diagnosis of dry eye * contact lens group only: regular contact lens wear exclusion criteria: * history of ocular surgery * history of laser refractive surgery * history of cataract surgery * dry eye group only: corneal pathology not associated with dry eye * contact lens group only: corneal pathology including dry eye * normal group only: history of contact lens wear or dry eye or corneal pathology
sleep and glucose regulation in youth with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus; Sleep

Summary: the purpose of this project is to look at how sleep affects glucose values in children with type 1 diabetes mellitus. it will also evaluate if glucose is affected by times of day due to the body's own internal rhythm also known as the circadian rhythm.

diabetes mellitus (dm) is one of the most prevalent chronic pediatric diseases, affecting 2.80 cases per 1000 youth between the ages of 10 and 19. since the crux of diabetes management is glucose regulation, any further challenges such as stress and/or poor sleep may make glucose regulation even more difficult. mounting evidence supports the association between inadequate sleep and obesity as well as metabolic syndrome. despite emerging findings supporting that total sleep time (tst) may contribute to the risk of obesity and/or metabolic complications, less research has been focused on type 1 diabetes mellitus (t1dm) and on other sleep parameters. participants will have a continuous glucose monitor (cgm) and actigraph placed which they will wear for 5 days. at the end of the 5 days, they will return the glucose meter, cgm, and actigraph to a clinic staff or research team member to download their data. they will provide us with a glucose log that contains the glucose levels obtained from a fingerstick capillary glucose meter. in this log, participants will also record their activities, meals, and insulin administered. they will also provide us with a sleep diary. in addition, participants will have the option for the child to undergo polysomnography (sleep study) for one night in their home or two nights in the sleep lab.

Eligibility criteria:
inclusion criteria: * type i diabetes mellitus * age of 10-16 year old exclusion criteria: * significant developmental delay * any other condition that in the opinion of the medical treatment team would interfere with his/her ability to participate

Keywords: pediatrics sleep glucose regulation type 1 diabetes mellitus
ulna length in black children

Conditions: Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)

Summary: height measurement is unreliable when neuromuscular weakness or spinal deformity is present. the aim of this study was to accurately predict pulmonary function from a limb segment (ulna) measurement that is precise and reproducible. equations are available in caucasian children but are not available in children of sub-saharian or caribbean ethnicity, which was the aim of the study. to this end, 350 black children referred for pulmonary function testing for asthma follow-up will be included.

ulna (dominant and non-dominant arm), height measurement in 350 asthmatic children of sub-saharian or caribbean ethnicity (both parents). repeatability analysis (ulna and height) for the first fifty children. recording of pulmonary function tests results (spirometry, resistance measurements)

Eligibility criteria:
inclusion criteria: * age: 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up. exclusion criteria: * chronic disease excepting asthma, prematurity (\ 3/year), high dosage of inhaled steroid

Keywords: ulna; healthy children; height predicted
a comparison of electrical ilioinguinal nerve stimulation with intravesical irrigation for bladder pain syndrome

Conditions: Painful Bladder Syndrome

Summary: the purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (eins) is more effective than intravesical irrigation (ii) in treating bladder pain syndrome.

the purpose of this study is to determine whether electrical ilioinguinal nerve stimulation (eins) is more effective than intravesical irrigation (ii) in treating bladder pain syndrome.

Eligibility criteria:
diagnostic criteria: 1. complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology. 2. negative in urine routine test or urine cultivation. 3. urinating at least 7 times per day or having some urgency or pain (measured on linear analog scales) inclusion criteria: 1. providing informed consent to participate in the study; 2. willing to undergo a cystoscopy under general or regional anesthesia when indicated during the course of the study; 3. female patients meeting the diagnostic criteria; 4. age ≥18 years and ≤80 years. 5. disease course ≥ 6 months exclusion criteria: 1. bladder capacity of greater than 350 ml on awake cystometry; 2. absence of an intense urge to void with the bladder is filled to 150 ml of liquid filling medium; 3. the demonstration of phasic involuntary bladder contractions on cystometry using the fill rate just described; 4. duration of symptoms less than 9 months; 5. absence of nocturia; 6. symptoms relieved by antimicrobial agents, urinary antiseptic agents, anticholinergic agents, or antispasmodic agents; 7. a frequency of urination while awake of less than 8 times per day; 8. a diagnosis of bacterial cystitis or prostatitis within a 3-month period; 9. bladder or ureteral calculi; 10. active genital herpes; 11. uterine, cervical, vaginal, or urethral cancer; 12. urethral diverticulum; 13. cyclophosphamide or any type of chemical cystitis; 14. tuberculous cystitis; 15. radiation cystitis; 16. benign or malignant bladder tumors; 17. vaginitis; 18. age younger than 18 years.

Keywords: electrical ilioinguinal nerve stimulation bladder pain syndrome intravesical irrigation
pnf techniques to improve bed mobility, transfer and early trunk control in stroke patients

Conditions: Stroke

Summary: trunk control is an important factor which is disturbed after the stroke. the literature reviews suggest that trunk exercises are required to achieve good trunk stability which is essential for balance, daily functional activities and higher function tasks. by keeping these facts in view present study aims at evaluating the efficacy of pnf techniques \& conventional trunk exercise to improve trunk control in recovery stage hemiplegic patients objective: to determine proprioceptive neuromuscular facilitation (pnf) techniques to improve bed mobility, transfer and early trunk control in stroke patients

50 patients was included and allocated into 2 groups, group a consisting of 25 patients who received pnf techniques for trunk to improve trunk control. group b consisting of 25 patients who received conventional trunk exercises to improve trunk control. trunk control was assessed pre and post treatment with the help of trunk impairment scale and icu mobility scale. data was collected by icu mobility scale \& trunk impairment scale

Eligibility criteria:
inclusion criteria: * stroke (acute stage) * first attack without any prior residual impairment. * middle cerebral artery syndrome exclusion criteria: * cognitive deficits or aphasia * neurological disorders e.g, parkinson's disease. * heart failure * systemic orthopaedic and psychological disorders
traumatologic acute pain management with fentanyl transdermal therapeutic system (tts)

Conditions: Hip Fractures (ICD-10 72.01-72.2)

Summary: aim of the study is an examination whether a modified perioperative pain management system, that integrates the 2017 european society of anaesthesiology (esa) guidelines for treatment of postoperative delirium, can improve patient's wellbeing in comparison to the current certified standard management.

aim of the study is to evaluate whether the integration of the 2017 esa guidelines for treatment of postoperative delirium in a pain management, can improve patient's wellbeing in comparison to the current certified standard management. adherence to the modified management includes minimizing nil per os time, renouncing benzodiazepines, 1.8 ltr crystalloid infusion per day, simplified standard medication option and postoperative 12µg/h fentanyl tts for 72h (for wound pain).

Eligibility criteria:
inclusion criteria: * adult patients with hip fractures that have to be operated (icd s72.01-s72.2) exclusion criteria: * severe liver damage * ongoing dialysis therapy * monoamine oxidase inhibitor intake * inability to give consent to trial participation
dupilumab in japanese patients with chronic rhinosinusitis with nasal polyp (sinus-m52)

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this was a phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (sc) injection monotherapy in japanese participants aged 18 or older with crswnp that is not adequately controlled with existing therapies. duration of study period (per participant): * screening period (2 to 4 weeks) * intervention period (up to 52 weeks±3 days)


Eligibility criteria:
inclusion criteria: * participants ≧18 years of age. * participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (scs) anytime within the past 2 years; and/or had a medical contraindication / intolerance to scs; and/or had prior surgery for np at the screening visit, had: * an endoscopic bilateral nps of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity). * ongoing symptoms (for at least 8 weeks prior to visit \[v\] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at v1 and a weekly average severity of greater than 1 at the time of enrollment (v2), and loss of smell, rhinorrhea (anterior/posterior). * participant's body weight \> 30 kg at v1. * signed written informed consent. exclusion criteria: * participant with conditions/concomitant diseases making them non evaluable at v1 or for the primary efficacy endpoint such as: antrochoanal polyps; nasal septal deviation that would occlude at least one nostril; acute sinusitis, nasal infection or upper respiratory infection; ongoing rhinitis medicamentosa; eosinophilic granulomatosis with polyangiitis (churg-strauss syndrome), granulomatosis with polyangiitis (wegener's granulomatosis), young's syndrome, kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis; radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis; * participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc). * participant diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before v1 or during screening * undergone any and/or sinus intranasal surgery within 6 months before v1. * participant who had participated in prior dupilumab clinical study or had been treated with commercially available dupilumab the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.