Kornimate/medical-research-clean huggingface dataset:
the leaky lung test

Conditions: Asthma; Allergy; Reactive Airway Disease; Lung Diseases, Obstructive

Summary: this is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.

a cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to fda approved protocols for bronchoprovocation. mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. this is a proof of concept study and not a trial of new therapeutics.

Eligibility criteria:
inclusion criteria: asthma the diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. consistent historical features of asthma include episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). consistent physical findings of asthma include audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. subjects will need to be free of asthma symptoms at time of challenge testing. most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test. inclusion criteria: non-asthmatic controls healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test. exclusion criteria: 1. \>5 pack year history of tobacco use or active smoking. 2. other chronic or active lung diseases (e.g. copd, pulmonary fibrosis, lung cancer) 3. history of significant renal insufficiency of liver disease 4. asthma subjects with severe disease according to naepp guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids) 5. asthma subjects with a baseline fev1\<65% predicted 6. asthma subjects unwilling or unable to withhold medications prior to testing 7. pregnant women.
safety, efficacy, and pharmacokinetics of adalimumab in japanese children with juvenile rheumatoid arthritis

Conditions: Juvenile Rheumatoid Arthritis

Summary: to evaluate efficacy, safety and pharmacokinetics of adalimumab in japanese children with polyarticular juvenile rheumatoid arthritis

this was an open-label long-term study that was completed following study drug approval in japan for the treatment of jra. data are presented through week 144 and for the final visit.

Eligibility criteria:
inclusion criteria * diagnosis of polyarticular juvenile rheumatoid arthritis (jra) according to the criteria of the american college on rheumatology (acr) * disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (nsaids) or methotrexate (mtx) * presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness) * stable dosage of mtx for at least 12 weeks prior to the screening visit or discontinuation of mtx at least 14 days prior to baseline visit (day 1) * discontinuation of disease-modifying antirheumatic drugs (dmards) other than mtx at least 28 days before screening visit exclusion criteria * history of inflammatory joint disease other than jra * functional class iv jra by acr criteria * clinically significant cardiac disease or laboratory abnormalities * any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Keywords: juvenile rheumatoid arthritis
an epidemiological study to assess the psychosocial and symptomatic remission and community integration status in patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to estimate the level of symptomatic and psychosocial remission of patients with schizophrenia and schizoaffective disorder in standard clinical practice as a function of the degree of adherence to antipsychotic treatment. the secondary objectives are to study the level of community integration of the patients included in the study, and its influencing factors, to analyze the role of various sociodemographic factors, factors related to the course of disease and the psychopathological status of the patient in community integration and remission, to analyze the potential predictors of a favorable course (symptomatic and psychosocial remission) and a poor course (no symptomatic or psychosocial remission), to assess the impact of treatment adherence on the change in the functional and community integration status of patients (based on the occupation, independence level, and degree of disability variables), to assess the significance of premorbid (academic and social) adjustment in the symptomatic and functional remission and the community integration status of patients and to correlate the level of insight to the remission and integration status of patients.

this is a retrospective, cross-sectional, non-interventional observational, cohort epidemiological study conducted in the outpatient mental health facility setting in patients with schizophrenia. the inclusion of two patient cohorts is contemplated, recruited in mental health facilities. one cohort will involve patients estimated to have inadequate adherence to antipsychotic treatment, while the other will consist of patients with adequate adherence to such treatment. n/a

Eligibility criteria:
inclusion criteria: * patients with schizophrenia or schizoaffective disorder being followed-up at a mental health facility * whose clinical records of recent years may be accessed * who has signed informed consent, stating that he/she understands the study purpose and requirements and gives consent to participate in the study * in whom the psychiatrist and main caregiver may estimate the degree of adherence to antipsychotic treatment during the last two years * not hospitalized in acute disorder units in the last 12 months exclusion criteria: * patients with psychiatric disease other than schizophrenia or schizoaffective disorder who have been diagnosed with severe to moderate mental retardation, organic disorders of personality, and/or severe and/or disabling neurological disease * patients who are actively participating in any clinical trial/study

Keywords: schizophrenia schizoaffective disorder remission psychosocial symtomatic integration schizoaffective adherence
mitro-annular disjunction in cardiac magnetic resonance

Conditions: Mitral Valve Prolapse Syndrome; Arrhythmogenic Bileaflet Mitral Prolapse; Mitral Valve Disorder

Summary: mitral annular disjunction (mad) is an abnormal atrial displacement of the mitral valve leaflet hinge point. mad is gaining clinical importance for several studies reporting its association to mitral valve prolapse (mvp), complex ventricular arrhythmias and sudden cardiac death. on the other hand, other studies found mad as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication. cardiac magnetic resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. additionally, cardiac magnetic resonance (cmr) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small mad. therefore, in relation to the scarcity of data about mad prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of mad in patients submitted to cmr independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.

multicenter retrospective study. all cardiac mri study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of mad, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at lge and ecv evaluation. finally, the association between mad and arrhythmias will be investigated.

Eligibility criteria:
inclusion criteria: • consecutive adult patients (age ≥18 years-old), submitted to cardiac magnetic resonance independently by the clinical suspicions in the first 6 month of 2019 (from january to june 2019) that have signed an informed consent authorizing data collection for future retrospective clinical research protocols exclusion criteria: • pediatric patients (age \<18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of lge images, lack of clinical information about presence of arrhythmias. the timeline was selected to avoid the impact of covid-19 pandemic on cmr availability, scheduling, and findings.

Keywords: mitral annular disjunction, mitral prolapse, arrhthymia
implementation of a rapid recovery protocol in total knee arthroplasty

Conditions: Fast Track; Tranexamic Acid Adverse Reaction; Knee Osteoarthritis

Summary: patients undergoing total knee arthroplasty will follow two different rehabilitation protocols. in one of them, they will start walking the day of surgery and discharged on a 48 hours basis. on the other one, start walking 3 days after surgery and discharged on a 96 hours basis. outcomes will be satisfaction, pain, range of movement, incidence of dvt and overall complications.

randomization will be performed concealed the day before surgery. tranexamic acid will be used in both groups. rapid recovery group will not be using a drain, whereas the standard protocol group will have one.

Eligibility criteria:
inclusion criteria: * knee osteoarthritis willing to undergo total knee arthroplasty * age 55-79 * consent exclusion criteria: * hipersensibility to any of the components used * epilepsy * pulmonary embolism

Keywords: fast track total knee arthroplasty tranexamic acid drain
the effect of leucine on body composition and muscle characteristics in elderly, type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes exclusion criteria: * impaired renal or liver function * cardiac disease * subjects with metal implants * hypertension * diabetes complications * exogenous insulin therapy

Keywords: elderly
feasibility of the braingate2 neural interface system in persons with tetraplegia

Conditions: Anarthria; Dysarthria; Tetraplegia; Spinal Cord Injuries; Amyotrophic Lateral Sclerosis; Brain Stem Infarctions; Locked in Syndrome; Muscular Dystrophies

Summary: the purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

the goal of the braingate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Eligibility criteria:
inclusion criteria: * between 18 and 80 years of age. * participants must have a diagnosis of amyotrophic lateral sclerosis (als) as verified by a clinical expert in neurologic diseases. * participants with a diagnosis of als with anarthria, or severe dysarthria with decline in the preceding four months. * must be within a three-hour drive of the study site and geographically stable for at least 15 months after enrollment. exclusion criteria: * visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * chronic oral or intravenous steroids or immunosuppressive therapy * other serious disease or disorder that could seriously affect ability to participate in the study (there are additional exclusion criteria)
exercise for adults with limited mobility

Conditions: Mobility Limitation; Fall

Summary: the purpose of this study is to evaluate the effectiveness of a structured and progressive task-oriented, community based exercise program for older adults who have limitations in mobility and examine whether improvements in mobility and quality of life would be seen following completion at 6 months.


Eligibility criteria:
inclusion criteria: * limitations in mobility as evidenced by 6 minute walk test score of \< 499 meters * motivation to participate in an exercise program exclusion criteria: * unable to follow commands * unstable cardiac status * greater than minimal assist for mobility
partial adenoidectomy in cases of velopharyngeal dysfunction

Conditions: Velopharyngeal Insufficiency; Velopharyngeal Incompetence Due to Cleft Palate

Summary: the velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. it consists of the lateral and posterior pharyngeal walls as well as the soft palate. the role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.

velopharyngeal dysfunction is the inability to separate the oral and nasal cavities adequately during speech production through the actions of the velum and pharynx. velopharyngeal dysfunction can be caused due to lack of tissue (velopharyngeal insufficiency) or lack of proper movement (velopharyngeal incompetence) of the walls. while velopharyngeal dysfunction is commonly associated with cleft lip and palate, it can also be seen with submucous cleft and other noncleft conditions such as ablative palatal lesions, adenoidectomy, deafness or hearing loss, and cerebral palsy. in velopharyngeal dysfunction, the incompletely closed velopharyngeal valve causes an inability to effectively manage the air stream for continuous speech causing hypernasal speech. adenoid hypertrophy may play a role in velopharyngeal closure especially in patients with palatal abnormality. in 1958, gibb indicated an incidence of hypernasality postadenoidectomy in approximately 1 of 2000 cases. closure pattern of velopharyngeal valve in typical patients is velo-adenoidal rather than velopharyngeal closure. adenoid mass is vital to velopharyngeal closure in such patients and removal necessitates a change in the pattern of velopharyngeal valving. trans-oral endoscopic partial (superior) adenoidectomy adenoidectomy enables the surgeon to inspect the velopharyngeal valve during the procedure; thus avoiding occurrence of velopharyngeal dysfunction.

Eligibility criteria:
inclusion criteria: * adenoid enlargement causing obstructive sleep-disordered breathing (osdb) with velopharyngeal insufficiency (proved or suspected). exclusion criteria: * patients who had undergone any secondary corrective surgery for velopharyngeal insufficiency. * patients with craniofacial anomalies. * any associated medical comorbidity that contraindicates general anesthesia. * refusal of enrollment in the research by the patients or care givers.
oct and early cognitive impairment in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer \& ganglion cell inner plexiform layer in ms.

cross-sectional study design, including 60 patients and 30 healthy controls. subjects were investigated clinically, underwent retinal optical coherence tomography (oct) and comprehensive cognitive assessments. the correlation between these modalities was evaluated by spearman correlation.

Eligibility criteria:
inclusion criteria: * 60 ms patients diagnosed according to the revised mcdonald criteria 2010 were included * 30 healthy subjects with age and sex match control group. exclusion criteria: * medical disorder other than ms that may grossly affect cognitive functions * pregnancy, * previous neurological or neuropsychiatric disorders, * alcohol or drug abuse, * mri findings which could not be attributed to ms. * severe visual disorders (\> ± 6.0 dpt.) * history of ocular surgery, glaucoma or diabetes.
nasal naloxone for narcotic overdose

Conditions: Drug Overdose

Summary: the goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. ambulance squads in adams, clermont, and scioto counties in southern ohio will be randomized to provide either standard care or nasal (in) naloxone as the initial response to a suspected opioid overdose. standard care includes administration of naloxone by intravenous (iv), intramuscular (im) or intraosseus (io) methods.

this is a randomized, prospective trial that will compare clinical outcomes for parenteral naloxone according to the standard of care (tau; administration via intravenous \[iv\], intramuscular \[im\] or intraosseus \[io\] delivery) versus intranasal \[in\] for the prehospital emergency treatment of suspected opioid overdose. ambulance squads in adams, clermont, and scioto counties in southern ohio will be randomized to administer either standard care or in naloxone as the initial response to a suspected opioid overdose.

Eligibility criteria:
inclusion criteria: * presence of hyperventilation or respiratory arrest or * ems assessment that the person needs naloxone for possible opioid or unknown drug overdose exclusion criteria: * ems assessment that the participant is less than 12 years old

Keywords: heroin prescription pain killers narcotics
supine mri in breast cancer patients undergoing upfront surgery or receiving neoadjuvant therapy

Conditions: Breast Cancer

Summary: this research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'mri') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).

the procedure involved is called a supine breast magnetic resonance imaging (mri).in this study, the investigators are evaluating the value of supine mri in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy. the purpose of this study is to assess the value of supine breast mri as a new imaging method to assist in surgical treatment planning. it is possible that the use of supine breast mri will help your doctor see the size and location of tumors more accurately

Eligibility criteria:
inclusion criteria: * participants must be female * participants must have a pre-operative standard mammogram with or without ultrasound. * participants must have biopsy confirmed and clinical stage i, stage ii, or stage iii non-inflammatory breast carcinoma. if biopsy was done at an outside hospital, pathology will be reviewed at (bwh, bwfh) * patient must meet standard mri guidelines and be able and willing to undergo mri * participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following nat (this takes into account tumor to breast size ratio appropriate for bct, and the ability to undergo standard radiation therapy post-operatively). * study participants will be restricted to those aged ≥18 years old. this age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * participants with a known brca 1 or 2 mutation. * participants with a known li-fraumeni or cowden's disease. * participants with prior mantle radiation. * participants with inflammatory breast cancer or multi-centric disease * participants who are pregnant. * participants who are already enrolled in a conflicting investigational trial * participants with known active collagen vascular disease. * participants with prior history of ipsilateral breast carcinoma treated with bcs and radiation therapy. * patients who have biopsy confirmed multi-centric disease. * participants who are unable to undergo mri because of documented contra-indications for contrast-enhanced mri, including but not limited to renal failure * participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the mri scanner.

Keywords: breast cancer
corneal endothelial cell changes after phacoemulsification in patients with type 2 diabetes mellitus

Conditions: Cataract; Diabetes Mellitus

Summary: this study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

the investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. the corneal endothelial cell density, variation in endothelial cell size (cv), percentage of hexagonal cells, and central corneal thickness(cct) were recorded at baseline and at 3 months postoperatively.then, the investigators compared the two sets of data. at last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Eligibility criteria:
inclusion criteria: the experimental group: 1. clinical diagnosis of cataract 2. type 2 diabetes mellitus 3. the recent blood glucose control was stable 4. the glycosylated hemoglobin \< 8% the control group: 1. clinical diagnosis of cataract 2. no history of type 2 diabetes exclusion criteria: 1. corneal lesions 2. anterior inflammation 3. ocular trauma or surgical history 4. glaucoma 5. corneal endothelial cell density \< 1500 / mm squared

Keywords: cataract phacoemulsification type 2 diabetes mellitus corneal endothelial cells
safety, pharmacokinetics and pharmacodynamics of tki258 in subjects with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the primary objective is to determine the maximum tolerated dose (mtd), dose limiting toxicity (dlt), and safety profile of tki258 when administered to subjects with acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of acute myeloid leukemia * eighteen years of age or older * life expectancy of at least 2 months exclusion criteria: * intracranial disease or epidural disease * clinically significant cardiac disease * diabetes mellitus uncontrolled with medication * pregnant or breast feeding women * dementia or altered mental status * known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands * previous pericarditis * malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting

Keywords: acute myeloid leukemia