Kornimate/medical-research-clean huggingface dataset:
the role of macrophage activation in lung injury following ozone exposure

Conditions: Air Pollution

Summary: the purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. the exposure visits will be at least 2 weeks apart. subjects will be asked to produce sputum through coughing after each exposure. the samples will be analyzed for macrophage activity.

subjects will be asked to come to the rutgers eohsi clinical center (piscataway, nj) for 5 study visits. a physical exam to determine eligibility will be done at the first study visit. if the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits, at least 2 weeks apart. one exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. during the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). a follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. blood and exhaled breath samples will also be collected at each visit.

Eligibility criteria:
inclusion criteria: * vaccinated against covid-19 exclusion criteria: * cardiovascular disease * respiratory disease * recent (within 4 weeks) respiratory or covid-19 symptoms * diabetes * pregnancy * hiv infection * history of smoking within the past 5 years. * orthopedic or rheumatologic conditions which would interfere with cycle use * inability to produce a sputum plug at screening * daily use of antioxidant supplements, excluding those in a multivitamin. these supplements include vitamin c or e, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.

Keywords: macrophage
assessment of blood glucose monitoring systems

Conditions: Diabetes

Summary: system accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to iso 15197:2013


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

Keywords: blood glucose monitoring systems iso 15197 system accuracy
a dose-escalation study in participants with recurrent malignant glioma

Conditions: Glioma

Summary: this is a study of oral ly2157299 as monotherapy and in combination with lomustine in participants with recurrent malignant glioma.


Eligibility criteria:
inclusion criteria: * have given written informed consent * have histological or cytological evidence of relapsed malignant glioma (such as glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma) for which no treatment of higher priority exists * available baseline tumor specimen is required prior to considering participant to be enrolled. the original diagnostic tumor tissue is sufficient for this inclusion criteria, but where possible, freshly obtained tumor biopsy material may be obtained * measurable disease to allow assessment of tumor response based on radiographic assessment following macdonald criteria and response evaluation criteria in solid tumors (recist) * have sufficient hepatic, renal, and hematological function * have a performance status of ≤2 on the eastern cooperative oncology group (ecog) scale * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy or other investigational therapy for at least 30 days prior to study enrollment and recovered from the acute effects of therapy * able to swallow tablets and capsules * for females, reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method (including intrauterine or barrier devices) during and for 3 to 6 months after the study * male participants must be willing to use contraception during and for 3 to 6 months after the study exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have moderate or severe cardiac disease: * have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, new york heart association (nyha) class iii/iv congestive heart failure, or uncontrolled hypertension * have documented major electrocardiogram (ecg) abnormalities at the investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle branch blocks, ventricular hypertrophy, or recent myocardial infarction) * have major abnormalities documented by echocardiography with doppler (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction (lvef) \<50%, evaluation based on the institutional lower limit of normal) * have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, marfan syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography \[ct\] scan with contrast) * have current acute or chronic leukemia * women who are pregnant or lactating * have received prior nitrosourea (including lomustine) therapy
ribociclib in combination with non-steroidal aromatase inhibitors in patients with advanced breast cancer

Conditions: Breast Cancer

Summary: observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with hr+/her2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.

the study was conducted in 11 brazilian sites specialized in the treatment of this condition. the study data were collected from the review of medical records by the investigator (or designated). the sites must have had adequate medical records to ensure robust medical record review. therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.

Eligibility criteria:
inclusion criteria * female patient ≥ 18 years of age. all the patients must have at least one year of follow-up * patients at an age not consistent with postmenopausal status could only participate if they had oophorectomy surgery or being on treatment with goserelin for ovarian suppression post-menopausal women defined as age ≥ 60 years old or \< 60 years old and amenorrhea for 12 months or more (in the absence of chemotherapy, tamoxifen, toremifene or goserelin use for ovarian suppression) * confirmed diagnosis of hr+/her2- locally advanced or metastatic bc * never in use of cdk 4/6i exclusion criteria * patients in menopause status other than postmenopausal (young patients must have undergone oophorectomy being on treatment with goserelin for ovarian suppression to be characterized as postmenopausal) * previous use, at any time, of cdk 4/6i * the patient received any previous systemic therapy for advanced breast cancer patients who have received (neo)adjuvant therapy for breast cancer are eligible. if previous (neo) adjuvant therapy has included letrozole or anastrozole, the disease- free interval should be longer than 12 months from completion of treatment until entry in this trial patients who received ≤28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible * uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities

Keywords: hr+/her2-, advanced breast cancer, ribociclib, non-steroidal aromatase inhibitors, first-line treatment
suture reinforcement to reduce the leak rate after sleeve gastrectomy

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Leak, Anastomotic; Bleeding

Summary: staple line reinforcement (slr) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. the aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.


Eligibility criteria:
inclusion criteria: * bmi\>40 kg/m2 * bmi\>35 kg/m2with at least one associated major comorbidity exclusion criteria: * secondary obesity due to endocrine and psychological disorders * patients under antiaggregant and anticoagulant therapy * re-do surgery.
nestacell® mesenchymal stem cell to treat patients with severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this is phase ii study to assess the efficacy of nestacell® (mesenchymal stem cell) to treat severe covid-19 pneumonia.

the number of infections of covid-19 worldwide has killed thousands and is continually rising. the novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ace2), a protective enzyme against lung damage. in addition, the cellular serine protease tmprss2 for hcov-19 spike protein priming is also essential for the host cell entry and spread. coronaviruses can be deadly, in large part because they cause "cytokine storms." these storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it. mscs have been widely used in cell-based therapy, from basic research to clinical trials safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases. nestacell® is a mesenchymal stem cell therapy produced by cellavita and proved to be safe in previous clinical trials. the aim of this study is assess the efficacy of nestcell® as an add-on therapy to standard treatment to treat patients with severe covid-19 pneumonia. . patients included will be randomized to receive 2x10\^7 cells (20 million cells) on days 1, 3, 5 and 7.

Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥ 18 years 2. present a confirmed or pending diagnosis of covid-19, but with tomographic and clinical signs strongly suggestive of sars-cov-2 infection (covid-19), with pulmonary impairment greater than or equal to 50% and: i. oxygen saturation \<95%; ii. curb-65 rating ≥ a 4; d) participants with a score on who ordinal scale that measures illness severity over time equal to 5 (hospitalized with non-invasive ventilation or high-flow oxygen). exclusion criteria: 1. patients with autoimmune diseases in the past or screening; 2. those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis; 3. known or self-reported hiv or syphilis infected persons; 4. have participated in stem cell clinical research; 5. pregnant or lactating women or those who have fertility plans in the past year; 6. the estimated life cycle is less than 48 hours; 7. other conditions that the researcher thinks are not suitable for participating in the experiment. 8. shock 9. continuous use of immunosuppressive agents or organ transplants in the past 6 months;
isolated acth deficiency in patients with hashimoto thyroiditis

Conditions: Hashimoto Disease; Adrenal Insufficiency

Summary: the purpose of this study is to determine whether patients with hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

many patients with hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated acth deficiency was found. in this study a 1 µg acth test is performed to evaluate the adrenocortical function.

Eligibility criteria:
inclusion criteria: * hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent exclusion criteria: * • hypothyroidism of other origin * pregnancy and lactation * oral contraception * glucocorticoid therapy during the last 2 months * history of malignancy or chronic infections (hepatitis, hiv)

Keywords: isolated acth deficiency hashimoto disease hashimoto thyroiditis autoimmune thyroiditis
home visit intervention in pediatric palliative care

Conditions: Pediatric Cancer; Palliative

Summary: a randomized controlled trial to compare the quality of life between participants who were given palliative care (a 3-month home visit) and those who were not (intervention vs control group) was conducted. participants consisted of children with cancer aged 2-18 years old. a two-way communication between a trained health worker and participants with or without their parents were conducted as the intervention (report by proxy or self-report). interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance. in the first and twelfth week of the intervention, all participants were assessed with the pediatric quality of life inventory (pedsqltm) questionnaire cancer module 3.0. symptomps intensityof anorexia, sleep diturbance, and pain will be asessed in each visit. participants were followed, emergency room (er) admissions were recorded during follow up period. during the follow up period, er admissions were recorded further.


Eligibility criteria:
inclusion criteria: * child age 2-18 years old with malignancies who undergo treatments at the department of child health of cipto mangunkusumo hospital, during the study period. * all participants who meet the criteria to get palliative care, participants with a total score ≥ 4 based on palliative screening form. * participants and or parents agree to be enrolled in study exclusion criteria: * patients who live outside jakarta and therefore unreachable to get palliative intervention

Keywords: palliative cancer pediatric
study of early enteral dextrose in sepsis

Conditions: Sepsis

Summary: this study is a prospective single-center randomized double-blinded placebo-controlled clinical trial testing the effects of early enteral dextrose as a therapeutic agent in critically ill patients with sepsis. primary outcomes are differences in circulating plasma levels of the pro-inflammatory cytokine il-6 to be tested 24 hours after the start of enteral infusion. secondary outcomes include differences in circulating incretin hormone levels, differences in other pro-inflammatory cytokines including il-1β and tnf-α, changes in intestinal microbial composition and function after intervention, glycemic control and variability as assessed by capillary blood glucose measurements and exogenous insulin dosing during the intervention period, and clinical outcomes including intensive care unit (icu) and hospital stay and in-hospital mortality.

the central objective of this research project is to determine how early caloric support impacts inflammatory and metabolic outcomes in the acute phase of sepsis. preliminary data from our mouse models suggest that provision of dextrose via an intravenous route, even at low levels early in the course of sepsis, markedly impairs glucose tolerance and decreases insulin sensitivity and insulin secretion. in contrast, provision of low-level dextrose by the enteral route at identical levels during the early phase of sepsis is associated with decreased inflammation, increased secretion of beneficial intestine-derived incretin hormones, and significant improvements in glucose metabolism. the goals of this clinical study are to translate findings on the beneficial role of early enteral dextrose in a pilot interventional trial in critically-ill patients with sepsis. this clinical trial will provide further insight into the optimal timing and route of early caloric support in the care of septic patients-an area of clinical practice that will benefit from further studies in fundamental biology and clear guidelines for physicians.

Eligibility criteria:
inclusion criteria: 1. new presentation of sepsis characterized by a confirmed or suspected infection, with an acute increase from baseline in a modified sepsis-related organ failure assessment (sofa) score of greater than or equal to 2 points. if baseline values are unknown, baseline sofa score of 0 will be assumed. 2. available enteral access defined by: (1) an existing nasogastric or orogastric tube, (2) plans to place a nasogastric or orogastric tube, or (3) an existing percutaneous endoscopic gastrostomy (peg) tube. 3. less than 48 hours since meeting criteria for sepsis. 4. expected to stay at least 24 hours in the icu. exclusion criteria: 1. pre-existing continuous enteral tube feed use prior to study entry. 2. diabetic ketoacidosis or diabetic hyperosmolar hyperglycemic syndrome. 3. previously enrolled in this study within the same hospital admission. 4. icu physician request to exclude patient based on clinical assessment.

Keywords: enteral nutrition inflammation incretin hormones microbiome
frequency of asymptomatic left ventricular diastolic dysfunction in diabetes mellitus type 2

Conditions: Diastolic Dysfunction

Summary: patients with type 2 dm may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages type 2 dm is associated with various types of subclinical target organ damage resulting in elevated risk of cvd events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. this entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography.

patients with type 2 dm may develop a cardiomyopathy often called diabetic cardiomyopathy which is characterized by left ventricular diastolic dysfunction in early stages type 2 dm is associated with various types of subclinical target organ damage resulting in elevated risk of cvd events, moreover there is growing evidence that a prediabetic status, such as impaired fasting glucose is also related to subclinical target organ damage when compared to a group with normal glucose metabolism diabetes mellitus is a well-studied major risk factor for coronary heart diseases, which is one of the leading causes of death worldwide. another distinct entity of diabetes-related cardiac affection is the diabetic cardiomyopathy. this entity of cardic affection by diabetes still needs more and more attention, not only because it is common in diabetic patients, but also because of its easy detection by the simple, inexpensive and widely available diagnostic echocardiography. the proposed mechanisms that may be implicated in the pathogenesis of diabetic cardiomyopathy include autonomic dysfunction, microvascular disease, interstitial fibrosis and metabolic disorders. however, the actual causes and mechanisms remain unclear.

Eligibility criteria:
inclusion criteria: * dm type 2 who are asymptomatic of any cardiac symptom. exclusion criteria: * patients of known hypertension with or without treatment. * cardiac arrhythmias. * cardiomyopathy. * valvular heart disease. * heart failure. * chronic pulmonary disease. * extreme age. * chronic renal failure. * subjects with poor transthoracic echo window.

Keywords: diastolic dysfunction
study of the treatment of tendinopathy unruptured of rotator cuff by intramuscular injection of botulinum toxin

Conditions: Tendinopathy Rotator Cuff

Summary: botulinum toxin is used in musculoskeletal therapy routinely for 15 years. this is one of the most potent neurotoxins. it comes in 7 serotypes (a to g).therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible. it has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. the analgesic effect occurred even prior to the release muscular. several randomized studies have been published about it. the investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.


Eligibility criteria:
inclusion criteria: * signed consent * active social care * compliant patient with protocol * patient more than 18 years * positive neer test exclusion criteria: * prior study exclusion period * protected patient * study refusal * deficient patient * rheumatoid arthritis, osteoarthritis, chondrocalcinosis. * microcrystalline arthritis. * active infection . * history of hypersensitivity reaction during a previous injection of botulinum toxin * bilateral involvement * neurological deficit * depression * history of shoulder surgery * pregnant or breast feeding women * systemic disease (diabeta, vascularitis) * known neurological disease * intraarticular associate disease * acromioclavicular associate disease * myasthenia * botulinum toxin is not recommended in combination with aminoglycosides

Keywords: shoulder joint a02.835.583.748
the effects of the use of baby mobile accompanied with brahms lullaby on the infants during sternum dressing

Conditions: Pain, Procedural (During Sternum Dressing on Infants); Physiological Parameters During Sternum Dressing in Babies

Summary: the study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by brahms lullaby on physiological parameters and pain level during sternum dressing in babies. the research was carried out with 76 babies followed up in the pediatric cardiovascular surgery intensive care unit between august 2020 and february 2021 (baby mobile group accompanied by brahms lullaby: 38, control group: 38). data were collected by using the "baby monitoring form" and "flacc pain scale".


Eligibility criteria:
inclusion criteria: * being 1-12 months * being volunteer for research * operated for congenital heart disease * got sternum incision * no other chronic illness * no similar surgical experiment before * no visual impairment * no hearing impairment * no mental or neurological impairment * hospitalization experience exclusion criteria: -

Keywords: sternum dressing infant brahms lullaby baby mobile pain physiological parameters