Kornimate/medical-research-clean huggingface dataset:
analysis of advanced physiological ventilatory parameters during spontaneous breathing effort in patients with acute hypoxemic respiratory failure

Conditions: Acute Hypoxic Respiratory Failure

Summary: the aim of this prospective physiological cohort study conducted in a medical intensive care unit (icu) at hospital del mar in barcelona, spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (δpes), respiratory muscular pressure (pmus), and transdiaphragmatic pressure swing (δpdi)) in patients with acute hypoxemic respiratory failure (ahrf) undergoing invasive mechanical ventilation (imv), during the active breathing phase in relation to icu survival. the investigators hypothesized that ahrf patients on imv with better outcome (i.e., icu survivors) spend more time within the "safe" range of respiratory effort during the active breathing phase compared to non-survivors. ahrf patients on imv were continuously monitored with esophageal and gastric manometry from the detection of the onset of respiratory effort for up to 7 days, or until extubation, or until death, whichever occurred first.

to characterize in detail the evolution of respiratory effort over time, the investigators conducted a prospective observational cohort study with continuous recordings of airway pressure, flow, esophageal and gastric pressures for up to 7 days after the onset of respiratory effort in ahrf patients on imv. patients were classified into two groups: icu survivors and icu non-survivors. the primary objective of the study was to analyze the proportion of time spent within a specified "safe" range for pmus, δpes, and δpdi (respiratory effort physiological variables), during spontaneous breathing, comparing both groups during the first 7 days after the initiation of respiratory effort. the secondary objective was to analyze the median values of δpes, pmus, and δpdi during the monitorization period (active breathing phase) between the two groups.

Eligibility criteria:
inclusion criteria: * acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion exclusion criteria: * presence of chest drains * contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices) * concomitant acute exacerbation of obstructive airways disease
lifestyle interventions to prevent cognitive deficits in subjects with depressive symptoms: from mechanisms to clinical practice

Conditions: Major Depressive Disorder (MDD); Physical Activity; Inflammation; Metabolome; Gut Microbiota; Depressive Symptoms

Summary: the goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline. the main questions it aims to answer are: * does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms? * does cognitive training help prevent mental difficulties in people at risk of cognitive decline? * do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors? researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health. the participants: * will take part to online sessions on healthy eating based on the mediterranean diet * some will do regular exercise, supervised by a personal trainer * others will do weekly cognitive training in small groups at the hospital * they will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.


Eligibility criteria:
inclusion criteria: * aged between 50 and 80 years; * diagnosis of ddm according to dsm-5 or depressive symptoms (phq-9 or gds-15 ≥ 5, the choice of test will be justified by the participant's age); * no cognitive impairment or mild functional impairment (mmse \> 24) * ability to provide written informed consent. exclusion criteria: * active gastrointestinal disorders; * autoimmune disorders; * chronic inflammatory disorders; * diagnosis of dementia; * use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.

Keywords: depression cognition nutrition
covidnoche trial (hfno versus cpap helmet) in covid-19 pneumonia

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2; Hypoxemic Respiratory Failure; Pneumonia, Viral; COVID

Summary: the purpose of the covidnoche trial (hfno versus cpap helmet evaluation in covid-19 pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet cpap versus hfno) for acute hypoxemic respiratory failure from covid-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.

coronavirus disease 2019 (covid-19) is a respiratory illness that can cause acute arterial hypoxemia. treatment with invasive ventilation improves oxygenation yet results in death in over 50% of cases. the high incidence of disease has also reduced resources needed to safely deliver invasive ventilation including mechanical ventilators and intravenous sedation. non-invasive respiratory support has been shown to be efficacious in acute hypoxemic respiratory failure from other etiologies and has the potential to reduce rates of intubation and the time spent on mechanical ventilation in covid-19. however, it is unknown which type of support is the most effective, limiting the ability to improve clinical outcomes and appropriately allocate resources. to help guide clinical practice and policy, it is critical to understand the comparative effectiveness of two forms of non-invasive respiratory support used worldwide, continuous positive airway pressure (cpap) delivered via a helmet interface and high flow nasal oxygen (hfno).

Eligibility criteria:
inclusion criteria: * adult patients with confirmed covid-19 with an sp02 \< 92% on ≥ 6 liters nc admitted to a penn medicine advanced respiratory unit. an advanced respiratory unit is a unit capable of non-invasive respiratory support such as an icu or intermediate care unit. exclusion criteria: patients will be excluded if they meet ≥ 1 of the following criteria based on current penn medicine respiratory guidelines and prior trials of non-invasive respiratory support: * respiratory failure related to other etiology (e.g. exacerbation of chronic obstructive pulmonary disease, acute pulmonary edema) * baseline oxygen requirement * diagnosis of acute or chronic hypoventilation * tracheostomy * claustrophobia * prior intubation during hospitalization * urgent need for endotracheal intubation * other contraindications to non-invasive respiratory support (glasgow coma scale lower than 8, absence of airway protective gag reflex, elevated intracranial pressure, upper airway obstruction) * patient dose not wave to receive the assigned intervention.
vascular cognitive decline and dementia

Conditions: Ischemic Stroke; Transient Ischemic Attack

Summary: the enigma study is a single-centre prospective clinical observational study with the aim to investigate vascular contributions to cognitive decline and dementia. by studying mri-defined capillary dysfunction and ev profiles, the enigma study links novel imaging and basic research techniques to a clinical cohort of stroke patients. with this study we hope to enhance the understanding of the mechanisms behind post-stroke cognitive decline and dementia.

post-stroke cognitive impairment (psci) is common. however, the underlying pathophysiology remains largely unknown. understanding how microvascular changes relate to psci and finding markers that can predict psci, could be a first step towards better screening and management. cerebral capillary dysfunction is characterized by limited oxygen extraction from the brain capillaries due to age- and risk factor-related capillary flow heterogeneity. capillary dysfunction is a pathophysiological feature of cerebral small vessel disease (csvd) and may play an important role in the vascular mechanisms underlying psci. extracellular vesicles (evs) carry molecules between cells. ev profiles may change during acute stroke, in the chronic stroke phase, and according to the level of csvd, and ev profiles may therefore act as disease biomarkers. the enigma study aims to investigate capillary dysfunction and ev profiles as predictors of cognitive function one year after acute ischemic stroke (ais) and transient ischemic attack (tia). consecutive patients with ais and tia are included and followed for one year with follow-up visits at three and 12 months. an mri is performed at 24 hours and 12 months after admission. ev profiles will be characterised from blood samples drawn at 24 hours and three months after admission. cognitive function is assessed three and 12 months after ais and tia using the repeatable battery for the assessment of neuropsychological status and the montreal cognitive assessment (moca). the study has two main objectives: 1) to study associations between capillary dysfunction and psci and 2) to assess associations between ev profiles and psci.

Eligibility criteria:
inclusion criteria: * ais or tia with a clinically relevant diffusion restriction identified on mri dwi-sequence on admission * admittance within 24 hours from symptom onset * age ≥ 60 exclusion criteria: * dependency in activities of daily living (mrs score \> 2) * known dementia, neurodegenerative disease, or other significant brain disease * concomitant life-threatening disease * contraindications to undergo mri * allergy or intolerance to mri contrast agents * egfr \< 30 * unable to give written informed consent * deemed unfit for follow-up

Keywords: dementia cognitive impairment mri extracellular vesicles stroke
exhaustive genetic and immunological characterization of colon, kidney and liver tumors

Conditions: Colorectal Adenocarcinoma; Hepatic Carcinoma; Kidney Adenocarcinoma

Summary: over the last 10 years, technological advances in molecular biology enabled a more accurate genomic characterization of tumors. for each tumor location, this led to the identification of subgroups with similar molecular characteristics. this identification allowed the development of targeted therapies and thus to improve the patient prognosis. this molecular characterization has also revealed the tumor heterogeneity. it may be the cause of treatment resistance and therefore of relapses. additionally, tumor cells are in constant dialogue with their microenvironment composed of different immune or non immune cells. this microenvironment is now targeted in cancer treatment. to date, there are few studies that combine a deep genomic characterization of both tumor and tumor microenvironment of the patient. combining the two types of studies on the same tumor should help to define new therapeutic targets and should allow a combination of targeted and immunomodulatory therapies. to this end, our project is to conduct an exhaustive integrated exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in colon, kidney and liver cancer).

the design consists in recruiting 50 patients per tumor location (colon, kidney, liver). for colorectal and kidney cancers, a prospective enrollment will be done for patients who have consented to the study. a retrospective enrollment will be done for patients with liver cancer only and who have consented to a national biological resource center form with genetic study approval. the tumor samples will be taken during surgery. blood and tumors samples will be taken as part of the treatment. in case of a accidental germline discovery a management by a genetic consulting will be proposed.

Eligibility criteria:
inclusion criteria: * for colorectal cancer group : patient with stage iii colon carcinoma * for kidney cancer group : patient with primary clear cell carcinoma more than 4 cm * for liver cancer group : patient with advanced hepatocellular carcinoma : biopsy or resected bclc (barcelona clinic liver cancer) stage b or c * patients who have consented to the study exclusion criteria: * patients receiving neoadjuvant therapy are not eligible

Keywords: exhaustive genetic and immunological analyses targeted therapies colon cancer kidney cancer liver cancer immunological tumor microenvironment tumor microenvironment heterogeneity
targeted temperature management after in-hospital cardiac arrest

Conditions: Hypoxic Ischemic Encephalopathy

Summary: the purpose of this study is to determine whether targeted temperature management at 36.0˚c(ttm-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(ihca) will reduce death and disability compared with fever control. for this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from ihca. eligible patients will be randomly assigned in a 2:1 ratio to either ttm-36(n=40) or conventional treatment group(n=20). randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).


Eligibility criteria:
inclusion criteria: * age 18-80 years * in-hospital cardiac arrest requiring chest compression for \> 2 minutes * sustained restoration of spontaneous circulation(rosc) for \> 20 minutes after cardiopulmonary resuscitation(cpr) * unresponsive state(lack of meaningful response to verbal commands) for \> 20 minutes after sustained rosc * informed consents from a patient's family member exclusion criteria: * unavailable ttm within 2 hours after rosc * cpr duration \> 30 minutes * unwitnessed arrest with initial rhythm asystole * under or planned for extracorporeal membrane oxygenation(ecmo) * initial body temperature \< 33 °c * preexisting terminal illness with life expectancy \<6 months * pre-admission cpc score of 3-5 * pre-admission mrs score 4-6 * unresponsive(stupor or coma) before cardiac arrest * suspected or confirmed cause of cardiac arrest is diseases of the central nervous system, such as stroke, brain tumor, or amyotrophic lateral sclerosis * any condition in which direct skin surface cooling would be contraindicated, such as large burns, unhealed surgical wounds, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity * active massive bleeding * major surgery within last 48 hours * cardiothoracic surgery within 14 days * planned surgery within next 72 hours after rosc * enrolled in other clinical trials * pregnant women * do-not-resuscitate(dnr) state * patients whose family or treating physicians refuse to join this study

Keywords: targeted temperature management(ttm) in-hospital cardiac arrest(ihca) restoration of spontaneous circulation(rosc) unconsciousness brain injury
prospective validation of cough, dyspnea, and quality of life questionnaires in patients with ipf

Conditions: Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (qol) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in idiopathic pulmonary fibrosis (ipf) patients. these questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to ipf. our hypothesis is that worsening of cough, dyspnea, and cough-related qol questionnaire scores will correlate with physiologic markers of ipf severity and worsening of disease. written, valid questionnaires measuring cough, dyspnea, and qol are important to assess the benefit of investigational drugs under development to treat patients with ipf.

this study in patients with ipf will determine the validity, responsiveness, and reliability of two cough measures (the leicester cough questionnaire (lcq), as well as visual analogue scales (vass) for cough severity and distress; one dyspnea measure (the baseline and transition dyspnea index (bdi/tdi); and two health-related quality of life (hrql) measures (the obstructive lung disease-specific saint george's respiratory questionnaire (sgrq) and the ipf-specific 'a tool to assess qol in ipf' (ataq-ipf). both the sgrq and ataq include cough questions. study participants will complete all questionnaires at baseline, 6, 12, and 18 months at the time of their usual clinic visits. physiologic data will be collected at the same time of these visits including pulmonary function testing, exercise oxygen saturation, and changes in medications and health status. changes in cough, dyspnea and qol scores will be correlated with concurrent changes in physiologic markers of ipf severity. if a study participant has an acute worsening of their ipf, or undergoes lung transplantation, study questionnaires may be given at these additional timepoints when possible.

Eligibility criteria:
inclusion criteria: * completion of informed consent. * adults over the age of 18. * diagnosis of ipf per ats guidelines. * clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for lung transplantation. * no changes in immunosuppressive regimens (if applicable) over past month. exclusion criteria: * inability to understand or complete paper and pencil questionnaires. * patient not planning to return to stanford for clinic visits.

Keywords: interstitial lung disease (ild) idiopathic pulmonary fibrosis (ipf)
efficacy of adhesive tablets in treating oral ulcers (aphthous)

Conditions: Ulcer, Aphthous

Summary: recurrent aphthous stomatitis (ras) of the oral mucosa is a common and painful condition. despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration. the hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of ras. participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.


Eligibility criteria:
inclusion criteria (in healthy individuals): * age above 18 years old. * non-pregnant women. * healthy or controlled chronic diseases. * examination at the oral medicine clinic inclusion criteria (in ras patients): * age above 18 years old. * non-pregnant women. * clinical diagnosis of ras. * examination at the oral medicine clinic exclusion criteria: * oral lesion suspected to be malignant. * ulcerative oral lesion other than ras. * another experimental oral intervention within the last 24 hours. * pregnant women. * allergy to components of the pro-pe adhesive tablet

Keywords: aphthous oral
the travel ii trial: transcatheter right atrial-ventricular valve replacement with lux-valve via jugular vein

Conditions: Tricuspid Valve Regurgitation

Summary: the trial aims to evaluate the safety and effectiveness of lux-valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

the travel ii study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with lux-valve via jugular vein. a series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. subjects who meet the criteria will then receive lux-valve implantation via jugular vein if an informed consent is obtained.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years at time of consent. 2. subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent. 3. the site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroscore ii ≥ 7.0%) and the subject will get benefit from the intervention. 4. subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention. 5. subjects are with new york heart association (nyha) functional class iii or iv. 6. subjects are with normal left heart function (ef ≥ 50%). 7. no indications for left-sided or pulmonary valve intervention. 8. subjects must have severe or greater tricuspid regurgitation ( the vena contracta (vc) width ≥ 7 mm or the effective regurgitant orifice area (eroa) ≥ 40 mm2), which confirmed by the echocardiography core lab (ecl) via transthoracic echocardiogram (tte). exclusion criteria: 1. subjects with pulmonary hypertension (systolic pressure ≥ 55mmhg determined by right heart catheterization). 2. subjects with previous transcatheter or surgical tricuspid valve procedure. 3. subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure. 4. subjects with depressed right heart function (tricuspid annular plane systolic excursion (tapse) \< 10mm or right ventricle fractional area change (fac) \< 20%). 5. subjects with aortic stenosis (mean δp≥ 40mmhg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+). 6. subjects with active endocarditis or other infectious diseases. 7. subjects with untreated severe coronary artery disease. 8. subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure. 9. subjects with coagulation disorders. 10. subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure. 11. subjects with cognitive disorders that can not cooperate the study or follow-up. 12. subjects with less than 12 months life expectancy because of non-cardiac conditions.

Keywords: tricuspid valve regurgitation transcatheter tricuspid valve replacement lux-valve