Kornimate/medical-research-clean huggingface dataset:
a european study on medical management versus tag device + medical management for acute uncomplicated type b dissection

Conditions: Aortic Diseases

Summary: the purpose of this study is to compare endoluminal stent grafting with the gore tag device and best medical therapy (bmt) to bmt alone in the treatment of acute uncomplicated type b aortic dissections.

dissection of the aorta is a medical emergency requiring immediate surgery. type b dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. however, the treatment of patients with uncomplicated, acute type b dissections is controversial. best medical therapy (bmt) is the standard of care in these cases since surgical repair offers no additional survival advantage. however, endoluminal stent graft therapy with the gore tag thoracic endoprosthesis (gore tag device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type b dissection. the goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.

Eligibility criteria:
inclusion criteria: 1. presence of acute uncomplicated type b aortic dissection 2. able to tolerate endotracheal intubation and general anesthesia 3. maximum transverse diameter of the descending thoracic aorta \< 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology. 4. arterial anatomy is appropriate for stent graft therapy exclusion criteria: 1. asa classification = v 2. severe renal insufficiency defined as svs risk renal status = 3 3. severe respiratory insufficiency defined as svs risk pulmonary status = 3 4. presence of connective tissue disease 5. active infection or active vasculitides 6. positive pregnancy test 7. participation in another medical research study within 3 months of study enrollment 8. myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment 9. planned concomitant surgical procedures (other than left subclavian artery transposition or bypass), or major surgery within 30 days of study enrollment 10. history of drug abuse
regional anesthesia for cardiothoracic enhanced recovery (racer) study

Conditions: Congenital Heart Defect; Congenital Heart Disease; Anesthesia, Local; Opioid Use

Summary: the erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. the goals of this study are to determine if bilateral erector spinae plane blocks (espb) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (mv), perioperative opioid consumption, days in the intensive care unit (icu) and length of stay (los).


Eligibility criteria:
inclusion criteria: i) ages 0-99 ii) give consent/parental consent to participate in study iii) patients undergoing sternotomy for congenital heart repair surgeries exclusion criteria: i) participants who do not consent or have parental consent ii) patients who are clinically unstable or require urgent/emergent intervention iii) patients under 5kg
patient characteristics in advanced renal cell carcinoma and daily practice treatment with nexavar

Conditions: Carcinoma, Renal Cell; Carcinoma, Renal Cell (Advanced)

Summary: renal cell carcinoma accounts for roughly 3 % of all cancer. it is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. when this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. in these cases sorafenib can be a feasible therapeutic option. this non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. the main goal of this study focuses on patient characteristics and tumor status in rcc treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of advanced rcc and decision taken by the investigator to prescribe sorafenib exclusion criteria: * exclusion criteria must be read in conjunction with the local product information

Keywords: advanced renal cell carcinoma
post-caesarean section incisional infiltration with lidocaine versus lidocaine and epinephrine

Conditions: Pain, Postoperative

Summary: study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.

assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.

Eligibility criteria:
inclusion criteria: * women undergoing caesarean delivery under general anesthesia for various indications. * women refuse spinal anesthesia. exclusion criteria: * known or suspected sensitivity to local anesthesia. * medical disorders induced by pregnancy (pre-eclamptic toxemia, gestational diabetes mellitus, hepatic diseases, homeostatic disorder) * medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases). * women who hemo-dynamically unstable. * lack of adequate verbal communication.

Keywords: incisional infiltration cs lidocaine epinephrine adverse reaction to topical or infiltrative lidocaine
assessment of supportive care and educational needs to guide quality care improvements for patients with locally advanced and metastatic bladder cancer

Conditions: Screening Tool; Focus Group

Summary: the overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. adult individuals diagnosed with stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. all data collected will be linked to a study id number and hipaa identifiers will not be linked to study data. identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.


Eligibility criteria:
inclusion criteria: * patients are eligible to participate if they are diagnosed with stage 4 incurable locally advanced or metastatic bladder cancer * between 18 years and older (18-89 years) * have initiated any systemic treatment for advanced urothelial carcinoma * speak english speaking and are able to consent. exclusion criteria: * have a diagnosis of another advanced cancer that has required systemic therapy * or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.
arginine therapy for the treatment of pain in children with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (voe) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

arginine is a simple amino acid that is found in many foods and is part of the proteins in a human's body. patients with sickle cell disease have low levels of the amino acid arginine and these low levels may be related to pain episodes. increasing levels of arginine in the blood may lower pain and/or lower the amount of pain medication (like morphine) that is needed to treated them. it may also decrease the amount of time spent in the hospital. available data suggest that, l-arginine is a safe \& efficacious intervention with narcotic-sparing effects in pediatric scd patients with voe. the addition of a higher loading dose to the standard dose or use of a continuous infusion may provide additional clinical benefits by overcoming multiple mechanisms that limit global arginine bioavailability in scd.

Eligibility criteria:
inclusion criteria: * established diagnosis of sickle cell disease--hemoglobin ss (hb-ss) or sβᴼ-thalassemia * 7-21 years of age * weight \>= 25kg (55lbs) * pain requiring medical care in an acute care setting (emergency department (ed), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes. exclusion criteria: * decision to discharge home from acute care setting. * diagnosis of sickle cell disease with any of the following types: hemoglobin sc disease (hbsc), hemoglobin beta thalassemia (hb-beta thal), hemoglobin sd disease (hbsd), hemoglobin se disease (hbse), hemoglobin so disease (hbso), hemoglobin as carrier (hb as) * hemoglobin less than 5 gm/dl * immediate red cell transfusion anticipated * renal dysfunction: creatinine \>1.0 or 2 x baseline * mental status or neurological changes * acute stroke or clinical concern for stroke * pregnancy * allergy to arginine * previous hospitalization \< 7 days * use of inhaled nitric oxide, sildenafil or arginine within the last 14 days * not an appropriate candidate in the investigator's judgement
a study of the recombinant human interleukin-11 (i) (baijieyi) for prevention and treatment of chemotherapy-induced thrombocytopenia in patients with malignant tumor

Conditions: Chemotherapy-induced Thrombocytopenia

Summary: the aim of this retrospective study is to review and describe the safety and the efficacy of recombinant human interleukin-11 (i) i (baijieyi), using information already recorded in 20 medical records, the time periods include may 8th of 2008 to december 31st of 2016.


Eligibility criteria:
inclusion criteria: 1. prescriptions explicitly given to the injection of baijieyi; 2. confirmed by histopathological or cytological examination of malignant tumors and chemotherapy; 3. treatment: platelet count had reached below 75×10\^9/l after the treatment of chemotherapy and before using baijieyi; prevention: patients with chemotherapy at the beginning of the preventive administration of baijieyi, and chemotherapy is same with previous cycle; 4. male or female, aged 18-85 years; 5. the main research information required is complete. exclusion criteria: 1. using other platelets of chemicals or biological products in the in the chemotherapy cycle used baijieyi; 2. using drugs which can cause thrombocytopenia in the in the chemotherapy cycle used baijieyi; 3. bone marrow dysfunction or bone marrow involvement; 4. there are other causes of thrombocytopenia, such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenic purpura, and hypersplenism, in the course of the use of baijieyi.
predictive value of nu.q™ biomarkers to help guiding the management of osteoarticular infections

Conditions: Diabetic Foot; Chronic Osteomyelitis; Septic Arthritis

Summary: diabetic foot ulcers are frequent with average lifetime risk of 15%, and can lead to bone and joint infections. current protocols for their management include evaluation of ischemia, assessment of underlying bone infection, sharp debridement, off-loading and use of dressings that promote moist wound healing. extensive debridement is optimal for wound healing and decreases the risk of recurrence. however, extension of surgical debridement is left at the clinician judgement and thus lacks standardised protocols. plus, there is currently no known risk factors or specific biomarkers that can help guide the clinician for the extent of debridement or that can predict a recurrence in case of non-extensive debridement. the main objectives of the study are to either unravel a new biomarker, and/or identify risk factors associated with poor prognosis following surgical debridement in diabetic foot ulcers. histones, more specifically h3.1 subtype, have been associated with sepsis. the main hypothesis is that higher blood levels of h3.1 will be present in participants showing poor prognosis (i.e., having additional surgeries, amputation, death) and that a rise in h3.1 blood levels compared to baseline (before the 1st surgical intervention) would provide an early warning of relapse or treatment failure.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years old) suffering from diabetes mellitus (type 1 or 2) * diabetic foot ulcer with severe infection (grade 3 and 4 according to iwgdf 2019 classification) * scheduled surgical debridement exclusion criteria: * spondylodiscitis * pregnant or lactating women * previous enrolment in a clinical trial * consent declined by participant or tutor in case of incapacitation * tutor cannot be reached for consent in case of incapacitation

Keywords: diabetic foot osteoarticular infections
michi™ neuroprotection system (nps+f) filter debris analysis study (the f-1 study)

Conditions: Internal Carotid Artery Stenosis

Summary: this study will be conducted in up to 10 hospitals in europe, up to 75 patients will be enrolled. the purpose of the study is to evaluate any debris that may be captured in the inline filter of the michi(tm) neuroprotection system with filter (nps+f) during its use in a transcarotid stenting procedure. the michi nps+f is an embolic protection device that uses reverse flow to protect the brain during stenting of the internal carotid artery. it is ce marked and is used in routine practice for the purpose of this study.


Eligibility criteria:
inclusion and exclusion criteria per ce marked instructions for use inclusion criteria: 1. adequate central venous access 2. common carotid artery reference diameter of at least 6 mm 3. carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex doppler ultrasound (dus) or computerized axial tomography (ct) angiography or magnetic resonance (mr) angiography exclusion criteria: 1. patients in whom antiplatelet and/or anticoagulation therapy is contraindicated 2. patients with unresolved bleeding disorders 3. patients with severe disease of the ipsilateral common carotid artery

Keywords: internal carotid stenosis reverse flow carotid stenting michi(tm) nps+f
renin-angiotensin system inhibitors and covid-19

Conditions: COVID-19; Hypertension; Cardiovascular Diseases

Summary: multicentric non-profit observational study, in patients with covid-19 hospitalized in italy, conducted through a pseudonymised survey.

the recent sars-cov-2 coronavirus pandemic and subsequent spread of the disease called covid-19 brought back to the discussion a topic already highlighted during the sars-cov-4 crown-related sars epidemic of 2002. in particular, the angiotensin converting enzyme 2 (ace2) has been identified as a functional receptor for coronaviruses, therefore including sars-cov-2. ace2 is strongly expressed in the heart and lungs. sars-cov-2 mainly invades alveolar epithelial cells, resulting in respiratory symptoms. these symptoms could be made more severe in the presence of increased expression of ace2. ace2 levels can be increased by the use of renin-angiotensin system inhibitors (ras). this therapeutic class is particularly widespread, as it represents the most important pharmacological protection for widespread diseases such as high blood pressure, heart failure and ischemic heart disease. it is therefore possible to hypothesize that pharmacological treatment with ras inhibitors may be associated with a more severe symptomatology and clinic than covid-19. however, several observations from studies on sarscov, which are most likely also relevant for sars-cov-2 seem to suggest otherwise. indeed, it has been shown that the binding of coronavirus to ace2 leads to downregulation of ace2, which in turn causes an ace / ace2 imbalance excessive production of angiotensin by the related ace enzyme. angiotensin ii receptor 1 (at1r) stimulated by angiotensin causes an increase in pulmonary vascular permeability, thereby mediating an increase in lung damage. therefore, according to this hypothesis, the upregulation of ace2, caused by the chronic intake of at1r and ace inhibitors, could be protective through two mechanisms: the first, that of blocking in the at1 receptor; second, increasing ace2 levels decreases ace production of angiotensin and increases ace2 production of angiotensin 1-7. the quickest approach to evaluating these two opposing hypotheses is to analyze the medical records of covid-19 patients to determine whether patients on ras antagonist therapy have a different disease outcome than patients without the above therapy. this research aims to verify whether the chronic intake of ras inhibitors modifies the prevalence and severity of the clinical manifestation of covid-19.

Eligibility criteria:
inclusion criteria: patients affected by covid19 referring to italian outpatient clinics or hospitals exclusion criteria: -

Keywords: risk factors sars ace inibitors arb
a study of the safety of ren001 in patients with mcardle disease

Conditions: McArdle Disease

Summary: the purpose of this study is to assess ren001 safety in subjects with mcardle disease


Eligibility criteria:
inclusion criteria: * subjects must give written, signed and dated informed consent * confirmed diagnosis of mcardle disease * subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes * follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period. exclusion criteria: * documented history of ongoing rhabdomyolysis * evidence of acute crisis from their underlying disease * currently following or planning to start a ketogenic diet * treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer * have been hospitalized within the 3 months prior to screening for any major medical condition * severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator in discussion with the medical monitor, would make the subject inappropriate for entry into this study * pregnant or nursing females
extended hip ultrasound as anew protocol for septic hip in children

Conditions: Septic Arthritis

Summary: to establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .

septic arthritis is a severe life and function threatening condition with a 1-year mortality rate of up to 10% and residual functional impairments in 30% to 50% of cases . pediatric septic hip arthritis is an intra-articular infection in children that peaks in the first few years of life. the incidence of septic arthritis is low, with about 4-5 per 100000 child annually with about 50% of cases occur in children younger than 2 years of age with gender affection in male \> female (2:1 ratio). the hip joint involved in about 35% of all cases of septic arthritis. imaging studies contribute crucially to the optimal management of septic arthritis, thereby diminishing the risk of permanent functional loss .at present; magnetic resonance imaging (mri) is the most informative method. thus, mri assesses the severity of the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess, and/or bone edema. mri had 75% specificity and nearly 100% sensitivity for diagnosing concomitant abscess formation, cellulitis, or myositis . disadvantages of mri are high cost and limited availability on an emergency basis in some settings , ultrasonography of the bone and joints has been developing at a fast pace in recent years. ultrasonography is currently used in the management of septic arthritis to confirm the presence of a joint effusion and to guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the joint deep (e.g., hip). ultrasonography has high sensitivity and specificity for joint effusions .the difficulty of applying hip mri in pediatric age group patients especially neonates make challenge in the proper management of acute septic hip arthritis .the study aim to apply a new protocol in diagnosis of septic hip in children by doing extended hip ultrasound included psoas and quadriceps muscles.

Eligibility criteria:
inclusion criteria: * neonates, infants and children presented with suspected septic hip arthritis. exclusion criteria: * ddh
development of a quality of life measurement scale in hereditary haemorrhagic telangiectasia (hht) disease.

Conditions: Hereditary Hemorrhagic Telangiectasia

Summary: hereditary haemorrhagic telangiectasia (hht) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of 1/6000. it is manifested by haemorrhages, mucocutaneous telangiectasias and visceral arteriovenous malformations. these symptoms significantly affect the daily lives of patients, their social relationships and their working lives. has (haute autorité de santé) national recommendations focus on assessing and improving the quality of life (qol) of patients. many scales for measuring qol exist but they are most often general and therefore have the disadvantage of not taking into account the particularities of pathologies and their symptoms and do not allow to have a precise vision of their impact on qol. it is important to be able to evaluate this impact, to determine its nature and to quantify it so that health professional can adapt their proposal for the management of hht patients. and only the development of a specific and validated qol measurement scale will allow them to access this information. the aim of this study is to develop a scale of measurement of quality of life in hht disease and to validate it, a scale specific to hht, simple and fast to fill by the patients themselves.


Eligibility criteria:
inclusion criteria: * over 18 years * able to read french * with clinically confirmed hereditary haemorrhagic telangiectasia disease (presence of at least 3 curaçao criteria) and / or molecular biology * who received the information and did not object to participate in the study exclusion criteria: * none