Kornimate/medical-research-clean huggingface dataset:
galactooligosaccharide, immune strength, and digestive health

Conditions: Healthy

Summary: the purpose of this research study is to determine whether a functional fiber, galactooligosaccharide, can help maintain immune strength and digestive health in undergraduate students who are undergoing an academic stress (i.e., final exams). subjects will be asked to consume the fiber or placebo each day for eight weeks. immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 420 students and from the collection of fecal samples in a subgroup of students.

a prospective, randomized, parallel, double-blind, placebo controlled design will be used. healthy full-time undergraduate students undergoing fall 2009 final academic exams will be recruited from the university of florida. informed consent will be obtained. all subjects will be consented for the main intervention study and a subgroup (n=25/group or 75 total) of these subjects will also be consented to provide two stool samples at baseline and two stool samples during the week of final exams (approximately week 4 of the intervention). subjects will be stratified based on gender and randomized (n=140/group) to receive 0 g, 2.5 g, or 5.0 g of the fermentable fiber, galactooligosaccharides, for eight weeks around the time of their fall final exams. subjects will complete daily online questionnaires asking whether they are experiencing any cold/flu symptoms. weekly online questionnaires will collect information regarding gastrointestinal symptoms over the past week. the acute psychological stress associated with final exams will increase cold/flu symptoms. it is anticipated that students consuming the galactooligosaccharides versus the placebo will have more healthy days (i.e., days without cold symptoms) due to fiber induced changes in the beneficial bacteria within the colon, which reduces the burden on the immune system.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * willing to complete a daily assessment form via computer * willing to discontinue any immune-enhancing dietary supplements ( e.g., prebiotics and fiber supplements, probiotics, echinacea, fish oil, vitamin e \>100% of the rda or \>15 mg/day) * willing to take the fiber for 8 weeks * had a cold in last 12 months * have at least 1 final during the fall 2009 exam week, between saturday, december 12 and friday, december18, 2009 * daily access to a computer with internet access for the entire 8-wk study exclusion criteria: * current smoker * chronic allergies involving the upper respiratory tract (chronic = taking allergy medicine daily) * an allergy to milk * known illnesses or conditions that may impact perceived health such as hiv/aids, diabetes, renal or gastrointestinal diseases * received chemotherapy or other immune suppressing therapy within the last year * antibiotic therapy in the past two months * a cold or cold symptoms (on day of randomization)

Keywords: adults fiber cold flu stress microbiota
effectiveness of facet joint infiltration in low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to evaluate the effectiveness of facet joint infiltration with corticosteroids in the treatment of low back pain due to facet joint osteoarthritis.

sixty subjects with diagnostic of facet joint syndrome will be enrolled in the study. they were randomized into experimental and control groups. the experimental group will be submitted to intra-articular infiltration of six facet joints. the control group will be submitted to intramuscular injection of six lumbar paravertebral points. after the randomization, all subjects will be assessed by an investigator blinded to the groups. the assessment will be taken just before the interventions (t0) and them 7 , 30 , 90 and 180 days after the interventions. the following assessment instruments will be used: pain visual analogical scale (vas) (0-10cm), pain visual analogical scale during extension of the spine (vas e) (0-10cm), likert scale for improving (0-5), percentage scale of subjective improving perception(0-100%), rolland-morris questionnaire (0-24), short health survey questionnaire (sf36), accountability of medications taken for back pain: analgesics and non-steroidal antiinflammatories (nsaids).

Eligibility criteria:
inclusion criteria: * low back pain up to 3 months * pain on back extension * radiologic findings of facet joint osteoarthritis exclusion criteria: * other causes of back pain * fibromyalgia * diabetes, arterial hypertension or glaucoma not well controlled * patients with contrast allergy

Keywords: facet joint back pain osteoarthritis infiltration
a study to investigate the safety and efficacy of replenine®-vf in haemophilia b patients undergoing major surgery.

Conditions: Haemophilia B

Summary: the main objective of the study is to investigate the safety and efficacy of replenine®-vf administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia b undergoing major surgery.


Eligibility criteria:
inclusion criteria: * patients with moderate to severe haemophilia b (≤5% baseline factor ix level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving factor ix concentrate. exclusion criteria: -
model based fast anatomical mapping

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Summary: this prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mfam) to create left atrial (la) geometry for atrial fibrillation ablation.

this prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mfam) to create left atrial (la) geometry for atrial fibrillation ablation. specifically, the study will assess the following issues in atrial fibrillation ablation: 1. accuracy of map (defined as the distance between the ablation points and the surface of the mfam geometry) 2. left atrial geometry creation time 3. fluoroscopy time the clinical team will hypothesize that this approach will lead to accurate la geometry creation more rapidly and using less fluoroscopy than standard techniques

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * have af as follows: 1. paroxysmal af - defined as af that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting \< 7 days. 2. persistent af - defined as af that is sustained \> 7 days. episodes of af which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of af, but prior to 7 days, should also be classified as persistent af episodes. * are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed) * have the ability to understand the requirements of the study and sign the informed consent form. * are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements exclusion criteria: * rheumatic heart disease, * current intra-cardiac thrombus * class iv hf * unable to sign consent * unstable angina * recent cerebral ischemic events * contradiction to anticoagulation * prior cardiac surgery * complex congenital heart disease

Keywords: atrial fibrillation afib ablation paroxysmal persistent
the match investigation: ct myocardial perfusion and ct-ffr vs pet mpi

Conditions: Coronary Artery Disease

Summary: the overall goal of this project is to compare the absolute quantification of myocardial perfusion done by using ct myocardial perfusion imaging (ct-mpi) and the coronary flow measured by using ct fractional flow reserve analysis (ct-ffr) to the gold standard represented by pet myocardial perfusion imaging (pet-mpi).

participants will be patients who are scheduled to undergo pet myocardial perfusion imaging, which is the traditional method for evaluating patients with suspected blockages or narrowing of the heart vessels (coronary artery disease) causing impaired blood to flow to the heart muscle (myocardium). the purpose of the study is to determine and compare the newest heart imaging equipment which allows the non-invasive evaluation of coronary anatomy, coronary flow and myocardial perfusion in patients with suspected or proven coronary artery disease (cad) with the actual gold-standard for quantitative myocardial perfusion assessment. in order to achieve this aim, the study team will compare heart scan results from a computed tomography (ct) myocardial perfusion imaging (ct-mpi) scan and ct-fractional flow reserve (ffr) with the actual standard clinical care represented by a pet myocardial perfusion imaging (pet-mpi) study.

Eligibility criteria:
inclusion criteria: * referred for a clinically indicated ct-mpi for cad assessment * must provide written informed consent prior to any study-related procedures being performed * must be willing to comply with all clinical study procedures exclusion criteria: * pregnant or nursing females. the possibility of pregnancy will be excluded by testing (serum or urine ßhcg) within 24 hours before study agent administration, or if the woman has previous surgical sterilization, or if the woman is post menopausal, with minimum one (1) year history without menses. * currently taking or has taken within 48 hours the following excluded medications: * actoplus met (pioglitazone + metformin) * avandamet (rosiglitazone + metformin) * fortamet (metformin) * glucovance (glyburide +metformin) * glucophage (metformin) * glucophage extended-release (xr) (metformin) * glumetza (metformin) * janumet (sitagliptin + metformin) * metformin * metaglip (glipizide + metformin) * riomet (metformin) * acute psychiatric disorder * unwilling to comply with the requirements of the protocol * previously entered this study * known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study * suffers from claustrophobia * impaired renal function (gfr \< 45 ml/min) * acute hypotension (\<100 mm hg systolic) * 2nd or 3rd degree atrioventricular (av) block

Keywords: atherosclerosis cardiovascular disease myocardial ischemia imaging nuclear medicine radiology
magnetic resonance (mr) imaging & blood biomarkers for head and neck cancer

Conditions: Cutaneous Squamous Cell Carcinoma of the Head and Neck; Healthy Subject; Head and Neck Cancer

Summary: the goal of this research study is to find out if using additional mris and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. biomarker testing in the study may include genetic biomarkers. this is an investigational study. mris on this study are performed using fda-approved and commercially available methods. having added scans and blood tests is investigational. up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). all will take part at md anderson.

primary objectives: i. to assess the prognostic value of pretreatment volumetric tumor growth velocity (tgv), weekly tumor kinetics (tk), and blood biomarkers of mucosal head and neck cancers during radiation therapy (rt), using magnetic resonance imaging (mri). secondary objectives: i. to assess functional imaging kinetics as a marker of tumor locoregional control. ii. to correlate blood biomarkers with tumor kinetics during treatment. iii. to generate preliminary data for future trials. outline: patients undergo mri scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. after completion of study, patients are followed up weekly.

Eligibility criteria:
inclusion criteria: * biopsy proven diagnosis of squamous cell carcinoma (scc) of head and neck mucosa. clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of t staging * no distant metastases, based on routine staging workup * consent for blood collection for biomarker analysis * no head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies * eastern cooperative oncology group (ecog) = 0, 1, or 2 * dispositioned to curative intent radiotherapy * for females of child-bearing age, a negative pregnancy test exclusion criteria: * previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity) * pregnant or breast-feeding females * contraindications to magnetic resonance (mr) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators) * history of claustrophobia * contraindications to gadolinium contrast (e.g. kidney dysfunction)

Keywords: head and neck cancer magnetic resonance imaging mri biomarker testing blood draws questionnaires surveys
rectal spacers in prostate cancer patients undergoing radiation therapy

Conditions: Prostate Cancer

Summary: this is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. the goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. study visits: * screening * spacer placement * treatment planning simulation * end of the radiation treatment * 1,3,and 6-months fu visits.


Eligibility criteria:
inclusion criteria: 1. patients with prostate cancer ≥ 18 years of age. 2. patients are in one of the following risk groups: * t1-t3 prostate cancer with no posterior extra capsular extension * gleason score ≤ 7 3. planned for radiation treatment with rectal spacer. 4. ability to understand and the willingness to sign a written informed consent form. exclusion criteria: 1. metastatic disease. 2. previously treated localized adenocarcinoma of the prostate. 3. active inflammatory bowel disease requiring treatment with steroids. 4. prior total prostatectomy. 5. current urinary tract infection. 6. acute or chronic prostatitis.
establishing physiologic outcomes for ventricular unloading on va ecmo

Conditions: Cardiogenic Shock

Summary: aim 1: prospective, observational analysis of the association between echocardiographic measures of cardiac function and left ventricular unloading on va ecmo. aim 2: prospective, observational analysis of the association between clinical laboratory biomarkers and left ventricular unloading on va ecmo.

mechanical circulatory support (mcs) is increasingly utilized as a means of hemodynamic support among cardiogenic shock (cs) patients refractory to optimal medical management. mcs modalities include using either an intra-aortic balloon pump (iabp), impella®, or ecmo, each with unique benefit/harm profiles. among the various mcs devices, extracorporeal membrane oxygenation (ecmo) is described as the highest level of support, capable of providing 5+ liters per minute of oxygenated blood flow but is the most invasive. despite the benefit of maximal cardiopulmonary support, ecmo increases afterload in a failing heart. left ventricular (lv) unloading or decompression (using simultaneous iabp or impella®) has been suggested as potential improvement. observational studies suggest a benefit with lv unloading during va ecmo for cs, but the mechanisms underlying the association are poorly understood. prior to trials, a mechanistic understanding of the effect of different lv unloading strategies on key physiologic abnormalities in cs is needed, as the physiologic effects of lv unloading during va ecmo for cs remain insufficiently defined. the objective of this study is to define serial changes in common clinical variables routinely obtained during management of patients in cs. these clinical variables are readily accessible to clinicians, but are not typically collected in a sufficiently granular serial manner to characterize their utility as clinical biomarkers. by obtaining scheduled assessments, repeated in a prospective cohort over the clinical course of cs, the investigators will define the physiologic effects of different lv unloading strategies in cardiogenic shock. we will examine a) echocardiographic measures of ventricular distension, and b) blood biochemical measures of peripheral perfusion.

Eligibility criteria:
inclusion criteria: * patients who are 18 years of age or older * patients with cardiogenic shock * patients with mechanical circulatory support, specifically veno-arterial extracorporeal membrane oxygenation (va ecmo) inserted peripherally exclusion criteria: * none

Keywords: mechanical circulatory support
lung disease associated with rheumatoid arthritis

Conditions: Pulmonary Fibrosis

Summary: pulmonary fibrosis (pf) is a condition in which the lungs of a patient become scarred and fibrous. it has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (ra). the cause of the pulmonary fibrosis in patients with ra is unknown. patients participating in this study will undergo a series of tests and examinations before and throughout the study. the tests include blood and urine tests, electrical measures of heart function (ecg), chest x-rays, cat scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy. the goals of this study are to: 1. estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis, 2. describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis, 3. estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and 4. learn more about the factors that contribute to the development or progression fibrotic lung disease....

pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. it is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease.

Eligibility criteria:
* inclusion criteria: non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following: rheumatoid arthritis with biopsy-proven pulmonary fibrosis or; rheumatoid arthritis only, or; biopsy-proven idiopathic pulmonary fibrosis. exclusion criteria: forced expiratory volume in one second (fev1) less than 1l. inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium). chronic cardiopulmonary disorders other than pulmonary fibrosis. other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease). non-rheumatoid arthritis. viral infections associated with pulmonary fibrosis (e.g., hepatitis b, hepatitis c, human immunodeficiency virus). uncorrectable bleeding diathesis. pregnancy or lactation.

Keywords: interstitial lung disease collagen vascular disease extracellular matrix pulmonary function dtpa lung clearance scan natural history
overnight feeding study in glycogen storage disease type 1

Conditions: Glycogen Storage Disease Type 1 (GSD 1)

Summary: in this clinical cross-over study, we will compare the efficacy of different oral nutrition regimens for night-time glucose control in adult gsd 1 patients. three different over-night nutrition regimens (=interventions) will be compared in each patient sequentially, (1) uncooked corn starch (ucss, "maizena"), (2) modified corn-starch, (3) other carbohydrate (starch) containing meal. during each intervention, glucose profiles will be continuously monitored by continuous glucose monitoring (cgms). the duration of each intervention is 3d (mimimum) to 6d (maximum), depending on the quality of night-time glucose control and the technical quality of glucose sensor readings. between the interventions, the patients follow their normal prescribed diet.


Eligibility criteria:
inclusion criteria: * glycogen storage disease type 1 (type 1a and 1b) * stable nighttime glucose control without frequent or severe hypoglycaemia under current dietary treatment, according to capillary glucose measurements. exclusion criteria: * unstable night-time glucose control during the last 8 weeks with frequent (\> 4x weekly) hypoglycaemia during night-time, or a hospitalisation due to unstable glucose control during the last 4 weeks, or any episode of severe hypoglycaemia (requiring assistance or loss of consciousness) during the last 4 weeks. * pregnancy or breast feeding * drug or alcohol abuse * acute gastrointestinal problems (e.g. acute gastroenteritis) * known malignancy (e.g. hepatocellular carcinoma)
corneal lesions in intensive care unit (icu) clinical trial for proposing interventions and evaluating outcomes of nursing in the adult intensive care center clinical trial for proposing interventions and evaluating outcomes of nursing in the adult intensive care center

Conditions: Keratitis; Corneal Ulcer

Summary: the purpose of the study is find out the better measure to achieve corneal protection in an intensive care unit.

critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. however, the literature diverges on which is the best clinical practice for treatment. there is a scale for assessing the risk for corneal injury. thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. the specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. patients and methods: this study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .

Eligibility criteria:
inclusion criteria: * ramsay sedation scale 5 or 6 * glasgow coma scale lower than 7 * use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation * blink reflex less than 5 times per minute or ocular globe exposure exclusion criteria: * less than 48 hours in intensive care unit

Keywords: corneal diseases corneal ulcer nursing diagnosis intensive care units nursing randomized clinical trial
aggressive prostate cancers in elderly patients

Conditions: Prostatic Neoplasms

Summary: patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter bcr-free survival than younger ones. definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years.

Eligibility criteria:
inclusion criteria: * clinically localized prostate cancer * good health status * follow-up period more than 12 months exclusion criteria: * insufficient clinical data * poor health status * clinically advanced prostate cancer

Keywords: prostate-specific antigen radical prostatectomy