Kornimate/medical-research-clean huggingface dataset:
inflammatory markers and level of cortical hyperactivity

Conditions: Cognition Disorder

Summary: alzheimer's disease (ad) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease. in this project we will seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6 and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the gabaergic anesthetic propofol in older adults undergoing elective surgery.

alzheimer's disease (ad) is a progressive and fatal neurodegenerative disease that is manifested by severe cognitive impairment mainly from late life (\>65 years). it is now known that markers of damage begin decades before symptoms can be detected, at the stage called preclinical early ad, which progresses inexorably to mild cognitive impairment and ends in severe alzheimer's dementia. clinical studies have shown that both systemic inflammation and cortical and hippocampal hyperactivity are features present in patients during the early stages of the disease, however, they have not been directly related in a clinical context. in this project we will seek to relate the levels of the proinflammatory cytokines il-1beta, il-6 and tnf-alpha with the level of cortical hyperactivity evaluated with the electroencephalographic changes induced by the gabaergic anesthetic propofol in older adults undergoing elective surgery. the main goal of this project is to determine the levels of inflammatory markers and cortical hyperactivity in older adults. methodology: the project is an exploratory observational study of a prospective cohort of patients \> 60 years of age who will undergo elective surgery under general anesthesia. in the preoperative period, peripheral venous blood samples will be obtained and stored at -80 ° c and then analyzed by the simoa® analyzer, fully automated and digital equipment for performing immunoassays, based on simoa® technology, which provide an ultrasensitive signal and / or measurement up to 1000 times greater than conventional immunoassays (in the femtomolar range) of proteins. on the other hand, eeg signal at 128 hz and other variables from bis® monitor will be recorded to determine the level of cortical hyperactivity.

Eligibility criteria:
inclusion criteria: 1. adults over 60 years of age undergoing elective surgery 2. able to understand and sign an informed consent form exclusion criteria: 1. diagnosis of other neurological pathologies 2. no active acute or chronic decompensated diseases 3. no severe psychiatric illnesses 4. propofol allergy
the designer d-dimer deep vein thrombosis diagnosis (4d) study

Conditions: Suspected Deep Vein Thrombosis

Summary: this is a cohort study that will assess a new diagnostic management strategy for suspected deep vein thrombosis in outpatients.the new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test.

this is a prospective, multicentre, cohort study that will assess a new diagnostic management strategy for suspected deep vein thrombosis in outpatients. the new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test. less ultrasound testing will be performed because: i) more patients will have deep vein thrombosis excluded by combinations of clinical pretest probability and d-dimer results on the day of presentation; and, ii) in those who still need an ultrasound, a repeat ultrasound a week after a normal result will only be performed if the d-dimer result is markedly abnormal at initial presentation. the safety of this management strategy will be established by demonstrating a very low rate of proximal deep vein thrombosis or pulmonary embolism during 90 days follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. diagnostic test utilization will be assessed. all clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial d-dimer measurements and patient management.

Eligibility criteria:
inclusion criteria: 1) consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected deep vein thrombosis. exclusion criteria: 1. age less than 18 years. 2. treated with full-dose anticoagulation for ≥ 24 hours before d-dimer was measured. 3. d-dimer level known before clinical pretest probability documented. 4. ultrasound of the leg performed before clinical pretest probability was documented 5. ultrasound was or will be performed in a patient with low clinical pretest probability and a d-dimer \<1000(or equivalent), or with moderate clinical pretest probability and a d-dimer \<500 (or equivalent) (e.g. suspected bleeding). 6. ongoing need for anticoagulant therapy. 7. suspected pulmonary embolism. 8. superficial venous thrombosis that requires, or may require, anticoagulant therapy. 9. life expectancy less than 3 months. 10. previously confirmed episode of deep vein thrombosis. 11. geographic inaccessibility which precludes follow-up. 12. known pregnancy.

Keywords: deep vein thrombosis
randomized comparison of mynxgrip vascular closure device and manual compression for closure after femoral access angiography. the closure devices used in every day practice study, close-up iii trial

Conditions: Coronary Disease

Summary: is the mynxgrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.

prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the mynxgrip (test device) and manuel compression (standard comparator). safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.

Eligibility criteria:
inclusion criteria: * \>18 year * should be able to provide valid informed signed consent * cag, possibly including intracoronary measurement (ffr) or intracoronary imaging (ivus, optical coherence tomography (oct), nirs) exclusion criteria: * percutaneous coronary intervention (pci) procedure and/or implantation of stents * st-elevations myocardial infarction (stemi) * multiple punctures * active infection * groin haematoma before the closure procedure * known pseudoaneurysm or arteriovenous (av) fistula in the ipsilateral groin * cardiogenic shock * prior peripheral arterial surgery in abdomen or lower extremities * sheat size \>7 f * life expectancy less than one year * possible pregnancy or positive pregnancy test or breastfeeding women * simultaneous or planned subsequent femoral vein access * allergy to any of the components in the closure material left in the groin * puncture or closure with closure device at same site \< 30 days * puncture or closure with manuel compression at same site \< 5 days * patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device

Keywords: coronary angiography (cag)
promoting engagement in the drug resistant tb-hiv care continuum in south africa praxis study

Conditions: Adherence, Patient

Summary: the goal of the proposed study is to enhance adherence and retention in care for m/xdr-tb hiv patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

tuberculosis (tb) remains the leading cause of morbidity and mortality worldwide among people living with hiv (1). globally, the incidence of multidrug-resistant tuberculosis (mdr-tb) and extensively drug resistant tuberculosis (xdr-tb), the most drug-resistant forms of tb, has approximately doubled over the past fifteen years (1-3). nowhere has this increased incidence generated more concern than in south africa where interactions between tb and generalized hiv epidemics are causing 'explosive' tb incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (art) (7, 8). medication adherence, a key predictor of outcomes in m/xdr-tb and hiv treatment, is understudied in high burden tb-hiv settings (9-11). patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. demands of m/xdr-tb hiv treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. mtb culture positive with at least isoniazid and rifampicin resistance or molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin or polymerase chain reaction test (xpert mtb/rif) result showing mtb positive and rif resistance. or mtb positive with rifampicin monoresistance 3. initiating treatment for m/xdr-tb which includes bedaquiline (bdq) or moxifloxacin/levaquin 4. have capacity for informed consent 5. hiv positive patients: on art or initiating art within the following 4 weeks as per clinician recommendation exclusion criteria: 1. pregnancy 2. prisoners 3. discretion of ior or clinician
ck-0045 proof-of-concept study in participants with overweight / obesity and type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity and Overweight

Summary: the goal of this clinical trial is to learn if treatment with ck-0045 improves blood sugar control after a meal in participants with type 2 diabetes mellitus (t2dm) and overweight/obesity. it also aims to learn if ck-0045 can reduce body weight in these patients. the main question it aims to answer is: • does 16 weeks of treatment with ck-0045 improve blood sugar control after a meal in participants with overweight or obesity and t2dm? researchers will compare two dose levels of ck-0045 to a placebo arm (a look-alike substance that contains no drug) to see if ck-0045 improves blood sugar control. participants will: * have ck-0045 or placebo injected subcutaneously (under the skin) once weekly over a period of 16 weeks. * visit the clinic 24 times and stay overnight at 2 of the visits. * during the visits blood samples will be collected and several other assessments/examinations will be performed to learn about the effects (and potential side effects) of ck-0045.

phase 2a, randomized, double-blind, placebo-controlled, parallel group trial with weekly sc dosing of ck-0045 (2 dose levels) or placebo over 16 weeks followed by 8 weeks of follow-up in participants with overweight / obesity and t2dm. the total duration of involvement for each participant, screening through follow-up, will be approximately 30 weeks.

Eligibility criteria:
key inclusion criteria: * 18-74 years old male or female diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening * body mass index (bmi) between 27.0 and 40.0 kg/m\^2 at screening * treated with diet and exercise * hba1c 6.5-8.5%, both inclusive, at screening for participants taking 3 antidiabetic medications or hba1c 6.5-9.0%, both inclusive, at screening for participants taking 2 or less antidiabetic medications at stable doses for at least 3 months prior to screening key exclusion criteria: * any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have new york health association class iii or iv heart failure or any other clinically significant history or evidence of poorly controlled cardiovascular disorder(s) as judged by the investigator. * have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months. * history or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.

Keywords: ck-0045
the impact of pulmonary rehabilitation in interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: the purpose of this study is to determine if pulmonary rehabilitation has any effect on breathlessness, quality of life, physical function and depression in persons with interstitial lung disease.


Eligibility criteria:
inclusion criteria: * adults (\> 18 years old) with a diagnosis of ild who are referred to a participating pr program exclusion criteria: * inability to provide informed consent * inability to read and write english * any other medical condition that significantly limits the subject's ability to perform the functional measures * emphysema / chronic bronchitis (fev1 / fvc ratio \< 60%) * previous pulmonary rehabilitation

Keywords: pulmonary rehabilitation exercise therapy interstitial lung disease pulmonary fibrosis mobility limitation dyspnea mental health
the effect of topical lidocaine on pain scores during manual vacuum aspiration for nonviable pregnancies

Conditions: Nonviable Pregnancy

Summary: when a patient requires a manual vacuum aspiration (mva), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. she is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. minimizing the pain during this procedure must not be overlooked. there have been no randomized controlled trials evaluating pain control during mva for nonviable pregnancy, and the data is mixed regarding analgesia for mva for an elective abortion or other office procedures. women being treated at the women \& infants triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure. the hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.


Eligibility criteria:
inclusion criteria: * patient at the women and infants triage/women's emergency department * vital signs are stable * ages 18 and older * have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy * estimated gestational age up to 10 weeks * undergoing mva at the women and infants triage/women's emergency department * able to read english or spanish * able to give informed consent for involvement in the study exclusion criteria: * allergic to lidocaine, iodine or betadine * known sensitivity to any component of the lidocaine or placebo gel. * in acute distress * unable to give informed consent * unable to read english or spanish

Keywords: manual vacuum aspiration missed abortion incomplete abortion nonviable pregnancy topical lidocaine
protein top-up acceptability study for patients with increased protein needs

Conditions: Cancer; Neurological Injury; Respiratory Disease; Stroke

Summary: the aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

increased protein needs are frequently observed in disease and can be difficult for patients to achieve where oral food intake is compromised.where a standard ons or enteral tube feed cannot meet the needs of patients, a modular feed can be added to the regimen, a low calorie, low volume, ready to use, high protein liquid may help meet protein needs while preventing caloric overfeeding. 40 patients will be recruited in an attempt to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs. after a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance and dietary intake with their currently prescribed nutritional regimen, each patient will receive the high protein liquid feed daily for 28 days.

Eligibility criteria:
inclusion criteria: * 18 years of age and older. * patients under the care of a dietitian requiring oral or enteral nutritional support, with -increased protein needs. * to receive a minimum of 1 x 40ml hplm daily (orally or via enteral tube) while on the study. * informed consent obtained from the patient exclusion criteria: * total parenteral nutrition (100% of requirements). * patients with major hepatic dysfunction (i.e. decompensated liver disease). * patients with major renal dysfunction (i.e. requiring filtration or stage 4/5 chronic kidney disease (ckd)). * participation in other studies within 1 month prior to entry of this study. * patient with severe lactose intolerance. * pregnant or lactating. * patient lacks capacity to consent for themselves.
use of a modern breath sampling system (the pneumopipe® combined with an array of e-nose sensors) for the prediction of treatment response in persistent asthmatic children

Conditions: Asthma in Children

Summary: due to a large disease heterogeneity, the proper management of childhood asthma may be a challenging task. despite the screening of lung function is a fundamental tool, spirometry alone may not allow a reliable prediction of the disease prognosis, such as treatment response and asthma exacerbations. recently, it has been shown that the detection of volatile organic compounds (vocs) in exhaled breath (breathomics) is able to predict asthma exacerbations and to discriminate children with persistently controlled asthma from those with uncontrolled asthma. these studies have been realized through gas chromatography / mass spectroscopy techniques, which also provide information on specific compounds useful for pathophysiologic research; however, they are expensive and time consuming. an alternative approach, scarcely adopted so far, is based on cross-reactive nonspecific sensor arrays (e-noses), which may provide valuable information on disease status through pattern recognition algorithms or discriminant analyses of the global sensor response pattern (breath-fingerprint). in particular, the pneumopipe® (european patent 12425057.2, rome, italy) is a recent and innovative device allowing direct absorption of vocs on a cartridge after an individual has normally breathed in it for 3 min. it is a very simple and cheap procedure, suitable for non-collaborative populations. moreover, cartridges may be preferable over sampling bags in terms of preservation and transportability. this modern breath sampling system provides repeatable measurements, and negligible overlap has been observed with information provided by spirometry. the main objective of the present study is to assess whether baseline (pre-treatment) spirometry and e-nose measurements may predict asthma prognosis in persistent asthmatic children, in terms of response to the prescribed treatment with inhaled steroid (ics), and to provide simple rules for discriminating treatment responders and non-responders. the secondary aim is to assess e-nose ability to predict asthma exacerbations, disease control and adherence.


Eligibility criteria:
inclusion criteria: * male or female gender * age between 6 and 16 years * first asthma diagnosis according to gina recommendations (http://ginasthma.org), including assessment of the history of respiratory symptoms (wheezing, shortness of breath, chest tightness and cough) and environmental exposures (smoke, mold, vehicular traffic), spirometry (fev1/fvc\ 12% fev1 increase from baseline after bronchodilator inhalation) and skin prick tests. exclusion criteria: * exacerbations requiring oral corticosteroids in the last four weeks * use of controller medications (leukotriene receptor antagonists and/or inhaled corticosteroids) in the last four weeks * respiratory infections in the last four weeks * immunological, metabolic, cardiac or neurological diseases * major malformations of the respiratory system * active smoking.
emergence of gram-negative resistance in blood culture isolates of solid-organ transplant recipients

Conditions: Gram Negative Infection

Summary: the information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. data is needed regarding the date of admission, date of bloodstream infection and location of ward/icu so trends in the emergence of resistance and antibiotic usage can be detected.

we need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. we also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. the following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

Eligibility criteria:
inclusion criteria: * all patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005

Keywords: gram negative infection