Kornimate/medical-research-clean huggingface dataset:
assessment of efficacy of low intensity resistance training in women at risk for symptomatic knee osteoarthritis

Conditions: Knee Osteoarthritis; Symptomatic Knee Osteoarthritis

Summary: the purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (pbfr) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. the primary outcome will be change in isotonic double leg-press 1 repetition maximum (1rm) strength. the investigators will test the following hypotheses. in comparison with low-intensity resistance training without use of pbfr, a four-week low-intensity resistance-training program with pbfr will: primary hypothesis: increase (a) double leg-press 1rm strength and (b) isokinetic knee extensor strength secondary hypotheses: 1. increase quadriceps muscle volume assessed by mri 2. increase lower limb muscle power on (a) double leg-press at 40% 1rm and (b) a timed stair climb 3. not adversely effect knee pain or quality of life assessed by the knee injury and osteoarthritis outcome score (koos) questionnaire


Eligibility criteria:
inclusion criteria: * female * age 45-65 * bmi greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis exclusion criteria: * resistance training at any time in the last 3 months prior to study * bilateral knee replacement * lower limb amputation * lower limb surgery in the last 6 months that affects walking ability or ability to exercise * back, hip or knee problems that affect walking ability or ability to exercise * unable to walk without a cane or walker * inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica * multiple sclerosis * known neuropathy * self-report of diabetes * currently being treated for cancer or having untreated cancer * terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future) * peripheral vascular disease * history of myocardial infarction or stroke in the last year * history of deep venous thrombosis * chest pain during exercise or at rest * use of supplemental oxygen * inability to follow protocol (e.g. lack of ability to attend visits or understand instructions) * staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity) * concurrent study participation (such as the most study) * unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study

Keywords: knee osteoarthritis symptomatic knee osteoarthritis isotonic leg-press strength isokinetic knee extensor strength quadriceps volume
developing and testing a small private online course (spoc) for nurse-patient communication about sex.

Conditions: Nurse-Patient Relations

Summary: this is a three-year research project. the goal is to develop and test "the spoc-based blended teaching and learning platform (nightingale in gen-sex)" that integrates effective educational strategies and e-learning methods to meet the taiwanese nurse's learning needs. this project is aimed at resolving sexual education learning problems in nursing continuing education due to the time constraints at clinical sites and the shortage of teaching staff. nurse-patient communication attitudes and skills about sex will be enhanced.

the research team constructed a course for hospital nurses that followed the commonly used addie (analysis, design, development, implementation, and evaluation) model. the first year research purpose is to: (1) explore the characteristics of nursing-patient communication about sex and the core educational needs content for nurses using triangulation methods. (2) construct gender-sensitivity structures characteristics of nursing-patient communication about sex and course framework according to the modified delphi method results and course needs assessment. the second year develops the spoc-based blended teaching and learning platform (e-generation angel of happiness") and conducts a pilot study to test and correct the course content and method. in the third year a pretest-posttest randomized control group design will be implemented to investigate the effectiveness of the course "e-generation angel of happiness" in improving competencies of nurse-patient communication about sex, including attitudes, and practices, among nurses.

Eligibility criteria:
inclusion criteria: 1. 20 to 50 years old. 2. below n3 rank. 3. full-time nurse in clinical care. 4. have smartphones or computers, and be able to use and be online. 5. nurses who are willing to participate in this study and sign the consent form exclusion criteria: 1. will leave within 3 months. 2. unable to learn online. 3. the working units are surgery room, recovery room, hospice ward, supply center.

Keywords: sex education gender-sensitivity nurse-patient communication continuing education spoc
a pilot study to evaluate the effects of nateglinide vs. glibenclamide on renal hemodynamics and albumin excretion

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. the purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed at least 1 year before inclusion * blood glucose criteria must be met * microalbuminuria criteria must be met exclusion criteria: * pregnant or nursing females or females of childbearing potential not using a medically approved birth control method * blood glucose criteria outside the specified range * microalbuminuria criteria outside the specified range * serious cardiovascular events within the past 6 months * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes nateglinide
poct pct in outpatient lrti

Conditions: Antimicrobial Stewardship; Exacerbation of Allergic Asthma; Exacerbation Copd; Community-acquired Pneumonia; Lower Respiratory Tract and Lung Infections

Summary: lower respiratory tract infections (lrti) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. the primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (poct) for procalcitonin (pct) in identifying pneumonia as a bacterial infection in outpatients with lrti.

lower respiratory tract infections (lrti) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. despite the vast majority of lrti are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in lrti still drives antibiotic treatment today procalcitonin (pct) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (poct). the primary objective of the investigators study was to determine the diagnostic accuracy of poct pct in identifying bacterial infection in outpatients with lrti. all patients aged 18 years or older with signs and symptoms of an lrti as the leading diagnosis of the respiratory physicians are eligible. the medical assistant measure pct from venous or capillary whole blood using the portable commercially available brahms pct direct point-of-care test (thermo-fischer scientific). the stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. this immunoassay provides a quantitative result in 20 minutes. in suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. members of the study team conduct standardised phone interviews of all participants on day 28.

Eligibility criteria:
inclusion criteria: * age 18 years or older * clinical diagnosis of lower respiratory tract infection exclusion criteria: * active malignancies * cystic fibrosis * solid organ or stem cell transplantation * chronic infection (endocarditis, osteomyelitis, active tuberculosis) * pregnancy

Keywords: procalcitonin point-of-care-testing antimicrobial stewardship
diastolic hyperemia-free ratio in patients with cad

Conditions: Coronary Stenosis; Coronary Artery Disease

Summary: the investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio (dfr) and fractional flow reserve (ffr) during pre-interventional and post-interventional period using a 0.014" comet ii pressure guidewire

the physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention (pci) has become a standard practice for patients with coronary artery disease. fractional flow reserve (ffr) represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies. however, the ffr is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia, and the need for additional procedure time. recently, a physiologic index which does not require hyperemia, instantaneous wave free ratio (ifr), was introduced and recent trials showed non-inferiority of ifr-guided strategy for 1-year clinical outcome, compared with ffr-guided strategy. recently, not only ifr but also various intravascular pressure measurement techniques have been developed, one of which is diastolic hyperemia-free ratio (dfr). dfr uses the mean pd/pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure. dfr showed equivalence as compared to gold standard ffr in the discrimination of non-culprit lesions requiring revascularization in patients with nstemi. in the case of dfr, there is no issue in terms of safety because it is conducted in the same way as ifr, but there are not many studies on the validation between dfr and ffr. therefore, the present study aimed to identify the quality of concordance between dfr and ffr, determine the features associated with discrepancies in dfr and ffr.

Eligibility criteria:
inclusion criteria: * patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50\~90% stenosis of the coronary artery. * acute coronary syndrome patients with multivessel disease who have 50\~90% stenosis of a non-culprit vessel on coronary angiography. exclusion criteria: * patients with acute coronary syndrome and single vessel disease. * patients with hypersensitivity or contraindication to antiplatelet treatment. * female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study. * patients with a life expectancy shorter than 1 year.

Keywords: coronary artery disease ffr dfr
free middle turbinate flap for repair of low flow cerebrospinal fluid leak

Conditions: CSF Leakage

Summary: limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (csf) leak, and the results were inconclusive. the overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing csf leak during an endoscopic approach.

cerebrospinal fluid (csf) rhinorrhea results from an abnormal communication between the sinonasal cavity and the subarachnoid space. it may occur spontaneously or secondary to accidental or iatrogenic trauma. csf leak is a potentially devastating condition that can lead to ascending meningitis, pneumocephalus, and intracranial abscess. surgical repair is recommended for most patients with csf leaks to prevent the potential sequelae. multiple graft materials have been employed in the approach, including temporalis fascia, middle turbinate flap, fascia lata, fat, free cartilage or bone, vascularized nasoseptal flap and acellular skin grafts. among these options, vascular nasoseptal ﬂaps are the most popular materials at present. limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat csf rhinorrhea, and the results were inconclusive. there were a large number of cases using free middle turbinate flap for csf rhinorrhea repair in our institution. the purpose of this study was to determine the efficacy and safety of the free middle turbinate flap for repair of csf rhinorrhea.

Eligibility criteria:
inclusion criteria: * patients undergoing repairing of csf leak under transsphenoidal approach * dural defect smaller than 1cm * no extensive arachnoid dissection * no dissection into a ventricle or cistern exclusion criteria: * high flow csf leak
a study to compare pharmacokinetics, efficacy, safety, and immunogenicity of mb12 (proposed pembrolizumab biosimilar) to keytruda® in non-small cell lung cancer (benito study)

Conditions: Non Squamous Non Small Cell Lung Cancer

Summary: this is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (pk) and efficacy similarity study to compare the pk, efficacy, safety, and immunogenicity of mb12 versus keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous nsclc.


Eligibility criteria:
inclusion criteria: 1. adult male/female patients ≥18 years old at the time of signing the informed consent form (icf). 2. histologic or cytologic diagnosis of advanced nsclc, stage iv (defined by the 8th edition of the tumor node metastasis \[tnm\] classification), with no egfr sensitizing (activating) mutation or alk translocation, and who have not received prior systemic treatment for metastatic nsclc. in those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required. 3. at least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1. 4. known status of pd-l1 expression. 5. performance based on the eastern cooperative oncology group (ecog) performance status ≤1. 6. adequate hepatic, renal, hematologic, endocrine, and coagulation function. exclusion criteria: 1. predominantly squamous cell histology nsclc. mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible. 2. known history of central nervous system metastases and/or carcinomatous meningitis. 3. prior anti-programmed cell death (pd)-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t lymphocyte associated protein (ctla)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of t-cells or immune checkpoints). 4. major surgery within 3 weeks of the first dose of study treatment. 5. active autoimmune disease that has required systemic treatment in the last 2 years. 6. contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab. 7. has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.
comparative study to evaluate the cosmetic appearance of two brands (coopervision (cvi) vs. competitor) of color soft contact lenses.

Conditions: Myopia

Summary: comparative study to evaluate the cosmetic appearance of two brands (coopervision (cvi) vs. competitor)of color soft contact lenses

each lens pair comparison will require two visits over two days, as follows: visits: v1 (lens dispensing), v2 (20 minutes post lens settling). each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive). * has had a self-reported visual exam in the last two years. * is an adapted wearer of spherical soft contact lenses. * has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive). * has a spectacle cylinder up to 0.75 diopter (d) in each eye * can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logmar) or better in each eye. * has clear corneas and no active ocular disease. * has read, understood and signed the information consent letter. * is willing to wear his/hers spectacles over the study contact lenses. * is willing to comply with the wear schedule. * is willing to comply with the visit schedule. exclusion criteria: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day) * has a contact lens prescription outside the range of - 1.00 to -10.00d. * has a spectacle cylinder ≥1.00d of cylinder in either eye. * does not have a pair of corrective spectacles at the time of the visit. * cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logmar) or better in each eye. * presence of clinically significant (grade \> 2.0, scale 0-4) anterior segment abnormalities. * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
early biomarkers for arthritic pain to guide improved treatments for arthritis

Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis; Spondyloarthritis; Psoriatic Arthritis

Summary: osteoarthritis (oa) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. although oa is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. in this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.

osteoarthritis (oa) is the most common form of arthritis worldwide. oa causes major disability and pain and places a huge financial burden on healthcare worldwide. in recent work, the gene expression profile of bone marrow lesions (bml) in osteoarthritis has been evaluated. bml in oa have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. the plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee oa and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis. a study amendment was added in april 2020 due to covid-19. we are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. we will be evaluating the course of covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.

Eligibility criteria:
inclusion criteria: inclusion criteria for oa patients: * fulfilling the american college of rheumatology (acr) criteria for the diagnosis of knee osteoarthritis * symptomatic knee pain * on usual care for knee osteoarthritis including paracetamol and/or nsaids inclusion criteria for inflammatory arthritis patients: * fulfilling the american college of rheumatology (acr) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (anti-ccp antibodies \& rheumatoid factor checked ), psoriatic arthritis or spondyloarthropathy * symptomatic knee pain * on usual care for arthritis including disease-modifying anti-rheumatic drugs (dmards), paracetamol and/or nsaids exclusion criteria: * other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, polymyalgia rheumatica, gout, giant cell arteritis, sjogren's syndrome * history of uncontrolled depression * recent surgery * uncontrolled ischaemic heart disease * uncontrolled diabetes mellitus * alcohol consumption \> 14 units/week as per uk national guidelines * participants unable to give full informed consent

Keywords: pain inflammation
observation of non-technical skills in the pre-hospital care in the czech republic

Conditions: Non-technical Skills

Summary: the aim of the study is to find out if the emergency medical services (ems) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them.

the aim of the study is to find out if the emergency medical services (ems) crews are using the non-technical skills (teamwork and team leading, communication, decision making, situational awareness and task management) in the real practice and how well they use them. according to the observations of individual crews by field supervisors the use of non-technical skills will be compared between different groups (e.g. resuscitation, trauma, medical problems, non-emergency situations etc.). the comparison between the collaborators of the study is not the subject of the study. main hypothesis: the ems crews are using all of the aspects of non-technical skills appropriately. the field supervision is also the limitation of the study because it is done by different observers / supervisors, the observation therefore might by affected by subjective feelings. to minimise the subjective view of the situation all of the field supervisors undergo a uniform training of non-technical skills and how to observe and evaluate them.

Eligibility criteria:
inclusion criteria: * ems called * more than 2 crews on the scene * field supervisor present exclusion criteria: - team tool not filled completely

Keywords: non-technical skills pre-hospital care emergency medical services communication situational awareness task management decision making teamwork team leading