Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy evaluation of chondron compared with mircrofracture of knee

Conditions: Defect of Articular Cartilage; Articular Cartilage Disorder of Knee; Degeneration; Articular Cartilage, Knee

Summary: the purpose of this study is to evaluate safety and efficacy of chondron(autologous cultured chondrocyte) by comparing between chondron implantation and microfracture.

it is an open clinical trial. among the patients who received autologous cartilage cell graft using chondron (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. during the clinical trial period, the subjects should follow the instruction of clinician in charge. hospital visit is total 2 times\* regularly. at the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, mri test, and x-ray. if the selection time and the visit time are same, hospital visit will be one time\*.

Eligibility criteria:
inclusion criteria: - 1. patients who underwent autologous chondrocyte implantation using chondron (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago. 2. patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form exclusion criteria: - 1. patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial. 2. patients who underwent autologous chondrocyte implantation applying chondron (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.

Keywords: chonodron microfracture autologous cultured chondrocyte cartilage defect of knee
lyr-210 depot (lyr-210) for adult subjects with chronic sinusitis (lantern study)

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Summary: this is a phase ii, randomized, blinded, sham procedure-controlled, parallel-group trial to evaluate the efficacy, safety and tolerability of lyr-210 in adult subjects with chronic sinusitis.

lyr-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (mf) pre-loaded in a single use applicator. lyr-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. once in place, each lyr-210 drug depot is designed to gradually deliver sustained topical doses of mf to the inflamed mucosal sinus tissue over 24 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of cs. * two trials of medical treatments for cs in the past. * minimum cs symptom score. * ability to tolerate topical anesthesia. * has been informed of the nature of the study and has provided written informed consent as approved by the institutional review board (irb)/ethics committee (ec) of the respective clinical site. * agrees to comply with all study requirements. exclusion criteria: * have undergone previous sinus surgery. * pregnant or breast feeding. * known history of hypersensitivity or intolerance to corticosteroids. * history or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis. * known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range. * had dental procedure/implant on maxillary dentition within 4 weeks of the screening visit. * past or present functional vision in only one eye. * has cataracts * past, present, or planned organ transplant or chemotherapy with immunosuppression. * currently participating in an investigational drug or device study
identification of a multi-analyte profile for primary hyperoxaluria and comparison with healthy siblings and idiopathic hypercalciuria

Conditions: Primary Hyperoxaluria Type 1; Idiopathic Hypercalciuria

Summary: the aim of this study is to know the difference between protein profiles (multi-analyte profile) of ph1 patients, idiopathic hypercalciuria (ih) patients and ph1 patients 'siblings. idiopathic hypercalciuria is a less severe kidney disease that ph1, which also leads to the formation of kidney stones. the aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (ph1) that will significantly improve clinical diagnosis and prognosis.


Eligibility criteria:
inclusion criteria: * diagnosed with primary hyperoxaluria, type 1 (ph1-cohort a); or * confirmed with agxt mutation analysis (ph1-cohort a) * diagnosed with idiopathic hypercalciuria (ihc- cohort b); * potential subject diagnosed with ph1 or ih and has both data entered into the registry and has matched, archived random and 24-hour urine specimens obtained prior to any treatment intervention or is consented and enrolled into the registry or this specific study during the program; * healthy siblings of ph1 patients known not to have ph or any another stone disease or chronic disease will be consented and enrolled into this study through the local sites where their sibling is being treated for ph1 (this study meets the criteria for expedited review through local or central irbs); * healthy non-sibling controls known not to have ph or any another stone disease or chronic disease (healthy control-cohort c); * there is no upper or lower limit to the pediatric age range of enrolling infant, children and adolescent subjects, although it is understood that accurate and complete 24-hour urine collection in very young children and infants will be problematic and will be seriously considered in advance of individual patient or healthy controls enrollment; * egfr (glomerular filtration rate) \> 60 ml/min x 1.73 m2 with ph1 and ih patient cohorts matched by mean egfr from their initial study (or registry) enrollment/ data collection. exclusion criteria: * unwilling to provide written parent consent or adolescent assent to enroll into the international registry or this study; * potential ph1, hypercalciuria, or siblings of ph1 patients with other chronic or acute illness or disease that could potentially confound proteomic results; * healthy intra-familial siblings unwilling to provide a blood sample for serum creatinine; * unwilling to provide urine specimens or permit data abstraction for the registry or this study. * not covered by, or having the right to, social security
clinical and mechanistic study of patients (with covid-19 or not) with a recent acrosyndrome

Conditions: Adult Patients With Lesions on Fingers or Toes

Summary: the recent and unexpected occurrence of patients with the development of skin lesions on the hands and/ or feet has been described recently. as these cases occurred contemporaneously with the coronavirus disease 2019 (covid-19) and as it was the most often occurrence of de novo frostbites, the question raised of whether there is a direct link between the occurrence of these lesions and infection of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) the responsible for covid-19. indeed, mechanisms of these lesions and the precise correlation with sars-cov-2 remains poorly understood. therefore, this study aim to: 1. determine the possible link with this virus, 2. understand the mechanisms involved in the pathogenesis of these lesions.

in this study, the investigator designed a prospective interventional study in order to collect blood samples and skin lesion biopsy at significant time points in patients who present a skin lesion. the intervention in this study is limited to some blood samples and skin biopsies. two 7 ml tubes of blood will be collected at consultant time for essentially serological test for the sars-cov-2 and for analysing certain populations of white blood cells. the second additional blood sample of 7 ml will be collected around day 15 after inclusion in a dry tube to perform a serological test for sars-cov-2 at a distance from the onset of skin signs. a biopsy for histological study is usually done in patients with acrosyndrome. this is why this type of biopsy will be done as a routine care of these patients. an immunohistochemical study could complete the histological explorations using an anti-coronavirus antibody if arguments in favour of sars-cov-2 are demonstrated. in this study, patients who accept and sign informed consent will be proposed a skin biopsy on a characteristic lesion for freezing. this biopsy can be used for transcriptomic analysis. this may allow a better understanding of the mechanisms of the disease.

Eligibility criteria:
inclusion criteria: * adult patients * consultant for the recent occurrence of lesions on the fingers and or toes * having signed an informed consent * affiliated or entitled to a social security regime exclusion criteria: * patients under guardianship or under curate * patients under state medical assistance

Keywords: sars-cov-2 covid-19 acrosyndrome skin lesions
evaluation of therapeutic management in esbl-infected patients or carriers by providing and sharing a free tool - the "esbl toolkit"and interventional study of a prospective cohort of hiv+ patients searching for possible sexual transmission factors in esbl carriers

Conditions: AIDS Patients

Summary: bacterial resistance to antibiotics is a major public health problem. the epidemiology of enteric bacteria including e. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (esbl), responsible for resistance to almost all penicillins and cephalosporins. the resistance is up to 75% for quinolones, 67% for cotrimoxazole and 30-50% for aminoglycosides. the main phenomena causing this problem are: * the selection pressure by antibiotics, in their use in humans or animals * the hand transmission via the digestive reservoir (faeces) * easy spread of resistance mechanism in enterobacteriaceae due to transferable genetic support (plasmid) in this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with esbl in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices. the objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of esbl bacteria in the paca region and liguria by providing a tool : the "kit esbl". the " esbl toolkit" (also translated into italian) includes: * information on epidemiological data * a checklist edited for extra-hospital use (private practitioners, health care units other than hospitals) * a checklist edited for hospital use * a leaflet bmr for the patient explaining the problematic as well as hygiene measures * therapeutical protocols for hospital use and extra hospital use * an sample letter for the attending physician the objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on: * the prescription of appropriate antibiotics * the measures taken to prevent man to man transmission * the quality of information provided to the patient in this context we are also performing a multicentre prospective interventional cohort of hiv+ patients searching for possible sexual transmission factors in esbl (extended-spectrum ß-lacatamase-producing bacteria) carriers. we will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to esbl carriage. so far there is no data documented on esbl-carriage in a population of hiv-positive patients.


Eligibility criteria:
inclusion criteria: * age \> 18 * hiv+ patient of the hospital's outpatient clinic * signature of informed consent * affiliation of the social security system exclusion criteria * vulnerable persons: minor patient, wardship (tutelage), no liberty to act and speak * pregnancy and lactation: a urine pregnancy test will be performed for women of childbearing age. results will be reported by the physician selected by the patient
klhl14 expression as predicting factor of invasiveness in pitnet

Conditions: Invasiveness, Neoplasm

Summary: objective: the objective of this study is to evaluate the correlation between klhl14 expression and its cytoplasm-nuclear localisation and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions. this is a multicenter and multidisciplinary study, with the involvement of the departments of neurosurgery of the university of naples federico ii and the department of biosciences of the university of teramo.

the investigators would like to analyse the possible correlations between the expression, the cytoplasm-nuclear localisation and the activity of the protein klhl14 and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions. this study will be conducted on biological sample collected during surgery and primary cellular line derived from those samples. patients refer to neurosurgery for the detection of pituitary adenomas with various presenting symptoms that can be correlated to hormone production or to mass effect produced by the lesion on the optic apparatus or on the oculomotor nerves after invasion of the cavernous sinus. all patients undergo an ophthalmological clinical examination to define the presence of visual alteration and endocrinological assessment to determine eventual hormone hypersecretion. finally, radiological exams, as magnetic resonance of the sellar region, are performed on patients to evaluate the extension of the pathology, its relationship to the surrounding neurovascular structures and therefore guide neurosurgical resection which is typically performed via an endoscopic endonasal transsphenoidal approach. except for prolactin secreting pituitary adenomas, for which medical therapy with dopaminergic agonists is a viable approach, surgery with adenoma resection represent the gold standard for treatment.

Eligibility criteria:
inclusion criteria: * adult men or women (age 18-70) * patients affected by nonfunctioning pituitary adenomas. exclusion criteria: * prisoners * pregnant women * patient under 18 years * patients without capacity of discernment.
compression of left main coronary artery in patients with pulmonary arterial hypertension asymptomatic for angina

Conditions: Pulmonary Arterial Hypertension

Summary: the prevalence of critical ab extrinsic compression of left main coronary artery (lmca) is very high in patients with pulmonary arterial hypertension (pah) symptomatic for angina (up to 40% according to a recent study of 121 patients with pah). the element that most of all correlates with the degree of coronary stenosis is the diameter of the pulmonary artery (pa). in particular, a diameter ≥ 40 mm has a sensitivity of 83% and a specificity of 70% in patients with angina. critical stenosis of lmca is a risk factor for sudden death and in these condition percutaneous coronary angioplasty with stent implantation has proven to be a safe and effective long-term procedure. preliminary data from a retrospective analysis of the registry of patients with pah in bologna (arca registry, 109/2016/u/oss) highlights that even in pah patients asymptomatic for angina, compression of lmca can occur in up to 13% of patients and the main predictive parameter of compression was found to be a diameter ≥ 42 mm (with a sensitivity of 87% and a specificity of 77%). performing a screening test by coronary-ct scan in all subjects suffering of pah with a pa diameter ≥ 40 mm even if asymptomatic for angina could therefore help to identify patients with pah at increased risk for sudden death at an early stage.


Eligibility criteria:
inclusion criteria: * patients with pah (group 1 of world health organization pulmonary hypertension classification) who have undergone at least one pulmonary ct angiography with a pa trunk diameter ≥ 4 cm * age ≥18 years * asymptomaticity for angina pectoris or anginal equivalent exclusion criteria: * severe chronic kidney disease \[chronic kidney disease epidemiology collaboration (ckd-epi) estimated glomerular filtration rate \<30 ml/min) or need for dialysis * major allergy to iodinated contrast agent * intolerance or allergy to acetylsalicylic acid or clopidogrel * history of stroke or transient ischemic attack in the last 6 months or a history of intracranial haemorrhage * known cerebral arteriovenous malformation or aneurysm * known moderate or severe hepatic insufficiency (child pugh b or c) * thrombocytopenia (\<100.000/μl) or anemia (hemoglobin \<10 g/dl) * active bleeding or factors which, in the investigator's judgment, significantly increase the risk of bleeding * major surgery in the past 30 days * cancer in the active phase * pregnancy or breastfeeding * patient prognosis \<1 year in the opinion of the investigator * any condition that increases the risk of non-compliance or of being lost to follow-up * patients who have already undergone a lmca angioplasty * failure to obtain informed consent
prediction model of treatment efficacy for age-related macular degeneration based on multi-source imaging modalities

Conditions: Age-related Macular Degeneration (ARMD)

Summary: age-related macular degeneration (amd) is one of the main causes of blindness in the elderly population. intraocular injection of anti-vegf drugs for neovascular amd (namd) is the main treatment method at present. however, patients have different responses to anti-vegf therapy, and some patients do not respond well to short - and long-term treatment. in this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of namd in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of namd patients. by verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. its clinical application value was evaluated by calibration curve and decision curve. in addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. the purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for namd.


Eligibility criteria:
inclusion criteria: * patients diagnosed with namd by ophthalmic examinations including oct, octa, ffa and icga; * complete clinical data and imaging data of patients were available at baseline, 3 months and 1 year after anti-vegf treatment. exclusion criteria: * medical records showed other diseases affecting visual function or fundus imaging, such as macular edema, glaucoma, ocular trauma, etc; * medical records showed that two or more macular lesions coexist in the affected eye; * medical records showed that patients received other treatments within 1 year of anti-vegf therapy, such as intraocular laser therapy or ocular surgery; * medical records showed that there were ocular media opacity, dense macular hemorrhage, or severe macular atrophy, resulting in the inability to accurately measure the required parameters; * medical records showed the use of drugs known to cause retinal toxicity, or a history of radiation exposure.
effect of a booster dose of the japanese encephalitis vaccine ic51

Conditions: Japanese Encephalitis

Summary: the objective is to assess the effect of a booster vaccination on immunogenicity of ic51 in terms of seroconversion rate.


Eligibility criteria:
main inclusion criteria: * healthy adults who completed the primary immunization in study ic51 309 * male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test main exclusion criteria: • history of immunodeficiency or immunosuppressive therapy, known human immunodeficiency virus (hiv), or drug addiction including alcohol dependence
efficacy of an early rhythmic intervention in infancy

Conditions: Language Development; Language Development Disorders; Infant Development; Intervention

Summary: the present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity. specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). this intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. the efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. the efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. in addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention. the investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.


Eligibility criteria:
inclusion criteria: * healthy infants aged between 6 and 9 months * infants with and without familial risk for language disorders (infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders. * both parents are native-italian speakers exclusion criteria: * gestational age \< 37 weeks and/or birth-weight \< 2500 grams * apgar scores at birth at 1' and 5' \< 7 * bayley cognitive score \< 7 * presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.