Kornimate/medical-research-clean huggingface dataset:
covid-19 vaccination azv 2021-2023

Conditions: COVID-19; Vaccination; Immunity; Respiratory Failure

Summary: the study is aimed at the clinical and laboratory characteristics of patients with completed vaccination against sars-cov-2 admitted to the hospital in the standard ward and intensive care unit due to the severe course of covid-19.

the high number of patients hospitalized for covid-19 significantly affects the entire healthcare system, where 70-80% of the total number of patients are unvaccinated, however, approximately 20-30% of patients hospitalized for the disease covid-19 have undergone vaccination. the investigators assume the existence of several phenotypes of infection even in vaccinated patients, which may differ both in the rate of antibody formation, the dynamics of indicators of persistent virus replication, and the intensity of a potentially self-destructive inflammatory reaction and activation of coagulation. early identification of patients with completed vaccination who have a higher risk of a severe course of covid or a demonstrable inadequate immune response will allow individualization of treatment. finding out the risk characteristics of the patients is a question and the difference in the type of vaccine on the severity of the course of hospitalization and the clinical outcome of the patients can contribute to the optimization of the vaccination strategy of the population and to the early identification of risk groups of vaccinated persons from the point of view of the timely deployment of available post-exposure prophylaxis/treatment procedures.

Eligibility criteria:
inclusion criteria: * adult patients * covid-19 positiveness * vaccination against sars-cov-2 (any number of doses) exclusion criteria: * n/a
clad: finding biomarkers to predict rejection and/ or outcome after lung transplantation

Conditions: Lung Transplant Failure and Rejection; Primary Graft Dysfunction

Summary: lung transplantation is the ultimate treatment for end stage lung diseases. survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (clad). both acute cellular rejection and primary grade dysfunction (pgd) have been associated with the development of clad. in this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in pgd, acute rejection and the development of clad.

at specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. these will be analyzed in an attempt to identify possible biomarkers that will predict the development of pgd and/or clad.

Eligibility criteria:
inclusion criteria: * all lung transplant recipients \> 18 years signed icf (informed consent form) exclusion criteria: * none
home exercise and resiliency training (heart) club

Conditions: Fontan Physiology; Frailty

Summary: the purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of fontan-associated liver disease.

this study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. visit one will require participants to complete a cardiopulmonary exercise test (cpet), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. the second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.

Eligibility criteria:
inclusion criteria: * males and females with fontan physiology * 19 years old at age of enrollment exclusion criteria: * height less than 130 centimeter (cm) * pregnancy or the plan to become pregnant during the study period * current intravenous inotropic drugs * severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment * severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment * history of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms) * inability to complete exercise testing at baseline screening * noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results

Keywords: exercise program liver stiffness
study of talactoferrin oral solution for nosocomial infection in preterm infants

Conditions: Nosocomial Infections

Summary: this study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.


Eligibility criteria:
inclusion criteria: * birth weights ranging from 750 to 1500 grams * entry before 24 hours of age * informed-consent form signed by parent(s) or legal guardian * able to take liquid medication by mouth or feeding tube exclusion criteria * a major birth defect or malformation syndrome * chromosomal or inherited disorder * proven presence of an immunodeficiency * antenatal exposure to illicit substances * birth asphyxia * hiv or other congenital viral, bacterial, or fungal infection * lack of parental consent or refusal of attending neonatologist to allow participation * discretion of the investigator * the legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Keywords: pre-term infants pre-term infants 750 to 1500 grams
a prospective study on optimizing treatment for abpa

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: this study is being done to evaluate the efficacy of treatment using oral glucocorticoid, anti-fungal agent, anti-ige mab for patient with abpa.

this is a study randomly treating abpa patients with either anti-fungal agent plus ocs or anti-ige mab (omalizumab) plus ocs. ocs is the basic treatment for abpa by suppressing allergy and inflammation. prednisone tablets is given orally 0.5mg/kg/d for 4 weeks and gradually reduced to for a total usage of 6 months. reduction may failed if disease exacerbate. anti-fungal agent (mainly itraconazole) could reduce the load of fungus but its application is still controversial. the investigators use itraconazole 200mg bid for 8 months and 100mg bid for another 8 months. omalizumab was given 600mg q4w for at least 6 months. the investigators use anti-fungal agent and omalizumab as a supplement to ocs to evaluate the better treatment plan for abpa patients.

Eligibility criteria:
inclusion criteria: * 18\~75 years old, male or female * associated past medical history, including asthma, bronchiectasis, copd ect. * elevated serum total ige (\>100iu/ml) * elevated aspergillus specific ige exclusion criteria: * according to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness). * pregnancy or breastfeeding * abnormality of liver or kidney function

Keywords: allergic bronchopulmonary aspergillosis anti-fungal agent omalizumab oral corticosteroids
surveillance and image-guided biopsy of the esophagus using an ofdi capsule

Conditions: Barrett's Esophagus

Summary: the purpose of this research is to test the feasibility, sensitivity, and specificity of the marking optical frequency domain imaging (ofdi) capsule for diagnosing barrett's esophagus (be).

a total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (egd) will be asked to swallow the ofdi capsule while being unsedated. the capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. ofdi real-time images will be used for targeting of the region to be marked. once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks. immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. images obtained by the ofdi capsule will be compared to the images obtained by the clinical endoscopy and histology.

Eligibility criteria:
inclusion criteria: * patients must be undergoing an egd. * patients must be over the age of 18. * patients must be able to give informed consent. exclusion criteria: * patients who are on anti-platelet medications or anti-coagulation medications, and nsaids at the time of procedure. * or patients with a history of hemostasis disorders. * or patients with esophageal strictures.

Keywords: egd ofdi barrett's esophagus imaging biopsy oct
post-operative functional disability in unrecognized cognitive impairment (pof) study

Conditions: Cognitive Impairment (CI)

Summary: this is a prospective multicenter cohort study, which will determine the prevalence of preoperative cognitive impairment (ci) using the modified telephone interview for cognitive status (tics-m), eight-items interview to differentiate aging and dementia (ad8), telephone montreal cognitive assessment (t-moca), and a single cognitive question from the centers for disease control and prevention (cdc). we would also determine the (1) the degree of agreement in screening results between each cognitive screening tool, (2) risk factors associated with screening positive for ci on each tool, and (3) the prevalence and/or trajectory of postoperative delirium, sleep disturbances, functional disability, instrumental activities of daily living (iadl), depression, quality of health, frailty, and pain in older surgical patients and its association with ci. this study will target older patients from the pre-operative clinics at toronto western hospital and mount sinai hospital (msh), toronto. research staff will identify eligible patients who are scheduled for elective non-cardiac surgery. written informed consent to participate in the study will be obtained from all patients.

the primary aim of this study is to (1) determine the prevalence of ci preoperatively in older surgical adults using virtual or telephone cognitive instruments, (2) determine the degree of agreement in screening results between each cognitive screening tool, and (3) explore the prevalence and trajectory of preoperative and postoperative outcomes and its association with ci. the outcomes include functional disability, iadl, sleep disturbances, quality of health, frailty, pain and depression. in a preoperative assessment 1-30 days prior to their scheduled surgery, patients will be asked via telephone to complete tics-m and t-moca and an online questionnaire, including the ad8, cdc single cognitive question, world health organization disability assessment schedule 2.0 (whodas 2.0), iadl, euroqol 5 dimension (eq-5d-5l), geriatric depression scale (gds), 5-item frail questionnaire, (frail), visual analog pain scale (vas pain), single-item sleep quality scale (sqs), pittsburgh sleep quality index (psqi), and stop questionnaire. these questionnaires will be repeated at follow-up visits at 30-, 90-, and 180-days post-surgery. at the hospital on post-operatively days 1-3, the confusion assessment method (cam), sqs, and vas pain will be administered during the in-person visit. chart review of delirium will also be conducted during patients' stay at the hospital.

Eligibility criteria:
major inclusion criteria: * patients ≥ 65 years old; * patients scheduled for elective non-cardiac surgery * able to be contacted by telephone for follow up. major exclusion criteria: * patients with previous dementia diagnosis, * patients scheduled for outpatient surgery,
effects of exercise mode on cardiac fat and function

Conditions: Obesity

Summary: the overall goal of this project is to study the effects of exercise energy expenditure matched vigorous dynamic resistance training and aerobic training on cardiac fat, and its relationship to cardiac function and geometry using cardiac magnetic resonance imaging.

exercise-induced weight-loss is one of the most common strategies for reducing excess fat in overweight and obese individuals. although vigorous intensity may be more favorable promoting positive cardiac adaptations compared to low-moderate intensity, evidence of the positive effects of different exercise modes needs to be explored to allow for realistic comparisons with other strategies. research using cardiac magnetic resonance imaging that compares the effects of different modes of exercise - matched by exercise energy expenditure - on epicardial adipose tissue and paracardial adipose tissue, and how these interventions modify cardiac function and geometry have not been previously explored in obesity.

Eligibility criteria:
inclusion criteria: * sedentary * caucasian * bmi \>30 kg/m2 and \< 39.9 kg/m2 exclusion criteria: * known cardiovascular, metabolic, pulmonary disease or conditions * muscular-skeletal injuries * taking medications that affect endocrine or cardiovascular function * hypertension * being engaged in low intensity strength training more than two times per week or moderate-high intensity of any type of frequency * being pregnant * cigarette smoking * having non-removable pieces or devices incompatible with dxa and cmr assessment.

Keywords: obesity exercise cardiac fat cardiac magnetic resonance vascular health
radiotherapy planning based on positron emission tomography with fluoro-deoxyglucose for advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: simultaneous radio-chemotherapy in advanced non-small cell lung cancer. the study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of fdg-positive lesions. primary endpoint is the local disease control in the chest.

simultaneous radio-chemotherapy in advanced non-small cell lung cancer. the study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of fdg-positive lesions. primary endpoint is the local disease control in the chest

Eligibility criteria:
inclusion criteria: * histologically proved nsclc * uicc-stage i-iii, no resection planned * complete staging \< 6 wks before treatment including cranial ct * ecog \ 60% * age \> 18 \< * fev1 \> 1,0 l or \>35% * rt-planning according to protocol feasible * chemotherapy feasible * written informed consent exclusion criteria: * neuroendocrine tumors, plain broncho-alveolar-cell ca. * distant metastases, supraclavicular lymph node metastases * malignant pleural effusion * resection of actual tumor performed * inclusion in other study protocol * chemotherapy due to actual tumor before fdg-pet * induction-chemotherapy * acute vena cava superior syndrome * second malignancy other than basalioma * pregnancy, lactation * heart insufficiency nyha iii/iv * pneumoconiosis with active inflammatory changes of mediastinal lymph nodes * acute broncho-pulmonary infection at time of pet-examination

Keywords: nsclc fdg-pet radiotherapy planning target volumes
phoenix study - a study of pegasys (peginterferon alfa-2a (40kd)) and copegus (ribavirin) administered after liver transplantation for hepatitis c.

Conditions: Hepatitis C, Chronic

Summary: this 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic pegasys plus copegus after liver transplantation for hepatitis c, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis c infection. the anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age * positive hepatitis c virus rna at pre-transplantation * primary, single-organ recipient (cadaveric donor) * liver transplant between 10 and 16 weeks before treatment initiation exclusion criteria: * multi-organ or re-transplant recipient * evidence of current hepatitis b infection * seropositive for human immunodeficiency (hiv) infection
maestro lift-off: surgical assistance device in abdominal laparoscopic surgery

Conditions: Surgery

Summary: the objective of the study is to provide evidence for the safety and effectiveness of the maestro platform for surgical assistance in abdominal laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 to ≤ 75 years * scheduled for one of the following non-emergent laparoscopic procedure: cholecystectomy, hernia repair, appendectomy, bariatric surgery (gastric sleeve or gastric bypass), or colectomy. * willing to comply with protocol-specified follow-up evaluation * signed informed consent exclusion criteria: * advanced refusal of blood transfusion, if necessary; * active systemic or cutaneous infection or inflammation; * pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; * uncontrolled diabetes mellitus; * known, significant history of bleeding diathesis, or coagulopathy, or von willebrand's disease or current platelet count \< 100,000 cells/mm3, or baseline inr ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); * severe co-existing morbidities having a life expectancy of less than 30 days; * currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study; * significant anemia with a hemoglobin level less than 10 g/dl or a hematocrit less than 30%; * renal insufficiency (serum creatinine of \> 2.5 mg/dl); * females who are pregnant, planning to become pregnant within three months of the procedure, or lactating; * extreme morbid obesity (bmi greater than 45 kg/m2); * patients presenting with ascites; * patients presenting for emergency surgery; * previous surgery in the same anatomical location; * lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)

Keywords: abdominal laparoscopic surgery laparoscopic cholecystectomy laparoscopic hernia repair laparoscopic appendectomy laparoscopic bariatric surgery laparoscopic colectomy
reference intervals for sonoclot analysis in chinese

Conditions: Cardiovascular Diseases

Summary: the reference intervals for sonoclot analysis may be different between chinese and american. so far, no reference interval has been established in chinese for sonoclot analysis. this study is going to establish the first chinese reference intervals for sonoclot analysis and test whether they are different from american reference intervals.


Eligibility criteria:
inclusion criteria: * aged 18 and older * han ethnic exclusion criteria: * renal dysfunction * liver disorders * known coagulation disorders * patients taking medications in the last month
stereotactic radiosurgery and systemic dose chemotherapy for locally advanced lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage ii and iii lung cancer that is not amendable to surgical resection.

current standard of care for treatment of locally advanced (unresectable stage ii and all of stage iii) non-small cell lung cancer (nsclc) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). while outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months. this study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (sbrt). sbrt uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (sbrt would be able to be completed in 2 weeks or less). the biologically effective dose of sbrt is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. sbrt would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses. the purpose of this study is to explore sbrt in addition to systemic doses of chemotherapy in the treatment of locally advanced nsclc.

Eligibility criteria:
inclusion criteria: * nonsmall cell lung cancer (nsclc) (any histology) * unresectable stage ii * stage iii * tumor less than 8 cm * karnofsky performance scale (kps) of 50 or better * three or fewer mediastinal or hilar lymph nodes exclusion criteria * small cell lung cancer (sclc) * stage i and stage iv patients * stage ii patients eligible for surgical resection * concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease. * kps 40 or less (bed bound) * tumor size greater than 8 cm * inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking) * four or more medisatinal or hilar lymph nodes
the effects of r-methuifn-gamma on the lungs of patients with aids

Conditions: HIV Infections

Summary: to determine safety and tolerance of administering aerosolized recombinant interferon gamma (ifn-gamma) for 4 weeks in patients with aids. to examine activation of alveolar macrophages by aerosolized ifn-gamma administration. to determine if subcutaneous (sc) injection of ifn-gamma can activate alveolar macrophages in aids patients.


Eligibility criteria:
inclusion criteria patients must have: * diagnosis of aids with one or more opportunistic infections. * kaposi's sarcoma with prior history of opportunistic infection. * stable dose of zidovudine (azt) therapy. * preserved pulmonary, renal and hepatic function. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * presence of active infection. * active opportunistic infections. * cardiac disease. * central nervous system disorders. * history of seizures. * irreversible airway disease. patients with the following are excluded: * co-existing conditions and symptoms listed in patient exclusion co-existing conditions. prior medication: excluded within 4 weeks of study entry: * immunosuppressive therapy. * cytotoxic therapy. * excluded: * interferon gamma therapy.

Keywords: pulmonary alveoli macrophage activation interferon-gamma, recombinant injections, subcutaneous aerosols acquired immunodeficiency syndrome