Kornimate/medical-research-clean huggingface dataset:
personalized risk stratification model of follicular lymphoma patients

Conditions: Follicular Lymphoma

Summary: the study aims at developping and validating an integrated clinico-molecular model for an accurate identification of fl patients who are progression free and progressed, respectively, at 24 months after treatment.

already existing and coded tumor biological material and health-related personal data will be retrospectively collected. fl diagnosis will be confirmed by central pathology review. tumor somatic mutations, immunoglobulin gene rearrangement and mutation status will be analyzed by targeted deep next generation sequencing of tumor genomic dna. gene expression profiling will be performed by targeted rna-seq of biopsy-derived rna. an immunohistochemistry panel assessing both tumor phenotype and microenvironment cellular composition will be assessed by tissue macroarray. fish will be performed to characterize the most recurrent follicular lymphoma chromosomal translocations. the adjusted association between exposure variables and progression free survival will be estimated by cox regression. this approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a hierarchical molecular model to predict progression free survival at 24 months. the hierarchical order of relevance in predicting 24 months progression free survival among covariates will be established by recursive partitioning analysis. overall, this approach will allow the development of a multilayer dynamic model for anticipating progression within 24 months from treatment. the model developed in the training set will be tested in the validation sets and the model performance (c-index and net reclassification improvement) in the validation set will be compared with that in the training set. the accuracy of the multilayer model in predicting progression free survival at 24 months will be compared against the flipi using c-index and net reclassification improvement.

Eligibility criteria:
inclusion criteria: * diagnosis of fl after january 1st, 2004 (chemoimmunotherapy era) * availability of tumor material collected before initiation of medical therapy * availability of the baseline and follow-up annotations exclusion criteria: * none.

Keywords: personalized risk assessment risk stratification model
18fdg- pet/ct contribution to the assessment of lesion severity in cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is an autosomal recessive disorder caused by mutations in the cf trans-membrane conductance regulator (cftr) protein. cf is the most common inherited disease of caucasians, with a carrier frequency of 1 in 25-30 individuals. even with the impressive advances achieved in the understanding of the molecular basis and physiopathology of cf, it remains a life-threatening disorder that causes severe lung damage and nutritional deficiencies. it is generally accepted that early therapy could delay the progression of lung disease. a number of non-invasive methods are available to monitor disease activity in cf patients; however none of the currently used tools are able to monitor real-time events. recently high resolution computed tomography (hrct) has been used to monitor changes in lung structure. however, hrct does not allow differentiating between acute and chronic lesions. positron emission tomography (pet) with 18fluoro-deoxy-glucose (fdg) has already been used in a variety of settings to visualize inflammation or infection. fdg-pet imaging appears to be a promising new tool to quantify inflammation as it can detect clinically relevant changes even when no changes or minimal ones are detected by morphologic imaging. pet/ct may consequently be used to evaluate the severity of lung inflammation/infection in cf patients, and therefore the aim of this study is to evaluate the use of pet/ct for the assessment of the severity of lung inflammation/ infection in cf patients.

cystic fibrosis patients with active lung disease will undergo a high resolution pet-ct.pet/ct scans (ge st discovery pet/ct scanner) will be performed 60 to 90 minutes after injection of 5 mbq/kg of fdg. pet/ct will be repeated at the end of the treatment and compared with the results of the initial scan. pet and ct will be interpreted by a certified nuclear medicine physician and by a certified radiologist, respectively, blinded to clinical data, using the pet severity score (pss), based on the number and the intensity of fdg uptake of lung foci. intensity of uptake will be determined by calculating the mean value for the maximum standardized uptake values (msuv) of all foci. (suv = activity concentration in roi (region of interest) divided by injected dose / patient body weight). suv will be measured in normal lungs to receive the normal baseline control for the calculations. the correlation with clinical data (fev1% predicted) and sputum bacteriology will then be performed. inflammation status will also be followed by cytokine analysis.

Eligibility criteria:
inclusion criteria:cf patients with active lesions in their lungs - exclusion criteria:pregnancy, -

Keywords: cystic fibrosis
microneedling therapy with or without amnion bilayer sheeting on scar tissue

Conditions: Scars, Hypertrophic; Burn Scar

Summary: the aim of this study is to compare the outcome of microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scar tissue. a clinical trial will be conducted with 17 samples, from september to december 2021.

high degree burn injuries commonly result in abnormal scar formation, and therapy for this hypertrophic scar remains a challenge. for years, microoneedling has been used for treating hypertrophic scars, and an addition of amnion bilayer sheeting is expected to provide a more favorable outcome. this study aims to compare microneedling therapy with or without amnion bilayer sheeting on post-burn hypertrophic scars tissue. this is an interventional study with 17 samples, aged 18-50 years old. therapeutic outcomes will be evaluated using visual analog scale, degree of erythema, patient's subjective evaluation, dermoscope, biopsy, and skin ultrasound.

Eligibility criteria:
inclusion criteria: * male or female patients, aged 18-50 years old * patients with post-burn, mature hypertrophic scars, localized in any areas other than the face, with a minimum of 5 cm in diameter. * patients are willing to participate in the study and sign an informed consent form exclusion criteria: * patients with scars less than 5 cm in diameter * patients with scars localized solely in the face * hypertrophic scars with keloid * patients with comorbidities

Keywords: microneedling amnion bilayer scar
stroke rehabilitation: a systemized and hierarchized rehabilitation program for the brazilian unified health system

Conditions: Stroke, Ischemic

Summary: the goal of this clinical trial is to systemize and hierarchize a rehabilitation program for the brazilian unified health system in patients with stroke above 18 years of age and of both sexes. the main question it aims to answer is: * do patients with ischemic first episode of stroke have central nervous systems consequences due to peripheral and central nervous system sensibilization? * can stroke patients benefit from a systemized and hierarchized rehabilitation program with desensibilization interventions combined with multidisciplinary and educational programs? we will randomize 60 patients, 30 in each study arm. researchers will compare the intervention group with an active control whose treatment is the institutional conventional program to see if innovative desensibilization strategies yield superior results. authors will also investigate the role of genetic polymorphism and ancestrality in the outcome measures. participants will undertake an innovative or conventional rehabilitation program, according to the randomization.


Eligibility criteria:
inclusion criteria: * clinical and radiological (magnetic resonance or tomography) diagnosis of ischemic stroke; * single episode of stroke; * clinical stability according to medical assessment; * time since stroke onset no longer than 24 months; * capacity to understand the study procedures; * eligible to be admitted to hospitalization at the institute where the study will be conducted * agree to sign the informed consent form (icf). exclusion criteria: * presence of psychiatric disorders; * presence of subarachnoid hemorrhage; * presence of intracerebral hemorrhage; * presence of neuromuscular disorders; * presence of other neurological diseases or brain neoplasm; * presence of cognitive disorders measured with montreal cognitive assessment (moca), scores below 20 points; * presence of systemic arterial hypertension (systolic blood pressure ≥ 185mmhg or diastolic blood pressure ≥ 110 mmhg).
blossom: behavioral modification and lorcaserin second study for obesity management

Conditions: Obesity

Summary: the purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.

randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.

Eligibility criteria:
inclusion criteria: * overweight and/or obese men and women with a body mass index (bmi) 30 to 45 kg/m2 with or without a comorbid condition (e.g., hypertension, dyslipidemia, cv disease, glucose intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition. * ability to complete a 1 year study exclusion criteria: * pregnancy * diabetes mellitus (type i, ii or other) * history of symptomatic heart valve disease * serious or unstable current or past medical conditions

Keywords: obesity weight loss lorcaserin apd356 blossom hypertension dyslipidemia sleep apnea glucose tolerance cardiovascular disease arena
combined microfracture procedure promotes tendon healing

Conditions: Full Rotator Cuff Tear; Microfracture Procedure; Double Raw Repair

Summary: this study is a prospective randomized controlled study of combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. the patients with rotator cuff tear were randomly divided into groups before the operation. the patients were followed up before and 6 weeks, 3 months, 6 months, 12 months after surgery. in different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, mri performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of crimson duvet procedure with greenhouse procedure on the treatment of rotator cuff.


Eligibility criteria:
inclusion criteria: * arthroscopy confirmed small to medium full rotator cuff tear * unilateral rotator cuff injury * voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * young and middle-aged patients aged 20 to 60 exclusion criteria: * previous shoulder surgery (incision or arthroscopy) * combined with diseases of other parts of the same limb * combined with bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on * bilateral onset * unable or unwilling to receive clinical follow-up
the role of the gut microbiota in estrogen metabolism and dietary flax as a potential modulator.

Conditions: Menopause

Summary: the purpose of this pilot study is to determine if suppressing estrogen in premenopausal women results in changes in gut microbiota and if dietary flaxseed modulates these changes.

this pilot study will begin to address whether gut microbiota change with estrogen suppression. specifically, the investigators will test whether gut microbial diversity and abundance change in response to estrogen suppression and consumption of dietary flaxseed. to test this possibility the investigators will recruit premenopausal women (age 20-40 years old)and collect fecal samples before and after 1 month of estrogen suppression with gnrh agonist. the investigators will analyze the gut microbiota in response to estrogen loss and whether this differs with the consumption of flaxseed.

Eligibility criteria:
inclusion criteria: * healthy premenopausal women (20-40 years) * normal to overweight (22-29.9 kg/m2) * normally menstruating (25-35 day cycles) * not have used estrogen-based contraception for \>6 months. * sedentary to moderately active (exercise ≤120 min week-1) * must not be taking phytoestrogenic dietary supplements, or lipid- or glucose- lowering medications. exclusion criteria: * smoking * pregnancy or breastfeeding * hormonal contraceptive use (past 6 mo.) * women with contraindications to gnrhag: * history of fragility fracture * low bmd (i.e., proximal femur or lumbar spine z scores \< -2.0) * abnormal vaginal bleeding * history of breast cancer or other estrogen-dependent neoplasms * history of venous thromboembolic events * hypersensitivity to leuprolide acetate or benzyl alcohol (the vehicle for injection of leuprolide acetate) * evidence for depressive symptoms (score ≥ 18 on the beck depression inventory, bdi) * moderate or severe renal impairment defined as a calculated creatinine clearance \<50 ml/min based on the equation of cockcroft and gault91 * chronic hepatobiliary disease, conservatively defined as liver function tests (ast, alt, alkaline phosphatase, total bilirubin) \>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) * antibiotic or probiotic use within 2 months of sample collection
erythropoietin + iron therapy for anemic patients undergoing aortic valve replacement

Conditions: Anemia; Aortic Stenosis

Summary: the objective of the study is to evaluate the efficacy of erythropoietin (epo) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.

study design prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. the patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the institut universitaire de cardiologie et de pneumologie de quebec. sample size 100 patients (50 patients per group).

Eligibility criteria:
inclusion criteria: 1. patients ≥60-year old 2. symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention 3. anemia defined according to the world health organization (who) definition 69: 1. men: hemoglobin\<130 g/l 2. women: \<120 g/l exclusion criteria: 1. contraindication for transcatheter aortic valve replacement. 2. erythropoietin treatment within last 30 days before aortic valve replacement 3. known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before aortic valve replacement 4. ferritin\>800 µg/l 5. uncontrolled hypertension (blood pressure\>175/95 ) 6. platelet count\>450,000/l 7. recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days) 8. dialysis patients 9. hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure 10. active cancer or very high risk of thromboembolic events 11. known allergy or hypersensitivity to intravenous iron or erythropoietin therapy 12. no written consent

Keywords: anemia severe aortic stenosis red blood cell transfusion erythropoietin
study in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of gs-9674 (cilofexor), and the effect of food on gs-9674 pharmacokinetics and pharmacodynamics

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: this study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (pk) of cilofexor. the study will be conducted in 3 parts (part a, part b, and part c). participants will receive either cilofexor or cilofexor placebo. part a will proceed in 4 prespecified staggered cohorts. within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (period 1) to multiple-dose (period 2). based on the available safety, pharmacokinetics, and/or pharmacodynamics (pd) data from cohorts in part a and part c (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in part b. parts b and c will consist of adaptive cohorts and may be initiated in parallel. part b cohorts may be initiated in parallel with cohorts in part a if the total dose under evaluation is at or below a dose already evaluated. this study is partially blinded (no one is blinded on day -1).


Eligibility criteria:
key inclusion criteria: * healthy male and non-pregnant, non-lactating female volunteers * body mass index (bmi) 19 ≤ bmi ≤ 30 kg/m\^2 * normal 12-lead electrocardiogram (ecg) or one with abnormalities that are considered clinically insignificant by the investigator * normal renal function (estimated glomerular filtration rate calculated using the cockcroft-gault equation ≥ 80 ml/min) * no significant medical history, and in good general health as determined by the investigator at screening evaluation performed no more than 28 days prior to the scheduled first dose. note: other protocol defined inclusion/exclusion criteria may apply.
the clinical diagnosis meaning of mif in coronary heart disease

Conditions: Coronary Heart Disease

Summary: macrophage migration inhibitory factor (mif) is a pleiotropic cytokine that promote the inflammatory response.in animal studies, it has been found that mif is released in the ischaemic heart, promoting glucose uptake and protecting the heart from ischaemia-reperfusion injury.the mif concentration, influenced by age and myocardial ischemia, have different impact on myocardial functional recovery after ischemia.therefore, the purpose of this experiment is to study the clinical significance of mif in patients with coronary heart disease.

mif is a pleiotropic cytokine that promote the inflammatory response. mif is expressed in several cell types,including monocytes/macrophages, vascular smooth muscle and cardiomyocytes, and is released on stimulation from pre-formed storage pools. a foreign study reported that mif had demonstrated to offer protection from i/r-injury by activating adenosine monophosphate-activated protein kinase (ampk) and inhibiting c-jun nterminal kinase (jnk)-induced apoptosis of cardiomyocytes. in addition, animal experiments showed that mif was reduced in aged heart compared with young heart. coronary heart disease is a chronic ischemic disease, in which mif may play as a protective factor during the whole procedure. we observed individuals who will be taking coronary angiography during the hospitalization. individuals will be assigned to coronary-artery-disease group, which included acute coronary syndromes and stable ischemic heart disease, or non-coronary-artery-disease group, according to coronary angiography. all participants will be extracted 3ml blood sample 5 minutes before coronary angiography. coronary-artery-disease group will be taken another two blood samples, 5 minutes after the opening of the balloon and 5 minutes after the stents have been implanted, respectively.

Eligibility criteria:
inclusion criteria: control group: 1. enroll individuals who confirmed by coronary angiography without coronary heart 2. the age between 20 and 80 years old. 3. alanine aminotransferase(alt):10-55u/l, aspartate aminotransferase(ast):0-60u/l 4. glucose(glu-s):3.9-6.1mmol/l 5. triglycerides(trig):0.56-1.7mmol/l, cholesterol(chol):3.1-5.2mmol/l, high density lipoprotein(hdl):0.78-1.96mmol/l, high density lipoprotein(ldl):2.07-3.1mmol/l experimental group: 1. enroll individuals who confirmed by coronary angiography for coronary heart 2. the age between 20 and 80 years old. 3. alt:10-55u/l,ast:0-60u/l 4. glu-s:3.9-6.1mmol/l 5. trig:0.56-1.7mmol/l,chol:3.1-5.2mmol/l,hdl:0.78-1.96mmol/l,ldl:2.07-3.1mmol/l exclusion criteria: 1. inflammatory diseases,such as rheumatoid arthritis,sepsis,asthma and acute respiratory distress syndrome. 2. diabetes
assess the safety & immunogenicity of stored inactivated influenza h5n1 virus vaccine given with & without stored mf59 adjuvant

Conditions: A/Vietnam/H5N1 Influenza Virus

Summary: the main purpose of this study is to assess the usability of long-term stored h5n1 antigen and adjuvant. the study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza a/vietnam/h5n1 vaccine when administered with or without mf59® adjuvant.

this study is a randomized, double-blinded, phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza a/vietnam/h5n1 virus vaccine administered intramuscularly with or without mf59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. this study is designed to assist in stockpile management and will assess the usability of long-term stored h5n1 antigen (ie, stored \>10 years) and adjuvant (ie, stored \>5 years).

Eligibility criteria:
inclusion criteria: * male or nonpregnant female * provide written informed consent prior to study-related procedures * stable health status * access to consistent and reliable means of telephone contact * able to understand and comply with planned study procedures * agree to stay in contact with site, and no plans to move from study area for study duration exclusion criteria: * allergic to eggs, other vaccine components, or squalene-based adjuvants * women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding * females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry * have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months * have an active neoplastic disease or history of hematologic malignancy * have long term use (≥14 consecutive days) of glucocorticoids (\>20 mg/day) or high-dose inhaled steroids (\>800 mcg/day) within preceding 6 months * diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis * have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years