Kornimate/medical-research-clean huggingface dataset:
study comparing ebus & eus to mediastinoscopy in staging and detection of lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. the study will enroll 300 subjects, with 150 in each arm. three sites will be in the study, mayo rochester, mayo jacksonville and medical university of south carolina. mayo rochester will enroll approximately 125 subjects. this study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. the consenting subjects will receive eus and /or ebus- guided fna or mediastinoscopy/thoracoscopy.

this is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. the study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (musc, mayo clinic rochester and jacksonville). this sample size will provide sufficient statistical power (i.e. \>80%) using a non-inferiority study design with 1-sided hypothesis testing (farrington and manning 1990) to determine whether or not the sensitivity of the eus/ebus diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. this study requires subjects to agree to the selection of their standard of care procedure. subjects will be randomized (stratified computer generated randomization stratified y center and y ct positivity for pathologically enlarged \[\>1cm short axis\] node - 10 strata). randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. this study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. no additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.

Eligibility criteria:
inclusion criteria: * age 21 years or greater * pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection * known or suspected non-small cell carcinoma of the lung eligible for resection * ct scan performed within 45 days prior to evaluation for study participation * pet scan performed within 45 days prior to evaluation for study participation exclusion criteria: * pathologically proven metastatic disease * history of malignancy within 5 years other than (skin) basal cell carcinoma * enlarged ipsilateral mediastinal lymph nodes \> 2.5 cm in diameter * peripheral t1 tumors with normal mediastinal lymph nodes on ct and pet

Keywords: non small cell lung cancer mediastinum endobronchial ultrasound fine needle aspiration endoscopic ultrasound mediastinoscopy surgical or minimally invasive evaluation of mediastinum nsclc
linked-color imaging for the detection of colorectal flat lesions

Conditions: Colonic Polyp

Summary: linked color imaging (lci) was recently developed and uses a laser endoscopic system (fujifilm co, tokyo, japan) that acquires images by simultaneously using narrow-band short-wavelength light and white-light (wl) in an appropriate balance. lci is a new image-enhancing technology that is intended to enhance slight color differences in the red region of the mucosa. the acquired color information is reallocated to differentiate colors that are similar to the mucosal color, resulting in improved performance in depicting blood vessels, and additional image processing that enhances color separation for red color permits clear visualization of red blood vessels and white pits. this modality may increase the detection rate of colorectal polyps by enhancing the visibility of colonic mucosal vessels. in addition, it has been reported that lci increases the visibility of colorectal flat lesions and contributes to improvement of the detection rate for these lesions. the primary aim of the current study was to compare the detection rate of colorectal flat lesions of lci cap-assisted colonoscopy with wl cap-assisted colonoscopy in prospective randomized trial. in addition, we prospectively compared lci and wl with regard to the visibility of colorectal flat lesions found in this study.


Eligibility criteria:
inclusion criteria: * we enrolled consecutive patients who were referred for colonoscopy to our hospital for diagnostic work up of colonic symptoms, surveillance of colorectal polyps, and colorectal cancer screening. exclusion criteria: * familial colorectal cancer syndrome including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer syndrome, personal history of colorectal cancer or inflammatory bowel disease and those who had previous colonic resection. patients who were considered to be unsafe for polypectomy, including patients with bleeding tendency and those with severe comorbid illnesses, were excluded. those in whom \<90% of mucosa was seen due to mixture of semisolid and solid colonic contents were also excluded because of poor bowel preparation.
navigated total knee arthroplasty, the correlation to ct scans and clinical results

Conditions: Osteoarthrosis

Summary: total knee replacement is one of the most commonly performed orthopedic procedures. as of 2010, about 600,000 total knee replacements were being performed annually in the united states and these numbers are rising. the normal knee joint functions as a complex hinge allowing primarily ﬂexion and extension, rotation and gliding. the knee joint is made up of three compartments, the lateral, medial and anterior (patellofemoral). damage to the cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis, tumors, or congenital deformities. osteoarthritis and rheumatoid arthritis are the causes of the overwhelming majority of total joint arthroplasties. a successful total knee arthroplasty(tka) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems. the common techniques for total knee replacement are: 1. conventional method tkr 2. ct/mri-based preoperative navigated tkr 3. image-free intraoperative navigated tkr in our research we focus on the 3rd method using the orthopilot navigation system aesculap®, tutlingen, germany. this system is an active pc based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment. we aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in aesculap based tka using serview ct. furthermore, we will try to examine the existence of a correlation between the ct scans and the orthopilot navigation system output and assess the clinical outcome of the patient postoperatively. our hypothesis is that the intra-operative navigation system is accurate and correlated to ct images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,


Eligibility criteria:
inclusion criteria: * age over 18 * severe osteoarthrosis of the knee * failure of conservative treatment. exclusion criteria: * patients with severe vascular disease * secondary knee deformation due to muscular atrophy or disease * active infection * morbid obesity * neuropathic knee and osteomyelitis.
morphine in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (ami).


Eligibility criteria:
inclusion criteria: 1. acute myocardial infarction less than 6 hours defined by 1. prolonged chest pain (\>15 min) 2. in association with * st elevation 1mm or more in two contiguous leads * or occurence of q wave in three contiguous leads * or occurence of left bundle branch block 2. culprit lesion eligible for percutaneous coronary intervention (pci) 3. timi flow 0 before pci exclusion criteria: 1. fibrinolysis 2. allergy to morphine 3. active epilepsy 4. brain injury or intracranial hypertension 5. previous ami, coronary artery bypass graft (cabg) 6. cardiac arrest 7. cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion 8. mechanical ventilation at inclusion 9. significant ventricular arrhythmia or atrioventricular block type ii or iii at inclusion 10. decompensated chronic obstructive pulmonary disease at inclusion 11. chronic hepatocellular failure 12. mri contraindications 13. gadolinium chelates injection contraindications 14. current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine

Keywords: acute myocardial infarction cardioprotective effect pharmacological postconditioning morphine chlorhydrate cardiac mri
systolic time intervals in the diagnosis of heart failure in emergency departement

Conditions: Dyspnea

Summary: the gold standard for the diagnostic of acute heart failure is based on clinical, biological (bnp levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations. bnp dosages and echocardiography are not always available in many medical centers, especially in emergency departements, and are expensive. we investigated the use of alternative methods, such as the systolic time intervals (sti), in the diagnosis of acute heart failure (ahf) in emergency departement patients consulting for dyspnea.

ahf is a common cause for dyspnea, but still hard to diagnose. in emergency departements, physicians dispose of a variety of techniques helping them to identify patients with acute onset dyspnea due to cardiac causes and allowing them to initiate the appropriate therapeutics. techniques such as the n type brain natriuretic peptid (nt bnp) dosages and echocardiography, in addition to the clinical exam, are efficient in these cases but they encounter many problems: * the bnp dosages are non-conclusive in some cases (grey zone) and must be repeated wich takes time. * echocardiography is operator - dependent technique and could be misleading in some conditions. * both bnp and echocardiography are expensive and not found in many emergency structures, especially in poor countries. all the arguments pushed us to investigate other simpler and cheaper techniques to apply in these conditions. sti is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals: * pre-ejection period (pep): defined as the interval between the beginning of the qrs wave and the first heart sound (b1). * electro-mechanic activation time (emat): defined as the interval between the two heart sounds b1 and b2 * the pep / emat time in acute onset heart failure, the conduction times are increased, due to tissular lesions, which prolong the pep, also the myocardial contractility is deficient and the heart puts less time to eject the blood volume which decrease the emat and in summary the pep/emat is increased significatively. in this study protocol, we aimed to investigate the diagnostic performance of sti compared to conventional methods in the diagnosis of acute heart failure in emergency department settings.

Eligibility criteria:
inclusion criteria: * non traumatic dyspnea * age more than 18 years old. exclusion criteria: * ecg diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours * history of a heart transplant * pericardial effusion * chest wall deformity suspected of causing dyspnea * coma, shock,mechanical ventilation, vasopressor drugs * arrhythmia serious and sustained, pace maker severe mitral valve disease, severe pulmonary arterial hypertension * renal failure with creatinine \>350micromol/l

Keywords: impedance pep tevg dyspnea ahf bnp
diagnostic value of the electrocardiogram in fabry disease

Conditions: Fabry

Summary: cardiac complications occur in 78% of patients with fabry disease and are mainly characterized by a high frequency of left ventricular hypertrophy resulting from an accumulation of gl3 in cardiomyocytes. apart from family screening, left ventricular hypertrophy is an important factor in the diagnosis of fabry disease. this left ventricular hypertrophy is more often concentric and homogeneous, but it can also be asymmetric and mimic the patterns seen in so-called familial hypertrophic cardiomyopathies caused by mutations in the sarcomere protein genes. electrocardiogram has been suggested as a screening tool for fabry disease. analysis of the pq interval would be of interest. an algorithm has even been proposed to differentiate fabry disease from amyloidosis with excellent sensitivity and specificity. the only criterion of left ventricular hypertrophy used in all studies is the sokolov-lyon index, but this index has many limitations and does not appear to be discriminatory for fabry disease. other validated criteria for left ventricular hypertrophy, such as the cornell, lewis, gubner index or the romhilt-estes point score, have never been tested in fabry disease. the primary objective of our study is to evaluate the diagnostic value of different electrocardiographic scores of left ventricular hypertrophy in fabry disease.


Eligibility criteria:
inclusion criteria: * patients aged \> 18 years, with genetically confirmed fabry disease complicated by lvh. * patients aged \> 18 years, with sarcomeric hypertrophic cardiomyopathy. exclusion criteria: * patients aged \< 18 years. sarcomeric hypertrophic cardiomyopathy for which fabry disease has not been excluded by alpha-galactosidase a assay (in men) and genetic analysis (gla gene mutation) in women.
assessment of cost-effectiveness in two empirically-based psychotherapies for borderline personality disorder: a randomized controlled trial

Conditions: Treatment 1:Dialectical Behavior Therapy (DBT); Treatment 2:Dynamic Deconstructive Psychotherapy (DDP); Placebo

Summary: patients suffering from borderline personality disorder (bpd) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing bpd symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. these findings highlight the importance of effective outpatient treatments for bpd patients in public psychiatric hospital settings. in this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for bpd: dialectical behavior therapy (dbt) and dynamic deconstructive psychotherapy (ddp).

in this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for bpd: dialectical behavior therapy (dbt) and dynamic deconstructive psychotherapy (ddp). sixty-eight participants with bpd will be randomized to each of two treatment groups. participants and therapists will be recruited from the shalvata mhc, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in israel. a blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with ddp or dbt. therapist adherence will be systematically assessed in both treatments for 10% of sessions. primary outcome measure will be comprised of the incremental cost-effectiveness ratio (icer), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. secondary outcome measures will include bpd and depression symptom severity and quality of life. this study was submitted to the institutional review board of the shalvata mhc in november 2019, and is expected to be approved by late janury 2020.

Eligibility criteria:
inclusion criteria: * between 18 and 45 years old * diagnosis of bpd, * history of a suicide attempt within the prior year with presence of current suicidal ideation, * agrees to participate in psychotherapy * signed informed consent, exclusion criteria: * meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.
dietary fatty acids as complementary therapy in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to see how a dietary oil called conjugated linoleic acid, or cla, might be useful in combination with diabetes medication. some studies show that cla can modestly reduce body weight and body fat. our research idea is that taking cla will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.

the long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (t2dm). our central hypothesis is that cla reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, the rationale of this study is that using cla to reduce body weight and body fat in people with t2dm may improve efficacy and longevity of the oral diabetes medications in the management of t2dm. we plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims. specific aim 1: determine the ability of cla to reduce body weight and body fat mass in people using oral diabetes medication for management of t2dm. specific aim 2: determine the ability of cla to modulate insulin sensitivity when combined with oral diabetes medication. specific aim 3: determine the safety and tolerability of cla in combination with oral diabetes medication.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * hba1c ≤ 9% * overweight or obese (bmi ≥ 25 kg/m2 and ≤ 45 kg/m2) * age ≥ 30 and ≤ 70 years (postmenopausal if female) * stable medical therapy for past 3 months * stable body weight (within ± 2 kg) for past 3 months * plans to remain in the columbus, oh metropolitan area for at least 1 year exclusion criteria: * substance abuse * current use of prescription or over-the-counter medications or supplements known to affect body composition * current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(tzds) * current or previous diagnosis of congestive heart failure * self-report of claustrophobia * abnormal liver function * impaired cognitive function * current or previous diagnosis of renal disease * gastrointestinal diseases or disorders * current use of hormone therapies, or use within the past 3 months * discontinuation of diabetes medication

Keywords: type 2 diabetes mellitus conjugated linoleic acid weight loss rosiglitazone glucose control insulin sensitivity
impact of a 12-week pelvic floor training on urinary incontinence in functional fitness training athletes

Conditions: Strength; Muscle Activation; Urinary Incontinence (UI)

Summary: functional fitness training (fft) is a prominent exercise regimen, that has emerged as the dominant fitness trend of the 21st century , advocating high-intensity exercises with repetitive, impactful movements that often result in increased intra-abdominal pressure (iap) and neuromuscular fatigue. this demanding training pattern, characterized by minimal rest pauses, has been associated with potential health concerns, particularly urinary incontinence (ui). in athletes, ui is intricately connected to the frequency of exposure to increased iap during high-impact activities. these activities assume even greater significance in sports, particularly in fft, where there is an increased frequency of impactful foot contact on the ground and intensive abdominal exercises, potentially correlating with the overload of the pelvic floor muscles and the emergence of dysfunctions. therefore, this study aims to examine the effects of a 12-week training program focused on kegel exercises performed with diaphragmatic breathing in nulliparous female fft athletes. the central hypothesis postulates that after the 12-week intervention, these women will exhibit enhancements in both the muscular activation and contractile capacity of their pelvic floor, leading to a reduction in instances of urine leakage.


Eligibility criteria:
inclusion criteria: * nulliparous fft female athletes * had been practicing fft or weightlifting for at least 2 years * train a minimum of 3 days/week * had not previously performed pelvic floor exercises * had no medical contraindications or previous pelvic floor surgeries exclusion criteria: * any criterion that does not meet the inclusion criteria
effect of transmagnetic stimulation on conditioned pain modulation (cpm)

Conditions: Headache; Migraine

Summary: while some indications of the neural circuits involved in the conditioned pain modulation (cpm) process are now available, there is still need to clarify what parts of the brain are essential for this process, whether the spino-brainstem loop is largely sufficient to explain cpm or whether other cerebral and spinal regions such as frontal, somatosensory and other cortical regions contribute substantially. whereas mere observation of correlation between these circuits while activated by brain imaging is still of considerable interest, direct experimental manipulations by repetitive transcranial magnetic stimulation (rtms) could even establish insights into causal relationships.

rtms of different intensities, frequencies and location will be applied during cpm to evaluate the central mechanisms of pain modulation, their location and role in pain reduction through enhancement or suppression of activity in the relevant brain regions. in other words, cortical regions that may be implicated in cpm will be determined by augmenting or interrupting their activity via rtmsapplied to the areas under investigation. the regions will be the pain network sites, which are assumed to control the top-down influence on cpm and are superficial enough to be stimulated by the magnetic coil. these include primarily dlpfc (dorsolateral prefrontal cortex) and ofc (orbitofrontal cortex), with possible later addition of other relevant sites such as acc (anterior cortex cinguli), insula and somatosensory cortices, etc. since rtms may be administered in a manner that either reduces or enhances the excitability of the stimulated cortical region, it should be possible to clarify the inhibitory or excitatory role of these regions in the cpm process. in summary, the planned studies should allow for identifying the cortical regions of the descending pain system, which are critical as starting points for the top-down modulation of cpm.

Eligibility criteria:
inclusion criteria: * age 18-70 * males and females * right handed exclusion criteria: * metal in brain/skull * cardiac pacemaker * cohlear implants * history of head trauma * history of epilepsy or seizures * pregnancy

Keywords: tms cpm headache migraine eeg psychophysics