Kornimate/medical-research-clean huggingface dataset:
eplerenone in systemic right ventricle

Conditions: Transposition of Great Vessels; Atrial Switch Procedure

Summary: background: there is no clinical evidence supporting medical treatment for the failing systemic right ventricle in patients with transposition of the great vessels with atrial switch. cardiac magnetic resonance studies have shown a significant degree of myocardial fibrosis in right ventricles in the systemic position, which predisposes to systolic and diastolic dysfunction. aldosterone is a widely recognized neurohormonal marker involved in the formation of myocardial fibrosis and the treatment with aldosterone antagonists has shown a decrease in ventricular mass in hypertensive patients, presumably related to reduction of myocardial fibrosis. hypothesis: low dose of eplerenone, a selective mineralocorticoid receptor blocker, in patients with systemic right ventricle can reduce the ventricular mass by means of a reduction in myocardial fibrosis, resulting in improved systolic function. patients and methods: randomized, double blind, parallel clinical trial comparing eplerenone (50mg daily) with placebo. study population: adult patients (\>18 years) diagnosed with repaired transposition of the great arteries with atrial switch (senning or mustard techniques) routinely followed at a tertiary referral center. duration: 12 months. outcomes: right ventricular mass, myocardial fibrosis mass and ejection fraction assessed by cardiac magnetic resonance.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) * diagnosis of transposition of the great arteries repaired with atrial switch procedures (mustard or senning). * regular follow up at tertiary referral center. exclusion criteria: * concomitant disease with life expectancy \<1 year. * inclusion in heart transplant waiting list. * basal serum creatinine level \> 1.5 mg/dl. * basal serum potassium level \> 5.0 mmol/l. * intolerance to the investigational medical product. * treatment with spironolactone or eplerenone within the previous 6 months. * inability to undergo magnetic resonance imaging. * pregnancy or breast feeding. * denial of informed consent.

Keywords: transposition of the great arteries. transposition of the great vessels. mustard. senning.
a national study for blood based response monitoring of b-cell lymphoma patients

Conditions: NHL

Summary: observational prospective study. patients with dlbcl and hgbcl will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

the rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. to make this possible, a crucial condition is optimal identification of patients that will not be cured on r-chop. the aim of this protocol is to develop new tools to monitor treatment response and disease outcome. molecular monitoring of treatment response through liquid biopsies (lb) is such a promising new tool. the primary objective is to collect liquid biopsy samples of patients with newly diagnosed dlbcl/hgbcl to develop a blood based assay allowing biomarker driven treatment in the future. the secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay. this study is designed for patients with newly diagnosed dlbcl and hgbcl ≥ 18 yr.

Eligibility criteria:
inclusion criteria: * patients diagnosed with newly diagnosed dlbcl (including hgbcl- nos and hgbcl-dh) according to who classification 2016 * ann arbor stage ii-iv * patients intended to be treated with 6 cycles r-chop (or da-epoch-r) as first-line treatment (successive inclusion in hovon 151 or hovon 152 is possible) * age ≥ 18 years exclusion criteria: - patients with limited stage i, ii disease planned to receive 3 cycles of r-chop + radiotherapy, or 4 x r-chop+ 2r
mabthera (rituximab) in combination with chop (or chop-like) chemotherapy in patients with aggressive b-cell lymphoma

Conditions: Lymphoma, Lymphoma, Large B-Cell, Diffuse, Non-Hodgkin's Lymphoma, Lymphoma, Non Hodgkin, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Summary: evaluation of efficacy, safety profile and tolerability of rituximab (mabthera) in combination with chemotherapy in the treatment of diffuse large b-cell lymphoma (dlbcl). participants, who were not treated previously for dlbcl, will receive mabthera in combination with cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone (chop) or chop-like chemotherapy according to registered indication. patients will be followed up for safety and efficacy evaluation in accordance with routine practice. the study will be non-interventional and by its design purely observational. all treatments prescribed during the observation period will be at the treating physician's discretion and will be prescribed according to package labeling, within approved indication and local approval status of respective drugs.


Eligibility criteria:
inclusion criteria: * histologically confirmed cluster of differentiation antigen 20 (cd20) positive diffuse large b-cell lymphoma according to the world health organization/revised european-american classification of lymphoid neoplasms (who/real) classification * age \> or =18 years * performance status \< or = 2 on the eastern cooperative oncology group (ecog) scale * women of child-bearing potential must agree to use effective contraception for the entire treatment period and during the 12 months thereafter exclusion criteria: * transformed lymphoma (secondary to "low-grade" follicular lymphoma) * grade 1, 2 or 3a follicular lymphoma * primary or secondary central nervous system (cns) involvement * patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer * major surgery (excluding lymph node biopsy) within 28 days prior to registration. * poor renal function: serum creatinine \> 2.0 mg/dl (177 micromol/l) * pregnancy * poor hepatic function: total bilirubin \> 2.0 mg/dl (34 micromol/l), aspartate transaminase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]) or alanine transaminase (alt) (serum glutamic pyruvic transaminase \[sgpt\]) or alkaline phosphatase (ap) \> 3 x the upper limit of normal unless these abnormalities are related to lymphoma. * known human immunodeficiency virus (hiv) infection or active viral hepatitis, specifically hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. * serious underlying medical conditions, which could impair the ability of the patient to participate in the trial * life expectancy \< 6 months * known sensitivity or allergy to murine products * treatment within a clinical trial within 30 days prior to trial entry
comparison of effectiveness between pl and prp on knee osteoarthritis: a prospective,randomized,placebo-controlled trial

Conditions: Osteoarthritis (OA) of the Knee

Summary: this study will focus on grade i to iii knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.

the current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. the usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. platelet lysate is the product of complete activation from autologous platelet. it contains rich growth factors and cytokines such as pdgf, tgf-β, vegf, egf and igf, etc. it can support cell growth and doesn't have any white blood cells in it. it is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.

Eligibility criteria:
inclusion criteria: * 50 to 80 years old * study subjects must be willing to sign informed consent to participate in the study * in the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (visual analogue scale) is greater than or equal to 40 (the most pain is 100, not painful is 0) * morning joint stiffness is less than 30 minutes * x-ray：grade 1-3 radiographic oa as defined by the k-l classification exclusion criteria: * knee instability * the knee joint is obviously deformed (\> 5 degree valgus or varus deviation on x-ray) * clinical diagnosed as pes tendinitis, chondromalacia * taking nsaids or steroids (including oral and injection) within one week * using anticoagulant drugs for a long time * platelet count is less than 150,000 / ul, or coagulation disorders, prothrombin time (pt value) is less than 11 seconds or greater than 16 seconds * leukemia, sepsis, platelet dysfunction or other blood related diseases * tumors, infections or the trauma before the same site * pregnancy
a study to evaluate the safety, tolerability, pharmacokinetics (pk), proof of mechanism of gsk2618960 in primary sjögren's syndrome (pss)

Conditions: Autoimmune Diseases

Summary: this study aims to evaluate the safety, tolerability and pk of repeat dose administration of gsk2618960 in the treatment of pss. the study will contain two parts, part i will be open label and part ii will be randomized, double-blind. the minimum duration of part i \& part ii of the study will be 26 and 32 weeks respectively.


Eligibility criteria:
inclusion criteria: * part i and part ii: male and females aged 18-70 * part i and part ii: pss diagnosis according to the american-european consensus group criteria * part i and part ii: documented previous biopsy evidence of salivary gland inflammation consistent with pss and/or documented history of anti-ro and/or anti-la antibodies * part ii: has any of the following abnormalities at screening: hypergammaglobulinaemia \[serum immunoglobulin g (igg) greater than or equal to 16 gram per liter (g/l); presence of rheumatoid factor (rf); anti nuclear antibodies (ana) titer greater than or equal to 320:1. * stimulated whole salivary flow greater than 0.1 milliliter per minute (ml/min) at screening. * symptomatic oral dryness greater than or equal to 5 out of 10 on visual analogue scale (vas) scale and/or schirmer test less than 10 millimeter (mm) at screening. exclusion criteria: * part i and ii: secondary sjögren's syndrome * part i and ii: receiving cyclophosphamide, other biologic, immunosuppressive or immunomodulatory treatments * part i and ii: active infections, or history of recurrent infections * part i and ii: history of significant medical illness * part i and ii: history of lymphoma

Keywords: anti-il-7 receptor-alpha monoclonal antibody safety gsk2618960 primary sjögren's syndrome
real-world canadian cuvitru non-interventional study in subjects transitioning from subcutaneous immunoglobulin (cancun)

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: this study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to cuvitru in a real-world setting.


Eligibility criteria:
inclusion criteria (the participant will not be considered eligible for the study without meeting all of the criteria below): * voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent or assent as applicable to participate in the study; * participant \> 2 years of age with a documented diagnosis of pid or sid requiring igg replacement therapy, as defined by the international union of immunological societies scientific committee 2009 and by diagnostic criteria according to conley et al., 1999; * participant has received subcutaneous immunoglobulin (scig) therapy previous to cuvitru for at least 3 months; and * participant has received cuvitru in line with the product specification (cuvitru product monograph (baxalta canada corporation, 2018) at start of study exclusion criteria (participants are excluded from the study if any of the following criteria are met): * participation in any interventional clinical study within the last 30 days * participant participates in a clinical study in parallel during the observation period; and * participant had a dose change 30 days prior to transition to cuvitru for cohort 1
evaluation of extended wear technology

Conditions: Hearing Loss

Summary: evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.

a interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. after two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. participants will be blinded as to which device they are wearing in each ear. comfort and sound quality will be assessed for each device prior to removing from ears.

Eligibility criteria:
inclusion criteria: * mild, moderate and moderate severe hearing loss * previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues exclusion criteria: * participants who can only wear a size xxs (extra-extra small) extended wear device * asymmetrical hearing loss * other diagnosis that may cause hearing fluctuation * inability to tolerate physical fit of lyric devices * inability to be seen for four lab visits
effect of metoprolol in cardioprotection during an acute myocardial infarction. the metocard-cnic trial.

Conditions: Myocardial Infarction

Summary: the purpose of this study is to test whether early pre-reperfusion metoprolol administration in patients suffering and acute myocardial infarction might reduce the size of myocardial necrosis.

acute myocardial infarction (ami) is a chief cause of death worldwide. the best strategy to limit myocardial damage is to perform an early coronary reperfusion. however, despite reperfusion, the size of infarctions is many times large. infarct size has been recently shown to be a strong predictor of future cardiovascular events and mortality. therefore interventions aimed at reducing infarct size are the matter of intense research; but despite great efforts, no therapy has been shown to consistently limit infarct size. ß-blockers are a class of drugs that have been used to treat cardiovascular conditions for several decades. β-blockers reduce mortality when administered after an ami, and are a class ia indication in this context. what remains unclear is what timing and route of β-blocker administration gives the maximum cardioprotective effect. in particular, whether early β-blocker administration is able to reduce infarct size is a subject of debate. recent experimental data suggest that the β1 selective blocker metoprolol is able to limit the area of necrosis only when administered before reperfusion. the objective of this trial is to determine whether the administration of intravenous pre-reperfusion metoprolol might reduce infarct size.

Eligibility criteria:
inclusion criteria: 1. confirmed\* acute anterior wall myocardial infarction (st segment elevation ≥ 2mm in ≥ 2 contiguous leads \[one of which should be v2, v3, or v4\]). 2. killip class i or ii on diagnosis. * cases of non-confirmed infarction by enzymatic release (above 2 standard deviations from upper limit of ck and troponin) are excluded from efficacy analysis but kept in the safety analysis. exclusion criteria: 1. copd or asthma on active bronchodilator therapy 2. active treatment with beta blockers 3. left bundle branch block or pacemaker. 4. systolic blood pressure \<120 mmhg, heart rate \<60 bpm, or av block (pr˃240 ms or superior) on diagnosis.

Keywords: ischemia reperfusion myocardial infarction beta blockers metoprolol acute myocardial infarction necrosis salvaged myocardium
tissue biomarker for pegvisomant action

Conditions: Acromegaly

Summary: acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. pegvisomant works by blocking binding of gh to receptors found in tissues throughout the body. human studies have evaluated pegvisomant action by measuring reduction of igf-i levels in the blood. however, no studies have evaluated the effects of blocking gh receptors in tissues. in this study, we will study tissue biomarkers for pegvisomant action in gh and igf-i dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.


Eligibility criteria:
inclusion criteria: * diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on mri, elevated serum concentrations of igf1 (\>1.3 x uln), and inadequate gh suppression (\>0.4 ng/ml) following ogtt * candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy * normal lfts before treatment * dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement exclusion criteria: * treatment with a long-acting srl within 12 weeks before enrollment * presence of a macroadenoma with visual field defects as a result of chiasmatic compression * clinically significant hepatic abnormalities and/or ast or alt \>3 x uln on screening * known hypersensitivity to any of the test materials or related compounds * history of, or known current, problems with alcohol or drug abuse * any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude

Keywords: acromegaly
assessment of lung recruitablity of acute respiratory distress syndrome with sars-cov-2 pneumonia by electrical impedance tomography

Conditions: Critical Illness; ARDS

Summary: novel coronavirus (sars-cov-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ards). lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (peep) is recommended. however, it is not clear whether injured lungs from sars-cov-2 pneumonia have the same mechanical properties, especially response to peep as common ards. therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using eit (electrical impedance tomography) in patients with ards due to sars-cov-2 pneumonia.

the multi-center prospective observational study will enroll 20 adult ards patients under mechanical ventilation from intensive care units (icus) in japan and peru. informed consent will be waived due to the nature of observational study. patients with positive sars-cov-2 infection will be included. prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. the distribution of ventilation will be evaluated with eit.

Eligibility criteria:
inclusion criteria: 1. patients with positive sars-cov-2 infection＊ 2. patients with ards under mechanical ventilation＊＊ 3. patients ≧ 18 years old * definition of sars-cov-2 infection positive: sars-cov-2 infection is defined as being positive in rt-pcr (real time reverse transcriptase-polymerase chain reaction) assay using nasal or pharyngeal swab samples. * definition of ards is as per the berlin definition (pao2/fio2 ≦ 300 mmhg with peep ≧ 5 cmh2o) exclusion criteria: 1. contraindication for eit monitoring 1. unstable spine or pelvic fractures 2. pacemaker, automatic implantable cardioverter defibrillator 3. skin lesions between the 4th and 5th ribs where the eit belt is worn 2. home mechanical ventilation before inclusion 3. pregnancy 4. dnr (do-not-resuscitate) 5. increased intracranial pressure (\> 18 mmhg)

Keywords: sars-cov-2 electrical impedance tomography positive end expiratory pressure
prognostic value of circulating endothelial progenitor cells in aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: aneurysmal subarachnoid hemorrhage is a common and serious disease associated to a high rate of mortality and morbidity. severe definitive neurological impairment can concern up to 30% of patients in relation with elevated intracranial pressure, hemorrhage recurrence and symptomatic cerebral arterial vasospasm. this latter complication is defined as a reversible reduction of cerebral artery's diameter occurring between the 4th and the 14th day after bleeding. physiopathology is not well understood, but could involve endothelium, trough endothelial progenitor cells (epc). circulating epc are bone marrow-derived cells with capacity of vasculogenesis and angiogenesis. epc have been recognized playing a beneficial role in cardiovascular disease and ischemic stroke. epc have never been studied in aneurysmal subarachnoid hemorrhage. the primary objective of this study is to compare the number of circulating endothelial progenitor cells between patients with a good neurological outcome (defined as a glasgow outcome scale = 1 or 2) and patients with a poor neurological outcome (glasgow outcome scale = 3, 4 or 5). briefly, the number of circulating epc will be measured at admission, and at day 3, 6, 10, 14, 21 in each consecutive patient suffering aneurysmal subarachnoid hemorrhage and hospitalized in teaching hospital of besançon (france). the neurological outcome will be measured one year after subarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: * recent(\< 24 h) aneurysmal subarachnoid hemorrhage * written informed consent obtained from the patient or from close relatives exclusion criteria: * refusal to participate * non-aneurysmal subarachnoid hemorrhage * aneurysmal subarachnoid hemorrhage with estimated date of bleeding \> 24 h * chronic heart failure * chronic medication able to modify the plasmatic level of bnp * pregnancy

Keywords: endothelial progenitor cells aneurysmal subarachnoid hemorrhage vasospasm bnp
remote management of diabetic patients via data transmission by accu-chek 360 software

Conditions: Diabetes

Summary: the purpose of this study is to determine if providing some care to diabetic patients remotely, using accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.

this will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the accuchek 360 software. all will be capable of independent care of their diabetes. all patients will be 19-65 years of age. the end-points will include similar changes in hemoglobin a1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care. there will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.

Eligibility criteria:
inclusion criteria: * male and female * 19-65 years of age * type 1 and 2 diabetes * computer literate * independent care of diabetes * insulin pump allowed (spirit pump only) * females on birth control * can demonstrate competency in the use of the accuchek aviva meter, reliability in doing regular home blood sugar determinations exclusion criteria: * creatinine clearance \< 30 cc/min * severe loss of vision (diabetic retinopathy) * severe diabetic neuropathy * known or suspected diabetic gastroparesis * patients with heart disease * patients with liver disease * drug or substantial alcohol use * use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure * females that are pregnant or are capable of becoming pregnant * insulin pump use other than accucheck spirit pump