Kornimate/medical-research-clean huggingface dataset:
high-intensity interval training recuperates capacity of endogenous thrombin generation in patients with heart failure

Conditions: Heart Failure; High-intensity Interval Training

Summary: consumptive coagulopathy is associated with increased mortality in patients with heart failure (hf). physical activity influences the risk of major vascular thrombotic events. this study investigates how high-intensity interval training (hiit) affects the capacity of endogenous thrombin generation (tg) by modulating circulatory procoagulant microparticles (mps) in hf patients. thirty-eight hf patients and 38 age- and gender-matched normal counterparts (nc) were recruited into this study. the hf group performed hiit (3-min intervals at 40% and 80%vo2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks, whereas the nc group did not receive any form of intervention. plasma tg kinetics, procoagulant mps, coagulation-related factors, and oxidative stress/proinflammatory status were analyzed. the results demonstrated that the hf group exhibited (i) less endogenous thrombin potential (etp) and tg rate, (ii) lower concentration/activity of tissue factor (tf) and counts of tf-rich mps derived from blood cells, and (iiii) higher vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations, compared to the nc group did. however, hiit elevated plasma etp and tg rate, as well as, tf concentration/activity and blood cell-derived procoagulant mp levels in the hf patients. moreover, the exercise regimen also decreased vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations in patients with hf. hence, we conclude that hf reduces the capacity of endogenous tg in plasma, which is associated with decreased (or consumed) circulatory procoagulant mp levels. however, hiit alleviates hf-declined endogenous tg capacity and vascular endothelial damage through recuperating tf-related coagulation activity and suppressing oxidative stress/proinflammatory status.


Eligibility criteria:
inclusion criteria: * the hf was diagnosed if the patients had a left ventricular ejection fraction (lvef) \<40%. * all hf patients were new york heart association (nyha) functional class ii or iii and had received optimal treatment for at least 12 months according to american heart association/american college of cardiology guidelines. exclusion criteria: * patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (\<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.

Keywords: heart failure exercise microparticles thrombin
evaluating the feasibility of a web-app for pelvic floor health in pregnant women in the ferrol health area: the wapruin study

Conditions: Pregnancy; Pelvic Floor Disorder

Summary: this study aims to evaluate the feasibility of using a web-based application to improve pelvic floor health in pregnant women within the ferrol health area, spain. the intervention involves providing educational resources through a user-friendly digital platform, designed to empower women with knowledge about pelvic floor function and techniques for strengthening it during pregnancy. the study hypothesizes that a web-based educational tool can effectively increase awareness, engagement, and adherence to pelvic floor exercises among pregnant women, thereby contributing to improved maternal health outcomes. participants will include pregnant women from the ferrol health area, who will voluntarily use the application during their pregnancy. the study will assess outcomes related to usability, accessibility, and participant satisfaction with the application, as well as any improvements in pelvic floor-related health indicators. by addressing an important gap in maternal health education, this project has the potential to provide an innovative and scalable solution to enhance prenatal care.


Eligibility criteria:
inclusion criteria: * pregnant women attending their first prenatal consultation at the hospital arquitecto marcide. * pregnant women who voluntarily consent to participate in the study by signing the informed consent form. exclusion criteria: * pregnant women who do not have proficiency in the spanish language. * limitations in using the web-app (e.g., physical, cognitive, or technological barriers). * lack of internet access.
post-market clinical study of the cardiofocus endoscopic ablation system - adaptive contact (cf-eas-ac) for the treatment of symptomatic atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to confirm the safety and effectiveness of the cardiofocus endoscopic ablation system with adaptive contact in the treatment of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * symptomatic, paroxysmal atrial fibrillation (af) * 18 to 70 years of age * others exclusion criteria: * generally good overall health as determined by multiple criteria * willing to participate in a study * others
a study of human th-sc01 cell injection for treating perianal fistulas in patients with crohn's disease

Conditions: Perianal Fistula; Crohn's Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of human th-sc01 cell injection for the treatment of perianal fistulas in crohn's disease

this study is a phase 1, single-arm, safety and tolerability study of human th-sc01 cell injection for perianal fistulas in crohn's disease.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. subjects with crohn's disease diagnosed at least 6 months earlier according to the chinese consensus opinion on the diagnosis and treatment of inflammatory bowel diseases (beijing, 2018). 3. subjects with active perianal fistula and non active luminal cd defined by a cdai ≤ 200. 4. subjects with perianal fistula confirmed by clinical assessment and mri. 5. subjects aged between 18 and 70, both male and female. 6. all subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial. 7. subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (tnf-α) monoclonal antibodies and other biological agents. exclusion criteria: 1. subjects with active infection evaluated by the investigator. 2. subjects with crohn's disease requiring immediate therapy. 3. subjects with abscess or collections \>2 cm. 4. subjects with rectal and/or anal stenosis and/or active proctitis. 5. subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration. 6. subjects with abnormal laboratory results: liver function: total bilirubin \>=1.5 × uln, and aspartate aminotransferase (ast) and alanine aminotransferase (alt) \>=2 × uln; renal function: creatinine clearance below 60 ml/minute calculated using cockcroft-gault formula or by serum creatinine \>=1.5 × upper limit of normal (uln). 7. subjects with malignant tumors or a history of malignant tumors. 8. subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases. 9. serum virology test (hbeag, hcv antibody, hiv antibody, treponema pallidum antibody) positive. 10. subjects allergic to gentamicin sulfate, anesthetics or contrast media. 11. subjects allergic to mri contrast. 12. subjects who has received stem cells in a previous clinical study or as a therapeutic agent. 13. subjects who has major surgery or severe trauma within 6 months prior to the screening period. 14. subjects who has received any investigational drug within 3 months prior to the screening. 15. subjects deemed inappropriate by the investigator to participate in this clinical trial. 16. the female participant who is pregnant, or is lactating.
the fibrin patch soft tissue study

Conditions: Hemostasis

Summary: the effectiveness objective of this study is to evaluate whether fibrin patch is superior to surgicel™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.


Eligibility criteria:
inclusion criteria: * subjects \>= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures * presence of an appropriate soft tissue target bleeding site (tbs) as identified intraoperatively by the surgeon * subjects must be willing to participate in the study, and provide written informed consent exclusion criteria: * subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure * subject with tbs within an actively infected field * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine * subjects with known intolerance to blood products or to one of the components of the study product * subjects unwilling to receive blood products * subjects with immunodeficiency diseases (including known hiv) * subjects who are known, current alcohol and / or drug abusers * subjects who have participated in another investigational drug or device research study within 30 days of enrollment * female subjects who are pregnant or nursing
healthcare-associated links in transmission of nontuberculous mycobacteria in cystic fibrosis

Conditions: Cystic Fibrosis; Nontuberculous Mycobacterium Infection

Summary: sources of ntm infection and modes of transmission among cf patients are poorly understood. healthcare-associated transmission of ntm among cf patients has been suspected and is of growing concern for cf centers. there is a need for a systematic evidence-based approach to investigating potential episodes of healthcare-associated transmission. clusters of highly similar strains of ntm in cf patients cared for at the same cf center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from water sources within a healthcare setting. the primary objective of the study is to facilitate a standardized process by which cf centers may perform data abstraction on patients identified with highly similar ntm isolates and determine if clustered ntm strains are related to strains isolated from healthcare setting water biofilm sources. halt ntm is available to the entire cf foundation care network, under a collaborative agreement, to initiate a standardized, independent, confidential, internal ntm outbreak investigation. patients that are identified by whole genome sequencing as having highly similar ntm strains and receiving care in the same cf care center are eligible. the study's primary endpoint is to identify potential modes and sources of healthcare-associated acquisition of cf ntm, thereby revealing risk factors for ntm acquisition.


Eligibility criteria:
inclusion criteria: * participants with cystic fibrosis and respiratory ntm growth on one or more occasions exclusion criteria: * participants without cystic fibrosis * participants without pulmonary ntm growth
a study of end of dose phenomena in subcutaneous natalizumab treated multiple sclerosis (ms) participants

Conditions: Multiple Sclerosis

Summary: the primary objective of this study is to better understand the pathophysiological background of end-of-dose symptoms (eod) and thereby determine the percentage of participants who develop eod under natalizumab (ntz) as an example of interval therapy in ms and to detect specific changes through multimodal analyses, including radiological, blood and digital health measurements, that may be used as potential biomarkers in the future to map eod.

participants will additionally be offered to record daily activity and sleep patterns as well as heart rate for the duration of the study.

Eligibility criteria:
key inclusion criteria: * diagnosed relapsing-remitting multiple sclerosis (rrms) according to 2017 revised mcdonald criteria * initiation of treatment with sc ntz according to summary of product characteristic (smpc) and in accordance to national guidelines or * continuing treatment with iv ntz * owns and be able to handle a smartphone key exclusion criteria: * participants with an acute ms relapse and/or a history of intravenous corticosteroid treatment within past six weeks * any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia * diagnosis of primary or secondary progressive ms * additional immunosuppression except of natalizumab note: other protocol defined inclusion/exclusion criteria may apply.
racz catheter technique versus conventional technique in lumbar epidural steroid injection for management of low back pain

Conditions: Racz Catheter; Conventional; Lumbar; Epidural; Steroid Injection; Low Back Pain

Summary: the aim of this study is to compare racz catheter technique and conventional technique in lumbar epidural steroid injection for the management of low back pain.

low back pain (lbp) is defined as a localized discomfort sensation below the costal margin and above the inferior gluteal folds, with or without leg pain. conservative treatment for lbp is focused on delaying or preventing the need for surgery. indeed, lbp can improve spontaneously or with non-surgical treatment. however, cases that fail to improve with conservative management may need to be considered for a surgical approach. the epidural injection is a well-founded anesthetic and analgesic technique; moreover, nowadays, new technological devices can help anesthesiologists to learn and to administer it. one of these devices is racz catheter epidural adhesiolysis. racz catheter epidural adhesiolysis treatment addresses two issues, the injectate always reaches the area being targeted also the injections are likely to loosen fibrotic adhesions which may be the main cause of the pain in some cases.

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years. * both sexes. * patients suffering from persistent lumbar pain, grade 1 spondylolisthesis, facet osteoarthropathy, and small disc on radiological findings. exclusion criteria: * uncooperative patients. * contraindications to perform the proper technique e.g., coagulopathy and skin infection. * history of allergy to contrast medium. * rupture disc. * lumbar canal stenosis. * previously operated traditional spine surgeries.
arthroereisis with corrective osteotomy versus arthroereisis alone in management of symptomatic flexible pes planovalgus in adolescents

Conditions: Pes Plano Valgus

Summary: arthroereisis ,corrective osteotomies, flexible pes planovalgus, adolescents


Eligibility criteria:
inclusion criteria: * cases complaining of flexible pes planovalgus non responsive for conservative treatment and cases with generalized ligamentous laxity exclusion criteria: * neurological disorders and rigid peaplanovalgus
a research study looking at how oral semaglutide works in people with type 2 diabetes in the united kingdom, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower their blood sugar levels. participants will get rybelsus® as prescribed by the study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor. participants will be asked to complete some questionnaires about their diabetes treatment. participants will complete these during their normally scheduled visits with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available glycated haemoglobin (hba1c) value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (visit 1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (visit 1) if in line with local clinical practice * treatment naïve to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of 14 days or less. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
incidence and prognostic value of delirium in patients with acute coronary syndromes

Conditions: Delirium

Summary: the purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a intensive care unit patients.

the present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Eligibility criteria:
inclusion criteria: * admission in cardiac intensive care unit * age ≥ 65 years exclusion criteria: * none
effect of the natural sweeteners erythritol and xylitol on vascular function in obese volunteers

Conditions: Obesity

Summary: sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. both substances are already in use in the food industry and are freely available. since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. a pilot study recently undertaken in the us (flint n, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. in this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.


Eligibility criteria:
inclusion criteria: * obese volunteers (bmi \> 30kg/m2) * aged 18- max. 55 years * otherwise healthy. exclusion criteria: * known cardiovascular disease * diabetes mellitus * smoking and drug abuse * arterial hypertension with antihypertensive treatment * dyslipidaemia with statin therapy * known chronic hepatic disease (nash, hepatitis). * known renal disease: kidney failure * pregnancy * chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract * substance abuse, alcohol abuse. * inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (german).
verifynow® prutest® cardiovascular population expected values on-drug study

Conditions: Coronary Disease; Platelet Aggregation

Summary: the purpose of this study is to determine the range of expected prutest values in patients in the intended use population receiving dual antiplatelet treatment with aspirin and prasugrel (effient®), or ticagrelor (brilinta®).

the on-drug reference range study will be performed by measuring venous blood samples in duplicate collected from patients receiving prasugrel (effient®), or ticagrelor (brilinta®). subjects must be on aspirin at the doses prescribed by their treating physician. when possible, venous blood samples may be collected in conjunction with routine laboratory testing, to minimize the number of needle sticks for the subject. alternatively, samples may be collected separately to complete the study. a cbc measurement must be performed for each enrolled subject from a sample collected at the time of blood draw or within ± one week and tested at a certified laboratory. samples for prutest collected in conjunction with a cbc must be drawn after the prutest sample. up to 130 subjects will be enrolled in the study to facilitate collection of the minimum number of blood samples needed to determine the on-drug reference range of prasugrel (effient®), or ticagrelor (brilinta®).

Eligibility criteria:
inclusion criteria: * • males and females 18 years and older * able and willing to provide written informed consent. * current treatment with aspirin (any dose). * have a planned or scheduled percutaneous coronary intervention (pci) with the potential to receive treatment with prasugrel (effient®), or ticagrelor (brilinta®) following an oral loading dose or on maintenance treatment for a minimum of seven days who may have symptomatic cerebrovascular disease (transient ischemic attack or following a thrombotic stroke) or cardiovascular disease. exclusion criteria: * • unable to provide written informed consent. * currently receiving an investigational antiplatelet agent. * gp iib/iiia therapy (reopro®, integrilin®, aggrastat®) within the past 2 weeks. * received any therapy containing dipyridamole (persantine®, aggrenox®) within the past 2 weeks. * women who may be pregnant or are of child bearing potential

Keywords: aggregation platelet p2y12 inhibitor aspirin
drug management of juvenile idiopathic arthritis in covid-19 context : impact on therapeutical managment

Conditions: Juvenile Idiopathic Arthritis; COVID 19; Treatment

Summary: the current situation of sars-cov-2 pandemic generates fears in the general population. among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. juvenile idiopathic arthritis is concerns by these fears (the patient and their parents). patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. the present study will characterize this issue by defining the proportion of patients whose usual treatment of juvenile idiopathic arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.


Eligibility criteria:
inclusion criteria: * juvenile idiopathic arthritis satisfying edmonton criteria * ongoing dmard therapy or ains for 3 months exclusion criteria: * inhability to consent