Kornimate/medical-research-clean huggingface dataset:
nu-mask intraoral airway device versus conventional bag valve mask ventilation crossover trial

Conditions: Apnea

Summary: this study comprised a randomized cross-over trial of ventilation using the numask intraoral mask versus conventional bag valve mask in a cadaver model among united states army combat medics.

this study comprised a randomized crossover trial of adult united states army combat medic volunteers participating in a cadaver laboratory as part of their training. the study took place in bulverde, tx. participants were randomized to perform cadaver ventilation first using either the novel nu-maskr intraoral device or conventional bag valve mask. a one handed seal technique was used to simulate single operator ventilation. participants were responsible for mask placement while a ventilator delivered 10 breaths each with a standardized tidal volume of 750 ml. after a 5-minute washout period, they performed ventilation using the alternative device. the primary outcome measure was air leak as calculated by subtracting tidal volume received from tidal volume delivered as measured by the ventilator.

Eligibility criteria:
inclusion criteria: * united states army combat medics exclusion criteria: * injuries precluding performance of bag valve mask ventilation
long-term follow-up in patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"

Conditions: Sleep Apnea

Summary: the meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the efcr department of the chuga between 2006 and 2015, presenting a sleep apnea syndrome (sas) with exploration of their arterial stiffness via the measurement of pulse wave velocity (pwv). currently, we do not have long-term follow-up data for these patients. the first objective of the "pwv follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. the prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire. others secondary objectives are to evaluate the impact of continuous positive airway pressure (cpap, the reference treatment for osa) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

the meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the efcr department of the chuga between 2006 and 2015, presenting a sleep apnea syndrome (sas) with exploration of their arterial stiffness via the measurement of pulse wave velocity (pwv). the 9 studies were referred as : adisas (nct011968), agirsasadom (nct010902), bpco (nct004044), bpco-sas (nct01195064), diametasas, aortic dissection (nct01068691), infrasas (nct010892), valsas (nct004094), niv-ohs (nct006030). the objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of sas. currently, we do not have long-term follow-up data for these patients. the first objective of the "pwv follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. the prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire. others secondary objectives are to evaluate the impact of continuous positive airway pressure (cpap, the reference treatment for osa) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Eligibility criteria:
inclusion criteria: * already included in the meta-analysis "sleep apnea syndrome and arterial stiffness". exclusion criteria: * refusal to participate * family not reachable and death not identified in the hospital medical base * persons under judicial protection (article l1122-2 of the public health code) and patients under guardianship or curatorship

Keywords: sleep apnea follow-up cardiovascular event metabolic event incident cancer death
a phase 2, open-label, multicenter study of the garft inhibitor in patients with metastatic non-small cell lung cancer

Conditions: Lung Neoplasms

Summary: the primary objective of this study is to determine safety and activity of a novel anticancer agent in patients with metastatic non-small cell lung cancer who failed 2 or 3 prior systemic treatments.


Eligibility criteria:
inclusion criteria: * presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis) * treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy) * capable of understanding the nature of the trial and willing to give written informed consent * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * hemoglobin level of \>=9 g/dl, absolute granulocyte count of \>=1.5 \&#215; 109/l, and platelet count of \>=100 \&#215; 109/l * adequate renal function, as documented by a serum creatinine level of \ =60 ml/min * adequate liver function, as demonstrated by a total bilirubin level of \<=1.5 times uln; levels of serum glutamate oxaloacetic transaminase (sgot) (aspartate aminotransferase \[ast\]) and serum glutamate pyruvate transaminase (sgpt) (alanine aminotransferase \[alt\]) \<=2 times uln. if the patient has liver involvement then ast and alt should be \<=5 times uln * for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age * life expectancy estimated at greater than 12 weeks exclusion criteria: * history of blood transfusion within the last 14 days * need of concurrent administration of allopurinol * history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin c within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy) * any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol * any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives * receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents) * pregnant or breast-feeding * previous treatment with garft inhibitors * history of radiation therapy to more than 40% of the marrow space * history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years * active brain metastases (requiring treatment or progressing)
efficacy and safety from a high-dosed sublingual grass pollen preparation

Conditions: Allergy; Rhinitis; Conjunctivitis

Summary: efficacy and safety from a high-dosed sublingual grass pollen preparation


Eligibility criteria:
inclusion criteria: * allergic rhinoconjunctivitis attributable to grass pollen * positive spt * positive east * positive provocation test exclusion criteria: * serious chronic disease * other perennial allergies

Keywords: sublingual grass pollen preparation ige-mediated allergic disease attributed to grass pollen
zoonotic influenza surveillance in belgium

Conditions: Influenza, Human

Summary: the project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. people working with potentially infected animals have the highest risk. moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people. currently, highly pathogenic clade2.3.4.4b h5 avian influenza viruses are continuously circulating in wild birds in belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. several reports of suspected human infection have been made by different countries. in addition, the virus was detected in sick non-human mammals. the large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). this increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans. likewise, there have also been an increased number of human cases of swine influenza reported by several european countries. a pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic. as a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.


Eligibility criteria:
inclusion criteria: * worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study * to have regular contacts with animals within job/activity framework * being committed to take the regular samples exclusion criteria: - people who had a broken nose might have difficulties to perform self-swabbing
post-acute care for patients with hip fracture

Conditions: Hip Fractures; Activities of Daily Living

Summary: background and purpose: hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (pac) to reduce acute hospitalization, and to improve the quality of care. pac services can be delivered by hospital/facility-based and home-based services. previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. taiwan has implemented pac plan for hip fractures since 2017, but relevant evidences are limited. therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of pac for patients with hip fractures.

methods: this is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the taipei city hospital. they will be provided home-based pac, hospital-based pac, or no formal pac based on the medical judgment and patients/families' willingness. the period of pac will be two to three weeks after the acute hospitalization. assessments include physical function (30 seconds sit to stand, barthel index, and harris hip score), numerical pain rating scale, euroqol instrument (eq-5d), caregiver strain index, and using of medical resources. the assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. the follow-up assessment will be at 1, 3, 6, and 12 months after operation. the cost-effectiveness ratio will be defined as the new taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 50 2. first hip fracture 3. stable medical condition exclusion criteria: 1. hip fracture caused by major trauma or pathological condition 2. multiple fractures 3. severe physical disability before the hip fracture 4. unable to cooperate with treatment 5. further inpatient treatment

Keywords: hip fractures post-acute care home-based care hospital-based care activities of daily living cost effectiveness analysis
safety of liraglutide in pediatric patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).


Eligibility criteria:
inclusion criteria: * bmi greater than 85th percentile for age and gender * currently being treated with diet and exercise or metformin alone * hba1c (glycosylated haemoglobin) between 6.5 and 11.0% exclusion criteria: * any clinically significant disease other than type 2 diabetes, as judged by the trial physician * previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)
determination of aldh1b1 and aldh2 polymorphisms frequency in the brazilian population

Conditions: Oral Squamous Cell Carcinoma (OSCC)

Summary: a case-control study with oral squamous cell carcinoma (oscc) patients from instituto do câncer do estado de são paulo (icesp) and healthy volunteers. in this study, it will be collected saliva samples from both groups that will be submitted to sequencing analysis to evaluate the frequency of aldh1b1 and aldh2 polymorphisms in the brazilian population. also, correlate oscc risk to alcohol consumption or smoke, by applied questionnaires.

according to the world health organization (who), in 2016 there were 3 million deaths worldwide from alcohol abuse. aldh1b1 and aldh2 proteins are involved in the alcohol metabolism promoting the conversion of acetaldehyde to acetate. the genes that encode these proteins have genetic variants, also called polymorphisms, that can promote changes in their functions such as the accumulation of acetaldehyde in the body, resulting in facial flushing, tachycardia and headache. studies reported the correlation between alcohol consumption and/or smoking and these polymorphisms to a higher risk for head and neck cancer, including oral squamous cell carcinoma (oscc). the aim of this study is to determine the frequency of the aldh1b1 and aldh2 polymorphisms in the brazilian population, in addition to estimating the risk for oscc among those with polymorphisms. for this, unstimulated saliva samples will be collected from oscc patients and healthy volunteers. all study participants must complete two questionnaires on alcohol consumption, smoking and disease history. saliva samples will be collected using the dna/rna shield saliva collection kit and stored at -20ºc. the dna will be extracted, quantified by the nanodrop equipment and amplified by the polymerase chain reaction (pcr), using specific primers for each of the genetic variants. the pcr product will be sent to the sequencing service of the centro de pesquisas sobre o genoma humano e células-tronco/ibusp, where the sanger sequencing technique will be performed and the results will be analyzed in the icb-usp laboratory. for the group of patients, medical records will be monitored to correlate clinical data and genetic variants with overall survival. these data will allow the characterization of the genetic variants of aldh1b1 and aldh2 in the brazilian population and support the development of future public policies to reduce the main risk factors for oscc, especially among those with these genetic variants.

Eligibility criteria:
inclusion criteria: * oscc diagnostic for case group * able to read and sign the consent form. * able for saliva collection. * able to understand the applied questionnaires. exclusion criteria: * unable to read and sign the consent form. * unable for saliva collection. * unable to understand the applied questionnaires. * oscc patient's companions for healthy volunteers.

Keywords: oral squamous cell carcinoma aldh1b1 aldh2 polymorphism
study of su011248 in patients with metastatic non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to test whether su011248 has activity and is safe in patients with metastatic non-small cell lung cancer (nsclc) who have failed a platinum-containing regimen and docetaxel.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic non-small cell lung cancer that cannot be cured with surgery, radiation, or combination thereof * no more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy * evidence of measurable disease by radiographic technique * male or female, 18 years or older * ecog performance status of 0 or 1 * resolution of all acute toxicities of prior therapies * adequate organ function exclusion criteria: * major surgery or radiation therapy within 4 weeks * severe hemorrhage within 4 weeks * previous treatment with anti-angiogenesis agents * diagnosis of second malignancy within last five 5 years * history of or known brain metastases, spinal cord compression, or carcinomatous meningitis * known hiv * serious acute or chronic illness * current treatment on another clinical trial * pregnant or breastfeeding

Keywords: non-small cell lung cancer, carcinoma, sunitinib, phase 2
evaluation of nt pro bnp guided therapy on hospitalization rate and mortality in patients with chronic hf nyha ii-iy

Conditions: Chronic Heart Failure

Summary: to use continuous measurement of nt pro bnp level as guide in therapy patients with chf.

group of 100 patients with chf, nyha ii-iy will be followed for 1 years in outpatient clinic of our hospital for hospitalization, death, 6 min walking protocol, number of decompensation as a primary end point. 50 patients will be treated according usual practice in outpatient clinics and in 50 patients will be additionally used level of nt pro bnp as additional parameter.if level nt pro bnp will be goes down will not be changes in treatment regiment. if level of nt pro bnp will be increased treatment will be intensified.at the end of 1 year follow up we will compare the result of two strategies.

Eligibility criteria:
inclusion criteria: * patient older 18 y.old with chf nyha ii-iy. exclusion criteria: * all conditions with life expectancy less than 2 years.

Keywords: hospitalization and death from exacerbation chf.
accelerated theta burst in chronic pain: a biomarker study

Conditions: Chronic Pain

Summary: this study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. in this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. all participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.

repetitive transcranial magnetic stimulation (rtms) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. the approved method for treatment is 10hz stimulation for 40 min over the left dorsolateral prefrontal cortex (l-dlpfc). this methodology has been very successful in real world situations. the limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. this study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Eligibility criteria:
inclusion criteria: 1. patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 fibromyalgia diagnostic criteria (wolfe et al., 2010) 2. age 18 - 70 3. right-handed 4. agree to having fmri scans as well as rtms sessions 5. proficiency in english sufficient to complete questionnaires / follow instructions during fmri assessments and treatment 6. women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study 7. participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. antidepressant must be of the ssri class only (if currently on a different antidepressant, patients will be switched to an ssri). they must maintain that same antidepressant regimen throughout the study duration. exclusion criteria: 1. history of mi, cabg, chf, or other cardiac history. 2. any condition that would contraindicate mri (such as ferromagnetic metal in the body) 3. pregnancy or breastfeeding 4. any neurological condition, history of epilepsy, history of rtms failure with fda approved rtms parameters, history of any implanted device or psychosurgery for depression, history of receiving ect. ocd, narcolepsy or any additional significant neurological disorder as determined by the pi. 5. autism spectrum disorder 6. inability to stop taking medication contraindicated with treatment 7. any significant psychiatric disorder as identified on the mini international neuropsychiatric interview and determined by the pi 8. a positive urine toxicology screen

Keywords: chronic pain repetitive transcranial magnetic stimulation (rtms) accelerated theta burst stimulation (atbs) stanford accelerated intelligent neuromodulation therapy (saint)
evaluation of oral pca device - pcoa™ acute

Conditions: Pain, Postoperative

Summary: randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. the study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - pcoa™ acute and compare it to the conventional procedure of nurse providing analgesics.


Eligibility criteria:
inclusion criteria: 1. operative procedure with at least 3 days' hospital stay. 2. planned post-operative pain therapy with oral medication using a strong opioid. 3. no contra-indication for opioid therapy. 4. no contra-indication for oral pain therapy. 5. patient was able to understand and complete the questionnaire. 6. patient signed an informed consent form. exclusion criteria: 1. opioid or drug addiction. 2. opioid intolerance. 3. pain therapy using iv pca or infusion. 4. rejection of opioid therapy. 5. not able to swallow medicine. -