Kornimate/medical-research-clean huggingface dataset:
exploration of the effectiveness of vibrational intervention in improving insomnia symptoms

Conditions: Chronic Insomnia

Summary: study purpose the purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. additionally, the study aims to explore its potential effects on memory enhancement. the primary objectives of the study are to address the following questions: * does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia? * does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia? researchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia. participant involvement participants in the study will: * record daily sleep diaries via a mobile application for a total of 9 weeks * receive daily intervention during a 4-week intervention phase as scheduled by the study * complete weekly self-reported sleep questionnaires through the app * undergo memory performance assessments at the beginning and end of the study


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years, regardless of gender; * diagnosed with chronic insomnia disorder according to dsm-5 criteria, with a primary complaint of difficulty falling asleep (sleep onset latency \> 30 minutes), occurring ≥3 times per week, lasting for more than 3 months but less than 3 years; * able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction. exclusion criteria: * presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome; * epworth sleepiness scale (ess) score \> 10; * use of any sleep-related medication within the past month; * patient health questionnaire-9 (phq-9) score \> 15 or generalized anxiety disorder-7 (gad-7) score \> 10; * currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study; * working night shifts or rotating shifts; * clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, or parkinson's disease, or psychiatric disorders such as bipolar disorder, obsessive-compulsive disorder, phobias, or panic disorder; * substance abuse (including alcohol or drugs), defined as more than 14 drinks/week for males or 12 drinks/week for females.

Keywords: chronic insomnia vibrational neuromodulation vibration
pilot study for the application of low power external bioelectronic devices in the diagnosis of bronchial asthma.

Conditions: Asthma Bronchiale

Summary: the objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects.

the objective of this project is to detect acoustic signals generated by the respiratory system in patients with asthma using the acoustic sensor; and then, retrospectively, to use these signals to carry out signal processing research, with the aim of trying to identify signal characteristics that can be used to differentiate asthma patients from people who do not have the disease. the hypothesis, therefore, is that it is possible to target through external smart bioelectronic devices and wireless connectivity (wearables) the initial signals of the pathophysiology of bronchial asthma and differentiate them from the signals of the normal respiratory physiology of a healthy individual. similarly, detection of such signals would not only be useful for asthma diagnosis but also for monitoring and early detection of exacerbations before they can be detected by the usual respiratory functional tests. the patients will first visit the asthma unit where the diagnostic tests will be undertaken. then the subjects will take the acoustic sensor home with them and wear it during sleep for at least two weeks.

Eligibility criteria:
inclusion criteria: * male or female, aged \>= 18 and \< 65. * ability to access applications on mobile device, technical understanding and minimal technological skills * subject has provided informed consent and is willing to comply with the study procedures. exclusion criteria: * subject does not consent to the study * subject does not comply with inclusion criteria * subject has a known allergy to medical adhesives

Keywords: asthma
investigation of the uterine cervix using cervicalmd

Conditions: Colposcopy

Summary: the purpose of this study is to demonstrate the cervicalmd device's ability to collect digital imagery suitable for a colposcopy examination.


Eligibility criteria:
inclusion criteria: * female * negative pregnancy test * abnormal pap smear * 18 years and older * presence of a cervix exclusion criteria: * pregnant * absence of a cervix * less than 18 years old * male

Keywords: colposcopy cervical intraepithelial neoplasia cervical cancer cervical precancer
traduction and validation of the central sentitization inventory into french

Conditions: Fibromyalgia; Heathy Volunteers

Summary: the study will include a translation of the central sensisization inventory into french and a cultural validation of the french version of the questionnaire (reliability, discrimination and comparison with other questionnaires).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of fibromyalgia (group 1) * clinical diagnosis of a acute of subacute ankle spain (group 2) * healthy volunteer (group 3) exclusion criteria: * having any chronic pain (group 1 and group 2)

Keywords: questionnaire translation
study investigating a pegylated recombinant factor viii (bax 855) for hemophilia a (prolong-ate study)

Conditions: Hemophilia A

Summary: to assess efficacy and safety, including immunogenicity of bax 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (ptps) with severe hemophilia a to determine the pharmacokinetic (pk) parameters of bax 855.


Eligibility criteria:
main inclusion criteria: * participant and/or legal representative has/have voluntarily provided signed informed consent * participant is 12 to 65 years old at the time of screening * participant is male with severe hemophilia a (factor viii (fviii) clotting activity \< 1%) as confirmed by central laboratory at screening after the appropriate washout period or a documented fviii clotting activity \<1% * participant has been previously treated with plasma-derived fviii concentrates or recombinant fviii for ≥150 documented exposure days (eds) * participant is currently receiving prophylaxis or on-demand therapy with fviii * participant is willing and able to comply with the requirements of the protocol main exclusion criteria: * participant has detectable fviii inhibitory antibodies (≥ 0.6 bethesda units (bu) using the nijmegen modification of the bethesda assay) as confirmed by central laboratory at screening * participant has history of fviii inhibitory antibodies (≥ 0.4 bu using the nijmegen modification of the bethesda assay or ≥ 0.6 bu using the bethesda assay) at any time prior to screening * participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia a (eg, qualitative platelet defect or von willebrand's disease).
a study to evaluate scales for repetitive and restricted behaviors in children, adolescents, and adults with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: this is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different asd sub-populations over time. this study will also explore the use of digital biomarkers.


Eligibility criteria:
inclusion criteria for all participants * males and females * availability of a parent or other reliable caregiver. the same person must agree to accompany the participant to all clinic visits and provide information about the participant's behavior and symptoms inclusion criteria for participants with autism spectrum disorders (asd)(diagnostic evaluations will be completed at study site by research staff and supervised by a licensed psychologist) * age: 5-45 years * diagnosis of asd based on the diagnostic and statistical manual of mental disorders (dsm-5), and the autism diagnostic observation schedule (ados-2). * children's yale-brown obsessive compulsive scale modified for asd (cy-bocs-asd) total score of at least 12 * clinical global impression-severity (cgi-s) scale of at least 4 about participant's current autism severity * intelligence quotient (iq) score of 50 or above as assessed by the abbreviated intelligence quotient (abiq) sb5 scale * all medications and treatments are expected to be stable for the duration of the study inclusion criteria for typically developing (td) healthy participants -td participants aged 5-45 years exclusion criteria for all participants * participation in an in investigational drug or device study within 4 weeks or 5 times the half-life of the investigational molecule prior to screening, and participant is not expected to enroll in any other trial during the study * co-occurring disease, condition, or treatment that might interfere with the conduct of the study or pose an unacceptable risk to the participant * unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with study objectives exclusion criteria for participants with asd -known "syndromic" asd (e.g. fragile x syndrome, angelman syndrome, prader-willi, rett's syndrome, tuberous sclerosis, dup15q syndrome) history of alcohol misuse and/or illicit drug use during the last 12 months of the study exclusion criteria for td healthy participants -td healthy participants with a first-degree relative with asd
antibody detection of vaccine-induced secretory effects

Conditions: Covid19; Humoral Acquired Immunodeficiency; Coronavirus; SARS-CoV Infection

Summary: the purpose of this research study is to conduct a prospective longitudinal surveillance research study, enrolling approximately 60 lactating mothers who receive the sars-cov-2 vaccine, and then following their clinical and laboratory parameters for up to 12 months. the overall goal is to investigate the characteristics of antibody formation in lactating women receiving sars-cov-2 vaccination, documenting the antibody isotypes, titers, duration, and transfer into milk over time.

as the global and pandemic spread of the novel coronavirus (sars-cov-2, covid-19) continues, many knowledge gaps remain regarding the epidemiology and transmission of infection, the immunological responses after viral exposure, and the immunological protection after vaccine administration. cincinnati had its first confirmed case of covid-19 on march 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread has continued over the past 10 months with several distinct infection surges. as sars-cov-2 vaccines are becoming available in early 2021, it is important to understand the immunological effects of these vaccines and to contrast them to the effects of natural infection. of particular interest are the immunological effects of sars-cov-2 vaccines for lactating women, and whether breast milk will include secretory antibodies against the virus that potentially confer protection to the breastfeeding infant. the investigators have a unique but time-limited opportunity to track the humoral immunological responses of sars-cov-2 vaccination among lactating women. the investigators designed antibody detection of vaccine-induced secretory effects (advise) to collect and analyze serial breast milk samples for secretory antibody responses, along with periodic blood testing of the mothers and their breastfeeding children. in advise, the investigators will document the prevalence and cumulative incidence of secretory antibody responses to sars-cov-2 vaccines, and gain insights into the protective immunological effects of elective vaccine administration.

Eligibility criteria:
inclusion criteria: * age ≥ 18.0 years at the time of enrollment * currently lactating mothers * planning to receive the sars-cov-2 vaccine in the next 60 days, or vaccinated with the sars-cov-2 vaccine within the past 60 days * cell phone that can be used for text messaging or web-based viewing of surveys * willing and able to provide informed consent * ability to comply with all study related evaluations and follow-up exclusion criteria: * any condition or illness that makes study participation ill-advised
using intensity modulated radiation therapy (imrt) for brain metastases

Conditions: Neoplasm Metastasis

Summary: the purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.

traditionally, whole brain radiation therapy (wbrt) has been the primary therapy for patients with brain metastases. despite this therapy, patients still have poor survival of four to six months. untreated patients have a median survival of one month. up to one half of these patients die of causes related to the presence of brain metastases. in a phase i/ii rtog trial, the efficacy and safety of delivering accelerated fractionation was investigated in patients with good prognostic factors. no toxicity was observed with escalating dose of irradiation up 70.40gy in 1.6gy twice daily treatments. however, in a randomized trial, the use of hyperfractionation did not appear to improve survival when compared to 30gy whole brain irradiation delivered in 10 fractions. current therapeutic approach also includes stereotactic radiosurgery (srs). several retrospective studies have demonstrated improved local tumor control of 80% with addition of srs to wbrt. these local control rates were comparable to surgery. in a recently published randomized trial by rtog 95-08 (tju accrued 42 patients to this trial), andrews et al. demonstrated improved survival in patients with solitary brain lesion treated with srs. median survival was 6.5 months in patients treated with wbrt and srs compared to 4.9 months in patients treated with wbrt alone. also, these patients were more likely to have stable or improved performance status.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy * 2-5 parenchymal brain metastases on magnetic resonance imaging (mri) with a maximum size of 4 cm * partial resection allowed. complete resection allowed only in patients with more than 3 lesions. * karnofsky performance status (kps) equal to or greater than 60 * neurologic function equal to or greater than 2 exclusion criteria: * recurrent brain tumors * major medical or psychiatric illnesses * metastases in brainstem, midbrain, pons, or medulla * patients with leukemia or lymphoma

Keywords: brain metastases parenchymal neoplasm imrt intensity modulated radiation therapy
clinical assessment of dailies total1® (dt1) multifocal

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate dailies total1® multifocal (dtl mf) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.


Eligibility criteria:
inclusion criteria: * must sign an informed consent document; * current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening eligibility questionnaire; * requires a near spectacle add of +0.50 to +2.50 diopters (d) (inclusive); * requires lenses within the power range of study lenses to be fitted; * best corrected va (bcva) of 20/30 (0.2 logarithmic minimum angle of resolution \[logmar\]) or better in each eye at distance; * willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any eye condition that contraindicates wearing contact lenses as determined by the investigator; * any use of medications for which contact lens wear could be contraindicated, as determined by the investigator; * monocular (only one eye functional) or fit with only 1 lens; * fitted with monovision; * prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.); * history of herpetic keratitis, ocular surgery, or irregular cornea; * currently wearing dt1 mf contact lenses; * other protocol-defined exclusion criteria may apply.

Keywords: myopia presbyopia
couple-focused intervention for sun protection

Conditions: Skin Cancer Prevention

Summary: the goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. first, the investigators will develop the intervention website, sun safe partners online. next, the investigators will gather feedback and preferences for content in a small sample of couples who do not regularly engage in sun protection practices. the investigators will also gather preliminary information regarding the impact of the couple-based intervention.

aim 1: to develop and evaluate the feasibility of a couple-based sun protection intervention. aim 2: to examine the impact of the couple-based sun protection intervention on sun protection practices, individual attitudes, relationship perspective on sun protection, and couples' discussion with each other and their supportive communications about sun protection. aim 3: to develop and refine a sunsafe partners online intervention. this process includes refining existing intervention content drawn from the first phase of this pilot research as well as formative and usability studies to obtain user-generated feedback on additional content and the approach. aim 4: to gather pilot data on participation in and evaluations of the sun safe partner's intervention from aim 3. arm 1: web-based intervention called sun safe partners online arm 2: generic online sun safety information intervention- 4 links emailed to participants

Eligibility criteria:
inclusion criteria: 1. both partners age 18-75 years or 19-75 in nebraska and alabama given the age of majority in those states; 2. married or co-habiting with a significant other for at least one year; 3. partner 1 willing to to provide contact information for their spouse; 4. partner 1 and spouse respond with never, rarely, sometimes, or often to question " when outdoors in warm weather, how often do participants protect their skin (by staying in the shade or covering your body with protective clothes or 30+ spf sunscreen)?" those who respond with always to this question will be excluded. 5. partner 1 and spouse have an email account and internet access. exclusion criteria: partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma) -

Keywords: skin cancer
acceptability of video games to promote asthma education and self-management in children

Conditions: Asthma

Summary: asthma is a chronic lung disease affecting over 800,000 canadian children. knowing how to avoid asthma triggers, to take care of one's health, and to know when and why to do one's treatment can help prevent asthma crises, and have a better quality of life. games in health can make the management of asthma easier by helping the child better understand his condition, his triggers, and manage his asthma by himself. games also offer a personalized experience, where players can receive feedback about their learning. however, few studies explored the use of games in childhood asthma. this study will test 4 games for children with asthma. through different characters and scenarios, the goals of the games are to help the child with asthma to better recognize and manage his asthma triggers and symptoms. the objectives of this study are: * evaluate the acceptability of these games in children with asthma * gather feedback on the games to guide future development


Eligibility criteria:
inclusion criteria: along with a parent, children * aged 8-12 years inclusively * with physician-diagnosed asthma * who are on a daily controller medication * who understand french or english. exclusion criteria: children with * chronic respiratory conditions other than asthma * cardiovascular diseases * neuromuscular disorders * developmental delay.

Keywords: video games
community-based management of hypertension in nepal

Conditions: Hypertension

Summary: hypertension contributes to significant burden of cardiovascular diseases (cvds) in low and middle-income countries; however responses to cvds are inadequate particularly due to lack of conclusive evidence on population based approach to hypertension control. this is a community based cluster randomized trial involving family based health education through female community health volunteers in nepal. people ≥25 years of age and who are listed in the voter list 2006 of electoral commission of nepal who were either hypertensive, pre-hypertensive or normotensive are eligible for eligible for participation in the study. a computer generated random codes will be used to divide clusters into treatment and control arm. fchvs will conduct family based health education and blood pressure measurements in the treatment arm vs not any interventions in control arm. independent assessors will conduct the baseline and end line assessment of the intervention. intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. student t-tests for normally distributed variables and chi-squared tests for categorical variables will be used. in the event that randomization do not control for differences between the treatment and control groups on baseline characteristics, the investigators will statistically control for those differences in subsequent analysis of program effects. the final outcome will be modeled by using multiple linear regressions analysis. the investigators hope that if the intervention outcomes shows positive effects in treatment arm, this approach can be adopted into the existing health care delivery system in nepal. assessing the fchvs' ability may further contribute to developing a policy that can be scaled-up to a national level. the lessons learned from this project may also be replicated in rural areas and similar settings elsewhere in the world.


Eligibility criteria:
inclusion criteria: * people ≥25 years of age and who are listed in the voter list of 2006 and those participated in our prevalence study are eligible for inclusion in the baseline survey. - person who give consent to participate in our intervention study, * does not have any plan to migrate from lekhnath municipality for at least 1 year, * non-pregnant women and * personal who are not severely ill will be included as eligible participants. exclusion criteria: * no consent * pregnant women * severely il * plan for migration for the study municipality within 1 year