Kornimate/medical-research-clean huggingface dataset:
observe the effectiveness and safety of ranibizumab in real life setting

Conditions: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion; Wet Age Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Summary: this study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.


Eligibility criteria:
inclusion criteria: * adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label * willing and able to provide informed written consent personally or by legal proxy exclusion criteria: * simultaneous participation in a study that includes administration of any investigational drug or procedure * systemic or ocular treatment with any vegf inhibitor other than ranibizumab in the 90 days prior to enrollment * other protocol-defined inclusion/exclusion criteria may apply

Keywords: ophthalmology, age-related macular degeneration, diabetic macular edema, retinal vein occlusion, ranibizumab ophthalmology age-related macular degeneration diabetic macular edema retinal vein occlusion luminous ranibizumab
multicenter cohort study of aav in hunan of china

Conditions: ANCA Associated Vasculitis

Summary: this study aimed to explore the incidence of anti-neutrophil cytoplasmic antibody (anca）-associated vasculitis (aav) progression and its association with adverse consequences. it will enroll approximately 500 aav patients in hunan province of china and follow-up for at least 5 years. demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. the principal clinical outcomes of the study consist of end stage renal disease (esrd) and death.

the study is a multicenter prospective cohort study, aimed to explore the incidence of aav and its progression and association with adverse consequences. the study will establish a baseline cohort of 500 aav patients in hunan province of china. the follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up. the baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. the laboratory parameters of chemistry test. after the baseline visit, participants will return annually for follow-up visits and evaluation. the evaluating items of follow-up visits are similar to the baseline visit, and sample collection. the principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. death is further clarified as cardiac, infectious, renal, others, or unknown.

Eligibility criteria:
inclusion criteria: * fulfill 2012 criteria of anca associated vasculitis and agree to sign informed consent exclusion criteria: * do not agree to sign informed consent

Keywords: anca associated vasculitis esrd outcome
tocilizumab and covid-19 : risk of severe infection

Conditions: Covid19

Summary: sars-cov2 is responsible for a pandemic that has been evolving for approximately 18 months. the virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. the initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. a large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. although dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. the widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (sarilumab and tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. a possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. the objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of tocilizumab according to the severity of the patients.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * french-speaking patient * patient with covid-19 documented by pcr test or chest ct scan exclusion criteria: * no confirmation of suspected covid-19 * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his/her data for this research
drug-drug interaction study between edp-938, tacrolimus, dabigatran, rosuvastatin and midazolam in healthy subjects

Conditions: RSV Infection

Summary: a non-randomized, open-label, three-part, drug-drug interaction study to evaluate the effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the pharmacokinetics and safety of edp-938 in healthy subjects


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 90 days after the last dose of edp 938. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * participation in a clinical trial within 30 days prior to the first dose of study drug. * for part 1 subjects: * clinical history or evidence at screening consistent with hyperkalemia, hypertension and/or diabetes mellitus * for part 2 subjects: * clinical history or evidence at screening of medically significant bleeding * history of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (sle), or recurrent spontaneous abortions * a platelet count \ uln, or aptt \> uln at screening * ongoing daily use of nonsteroidal anti-inflammatory drugs * for part 3 subjects: * ast and/or alt \>uln at screening * for part 4 subjects: * history of glaucoma

Keywords: drug-drug interaction
pharmacokinetic study comparing tiotropium easyhaler and spiriva handihaler

Conditions: Healthy Subjects

Summary: absorption of inhaled tiotropium is compared between three tiotropium easyhaler products and spiriva capsules inhaled via handihaler. all subjects will receive all products as a single dose.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects * 18-60 years old * body mass index \>19 and \<30 kg/m2 * weight at least 50 kg * written informed consent obtained exclusion criteria: * evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease. * any condition requiring regular concomitant treatment. * any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject. * known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose. * pregnant or lactating females and females of childbearing potential not using proper contraception. * blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration
hydration status assessment through body composition monitoring in patients with acute myocardial infarction

Conditions: Dehydration; Acute Myocardial Infarction; Renal Artery Stenosis

Summary: aims: * evaluate the hydric status through bioimpedance spectroscopy in consecutive acute myocardial infarction patients referred for primary pci; * assessment of renal artery stenosis incidence through renal angiography in consecutive stemi patients; * fully characterize the complex hydration, metabolic and endothelial profile of these patients in the attempt to define the role played by dehydration in the complex dynamics of acute myocardial infarction.

gathered data: * descriptive general demographic data; * previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - cabg, known renal disease); * cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia); * routine biological data; * metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue; * information regarding primary pci (less than 12 hours of ischemic symptoms); * coronarographic details, type of used stent, periprocedural specific complications, final timi - thrombolysis in myocardial infarction - flow); * echocardiography at admission (lvef); * renal arteries angiographic details performed in the same time with pci (two independent operators evaluate stenosis based on a predefined scale); * renal diameters; * measurement of arterial stiffness through sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial); * in-hospital and one month follow-up mace.

Eligibility criteria:
inclusion criteria: * adults with st elevation myocardial infarction (\<12h) diagnostic confirmed; * included in the romanian national programme of primary percutaneous revascularisation (for who the guidelines recommend primary pci); exclusion criteria: * patients who do not sign informed consent for primary pci

Keywords: dehydration primary pci acute myocardial infarction bioimpedance renal angiography
short-term prognosis evaluation of transient ischemic attack patients using abcd2 score

Conditions: Ischemic Attack, Transient

Summary: the purpose of this study is to determine whether the abcd2 score can be used in patients with transient ischemic attack, admitted to beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.

the feasibility of risk stratification of patients with acute transient ischemic attack admitted to beijing anzhen hospital by the abcd2 score system is yet to be determined. the aim of this paper was to evaluate and validate the short-term prognosis of tia patients in peking area using this new score system.

Eligibility criteria:
inclusion criteria: * every patient admitted to beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour. * magnetic resonance imaging negative on dwi(no fresh infarction). * old infarction or not the criminal infarction. exclusion criteria: * patients with hemorrhage stroke were excluded.

Keywords: tia prognosis evaluation management
human umbilical-cord-derived mesenchymal stem cell therapy in ischemic cardiomyopathy

Conditions: Chronic Ischemic Heart Disease; Heart Failure; Angina

Summary: phase i-ii clinical trial-safety and efficacy of umbilical cord derived mesenchymal stem cells (uc-mscs) in patients with chronic heart ischemia cohort and perspective study.

phase i-ii clinical trial-safety and efficacy of umbilical-cord-derived mesenchymal stem cell (uc-msc) in patients with chronic heart ischemia cohort and prospective study. forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. the patients who are willing to receive stem cell transplantation will receive uc-mscs by coronary injection. the patients in control group will not receive any intervention. every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects. the day of infusion will be considered day zero. from that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months. clinical results will be analyzed after completion of 12 months of followup.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 y * no option for pci or cabg (angiographies evaluated by an independent interventional cardiologist). * maximal tolerable angina and heart failure medication * nyha functional classification (i-iii) * signed informed consent exclusion criteria: * severe liver or renal dysfunction or hemorrhagic diseases not suitable for pci. * severe cerebral ischemic stroke or cerebral hemorrhage within 6 month. * history with malignant disease within 5 y of inclusion or suspected malignity * severe heart failure (nyha functional classification iv) * diminished functional capacity for other reasons such as copd, alcoholic cardiomyopathy, or viral myocarditis * clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia * clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment * patients with reduced immune response or treated with immunosuppressive medication * combined with severe infectious diseases * pregnant or fertile women * socially and mentally disabilities

Keywords: cellular therapy chronic ischemic heart disease phase 1/2 clinical study human umbilical cord mesenchymal stem cell ischemic heart disease allogeneic stem cell transplantation
usefulness of a telemedicine system for osa patients follow-up with high cardiovascular risk

Conditions: Sleep Apnea, Obstructive; Obstructive Sleep Apnea Syndrome

Summary: the aim of this study is to determine the usefulness of a telemedicine system for the follow-up of osa patients with a high cardiovascular risk. our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.

the obstructive sleep apnea syndrome (osas) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. the continuous positive airway pressure is the gold standard treatment for osas. it consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. cpap treatment reduces cardiovascular morbi-mortality. osas is associated with cardiovascular mortality. a dose response effect exists between severity and arterial blood pressure. a recent meta-analysis has shown in unselected osas patients with or without hypertension, treated or non-treated for hypertension, cpap reduces 24 h ambulatory blood pressure of approximately 2 mmhg. this decrease corresponds to a significant reduction in cardiovascular risk. the aim of the present study is to include osas patients with a high cardiovascular risk and to measure the effect of cpap on home measurements of arterial blood pressure. this controlled randomized trial will compare the effect cpap on arterial blood pressure in a group with a telemedicine system versus a group with standard home care cpap treatment. an interim analysis will be carried out when 100 patients have been included in the study.

Eligibility criteria:
inclusion criteria: * 18 to 85 years old men and women * stable patient * bmi\<40kg/m² * osa patients diagnosed with polysomnography or polygraphy * score\>5% and/or cardiovascular disease pas history : * transient ischemic attack, stroke, cerebral haemorrhagy * myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism exclusion criteria: * central sleep apnea syndrome * score\<5% * cardiac failure * past history of hypercapnic chronic respiratory failure * past history of severe or intercurrent pathology which can not allow the patient follow-up * incapacitated patients in accordance with article l 1121-6 of the public health code * patients taking part in another clinical trial

Keywords: obstructive sleep apnea syndrome score telemedicine arterial blood pressure daily physical activity
melatonin for delirium prophylaxis

Conditions: Delirium

Summary: delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. this neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions. a critical precipitating and maintaining feature of delirium is disrupted sleep. melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. there is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. we hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.


Eligibility criteria:
inclusion criteria: * 65 years of age or greater * admitted to hospital under the care of the hospitalist service or sub-acute medicine wards. exclusion criteria: * those who are suspected to be delirious at the time of their initial presentation; * those who are already taking melatonin prior to admission; * those who are not expected to live more than 48 hours; * those suffering severe dementia (as indicated by a score of 6-7 on the global deterioration scale adapted by dr. doug drummond from reisberg et al. (reisberg 1982); * those who are unable to reliably take oral medications; * those presenting with an intracranial bleed, seizure or acute stroke; * those with a known allergy or adverse reaction to the study compounds; * those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate; * those anticipated to require surgery early in their hospitalization.

Keywords: melatonin sleep delirium
how side effects of avonex are affected by gradually increasing to full dose vs starting at full dose

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this study is to find out if starting at low dose avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of avonex treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of clinically-definite relapsing-remitting multiple sclerosis exclusion criteria: * any product information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy * use of avonex, but not other interferon therapies, in the 3 months prior to randomisation into the study * a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation. * history of seizure in the 3 months prior to randomisation * history of suicidal ideation or severe depression within the 3 months prior to randomisation. * other inclusion and exclusion criteria may apply per study protocol

Keywords: multiple sclerosis avonex side effects flu like symptoms
vitamin k2 intervention in patients with vitamin k antagonists

Conditions: Thrombosis

Summary: the objective of the safe k study is to demonstrate that in patients treated with the antagonists of vitamin k (vka), a daily intake of vitamin k2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.in addition, the study evaluates if regular consumption of vitamin k2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.

randomisation of the study subjects will be done by two randomisation lists depending on whether the dose of vka is high or low. randomisation will be balanced and stratified depending on the average dose of vka before the inclusion in order that each arm would have the same number of patients receiving a dose lower than the used anticoagulant treatments. the level of vitamin k intake will be determined during the study visits using dietary questionnaire.

Eligibility criteria:
inclusion criteria: * treated with anticoagulants * inr range between 2-3 * ttr (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion exclusion criteria: * consumption of significant amounts of products conatining vitamin k * regular consumption of dietary supplements susceptible to contain vitamin k * milk intolerant or refusing a daily consumption of dairy product * previous insufficient earlier therapeutic vka follow-up * cardiac, renal or severe respiratory insufficiency, diseases interfering fat absorption, significant abnormalities in safety parameters, clinically significant thrombotic or hemorrhagic event

Keywords: anticoagulant therapy inr vitamin k2 vitamin k antagonist
safety and efficacy of seroquel in first episode schizophrenia

Conditions: Schizophrenia

Summary: to compare the safety, tolerability and efficacy of seroquel and risperidone in first episode schizophrenia


Eligibility criteria:
inclusion criteria: * age 18-35 years meet icd-10 criteria for schizophrenia no abnormaility on clinical examination no previous episode of psychosis no previous antipsychotics of any kind in last 3 months exclusion criteria: * have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures have received anticholinergics within 10 days of baseline aseessment have received mood stabilizers or anti depressants within 2 weeks

Keywords: schizophrenia