Kornimate/medical-research-clean huggingface dataset:
phonak behind-the-ear quality evaluation

Conditions: Hearing Loss, Sensorineural

Summary: subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a phonak bte (behind-the-ear) hearing aid.

speech intelligibility performance will be measured with a new generation bte hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Eligibility criteria:
inclusion criteria: * severe to profound hearing loss (4 frequency pure tone average 65-94 db) * 18+ years old * good written and spoken english language skills * able to fill in a questionnaire conscientiously * experienced hearing aid user * able to produce a reliable hearing test result * able to describe listening impressions/experiences and the use of the hearing aids exclusion criteria: * not willing to test the hearing aids * has auricle deformities that prevents secure placement of the hearing aids * has limited mobility and is not able to attend the appointments * not willing to wear the hearing aids for at least 8 hours per day * known hypersensitivity or allergy with synthetic materials * self reports symptoms of vertigo, dizziness, fluctuating hearing loss * hints of psychological problems * suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)
relation of carotid artery plaque inflammation, covert stroke and white matter disease

Conditions: TIA; Stroke; Carotid Artery Stenosis

Summary: the investigators hypothesize that inflammation in carotid plaque is predictive of the extent of ischemic lesion burden on the brain and will add to risk stratification for individuals with carotid disease.

objectives: 1. to investigate the relationship of carotid inflammation, as measured by fdg positron emission tomography (pet) to standardized uptake value in atherosclerotic plaque, with the number of covert brain infarcts. 2. to investigate the relationship of fdg pet standardized uptake value with the relative volume of white matter hyperintensity. 3. to correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.

Eligibility criteria:
inclusion criteria: * age 60 or greater at time of enrollment * written informed consent from patient or legal representative * diagnosis of stroke or tia made by a stroke specialist within 90 days and fulfilling the following criteria: * a tia must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours. * a stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. post event modified rankin score of 2 or less. * stroke meets the trial of org 10172 in acute stroke treatment (toast) criteria for large artery atherosclerosis * carotid doppler, cta or mra confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. stenosis will be measured following the method used in nascet for cta and mra. carotid doppler measurements will follow the criteria defined by the society for ultrasound consensus conference. * 12 lead ecg or holter monitor confirming the absence of atrial fibrillation. exclusion criteria: * tia or stroke in the vertebrobasilar system * index event was primary hemorrhage * history of intermittent atrial fibrillation * cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global lv dysfunction, congenital cardiac defect) * diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (ehlers-danlos, marfans) * sinovenous thrombosis, endocarditis or hypercoagulable state * pacemaker, icd or other contraindications to mri * diminished kidney function * contraindication to radiation exposure (eg: pregnancy) * severe claustrophobia

Keywords: white matter hyperintensity stroke carotid artery plaque inflammation fdg pet mri tia
kalogon pilot fatigue and comfort study

Conditions: B52 Pilot Fatigue and Comfort

Summary: the goal of this experimental study is to compare 2 different seat cushions in b52 cockpit seats to see if they affect pilot fatigue and comfort. the main questions it aims to answer are: 1. does the kalogon af prototype seat cushion improve pilot comfort compared to the standard seat cushion? 2. does the kalogon af prototype seat cushion reduce pilot fatigue compared to the standard cushion? participants will spend 8 hours in a simulated cockpit playing a flight simulator. they will fill out multiple questionnaires and take 2 attention/reaction time tests throughout the 8-hours.

participants will be screened for eligibility and if they qualify will be asked to provide informed consent and sign a photo release. participants will be asked to avoid caffeine consumption on the day of testing, wear comfortable clothing with no back pockets on the pants/shorts, and bring food and water for them to consume during testing. once informed consent is given, they will be measured and weighed. they will then be given a flight suit to wear. once they are in the flight suit, the first 5-minute psychomotor vigilance task test (pvt) will be administered. once completed, the participant will be strapped into the pilot seat. once the participant is properly secured to the pilot seat, the 8-hour timer will be started and the first subjective fatigue survey will be administered. once the questionnaire is completed they will begin playing the flight simulator. participants will be encouraged to minimize bathroom breaks and will be given specific times to eat. at the 4-hour mark, the second subjective fatigue survey will be administered. at the end of the 8 hours, a second pvt will be administered, followed by the final subjective fatigue survey.

Eligibility criteria:
inclusion criteria: * signed informed consent * 18 to 35 years old * ambulatory * able to sit for up to 12 hours with minimal breaks * able to follow instructions in english exclusion criteria: * weight \ 250 lbs * pregnant * travel across time zones in the last 7 days * history of: * chronic pain * asthma or other bronchospasm diagnoses * abnormalities of the heart valves, major vessels, heart rate or rhythm, any condition leading to poor circulation, increased risk of blood clots * chronic disease of abdominal organs including hepatitis and inflammatory bowel disease * un-united fractures, instability of a major joint, retained orthopedic fixation devices, severe scoliosis, or disorder of the skeletal muscles * psoriasis * psychosis, schizophrenia, or other severe mental health disorder * seizure disorders * sleeping disorders * taking any of the following medications: * opiates * muscle relaxants * anticholinergics * sedating antihistamines * anti-psychotics

Keywords: b52 pilot us air force comfort fatigue dynamic cushion
hypertension in black americans: a life course approach

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to investigate the relationship between life-stress factors associated with socioeconomic conditions and hypertension.

background: increasingly, researchers are recognizing that risk for cardiovascular disease (cvd) in adulthood is rooted in the social and material life conditions of childhood, and that these childhood conditions may predict risk for cvd above and beyond traditional adulthood indicators of socioeconomic status (ses) such as education, occupation or income. nowhere is this life course perspective on cvd risk more important than in the case of african americans, especially the generation that "came of age" in the u.s. south in the late 1950s and 1960s, the peak years of the modern civil rights movement. while some african american members of this age cohort were able to take advantage of the new opportunities for economic advancement, some others were not, resulting thereafter in different life course trajectories of exposure to social and economic hardship. the relationship between variations in these social and economic life course trajectories, and cvd risk (specifically hypertension) in adulthood, has not been investigated in african americans. design narrative: the study uses the pitt county, (nc) cohort, a community sample of african americans (n=1784, 66 percent female, 80 percent response rate) who were between 25-50 years of age at baseline in 1988. normotensives in the baseline sample were re-examined in 1993 (n=1195, 66 percent female, 85 percent response rate). in addition to measuring blood pressure, extensive data on psychosocial, behavioral, and anthropometric characteristics were obtained at both times. the study re-examines the original cohort in 2001; the anticipated sample size is 1142 individuals (717 women and 425 men). starting from age 20, respondents' reported exposure to three domains of socioenvironmental stressors will be assessed: (1) adverse socioeconomic conditions; (2) low levels of social integration; and (3) racial discrimination. taken individually, and then collectively, the greater the cumulative life course exposure to these stressors, the greater the risk for adult hypertension is expected to be. the primary analyses will focus on the relationship between pre-1988 exposures and 1988 blood pressure status (retrospective analyses), and the relationship between pre-1988 exposures and changes in blood pressure status between 1988 and 2001(prospective analyses).

Eligibility criteria:
no eligibility criteria
the rbans-h in older adults with normal hearing or age-related hearing loss

Conditions: Normal Hearing

Summary: the present cross-sectional study aims to examine the cognitive capabilities of older adults, aged 50 to 89, with normal hearing or age-related hearing loss by means of the repeatable battery for the assessment of neuropsychological status for hearing impaired individuals (rbans-h). secondly, the correlations between cognition on the one hand and hearing and speech reception capabilities on the other hand are investigated. for this purpose, twenty participants are included in the age categories 50 to 59, 60 to 69, 70 to 79 and 80 to 89, bringing the total number to 80. three questionnaires are administered to the participants: the health utilities index-2/3 (hui 2/3), dizziness handicap inventory (dhi) and a general questionnaire on education and profession, medical history, hearing aid use and tinnitus. also an audiological examination is performed, including pure tone audiometry, speech in quiet and speech in noise audiometry. finally, cognition is assessed using the rbans-h.


Eligibility criteria:
inclusion criteria: * hearing: air conduction hearing thresholds according to age, based on the iso standards * age: 50 - 89 exclusion criteria: * history of any neurological disease * history of otological surgery or disease

Keywords: rbans-h older adults normal hearing cognition age-related hearing loss
acceptability and safety of switching from subutex or other opioid drug dependence therapy to suboxone (nis p05444)

Conditions: Opioid-Related Disorders; Opiate Dependence; Drug Abuse

Summary: the purpose of this study is to evaluate the acceptability and safety of switching to suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. subjects, for whom a therapy with suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on day 1 of the study. the dosage will be adjusted between day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the smpc of suboxone®. data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of month 12.

nonprobability sampling was done by invitation to volunteer.

Eligibility criteria:
inclusion criteria: * all patients on substitution therapy, that are willing to switch to suboxone, can be included. * therapeutic indications and contraindications for suboxone® must be taken into consideration when selecting patients. exclusion criteria: * according to product information * in accordance with the product information pregnant women will be excluded.

Keywords: suboxone subutex buprenorphine naloxone
rxsight light adjustable lens and light delivery device new enrollment study

Conditions: Aphakia; Cataract

Summary: the primary objective of this study is to conduct a post-approval study which compares the lal to a monofocal control iol for safety outcomes.


Eligibility criteria:
inclusion criteria: * must sign a written informed consent form and be willing to undergo cataract surgery for the implantation of an iol with random assignment to either the rxsight lal or the monofocal control iol. * between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * willing and able to comply with the requirements for study specific procedures and visits. * able to complete a written questionnaire in english. exclusion criteria: * pre-existing macular disease in either eye. * patients with sufficiently dense cataracts that preclude examination of the macula in either eye. * history of uveitis in either eye. * evidence of ectasia in either eye. * previous intraocular surgery in either eye. eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus. * subjects taking systemic medication that may increase sensitivity to uv light. * subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * history of ocular herpes simplex virus in either eye.

Keywords: light adjustable lens lal intraocular lens
a study of erwinaze administered intravenously in patients who had an allergy to frontline asparaginase therapy

Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma

Summary: this study will utilize erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. the study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 iu/ml during the first 2 weeks of treatment with 3 times per week iv dosing.


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (all) or lymphoblastic lymphoma, * ages \>/= 1 and \</= to 30 years at the time of initial diagnosis * undergoing asparaginase treatment for all or lymphoblastic lymphoma * documented grade 2 or higher hypersensitivity reaction to native or pegylated e. coli asparaginase or calaspargase pegol * must have two remaining weeks of native e. coli asparaginase treatment or 1 remaining dose of either pegaspargase or calaspargase pegol * direct bilirubin less than or equal to grade 2 * amylase and lipase within normal limits (per institutional standards) * signed informed consent by the patient is greater than or equal to 18 years or by the parent if the patient is younger than 18 years old. exclusion criteria: -

Keywords: acute lymphoblastic leukemia lymphoblastic lymphoma erwinaze asparaginase eusa pharma pharmacokinetic study nsaa
understanding the rarest gynecological cancers: a multi -omics platform for improved patients management

Conditions: Uterine Sarcoma; Vulvar Cancer; Non Epithelial Ovarian Cancers (NEOC)

Summary: rare gynecological cancers including uterine sarcomas, vulvar and non-epithelial ovarian cancers, are under-studied diseases and the absence of standardized diagnostic and therapeutic approaches or tailored clinical guidelines led to low survival rates and/or poor quality of life outcomes. the roar project aims at increasing the molecular understanding of these diseases in a multidisciplinary, interinstitutional setting including gynecologic oncologists, medical oncologists, phase i researchers, pathologists, molecular pathologist, research nurses, genetists, bioinformatics, psychologists and patients' advocacy groups. the project will pursue this aim through the following activities: 1. harmonizing procedures and enabling safe and easy data sharing across all involved institutions; this will be achieved by reviewing the available clinical and molecular data (wp1), establishing an interinstitutional second-opinion board (wp2/task1), developing a dedicated electronic customized research form (wp2/task2) and deploying a genomics platform (wp2/task3). 2. performing comprehensive somatic and transcriptional profiling as well as immunological landscape assessments on high quality annotated samples stored in a biobank dedicated to rare gynecological cancers; this will require systematic and standardized clinical data and biological samples collection (wp3/wp4), standardization of pre-analytical and sequencing procedures (wp5/6). the board will tailor indications and modalities for genomics and liquid biopsy assessments based on clinical features. 3. evaluating the clinical impact of the board on rare gynecological cancers management and, through the evidence gathered, implementing diagnostic and therapeutic strategies; this will include analyzing the activities of the board (wp7/task 1.1), integrating -omics data in the board report (wp7/task 1.2), evaluating liquid biopsy role in identifying minimal residual disease post-surgery, disease monitoring over time, capability of capturing tumor heterogeneity at baseline and identifying hot spot actionable molecular alterations. finally, the evidence gathered from the roar project, will allow update of clinical guidelines or provide new recommendations for each rare gynecological cancer included. the results of roar will also be disseminated through direct access to the integrated platform developed.


Eligibility criteria:
inclusion criteria: * \>18 years old histological diagnosis of: non-epithelial ovarian tumors uterine sarcomas vulvar cancer exclusion criteria: * active hiv, hbv, or hcv infection synchronous neoplasms non-rare histologies of gynecological malignancies
randomized controlled feasibility trial of the fearon algorithm to improve management of unstable warfarin

Conditions: Hypoprothrombinemia

Summary: patients on warfarin but with unstable international normalized ratio (inr) will be recruited to a randomized trial comparing dosing based on an algorithm (fearon algorithm, named after the mathematician michael fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management main outcome is improvement in time in therapeutic range.

patients with very variable inrs resulting in a low proportion of time in therapeutic range (ttr) have a higher risk of both bleeding complications and thromboembolic events. a good ttr is generally considered to be over 60% and "excellent ttr" is above 72% of time in range. the investigators will recruit patients with a ttr below 50%. the fearon algorithm provides a more thorough understanding of the individual responses to changes in warfarin dose and with a personalized nomogram for dose adjustments and timing of laboratory tests the investigators have an opportunity to improve the ttr and on a larger scale to reduce clinically important adverse events. before embarking on a large randomized trial with this revised fearon algorithm-derived nomogram this pilot study with a randomized, open-label design will be performed to demonstrate proof of principle.

Eligibility criteria:
inclusion criteria: * patients with mechanical heart valve prosthesis managed for the warfarin therapy by the thrombosis service at hhs-general hospital. * treated with warfarin for at least 1 year. * therapeutic inr range 2.0-3.0 or 2.5-3.5. * ttr in the lowest quartile exclusion criteria: * known poor compliance due to for example alcohol abuse or cognitive impairment * refusal to provide written informed consent

Keywords: heart valve prosthesis anticoagulation warfarin
study of nutrition and activity in kids

Conditions: Obesity, Adolescent; Adolescent Behavior

Summary: while a substantial body of research suggests that rrv is related to obesity, there is very little research on factors that contribute to the rrv of food, particularly how patterns of eating can increase or decrease the motivation to eat specific foods. previous work has demonstrated that a subset of individuals with obesity show increases in rrv of food after repeated consumption of large portions of high energy density (hed) snack foods, which has been conceptualized as sensitization. preliminary data suggest that sensitization of the rrv of hed food is a predictor of weight gain over time. however, more work needs to be done to address this relationship using a planned, prospective study design, using adolescent research subjects, and examining potential moderators of this relationship. the purpose of this study is to identify risk and protective factors to excess zbmi change in adolescents over time. aim 1 was to measure the relative reinforcing value (rrv) of a preferred hed and low energy density (led) snack food before and after 2-weeks of daily exposure. aim 2 was to assess the rrv of exercise and sedentary activity. hypotheses include 1) sensitization to hed food will be associated with greater zbmi at the time of testing as well as greater zbmi change over time 2) sensitization to led food will be associated with lower zbmi at the time of testing in adolescents and less zbmi change over time. 3) greater rrv of exercise will be protective against zbmi increases over time.


Eligibility criteria:
inclusion criteria: * between 12-14yoa (male and female) * zbmi: -1.5 to +2.0 (\*determined by height/weight measurement at visit 1) * neutral or higher liking of the study foods * willingness to complete 9 study visits over 2 years. exclusion criteria: * -metabolic or endocrine disorder * use of medications known to effect appetite (ritalin, adderall, concerta, wellbutrin, prednisone, etc) * unwilling to complete the study visits * allergy to study foods * dislike of study foods (\*determined via preference for study foods forms at visit 1) * parent report that child reads below 4th grade reading level * parent report that child cannot complete light physical activity without assistance * no english speaking parent or legal guardian (therefore cannot provide consent in english nor answer questionnaires for this study) \* all other exclusion criteria are assessed from survey monkey screening in advance of the first appointment vis parental report. at the first appointment the child is directly asses for height, weight, and the linking of study foods.

Keywords: adolescent obesity relative reinforcing value physical activity weight change