Kornimate/medical-research-clean huggingface dataset:
l-arginine in severe asthma patients grouped by exhaled nitric oxide levels

Conditions: Asthma; Inflammation

Summary: the major impact of this study will be to identify the adult severe asthma cohort that will benefit from supplemental l-arginine therapy. the investigators hypothesize that a subset of adult severe asthma patients will respond to supplemental l-arginine and derive clinical benefit from the addition of this therapy to standard-of-care asthma medications. the investigators hypothesize that the patients that benefit most will have low exhaled nitric oxide concentrations (\< 20 ppb) at baseline.

we hypothesize that a subset of adult severe asthma patients will respond to supplemental l-arginine and derive clinical benefit from the addition of this therapy to standard-of-care medications. we hypothesize that these patients will have lower exhaled no concentrations (\ 25 ppb. the major impact of this study will be to identify the adult severe asthma cohort that will benefit from supplemental l-arginine therapy to define the underlying mechanisms of arginine benefit in asthma. this follows our initial 20 subject trial of l-arginine in asthma subjects (kenyon et al., pharmaceuticals 2011) that was designed to determine how l-arginine was metabolized (by testing serum markers) and whether certain participants had clinical benefit. to do this, we will recruit a total of 50 ats-defined severe asthmatic subjects with ongoing asthma exacerbations in past two months and enroll them in a randomized, blinded, placebo-controlled, cross-over designed trial of l-arginine and placebo. we will compare 25 subjects with "low" feno \ 25 ppb.

Eligibility criteria:
inclusion criteria: * adults \>18 yrs of age * diagnosis of severe asthma based on american thoracic society workshop definition (am j respir crit care med 2000; 162:2341) * active asthma medications of high dose inhaled corticosteroids plus long-acting beta agonist * history of recent asthma exacerbations or asthma control test score \< 20/25 exclusion criteria: * \<19 yrs of age * forced expiratory volume 1sec \<30% predicted * pregnant or nursing women * current smokers or smoking history \> 15 pack years * actively taking or known intolerance to l-arginine

Keywords: asthma severe asthma
normoxic challenges utility to evaluate blood loss

Conditions: Hemorrhage

Summary: this study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on do2 during surgical procedures.


Eligibility criteria:
inclusion criteria: * elective surgery * high risk of intraoperative blood loss * general anaesthesia exclusion criteria: * respiratory insufficiency * ischemic heart disease * stroke * asa classification \> 3 * laparoscopic surgery
distress reduction by activity tracking and activity enhancement by mobile support group in oncology

Conditions: Breast Cancer; Mobile Community

Summary: this study aims to investigate the effect of the formation of social networks using smartphones can help increase physical activity and reduce stress in survivors after breast cancer treatment surgery.


Eligibility criteria:
inclusion criteria: * stage 0-iii breast cancer * ecog performance status 0 * patient who underwent surgery for breast cancer * patients with their own smartphones and who can use smartphone apps exclusion criteria: * breast cancer recurrence or metastasis * severe medical illness * need to adjubant chemotherapy

Keywords: breast cancer survivors mobile community distress
clinical trial of endovenous 940 and 1470 laser ablation for treating great saphenous veins

Conditions: Varicose Veins; Insufficiency of Great Saphenous Vein

Summary: a clinical randomized controlled trial, comparing 2 endovenous laser ablation (evla) techniques in patients with insufficiency of the great saphenous vein (gsv). there are multiple evla devices available, with different wavelengths. in the netherlands, 940 nm diode and 1470 nm nd:yag laser are the most frequently used devices. both devices also proven to be equally effective in occluding the gsv. however, little is known about differences in patient-related outcomes. therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm evla, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. the secondary outcomes are complications and effectiveness of the treatment. it is thought that possibly the 1470 nm elva will give lower pain scores and higher patient satisfaction than 940 nm evla. no differences are expected in complication rate and effectiveness between the two treatments.

\* study type: interventional. randomized comparative clinical trial.. * outcome measures: * primary study outcomes: patient reported outcomes: 1. pain score and use of painkillers, assessed with a numeric rating scale (nrs) of pain. 2. treatment satisfaction, assessed with a nrs of satisfaction. 3. health related quality of life, assessed with dutch translated aberdeen varicose vein questionnaire (avvq) and eq-5d questionnaire. * secondary study outcomes: 1. number of patients with adverse events. major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. minor complications: ecchymosis and hyperpigmentation. 2. obliteration of varicose vein and/or absence of reflux (\> 0.5 sec. of retrograde flow) along the treated segment of the gsv. this is measured using us examination. * outcome measures time frame: follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment. \* focus of the study: varicose great saphenous veins (gsv) * intervention information: * intervention name: endovenous laser ablation (evla) * intervention type: 1. evla with 940 nm diode laser 2. evla with 1470 nm nd:yag laser * arm information: both interventions are active comparators. * locations: rotterdam, zuid-holland, the netherlands

Eligibility criteria:
inclusion criteria: * patients over 18 years old * insufficiency of the gsv measured with ultrasound imaging, reflux \> 0.5 sec, and diameter of vein \> 0.5 cm * symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ c2) * no prior treatment of the insufficient gsv * informed consent exclusion criteria: * acute deep or superficial vein thrombosis * agenesis of deep vein system * vascular malformation or syndrome * post-thrombotic syndrome, occlusive type * pregnancy * immobility * allergy to lidocaine * arterial insufficiency * diameter of gsv ≤ 0.5 mm at puncture site
turkish version of mini-bestest, validity and reliability for adult participants with sensoriomotor impairments

Conditions: Parkinson Disease; Multiple Sclerosis; Trauma, Brain

Summary: the aim of this study is to present the turkish version of minibestest which evaluates the reasons of balance deficit and postural control. accordingly, a practice of validity and reliability on adult patients with sensoriomotor impairments will be performed by utilizing the turkish version of minibestest in this study.

physical therapists encounter postural control problems frequently. these problems require multifaceted assessment. therefore, the treatment of postural control problems should be planned after a multifaceted assessment. balance evaluation systems test (bestest) comprises 27 items and evaluate all components of postural control. minibestest is a shortened version of bestest with 14 tasks. minibestest still addresses almost all components of postural control and can be performed 15 min. minibestest is one of the most common methods which practiced on adult patients. the aim of this study is to present the turkish version of minibestest which evaluates the reasons of balance deficit and postural control. accordingly, a practice of validity and reliability on adult participants with sensoriomotor impairments will be performed by utilizing the turkish version of minibestest in this study.

Eligibility criteria:
inclusion criteria: clinical diagnosis of sensoriomotor impairment able to walk with or without an assistive device (e.g. walker, cane, ankle-foot orthosis...) ability to tolerate the balance tasks without fatigue. exclusion criteria: severe cognitive or communication impairments hemodynamic or clinical instability.

Keywords: mini bestest balance defisit postural control sensoriomotor impairment
combination therapy with myocet® (doxorubicin hcl liposome for injection) in participants with her2-positive breast cancer

Conditions: Breast Cancer

Summary: to evaluate the efficacy and safety of treatment with myocet® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage ii or iii breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (her2) gene.


Eligibility criteria:
main inclusion criteria: * treatment-naive participants with stage ii or iii invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of her2. * participants have at least 1 bidimensionally measurable lesion according to the world health organization (who) criteria. * the participant has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * the participant has an lvef of at least 55% as assessed by multigated acquisition (muga) scan (preferred) or echocardiography. * the participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges. * women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug. main exclusion criteria: the participant: * has received previous cancer therapy for breast cancer. * has any history of chf, angina pectoris, or myocardial infarction. * has uncontrolled hypertension. * has infection, peptic ulcer, or unstable diabetes mellitus. * has been treated with live virus vaccines within 8 weeks before the first administration of study drug. * has impaired hepatic or renal function. * is a pregnant or lactating woman. (any women becoming pregnant during the study will be withdrawn from the study.) * has used an investigational drug within one month before the screening visit. * has a known hypersensitivity to any of the study drugs or to their active ingredients. * has an inflammatory breast cancer. * has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). note: other inclusion and exclusion criteria may apply.
efficacy and safety of lumiracoxib 400 mg once daily in acute flares of gout

Conditions: Acute Gouty Arthritis

Summary: this study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. this is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy


Eligibility criteria:
inclusion criteria: * ambulatory cooperative male or female patients of at least 18 years of age * with an acute attack of gout in 4 joints or less, diagnosed clinically according to the acr 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study * who present at baseline with an acute pain intensity of at least moderate. exclusion criteria: * with an acute attack of gout before the last 48 hours prior to evaluation * with polyarticular gout involving \> 4 joints * with rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
a dose-response study to validate the biomarkers for whole grain dietary intake

Conditions: Chronic Disease Prevention

Summary: dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. because there are significant disparities in genetic background and dietary patterns between chinese and western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in chinese populations. to address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.

an acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of wg wheat flour administered were 0 g, 25g, 50 g and 100 g. experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.

Eligibility criteria:
inclusion criteria: * healthy men and women * age 18-40 years * bmi 18.5-23.9 kg/m2. exclusion criteria: * pregnancy or breastfeeding * vegetarian; * smokers; * acute and chronic diseases; * allergic to wheat; * frequent nutrients supplement use; * medication use of antibiotics within 1-month; * more than 3 kg weight change within 3-month; * unwillingness to follow dietary restrictions;

Keywords: whole grain
evaluer l'impact predictif du score meessi pour la stratification du risque des patients admis pour insuffisance cardiaque aigue dans les structures d'urgences

Conditions: Acurate Heart Failure

Summary: our primary purpose is to assess meessi score in predicting mortality and readmission of patients managed for acute heart failure (ahf) in emergency department. european society of cardiology recommend risk stratification for patients with ahf. meessi score is not prospectively validated out of spain.


Eligibility criteria:
inclusion criteria: * major patient * patient admitted to emergencies with suspicion of ica according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging * patient with health insurance * subject who accept to participate in the research exclusion criteria: * patient who refuse to participate in the study * patient with coronary syndrome with st segment elevation * other diagnosis of dyspnea * persons deprived of their freedom or under the protection of justice * persons under guardianship or curatorship * impossibility of giving the patient informed information * pregnant woman

Keywords: caring emergency
whole food plant-based diet effect on obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Daytime Sleepiness

Summary: this research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * daytime sleepiness with ess score ≥ 5. * patient's prior sleep study with ahi between ≥ 10 and ≤ 45 (4% scoring criterion). * on treatment for osa, failed or not willing to use all other osa treatment options * has access to a weight scale at home or able to come into the sleep clinic to be weighed after the 8-week plant-based diet period. exclusion criteria: * pregnancy or lactation. * current use of a vegan diet. * bmi ≤ 22. * complex, central sleep apnea. * pre-existing significant degree of cardio-pulmonary disease-heart failure with reduced ef of 35 or lower, unstable arrythmia, severe degree of pulmonary hypertension, severe degree of obstructive or restrictive lung disease including copd and interstitial lung disease. * on weight loss medications or starting new exercise regimen during the 8-week plant-based diet period.
study of carotid occlusion and neurocognition

Conditions: Carotid Artery Diseases

Summary: to determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (ec-ic) bypass or medical therapy alone in the carotid occlusion surgery study (coss).

the carotid occlusion surgery study (coss) evaluates whether a surgical operation, ec-ic bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one main artery in the neck that supplies blood to the brain (the carotid artery). the operation bypasses the blockage so more blood can flow to the brain. only people with decreased blood flow to the brain, as demonstrated on a pet (positron emission tomographic) scan, are randomized into the coss study. among patients randomized into the coss study, recon will evaluate whether restoring the blood flow to the brain (with ec-ic bypass surgery) will also improve mental functioning. participants in both the surgical and medical groups of the coss study will participate in the recon study. by comparing the mental functioning of the participants in both treatment groups over the course of 2 years, the investigators hope to determine whether the ec-ic bypass operation also helps improve or maintain mental functioning.

Eligibility criteria:
inclusion criteria: * enrollment into carotid occlusion surgery study exclusion criteria: * prior diagnosis of dementia

Keywords: carotid occlusion cognition
impact of vaccenic acid consumption on the metabolism of saturated fatty acids: relationship with cardiovascular risk factors

Conditions: Cardiovascular Disease

Summary: the investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a trans fatty acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.

111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric, randomised, double-blind, controlled 4-week study. all the volunteers consumed 3 experimental products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55 g fat/day.

Eligibility criteria:
inclusion criteria: * hdl cholesterol, g/l \> 0.4 * triacylglycerol g/l \<1.50 * ldl cholesterol g/l \<1.60 * waist size \< 94 cm (men) or 80 cm (women) * affiliated to national health insurance * normal blood pressure (diastolic \<90 mm hg, systolic \<140 mm hg) * for women: effective contraception * subject giving his/her written informed consent * subject willing to comply with the study procedures exclusion criteria: * reported food allergies * currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study * hepatic or renal impairments * positive serologies to hiv or hcv, * blood donation done less than 2 months before the start of the study * chronic pathologies * refusal to be registered on the national volunteers data file * being in exclusion on the national volunteers data file

Keywords: tfa sfa clinical trial fat milk
effect of meibomian gland probing on ocular surface in ocular rosacea

Conditions: Meibomian Gland Dysfunction

Summary: meibomian glands (mg) are modified sebaceous glands associated with the tarsus (collagenous structural component) of the upper and lower eyelids. meibomian glands produce lipid-based secretions which are an integral and stabilizing part of the tear film. in blepharitis and ocular rosacea (two known causes of obstructive meibomian gland dysfunction (o-mgd), inflammation of the lid margins causes blockage of the meibomian gland orifices, changes in glandular secretions, and dropout of the glands themselves. this limits the production, secretion, and quality of meibum. with less oil in the tear film, the aqueous portion of tears is not stable and evaporates quickly which leads to dry eye.

meibomian gland probing is a relatively new, safe, and effective technique for treating obstructive meibomian gland dysfunction (o-mgd). it involves topical anesthesia of the eyelid margins and insertion of a 2 mm or 4 mm sterile, beveled, solid stainless steel probe at the slit lamp. meibomian gland probing has been reported to alleviate symptoms (lid tenderness / lid margin congestion) of o-mgd (maskin, 2010). it has also been shown to improve meibum lipid levels, viscosity, and tear breakup time (nakayama, kawashima, kaido, arita, \& tsubota, 2015). though probing has been investigated in a few small studies of o-mgd, only one small study of 10 participants has investigated meibomian gland probing in ocular rosacea (wladis, 2012). this study showed improvement in ocular surface disease index (osdi, a standardized questionnaire assessing dry eye) but did not show objective improvement by way of examination findings or analysis of meibum (wladis, 2012). in our study, investigators intend to further investigate meibomian gland probing in participants with diagnosed ocular rosacea. investigators hypothesize that after probing of one eye, investigators will note improvements in participants symptoms as reflected in improvement in osdi scores, reductions in inflamma-dry measures (measure of matrix metalloproteinase (mmp-9), an inflammatory marker elevated in tears of participants with dry eye), decreased tear fluid osmolarity, decreased meibum viscosity on expression . objective improvement in lid margin disease (noting collarettes, pitting, telangiectasia of lid margins, thickening / irregularity of lid margins, lid margin tenderness; improvement in tear break up time (tbut); and improvement in corneal fluorescein / lissamine green staining).

Eligibility criteria:
inclusion criteria: • diagnosed ocular rosacea +/- facial rosacea exclusion criteria: * prior meibomian gland probing * prior treatment with lipiflow * cicatricial disease * sjogren's syndrome * prior radiation therapy to face / head * allergy to lissamine green and fluorescein
endoclot for hemostasis and preventing post-procedure bleeding after endoscopic mucosal resection

Conditions: Endoscopic Hemostasis; Colonic Polyps

Summary: endoscopic mucosal resection (emr) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. para-procedure bleeding is one of the common complication following emr. several endoscopic hemostasis methods are currently in use including metallic hemoclip. endoclot® absorbable polysaccharide hemostat (paph) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. this randomized controlled study has been designed to compare paph with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after emr.


Eligibility criteria:
inclusion criteria: * consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by emr. exclusion criteria: * severe cardiovascular diseases, liver and kidney dysfunction; * platelet and coagulation dysfunction (plt \ 2); * cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure; * cases unavailable for follow-up.

Keywords: endoscopic hemostasis metallic hemoclip endoclot absorbable polysaccharide hemostat colonic polyps