Kornimate/medical-research-clean huggingface dataset:
an open, multicenter, randomized, dose-ranging study of azithromycin in the treatment of disseminated mycobacterium avium-intracellulare complex infection (mac) in patients with acquired immune deficiency syndrome (aids)

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of mycobacterium avium bacteremia in aids patients.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * medications allowed under a treatment ind program. patients must have: * hiv infection. * disseminated mycobacterium avium complex. * fever (\> 100 degrees f) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia). * life expectancy of at least the duration of the study. * consent of parent or guardian if below the legal age of consent. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * known hypersensitivity or significant intolerance to macrolide antibiotics. * inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy). prior medication: excluded: * treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry. * any other antibiotic with known activity against m. avium within 7 days prior to study entry. not expected to comply with the requirements of the protocol, in the opinion of the investigator.

Keywords: mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome azithromycin
stereotactic aspiration for primary brainstem hemorrhage based on 'zhe-er classification'

Conditions: Primary Brainstem Hemorrhage

Summary: the purpose of this study is to determine the benefit of stereotaxic aspiration for patients with primary brainstem hemorrhage with the guidance of 'zhe-er classification'

this is a retrospective study aiming to analyze the clinical record of patients from march 2014 to october 2020. this study is indicated for primary brainstem hemorrhage.

Eligibility criteria:
no new patients will be enrolled within this project inclusion criteria: * patients undergoing a stereotaxic aspiration or conservative therapy from 3/2014 to 10/2020 in 2nd affiliated hospital, school of medicine, zhejiang university, china exclusion criteria: * patients with secondary brainstem hemorrhage due to blood vessel malformation, trauma, or malignancies
scottish computed tomography of the heart trial

Conditions: Angina Pectoris; Coronary Heart Disease

Summary: the primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. however, this technology has not been robustly evaluated in any systematic approach. using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across scotland. this will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. this study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

Eligibility criteria:
inclusion criteria: * 18 and ≤75 years of age * attendance at the rapid access chest pain clinic exclusion criteria: * inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner * severe renal failure (serum creatinine \>200 µmol/l or estimated glomerular filtration rate \<30 ml/min) * previous recruitment to the trial * major allergy to iodinated contrast agent * unable to give informed consent * known pregnancy * acute coronary syndrome within 3 months

Keywords: angina coronary heart disease computed tomography angiogram coronary artery calcium score chest pain angina pectoris due to coronary heart disease
association of single nucleotide polymorphisms (snps) in metalloproteinases (mmps) genes with the risk of primary knee osteoarthritis in greek population.

Conditions: Metalloproteinase SNPs -1575 G/A MMP-2, 836 A/G MMP-9 and -77 A/G MMP-13 and Risk for Developing Knee Osteoarthritis in Greek Population

Summary: does the presence of gene polymorphisms -1575g / a in the mmp-2 gene, 836a / g in the mmp-9 gene and -77a / g in the mmp-13 gene, affect the risk of developing idiopathic knee osteoarthritis in the greek population?

this is a prospective case-control study in which the patients' genotype will be studied against the genotype of the controls. the study is prospective and not retrospective, as data will be collected from patients with primary knee osteoarthritis as well as the control group from the outset. the study intends to include 200 people. the first group consists of 100 individuals suffering from knee osteoarthritis, while the second group will include 100 healthy controls without osteoarthritis. from each one dna will be isolated and analyzed from collected blood. the prospective study allows valid data to be collected on patient demographics and disease severity. due to the large number of cases of the disease, it is estimated that the necessary specimens will be collected within a reasonable time from the beginning of this thesis. the choice of the patient-control study is necessary to limit the influence of confounding factors (age, gender, obesity, etc.). this type of study includes rigorous selection of patients and controls with specific entry and exclusion criteria, selection of controls based on matching patient characteristics, stratification, and subgroup analyzes. the final result will be a comparison of the incidence of specific gene polymorphisms between patients with knee osteoarthritis and the normal population.

Eligibility criteria:
inclusion criteria: * patients with primary knee osteoarthritis are selected based on clinical symptoms and radiological imaging with a score at least 2 on the kellgren \& lawrence scale. * patients without symptomatology or radiographic image of knee osteoarthritis (score \<2 on kellgren \& lawrence scale) will be selected as controls. exclusion criteria: * systemic inflammatory disease * rheumatic disease * liver disease * renal failure * neoplasm or other chronic disease

Keywords: mmps , snps, knee osteoarthritis, -1575g/a mmp-2 , 836a/g mmp-9 , -77a/g mmp-13
markers of inflammation and metabolism in the er

Conditions: Acute Infection; Sepsis

Summary: adult patients with suspected or confirmed infection and who will be sampled for blood culture will be recruited. blood samples are collected for the analysis of matrix metalloproteinases (mmp) and their inhibitors. we also aim to analyse metabolic changes and use the samples for analysis of blood lactate, metabolomics, and fibroblast growth factor 21 (fgf-21) as well. the primary aim of the study is to test the performance of mmp-8 in finding severely ill patients who will need treatment in high dependency unit or intensive care. the secondary aim is to study the metabolic changes in acutely ill patients with infection.

adult patients with suspected or confirmed infection and who will be sampled for blood culture (a surrogate for suspected severe infection) will be recruited from three large emergency departments in a university hospital. two blood samples will be collected: one for the analysis of matrix metalloproteinases, their inhibitor tissue inhibitor of metalloproteinase-1 (timp-1), fgf-21 and metabolomic analyses. another blood sample is for the analysis of blood lactate. clinical data will be collected to calculate quick sofa (qsofa), in order to test whether lactate and/or mmp-8 will improve the prognostic model if they are added to qsofa. the primary outcome measure is the number of days alive without the need for icu or high dependency unit treatment. the ability of mmp-8 to discriminate severe infection from uneventful course of the disease will be studied. the secondary aim is to study the metabolic changes in acutely ill patients with infection and compare these variables between survivors and non-survivors. the planned number of patients recruited is 924. during this study the feasibility of a bedside rapid analysis of mmp-8 will be tested in 30 patients and the results obtained using the rapid analyser compared with laboratory results obtained using elisa.

Eligibility criteria:
inclusion criteria: age 18 or more suspected or confirmed infection admitted to any of the three emergency departments of university hospital decision of blood culture exclusion criteria: age \<18 cancer with metastases decision of treatment limitation probable or made consent not obtainable

Keywords: mmp matrix metalloproteinase metabolomics fgf-21 quick sofa infection triage
community diabetes education program evaluation "code evaluation"

Conditions: Diabetes Mellitus

Summary: the study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. we expect an improvement in overall glycemic control in the experimental group of at least 20%. we also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ada standards of care4 in the experimental group.


Eligibility criteria:
inclusion criteria: * people with no health insurance exclusion criteria: * people with any type of health insurance coverage
improving medication management in world trade center responders

Conditions: Polypharmacy

Summary: by 2030, the majority of world trade center (wtc) rescue and recovery workers (responders) will be aged 65 and over and at risk for aging-related conditions and consequences including the concurrent use of five or more medications (i.e., polypharmacy). the purpose of this research study is to investigate an educational approach targeting polypharmacy through de-prescribing unnecessary and burdensome medications via the support of informed discussions between wtc responders and their prescribing physicians.

de-prescribing is the act of reducing or stopping medications that are no longer necessary or may cause harm, to reduce adverse drug reactions and ensure the safety of patients. polypharmacy is the simultaneous use of five or more medications. through education brochures and discussions about potential side effects of medications, the research team will see whether these approaches lead to discussions between a study participant (wtc responder) and the prescribing physician, to make informed decisions about management of medications. specifically, the participant will be provided information about one of the five medication classes they may be taking that are known to have potential side effects for older adults: proton pump inhibitors (ppis), benzodiazepine (bzs) and non-benzodiazepine sedative hypnotics ("z-drugs"), first-generation antihistamines (fga), and skeletal muscle relaxants (smr) to determine their necessity. to be clear, changes to medications will only be done under the guidance of the prescriber. study participants will be asked to complete baseline surveys that ask about beliefs and attitudes regarding medications and de-prescribing; review patient education brochure about a medication the participant is taking; discuss deprescribing options with the participant's prescriber; and complete a survey regarding acceptance of the deprescribing intervention and how this process may have affected the physician-patient relationship.

Eligibility criteria:
inclusion criteria: * a wtc responder already enrolled in the "promoting healthy aging among wtc responders: frailty trajectories and intervention strategies" study cohort * aged 50 years or older, and * taking one of the five medication classes: * proton pump inhibitors (ppis), * benzodiazepine (bzs) and * non-benzodiazepine sedative hypnotics ("z-drugs"), * first-generation antihistamines (fga), and * skeletal muscle relaxants (smr). exclusion criteria: * none

Keywords: deprescribe medication management
digital early labour. a digital application for coping in early phase of labour.

Conditions: Pregnancy Related

Summary: all first-time mothers in sweden are offered parental support, but local conditions mean that not everyone gets the opportunity to take part in this. studies show that there is a lack of evidence-based guidelines for the design of parental support in maternal health care. early labour or latent phase of labour is the part of childbirth were women often feel insecure, in stress and left out from care. first-time mothers who have no experience of one labour before are particularly vulnerable. many women today use digital applications during pregnancy and in connection with childbirth. there are several digital applications that will help the woman by guiding her and her partner in different decisions about labour, but it is necessary to offer evidence-based, credible electronic and digital solutions for expectant parents. a meta-synthesis from 2018 showed that women use the internet often and the information they receive there has a great influence on their different choices in connection with childbirth. volume, accessibility, and convenience about digital solutions play a crucial role for women and partners. the digital application contraction coper is designed and tested by the company birth by heart © in order to facilitate in early labour for the pregnant woman and her partner. the overall purpose of the project is to evaluate whether the application contraction coper can contribute to reduced anxiety and stress during pregnancy and childbirth and whether an additional support from a midwife can increase the application use and satisfaction of women when using the application. a randomized controlled trial is planned where first-time mothers after pregnancy week 25 are invited to participation via social platforms. participating first-time mothers are randomly assigned to one of three groups; experiment group one, which gets access to the application contraction coper, experiment group two contraction coper plus which gets access to both the application and support of midwives, so-called "blended" care, or three, the control group offered customary maternity care only. data collection is conducted using questionnaires, mobile application and activity bracelet.

the primary outcome is emotional stress in early labour measured with the dimension "emotional distress" in the questionnaire early labour experience questionnaire (eleq) secondary outcomes are fear of birth scale(fobs), childbirth experience questionnaire (ceq), used pain relief methods during labour and birth, mode of birth, amount of time used in the application as well as heart rate, sleep and activity for the experimental groups that had activity bracelets in addition.

Eligibility criteria:
inclusion criteria: * first time mothers * from pregnancy week 25. * swedish or english spoken. * having a smartphone, android or apple application. exclusion criteria: °multiparas.

Keywords: emotional distress digital application
rca for crrt in liver failure and high risk bleeding patients

Conditions: Liver Failure

Summary: the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of rca versus no anticoagulation for crrt in patients with liver failure and high risk bleeding.

liver failure (lf) is a common co-morbidity in critical care patients who need continuous renal replacement therapy (crrt). patients with lf are usually associated with impaired coagulation, impaired metabolic ability of anticoagulants, and increased bleeding risk. kdigo guideline recommended no-anticoagulation for crrt in patients with liver failure and increased bleeding risk. however, the averaged crrt circuit lifespan under no-coagulation was reported to be 7-8 hours in patients with liver failure. commonly, a crrt regimen needs more than 24 hours treatment, which means 3-4 filters replacement for one regimen in liver failure patients underwent no-anticoagulation crrt. several observational studies suggested that regional citrate anticoagulation (rca) during crrt was effective and safe in patients with liver failure. therefore, the current opinions on the anticoagulation strategy for crrt in patients with liver failure and high bleeding risk are controversial. therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of rca versus no anticoagulation for crrt in patients with liver failure and high risk bleeding.

Eligibility criteria:
inclusion criteria: * liver failure (acute liver failure and chronic liver failure) * high bleeding risk * scheduled crrt treatment * informed consent exclusion criteria: * use of other anticoagulants * uncorrectable hypoxemia (pao2 \< 60 mmhg) or systemic hypoperfusion shock * pregnancy or lactation * fistula, crrt treatment time \< 12 hours

Keywords: crrt liver failure filter lifespan bleeding
etanercept and methotrexate in combination or as monotherapy in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

the study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period. at or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.

Eligibility criteria:
key inclusion criteria: * subject must have a diagnosis of psoriatic arthritis (psa) by the classification criteria for psoriatic arthritis (caspar) criteria. * subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline. * subject has an active psoriatic skin lesion * subject is naïve to etanercept and any other biologic for the treatment for psa or psoriasis. * subject has no prior use of methotrexate for psa. * subject has no history of tuberculosis * subject has a negative test for tuberculosis, hepatitis b and c. exclusion criteria: * subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (hiv) infection. * subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product. * subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.

Keywords: psoriatic arthritis arthritis, psoriasis etanercept enbrel methotrexate minimal disease activity
serum concentration of cefoxitin used for antibiotic prophylaxis in obese patients undergoing bariatric surgery

Conditions: Obese; Antibiotic Prophylaxis; Bariatric Surgery Candidate

Summary: obesity is a pandemic problem in modern societies. bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. obesity and bariatric surgery are known to be risk factors of surgical site infections (ssi). the occurrence of ssi increases health cost and the duration of hospitalization. however, an appropriate antibiotic prophylaxis has been shown to reduce ssi. as recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. however, this recommendation lies on a low level of evidence. besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. in france, for instance, the intravenous second generation cephalosporin cefoxitin is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery. obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. this population was more likely to be under-dosed. the aim of this study is to analyse the appropriateness of the reference dose of intravenous cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. this will be a 2-year prospective monocentric study held in the university hospital of nancy, france. a large group of obese patients (\~300) will be included. serial serum concentration measurements of cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. this study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years-old, * severely obese patient with a bmi ≥ 35 kg.m-2, * scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy, * affiliated to social security, * the patient is able to consent to clinical research and has received all information on the study design/protocol, * signed/written informed consent exclusion criteria: * refuse to consent to the study or the patient is unable to consent, * allergy/anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected, * pregnancy, * persons deprived of their liberty by judicial or administrative decision, * urgent or emergent surgery.

Keywords: obese bariatric surgery antibiotic prophylaxis cefoxitin