Kornimate/medical-research-clean huggingface dataset:
feasibility and safety of same day discharge after atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: catheter ablation with pulmonary vein (pv) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation. the conventional approach for post-procedure care has been for the patient to stay overnight and be discharged the next day. however, the overall incidence of procedure related complications of catheter ablation for atrial fibrillation in high volume centers is low. new technologies have been introduced and improve the safety of the ablation procedure. discharging patients the same day after ablation is a practice that's currently followed by many centers in the united states and abroad. the investigators' hypothesis is that the currently available advanced technologies allow for the same-day safe discharge of patients after catheter ablation. the investigators propose a prospective single-arm study to evaluate the feasibility and safety of the same-day discharge after af ablation at mgh. the protocol of same-day discharge will include the use of a commercially available venous closure device, early ambulation, bed-side echocardiogram, and follow-up phone calls at day 1 and 3 post-procedure.


Eligibility criteria:
inclusion criteria: * age \>18 - age \< 75 yr * documentation of atrial fibrillation (af) or atypical atrial flutter * all patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements exclusion criteria: * heart failure with reduced ejection fraction less than 40% * any reversible cause of af (post-surgery, thyroid disorder, etc.) * inr \> 4.0 at the time of the procedure * mental impairment precluding verbal consent or completing follow up * patients with any other significant uncontrolled or unstable medical condition * women who are known to be pregnant or have had a positive β-hcg test within 7 days prior to procedure * presence of left atrial thrombus * patients with prior prostate hypertrophy or bladder surgery * bmi \> 40 or bmi \<20 * patients with h/o symptomatic heart failure * patients with severe aortic stenosis (as) or severe mitral regurgitation (mr) * patients who require femoral arterial line for blood pressure monitoring
acute effects of an oral fat load on skeletal muscle and hepatic insulin sensitivity

Conditions: Insulin Sensitivity

Summary: the development of type 2 diabetes is based on a combination of insulin resistance and beta cell dysfunction. in the last years, elevated ffa were recognized as a key players in the pathogenesis of insulin resistance and type 2 diabetes. the study compares the acute effects of an oral lipid bolus on insulin sensitivity and hepatic glucose metabolism in healthy humans.

a dysregulation of lipid metabolism with increased levels of free fatty acids (ffa) represents one key mechanism in the pathogenesis of insulin resistance, which contributes to the development of type 2 diabetes (t2d). in most cases, dyslipidemia is related to obesity and the metabolic syndrome. not only skeletal muscle glucose uptake, but also hepatic glucose fluxes are altered in insulin resistant states. in obese and t2d subjects, rates of gluconeogenesis (gng) are increased, but in obese normoglycemic subjects endogenous glucose production (egp) remains constant because of downregulation of glycogenolysis (gl). however, in t2d subjects, both gng and gl are elevated, contributing to fasting and postprandial hyperglycemia. therefore, elevated gng rates may represent an early event in the pathophysiology of insulin resistance and t2d. preliminary studies of our institute show that intravenous lipid infusion with subsequent elevation of ffa results in increased gng rates without alteration of egp in lean, non-diabetic subjects. in another recent study we investigated the effects of an oral fat load on hepatic insulin sensitivity. as expected, we did not find any alterations in egp; however, rates of gng and gl have not been assessed. the aim of this study is to analyze the effects of an oral fat load with transiently elevated levels of circulating lipids on hepatic glucose fluxes, especially gng and gl, to elucidate the role of dietary fat in the induction of insulin resistance in healthy humans. in this randomized, controlled cross-over study, effects of oral palm oil and canola oil ingestion will be investigated in young, healthy lean subjects. hepatic glucose fluxes will be assessed by two independent methods, in vivo magnet resonance spectroscopy (mrs) and the deuterated water/acetaminophen method, which also allows for the determination of glycogen cycling rates. furthermore, hepatic phosphorus metabolites and liver fat content will be monitored by mrs.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects * age 20-40 * bmi 20-25 kg/m2 exclusion criteria: * hyperlipidemia * smoking * pregnancy * allergy against paracetamol/palm oil/canola oil * contraindication for mri investigations * anaemia * taking drugs influencing lipid or glucose metabolism, the immune system or antihypertensive treatment * m. meulengracht * hepatitis/hiv * chronic diseases

Keywords: oral fat insulin sensitivity
development of a novel convolution neural network for arrhythmia classification

Conditions: Arrhythmias, Cardiac; Cardiac Arrest; Cardiac Arrythmias

Summary: identifying the correct arrhythmia at the time of a clinic event including cardiac arrest is of high priority to patients, healthcare organizations, and to public health. recent developments in artificial intelligence and machine learning are providing new opportunities to rapidly and accurately diagnose cardiac arrhythmias and for how new mobile health and cardiac telemetry devices are used in patient care. the current investigation aims to validate a new artificial intelligence statistical approach called 'convolution neural network classifier' and its performance to different arrhythmias diagnosed on 12-lead ecgs and single-lead holter/event monitoring. these arrhythmias include; atrial fibrillation, supraventricular tachycardia, av-block, asystole, ventricular tachycardia and ventricular fibrillation, and will be benchmarked to the american heart association performance criteria (95% one-sided confidence interval of 67-92% based on arrhythmia type). in order to do so, the study approach is to create a large ecg database of de-identified raw ecg data, and to train the neural network on the ecg data in order to improve the diagnostic accuracy.


Eligibility criteria:
inclusion criteria: * all ecg data compiled from 12-lead ecg, single, and multiple lead databases exclusion criteria: * none

Keywords: artificial intelligence machine learning neural network cardiac arrhythmia ecg ekg
correlation between hepatic fibrosis and cardiovascular risk evaluated by non-invasive tests in patients with nafld

Conditions: NAFLD

Summary: this study aims to examine the link between non-alcoholic fatty liver disease (nafld) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. the study would clarify the value and the role of the coronary calcium score (cac score) in the screening for coronary disease in this population at high cardiovascular risk.

hepatic fibrosis and cardiovascular risk are evaluated by non invasive tests

Eligibility criteria:
inclusion criteria: * nafld patients regardless of disease stage of severity (from simple steatosis to cirrhosis) * patient without known heart disease * patient agreeing to participate and who has given his non opposition exclusion criteria: * association with another cause of liver disease * already known coronary artery disease * pregnancy or breastfeeding in progress

Keywords: cac score liver fibrosis cardiovascular risk metabolic syndrome
trodat 1 spect and dopamine polymorphism

Conditions: Parkinson Disease

Summary: the study population will include 100 parkinsonian patients in early stage of disease, with total duration not exeeding 5 years. the patients will undergo neurologic examination and evaluation of disease severity using the unified pd rating scale. subsequently a brain spect will be performed using tc-99m-trodat1.

the study sample will include 100 israeli jewish patients with early idiopathic pd who were not treated with anti-parkinson drugs. the clinical diagnosis will be based on the criteria of the united kingdom parkinson disease society brain bank.5 all patients will undergo tc-99m-trodat1 spect. the severity of the motor symptoms will be assessed with the unified pd rating scale (updrs). genomic dna is extracted from peripheral blood leukocytes for genetic analysis.

Eligibility criteria:
inclusion criteria: inclusion criteria were 1. early israeli pd patients 2. of jewish origin, males or females 3. undergoing dat-scan examination in wolfson medical center at early stage of disease, accompanied by a updrs evaluation at that stage,performed by a trained neurologist 4. patients did not use any type of anti-parkinsonian drug type, at time of dat-scan performance and updrs evaluation 5. dna sample was obtained 6. patients were able to sign an informed consent form to participate in this study. exclusion criteria: * patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.

Keywords: severity of disease
a study to evaluate the safety and effectiveness of ertapenem versus ceftriaxone/metronidazole in the treatment of intra-abdominal infections in adults (0826-802)

Conditions: Intra-abdominal Infection

Summary: a multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.


Eligibility criteria:
inclusion criteria: * male or female patients age 18 or older * patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain exclusion criteria: * patient has another infection, other than abdominal * female patient is pregnant or planning to become pregnant
pilot feasibility study of the safety and efficacy of anakinra in heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: this will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of interleukin-1 (il-1) blockade with anakinra in patients with stable heart failure with preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * symptoms and signs of congestive heart failure * recent imaging study (\ 50% and left ventricular end diastolic volume index (lvedvi) \<97ml/m2 * evidence of abnormal left ventricular (lv) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following: 1. invasive hemodynamic measurements * mean pulmonary capillary wedge pressure (mpcw) \>12 * left ventricular end diastolic pressure (lvedp) \>16 mmhg 2. tissue doppler echocardiogram * e/e' \>15 * e/e' 8-15 and one of the following * left ventricular hypertrophy (lvh) * atrial fibrillation * left atrial enlargement * e/a \ 280 (if \>50yrs of age) 3. biomarkers * brain natriuretic peptide (bnp) \>200pg/ml exclusion criteria: * age \<18 * recent changes (previous 3 months) in hf maintenance medications (beta-blockers, angiotensin converting enzyme \[ace\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics) * hospitalization for worsening heart failure (hf) or acute decompensated hf within the previous 12months * anticipated need for cardiac resynchronization therapy (crt) or automated-implantable cardioverter defibrillator (aicd) * angina or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing * active infection including chronic infection * active cancer * recent (\<14 days) use of anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs \[nsaids\]), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study * pregnancy (determined by urine pregnancy test in women of childbearing potential) * inability to give informed consent * other conditions limiting completion of cardiopulmonary exercise test or completion of the study

Keywords: heart failure with preserved ejection fraction diastolic heart failure aerobic exercise performance
phase iii randomized, double-blind, placebo-controlled study of dichlorphenamide for periodic paralyses and associated sodium channel disorders

Conditions: Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Paramyotonia Congenita

Summary: objectives: i. assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution and diagnosis. the weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover. patients are randomly assigned to oral dichlorphenamide (dcp) or placebo for 9 weeks and then cross to the alternate treatment. patients on dcp at baseline continue on the same dose; those on acetazolamide (acz) at baseline receive a dcp dose equivalent to one fifth of the acz dose.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- hypokalemic periodic paralysis typical clinical profile normal serum thyroxine hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member periodic paralysis associated with sodium channel 17q alpha-subunit, e.g.: * hyperkalemic periodic paralysis with or without myotonia * paramyotonia congenita with periodic paralysis distinct, regular episodes of weakness at least once a week and no more than 3 times a day no history of worsening symptoms with carbonic anhydrase inhibitor no history of life-threatening weakness episodes prior to treatment no atypical periodic paralysis without demonstrable 17q alpha-subunit defect --prior/concurrent therapy-- no requirement for the following agents, unless for periodic paralysis: * diuretics * antiepileptics * antiarrhythmics * magnesium supplements * steroids * calcium supplements * beta-blockers * potassium supplements * calcium channel blockers --patient characteristics-- hepatic: no hepatic disease renal: * no renal failure * no nephrolithiasis cardiovascular: * no heart disease * no cardiac arrhythmia pulmonary: no restrictive or obstructive lung disease other: * no active thyroid disease * no pregnant women

Keywords: neurologic and psychiatric disorders periodic paralysis rare disease
a phase 3 study of du-176b, prevention of venous thromboembolism in patients after total knee arthroplasty

Conditions: Venous Thromboembolism

Summary: the objective of this study is to assess the efficacy and safety of du-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients undergoing unilateral total knee arthroplasty exclusion criteria: * subjects with risks of hemorrhage * subjects with thromboembolic risks * subjects who weigh less than 40 kg * subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.

Keywords: anticoagulant venus thromboembolism thrombosis thromboembolism embolism and thrombosis deep vein thrombosis du-176b edoxaban factor xa total knee arthroplasty enoxaparin sodium
study of the involvement of il-17 / il-22 pathway in bacterial exacerbations of copd

Conditions: Pulmonary Disease, Chronic Obstructive; Bacterial Infections

Summary: chronic obstructive pulmonary disease (copd) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. the chronic course of copd is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of copd patients. a bacterial etiology for these exacerbations is common (almost 50%). moreover, airway bacterial colonization linked to an increased susceptibility is observed in copd patients. effective th17 immune response is needed to develop a good response against bacteria. thus, this study aims to demonstrate that there is a defective il-17/ il-22 response to bacteria in copd leading to airway bacterial colonization and infection.


Eligibility criteria:
inclusion criteria: * diagnosed copd according gold guidelines * current or ex-smoker (at least 10 pack-years) * hospitalized for copd exacerbation exclusion criteria: * asthma or cystic fibrosis * no other chronic lung disease * solid tumor unhealed or not considered in remission * inhaled drug consumption * women of childbearing potential without effective contraception * pregnant or breastfeeding women * incapable of consent * lack of social security coverage

Keywords: interleukin-17 interleukin-22 microbiota exacerbations immunity mucosal
prospective study comparing extended with limited pelvic lymphadenectomy in intermediate and high risk prostate cancer patients undergoing radical prostatectomy

Conditions: Prostate Cancer

Summary: prostate cancer is currently the second most common cause of cancer death in men in western countries. lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically indicated in intermediate and high risk prostate cancer patients and is held at the same time of prostatectomy. a traditionally pelvic lymphadenectomy covers the obturator chain bilaterally. recently, some studies have demonstrated the existence of lymph node involvement outside the traditional boundaries of classical lymphadenectomy, recommending therefore extended dissection; this also includes the external / internal / common iliac chains and presacral. thus lymphadenectomy, according to these authors, would also has a therapeutic role, besides helping in better staging. although some retrospective studies report an association between lymphadenectomy and tumor progression, the exact impact of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not clearly established, mainly by lack of prospective randomized studies on the subject . the study objectives are to compare the oncologic results of extended lymphadenectomy versus limited in order to elucidate the role of extended dissection in lymph node staging and results of treatment in terms of increased tumor cure. the investigators also intend to identify patients who may benefit from oncologically extended procedure. to do this, the investigators will evaluate prospectively patients diagnosed with prostate cancer at intermediate or high risk indicating lymphadenectomy and radical prostatectomy. these patients will be randomized to the extended versus limited lymphadenectomy and the investigators will compare the lymph node metastasis and pattern of spread of prostate cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis and cancer-specific survival.


Eligibility criteria:
inclusion criteria: * prostate cancer patients with intermediate or high risk and with indication of radical prostatectomy and lnd * absence of bone metastasis or other organ imaging test (mri or scintigraphy) * absence of hormone treatment * absence of radiotherapy * signing an informed consent * availability and adequacy of lymph node tissue samples to perform the immunohistochemical exclusion criteria: * life expectancy less than 10 years * absence of clinical conditions for the procedure * laparoscopic or perineal surgery * presence of bone or visceral metastasis * neoadjuvant treatment * another malignant neoplasia * prior abdominal or pelvic surgery

Keywords: prostate cancer prostate specific antigen lymphadenectomy limited lymphadenectomy extended lymphadenectomy immunohistochemistry
botox® treatment in pediatric upper limb spasticity

Conditions: Pediatrics; Muscle Spasticity; Cerebral Palsy; Stroke

Summary: this study will evaluate the safety and efficacy of botox® (botulinum toxin type a) in pediatric patients with upper limb spasticity.


Eligibility criteria:
inclusion criteria: * minimum weight of 10 kg/22 lb * upper limb spasticity due to cerebral palsy or stroke exclusion criteria: * muscular dystrophy, myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease * uncontrolled epilepsy * botulinum toxin therapy of any serotype for any condition within the last 6 months * previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study * previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study
isolated vascularized gastric tube biliary enteric drainage: a paediatric case series experience.

Conditions: Biliary Obstruction; Choledochal Cyst

Summary: this was a retrospective case series experience of paediatric patients who had an isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. we reviewed our experience and outcomes.

background despite the enormous surgical advancements in the last century, access to the biliary system is lost when a roux-en-y (ry) biliary drainage procedure is performed. attempts have been made to overcome this inconvenient sequel of ry biliary drainage by the use of variations in the ry anastomosis, small bowel grafts and vascular grafts. these have been predominantly unsuccessful. the use of an isolated vascularized gastric tube (ivgt) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. the investigators have adopted the technique of using an ivgt graft for bile duct reconstruction in the paediatric patients at their institution. method the investigators reviewed theirr experience at greys hospital, pietermaritzburg. this was a retrospective review of all paediatric patients who had undergone an ivgt graft procedure for biliary tract anatomical obstruction in the past five years. the investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

Eligibility criteria:
inclusion criteria: * all patients from birth to 12 years with biliary tract obstruction requiring surgery. exclusion criteria: * biliary atresia

Keywords: choledochal cyst paediatric roux-en-y bile drainage gastric conduit