Kornimate/medical-research-clean huggingface dataset:
radiation therapy in treating patients with stage i or stage ii non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. it is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. purpose: this randomized phase ii trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage i or stage ii non-small cell lung cancer.

objectives: primary * to compare the incidence of toxicity with two established stereotactic body radiotherapy (sbrt) regimens in patients with node-negative, peripheral stage i or ii non-small cell lung cancer. secondary * to compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established sbrt regimens. * to correlate outcomes and toxicities with imaging and patient and tumor biomarkers. outline: patients are stratified according to karnofsky performance status and treatment center. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo 1 high-dose fraction of stereotactic body radiotherapy (sbrt). * arm ii: patients undergo 3 high-dose fractions (approximately 1 week apart) of sbrt. quality of life is assessed periodically by the eortc qlq-c30 and -lc13 questionnaires blood and tissue samples may be collected periodically and examined for biomarkers via elisa and immunoblotting. after completion of study treatment, patients are followed for 5 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer * t1-t2, n0 disease measuring ≤ 5 cm( t3 tumor based on chest wall involvement is excluded) * surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable or patient refuses surgical resection * age \>= 18 exclusion criteria: * prior thoracic radiation therapy * t2 or t3 tumor greater than 5 cm or t3 tumor based on chest wall involvement * node positive or metastatic disease * tumor location within the zone of the proximal bronchial tree. the proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. the zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree. * no other conditions deemed by the pi or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly) * pregnant or unwilling to use adequate contraception

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer
effects of chd prevention on lipoprotein subclasses

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to assess the influence of hdl-subclasses with coronary disease progression, and to identify factors influencing hdl subclasses at baseline and over time.

background: the stanford coronary risk intervention project was a four-year randomized clinical trial that showed that risk reduction through lifestyle change and lipid-lowering medications significantly reduced the rate of narrowing of the minimum diameter of coronary artery segments with angiographically visible lesions in 119 patients versus 127 controls who received usual physician care. in collaboration with this trial, dr. ronald krauss measured high-density lipoprotein (hdl) subclasses by gradient gel electrophoresis. hdl may be divided into two hdl2 and three hdl3 subclasses that are approximated by their estimated particle diameters: hdl3c (7.2-7.8 nm), hdl3b (7.8-8.2 nm), hdl3a (8.2- 8.8 nm), hdl2a (8.8-9.7 nm) and hdl2b (9.7-12.9 nm). the hdl- distribution can also be characterized by the diameter of the predominant peak, which may lie in either the hdl3b or hdl3a interval. case control and angiographic studies suggest that coronary heart disease risk is increased when hdl2b is reduced relative to hdl3c and hdl3b. see also study 27. design narrative: using data from the stanford coronary risk intervention project (scrip), the following specific questions were examined : 1. did the risk reduction program change specific hdtl subclasses as compared to controls? 2. did the hdl gradient gel profile characterize men most likely to benefit from multifactor risk reduction? 3. did hdl-subclasses change significantly in patients that reduced fat intake, reduced body weight, or who took one or more of the following medications: colestipol, nicotinic acid, clofibrate, probucol, gemfibrozil, fenofibrate, lovastatin, guar gum or fish oils? 4. what were the cross-sectional associations of hdl-subclasses with adiposity, fasting and post-load insulin and glucose, diet and medications at baseline? preliminary analyses suggested that: 1) during the trial, men in the treatment group increased hdl2b; 2) the special intervention was most effective in reducing coronary disease progression in subjects with a baseline predominant hdl-peak diameter below the median; 3) hdl- subclasses were more strongly influenced by diet and adiposity than by drugs during the trial; 4) carbohydrates, alcohol and caffeine were associated with specific subclasses at baseline. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
watchful waiting. an observational study of patients with rectal cancer after concomitant radiation and chemotherapy

Conditions: Rectal Cancer

Summary: the purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma. over the past 2 years vejle hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response. patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). at the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. the final evaluation is performed 6 weeks after end of treatment. patients with complete remission are offered observation. patients with residual tumor are advised to be operated. follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. a yearly follow-up is scheduled for the fourth and fifth year.

Eligibility criteria:
inclusion criteria: * histopathologically verified adenocarcinoma in the rectum * planned apr or ultra low resection * primary resectable t2 or t3 tumor * distance from anus to lower edge of tumor ≤ 6 cm * suited for curative intended radiation and chemotherapy * accept taking of biopsy and blood samples for translational research * age ≥ 18 years * normal function of bone marrow * leukocytes ≥ 3 x 10\^9/l * thrombocytes ≥ 100 * normal liver function * alat \< 2.5 x upper normal value * bilirubin \< 2.5 x upper normal value * renal function * serum creatinin \< 1.5 x upper normal value * written and orally informed consent exclusion criteria: * other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri * distant metastases * pregnant or breast feeding patients

Keywords: watchful waiting rectal cancer observation avoid operation
pasteurization of mother's own milk for preterm infants

Conditions: Sepsis

Summary: we hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.

in this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(nicu) of the university hospitals leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. the duration of the study is from birth to eight weeks of age or to discharge from the nicu, whichever occurs first. the need to ensure proper handling of the milk precludes true blinding of the caregivers. the institutional review board approved the study and written informed parental consent iss obtained before enrolment.

Eligibility criteria:
inclusion criteria: * all patients born before 32 weeks of gestational age and/or with bw below 1500 g admitted to the tertiary nicu of the university hospitals leuven within 24 hours of birth exclusion criteria: * died within 24 hours after birth * no consent * admitted after 24 hours of birth

Keywords: pasteurization human milk very low birth weight infants
intermediate dose of iv mtx as cns prophylaxis for high risk dlbcl

Conditions: Diffuse Large B Cell Lymphoma; Central Nervous System Lymphoma

Summary: central nervous system (cns) relapse is a devastating event of diffuse large b cell lymphoma (dlbcl). it occurs in 4%-7% of dlbcl in general and the rate is considerably higher in high-risk patients, resulting in a poor outcome.effective methods of cns prophylaxis have not yet been developed. evidence for intrathecal or intravenous mtx are both controversial. in one previous study of pumch, iv mtx at a dose of 1g/m2 could significantly decrease the 2 year cns relapse rate of high risk dlbcl(1.1% vs 12.1% for historic cohort, p=0.003). in current study, the investigators are aiming to confirm its efficacy through phase iii study with intrathecal mtx as the controlled arm.

in this prospective, phase iii, multicenter, randomized, controlled study, the investigatirs aim to compare the efficacy of intravenous mtx(iv arm) at a dose of 1g/m2 with intrathecal mtx(it arm) in terms of preventing cns relapse. all the patients will recieve rchop regimen as front-line treatment of dlbcl. patients in iv arm will recieve 4 course of iv mtx, which is incorporated into the rchop, naming r-mtx-chop regimen. patients in it arm will be given intrathecal mtx for 4 courses (one time for each course). 2 year cns relapse rate is the primary endpoint while 2 year pfs, 2 year os and safety are the secondary endpoint.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * with high cns risk, which was defined as involvement of more than one extranodal site, or involvement of particular extranodal sites such as bone marrow, breasts, testes, paranasal sinuses, epidural space, adrenal glands, kidney and female genital system; * first-line treatment planned to be rchop * absence of cns involvement at presentation exclusion criteria: * primary cns lymphoma * already have cns involvement at diagnosis * primary mediastinal lymphoma, intravascular large b-cell lymphoma, dlbcl leg-type, burkitt lymphoma, high-grade lymphomas, double expressor lymphoma * with active infection or other malignancy * severe liver or kidney insufficiency * allergy to any medication we plan to use

Keywords: central nervous system prophylaxis methotrexate
an open, prospective, randomized, multicenter study of the efficacy and safety of intravenous followed by oral azithromycin versus cefuroxime alone or with oral erythromycin for the treatment of chinese patients who were hospitalized for pneumonia

Conditions: Pneumonia

Summary: to validate the efficacy and safety of azithromycin for the treatment of chinese patients hospitalized with community-acquired pneumonia (cap), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.


Eligibility criteria:
inclusion criteria: inclusion criteria: * patients hospitalized with a diagnosis of community acquired pneumonia (cap) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest x-ray with or without pleural effusion plus at least 1 of the following: new cough and expectoration or progression of respiratory symptoms with purulent sputum with or without chest pain; fever; auscultatory findings such as rales or evidence of pulmonary consolidation; blood leukocyte count \>10×109/l or \ 15% bands or a blood leukocyte count between 4 and 10 with neutropils greater than or equal to 75% exclusion criteria: exclusion criteria: * patients with hospital acquired pneumonia, aspiration pneumonia, severe pneumonia, history of post-obstructive pneumonia, active tuberculosis or bronchitis, bronchiectasis or chronic obstructive pulmonary disease without evidence of acute infection were not eligible for this study * patients treated with any systemic antibiotic within 72 hours prior to study entry were not eligible unless the medication was, in the opinion of the investigators, classified as having failed
a pilot study on the effect and safety of iluvien® in chronic diabetic macular edema patients

Conditions: Diabetic Macular Edema

Summary: to provide treating physicians with experience with iluvien as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (dme) patients judged insufficiently responsive to available therapies.


Eligibility criteria:
chronic dme patients considered insufficiently responsive to available therapies (laser, anti-vegf) with or without intravitreal corticosteroid therapy. inclusion criteria: * adults (≥18 years) with chronic dme; * patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-vegf injections in the last 6 months, and the following: 1. mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in zeiss cirrus or ≥ 305 um in women and ≥ 320 um in men in heidelberg spectralis, in the study eye as measured using sd-oct; 2. vision impairment (20/50 to 20/400 using snellen visual acuity equivalent) related to dme; 3. if in the investigator's opinion a further improvement is possible. exclusion criteria: * iop \> 21 mmhg at screening (day -14) in the study eye. * historical rise in iop \> 25 mmhg following treatment with an intravitreal corticosteroid in the study eye. * use of ≥ 2 active agents as iop-lowering medications to control iop at screening in the study eye. * vitreomacular traction in dme and opaque media in the study eye. * severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye. * pregnant or breastfeeding women. * active angiographic central macular ischaemia before baseline in the study eye. * pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye. * presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are: using a highly effective method of birth control.

Keywords: chronic diabetic macular edema iluvien intra-vitreal injections pilot study
efficacy of losartan in preventing progression of copd

Conditions: COPD; Emphysema; Chronic Bronchitis; Smoking

Summary: evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. the goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (copd).

participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. during that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. these tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with copd.

Eligibility criteria:
inclusion criteria: * adults with copd who are either active or former smokers exclusion criteria: * clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.

Keywords: copd emphysema angiotensin receptor blocker
dilipo (dilutional hyponatremia)

Conditions: Congestive Heart Failure

Summary: primary: * to assess the efficacy of sr121463b in correcting hyponatremia in patients with dilutional hyponatremia other than siadh or cirrhosis secondary: * to assess the long-term efficacy of sr121463b in maintaining normonatremia in these patients * to assess the safety and tolerability of sr121463b

sr121463b is an orally effective non-peptide, potent, and highly selective v2 receptor antagonist causing free water elimination in animals and humans

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 higher * dilutional hyponatremia with serum sodium between 115 and 132 mmol/l * ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign) exclusion criteria: * presence of known or untreated adrenal insufficiency, siadh or cirrhosis, or hyperthyroidism * presence of signs of hypovolemia * administration of other v2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration * presence of uncontrolled diabetes with fasting glycemia ³ 200 mg/dl (³ 11.09 mmol/l) * patients considered by the investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious) * administration of inducers of cyp3a4 (phenobarbital, phenytoin, rifampin, saint john's wort) or potent and moderate inhibitors of cyp3a4 within two weeks prior to study drug administration * presence or history of allergic reaction to sr121463b8 * previous study with sr121463b * inadequate hematological, renal, and hepatic functions: hemoglobin (hb) \ 175 mol/l (or clearance of creatinine \ 2 x upper limit of normal (uln) * qtcb 500 ³ ms * positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential * pregnancy or breast-feeding

Keywords: hyponatremia
neutralizing antibody level after covid-19 vaccination

Conditions: Covid19

Summary: 1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after covid-19 vaccination 2. investigate the factors on antibody titer.

1. serial of neutralizing antibody at 2, 4, 6, 9, 12 month after covid-19 vaccination 1) semi-quantitative measurement of neutralizing antibody at 2, 4, 6, 9, 12 month after covid-19 vaccination 2) investigate the duration maintaining acceptable range (over 30% inhibition) 2. investigate the factors on antibody titer at 2 month after vaccination 1) potential factors: age, sex, body weight, height, use of medication, use of antipyretics (nsaid or tyrenol), side effect of covid-19 vaccination 2) correlation between antibody titer and potential factors 3. compare 4 diagnostic elisa kit at 2 month after vaccination 1) measure neutralizung antibody using elisa kits from 4 different companies 2) investigate correlation coefficient of antibody titer between companies

Eligibility criteria:
inclusion criteria: * healthcare works after completion of covid-19 vaccination * 20-60 years * sign the agreement of study exclusion criteria: * serious underlying diseases
sex hormones and pericardial adipose tissue

Conditions: Pericardial Adipose Tissue and Sex Hormones

Summary: in this study, our aim is to show the relation between sex hormones and pat and to confirm whether pat is associated with coronary artery calcification (cac) in different testosterone levels in the males.


Eligibility criteria:
inclusion criteria: * 3213 males * african american * caucasian * asian (largely chinese) and hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002) exclusion criteria: * patients with known coronary artery disease
effect of antiseizure medication on hormone levels and sexual function in men with epilepsy

Conditions: Seizure Disorder; Epilepsy

Summary: the purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.

this study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. you will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.

Eligibility criteria:
inclusion criteria: * must be a male between 18-50 years of age * must have seizures * must be on antiseizure medication for at least six months duration exclusion criteria: * must not have taken hormones, major tranquilizers or antidepressants for at least 3 months

Keywords: seizure disorder hypogonadism sexual function epilepsy
plasmapuane cov-2 : efficacy and safety of immune covid-19 plasma in covid-19 pneumonia in non itu patients

Conditions: Covid-19 Pneumonia

Summary: aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in itu with pneumonia and respiratory symptoms within seven days from the beginning of symptoms. efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to itu. .safety is considered in relation to adverse reactions to plasma infusion.


Eligibility criteria:
inclusion criteria: * \> 18 years * hospitalized patients with positive covid-19 swab with respiratory symptoms and ct confirmation of covid-19 chest disease admitted to non itu recovery area. * informed consent for plasma infusion * informed consent to blood samples storing for future studies. exclusion criteria: * pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study * immunoglobulin infusion in the last month contraindication to transfusion or previous adverse reaction

Keywords: covid-19 pneumonia convalescent plasma hyperimmune plasma