Kornimate/medical-research-clean huggingface dataset:
chronic transcranial direct current stimulation in patients with systemic autoimmune myopathies

Conditions: Myopathy

Summary: systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. the transcranial direct current stimulation technique has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. however, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in the patients with systemic autoimmune myopathies.

systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. depending on the clinical, pathophysiological and laboratory characteristics, they may be subdivided into polymyositis, dermatomyositis, antissintetase syndrome, immune-mediated necrotizing myopathy, and among others. recently, the literature has been presenting better pharmacological treatment options to control these diseases. despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. on the other hand, the association of the transcranial current stimulation technique with motor recovery has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. however, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of chronic transcranial current stimulation session - associated with aerobic exercises - in patients with systemic autoimmune myopathies.

Eligibility criteria:
inclusion criteria: * classification criteria - eular/acr 2017 * classification critera - connors et al. exclusion criteria: * neoplasia * using heart pacemarker * using visceral metalic clips * infections (hiv, htlv-1, hepatitis, etc) * pregnance * previous historical of convulsions or epilepsies
effects of epa on prostate cancer cells proliferation and quality of life

Conditions: Prostate Cancer

Summary: prostate cancer, the most frequently diagnosed cancer among occidental men, is associated with a major individual and societal burden. although still controversial, the literature suggests that a high consumption of omega-3 fatty acids (ω3) has protective effects against prostate cancer. one of the proposed mechanisms of action of ω3 lies in their anti-inflammatory properties. in addition, there are some observational evidences suggesting an association of ω3 intake with a lower rate of depression in cancer patients. however, no clinical study has tested the efficacy of ω3 supplementation on psychological and quality of life outcomes in that population. several evidences point to a possible involvement of inflammation in psychological issues. reducing the systemic inflammatory state may have beneficial impact on the quality of life of these patients. preliminary work from this team of investigators, in a cohort of patients managed with active surveillance for their low-grade prostate cancer, show a strong inverse association between the risk of prostate cancer progression (to high-grade) and the level of prostatic eicosapentanoic acid (epa- a type of ω3). hypothesis: epa-rich monoglycerides fish oil (mag-epa) has global positive effects on prostate cancer cell proliferation, inflammation and on the patient's psychosocial functioning and quality of life. the investigators propose a double blind, randomized controlled clinical trial. 130 consecutive patients suffering from high-risk prostate cancer who choose to be treated by radical prostatectomy will be eligible to this study. the presence of high-grade cancer will be mandatory. the intervention, a daily supplementation with 3g supplement of fish oil monoglycerides rich in epa, vs. placebo capsules containing high oleic sunflower oil, will start six weeks before the prostatectomy and will continue for one year after surgery. the potential confounding variables will be measured before the start of the intervention: age, anthropometric parameters, stage and clinical and pathological tumor grade (gleason score), pre-operative level of prostate specific antigen and diet. this project proposes a simple intervention by dietary supplementation that could eventually help to reduce the incidence and/or progression of prostate cancer, and the consequences of its treatment, and thus could contribute to diminish the heavy individual and societal burden of prostate cancer. the clinical data generated by this trial will serve as solid basis for a large-scale phase iii clinical trial.


Eligibility criteria:
inclusion criteria: * prostate cancer (gleason score \>= 7) * patient has chosen to undergo radical prostatectomy * patient agrees to stop taking any omega-3 supplements at least 3 months before the start of the study * patient has provided informed consent exclusion criteria: * allergy to fish and sunflower * suffering from a bipolar disorder

Keywords: prostatectomy omega-3 fatty acids quality of life inflammation cellular proliferation
comparison of electrotherapies for chronic low back pain

Conditions: Non-specific Chronic Low Back Pain

Summary: the intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the h-wave® device with a commonly used tens device with a sub-therapeutic electrocurrent device. this study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. the results for h-wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.

h-wave® device stimulation (intervention a) plus usual care, transcutaneous electrical nerve stimulation (tens) (intervention b) plus usual care, and sham electrotherapy plus usual care (control). each treatment arm will have identical participants enrolled (n=38 per arm) of with the same number of visits and investigator contact time. eligible participants will be allocated through computerized randomization utilizing a stratified permuted-block randomization employing random block sizes. allocation is concealed. participants and assessors will be blinded. participants will not be told what types of electrotherapy devices are being studied, only that there are different types, and that they may be randomized to receive a sham device. patients will be instructed on the use of the device they received to perform daily home therapy. subjects will be assessed at week 1, 4, 8 and 12 for the primary and secondary outcomes measures. compliance to treatment will be measured through an electronic meter on each of the devices, as well as by patient diary. patients will be allowed to receive usual care from their own health care provider, with the exception of invasive procedures or surgery. results will be analyzed by intention to treat methods.

Eligibility criteria:
inclusion criteria: * chronic low back pain of at least 3 months duration * ages 18-65 * current vas pain rating of 5 on 10 point scale * no pain below the knee * 75% of pain located in low back or buttock pain rather than lower extremity pain * proficient in english * able to complete and tolerate treatment for the study period. exclusion criteria: * prior home use of h-wave device or tens. * prior history of spinal fusion or failed spinal surgery syndrome. * laminectomy, laminotomy or discectomy within 12 months of enrollment. * diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment. * current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices. * active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder). * patients currently or who become pregnant will be excluded.

Keywords: chronic low back pain electrotherapy h-wave h wave tens trial
access hbv assays - european union (eu) clinical trial protocol -

Conditions: HBV

Summary: the objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the access hbv serological marker assays on the dxi 9000 access immunoassay analyzer. the study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational hepatitis b virus assays as required per the european union common technical specification. all samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. pseudo-anonymised collection of samples will require documented patient consent (oral or written).

sensitivity to final status on presumed hbv serological marker positive subjects will be calculated. specificity will be calculated from hospitalized patients and blood donors specimens. false initial reactive rate will be calculated on fresh hospitalized patient samples for access hbsag assay only (qualitative).

Eligibility criteria:
inclusion criteria: * subject aged ≥ 18 years, * subject who has provided consent (oral or written) or sample collected under waiver * with sufficient volume to perform clinical trial testing * and belonging to one of the following enrollment groups: * unselected blood donors * hospitalized patients * presumed hbsag positive patients by confirmatory testing of a ce-marked assay * patients having recovered from natural hbv infection, presumed anti-hbs positive (i.e. anti-hbs and anti-hbc total positive by ce-marked assays) * patients having received hbv vaccination, presumed anti-hbs positive (confirmed by testing at the time of enrollment, i.e. positive for anti-hbs and negative for anti-hbc by ce-marked assays). * presumed anti-hbc total positive patients by a ce-marked assay * presumed anti-hbc igm positive patients by a ce-marked assay with acute/recent hbv infection 8 * presumed hbeag positive patients by a ce-marked assay * presumed anti-hbe positive patients by a ce-marked assay * patients with chronic hbv infection exclusion criteria: * samples from subjects already included in the study\* (\* patient can be included only once per hbv marker study, but can potentially be enrolled for several separate hbv marker studies.)

Keywords: hepatitis b surface antigen (hbsag) total hepatitis b core antibody (hbct) hepatitis b e antigen (hbeag) hepatitis b e antibody (hbeab) hepatitis b surface antibody (hbsab) igm antibody to hepatitis b core antigen (hbc igm)
multicenter, randomized, double-blind, double-dummy, parallel-group comparison of the remission rates of once daily treatment with esomeprazole 20mg and lansoprazole 15mg for 6 months in patients whose ee has been healed

Conditions: Erosive Esophagitis

Summary: a study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (ee) that is in remission (i.e. previously healed ee).


Eligibility criteria:
inclusion criteria: * episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline * confirmed diagnosis of erosive esophagus, patients must undergo an endoscopy before entering the study. exclusion criteria: * any signs of gastrointestinal bleeding at the time of the starting the study. * any previous gastric or esophageal surgery. * various gastrointestinal diseases as listed in the protocol.

Keywords: erosive esophagitis nexium esomeprazole lansoprazole heartburn
use of procalcitonin in the diagnosis of pleural effusion

Conditions: Pleural Effusion

Summary: among several markers of inflammation and sepsis, procalcitonin (pct) markers is being studied to investigate their accuracy for the diagnosis of bacterial infections. pct is the prehormone of calcitonin, which is normally secreted by the c cells of the thyroid in response to hypercalcemia; under these normal conditions, negligible serumpct concentrations are detected. the mechanism proposed for pct production after inflammation and its role are still not completely known. it is believed that pct is produced by the liver and peripheral blood mononuclear cells, modulated by lipopolysaccharides and sepsis-related cytokines. it binds to polysaccharides in pathogens, activating the classical complement pathway. the reported diagnostic accuracy of pct for the diagnosis of bacterial infections has varied across studies.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pleural effusion * pleural effusion proved by chest sonography exclusion criteria: * conditions for which thoracentesis are contraindicated * pregnancy

Keywords: pleural effusion procalcitonin
clinical outcomes and urodynamic effects after vaginal tailored mesh surgery for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: to evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh surgeries.

we will review the medical records (including medical data, urodynamic data, pad weight data, etc) of women who underwent either anterior or posterior novel vaginal tailored mesh surgeries at national taiwan university hospital between november 2011 and november 2013.

Eligibility criteria:
inclusion criteria: * all women with pelvic organ prolapse who underwent either anterior or/and posterior vaginal tailored mesh surgeries in national taiwan university hospital between november 2011 and november 2013 exclusion criteria: nil

Keywords: pelvic organ prolapse, vaginal mesh, urodynamic studies
hypofractionated radiation therapy for glioblastoma

Conditions: Glioblastoma Multiforme

Summary: notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.


Eligibility criteria:
inclusion criteria: * patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma. * who performance status of 2 or less and adequate hematologic, renal, and hepatic function. exclusion criteria: * prior diagnosis of cancer, unless disease free for \> 3 years * previous history of radiotherapy in the head and neck region (except initial larynx tumor - t1, t2 / n0m0). * specific severe, active co-morbidities * tumor located in the brainstem * presence of leptomeningeal carcinomatosis * multicentric tumor
screening for atrial fibrillation in elderly women older than 70 years

Conditions: Atrial Fibrillation New Onset

Summary: screening for atrial fibrillation in elderly women (safe-w) is a pilot study evaluating the prevalence of atrial fibrillation (afib) in a rapidly aging segment of the population. studies have shown that women with afib are more likely to be symptomatic, have increased mortality from stroke resulting from afib, and are less likely to receive treatment for afib. university of maryland department of neurology and vascular neurology are recruiting women older than 70 years of age to participate in the study.

atrial fibrillation or irregular heart beat is seen in 1/3rd of patients that present with stroke. atrial fibrillation is being increasingly seen in women older than 70 as women are likely to live longer. women are more likely to die from atrial fibrillation related stroke and are more likely to have symptoms from uncontrolled atrial fibrillation. they are also less likely to be treated with blood thinners to prevent stroke. this section of the population has been underrepresented in other studies on atrial fibrillation and the aim of this study is to proactively screen women older than 70 who are at risk for atrial fibrillation by using a wearable cardiac monitor.

Eligibility criteria:
inclusion criteria: 1. female sex 2. no previous diagnosis of atrial fibrillation 3. age ≥70 years 4. cha2ds2-vasc score ≥4 exclusion criteria: 1. life expectancy \< 2 years 2. dementia or other neurologic condition which would make outpatient follow-up difficult 3. cha2ds2-vasc score ≤3 4. any compliance issues - such as heavy alcohol/drug use that would impede follow up.
a trial comparing the efficacy and safety of hr17031 injection to ins068 injection and to shr20004 injection in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this trial is to compare the efficacy and safety of hr17031 versus ins068 and shr20004 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-70 age years, both inclusive; 2. bmi is 20.0 to 40.0 kg/m2, both inclusive; 3. type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 4. hba1c 7.5-11.0% (both inclusive) by local laboratory analysis; 5. at screening: 1) treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose \[mtd, ≥1000 mg\]) for ≥3 months, or 2) treatment with metformin at the above dose level combined with a second oad (agi, su, tzd, glinides, dpp-4i or sglt2i) on a stable dose (≥half of the max approved dose according to local label, or at the mtd) for ≥3 months. exclusion criteria: 1. use of systemic glucocorticoids within 3 months prior to the screening; 2. use of weight loss drugs within 3 months prior to the screening. 3. treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes); 4. laboratory findings at the screening visit: * amylase and/or lipase \>3 x upper limit of normal (uln); * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 x uln; * moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin; * urinary albumin creatinine ratio (uacr) ≥300 mg/g; * total bilirubin \>2.0 x uln; * calcitonin ≥50 ng/l; 5. personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)； 6. cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures; 7. severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg); 8. proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 9. history of pancreatitis (acute or chronic); 10. pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (wocbp) or male subject not using adequate contraceptive measures；
clinical validation of the withings ecg monitor for the detection of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the aim of the study is to demonstrate the performance of withings wbs08 in the automatic identification of atrial fibrillation and sinus rhythm.

patients included will be those presenting for consultation in the various participating clinical services. for each patient, an ecg will be recorded with the wbs08 and with the reference device cardiovit ft1, at rest and after an exercise session.

Eligibility criteria:
inclusion criteria: * male or female who are 18 years of age or older * subject able to read, understand and provide written informed consent * subject willing and able to participate in the study procedures as described in the consent form * subject able to communicate effectively with and willing to follow instructions from the study staff * subject affiliated to a social security system for subjects enrolled into the af population, subjects must have a known diagnosis of af and be in af at the time of screening. subjects may have any type of af including paroxysmal, persistent, and permanent af. exclusion criteria: * vulnerable subject with regard to regulations in force : * subject who is deprived of liberty by judicial, medical or administrative decision, * underage subject, * legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form * subject within several of the above categories * subject who refused to participate in the study * subject mentally impaired resulting in limited ability to cooperate * subject with a pacemaker, icd (implantable cardioverter defibrillator) or other implanted electronic stimulator * patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being ablle to hold still (e.g parkinson disease) * patient unable to stay in an upright position for the duration of study measures * acute myocardial infarction (mi) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, may increase the risk to the subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) * acute pulmonary embolism or pulmonary infarction, within 90 days of screening * stroke or transient ischemic attack within 90 days of screening * active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3rd degree heart block). * history of abnormal life-threatening rhythms as determined by the investigator (e.g., ventricular tachycardia, ventricular fibrillation, 3rd degree heart block) * symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites * known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ecg) electrodes including known allergy or sensitivity to fluoroelastomer bands * weight more than 180 kg