Kornimate/medical-research-clean huggingface dataset:
severe hypoxemia : prevalence, treatment and outcome

Conditions: Critically Ill Patients Admitted in ICU

Summary: hypoxemia is usually observed during icu stay. nevertheless, the prevalence of hypoxemia among patients admitted in icu is not well known, in partly due to a lack of a consensual definition. some of these patients meet the criteria of acute respiratory distress syndrome whom the definition has been recently modified in 2011. many uncertainties are remaining in considering the patients with ards: prevalence of the category of "mild ards", the proportion of patients with invasive mechanical ventilation, the therapeutic modalities and the prognosis, in particular, the move towards a more severe ards category. finally, many patients with hypoxemia do not meet ards definition. the prevalence of this population in icu is unknown, likewise its prognosis. in this way, it would be interesting to compare, for each levels of hypoxemia (mild, moderate and severe) the prognosis of the patients with and without ards. the main objective of the spectrum study is to assess the prevalence of hypoxemia in french-speaking intensive care unit in 2016 in using a single-day point-prevalence study design. two periods of inclusion have been, actually, planned: from the 29th mars to the 31st mars and from the 5th to the 7th april. in each participating center, the day of the study will be chosen among these periods.


Eligibility criteria:
inclusion criteria: * age 18 and older * hospitalized in icu during the 24 hours of the study * information provided to the patient or proxy exclusion criteria: * pregnant or breast-feeding woman * patient under guardianship or curators * lack of social insurance

Keywords: intensive care prevalence hypoxemia ards
safety and efficacy study of fs 4 iu vh s/d (fibrin sealant with 4iu/ml thrombin, vapor heated, solvent/detergent treated) to adhere split thickness skin grafts and improve wound healing in burn patients

Conditions: Deep Partial or Full Thickness Wounds

Summary: the primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether fs 4iu vh s/d is equivalent or superior to the current standard of care (staples). the primary endpoint is achievement of complete (100%) wound closure within 28 days.


Eligibility criteria:
inclusion criteria: * subjects or their legal representatives, who have read, understood and signed a written informed consent. * subjects of either sex. * female subjects of childbearing potential with a negative urine or serum pregnancy test on admission. * subjects who are \<= 65 years of age including pediatric subjects of all ages. * subjects with total burn wounds measuring \<= 40% tbsa. * subjects with a contiguous deep partial thickness/full thickness wound, between 2% and 8% tbsa or two comparable, bilateral wounds each measuring between 1% and 4% tbsa. * wounds designated as test sites require autologous sheet skin grafts with a thickness of 8/1000" - 16/1000" * subjects who are able, and willing to comply with the procedures required by the protocol. exclusion criteria: * subjects with electrical burns. * subjects with chemical burns * digits and genitalia are excluded as test sites. * subjects with infection at test area/test sites. * subjects with test sites previously randomized and treated in this study. * subjects with venous or arterial vascular disorder that directly affects a designated test area/test site. * subjects with pre-existing hemolytic anemia * subjects with diabetes mellitus. * subjects with documented history of pathologically or pharmacologically induced immune deficiency. * subjects judged to be chronically malnourished. * subjects that are judged to have significant pulmonary compromise. * subjects receiving systemic corticosteroids within 30 days prior to skin grafting (not including inhaled steroids). * subjects with known or suspected hypersensitivity to bovine proteins. * subjects participating in another clinical trial that is evaluating an unapproved drug or device.

Keywords: autologous sheet skin grafts fs 4iu vh s/d skin grafts burn
levocetirizine effect on nasal nitric oxide and nasal eosinophils in subjects with perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.


Eligibility criteria:
inclusion criteria: * icf signed * diagnosis of par for 6-12 months greater * 12 years and older * decreased nasal no values at baseline * compliance and ability to perform maneuvers and responsibilities exclusion criteria: * oral or systemic steroids for 60 days prior * inhaled, nasal, nebulized steroids w/i 4 weeks * hospitalization or life threatening asthma * use of nasal or oral antihistamines w/i 4 weeks * upper or lower airways infection * direct cigarette smoke exposure
urinary steroid metabolites in autism

Conditions: Autism; Autism Spectrum Disorder

Summary: deviation of hormone formation within nerve cells and nerve system provides autism spectrum disorder and neurodevelopment retardation through interaction of steroids with neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear steroid receptors. urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.

autism spectrum disorder presents many alterations in amino acid metabolism and in neurotransmitter systems (gamma amino acid system, glutamate-glutamine, nicotine-acid, serotonin-system) . also alteration in gene activation within nerve cells and lymphocyte cultures encloses over 600 genes, affecting a wide field of enzymes , metabolic pathways and hormone formation. male hormones and their precursors are often increased and their influence to nerve cell growth and spine formation is evident. the diagnosis of autism spectrum disorder is made in accordance of criteria of the diagnostic and statistical manual of mental disorders iv (dsm-iv) of the american psychiatric association by an experienced and specialised paediatrician or psychologist and /or by an autism diagnostic interview-revised (adi-r) or autism diagnostic observation schedule (ados) . overnight urine with measurement of quantity and time will be collected and a little part of the urinary samples will be frozen for storage till analysis. age, weight and length of the children at collection time will be ascertained. four stratified groups (autistic boys, girls, and healthy controls, boys and girls, each age 5-15) will be formed. urinary samples will further remain anonymous through an identification-number (id). analysis of hormones and the most of the known metabolites excreted in urine will be performed by a specialised laboratory using gas chromatography-mass spectrometry (gc/ms) analysis (university hospital bern, steroid laboratory, switzerland). the statistical analysis, with age, gender, weight, diagnosis and hormone analysis results as factors , consists in linear regression analysis to detect deviation in hormone formation and metabolism.

Eligibility criteria:
inclusion criteria: * autism spectrum disorder * age 5-15 years exclusion criteria: * epilepsia * psychotropic medication * other severe illness

Keywords: autism autism spectrum disorder steroids steroid metabolites urinary steroid metabolites hormone formation androgen precursor
umbilical cord mesenchymal stem cells injection for peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

the present study is designed to implant ucb-msc in patients with cli, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.

Eligibility criteria:
inclusion criteria: 1. age of 18-75 years 2. patients confirmed diagnosed peripheral vascular disease , ankle-brachial index \< 0.9 3. poor distal arterial outflow tract 4. patient had at least 3 months conservative treatment ,which resulted in little or no improvement 5. poor physical condition can not tolerate surgery 6. patients are willing to participate in the study and sign the informed consent. exclusion criteria: 1. renal function damage (over 2 x upper normal range) liver function damage (over 3 x upper normal range ) 2. severe or acute organ damage 3. presence of malignancy 4. pregnancy or lactating patients 5. hiv positive 6. abi≧0.9 7. a history of severe allergies related cell therapy 8. conservative treatment \< 3 months 9. acute limb ischemia 10. local obvious infection uncontrolled 11. alcoholics or drug abusers within a year 12. severe psychiatric disorder. 13. patients need surgical treatment 14. above the ankle gangrene 15. patients with other factors which were considered not to be suitable to participate in the study by the investigators.
spread-net: practices enabling adapting and disseminating in the safety net

Conditions: Diabetes Mellitus; Cardiovascular Disease

Summary: the investigators propose to compare the effectiveness of 3 strategies (low, medium, high intensity) at supporting chcs' implementation of the all initiative (an intervention shown to reduce patients' cardiovascular disease (cvd) event risk), through a cluster-randomized trial.

the investigators propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based all intervention. to do so, the investigators will randomize 30 community health centers (chcs) to receive 1 of 3 implementation support strategies: low support (toolkit only), medium (toolkit, staff training), high (toolkit, training, on-site facilitation). the study aims are as follows: aim 1: compare the effectiveness of the 3 strategies (low, medium, high intensity) at supporting chcs' implementation of the all intervention, through a cluster-randomized trial. hypothesis: clinics randomized to receive more implementation support will be more likely than those randomized to receive less support (high\>medium\>low) to significantly improve the percent of their patients with (i) guideline-appropriate prescriptions for ace/arbs and statins, and (ii) last blood pressure (bp) and low-density lipoprotein (ldl) under control). aim 2: assess how effectively the 3 strategies support intervention sustainability at 12, 24 and 36 months post-implementation, measured as maintenance of change over time (outcomes as in aim 1). hypothesis: clinics randomized to receive more implementation support will be more likely to maintain changes in the outcomes of interest. aim 3: identify clinic characteristics associated with the support strategies' effectiveness (e.g. decision-making structures, leadership support, team processes / characteristics, readiness and capacity for change). research questions: what are the characteristics of clinics that achieve sustained change even with less implementation support, and of those that do not achieve change even with more support?

Eligibility criteria:
inclusion criteria: * convenience sample, all patients with diabetes mellitus from 30 community health clinics (chcs) that are members of ochin, inc. exclusion criteria: * patients without diagnosed dm

Keywords: implementation strategies diabetes mellitus cardiovascular disease community health centers quality improvement translational medical research
the role of myristic acid in serum for early diagnosis of sepsis and comparison with selected biomarkers of sepsis

Conditions: Sepsis Syndrome; Systemic Inflammatory Response Syndrome

Summary: the aim of the study is to measure serum levels of myristic acid in septic patients and to compare them with myristic acid serum levels in patients with systemic inflammatory response syndrome of non infective etiology and in healthy volunteers. furthermore, other biomarkers of sepsis are evaluated in comparison with microbiological findings detected either by standard hemocultures or by molecular biological methods.

currently, there is an array of biomarkers potentially useful in diagnosis and prognosis in septic patients, either alone or in combination. only a fraction of them is used in clinical practice. the reasons vary, low sensitivity or specificity is the main one, cost/benefit or difficult processing with the need of highly specialized laboratory to name the other. recent pilot study from swedish authors (a.m.kauppi et al.) published in 2016 showed high correlation of myristic acid levels in blood in patients with sepsis and bacteraemia. there was no other publication on this molecule in relation to sepsis before. cambiaghi et al. observed its significant decrease in nonresponders to the treatment of septic shock. myristic acid is an organic acid of linear structure. measurement of its level will be performed using gas chromatography linked with mass spectrometry.

Eligibility criteria:
inclusion criteria: * sepsis or septic shock. * systemic inflammatory response syndrome. * subjects without systemic inflammation. exclusion criteria: * there is no exclusion criteria in the study

Keywords: sepsis septic shock systemic inflammatory response syndrome tetradecanoic acid myristic acid
activating behavior for lasting engagement after stroke

Conditions: Stroke; Physical Activity; Sedentary Lifestyle; Behavior, Health; Physical Disability

Summary: stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for exacerbation of chronic health conditions. this may lead to recurrent stroke. subtle cognitive impairments are common after stroke and can lead to difficulty self-monitoring and problem solving to overcome barriers to physical activity. investigators developed the activating behavior for lasting engagement (able) intervention to promote activity scheduling, self-monitoring, and problem solving activity over the full day. this study examines the effects of the able intervention on sedentary behavior after stroke.

the study advisory committee added a dose-matched, no-intervention delayed baseline to the study protocol following initial documentation of this study protocol on clinicaltrials.gov. the purpose of this delayed baseline design was to assess the baseline stability on the primary and secondary outcomes. the addition of this timepoint resulted in a shift of post-intervention timepoints as follows: baseline 1 (week 1), baseline 2 (week 6), post-intervention (week 11), and follow-up (week 18). intervention was delivered between baseline 2 and post-intervention.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ischemic or hemorrhagic stroke 2. ≥6 months and ≤24 months post-stroke 3. ≥18 years of age 4. ambulatory in the community with or without an assistive device (e.g. walker, cane) 5. self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using the sedentary behavior questionnaire) 6. reside within 50 miles of pittsburgh, pennsylvania exclusion criteria: 1. severe aphasia (boston diagnostic aphasia examination score ≤1) 2. currently receiving outpatient or home care rehabilitation services (physical therapy, occupational therapy, or speech therapy) 3. current active cancer treatment 4. medical history of neurodegenerative disorder (i.e. dementia, parkinson's disease, multiple sclerosis, lou gehrig's disease (als), glioblastoma, myasthenia gravis) 5. current major depressive disorder, psychiatric condition, substance abuse (patient health questionnaire-9, prime-md/mini)

Keywords: rehabilitation disability
duration of effect of biotene spray in patients with dry mouth

Conditions: Dry Mouth

Summary: to determine the duration of effect of a single dose of biotène moisturizing mouth spray in subjects who complain of a clinically dry mouth. the effect of the product will be compared to a control spray (water).


Eligibility criteria:
inclusion criteria: * adults who are in good general health and reply initially affirmatively to the question, "do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep?" this question is an adaptation of the question used successfully by jose and others (2016) to recruit study subjects. * adults who are able to communicate easily in english and who are able to demonstrate understanding of the study instructions. * adults who are physically able to perform an unstimulated whole saliva flow rate (uwsfr) test and who produce 0.2 ml/min or less of saliva. exclusion criteria: * adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications. * adults who regularly "self-medicate" their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits. * adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction) * adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver. * adults with a known allergy to any of the ingredients in biotène spray (eg. dairy allergy)
efficacy and time and resources for hylenex-facilitated sc rehydration versus ort for dehydrated children in the emergency department (ed)

Conditions: Dehydration

Summary: the purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ed setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated sc rehydration versus oral rehydration therapy.


Eligibility criteria:
inclusion criteria: * male or female and aged 2 months to 2 years * presenting to ed with mild or moderate dehydration * candidate for both parenteral and oral rehydration therapies * healthy, except for underlying etiology for dehydration * naive to ort or having received attempted ort at home for current occurrence of dehydration. * pre-dehydration body weight greater than 5th percentile for age exclusion criteria: * severe dehydration * shock or a life-threatening situation * any condition precluding sc infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for sc infusion * medical reason or condition precluding administration of ort * indwelling iv catheter (except one intended only for laboratory sample collection) or anticipated need for iv therapy during the study * anticipated need for hospitalization(other than for rehydration) * known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant * known hyponatremia, hypernatremia or hypokalemia * medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration * participation in an investigational drug or device study within 30 days before participation in this study

Keywords: dehydration fluid therapy hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rhuph20 pediatric ort
protein and weight loss in teenagers

Conditions: Pediatric Obesity

Summary: the aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the u.s. department of agriculture (usda) myplate nutrition guide. the investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.

aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the usda myplate nutrition guide. it is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on bmi-z score over 12 weeks compared to participants in the lower dietary protein treatment. aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake). it is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention. aim 3 is to test if change in the hexosamine biosynthetic pathway (hbp) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (gfat) and glycosylation measured as o-linked n-acetylglucosamine (glcnac) transferase (ogt) differ by dietary treatment. it is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of gfat and glycosylation (ogt) due to decreased carbohydrate intake compared to the lower protein treatment. exploratory aims: as exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).

Eligibility criteria:
inclusion criteria: * be male or female * be between the ages of 12 and 17, inclusive * be at or above the 85th bmi percentile (a number calculated from the participants height, weight, sex, and date of birth) * be willing to fast for 12 hours prior to clinic study visits 2 and 4 * be willing to participate in the research study exclusion criteria: * health conditions: * has hiv or aids * has uncontrolled cvd or arrhythmia * has type i or type ii diabetes. * is unable or unwilling to complete the study procedures * participant may not qualify for this study based on other exclusion criteria not listed. the study coordinator will go over this information in detail. medications: * diuretics * beta-blocker * weight loss medications, diet pills * anti-inflammatory drugs (corticosteroid/anabolic steroid/nsaid) * antipsychotic medications * other medications that may affect fluid balance or weight lifestyle: • plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.

Keywords: adolescent obesity childhood obesity anthropometry body weights and measures