Kornimate/medical-research-clean huggingface dataset:
investigation of cardiopulmonary parameters, motor development and muscle strength in ds with and without chd

Conditions: Congenital Heart Defects; Down Syndrome; Gross Motor Development Delay

Summary: congenital heart diseases (chd) are detected in 40-60% of individuals with down syndrome (ds) and increase the risk of developmental delay in the presence of syndromes. the aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in ds children with and without chd. demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. gross motor development was evaluated with gross motor function measure (gmfm-88). hand grip strength was measured with the baseline pneumatic bulb dynamometer.


Eligibility criteria:
inclusion criteria: * diagnosed with down syndrome as a result of genetic analysis, * for the congenital heart disease group; undergoing cardiac surgery at least 6 months before the evaluation, diagnosed as chd by a pediatric cardiologist based on echocardiographic findings, * for the group without congenital heart disease, patients who have not undergone cardiac surgery, are asymptomatic with a septal defect smaller than 4-5 mm, are expected to close, and are hemodynamically normal by a pediatric cardiologist, * children whose families were informed about the study and gave written consent to participate in the study were included in the study. exclusion criteria: * having another genetic abnormality other than down syndrome, * undergoing surgery other than cardiac surgery, * having an orthopedic or neurological problem, * respiratory support, * with atlantoaxial instability, * children with hematological disease were not included in the study.

Keywords: congenital heart defects down syndrome motor skills
a study of concomitant camrelizumab with chemoradiation for locally advanced head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the goal of this study is to determine the efficacy and safety of camrelizumab given concomitantly with chemoradiation in participants with unresectable, locally advanced head and neck squamous cell carcinoma (la-hnscc). all participants will receive camrelizumab in addition to chemoradiation, the standard treatment for la-hnscc.


Eligibility criteria:
inclusion criteria: * written informed consent * has a pathologically proven new diagnosis of head and neck squamous cell carcinoma * has unresectable disease and is eligible for definitive chemoradiation based on investigator decision * has eastern cooperative oncology group (ecog) performance status 0-1 * has evaluable tumor burden (measurable and/or non-measurable tumor lesions) based on recist version 1.1 * has adequate organ function as defined * female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy * female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy exclusion criteria: * has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer * is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy * has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization * has a history of severe hypersensitivity reaction to camrelizumab, cisplatin or radiotherapy * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy * has received prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody or has previously participated in clinical studies with camrelizumab * has received a live vaccine within 30 days prior to the first dose of study therapy * has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study * has not recovered from major surgery prior to starting study therapy * has known active hepatitis b or c * has known history of human immunodeficiency virus (hiv) * has a significant cardiovascular disease * has an active autoimmune disease that has required systemic treatment in the past 2 years. replacement therapy is not considered a form of systemic treatment * has had previous allogeneic tissue/solid organ transplant * has active infection requiring systemic therapy * is pregnant or breast feeding

Keywords: head and neck squamous cell carcinoma immune checkpoint inhibitors chemoradiation
superior labral tear from anterior to posterior (slap) repair versus biceps tenodesis for slap tears in the shoulder

Conditions: SLAP Tear

Summary: biceps tenodesis is currently advocated for older, less active patients, but to date is not often advocated for superior labral tear from anterior to posterior (slap) tears in young, active patients. the ideal surgical management for this pathology is not clearly known. more surgeons are using biceps tenodesis as a treatment for slap tears, including in the young, active population. if this study were to demonstrate that biceps tenodesis is similar to or better than slap repair, this would fundamentally change the treatment of slap tears. perhaps more importantly, it would likely mean a less involved rehabilitation and earlier return to activities for patients with this pathology.


Eligibility criteria:
inclusion criteria: - primary isolated slap tear, confirmed on mri exclusion criteria: * concomitant procedure needed such as a labral repair, rotator cuff repair or distal clavicle excision. * revision surgery * previous shoulder surgery * major medical illness * inability to speak or read english

Keywords: slap repair biceps tenodesis
characterization of methylation patterns in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatocellular Cancer; Cirrhosis

Summary: this study is being performed as part of the development process of the liver epicheck test which includes the identification of different methylation profiles in hcc (hepatocellular carcinoma) patients compare to cancer free control in blood samples

this is a prospective, multi-center, observational study aimed to collect blood samples and de-identified clinical data from subjects diagnosed with hcc (cases arm) and subjects with high risk for hcc which are undergoing routine surveillance for hcc.

Eligibility criteria:
inclusion criteria - case group: * age ≥ 22 years * subjects who are willing and able to provide written informed consent * subjects with confirmed diagnosis of hcc, naïve to tumor directed therapy exclusion criteria - case group: * subjects with current cancer of any kind, other than hepatocellular carcinoma * subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected * coinfection with hiv * prior solid organ transplant inclusion criteria - control group: * age ≥ 22 years * subjects who are willing and able to provide written informed consent * subjects diagnosed with one of the following: i. subjects with hcv and cirrhosis ii. subjects with hbv and cirrhosis iii. non-cirrhotic chronic hbv subjects at intermediate or high risk of hcc, according to easl clinical practice guidelines for the management of hepatocellular carcinoma iv. subjects with non-alcoholic fatty liver disease (nafld) with cirrhosis. v. cirrhotic patients due to any other reasons, including alcohol disease * subjects currently undergoing surveillance for hepatocellular carcinoma * hcc surveillance imaging (e.g., us, ct, mri) performed within 3 months prior to baseline visit * subjects with compensated liver function as measured by child-pugh score a or b7 without ascites (all measures should be from the last three months) exclusion criteria - control group: * subjects with current cancer of any kind, other than hepatocellular carcinoma * subjects with a history of cancer of any kind (including hepatocellular carcinoma), other than non-melanoma skin cancer completely resected * coinfection with hiv * prior solid organ transplant * current substance abuse

Keywords: cirrhosis hepatocellular carcinoma methylation hcc
clinician utilization of corus cad (or asges) in primary care provider decision making

Conditions: Coronary Artery Disease; Angina Pectoris; Chest Pain; Cardiovascular Diseases; CAD; CVD; Coronary Heart Disease; CHD

Summary: this retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a corus cad (age/sex/gene expression score - asges) result compared to patients who did not have the test performed (matched control patients).

this retrospective study will investigate clinician behavior in diagnosing patients with possible obstructive coronary artery disease who received a corus cad (age/sex/gene expression score - asges) result compared to patients who did not have the test performed (matched control patients). the data collected will be from primary care practices and will also assess one to two year health outcomes (mace, procedure complications). furthermore, in these real world practice settings, the study will investigate the economic impact of corus cad (asges) usage at each practice using practice specific data, when available.

Eligibility criteria:
inclusion criteria: for corus cad (age/sex/gene expression score - asges) arm: * symptoms suggestive of obstructive cad, according to the opinion of the site clinician * age \>= 21 years * resulted corus cad (asges) test used during the evaluation and/or diagnosis of symptoms suggestive of obstructive coronary artery disease (cad), preferably 1 year prior to data collection date. for control arm: * symptoms suggestive of obstructive cad, according to the opinion of the site clinician * eligible for corus cad (asges) (see exclusion criteria) * matched to corus cad (asges) patients by sex, age +/-2.5 years, and presenting symptoms exclusion criteria: * history of myocardial infarction (mi) or cad prior to the index evaluation * presentation of high risk unstable angina for the index evaluation * concurrent systemic infection or inflammatory process * concurrent mi or acute coronary syndrome * known diabetes mellitus diagnosis or laboratory test results suggestive of a diagnosis of diabetes mellitus (e.g., hba1c \>=6.5) * use of steroids, immunosuppressive agents, or chemotherapeutic agents, at time of chest pain presentation

Keywords: corus cad asges coronary artery disease gene expression age/sex/gene expression score ges angina pectoris chest pain cardiovascular disease cad cvd chd coronary heart disease precision medicine clinical utility
high-resolution 7 tesla mri of c-spine - comparison with 3 tesla mri

Conditions: Magnetic Resonance Imaging; Cervical Spine Disease

Summary: high-resolution mri (7 tesla) of the cervical spine is capable to differentiate osseous spurs from discus-material and better depict the compressed nerve in the neuroforamen compared to 3t mri. provide the surgeon with a detailed high-resolution anatomical image before surgery and potential no need for ct (if the bony anatomy is of crucial importance).


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature (appendix informed consent form) * \>18 years old * patients with cervical back pain (radiculopathy) and scheduled surgery for foraminal stenosis or central stenosis or cervical periradicular injection therapy (prt) exclusion criteria: * previous surgery * tumor patients * pregnancy or breast feeding * any mri contra-indications
post-marketing surveillance of lenvima in korean patients

Conditions: Differentiated Thyroid Carcinoma (DTC)

Summary: the purpose of this post-marketing surveillance (pms) is to observe the safety profile of lenvima (lenvatinib) in normal clinical practice setting.


Eligibility criteria:
inclusion criteria: participants who meet the following criteria will be eligible for inclusion in the study: 1. participants with approved indication for lenvatinib in korea 2. participants who have written consent for use of personal and medical information for the study purpose exclusion criteria: investigators will refer to approved indications and contraindications regarding exclusion criteria

Keywords: post-marketing surveillance lenvima lenvatinib e7080 differentiated thyroid carcinoma refractory to radioactive iodine progressive locally recurrent metastatic
a safety study to evaluate the antiviral activity of darunavir in combination with ritonavir in hiv 1 infected children

Conditions: Human Immunodeficiency Virus 1

Summary: the purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (drv/rtv), in combination with other antiretroviral drugs (arvs), in treatment-experienced human immunodeficiency virus 1 (hiv 1) infected children.

this is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity. approximately 24 hiv-1 infected children will be enrolled in this study. the study consists of a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. participants will receive drv/rtv according to their body weight. safety evaluations will include assessment of adverse events, laboratory tests, physical examination, neurologic examination, vital signs, and electrocardiogram. the total duration of the study will be 56 weeks.

Eligibility criteria:
inclusion criteria: * participants with a documented hiv 1 infection (by any of the local standard diagnostic methods, such as hiv pcr-dna, elisa or western blot (wb) test for hiv antibodies, etc.) * body weight from 10 kg to less than 20 kg at screening * participants currently on stable art (anti retroviral therapy) for at least 12 weeks, who need to change their arv regimen because it is currently failing, with a viral load of greater than 1000 copies/ml * screening genotype resistance test results showing less than 3 drv resistance-associated mutations * parents or legal representative willing and able to give consent exclusion criteria: * participants with presence of any currently active conditions included in the listing of who ( world health organisation) clinical stage 4 and participants with presence of a non-hiv encephalopathy * administration of any arv (antiretroviral) or non-arv investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available * life expectancy less than 6 months, according to the judgment of the investigator * co-enrollment in other clinical and/or cohort trials without written permission of the sponsor * participants with any active clinically significant disease (eg, tuberculosis \[tb\], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the subject's safety or outcome of the study

Keywords: human immunodeficiency virus 1 hiv-1 darunavir ritonavir norvir
changes of the corneal endothelial cell count after artisan phakic intraocular lens implantation

Conditions: High Myopia

Summary: the investigator will evaluate the change in endothelial cell count in eyes implanted with the iris-claw phakic artisan lens for treatment of moderate to high myopia using specular microscopy

iris-fixated phakic intraocular lenses (piols) are used worldwide to correct high myopia, hyperopia, and astigmatism. it is used to correct high degrees of myopia in patients for whom laser excimer refractive surgery is not indicated. the artisan lens is designed to minimize the contact between the iris and the iol resulting in less halo and glare from the prism effect. several clinical studies show that the visual results of the artisan lens are stable and predictable. artisan phakic iols provides precise predictability. there have been concerns that the anterior chamber lens could damage the endothelial cell layer because of its proximity to the cornea. the manufacturer advises using the artisan lens only in eyes with an ecd greater than 2000 cells/mm2 and an acd greater than 2.6 mm. corneal endothelium is metabolically active and responsible for keeping the corneal stroma in its usual dehydrated state of 70% water. loss of endothelial cells from increasing age, trauma, disease, or corneal surgery can reduce the density of endothelial cells and affect the ability of the endothelium to maintain it's primary function. alterations in the corneal endothelium depend on surgical technique and style; although endothelial cell loss is mainly the result of surgical trauma, continuous endothelial cell loss can occur. late corneal decompensation often occurs in the absence of direct intraoperative endothelial trauma. these complications can be explained by the toxic effect of inflammatory mediators on the corneal endothelium. specular microscopy is used to view and record non-invasively the image of the corneal endothelial cell layer.

Eligibility criteria:
inclusion criteria: * an age greater than 20 years, stable myopia with a variation in spherical equivalent of less than -0.50 diopter (d) during the 12 month preoperative period, a normal anterior segment with an acd (i.e., the area between the corneal endothelium and the central anterior lens capsule) greater than 3.00 mm, an endothelial cell count of 2000 cells/mm2 or greater, no corneal, pupil, or iris abnormalities; and no history of glaucoma and chronic or recurrent uveitis , having contraindications to laser in situ keratomileusis based on pachymetric data or other corneal shape characteristics, and an intraocular pressure of 20 mm hg or less. exclusion criteria: * an acd less than 3.0 mm, history of ocular surgery, glaucoma, chronic uveitis, or preexisting ocular pathologic features or abnormalities.

Keywords: artisan
hemodynamic instability of patient with spontaneous subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Spontaneous; Subarachnoid Hemorrhage, Aneurysmal

Summary: the goal of this observational study is to learn about the role of biomarkers in spontaneous subarachnoid hemorrhage (ssah) as predictors of severity of clinical outcome. the test of biomarkers is based on regular blood and urinary samples. blood levels of highly specific cardiac troponin (ctni), natriuretic peptides (nt-probnp), s100 beta protein, neuron-specific enolase (nse), glial fibrillary acidic protein (gfap), ubiquitin carboxy-terminal hydrolase (uch-l1), soluble tumor necrosis factor receptor-2 (sst2), and soluble urokinase plasminogen activator receptor (supar), as well as urinary levels of epinephrine and norepinephrine are the biomarkers explored. all adult participants with spontaneous subarachnoid hemorrhage are involved in the study. the main questions aim to answer are: * which of these molecules can be prognostic for patients' outcome * which are the prognostic levels of these biomarkers to predict patients' outcome. participants will undergo blood and urinary samples during hospitalization at 24 hours, 72 hours and after 7 days.

spontaneous subarachnoid hemorrhage (ssah) is one of the most severe neurological conditions. the hemodynamic instability due to endogenous catecholamine response and inflammatory patterns influences the risk of an unfavorable outcome and the development of clinical implications such as neurological and non-neurological issues. serum levels of highly specific cardiac troponin (ctni), natriuretic peptides (nt-probnp), s100 beta protein, neuron-specific enolase (nse), glial fibrillary acidic protein (gfap), ubiquitin carboxy-terminal hydrolase (uch-l1), soluble tumor necrosis factor receptor-2 (sst2), and soluble urokinase plasminogen activator receptor (supar), as well as urinary levels of epinephrine and norepinephrine, can be measured as biomarkers in ssah to explore the systemic response to the stress of bleeding. however, not all ssah cases equally develop this endogenous cascade responsible for neurological and systemic events. there is no clear validation of threshold levels of endogenous factors applicable in clinical practice to define hemodynamic instability that has only a neurological or multi-organ impact post-sah.

Eligibility criteria:
inclusion criteria: * patients with spontaneous subarachnoid hemorrhage, including those with perimesencephalic subarachnoid hemorrhage and aneurysmal subarachnoid hemorrhage. * adult patients. * confirmed presence of spontaneous subarachnoid hemorrhage through neuroimaging. * obtained informed consent for specific study biomarkers exclusion criteria: * age \<18 years. * post-traumatic subarachnoid hemorrhage.
the impact of inhaled furosemide and perorally administered levodropropizine on dyspnea in patients with respiratory diseases

Conditions: Dyspnea

Summary: the goal of this monocentric double blinded cross over trial is to evaluate safety and tolerability of inhaled furosemide in patients with pulmonary diseases and dyspnea. the main question\[s\] it aims to answer are: * is inhaled furosemide safe and well tolerated? * is inhaled furosemide capable of dyspnea suppression and is there any additive effect of levodropropizine participants will be given: * inhaled furosemide or placebo in double blinded cross over manner. dyspnea severity and vital functions will be measured, adverse reactions monitored * all participants will receive levodropropizine open label. dyspnea severity and vital functions will be measured, adverse reactions monitored

102 subjects from the pool of patients hospitalized in our pulmonary clinics will be randomized in 1:1 ratio to 2 arms in double blinded manner. subjects in both arms will inhale first vial of study medication - furosemide 40 mg or placebo (saline). dyspnea severity and vital functions will be measured, adverse reactions will be monitored. after an hour the subjects will inhale the second vial of study medication followed by the same procedure as earlier. neither subjects, nor investigators will know which vial contains furosemide and which contains placebo. at last all subjects will receive levodropropizine open label and the dyspnea severity, vital signs and adverse reaction will be monitored for another hour. the measured values will be statistically evaluated a results published.

Eligibility criteria:
inclusion criteria: * ability to understand and sing written consent * ability to use visual analogue (vas) and borg dyspnea scale * presence of lung disease (asthma, chronic obstructive pulmonary disease, interstitial pulmonary disease, tumour affecting lungs, coronavirus disease 2019 (covid19), drug induced dyspnea, lung infection) * dyspnea at least 50 points in vas and at least 5 point in borg dyspnea scale * women of childbearing age consent ot avoid sexual intercourse during the study participation exclusion criteria: * hypersensitivity to furosemide, levodropropizine or any additives in studied drugs * mucociliary disorder (kartegener syndrome, ciliary dyskinesis) * severe liver disease - cirrhosis child pugh b or c * renal failure, creatinine clearance less than 35 ml/min * unstable patient requiring frequent treatment changes * patients with continual intravenous medication requiring modification of their therapy more often than ever 4 hours * unability to participate in all study procedures * pregnancy, breast feeding * participation in other clinical trial with administration of study drug in last 28 days or 5 half times of studied drug (the longer period is taken into account) before screening