Kornimate/medical-research-clean huggingface dataset:
symbicort in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with copd.


Eligibility criteria:
inclusion criteria: * patients with copd treated with budesonide/formoterol exclusion criteria: * limitations; possible risks; warnings; contraindications mentioned in the spc.

Keywords: treatment of copd related to the budesonide/formoterole therapy in patients with copd.
long-term outcomes after hypothermic oxygenated machine perfusion of donor livers using real-world data

Conditions: Organ Preservation; Liver Transplantation; Hypothermic Machine Perfusion

Summary: end-ischemic hypothermic oxygenated machine perfusion (hope) of human donor livers mitigates ischemia-reperfusion injury, resulting in a reduction of post-reperfusion syndrome, early allograft dysfunction and biliary complications, when compared with static cold storage. according to ideal-d (idea, development, exploration, assessment, long term study-framework for devices), with several published randomized controlled trials on short-to-medium term outcomes, scientific evidence for hope has currently reached stage 3. assessment of long-term outcomes after hope preservation based on real-world data (i.e., ideal-d stage 4) is currently still lacking. therefore, we aim to conduct an international, multi-center, retrospective, observational cohort study to assess long-term outcomes after transplantation of donor livers preserved by hypothermic oxygenated machine perfusion (hope).


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) who underwent liver transplantation of donor livers preserved with end-ischemic hope (including donation after normothermic regional perfusion) between 01.01.2012 and 31.12.2021. exclusion criteria: * simultaneous multiorgan transplantations, sequential normothermic machine perfusion (e.g., dhope-cor-nmp, but not nrp), living partial liver donation.
stress echocardiography versus coronary angiography for left main stenosis detection

Conditions: Left Main Coronary Artery Disease; Stenosis

Summary: left main stenosis use to be treated by bypass but with the improvement of angioplasty techniques, an increasing number of patients are submit to left main coronary angioplasty. consequences of left main intra stent stenosis can be disastrous yet, for the moment, no precise recommendation concerning the follow up of these patients exist. the investigators ought to determine if stress echocardiography can predict left main intra stent stenosis as well (non inferiorly)as control angiography that use to be done.

all patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).

Eligibility criteria:
inclusion criteria: * patients over 18 years old able to give consent and having had left main angioplasty. exclusion criteria: * bypass on the left anterior descending coronary artery or left circumflex (" protected left main ") * treating physician judge that angiography need to be done straightaway * follow up elsewhere than the chus * patient refusal * pregnant women * stress echo contraindication(severe high blood pressure or malignant arrhythmia)or condition that limits interpretation (left bundle branch block or pacemaker rhythm)

Keywords: left main coronary artery coronary artery disease stress echography intrastent stenosis
strive - resilience curriculum for novice physicians-in-training

Conditions: Stress, Emotional

Summary: the goal of this trial is to compare self-reported resilience scores in junior physicians-in-training after completion of formal resilience training. the main questions this trial aims to answer are: * does formal resilience training improve self-reported resilience scores? * does the timing of resilience training (i.e., first vs second year of residency training) impact the effect of training? all participants will be provided with resources on resilience and learner support as per usual institutional practice. the intervention group will also participate in a formal resilience training program. researchers will compare self-reported resilience scores 3 months after training to determine the effect of the training program.

physician wellness has gained much attention over recent years due to growing concerns regarding mental illness and burnout. the covid-19 pandemic further highlighted the importance of physician health. resilience, defined as the capacity of an individual to adapt well and even thrive in the setting of adversity and stress, has been identified as an indicator of physician wellness. resilience is a multidimensional concept that integrates personal factors, such as personality, with previous challenging experiences, leading to positive adaptation. simulation training for resilience in various environments (strive) is an adaptation of a formal resilience curriculum developed by the department of national defense in canada for military personnel. fundamental skills learned during the course are applied and reinforced through experiential learning with high-fidelity simulation accompanied by effective debriefing. physicians-in-training have been identified as a population cohort with a high prevalence of burnout, depersonalization, and fatigue. research demonstrates that institutional culture on wellbeing has a greater impact on resident satisfaction compared to the area of specialization. therefore, we propose that institutional curricula and training in physician wellness may improve self-reported resilience in physicians-in-training. the study will be conducted at london health sciences centre, university hospital in london, ontario. a total of 60 participants will be recruited from the pgy-1 and pgy-2 residents from the anesthesia and emergency medicine residency programs at the commencement of the academic year 2023. the study aims to compare self-reported resilience of participants before and after the training, to determine if there is a statistically significant improvement in resilience scores, based on the cd-risc-10 scores at 3 months.

Eligibility criteria:
inclusion criteria: * all first- and second-year medical residents enrolled in the schulich school of medicine \& dentistry anesthesia and emergency medicine postgraduate residency programs will be eligible to participate, regardless of age, gender, health status, or race. the respective residency program directors have approved study content and procedure. exclusion criteria: * none
influence of flexion distraction manipulation on measures of performance and postural control

Conditions: Spine Condition; Low Back Pain

Summary: this research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.

objective this research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices. methods: all patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale \[qvas\]) will be invited to participate. the goal is to recruit 150 participants from approximately 10 chiropractic practices. volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. at baseline and each subsequent testing visit, participants will complete the following: * a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain * keele start back screening tool * assessment of balance confidence questionnaire (abc-6) * posture testing via force plate: modified test of sensory integration and balance (mctsib), single leg stance, limits of stability, * timed up and go and 5 times sit to stand tests the design of this study is observational, pre-post. posture and performance testing is expected to last no more than 10 minutes per participant per visit. subjective data will be captured via redcap while objective data will be recorded by each clinician and uploaded to secure server. the design of this study is observational, pre-post. posture and performance testing is expected to last no more than 10 minutes per participant per visit. subjective data will be captured via redcap while objective data will be recorded by each clinician and uploaded to secure server.

Eligibility criteria:
inclusion criteria: * new patients with spinal pain, * patients will be between 18-100 years of age. * all patients with spinal pain who - can safely stand and perform the basic parameters of the test at a 7 or below on qualitative visual analog scale (qvas) on pain will be invited to participate. exclusion criteria: -patients unable to stand normally with more than a 7 / 10 on the qvas.

Keywords: spine low back pain spinal manipulation spinal mobilization spinal stenosis
evaluation of the "st500 single- dose gel" in patients with symptomatic long head of the biceps tendon injury

Conditions: Long Head of Biceps Rupture

Summary: single arm, post-market, confirmatory, interventional clinical investigation - medical device

the aim of this single arm, post-market, confirmatory, interventional clinical investigation was to evaluate the effect on shoulder functionality and symptoms in patients affected by lhbt injury of a ha-based gel containing a peptide mixture, the st500 single-dose gel (st500tm), topically applied to the shoulder.

Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥18 years at the time of the signature of icf. 2. unilateral or bilateral lhbt injury of mild or moderate severity (cms ≤ 70). 3. willing to follow all study procedures, including attending all site visits, tests and examinations. 4. willing to participate in the study and sign the icf. exclusion criteria: 1. other - different - clinical conditions of the shoulder requiring surgical intervention as well as full rotator cuff tears and lhbt lesions classified as type iv, v, or vi. 2. previous shoulder(s) surgery. 3. infective or inflammatory processes near the area of treatment. 4. damaged skin in the area of treatment. 5. ongoing cutaneous allergies. 6. serious and chronical pathological skin conditions (i.e., rosacea, psoriasis, vitiligo) including diagnosticated cancer with/without ongoing antitumor therapy. 7. allergy to device components (sodium hyaluronate; sh-polypeptide-29; sh-tripeptide-1; demineralized water; glycerin; propylene glycol; ethylhexylglycerin; panthenol; peg-40 hydrogenated castor oil; sodium hydroxide; xanthan gum; phenoxyethanol; benzoic acid; carbomer; dehydroacetic acid; disodium edta). 8. any other systemic or local therapy for the treatment of lhbt injury (only physiotherapy is allowed). 9. any other systemic or local therapy (e.g. corticosteroids) for the treatment of other inflammatory diseases (e.g. dermatitis, acute or chronic bronchitis, gastroenteritis, etc.) or painful states (e.g. headache, dental abscess, etc.) that may interfere with the clinical course of lhbt injury under treatment with the medical device st500 (only the use of paracetamol, according the procedures described in the protocol, is allowed to treat the painful state related to lhbt injury). 10. high consumption of analgesic drugs for the painful state upon clinician judgement (i.e., nsaids + opioid or nsaids + steroids). 11. immune system illnesses. 12. uncontrolled systemic diseases. 13. known drug and/or alcohol abuse. 14. mental incapacity that precludes adequate understanding or cooperation. 15. participation in another investigational study. 16. pregnancy or breastfeeding.

Keywords: long head of biceps long head of biceps tendon injury hyaluronic acid peptides lhbt injury constant-murley score
vaccine therapy with or without donor lymphocyte infusion in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant

Conditions: Leukemia; Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant. purpose: this clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.

objectives: * determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after hla-matched related sibling nonmyeloablative hematopoietic stem cell transplantation. * evaluate the safety and tolerability of this regimen in these patients. * determine the maximum tolerated dose of donor lymphocyte infusions in these patients. outline: patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo hla-matched related sibling nonmyeloablative hematopoietic stem cell transplantation (hsct). patients then receive cancer cell vaccine with or without donor lymphocyte infusion. the donor lymphocytes are obtained from the same relative who donated stem cells for the hsct. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * confirmed diagnosis of 1 of the following: * acute myeloid leukemia (aml), meeting any of the following criteria: * relapsed disease * aml arising from myelodysplastic syndromes * primary refractory disease * de novo aml with high-risk features * acute lymphoblastic leukemia (all), meeting any of the following criteria: * de novo all that is philadelphia chromosome positive or with t(4,11) cytogenetic features * relapsed disease * multiple myeloma (in need of treatment) * planning to undergo hla-matched related sibling nonmyeloablative hematopoietic stem cell transplantation patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia secondary acute myeloid leukemia stage iii multiple myeloma untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia stage i multiple myeloma stage ii multiple myeloma refractory multiple myeloma
immunological and viral parameters in patients receiving anti-epileptic drugs

Conditions: Epilepsy; Drug Hypersensitivity Syndrome

Summary: a recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. the aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. in particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. this study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.


Eligibility criteria:
inclusion criteria: * patients age over 18 years * patient for whom treatment of antiepileptic class will be started or was set for less than 48 hours and including one of the following molecules (as princeps or generic equivalent form): sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine eslicarbazepine acetate. * patient or patient's representative who was informed and signed the consent form * effective contraception in women of childbearing age * affiliation to health insurance exclusion criteria: * immunosuppressive therapy in progress or acquired immunodeficiency * patient with meningitis or meningoencephalitis * patient with known contraindications to any molecules indicated in the study * major patient protection (guardianship) or deprived of liberty by judicial or administrative decision. * patient participating in another clinical trial or participated in another trial in the month before. * pregnant or breastfeeding women.
study to assess the concentration of avibactam and ceftazidime in epithelial lining fluid and plasma

Conditions: Healthy

Summary: this is an open-label study divided in 2 parts and 3 cohorts to determine the concentration of avibactam and ceftazidime in the lining of the lungs and the blood.

a phase i open-label, 2-part, 3-cohort, single-centre study to assess the concentration of avibactam and ceftazidime in epithelial lining fluid and plasma using at least two different dosing regimens in healthy volunteers

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male and female subjects with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. female subjects must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child-bearing potential * male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the ip * have a body mass index (bmi) between 19 and 30 kg/m2 * as judged by the investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements exclusion criteria: * history or presence of any clinically significant disease or disorder (including a history of chronic respiratory disease eg, asthma, chronic obstructive pulmonary disease \[copd\], cystic fibrosis or interstitial lung disease) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * known allergy to lidocaine/lignocaine, midazolam, alfentanyl or other topical anaesthetics/sedatives in similar classes to these agents * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ip * any clinically significant abnormalities in physical examination, lung function test, ecg, clinical chemistry, haematology, coagulation screen, or urinalysis results as judged by the investigator

Keywords: phase 1 open label healthy male and female (post menopausal) volunteers pharmacokinetics caz104 avibactam ceftazidime open label, at least 2 different regimens, concentration of investigational product (ip), caz104, avibactam, ceftazidime, cmax, tmax
interrelation between bronchial asthma and smoking

Conditions: Bronchial Asthma

Summary: smoking occurs frequently in patients with asthma. recent surveys on smoking prevalence report 21-26% current smokers in populations of patients with asthma. detrimental effects of active smoking in asthma include worse asthma control, an impaired response to corticosteroids and accelerated lung function decline.

the mechanisms by which cigarette smoking contributes to disease severity in asthma are incompletely understood, but it has been suggested that cigarette smoking may change inflammation and airway remodelling in asthma to become more similar to that in copd (chronic obstructive pulmonary disease). any form of tobacco use, especially cigarette smoking, plays an important role in this disease. asthmatic smokers are prone to several negative outcomes. cigarette smoking by itself is associated with airway inflammation and features of airway remodelling including increased epithelial proliferation, squamous cell metaplasia, goblet cell hyperplasia, smooth muscle hypertrophy, and increases in bronchial glands mass. corticosteroid insensitivity is an important clinical feature of asthma, particularly in patients with severe disease and smokers. the mechanisms of corticosteroid insensitivity in asthmatic patients are poorly understood. one of the major problems in the treatment of smoking asthma patients is the lack of efficacy data in this group of patients as smokers have almost always been excluded from studies on asthma due to perceived concerns about recruiting patients with copd. therefore, there is a lack of specific information about the treatment of asthma in smokers. the asthmatic smoker is a special phenotype with important therapeutic and prognostic clinical implications.

Eligibility criteria:
inclusion criteria: 1. stable asthmatic patients (however smokers, or non-smokers) will be included (stable asthmatic defined as no emergency clinic or hospital visit, oral corticosteroid prescription, or change in asthma treatment in the past month) and (current smoking was defined as 5 or more cigarettes per day and a smoking history of 5 pack years or greater). 2. treatment with long-acting b2-agonists, and leukotriene receptor antagonists was allowed. exclusion criteria: 1. acute severe asthma. 2. causes of airway obstruction other than asthma as copd patients, bronchiectasis......etc. 3. age \ 45 years old. 4. body mass index \>35. 5. requirement for treatment with or the presence of conditions likely to be exacerbated by oral corticosteroids 6. the intention to stop smoking. eligibility for the study required demonstration of reversible airflow obstruction (fev1 bronchodilator response to b2 agonist of \>12% \[and \>200 ml\]) or a positive methacholine test result. all lung function assessments met relevant international consensus guidelines.
physical activity recommendation behaviour in german psychiatrists

Conditions: Mental Disorder; Physical Activity

Summary: the purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in german psychiatrists working with patients with mental disorders.

physical activity plays an important role in the prevention and treatment of mental disorders. despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations. psychiatrists play a key role in the recommendation of physical activity to their patients. there are no previous studies that examine physical activity recommendation behaviour in german psychiatrists. the purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in german psychiatrists working with patients with mental disorders.

Eligibility criteria:
inclusion criteria: * physician specialized in psychiatry or currently in training for specialization in psychiatry * currently working with patients with mental disorders * at least 18 years old * sufficient german skills for answering the questionnaire exclusion criteria: none

Keywords: physical activity mental disorder recommendation behaviour mental health exercise