Kornimate/medical-research-clean huggingface dataset:
versi retriever approving trial in japan

Conditions: Stroke, Acute

Summary: this is versi retriever mechanical thrombectomy device approving study in japan. multi center, single arm, prospective registry trial. physicians control trial, conducted my n sakai, kobe city medical center general hospital.

this is versi retriever mechanical thrombectomy device approving study in japan. multi center, single arm, prospective registry trial. physicians control trial, conducted my n sakai, kobe city medical center general hospital. 60 cases will be enrolled and 90 days follow up need. primary endpoint is favorable clinical outcome, mrs 0-2. secondary endpoint are mortality in 90days, immediate successful recanalization, tici 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.

Eligibility criteria:
inclusion criteria: * acute onset neurological sympto m related to occluded vessel * within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis * contra-indication or failed to int ravenous rt-pa * accessible occlusion at ica, mc a, va, ba, pca * 5-30 of nihss * 0-2 of mrs before onset * obtain documented informed co ntent exclusion criteria: * following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain * occlude 2 major vessel territory * allege for contrast media, * abnormal ptt/aptt within 4 h ours intravenous heparin * hemorrhagic tendency or 3 or more inr with warfarin administration * 30000cc or less of platelet * 50mg/dl or less of blood sugar * uncontrolled blood pressure, 185mmhg or more at systolic, 110m mhg or more at diastolic * 90days or less life expancy * pregnant or lactating * join another trial of medicine or medical device * ineligible for trial

Keywords: acute ischemic stroke
eisenmenger's syndrome in adults with chd

Conditions: Congenital Disorders

Summary: review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with sildenafil (a pde-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart disease.

the primary objective of this study is to examine medical records of patients with eisenmenger's syndrome in order to determine the effect of endothelin receptor antagonists, alone or in combination, with sildenafil, on symptoms of pulmonary hypertension. this review will be conducted on standard of care procedures such as new york heart association (nyha) classification, six-minute walk exercise capacity, pulmonary pressures and oxygens saturations. pulmonary pressures determined by echo or cardiac catheterization will be analyzed where available. we hypothesize that patients with congenital heart defects who develop es will have an improved six-minute walk distance, improved pulmonary arterial pressures and improved oxygenation after treatment with endothelin receptor antagonists and other pulmonary vasodilators.

Eligibility criteria:
inclusion criteria: * congenital heart disease (unoperated, palliated or repaired) eisenmenger's syndrome age 18 to 80 exclusion criteria: * those who do not meet inclusion criteria

Keywords: adult congenital heart disease eisenmenger's syndrome bosentan sitaxsetan sildenafil
neck pain in danish military pilots and flight crew

Conditions: Neck Pain

Summary: the purpose of this study is to determine the prevalence of neck and shoulder pain in danish fighter pilots, helicopter pilots and helicopter flight crew and to evaluate the effect of a 24 weeks exercise intervention for fighter pilots.


Eligibility criteria:
inclusion criteria: * military fighter and helicopter pilots and crew * active flying 2006 or later exclusion criteria: * pilots and crew not active since 2005 or earlier * pilots and crew with other nationality than danish

Keywords: neck pain exercise pilots crew
pilot study of the fantom bioresorbable scaffold (fantom i)

Conditions: Coronary Artery Disease

Summary: the fantom i pilot study is intended to assess safety of the fantom bioresorbable coronary scaffold in native coronary arteries.


Eligibility criteria:
inclusion criteria: * patient has evidence of myocardial ischemia or a positive functional study * patient has a normal ck-mb * target lesion has a visually estimated stenosis of ≥50% and \<100% * target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.7mm and ≤ 3.3mm * target lesion length must be ≤ 14mm exclusion criteria: * patient has experienced a myocardial infarction (ck-mb or troponin \> 5 x uln) within 72 hours of the procedure * patient has a left ventricular ejection fraction \< 25% * patient has unprotected lest main coronary disease with ≥50% stenosis * the target vessel is totally occluded (timi flow 0 or 1) * target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis). * target lesion is located within a bypass graft * target lesion has possible or definite thrombus
erlotinib or placebo following chemoradiotherapy (chemo/rt) in stage iii non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung; Non-small Cell Lung Cancer; NSCLC

Summary: this is a national, randomized, web-based, double-blind study to determine whether erlotinib (tarceva) compared to placebo improves progression-free survival (pfs) for patients with inoperable, stage iii nsclc following concurrent docetaxel, carboplatin and thoracic radiotherapy. we hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

the promising activity of erlotinib as a single agent in advanced refractory nsclc along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage iii nsclc following completion of concomitant chemoradiation. although, a subset of patients with unresectable stage iii nsclc will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. we hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.

Eligibility criteria:
inclusion criteria: * unresectable, stage iiia or iiib nsclc (measurable disease is not required) * no evidence of metastatic disease * no prior treatment * adequate organ function * adequate pulmonary function (fev \>= 1.0l or predicted fev \>0.8l) exclusion criteria: * metastasis * prior treatment * malignant pleural or pericardial effusion * peripheral neuropathy \>= grade 2

Keywords: erlotinib tarceva web based stage iii nsclc
determine effect of enzalutamide (mdv3100) on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide

Conditions: Metastatic Progressive Castration-resistant Prostate Cancer

Summary: this study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.


Eligibility criteria:
inclusion criteria: * confirmed prostate cancer * presence of metastatic disease to the bone * ongoing androgen deprivation therapy exclusion criteria: * severe concurrent disease * metastases in the brain
predictive model for mortality in older people with critical illness

Conditions: Critical Illness

Summary: the present study aims to develop a predictive model to identify elderly patients with the highest likelihood of mortality upon admission to an intensive care unit.


Eligibility criteria:
inclusion criteria: * men and women aged 75 or older. * admission to an icu from the emergency department. * availability of or possibility to contact a participant's informant. * informed consent for participation in the study, either by the participant or a valid legal representative. exclusion criteria: participants meeting any of the following exclusion criteria will not be included in the study: * patients transferred to the emergency department from a hospital ward. * patients who die within the first 24 hours of icu admission. * patients admitted to step-down units. * patients requiring icu admission for any of the following reasons: orotracheal intubation or advanced cardiopulmonary resuscitation performed prior to arrival at the emergency department. av block awaiting pacemaker implantation. activation of the stemi or stroke care pathway. post-cardiac catheterization for acute coronary syndrome. * participation in another clinical study involving an intervention, procedure, or visit schedule that is incompatible with the present study.

Keywords: critical illness mortality aged intensive care units
risk factors contributing to the development of microalbuminuria

Conditions: Microalbuminuria

Summary: this research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. we hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. the rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.

the primary objective of this research project is to determine risk factors related to the development of microalbuminuria. the secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. subjects found to have microalbuminuria will be offered therapy with the arb losartan and will be followed at three months to determine if there has been a reduction in levels.

Eligibility criteria:
inclusion criteria: * participation in the double exposure study * elevated microalbuminuria

Keywords: microalbuminuria risk factors
the patient cohort for bariatric surgery

Conditions: Height, Weight, Waist Circumference, Hip Circumference; Preoperative Laboratory Examination Status; Preoperative Routine Examination Results; Laboratory and Examination Results During Follow-up

Summary: this study is based at the national integrated traditional chinese and western medicine medical center and leverages the centralized strengths of our department, which integrates multiple disciplines (general surgery, endocrinology, nutrition, exercise, and traditional chinese medicine). it focuses on key scientific issues in the comprehensive management of bariatric surgery throughout the entire treatment cycle. by recording key indicators of patients before and after surgery and using methods such as machine learning to predict postoperative complications, we aim to enhance precision management. ultimately, we will establish a refined diagnosis and treatment system for metabolic weight loss surgery, promote its application, and thereby raise the standardized management level of weight loss and metabolic disciplines in our hospital and primary care units nationwide. this will improve patient outcomes and reduce the healthcare burden.


Eligibility criteria:
inclusion criteria: * 1、for those with simple obesity, bmi ≥ 32.5, or 27.5 ≤ bmi \< 32.5, who have difficulty controlling their condition with lifestyle modifications and medical treatment, and who meet at least two criteria for metabolic syndrome components, or have comorbidities. 2、for those with simple obesity, 27.5 ≤ bmi \< 32.5, and with male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm, and imaging studies suggesting central obesity. 3、for those with type 2 diabetes, bmi ≥ 27.5, who still have some residual insulin secretion capacity. exclusion criteria: * 1、non-obese type 1 diabetes; 2、those for whom the purpose of treatment is t2dm, but whose pancreatic beta-cell function is largely lost, with a bmi \ 65 years; 4、pregnant women with diabetes and patients with certain special types of diabetes; 5、those with a cognitive disorder or immature intelligence, and who cannot control their behavior; 6、those whose expectations for the surgery are not realistic; 7、those unwilling to assume the risks of potential surgical complications; 8、those unable to comply with postoperative dietary and lifestyle changes, showing poor compliance; 9、those in poor general health, who are unable to tolerate general anesthesia or surgery.
"acetic acid chromoendoscopy in barrett's esophagus surveillance

Conditions: Barrett's Esophagus

Summary: neoplasia in barrett's esophagus could be missed during routine random biopsies. we propose a study using chromoendoscopy with acetic acid to increase the yield of biopsies in detecting neoplasia.

neoplasia in barrett's esophagus is often focal and can be missed by nontargeted biopsies alone. in recent years, various advanced endoscopic techniques have been utilized, but with varying success rates. narrow-band imaging, trimodal imaging, spectral imaging and i-scan are technologies that are manufacturer dependent with limited varying success rates and have financial implications. at our institution, narrow band imaging is routinely utilized as a diagnostic tool for detecting barrett's esophagus. acetic acid is a commonly available dye that has been used in the detection of neoplasia in barrett's esophagus. this study is aimed to prove the effectiveness of acetic acid chromoendoscopy in our barrett's esophagus surveillance population. the goal is to compare the neoplasia yield of acetic acid chromoendoscopy with that of standardized random biopsy protocol. the sensitivity and specificity for neoplasia detection by these two methods will also be analyzed. investigators plan to conduct this prospective randomized study for a period of one and a half years (beginning august 1, 2015, ending february 29, 2016). based on data from 2014, we anticipate to enroll approximately 185 patients. all gastroenterologists (with privileges at doctors hospital at renaissance) will participate in this study. patients will be randomized to either acetic acid chromoendoscopy or current standard of care (standardized random biopsy protocol utilizing narrow band imaging). random biopsies from both protocols and targeted biopsies (if identified) will be obtained and submitted to pathology department. these will be reviewed independently by two pathologists. any discordant results will be reviewed by an outside expert pathologist. statistical data analysis will be performed utilizing datadesk xl software.

Eligibility criteria:
inclusion criteria: * patients 18 years and older * previous diagnosis of barrett's esophagus, confirmed by pathology. exclusion criteria: * patients diagnosed with any level of dysplasia on previous esophageal biopsies. * patients who had esophageal therapy with halo radiofrequency ablation in the past, or esophagectomy. * history of allergy to acetic acid * history of esophageal dysplasia or cancer * esophageal ulcerations * esophageal candida * esophageal varices * patients with active esophagitis * patients who cannot provide a valid consent * patients who are currently pregnant

Keywords: barrett's esophagus acetic acid chromoendoscopy
periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation (popular pause tavi)

Conditions: Aortic Valve Disease; Aortic Valve Stenosis; Stroke; Bleeding; Vascular Complications; Myocardial Infarction; Thrombosis Embolism

Summary: transcatheter aortic valve implantation (tavi) is a rapidly growing treatment option for patients with aortic valve stenosis. stroke is a feared complication of tavi, with an incidence of around 4-5% in the first 30 days. up to 50% of patients undergoing tavi have an indication for oral anticoagulants (oac) mostly for atrial fibrillation. oac use during tavi could increase bleeding complications, but interruption during tavi may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). recent observational data suggest that periprocedural continuation of oac is safe and might decrease the risk of stroke. beside the potential reduction of thromboembolic events, continuation of oac is associated with an evident clinical ancillary benefit for patients and staff. since periprocedural oac interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen. hypothesis: periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days


Eligibility criteria:
inclusion criteria: * planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure * uses oral anticoagulation at screening * provided written informed consent exclusion criteria: patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.: * mechanical heart valve prosthesis * intracardiac thrombus * \< 3 months after venous thromboembolism * \< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation

Keywords: transcatheter aortic valve implantation (tavi) transcatheter aortic valve replacement (tavr) aortic valve disease aortic valve stenosis stroke bleeding vascular complications myocardial infarction thrombosis embolism heart diseases oral anticoagulation warfarin vitamin k antagonist direct acting oral anticoagulants protamine
inferior vena cava assessment in term pregnancy using ultrasound: a feasibility study of subxiphoid and ruq views

Conditions: Hypotension; Hypovolemic Shock

Summary: this study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (ivc), a large vein that returns blood to the heart. ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. it is hoped that imaging of the ivc will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. this study will not involve any change in management of the participating patients.

anesthesiology consultants and trainees with us experience will first perform scans from the ruq view starting on the mid-axillary line at the t4 intercostal space, looking to obtain a view of the ivc as it enters the right atrium (ra). following successful acquisition, the examiner will perform scan from the subxiphoid position, looking to obtain the same view of the ivc transitioning into the ra. primary endpoint will be time to obtaining quality of images. the investigator will use a stopwatch to time acquisition of images. if the duration of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. each image will be separately reviewed by 2 different us specialists with extensive us experience. images will be assessed according to a likert scale from 1 to 5. (very poor (1), poor (2), acceptable (3), good (4), very good (5)) secondary endpoints will be assessed as follows: 1. acceptability: all patients participating in the study will complete a questionnaire to assess acceptability. 2. comfort: during the exam the patient will have the option to suspend the scan by stating they are uncomfortable and wish to stop. each request will be noted and taken into the account at data analysis. furthermore, patients will be given a questionnaire at the end of the scan and asked to rate their comfort level during procedure according to likert scale. (very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very uncomfortable (1)) 3. ease of exam: examiner will rate the ease of image acquirement according to likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5))

Eligibility criteria:
inclusion criteria: * adults pregnant females, * age 18-45, * term pregnancy parturients not in established labor singleton pregnancies exclusion criteria: * advanced labor, * multiple gestations, * maternal or fetal distress, * bmi \> 45. * inability to obtain informed consent
multidisciplinary approach to the treatment of insomnia and comorbid sleep apnea

Conditions: Obstructive Sleep Apnea; Insomnia

Summary: the overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with obstructive sleep apnea (osa) and comorbid insomnia. specific aim 1: to determine the efficacy of a treatment model combining cognitive behavioral therapy (cbt) and continued positive airway pressure(cpap) for individuals with osa and comorbid insomnia. specific aim 2: to determine if there are relative benefits in the sequence of treatment initiation. specific aim 3: to examine the mechanisms between insomnia symptoms and cpap adherence.

osa is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of osa treatment. it is currently unknown if direct treatment of insomnia will enhance outcomes of osa treatment. the investigators at the rush sleep disorders center have developed an approach that combines cbt for insomnia delivered by a psychologist with cpap therapy managed by a physician. building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating osa using cpap alone.

Eligibility criteria:
inclusion criteria: * males and females age 18 and older. * meets criteria for obstructive sleep apnea * meets criteria for an insomnia disorder exclusion criteria: * comorbid medical condition that requires immediate treatment of osa * severe cases of osa that require immediate treatment * psychiatric conditions that may interfere with study protocol or uncontrolled psychiatric conditions that require immediate treatment * comorbid sleep disorders that require treatment outside of the study protocol * other sleep-related breathing disorder besides osa * excessive daytime sleepiness that requires immediate treatment or presents significant risk * cpap use or formal cbt for insomnia within the past 6 months

Keywords: cbt cpap multidisciplinary treatment combination treatment