Kornimate/medical-research-clean huggingface dataset:
short and optimal duration of dual antiplatelet therapy study

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of cobalt-chromium everolimus-eluting stents.

"thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (bms). on the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: dapt) for more than 1 year after drug-eluting stent (des) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. in the reset study, which was carried out in clinical practice in japan, dapt was performed for at least 1 year in 90% of the patients. however, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. these results suggest that the optimal duration of dapt after des implantation may be shorter than 6 months. with respect to everolimus-eluting stent (ees), which is the most widely used des in japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation des and with bms in large-scale observational study and randomized comparative studies and their meta-analyses. considering that long-term dapt obviously increases hemorrhagic complications compared to aspirin monotherapy, it is desirable to reduce the duration of dapt as far as possible, if long-term dapt is not effective in inhibiting the incidence of serious cardiovascular events. moreover, long-term dapt enormously increases medical expenses. in this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an ees (xience prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.

Eligibility criteria:
inclusion criteria: * patients who received pci using everolimus-eluting cobalt-chromium stents exclusion criteria: * patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents

Keywords: anti-platelet therapy
study of sacituzumab govitecan versus standard of care in participants with previously treated extensive stage small cell lung cancer

Conditions: Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Summary: the goal of this clinical study is to learn more about the study drug sacituzumab govitecan (sg; trodelvy®; gs-0132; immu 132), versus standard of care (soc) in participants with previously treated extensive stage small cell lung cancer (es-sclc). the primary objectives of this study are to compare the effect of sg to soc on objective response rate (orr) as assessed by blinded independent central review (bicr) according to the response evaluation criteria in solid tumors and to compare the effect of sg to soc on overall survival (os).


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of sclc. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) as assessed by investigator per recist v1.1 criteria. * documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (pd-1) or programmed cell death ligand 1 (pd-l1; pd-1 and pd-l1 are hereafter referred to as pd-(l)1) for es-sclc. key exclusion criteria: * chemotherapy-free interval (ctfi) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \< 30 days (independent of the immunotherapy maintenance). * received any prior treatment with irinotecan, topotecan, sg, sn-38, exatecan derivatives, and similar agents targeting topoisomerase i. * untreated central nervous system (cns) metastases and/or carcinomatous meningitis. participants with previously treated brain metastases may participate provided they have stable cns disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. note: other protocol defined inclusion/exclusion criteria may apply.
covid-19: salvage tocilizumab as a rescue measure

Conditions: Covid19

Summary: evaluating the efficacy of tocilizumab in hospitalized patients in the inflammatory phase of covid-19. randomization 2:1 (tcz:standard of care).


Eligibility criteria:
inclusion criteria: * written informed consaent obtained * hospitalized with covid-19 disease * age \>/= 18 years * sars cov-2 nho posit * sp=2 \ 30 /min * any 2 of the 4: p-il-6 \> 2 x uln / p-ferritin \> 2 x uln / p-fidd \>1.5 mg/l / p- crp \>40 mg/l without obvious presence of bacterial infection (normal values: p -il-6 \<5.9 ng/l; p-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; p-fidd (fibrin degradation products, d-dimer) \<0.5 mg/l; p-crp \<10 mg/l) exclusion criteria: * known severe allergic reactions to monoclonal antibodies * active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides covid-19) * in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day) * pregnant or lactating women. if needed, exclusion of pregnancy should be performed by laboratory test (u-hcg-o). * participating in other drug clinical trials * absolute neutrophil count \< 1 x10e9/l * platelet count \<50 x10e9/l * alat \>10x uln

Keywords: covid-19 new coronavirus disease tocilizumab
idiopathic pulmonary fibrosis--pathogenesis and staging - scor in occupational and immunological lung diseases

Conditions: Lung Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial; Scleroderma, Systemic

Summary: to conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary fibrosis (ipf) and patients with progressive systemic sclerosis (pss), with and without associated lung disease.

background: idiopathic pulmonary fibrosis (ipf) is a disease of unknown etiology characterized pathologically by a chronic inflammatory process (alveolitis) that precedes and likely controls the alterations in connective tissue matrix that eventually destroys the normal lung architecture. the mechanisms involved in this process are not known. a complex cell-cell interactive sequence, involving principally neutrophils, lymphocytes, macrophages, fibroblast, and epithelial cells is believed to be responsible. the scor in occupational and immunological lung diseases was first awarded in december, 1981. the subproject on idiopathic pulmonary fibrosis was first awarded in december, 1986. design narrative: the cross-sectional comparison examined bronchoalveolar lavage, high resolution, thin-section computer tomography (hrct), neutrophil or monocyte labeled scintigraphy). the serial, longitudinal evaluation monitored the progression of disease. the study of pss patients, without disease or with subclinical disease, was particularly useful because it allowed examination of the early events in the pathogenesis of ipf. the long-term goal of the project was to determine what alterations in cellular composition, function and trafficking occurred in the lung parenchyma of patients with ipf and to relate these alterations to the disease stage, prognosis, and therapeutic responsiveness. the major objectives of the study were: (1) to continue the prospective, longitudinal study of carefully defined cases of ipf; (2) to initiate a study of patients with pss, a disease that provided a useful paradigm for studying the early events of the disease; (3) to determine the role of the lymphocyte in ipf, by defining the subset of t lymphocytes responsible for modulating macrophage function; (4) to establish the role of non-invasive techniques (bronchoalveolar lavage (bal), hrct scanning and scintigraphy -- neutrophil and monocyte labelled cells) in assessing the activity of inflammation in carefully evaluated patients; (5) to determine the relationship of these results to the -- carefully defined and serially obtained -- clinical, radiographical, and physiological findings and to the histopathologic abnormalities (in patients that underwent lung biopsy, predominantly ipf cases). (6) to perform studies utilizing blood, bal fluid and lung tissue in an effort to understand the pathogenic mechanisms that underlied the inflammatory/immune cellular injury and fibrosis that characterize this disease. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
no eligibility criteria
family activation and communication about errors and safety (faces)

Conditions: Family Reported Errors and Adverse Events

Summary: miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the joint commission. efforts to improve patient safety in hospitals have centered on improving communication between providers. while provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. this proposal seeks to develop a family safety reporting intervention.


Eligibility criteria:
inclusion criteria: * primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s) * country of origin: united states * primarily english- or spanish-speaking exclusion criteria: * international patients
pth and calcium responses to exercise (pace) in older adults

Conditions: Osteoporosis

Summary: exercise that causes a decline in serum calcium (ca) as a result of dermal ca loss stimulates bone resorption via an increase in parathyroid hormone (pth).

determine whether the magnitude of dermal ca loss (i.e., sweating) during exercise is a determinant of the decline in ica and increases in pth and carboxy-terminal collagen crosslinks (ctx; marker of bone resorption). the proposed experiment will address this by manipulating the rate of dermal ca loss (moderate vs high sweating rate) to determine whether this is the trigger for the cascade described in figure 1. this will be achieved by having participants perform two identical exercise bouts under different thermal conditions (warm vs cool).

Eligibility criteria:
inclusion criteria: * healthy adults aged 60-80 y exclusion criteria: * use of medications in the past 6 months known to affect bone metabolism (e.g., bisphosphonates, thiazide diuretics, oral glucocorticoids) * bmd t score \< -2.5 at the total hip or lumbar spine * known disease or condition associated with intestinal malabsorption * moderate or severe renal impairment defined as an estimated glomerular filtration rate of \<60 ml/min/1.73m2 based on the mdrd equation * chronic hepatobiliary disease, defined as liver function tests (ast, alt) \>1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed * thyroid dysfunction, defined as an ultrasensitive tsh \ 5.0 mu/l; volunteers with abnormal tsh values will be re-considered for participation in the study after follow-up evaluation by the pcp with initiation or adjustment of thyroid hormone replacement * serum calcium \ 10.3 mg/dl * serum 25(oh)d \ 20 ng/ml after vitamin d supplementation * uncontrolled hypertension defined as resting systolic bp \>150 mmhg or diastolic bp\>90 mmhg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the pcp with initiation or adjustment of anti-hypertensive medications * history of type 1 or type 2 diabetes * cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, st segment depression) or serious arrhythmias at rest or during the graded exercise test (gxt) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist * diagnosis or history of asthma

Keywords: parathyroid hormone (pth) bone mineral density (bmd)
investigation of the value of ctdna in diagnosis, treatment, and surveillance of surgically resectable colorectal cancer

Conditions: Rectal Cancer, Adenocarcinoma; Neoadjuvant Chemoradiation

Summary: in this study, we aim to investigate the value of circulating tumor dna (ctdna) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctdna, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.

a prospective, observational study to determine the value of circulating tumor dna (ctdna) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis. research objects: patients with surgically resectable colorectal cancer. after giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to nccn guidelines. serial analysis of ctdna will be performed at specific time points including pre-treatment, (post-ncrt for ncrt patients), postoperative week 1, post-act, postoperative year 1, 2, and 3. the next-generation sequencing of surgical specimens will be performed as well. participants will be observed and examined during the entire course of treatment and the follow-up period. the 3 year disease free survival (3y-dfs) will be the primary end-point.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 75 years old. 2. patients with surgically resectable colorectal cancer, while without distal metastasis of the disease. 3. patients with asa physical status scroe of i to iii. 4. patients who can fully understand the content of the informed consent form and sign it upon their own opinions. 5. patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups. exclusion criteria: 1. patient has any underlying or current medical condition, which, in the opinion of the investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.). 2. patient is pregnant or lactating. 3. patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma. 4. patient is participating in any other clinical trials within 30 days prior to screening. 5. patient has severe mental illness. 6. patient has any other conditions, which, in the opinion of the investigator, would interfere with the evaluation of the subject.

Keywords: rectal cancer neoajuvant chemoradiation circulating tumor dna
losartan in prevention of radiation-induced heart failure

Conditions: Breast Cancer; Myocardial Fibrosis; Radiation-Induced Fibrosis

Summary: this study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. the interventions involved in this study are: * losartan * radiation therapy (standard of care)

this is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy. losartan is an u.s. food and drug administration (fda) approved drug used to treat hypertension (high blood pressure) and heart failure. the u.s. food and drug administration (fda) has not approved losartan for use in the treatment of breast cancer. the fda has approved radiation therapy as a treatment option for breast cancer. the research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. it is expected participants will be on the study for 1 year. it is expected that about 10 people will take part in this research study.

Eligibility criteria:
inclusion criteria: -\>18 years of age * non-metastatic breast cancer patients who are scheduled to receive conventional left breast/chest wall rt inclusive of treatment to the internal mammary lymph nodes (imns) * prior chemotherapy is permitted * patients must have left-sided breast cancer * ability to understand and the willingness to sign a written informed consent document * no contraindication to mri exclusion criteria: * person who is pregnant or breastfeeding. * patient unable to swallow oral medication. * patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity * patients already receiving ace/arbs. * patients with a history of allergic reactions to losartan biosimilars.

Keywords: breast cancer myocardial fibrosis radiation-induced fibrosis
evaluating comparative effectiveness of empagliflozin in type 2 diabetes population with and without chronic kidney disease

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (dpp4i) in patients with type 2 diabetes mellitus (t2dm) with and without established kidney disease. the secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any sodium glucose co-transporter-2 inhibitors (sglt2i) compared to glucagon-like peptide-1 receptor agonists (glp1ra) in patients with t2dm.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old * having a diagnosis of type 2 diabetes in 12 months before the index date (defined as the date of initiation of empagliflozin or glucagon-like peptide-1 receptor agonists (glp1ra) or dipeptidyl peptidate-4 inhibitor (dpp4i), based on the cohort evaluated), based on international classification of diseases (icd)-9 and -10 codes and other available data * record of prescription for empagliflozin, any sodium glucose co-transporter-2 inhibitors (sglt2i), any dpp4 inhibitor, or any glp1ra use between 1 january 2015 and 31 december 2020, and * no record of any prescription for the drugs being compared during the 12 months + 30-day grace preceding the index date period, i.e., * for the primary comparison of initiation of empagliflozin versus dpp4i, patients will not have any prescription for empagliflozin/any sglt2i or dpp4i during the preceding 12 months + 30-day grace period. * for the comparison of initiation of sglt2i versus glp1ra, patients will not have any prescription for sglt2i or glp1ra during the preceding 12 months + 30-day grace period. * for the comparison of initiation of empagliflozin versus glp1ra, patients will not have any prescription for empagliflozin/any sglt2i or glp1ra during the preceding 12 months + 30-day grace period. exclusion criteria: * aged \<18 years on the first prescription date of the qualifying prescription, * pre-existing diagnosis of type 1 diabetes mellitus (t1dm) during the 12 months before the index date, * having a disqualifying diagnosis during the 12 months before the index date, defined as having at least one of the following: estimated glomerular filtration rate (egfr) \<30, dialysis, polycystic kidney disease or a kidney transplant, * \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of drug use during this period, defined as not having at least 1 ambulatory visit and at least 1 medication prescription during the preceding 12 months, and * missing or ambiguous data on serum creatinine in the 12 months prior to the index date or sex
retrospective review of cachexia in lung and gastrointestinal cancer patients

Conditions: Cachexia

Summary: the objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated at ut southwestern medical center and parkland hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

the definition of cachexia has not been fully elucidated, but there are many similar parameters and guidelines associated with identifying patients with cachexia. cachexia is a clinical diagnosis associated with weight loss, decreased muscle mass (sarcopenia), decreased strength, fatigue, and an increased inflammatory state. patients with cachexia have a poorer prognosis than patients who have maintained their weight. also, patients who have lost weight prior to initiating definitive therapy have worse side effects from subsequent therapy. this study involves no treatment or invasive procedures. the chart review will attempt to characterize lung and gastrointestinal cancer related cachexia in the setting of a palliative care clinic including both primary treatment and treatment at the time of recurrence. interventions in cachectic patients for weight control including nutritional support and supplements, pain control, anti-inflammatory medications, and appetite stimulants will be tracked along with clinical markers including weight and laboratory values.

Eligibility criteria:
inclusion criteria: medical charts representing patients with a diagnosis of lung or gastrointestinal cancer with a tissue diagnosis from 1/1/2005 and onward treated at ut southwestern or parkland. exclusion criteria: there will be no absolute exclusion criteria as long as the inclusion criteria have been met.

Keywords: lung and gastrointestinal malignancies
physical activity return after popliteal artery entrapement syndrome surgery

Conditions: Popliteal Artery Entrapment

Summary: evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale


Eligibility criteria:
inclusion criteria: * popliteal artery entrapement syndrome surgery between 2010 and 2020 at the university center of angers exclusion criteria: * denied to participate