Kornimate/medical-research-clean huggingface dataset:
wearable assisted viral evidence (wave) study a decentralized, prospective study exploring the relationship between passively-collected data from wearable activity devices and respiratory viral infections

Conditions: Influenza, Human; COVID-19; Influenza A; Influenza B; Respiratory Syncytial Virus (RSV)

Summary: the goal of this decentralized, observational study is to enroll and observe adults in the contingent united states during the 2023-2024 flu season. the main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (rvi) from pcr testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic rvi and understand the algorithm's performance metrics.


Eligibility criteria:
inclusion criteria: * lives in the united states * speaks, reads, and understands english * currently owns and uses a consumer wearable device (apple watch, garmin, or fitbit) with necessary step and heart rate data at minimum or willing to wear a study-provided device and download the fitbit app * willing to connect their wearable device to the evidation platform and wear it daily for at least 10 hours for the duration of the study * owns a smartphone with apple ios 15 installed or higher or android version 9.0 installed or higher or willing to update * willing to respond to daily and weekly questionnaires for a 10-week period * willing to complete at-home nasal swab tests and return the nasal swab samples within 24 hours of being asked to complete it * meets data density requirements for wearable devices exclusion criteria: * self reported diagnosis of both flu and covid by a healthcare professional or using an at-home test in the past 3 months * currently enrolled in another interventional study to prevent or treat covid-19 or another flu-related program being conducted by evidation (individuals currently participating in evidation's flusmart program will be told that their participation will be paused) * has a primary mailing address that is a p.o box, army post office (apo), fleet post office (fpo), or diplomatic post office (dpo) address, or u.s. military base located overseas, or u.s. territories (puerto rico, u.s. virgin islands, guam, northern mariana island, or american samoa)

Keywords: flu influenza rsv covid wearable
effect of web-based education on gestational diabetes mellitus and health management self efficacy

Conditions: Pregnancy Complications; Efficacy, Self

Summary: this randomized controlled study aimed to examine the effect of web-based education related to gestational diabetes mellitus on women health management self-efficacy and maternal-fetal-neonatal results.

objective: to examine the effect of web-based education related to gestational diabetes mellitus on women health management self-efficacy and maternal-fetal-neonatal results. design: randomized controlled study. patients: thirty one pregnant women were included in the intervention group and thirty four pregnant women in the control group. interventions: for 8 weeks, web-based education for gestational diabetes mellitus was offered to pregnant women who diagnosed with gestational diabetes mellitus for the first time. the data were collected before web-based education, after web-based education and postpartum between 4-12 weeks at three different times. control group was offered routine clinical procedure. main outcome measures: health management self efficacy (primary outcomes), maternal-fetal-neonatal results (secondary outcome).

Eligibility criteria:
inclusion criteria: * being 18 years or older * being primigravida or multigravida * getting a diagnosis of gestational diabetes mellitus * having a gestational week between 24-28 * having a single fetus * ability to use the internet (computer, tablet, smart phone, etc.) * voluntary participation in the research exclusion criteria: * having a diagnosis of type 1 and type 2 diabetes mellitus * having another chronic disease * having a visual or hearing impairment * having a psychiatric medical diagnosis * having a diagnosis of risky pregnancy not related to gdm

Keywords: gestational diabetes mellitus self efficacy web based education
long-term follow-up of a cohort of participants prescribed epidyolex in france in a real-life setting

Conditions: Seizures

Summary: this is a multi-center, non-interventional and prospective study of patients receiving epidyolex as part of standard clinical practice in france. the study will state an overview of patient characteristics and clinical history (including age, sex, diagnosis, duration of epilepsy, predominant seizure type, previous medications, current co-medications and epidyolex dose), and an evaluation of retention rates, safety profile, seizure activity, changes in executive function and quality of life measured in a 2-year follow-up period.


Eligibility criteria:
key inclusion criteria: * individuals for whom treatment with epidyolex has been initiated by a physician with experience in the treatment of epilepsy. * the participant and/or parent(s)/legal representative is willing and able to give informed consent/assent for participation in the study. key exclusion criteria: * previously initiated with epidyolex before the start of the study (especially during the french early access program (eap)).

Keywords: seizure therapy cannabidiol gw cbd epidyolex epidiolex jazz cbd
effect of acetazolamide on postural control in lowlanders older than 40 years at altitude

Conditions: Altitude Hypoxia

Summary: randomized, placebo controlled trial evaluating the effect of acetazolamide on postural control in lowlanders older than 40 years travelling from 760 m to 3'100 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on the postural control in lowlanders older than 40 years travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3'100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3'100 m. an interim analysis will be carried out when 80 participants will have completed the study or after the first year. the peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria:
inclusion criteria: * healthy men and women, age 40-75 yrs, without any disease and need of medication. * born, raised and currently living at low altitude (\<800m). * written informed consent. * kyrgyz ethnicity exclusion criteria: * any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. * any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol. * allergy to acetazolamide and other sulfonamides.

Keywords: healthy participants older than 40 years postural control prevention acetazolamide
deep neuromuscular block on postoperative delirium in lumbar surgery

Conditions: Lumbar Spine Disease

Summary: the effect of deep neuromuscular blockade (nmb) during spine surgery reduced postoperative pain and bleeding in recent studies. therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep nmb is expected to reduce the postoperative delirium. this study was designed to determine whether the deep nmb lowered the incidence of delirium after lumbar surgery.


Eligibility criteria:
inclusion criteria: * aged 70 and more; * scheduled for an elective lumbar spine surgery; * asa physical status 1-3 exclusion criteria: * diagnosed neuromuscular disorder; * contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block; * patient with pre-existing cognitive impairment or dementia
monocentric observational study on the diagnostic and prognostic role of 18f-psma pet (pet/ct and pet/mr) in prostate cancer

Conditions: Prostate Cancer

Summary: the general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of pet images with 18f-psma in all stages of the disease in patients with prostate cancer. to this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. the latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. this methodology is very promising, but also recent and therefore little studied and standardized. our objective is also to investigate how to optimize it from a purely methodological point of view.

in this study, all pet images with 18f-psma will be considered, but also the ct or mr images associated with them to allow better anatomical localization. this study will allow us to investigate the diagnostic and prognostic role of l8f-psma pet, also evaluating its predictive value in terms of disease course, development of metastases and mortality. the retrospective part of this protocol is necessary for the acquisition of a sufficiently large amount of data to guarantee adequate statistical power for the study.

Eligibility criteria:
inclusion criteria: * adult male patients; * patients with histopathological diagnosis of prostate cancer undergoing staging or restaging; * patients with clinical indication for pet examination with 18 f-psma; exclusion criteria: * medical conditions that do not allow the acquisition of pet images; * allergic reactions to iodinated contrast medium or creatinine levels \>2mg/dl.
influence of different forms of exercise training in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

swimming and other water-based physical activities represent an effective form of aerobic-dynamic exercise. however, existing guidelines mainly advise caution when recommending water-based activities to patients with coronary artery disease. to date, safety and efficacy of short-term water-based exercise in patients with coronary artery diseases have only scarcely been addressed. cardiovascular rehabilitation is an integral part of management after a myocardial infarction or coronary procedure. most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence. most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence. research has mainly been focused on the impact assessment of the standard forms of physical training, they studied various forms of physical exercise, mainly land-based. no previous study has reported on the effect of exercise in water as an integral element of standard cardiac rehabilitation in coronary patients on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization) exclusion criteria: * unstable coronary artery disease, ejection fraction of the left ventricle of 40% or less, heart valve defect that dictate specific treatment, condition after valve replacement, heart rhythm disorders, the presence of a permanent pacemaker, contraindications to exercise, inability to perform exercise testing, mental retardation, severe anemia, obstructive/restrictive lung disease severe degree, recent thrombo embolic events, age over 80 years.

Keywords: cardiac rehabilitation coronary artery disease
fetal haemoglobin and cerebral and peripheral oxygenation.

Conditions: Preterm Birth; Oxygen Toxicity; Fetal Hemoglobin

Summary: the aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by nirs (near-infrared spectroscopy ), and the fhbf (fraction of fetal hemoglobin) and absolute hbf (fetal hemoglobin) concentration in postnatal conditions in term and preterm neonates.

during gestation the main fetal oxygen carrier is fetal hemoglobin (hbf). hbf exhibits a significantly higher affinity for oxygen when compared to adult hemoglobin (hba), which makes it more suitable for oxygen extraction at the lower partial oxygen pressures in utero. although the regulation of hbf expression is determined developmentally, recent studies report a respectable variation in the fraction of hbf in neonates. such data suggest that the differences in hbf expression could affect end-tissue oxygenation in neonates. the methodology for measuring oxygen saturation and extraction in cerebral and peripheral tissues of neonates using the near-infrared spectroscopy (nirs) has been well practiced in our study group. however, the method has not yet been used to investigate whether the fraction of fetal hemoglobin (fhbf) plays a significant role in cerebral and peripheral oxygenation in neonates. the aim of this study is to investigate the relationship between cerebral and peripheral oxygenation and oxygen extraction, as measured by nirs, and the fhbf and absolute hbf concentration in postnatal conditions in term and preterm neonates.

Eligibility criteria:
inclusion criteria: * term and preterm neonates admitted to the neonatal intensive care unit (nicu) * decision to conduct full life support * written informed consent exclusion criteria: * no decision to conduct full life support * no written informed consent * congenital malformations * family history of haemoglobinopathies (e.g. sickle cell anaemia, thalassaemia)

Keywords: fetal hemoglobin preterm neonate term neonate near-infrared spectroscopy cerebral oxygenation peripheral oxygenation fractional tissue oxygen extraction
comparison of two daily disposable contact lenses over 1-week of wear

Conditions: Myopia

Summary: this is a one week 2x2 crossover study comparing delefilcon a with etafilcon a, with a primary hypothesis of comparing the handling of each lens. additional secondary markers are measured looking at subjective comfort and vision of the lenses.


Eligibility criteria:
inclusion criteria: * the subject must be between 18 and 45 years of age (inclusive) with no presbyopic add. * the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. this should be recorded on the case report form (crf). * the subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week. * the subject must be a current successful soft contact lens wearer in both eyes * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * the subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00d to -6.00d in each eye. * the subject's refractive astigmatism must be less than or equal to 0.75d in both eyes. * the subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. * the subject must require a visual correction in both eyes (no monofit or monovision allowed). * the subject must have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: 1. no amblyopia. 2. no evidence of lid abnormality or infection (including blepharitis/meibomitis). 3. no conjunctival abnormality or infection. 4. no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities). 5. no other active ocular disease. exclusion criteria: * any ocular or systemic allergies or diseases that may interfere with contact lens wear. * any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation. * no extended wear in the last 3 months. * diabetes. * infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. hiv). * employee or family member of the staff of the investigational site.
tdcs effects on chronic low back pain

Conditions: Low Back Pain; Chronic Pain

Summary: back school (bs) is a behavioural intervention designed to treat and prevent chronic low back pain. up to date clinical research studies have shown that transcranial direct current stimulation (tdcs) is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain and facilitating the mechanisms inhibitors descendants of pain control. the aim of this study is to test the feasibility of combining tdcs with a behavioural intervention (i.e. bs) in subjects with chronic low back pain.

chronic low back pain involves high individual and social costs. back school (bs) is a behavioural intervention designed to treat and prevent the aforementioned condition. up to date clinical research studies have shown that transcranial direct current stimulation (tdcs) can be considered a reliable tool for chronic pain. it has been shown how tdcs is able to decrease the intensity and duration of pain modulating the activity of brain areas involved in the circuits that regulate pain, such as the thalamus, and facilitating the mechanisms inhibitors descendants of pain control. the aim of this study is to test the feasibility of combining tdcs with a behavioural intervention (i.e. bs) in subjects with chronic low back pain. specifically, we will test their effects on low back pain intensity and participation of patients' in daily activities.

Eligibility criteria:
inclusion criteria: * males and females aged \> 18 years and \<75 years * presence of non-specific chronic low back pain diagnosed \> 2 years * presence of a chronic pain measurable with the vas scale not less than 3 during a 2 weeks daily vas monitoring * pain refractory to drugs (opioid analgesics, tricyclic antidepressants, antiepileptic drugs). it is considered a refractory pain if there is at least 6 months of treatment with at least 2/3 of the above drugs exclusion criteria: * spine surgery * cognitive impairment assessed with mini mental status examination \<24 * contraindications to tdcs: presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants) * contraindications to tdcs: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current * neurological or psychiatric pathology * severe cardio-pulmonary, renal, hepatic diseases * pregnancy

Keywords: low back pain chronic pain tdcs transcranial direct current stimulation
a survey to assess participants', caregivers', and nurses' use and understanding of educational material on velaglucerase alfa (vpriv) home infusion

Conditions: Gaucher Disease

Summary: the main purpose of this survey is to determine participants', caregivers', and nurses' understanding and use of educational materials (em) on vpriv home treatment. em includes an infusion diary and guide and an emergency plan related to vpriv infusion given at home for gaucher disease. the survey is conducted in european countries. data will be collected directly from participants, caregivers, and nurses in form of a questionnaire, electronic or paper.

the participants diagnosed with gaucher disease receiving vpriv® home infusion, their caregivers and home infusion nurses were observed in this study. this cross-sectional study will determine and assess the understanding of the educational material (em), including infusion diary and emergency plan associated with vpriv® home infusion in participants diagnosed with gaucher disease, their caregivers and home infusion nurses. the study will recruit approximately 30 participants/caregivers and 30 home infusion nurses. the survey will be conducted through non-nominative web-based questionnaires that will be completed in approximately 10-15 minutes. all participants will be enrolled in a single observational group: • vpriv® home infusion the trial will be conducted in home-based setting in austria, belgium, finland, france, germany, italy, the netherlands, and spain.

Eligibility criteria:
inclusion criteria: 1. gaucher disease participants who receive vpriv® for home infusion and their caregivers. 2. home infusion nurses administering vpriv® to participants with gaucher disease at home. exclusion criteria: potential respondents will be excluded if they have conflicts of interest with the survey (e.g., if they are employed by regulatory bodies, or pharmaceutical industry).

Keywords: drug therapy