Kornimate/medical-research-clean huggingface dataset:
tracheal intubation and prehospital emergency setting

Conditions: Tracheal Intubation Morbidity; Emergency Medicine

Summary: in prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. there are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. the objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

national and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. in contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. however, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. the last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010. difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. another study with more than 2000 patients had found a rate of 6%. a study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. the algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. the objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. the investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. the follow up will be restricted to the area of prehospital emergency setting.

Eligibility criteria:
inclusion criteria: * all patients intubated by emergency medical system (ems) team exclusion criteria: * none

Keywords: difficult intubation prehospital emergency risk factors
a 15-year single center experience of endovascular treatment of transplant renal artery stenosis

Conditions: Unrecognized Condition

Summary: stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft. endovascular treatment is first-line treatment. the main objective of this study is to identify the predictive factors of failure of peri-anastomotic.

the aim of this study was to evaluate the post-operative outcomes following endovascular treatment of tras (transplant renal artery stenosis). this retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017. the stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure.

Eligibility criteria:
inclusion criteria: * all patients who had a renal transplant from brain-dead donors or from living donors * all patients who had a transplant renal artery stenosis exclusion criteria: * none

Keywords: transplant renal artery stenosis endovascular repair post-operative outcome
evaluating the clinical effectiveness of 3d printing for a patient-specific silicone stent airway implant

Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema

Summary: the goal of the small feasibility trial is to establish a method, material, and patient-specific design that is superior to what is in use today. the first round of patients are well known to the physician investigator and are familiar with the problem that is being resolved. the end goal of the project is to create a new patient-specific design that will last longer, fit better, and cause less trauma to the airway and the patient.

subjects will be selected from physician investigator's clinical practice where patients have had failure of current stenting procedures to achieve an adequate clinical outcome. a routine ct scan of the chest is required on all individuals going through the procedure for stent placement (rigid bronchoscopy). the physician investigator will use this ct scan to measure and build a patient-specific stent or modify existing stents to fit the specific need.

Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign an informed consent form. 2. patients must be at least 18 years of age 3. patients must be able to undergo routine non-contrast ct scans of the chest 4. patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation. 5. the patients must have at least an expected 6 month survival. 6. patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management. 7. patient must be able to personally provide consent and be able to describe dyspnea and qol and other patient-reported outcomes (pros) required by study design 8. patient must require a stent that is within the design envelope of the patient-specific stents, as defined by cos exclusion criteria: 1. patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies. 2. chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (i.e. plavix within one year of drug eluding cardiac stent (des)or 6 weeks following bare metal coronary stent) 3. unstable cardiac disease 4. allergy to silicone 5. stenting to manage vascular compression syndromes. 6. multi-drug resistant bacterial or fungal chronic infections 7. emergent/urgent clinically indicated stent. 8. chronic/permanent mechanical ventilation.
cerebral safety after pulsed-field ablation of atrial fibrillation

Conditions: Ischaemic Cerebral Infarction

Summary: a study evaluating the incidence of ischaemic lesions detected by brain mri scan in subjects undergoing pulsed-field ablation for atrial fibrillation (varipulse system).

an observational study evaluating the incidence of ischaemic lesions on brain mri performed after ablation of atrial fibrillation using the varipulse catheter. 1. a baseline mri scan will be carried out one day before the procedure. 2. a post-procedure mri scan will be performed 24-36 hours after the procedure. 3. a follow-up mri will be performed within 1 year after the ablation. paroxysmal and non-paroxysmal af patients will be included. regarding the extent of ablation lesions, pulmonary vein isolation (pvi) will be performed in paroxysmal af, whereas pvi + left atrial posterior wall ablation will be performed in non-paroxysmal patients. all procedures will be performed under intracardiac echocardiography guidance. the patients will undergo a neurocognitive evaluation: 1. one day before the procedure: montreal cognitive assessment (the moca test) 2. 24-36 hours after the procedure: the national institutes of health stroke scale (nihss) 3. up to 1 year after the procedure the moca test.

Eligibility criteria:
inclusion criteria: * af with an indication for ablation exclusion criteria: * mri contraindication
format clinical study

Conditions: Symptomatic Vascular Disease of the Iliac Arteries

Summary: the format clinical study is a clinical trial to evaluate the safety and effectiveness of the formula™ 535 iliac balloon-expandable stent in treatment of symptomatic vascular disease of the iliac arteries.


Eligibility criteria:
inclusion criteria: * up to two documented common or external iliac artery lesions (one on each side), with \>50% diameter stenosis, suitable for stenting * iliac artery reference vessel diameter of 5-10 mm * rutherford category 1, 2, 3, or 4. exclusion criteria: * less than 18 years of age * lesion site \ 100 mm in length * external iliac artery lesion visually estimated to be 100% occluded * presence of infrarenal aortic aneurysm \>4 cm (treated or untreated) * presence of any aneurysm (treated or untreated) within target vessel * significant stenosis (\>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as \< 30% residual stenosis) * absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot) * angiographically evident thrombus within the target vessel (treated or untreated) * lesion is in an iliac artery that has been previously stented

Keywords: peripheral artery disease iliac arteries balloon-expandable stent
post marketing surveillance of synflorix vaccine safety among infants in korea

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to collect safety information following routine vaccination with synflorix™ among infants in korea.

rationale for the protocol amendment: the therapeutic indication for synflorix in korea has been updated. the protocol is being amended to reflect this update.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representatives can and will comply with the requirements of the protocol. * korean male or female subjects whose age while receiving the first vaccination with synflorix is 6 weeks - 5 years. * written, signed or thumb-printed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. where parent(s)/legally acceptable representatives are illiterate, the consent form will be countersigned by a witness. exclusion criteria: * at the time of post marketing surveillance entry, the contraindications and precautions of use indicated in the local prescribing information should be checked and the infant must not be included in the post marketing surveillance if there is any contraindication. any changes in the locally approved prescribing information must be implemented immediately. * subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. subjects who had previous administration of a pneumococcal vaccine other than synforix will not be enrolled into the study. * a male or female children \>= 5 years of age at study entry.

Keywords: pneumococcal vaccine safety synflorix pneumococcal diseases
covid-19 vaccination in oncologic patients

Conditions: Covid19; Oncologic Disorders

Summary: evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved sars-cov-2 vaccines

all patients that present themselves newly at the outpatient-clinic of the department of radiooncology at the ordensklinikum linz gmbh, barmherzige schwestern during a period of six months are eligible for participation. after being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. patients who already received one or two doses of sars-cov-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying sars-cov-2 s binding antibody titres after at least 35 days from initial vaccination. patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of sars-cov-2 s binding antibody titres before and after vaccination.

Eligibility criteria:
inclusion criteria: study population for the cross-sectional study (patients with previous sars-cov-2 infection of previous vaccination, evaluation of willingness to get vaccinated: * patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from april to september 2021 who will undergo active treatment. * age: 18-120 years patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period. longitudinal study: * patients that have not yet received sars-cov-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy. * age: 18-120 years exclusion criteria: * lack of written consent * patients, that are mentally or physically incapable of completing a questionnaire * age: \< 18 years * a previous sars-cov-2 infection is no exclusion criteria!

Keywords: radiotherapy sars-cov-2 vaccine immune response oncologic therapies immunosuppression sars-cov-2 s binding antibodies vaccination willingness vaccination side effects
ureteral stent exchange abstention in urinary tract infections

Conditions: Urinary Tract Infections; Urinary Catheterization

Summary: the committee of infectiology of the french association of urology (ciafu) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (usauti) prevention, diagnosis and treatment. since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of us in case of usauti. this study aims to evaluate whether "after guidelines group" patients treated for usauti had different occurrence of at least one relapse or recurrence than "before guidelines group".


Eligibility criteria:
inclusion criteria: * all patients with indwelling ureteral catheter * and confirmed or probable urinary tract infection exclusion criteria: * patient's opposition * history of ileal conduit urinary diversion * second or more urinary tract infection during the study period
biomarkers in obstructive sleep apnea surgery

Conditions: Obstructive Sleep Apnea

Summary: recent years have witnessed major advances in the understanding of the hormonal, metabolic, and biochemical changes that occur in obstructive sleep apnea (osa). this project evaluates the biomarkers that measure the most significant health impacts of this disorder and creates a specimen bank that will facilitate evaluations of additional biomarkers in the future.

this is a case-control study to examine the relationship between obstructive sleep apnea (osa) and elevated levels of leptin, homocysteine, and c-reactive protein (crp) in moderate or severe osa and control patients. this is followed by a prospective cohort study to examine the relationship between surgical treatment of moderate or severe osa and serum levels of these biomarkers. the short-term goals of this study consider the abnormalities in biomarker levels associated with osa and specific aspects of the disorder as well as whether the changes seen after surgical treatment of osa mirror those demonstrated after efficacious non-surgical treatment. the long term goals are in two areas: 1) the development of measures to determine which patients require treatment for sleep-disordered breathing and to monitor the effectiveness of therapy, and 2) a deeper understanding of the connection between osa and its adverse health consequences.

Eligibility criteria:
inclusion criteria: * osa group is adults with moderate or severe osa (apnea \>= 15 based on preoperative sleep study) undergoing surgical treatment. assessment is done prior to surgery. * control group is overweight (body mass \>25) adults without osa (apnea-hypopnea index \<5 based on sleep study) or other sleep disorders. assessment is prior to treatment.

Keywords: obstructive sleep apnea leptin homocysteine c-reactive protein
discovery of sirolimus sensitive biomarkers in blood

Conditions: Lymphangioleiomyomatosis

Summary: background: lymphangioleiomyomatosis (lam) is a rare, progressive disease. it usually affects women in the prime of their lives. it typically results in lung destruction. studies have shown that a drug called sirolimus stabilizes lung function in people with lam. but researchers do not know what drug dose and blood serum levels are needed to reach this stability. researchers want to learn more about the right dose of sirolimus for people with lam. objective: to determine if blood and urine markers after 1 dose and again after 9 months can be used to evaluate the correct dose of sirolimus for people with lam. eligibility: women ages 18-90 with lam whose doctors have decided they should start taking sirolimus to treat it. design: at visit 1, participants will take their first dose of sirolimus by mouth at the clinic. they will have blood and urine collected. participants will take 1 tablet of the study drug each day. visit 2 will be 3 months after visit 1. participants will have blood and urine collected. visit 3 will be 9 months after visit 1. participants will have blood and urine collected. participant samples will be stored in a secure place. no personal data will be connected to them.

sirolimus (rapamycin), which acts as a targeted inhibitor of the protein mechanistic target of rapamycin (mtor), has been shown to be effective in patients with lymphangioleiomyomatosis (lam). it stabilizes lung function, resolves chylous effusions and lymphangioleiomas and shrinks angiomyolipomas. the current study is to understand better the short-term action of the drug by following the effects on potential biomarkers in blood and urine. patients with lam will have samples taken prior to administration of first dose of the drug, at 1 hr and then at 23 hours after the drug (trough level). at 3 and 9 months, samples will be obtained at trough and 1 hour after the dose. molecular and cellular analyses will be performed to look for potential biomarkers.

Eligibility criteria:
* inclusion criteria * female 18 to 90 years of age * diagnosis of lam * initiation of sirolimus therapy (2mg daily) based on standard-of-care pulmonary indications and the advice of the patient s local physician exclusion criteria * unable to travel to the nih * unable to provide informed consent * advanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures * women who are pregnant or lactating

Keywords: mtorc1 inhibition vegf-d microrna natural history
studying biomarkers as a diagnostic tool in samples from younger patients with b-cell acute lymphoblastic leukemia

Conditions: B-cell Childhood Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia

Summary: this clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with b-cell acute lymphoblastic leukemia. finding specific biomarkers may help improve the treatment of patients with b-cell acute lymphoblastic leukemia

study subtype: ancillary/correlative observational study model: case-only time perspective: retrospective biospecimen retention: samples with dna biospecimen description: fresh and frozen bone marrow cells study population description: patients with b-cell acute lymphoblastic samples banked at the cog cell bank sampling method: non-probability sample objectives: i. to determine whether we can identify individuals within a specific sub-group of pre-b acute lymphoblastic leukemia (all) patients that will eventually recur. ii. to identify replication-timing changes as a biomarker for further risk prediction. iii. to identify differences between patients of similar subtype, and choose candidate differences to analyze by methods that are compatible with frozen samples. outline: archived cell samples are analyzed for replication timing by flow cytometry, microarray, and single-cell fluorescence in situ hybridization (fish) assays. replication-timing results among cases and controls are also analyzed.

Eligibility criteria:
inclusion criteria: * frozen viable cell samples from patients with b-cell acute lymphoblastic (all) of any outcome from the children's oncology group (cog) all cell bank (part 1) * freshand frozen cell samples from patients with b-cell all with known outcomes from the cog all cell bank (part 2) meeting 1 of the following criteria: * samples from patients who experienced an early recurrence within 36 months of diagnosis (cases) * samples from patients who remain in prolonged remission (controls) * no samples meeting either of the following criteria: * very-high-risk features * philadelphia chromosome positive * hypodiploid * mll (11q23) rearranged * known favorable risk factors * hyperdiploid * t(12;21) (etv6/runx1)
a study of the effect of iw-1701 (olinciguat), a stimulator of soluble guanylate cyclase (sgc), on patients with sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: the primary objective of the 1701-202 strong scd study is to evaluate the safety and tolerability of different dose levels of iw-1701 compared with placebo when administered daily for approximately 12 weeks to patients with stable scd. exploratory objectives include evaluation of pharmacokinetic (pk) as well as evaluation of the effect of iw-1701 on symptoms of scd, health-related quality of life, and biomarkers of pharmacodynamic (pd) activity.


Eligibility criteria:
inclusion criteria 1. patient is ambulatory male or female 16 to 70 years of age at the screening visit. 2. patient has scd, including homozygous hemoglobin s (hbss), hemoglobin sc disease (hbsc), heterozygous hemoglobin s-beta zero (hbsβ0)-thalassemia, or heterozygous hemoglobin s-beta plus (hbsβ+)-thalassemia, documented in their medical history. 3. if patient is on medication(s) for scd, such as hydroxyurea (hu), are on a stable regimen. 4. per medical history and/or patient recall, patient has had at least 1 and no more than 10 sickle cell-related pain crises in the 12 months before the screening visit and none occurring in the 4 weeks before the randomization visit. 5. patient completes daily ediary entries for at least 10 days during the last 14 days of the run in period as assessed at the randomization visit. 6. women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the screening visit through 90 days after the final dose of study drug. 7. male patients must be surgically sterile by vasectomy (conducted ≥60 days before the screening visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception and agree to refrain from sperm donation from the screening visit through 90 days after the final dose of study drug. exclusion criteria 1. patient requires a program of prescheduled, regularly administered chronic blood transfusion therapy. 2. patient has been hospitalized for an scd-related complication in the 4 weeks before the randomization visit. 3. patient has taken opioid(s) \>200 morphine mg equivalent/day within the 4 weeks before the randomization visit. 4. patient is taking aspirin ≥325 mg daily, p2y12 inhibitors, any anticoagulant medication, specific inhibitors of phosphodiesterase 5 (pde5), nonspecific inhibitors of phosphodiesterase 5 (pde5), moderate or strong cytochrome p450 3a (cyp3a) inhibitors, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide donors in any form. 5. patient has major concurrent illness or medical condition that in the opinion of the investigator would preclude participation in a clinical study. note: other inclusion and exclusion criteria apply, per protocol

Keywords: sickle cell disease scd olinciguat iw-1701