Kornimate/medical-research-clean huggingface dataset:
topical ionic contra-viral therapy in actinic keratosis

Conditions: Actinic Keratosis

Summary: to explore the pharmacodynamics and evaluate safety, tolerability and clinical efficacy of icvt comprised of digoxin and furosemide (dual agent), digoxin (single agent), furosemide (single agent) in patients with ak.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years or older with verified condition of general good health (with exception of ak) * confirmed clinical ak diagnosis by dermatologist * subjects must have at least 2 facial fields of at least 25 cm² (but preferably \>35 cm²) present at screening and baseline visit where more than 2 ak lesions are visible in each field (preferably the forehead, temple or cheek) * subjects must be able to participate and willing to give written informed consent and to comply with the study restrictions * subjects must be able to communicate well with the investigator in dutch * subjects willing to refrain from using other topical products in the treatment area, or prohibited medication for the duration of the study * subjects must be willing to limit sun exposure of the involved skin to the extent vocationally possible * subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose. exclusion criteria: * have used or received any treatment for ak in the treatment area within 28 days prior to enrollment (including topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for aks) * have any current pathologically relevant skin conditions in the field area other than ak (e.g. squamous cell carcinoma or basal cell carcinoma). * have a known hypersensitivity to any of the investigational product ingredients, including digoxin and furosemide. * current use of systemic digoxin or furosemide. * participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year * loss or donation of blood over 500 ml within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study. * if a woman of childbearing potential, pregnant, or breast-feeding, or planning to become pregnant during the study.
treatment for post-stroke depression

Conditions: Stroke; Depression

Summary: the purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

this trial will compare outcomes in depressed patients receiving the activate-initiate-monitor (aim) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. patients are screened for depression 1 to 2 months post-stroke. patients with depression are then randomized to the aim intervention or control group. patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients. the aim intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. control patients are evaluated and treated with usual care by their physicians. patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.

Eligibility criteria:
* no severe language or cognitive deficits, * life expectancy of at least 9 months, and * willingness to participate.

Keywords: stroke depression
myofunctional and respiratory intervention on phonation in stroke

Conditions: Stroke

Summary: patients with stroke frequently present phonation difficulties. an intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.

patients with stroke frequently present phonation difficulties. an intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. a combination of both may be of interest to improve phonation parameters.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of chronic stroke (duration above 6 months). * age over 18 years exclusion criteria: * communication or cognitive deficits that prevented them from following verbal commands.
a comprehensive practice-friendly model for promoting healthy behaviors

Conditions: Unhealthy Diet, Exercise, Smoking, and Alcohol Use

Summary: using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.

we posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. they must be comprehensive (addressing multiple behaviors and the "5 as"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the chronic care model. we will test the effectiveness and implementation of an innovative "packaged" intervention with these features. six acorn-affiliated practices will adopt a brief (3 minute) routine to deliver a1-3 (ask, advise, agree) in the office and to offer patients four options for intensive assistance (assist \[a4\], arrange \[a5\]) outside the office. patients can select 9 months of online, telephone, or group counseling; or usual care. an electronic health record (ehr) will expedite the in-office intervention and referrals. outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from ehr data, "counselee" surveys, and patient/staff interviews). we hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the common measures for physical activity, diet, smoking, and alcohol use). ehr-captured data will measure re-aim parameters, including reach (14 sub-measures), adoption, and maintenance. surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore implementation issues and suggested improvements. we hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. we strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. if our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.

Eligibility criteria:
inclusion criteria: all individuals over the age of 8 years presenting for care in 9 primary care practices exclusion criteria: none

Keywords: health behavior prevention informatics electronic health record
wellbeing and stress among mobile phone dispatched lay responders

Conditions: Stress, Psychological; Post-traumatic Stress

Summary: the aim of this study is to provide detailed information on state of mind, psychological wellbeing and stress for lay responders dispatched to suspected ohca via a mobile phone application. the heartunner system is a mobile phone positioning system for dispatch of cpr-trained lay volunteers to nearby suspected out-of-hospital cardiac arrests (ohcas). after downloading of a mobile phone application (the heartrunner application), and given consent of participation, the lay responders are dispatched to nearby suspected ohca. the lay responders are either dispatched directly to the scene of the suspected ohca to perform cpr, or to fetch the nearest aed. the location of the ohca and available aeds are displayed on a map, facilitated by the heartrunner application. the heartrunner system is studied through "the samba-trial" on clinical outcomes for ohca patients (clinicaltrials.gov identifier: nct02992873). the psychological effects among the lay responders will be evaluated with an online survey adjacent to dispatch and after 4-6 weeks. the results of the survey will be compared both intra-individual, and to a control group of not dispatched lay responders within the heartrunner system. descriptive statistics regarding interventions, age, gender and former experience will also be presented.

please see the attacehd study protocol for details

Eligibility criteria:
inclusion criteria: * mobile phone dispatched lay responders who reached the scene a suspected cardiac arrest. * located lay responders who was not dispatched due to technical or human reasons (no feedback from app to system). exclusion criteria: * mobile phone lay responders who declined the mission for dispatch to a suspected cardiac arrest. * mobile phone lay responders that already answered the survey. * mobile phone dispatched lay responders who accepted the mission but was aborted due to distance or did not reach the scene.
hypertrophic cardiomyopathy federated learning implementation platform

Conditions: Hypertrophic Cardiomyopathy

Summary: hcm flip study is a two-phase protocol focusing on the detection of hypertrophic cardiomyopathy using electrocardiograms and echocardiograms through federated learning.

hcm flip (hypertrophic cardiomyopathy federated learning implementation platform) aim to build and test a model's system impact to detect hypertrophic cardiomyopathy (hcm) by training a machine learning (ml) model with electrocardiograms (ecgs) and echocardiograms (echos). approximately 10-1000 hcm cases and 30-10,000 age/sex-matched controls per institution, depending on size, will be included in the study. we hypothesize that a federated ml model will discriminate cases of hcm from those without hcm in a real-world setting.

Eligibility criteria:
hcm-labeled case inclusion criteria: * patients with maximum left ventricular wall thickness exceeding 15 mm (including the right ventricular component of the septum) without any other explanation for ventricular hypertrophy (e.g., severe hypertension, cardiac amyloidosis, severe as, as determined by local investigators). the measurement could be made in an echo or on magnetic resonance imaging (mri). * patients must have \> one (1) ecg and/or \> one (1) echo available that meet minimum compatibility requirements. if multiple ecgs and echos are available per patient, then all available data meeting compatibility requirements will be used for model training purposes. hcm-labeled case exclusion criteria: * any sign of infiltration found in cardiac mri, if performed. control case (non-hcm) inclusion criteria: * no diagnosis of hcm * age/sex are matched to hcm cases (+/- 5 years, if possible; +/- 10 years if numbers do not permit). * patient must have \> one (1) ecg and/or \> one (1) echo available that meet minimum compatibility requirements. if multiple ecgs and echos are available per patient, then all available data meeting compatibility requirements will be used for model training purposes. control case (non-hcm) exclusion criteria * suggestion of hcm in a clinically obtained echo or cardiac mri report unless subsequently confirmed no diagnosis of hcm. any new clinical information discovered during the study will be left to the discretion of the local investigator.

Keywords: hcm hypertrophic cardiomyopathy federated learning federated learning platform flp
study to investigate the safety and efficacy of brii-835 and brii-179 combination therapy treating chronic hepatitis b virus (hbv) infection

Conditions: Hepatitis B, Chronic

Summary: this is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment brii-835 (vir-2218) and brii-179 (vbi-2601) in adult participants with chronic hbv infection


Eligibility criteria:
inclusion criteria: * male or female aged 18 - 60 * body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2 * chronic hbv infection as defined by a positive serum hbsag for ≥ 6 months exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * significant fibrosis or cirrhosis * history or evidence of drug or alcohol abuse * history of intolerance to sc or im injection * history of chronic liver disease from any cause other than chronic hbv infection * history of hepatic decompensation

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis
the cinch-fmr post-market registry: percutaneous repair in functional mitral regurgitation

Conditions: Functional Mitral Regurgitation; Mitral Regurgitation

Summary: this is a retrospective and prospective, multi-center, post-market observational registry study. the primary objective of this post market registry is to continue to evaluate the long term safety and performance of the carillon® mitral contour system® (cmcs) in a commercial (post market) setting.

there are more than 22 million people worldwide with heart failure, including 5.3 million in the united states . functional mitral regurgitation (mr), leakage of the mitral valve due to dilation of the left ventricle and annulus, occurs as a consequence of heart failure. cardiac dimensions has developed proprietary technology designed to address functional mitral regurgitation in a minimally invasive manner. previous studies have established that the carillon® therapy has caused a significant reduction in functional mr. this reduction in mr results in clinically significant improvements in exercise tolerance, quality of life, and thus overall function in a symptomatic heart failure population. to supplement the findings from these previous studies, cardiac dimensions is conducting this post-market registry of the carillon® mitral contour system® (cmcs) in patients with functional mitral regurgitation. this registry is a retrospective and prospective, multi-center, clinical registry designed to further characterize the acute and long-term safety and performance profile of the cmcs. up to 250 implanted patients will be enrolled at up to 40 centers located in the european union and countries that recognize the ce-mark as a valid marketing authorization. patients enrolled in the registry have received the carillon implant and will be assessed to document the long-term safety and performance of the device. these patients will be followed according to routine standard of care post procedure follow up assessments.

Eligibility criteria:
inclusion criteria: 1. patients with functional mitral regurgitation (i.e., dilated cardiomyopathy), in accordance with ce-mark approved labeling 2. patients implanted with the carillon device 3. patients must be ≥ 18 years old 4. patients require informed consent prior to inclusion in this registry 5. minimum baseline data, as described in cinch protocol, including: * hemodynamic measures (by echocardiography) * baseline must include the following measurements: mr grade, lvef (%), lvedd, lad, and ap \& ml diameters * nyha classification

Keywords: functional mitral regurgitation mitral regurgitation cardiac dimensions carillon mitral contour system cinch cinch fmr carillon cmcs
risk perception associated with covid-19 among anesthetists

Conditions: Cross Sectional Hospital Based Study

Summary: since the outbreak of the covid-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. so, they are subjected to a higher risk of infection compared to many other medical specialties. as a result, they are more subjected to psychological stresses. this study aimed to assess the level of stress associated with the covid-19 pandemic among anesthesiologists.

this is a cross-sectional, hospital-based survey conducted using an online questionnaire after getting irb approval. the primary outcomes are to evaluate the prevalence of anxiety, depression, and post-traumatic stress disorder (ptsd) among anesthesiologists working in saudi arabia. the secondary outcomes include the association of the socio-demographic and occupational characteristics with mental health in the study sample. the survey sent to the target participants using a web-based software platform (https://www.surveymonkey.com/r/zj98btj) though the saudi society of anesthesia. the study sample included anesthetists and their allied health care providers (nurses and technicians) involved in the management of covid-19 patients. data were analyzed using spss version 21. descriptive analyses were conducted, and the ranked data for each level for symptoms of depression, anxiety, and ptsd were presented as numbers and percentages. multi-variable logistic regression analysis was used to explore potential influence factors on the outcomes. p-values of less than 0.05 were considered statistically significant.

Eligibility criteria:
inclusion criteria: * the survey included anesthesia physicians, anesthesia technicians and nurses, and those involved in the management of covid-19 infected patients in the or, icu, or er. exclusion criteria: * the exclusion criteria include age \ 60 years, incomplete data, or those who were outside saudi arabia during the time of the covid-19 pandemic.

Keywords: covid-19 pandemic, anesthetists, psychological stress, anxiety, depression, ptsd
alternative prophylaxis in female recurrent urinary tract infections

Conditions: Urinary Tract Infections; Urinary Tract Infection (UTI)

Summary: urological pathogens are effected by rising antimicrobial resistance rates due to the frequent use of antimicrobials for treatment and prophylaxis. intravesical instillation with hyaluronic acid (ha) and chondroitin sulphate (cs) obtained positive outcomes in the treatment of overactive bladder, radiation cystitis and interstitial cystitis by replenishment of the glycosaminoglycan layer of the bladder. this study is to investigate whether intravesical instillation with ha-cs in patients with recurrent urinary tract infections (ruti) is superior to a placebo instillation in terms of reduction of rate of symptomatic urinary tract infections (utis) (based on clinical diagnosis) needing treatment with antimicrobials within 12 months after randomisation.


Eligibility criteria:
inclusion criteria: * documented history of ruti, defined as ≥ 3 episodes of (un)complicated uti documented by urine culture with the isolation of ≥103 cfu/ml of an identified pathogen in the last year with clinical symptoms or 2 episodes in the last 6 month exclusion criteria: * no informed consent * concomitant uti (\< 7 days prior to randomisation) * ongoing antimicrobial prophylaxis (e.g. for ruti or for any other reason like endocarditis, transplanted patients under immunosuppression) * ongoing prophylactic strategy (e.g. immunoactive prophylaxis) * documented underlying urogenital abnormality (e.g. significant post voiding residual volume (\>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux, urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic pelvic floor disorder (e.g. genital prolapse stage ≥ ii) * concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use) * urogenital urological or gynecological surgery \< 6 weeks * known allergy to the study medication * use of spermicides or intrauterine device * pregnancy

Keywords: hyaluronic acid (ha) chondroitin sulphate (cs) antimicrobial resistance rates intravesical instillation ha-cs instillations recurrent urinary tract infection (ruti)
effect of tele rehabilitation in breaking barriers with mobility impairments in rural areas (rct)

Conditions: Mobility Limitation

Summary: tele-rehabilitation offers remote healthcare services via telecommunication technology to patients who face challenges in accessing traditional in-person rehabilitation. this randomized controlled trial investigated the effectiveness of tele-rehabilitation in overcoming mobility impairments in rural pakistan.

a total of 92 participants, equally divided into intervention and control groups, were assessed. the intervention group received a 6-month tele-rehabilitation program, including video consultations, home visits, structured calls, and text messages.

Eligibility criteria:
inclusion criteria: * people will be eligible for participation if they have had any disorder causing mobility impairment, * lives in rural areas, * are over the age of 20, * have been discharged from inpatient, outpatient and community physiotherapy living in their home, (saywell, vandal et al. 2012) * have medical approval from their general practitioner to engage in low to medium level exercise programs, * at least 3 score on telephone cognitive screening questionnaire (callahan, unverzagt et al. 2002) * have limitation in mobility, physical function of arm, leg or both. exclusion criteria: * if they have confirmed cerebellar or brain stem stroke, * tele rehabilitation involvement require frequent communication with physiotherapist so using interpreter is considered impractical, * participants enrolled in other rehabilitation programs, * lack of necessary devices (e.g, internet, smartphone, tablet, computer) for tele rehabilitation.
a 10-week study evaluating the efficacy and safety of pd 0332334 in patients with generalized anxiety disorder (2)

Conditions: Generalized Anxiety Disorder

Summary: this is a 10-week trial that evaluates the efficacy and safety of pd 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.

on february 23rd 2009, a decision to terminate further development for pd 0332334 was communicated to investigators in this study. the decision to terminate this study was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * diagnosis of gad (diagnostic and statistical manual iv \[dsm iv\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the mini international neuropsychiatric interview (mini) for dsm iv axis i disorders and other clinical information. subjects with specific phobia(s) (as defined in dsm iv) or dysthymic disorder will be allowed in the study. * subjects must have a ham a total score ≥20 at the screening (v1) and randomization (v2) visits. subjects must also have a covi anxiety scale score of ≥9 and a raskin depression scale score ≤7 at the screening (v1) visit to ensure predominance of anxiety symptoms over depression symptoms. exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies). * any of the following current (within the past 6 months through the present) dsm-iv axis i diagnosis: major depressive disorder, obsessive compulsive disorder, panic disorder, agoraphobia, posttraumatic stress disorder, anorexia, bulimia, caffeine induced anxiety disorder, alcohol or substance abuse or dependence unless in full remission for at least 6 months, social anxiety disorder. * any of the following past or current dsm-iv axis i diagnoses: schizophrenia, psychotic disorder, delirium, dementia, amnestic, and other clinically significant cognitive disorders, bipolar or schizoaffective disorder, cyclothymic disorder, dissociative disorders. * antisocial or borderline personality disorder. * serious suicidal risk per the clinical investigator's judgment.

Keywords: pd 0332334 phase 3 pivotal trial