Kornimate/medical-research-clean huggingface dataset:
middle meningeal artery embolization for chronic subdural hematomas (stormm)

Conditions: Chronic Subdural Hematomas; Cerebral Compression Due to Injury

Summary: chronic subdural hematomas (cshd) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. surgery is typically performed once neurological symptoms develop. recent studies suggest that arteries nourished by the middle meningeal artery (mma) may be responsible for hematoma progression and that mma embolization is clinically useful. there is less evidence, that embolization of mma also may be a treatment option for individuals without surgical treatment. the investigators propose a multicentre study to investigate both potentials: (1) assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; arms 1 and 2), (2) assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, arms 3 and 4).

evidence to support the benefit of mma embolization remains limited and the risk-benefit balance remains unclear. case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. the potential efficacy of mma embolization as a treatment therefore requires higher level evidence in the form of randomized control trials. the benefit of the embolization is a substantial reduction in recurrence of csdh, which has been reported to be as high 1 in 3-4 patients. recurrence of csdh can lead to additional surgery and complications. first objective: evaluate the recurrence rates of csdh after combined surgical and mma embolization treatments (arm 2) versus surgery alone (arms 1). second objective: the second objective is to evaluate the stability and regression of csdh after for all the arms of the study at follow-up.

Eligibility criteria:
inclusion criteria: * age: 18-100 * consent possible * csdh located at the convexities * patients with symptomatic csdh * patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment exclusion criteria: * consent not possible * pregnancy * prisoner * angiography contraindication * patient for whom follow-up is problematic (e.g. distant residency, homeless ...) * previous surgery for csdh
dental appliance to treat sdb in children

Conditions: Snoring; Apnea, Obstructive; Upper Airway Resistance Syndrome; Sleep-Disordered Breathing

Summary: the clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.

the purpose of this study is to evaluate the safety and efficacy of an mouthguard (vivos grow/vivos way) to reduce sleep-disordered breathing (sdb) in children, including: snoring, mild to moderate obstructive sleep apnea (osa), and upper airway resistance syndrome (uars) in children. the subjects enrolled in this study will be using the vivos grow/vivos way to correct orthodontic issues and must also present with signs of sdb. the study will recruit pediatric subjects who have already elected to utilize the study device for their orthodontic treatment; if they meet the inclusion and exclusion criteria they can be included in the study.

Eligibility criteria:
inclusion criteria: * over the age of 6 and under the age of 18 years * permanent dentition or mixed dentition at time of evaluation * diagnosis of sleep-disordered breathing (including snoring, upper airway resistance syndrome, and/or mild to moderate obstructive sleep apnea) * have chosen to have orthodontic treatment * living in the united states * signed informed consent form exclusion criteria: * poor oral hygiene * uncontrolled diabetes * severe obstructive sleep apnea (ahi\> 10/hr) * enlarged tonsils of a grade 4 (\>75% of space between pillars) * diagnosed with a temporomandibular join condition (tmj) * any severe breathing or respiratory disorder, such as chronic asthma, emphysema, copd, or a similar condition * orthodontic braces in situ
cohort study for the assessment of long-term impact of covid-19 among mild covid-19 patients in brazil

Conditions: COVID-19; Quality of Life; Disability Physical; Disabilities Mental

Summary: the present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult patients with mild covid-19. adult patients with symptomatic covid-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * positive polymerase chain reaction (pcr) test for sars-cov-2; * at least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea; * outpatient covid-19 care at the moment of enrollment (without indication for in-hospital care). exclusion criteria: * severe comorbidity with life expectancy less than 3 months; * absence of proxy for patients with communication difficulties; * absence of telephone contact; * refusal or withdrawal of agreement to participate; * previous enrollment in the study.
drug use investigation (dui) of yazflex for endometriosis-associated pelvic pain and/or dysmenorrhea

Conditions: Endometriosis and Dysmenorrhea

Summary: this study is a japanese post-marketing surveillance (pms) which is required by the regulatory authorities. general objective of pms is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

it is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with yazflex in endometriosis or dysmenorrhea indication. a total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years. the treatment should be performed in japan based on the product label. the patients will be observed for up to 2 years (1 year at the earliest) during their yazflex treatment. the outcome variables for the primary objective are treatment emergent adverse events (teaes) and adverse drug reactions (adrs). the outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.

Eligibility criteria:
inclusion criteria: * patients with endometriosis-associated pelvic pain and/or dysmenorrhea. * patients for whom the decision to initiate treatment with yazflex is made as per physician's clinical practice. exclusion criteria: - patients participating in an investigational program with interventions outside of routine clinical practice.
the effect of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels

Conditions: Healthy Participants

Summary: the planned study aims to contribute to the existing literature by comparatively evaluating the effects of online and face-to-face laughter yoga interventions on nurses, focusing on stress, sleep quality, and burnout. in line with this purpose, the research hypotheses are as follows: h1. laughter yoga intervention provided to nurses has a positive effect on their perceived stress levels. h2. laughter yoga intervention provided to nurses has a positive effect on their sleep quality. h3. laughter yoga intervention provided to nurses has a positive effect on their burnout levels. h4. there is a significant difference between the effects of online and face-to-face laughter yoga interventions.

this study investigated whether laughter yoga can help reduce stress, improve sleep, and prevent burnout among nurses. nurses often work in challenging conditions with long shifts, which can negatively affect their mental and physical health. in this study, nurses were divided into three groups: one received face-to-face laughter yoga, another participated in laughter yoga online, and the third group did not receive any intervention. laughter yoga sessions were conducted twice a week for two weeks and included deep breathing, playful activities, and laughter exercises. participants completed surveys before and after the sessions to measure their stress levels, sleep quality, and signs of burnout. the results showed that nurses who participated in the online laughter yoga program experienced better sleep, felt less emotionally exhausted, and had a stronger sense of personal accomplishment. these benefits were not observed in the face-to-face or control groups. interestingly, the program did not significantly reduce stress levels in any of the groups. this study suggests that online laughter yoga may be a useful and accessible tool to support the well-being of nurses, especially in healthcare settings where in-person wellness programs are difficult to organize.

Eligibility criteria:
inclusion criteria: * working as a nurse * over 18 years old exclusion criteria: * no uncontrolled hypertension * no history of abdominal surgery in the last three months * not suffering from glaucoma, hernia or epilepsy * not receiving psychiatric diagnosis and treatment * not receiving sleep-related diagnosis and treatment * having incontinence

Keywords: burnout level laughter yoga nurses stress sleep quality
the effect of transition to adulthood education program on family quality of life and perceived stress level

Conditions: Intellectual Disability

Summary: negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. it has been found that parents who care for their children with intellectual disability (id) for a long time have difficulties in coping with stress and their quality of life is adversely affected. however, families play a key role in maintaining the care of their children with id, so it is very important that parents are supported in the matters they need.

mothers are generally the people who take on a large part of the burden of care for their children with intellectual disability (id) in the family and are most affected by the negativities brought by the conditions. providing support to mothers for the care and future planning of their children who have just passed into adult life and for their future planning is important both in terms of maintaining family well-being and creating positive effects in the lives of individuals with mental disabilities. with this study, it is aimed to increase the quality of life of mothers and to reduce perceived stress levels with the training (yegep) modules to be given for the changing care needs of individuals with id who have reached adulthood or are in transition. in addition, it is expected that the health risks of young adults with id will be determined at an early stage, and their health will be improved and protected.

Eligibility criteria:
inclusion criteria: * whose child is registered with the disability center, * have a young adult child between the ages of 20 and 35 with moderate and severe mental disabilities, * speaking turkish and literate turkish, * not visually and speech impaired, * mothers who volunteered to participate in the study will be included. exclusion criteria: • mothers who did not volunteer to participate in the study and were illiterate in turkish were not included in the study.
effect of caudal vs. penile block on the incidence of hypospadias complications

Conditions: Complication of Anesthesia

Summary: hypospadias is one of the most common congenital malformations in male babies, affecting approximately 1 in every 200-300 live male births. this condition is characterized by an abnormal location of the urethral meatus, located on the ventral side of the penis, anywhere from the glans to the perineum. treatment of hypospadias is primarily surgical and aims at functional and cosmetic correction. however, surgery is often complex and can be associated with a significant risk of complications, such as fistula formation, wound dehiscence, urethral stricture, and dissatisfaction with cosmetic results. the search for optimal surgical techniques and postoperative management strategies that can reduce these complications continues. postoperative pain after penile surgery can cause agitation and anxiety in children, which can also lead to stress and tension in parents. in addition to ensuring the comfort of both children and parents, pain control reduces complications in the postoperative period and accelerates recovery. different techniques such as local anesthesia, sedoanalgesia, general anesthesia or regional anesthesia are used in penile surgery. caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, its anesthetic safety and effectiveness have been proven in recent years, and caudal block is generally applied safely to provide postoperative analgesia in these patients. these block applications reduce the need for analgesic and anesthetic drugs and prolong the pain-free period. at the same time, this method is easy and safe to apply. however, some anesthetic complications of caudal block have been reported in previous studies6. it has also been suggested that the use of caudal nerve block is a potential risk factor contributing to surgical complications in hypospadias surgeries. this was first reported by kundra and his team in 2012. in the study, they noted that the fistula rate increased to 19.2% in patients receiving caudal nerve block compared to a 0% fistula rate in those receiving penile block during one-stage hypospadias repair. since the initial findings of kundra and his team, the use of caudal anesthesia during hypospadias repair has been a subject of ongoing debate. caudal nerve block, a regional anesthesia technique, is widely used in pediatric infraumbilical surgeries, and its safety and effectiveness as an anesthetic are well established. the purpose of this study was to evaluate the potential effect of caudal nerve block anesthesia on postoperative surgical outcomes in male patients aged 6-48 months undergoing hypospadias repair


Eligibility criteria:
inclusion criteria: * hypospadias exclusion criteria: * the patients who alder than 48 month
effect of changing sedentary behavior in youth

Conditions: Obesity

Summary: the primary aim is to examine how reduction in sedentary behaviors influences physical activity and energy intake.

many youth find television, videos and computer games to be very reinforcing, and they choose to be sedentary rather than physically active. sedentary behaviors can influence energy balance and body weight by reducing physical activity and increasing energy intake. research from our laboratory has shown that reducing sedentary behavior can increase physical activity and decrease energy intake, but there is substantial variability in the response of youth to reductions in sedentary behavior. the present proposal is designed to extend our research and explore theoretical models that may help understand why youth vary in their response to increase physical activity when targeted sedentary behaviors are reduced. we hypothesize that the increase in physical activity when sedentary behaviors are reduced is related to the relative reinforcing value (rrv) of physical activity to sedentary behaviors. the rrv of physical activity is a measure of the motivation to be active in youth, and overweight youth who are inactive find physical activity relatively less reinforcing than less overweight youth. we predict that rrv of physical activity will be positively related to the substitution of total physical activity and physical activity in the moderate to vigorous intensity range for sedentary behaviors when targeted sedentary behaviors are reduced. to test this hypothesis, we will study 60 overweight and at risk for overweight 8-12 year-old youth who differ in the rrv of physical activity to sedentary behavior, with equal numbers of boys and girls, in 3 phases: baseline, and reduce television watching from baseline by 25 percent and 50 percent. each phase will be implemented for three weeks. order of experimental phases will be counterbalanced across subjects. it is also predicted that reducing sedentary behavior will reduce energy intake and dietary fat intake, and the reduction in energy intake will be greatest for youth with stronger association between eating with television watching and other targeted sedentary behaviors. liking and outcome expectancy of physical activity will be studied as additional predictors of substitution of physical activity for reductions in sedentary behaviors. developing a better understanding of why obese youth increase physical activity or decrease energy intake when sedentary behaviors are reduced is important for the treatment of pediatric obesity.

Eligibility criteria:
inclusion criteria: * above the 85th bmi percentile * reside in one primary household * engage in at least 18 hours of sedentary behavior a week exclusion criteria: * none

Keywords: physical activity relative reinforcing value sedentary behavior obesity
cervical ripening in obese women: efficacy of 25 mcg versus 50 mcg of misoprostol

Conditions: Induction of Labor Affected Fetus / Newborn

Summary: this is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

we will perform a prospective, randomized, double-blind clinical trial with parallel assignment. obese women (delivery bmi 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. our primary outcome will be the rate of successful induction. secondary outcomes will include ability to achieve a bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, nicu admission.

Eligibility criteria:
inclusion criteria: * labor induction, bmi of 30 or greater, english speaking exclusion criteria: * prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, contraindication to labor induction
accuracy of owlet smart sock sensor 3rd generation with profound hypoxia

Conditions: Hypoxia

Summary: performance testing of pulse oximeters. the protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. the blood sample is analyzed for oxygen saturation with a gold standard bench co-oximeter. this protocol is aligned with the latest iso and fda guidance documents for pulse oximeter testing.


Eligibility criteria:
inclusion criteria: * the subject is male or female, aged ≥18 and \<50. * the subject is in good general health with no evidence of any medical problems. * the subject is fluent in both written and spoken english. * the subject has provided informed consent and is willing to comply with the study procedures. exclusion criteria: * the subject is obese (bmi\>30). * the subject has a known history of heart disease, lung disease, kidney or liver disease. * diagnosis of asthma, sleep apnea, or use of cpap. * subject has diabetes. * subject has a clotting disorder. * the subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. * the subject has any other serious systemic illness. * the subject is a current smoker. * any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. * the subject has a history of fainting or vasovagal response. * the subject has a history of sensitivity to local anesthesia. * the subject has a diagnosis of raynaud's disease. * the subject has unacceptable collateral circulation based on exam by the investigator (allen's test). * the subject is pregnant, lactating or trying to get pregnant. * the subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. * the subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Keywords: verification of spo2 accuracy induced hypoxia owlet smart sock pulse oximeter
study comparing immune response to, and safety of, fluviral and fluzone influenza vaccines in persons 50 y.o. and over

Conditions: Influenza

Summary: the goal of this study is to determine whether the immune responses induced by fluviral, the investigational vaccine, are comparable to those induced by fluzone, which is an influenza vaccine currently licensed in the u.s. the study focuses on persons 50 years old and over. in addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.

yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. fluviral, a product now licensed in canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed u.s. vaccine in persons 50 y.o. and over.

Eligibility criteria:
inclusion criteria: * stable health status * access to a consistent means of telephone contact. * comprehension of study requirements, availability for study duration * availability and ability to attend scheduled visits * females post menopausal, sterile or using accepted contraceptive measures * competence to provide informed consent exclusion criteria: * presence of significant acute or chronic medical or neuropsych. illness * new medical or surgical treatment w/i 1 month * change in medication dose due to uncontrolled symptoms w/i 1 month * hospitalization w/i 1 month * any unusual risk (for age group) of serious adverse events w/i 1 month * any neuropsychiatric condition altering competence for consent * any neuropsychiatric condition preventing accurate safety reports * febrile illness on day of treatment * employment in professions at high risk of influenza transmission * residence in a long-term-care facility or with an immunocompromised person * systolic bp over 150, diastolic over 90, resting pulse under 50 or over 100 * cancer w/i 3 years * immunosuppressive of immunodeficient conditions * treatment with systemic glucocorticoids \> replacement * treatment with cytotoxic or immunosuppressant drugs * treatment with immune globulins * clotting disorders that increase the risks of intramuscular injections * history of demyelinating disease or gbs * pregnancy or nursing * absence of contraceptive practices in women with childbearing potential * planned administration of non-influenza vaccines within 30 days * receipt of any investigational drug within 30 days * receipt of immune globulin treatment within 3 months * known or suspected allergy to egg proteins, gelatin, or thimerosal * history of severe adverse reactions toflu vaccines * prior receipt of 2005-6 influenza vaccine

Keywords: vaccine elderly immunogenicity safety