Kornimate/medical-research-clean huggingface dataset:
assessment of correlation between changes of shear wave elastography and surface electromyogram of the masseter

Conditions: Masseter Muscle Spasm

Summary: diagnoses and follow up of muscles diseases lack imaging. severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. supersonic shearwave imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties. in this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.


Eligibility criteria:
inclusion criteria: * people with social security. * people aged 20 to 40 years, of both sexes. * people that gave and signed consent to participate in the study. exclusion criteria: * any concomitant muscle disease (myopathy, myositis...) * botulinum toxin injections in the masseter in the last 3 months preceding the study. * any treatment that induces muscular effect (baclofen, benzodiazepine) * bruxism or any masticatory apparatus disease * any surgery of the masticatory apparatus

Keywords: shear wave elastography surface electromyogram masseter
easyband goal trial

Conditions: Morbid Obesity

Summary: safety, effectiveness, and performance of allergan's easyband telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.


Eligibility criteria:
inclusion criteria: * minimum 3 year history of morbid obesity with documented failure of conservative, non-surgical means of weight reduction within 1 year prior to the screening visit; * bmi \>/= 40 kg/m2, or bmi \>/= 35 kg/m2 and \</= 40 kg/m2 with one or more significant medical conditions related to obesity; * candidate for surgical weight loss intervention exclusion criteria: * previous surgical treatment of obesity; * patient already implanted with a device sensitive to radiofrequency emissions (implantable pacemaker, implantable defibrillator, etc); * physical or emotional conditions that may prohibit surgery
a study to evaluate the pharmacodynamic, efficacy and safety of shr-1703 in asthma patients with eosinophil phenotype

Conditions: Asthma With Eosinophilic Phenotype

Summary: the purpose of this study is to evaluate the pharmacodynamic, efficacy and safety of shr-1703 in asthma patients with eosinophil phenotype.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 75years (inclusive). 2. weight ≥40 kg. 3. history of asthma≥ 1 year. 4. documented treatment with medium or high daily dose inhaled corticosteroid with additional controller medication within the 3 months prior to randomization. 5. previously confirmed history of one or more asthma exacerbations within 1 year prior to randomization. 6. blood eosinophils of ≥150 cells/µl at screening and baseline. 7. pre-bronchodilator fev1% pred≥40% and\<80% at screening and baseline. 8. asthma control questionnaire-6 score≥1.5. 9. use highly effective contraceptive measures. 10. willing to sign the informed consent form to participate in this study. exclusion criteria: 1. subjects with clinically significant pulmonary diseases； 2. subjects with other diseases that could lead to elevated eosinophils； 3. subjects with immunodeficiency； 4. poorly controlled hypertension; 5. subjects with severe cerebrovascular disease; 6. subjects with infection history requiring clinical intervention； 7. subjects with parasitic infection； 8. diagnosed malignant tumor within 5 years prior to randomization; 9. used non-selective β-blockers within 1 week prior to randomization; 10. used either 5-lipoxygenase inhibitor or phosphodiesterase-4 inhibitor within 1 week prior to randomization; 11. blood donation or massive blood loss, or transfusion of blood products or immunoglobulins within 4 weeks prior to randomization; 12. live attenuated vaccine inoculated within 4 weeks before randomization; 13. allergen immunotherapy within 8 weeks prior to randomization； 14. used systemic immunosuppressants or immunomodulators, or biologics or th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug; 15. bronchial thermoplasty within 1 year prior to randomization； 16. subjects have planned surgery or other medical procedures that may affect evaluation during the study period; 17. subjects with significant laboratory abnormality at screening； 18. subjects have prolonged qtc interval or other electrocardiogram abnormality with significant safety risk at screening; 19. current smokers or ex-smokers who have given up smoking for \ 10 pack years; 20. history of drug or substance abuse or alcohol abuse within 1 year prior to screening; 21. subjects participated another clinical studies and received active drug within 30 days or 5 half-lives prior to screening; 22. subjects is pregnant, lactating,or planning to become pregnant; 23. subjects have a known history of hypersensitivity or intolerance to anti-il-5 mabs or other biological agents; 24. other conditions unsuitable for participation in the study per investigator judgement.
interscalene block versus superior trunk block

Conditions: Joint Disease; Pain; Pain, Acute; Pain, Chronic

Summary: sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block (stb) and interscalene block (isb) for arthroscopic shoulder surgery (labral repair, stabilization, rotator cuff repair).


Eligibility criteria:
inclusion criteria: * patients who will be undergoing primary unilateral labral repair/stabilization of the shoulder * age 18 to 80 years * planned use of general anesthesia with lma and interscalene or superior trunk block * ability to follow study protocol * english speaking * asa i - iii exclusion criteria: pre-existing neuropathy of the operative limb * younger than 18 years old and older than 80 * patients with pulmonary severe respiratory disease * allergy to one of the study medications * chronic gabapentin/pregabalin use (regular use for longer than 3 months) * chronic opioid use (taking opioids for longer than 3 months) * contraindication to general anesthesia, interscalene or superior trunk block * herniated cervical disk, cervical myelopathy * bmi \>35
study of the protective effect of low-dose aspirin on renal function in patients with early diabetic nephropathy

Conditions: Diabetic Nephropathy Type 2

Summary: this is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg/day) in renal and cardiac function protection in people with diabetic nephropathy.


Eligibility criteria:
inclusion criteria: * 1.voluntarily sign informed consent;2.meet the diagnosis of diabetic nephropathy: in the case of identifying diabetes as the cause of kidney damage and excluding chronic kidney disease caused by other causes, at least one of the following is present:①. in the case of excluding interference factors, at least 2 uacr≥30mg/g or uaer≥30mg/24h (≥20ug/min) in 3 tests within 3\~6 months. ②. egfr\ 30ml/min/(1.73m2)-1； exclusion criteria: * (1) history of cardiovascular or cerebrovascular events (defined by the patient's medical history and/or instrumental examination results); (2)insufficient glycemic control (i.e., glycated hemoglobin ≥8%); (3) uncontrolled blood pressure despite taking antihypertensive drugs (≥140/≥85mmhg); (4) previous major bleeding (i.e., intracranial hemorrhage); (5) previous gastrointestinal ulcers; (6) clinical diagnosis of type 1 diabetes mellitus (diagnosis of diabetes mellitus and use of insulin before age 35);(7) patients with ckdg4 or g5 (i.e., egfr\<30 ml/min/1.73 m2 or dialysis) ;(8) chronic active infection or; (9) evidence of malignancy within the past 5 years. patients with tumour disease in situ who are successfully treated only by local resection can be included in the study (including non-melanoma skin cancer in situ); (10) autoimmune diseases; (11) persistent arrhythmias requiring anticoagulation therapy (i.e., atrial fibrillation). in this category, isolated ventricular/supraventricular presystoles; (12) use of nsaids or other antiplatelet drugs in the past 30 days; (13) cirrhosis of any etiology; (14) use of anticoagulants; (15) life expectancy less than 1 year; (16) known aspirin allergy; (17) known pregnancy; and (18) severe mental illness.
apixaban in atrial fibrillation registry

Conditions: Atrial Fibrillation

Summary: objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.

atrial fibrillation (af) confers a substantial risk of mortality and morbidity from stroke and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden in europe. stroke prevention is central to the management of af patients, with oral anticoagulation (oac) using well-controlled adjusted dose vitamin k antagonists or novel oacs being recommended for patients with af with ≥1 stroke risk factors. also, the 2012 focused update of the esc guidelines strongly advocates a clinical practice shift so that the initial decision step now is the identification of 'truly low risk' patients, essentially those age\<65 without any stroke risk factors (both male and female), who do not need any antithrombotic therapy. the esc guidelines only recommend use of the cha2ds2-vasc score for stroke risk assessment, and the 'low risk' patients are defined as those with a cha2ds2-vasc score=0 (males) or score=1 (females). subsequent to this initial step of identifying the low risk patients, effective stroke prevention (which is essentially oac) can then be offered to af patients with ≥1 stroke risk factors, with treatment decisions made in consultation with patients and incorporating their preferences. despite these recommendations, a substantial number of patients with af is not treated with oac. on the other hand, patients with af and low risk are being "overtreated", receiving oac despite a chads-vasc score of 0. therefore, this registry will determine, if patients with non-valvular af are treated ac-cording to current guidelines. apixaban is an oral factor xa inhibitor, which has been tested in a number of indications. in the averroes study in patients with non-valvular atrial fibrillation deemed not suitable for treatment with a vitamin-k antagonist apixaban compared to aspirin reduced the incidence of stroke and systemic embolism without increasing bleeding complications. in the large aristotele study apixaban was superior to warfarin, it re-duced the primary endpoint of stroke and systemic embolism caused less bleeding and reduced all-cause mortality. subsequently apixaban has been approved by the european health authorities for the use in patients with atrial fibrillation. it is therefore of interest to determine use of apixaban in real life with respect to patient selection, adherence to therapy and midterm efficacy and safety.

Eligibility criteria:
inclusion criteria: * age ≥18 years * non-valvular atrial fibrillation * in hospitals or specialized or non-specialised office-based centres * written informed consent for participation in observational study (incl. telephone follow-ups) * not simultaneously participating in any randomized trial exclusion criteria: no exclusion criteria

Keywords: newly diagnosed paroxysmal persistent
a study to assess efficacy of hl036 in subjects with dry eyes

Conditions: Dry Eye

Summary: the objective of this study was to compare the safety and efficacy of 0.10% and 0.25% hl036 ophthalmic solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * have a patient-reported history of dry eye for at least 6 months prior to enrollment * have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 * have in the study eye a schirmer's test score of ≤ 10 mm and ≥ 1 mm at visits 1 and 2 exclusion criteria: * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1 * have used restasis® or xiidra® within 60 days of visit 1 * be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (otc) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study) * have an uncontrolled systemic disease * be a woman who is pregnant, nursing or planning a pregnancy
immune response to toll-like receptor 9-agonist adjuvanted pneumococcal vaccination in hiv infected adults

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether tlr-9 adjuvanted pneumococcal is more immunogenic than pneumococcal vaccination alone in hiv-infected adults.

pneumococcal disease is a major source of morbidity and mortality in hiv-patients. hiv-patients are vaccine hyporesponders. a good immune response to pneumococcal vaccination enhances vaccine effectiveness, thereby preventing the morbidity and mortality caused by pneumococcal disease. even when an optimized regimen containing both conjugated and polysaccharide pneumococcal vaccine is used, only 13% of the immunized hiv patients are high responders at week 96. recent data indicate that tlr9-agonists have excellent vaccine adjuvant potential and are safe to use in immunocompetent as well as immunocompromised individuals. the aim of this study is to evaluate the qualitative and quantitive immune response to pneumococcal vaccination with or without tlr9-agonist in hiv-infected adults

Eligibility criteria:
inclusion criteria: * written informed consent and authority statement provided according to local regulatory and ethical practice using a participant information sheet and informed consent form approved by the responsible ethics committee. * hiv-seropositive individuals. exclusion criteria: * pregnancy as determined by a positive urine beta-hcg (if female) * participant unwilling to use reliable contraception methods for the duration of the trial. reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female) * currently breast-feeding (if female) * latest cd4 count \< 200 x106 cells/µl * viral load (hiv rna) \> 50 copies/ml if on haart (defined as at least three antiretrovirals including either a protease inhibitor or a nnrti, i.e. combivir 300/150 mg x2 + stocrin 600 mg x1 for a minimum of 6 months) * previous enrollment in this study * any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the principal investigator (pi), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia) * unable to follow protocol regimen * pneumococcal vaccination 5 years or less prior to inclusion * planned participation in other vaccination trials during the time of the study

Keywords: antibody formation antibody affinity immunity pneumococcal vaccines oligodeoxyribonucleotides
preoperative pain, function, and activity for total hip and knee arthroplasty patients

Conditions: Arthroplasty

Summary: this study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.

the investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. with this knowledge the investigators will be able to initiate sufficient treatment already before operation.

Eligibility criteria:
inclusion criteria: * total hip arthroplasty patients * total knee arthroplasty patients exclusion criteria: * inability to speak and understand danish * inability to perform the functional measurements due to other conditions

Keywords: muscle strength, functional performance, joint replacement
studying tumor tissue samples from patients with early-stage breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at tumor tissue samples from patients with early-stage breast cancer.

objectives: * to characterize differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by oncotype dx assay (a reverse transcriptase-pcr-based assay). * to develop a computer-aided design (cad)-based system of analysis of digitized histological images that would perform as well as oncotype dx assay in stratifying estrogen receptor-positive (er+) breast cancer into prognostic categories. * to identify new therapeutic targets in the pi3-kinase signaling pathway for a subset of poor-prognosis er+ breast cancers. outline: patients who had oncotype dx assay (a reverse transcriptase-pcr-based assay) performed for their breast cancer are identified by review of medical records. diagnostic h\&e stained tumor tissue samples are reviewed by a pathologist. relevant pathologic features of the tumor (size, stage, grade, estrogen receptor, progesterone receptor, and her2 staining) and linked oncotype dx score are recorded. the h\&e stained tumor tissue samples are scanned to create high-resolution digital images. the images from each tissue sample are subjected to image analysis algorithms to identify sets of image features that most clearly separate tumors with low recurrence scores from those with high recurrence scores. unstained paraffin sections from each tumor tissue sample, when available, are processed using ihc to analyze pi3-kinase signaling pathway (pten expression). staining for other components of the pi3-kinase signaling pathway, phospo-akt, and other proteins of interest is also performed. dna is extracted from the samples and subjected to pyrosequencing analysis on exons 9 and 20 of pi3kca. sequencing of other relevant potential oncogenes, such as akt, is also performed. statistical analysis is performed to look for a correlation between oncotype dx scores and the presence of pi3kca mutations and/or loss of pten expression.

Eligibility criteria:
disease characteristics: * diagnosis of early-stage breast cancer for which an oncotype dx assay has been performed * must have diagnostic h\&e stained tumor tissue samples available * hormone receptor status: * estrogen receptor-positive tumor patient characteristics: * menopausal status not specified prior concurrent therapy: * not specified

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer estrogen receptor-positive breast cancer male breast cancer
using spectrally encoded confocal microscopy (secm) to visualise the esophagus using an secm probe

Conditions: Barrett's Esophagus

Summary: the study is being done to test the feasibility and tolerability of a secm imaging probe in patients with barrett's esophagus (be). subjects will undergo secm probe imaging while they are under conscious sedation. spiral secm imaging will be performed continuously over a pre-determined length. patients will later be asked for their feedback.

subjects with a previous diagnosis of barrett's esophagus will be recruited in the study and undergo secm probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. the probe will be inserted the predetermined required distance in the esophagus using a guide wire. once the secm imaging probe is in place, spiral secm image data will be continuously collected over a pre-determined length (approximately 5cm).

Eligibility criteria:
inclusion criteria: * a previous diagnosis of barrett's esophagus * patients must be over the age of 18 * patient must be able to give informed consent exclusion criteria: * subjects with any history of intestinal strictures * or subjects with a history of prior gi surgery * or subjects with a history of intestinal crohn's disease.

Keywords: secm esophagus imaging
atrial fibrillation with heart failure with preserved ejection fraction: treatment strategies-catheter ablation vs. anti-atrial arrhythmia drugs

Conditions: HFpEF - Heart Failure with Preserved Ejection Fraction; Atrial Fibrillation (AF)

Summary: a comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of mace) and reduces the recurrence rate of atrial fibrillation (af) in patients with af and heart failure with preserved ejection fraction (hfpef), compared to anti-atrial arrhythmia drugs (aad). this trial was randomly divided into two groups: the anti-aad drug group and the catheter ablation group.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * the patient is willing and able to comply with the protocol and has provided written informed consent. * paroxysmal or persistent atrial fibrillation (af).（persistent af was defined as af which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. included within the category of persistent af is 'long-standing persistent af', defined as continuous af of \>1-year duration. af episodes had to be documented in the last 3 months prior to enrollment by ecg, holter ecg, loop recorder, memory of the implanted device (icd/crt-d), or any other suitable device.） * failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs. * diagnosed with heart failure with preserved ejection fraction (hfpef).（(1) a history of hospitalization for hf with symptoms classified as new york heart association (nyha) class ii, iii, or iv; (2) lvef ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of n-terminal pro-brain natriuretic peptide (nt-probnp), with a threshold of ≥400 pg/ml for pa-tients with sr at admission and ≥600 pg/ml for patients with af at admis-sion.) * new york heart association class ii, iii, or iv. exclusion criteria: * previous left heart ablation procedure for af. * contraindication to chronic anticoagulation therapy or heparin. * documented left atrial diameter \>6 cm, optimally from the parasternal long-axis view. * acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment. * planned cardiovascular intervention. * listed for heart transplant. * cardiac assist device implanted. * life expectancy ≤ 12 months. * mental or physical inability to participate in the study. * requirement for dialysis due to terminal renal failure. * woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age. * enrollment in another investigational drug or device study, or participation in another telemonitoring concept.