Kornimate/medical-research-clean huggingface dataset:
the gore scaffold clinical study

Conditions: Carotid Artery Disease; Carotid Artery Stenosis

Summary: evaluate the safety and efficacy of the gore® carotid stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy

this is a prospective, multicenter, single-arm clinical study comparing outcomes with the gore® carotid stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years old at informed consent * patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone. * patient is willing to provide written informed consent prior to enrollment in study. * patient is either: * symptomatic with carotid stenosis ≥50% as determined by angiography using nascet methodology. symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; transient ischemic attack (tia) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; or * asymptomatic with carotid stenosis ≥80% as determined by angiography using nascet methodology * patient must be considered high risk for adverse events during carotid endarterectomy note: additional inclusion criteria may apply exclusion criteria: * patient has life expectancy of less than one year. * patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke. * patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (pfo), mechanical heart valve, or deep vein thrombosis (dvt) treated within 6 months). * patient has had an acute myocardial infarction within 72 hours prior to the index procedure. * patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments. * patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure. note: additional exclusion criteria may apply

Keywords: stroke carotid artery stenting (cas) embolic protection device (epd) stent carotid stenosis constriction, pathologic carotid artery diseases cerebrovascular disorders brain diseases central nervous system diseases nervous system diseases arterial occlusive diseases vascular diseases cardiovascular diseases pathological conditions, anatomical angioplasty
pilot trial of surfactant therapy for preterm neonates 5-21 days old with respiratory decompensation

Conditions: Respiratory Distress Syndrome

Summary: the purpose of the study is to determine whether additional surfactant(infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.

pulmonary surfactant is required for normal lung function. preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein b content. we propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x fio2) rising from a baseline of \ 3.5, sustained for \> 24 hours. infants will receive two doses of infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the hospital of the university of pennsylvania, and women and children's hospital of buffalo.

Eligibility criteria:
inclusion criteria: * less than 1250 gm birthweight * day 5-21 of life * intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline \ 3.5, sustained for \>24hr. note: prior surfactant therapy at birth is neither an inclusion nor exclusion criterion. exclusion criteria: * serious congenital malformations * life expectancy \< 7 days from enrollment * patent ductus arteriosus at time of decompensation * pulmonary hemorrhage as cause of respiratory decompensation * active air leak syndrome at time of decompensation * postnatal steroid therapy for lung disease

Keywords: prematurity lung disease hyaline membrane surfactant
intra-articular corticosteroid injection compared with single-shot hyaluronic acid for treatment of osteoarthritis knee

Conditions: Knee Osteoarthritis

Summary: corticosteroid and hylan g-f 20 are both effective in improving pain and function of osteoarthritic knee patients.

corticosteroid and hylan g-f 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee oa * knee pain for most days of the prior month * radiographic evidence consistent with knee oa * aged between 40 and 80 years old exclusion criteria: * lumbar spondylosis * gross deformity of the knee * co-existent inflammatory or crystal arthritis * prior knee surgery * injury to the knee in the preceding 6 months * any intra-articular injection in the preceding 3 months * pregnant or lactating * current infection in the affected knee * inability to provide informed consent

Keywords: knee osteoarthritis corticosteroid hyaluronic acid intra-articular injection
combination effects of pregabalin and dexmedetomidine on postoperative pain

Conditions: Pain, Postoperative

Summary: pregabalin and dexmedetomidine have been introduced to manage postoperative pain. the present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia

one hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group c (n = 31, placebo), group p (n = 33, pregabalin), group pd (n = 29, pregabalin and dexmedetomidine) or group d (n = 31, dexmedetomidine). one hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg iv dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (vas), ketorolac dose, and patient controlled analgesics (pca) volume consumed were recorded.

Eligibility criteria:
inclusion criteria: * asa i-ii * aged 18-75 years one hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia exclusion criteria: * pregnant * allergic and/or contraindicated to the study drugs * american society of anesthesiologists (asa) score iii and above * having drug * alcohol addiction * renal failure * diabetes mellitus * epilepsy * currently using opioids for chronic pain and/or any of the drugs studied.

Keywords: pregabalin, dexmedetomidine, postoperative pain
effect of transversus abdominis plane block combined with dexmedetomidine infusion on the prognosis in elderly patients undergoing abdominal surgery

Conditions: Colorectal Neoplasms; Aged

Summary: to compare the prognosis of elderly patients undergoing radical resection of colorectal cancer treated with general anesthesia and general anesthesia combined with transversus abdominis plane block and continuous infusion of dexmedetomidine. the incidence of postoperative delirium, postoperative acute pain moderately to severely and poor postoperative recovery were composite endpoints to determine the prognosis of patients.


Eligibility criteria:
inclusion criteria: * aged 65-80 years,regardless of gender * american society of anesthesiologists physical status i-iii * undergoing elective radical resection of colorectal cancer * sign informed consent exclusion criteria: * could not cooperate to complete the pain vas evaluation * could not cooperate to complete the cognitive function assessment

Keywords: delirium pain, postoperative dexmedetomidine transversus abdominis plane block
valve leaflet motion in sutureless bioprosthetic aortic valves

Conditions: Aortic Valve Stenosis; Heart Valve Disease

Summary: a single-center prospective interventional trial. patients implanted with a sutureless bioprosthetic aortic valve at karolinska university hospital in stockholm, sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (ct) of the heart will be performed. the aim of the ct is to assess valve leaflet motion. results of the ct examination, preoperative clinical characteristics, and postoperative clinical data will be registered. data will be collected prospectively and retrospectively. informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility criteria:
inclusion criteria: * implanted with a sutureless perceval (sorin group) sutureless bioprosthetic aortic valve at karolinska university hospital in stockholm, sweden between 2012 and 2016 * provide written informed consent exclusion criteria: * contraindication for ct with intravenous contrast injection
study of alemtuzumab to treat advanced mycosis fungoides/sezary syndrome

Conditions: Mycosis Fungoides; Sezary Syndrome

Summary: the investigators designed a compassionate basis phase ii study for refractory/relapsed mycosis fungoides/sezary syndrome consisting of alemtuzumab (campath) for primary evaluation of overall response and time to relapse. other goals to consider are toxicity and time to new therapy.

* 20 relapsed or refractory advanced mycosis fungoides/sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks. * patients must have serology negative for human t-lymphotropic virus 1 (htlv-1) and until three different regimens of chemotherapy. * follow up for one year after last cycle of alemtuzumab.

Eligibility criteria:
inclusion criteria: * above 18 years old * eastern cooperative oncology group (ecog) 0-2 * liver and renal function test less than twice upper label * no active infection * written informed consent * one to three regimens of previous chemotherapies exclusion criteria: * abnormal renal or hepatic function * mycosis fungoides/sezary syndrome in transformation * hiv + * htlv-1 + * pregnancy * lactation

Keywords: alemtuzumab mycosis fungoides sezary
effectiveness of treatments for cirrhosis with varicose veins

Conditions: Esophageal Varices Bleeding; Portal Hypertension

Summary: liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (tips), and surgical interventions. however, mortality remains high, and each treatment modality has its own limitations and controversies. this study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis b, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. the study includes patients admitted for portal hypertension-related esophagogastric varices from february 2022 to december 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and child-pugh classification, will be collected. follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. the primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications. the sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. statistical analysis will be performed using spss 24.0 and r software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or fisher's exact test. the study has been approved by the ethics committee, and informed consent will be obtained from all participants.


Eligibility criteria:
inclusion criteria: ① age greater than 18 years, with no gender restriction. ② patients admitted for portal hypertension-related esophageal and gastric varices from february 2022 to december 2024. exclusion criteria: * age \< 18 years ② absence of esophageal or gastric varices ③ incomplete medical history records
cpet predicts long-term survival and positive response to crt

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the study tested the usefulness of cardiopulmonary exercise test (cpet) in selection of potential responders to crt.

cardiac resynchronization therapy (crt) is an acknowledged therapy of selected patients with heart failure (hf). one of the unresolved problems is high percentage of non-responders to crt, reaching 40%. no single parameter, helpful in identifying non-responders prior to crt implantation, was found. the study included patients with hf of ischemic or non-ischemic etiology, in nyha class ii-iv, ef≤35% and qrs≥120ms. all the patients had crt implanted. clinical evaluation, cpet and nt-probnp levels measurement were performed before crt implantation and after 3-6 months. improvement in hf symptoms of one or more nyha class correlated with two-years survival. it was used as the criterion of positive response to crt.

Eligibility criteria:
inclusion criteria: * hf in class iii or iv according to new york heart association (nyha) in the course of ischemic (icm) or non-ischemic cardiomyopathy (nicm), qrs complex duration ≥ 120ms, ef ≤35% and dilatation of the left ventricle diastolic diameter \>55mm (lvdd), according to the esc guidelines in 2007 * hf in nyha class ii, lbbb with qrs complex duration ≥ 150 ms according to the guidelines update in 2010 * optimal pharmacotherapy of hf in the period of three months prior to the study entry. * the expected survival of the patient \> 1 year. exclusion criteria: * severe chronic obstructive pulmonary disease (fev1 \<30%) * inability to perform a stress test on a treadmill

Keywords: heart failure cardiac resynchronization therapy cardiopulmonary exercise test responders to crt non-responders to crt survival prognosis after crt
comparison of loss of resistance techniques

Conditions: Pain Relief

Summary: the purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

when the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. this is used to help identify the placement of the epidural needle. both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. in group saline, 3 ml of saline will be used. in group air, 3 ml of air will be used in the syringe during the procedure. the medicine will be administered in the usual manner the doctor has identified the correct location for administration. the amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

Eligibility criteria:
inclusion criteria: * pregnant females weighing less than or equal to 250 lbs * request for neuraxial labor analgesia exclusion criteria: * asa physical status greater than ii

Keywords: quality of pain relief with 2 different methods of identifying epidural space
a pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.

Conditions: Advanced Solid Tumors

Summary: a pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.

this study is designed to assess the mass balance of \[14c\]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. subjects may continue on linifanib after completion of the metabolism study. the results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.

Eligibility criteria:
inclusion criteria * subject must be \>/= 18 years of age. * subject must have a histologically or cytologically confirmed non-hematologic malignancy. * eastern cooperative oncology group (ecog) performance score of 0 to 2. * subject must have adequate bone marrow, renal and hepatic function. * subject must have partial thromboplastin time (ptt) \</= 1.5 x upper limit of normal (uln) and international normalized ratio (inr) \</= 1.5. * subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent. exclusion criteria * subject has received previous administration of a radiolabeled research substance within 12 months prior to study day 1 or exposure to significant radiation (e.g., barium meal, etc.) within the past 3 months or within a period defined by 5 half-lives, whichever is shorter, prior to study day 1. * subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a period defined by 5 half-lives, whichever is shorter, prior to study day 1. * subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g., rifampin) of cytochrome p450 3a (cyp3a) within 1 month prior to study day 1. * subject has not recovered to less than or equal to grade 1 clinically significant adverse effects/toxicities of the previous therapy. * subject has undergone major surgery within 21 days of study day 1. * the subject has brain or meningeal metastases. * the subject has non-small cell lung cancer (nsclc) with a predominant squamous cell histology. * subject is receiving therapeutic anticoagulation therapy. * subject has a history of/or currently exhibits clinically significant events of bleeding (e.g., hemoptysis). * subject has proteinuria common terminology criteria (ctc) grade \> 2 at baseline. * subject currently exhibits symptomatic or persistent, uncontrolled hypertension. * subject has a history of myocardial infarction within 6 months. * subject has known autoimmune disease with renal involvement. * subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (hiv). * clinically significant uncontrolled conditions/medical symptoms. * subject has a documented left ventricular (lv) ejection fraction \< 50%. * subject has previously received linifanib.
the healthy families project

Conditions: Childhood Obesity

Summary: a primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices. enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( pdas). the impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation. among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children \> bmi 85% will be recruited. they will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing. the hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.

1. using hand held pdas, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. screening results will be summarized immediately by the pda and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior 2. we will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the pda screening and counseling program. 3. to support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change. 4. we will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have bmi \>85%. 200 families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. we will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of bmi z scores after 6 months.

Eligibility criteria:
inclusion criteria: * families with children ages 4 to 11 years * for post visit supports; children \> 85% for age bmi

Keywords: childhood obesity primary care counseling screening