Kornimate/medical-research-clean huggingface dataset:
pain elimination and anxiety control through experiential virtual reality

Conditions: Procedural Pain; Procedural Anxiety

Summary: the goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. the main question\[s\] it aims to answer \[is/are\]: * will active virtual reality reduce pain score on faces pain scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care? * will active virtual reality reduce anxiety score on visual analog scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care? if there is a comparison group: researchers will compare active group to passive group and standard of care. participants will randomized into active virtual reality, passive virtual reality or standard of care arms.


Eligibility criteria:
inclusion criteria: * children and adolescents 8-21 years old undergoing iv placement . * ability to understand study procedures and to comply with them for the entire length of the study. * participants and caregiver speaking english or spanish. exclusion criteria: * participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation). * participants receiving narcotics, opioids, or anxiolytics 8 hours prior (tylenol and ibuprofen do not count). * participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation). * critically ill participants (esi 1).
an exploratory study of xp21279 (with lodosyn®) and sinemet® in parkinson's disease subjects

Conditions: Parkinson's Disease

Summary: the purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of xp21279 sustained release formulation \[administered with lodosyn® (carbidopa)\] and sinemet® tablets in subjects with parkinson's disease with motor fluctuations.

this is a phase 1/phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of xp21279 sustained release formulation \[administered with lodosyn® (carbidopa)\] and sinemet® tablets in subjects with parkinson's disease and to explore dose correspondence between xp21279 and sinemet® to guide dose selection for future studies in the target population (subjects with parkinson's disease with motor fluctuations on sinemet®).

Eligibility criteria:
inclusion criteria: 1. subjects with a clinical diagnosis of idiopathic parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity). 2. subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (days -4 to -2) in the screening period. 3. subjects must be on stable tid or qid sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to screening. exclusion criteria: 1. history, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism. 2. subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the updrs at screening. 3. subjects who are dosing with sinemet® or carbidopa/levodopa during the night time. 4. subjects who have significant neurological symptoms not accounted for by parkinson's disease. 5. subjects who are taking concomitantly comt inhibitors (i.e., entacapone or tolcapone) or treated with stalevo®, sinemet® cr, or madopar®/prolopa® (levodopa/benserazide).
clinic-based versus hotspot-focused active tb case finding

Conditions: Tuberculosis, Pulmonary; Mycobacterium Tuberculosis Infection

Summary: this five-year study will evaluate two strategies for conducting tuberculosis (tb) active case finding (acf) and linkage to tb treatment or tb preventive therapy (tpt) in peri-urban uganda. the two strategies differ in the location where acf activities are performed: a "facility-based" acf/tpt strategy will perform acf, plus linkage to tpt, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of tb suspicion or symptoms. alternatively, a "hotspot-based" strategy will use routine notification data and local expertise to identify local tb hotspots - defined as the geographic areas though to have the highest burden of undiagnosed tb per estimated population. the same infrastructure (personnel, equipment, supplies, etc.) for acf/tpt will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to tpt. the two interventions will be compared in a type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. the study will evaluate whether hotspot-focused acf/tpt results in a greater number of tb patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based acf/tpt. secondarily, it will also compare the two interventions in terms of number of people initiated on tpt, and it will compare tb cases detected in regions performing acf/tpt (either approach) against cases detected in regions that continue to perform the standard of care.


Eligibility criteria:
inclusion criteria: * age ≥15 years, or age 5-14 and a close contact of someone diagnosed with tb, * provision of oral informed consent, or, if age \<18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study * ability to communicate with study staff in english or luganda, or availability of a capable interpreter who is acceptable to the participant exclusion criteria: * on treatment for, or diagnosed with but not yet treated for, active tb
asphyxia associated metabolite biomarker investigation 2

Conditions: Birth Asphyxia

Summary: follow-up of participants of aambi1 study at age of at least 2 years. aambi1(clinicaltrials.gov id: nct03354208): verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. these biomarkers linked to asphyxia have been identified in animal studies.

follow-up on neuro-developmental status of study participants of aambi1. aambi1(clinicaltrials.gov id: nct03354208): the aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. the population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Eligibility criteria:
inclusion criteria: * infants previously enrolled in the aambi1 study exclusion criteria: * missing valid written informed parental consent

Keywords: biomarkers asphyxia hypoxic ischemic encephalopathy
family-based counseling models for young children

Conditions: Dental Plaque; Dental Caries; Behaviorial Habits

Summary: the purpose of this study is to compare the effects of two new family-based oral health promotion programs with the routine program in use earlier in vantaa public dental service. the children born in 2008 were followed from their first visit to public dental service at the age of 6-12 months to their dental examination at the age of 2-2½ years. the outcome measures are the colonization of mutans streptococci in dental plaque, dental caries, and the oral health habits of two-year-olds.

the investigators hypothesized that the training of the dental professionals involved in children's examinations could improve the quality of the counseling, raise the level of commitment, and give them a new kind of perspective on early childhood oral health counseling. health promotion programs with clinical guidance aimed also at the parents themselves might commit the families to maintain their children's good oral health. all programs (two new and the control program) consisted of the basic elements of oral health counseling for the children. the counseling included regular oral hygiene, i.e. tooth brushing with fluoride-containing toothpaste twice a day, advice of a healthy diet with proper timing and composition of meals avoiding sugary snacks, and to use xylitol products on regular basis. additionally, in the program of oral hygiene and fluoride, the parents were given counseling on how to brush their own teeth with fluoride-containing toothpaste and clean between them. in the program of diet and xylitol parent was asked to fill in one-day diary of his or her own diet in the waiting room, and the dental professional pointed out the frequency of meals and snacks, as well as suggested the use of xylitol 5 grams per day. the children, accompanied by their parents, were clinically examined in various health clinics of the vantaa public dental service. at the regular two-year visit, the dental hygienists and in-service trained dental nurses tested the children for mutans streptococci in plaque. the transtheoretical model and the motivational interviewing were introduced to the dental hygienists and in-service trained dental nurses to use in preventive counseling. the results of this study will be published in three articles.

Eligibility criteria:
inclusion criteria: * first born children born in 2008 exclusion criteria: * not first born children

Keywords: young children counseling fluoride xylitol
serpin c and soluble fms-like tyrosine kinase-1 levels in normotensive pregnant women may predict the development of preeclampsia

Conditions: Pre-Eclampsia

Summary: evaluation of the predictability of estimated levels of serpin c, sflt-1 and placental growth factor (plgf) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop pe during the course of pregnancy.


Eligibility criteria:
inclusion criteria: * normotensive pregnant women had singleton fetus presenting during the 1st trimester * free of exclusion criteria exclusion criteria: * age * sex * hypertension
epidemiology and management of metastatic breast cancer

Conditions: Breast Cancer Nos Metastatic Recurrent

Summary: this is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . the main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

epidemiology and therapeutic management of metastatic breast cancer in romania: a retrospective cohort study

Eligibility criteria:
inclusion criteria: * female aged 18 years and over diagnosis of breast cancer according to icd-10 diagnostic criteria with confirmed metastasis * confirmed diagnosis between 1st july 2010 - 30th june 2011 * female patient managed for her disease at the same setting where final diagnosis of mbc was performed exclusion criteria: * history of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer)

Keywords: metastatic breast cancer, epidemiology, retrospective cohort
intensified secondary prevention intending a reduction of recurrent events in tia and minor stroke patients

Conditions: Mini-Stroke

Summary: patients after tia or stroke are at high risk of experiencing a new stroke or myocardial infarction. poor adherence to evidence based secondary prevention regimens is frequently seen. support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. the investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.

although effective methods of secondary prevention after stroke or tia are available, adherence to recommended evidence-based treatments is often poor. programs for supported secondary prevention after cerebrovascular events with improved health education are promising but have not been evaluated regarding recurrent event reduction so far. a prospective randomized trial has been started to assess the effectiveness of a patient centered structured support program intending a reduction of recurrent vascular events. usual care consists of structured information given at discharge as well as regular outpatient care by general practitioners. the support program additionally employs a stepwise intensified support program with up to eight appointments over two years in outpatient clinics. results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. they are also offered assistance in finding appropriate physical activities or smoking cessation programs. patients are randomized to regular care or regular care plus support program and will be followed-up until the total number of 317 primary endpoints has been reached. the composite primary endpoint consists of stroke, major coronary event and vascular death.

Eligibility criteria:
inclusion criteria: * acute cerebrovascular event (either tia or minor stroke within 14 days before study inclusion) according to the following definitions: * tia (clinical restitution within 24 hours and abcd2-score ≥3) or visible dwi-lesion in mri * minor stroke (mrankin ≤2 at time of inclusion) * patients with at least one of the following treatable risk factors: * arterial hypertension * diabetes mellitus * atrial fibrillation * smoking * written informed consent prior to study inclusion * realistic perspective in keeping the outpatient appointments exclusion criteria: * distance from home to study center not in suitable range for keeping the outpatient appointments * cognitive impairment jeopardizing adherence to the support program * modified rankin score \>2 at time of study inclusion * malignant disease with life expectancy of less than 3 years * relevant alcohol or other substance abuse (except for nicotine) * stroke or tia etiology without options for evidence based secondary prevention (e.g. dissection or vasculitis)

Keywords: stroke, tia, secondary prevention, support program, multifactorial intervention
carbon-13 magnetic resonance spectroscopy in glycogen storage diseases

Conditions: Glycogen Storage Disease; McArdle Disease; Pompe Disease (Late-onset)

Summary: the project will use carbon-13 magnetic resonance spectroscopy to assess whether high glycogen levels in skeletal muscle of patients with glycogen storage diseases is a prelude for muscle damage. patients with glycogen storage diseases will be examined using carbon-13 mr-spectroscopy to quantify the glycogen levels in lumbar, thigh and calf-muscles. the pattern of glycogen concentration will be compared to the pattern of muscle atrophy found in the literature.


Eligibility criteria:
inclusion criteria: * subjects with genetically verified neuromuscular disease or healthy control * healthy controls needs to be healthy to be included, evaluated by the investigator exclusion criteria: * ferrous objects in or around the body * pacemaker or other implanted electronic devices * claustrophobia * inability to understand the purpose of the trial or corporate for the conduction of the experiments. * participation in other trials that may interfere with the results. * competing conditions at risk of compromising the results of the study, evaluated by the investigator. * strenuous exercise in the preceding 2 days before examination * pregnancy or breastfeeding
epiwatch: evaluation of a non-eeg physiological signal based seizure monitoring system

Conditions: Epilepsy, Tonic-Clonic

Summary: to demonstrate the safety and effectiveness of the epiwatch device in identifying tonic-clonic (tc) seizures, notifying a third-party of tc seizure occurrence, and collecting non-eeg physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (emu).

to demonstrate the safety and effectiveness of the epiwatch device in identifying tonic-clonic (tc) seizures, notifying a third-party of tc seizure occurrence, and collecting non-eeg physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (emu). eligible subjects will be issued an epiwatch device upon admittance into the emu. the events detected by the epiwatch will be compared to tc seizures as determined by epileptologists' interpretation of video-eeg recorded for the subject to determine the effectiveness of epiwatch in detecting tc seizures. emu standard care practices will not be modified for subjects.

Eligibility criteria:
inclusion criteria: * admitted to a site emu for video-eeg monitoring * age five and older at the time of enrollment * has a clinical history of tonic-clonic (tc) seizures or potential for tc seizures * willing and able to comply with study procedures exclusion criteria: * has participated previously in epiwatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors * has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch * inability or unwillingness to comply with study procedures

Keywords: seizure detection seizure digital health
closed-loop transcranial alternating current stimulation for the treatment of depression

Conditions: Depression; Major Depressive Disorder; tACS

Summary: the purpose of this research study is to study closed-loop transcranial alternating current stimulation (tacs) to determine its effects on symptoms of depression in people with major depressive disorder.

the purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tacs for the treatment of major depressive disorder (mdd) in an open-label pilot study. we will recruit up to 35 participants with unipolar, non-psychotic mdd. participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey. potential participants fill-in an electronic pre-screening form. if potentially eligible, a remote screening visit is performed. if eligible, participants attend five consecutive, daily stimulation sessions. clinical assessments will be performed at baseline (day 1 of stimulation, d1), day five of stimulation (d5), and at their follow-up visit (14 days after the completion of stimulation, fu2) using the hamilton depression rating scale (hdrs-17). for a subset of patients, electroencephalography (eeg) is collected at d1 prior to stimulation and after stimulation and again at fu2. for a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.

Eligibility criteria:
inclusion criteria: * ages 18-70 years * diagnostic and statistical manual, 5th edition (dsm-5) diagnosis of mdd; unipolar, non-psychotic * hamilton rating depression rating scale (hrds-17) score \>8 * low suicide risk as determined by the columbia-suicide severity rating scale (c-ssrs) triage form (no intent or plan) * capacity to understand all relevant risks and potential benefits of the study (informed consent) exclusion criteria: * dsm-5 diagnosis of severe alcohol use disorder (aud) within the last 12 months. * dsm-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months. * lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism * current use of benzodiazepines \> 20mg diazepam/d equivalent * antidepressant dose change within the last 2 weeks * initiated new antidepressant within the last 4 weeks
prospective study of staphylococcus aureus clinical isolates versus colonization: rnas as potential biomarkers for bloodstream infections

Conditions: Staphylococcus Aureus

Summary: the primary objective is to demonstrate that the risk of s. aureus bacteremia (sab) is correlated to the rna iii and sprd rnas expression

staphylococcus aureus ranks among the top three organisms for community-acquired, healthcare-related and nosocomial infections in humans. it lives as a commensal organism but can also provoke very severe diseases. identifying markers of the 'colonization/disease' transition is of paramount importance. we recently found that an association of two regulatory rnas was associated with s. aureus infection rather than colonization and with the severity of infection. those preliminary results have to be confirmed with a more important prospective cohort.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age; * patients hospitalized at the university hospital of rennes, with according to groups: 1. : colonized subjects: * any patient hospitalized at the university hospital of rennes, or any health professional, in whom a colonization screening with s. aureus is performed in routine care and a colonization with s. aureus is documented; (for information, this screening is carried out frequently at the university hospital of rennes for different reasons (before surgery or procedure requiring the installation of equipment, screening of contact cases of infected cases, investigation during a nosocomial epidemic...). these people are hospitalized for reasons other than s. aureus infection and in different departments, but the samples are collected centrally in the institution's bacteriology laboratory.) 2. : patients hospitalized for bsa: * patients hospitalized in the infectious diseases and medical intensive care unit and in the surgical intensive care unit, for whom a bsa is documented at the bacteriology laboratory of the university hospital of rennes; * patients for whom nasal carrying screening for s. aureus is prescribed as part of their management; * these patients will be classified into two groups: 1. serious clinic (cg): * bsa ; * associated with signs of sepsis according to the 20168 international definition: * sofa score (see appendix 3) 2 ; * septic shock will be defined as the existence of sepsis associated with persistent low blood pressure requiring the administration of vasopressors to obtain an average blood pressure (map) 65 mmhg and an arterial lactate dosage 2 mmol/l despite adequate vascular filling. 2) non-serious clinic (cng): * bsa ; * which does not meet the definition of the cg group. * having expressed their opposition to this research or whose trusted person does not oppose the research if the patient is not able to give an informed opinion. exclusion criteria: * pregnant or breastfeeding women; * persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty; * s. aureus strain producing leucocidin from panton-valentine;

Keywords: staphylococcus aureus