Kornimate/medical-research-clean huggingface dataset:
comparative effects of fish oil supplementation and a montelukast on eib and airway inflammation in asthma

Conditions: Asthma

Summary: combining fish oil supplementation and montelukast \[a commonly used cyst lt1 receptor antagonist to treat exercise-induced bronchoconstriction (eib)\] will provide a greater antiinflammatory effect against developing eib that either agent alone

the aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (eib). an important question is how dietary fish oil supplementation fits in with the available armamentarium \[e.g., leukotriene (lt) modifiers\] to decrease the expression of lts, and whether fish oil supplementation may be additive, or used in its own right to block the eib response. for example, it is possible that a combination of fish oil supplementation and a cyst lt1 receptor antagonist (ltra) may provide a greater antiinflammatory effect against developing eib that either agent alone.

Eligibility criteria:
inclusion criteria: * demonstrate a fall in post-exercise fev1 of \> 10% after dry air exercise challenge for the diagnosis of eib and * \> 12% increase in fev1 from the baseline value after the administration of a β2-agonist. however, if the bronchodilator response is \< 12% increase in fev1 from the baseline value then asthmatic subjects with eib must further demonstrate * a \< 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in fev1 (pc20) exclusion criteria: * subjects will be excluded if they are pregnant * have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time * taking aspirin medication and have a resting fev1 less than 65% predicted. * a complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit \< 35 will be excluded from participation in the study. * in addition, subjects will also be excluded if they have a history of taking n-3 pufa supplements or supplements with antioxidants above the levels recommended for adequate intake, or regularly consume more than one fish meal per week.

Keywords: asthma inflammation airway fish oil singulair
ketogenic diet in rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis; Inflammation; Obesity; Ketogenic Dieting; Metabolic Syndrome

Summary: this is a 6-week ketogenic diet (kd) intervention where participants with rheumatoid arthritis (ra) will follow a kd plan, supervised and monitored by a dietician. participants will be provided extensive educational and ongoing support on the kd, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. participants will fill out health related questionnaires and undergo assessments of body composition, ra disease activity. this study also includes blood draws and fat biopsy of the abdominal region.


Eligibility criteria:
inclusion criteria: * diagnosis of ra according to the acr/eular 2010 criteria for ra. * on stable doses of dmards and/ or biological agents (≥ 2 months prior to study enrollment) exclusion criteria: * chronic inflammatory/ autoimmune disease other than ra (e.g. gout, inflammatory bowel disease such as crohn's disease or ulcerative colitis, lupus, myositis, etc.) * prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections) * insulin use * hospitalization in the 30 days prior to study enrollment * acute or uncontrolled disease (e.g. cirrhosis, copd, ckd) * malignancy * chronic infection (hiv, hep b/c, etc.) * heavy drinking * on a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment) * recent weight loss (\>5% in the last 2 months)
ntla-3001 in adults with alpha-1 antitrypsin deficiency-associated lung disease

Conditions: Lung Disease; Pulmonary Disease; AATD; Alpha-1 Antitrypsin Deficiency; Alpha-1 Antitrypsin Deficiency-associated Lung Disease

Summary: this study will be conducted to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of ntla-3001 in adults with alpha-1 antitrypsin deficiency (aatd) -associated lung disease

this study consists of 2 parts: phase 1 is an open-label, single-arm ascending dose study to characterize the safety and activity of ntla3001 and identify the dose for evaluation in phase 2. phase 2 will follow as an open-label, dose expansion study to further characterize the safety and clinical activity of ntla-3001 and provide an initial assessment of the effect of ntla-3001 on clinical measures of pulmonary function.

Eligibility criteria:
inclusion: 1. age 18 years to 75 years 2. diagnosis of aatd zz/znull genotypes 3. fev1 ≥35% and ≤65% 4. no evidence of liver cirrhosis 5. adequate chemistry and hematology measures at screening 6. participants must agree not to participate in another interventional study for the duration of this trial. 7. participants must be capable of providing signed informed consent exclusion criteria: 1. aatd genotypes outside of zz or znull 2. participants with total antibodies to adeno-associated virus (aav) serotype above laboratory assay cut off 3. participants who have known negative reaction or hypersensitivity to any lipid nanoparticles (lnp) component. 4. any condition that, in the investigator's opinion, could adversely affect the safety of the participant. 5. unwilling to comply with study procedures.

Keywords: aatd
stereotactic ablative radiotherapy for hepatocellular carcinoma with major portal vein invasion

Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombus

Summary: recently, several studies reported promising outcomes of patients after external beam radiotherapy (ebrt) for hepatocellular carcinoma (hcc) with portal vein tumor thrombosis. however, conventional ebrt is composed of many fractions (20-35 fractions). on the other hand, stereotactic ablative radiotherapy is a newly emerging treatment method to deliver a high dose of radiation to the target using a few fractions with a high precision within body. sabr increases radiation biologic effect for tumor, makes patients more comfortable due to reduction of the number of hospital visit, and enables patients to receive another treatment more quickly. this study will evaluate sabr effect with 40 gy in 4 fractions for hcc with major portal vein tumor thrombosis.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 20 years of age * initially diagnosed or recurrent hepatocellular carcinoma (hcc) * eastern cooperative oncology group performance status 0 or 1 * hcc with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) * cirrhotic status of child pugh class a or b7 * patients can have extra-hepatic disease; provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with radiotherapy, chemotherapy and target agent etc; patient survival is expected to be at least 6 months. * patient or guardian must be able to provide verbal and written informed consent exclusion criteria: * prior trans-arterial chemo-embolization ≥4 after diagnosis of major portal vein tumor thrombosis * severe complication caused by liver cirrhosis eg. variceal bleeding, poorly controlled ascites, hepatic encephalopathy) * uncontrolled inter-current illness except liver cirrhosis

Keywords: hepatocellular carcinoma stereotactic ablative radiotherapy stereotactic body radiotherapy portal vein tumor thrombus
autotaxin as abiomarker in systemic lupus erythematosus patients

Conditions: SLE (Systemic Lupus)

Summary: * estimation of the serum atx level in sle patients in comparison to healthy subjects. * evaluation of the relation of serum atx level with disease activity and different clinical manifestation in sle patients

systemic lupus erythematosus (sle) is a chronic multisystem autoimmune inflammatory disease with unknown etiology . however, several genetic, immunological and environmental factors play a role in the etiopathogenesis of sle . during the disease course, patients may be presented with diverse clinical manifestations (mucocutaneous, articular, neurological, or renal manifestations) . anti-nuclear antibodies(ana), anti- double stranded dna (ds-dna)and anti smith(sm) antibodies are common biomarkers of sle. however the sensitivity and specificity of the current biomarkers are not ideal that the diagnosis of sle can be missed . lysophospholipids are phospholipids with only one fatty acid chain, such as lysophosphatidic acid (lpa) and lysophosphatidylserine. autotaxin (atx), one of the enzymes that catalyze the formation of lysophospholipid, is mainly responsible for the production of lpa in blood . tumor necrosis factor (tnf), interleukin-6 (il-6), and type i interferons, have been reported to induce the expression of atx . atx was reported recently as potential biomarkers of various diseases (serum atx in malignancy and chronic hepatitis c, while in acute myocardial infarction atx was overexpressed in cardiac tissue and in the synovium of rheumatoid arthritis patients) . several studies have reported that serum atx concentrations were higher in females than in males . the mrna expression of atx was found to be significantly induced by estrogen . there is growing evidence that atx may play a role in the pathogenesis of sle. few recent studies have reported that serum atx level can be a possible novel biomarker and key molecule in sle .

Eligibility criteria:
inclusion criteria: * patients who will be diagnosed as sle according to the 2012 systemic lupus international collaborating clinics (slicc) criteria . * sle patients older than 18 years old. exclusion criteria: * sle patients younger than 18 years old. * patients with other rheumatic diseases or overlap syndromes. * patients with malignancy. * patients with chronic hepatitis c.
analysis of surface ekg signals to identify myocardial dysfunction in patients at risk for coronary artery disease

Conditions: Coronary Artery Disease

Summary: 1. the myovista device is capable of detecting surface electrocardiogram signals and sensitive in detecting coronary artery disease compared to traditional computed tomography angiography (cta) 2. electrophysiological signals at the cellular level of myocardium are related to specific patterns on the myovista device 3. changes in myovista device output and can indicative of future cad outcomes and need for revascularization

background myocardial ischemia is caused by myocardial oxygen supply and demand mismatch. despite that coronary artery disease (cad) is the major cause of myocardial ischemia, the symptoms may occur even in the absence of significant cad. one of the mechanisms suggested for myocardial ischemia in these patients is microvascular ischemia (i.e. mismatch in microscopic vessels), affecting the myocardium (i.e. heart muscle) at the cellular level. a novel electrocardiographic recording method, the iecg is capable of capturing and amplifying signals from the cellular level that are much lower biologic signals than those processed by a traditional electrocardiogram (ecg). these recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. this novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases. specific aims aim#1: study the feasibility of detection of cad using iecg compared to computed tomographic coronary angiography (cta). aim#2: study the association between patterns of iecg and myocardial dysfunction in patients without cad compared to echocardiography. aim#3: study the effect of changes in iecg output on future outcomes of cad and need for revascularization.

Eligibility criteria:
inclusion criteria: * sinus rhythms * age\>18 years * both genders exclusion criteria: * acute coronary syndromes(acs) * contraindications to the administration of iodinated contrast * pregnancy * coronary artery bypass surgery (cabg) * history of cardiac valvular replacement * implanted cardiac pacemaker * chest deformities * unwilling or unable to provide informed consent for study participation * enrolled in another clinical study

Keywords: coronary artery disease iecg myovista heart test labs wavelet analysis surface electrocardiogram
s-1 and irinotecan combination chemotherapy for advanced gastric cancer

Conditions: Gastric Cancer

Summary: the primary goal of this phase ii trial is to evaluate the response rate of combination chemotherapy with s-1 and irinotecan in patients with advanced gastric cancer as a first-line therapy.


Eligibility criteria:
inclusion criteria: * pathologically proven unresectable adenocarcinoma of stomach * with uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional ct scan, x-ray or physical examination, or 1cm on spiral ct scan) * age 18 to 70 years old * estimated life expectancy of more than 3 months * ecog performance status of 2 or lower * adequate bone marrow function(absolute neutrophil count \[anc\] ≥1,500/µl, hemoglobin ≥9.0 g/dl,and platelets ≥100,000/µl) * adequate kidney function (serum creatinine \< 1.5 mg/dl) * adequate liver function (serum total bilirubin \< 2 times the upper normal limit (unl); serum transaminases levels \<3 times \[\<5 times for patients with liver metastasis\] unl) * no prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or s-1 or camptothecin analogues was excluded) * no prior radiation therapy for at least 4 weeks before enrollment in the study exclusion criteria: * other tumor type than adenocarcinoma * central nervous system (cns) metastases or prior radiation for cns metastases * gastric outlet obstruction or intestinal obstruction * evidence of gastrointestinal bleeding * the patient has bony lesions as the sole evaluable disease. * past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri * pregnant or lactating women, women of childbearing potential not employing adequate contraception * other serious illness or medical conditions * unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * history of significant neurologic or psychiatric disorders including dementia or seizures * active uncontrolled infection * other serious underlying medical conditions which could impair the ability of the patient to participate in the study * concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy * concomitant drug medication; the following drugs cause drug interaction with s-1. i. warfarin, phenprocoumon: increase bleeding tendency ii. increase blood concentration of phenytoin iii. sorivudine: inhibit dpd -\> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of s-1

Keywords: advanced gastric cancer first-line therapy s-1 irinotecan
use of indirect calorimetry in obesity

Conditions: Metabolism Disorder; Overweight and Obesity

Summary: the investigators will retrospectively analyze and compare data of 2 groups of overweight and obese patients: subjects who followed a diet based on resting energy expenditure (ree) measured by indirect calorimetry and subjects who followed a diet based on ree estimated by the harris-benedict equation. propensity score adjustment will be used to adjust for known differences between the 2 groups


Eligibility criteria:
inclusion criteria: * bmi \>25 * age ranging from 20 to 86 years exclusion criteria: * bmi\<25 * age \<20 * age \>86
low energy availability, menstrual irregularity, and low bone mass

Conditions: Bone Density; Energy Availability

Summary: this study examines the role of energy availability on menstrual function and bone mass in female adolescent endurance athletes. specific evaluations include dietary intake, exercise energy expenditure, training schedules, menstrual function and bone density.

the purpose of this project is to examine the relationships among low energy availability, h-p-a axis, menstrual function and bone density and bone turnover in high school female cross country runners. our objectives are to: 1)determine energy intake, exercise energy expenditure, and fat-free mass to examine energy availability; 2)in a subset of runners, using double labelled water, estimate total energy expenditure and indirect calorimetry to estimate resting metabolic rate; 3)assess the relationship between energy availability, hormones that regulate bone turnover, markers of bone formation and resorption and bone mineral content and density; 4)identify the relationship between energy availability, hormones that regulate menstrual function and current menstrual status; and 5)determine the energy intake and energy expenditure variables exhibiting the strongest associations with energy availability.

Eligibility criteria:
inclusion criteria: * high school female cross country runners * ages 15-17 years * 1-5 years experience as cross country runner * 25 miles or more/week training exclusion criteria: * medications known to affect bone metabolism * pregnancy

Keywords: bone density energy availability menstrual status female adolescent
a multicentre, cohort study of screening and preventive intervention for latent tuberculosis infection in children

Conditions: Children LTBI

Summary: the management of latent mycobacterium tuberculosis infection is a new priority action for the who end tuberculosis (tb) strategy. however, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of china. here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.

1. baseline analysis of a population-based, multicentre, prospective cohort study 1. a baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18). 2. eligible participants were identifi ed by door-to-door survey with a household sampling design. 3. participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (quantiferon \[qft\]) to test for latent infection. 2. incidence of active tuberculosis in individuals with latent tuberculosis infection in children of china under different treatment regimens 1. individuals who had tuberculosis infection at baseline (qft-positivity or tst tuberculin reaction size \[induration\] of ≥10 mm) were divided and treatment with different therapeutic schedule. 2. follow-up study were conducted to assess the proportion of latent tb infection converted to active tb

Eligibility criteria:
inclusion criteria: * children (0-18 years old). * children with qft-positive or tst induration ≥10 mm). exclusion criteria: * patients are allergic to anti-tuberculsis drugs. * parents and/or guardians do not agree to participate in this study. * participants with active tuberculosis.

Keywords: children ltbi intervention
primary vs secondary closure of tracheo-cutaneous fistulas

Conditions: Tracheostomy Complication; Post Tracheostomy Complications; Tracheostomy

Summary: the mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.

in this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. the investigators intend to randomly allocate them a mean of closure, either primary or secondary. once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. different questionnaires will be used to best evaluate a range of variables.

Eligibility criteria:
inclusion criteria: * being covered by the ramq * having a tracheostomy either percutaneous or surgical * being ready for canula removal and closure of the fistula exclusion criteria: * presenting a contraindication to primary tracheotomy closure (granuloma) * unable to consent * refusal to participate

Keywords: tracheostomy tracheostomy closure tracheocutaneous fistula
impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a prospective, randomized controlled trial.

Conditions: De Novo Hypoxemic Acute Respiratory Failure (hARF)

Summary: de novo hypoxemic acute respiratory failure (harf) is one of the main causes of intensive care unit (icu) admission. in de novo harf, intubation is associated with a dramatic increase in mortality rate. compared to standard oxygen, the use of high-flow oxygen nasal cannula (hfnc) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. even with hfnc, the intubation rate remains high. this is the reason why adjunctive therapies, administered in addition to hfnc are needed. continuous positive airway pressure (cpap) is one of these adjunctive therapies. cpap provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. in addition, as opposed to pressure support, cpap is well tolerated during long periods of time. therefore, applying cpap in addition to hfnc may reduce intubation rate and in turn mortality rate. the present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a prospective, randomized controlled trial


Eligibility criteria:
inclusion criteria: 1. adults (≥ 18 years old) 2. admitted in the icu for ≤ 24 hours 3. de novo harf defined by the three following criteria: 1. respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration 2. pao2/fio2 ≤ 200 mmhg under hfnc with flow ≥ 45 l/min, actual fio2 being considered. 3. uni or bilateral pulmonary infiltrate on chest x-ray or ct scan 4. informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent exclusion criteria: 1. refusal of study participation by the patient or the proxy 2. anatomical factors precluding the use of a nasal cannula or cpap 3. long term oxygen 4. home cpap or niv 5. hypercapnia indicating niv (paco2 \> 45 mmhg) 6. isolated cardiogenic pulmonary oedema indicating niv 7. known pregnancy or breastfeeding 8. absence of coverage by the french statutory health care insurance system 9. surgery within the last 6 days 10. use of vasopressors (norepinephrine\>0.3 mcg/kg/min) 11. glasgow coma scale \< 13 12. urgent need for endotracheal intubation 13. patients at an end-of-life stage receiving compational oxygenation

Keywords: continuous positive airway pressure high flow nasal cannula oxygen therapy de novo hypoxemic acute respiratory failure intensive care unit mortality mechanical ventilation non-invasive ventilation