Kornimate/medical-research-clean huggingface dataset:
a study to assess the incidence of skin cancers in patients with epidermolysis bullosa receiving filsuvez

Conditions: Epidermolysis Bullosa, Dystrophic; Epidermolysis Bullosa, Junctional

Summary: in patients with epidermolysis bullosa (eb), collagen does not form properly, so their skin is very fragile and blisters easily. such patients are also at greatly increased risk of developing skin cancers. filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of eb. in this observational study, patients with either dystrophic eb (deb) or junctional eb (jeb) will receive standard of care treatment, whether filsuvez or something else, and will be followed for up to 5 years. the main purpose is to see if the use of filsuvez affects the likelihood of developing skin malignancies in these patient populations.

some forms of eb are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma (scc), as well as increased incidence of other skin malignancies including basal cell carcinoma (bcc) and malignant melanoma (mm). this long-term non-interventional study will assess all types of skin malignancies (scc, bcc, and mm) in deb and jeb patients. it is an observational study of real-world treatment practices, in which patients will receive standard of care therapy whatever that may entail. data will be obtained from two sources: clinical study centers in the european union (eu) and the united kingdom (uk), and pre-existing eb registries in the eu. participants will be followed for up to 5 years, and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking filsuvez.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of dystrophic eb or junctional eb exclusion criteria: * none

Keywords: filsuvez birch bark extract
respiratory drive in patients with univentricular congenital heart disease

Conditions: Univentricular Heart; Children, Adult

Summary: the aim is to evaluate the correlation between the respiratory control to hypercapnia at rest and the ve/vco2 slope measured during cardiopulmonary exercise testing. the hypothesis is that patient with univentricular congenital heart disease have a increasing of respiratory drive like chronic heart failure. this increasing of respiratory drive could participate in the increasing of ve/vco2 slope measured during cardiopulmonary exercise testing and in the genese of central apnea index during the sleep.

the patients with univentricular congenital heart disease will perform : * a cardiopulmonary exercise testing with measure ve/vco2 slope, * a measure of the respiratory drive to hypercapnia with occlusion pressure during the rebreathing with at rest (p0,1/petco2). * a polysomnography with a scoring of central apnea index. correlation will be evaluate between p 0,1/petco2 with ve/vco2 slope and between p0,1/petco2 central apnea index.

Eligibility criteria:
inclusion criteria: * functionally univentricular congenital heart disease * age ≥ 8 years * consent of the adult patient or the parents or legal guardians of the minor patient. * beneficiary of the social security scheme exclusion criteria: * size \<120 cm (minimum size for the stress test) * medical contraindication to exercise test or presence of : myocardial infarction less than 3 months old, unstable angina, uncontrolled severe arrhythmias, symptomatic aortic stenosis, uncontrolled heart failure, pulmonary embolism, evolutionary phlebitis, pericarditis, myocarditis, progressive endocarditis, aortic dissection * unstable patient with severe intellectual disability or complex pathology making polysomnography impossible * pregnant woman

Keywords: univentricular congenital heart sleep apnea polysomnography respiratory drive ve/vco2 slope
efficacy of silver diamine fluoride and its parental perception

Conditions: Dental Caries in Children

Summary: this randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (cpp-acp) in arresting dental caries in children.

the present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (sdf) in arresting dentin caries lesions when compared to mi varnish a 5% sodium fluoride varnish which also contains recaldent™\* (cpp-acp): casein phosphopeptide-amorphous calcium phosphate. for this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: group (1) sdf and group (2) mi varnish. each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents. parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of sdf before their involvement by written consent. the international caries detection and assessment system (icdas ii) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a who probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.

Eligibility criteria:
inclusion criteria: 1. normal healthy children without any systemic disease asa 1 physical status. 2. children with at least one carious dentin lesion in their primary teeth, code 5 (icdas ii) exclusion criteria: 1. children who suffer from major systemic diseases and require long term medications. 2. children refuse the study intervention. 3. children with silver or milk product sensitivity. 4. presence of any gingival or perioral ulceration or stomatitis. 5. tooth with abscess, fistula or severe pain.
study on structum® in adult patients with osteoarthritis (trust)

Conditions: Osteoarthritis, Knee

Summary: chondroitin sulfate (cs) is a sysadoa and a natural biomacromolecule belonging to the class of glycosaminoglycans. cs is a major component of the extracellular matrix (ecm), where it constitutes an essential component of proteoglycans. to this date, no real-world studies have been conducted to precisely describe the burden associated with oa among patients treated with cs.therefore, an observational, descriptive, prospective, national study will be conducted to describe the burden associated with oa and the quality of life of patients treated with structum® in poland.

this is an observational, descriptive, national, multicentric, prospective, longitudinal study, which will be conducted over a 6-month follow-up period for each patient. the study will not provide or recommend any specific treatment or procedures. all patients affected by oa in the knee, for whom structum® is prescribed in a participating center, will be screened in a consecutive manner for eligibility. the study will focus exclusively on patients with oa in the knee as this is the joint most frequently affected and most easily assessed for oa patients. two additional data collections can be anticipated for these patients as part of their standard of care follow-up visits, which will usually occur around 3 and 6 months after the initial study visit.the patient enrolment period is expected to be 6 months, with a total study duration of 12 months.

Eligibility criteria:
inclusion criteria: * male or female patients aged 50 to 80 years at inclusion * of knee oa (either a patient newly diagnosed \[at inclusion\] or with history of knee oa) based on at least the following items 1 and/or 2: 1. knee pain lasting for at least 3 months; 2. patient in the active phase of knee oa disease (knee pain score ≥ 40mm at inclusion on the visual analog scale \[vas\] 0-100 mm); 3. knee radiographs showing knee joint narrowing and/or osteophytes. * patients who have been prescribed, for the first time or not, structum®. * if patient is taking any nsaids or other analgesics, patient could be on stable dose at least one week before inclusion to the study. * patients able to visit the clinic and attend follow-up visits. * patients having signed an informed consent form, according to local regulations. exclusion criteria: * patients with any ongoing chondroitin sulfate treatment at inclusion or during the last 3 months. * plasma (in the last 3 months). no glucocorticoids administration in the last 3 months before inclusion. that does not include nsaids, paracetamol and other analgesic medications (e.g. tramadol). * patients with an artificial knee joint, including unilateral. * patients scheduled to undergo knee replacement surgery in the next 6 months. * patients with a severe general condition that prevents them from being included in the study as assessed by the investigator. * patients participating in interventional trials on investigational drugs at the time of inclusion.
clinical pharmacology study of mra in patient with rheumatoid arthritis (ra) with renal impairment

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, clinical pharmacology study to evaluate the safety and pk of mra in patients with ra with renal impairment.


Eligibility criteria:
inclusion criteria * patients who are diagnosed with ra according to the 1987 acr (american college of rheumatology) classification criteria * patients with ra at least 6 months prior to enrollment * patients with a creatinine clearance not less than 10 ml/min but no higher than 80 ml/min exclusion criteria * patients with class iv steinbrocker functional impairment at enrollment * patients who are undergoing dialysis * patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
resuscitation decisions in the emergency department (ed)

Conditions: Resuscitation

Summary: the investigators will retrospectively examine the connection between resuscitation decisions of admitted patients at the ed of the university hospital of basel and several demographic and health related measures. additionally there will be an examination, which patient characterestics may have lead to patients not having been asked about resuscitation decisions.


Eligibility criteria:
inclusion criteria: * patients admitted to the emergency department (duration of hospitalisation more than 24 h). * patients with a research consent "yes". exclusion criteria: * patients being discharged within less than 24 hours. * patients with a research consent "no".

Keywords: resuscitation decision
ai-driven cancer diagnosis and prediction with ehr

Conditions: Tumor

Summary: this is a multi-center, clinical study designed to evaluate the application and effectiveness of an ai-assisted predictive model for identifying and diagnosing cancer, leveraging multimodal health data.

cancer diagnosis and early detection are crucial for improving patient outcomes and survival rates. early identification of cancers and appropriate intervention can significantly impact treatment success and prognosis. in clinical practice, oncologists often need to integrate a variety of patient data, including medical history, laboratory test results, imaging data such as ct scans and mris, and genetic markers, to make an accurate diagnosis and develop a personalized treatment plan. as precision medicine becomes increasingly important, the challenge remains to identify cancer at early stages, especially when symptoms are subtle or absent. recent advancements in artificial intelligence and data analysis techniques have shown great promise in enhancing the diagnostic accuracy and speed of cancer detection. this study aims to develop an ai-assisted decision-making system by integrating multimodal data from electronic health records, imaging, laboratory results, and genetic data. the objective is to improve diagnostic accuracy, optimize clinical workflows, and provide more personalized treatment options for cancer patients. ultimately, this system seeks to improve early detection, guide effective treatment strategies, and enhance patient survival rates.

Eligibility criteria:
inclusion criteria: 1、patients with comprehensive electronic health records (ehrs), including medical history, laboratory test results, imaging data, and genetic data (if available). 2. individuals without severe cognitive impairments or conditions that would prevent them from providing informed consent or participating in the study. 3. parents or guardians must provide informed consent for minors, while adult participants must provide informed consent for themselves. exclusion criteria: 1. patients with incomplete or missing key electronic health record data or insufficient follow-up data. 2. individuals with severe cognitive disorders or other terminal illnesses that would prevent meaningful participation. 3. pregnant women (although pediatric cancers are being considered, pregnant women would be excluded for safety reasons).

Keywords: tumor early disease prediction ai-assisted diagnosis
endoscopic robot-assisted simple enucleation versus standard robot-assisted partial nephrectomy in the treatment of t1 renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(erase) and standard robot-assisted partial nephrectomy(rapn) in the treatment of t1 renal cell carcinoma.

simple enucleation (se) consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue, which appears to reserve more renal parenchyma without compromising oncologic safety, may be an alternative to standard partial nephrectomy (pn). although published studies showed excellent long-term oncologic results, many urologists still consider se an unsafe technique with a high risk of incomplete tumor excision. the aim of this study is to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(erase) and standard robot-assisted partial nephrectomy(rapn) in the treatment of t1 renal cell carcinoma.

Eligibility criteria:
inclusion criteria: 1. patients with sporadic, unilateral, newly diagnosed t1 presumed renal cell carcinoma 2. ecog score \<=1 3. renal score \<=9 4. patients with normal contralateral renal function 5. patients giving consent to the participation in the current clinical trial exclusion criteria: 1. intolerance of robotic surgery 2. metastastic renal cell carcinoma 3. renal score \>=10 4. entry into collection system or hematuria 5. patients with a history of other renal diseases, such as urinary lithiasis 6. patients with a history of renal surgery
an investigational drug study to treat respiratory symptoms associated with respiratory syncytial virus (rsv) bronchiolitis (0476-272)

Conditions: Bronchiolitis

Summary: the purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of rsv bronchiolitis in children 3 to 24 months of age.


Eligibility criteria:
inclusion criteria: * hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of rsv-induced bronchiolitis. approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined respiratory severity score as required by the study. exclusion criteria: * asthma or other wheezing disorder. the primary investigator will evaluate whether there are other reasons why a child may not participate.

Keywords: rsv bronchiolitis
prophylactic vs therapeutic anticoagulation in symptomatic isolated distal deep vein thrombosis

Conditions: Venous Thrombosis

Summary: the efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (iddvt). the latest antithrombotic therapy for vte disease guideline suggested using the same anticoagulation as for patients with acute proximal dvt in patients with acute iddvt. however, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic iddvt of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.


Eligibility criteria:
inclusion criteria: * patients aged 18-90 * outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal dvt * compliance to the scheduled follow up plan * ability and willing to participate and sign the informed consent. exclusion criteria: * any absolute contraindication to anticoagulant treatment * pregnancy or breast-feeding * systolic pressure \> 180 mmhg or diastolic pressure \> 100 mmhg * platelet count \< 100 × 10⁹ /l * serum creatinine \> 180 mmol/l or creatinine clearance ≤30 ml/min * liver disease associated with coagulopathy and high risk of bleeding * clinically suspected or confirmed pulmonary embolism * ipsilateral or contralateral proximal dvt * any indication for long-term anticoagulation * enrolled in another clinical trial simultaneously * life expectancy \< 6 months
enhancing donated after cardiac death (dcd) utilization with thrombolytic therapy

Conditions: Liver Transplantation; Kidney Transplantation

Summary: we hypothesize that delayed graft function and itbs events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. treatment of the dcd organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

the waiting list for kidney and liver transplantation continues to increase in the united states, and therefore the need grows for additional donor organs. utilization of organs donated after cardiac death (dcd) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (itbs). we hypothesize that delayed graft function and itbs events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. treatment of the dcd organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older * subjects willing/able to provide written consent * subjects willing/able to comply with study requirements * subjects who will receive a solitary organ transplant exclusion criteria: * subjects requiring multi-organ transplants * women who are pregnant * subjects with current severe systemic infection * subjects with an active infection
efficacy study of everolimus on renal function in heart transplant recipients with established chronic renal failure

Conditions: Cardiac Transplantation; Chronic Renal Insufficiency

Summary: after transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of cni and/or introduction of everolimus. the risk or benefits of these strategies were not clearly evaluated by specific clinical trials. this study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on : * renal function improvement * vasculopathy and major cardiac event reduction * maintenance of immunosuppressive efficacy


Eligibility criteria:
inclusion criteria: * male or female cardiac recipients over 18 years old * first or second heart transplant, more than one year following surgery * patients with renal failure assessed by cgfr 30 to 60 ml/min/1,73m² calculated by mdrd4 formula * patients volunteer to participate in the study, with a written informed consent signed * affiliation to a national health insurance program exclusion criteria: * current cni-free immunosuppressive regimen * patients currently or previously treated with a mtor inhibitor any time prior randomization * patients who are recipients for a multiple solid organ transplant * treated acute rejection episode within three months prior randomization * congestive heart failure (nyha class iii or iv) and/or vef \< 30 % and/or patient waiting for a re-transplantation * scheduled surgical intervention * platelet count \< 50 g/l * severe hepatic insufficiency (sgpt and/or sgot \> 3n) * major lipidic profile abnormalities (total cholesterol \> 3g/l and/or tg \> 5g/l) * proteinuria/creatinuria \> 0,08 g/mmol * severe renal failure attested by cgfr \< 30 ml/min/1.73m² (mdrd4) * history of hypersensitivity to everolimus, sirolimus or excipients * history of hypersensitivity to macrolides * pregnancy and breast feeding * childbearing age women without efficient contraception * law protected patients * patients in emergency unable to express their consent * history of hypersensitivity to cyclosporine or st-john's wort, stiripentol, bosentan, rosuvastatin * history of hypersensitivity to tacrolimus, macrolides or excipients * history of hypersensitivity to azathioprine * history of hypersensitivity to mycophénolate mofetil or excipients

Keywords: cardiac transplantation chronic renal insufficiency everolimus
the effect of vitamin k supplementation on glucose metabolism

Conditions: Diabetes; Prediabetic State

Summary: the purpose of this study is to test whether vitamin k supplementation has an effect on glucose metabolism in terms of acute beta cell response.

recently, many studies have reported that vitamin k metabolism is related to glucose metabolism. the suggested mechanisms connecting vitamin k metabolism and glucose metabolism, are inflammation responses and osteocalcin effect on glucose metabolism. most of the studies have investigated fasting glucose and insulin sensitive index, few have assessed glucose-intake-stimulated responses in regard to vitamin k supplementation. the purpose of this study is to test whether vitamin k supplementation has an effect on glucose metabolism in terms of acute beta cell response using intravenous glucose tolerance test.

Eligibility criteria:
inclusion criteria: * healthy male volunteer older than 20 years exclusion criteria: * subjects with (a history of) diabetes * subjects receiving medication related to diabetes or obesity * subjects receiving warfarin

Keywords: vitamin k beta cell glucose metabolism insulin resistance
comparison of focused and radial extracorporeal shock wave for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. this study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. however, there was no study comparing these two methods. considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Eligibility criteria:
inclusion criteria: * clinical and electrophysiological diagnosis of cts exclusion criteria: * cervical radiculopathy * polyneuropathy * brachial plexopathy * thoracic outlet syndrome * previous wrist surgery or steroid injection for cts

Keywords: carpal tunnel syndrome extracorporeal shock wave