Kornimate/medical-research-clean huggingface dataset:
replication of the grade diabetes trial in healthcare claims data

Conditions: Diabetes

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
inclusion criteria: * age greater or equal than 30: days \[0,0\] * diagnosis of type 2 diabetes: days \[- all data, 0\] * 2+ recorded hba1c levels: days \[-365,0\] * metformin use: days \[-30, 0\] exclusion criteria: * type 1 or secondary dm: days \[-all data, 0\] * previous organ transplant: days \[-all data, 0\] * hiv/aids: days \[-all data, 0\] * history of bariatric surgery: days \[-all data, 0\] * congestive heart failure: days \[-all data, 0\] * nyha \>=3: days \[-all data, 0\] * pancreatitis: days \[-all data, 0\] * medullary thyroid cancer/men-2: days \[-all data, 0\] * history of mi: days \[-365, 0\] * stroke: days \[-365, 0\] * coronary revascularization: days \[-365, 0\] * ptca/stenting/cabg: days \[-365, 0\] * trans myocardial revascularization: days \[-365, 0\] * carotid bypass: days \[-365, 0\] * cerebrovascular revascularization: days \[-365, 0\] * pvd: days \[-365, 0\] * cci \>=10: days \[-365, 0\] * history of cancer, other than non-melanoma skin cancer: days \[-1,825, 0\] * treatment of metformin more than 10 years: days \[-3,650, 0\] * treatment with any diabetes drug other than metformin; pcos; symptomatic hyperglycemia; pregnancy; gestational diabetes: days \[-180, 0\] * history of hemolytic anemia; history of severe liver disease; current alcoholism; chronic transfusion requirement; esrd: days \[-180, 0\] * oral, iv, or im cortisone, hydrocortisone, prednisone, methylprednisone, or dexamethasone: days \[-90, 0\] * treatment with atypical antipsychotics, language barriers, nursing home, or missing age or gender: days {-180, 0\] * hospitalization with length of stay \>3 days: days \[-30, 0\]
effect of intracorneal ring segments on posterior corneal tomography in eyes with keratoconus

Conditions: Keratoconus; Keratoconus Posterior

Summary: our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.

procedure: femtosecond laser assisted implantation of intracorneal ring segments in keratoconus patients uncorrected visual acuity (ucva), best corrected visual acuity (bcva), refraction, keratometric (k) readings of the anterior and posterior surface, corneal asphericity (q value) of the anterior and posterior surface, and anterior and posterior elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12 months after surgery.

Eligibility criteria:
inclusion criteria * patients with keratoconus grade 1, 2 or 3 according to amsler-krumeich classification. * best corrected visual acuity (bcva) ≤ 6/12. * mean front keratometric (k) readings ≤ 60 diopters (d). * corneal thickness ≥ 400 µm at the location of icrs implantation. * clear central cornea exclusion criteria * central corneal opacity. * previous corneal laser refractive surgery. * previous corneal collagen cross linking. * previous cataract surgery or phakic iol implantation. * history of herpetic keratitis. * history of acute hydrops. * ocular comorbidities such as cataract, glaucoma or retinal disease. * systemic diseases affecting healing process such as autoimmune or connective tissue disease.

Keywords: keratoconus intracorneal ring segments posterior corneal surface
diffusion weighted mri enables differential diagnosis between pyocele and mucocele

Conditions: Pyocele; Sinus

Summary: diffusion mri should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined

on the basis of the apparent diffusion coefficient, the content of a para nasal sinus could be defined as simple mucus or pus. this differentiation is very important for the clinician for prompt treatment. the aim of this study is to retrospectively measure this coefficient and to correlate it to clinica data.

Eligibility criteria:
inclusion criteria: * paranasal sinus mri with a diffusion weighted sequence exclusion criteria: * no clinical examination available * no bateriologic sample available

Keywords: sinus, pyocele, mri
decision aids to improve knowledge in patients with prostate cancer

Conditions: Prostate Cancer

Summary: this randomized phase iii trial studies how well decision aids work in improving knowledge in patients with prostate cancer. decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.


Eligibility criteria:
inclusion criteria: * patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage t1-3n0m0; in addition, patients must have: gleason score 6-10 * prostate-specific antigen (psa) \< 50 ng/ml * patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible * scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options) * patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed * patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * patients must be able to read and comprehend english; non-english-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
nasopharyngeal airway facilitate transnasal humidified rapid insufflation ventilatory exchange

Conditions: Hypoxia; Hypercapnia

Summary: for performing transnasal humidified rapid insufflation ventilatory exchange (thrive), jaw-thrust maneuver have to maintain to make sure the airway open and the co2 clearance during apnoea. the objective of present study is to prove that nasopharyngeal airway facilitate thrive and no need jaw-thrust maneuver and maintain the similar po2 and pco2 during apnoea.


Eligibility criteria:
inclusion criteria: * signed informed consent. * undergoing surgery with general anaesthesia. * adult, \>18 years old. * american society of anesthesiology classification i-ii. exclusion criteria: * coagulation disorders or a tendency of nose bleeding * an episode/exacerbation of congestive heart failure (chf) that requires a change in medication, diet or hospitalization from any cause in the last 6 months * severe aortic stenosis or mitral stenosis; * cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (cabg), valve replacement surgery) in the last 6 months; * acute myocardial infarction in the last 6 months; * acute arrhythmia (including both tachycardia and bradycardia) with hemodynamic instability; * diagnosed copd or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy); * increased intracranial pressure; * asa \>ii; * mouth, nose, or throat infection; * fever, defined as core body temperature \> 37.5°c; * pregnancy, breastfeeding or positive pregnancy test; * emergency procedure. * patient with known or suspected difficult airway
spearhead 2 study in subjects with recurrent or metastatic head and neck cancer

Conditions: Head and Neck Cancer

Summary: this is a study to investigate the efficacy and safety of adp-a2m4 in combination with pembrolizumab in hla-a\*02 eligible and mage-a4 positive subjects with recurrent or metastatic head and neck cancer.


Eligibility criteria:
key inclusion criteria * age ≥18 and \<75 years * diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology. * checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). may have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy. * subjects that have already received pembrolizumab (alone or in combination) and are progressing or have completed immune checkpoint inhibitor therapy for recurrent/metastatic disease, may still be enrolled and will skip part a of the study. these subjects will enroll into part b when manufactured t cells are available. * measurable disease according to recist v1.1. * hla-a\*02 positive by central laboratory. * tumor shows mage-a4 expression confirmed by central laboratory. * ecog performance status of 0 or 1. * left ventricular ejection fraction (lvef) ≥50%. note: other protocol defined inclusion criteria may apply key exclusion criteria: * positive for any hla-a\*02 allele other than: one of the inclusion alleles, hla- a\*02:07p or hla-a\*02 null alleles * history of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody. * history of autoimmune or immune mediated disease * leptomeningeal disease, carcinomatous meningitis or cns metastases. * other prior malignancy that is not considered by the investigator to be in complete remission * clinically significant cardiovascular disease * uncontrolled intercurrent illness * active infection with human immunodeficiency virus, hepatitis b virus, hepatitis c virus, or human t cell leukemia virus * pregnant or breastfeeding note: other protocol defined exclusion criteria may apply.

Keywords: cell therapy t-cell therapy spear t-cell head and neck cancer mage-a4 adp-a2m4 immuno-oncology
indobufen versus aspirin after coronary drug-eluting stent implantation in elderly patients with acute coronary syndrome

Conditions: Coronary Artery Disease

Summary: the option2 trial (randomized controlled trial of indobufen versus aspirin after coronary drug-eluting stent implantation in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (dapt) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional dapt (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (acs) patients aged over 70 years old undergoing coronary drug-eluting stent (des) implantation.


Eligibility criteria:
inclusion criteria: * age over 70 years old * diagnosed with acute coronary syndrome (unstable angina/ non-st elevation myocardial infarction/ st elevation myocardial infarction) * treated with at least 1 des implanted in the coronary lesion * receiving dual antiplatelet therapy (aspirin plus ticagrelor) * agree to attend the trial exclusion criteria: * elective surgical procedure planned within 12 months * life expectancy ≤1 year * known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (nsaids) * history of cerebral hemorrhage * history of stroke in six months * active bleeding * known relevant hematological deviations * known, clinically important thrombocytopenia (i.e., \<100\*10\^9/l) or anemia (i.e., \<90g/l) * active cancer * concomitant use of oral anticoagulants * active participation in another clinical study * other situations in which the investigator considers unsuitable to attend the study
children's health study diet and air pollution

Conditions: Diet Habit; Pollution; Exposure; Child Obesity

Summary: this study is built upon the existing data in the children's health study to examine the longitudinal association between childhood exposure to air pollutants and changes in diet among adolescents.


Eligibility criteria:
inclusion criteria: * children of 4th and 7th grades were enrolled from 12 southern california communities exclusion criteria: * extreme mean caloric intake (\>5000 or \< 500 kcal/day) or no demographic information
efficacy and safety of early covid-19 convalescent plasma in patients admitted for covid-19 infection

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Summary: currently there is no standard treatment for sars-cov-2 infection. use of convalescent plasma has been studied in outbreaks of other respiratory infections, including sars-cov-1 , mers-cov and hantavirus infection. this study is an open-label randomized trial in which patients with high risk of covid19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. covid-19 convalescent plasma will be collected from individuals according to the institutional protocol.


Eligibility criteria:
inclusion criteria: * patient older than 18 years * call score ≥ 9 (progression risk score) * pcr-confirmed covid-19 infection with equal or less than 7 days of symptoms (or imaging consistent with covid-19 pneumonia and confirmed covid-19 contact) * any symptoms of covid-19 infection * admission due to covid-19 infection * signed informed consent * ecog before covid-19 infection 0-2 exclusion criteria: * pafi \<200 or mechanical ventilation indication * clinically relevant co-infection at admission * pregnancy or lactation * iga deficiency or iga nephropathy * immunoglobulin or plasma administration in the last 60 days * contraindication to transfusion or previous allergy to blood-derived products * do-not-resuscitate status * patients receiving other investigational drug for covid-19 in a clinical trial * any condition, that in opinion of the investigator may increase the risk associated with study participation or interfere with the interpretation of study results.

Keywords: plasma covid-19 severe acute respiratory syndrome coronavirus 2
amino acids for cardiac surgery associated aki

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * undergoing cardiac surgery and expected to be high risk exclusion criteria: * preoperative extracorporeal organ support * ckd history (gfr\ 1 year\]) * serum creatinine defined preoperative aki.

Keywords: cardiac surgery
collection of samples from patients with mds

Conditions: Myelodysplastic Syndromes(MDS)

Summary: the purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating mds.

goals of the study: the purpose of this study is to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's mds cells and to assess the feasibility of immunizing and expanding one or more of the patient's t cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

Eligibility criteria:
patients must meet the following initial inclusion criteria: * diagnosis or suspected diagnosis of mds or ccus * age 18 or older patient exclusion criteria: * currently receiving or within 3 months has received hypomethylating agent(s), lenalidomide, cytotoxic agents, or within the previous 4 weeks corticosteroids \> 5 mg prednisone daily or any other immunosuppressants * previous allogenic transplant * inability to provide consent * prisoners
an investigational drug study to lower non-cholesterol sterol levels associated with sitosterolemia (0653-062)(completed)

Conditions: Lipid Metabolism, Inborn Errors; Heart Disease

Summary: this is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. these patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. this study investigates whether absorption of these non-cholesterols can be reduced in these patients.

the duration of treatment is 26 weeks.

Eligibility criteria:
inclusion criteria: * 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry. exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Keywords: sitosterolemia
pilot trial of supplemental vitamin a and nicotinamide

Conditions: Skin Cancer; Kidney Transplant Recipients

Summary: the goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (nam; a derivative of vitamin b3 \[niacin\]) and vitamin a in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.


Eligibility criteria:
inclusion criteria: * 18 years old or greater; * either history of 2 or more histologically confirmed invasive cutaneous sccs in the past 2 years or * at least one previously billed healthcare common procedure coding system code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system); * understands, reads, and writes english proficiently. exclusion criteria: * liver disease; * active peptic ulcer disease; * recent myocardial infarction; * hypotension; * internal malignancy within past 5 years; * renal impairment with egfr\<15 ml/min/1.73 m2; * being unable for follow up due to social reasons; * gorlin's syndrome or other genetic skin cancer syndrome; * huge number of current skin cancers; * metastatic scc or invasive melanoma within the past 5 years; * pregnancy or lactation; * need for ongoing carbamazepine use (which could have a possible interaction with nam); * use of acitretin or other oral retinoids within the past 6 months; * use of supplemental nam, niacin, vitamin a, or beta carotene within the past 6 months; * field treatment for actinic keratoses (aks) within the previous 4 weeks; * use of topical steroids.
percutaneous dilatational tracheostomy and thyroid isthmus penetration

Conditions: Tracheostomy Complication

Summary: a prospective randomized interventional study will be conducted in the military university hospital prague at the department of anesthesiology and intensive care. the incidence of thyroid isthmus penetration will be evaluated during percutaneous dilatational tracheostomy in two groups (ultrasound-guided puncture vs. standard approach using only anatomical landmarks).

a prospective randomized interventional study will be conducted in the military university hospital prague at the department of anesthesiology and intensive care. patients indicated by the attending physician to percutaneous dilatational tracheostomy (pdts) due to long-term need for mechanical ventilation will be randomly divided into two groups. the standard procedure group will undergo pdts by the attending physician in the standard manner based on clinical examination and anatomical landmarks using bronchoscopic navigation. in the second group, the attending physician will additionally use ultrasound navigation during the procedure. after insertion of the guidewire, before dilation is performed, patients in both groups will be examined by ultrasound by an independent physician - the study investigator - who will verify the position of the guidewire and its relationship to the surrounding structures. in case of malposition of the guidewire (unacceptable lateral or craniocaudal), the penetration site will be adjusted and the pdts completed.

Eligibility criteria:
inclusion criteria: * 18 years and older * long-term need for mechanical ventilation exclusion criteria: * not willing to participate

Keywords: percutaneous dilatational tracheostomy ultrasound mechanical ventilation
a phase 4 study of brodalumab (khk4827) in subjects with moderate to severe plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: the objective of this study is assessing the efficacy and safety of brodalumab in chinese subjects with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * those who are ≥18 and ≤70 years of age at the time of signing the written informed consent form * those who have involved bsa (the percentage (%) of body surface area involved with lesion) ≥10%, pasi (psoriasis area and severity index) ≥12 and spga (static physician's global assessment) ≥ 3 at screening and at baseline. exclusion criteria: * those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis * those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug.
maternal and offspring outcomes in pregnant women with pre-existing ascvd

Conditions: Cardiovascular Diseases; Atherosclerosis; Pregnancy Complications; Adverse Cardiac Event; Adverse Birth Outcomes

Summary: a growing body of evidence supports associations between cardiovascular health and adverse pregnancy outcome and between adverse pregnancy outcome and atherosclerotic cardiovascular disease and builds on the well-established pathways known to exist between cardiovascular health and atherosclerotic cardiovascular disease across the life course and intergenerationally. furthermore, previous studies frequently lack comprehensive long-term follow-up, making it difficult to assess the enduring impacts of maternal cardiovascular health on postpartum outcomes and long-term maternal and child health.

the current study aimed to evaluate the associations between maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes, and the combined effect of maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes on the risk of long-term adverse events of offspring.

Eligibility criteria:
inclusion criteria: * women with live birth from korea (between january 1, 2005 to december 31, 2019) exclusion criteria: * none

Keywords: atherosclerotic cardiovascular disease major adverse cardiac and cerebrovascular event adverse pregnancy outcome adverse birth outcomes