Kornimate/medical-research-clean huggingface dataset:
a comparison of user-adjusted and audiologist-adjusted hearing amplification

Conditions: Hearing Loss

Summary: fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. for the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (nal-nl2) and subsequent fine tuning to optimize adjustments based on participant feedback. the second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. a cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. participants will be blinded to the condition. during each seven-day field trial, users will have access to a volume control, following the end of the two trials, participants will return to the lab for outcome assessment.


Eligibility criteria:
inclusion criteria: * bilateral hearing loss with a minimum of 40 db hl thresholds at 2000 hz * english speaking exclusion criteria: * score less than 21 on the moca (montreal cognitive assessment) * evidence of conductive or retrocochlear pathology

Keywords: hearing aid self-fitting
determination of baseline thyroid status values in french adult population

Conditions: Healthy

Summary: the objective of this study is to establish reference values in the general population from a beckman coulter dxi chemiluminescence assay. indeed, the lack of harmonization of the methods of the dosage remains a major difficulty to optimize the management of patients with thyroid disease. this supplier has recently optimized its dosing kit according to the 3rd international standard of the who (irb 81/565) for the tsh (thyroid stimulating hormon). it is necessary to carry out a study of the distribution of the values of this tsh within our metropolitan population. the current data proposed by the supplier come from a study of a north american population. investigators propose to define usual values for thyroid status markers (tsh, ft4 \[free thyroxine\], ft3 \[free triiodothyroxine\]) from healthy efs (french blood establishment) donors who meet the standard exclusion criteria for this type of study.


Eligibility criteria:
inclusion criteria: * donors (18-70 years old) volunteers at efs exclusion criteria: * pregnancy, * known antecedents of thyroid diseases (goiter, nodule, hypo or hyperthyroidism), * current antithyroid treatment (neomercazole \[thyrozol(r)\], levothyroxyn lt4 \[levothyrox(r)\], ...), * cardiac treatment with amiodarone (cordarone(r)), * injection of iodinated contrast medium less than 1 month old
tace combined with camrelizumab and apatinib in intermediate and advanced hepatocelluar carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of tace in combination with camrelizumab and apatinib versus tace in patients with intermediate- and advanced hcc.

this is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (tace) in combination with camrelizumab and apatinib versus tace in patients with intermediate- and advanced hepatocellular carcinoma (hcc). the primary hypotheses is that tace in combination with camrelizumab and apatinib is superior to tace alone with respect to progression-free survival (pfs).

Eligibility criteria:
inclusion criteria: * has a diagnosis of hcc confirmed by radiology, histology, or cytology -≥18 years * china liver cancer staging: ib-iiia * child-pugh score ≤6 point * previous tace treatment(≤2 times) is permitted * adequate organ and marrow function exclusion criteria: * participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated \>5 years prior to enrolment with no recurrence * participants who have severe allergy to iodine, and unable to receive tace * participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation * participants who had congenital or acquired immune deficiency, such as hiv infection * participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding * participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ ctcae grade 3 deep vein thrombosis and pulmonary embolism
assessment of hemodynamic response during intubation between rigid laryngoscopy and track light in coronary patients

Conditions: Coronary Disease Undergoing CABG

Summary: opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes. in this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.


Eligibility criteria:
inclusion criteria: * coronary disease asa 2 e 3 using beta-blockers exclusion criteria: * emergency surgery arrythmia other antiarrythmic drugs

Keywords: intubation coronary disease hemodynamic response anesthesia with tracheal intubation assessment of hemodynamic response
3d analysis of palatal morphology of growing patients treated with rapid palatal expander.

Conditions: Cross-bite; Malocclusion in Children

Summary: the aim of the present study is to assess the changes of palatal morphology among growing patients with different vertical facial growth patterns treated with rapid palatal expander. thirty-six patients referred to "policlinico agostino gemelli" university hospital will be selected. the eligible criteria are posterior cross-bite, mixed dentition, skeletal class i relationship and prepubertal stage of cervical vertebral maturation. the patients will be split into three groups according to facial divergency (hyper-, hypo-, normodivergent subjects). for each subject, digital dental casts will be recorded before and after treatment using an intraoral scanner. to evaluate two-dimensional maxillary arch changes, linear measurements will be done. to study comprehensively the palatal shape, a set of 240 landmark and semi-landmarks will be digitized on the palatal vault. then, geometric morphometric analysis (gma) will be performed to compare morphological variations of the palate among different vertical facial growth pattern groups.


Eligibility criteria:
inclusion criteria: * caucasian origin; * mixed dentition stage; * angle class i or straight step or mesial step molar relationship in primary dentition; * skeletal class i (anb angle between 0° and 5°); * vertical dimension evaluated on lateral cephalograms: sn\^gogn\>37°: hyperdivergent, sn\^gogn\ 37°: normodivergent; * cervical vertebral stage 1 or 2 (cvs methods 1-2); * posterior cross-bite including deciduous or permanent teeth; * presence of good quality pre-treatment records (history, intraoral and extraoral photographs, oral scan, panoramic radiographs, and lateral cephalometric radiographs with reference ruler); * oral scan and photographs available for each subject 6 months after the beginning of the therapy; * signing the informed consent form. exclusion criteria: * previous orthodontic treatment; * tooth agenesis or supernumerary teeth; * craniofacial abnormalities; * tooth impaction in the maxilla; * torus palatinus; * history of dental trauma (avulsion and alveolar/jaw fracture); * refusal to sign consent form.
evaluating the impact of a school-based fruit and vegetable co-op on cardiometabolic child and parents health in a persistent poverty area

Conditions: Child Obesity; Cardiometabolic Health

Summary: the purpose of this study is to examine the effects of the (brighter bites (bb) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (hba1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (fv)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

the purpose of this study is to examine the effects of the (brighter bites (bb) intervention compared to wait-list control at post intervention on changes in primary child outcomes (hba1c, and vegetable intake), to examine the effects of the bb intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (fv)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the bb intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Eligibility criteria:
inclusion criteria: * enrollment of 100 1st, 2nd, and 3rd grade students * high proportion of children participating in the free and reduced lunch (frl) program (\>70%) * willingness to implement a coordinated school health (csh) program exclusion criteria: * prior participation in bb in the previous school year * children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures

Keywords: brighter bites
safety and efficacy study of avb-s6-500 (batiraxcept) in patients with advanced pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: this is a phase 1b/2 study of batiraxcept (avb-s6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. the phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. the phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.


Eligibility criteria:
inclusion criteria: * age 18 years or older * histologically or cytologically confirmed pancreatic adenocarcinoma. must have locally advanced, recurrent, or metastatic disease ineligible for curative intent treatment(s) and eligible for first line systemic treatment. * must have radiologic imaging with a computed tomography (ct) scan or magnetic resonance imaging (mri) within 22 days of study entry * must have at least one measurable lesion according to recist 1.1 * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate gastrointestinal (gi), bone marrow, liver and kidney function * life expectancy minimum of \> 12 weeks * adequate recovery from surgery to grade 1 or baseline with at least 28 days from time of major surgery exclusion criteria: * received last dose of chemotherapy (neoadjuvant or adjuvant), surgery, or radiation treatment with curative intent within 6 months prior to study entry * islet-cell neoplasms * prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, breast or melanoma * symptomatic uncontrolled central nervous system (cns) metastasis or brain metastases unless adequately treated and controlled * evidence of clinically significant third spacing (e.g. pleural effusion, ascites, anasarca, etc.) within 28 days prior to study entry * serious active infection requiring iv antibiotics and/or hospitalization at study entry * active human immune deficiency (hiv) syndrome, hepatitis b, hepatitis c, or other active viral illness

Keywords: locally advanced recurrent metastatic pancreatic exocrine pancreas adenocarcinoma
processing and effects of cannabis

Conditions: Hypotension; Tachycardia

Summary: the purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.

in europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming "high" or "stoned"). the active compound in cannabis is thc (tetrahydrocannabinol). in recent years the strength of cannabis (marihuana) available on the market in the netherland has increased (especially "netherweed"). the thc-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). however, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of thc. information is lacking about the effects of cannabis at higher levels of exposure. because of this, the ministry of health, welfare, and sports of the netherlands ordered the investigators to perform a study to gain more insight in this issue.

Eligibility criteria:
inclusion criteria: * cannabis users (2-9 joints per month) exclusion criteria: * psychiatric illness * evidence of excessive alcohol abuse * use of other drugs

Keywords: cannabis tetrahydrocannabinol pharmacokinetics psychomotor tests event related potentials
the very old intensive care patient: a multinational prospective observation study

Conditions: Critical Illness; Old Age; Debility; Survival

Summary: * the primary aim is to document the incidence and short-term outcome of the elderly icu patient (≥ 80 years) using a multicentre, multi national approach * the secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group * to create hypothesis for further studies, in particular on various outcome prediction

the investigators have chosen to use a prospective registration of routinely collected data in this icu population. the study is mainly european based, but will also allow for icus outside europe to participate. 20 consecutive icu admission in patients ≥ 80 years of age will be collected or all patients ≥ 80 years in a three months' period (whatever comes first). data are collected electronically through an e-crf and with baseline documentation of the icu. the database is located in denmark, at the department of epidemiology, university of aarhus (http://vip1study.com/) . each icu will only have access through the database of their own patients, and patient id is not registered (names, birth-date or social security numbers) so it is in that sense anonymous. even with de-identified data, most countries must seek necessary consent from the authorities to collect such data, and hence there will be a period between icu recruitment (starting april 2016) and patient recruitment (october 1. 2016) to allow for this to be done prior to study start. the goal is to recruit at least 100 icus which will give data from approximately 2000 elderly patients.

Eligibility criteria:
inclusion criteria: * all admissions in the group exclusion criteria: * none
macular tractional retinoschisis in proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: objective: to evaluate the clinical manifestations and surgical prognosis of macular tractional retinoschisis in proliferative diabetic retinopathy. design: retrospective case series. participants: cases with macular tractional retinoschisis with or without combined traction detachment (trd) in proliferative diabetic retinopathy confirmed by optical coherence tomography (oct) at a single institution between january 2007 and august 2010. methods: cases were divided into two groups. group a had tractional retinoschisis only while group b had trd with retinoschisis of the elevated retina. clinical data including oct findings were recorded and analyzed. main outcome measures: demographic data, clinical pictures, surgical results, and oct findings will be compared between two the groups.

fibrovascular tissue induced macular elevation is an important cause of visual loss in proliferative diabetic retinopathy (pdr). there are two main types of macular elevations in pdr: traction retinal detachment (trd) and tractional retinoschisis. these two conditions may coexist either in the form of retinoschisis within the detached retina or predominantly retinoschisis with a small subfoveal fluid pocket. optical coherence tomography (oct) studies have shown that in tractional retinoschisis, the inner retinal layer is normal reflective; outer layer is less reflective but not optically empty. bridging columnar tissues are frequently observed between the inner and outer layers. histopathological study by faulborn et al showed adherence of posterior hyaloid membrane to the retina plus vitreous body shrinkage might induce retinal elevation with splitting of the outer plexiform layer, leading to retinoschisis. the bridging columnar tissues between inner and outer layers of the split retina mainly consisted of muller cells. although tractional retinoschisis with or without retinal detachment has been suggested as the most frequent pattern of tractional macular elevation in eyes with proliferative diabetic retinopathy1, and peripheral retinoschisis are frequently found during operation for complications of pdr, studies on clinical manifestations and post-operative visual prognosis of macular traction schisis are limited. lincoff reported a relatively good prognosis in eyes with tractional retinoschisis after vitrectomy. no other large series specifically aimed at this entity can be found. in this report, we will retrospectively study the clinical pictures of tractional retinoschisis on the macula. morphological changes and functional outcomes after surgery will be discussed. correlations between visual acuity and specific findings on color fundus pictures and oct will be evaluated. we will also analyze different behaviors of schisis only and combined tractional retinal detachment with schisis.

Eligibility criteria:
inclusion criteria: tractional retinoschisis without trd in pdr tractional retinoschisis with trd in pdr exclusion criteria: active vitreous hemorrhage

Keywords: tractional retinoschisis traction retinal detachment
cromolyn detection of silent aspiration

Conditions: Gastroesophageal Reflux; Respiratory Aspiration; Idiopathic Pulmonary Fibrosis; Lung Transplantation

Summary: the overall purpose of this project is to develop and validate a simple, non-invasive method to detect aspiration of gastro-intestinal fluid into the respiratory tract. in the inpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 4 ingestions (at 2h intervals) of a 200 ml of a 1mg/ml solution of cromolyn sodium, by 5 healthy control subjects and 5 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of ger (gastroesophageal reflux) with microaspiration. in the outpatient setting, the investigators will compare the quantity of cromolyn detected in urine collected overnight after 1 ingestions (at 4h intervals) of a 200 ml of a 1mg/ml solution of cromolyn sodium, by 10 patients (3-6 with pulmonary fibrosis; and 3-6 either awaiting or recently undergone lung transplantation) with clinical and laboratory evidence of ger (gastroesophageal reflux) with microaspiration.


Eligibility criteria:
inclusion criteria: healthy participants * adult non-smokers * females only - negative urine pregnancy test lung transplant patients * adult patients awaiting (or recently undergone) - lung transplant * evidence of gastro-esophageal reflux with probable recurrent aspiration * females only - negative urine pregnancy test idiopathic pulmonary fibrosis patients * adult patients currently enrolled in on-going university of california, san francisco study of prevalence of recurrent ger with aspiration in idiopathic pulmonary fibrosis * evidence of gastro-esophageal reflux with probable recurrent aspiration * females only - negative urine pregnancy test exclusion criteria: healthy participants * history of dysphagia * ger * recurrent cough * asthma * pneumonia after childhood * sleep impairment * use of drugs or alcohol impairing consciousness * impaired gag reflex on physical examination * any other significant medical illness (e.g., morbid obesity, diabetes, neurologic disease, etc.) that in the opinion of the investigator could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study * greater than 5 pack years lifetime smoking history * history of intolerance or allergy to cromolyn sodium lung transplant patients * history of intolerance or allergy to cromolyn sodium * history of nissen fundoplication ipf patients * history of intolerance or allergy to cromolyn sodium * history of nissen fundoplication
continuous ultrasound guided erector spinae plane block vs thoracic paravertebral block

Conditions: Postoperative Pain

Summary: in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous tpvb and continuous espb) in relieving thoracotomy pain

general anesthesia will be induced with fentanyl (1-2 μg/kg), propofol (2-3 mg/kg), and atracurium (0.5-0.8 mg/kg). pressure controlled volume guarantee ventilation mode will be used to maintain o2 saturation above 98% and end tidal co2 around 30-35 mmhg. anesthesia will be maintained with isoflurane 1.2 minimum alveolar concentration inhalation after induction group a: patients will receive loading dose of 20 ml 0.25% bupivacaine then continuous infusion u/s-guided tpvb of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and group b: patients will receive loading dose of 20 ml 0.25% bupivacaine then continuous u/s-guided espb of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

Eligibility criteria:
inclusion criteria: - eligible 40 patients will be older than 21 years old with american society of anesthesia physical status i\& ii scheduled for elective thoracotomy exclusion criteria: * patients who are: * uncooperative. * having allergy to any of the study drugs. * known abuse of alcohol or medication. * having local infection at the site of injection or systemic infection. * pregnancy. * with coagulation disorders or on anticoagulation therapy