Kornimate/medical-research-clean huggingface dataset:
evaluation of modified bite-block for invasive imaging procedures

Conditions: Bite Block

Summary: the purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia. these dental protector devices are class i devices which are exempt from the fda 510(k) premarket notification requirements.

bite block is a single-use medical device used to keep the mouth open during invasive imaging procedures and prevent the patient from biting the imaging probe. the purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography exam procedures in patients who are either sedated or under general anesthesia. the commercially available bite blocks are almost exclusively made of hard plastic that does not conform well to the patient's mouth with additional protrusions used to secure the bite block in place that have the potential to cause patient injury. hard plastic is used to prevent patient from biting down on the imaging probe while side protrusions are used to strap the bite block down to prevent dislodgment. modified bite block is made of softer material with improved mouth fit and no need for strapping the bite block to keep it in place. softer material is more comfortable while the designs mimics mouth guard used in dentistry to protect patient's teeth and keep the bite block in place while sleeping. the specific aims of this project include: * assessment of patient comfort during invasive imaging procedure * assessment of provider satisfaction with the bite block * assessment of patient lip/gum/teeth injury after bite block use * assessment of imaging probe damage after procedure * assessment of bite block's ability to stay in place during procedure

Eligibility criteria:
inclusion criteria: * 18 years of age or older * undergoing stand-alone transesophageal echocardiography exam under sedation or general anesthesia * undergoing procedure that requires transesophageal echocardiography exam during the procedure under general anesthesia * cardiology and cardiac anesthesiology echocardiographers performing transesophageal echocardiography exam who wish to participate exclusion criteria: * less than 18 years of age * any procedure that does not require transesophageal echocardiography exam during the procedure

Keywords: bite block, transesophageal echocardiography
the association of miltefosine and pentoxifylline to treat mucosal and cutaneous leishmaniasis: a clinical trial in brazil

Conditions: Leishmaniasis

Summary: mucocutaneous leishmaniasis is endemic in the central region of brazil and other countries worldwide. the standard treatment with meglumine antimoniate has a high rate of important adverse effects. this interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.


Eligibility criteria:
inclusion criteria: * mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis; * for patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm; * ages between 18 and 80 years old; * fertile female patients should use at least two contraceptive methods (hormonal and barrier); * agree to participate in the study and sign the informed consent term. exclusion criteria: * use of any leishmanicidal drugs six months prior; * clinical or laboratorial evidences of electrocardiographic disorders; * renal, hepatic, cardiac diseases, uncontrolled diabetes or aids; * hypersensitivity to meglucamine antimoniate; * pregnancy or lactation; * fertile females that do not agree to use contraceptive methods; * patients that do not agree to the informed consent term.

Keywords: leishmaniasis mucocutaneous miltefosine pentoxifylline
body composition and acute stroke

Conditions: Acute Stroke

Summary: body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. in this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

a stroke commonly causes weakness and loss of independence. predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. premorbid physiological status has been less studied in stroke. however, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery. in this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). it will be studied using impedance analysis and morphological measurements on the temporal muscle. in a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (inbody bwa) will be performed to measure a skeletal mass index (smi) and phase angle. the properties of the temporal muscle (thickness and surface) will also be measured at t1, within 72 first hours after the stroke. clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume). the aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. functional assessment will be performed with modified rankin score (mrs). it is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.

Eligibility criteria:
inclusion criteria: * volunteer stroke patients in acute phase * age ≥ 18 years * having had a brain mri * able to understand assessment guidelines * not having objected to participate in the study after being duly informed exclusion criteria: * person under tutorship or curatorship * person under court protection * persons deprived of their liberty * pregnant or breastfeeding women * have a pacemaker or defibrillator

Keywords: stroke body composition bioimpedancemetry temporal muscle sarcopenia
study of efficacy and safety of xolair® (omalizumab) in chinese patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to h1 antihistamines (h1ah) therapy in adult patients suffering from chronic spontaneous urticaria (csu) who remained symptomatic despite h1ah therapy.

this was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory csu who remained symptomatic despite approved-dosed h1ah treatment. the study consisted of three distinct epochs over 24 weeks: screening epoch (day -28 to day -1), randomized treatment epoch (day 1 to week 12) and post-treatment follow-up epoch (week 12 to week 20). patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (tb) status at baseline (yes/no). on day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on day 1, week 4, and week 8) during the 12-week double-blind randomized-treatment epoch. patients visited the study center at 4-week intervals. patients were instructed to stay on the same csu h1ah treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. they were allowed to use diphenhydramine as rescue medication during all epochs. the last dose of the study drug during the randomized-treatment epoch was administered at week 8 study visit, however, the last assessment was done at week 12. after the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.

Eligibility criteria:
main inclusion criteria: * symptomatic csu patients with csu diagnosis for at least 6 months. * patients must have been on an approved dose of an h1ah for csu for at least the 3 consecutive days immediately prior to the day -14 screening visit * patients must have documented current use on the day of the initial screening visit main exclusion criteria * clearly defined underlying etiology for chronic urticarias other than csu (main manifestation being physical urticaria) * other skin disease associated with itch urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer

Keywords: chronic spontaneous urticaria iss7 uas7 omalizumab china
phase i study of tin mesoporphyrin in patients on long term heme therapy for prevention of acute attacks of porphyria

Conditions: Porphyria

Summary: objectives: i. evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria. ii. evaluate the safety and tolerability of tin mesoporphyrin in these patients.

protocol outline: this is an unblinded study. patients start a preventive heme regimen and are followed for 6 months prior to tin mesoporphyrin. the frequency of attacks is recorded. patients receive tin mesoporphyrin once a week for 6 months. patients must avoid sunlight during treatment and for 2 months thereafter. the frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored. patients are followed for 6 months after last treatment.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria causing 6 or more attacks per year fewer than 2 attacks in the preceding 6 months if already on preventive heme therapy --prior/concurrent therapy-- see disease characteristics --patient characteristics-- performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: urinary porphobilinogen at least 20 mg/24 hours during acute symptoms other: not pregnant fertile female patients must use effective contraception during and for 6 months prior to study no recurrent symptoms due to another illness no continuous (for longer than 1 month) symptoms of porphyria unless it is in addition to acute exacerbations no acute hemorrhagic disorder such as: gastrointestinal bleeding intracerebral hemorrhage no known hypersensitivity to tin mesoporphyrin no known hypersensitivity to any intravenous heme preparation no other condition which may increase risk to patient

Keywords: inborn errors of metabolism porphyria rare disease
a study to evaluate the safety of apixaban in acute coronary syndrome (acs) japanese patients

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg bid and 5.0 mg bid) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.

due to withdraw of global phase 3 study (appraise-2) for safety issue, b0661004 data monitoring committee (dmc) also recommended terminating this study. therefore, pfizer decided to stop this study.

Eligibility criteria:
inclusion criteria: * recent (≤ 7 days) acs * clinically stable, and receiving standard treatment (patients must be treated with aspirin ≤ 100 mg/day, with or without clopidogrel 75 mg/day or ticlopidine 200 mg/day) based on the physician's judgment) exclusion criteria: * scheduled/planned cardiac catheterization, pci, cabg or other invasive procedure planned in the 24 weeks (within treatment period) following randomization * persistent severe hypertension, defined as systolic blood pressure of ≥180 mm hg or diastolic pressure of ≥110 mm hg * active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any history of intracranial hemorrhage).
epidemiology of cardiovascular disease in diabetes

Conditions: Cardiovascular Diseases; Diabetes Mellitus, Non-insulin Dependent; Heart Diseases; Atherosclerosis; Diabetes Mellitus

Summary: to locate and identify genes contributing to the genetic component of subclinical cardiovascular disease (cvd) in type 2 diabetes and to evaluate the impact of lifestyle and environment on the expression of these genetic components of subclinical cvd.

background: atherosclerosis is the most important complication of diabetes and the reason for its accelerated course in patients with this condition is poorly understood. diabetes is increasing in prevalence and will exact a heavy disease burden on the united states population over the coming years. secondary prevention of atherosclerotic complications would be of great value. the rationale underlying genetic studies is that new pathways could be identified through functional genomics. design narrative: the following hypotheses are tested: 1) the risk of developing type 2 diabetes-associated cardiovascular disease (cvd) has a significant heritable component that can be measured, and 2) the chromosomal locations of genes contributing to cvd in type 2 diabetes can be determined and the genes identified using modern molecular genetic approaches. the investigators predict that these genetic factors can be detected in studies of sibling pairs with type 2 diabetes through genetic epidemiology methods and linkage analysis. type 2 diabetes-affected sibling pairs, unaffected siblings, and parents, if available, will be recruited and multiple clinical and subclinical measures of subclinical cvd risk will be assessed, including coronary artery calcification (cac), carotid arterial wall thickness (imt), ecg variables, and prevalent cvd. data on the patients are collected in one visit to the general clinical research center (gcrc) which includes an interview and physical examination, a resting 12-lead electrocardiogram (ecg), b-mode ultrasound of the carotid arteries, retrospectively gated helical ct (rghct), and a spectrum of clinical laboratory measures. genetic and epidemiological methods will be used to evaluate the familial aggregation of subclinical cvd taking into consideration the effects of shared environmental exposures (e.g. smoking, diet, alcohol intake and physical activity) and clinical measures (e.g., body mass index, blood pressure, lipids, age, sex, etc.). initial estimates of heritability suggest a significant heritable component to subclinical cvd. clinical evaluation will be followed by a comprehensive molecular genetic analysis of the sib pairs/families including a genome wide screen, which will be followed by a focused effort to create a high quality dataset by regenotyping or replacing problem markers. evidence for linkage to quantitative trait loci (qtls) influencing cac and imt will be pursued in those chromosomal regions showing suggestive evidence for linkage and then performing further analyses to detect associations with these "saturation" markers.

Eligibility criteria:
no eligibility criteria
wbsi guided personalized delivery of ttfields

Conditions: GBM; Glioma Glioblastoma Multiforme; Tumor, Brain

Summary: this research study is for glioblastoma (gbm) patients who will be beginning optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (ttfields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. as a part of this study, participants will either receive optune with "standard array mapping" (based on regular contrast enhanced mri) or an "alternative (more precise) array mapping" based on sophisticated state of the art mri techniques including "whole brain spectroscopy". whole brain mri spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular mri), by identifying certain metabolites that are present in cancer cells versus healthy tissue. this study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of ttfields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.


Eligibility criteria:
inclusion criteria: * adult population ≥ 22 years * histologically confirmed diagnosis of gbm or molecular gbm according to c-impact now criteria * have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cgy in 6 weeks or a hypofractionated course of 4000 cgy in 3 weeks * 3 harboring any genotype profiles (mgmt promoter methylation or unmethylation and/or isocitrate dehydrogenase (idh) mutant or idh wild-type) * possessing adequate hematological, hepatic and renal functions * willingness to receive ttfields exclusion criteria: * presence of infra-tentorial gbm * pregnancy * significant co-morbidities at baseline which would prevent maintenance tmz treatment * active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers, defibrillators and programmable shunts. , other implanted electronic devices in the brain. * sensitivity to conductive hydrogels like the gel used on electrocardiogram (ecg) stickers or transcutaneous electrical nerve stimulation (tens) electrodes. * presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.
efficiency of rosuvastatin versus the fixed combination of ezetimibe/simvastatin in outpatients

Conditions: Dyslipidemia

Summary: the aim of this study is to evaluate the effectiveness of rosuvastatin versus ezetimibe/simvastatin in dyslipidemic patients treated for at least 8 weeks.


Eligibility criteria:
inclusion criteria: * dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks * who have completed at least 80% of the treatment * to have determinations at least of ct, tg c-ldl and chdl before starting treatment and after 8 weeks of taking the medicine exclusion criteria: * initiating different therapy lipid lowering to rosuvastatin or ezetimibe/simvastatin

Keywords: hypercholesterolemia statins
apogee international

Conditions: Chronic Heart Failure

Summary: medtronic is sponsoring the apogee international registry to further confirm safety and efficacy of the hvad™ system when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a medtronic heartware™ hvad™ for bridge to transplant and destination therapy indications.

apogee international is a prospective, non-interventional, post-market, multi-site registry, conducted within medtronic's product surveillance registry (psr) platform. enrollment into apogee international will be comprised of newly implanted, commercial use patients with the heartware ventricular assist device system (hvad system). sites selected to participate are expected to collect data in at least one of these five modules: 1. logfile download; 2. anti-coagulation / anti-platelet management; 3. blood pressure (bp) management; 4. acoustic spectrum analysis; 5. infection control

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements; * enrollment into apogee international will be comprised of newly enrolled, commercial use patients with the heartware hvad system; * patient is consented prior to the hvad implant procedure. exclusion criteria: * patient who is, or is expected to be inaccessible for follow-up; * participation is excluded by local law; * patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the psr results.
the clinical value of serum kl-6 changes on evaluating disease development in different diffuse parenchymal lung disease

Conditions: Diffuse Parenchymal Lung Disease

Summary: diffuse parenchymal lung disease(dpld) is a chronic progressive fibrosis lung disease that with a highly variable clinical process.krebs von den lungen-6 (kl-6) is a high-molecular-weight glycoprotein, classified as human muc1 mucin, that is produced mainly by regenerating type ii pneumocytes.serum levels of kl-6 have been shown to be elevated in patients with dpld and could predict progress, but unaware of the differential threshold. the objective of this study was to perspectively and sequentially monitor serum kl-6 levels in patients with different dpld,then analyze its clinical value and find the differential threshold.

subjects and method: recruiting different dpld patients in our hospital between 2013 february and 2016 october, including polymyositis/dermatomyositis related interstitial lung disease (pm/dm-ild), rheumatoid arthritis related interstitial lung disease (ra - ild), interstitial pneumonia with autoimmune features(ipaf) and idiopathic pulmonary fibrosis(ipf), following up for enery 3 to 6 months. once condition deteriorated, patient could return at any time if necessary according to our clinical physician judgment. tumor markers，pulmonary function test(pft); chest thin-section ct examination and ct scores; serum kl-6 levels were acquired in all patients at baseline and follow-ups. serum kl-6 was measured on lumipulse g system(fujirebio, japan) by chemiluminescence enzyme immunoassay. all follow-up patients will be respectively divided into improved,stable and deteriotated group according to the official ats/ers statement. inclusion criteria: (1)patient with pm/dm-ild, ra-ild, ipaf, ipf.the diagnosis of patient were according to the official ats/ers statement and the american college of rheumatology/european league standard;(2)18 to 80 years old. exclusion criteria: (1)conbination with pulmonary tubenculersis,pulmonary infection,tumor;(2)no serum kl-6 or pulmonary function test or chest thin-section ct examintion ;(3)patient with severe hepatic and renal dysfunction,heart disease or receiving hemodialysis treatment;(4)pregnant or plan to be pregnant

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pm/dm-ild,ra-ild,ipaf,ipf exclusion criteria: * combined with pulmonary infection,pulmonary tuberculosis,carsinoma.

Keywords: serum kl-6 pulmonary function test ct score evaluation