Kornimate/medical-research-clean huggingface dataset:
balanced (egg) protein during obesity reduction: differential responses of insulin resistance by race

Conditions: Pre Diabetes; Obesity

Summary: the purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. the investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.

older (\>60 yrs) men and women (50% african american, 50% white) who are obese (bmi \>30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) weight loss intervention (wl-control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d; and 2) high protein weight loss intervention (wl-protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (\> 30g protein, 3/day, 60-70% egg protein). primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.

Eligibility criteria:
inclusion criteria: * age \> 60 years * identifies as caucasian/white or african-american/black * obese body weight (\>30 kg/m2) * able to speak and understand spoken and written english * elevated fasting plasma glucose (≥95 and \<126 mg/dl) * age-normal kidney function (≥ 45 ml/min/1.73 m2) exclusion criteria: * body weight \> 224 kg (limit of the bodpod) * treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dl) * presence of unstable, acutely symptomatic, or life-limiting illness * positive screen for dementia using mini-cog evaluation tool * neurological conditions causing functional or cognitive impairments * history of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation) * allergy or intolerance to egg products * unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months * inability to walk independently * unable to give consent * unable to complete written recording forms including journals of eating and exercise behaviors. * current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent * primary care physician advises against participation * smoker * unusually or unstable renal function

Keywords: egg protein aging health disparities weight loss
chest ultrasound of er patients with cough or sob

Conditions: Cough; Dyspnea; Wheezing

Summary: acute dyspnea (shortness of breath) is a common complaint for patients presenting to the emergency department (ed). the chest radiograph (cxr) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. there are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. on occasion, chest radiography findings are difficult to interpret. lung ultrasonography may offer a means of clarifying ambiguous results. the objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ed with shortness of breath, cough and/or wheezing.

acute dyspnea (shortness of breath) is a common complaint for patients presenting to the emergency department (ed). the chest radiograph (cxr) has been the mainstay in evaluating patients with shortness of breath and often provides the timely diagnosis of pneumonia, pneumothorax, pulmonary edema, among other primary diseases of the lung. there are limitations with chest radiograph such as large body mass (e.g, obesity) and patient positioning. on occasion, chest radiography findings are difficult to interpret. lung ultrasonography may offer a means of clarifying ambiguous results. advantages of ultrasound include real-time immediate evaluation, it is non-invasive and does not use radiation. the investigators seek to perform a prospective evaluation of patients presenting to the university of washington medical center ed for cough, wheezing and/or shortness of breath. the objective of this study to determine the usefulness of point of care lung ultrasound in evaluating patients presenting to the ed with shortness of breath, cough and/or wheezing. the specific aim of this study is to further define the utility of point-of-care ultrasound in the evaluation of emergency department patients presenting with cough, wheezing and/or shortness of breath. the investigators will compare ultrasound results to radiograph and tomography results when available, and to the physicians initial impression.

Eligibility criteria:
inclusion criteria: * presenting to the emergency department with cough, wheezing and/or dyspnea (shortness of breath) * referred for cxr and/or ct scan exclusion criteria: * life threatening medical condition requiring immediate treatment * unable to sit up for a chest ultrasound * unable to consent * pregnant * unable to speak, read and write in english

Keywords: emergency departments chest lung cough dyspnea wheezing ultrasound ultrasonography
evaluation of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity of ravulizumab administered intravenously in pediatric participants with generalized myasthenia gravis (gmg)

Conditions: Generalized Myasthenia Gravis; gMG

Summary: the primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gmg.


Eligibility criteria:
inclusion criteria: * diagnosis of gmg confirmed by a positive serologic test for anti-achr antibodies (abs) obtained at screening and/or during screening period * myasthenia gravis foundation of america (mgfa) clinical classification of class ii to class iv at screening * participants receiving treatment must be on a stable dosing regimen of adequate duration prior to screening and during the screening period. * eculizumab-experienced participants must have been enrolled and treated with eculizumab in study ecu-mg-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to screening. * all participants must be vaccinated against meningococcal infection exclusion criteria: medical conditions * any untreated thymic malignancy, carcinoma, or thymoma. * participants with a history of treated benign thymoma * history of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to screening * history of n meningitidis infection * known to be human immunodeficiency virus (hiv) positive * history of unexplained infections * known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the screening period

Keywords: generalized myasthenia gravis gmg
radiographic assessment of three dimensional mandibular position using splint-less patient specific implant

Conditions: Abnormality of Facial Skeleton

Summary: the purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. this approach utilized a personalized orthognathic surgical guide (posg) system, which comprised a set of cutting guides and 3d printed custom titanium fixation plates for bilateral sagittal split osteotomies (bssos). the cutting guides were first used to predrill screw holes and guide osteotomies. the custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation

surgical technique: the buccal bony surface of the mandible was exposed as a routine sagittal split osteotomy. first, the mandibular cutting guide was installed using the tooth-borne splint portion of the guide. second, the lower portion of the guide was temporarily fixed with titanium screws through the designed screw holes on the guide. the planned margins for vertical osteotomy/ ostectomy were then marked by a pencil. once the cutting guide was removed, the sagittal split osteotomy was completed as usual. finally, the distal and proximal segments were fixed together using the custom plates and screw holes that were used by the cutting guide. accuracy of preoperative surgical planning, and validation of the use of patient specific implants (psi) in bilateral sagittal split osteotomy (bsso) by comparing the planned outcomes to the actual postoperative outcomes by two methos. a)evaluation the discrepancy between planned and obtained post-operative position of the mandibular plates, rami, and occlusion by analyzing the discrepancies in terms of rotation (roll, pitch and yaw) and translation (antero-posterior, lateral and vertical). these movements were determined by incorporating the segments in homologous bounding-boxes, aligning the planned model to the post-op result colorimetric map inspection. b) measurements of the linear differences between the planned and postoperative positions of the mandibular midlines, the chin, and the gonial angle.

Eligibility criteria:
inclusion criteria: 1. patients suffering from skeletal deformity requiring mandibular orthognathic surgery (bilateral sagittal splitting osteotomy). 2. patients should be free from any systemic disease that may affect normal bone healing and predictable outcome. exclusion criteria: 1. patients with metabolic bone disease that affects bone healing. 2. intra-bony lesions that may affect the osteotomy healing. 3. patients with history of radiotherapy on the head and neck region
the effect of citrus extract on gastrointestinal health

Conditions: Irritable Bowel Syndrome

Summary: this randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * patients with ibs * calprotectin levels 15-150 µg/g feces * age 18-70 years * bmi \< 35 kg/m2 exclusion criteria: * comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator) * abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator) * use of immunosuppressive drugs within 3 months before study period * use of other medication interfering with endpoints * changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study * changes in clinical activity scores within 3 weeks prior to the study * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study * use of dietary supplements containing antioxidants, minerals and vitamins * excessive intake of foods with a high polyphenol concentration * use of antibiotics within 3 months prior to the start of study * use of pre-or probiotics within 1 month prior to the study * use of oral corticosteroids within 1 month prior to the study * blood donation within 1 month prior to the study * known pregnancy or lactation. * excessive drinking (\>20 alcoholic consumptions per week) * history of any side effects towards the intake of flavonoids or citrus fruits
probiotics and early microbial contact in preterm neonates

Conditions: Premature; Infant, Light-for-dates; Breastfeeding

Summary: probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. according to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. the investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. despite the promising data, the optimal probiotic intervention is yet to be established. the mechanisms by which probiotics exert their effects remain largely unknown. this research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. in particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. all of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. the purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial. the specific aims of the project are: 1. to determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured. 2. to investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. in particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. different potential probiotic strains will be assessed. 3. to elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.


Eligibility criteria:
inclusion criteria: * premature infant born at \<35 weeks gestational age exclusion criteria: * severe asphyxia * significant anomalies

Keywords: probiotics premature infant intestinal microbiota intestinal immunity breastfeeding
an observational study of the use and safety of xolair® during pregnancy

Conditions: Asthma

Summary: the xolair® pregnancy registry is an observational study established by genentech to obtain data on pregnancy outcomes in women who are exposed to xolair®. women exposed to at least one dose of xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. the evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. follow-up of the infant will be extended until the infant is 18 months old, if the woman continues xolair® treatment while breastfeeding.


Eligibility criteria:
inclusion criteria: - women who have been exposed to at least one dose of xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy exclusion criteria: * women not currently pregnant * women exposed to xolair® not during pregnancy but only while breastfeeding * re-enrollment of women who are pregnant for second (or more) time is not allowed
effect of high caloric diet on brain insulin sensitivity and inflammation

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: obesity if known to be associated with brain insulin resistance in humans and evidence is rapidly accumulating that brain insulin resistance influences peripheral metabolism, eating behavior and cognition. a reduced insulin response in the brain is found mainly in people with a metabolically unfavorable fat distribution - high visceral fat. visceral fat produces inflammatory mediators and elevated inflammatory levels are closely linked to insulin resistance. inflammation of the brain (i.e., neuroinflammation) has been proposed as a possible cause of brain insulin resistance. interestingly, rodent models of a high calorie diet show that these inflammatory mechanisms occur rapidly in the brain, even prior to weight gain of the animals. among other things, it has been shown in humans that a short-term increase in calories, especially carbohydrates and fats, reduces insulin sensitivity in the body and increases inflammatory parameters in the blood. whether a high-calorie diet triggers insulin resistance or inflammation in the human brain is currently unknown. aim of study: the aim of the study is to investigate the effects of a five-day high calorie diet in healthy young male volunteers on peripheral and brain insulin sensitivity as well as on eating behavior, mood and cognition. brain insulin sensitivity, peripheral metabolism and different behavioral assessments will be evaluated before, 1 week and 2 weeks after high caloric diet.


Eligibility criteria:
inclusion criteria: * bmi 19-24 kg/m2 * non smoking * normal glucose tolerance during 75g oral glucose tolerance test (ogtt) * exercise less than 2h per week exclusion criteria: * vegetarians and vegans * food allergies * working at night * professional athletes * not removable metal parts in or on the body * manifest cardiovascular disease * claustrophobia * recent surgery (less than 3 months) * simultaneous participation in other studies * acute disease or infection within the last 4 weeks * neurological and psychiatric disorders * treatment with centrally acting drugs * hemoglobin hb \<13g / dl * hypersensitivity to any of the substances used
observation study of t-gel (1%) in treatment of adolescent boys with hypogonadism

Conditions: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)

Summary: this study is to observe efficacy and safety after t-gel 1% treatment in delayed puberty adolescents. subjects who complete this trial may enter a 3 month extension study (umd-01-090e).


Eligibility criteria:
inclusion criteria: * primary or secondary hypogonadism or constitutional delay in growth and puberty (cdgp) exclusion criteria: * skin intolerance to alcohol or allergy to soy * generalized skin disease * contraindication to testosterone or androgen products

Keywords: hypogonadism
to compare the effect of liraglutide when given together with metformin with the effect of metformin given alone and with the effect of glimepiride and metformin given together

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, oceania, africa, asia and south america. this trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. two trial periods: a 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Eligibility criteria:
inclusion criteria: * subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (oads) for at least 3 months * hba1c: 7.0-11.0 % (both incl.) in subjects on oad monotherapy. 7.0-10.0 % (both incl.) in subjects on oad combination therapy * body mass index (bmi) less than or equal 40 kg/m2 exclusion criteria: * subjects treated with insulin within the last three months * subjects with any serious medical condition * females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods * subjects using any drug (except for oads), which in the investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
dose escalation study of gleevec and chlorambucil in previously treated chronic lymphocytic leukemia patients

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine maximum tolerated dose of gleevec in combination with chlorambucil in previously treated cll patients.

a recent study by aloyz et al demonstrated a synergistic effect of imatinib on chlorambucil-mediated cytotoxicity in cll cells in vitro. imatinib inhibits c-abl and sensitizes cells to chlorambucil. the phase i component of the study will determine the maximum tolerated dose and recommended phase ii dose of gleevec when used in combination with chlorambucil. once the maximum tolerated dose has been determined, a total of 16 patients will be enrolled in the phase ii component of the study. this study will determine the dose limiting toxicities, pharmacokinetics and pharmacodynamics of gleevec in combination with chlorambucil.

Eligibility criteria:
inclusion criteria: * b-cell chronic lymphocytic leukemia (a) rai stage 0-ii with indication for treatment by nci working group criteria: or (b) rai stage iii or iv. * received a minimum of one prior chemotherapy regimen. prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted. * white blood cell count \> 25 x 10\^9/l * ecog 0, 1,or 2. * adequate renal and hepatic function * platelets \> 75 x 10\^9/l, transfusion independent. * neutrophils \> 1.0 x 10\^9/l, transfusion independent exclusion criteria: * documented prolymphocytic leukemia (pll; prolymphocytes, 55% in blood) * active cardiovascular disease as defined by nyha class iii-iv categorization. * intercurrent illness or medical condition precluding safe administration of ribavirin. * concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency * known infection with hiv, hepatitis b or c. * concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma). * received any previous therapy for cll within 28 days prior to study entry.

Keywords: cll chronic lymphocytic leukemia leukemia gleevec chlorambucil