Kornimate/medical-research-clean huggingface dataset:
point of care virologic testing to improve outcomes of hiv-infected children

Conditions: Early Infant HIV Diagnosis

Summary: this is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the alere q point-of-care (poc) hiv diagnostic assay for use in resource-poor settings.

at public sector clinics in lusaka, zambia, approximately 4,000 hiv-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of hiv-infected children in zambia. there is a standard of care (soc) or control arm and an intervention arm known as the alere arm. in both study arms, early infant diagnosis (eid) will be provided at 6 weeks of life. infants randomized to the soc arm will receive eid through the existing prevention of mother-to-child-transmission (pmtct) program, with samples sent to an off-site laboratory for dna pcr testing. infants randomized to the intervention arm will receive poc diagnostic alere q qualitative test (along with a dried blood spot (dbs) drawn for confirmatory dna pcr). hiv-infected infants will be followed for 12 months. the acceptability of point-of-care testing for eid will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians. the feasibility will be assessed by a time-in-motion (tim) and value stream mapping (vsm) analyses will also be conducted to compare the alere q to two additional testing technologies.

Eligibility criteria:
inclusion criteria: * 4 to 12 weeks of life * documented hiv exposure through seropositive maternal or infant hiv antibody test * with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment exclusion criteria: * infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures

Keywords: hiv point-of-care hiv diagnosis alere q diagnostic children
induction agent and incidence of hypotension in heart failure patients undergoing lvad-implantation

Conditions: Blood Pressure, Low

Summary: the induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. for several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase. this observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (lvad).


Eligibility criteria:
inclusion criteria: - heart failure patients scheduled for implantation of left ventricular assist device (lvad) exclusion criteria: * pregnancy * presence of another cardiac assist device in the patient (for example ecls) * no consent of the patient

Keywords: blood pressure catecholamines heart failure high risk patients left ventricular assist device
adaptation of the uniform data set for telematic administration

Conditions: Dementia, Mild; Dementia of Alzheimer Type

Summary: the present project is an evolution of the previous rin 2019 study aimed at validating and standardizing the uniform data set (uds) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection. in the present study, a uds-based instrument that can be used in remote examiner-assisted telematic administration will be validated. this will be followed by standardization of the same on a sample of healthy subjects.


Eligibility criteria:
inclusion criteria: * female and male subject between 50 and 90 years * no negative score on the anamnestic questionnaire * internist pathology in pharmacological compensation * signing of informed consent exclusion criteria: * neurological pathologies * decompensated metabolic pathology * use of benzodiazepine and psychoactive drugs
cost-utility analysis treatment of bartholin's abscess : word catheter versus incision-drainage.

Conditions: Bartholin's Gland Abscess Treatment

Summary: bartholin's gland abscess is a condition requiring emergency consultation. placement of a word catheter, which is a minor technique used in france as a treatment of bartholin's abscess, can be done in an emergency room without hospitalization. actually, incision-drainage, which is the most widespread treatment in france, is performed on day surgery with or without overnight hospitalization. our hypothesis is that the use of word catheter compared to incision-drainage would not modify the quality of life of the patients but would allow a saving of up to 3 m€ per year in france.


Eligibility criteria:
inclusion criteria: abscess of bartholin's gland patient able to understand the protocol patient who signed informed consent patient with social insurance exclusion criteria: spontaneous fistulization of the abscess before surgical treatment abscess volume under 3 ml medical treatment which avoid incision or word catheter placement patients under guardianship unable to complete questionnaires patients not affiliated to social protection regimen pregnant or post-partum women (until 4 weeks after delivery)

Keywords: incision-drainage bartholin's abscess word catheter marsupialization cost-utility analysis
dry needling in multiple sclerosis

Conditions: Multiple Sclerosis; Spasticity

Summary: the investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have multiple sclerosis. dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. it differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. the investigators hope to see if dry needling also helps enhance balance and walking abilities. this might provide potential improvements inoverall mobility and balance.


Eligibility criteria:
inclusion criteria: * age 18 to 64 years * clinical diagnosis of multiple sclerosis based on the mcdonald criteria * spasticity in their lower legs * patient determined disease steps (pdds) score of 5 or below exclusion criteria: * inability to communicate effectively with study personnel * needle phobia * severe varicose veins * presence of an active implanted device * pregnancy * any active cancer or history within 1 year * known or suspected infection at the site of needling or in the surrounding area * presence of a fixed plantarflexion contracture at the ankle * acute fracture of dislocation in the region (bilateral lower extremity) * deep vein thrombosis or peripheral vascular disease * thrombophlebitis, or active osteomyelitis in the region (bilateral lower extremity) * any medication changes, including antispastic medicines, for the past three months.

Keywords: multiple sclerosis dry needling spasticity mobility balance
tiagabine to enhance slow wave sleep in patients with sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. interestingly, the severity of osa is profoundly reduced in deep sleep (called "slow wave sleep"), potentially via an increase in the stimulus required to arouse from sleep. here the investigators test the idea that the medication called "tiagabine" improves slow wave sleep and reduces osa severity. the investigators will also test whether tiagabine raises the arousal threshold (more negative esophageal pressure), and whether detailed osa "phenotyping" characteristics can predict the improvement in osa severity with this intervention.

the current study tests the primary hypothesis that tiagabine improves sleep apnea severity in patients with moderate-to-severe sleep apnea (apnea hypopnea index measured in supine non-rem sleep; hypopneas defined by 3% desaturation or arousal). the investigators test three secondary hypotheses that tiagabine: 1. increases the proportion of total sleep time in slow wave sleep 2. raises the non-rem arousal threshold (more negative esophageal pressure) via (1). 3. is preferentially effective in patients whose osa phenotype predicts that an increase in the arousal threshold is sufficient to resolve osa versus those without such favorable physiology. favorable physiology is defined here as having a low ventilatory drive at which stable breathing is theoretically feasible ("stable vdrive" is \<100% above eupneic ventilatory drive) due to any combination of a "high" upper airway muscle response, "good" passive anatomy (high vpassive), and "low" steady-state loop gain (see owens rl et al sleep 2014; wellman a et al j appl physiol 2011, 2013; eckert dj et al 2013 ajrccm).

Eligibility criteria:
inclusion criteria: * diagnosed osa (moderate-to-severe; apnea hypopnea index \>15 events/hr) exclusion criteria: * history of seizures

Keywords: arousal threshold phenotype tiagabine slow wave sleep
identification of breast cancer specific markers in patients compared to healthy participants

Conditions: Breast Neoplasms

Summary: this is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. an amendment to the research has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors.

in this research study different commercial ruo (research use only) antibodies will be purchased and then tested on blood samples obtained by participants affected by breast cancer and by healthy participants as control. sixty participants will be enrolled belonging to different categories: 20 participants affected by early breast cancer, 20 participants affected by metastatic breast cancer, and 20 healthy volunteers to be used as negative control. after signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. if all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. a 13 ml blood sample will be collected by the subjects and shipped to tethis laboratories in order to be processed and analysed. an amendment has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors. during the amendment, participants will be enrolled to test the analytical capacity of the antibodies evaluated in the first part on samples processed with different methods in order to select the optimal one for future development.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give and sign a written informed consent for participation in the study. * female aged 18 years or above. * diagnosed with early breast cancer (stage i and ii) or metastatic breast cancer. * healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer). exclusion criteria: * history of other malignancies other than breast cancer (for healthy participants includes also breast cancer). * undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer). * presence of known severe coagulation or haematological disorder * known pregnancy * absence of written signed informed consent for participation in the study

Keywords: breast cancer biomarker circulating tumoral cell immunofluorescence assay breast cancer
head-to-head comparison of empagliflozin and dapagliflozin

Conditions: Type2 Diabetes

Summary: this open-labeled, prospective, observational, 3-year, clinical study was conducted to compare the effectiveness and safety between empagliflozin (25 mg once daily) and dapagliflozin (10 mg once daily) in patients with inadequately controlled type 2 diabetes despite preexisting triple oad combination.

all participants included in this study were initially requested to initiate therapy with insulin, but they insisted on another form of oad. when participants declined insulin injection and requested another oad, they were not randomly assigned to each groups. it is fairly common among participants with t2d to decline insulin therapy, despite being aware of its importance and the benefits in controlling blood glucose. their lack of willingness to use insulin is explained by their avoidance of painful injections, the potential for body weight gain and their fear of hypoglycemia. the investigators conducted a regimen consisting of four oads, including empagliflozin or dapagliflozin, to confirm which regimen would be effective and safe.

Eligibility criteria:
inclusion criteria: * inadequately controlled under triple oads (metformin, glimepiride, dipeptidyl peptidase inhibitor) as evidenced by hba1c 7.5-12% exclusion criteria: * type 1 diabetes * gestational diabetes * diabetes due to secondary causes * receiving anticancer treatment * receiving glucocorticoids or immune-suppressants * have been treated with sodium-glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering this study

Keywords: empagliflozin dapagliflozin sodium-glucose cotransporter 2 inhibitors quadruple combination antidiabetic drugs
a study of lasmiditan (ly573144) over four migraine attacks

Conditions: Migraine

Summary: the reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.


Eligibility criteria:
inclusion criteria: * migraine with or without aura fulfilling the international headache society (ihs) diagnostic criteria 1.1 and 1.2.1 * history of disabling migraine for at least 1 year * migraine onset before the age of 50 years * history of 3 to 8 migraine attacks per month (\<15 headache days per month) during the past 3 months * midas score ≥11 * able and willing to complete an ediary to record the details of each migraine attack treated with study drug * women of child-bearing potential must be using or willing to use a highly effective form of contraception * agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed exclusion criteria: * known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets * history or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures * history of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, meniere's disease, vestibular migraine, and other vestibular disorders * history of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy) * history of orthostatic hypotension with syncope * significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria * participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide * history, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month) * use of more than 3 doses per month of either opioids or barbiturates * initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening * pregnant or breast-feeding women * history of drug or alcohol abuse/dependence within 1 year prior to screening * any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study * currently enrolled in any other clinical study involving an investigational product * relatives of, or staff directly reporting to, the investigator * participants who are employees of the sponsor

Keywords: acute treatment migraine pain multiple attacks headache
laughter frequency and fibromyalgia symptoms

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate whether daily laughter frequency is associated with pain intensity and emotional state ratings in individuals who have fibromyalgia syndrome.

participants will be asked to provide (or authorize the researcher to obtain) fibromyalgia diagnosis confirmation from a health care provider. initially, participants will complete a demographics form and two screening assessments. then for 14 days, they will be asked to rate their momentary mood and overall pain levels three times per day (shortly after waking up, around 3:00 p.m., and at about an hour before bedtime). at the same time, they will be asked to log each instance of laughter as it occurs, daily, for 14 days. they will carry the log with them throughout each day in order to document each instance of laughter.

Eligibility criteria:
inclusion criteria: * individuals who have fibromyalgia syndrome exclusion criteria: * none.
epigenetics modifications in obstructive sleep apnea

Conditions: Sleep Apnea; Snoring

Summary: changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in osa are linked with accelerated cardiovascular morbidity.

design. epiosa is a 5-yr non-interventional longitudinal prospective study being conducted at the sleep clinic of the hospital miguel servet, a large teaching hospital in zaragoza (spain). following a baseline visit, subjects are to be followed-up at 3 months, and then every year. subject participation. the investigators will enroll a total 300 consecutive osa male patients aged 20-60 yrs, with baseline apnea-hypopnea index ≥ 5 events per hour of sleep (ahi). in addition, 50 control subjects (ahi \< 5) aged 20-60 yrs and matched by body mass index (bmi) are also to be recruited. exclusion criteria will include any comorbid condition including alcohol and tobacco use. measurements: routine clinical assessment, full sleep study, bilateral carotid ultrasonography, biochemistry, circulating inflammatory cytokines, t cell subsets and epigenetics studies at baseline and every year until at least 5 years of follow-up.

Eligibility criteria:
inclusion criteria: * age between 18 to 60 exclusion criteria: * any comorbid condition

Keywords: sleep apnea obstructive sleep apnea subclinical atherosclerosis epigenetics t cells
a comprehensive longitudinal cohort study in type 2 diabetes with high risk of cardiovascular diseases in china

Conditions: Type 2 Diabetes

Summary: in 2010, the sponsor conducted an observational study, entitled as "nationwide assessment of cardiovascular risk factors: blood pressure, blood lipid, and blood glucose, in chinese patients with type 2 diabetes - 3b study " which was to evaluate the level of cardiovascular diseases (cvd) risk factor control and its regional difference in china. as a continuation, this extension of the 3b study is designed to assess the incidence of cardiovascular events, cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients with type 2 diabetes and with high risk of (cvd) with or without existing or history of coronary artery diseases.

limited by its cross sectional design, 3b study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. this information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors. the 3b extension study is thus designed to extend the 3b study by continuing to follow up on enrolled patients for 3 years. the 3b extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. it will be the first study of this scale in china based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. it will be conducted in collaboration with the advisory board of china cardiometabolic registries (ccmr).

Eligibility criteria:
inclusion criteria: * age 40 years or older * outpatients who meet the inclusion and exclusion criteria of 3b study * with hypertension,dyslipidemia and one of the following: * history of acute coronary artery disease or ischemic stroke * age \> 65 years old * overweight or obesity (bmi \> 24 kg/m2) * microalbuminuria or albuminuria * current smoker exclusion criteria: * patients with type 1 dm * pregnant or breast feeding women * patients who are unable to or not willing to return for follow up visits every 6 months for 3 years; * patients have severe heart failure (nyha class iii-iv) * patients with severe renal deficiency (creatinine clearance \< 30 ml/min) * patients who are not willing to sing the informed consent form; * patients who are participating in any other interventional clinical studies,

Keywords: patients with type 2 diabetes and participated in 3b study
use of decision support in the management of labour

Conditions: Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant; Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is; Possible

Summary: in women judged to require continuous electronic fetal heart rate monitoring (efm) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (ctg) reduce the number of 'poor neonatal outcomes'? this study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to ctgs displayed on the guardian™ system. specifically comparing: "no decision-support" - ctgs with no additional interpretation (uk standard care), compared with: "decision-support" - ctgs with the decision support software running that will alert clinicians to the presence of abnormalities in the ctg in real time. how the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the guardian™ system.


Eligibility criteria:
inclusion criteria: * require continuous electronical fetal monitoring during labour * they have a singleton or twin pregnancy * they are ≥ 35 weeks' gestation (≥ 245 days) * there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block * they are 16 years of age or older * they are able to give consent to participate in the trial as judged by the attending clinicians. exclusion criteria: * • triplets or higher order pregnancy * criteria for efm not met, including elective caesarean section prior to the onset of labour

Keywords: continuous electronic fetal monitoring labour pregnancy fetal distress