Kornimate/medical-research-clean huggingface dataset:
post-marketing surveillance of ofev capsules in chronic fibrosing interstitial lung diseases with a progressive phenotype in japan

Conditions: Lung Diseases, Interstitial

Summary: the primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of ofev capsules under the real world setting in patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (pf-ild).


Eligibility criteria:
inclusion criteria: * patients in japan with chronic fibrosing interstitial lung diseases with a progressive phenotype who are prescribed with ofev capsules and have never been treated with ofev capsules before enrolment will be included. exclusion criteria: * diagnosis of idiopathic pulmonary fibrosis * patients with chronic fibrosing interstitial lung diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
evaluation of renal function impairment on the pharmacokinetics of lee011

Conditions: Normal Renal Function; Impaired Renal Function

Summary: the purpose of this study is to characterize the pk and safety profile of lee011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.


Eligibility criteria:
inclusion criteria (all subjects): * male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations (except for renal impaired subjects). * subjects must have a bmi between 18 kg/m2 and 38 kg/m2 and weight at least 50 kg and no more than 120 kg. * additional inclusion criteria for subjects with normal renal function: * an absolute gfr as determined by mdrd equation and conversion within normal range as determined by gfr \> 90 ml/min inclusion criteria (for subjects with impaired renal function): - subjects must have documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable absolute gfr, for 4 weeks prior to study entry. exclusion criteria (all subjects): * subject has received a renal transplant at any time in the past and is on immunosuppressant therapy * history or presence of impaired cardiac function * any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs * administration of cyp3a4/5 inhibitors or inducers or cyp3a4 substrates with narrow therapeutic windows * administration of medications that prolong the qt interval * subject has a history of immunodeficiency diseases, including hiv, as confirmed by (hiv-1, hiv-2) test * receipt of investigational product in another clinical trial within 4 weeks of dosing exclusion criteria (for subjects with impaired renal function): * severe albuminuria \> 300 mg/day * subjects undergoing any method of dialysis * subjects with renal impairment due to hepatic disease (hepatorenal syndrome) other protocol-defined inclusion/exclusion may apply.
airborne ultrafine and fine particulate matter: a cause for endothelial dysfunction in man?

Conditions: Airway Inflammation

Summary: the purpose of this study is to examine biological pathways of altered blood vessel function resulting from breathing airborne particulate. blood artery function in healthy men will be measured after particulate exposure either on placebo or on an asthma medication that stops production of an inflammatory biological agent. lung and blood profiles will be obtained before and after exposure to exhaust fumes. we believe that the inflammatory agent produced by the lungs from breathing these particles causes abnormal artery function.

hourly ice resurfacing by gas and propane fueled machines creates high levels of ultrafine and fine particulate matter (pm1) in indoor ice rinks. pm1 exposure may disrupt the normal nitric oxide (no)/endothelin (et)-1 vasodilation system and promote atherosclerosis, and/or increase the risk of an acute cardiac event. our specific aims are 1) to determine whether impaired endothelial-mediated vasodilation and forearm muscle tissue reoxygenation rate and blood volume change (to reactive hyperemia following artery occlusion) is associated with combustion-derived pm1 exposure, and 2) to characterize a pm1 induced mechanism of endothelial dysfunction which occurs via a leukotriene (lt)-associated, airway generated tumor necrosis factor-alpha (tnf-a) mediated pathway. healthy low pm1 exposed males will be evaluated for endothelial dysfunction before and after artery occlusion using high resolution ultrasound and near-infrared spectroscopy (nirs), before and after moderate exercise in blinded high and low \[pm1\]. endothelial dysfunction among chronically pm¬1 exposed ice rink athletes will be determined to evaluate the feasibility of using this population as a model in future studies. tnf-a, il-8, ltb4, ltc4, ltd4, lte4, et-1, no, and differential cell counts will be measured in sputum and serum. \[pm1\] will be monitored and exposure levels will be typical of indoor ice rinks. lt involvement will be assessed in vivo by double-blind pharmacological manipulation during pm1 exposure during light exercise. results will demonstrate whether endothelial-mediated vasodilation and muscle hemodynamics are influenced by pm1 exposure, and will elucidate an lt initiated tnf-a mediated pathway in et-1 upregulation. our results should provide information for understanding the effects of pm1 exposure on the atherosclerotic process and cardiovascular risk, and give insight to novel treatment and diagnostic modalities.

Eligibility criteria:
inclusion criteria: * healthy male subjects * between 18 and 30 years of age * participant in endurance sport exclusion criteria: * history of blood clotting * history of coagulation problems * history of spontaneous pneumothorax

Keywords: particulate air pollution leukotriene asthma montelukast vascular endothelial dysfunction nitric oxide(no)endothelin (et) system
tonsillar retractor-induced subacute submassive tongue edema

Conditions: Side Effects; Tonsil Hypertrophy; Children, Only

Summary: this study aimed to detect tongue edema induced by the pressure exerted by tonsillar retractor; edema detection was made through tongue area measurement using ultrasonography (usg) in pediatric patients who underwent tonsillectomy surgeries.

the tongue is an ideal organ for ultrasonography (usg) evaluation. this study aimed to detect the occurrence of tongue edema through usg examination and to educate clinicians about the association between subacute tongue edema and tonsillar retractor in pediatric patients.

Eligibility criteria:
inclusion criteria for study group: * patients aged 16 years or younger * undergo tonsillectomy surgery * patients informed consent obtained from the parents exclusion criteria for study group: * patients aged older than 16 years * patients with a history of syndromal craniofacial abnormalities * patients with systemic disorders and other otolaryngologic problems inclusion criteria for control group: * patients aged 16 years or younger * patients who did not need tonsillectomy surgery and any head and neck procedures * patients who underwent endotracheal intubation under general anesthesia except tonsillectomy and head and neck surgery.

Keywords: ultrasonography children tonsil diagnostic imaging
effects of aerobic exercise on blood pressure levels of resistant hypertensive subjects

Conditions: Hypertension; Resistant Hypertension

Summary: the aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. after, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. in both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. in addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (dii derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.


Eligibility criteria:
inclusion criteria: * age between 40 and 70 years * men or women * body mass index under 40 kg / m² * able to participate in exercise * no regular physically active in the last 4 months exclusion criteria: - smoking; with history of ischemic stroke or hemorrhagic; or coronary heart disease; or obstructive pulmonary disease or chronic restrictive; or diabetes mellitus; or chronic atrial fibrillation.

Keywords: exercise aerobic exercise
utility of real-time contrast enhanced ultrasound (ceus) in the evaluation of soft tissue hematomas

Conditions: Hematoma

Summary: traumatic and non-traumatic soft tissue hematomas are frequently encountered in the acute care setting. the incidence of these hematomas appears to be on the rise secondary to the increased use of anticoagulants among older patients for a variety of medical conditions. the management of soft tissue hematomas depends on the accurate diagnosis of any ongoing bleeding as well as of identification of the injured vessel type. while the majority of cases can be managed conservatively, expanding hematomas leading to hemodynamic instability or ongoing blood loss might require embolization or surgical intervention. the mainstay diagnostic imaging modality is multidetector computed tomography (mdct) with intravenous contrast that allows accurate assessment of hematoma size, location as well as evaluation for active extravasation. however, many patients cannot undergo ct imaging due to underlying kidney disease, allergy to contrast, or due to concerns for radiation exposure, especially in young age. currently there are no alternative tests for these patients with a similarly high diagnostic accuracy available. this study intends to establish an imaging protocol and investigate the utility of contrast-enhanced ultrasound (ceus) in the diagnostic work-up of soft tissue hematoma as an ionizing radiation-free alternative to computed tomography (ct) that can be used independent from the kidney function of the patient.


Eligibility criteria:
inclusion criteria: * adult patients over the age of 18 who have a clinical suspicion of an actively bleeding soft-tissue hematoma as determined by the treating emergency provider. enrollment will be for one year or until a target of 20 patients is enrolled. exclusion criteria: * the investigators will exclude persons under the age of eighteen, vulnerable populations (pregnant patients and prisoners), need for immediate procedural intervention and those with known hypersensitivity to sulfur hexafluoride lipid containing microspheres as well as those who have a soft-tissue hematomas that are in an unfavorable anatomical location for ultrasound imaging.
evaluation of cardiac burden in patients with sever bronchial asthma

Conditions: Evaluation of Cardiac Burden in Patients With Sever Bronchial Asthma

Summary: evaluation of cardiac burden in patients with sever bronchial asthma

bronchial asthma is chronic bronchial inflammation of variable intensity accompanied by recurrent reversible airflow obstruction and symptoms such as coughing, wheezing, shortness of breath, and chest tightness ,with a worldwide increase over the last several decades (1). 1. sever asthma :means that asthma is uncontrolled despite adherence with maximal optimized therapy and treatment contributory factors or that worsens when high dose treatment is reduced. 2. globally. over 260 million people had poorly controlled asthma highest rate on australia.

Eligibility criteria:
inclusion criteria: * patients accepted to be involved in the study. * patients \>18 years old . exclusion criteria: * severe bronchial asthma patients who have other comorbidities as (chronic chest disease as copd,ild, bronchiectasis , , diabetic ,hypertensive ,mechanical ventilated patients, tracheostomized patients, ......) * patients \<18 years old . patients refuse to be involved in the study .
open-label study of epratuzumab in serologically-positive systemic lupus erythematosus patients with active disease

Conditions: Systemic Lupus Erythematosus

Summary: the primary objective of the study is to assess the safety of epratuzumab in patients with sle.


Eligibility criteria:
inclusion criteria: * sl0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure * patients must have maintained eligibility requirements throughout their participation in sl0007 * written informed consent signed prior to initiation of any study-specific assessments at visit 1 exclusion criteria: * patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study * active severe sle disease activity which involves the cns system (defined by bilag neurologic a level activity) including transverse myelitis, psychosis and seizures * active severe sle disease activity which involves the renal system (defined by bilag renal level a activity or grade iii or higher who nephritis) or serum creatinine \>2.5mg/dl or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria \>3.5gm/day * patients with a history of anti-phospholipid antibody syndrome and use of oral anticoagulants or anti-platelet treatment * patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.

Keywords: lupus monoclonal antibody b-cell immunotherapy
exercise-induced lactate and cognitive function (exlbc)

Conditions: Cognition; Sodium Bicarbonate; Lactate; Exercise

Summary: a single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. however, we do not fully understand the mechanism behind this process. a promising candidate mechanism is lactate, which was previously considered merely a waste product of our muscles during exercise. it is now recognized as an important molecule that is used by the brain as an energy source. studies have shown that increases in lactate during exercise are positively related to improved cognitive function after completion of exercise. another potential mechanism involves the increase in neurotrophins such as brain-derived neurotrophic factor (bdnf) following exercise. the increase in lactate and bdnf during exercise may be connected to cause these cognitive improvements. however, because lactate increases with higher exercise intensities, we currently do not know how lactate specifically impacts brain health. to address this, muscle and blood lactate concentrations can be experimentally manipulated during exercise using sodium bicarbonate (nahco3) supplementation and will allow us to explore how lactate specifically affects brain function. the purpose of this project is to investigate the effect of exercise-induced lactate on bdnf and cognition following oral nahco3 supplementation in young adults. we hypothesize that bdnf levels will be higher, and cognition will be improved in executive function, visuospatial memory, and working memory in the nahco3 condition due to higher plasma lactate during exercise compared to placebo.


Eligibility criteria:
inclusion criteria: * between the ages of 18-35 years old. * perform ≥150 minutes of moderate-to-vigorous aerobic activity per week. exclusion criteria: * diagnosis of type 2 diabetes. * presence of hypoglycaemia. * history of concussion(s) with persistent symptoms. * history of mental health conditions. * history of cardiovascular events requiring hospitalization (e.g., heart attack). * pre-existing injuries that prevent completion of aerobic exercise. * presence of colour-blindness.

Keywords: lactate sodium bicarbonate nahco3 cognition executive function acute exercise
myth of double crush syndrome in median nerve

Conditions: Cervical Radiculopathy; Median Nerve Disease

Summary: there is relation between the cervical radiculopathy and carpal tunnel syndrome and why the referred pain is fall at carpal tunnel not at elbow.

this is an observational cadaveric study which examined median nerve from shoulder to wrist by histological measurements to explain the difference at the median nerve.

Eligibility criteria:
inclusion criteria: * intact upper limb exclusion criteria: amputation at upper limb -

Keywords: wrist pain
thalomid and carboplatin for the treatment of pediatric brain stem glioma

Conditions: Brain Stem Neoplasms, Primary; Neoplasms, Brain Stem

Summary: treatment on this study combines two drugs: thalomid™ (thalidomide) and carboplatin. thalidomide has been available for many years and has been used to treat many different illnesses. carboplatin is an effective medicine in killing cancer cells. thalidomide works by blocking angiogenesis (the process of new blood vessel formation). if a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. this research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors. this study will try to find out how well thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. this study will look at how well thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. this study will also look at any side effects of these treatments.


Eligibility criteria:
inclusion criteria: * patients must be \>/= 3 and \</= 21 years of age. * patients must have a newly diagnosed or progressive brain stem tumor. * if biopsy has been performed, patients with both high and low grade astrocytomas are eligible. * non-histologically confirmed brain stem tumors are eligible. neuroradiographic confirmation of brain stem glioma is mandatory for study entry. * cervicomedullary junction tumors are ineligible. * patients with a diagnosis of nf-1 are ineligible. * patients must be registered within 6 weeks from diagnosis or recurrence. * patients must have life expectancy \> 6 weeks. * patients must have adequate hematologic and renal function: anc \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \</= 0.7 mg/dl (age 3-10yrs.), \</= 1.0 mg/dl (11-12yrs.). and \</= 1.2 (13-21yrs.). * written informed consent must be obtained according to institutional guidelines. * pregnant or nursing women are ineligible. * patients must be registered within 3 days prior to the start of protocol treatment. patients must not start treatment until informed consent is given and the patient is registered. willingness and ability to comply with the fda-mandated s.t.e.p.s.® program.

Keywords: brain stem glioma
evaluation of auditory fatigue in medical regulation assistants

Conditions: Auditory Fatigue

Summary: auditory monitoring of employees is currently based on pure-tone audiometry. however, this clinical examination does not prevent from deafness but established it a posteriori. from a preventive standpoint, it is important to detect hearing professional pain before the development of irreversible(s) clinical(s) symptom(s). the investigators' hypothesis is that auditory fatigue results from damages of primary and secondary central auditory pathways involving cognitive processes. the assessment of auditory fatigue includes the evaluation of speech intelligibility, short-term memory, working memory and perceived mental task load. the main objective of this study is to identify, among regulating medical assistants working with headset, a central auditory fatigue.


Eligibility criteria:
inclusion criteria: * participants without hearing loss and without ontological antecedents in the past 5 years * participants gave their written informed consent * participants are affiliated to the french social welfare * preliminary clinical examination exclusion criteria: * ontological antecedents in the past 5 years * pathology of the external or middle ear * abnormality in audiometric examination * participants already enrolled in an other research protocol * participants covered by articles l.1121-5 à l.1121-8 et l.1122-1-2 of the french public health code

Keywords: speech intelligibility short-term memory working memory perceived mental task load
extracorporeal co2 removal in copd exacerbation

Conditions: COPD Exacerbation

Summary: the minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory load during chronic obstructive pulmonary disease (copd) exacerbation, reducing the need to advance the respiratory care toward invasive mechanical ventilation in patients refractory to non-invasive ventilatory support (niv), or decreasing the need of ventilatory support in patients already invasively ventilated, thereby accelerating the weaning process. the investigators intend to perform a multi-center experimental non randomized single arm prospective study to investigate the efficacy of the decap smart in reducing the intubation rate or the duration of invasive mechanical ventilation in patients with copd treated either with niv or invasive mechanical ventilation (imv) for severe respiratory failure and hypercapnia. the results of the study will be compared to the data available in the literature.


Eligibility criteria:
inclusion criteria: * copd * severe acute respiratory failure * after at least two hours of continuous application of non-invasive ventilatory support (niv): * arterial ph ≤7.30 with an arterial pressure of co2 (paco2) \>20% of the baseline value and one of the following: * respiratory rate ≥30 breaths/min; * use of accessory muscles or paradoxical abdominal movements exclusion criteria: * failure to obtain consent * hemodynamic instability (map \< 60 mmhg) despite infusion of vasoactive drugs * contraindications to the administration of i.v. heparin (heparin induced thrombocytopenia, hemorrhage, etc.) * body weight \>120 kg * contraindication to continuation of active treatment (dnr)

Keywords: copd