Kornimate/medical-research-clean huggingface dataset:
efficacy of the athletes for life program to promote cardiovascular health

Conditions: Cardiovascular Fitness; Physical Activity

Summary: the purpose of this study was to test the efficacy of a fitness- and behavioral-focused intervention, athletes for life (afl), to improve cardiorespiratory fitness (crf) among 160 underserved families.

the athletes for life (afl) study was a 12-week randomized controlled trial designed to promote cardiorespiratory fitness (crf) and healthy lifestyle changes among parents and children. the original enrollment target was 160 families. a total of 149 parent-child dyads living in a southwestern u.s. metropolitan area were enrolled in the study. afl consisting of 24 structured, twice-weekly 90-min family-based, nutrition and sport/fitness-oriented sessions, and was delivered in a municipal recreation center. behavior change, including increased physical activity, and adherence were motivated through positive reinforcement techniques. families were randomized to either the afl program or a wait-list control group.

Eligibility criteria:
inclusion criteria: * parent ages 18 years and over * child ages 6-11 years exclusion criteria: * presence of a mental or physical condition that was contraindicated to participating in sports/exercise * having a chronic condition that limited mobility * taking medications that influenced body composition

Keywords: cardiovascular fitness physical activity obesity children adults
a phase 2 study of the 24-hour intraocular pressure lowering and systemic exposure of pf-04217329

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will characterize the effect of pf-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. blood samples will be collected to measure the amount of active metabolite of pf-04217329 in the plasma following dosing.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes * intraocular pressure (iop) of at least 22 mmhg and not more than 30 mmhg in either eye at 8 am after discontinuing previous glaucoma treatment * visual acuity correctable to 20/100 or better in each eye. exclusion criteria: * closed/barely open anterior chamber angle or a history of acute angle closure in either eye. * diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye. * advanced glaucoma or a history of severe central visual field loss in either eye. * history of ocular surgery or trauma in either eye within 6 months of the screening visit. * history of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
pilot study to evaluate effect of chx0.12/cpc 0.05 of sars-cov-2 viral load in covid-19 patients

Conditions: Covid19

Summary: randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of covid19+ patients using quantitative pcr, before and after use of active or placebo rinses


Eligibility criteria:
inclusion criteria: 1. be positive for sars-cocv-2 real-time pcr test 2. sars-cov-2 patients positive, with home and/or hospitalized care. 3. have a medical condition that allows them to perform a mouthwash for 1 minute. exclusion criteria: 1. pregnant. 2. people with impaired lung function who do not allow them to rinse. 3. patients with antiviral treatment for covid-19. 4. patients with diseases that affect saliva, sjogren's syndrome, and systemic lupus erythematosus. 5. any cause of immunosuppression (primary or secondary), including hiv. 6. chronic kidney disease 3b or older, coronary heart disease, uncontrolled diabetes (hb1ac \>7), uncontrolled high blood pressure, uncontrolled thyroid disease, history of cancer less than 1 year
urodynamic testing: can we improve patient experience?

Conditions: Urinary Incontinence; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms

Summary: the purpose of this study is to determine whether an intervention (pre-procedure telephone call by the investigators) will reduce anxiety in women undergoing urodynamic testing (udt) compared to usual care. our hypothesis is that women who receive the intervention will report less anxiety immediately before udt than women who receive usual care.

this is a non-blinded, randomized controlled trial. the clinical trial will investigate whether a telephone call by the investigator one week prior to urodynamic testing (udt) will decrease patient pre-procedure anxiety, improve patient-reported preparedness and increase satisfaction compared to usual care. patients who are scheduled for udt will be informed about the study. if the patient agrees to participate in the study, she will be randomized to one of 2 groups based on the week of her scheduled udt. group 1: standard counseling. this group will receive the standard counseling that all boston urogynecology associates (bua) patients would receive if they are scheduled to have urodynamic testing. this counseling will include a description of the procedure and a handout about urodynamic testing. on the day of their test the participants will be asked to complete a brief survey about their experience before and after their testing. the investigators will also collect some information from their medical record, such as age and prior urogynecologic procedures. group 2: standard counseling plus the intervention. the participants assigned to be in the intervention group will receive the standard counseling that all bua patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). this counseling includes a description of the procedure and a handout about urodynamic testing. in addition, the participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure. the investigator calling the participant will document the duration of the phone call and any questions asked by the participant. on the day of their test the participants will be asked to complete the same surveys as group 1. surveys given to the participants on the day of their udt appointment will include: 1. a pre-udt questionnaire that includes questions on demographics, overall anxiety, anxiety about specific elements of procedure, self-reported preparedness and satisfaction. 2. a brief post-udt questionnaire addressing test experience and pain.

Eligibility criteria:
inclusion criteria: 1. 18 years or greater 2. female 3. patients who have decided to schedule urodynamic testing to follow-up lower urinary tract dysfunction, pelvic organ prolapse, and/or urinary incontinence exclusion criteria: 1. pregnant 2. presence of indwelling catheters 3. history of prior urodynamic testing
assessment of immunoglobulins (igg) in a long-term non-interventional study

Conditions: Primary Immunodeficiency (PID); Secondary Immunodeficiency (SID); Neurological Autoimmune Disease

Summary: this non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (igg) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine clinical conditions in germany. long-term outcome data are collected on patient characteristics in the various indications, drug utilization of intravenous and subcutaneous igg (e.g. treatment and dosing patterns), effectiveness (i.e. number of infections), tolerability, health related quality of life, and economic variables (number of hospitalizations, sick-leave days etc.) with the possibility to estimate direct costs.

in view of the broad range of indications in immunodeficiency and immunomodulation, it is of interest to document the use of igg under the conditions of everyday practice and to analyze the endpoints (outcomes). a prospective cohort study such as this is an important evidence source for such rare diseases as those mentioned above. the aim of this outcome study is to fill the gap of the lack of long-term data in these rare diseases treated with igg.

Eligibility criteria:
inclusion criteria: * subjects of either gender with primary, severe secondary immunodeficiency and recurrent infections or neurological autoimmune diseases * naïve to igg, or pre-treated with igg * subject or parent/legally authorized representative has provided written informed consent. exclusion criteria: * none

Keywords: non-interventional trial immunodeficiency outcome study, registry long-term outcomes, drug utilization effectiveness, treatment patterns patient characteristics under real life conditions factors for treatment success long-term tolerability quality of life
unsupervised machine learning for clustering of septic patients to determine optimal treatment

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: the focus of this study will be to conduct a prospective, randomized controlled trial (rct) at cape regional medical center (crmc), oroville hospital (oh), and ucsf medical center (ucsf) in which a fluid treatment-specific algorithm will be applied to ehr data for the detection of severe sepsis. for patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at crmc, oh, and ucsf. the algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.


Eligibility criteria:
inclusion criteria: * all adults above age 18 who are a member of one of the clinical subpopulations studied in this trial are eligible to participate in the study. exclusion criteria: * under age 18

Keywords: dascena machine learning fluid administration clustering algorithm mortality diagnostic
post-marketing clinical study of rebamipide in patients with gastric ulcer

Conditions: Stomach Ulcer

Summary: to examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with h. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study


Eligibility criteria:
inclusion criteria: 1. patients aged 20 years or older at time of consent 2. h. pylori-positive patients meeting both of the following criteria:• assessed as h. pylori-positive by rapid urease test and/or 13c-urea breath test at pre-study examination, • assessed as h. pylori-antibody-positive by urine-based test after obtaining informed consent 3. patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• active (a1- or a2-stage by sakita/miwa classification）, • solitary, • longitudinal diameter: -\>5 mm 4. patients who have not received proton pump inhibitors (ppis), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy exclusion criteria: 1. patients who have previously received h. pylori eradication therapy 2. patients with acute gastric ulcer 3. patients with linear ulcer 4. patients with complication of duodenal ulcer (excluding cicatrix) 5. patients who have undergone upper-gi tract or vagal nerve resection 6. patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis 7. patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites) 8. patients with a history of amoxicillin shock 9. patients with infectious mononucleosis 10. patients with severe renal disorders 11. patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide 12. patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide 13. patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study 14. patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
efficacy and safety assessment of beltavac® with polymerized extract of hdm

Conditions: House Dust Mite Allergy

Summary: the trial is performed to assess efficacy and safety of beltavac with polymerized extract of house dust mites in allergic rhinoconjunctivitis associated or not with asthma


Eligibility criteria:
inclusion criteria: * written informed consent, signed and duly dated. * man or woman between 12 and 65 years old (both included). * patient with moderate or severe symptoms of persistent rhinitis according to the aria guide, associated or not with well or partially controlled asthma according to the gema 5.0 guide. * confirmation of sensitization to dpt or df with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific ige value of class 3 or higher (\> 3.5 ku / l) within the 6 months prior to the study. * negative pregnancy test. * nasal symptom and medication combined scale score ≥ 1.5 during the screening phase. exclusion criteria: * concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator. * poorly controlled asthma according to the gema 5.0 guideline * severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the gema 5.0 guideline. * autoimmune diseases or immunodeficiency. * malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study. * clinical history of anaphylaxis with cardio / respiratory symptoms. * hypersensitivity to any of the excipients of the investigational product. * immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study. * treatment with beta-blockers during the study. * patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years. * patients with immunotherapy with allergens other than dust mites during the study period. * patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against covid-19. * pregnant or nursing patients.
comparison of ventilation tubes among anesthetized pediatrics

Conditions: Pulmonary Ventilation

Summary: to discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. the study compares eight ventilator breathing tube of different length, diameter, material of the ventilator breathing tube. besides, the investigators also make an approach verify the change of body temperate under different gas flow(2l, and 5l).

in previous research, initial mechanical ventilator settings about children were as following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of respiratory pressure should be \<10 cmh2o in healthy patients; 3. respiratory pressures could be kept less than 28 to 30 cmh2o in patient with lung injury; 4. positive end-expiratory pressure was necessary, although the optimal level is unknown. however, few researches discussed about influences of different types of ventilation breathing tube. the investigators want to clarify the character about length, diameter, and material of the ventilation breathing tube under the ventilation system in relation to tidal volume, end tidal carbon dioxide, compliance among children and neonate. during this study, the participants will be 100 children who were asa class1, 2 and performed non-emergency, non-cardiac surgery, who will receive general anesthesia . the participants will divide into three groups according to different body weights (group n: \ 20kg), and would receipt total eight type of ventilator breathing tube test. primary outcome will be the difference of tidal volume, end tidal carbon dioxide and compliance. besides, secondary outcome will be the change of body temperate under different gas flow (2l, and 5l).

Eligibility criteria:
inclusion criteria: * with american society of anesthesiologists (asa) physical status classification 1\&2 * undergo elective surgery * intubation exclusion criteria: * cardiac-pulmonary surgery * had respiratory related disease

Keywords: pediatric ventilation breathing tube end-tidal carbon dioxide heart rate tidal volume blood temperature
use of jumping mechanography as a method to assess musculoskeletal status in older adults

Conditions: Musculoskeletal Status; Muscle Weakness

Summary: decline in muscle function may increase risk of hip fracture and decrease quality of life. different tests are currently used to measure muscle function but they do not work for all individuals. a test called "jumping mechanography," which measures jumping power, may be useful in more people and obtain better information. this study will help us determine whether this test is able to detect differences between muscle function in younger and older adults, as well as whether it is a safe method to use in all ages.


Eligibility criteria:
inclusion criteria: 1. women and men aged 20 to 30 or ≥ 60 years 2. able and willing to sign informed consent. 3. ability to stand without assistance. exclusion criteria: 1. acute pain different and/or worse than the individuals chronic baseline pain 2. history of recent trauma to musculoskeletal system 3. neuromuscular disease impairing balance to the degree of not being able to stand without assistance. 4. history of fragility fracture within the last year 5. patients with a bmd t-score of less than -3.5 at any measured site and a vertebral fracture. 6. history of severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study. 7. recent history of malignancy with metastasis to the musculoskeletal system.
microcirculatory effects of methylene blue

Conditions: Acute Circulatory Failure

Summary: international guidelines recommend methylene blue (mb) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (vs) after cardiopulmonary bypass cpb. macrocirculatory effects of mb in this setting are now well established but microcirculatory effects of mb remain unknown. the purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory vs post cpb. microcirculatory effect will be monitored before and one hour after mb infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (vot).


Eligibility criteria:
inclusion criteria: * patients receiving methylene blue prescribed by the clinician in charge of the patient * patient receiving a dose of norepinephrine \> 0.5µg/kg/min * normal or increase cardiac (\> 2 l.min-1.m-2) at the time of inclusion * vasoplegic syndrome post cardiopulmonary bypass for cardiac surgery exclusion criteria: * the need for hemodynamic intervention during the time of study (fluid resuscitation, introduction of inotropic or vasopressor support, change in inotropic support dose) * age under 18 years

Keywords: methylene blue
risk factors for ad-associated switch to mania

Conditions: Bipolar Disorder

Summary: the present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.

treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. the present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.

Eligibility criteria:
inclusion criteria: * bipolar i and ii disorder. exclusion criteria: * major medical comorbidities.

Keywords: switch
evaluation of a full face mask and headgear for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: currently fisher \& paykel healthcare (fph) is developing a new full face mask. the objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. the participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. the participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. neither the investigators or the participants will be blinded to the study.


Eligibility criteria:
inclusion criteria: * ahi ≥ 5 from the diagnostic night * ≥ 18 years of age * either prescribed apap or cpap or bi level for osa * existing full face users exclusion criteria: * inability to give informed consent * participant intolerance to pap * anatomical or physiological conditions making pap therapy inappropriate * current diagnosis of respiratory disease or co2 retention * pregnant or think they may be pregnant
inflammatory resolution in cardiometabolic health and disease

Conditions: Inflammation; Obesity; Cardiovascular Diseases

Summary: the specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. investigators will recruit volunteers that are metabolically healthy or unhealthy that fall within three bmi ranges: lean (18.-24.9 kg/m2), overweight (25.0-29.9 kg/m2) and obese (\>30.0 kg/m2). investigators hypothesize that metabolically healthy individuals have a superior endogenous capacity to regulate an inflammatory/resolving response.


Eligibility criteria:
inclusion criteria: * informed signed consent has been obtained from the volunteer. * the volunteer has a bmi greater than 18.5 kg/m2 * men and women over the age of 18 are included. exclusion criteria: * the study staff contacting a potential participant perceives that the individual has difficulty understanding the information. * an md determines that the individual is on too many medications to participate. * the individual takes a medication that is approved by the md, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw. * the individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication. * the individual has some form of chronic inflammation. * the individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin). * the individual uses immunosuppressive drugs (e.g., methotrexate). * the individual regularly consumes fish oils (omega 3). * the individual has significant gastrointestinal problems. * the individual smokes or uses chewing tobacco. * the individual has been drinking alcohol two days before the study visit. * the individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination. * the individual does not follow instructions given in the research study.