Kornimate/medical-research-clean huggingface dataset:
association between circulating immune cells and the tumor immune contexture in resectable non-small cell lung cancer

Conditions: Resectable Non-small Lung Cancer

Summary: with the recent approval of nivolumab for second-line treatment of stage iiib/iv non-small cell lung cancer (nsclc), immune checkpoint inhibitors are entering the standard of care for lung cancer. other immune checkpoint inhibitors are under evaluation, both in resectable and non-resectable nsclc. in order to refine our use of these molecules, comprehensive data on the immune contexture of nsclc are needed. moreover,a blood marker of this contexture would allow physicians to monitor the immune status of their patient's tumor and though to evaluate the rightful place of immunotherapy in the multimodal treatment of nsclc. no such blood marker has been validated so far. the lympholung study investigate the concordance between blood and intratumoral counts of immune cells in resectable stage i to iiia nsclc. by the use of 30-marker cytometry, a precise immune profile of nsclc will be depicted. the prognostic value of the circulating and intra-tumoral t regulator over total lymphocytes ratio for 2-year recurrence-free survival will also be addressed.


Eligibility criteria:
inclusion criteria: * men and women over 18 years of age * histologically- or cytologically- confirmed non-small cell lung cancer diagnostic * stage i, ii or iiia nsclc (according to version 7 of the international association for the study of lung cancer staging manual in thoracic oncology). staging must have included an abdominal and thoracic ctscan, a ctscan or mri of the brain and a 18fdg petscan * subjects for whom a surgical resection is indicated * signed written informed consent exclusion criteria: * - previous, ongoing or planned neo-adjuvant treatment (chemotherapy, targeted therapy, immunotherapy or radiotherapy) * contraindications to general anesthesia * contraindication to the planned surgical resection * history of immunosuppressive disorder * known history of testing positive for human immunodeficiency virus * subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 30 days of randomization. * clinical suspicion of active infection (either acute or chronic) * severe (hemoglobin \< 8.0 g/dl) or symptomatic anemia * women of childbearing potential must have a negative urine pregnancy test * women must not be breastfeeding * prisoners or subjects who are involuntarily incarcerated * subjects under guardianship
magnetic resonance imaging to study the normal eye

Conditions: Cataract; Lens Disease

Summary: this study will assess the value of improved magnetic resonance imaging (mri) techniques to study the lens of the human eye. knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; mri may provide an effective means for learning more about this eye disease. normal volunteers between 18 and 70 years of age may be eligible for this study. participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye. mri scans will be scheduled for a second visit. for this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. a device similar to a welder's helmet is placed on the head. attached to the device are an imaging probe and a small blinking light. the probe receives radio signals from the eye that a computer converts into images. during imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.

studies of human diabetic cataract and age related cataract formation have been hampered by unavailability of human tissues especially in the early stages of the disease. eye bank tissues are first used for cornea transplants so that by the time they become available for basic research studies, the lens is no longer suitable for biochemical nor histological studies. cataracts usually only become available after extraction which is at the end stage of their development. however, appropriate surgical lens specimens are no longer available because cataracts are generally extracted by the destructive phakoemulsification technique. therefore, noninvasive techniques are required in order to study the lens in vivo.

Eligibility criteria:
must be between 18 and 70 years of age of either sex. must not have uveitis, glaucoma, or be at risk for an adverse reaction to dilation or have a history of allergic reaction to one of lthe dilating agents to be used. must not have any metallic prosthesis, cardiac pacemakers, neural pacemakers, surgical clips in the brain or on blood vessels, surgically implanted metal plates, screws or pins, cochlear implants or metal objects in the body especially in the eye.

Keywords: magnetic resonance imaging human eye lens normal volunteers cataract human lens healthy volunteer
enhancement of physical fitness in older adults

Conditions: Pain; Physical Impairment

Summary: ageing is related to a decrease in physical fitness, disability and age related symptoms like nocturnal leg cramps (nlc). our research is focused on the enhancement of physical activity and mobility to increase physical fitness and decrease disability and nocturnal cramp in older adults.

the ageing population leads to an increase of chronic disease and disability and to a decrease of physical activity and adl performance. this circle can be reversed by physical exercise to increase physical fitness. the goal of this research is to establish the effects of a trainings program on adl performance, physical fitness and nocturnal cramps. furthermore the characteristics from participants who benefit from the program will be investigated by the research. the study design is a randomized intervention study. participants are elderly people, age 65 years and older, without cognitive impairment. intervention: the intervention is a physical trainings program. the intensity is moderate, the frequency is daily and the total duration is 6 weeks. the control group will be provided with an education program. main parameters are: physical fitness, nocturnal cramp severity and frequency.

Eligibility criteria:
inclusion criteria: * for patients to be included in our study, they had to experience regular episodes of nlc and are in good mental health. * the participants had to agree to the study protocol and complete the program. * after eligibility was verified, written informed consent was obtained. exclusion criteria: * older adults taking quinine or sleep medication and those with orthopedic problems or with severe medical problems and co morbidity, which can cause muscular spasms and/or cramps.

Keywords: older adults exercise stretching mobility
extension study of stage 1 subjects of study a3921009 for the prevention of acute rejection in kidney transplant patient

Conditions: Kidney Transplantation

Summary: a new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called jak3, is being developed by pfizer to prevent transplant rejection. in study a3921009, kidney transplant patients were given a jak inhibitor or tacrolimus for 6 months posttransplant. patients who completed study a3921009 were offered the opportunity to participate in study a3921021 which will extend the evaluation of safety and efficacy of cp-690,550 versus tacrolimus through 8 years posttransplant. in treatment group 1 (control arm), subjects will continue to receive tacrolimus. in treatment groups 2 and 3, subjects will continue to receive cp-690,550. per amendment 4, the tacrolimus comparator arm will be discontinued.


Eligibility criteria:
inclusion criteria: * enrollment in stage 1 of study a3921009 and have completed 6-months of treatment with trial medications (cp-690,550 or tacrolimus) * recipient of a first-time kidney transplant exclusion criteria: * subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy). * subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.

Keywords: immunosuppression jak3 inhibitor kidney transplant tofacitinib xeljanz cp-690 550 tacromilus mycophenolate mofetil
metoprolol in patients with hfref and copd

Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF); COPD (Chronic Obstructive Pulmonary Disease)

Summary: the goal of the clinical trial was to see if metoprolol was effective in treating patients with heart failure and chronic obstructive pulmonary disease. it will also learn about the safety of metoprolol. the main questions it aims to answer are: did metoprolol reduce the frequency of all-cause deaths and re-hospitalizations in subjects? what medical problems do participants experience after taking metoprolol? the researchers will compare different doses of metoprolol to see the best dose for metoprolol. participants will: take metoprolol 23.75mg/ day or the maximum tolerable dose of metoprolol daily for 24 months. regular outpatient follow-up visits to the research center. their symptoms and metoprolol dosage were recorded.


Eligibility criteria:
inclusion criteria: 1. a definite diagnosis of hfref (lvef≤40%), nyha ii to iv , and the disease is due to ischemic heart disease or dilated cardiomyopathy; 2. a definite diagnosis of copd with moderate or higher airflow limitation (fev1/fvc \< 0.7 and fev1 \< 80% of the expected value); 3. age ≥18 years old; 4. informed consent has been obtained and signed. exclusion criteria: 1. the dose of metoprolol before enrollment was more than 23.75mg/d; 2. resting heart rate \< 50 beats/min; 3. second or third degree atrioventricular block; 4. atrial fibrillation; 5. sick sinus syndrome; 6. systolic blood pressure \< 90mmhg; 7. acute attack of bronchial asthma; 8. liver insufficiency (serum transaminase \> 3 times the normal value); 9. renal insufficiency (egfr \ 2.5mg/dl\[\> 221μmol/l\]); 10. patients with serious physical diseases, such as cancer; 11. patients who have a history of allergy to the investigational drug or its ingredients; 12. participating in other clinical investigators; 13. during the study period, patients cannot live in the selected center for a long time, which is not conducive to the follow-up; 14. patients with disability, mobility disability, intellectual disability and other factors that may prevent normal participation in the study and follow-up, and their frailty was assessed by the frail frailty screening scale; intellectual mental status was assessed by the mini-mental state examination (mmse). 15. poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.

Keywords: heart failure with reduced ejection fraction chronic obstructive pulmonary disease metoprolol
zinc supplementation in cirrhotic patients

Conditions: Dysgeusia; Liver Cirrhosis

Summary: the purpose of this study is to evaluate the effect of zinc supplementation in the treatment for dysgeusia, progression disease and quality of life in patients with liver cirrhosis.

taste disorders are symptomatologies in patients with cirrhosis, these have a direct effect in modification of food consumption, increasing weight loss, anorexia and malnutrition, which impacts in decompensation rates and mortality. it has been proposed that zinc deficiency is one of the causes for development of taste disorders. the aim of this study is to describe the presence of taste disorders in patients with cirrhosis and evaluate the effect of zinc supplementation in treatment of taste disorders, and in progression of chronic liver disease.

Eligibility criteria:
inclusion criteria: * cirrhotic patients by any etiology, with any dysgeusia exclusion criteria: * patients with hepatic encephalopathy at the time of dysgeusia evaluation * patients with any neurological disease * patients with respiratory diseases ath the time of dysgeusia evaluation * patients with active alcohol consumption
covid-19 and nonalcoholic fatty liver disease

Conditions: Covid19; NAFLD

Summary: covid-19 is currently the leading public health problem, associated with a high risk of complications and death in risk groups of patients. non-alcoholic fatty liver disease (nafld) is the most common liver disease with a prevalence of 30% in the western population and is also recognized as an independent risk factor for the development of severe covid-19. in the pathogenesis of covid-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm leading to the development of severe forms of pneumonia, acute respiratory and multiorgan failure. the aim of this study is to investigate the clinical course, outcomes, and profile of inflammatory response in patients with covid-19 and nafld.

sars-cov-2 virus infection is currently the leading public health problem, associated with a high risk of complications and death in at-risk groups. risk factors for the development of severe forms of covid-19 include components of the metabolic syndrome (obesity, diabetes, dyslipidemia, and arterial hypertension), which are also associated with the development of nonalcoholic fatty liver disease (nafld). according to previously published, but mostly retrospective studies, nafld is a possible risk factor for the development of severe covid-19. . in the pathogenesis of covid-19, the key role is played by the hyperreactivity of the immune response, the so-called cytokine storm. according to recent research, activation of the th17 system could play a key role in the regulation of this excessive inflammatory response. furthermore, th17 lymphocytes and cytokines are important in the development and progression of nafld. the question is whether, due to th17 hyperreactivity, patients with nafld are at higher risk of developing severe forms of the disease and what is the profile of the th17 immune response to sars-cov-2 infection in this group of patients.

Eligibility criteria:
inclusion criteria: * adult patients diagnosed with covid-19 exclusion criteria: * immunosuppression * consumption of alcohol \> 20 g/day * hiv * chronic viral hepatitis * presence of other chronic liver disease (hemochromatosis, wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease) * pregnancy
pharmacogenetic study of different hormone therapies in recent menopause women

Conditions: Postmenopause

Summary: this is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and fto polymorphisms patients will be randomized to receive oral hormone treatment or non-oral hormone treatment the investigators hypothesis is that a different genotypes in the receptor estrogen gene and fto may have an influences on treatment response in metabolic markers and cardiovascular risk


Eligibility criteria:
inclusion criteria: * last menstrual period between 6 months and 3 years before the beginning of the study plus fsh levels higher than 35 iu/l; * age between 42 and 58 years; * no use of any medication known to interfere with hormonal, glucose, or lipoprotein levels in the past 3 months; * no use of steroidal or no steroidal anti-inflammatory drugs in the last 15 days. exclusion criteria: * patients with diabetes, * previous hysterectomy, * endometrial thickness \>0.5cm, * history of cancer, * thromboembolism, or * established cardiovascular disease
a long-term study to evaluate safety and efficacy of pregabalin in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in study a0081208 (nct00830167).


Eligibility criteria:
inclusion criteria: * patients must have met the inclusion criteria for the preceding fibromyalgia protocol a0081208, and must have received pregabalin/placebo under double-blind conditions. exclusion criteria: * patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study a0081208; which was determined to be related to the study medication by the investigator or the sponsor.
pediatrics testotoxicosis study [bicalutamide anastrozole treatment for testotoxicosis]

Conditions: Puberty, Precocious

Summary: the primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .


Eligibility criteria:
inclusion criteria: * provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements) * male aged 2 years and over * diagnosis of testotoxicosis based on the following: * clinical features of progressive sexual precocity documented by tanner staging and evidence of symmetrical testicular enlargement * clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age) * pubertal levels of serum testosterone * prepubertal levels of serum gonadotropins * lack of an increase in serum gonadotropin levels following gnrh stimulation * other pathology excluded by: * undetectable plasma b human chorionic gonadotropin (bhcg). samples with values below the loq will be reported as "\<10 iu/l" which in the clinical setting equate to 'undetectable'. * normal levels of 17-hydroxyprogesterone (17-ohp) * normal levels of dehydroepiandrosterone sulphate (dheas) * naive to anti androgen receptor therapy: (note: ketoconazole and spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors) * a documented reliable height measurement taken \> 6 months prior to study enrollment. additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment. (note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and \> 6 months prior to study entry) * subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis. exclusion criteria: * evidence of central precocious puberty as demonstrated by gnrh stimulation test * serum concentration of total or direct bilirubin, ggt, ast or alt greater than 1.5 times the upper limit of normal for age * serum concentration of creatinine greater than 1.5 times the upper limit of normal for age * any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance * known hypersensitivity to any of the study medications * participation in a clinical study at the time of enrollment

Keywords: testotoxicosis familial male-limited precocious puberty (fmpp)
comparison of denervation techniques for the treatment of knee osteoarthritis: continuous ablative radiofrequency vs. chemical denervation with absolute alcohol

Conditions: Osteoarthritis Knee; Chronic Pain

Summary: this randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. the study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.

this randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.

Eligibility criteria:
inclusion criteria: * adults aged ≥ 18 years. * knee pain for more than 3 months. * clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on x-ray, ultrasound, or magnetic resonance imaging (mri). exclusion criteria: * history of major joint interventions, such as previous knee surgery or arthroplasty. * severe joint effusion. * coagulation disorders or other clinical contraindications for the procedure. * uncontrolled comorbidities that increase procedural risk. * body mass index (bmi) \> 35. * cognitive impairment that affects the ability to understand and respond to pain assessment instruments.

Keywords: knee osteoarthritis chronic pain denervation radiofrequency ablation chemical neurolysis alcohol neurolysis genicular nerve ablation minimally invasive pain management interventional pain treatment pain relief
bile leak after liver surgery

Conditions: Bile Leak; Hepatic Resection; Liver Resection; Hepatectomy; Biliary Fistula

Summary: the definition of biliary fistula is heterogeneous and the more accepted is that proposed by the isgls. we devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the international study group of liver surgery (isgls).

data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. drains were maintained at least 7 days, and the bilirubin levels were measured in pod3, 5, and 7. drains were removed if the bilirubin level in pod7 was inferior than in pod5, and less than 10 mg/dl. statistical analysis on prognostic factors for biliary fistula was performed.

Eligibility criteria:
inclusion criteria: * any patient submitted to hepatic resection at our unit between the established frame time exclusion criteria: * any patient with incomplete data or follow-up
other effects of fluvastatin are investigated in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: other effects of fluvastatin are investigated in german patients with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * written informed consent * male and female patients, aged between 18 and 75 years * metabolic syndrome according to national cholesterol education program adult treatment panel iii (ncep atpiii) exclusion criteria: * history of heart failure * hiv positive * stroke other protocol defined inclusion and exclusion criteria may apply.

Keywords: metabolic syndrome, fluvastatin