Kornimate/medical-research-clean huggingface dataset:
pulmonary hypertension prevention in hemodialysis

Conditions: Chronic Kidney Disease

Summary: pulmonary hypertension is a new complication described in hemodialysis patients. in the last year these patients were treated by calcium carbonate orally to control serum phosphor. calcium phosphor deposits in pulmonary artery can explain this phenomena. the investigators want to investigate the new phosphor non calcium containing agents in hemodialysis patients and to measure the pulmonary pressure.

the investigators will measure pulmonary blood pressure before and after treatment with new phosphor binders, non calcium containing.

Eligibility criteria:
inclusion criteria: * hemodialysis patients without fistula exclusion criteria: * heart disease

Keywords: calcium phosphore renagel
a study to assess the pharmacokinetic (pk) comparability of 2 fixed subcutaneous (sc) doses of aducanumab (biib037) with a single, weight-based intravenous (iv) dose in healthy volunteers

Conditions: Healthy Volunteer

Summary: the primary objective of the study is to evaluate the pharmacokinetic (pk) comparability of 2 fixed subcutaneous (sc) doses of aducanumab with a single, weight-based intravenous (iv) dose of aducanumab in healthy volunteers. the secondary objectives of the study are to assess the safety and tolerability of aducanumab administered sc in healthy volunteers and to characterize additional pk parameters of 2 fixed sc doses of aducanumab and a single, weight-based iv dose of aducanumab.


Eligibility criteria:
key inclusion criteria: * have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive * japanese participant has both biological parents and all 4 grandparents of japanese descent * have a negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) on day -1 key exclusion criteria: * history of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator * history of severe allergic, anaphylactic or systemic hypersensitivity reactions, or of any allergic reactions that in the opinion of the investigator are likely to be exacerbated by aducanumab, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study * history of, or positive test result at screening for, human immunodeficiency virus * history of hepatitis c infection or positive test result at screening for hepatitis c virus antibody * symptoms consistent with sars-cov-2 infection, per the judgment of the investigator, within 14 days prior to day -1, including but not limited to fever (temperature \> 37.5 degrees celsius \[°c\]), sore throat, new and persistent cough, shortness of breath, diarrhea, muscle aches, or loss of taste or smell * current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to day -1, or 5 half-lives, whichever is longer * any immunization or vaccination given within 10 days prior to administration of study treatment and for 10 days after administration of study treatment * mini mental state examination score of \< 27 at screening note: other protocol defined inclusion/exclusion criteria may apply.
atrioventricular junction ablation and biventricular pacing for atrial fibrillation and heart failure

Conditions: Permanent Atrial Fibrillation

Summary: there is evidence of superiority of av junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. hypothesis of trial is that av junction ablation is superior to pharmacological therapy as regard hospitalization and mortality

prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases: "morbidity trial" (apaf-crt morbidity). small size (280 pts), follow-up 24 months. primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35% "mortality trial" (apaf-crt mortality). large size (pts included in morbidity trial plus additional \~1500 pts, long-term follow-up (at least 4 years). primary endpoint: total mortality. predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35%

Eligibility criteria:
inclusion criteria: to be eligible, each patient must be in the following condition: 1. permanent atrial fibrillation (\>6 months) which has been considered unsuitable for ablation or failed ablation 2. narrow qrs ≤ 110 ms 3. severely symptomatic (atrial fibrillation-related symptoms), refractory to drug therapy for rate control 4. at least one hospitalization related to atrial fibrillation and/or heart failure in the previous year (see definition below) exclusion criteria: 1. new york heart association (nyha) class iv and systolic blood pressure \<80 mmhg despite optimized therapy; 2. severe concomitant non-cardiac disease; 3. need for surgical intervention; 4. myocardial infarction within the previous 3 months; 5. previous implanted devices (pm/icd/crt)

Keywords: atrial fibrillation heart failure catheter ablation cardiac resynchronization therapy implantable defibrillator
cardiac catheterization in the management of pediatric cardiac patients at a.u.c.h.

Conditions: Cardiac Disease

Summary: the aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in a.u.c.h , and record the outcome in these cases.

cardiac catheterization is of two types: diagnostic and interventional . there has been recent advances in these procedures.there is an over 10y experience at the pediatric cardiology unit in assiut university children hospital ( a.u.c.h ) catheterization department. the procedure usually follows other investigations used for evaluation of the pediatric cardiac patients e.g. chest x-ray , ecg and echocardiography. the role of cardiac catheterization may be in the diagnosis of congenital cardiac anomalies as well as in the follow up of repair of some cardiac anomalies . on the other hand, the indications for interventional cardiac catheterization may be repair of atrial septal defect, transposition of great arteries palliation with balloon septostomy ,blood vessel dilatation e.g. aortic stenosis and coarctation of the aorta . in addition patent ductus arteriosus closure and others may be done by the interventional cardiac catheterization.

Eligibility criteria:
inclusion criteria: -all cases admitted for cardiac catheterization for diagnosis or intervention at assiut university children hospital exclusion criteria: * cases not admitted for diagnostic or interventional cardiac catheterization
drug interaction study between dorzagliatin and empagliflozin

Conditions: Patients

Summary: this is a phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with t2dm. pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.


Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with t2dm within at least 3 months prior to screening 2. male and/or female subjects between the ages of 30 and 65 years, inclusive; 3. body mass index (bmi) of 19 to 38 kg/m2, inclusive, at screening; 4. fasting c-peptide test result \>0.3 nmol/l (\>0.90 ng/ml); 5. hba1c ≥7% and ≤10.5%; exclusion criteria: 1. fasting blood glucose at screening or day -1 ≤110 or ≥270 mg/dl ; 2. type 1 diabetes mellitus; 3. reported incidence of severe hypoglycemia within 3 months prior to screening; 4. known contraindications to empagliflozin; 5. clinically significant gastrointestinal disorder; 6. history or symptoms of clinically significant cardiovascular disease; 7. history of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months; 8. reported history of clinically significant central nervous system disease including within one year prior to screening; 9. reported history of liver disease; 10. reported history of clinically significant renal disease; 11. estimated glomerular filtration rate (egfr) ≤60 ml/min/1.73m2; 12. acute or chronic metabolic acidosis, including diabetic ketoacidosis; 13. known or suspected malignancy; 14. any reported hypersensitivity or intolerance to empagliflozin; 15. antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or glp-1 agonist within 3 months prior to screening; 16. systolic blood pressure \ 160 mmhg or diastolic blood pressure \ 100 mmhg at screening; 17. a hospital admission or major surgery within 90 days prior to screening; 18. uncontrolled hypertriglyceridemia \>500 mg/dl; 19. positive blood screen for hiv, hbsag, or hepatitis c antibody; 20. positive pregnancy test result; 21. treated with any investigational drugs within 6 weeks prior to screening; 22. reported history of prescription drug abuse; 23. reported history of alcohol abuse 24. reported history of donation or acute loss of blood during the 90 days prior to screening;
short and long term treatment with 4-ap in ambulatory sma patients

Conditions: Spinal Muscular Atrophy

Summary: the purpose of this study is to assess whether 4-ap (dalfampridine-er, ampyra) improves walking ability and endurance in adult patients with spinal muscular atrophy (sma) type 3 compared to placebo and whether the duration of treatment affects outcome.

spinal muscular atrophy (sma) is a genetically determined neuromuscular disorder that results in muscle weakness and impaired functional mobility. fatigue is a common symptom in sma with a resultant impact on physical function and quality of life however the precise mechanisms are unknown. at present there is no treatment for sma. there is evidence that 4-ap improves function in sma animal models. in patients with multiple sclerosis, 4-ap was found to improve walking ability and diminish fatigue. the purpose of the study is to determine whether treatment with 4-ap is associated with an increase in walking speed and endurance compared to placebo and whether the duration of treatment affects outcome. the study comprises a short term treatment trial in which participants are treated for 2 weeks with 4-ap and placebo in random sequence followed by a long treatment trial of 6 weeks in which patients are also treated with placebo and 4 ap. the primary outcome measure of the clinical study will be the six minute walk test (6mwt), which has been documented to be a valid and sensitive instrument to identify fatigue among ambulatory sma patients. we will also assess the effect of 4-ap on muscle and nerve electrical function via electromyography (emg) during the short term trial. results of this study may provide support for larger clinical trials.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 50 years at the time of enrollment 2. have genetically confirmed sma 3 (homozygous absence of smn1 exon 7) 3. ability to walk at least 25 meters without assistance 4. be free of major orthopedic deformities (i.e. scoliosis, contractures) 5. normal cystatin c clearance (\> 80 ml/min) exclusion criteria: 1. patients with a history of seizures 2. patients with any renal impairment 3. inability to comply with the study procedures 4. unstable medical illness 5. any ventilatory assistance 6. taking experimental medication for sma other than under this protocol 7. pregnancy or lactation 8. menstruating women, not sterilized or not using effective birth control 9. planning to undergo scoliosis surgery within the next 10 months 10. inability to give informed consent

Keywords: spinal muscular atrophy 4-aminopyridine dalfampridine ampyra
study of inhaled carbon monoxide to treat idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

idiopathic pulmonary fibrosis (ipf) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. there are currently no effective therapies for ipf. over the past two decades, preclinical studies of inhaled low dose carbon monoxide (co) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for ipf. co therapy has been well tolerated in phase i and phase ii human trials to date. this phase ii study is designed to investigate whether ipf patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (mmp7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

Eligibility criteria:
inclusion criteria: * adults above the age of 18 and equal to or below the age of 85 * diagnosis of ipf by biopsy or * american thoracic society (ats)/european respiratory society (ers)/ latin american thoracic association (alat) guidelines (am j respir crit care med vol 183. pp 788-824,2011) * forced vital capacity (fvc) greater than or equal to 50% predicted, greater than or equal to one month off all medications prescribed for ipf exclusion criteria: * evidence of active infection within the last month * significant obstructive respiratory defect * supplemental oxygen required to maintain an oxygen saturation over 88% at rest * history of myocardial infarction within the last year, heart failure within the last 3 years or cardiac arrhythmia requiring drug therapy * history of smoking within 4 weeks of screening * pregnancy or lactation * participation in another therapeutic clinical trial

Keywords: idiopathic pulmonary fibrosis ipf pulmonary fibrosis carbon monoxide
evaluation of efficacy and tolerability of hizentra®

Conditions: Primary Immunodeficiency Disorders

Summary: the purpose of this study is to measure the changes in the treatment satisfaction questionnaire for medication in the areas of effectiveness, side effects, and convenience of administration of each medication in primary immunodeficiency disorder (pidd) subjects transitioning from subcutaneous vivaglobin® to hizentra®.

this trial will evaluate subjects with primary immunodeficiency disorder (pidd) who are currently self-infusing vivaglobin therapy for at least six months prior to changing to hizentra® therapy. following screening and enrollment, subjects will continue to self-infuse vivaglobin® for seven infusions and then be converted to subcutaneous hizentra® treatment which they will continue for the next 6 months. the study will determine if hizentra® provides improved subject satisfaction by treatment satisfaction questionnaire for medication. diaries related to the local site reactions, the number of infusion sites per subject/per dose, volume of hizentra® per site, duration of infusions, systemic side effects of the new medication and dose on igg levels and antibody titers, and local site reactions with hizentra®.

Eligibility criteria:
inclusion criteria: * subjects currently self-infusing with vivaglobin® for at least six months prior to enrollment. * diagnosis of antibody deficiency due to primary immune deficiency disease. * stable serum igg levels of \> 550 mg/dl while on vivaglobin® based on two determinations at least 8 weeks apart and obtained within 6 months of entry. * willing to sign consent and follow study schedule. * 1 year to 75 years of age. exclusion criteria: * evidence of acute systemic illness or infection at within four weeks of screening or enrollment. * any serious grade 3 or greater toxicity at screening. * history of bleeding or chronic skin disorders. * selective iga deficiency in absence of other antibody deficiencies * history of anaphylactic or severe systemic reaction to vivaglobin. * pregnant or breastfeeding females. * use of systemic pre-medication prior to scig. * protein losing enteropathy or nephritic syndrome. * any condition that in the opinion of the investigator would interfere with the conduct of the study. * subject or guardian unwilling to sign consent or adhere to study schedule.

Keywords: immunodeficiency
plasmapheresis for nephrogenic fibrosing dermopathy (nfd)/nephrogenic systemic fibrosis (nsf)

Conditions: Nephrogenic Fibrosing Dermopathy; Nephrogenic Systemic Fibrosis

Summary: the purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (nfd)/nephrogenic systemic fibrosis (nsf).


Eligibility criteria:
inclusion criteria: * diagnosed with nfd/nsf following a kidney transplant * diagnosed with nfd/nsf following a liver transplant * nfd/nsf and who have not had a kidney or liver transplant * diagnosed with nfd/nsf and who have not had a kidney or liver transplant

Keywords: nephrogenic fibrosing dermopathy (nfd) nephrogenic systemic fibrosis (nsf)
msfc versus dam. a smartphone application for multiple sclerosis self-assessment.

Conditions: Multiple Sclerosis

Summary: multiple sclerosis functional composite score (msfc) is one of the gold standard for multiple sclerosis (ms) patient clinical evaluation. however, its practical implementation is not always optimal as it can prove to be very time consuming. moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status. a mobile application called digital self-assessment for multiple sclerosis (dam) was developed in order to replicate each of msfc tests available in order to assess ms progression in the patient environment.

patients are selected during a consultation at the neurology department of the pitié-salpêtrière hospital (france). each patient is given access to dam on their own or a provided iphone. during the enrolment visit, patients have to complete a msfc and dam evaluation (v0). through a push-notification on their phone, patients are reminded to perform two dam evaluations at home at days 30 (v1) and 60 (v2). at day 90 (v3), they have to come back to hospital for a second msfc and dam evaluation

Eligibility criteria:
inclusion criteria: * patients with an established diagnosis of multiple sclerosis according to the macdonald criterias whatever the progression stage, that are monitored by dr. maillart as part of her consultation at the neurology department of the pitié-salpêtrière hospital. * patients with an iphone (at ios 8 or higher). * patients age ≥18 years. * patients with an initial score of edss between 0 to 6.5 * no attack since at least 1 month * last solumedrol injection at least 1 month ago exclusion criteria: * patients who are not capable of using a smartphone application. * patients who do not have the capacity to give their consent. * patients who do not speak french * patients who are bedridden or with a daily activity of less than 2 hours per day * patients with acute asthenia * patients experiencing an attack once enrolled in the study (will be considered as dropouts)

Keywords: dam multiple sclerosis msfc application smartphone
therapeutic efficacy of cutaneous application of postbiotic n-(1-carbamoyl-2-phenyl-ethyl) butyramide (fba) in pediatric subjects affected by atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (sm), which normally contributes to maintaining skin integrity and modulating host inflammatory responses. this alteration leads to a lower production of butyrate, a short-chain fatty acid capable of reducing skin permeability by improving barrier integrity, performing a trophic effect on the skin and suppressing local inflammatory responses. furthermore, a reduction of butyrate in patients with ad has also been demonstrated at the intestinal level. conventional therapy for ad consists of eliminating exacerbating factors, applying emollients and in exacerbations, or in moderate/severe forms, applying topical steroids or topical calcineurin inhibitors. the possibility of using emollients containing substances physiologically present in the skin, such as butyrate, could represent a safe treatment strategy, capable of reducing exacerbations and therefore the evolution towards moderate-severe forms of ad. on the basis of these premises, the bupad study aims to evaluate the therapeutic efficacy of the cutaneous application of a butyrate releaser, the postbiotic n-(1-carbamoyl-2-phenyl-ethyl) butyramide (fba) in a cosmetic formulation, in children affected by ad.


Eligibility criteria:
inclusion criteria: * both sexes; * age: 6-36 months * caucasian ethnicity * diagnosis of atopic dermatitis * written informed consent of parents/legal guardians exclusion criteria: * age \ 36 months * non-caucasian ethnicity * skin infections * ichthyosis * food allergies * chronic systemic diseases * congenital heart defects * tuberculosis * autoimmune disorders * immunodeficiency * inflammatory bowel disease * celiac disease * cystic fibrosis * metabolic disorders * neoplasms * chronic pulmonary disorders * gastrointestinal tract malformations * respiratory tract malformations * intake of systemic prebiotics/probiotics/synbiotics/immunomodulators 4 weeks prior to enrollment * treatment with topical immunomodulators (tacrolimus or pimecrolimus) within 3 months prior to enrollment * use of topical or systemic corticosteroids or calcineurin antagonists or phototherapy within the previous 4 weeks * investigator uncertainty about the subject's willingness or ability to comply with protocol requirements * participation in any other study involving investigational or marketed products concurrently or within two weeks prior to study entry hypersensitivity to any component of the investigational product * absence of written informed consent
remote ischemic preconditioning induces myocardial risk signaling pathway in patients undergoing valvular heart surgery

Conditions: Patients With Elective Aortic Valve Replacement

Summary: the aim of this study is to investigate whether ripc protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium


Eligibility criteria:
inclusion criteria: * patients aged ≥20 years with severe degenerative as presenting concentric remodeling of the lv, who were scheduled for avr exclusion criteria: * diabetes mellitus, * coronary stenosis ≥70%, * renal failure (serum creatinine \> 2.0 mg/dl), * upper arm peripheral vascular disease, * lv ejection fraction \<50%

Keywords: remote ischemic preconditioning cardiac surgery left ventricular hypertrophy reperfusion injury salvage kinase