Kornimate/medical-research-clean huggingface dataset:
electronic archive of patients with congenital heart disease and diagnosis of infective endocarditis

Conditions: Congenital Heart Disease (CHD); Infective Endocarditis (IE)

Summary: the objective of the study is to create an electronic archive in which to census all newly diagnosed or already diagnosed cases of infective endocarditis and congenital heart disease after 01 january 2022 at the irccs aou bologna pediatric and developmental age cardiology center so that be able to describe the clinical and echocardiographic features in patients with congenital heart disease and infective endocarditis in this population in order to be able to define new diagnostic/epidemiological hypotheses and the identification of predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital heart disease and ei.

it is well known in the literature that in patients with congenital heart disease, the risk of developing infective endocarditis (ie) is higher than in the general population with significant variation according to the underlying heart disease.it is essential to identify patients with congenital heart disease at higher risk of developing infective endocarditis and its related complications.therefore, it is necessary to study the case history of patients with infective endocarditis and heart disease congenital heart disease (analysis of clinical-instrumental data, medical history, comorbidities, the cardiovascular adverse events and population mortality). the objective of the study is to create an electronic archive in which to census all newly diagnosed or already diagnosed cases of infective endocarditis and congenital heart disease after 01 january 2022 at the irccs aou bologna pediatric and developmental age cardiology center so that be able to describe the clinical and echocardiographic features in patients with congenital heart disease and infective endocarditis in this population in order to be able to define new diagnostic/epidemiological hypotheses and the identification of predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital heart disease and ei.

Eligibility criteria:
inclusion criteria: * patients with congenital heart disease and established diagnosis of infective endocarditis referred to the uo cardiology and pediatric cardiac surgery dell'irccs aou of bologna from 01/01/2000 until to approval (retrospective phase) and from approval until at least 31/12/2027 (prospective phase) * obtaining informed consent for participation in the study exclusion criteria: * no one
high dose atorvastatin for preventing periprocedural ischemic brain damage during carotid artery stenting

Conditions: Carotid Artery Stenosis

Summary: the purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a daily (qd) from 3 days before to 3 days after cas, then 20 mg qd until 30 days after cas) is superior to conventional-dose atorvastatin treatment (20 mg qd from 3 days before to 30 days after cas), in terms of efficacy for prevention of periprocedural ischemic brain damage in chinese patients undergoing cas.

chinese patients with carotid stenosis scheduled for selective cas will be randomized into two groups. the high-dose atorvastatin group will receive atorvastatin 80 mg qd from 3 days before to 3 days after cas, then 20 mg qd until 30 days after cas, while the conventional-dose atorvastatin group will receive atorvastatin 20 mg qd from 3 days before to 30 days after cas. all patients will receive cerebral diffusion-weighted (dw)-mri within 7 days before cas. then, they will also receive repeated dw-mri within 5 days after cas. efficacy for prevention of periprocedural ischemic brain damage of the two different atorvastatin treatments will be compared, in terms of periprocedural incidence of transient ischemic attack (tia)/ ischaemic stroke or new ischemic lesions on cerebral dw-mri.

Eligibility criteria:
inclusion criteria: * ≥ 50% stenosis of internal carotid artery in symptomatic patients; or ≥ 70% stenosis of internal carotid artery in asymptomatic patients * received statin therapy for ≥ 2weeks before inclusion exclusion criteria: * nonatherosclerotic carotid disease (dissection, radiation-induced stenosis) * received endovascular procedure within 30 days before inclusion * cas during the procedure of urgent endovascular therapy for acute ischaemic stroke * need for oral anticoagulant therapy * high risk of bleeding or contraindications to antiplatelet therapy (eg: platelet count \<70 x 109/l) * active hepatic disease or hepatic dysfunction, or aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 1.5 upper normal limit * myopathy or increased creatine kinase (ck) \> 2 upper normal limit * renal failure with serum creatinine (scr) \> 3 mg/dl or 264μmol/l * unable to undergo mri because of claustrophobia or pacemaker * pregnancy, lactation, or child bearing potential women without any effective contraception

Keywords: atorvastatin
postoperative adjuvant therapy of donafenib for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Adjuvant Therapy

Summary: this study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent hepatocellular carcinoma. this is a multicenter, randomized controlled study.


Eligibility criteria:
inclusion criteria: * participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization * high risk of recurrence as assessed by tumor characteristics * without any anti-tumor therapy before surgery, except preoperative tace therapy, traditional chinese medicine therapy and interferon therapy * child-pugh class a statu * ecog performance status of 0 or 1 * ct/mr confirmed no recurrence or metastasis at ≥4 weeks after surgery * expected survival time of no less than 3 months exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc * evidence of residual or a history of spontaneous tumor rupture * recurrent hcc * prior received liver transplantation * prior anti tumor therapy for treatment of hcc (including sorafenib or any other molecular therapy, anti-pd-1 antibody and other immunotherapies, folfox systemic chemotherapy) is excluded * afp does not return to normal 4 weeks after operation

Keywords: hepatocellular carcinoma adjuvant therapy
acgh impacts survival in plasma cell ptld

Conditions: Post-transplantation Lymphoproliferative Disorders

Summary: plasma-cell post-transplantation lymphoproliferative disorders (pc-ptld) are rare monomorphic ptld divided into plasma cell myeloma (pcm) and plasmacytoma-like lesion (pll) ptld. to date, there is no exhaustive published cytogenetic data on pc-ptld. the investigators report array-based comparative genomic hybridization (acgh) of 10 cases of pcm and pll-ptld.


Eligibility criteria:
inclusion criteria: * who classification 2008 as monomorphic pcm (plasma cell myeloma) or pll (plasmacytoma like lesion) / ptld (post transplantation lymphoproliferative disorders). exclusion criteria: * other than pcm or pll ptld at diagnosis
follow-up of patients with curative-intent surgical resection for nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: the guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (nsclc).no international consensus is published concerning follow-up of resected nsclc patients.recent studies have outlined that positron emission tomography (pet) scanning may be accurate in early detection of recurrences by comparison to computed tomography (ct). the aim of this study is to compare follow-up by conventional methods versus pet. patients are randomly assigned to two arms. in the first arm, thorax ct with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. in the second arm, pet scanning is only. for brain metastasis detection, ct is performed in the two arms. recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. pet and ct are interpreted separately by two nuclear physicians and two radiologists. the direct cost of follow-up procedure is determined in the two groups. the calculated sample is composed of 60 patients in each arm to detect significant difference. the ethics committee of universitary hospital of limoges approves the study.


Eligibility criteria:
inclusion criteria: * all patients who underwent resection for nsclc * informed consent exclusion criteria: * patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells. * patients with non-resected nsclc or with metastasis * patients who have previous malignancy, except basal cell carcinoma of the skin -

Keywords: lung cancer, 18 fdg, pet
clinical investigation of galnobax® for the treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to determine safety and efficacy of a new gel formulation of esmolol hydrochloride (galnobax®) for the treatment of diabetic foot ulcer (dfu). the study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in galnobax treated groups versus placebo group.

this is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase i/ii study of galnobax® in subjects with diabetic foot ulcers. additionally the effect of dosage and frequency of application will also be studied . the total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * subjects aged 18 to 95 years, inclusive, with type 1 or type 2 diabetes undergoing therapy for glycemic control * subjects having below knee ulcer of at least 4 week and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons * ulcer should be clinically non-infected * ulcer area (length x width) measurement between 1.5 cm2 and 10 cm2, inclusive and post debridement ulcer area less than or equal to 12 cm2. * full-thickness ulcer of grade 1 or grade 2 as per wagner's classification system * recently debrided ulcer (2 weeks prior to screening) and post debridement ulcer free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining, comprised of healthy vascularized tissue as determined by the investigator * inability to perceive 10 grams pressure using semmes-weinstein 5.07 monofilament in the peri-ulcer area * ankle brachial index between 0.7 and 1.2 exclusion criteria: * actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis. * subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the investigator * glycosylated hemoglobin (hba1c) \>12% * diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications * subject diagnosed with cancer undergoing chemotherapy * revascularization surgery 4 weeks prior to signing the icf * renal failure as defined by serum creatinine \>3.0 mg/dl or renal insufficiency requiring frequent dialysis * poor nutritional status as measured by serum albumin \<3.0 g/dl * active charcot or other structural deformity that would prevent adequate off-loading of the study foot

Keywords: diabetic foot ulcer diabetic wound chronic non healing ulcer
selective caries vs stepwise caries removal technique in deep carious lesions

Conditions: Caries

Summary: the aim of this clinical study is to compare and evaluate the success of selective caries vs stepwise caries removal techniques in treatment of dental caries.

the patient will be selected as per the pre-defined eligibility criteria. written informed consent will be taken from each consenting participant. initial caries excavation will be done under rubber dam isolation. the patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. composite restoration with glass ionomer liner will be then placed in both groups. additional complete caries excavation will be done in the stepwise caries removal group after six months.

Eligibility criteria:
inclusion criteria: * outpatient in age range of 18yr-60yr * permanent mandibular posterior teeth with deep caries * caries extending to \>3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph * positive response to cold test and electric pulp test exclusion criteria: * any general disease affecting the caries e.g. patient under head and neck radiotherapy * patients with immuno-compromised status * tooth with fracture line, cracks.
preventing injuries in young football players

Conditions: Injury Prevention

Summary: football is the most popular sport in the world, with 260 million male and female active participants, including \~113,000 fifa registered professional players. playing football is fun and can provide many health benefits, however, it also presents a high injury risk. studies on elite and non-elite footballers have reported similar injury rates in both genders. the most common football-related injuries are the knee and ankle ligament and thigh muscle strains, over the past two decades, significant advancement has been made in the field of injury prevention in football. there are used trials to prevent specific injuries, as ankle sprain, acl injuries, hamstring strains, etc. on the other hand, there are created programs designed to prevent a wider spectrum of injuries like fifa11+. therefore, the aim of this study is to investigate the effect of a new injury prevention program on the overall injury incidence in young football players.


Eligibility criteria:
inclusion criteria: officially registered football club in the football federation of kosovo players must be between 13-19 years old regular training must take place at least three times per week exclusion criteria: teams already using an injury prevention program injured players
concept: crossover efficacy pain trial in motor cortex stimulation for intractable neuropathic pain

Conditions: Pain, Intractable; Facial Pain

Summary: the concept study has been designed to evaluate the safety and the efficacy of motor cortex stimulation (mcs) with a new cortical lead (circular lead, eight electrodes, medtronic inc, minneapolis, usa) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (cpsp) and trigeminal neuropathic pain (tgn)/facial pain.


Eligibility criteria:
inclusion criteria: * cpsp or tgn/facial pain refractory to other medical treatments * pain \> 1 year prior to baseline * pain intensity with an average daily vas score \> 5 demonstrated by 12 ratings across 4 days * stable pain medication for \> 1 month prior to baseline exclusion criteria: * cpsp with important paresis/severe motor deficit in the area of pain * tgn/facial pain with complete deafferentation pain * atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified * pain associated with malignant neoplastic disease anywhere in the body or head * history of epilepsy * presence of a deterioration of cognitive functions

Keywords: motor cortex stimulation pain treatment central post-stroke pain (cpsp) trigeminal neuropathic pain (tgn) facial pain neurostimuation cortical lead neuropathic pain
urine extracellular vesicles: non-invasive biomarkers of β-cell function and novel therapeutic agents in diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Summary: diabetes mellitus is a common chronic disease with a huge socioeconomic burden worldwide. type 1 diabetes(t1d) accounts for nearly 95% of diabetes in pediatric age and a lifelong dependence on exogenous insulin. its diagnosis is based on symptoms and/or autoantibodies, both identified too late to avoid the disease progress. ideally, children should be screened whilst assymptomatic, when there is endogenous insulin production, but c-peptide and beta-cell function are starting to decline. early diagnosis would allow interventions capable of preventing disease progress and/or to preserve beta-cell function, ultimately delaying/avoiding insulin dependence. given their association with pathogenesis of diabetes, extracellular vesicles have emerged as potential biomarkers for diagnosis and progression of diabetes. this project proposes the development of a non-invasive biomarker of preclinical t1d, based on mirna characterization in urine, allowing a timely identification of children that can benefit from preventive therapies and, in the future, to cure t1d.


Eligibility criteria:
inclusion criteria: * t1d group: children diagnosed with t1d, according to internationally defined criteria, with at least one positive pancreatic antibody and under functional insulin. * genetic-related group: children without t1d, age- and sex-matched with t1d group, recruited among t1d relatives; * control group: children without t1d, age- and sex-matched with t1d group, recruited from general endocrinology clinics, among children without disease or genetic relation with t1d children; exclusion criteria: * obesity, according to who standards for pediatrics; * hypertension, as ≥95th percentile according to international consensus; * other auto-immune diseases; * diabetes in the context of syndromic features/secondary to treatments; * hypothyroidism, adrenal insufficiency or hypercortisolism; * children under somatotropin/oncologic treatment; * under medications affecting glucose metabolism

Keywords: non-invasive biomarker of beta cell function in urine
the safety and efficacy of 5-ht3 receptor antagonist (ramosetron) for the treatment of fecal incontinence

Conditions: Fecal Incontinence

Summary: this clinical trial aims to assess the effectiveness of ramosetron compared to psyllium, a gold standard therapy, in patients with fecal incontinence. the primary questions it seeks to answer are: 1. does ramosetron improve the symptoms of fecal incontinence? 2. is ramosetron superior to psyllium in terms of symptom improvement and its impact on quality of life? participants will be randomly assigned to one of two groups, either taking ramosetron or psyllium for one month. they will be asked to complete a questionnaire. researchers will then compare the fecal incontinence severity index between the ramosetron and psyllium groups to determine whether ramosetron provides superior symptom relief compared to psyllium.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with fecal incontinence (patients with 2 or more symptoms of fecal incontinence per month for at least 3 months). 2. patients who are able to understand and comply with this study. 3. individuals who are agreeable to being on contraception for the duration of the study. exclusion criteria: 1. patients who have difficulty swallowing medications 2. patients with gastrointestinal deformities due to surgery 3. patients with malabsorption 4. patients with inflammatory bowel disease (ibd) 5. patients undergoing treatment for cancer of the gastrointestinal tract 6. patients who are allergic to the study drug 7. patients with overflow incontinence and fecal impaction on rectal residual examination (dre) or bristol stool scale of 3 or less. 8. patients taking medication for fecal incontinence within 1 month of study entry. 9. pregnant or lactating women. 10. patients with contraindications to any of the study drugs (i.e., intestinal obstruction, intestinal stones, acute abdomen, undiagnosed abdominal pain/nausea/vomiting, gastrointestinal stenosis and dysphagia, patients with megacolon syndrome, severe diabetes, etc.). 11. patients taking an agent that is contraindicated in combination with either study drug. 12. patients deemed by the investigator and staff to be unsuitable for participation in the study.
the study on effects of acute exposure to high altitude hypoxia on cognitive function in lowlanders

Conditions: Cognition

Summary: the purpose of this study is to investigate the impact of rapid elevation to 3,800 meters on the cognitive function of low-altitude residents through a plateau field and plain control study, and explore the objective indicators related to the impaired cognitive function.

this study intends to recruit 60 healthy young people residing in plain area to 3000 m. participants were divided into two groups: the plateau group (n=30) and the plain group (n=30). firstly, we collected baseline data one week before the plateau group rushed to the plateau, and then repeated the above data collection at the same time on day 1 (3-5 hours after arrival), day 2, day 3, day 5, and day 7 after entering the plateau. the plain group was studied in the plain according to the same test plan. finally, analyze and find out the main types of cognitive impairment, and explore the physiological prediction index, including exploring the characteristics of eeg changes before and after entering the plateau.

Eligibility criteria:
inclusion criteria: * lived in plain, never entered the plateau exclusion criteria: * patients with epilepsy, migraine, brain injury, stroke and other neuropsychiatric diseases; * central nervous system drugs; * history of heart or head surgery; * mmse score \< 25; * patients suffering from pulmonary heart disease, chronic obstructive pulmonary disease, emphysema, pulmonary embolism and other serious respiratory diseases; * patients with negative resistance to the study and poor compliance.