Kornimate/medical-research-clean huggingface dataset:
comparative effects of triple inhaled therapy with budesonide/glycopyrronium/formoterol versus fluticasone furoate/umeclidinium/vilanterol on small airway disease in copd patients: a randomized crossover study

Conditions: COPD; Chronic Obstructive Pulmonary Disease (COPD); Small Airway Disease; Triple Therapy; Lung Function

Summary: the goal of this clinical trial is to determine if triple inhaled therapy with budesonide/glycopyrronium/formoterol (bgf) and fluticasone furoate/umeclidinium/vilanterol (fuv) are effective in treating patients with stable chronic obstructive pulmonary disease (copd). it will also assess the safety of both drugs. the main questions it aims to answer are: * does bgf demonstrate a comparable effect to fuv in copd participants? * what medical problems do participants experience when taking bgfand fuv?

this study is a randomized crossover study. copd patients aged 40 years or older with stable disease are included. each patient receives four weeks of treatment with either bgf or fuv followed by a one-week washout period, and then four weeks of treatment with the other drug. respiratory symptoms are assessed using modified medical research council (mmrc) dyspnea scale and copd assessment test (cat). pulmonary function is assessed by spirometry with bronchodilator testing, and adverse events were recorded. spirometry data, including forced expiratory volume in 1 second (fev1), forced vital capacity (fvc), and forced expiratory flow at 25-75% of fvc (fef25-75) are also collected. impulse oscillometry (ios) is also performed, with results reported as r5, r20, r5-r20, x5, fres, and ax.

Eligibility criteria:
inclusion criteria: * copd diagnosis confirmed by spirometry (post-bronchodilator fev1/fvc \< 70%) * aged 40-80 years * smoking 10 pack-years or more * postbronchodilator fev1 \< 80% exclusion criteria: * history of copd exacerbation within 3 months * asthma, bronchiectasis, pulmonary fibrosis * inability to perform spirometry, impulse oscillometry, or 6-minute walk test * pregnant or breastfeeding women

Keywords: copd chronic obstructive pulmonary disease small airway disease triple inhaled therapy budesonide/glycopyrronium/formoterol fluticasone furoate/umeclidinium/vilanterol
covid-19, acute myocardial infarctions and strokes in france

Conditions: COVID-19; Acute Cardiovascular Condition; Acute Neurovascular Condition; Stroke; Acute Myocardial Infarction

Summary: the covid-19 pandemic has had dramatic effects on health systems and on non-covid health care. using french inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in france during and after the national lockdown.


Eligibility criteria:
inclusion criteria: - adults admitted in 2018, 2019 or 2020 in a french hospital for acute coronary syndrom or stroke exclusion criteria: - none
2nd_computerized asthma specific quality of life(caqol)

Conditions: Persistent Asthma Patient

Summary: comparison of the responsiveness of two different asthma-specific qol measures (aqlq and caqol) in korean patients with persistent asthma


Eligibility criteria:
inclusion criteria: * patient aged 20-70 years * patient diagnosed with asthma over six months ago * asthma diagnosis * airway reversibility, fev1 ≥ 12% and 200ml or * airway hyper-responsiveness, pc20 \< 16 mg/ml or * more than two weeks, more than 2 times a day in excess of 20% pefr diurnal variability patient * fev1 55-100% of predicted value patient * inhaled corticosteroids alone or inhaled corticosteroids and beta agonists used patient * currently, at least if you have one or more asthma symptoms, asthma control test (act • asthma control test) score of less than 19 characters * patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by irb of ajou university medical center before the participation in this trial exclusion criteria: * current smoking or smoking in the past 15packyears * patients who show a symptom of an acute disease within 14 days before the beginning of this trial (administration of trial medication) * recent changes in asthma treatment for 28days * chronic diseases that affect the quality of life

Keywords: aqlq and caqol
utility of caml as diagnostic for early stage lung cancer

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Summary: primary objective determine the prevalence of camls in patients with pulmonary nodules. secondary objectives determine the positive and negative predictive value of camls in patients with pulmonary nodules who undergo biopsy. model combinations of clinical factors with the presence/absence of camls to refine strategies for assessment of patients with pulmonary nodules. evaluate whether these measures result in enhanced t-cell activity and/or nk cell function and number


Eligibility criteria:
inclusion criteria: * referral for a pulmonary nodule that has not yet been biopsied and that meets the definition of an "indeterminate" nodules (i.e. 0.8-3.0 cm). * no prior diagnosis of lung cancer or other invasive malignancy within the past 5 years. * no history of rheumatologic disease. * age \> 18 years. * ability to understand and willingness to sign a written informed consent and hipaa consent document exclusion criteria: * patients with active, known or suspected autoimmune disease. * prior diagnosis of lung cancer or other invasive malignancy within the past 5 years. * uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements. this includes but is not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * known hiv-positive patients on combination antiretroviral therapy are ineligible because of the abnormal immune response that results from hiv disease (testing is not required). * patients should be excluded if they are known to be positive for hepatitis b virus surface antigen (hbv sag) or hepatitis c virus ribonucleic acid (hcv antibody) indicating acute or chronic infection (testing is not required). * subjects with any history of interstitial lung disease or a history of \> or = to grade 2 radiation pneumonitis.

Keywords: caml early detection
limb salvage post venous injury:case series

Conditions: Limb Salvage

Summary: the venous injury diagnosis depends on history of trauma with symptoms and signs suggestive of venous injuries and color flow duplex study is of increasing value as a screen for detection of an occult venous injuries. it is associated with arterial, peripheral nerve injuries and bone fractures. within this study of one-year duration, a seventy-five patients with acute venous injuries were included. the injured vein was either repaired or ligated according to hemodynamic state of patient and site and type of injury.

this is a retrospective cross section study of one-year duration from january 2017 and january 2019 at najaf teaching medical city/iraq . the study included a seventy-five patients with acute venous injuries. the venous surgical interference for late complicated vascular injuries and iatrogenic venous injuries were excluded and the information was obtained from the hospital records and direct evaluation of patients.

Eligibility criteria:
inclusion criteria: all in surgical emergency departments exclusion criteria: nil

Keywords: limb salvage venous injury edema amputation fasciotomy.
evaluation of the clinical performance of the quantra system with the qstat cartridge in trauma

Conditions: Blood Loss Massive; Trauma

Summary: this pilot study will evaluate the performance of the quantra system comprised of the quantra hemostasis analyzer with the qstat cartridge in trauma patients.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the qstat cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. this includes the trauma patient population. the cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. this single-center, prospective, observational pilot study will evaluate the performance of the quantra system with the qstat cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject is a trauma patient and is a candidate for a rotem test to be performed to access coagulopathy * subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury. * subject is willing to participate, and is willing to consent (either prospectively or by deferred consent) exclusion criteria: * subject is younger than 18 years of age * subject weighs less than 110 pounds * subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit * subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent) * subject is currently enrolled in a distinct study that might confound the results of the proposed study * subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Keywords: viscoelastic testing coagulation quantra hemostasis
safety and efficacy of the universal neonatal foot orthosis in the treatment of metatarsus adductus (mta)

Conditions: Metatarsus Adductus; Metatarsus Varus

Summary: this is a prospective, randomized, control, open label study in which up to 50 subjects with metatarsus adductus (mta) will be enrolled. subjects will be treated with the standard casting or using the unfo-s device for total time of 20 weeks.


Eligibility criteria:
inclusion criteria: * subjects with an acute mta that did not receive any treatment for this condition * consenting parents * ages 1-4 months exclusion criteria: * participation in another clinical trial. * neuromuscular disorders * any condition which in the opinion of the investigator renders the subject ineligible for study participation.

Keywords: mta metatarsus metatarsus adductus, also known as metatarsus varus
evaluation of a tdm program for intensive care patients in the cerebrospinal fluid

Conditions: Ventriculitis, Infectious

Summary: therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. research results have shown subtherapeutic blood concentrations in those patients. however, the amount of antibiotics in the cerebrospinal fluid (csf) in patients with ventriculitis or meningitis is still unclear. this study is a prospective study to evaluate the concentration of different antibiotics in the csf in patients with an external ventricular drainage compared to antibiotic blood concentration.

bacterial infections are still associated with a high mortality in intensive care unit patients. especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. therefore, antibiotic therapy is the only causal opportunity to treat those infections. however, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. furthermore, it is important that the concentration in the blood as well as in the effect-compartment "csf" is sufficient. less data of the last years describe antibiotic concentrations in the csf and show subtherapeutic levels, which is endangering for the therapeutic success. the introduced study is a prospective, observational study that analyses antibiotic concentrations in csf in critically ill patients. the distribution between csf and blood will be evaluated by comparing these two compartments.

Eligibility criteria:
inclusion criteria: * written approval of the legal guardian * external ventricular drainage * antibiotic therapy exclusion criteria: * no approval * no antibiotic therapy or no external ventricular drainage

Keywords: therapeutic drug monitoring (tdm) critically ill patients cerebrospinal fluid
semaglutide and albuminuria reduction trial in obese individuals without diabetes

Conditions: Obesity; Albuminuria

Summary: study to assess the effects of weekly subcutaneous administration of the glp1-ra semaglutide 2.4mg on kidney function parameters in obese/overweight individuals at high risk of ckd progression.

glucagon like peptide 1 receptor agonist (glp1-ra) therapies have been introduced as antidiabetic drugs. in addition, glp1-ra therapies reduce body weight, in patients with and without diabetes, without inducing hypoglycemia. moreover, glp1-ra reduce albuminuria in patients with type 2 diabetes, and liraglutide and semaglutide have been shown to improve various risk markers of ckd progression in non-diabetic obese individuals. it is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals. the main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. this will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index ≥ 27 kg/m2 * albuminuria ≥ 30 mg/g and ≤ 3500 mg/g * egfr ≥ 25 ml/min/1.73m2 * stable renal function prior to entry into the study defined as no more than 30% egfr change in 3 months prior to enrolment * signed informed consent exclusion criteria: * diagnosis with type 1 or type 2 diabetes * hba1c ≥ 6.5% at screening * cardiovascular disease event in 3 months prior to enrollment * treatment with glp-1 ra \< 4 weeks prior to screening * uncontrolled thyroid disease tsh\>6.0 miu/l or \<0.4 miu/l at screening * acute pancreatitis \< 180 days prior to screening * history or presence of chronic pancreatitis * females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures

Keywords: smart semaglutide umcg lambers heerspink
safe use of cpap and peep during induction of general anesthesia

Conditions: General Anesthesia

Summary: the study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (peep) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without peep immediately after apnoea.

using a continuous positive pressure (cpap) during preoxygenation, followed by pressure controlled ventilation with peep after apnoea during induction of general anesthesia, might offer several benefits but safety issues needs more investigation. this study compares the safety of using pressure controlled with peep during induction of general anesthesia immediately after apnoea to a standard method starting ventilation manually without peep immediately after apnoea.

Eligibility criteria:
inclusion criteria: * normal or overweight patients scheduled for day case surgery in general anesthesia. * american society of anesthesiologists functional class i-iii. * body mass index 18.5-30. exclusion criteria: * increased risk of regurgitation of gastric content. * symptomatic asthma, copd or heart failure. * peripheral oxygen saturation (spo2) breathing air \<94 % * anticipated difficult airway. * beard. * anatomical features making it difficult to keep a tight seal during maskventilation.

Keywords: positive end-expiratory pressure mechanical ventilation induction of anesthesia
safety and tolerability of abelacimab (maa868) vs. rivaroxaban in patients with atrial fibrillation

Conditions: Atrial Fibrillation (AF); Stroke

Summary: the purpose of the ant-006 study is to evaluate the bleeding profile of abelacimab relative to rivaroxaban in patients with atrial fibrillation (af) at moderate-to-high risk of stroke.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 55 years old * patients with a history of atrial fibrillation (af) or atrial flutter with planned indefinite anticoagulation * patients with a cha2ds2-vasc of ≥4 or a cha2ds2-vasc of ≥3 with at least 1 of the following: 1. planned concomitant use of antiplatelet medication use (i.e., aspirin and/or p2y12 inhibitor) for the duration of the trial 2. creatinine clearance (crcl) ≤50 ml/min by the cockcroft-gault equation exclusion criteria: * history of hypersensitivity to any of the study drugs (including rivaroxaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for rivaroxaban * patients with an intracranial or intraocular bleed within the 3 months prior to screening * clinically significant mitral stenosis (valve area \<1.5 cm2) * mechanical heart valve or other indication for anticoagulation therapy other than atrial fibrillation (e.g., venous thromboembolism) * known presence of an atrial myxoma or left ventricular thrombus * history of left atrial appendage closure or removal * active endocarditis other protocol defined inclusion/exclusion criteria may apply

Keywords: randomized prospective blinded endpoint evaluation abelacimab maa868 rivaroxaban atrial fibrillation factor xi stroke bleeding events anti-coagulant anticoagulation therapy
acute neuroimmune effects of alcohol using free water imaging

Conditions: Alcohol Drinking

Summary: this study examines the effects of moderate alcohol intake on the brain, the immune system, and cognition.

the study involves a within-subjects, pre/post design to assess the effects of a moderate dose of alcohol on immune biomarkers, neurobiological measures, and cognitive functioning. the study recruits healthy adults (ages 21-45) from the community to complete the experimental protocol. participants complete magnetic resonance imaging scans, blood sample collection, and cognitive testing in the context of alcohol consumption.

Eligibility criteria:
inclusion criteria: * ages 21-45 years * able to speak and read english at least at 8th grade level * moderate self-reported alcohol use in the past year * body mass index in normal to overweight range * right-handed exclusion criteria: * history of heavy drinking * currently seeking alcohol or drug treatment * chronic disease requiring use of medication * recent antibiotic or probiotic use * chronic daily use of nsaids * chronic gi disorder * use of illicit drugs * major psychiatric disorder or suicidality * fainting, weakness, infection, excessive bruising, or distress resulting from standard blood draw * safety contraindication for mri scan * inability to abstain from use of tobacco products prior to or during study * inability to abstain from use of cannabis prior to or during study * pregnant, nursing, or may become pregnant
virtual reality to reduce labor pain

Conditions: Labor Pain; Virtual Reality; Hypnosis

Summary: background and goal of study labor pain remains an area where different analgesia options are looked for, more specifically non-pharmacological remedies are popular. hypnosis and virtual reality (vr) have been studied with encouraging results. however, until now, the combination of vr and hypnosis (vrh) has not been assessed during labor, although it has shown promising results in other acute pain areas. the vrh4l study will evaluate the efficacy of virtual reality hypnosis (vrh) in reducing pain during labor. hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (aqua ®, oncomfort sa). for this prospective, interventional parallel group, monocentric randomized controlled trial full term women who were planned for an induction of labor at the st-jean hospital in brussels from march to may 2021 were included. women with complicated pregnancies and patients with contraindications to vr were excluded. patients were randomized in two arms. in the vrh group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care. patients in the control group received only standard care. primary outcome was the difference in post intervention pain score between the two arms. secondary outcomes were the difference in pain score 30 minutes after the intervention, vital signs correlated to pain, satisfaction of the experience, interaction with the midwife and prevalence of side effects. data was analyzed using the student's t test.


Eligibility criteria:
inclusion criteria: 1. age: ≥ 18 and ≤ 45 years 2. pregnant with term gestation 3. willing to adhere to the rules linked to the use of the vrh headset: turning off mobile phone, visit bathroom in advance, no new visitors and no interference of the partner other than when the woman would ask him so 4. provision of written informed consent 5. induced labor exclusion criteria: 1. complicated pregnancy ( hellp,...) 2. scheduled caesarian delivery 3. receipt of epidural analgesia or opioid painkillers before start active labor phase 4. low auditory acuity that precludes use of the device 5. low visual acuity that precludes use of the device 6. head or face wounds precluding use of the device 7. schizophrenia 8. epilepsy 9. dizziness 10. non-proficiency in french and/or dutch (research language)

Keywords: non-pharmacological analgesia