Kornimate/medical-research-clean huggingface dataset:
effectiveness of a mobile application in improving employees' social well-being.

Conditions: Loneliness; Social Isolation; Social Support; Depressive Symptoms

Summary: the goal of this cluster randomized controlled trial is to learn if using frendie pro mobile application at workplaces improves social well-being in employees. the main questions it aims to answer are: does using frendie pro mobile application at work for 6 months reduce loneliness in employees? does using fendie pro mobile application at work for 6 months reduce social isolation in employees? researchers will compare employees from workplaces that use the frendie pro mobile application to employees from workplaces that do not use the mobile application to see if there are differences in their levels of social well-being (loneliness, social isolation, perceived social support, depressive symptoms). participants will be given access to the frendie pro mobile application and encouraged to use it by employers.

participants will be recruited from workplaces that use the frendie pro mobile application. after collecting baseline data, each workplace will be randomly assigned to treatment or control conditions. the unit of randomization is a workplace (or a team or department in bigger organizations). the intervention group will be encouraged to download and start using the frendie pro mobile application. the control group will be informed of the date when they will have access to it (six months after the baseline). both groups are asked to participate in two follow-ups - a 3-month follow-up and a 6-month follow-up.

Eligibility criteria:
inclusion criteria: * all employees working at the company/team/department participating in the study and starting to use the frendie pro mobile application within the study period. * ability to fill the questionnaires online in finnish exclusion criteria: * incapable of using questionnaire online * does not know finnish well enough to answer the questions

Keywords: loneliness work well-being social well-being
intravenous labetalol versus hydralazine in preeclampsia

Conditions: Preeclampsia Severe

Summary: we study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome


Eligibility criteria:
inclusion criteria: * patient with clinical diagnosis of sever preeclampsia exclusion criteria: patient with history of previous intracranial lesion patient with history of heart disease/allergy to drug patient with history of arrhythmia/anticoagulation any craniotemporal lesion -
phase ia malaria vaccine trial of two virosome-formulated peptides

Conditions: Falciparum Malaria

Summary: influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. the aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans.

influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. the aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides. the specific objective was to demonstrate the safety and immunogenicity of two virosome-formulated p. falciparum protein derived synthetic peptide antigens given in two different doses alone or in combination. methodology the design was a single blind, randomized, placebo controlled, dose-escalating study involving 46 healthy caucasian volunteers aged 18-45 years. five groups of 8 subjects received virosomal formulations containing 10 ug or 50 ug of ama 49-cpe, an apical membrane antigen-1 (ama-1) derived synthetic phospatidylethanolamine (pe)-peptide conjugate or 10 ug or 50 ug of uk39, a circumsporozoite protein (csp) derived synthetic pe-peptide conjugate or 50 ug of both antigens each. a control group of 6 subjects received unmodified virosomes. virosomal formulations of the antigens (designated pev301 and pev302 for the ama-1 and the csp virosomal vaccine, respectively) or unmodified virosomes were injected i. m. on days 0, 60 and 180.

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes, aged between 18 and 45 years, with a bmi \> 18.5 and \<30 were included if they gave written informed consent exclusion criteria: * chronix or acute illness, immunosuppression, lived in the past in a malaria endemic area, had visited such an area in the last 12 months, or had a history of clinical malaria

Keywords: malaria vaccine plasmodium falciparum phase i peptide virosome safety immunogenicity
ehr-integrated ruti texting platform

Conditions: Recurrent Urinary Tract Infection

Summary: the goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (uti). the main question it aims to answer is: • can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent utis as compared to usual care? participants enrolled onto the texting platform will: • receive evidence-based clinical guidance for the management of symptoms of uti and receive educational videos on how to prevent utis. an important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent uti.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. females who currently meet the criteria for recurrent utis 4. age 18 years or older 5. owns a mobile device with text messaging capability 6. ability to read and write english 7. currently receiving care from a provider in penn urogynecology or penn urology exclusion criteria: 1. history of known multidrug resistant utis 2. history of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain 3. on continuous suppressive antibiotics currently 4. currently pregnant or within 6 weeks of pregnancy 5. transplant patient on immunosuppressive medication currently 6. practice of chronic self-catheterization

Keywords: unnecessary antibiotics self-management digital platform texting implementation science recurrent uti healthcare utilization patient education
a randomized controlled study of family based ef training for schoolage children with adhd

Conditions: ADHD; Child, Only

Summary: the goal of this study is to provide a new treatment approach for schoolage children with adhd, which could facilitate the ef developing well to achieve better outcome.

adhd in preschoolers has become established as a valid psychiatric disorder with characterized core deficits of executive function (ef). the ef impairments occurred in preschool period could persist to childhood, adolescent and adulthood, causing extensive and deep damage of individual's academic and career achievement, social function, and peer relationship. although medication showed significant effectiveness in controlling the core symptoms of adhd, it failed to help patients master compensatory strategies to cope with functional impairments in learning and life events. the family intervention program for school-age adhd children is still rare, and it is a blank field in china. at present, most of these related studies have not integrated task training in realistic scenarios with parent training, and lack of randomized and controlled settings, which makes the effect of intervention less convincing. therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of family-based executive function training for schoolage children with adhd, and follow the subjects to observe whether the therapeutic efficacy would persist. in the mean time, the investigators also observe the factors which can influence the therapeutic efficacy. the goal of this study is to provide a new treatment approach for schoolage children with adhd, which could facilitate the ef developing well to achieve better outcome.

Eligibility criteria:
inclusion criteria: 1. meet both the criteria of adhd based on the interview by the cdis and clinical diagnosis with dsm-5; 2. full-scale iq estimated bythe wechsler intelligence scale for children-revised form (wisc-r) above 80; 3. their parents volunteered to participate in this study. exclusion criteria: 1. child with severe mental disorder or physical disease that might interfere the assessment and intervention, such as autistic spectrum disorder(asd), schizophrenia, epilepsy, traumatic brain injury, etc.; 2. parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..

Keywords: adhd executive function schoolage family-based intervention
enhancing support for women at risk for heart disease

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Heart Disease Risk Reduction; Diabetes Mellitus, Non-insulin Dependent

Summary: to test a practical, theory-based intervention to achieve long-term behavior change for postmenopausal women with type 2 diabetes at high risk for developing coronary heart disease (chd).

background: the overall goal of this study was to test a practical, theory-based intervention to achieve long-term behavior change for women with type 2 diabetes at high risk for developing coronary heart disease (chd). epidemiological and clinical studies suggest that diabetes is associated with increased risk for chd that is greater in women than in men. chd is a major cause of death and functional limitations in women, but the vast majority of chd studies have primarily involved middle-aged men. there is convincing research evidence that healthy lifestyle behaviors, including low-fat diet, physical activity, stress management, smoking cessation, and social support, can reduce chd risk the study was initiated in response to a request for applications released in october 1997 by the national institutes of health office of the director on "innovative approaches to disease prevention through behavior change." design narrative: the study was a randomized trial to compare short-term (6-month) outcomes in women receiving usual care compared to a modified ornish-type comprehensive lifestyle management (clm) intervention. participants (n = 279) were randomized to usual care (uc) or mediterranean lifestyle program, a lifestyle change intervention aimed at the behavioral risk factors (eating patterns, physical activity, stress management, and social support) affecting risk for chd in postmenopausal women with type 2 diabetes. after 6 months, women in the clm condition were randomized to one of two approaches for providing support either lay-led group support or personalized computer-based support - to evaluate these strategies in enhancing longer-term maintenance of effects. outcomes included multiple chd lifestyle behaviors (e.g., dietary intake, exercise levels, stress management, smoking cessation), physiological risk factors associated with chd (e.g., serum lipids, hypertension, weight, vascular reactivity), hba1c (glycated hemoglobin, a measure of diabetes), and quality of life (e.g., depression, functioning).

Eligibility criteria:
no eligibility criteria
crail - controlled reperfusion of the acutely ischemic limb

Conditions: Lower Extremity Ischemia

Summary: the purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (rutherford iia to iii) * informed consent of the patient exclusion criteria: * previous attempt of recanalisation (e.g. lysis therapy) * known a. poplitea aneurysm of the affected extremity * severe heart failure nyha iv * known atrial thrombus * terminal renal insufficiency (creatinine \>10mg/dl or current dialysis therapy, previous transplantation of kidney) * hypersensitivity to allopurinol * hypersensitivity to one component part of the reperfusion solution * participation in a clinical trial during the study or 30 days before * pregnancy or lactation * patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial * abuse to drugs or alcohol

Keywords: lower extremity ischemia
a digital life story to support person-centred care for older adults with dementia perspectives

Conditions: Cognitive Impairment; Dementia

Summary: person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. active use of the life story can create security for a person with dementia and their carers. the written life story describes the person and their life experiences, which can define the person's identity. national guidelines for care and nursing in dementia and blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. research shows that a life story can be designed in several ways. for example, in book form, as a brochure, collage, memory box or electronically. the life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. as more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document. overall aim: to test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. study i: exploring the research area of the life story in digital form. study ii: focus group interviews with healthcare professionals. study iii: test the application, min memoria. study iv: observations on the use of the application.


Eligibility criteria:
inclusion criteria: * healthcare professionals using a life story in daily care. exclusion criteria: * n/a
efficacy and safety study in the treatment of chronic diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to determine the safety and efficacy of dermal-lsr plus standard of care (soc) for the treatment of diabetic foot ulcers (dfu)in comparison to the treatment to soc alone.

the study is a pivotal, prospective, randomized, controlled, open-label, multi-center study that will evaluate the effectiveness and safety of topically applied dermal-lsr in chronic dfus.

Eligibility criteria:
inclusion criteria: * has signed a written informed consent prior to the first study intervention * is at least 18 and \<85 years of age * has one or more diabetic foot ulcers on the target limb, with only one marked for the study (target ulcer). it must have the following characteristics:plantar; grade 2 per curative health services classification; non-infected; neuropathic; non-malignant; at least 1.0-25cm\^2 post-debridement; present for at least 6 weeks * has type i or ii diabetes mellitus with an hba1c between 6-10% * has a maximum fasting blood glucose level of 13.8 mmol/l * an ankle-brachial systolic pressure index between 0.7 and 1.3 * if female and of childbearing potential has a negative serum pregnancy test and is neither breastfeeding or intending to become pregnant during the study * able and willing to attend the scheduled visits and comply with study procedures. exclusion criteria: * known or suspected disease of the immune system * active or untreated malignancy or active, uncontrolled connective tissue disease * treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment * presence of necrosis, purulence or sinus tracts that cannot be removed by debridement * has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb \< 4 weeks prior to enrollment * active febrile illness * ast, alt, alp \>3x the normal upper limit * serum creatinine \>2x the normal upper limit * osteomyelitis * active charcot * use of any topical treatments other than soc (standard of care)at the time of enrollment * enrollment in any investigational clinical trial within 30 days of the screening visit * known or suspected hypersensitivity to any study product components * recent or current history of alcohol or drug abuse * any condition, which in the opinion of the investigator, would interfere with the evaluation of the study product or poses a health risk to the subject * all site personnel directly affiliated with this study and their immediate families

Keywords: diabetic foot ulcer diabetes mellitus debridement dermal-lsr standard of care
impact of analgesia on success of external version: comparison of spinal anesthesia versus sedation

Conditions: Breech Presentation

Summary: at the time of birth, nearly 5% of children are in breech presentation. this type of presentation requires a medical environment and leads to more frequent use of caesarean sections. this is why the external version can be proposed, usually from the 36th week. its success rate is 40%, and is usually performed under simple sedation. one of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. the study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with 36 weeks of amenorrhea (sa) a fetus breech or transverse presentation * covered by a an insurance system * signed contentment exclusion criteria: obstetric contraindications: * placenta previa * 3rd trimester bleeding * suspicion of fetal anoxia * patient has already received more than one caesarean section * multi-fetal pregnancy * hiv + * anticoagulant therapy anesthesiologic contraindications: * infection at the puncture site, systemic infection or severe sepsis * intracranial hypertension * uncompensated heart failure * constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent * neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery * syringomyelia

Keywords: sedation spinal anesthesia
lifestyle intervention for patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the lims study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (ms). the patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.

this study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (ms) on daily functioning. ms patients will participate in the online lifestyle intervention of voeding leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. a subsample (n=200) will also take part in measurements through mobile applications. the investigators hypothesize that the lifestyle program will reduce the impact of ms on the patients' daily functioning.

Eligibility criteria:
eligibility criteria to participate in the online lifestyle intervention: inclusion criteria: * ms diagnosis * motivated to adapt their lifestyle * able to complete online questionnaires by themselves * able to do grocery shopping and to (let someone) prepare the meals from the program * in a subpopulation (n=200): daily use of a smartphone exclusion criteria: * not able to participate in an online lifestyle intervention (e.g. not having an email address, laptop/computer, internet) * an inability to speak or read dutch * vegan diet * not willing to eat fish * bmi \ 35 kg/m2 * pregnant or breastfeeding * diagnosis of an eating disorder or psychiatric disorder (according to the dsm-v criteria) * history of bariatric surgery * another disorder, such as inflammatory bowel disease (e.g. crohn's disease or ulcerative colitis), cardiovascular disease (e.g. severe heart failure), malignancy, diabetes type 1 and 2 * having previously participated in a lifestyle intervention of voeding leeft or currently participating in another lifestyle program or lifestyle study. * currently under treatment at a dietician or lifestyle coach

Keywords: lifestyle
rose bengal electromagnetic activation with green light for infection reduction

Conditions: Acanthamoeba Keratitis; Fungal Keratitis

Summary: rose bengal electromagnetic activation with green light for infection reduction (reagir ) is an international, randomized, doubled masked, clinical trial. the purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose bengal (rb-pdt). patients presenting to one of the aravind eye hospitals in india or to the federal university of são paulo ophthalmology clinic in brazil with either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as snellen visual acuity of 20/40 or worse, will be eligible for inclusion. those who agree to participate will be randomized to one of two treatment groups: group 4, sham rb-pdt: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham rb-pdt group 5, rb-pdt: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus rb-pdt.


Eligibility criteria:
inclusion criteria: * presence of smear or culture positive fungal or acanthamoeba ulcer; smear or culture negative ulcer; or any atypical bacteria (such as nocardia) * moderate to severe vision loss, defined as snellen visual acuity of 20/40 (6/12) or worse * corneal thickness ≥350 µm, as measured on as-oct * age over 18 years * basic understanding of the study as determined by the physician * commitment to return for follow up visits exclusion criteria: * evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain) * impending or frank perforation at recruitment * involvement of sclera at presentation * non-infectious or autoimmune keratitis * history of corneal transplantation * history of intraocular surgery within last three months * pinhole visual acuity worse than 20/200 in the unaffected eye * participants who are decisionally and/or cognitively impaired * presence of demestocele at recruitment