Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of eculizumab in chinese adults with gmg

Conditions: Generalized Myasthenia Gravis (gMG); Refractory gMG

Summary: this is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, pk, pd, and immunogenicity of eculizumab in chinese participants with refractory gmg. approximately 15 participants will be enrolled in the study.

this post-approval study is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, pk, pd, and immunogenicity of eculizumab in chinese participants with refractory gmg. there will be 3 periods in this study: screening period (up to 4 weeks), treatment period (26 weeks, including an induction phase and a maintenance phase), and safety follow-up period (8 weeks). the overall study duration for an individual participant is estimated to be up to 38 weeks. approximately 15 participants will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * diagnosis of mg must be made by the following tests: 1. positive serologic test for anti-achr abs as confirmed at screening, and 2. one of the following: 1. abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or 2. history of positive anticholinesterase test, eg, neostigmine test, or 3. participant has demonstrated improvement in mg signs on oral cholinesterase inhibitors as assessed by the treating physician * mgfa clinical classification class ii to iv at screening * mg-adl total score must be ≥ 6 at screening and day 1 * participants who have: 1. failed treatment with 2 or more ists over one year (either in combination or as monotherapy), ie, continue to have impairment adls (persistent weakness, experience crisis, or unable to tolerate ist) despite ists or, 2. failed at least one ist and require chronic pe or ivig to control symptoms, ie, participants who require pe or ivig on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months exclusion criteria: * any untreated thymic malignancy, carcinoma, or thymoma * history of thymectomy or any other thymic surgery within 6 months prior to screening. participants with a history of treated thymic malignancy or carcinoma are eligible if they meet all of the following conditions: 1. treatment completed \> 5 years prior to the screening visit 2. no recurrence within the 5 years prior to the screening visit 3. no radiological indication of recurrence in a computed tomography (ct) or magnetic resonance imaging (mri) scan, including administration of intravenous (iv) contrast, performed within 6 months of first dose on day 1 * weakness only affecting ocular or peri-ocular muscles (mgfa class i) * mg crisis at screening (mgfa class v). however, such participants may be rescreened with alexion approval once they are treated and medically stable, in the opinion of the investigator * history of n meningitidis infection or unresolved meningococcal disease

Keywords: generalized myasthenia gravis (gmg) refractory gmg eculizumab
local phase iv, gastroesophageal reflux disease (gerd) sleep study us

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (gerd).


Eligibility criteria:
inclusion criteria: * prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of ee; * prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week; * prior to the run-in period, a history of sleep disturbances associated with gerd for 1 month or more; exclusion criteria: * any condition other than gerd that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance * sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation; * proton pump inhibitor (ppi) use within 1 week prior to screening. the only allowable acid modifying rescue medication is gelusil® during the run-in period. only study medication and rescue medication (gelusil®) is allowed during the treatment period for treatment of acid mediated symptoms

Keywords: gerd esophageal reflux gastro-esophageal reflux regurgitation gastric
otc hearing aid and mci

Conditions: Hearing Loss; Mild Cognitive Impairment; Alzheimer Disease and Related Dementias (ADRD)

Summary: the goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (mci) or alzheimer's disease and related dementias (adrd), over-the-counter (otc) hearing aids: 1. improve communication 2. whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. whether alternative remediation (such as targeted communication strategies) offer similar benefits. participants and a communication partner will be randomized into an otc first or communication strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

this is a single blind cross-over study comparing otc hearing aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and mci and a communication partner. due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.

Eligibility criteria:
inclusion criteria: * over 60 years of age * mild dementia or mild cognitive impairment. diagnosis will be made at participating memory evaluation centers (see recruitment). * mild to moderate bilateral hearing loss and no current hearing aid use. * a communication partner who is able and willing to participate in the study. * no vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration) * able to provide own consent as evaluated by the consent assessment exclusion criteria: 1. clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study. 2. history of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., down's syndrome), or head/neck cancer 3. positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression) 4. co-enrolled in other intervention studies targeting hearing, language, or communication strategies. 5. history or current fluctuating hearing loss

Keywords: over-the-counter hearing aids
acute effect of fructose on lipid metabolism and gender differences

Conditions: Lipid Metabolism

Summary: it has been widely documented that fructose overfeeding increases plasma triglycerides and hepatic de novo lipogenesis, and impairs insulin sensitivity in healthy male volunteers. the effect of gender on the metabolic responses to fructose remains an important open question, however. the objective of this study is to compare the effect of an acute oral fructose load on carbohydrate and lipid metabolism in healthy young males and females.

the study is aimed at comparing the effects of oral fructose on several specific metabolic pathways in males and females.participants will receive an isoenergetic diet containing 55% carbohydrate, 15% protein and 35% lipids for three days prior to testing. after this period of controlled diet, they will be studied for 2 hours in the post-absorptive state (time 0-120 min) and over a 6 hours period (time 120-480 min) during which they will receive 4 loads of 0,30 g/kg fat free mass u-13c labelled fructose, at times 120, 180, 240, 300. throughout the study, deuterated glucose and glycerol will be infused to monitor whole body glucose production and glycerol turnover. the following parameters will be monitored in basal conditions and after the ingestion of the load of fructose: * glycerol turnover(glycerol 2h5) * de novo lipogenesis (incorporation of 13c into palmitate of vldls) * whole body energy expenditure and net substrate oxydation (indirect calorimetry) * net fructose oxidation (breath 13co2) * glucose turnover: (6,6 2h2 glucose) * plasma glucose, free fatty acids, ketone bodies, lactate, insulin, triacylglycerol, total cholesterol, vldl, ldl, and hdl subfractions an adipose tissue (periumbilical subcutaneous) biopsy will be obtaine by needle aspiration under local anesthesia in fasting conditions (time 0 min) and after fructose (time 480 min) to assess the effects of fructose on adipose gene expression profile. key genes involved in the regulation of carbohydrate (glut 4, hexokinase, pdh-kinase), lipid (fat-cd36, fabp, acetylcoa carboxylase, malonyl-coa decarboxylase, pparg) and energy metabolism (pgc-1a, ucp2)will be monitored results obtained in males and females will be compared with two-way analysis of variance

Eligibility criteria:
inclusion criteria: * males and females * age 18-35 * healthy * body mass indexes (bmi) between 19 and 25 kg/m2 * informed consent obtained exclusion criteria: * smokers * alcohol intake \> 30g/day * drug abuse * diabetes mellitus

Keywords: dietary fructose plasma lipids healthy humans gender differences hepatic de novo lipogenesis
family relationships and nutrition in tggd youth and young adults

Conditions: Family Relations; Nutrition Disorders; Health Behavior; Transgenderism

Summary: the purpose of this study is to assess how family relationships are related to health and nutrition behaviors among transgender and gender diverse youth and young adults.

the study is recruiting the following populations: parents of transgender and gender diverse youth, transgender and gender diverse young adults, and transgender and gender diverse youth. participants over the age of 18 will be recruited via amazon mechanical turk (mturk), and youth participants will be recruited via parent referral. age and role-appropriate surveys will be administered to the three distinct populations. a waiver of written consent for participation will be used per survey protocol. after participants receive a recruitment statement about the study and the potential risks, willing participants will take a 10-20 minute survey to provide data regarding demographics, height and weight, food habits, physical activity, food security, health support, risk-taking behaviors, past health diagnoses, and family environment. no personal identifiers will be collected and all responses will remain confidential. our main question is whether family acceptance of a transgender or gender diverse (tggd) youth and young adults is related to health, nutrition, and risk-taking behaviors.

Eligibility criteria:
inclusion criteria: tggd young adults: * 18 to 25 years of age * self-identify as transgender or gender diverse * a resident of the united states of america or canada * english speaking. parent of tggd youth * a parent of a 12-17 year old tggd youth * a resident of the united states of america or canada * english speaking * have a child that self-identifies as transgender or gender diverse tggd youth * 12 to 17 years of age * self-identify as transgender or gender diverse * a resident of the united states of america or canada * english speaking exclusion criteria: tggd young adults * less than 18 years of age or greater than 25 years of age * self-identify as cis-gender * not a resident of the united states of america or canada * non-english speaking parent of tggd youth: * parents of children that are less than 12 years of age or greater than 17 years of age * not a resident of the united states of america or canada * non-english speaking * does not identify as a parent of a tggd child tggd youth * less than 12 years of age or greater than 17 years of age * does not self-identify as transgender or gender diverse * not a resident of the united states of america or canada * non-english speaking

Keywords: youth young adult transgender gender diverse nutrition health behavior family relationship trans eating disorder food insecurity malnutrition physical activity
high tea consumption on smoking related oxidative stress

Conditions: Lung Cancer Prevention

Summary: the overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.


Eligibility criteria:
inclusion criteria: * fev1 \< 85% and at least 25 pack-years of current or former smoking history. * no diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years. * meets the southwest oncology group (swog) performance status criteria of 0-1. * not be pregnant or intending to get pregnant during the study period (women participants). * willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period. * willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months) * willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months). * subjects cannot take mega-doses of vitamins during the trial. this is defined as more than 400 iu of vitamin e, 200 ug of selenium, or 1 gm of vitamin c per day, or more than the tolerable upper limits of any other supplement as defined in the dietary reference intake panels developed by the food and nutrition board under the institute of medicine. such vitamin therapy must be discontinued at least 2 weeks prior to study entry. exclusion criteria: * subjects immunosuppressed by virtue of medication or disease. * serious concurrent illness that could interfere with study regimen. * subjects with a history of invasive cancer within the past 5 years. * subjects who are drinking more than 5 cups of non-herbal tea per week. * subjects who cannot or are unwilling to consume caffeinated beverages. * subjects unable to perform forced expiratory maneuver during spirometry testing. * more than one acute emphysema exacerbation within the last 6 month -period . * subjects on oxygen. * women with positive urinary pregnancy test.
involvement of lymphocyte type b in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the involvement of lymphocyte type b in amyotrophic lateral sclerosis (als) patients will be compared to lymphocyte in healthy subjects.


Eligibility criteria:
inclusion criteria: * als patients who could sign icf. exclusion criteria: * no als patients age less than 18 years.
motor learning for the lumbar spine using sensor-based postural feedback: a randomized controlled trial

Conditions: Chronic Non-specific Low Back Pain

Summary: a large subgroup of patients with chronic non-specific low back pain have motor control impairments. during motor control exercises, different forms of external feedback can be used to support training. this randomized controlled trial will investigate the effectiveness of different forms of external feedback during the learning phase of a motor control task for the lumbar spine in healthy subjects and patients with chronic non-specific low back pain (cnslbp). both healthy subjects and patients with cnslbp will be randomized into three groups: one group will receive feedback from motion sensors, one group from a mirror and one group will receive no feedback (control group). a single session intervention with measurements at baseline and immediately post-intervention will be used.


Eligibility criteria:
inclusion criteria: * chronic non-specific low back pain * age 18-65 * able to understand dutch exclusion criteria: * subjects that received lumbar stabilization exercises in the past year * spinal surgery in the past * pregnancy * serious underlying pathologies (e.g. multiple sclerosis, tumors,...) * signs or symptoms of nerve root involvement * any physical condition at the moment of testing that can interfere with activities of daily living (e.g. serious knee pain) * known skin-allergy for tape * bmi \> 30kg/m²
the covid-19 pandemic process increase latex glove use and latex allergy complaints in hospital nurses? survey study

Conditions: COVID-19 Pandemic; Nurse's Role; Allergy; Latex Allergy

Summary: background: global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of covid-19 disease. the increase in covi̇d-19 patients in the last two years has increased the rate of use of latex gloves in nurses. it is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses. aim: the aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the covid-19 pandemic in hospital nurses.

background: global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of covid-19 disease. the increase in covi̇d-19 patients in the last two years has increased the rate of use of latex gloves in nurses. it is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses. aim: the aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the covid-19 pandemic in hospital nurses. materials and methods: ethical and legal permissions were obtained before starting the research. research; it was conducted in a descriptive and cross-sectional manner at hatay training and research hospital between may 15 and june 15, 2021. the sample of the study consisted of 448 nurses who volunteered to participate in the study. the data of the study were collected with data collection forms created by the researchers as a result of literature reviews. the data of the research were collected by the online questionnaire method. analysis of the data was analyzed with appropriate statistical methods in spss 21.0 program. p\<0.05 value was accepted for statistical significance.

Eligibility criteria:
inclusion criteria: * over 18 years old * working as a nurse in hatay training and research hospital, working in hatay training and research hospital for the last month according to the date of the research * nurses who volunteered to participate in the study were included in the study. exclusion criteria: * nurses who want to leave the study at any stage of the study after being included in the study

Keywords: latex allergy latex gloves corona virus disease nursing
the effect of sugammadex during transcranial electrical motor evoked potential monitoring in spinal surgery

Conditions: Sugammadex

Summary: transcranial motor evoked potential (tcmep) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (nmb) because of its potential interference with signal interpretation. however, full blockade offers increased anesthetic management options and facilitates surgery. here, investigators want to assess the effect of sugammadex during tcmep in adult patients. sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in train-of-four (tof), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. whereas no muscle relaxant will be given after anesthetic induction in control group. the primary aim of this study is to compare mean value of amplitudes of tcmeps in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.


Eligibility criteria:
inclusion criteria: * 18-65 years * asa status i-ii * patients undergo thoracic or lumbar spinal surgery * tcmep monitoring during the surgery * informed consent signed by patients exclusion criteria: * bmi ≥35 kg/m-2 * history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s) * history or family history of malignant hyperthermia * allergies to sugammadex, nmbs or other medication(s) used during general anesthesia * anemia, hemoglobin \<110g/l, * tcmeps stimulate or record site infection * preoperative neurological dysfunction in both upper extremities * cardiac pacemaker * pregnancy and breast-feeding
benefits of a higher protein, 'egg-cellent' breakfast in the classroom

Conditions: Breakfast; Obesity; Mood; Eating Behavior

Summary: this study will test whether whether the implementation of and egg-cellent 'breakfast in the classroom' improves school breakfast participation and breakfast consumption in middle school adolescents; whether the implementation of 'breakfast in the classroom' improves appetite control, mood, cognitive performance, and unhealthy snacking behavior in middle school adolescents when compared to a traditional school breakfast program.

the investigators propose an 4-week cross-over design breakfast study in children enrolled in 6-8th grade within the center school district in the kansas city, missouri. this school will begin their 'breakfast in the classroom' program on march 26, 2018. prior to the start of 'breakfast in the classroom', baseline data will be collected on the students who wish to participate in the study. baseline data includes anthropometric assessments; demographics; current eating habits; cognitive performance; appetite; and mood. following baseline, the students will be provided a breakfast that meets all the requirements for a reimbursable school breakfast with the addition of two eggs for 3-weeks: at 4 weeks (3 weeks after initiation of the program), the study participants will complete a similar outcomes to those completed at baseline.

Eligibility criteria:
inclusion criteria: * all students from the center middle school in kansas city, mo who choose to participate and whose parent/legal guardian (excluding wards of the state) signs the consent will be included. exclusion criteria: * wards of the state will be excluded from this study.

Keywords: breakfast obesity mood eating behavior cognitive function