Kornimate/medical-research-clean huggingface dataset:
an observational study of efficacy and safety of modern insulin in diabetes patients switched from anti-diabetic treatment

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the gulf countries.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * treatment with any diabetes treatment other than novomix® 30, levemir® and/or novorapid® * selection will be at the discretion of the individual physician exclusion criteria: * current treatment with levemir®, novomix® 30 and/or novorapid® * previous enrolled in this study * hypersensitivity to levemir®, novomix® 30 and/or novorapid® or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
electronic alert to improve testing for primary aldosteronism in patients with hypertension

Conditions: Primary Aldosteronism; Resistant Hypertension; Secondary Hypertension; Hyperaldosteronism; Mineralocorticoid Excess; Hypertension

Summary: primary aldosteronism (pa) is common but rarely recognized cause of hypertension that carries excess cardiovascular and renal risk and has approved targeted treatments. despite current clinical guidelines that recommend screening in a defined set of high-risk populations, less than 5% of eligible patients are ever screened for pa. this study aims to evaluate the impact of a computer decision support best practice advisory (bpa) alert on rates of screening for pa in guideline-eligible patients, referral to specialist pa care, and treatment with mineralocorticoid receptor antagonists.

the study protocol is a single-center quality improvement initiative performed as a cluster-randomized controlled trial designed to evaluate the impact of an epic electronic health record best practice advisory (bpa) alert on rates of screening for pa in guideline-eligible patients. 1600 patients meeting inclusion/exclusion criteria for primary aldosteronism (pa) screening will comprise the study population, with randomization of alert/no alert occurring at the level of their treating clinician (attending physician, nurse practitioner, or physician assistant) to minimize spillover/contamination effects of the bpa onto other patients treated by the same clinician. treating clinicians within primary care and relevant specialties including endocrinology, nephrology, and cardiology will be randomized 1:1 to receive or not receive a bpa prompting screening for pa with laboratory testing of plasma aldosterone, plasma renin activity, and a basic metabolic panel, as well as an order for an e-consult to provide guidance on interpretation of results, for eligible patients. outcomes will be ascertained by electronic health record review at 6 months.

Eligibility criteria:
inclusion criteria: * adults 18+ * seen by clinician at one of the intervention practices at least once in the prior 2 years * history of hypertension (icd code) plus ≥1 of the below: * outpatient bp \>150/100 on 2 or more occasions * three or more current antihypertensive medication prescriptions * potassium level \<3.5meq/l or potassium supplement prescription in the last 5 years * history of atrial fibrillation or atrial flutter (icd code) exclusion criteria: * history of primary aldosteronism (icd code) * prescription for a mineralocorticoid receptor antagonist (mra) within the last 3 months

Keywords: computer decision support primary aldosteronism
impact of combined behavioral interventions on cognitive outcomes in mci

Conditions: Mild Cognitive Impairment

Summary: vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. this, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. this application, therefore, proposes a randomized controlled trial (rct; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (brain hq, posit science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (mci).


Eligibility criteria:
inclusion criteria: * mci diagnosis (can be self referral, will determine eligibility at baseline) exclusion criteria: * dementia diagnosis * head trauma * neuro/psychiatric disorders * current substance dependence * sensory/mobility deficits * no more than 1 hour of purposeful, aerobic activity/week * currently engaging in any other brain-stimulating computer program (no more than 1 hour a week)
association between craniofacial fractures and brain injuries: diagnostic and therapeutic considerations

Conditions: Brain Injuries; Skull Fractures

Summary: this study evaluates the association between traumatic brain injuries and craniofacial or/and skull fractures. purpose is to find out the amount of missed diagnoses and improve primary diagnostics of trauma patients.

a part of mild tbis remains undiagnosed. therefore the primary diagnostics of trauma patients needs to be improved. according to some studies, a part of trauma patients' concomitant injuries weren't diagnosed in the emergency room (er) but were diagnosed later in the clinics. in addition to difficult diagnostics the treatment of these patients demands close co- operation between many specialities. the aim of this study is to evaluate the association between tbis and facial fractures. the real amount of facial fractures in patients with severe tbi and the clinical significance of these fractures are evaluated. also the number of patients with facial fractures and a concomitant tbi is evaluated. the aim is to find out the amount of patients with missed diagnoses. other aims of are to determine the effect of the type or location of a facial fracture on the in- cidence and severity of tbi. with the help of the results it would be possible to improve the comprehensive diagnostics and early treatment of patients with a facial fracture or a tbi. the retrospective and prospective data on patients with tbi and/or facial fracture are collect- ed at turku university hospital. the comparison of the two groups will give information on the amount of patients with missed diagnosis of tbi or facial fracture. the results can be utilised in planning strategy for comprehensive diagnostics and treatment of the patients. in the research group the investigators have specialists in the fields of oral and maxillofacial surgery, neurol- ogy and otorhinolaryngology.

Eligibility criteria:
inclusion criteria: * severe traumatic brain injury, gcs 8 or less and/or craniofacial fracture exclusion criteria: * died before admitted to hospital
the effect of cilostazol compared to aspirin on endothelial function in acute cerebral ischemia patients

Conditions: Ischemic Stroke; Endothelial Dysfunction

Summary: patients presenting with acute cerebral ischemic events are randomly assigned into aspirin (n=40) or cilostazol (n=40) group in a double-blinded manner. fmd is measured as a primary outcome at baseline (t0) and 90 days (t1). serious and non-serious adverse events were described.

this investigator-initiated, randomized, double-blind trial is prospectively conducted with two-arm parallel treatment groups and a single dose scheme: 100 mg aspirin daily and cilostazol placebo twice daily versus aspirin placebo daily and 100 mg cilostazol twice daily. a total of 80 eligible patients is planned to be recruited. all included patients undergo diagnostic studies including routine blood tests and cardiologic work-ups. the primary outcome is differences in endothelial function in the two groups measured by means of fmd on admission and at 3 months. according to previous studies, the adverse effects in two groups are investigated.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke confirmed by diffusion weighted imaging 2. transient ischemic attack (tia) within 7 days exclusion criteria: 1. there is intracranial hemorrhage on imaging study 2. patients is previously taking antiplatelets, vitamin k antagonists, factor xa antagonists, or chronic treatment with systemic steroidal and non-steroidal anti-inflammatory drugs 3. patients who received fibrinolytics within the previous 48 hours 4. cognitive impairment interfering with the possibility of obtaining informed consent 5. pregnancy 6. participation in another pharmacological study 7. peptic ulcer disease or hematological abnormality 8. initial modified barthel index \<30 points 9. liver function tests exceeding a 2-fold upper range value.
the effect of vırtual realıty glasses on heart faılure patıents

Conditions: Heart Failure

Summary: anxiety and sleep disorders are among the most common symptoms in heart failure patients. in addition to pharmacological methods for anxiety and sleep disorders, non-pharmacological methods can also be used. among these, anxiety and sleep disorders can be prevented with virtual reality glasses aimed at distraction. this study will be conducted to evaluate the effect of breathing exercises performed with virtual reality glasses on anxiety, sleep quality, and respiratory parameters. the study will be conducted with a total of 45 patients, 15 virtual reality glasses + breathing exercises, 15 breathing exercises, and 15 controls. those in the virtual reality glasses + breathing exercises group will perform breathing exercises with virtual reality glasses once a day for 7 days. those in the breathing exercises group will perform only breathing exercises once a day for 7 days. anxiety, sleep disorders, and respiratory parameters of the patients will be examined.


Eligibility criteria:
inclusion criteria: * 18 years of age or older, * verbal communication, * place and time oriented, * without any psychiatric illness, * patients diagnosed with hf with nyha class iii-iv symptoms, * left ventricular ejection fraction ≥50% (lvef-cf/hfpef), between 40-49% (sef-cf/hfmref), hf below 40% (def-cf/hfref), * high levels of natriuretic peptides (bnp\&gt;35 pg/ml and/or ntprobnp\&gt;125 pg/ml), * there is no deformity or diagnosis related to the musculoskeletal system that may prevent breathing exercise, * chronic diseases such as hypertension (stage 1 and 2 ht) and diabetes mellitus are stable and the treatment for these diagnoses has not been changed in the last month, * who have not previously received respiratory exercise training and have not participated in a rehabilitation program, * patients who volunteer to participate in the study will be included in the study exclusion criteria: * life signs are so abnormal as to preclude intervention, * patients with migraine, vertigo, active nausea-vomiting, headache, dizziness will not be included in the study.

Keywords: heart failure virtual reality glasses anxiety respiration sleep quality
genetic of response to acute saline load test in hypertension (naload)

Conditions: Hypertension,Essential; Salt; Excess; Genetic Hypertension; Genetic Predisposition to Disease

Summary: nhp referred to our outpatient clinic will be enrolled (150 newly recruited) in acute saline test for phenotype characterisation of pnat relationship(7). for each patient we will collect urine and blood samples for standard clinical biochemistry, including electrolytes, creatinine, eo, aldosterone, plasma renin activity, urinary uromodulin (elisa), urinary and serum uric acid and blood samples for genetic test.

acute salt load test: after the equilibration period and achievement of a steady state, a constant-rate i.v. infusion of 2 l of 0.9% nacl was carried out in 2 hours. bp (mean of 3 measurements taken 3 minutes apart) was measured every 30 minutes during the 2 hours of loading and 3 times at 3-min intervals at the end of the infusion. these last 3 bp values were averaged and used in the analysis. the results of these tests will be added to an already collected database of salt load test collected in the previous studies (already published)

Eligibility criteria:
inclusion criteria: * age 18 to 65years; * body mass index (bmi) \<30 kg/m2; * na intake, evaluated as urinary na excretion of \ 140 mm hg and diastolic bp (dbp) \>90 mm hg in 3 consecutive visits to their family doctors. exclusion criteria: * female patients * history of myocardial infarction, * stroke, * congestive heart failure, * liver disease, secondary cause of hypertension, * diabetes, * severe hypertension (\>160/110 mm hg), * abuse of drugs or alcohol, .creatinine clearance \< 80 ml/m. secondary forms of hypertension (e.g. primary aldosteronism) were ruled out with specific investigations when deemed appropriate

Keywords: hypertension salt sensitivity genetic
muscle loss and fatigue as a consequence of radiotherapy

Conditions: Breast Cancer; Fatigue; Sarcopenia

Summary: this study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. this study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.

this study uses a patient reported survey to assess fatigue prior to radiotherapy for breast cancer. fatigue is measured again at the completion of radiation treatments and at one and three months following completion of radiation. muscle measurements are made outside the treatment area using ct scans prior to radiation treatment, at the completion of radiation treatment and at one and three months after radiation treatment. the degree of fatigue and changes in muscle will be assessed. changes will be correlated to determine if muscle loss contributes to fatigue.

Eligibility criteria:
inclusion criteria: 1. women age ≥ 18 years 2. non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care 3. able to provide informed consent 4. able to complete the brief fatigue inventory questionnaire - exclusion criteria: 1. pregnant 2. inability to meet eligibility requirements -

Keywords: radiotherapy
consumer access to personal health information for asthma self-management

Conditions: Asthma

Summary: this study is to compare smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. the primary hypothesis: health outcome - the breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice

this study is a multi-centre, randomized controlled trial comparing a web-based (smart phone mobile device, tablet and/or personal computer pc) asthma action plan application to best practice/usual care within an asthma program. a third external comparator arm will compare participants to all patients with asthma in ontario using data obtained from the ontario asthma surveillance information system (oasis) cohort, created from administrative data sets within the institute for clinical evaluative sciences (ices). subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. the study will enrol approximately 400 patients in total at all study sites.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma * age 18 of age or older * familiar with web technology * provide consent * understand/read/write english exclusion criteria: - indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (cystic fibrosis, chronic obstructive pulmonary disease, bronchiectasis)
role of two rehabilitative treatments and diet in the modulation of inflammation in patients with knee prosthesis.

Conditions: Knee Pain Swelling

Summary: the investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period

the main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the mediterranean diet. methods. 34 patients were recruited, and divided into three groups. the control group followed the normal rehabilitation protocol. the other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. the outcomes (pcr, esr, oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.

Eligibility criteria:
inclusion criteria * 50\<age\<80 years * bicompartmental knee arthroplasty * weight bearing 7 days after surgery * transfusions according to hospital protocol * alteration of the indices at t0 * standard analgesic therapy exclusion criteria: * joint replacements from other units * inflammatory arthropathies * autoimmune / rheumatic diseases * obesity * diabetes mellitus * infections

Keywords: total knee arthroplasty (tka) c-reactive protein (crp) erythrosedimentation rate (esr) over knee oedema (edo) under knee oedema (edu) mediet questionnaire
previously implanted pudendal nerve stimulation

Conditions: Urinary Retention; Underactive Bladder

Summary: this study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.

the pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. electrical stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain. researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.

Eligibility criteria:
inclusion criteria: * previously received an implanted neurostimulator at the pudendal nerve * adult (18 or older), capable of providing own informed consent and communicating clearly with the research team * capable of speaking, reading, and understanding english, as all study questionnaires are standardized assessments only available in english. * capable of attending the experimental session exclusion criteria: * pregnant or planning to become pregnant during study. if a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy * currently has a urinary tract infection (uti) * currently has or tested positive in the last 14 days for covid-19, or is symptomatic for covid-19 * unwilling to allow de-identified data to be stored for future use or shared with other researchers

Keywords: pudendal nerve mapping nerve stimulation
safety, tolerability and efficacy study of the monoclonal antibody, ct-011, in patients with metastatic melanoma

Conditions: Melanoma; Malignant Melanoma

Summary: the purpose of this research study is to see if the study drug, ct-011, is safe to give and if it helps people with melanoma that has spread to other areas of their body. ct-011 is a monoclonal antibody. monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). monoclonal antibodies are antibodies made in a lab instead of by the immune system which then recruit the immune system to help fight cancer cells. all final eligible subjects will receive an intravenous infusion of ct-011. this study will test two dose levels of the study drug: group 1: patients in this group will be given the study drug at dose level 1 (1.5 mg/kg). group 2: patients in this group will be given the study drug at dose level 2 (6.0 mg/kg). each group will be given the study drug through an iv (a needle put into a vein in the arm) on day 1. after day 1, the study drug will be given every other week. patients may be given a total of up to 27 study drug infusions for about 12 months while they are in the study. approximately 100 patients will participate in this study.


Eligibility criteria:
inclusion criteria: 1. participants must have a histologically or cytologically documented diagnosis of metastatic melanoma. 2. participants age is 18 years or older. 3. stage iv disease that is clearly progressive since last therapy 4. ecog performance status of 0 or 1. exclusion criteria: 1. patients with uveal melanoma. 2. active autoimmune disease, symptoms or conditions except for vitiligo, type i diabetes, treated thyroiditis, asymptomatic laboratory evidence of autoimmune disease (eg: + ana, +rf, antithyroglobulin antibodies) or mild arthritis requiring no therapy or manageable with nsaids. 3. prior use of anti pd-1, anti pd-l1 or pd-l2 therapy. 4. more than 3 prior lines of treatment for metastatic melanoma including approved and investigational treatments. 5. women of child bearing potential who are pregnant note: this is only a partial list of eligibility criteria.
stress management for chronic headaches

Conditions: Headaches

Summary: this interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. these two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.


Eligibility criteria:
inclusion criteria: * undergraduate students at wayne state university who have chronic headaches exclusion criteria: * insufficiently frequent headaches * uninterested in engaging in a stress management intervention * headaches appear due to substance use or head trauma

Keywords: headaches stress management assertiveness training relaxation training emotional expression
safety and efficacy of polymyxin b hemoperfusion (pmx) for septic shock

Conditions: Septic Shock; Endotoxemia

Summary: to compare the safety and efficacy of the pmx cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the pmx cartridge, versus subjects who receive standard medical care alone.


Eligibility criteria:
inclusion criteria: * hypotension requiring vasopressor support * the subject must have received intravenous fluid resuscitation * documented or suspected infection * endotoxin activity assay ≥ 0.60 eaa units * evidence of at least 1 new onset organ dysfunction exclusion criteria: * inability to achieve or maintain a minimum mean arterial pressure (map) of 65mmhg * subject has end stage renal disease and requires chronic dialysis * there is clinical support for non-septic shock * subject has had chest compressions as part of cpr * subject has had an acute myocardial infarction (ami) * subject has uncontrolled hemorrhage * major trauma within 36 hours of screening * subject has severe granulocytopenia * hiv infection with a last known or suspected cd4 count of \<50/mm3 * subject has sustained extensive third-degree burns * body weight \< 35 kg (77 pounds) * known hypersensitivity to polymyxin b * subject has known sensitivity or allergy to heparin * subject has screening mod score of ≤9