Kornimate/medical-research-clean huggingface dataset:
case management and peer support groups for prophylaxis adherence in rheumatic heart disease

Conditions: Rheumatic Heart Disease

Summary: the objective of camps is to test and evaluate scalable models of secondary antibiotic adherence support for children newly diagnosed with rheumatic heart disease. aim 1: determine 1-year bpg adherence rates of children newly diagnosed with latent rhd in uganda randomized to two support strategies: (1) usual care (arm 1) (2) peer group + case manager strategy (arm 2). aim 2: explore patient reported outcomes including treatment satisfaction, patient health-related quality of life, and care giver quality of life, in relation to support strategy and adherence.

while significant strides have been made in echo screening for early detection of rhd and establishment of rhd registries, these efforts are diluted by poor adherence to secondary antibiotic prophylaxis (sap). in a systematic review by kevat et al which included 20 global programs, only 20% were able to maintain patients on at least 80% adherence (the minimum acceptable level). other studies demonstrate similar findings, with adherence ranging from as low as 20% up to 75%. these studies demonstrate that non-adherence undermines most global sap programs. despite low adherence to rhd secondary prophylaxis globally, studies have demonstrated that ideal rhd sap adherence can be achieved, but within the confines of strict trial conditions (goal trial). currently, there is a dearth of research into pragmatic, scalable approaches to improve rhd sap adherence. in their systematic review of effectiveness and integration of rhd prevention and control programs, abrams et. al. advise that prevention and treatment programs should be integrated into general health systems and strengthen local systems. case managers and peer support groups (camps) will be a pragmatic randomized trial of two support strategies for rheumatic heart disease secondary antibiotic prophylaxis, integrated into routine care. hence, camps will address the gap that exists between ideal adherence achieved within the confines of a strict research trial and practical and scalable solutions that can be translated to real-world settings.

Eligibility criteria:
inclusion criteria: 1. ages 5-17 2. new diagnosis of latent rheumatic heart disease (rhd) as determined through school screening - exclusion criteria: 1. medical contraindication to sap (bleeding risk, allergy) 2. co-morbid conditions that have already resulted in prescription of sap (typically hiv, sickle cell disease, renal disease)

Keywords: adherence clinical trial community intervention
cytokines and cognitive decline in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of alzheimer's disease (ad). beside these 2 lesions, inflammation response is described in the brain of patients with ad. the main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, tnfα and chemochine rantes) and the rapidity of the cognitive decline in ad over a 2-year follow-up. secondary objectives include: * the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with ad (mmse: 16-25) * correlation between plasma cytokines levels and expression of the protein kinase pkr (involved in death cell) in blood mononuclear cells.


Eligibility criteria:
inclusion criteria: * alzheimer's disease (ad)patients * mmse score: 16-25 * written informed consent exclusion criteria: * ad patients with specific treatment for ad before inclusion mmse score under 16 or over 25 at inclusion * patients with anti-inflammatory drugs (non steroids or corticosteroids) or immunosuppressive agents * patients with acute disease (infectious disease, rheumatologic disease) or chronic disease (malignancy, infectious, rheumatologic disease) that could interact with plasma cytokines level * patients with a life threatening disease
comparison of prostate fusion biopsies with software and cognitive

Conditions: Prostate Cancer Detection; Fusion Prostate Biopsy

Summary: this study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpmri (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (bk-fusion®). half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.

various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpmri. the two most frequently used are cognitive fusion, in which the physician locates the areas where the mpmri detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpmri are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.

Eligibility criteria:
inclusion criteria: * age over 40 years. * mpmri carried out in our center. * presence of lesions with piradsv.2 ≥ 3. * acceptance to participate in the study. exclusion criteria: * psa\> 30 ng / ml * treatment with 5-aris (5-alpha-reductase inhibitors). * previous diagnosis of pca. * tr\> t3.

Keywords: prostate biopsy mpmri
clinical equivalence of two generic butenafine hydrochloride 1% creams as compared to lotrimin ultra cream in patients with interdigital tinea pedis

Conditions: Interdigital Tinea Pedis

Summary: to demonstrate comparable safety and efficacy of taro pharmaceuticals, inc butenafine hydrochloride cream 1% test product and lotrimin ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non lactating females 18 years of age or older. 2. signed informed consent form, which meets all criteria of current fda regulations and the requirements of the india regulatory authorities. 3. if female and of child bearing potential, have a negative urine pregnancy test at the baseline visit, 4. a total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. in addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling 5. a confirmed clinical diagnosis of interdigital tinea pedis. 6. the presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic koh wet mount examination (potassium hydroxide mount preparation). 7. identification of an appropriate dermatophyte by culture sent to the central laboratory. the appropriate dermatophytes are trichophyton rubrum, trichophyton mentagrophytes or epidermophyton floccosum. exclusion criteria: 1. use of any of the following within the indicated timeline: * oral or injectable steroids within four weeks of the study start. * any oral anti-fungals within 4 weeks of the study start. * use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start. * any prescription or otc topical antifungal on the feet within two weeks prior to study entry. * use of any antihistamines within 72 hours of the study start. 2. any known hypersensitivity to butenafine or other antifungal agents. 3. evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the investigators evaluation of tinea pedis. 4. patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.

Keywords: tinea pedis interdigital
a survey to evaluate diabetes management, control, chronic complications, psychosocial aspects of children with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this study is conducted in africa. the aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in algeria.


Eligibility criteria:
inclusion criteria: * informed consent obtained from the patient and his legal representative before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * type 1 diabetes * time since diabetes diagnosed at least 5 years * followed for diabetes at consultation for at least 12 months exclusion criteria: * patient previously included in this study * secondary diabetes * pregnant patient * patient consulting for an emergency
clinical evaluation of mosquito coils to control malaria in china

Conditions: Malaria

Summary: although mosquito coils are widely used, there is no robust evidence that their use can provide clinical reduction in malaria. this study will randomise 4 groups of 400 houses, each with 5 people, in rural china and monitor cases of malaria in each group each month for 6 months. the treatment groups will include coils, treated bed nets, coils plus treated bed nets, or no treatment (control). all cases detected will be given prompt appropriate treatment.

mosquito coils are extremely widely used by households across the world and reportedly make up the largest single family expenditure on any health-related items in many developing countries. despite their widespread use there has been no robust clinical evaluation to determine whether they can provide protection from malaria. this study is designed to determine if using coils (and / or llin) each evening can reduce malaria at the household level. the study will be a single-blind, randomised clinical evaluation clustered at the household level. there will be 4 treatment arms, coils / insecticide treated nets / coils + itn / no treatment. each arm will include 400 households each with 5 people / household (total of 8000 people). a maximum of 20% of houses in any village will be enrolled to reduce any effects of diversion of mosquitoes by any treatment. epidemiological factors and baseline malaria prevalence will be recorded during a pre-intervention baseline month by questionnaire and rapid diagnostic test (rdt) using species-specific dip sticks for malaria. post intervention will be 5 further monthly visits during the malaria season to detect new cases by rdt, reported fevers and operational data (compliance, adverse effects etc). primary outcome clinical measures will be incidence of malaria (p. falciparum / p. vivax) comparing new cases in each of the 3 treatment \& non-treatment groups. all cases will be treated promptly according to local policy. at the end of the study, all households which did not have a treated bed net will be provided with one. secondary non-clinical outcome measures will include entomological data collected in houses using / non using coils in sentinel villages at baseline \& during the study. cdc mosquito light traps will be used to record number / species / feeding status / parity (age) / sporozoite infection rates of mosquitoes in houses using / not-using coils following a randomised latin square design. such entomological data can be used to determine reduction in vector species mosquitoes entering houses using coils and / or itn. ethical approval for the study has been granted by the lshtm university of london ethics committee and the yunnan bureau of health, p.r.china.

Eligibility criteria:
inclusion criteria: * 6 years plus, * no allergy to products in use, * not pregnant / breast feeding exclusion criteria: * not sleeping at home each night

Keywords: malaria mosquito control mosquito coils llin
postoperative cognitive dysfunction in elderly

Conditions: Postoperative Cognitive Dysfunction

Summary: interventional study of early postoperative cognitive dysfunction in elderly patients undergoing general anesthesia the main purpose of this study is to determine the incidence of early postoperative cognitive dysfunction in elderly patients and its time course. this study will first evaluate the preoperative cognitive function of elderly patients based on several criteria including complete patient history, laboratory and instrumental exams, and the following measures in order to identify conditions and pathologies that may influence cognitive function. * mini mental state examination * geriatric index of comorbidity * geriatric depression scale the following neuropsychological tests will be performed on the same day within 7 days of surgery (baseline): * trail making test b-a * digit span * digit symbol substitution test the three cognitive function assessments will be repeated at the following postoperative time points and the change from the preoperative baseline to each time will be evaluated: * day 2 (time point 1) * day 4 (time point 2) * between days 85 and 90 (time point 3) if the patient seems confused before the postoperative administration of these tests, the neecham confusion scale will be used to evaluate the patient for the presence of postoperative delirium; if delirium is not detected, the cognitive function tests will be administered.

this study has three specific aims: 1. to define the frequency of occurrence of early post-operative cognitive dysfunction and its time course. 2. to assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors. 3. to compare our results with those from the international literature.

Eligibility criteria:
inclusion criteria: * age \> 65 years * surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental exclusion criteria: * a score of 20 or less on the mini-mental state examination (mmse) * illiteracy * can't understand italian language * serious hearing or vision impairment not treatable * a history of any disease of the central nervous system * a current or past history of psychiatric illness * a current use of major tranquilizers or antidepressants * alcoholism or drug dependence or abuse * scheduled to undergo cardiac, carotid or intracranial procedures * not expected to be alive or available to complete testing at 90 days after surgery

Keywords: post-operative cognitive dysfunction elderly mini mental state examination geriatric index of comorbidity geriatric depression scale trail making test b-a digit span digit symbol substitution test
cerament™| bone void filler device registry

Conditions: Orthopedic Disorder

Summary: a device registry to compile data on the performance of cerament bone void filler in normal use.

a device registry to compile data on the performance of cerament bone void filler in normal use.

Eligibility criteria:
inclusion criteria: * 18 years and over (on the day of surgery) * receive cerament bvf as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the ifu for the implanted product * in receipt of patient information leaflet and have signed appropriately designed informed consent exclusion criteria: * any exclusion criteria as per ifu for cerament bvf * any off-label use
carpal tunnel syndrome in patients with psoriatic arthritis; ultrasonography and magnetic resonance imaging findings

Conditions: Carpal Tunnel Syndrome; Psoriatic Arthritis

Summary: this study aimed to investigate relationship between cts diagnosis with electrodiagnostic studies and median nerve's cross-sectional area measered by us and mri in psa patients.

carpal tunnel syndrome (cts) is a type of entrapment neuropathy, caused by compression of the median nerve in the carpal tunnel at the wrist1. it accounts for about 90% of all entrapment neuropathies. but there is no gold standard technique for diagnosing cts. electrodiagnostic studies (eds) are generally used in differential diagnosis because the symptoms may be difficult to interpret. unfortunetely eds has some limitations. the factors can limit eds are that it is not comfortable for patients and physicians, may require interventional procedures, need patient cooperation, provide limited information on the etiology of cts, time consuming, and can not be used in some patient groups such as patients with dermatological contraindications. recent years, magnetic resonance imaging (mri) and ultrasonography (us) have facilitated the diagnosis of cts. the median nerve cross-sectional area (csa) measured by us or mri has been found to be associated with cts. however, there are studies with conflicting results regarding the median nerve csa in patients with rheumatic diseases. psoriatic arthritis (psa), a kind of rheumatic disease, occurs in up to 30% of people with psoriasis and can have serious debilitating effects on the peripheral joints, spine, tendon insertions, and fingers. to our knowlage, any study didn't assess mri measurements of median nerve csa in psa patients. in this study we aimed to assess cts's us and mri findings in patients with psa and compare them healty controls.

Eligibility criteria:
inclusion criteria: * psa patients according to the caspar criteria who consecutively applied to the ftr outpatient clinic for psa follow-up and healthy volunteers who applied to the ftr outpatient clinic enrolled in the study. exclusion criteria: * patients were excluded from the study if they had history of conditions associated with an increased incidence of cts except psa (diabetes mellitus, pregnancy, hypothyroidism, renal failure or other severe systemic diseases); history or clinical/electrophyscologic finding of radiculopathy, plexopathy, polyneuropathy or any nervous system diseases; history of fractures, severe trauma or surgical interventions involving the wrist; bifid median nerve on wrist imaging and under the age of 18, over the age of 65. there was no history of rheumatic disease in the healthy volunteer group.

Keywords: carpal tunnel syndrome psoriatic arthritis ultrasonography magnetic resonance imaging
effects of silica and asbestos fibres on the efferocytosis capacities of macrophages

Conditions: History of Exposure to Silica or Asbestosis; Positive Testing for ANA as a Marker of Systemic Autoimmune Diseases

Summary: evaluation of the efferocytosis capacities of blood monocyte derived macrophages (mdm) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of mdm from healthy donors.

patients with a proven history or current exposure will have 4 edta tubes drawn, approximately 24ml of fresh whole blood for efferocytosis assessment and : * 2 x 6ml serum tubes for the assessment of antinuclear antibody (ana) positivity, serum high-mobility group box 1 (hmgb1) and osteopontin for patients exposed to asbestos * 1 x 6ml serum tube for serum hmgb1 and osteopontin for patients exposed to silica

Eligibility criteria:
inclusion criteria: * patient older than 18 yo * addressed to the department of occupational disease * with a history of asbestosis or silica exposure evaluated by a dedicated questionnaire and a throughout examination of the history of occupations, according to standard procedures for the follow-up of at risk workers. * persons who received an oral and written information on the protocol and signed the informed consent form exclusion criteria: * pregnant or breastfeeding women * subject legally protected (under judicial protection, guardianship), persons deprived of liberty

Keywords: efferocytosis macrophages silica asbestosis hmgb1 osteopontin
the influence of atropine on choroidal thickness

Conditions: Myopia

Summary: atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. a previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. the aim of this study is to characterize the effects of atropine on choroidal thickness and the influence of time of administration (am vs pm). it is hypothesized that the atropine's effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm, where thicker baseline thickness will show a reduced choroidal response.

atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. a previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. the choroid shows diurnal variation and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown. thus, the objective of this study is to provide data to characterize the influence of atropine on choroid thickness. the study aims are to: 1. determine the effect of am or pm atropine application on choroid thickness 2. determine the effect of atropine on choroid thickness in relationship to baseline thickness participants will be asked to attend a screening session and 13 study visits. following the screening visit, participants will be scheduled to return for 4 visits across 12 hours (4 hour intervals starting from 8am) in a single day where eye shape measurements will be taken to characterize diurnal variations in eye shape. subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in the morning or a night. measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation. after a 2 week washout period, 1% atropine eye drops will be administered either in the morning or at night (the visit that was not previously scheduled) and measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation.

Eligibility criteria:
inclusion criteria: * good general and ocular health * soft contact lens wearers to cease lens wear for at least 24 hours * no previous rigid gas permeable lens wear exclusion criteria: * history of ocular surgery, including refractive surgery * amblyopia * use of ocular medications * known allergies or sensitivity to atropine * pregnant, plan to become pregnant, or are breastfeeding * taking monoamine oxidase inhibitors (maois)