Kornimate/medical-research-clean huggingface dataset:
sustaining home heart failure palliative care in rural appalachia

Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Summary: the aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural appalachia. this intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.

this study uses a randomized control trial (rct) design to test the integrated nurse-led intervention bundle of home palliative care intervention (hf-fampalhomecare) for patients with heart failure (hf) and their family caregivers. (104 patient-family caregiver dyads). the researcher will compare hf-fampalhomecare to the standard control group to see if the participants in hf-fampalhomecare group will report better health outcomes than the standard control group at the completion of the study at 12 months. aim 1: compared to the control group at 3, 6, 9 months, and 1-year follow-up: hypothesis 1a. the patients in the intervention group will have higher scores on hf-related health quality-of-life measure and on the world health organization (who) aging functional health well-being scale. hypothesis 1b. the family caregivers in the intervention group will have higher scores on the world health organization (who) aging functional health well-being scale. aim 2: compared to the control group at 3, 6, 9 months, and 1-year follow-up: hypothesis 2a. the patients in the intervention group will have (a) lower depression and anxiety scores and (b) higher numbers of signed eol advance directives. hypothesis 2b. the family caregivers in the intervention group will have (a) lower depression and anxiety scores, (b) lower home caregiving burden scores, and (c) improved home hf eolpc preparedness and improved home palliative care scores. all participants receive standard care, which is routine hf instruction from their care providers. the hf-fampalhomecare group receives 5-session intervention includes 2 home visits, and 3 bi-weekly telephone calls on hf home eolpc care. three follow-up telephone calls will be provided at 3, 6, 9, and 12 months. control subjects will receive the same hf home care information after 12-month. data collection for both groups are conducted at baseline, 3, 6, 9, and 12 months.

Eligibility criteria:
inclusion criteria: 1. adult patients' age between 50 to 80 years with advanced hf (nyha iii or iv), diagnosed by physician 2. caregivers' age between 45 to 80 years. 3. alert and consent to participate 4. able to read and understand english exclusion criteria: 1. already received or are on a waiting list for a heart transplant or left ventricular assist device (lvad) 2. diagnosed with a terminal illness or dementia, such as alzheimer's disease

Keywords: advanced heart failure home palliative care family caregiver rural appalachia
phase i study to investigate the alcohol interaction of sk3530

Conditions: Erectile Dysfunction

Summary: this study was designed to investigate the alcohol effect of sk3530 on the pharmacokinetics (pks) and safety.

this study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, sk3530 100mg alone, 0.5g/kg of alcohol alone, and sk3530 plus alcohol together. there was a minimum of a 7 day washout period between treatments. the alcohol was diluted to 240 ml with water. the contents were drunk in 1 minutes or less. for sk3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Eligibility criteria:
inclusion criteria: * ages 20 to 50 * body weight of ibm ± 20% exclusion criteria: * cardiovascular disease * color-blindness or weakness * no availability to intake 0.5 g/kg alcohol * abnormal supine blood preesure

Keywords: sk3530 alcohol pharmacokinetics safety
degenerative consequences of congenital deafness

Conditions: Congenital Deafness

Summary: in this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). the investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. the investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. lastly, the investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. the primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.


Eligibility criteria:
inclusion criteria: * cochlear nucleus cochlear implant users or advanced bionics cochlear implant users * native speakers of english * early onset of deafness (\< 3 years of age); no requirement for age at implantation * late onset of deafness (\> 3 years of age); matched in duration of deafness to the early onset group * has had device experience for at least one year * can be child or adult at the time of enrollment exclusion criteria: * none
ym150 for prevention of venous thromboembolism in patients with acute medical illness

Conditions: Venous Thromboembolism

Summary: to evaluate the safety and efficacy of the oral dose of ym150 for prevention of venous thromboembolism (vte) in patients with acute medical illness.


Eligibility criteria:
inclusion criteria: * patient is hospitalized within 2 days before the study and has more than 1 basic vte risks * complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization * written informed consent obtained exclusion criteria: * subject has history of deep vein thrombosis and/or pulmonary embolism * subject has a hemorrhagic disorder and/or coagulation disorder * subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent * subject has an acute bacterial endocarditis * subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke * subject is receiving anticoagulants/antiplatelet agents * subject has a body weight less than 40 kg * major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods

Keywords: ym150 bleeding vte fxa inhibitor deep vein thrombosis venous thromboembolism
study evaluating the safety of moa-728 administered orally to healthy subjects

Conditions: Postoperative Complications; Constipation

Summary: this is the first multiple-dose experience in humans with moa-728 in an oral formulation. this study will provide an assessment of the safety, tolerability, and pharmacokinetics (pk) of moa-728 following administration of ascending multiple oral doses to healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy men and women

Keywords: safety health pharmacokinetics ileus
myotonometric measurement of myofascial trigger points: reliability, validity and sensitivity

Conditions: Muscle Tone Abnormalities

Summary: the aims of this study are: * to examine the inter-rater reliability to assess myofascial trigger points using a myotonometer * to determinate the strength of the correlation between myotonometric parameters and isokinetic parameters * to evaluate the sensitivity of myotonometric measurements to detect the location of myofascial trigger points

previous researches have used complicated and expensive methods to measure mechanical properties of muscle tone like isokinetic dynamometer. the purpose of this investigation is to establish the reliability, validity and sensitivity of a myotonometer to assess myofascial trigger points. the results of this study will verify the inter-reliability of a myotonometer device in order to evaluate muscle tone, examine correlations and associations between myotonometric measurements and isokinetic measurements and provide a measurable understanding of the location of myofascial trigger points. assessment: myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle tone in non-injured subjects but isokinetic machine is a heavy and expensive equipment. outcome measures: myotonometric measures will include muscle frequency, decrement (elasticity) and stiffness. isokinetic measures will include passive resistive torque to ankle dorsiflexion and dorsiflexion passive range of motion (prom) all outcome measures will be evaluated once.

Eligibility criteria:
inclusion criteria: * age range 18-55 years. * healthy volunteers. * presence of a latent medial mtrp of the soleus muscle. * being able to provide written informed consent. * being able to follow instructions and realize clinical tests. exclusion criteria: * any history of ipsilateral lower limb severe injury or intervention (e.g. fracture, surgical intervention). * pain or musculoskeletal injury, ligament injury, tendonitis or plantar fasciitis in the ipsilateral leg for six months previous to the evaluation. * peripheral or central nervous system neurological disease. * altered sensitivity in the studied area. * treatment of a myofascial trigger point in the sural triceps in the six months previous to the evaluation.

Keywords: myofascial trigger points myotonometry isokinetic dynamometry assessment reliability
the immunogenicity, safety, and effectiveness of the covid-19 inactivated vaccine

Conditions: COVID-19

Summary: to fast respond the coronavirus disease of 2019 (covid-19) pandemic, the indonesian government has launched "vaksinasi gotong royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (the indonesian ministry of health, 2021). vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) inactivated vaccines produced by sinopharm. the indonesian national agency of drug and food control (nadfc) has issued an emergency use authorization (eua) for several covid-19 vaccines, including the sars-cov-2 vaccine (vero cell) inactivated produced by sinopharm (nadfc, 2021). following eua, kimia farma indonesia as the holder of eua has the obligation to monitor the safety and effectiveness in indonesian population.


Eligibility criteria:
inclusion criteria: male or female subjects aged 18 years old and above; will receive the sars-cov-2 vaccine (vero cell) inactivated produced by sinopharm; obtain informed consent to participate this study exclusion criteria: previous sars-cov-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; history of sars-cov-2 infection within the last 3 months
primary care stepping stones triple p for children with autism

Conditions: Autism

Summary: the purpose of this study is to determine the effectiveness of primary care stepping stones triple p (pc-ss triple p), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with autism (aged 2-12 years), increase parental resilience and decrease parental stress.

research literature exists on best practices for screening and diagnosing children with autism. however, less is known about how to intervene with the child's parent. across studies, relative to parents of children without disabilities, parents of children with autism have reported higher levels of stress and lower levels of parenting competence. such stress places children at risk for adverse developmental outcomes the proposed study aims to determine the effectiveness of primary care stepping stones triple p (pc-ss triple p), an empirically supported parent mediated intervention, to improve the behavioral functioning of children newly diagnosed with autism (aged 2-12 years), increase parental resilience and decrease parental stress. the specific hypotheses include: 1. children whose parents receive pc-ss triple p will demonstrate significantly greater improvements in their behavioral functioning than children of parents receiving wait-list control (wlc) at service closure. 2. at service closure, parents receiving the pc-ss triple p intervention will be more resilient and demonstrate lower levels of stress than parents in the wait-list control (wlc) condition. 3. parenting resilience and levels of parental stress will be positively associated with improvements in child behavior. seventy-six parents of children newly diagnosed with autism will be randomized into one of two conditions: a) pc-ss triple p (n=38) or b) wait list control (wlc; n=38). study data will be collected with the assistance of a data collector appropriately trained in human subject rights protections. it is anticipated that the present project will assist in the development and use of evidence-based practices for working with parents of children newly diagnosed with autism within pediatric settings.

Eligibility criteria:
inclusion criteria: parent inclusion criteria: * being at least 18 years of age index child inclusion criteria: * receives a diagnostic and statistical manual v (dsm-v) diagnosis of autism with mild or moderate severity within 12 months of study onset. * age is \> or equal to 24 months (2 years, 0 months) and \< or equal to 155 months old (12 years, 11 months). exclusion criteria: parent exclusion criteria: * inability to provide informed consent. * being non-english speaking. index child exclusion criteria: * being a ward of the state of missouri. * being a sibling of another study participant.

Keywords: parental resilience parental stress family adaptation autistic disorder behavior child behavior child development disorders pervasive developmental disabilities caregivers parents parenting primary health care
efficacy of 5 weeks of treatment with bgg492 in patients with spasticity due to multiple sclerosis

Conditions: Muscle Spasticity Due to Multiple Sclerosis

Summary: to evaluate efficacy and safety of bgg492 versus placebo on moderate to severe spasticity due to multiple sclerosis


Eligibility criteria:
key inclusion criteria: * diagnosis of multiple sclerosis (ms) of any type. * ms diagnosis at least 6 months prior to screening. * stable ms with no relapse within 3 months prior to screening. * treated or untreated spasticity due to ms for at least 3 months prior to screening, not wholly relieved with antispasticity medications. key exclusion criteria: * patients with symptoms of spasticity not due to ms. * patients taking three or more different anti-spasticity medications. * acute ms exacerbation requiring treatment within 3 months of the screening visit. * initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for ms within 3 months of the screening visit. * use of baclofen pump at any time. * wheelchair or bed-bound patients.

Keywords: spasticity multiple sclerosis
rehabilitation coordinators in specialist psychiatry

Conditions: Mental Disorder; Rehabilitation

Summary: reko-a is a randomized controlled intervention study that addressed women and men on sick leave in uppsala county. participants which are on sick leave due to mental illness.


Eligibility criteria:
inclusion criteria: * be on sick leave * have moderate to severe affective and / or moderate / severe anxiety disorder, such as: bipolar disorder, depression, posttraumatic stress disorder, generalized anxiety disorder, neuropsychiatric disability * enrolled at the academic hospital in uppsala exclusion criteria: * high suicidal risk * extensive somatic disorders (somatic multichannel) * patients outside uppsala county * taking part in an ongoing vocational rehabilitation

Keywords: mental disorder rehabilitation
comparison of corticotomy and micro-osteoperforation during canine retraction

Conditions: Malocclusion, Class I/II

Summary: corticotomy and micro-osteoperforation (mop) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. mop is less invasive; however, it is unclear whether it is as effective as a corticotomy. the purpose of this study was to compare the maxillary canine retraction achieved by these techniques.

thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. subjects with previous orthodontic or endodontic treatment of canines were excluded. at least 3 months post-extraction, mops, and corticotomies were performed distal to the canines. mini-screws with closed-coil springs (150g) were used for canine retraction. dental casts were attained at baseline (t0) and 3 months post-intervention (t1). calibrated examiners measured the distances from the canine to the second premolar on both sides. a signed-rank sum test was used to compare canine retraction achieved in 3 months (t0-t1) in two sides

Eligibility criteria:
inclusion criteria: * healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding exclusion criteria: * previous orthodontic or endodontic treatment of the canines

Keywords: corticotomy; mop; tooth movement
feasibility and clinical utility of cell-free dna (cfdna) in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in texas

Conditions: Lymphoma

Summary: to test the feasibility of collecting cell-free dna (cfdna) samples from dlbcl patients before and after treatment. cfdna is dna traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

primary objective: • to determine the feasibility and clinical utility of ctdna in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in texas. secondary objectives: * to provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations * levels of cfdna and its association with both efs and os in patients receiving therapy

Eligibility criteria:
inclusion criteria: 1. male/female patients who are at least 18 years of age on the day of informed consent signing. 2. patients must have a histologically documented diffuse large b-cell lymphoma requiring therapy. 3. provision of written informed consent for the study. 4. pregnant women not included 5. cognitively impaired adults are not included. exclusion criteria: none
overtaking intra and inter tumoral heterogeneity in von hippel-lindau related renal cancer

Conditions: Clear Cell Renal Cell Carcinoma; VHL Syndrome

Summary: the goal of this study is to comprehensively map intra and inter tumor heterogeneity of ccrcc in vhl patients through the use of imaging, molecular biology and genomics techniques.

it was hypothesized that the high intra- inter-tumor heterogeneity of sporadic ccrcc also defines vhl-ccrccs, including different lesions within individual patients, and it was assumed that decoding vhl-ccrcc heterogeneity by coupling imaging, histology and molecular profiling of multiregional biopsies would help improve diagnostic tests and therapeutic choices for vhl patients. in order to comprehensively map intra and inter tumor heterogeneity of ccrcc in vhl patients, the aims of the study are: 1. to integrate pre-surgery imaging using conventional multiparametric mri with tumor histology of geographical predeterminated multi-region biopsies in each ccrcc of vhl patients. 2. to combine multiplex immunohistochemistry, bulk and single cell rna sequencing and somatic mutations analysis with pan-tumor histological assessment. 3. to optimize a protocol to generate vhl-ccrcc-derived tumor organoids (patient-derived organoids, pdo) and test anti tumor agents like hif2alpha inhibitor in organoid cultures representative of intra- and inter-tumor heterogeneity. this study will develop standardized models for diagnosis and molecular characterization of ccrcc in vhl disease using a combination of imaging, intrasurgical biopsying and multi-omics analysis. it will benefit of a clinical and research program devoted to vhl disease established at osr in 2021 that centralizes italian vhl patients. since the current study relies on tumor biopsy techniques that are already established in clinical practice, the translational findings will be directly available and immediately affecting patients' care.

Eligibility criteria:
inclusion criteria: * vhl syndrome * presence of at least 3 kidney tumors larger that 3cm to be surgically removed exclusion criteria: * absence of vhl * quantity of kidney tumors \< 3 * absence of surgery performance
acute effect of instrument-assisted soft tissue mobilization on hamstring flexibility via fascial chain

Conditions: Healthy

Summary: instrument assisted soft tissue mobilization (iastm) is one of the methods used to achieve fascial release. in this study, it will be examined whether there will be an increase in hamstring flexibility by releasing the superficial posterior fascial chain as a result of the iastm technique to be applied over the triceps surae muscle and plantar fascia. sociodemographic information of individuals who meet the inclusion criteria and volunteer to participate in the study will be obtained, and straight leg lift test and popliteal angle measurement will be performed with the digital inclinometer (baseline digital inclinometer) to be provided within the scope of the project to measure hamstring flexibility. then, iastm will be applied to the triceps surae muscle and plantar fascia for 15 minutes. measurements will be repeated after the application.


Eligibility criteria:
inclusion criteria: * healthy individuals with a straight leg lift test less than 80° and a popliteal angle greater than 15° will be included in the study. exclusion criteria: * individuals with a history of lower extremity fractures, lumbar disc herniation, acute pain, a history of lesion in the hamstring muscles at least 1 month before the study, knee or hip prosthesis, and those using drugs that may affect the measurements (e.g., muscle relaxants) will not be included in the study.