Kornimate/medical-research-clean huggingface dataset:
low-density lipoprotein cholesterol reduction with state-of-the-art therapy in secondary prevention and major cardiovascular adverse events: republic of srpska registry

Conditions: Acute Coronary Syndrome; Dyslipidemias

Summary: recent trials have demonstrated that a reduction in low-density lipoprotein cholesterol (ldl-c) reduces cardiovascular adverse events following acute coronary syndrome (acs). however, the data coming from the real-world setting are limited. therefore, the aim of the study is to assess the association between ldl-c changes with prognosis in patients who survive acs. patients with acs will be followed for mortality and major events for at least 1 year. changes in ldl-c between the acs and a 6- to 10-week follow-up visit will be analysed. the associations between quartiles of ldl-c change and therapy intensity with outcomes will be investigated using adjusted cox regression analyses.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome exclusion criteria: -
oral tofacitinib in adult subjects with discoid lupus erythematosus (dle) and systemic lupus erythematosus (sle)

Conditions: Discoid Lupus Erythematosus; Systemic Lupus Erythematosus

Summary: evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent sle.

discoid lupus erythematosus (dle ) and systemic lupus erythematosus (sle) can be devastating diseases with a significant impact on quality of life. dle is currently treated with potent topical steroids, antimalarials, and immunosuppressants. recent research has determined that dle is a th1 mediated disease. there is increasing evidence that jak inhibitors such as tofacitinib can treat the th1 mediated diseases such as alopecia areata. therefore the goal of this study is to determine if jak inhibitors can successfully treat dle. tofacitinib has not previously been studied in dle. this will be a pilot study that is descriptive for early clinical impressions and molecular mechanisms in order to obtain initial information to potentially design an appropriately -powered phase 2 or 3 study for efficacy of jak inhibitors that could take place in the future

Eligibility criteria:
inclusion criteria: * adults 18 years to ≤ 65 years of age with clinical diagnosis of dle (and at least half of patients with a diagnosis of sle) as determined by the principal investigator by medical history and physical exam. * able to understand consent procedure * able to comply with protocol activities * have had a diagnosis of biopsy proven dle for at least 6 months prior to visit 1 (baseline/day 1). * at screening and visit 1 (baseline/day 1), have had dle covering at least 5% of total body surface area (bsa) or sle with dle covering at least 2% of bsa as determined by the hand print method (one palm is equivalent to 1% bsa). exclusion criteria: * patients not able to understand consent procedure * patients unable to comply with protocol activities * other skin conditions at baseline that would interfere with evaluation of dle. * topical corticosteroid within the past 2 weeks * systemic therapy is allowed if on a stable dose and using for at least 3 months -background therapies outlined in protocol * concomitant use of moderate to potent inhibitors and inducers of cyp3a4/5 * women who are pregnant or wish to become pregnant, or who are lactating. women of childbearing potential must use effective contraceptive methods in order to participate in tofacitinib clinical studies * history of infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to first dose of study drug or history of infection requiring antimicrobial therapy within 2 weeks prior to first dose of study drug
efficacy and safety study of xyotax to treat prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to determine whether xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.

prostate cancer is the second leading cause of cancer death in american men. hormonal ablation, in the form of medical or surgical castration, is the cornerstone of management for metastatic prostate cancer; however, treatment options for a patient in whom androgen ablation fails are limited. docetaxel and paclitaxel, taxanes that are cell cycle specific, play a major role in advanced hormone-refractory prostate cancer treatment. in preclinical studies, xyotax, a conjugate of paclitaxel with enhanced permeability and retention in tumor tissue, has an improved therapeutic profile, with both decreased systemic drug-related toxicities and enhanced efficacy. xyotax as a single agent has been studied in a broad variety of syngeneic and xenogeneic tumor models. recognizing that taxanes are active in prostate cancer and preclinical data reports activity with xyotax in docetaxel and paclitaxel resistant cell lines, there is significant rationale to develop this agent in prostate cancer. thus, a phase ii study is needed to evaluate the antitumor activity in two subsets of hormone refractory prostate cancer patients: those with no prior systemic and those with one prior systemic therapy.

Eligibility criteria:
inclusion criteria: * progressing adenocarcinoma of the prostate having failed prior hormone therapy * free of serious co-morbidity * have a life expectancy of ≥ 24 weeks * maintaining castrate status (either surgically or hormonally) exclusion criteria: * patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by mri for at least 6 months * patients known to be hiv positive * patients with active autoimmune disease * patients involving concurrent anticancer drug therapy * patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable chf, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)

Keywords: adenocarcinoma of the prostate recurrent prostate cancer hormone refractory prostate cancer
the hf-hrv registry

Conditions: Heart Failure; Arrhythmia

Summary: the registry will evaluate how hrv monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.


Eligibility criteria:
inclusion criteria: * patients receiving their first crt-d * patients who sign and date a patient informed consent prior to device implant * patients who are available and willing to attend follow-up visits at the study center in which they were enrolled exclusion criteria: * patients who are anticipated to receive pacing modes other than ddd or vdd (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy * patients who are younger than 18 years of age * patients whose life expectancy is less than six-months due to other medical conditions * patients with or who are likely to receive a tricuspid or other valve prosthesis * patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study * women who are pregnant
board game project for adolescents with tourette syndrome

Conditions: Tourette Syndrome in Adolescence; Social Adjustment; Psychosocial Functioning

Summary: the study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.

this study utilizes a randomized control study design. according to the situated learning theory and qualitative research findings, this study develops a board game. this study enrolled adolescents with tourette syndrome aged 12 to 18 as the subjects. participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. the control group received the usual standard of care (psychoeducation regarding tourette syndrome and one 50-mg tablet of pyridoxine daily). the effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with ts.

Eligibility criteria:
inclusion criteria: * adolescents between the ages of 12 and 18 years were diagnosed with tourette syndrome or chronic tics disorder by a pediatrician, according to the dsm v. * ability to speak and understand mandarin. * adolescents and their parents were willing to participate and fill in consent forms. exclusion criteria: · adolescents with tourette syndrome have mental illness and serious diseases.

Keywords: tourette syndrome depression social adjustment board game positive mental health
observational study to assess the adequacy of methadone dosage, in heroin addicted patients in a mmt.

Conditions: Heroin Addiction

Summary: the purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. the efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. the patients will be observed for two years.

500 patients will be selected among all patients addicted to heroin according to dsm-iv_tr (diagnostic and statistical manual of mental disorders iv_ text revision), in maintenance methadone treatment, observed in the involved sites. the investigators will use treatment schemes with methadon conform to clinical practice and according to spc (summary of product characteristics). the enrollment will be competitive. patients that meet incl/excl and that sign the informed consent, will be observed for 2 years. follow up visits will be performed according to routine procedures, for patients that belong regularly to site at 3/6/9/12/18/24 months post v1. during the visits, patients will be assessed by validated and used as clinical practice questionnaires . for the evaluations of tolerability and safety the laboratory tests and electrocardiograms routinely performed will be collected.

Eligibility criteria:
inclusion criteria: * both sexes * over 18 years of age * patients with a diagnosis of heroin addiction according to icd-10 (international classification of diseases) * patients who have undertaken a methadone maintenance treatment * adhesion to observational study by signing informed consent. exclusion criteria: * inability to follow the observation * diagnosis of decompensated psychotic disorders

Keywords: methadone heroin addiction methadone maintenance treatment adequate dosage of methadone
effects of fairytales on preschool children with attention deficit hyperactivity disorder

Conditions: Developmental Delay; Preschool Children; Attention Deficit Hyperactivity Disorder

Summary: under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with attention deficit hyperactivity disorder with developmental delays.

thirty preschool children with attention deficit hyperactivity disorder and developmental delays will be enrolled in regular traditional rehabilitation programs. they will be randomized to the intervention group and control group. the participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. the participants of both groups will continue to receive the traditional rehabilitation programs. therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment. the evaluator will be blinded to the group's allocation during the whole course of the intervention.

Eligibility criteria:
inclusion criteria: * preschool children with a diagnosis of attention deficit hyperactivity disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater exclusion criteria: * age less than 3 or greater than 6 of children diagnosed with attention deficit hyperactivity disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
optimization of a photoretinoscopy method for determining the objective refraction of children

Conditions: Ametropia

Summary: the objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

a single visit will be necessary. after informed consent, and checking of the inclusion and exclusion criteria, investigators will perform measurements with an autorefractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an autorefractometer under cyclopegia.

Eligibility criteria:
inclusion criteria: * voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old) * at least 6 years old and up to 12 years old at time of informed consent and assent * average of the equivalent sphere(sph+cyl/2) of both eye included in the interval \[-10.00, +0.75\] * cylindrical refractive error between 0 and 4.00 d on both eyes * corrected binocular visual acuity in distance vision at least 6/9 exclusion criteria: * incapable of expressing consent * all categories of persons particularly protected by law * subject in another study which might have an influence on vision or interfere with study assessment * less than 6 years old, or 13 years old or above at time of informed consent and assent * amblyopia, cataract, strabismus. * aphakic or pseudophakic (intraocular implant) * reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye. * self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) * any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...), * any myopia control solutions that could affect refractive status of the eye (e.g. atropine eye drops, orthokeratology)
a phase i trial of tecogalan sodium (ds-4152) administered as an infusion every 21 days

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to evaluate the safety of different doses and dosing regimens of tecogalan sodium (ds-4152) and to establish the mtd at each of the different dosing schedules.

patients receive intravenous ds-4152 by infusion once every 21 days; courses may repeat. patients undergo weekly follow-up. a punch biopsy will be obtained from patients with kaposi's sarcoma.

Eligibility criteria:
inclusion criteria patients must have: * kaposi's sarcoma plus hiv infection or metastatic solid tumor. * life expectancy of at least 12 weeks. * no symptomatic aids-defining opportunistic infection within the past 4 weeks. * recovered from toxicity of any prior anticancer therapy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * leukemia or lymphoma. * current gastrointestinal bleeding by stool guaiac. * extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. * active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. * acute intercurrent infection other than genital herpes. * symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. concurrent medication: excluded: * other anticancer therapy. * other investigational agents. patients with the following prior conditions are excluded: * history of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. * history of myocardial infarction within past 6 months. prior medication: excluded: * anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin c). * investigational agents within the past 4 weeks.

Keywords: neoplasms sarcoma, kaposi acquired immunodeficiency syndrome antineoplastic agents tecogalan
post-stroke enhancement of delirium outcomes with reduction in neuro-checks

Conditions: Stroke, Acute; Stroke, Ischemic; Delirium; Neuro: Cerebrovascular Accident

Summary: there have been limited studies on delirium in patients hospitalized with acute stroke. there have been no studies on the potential impact of overnight neuro-checks and resulting sleep disruption on delirium or other outcomes. additional research is needed to determine if overnight checks are necessary or even harmful. we aim to find out if stopping overnight neuro checks may prevent delirium and benefit the patient.

this study hopes to challenge the clinical paradigm that all patients with acute stroke need around-the-clock neuro-checks. the practice of conducting an nihss every 4 hours on patients with acute stroke has never been validated, particularly in clinically stable patients, but is the standard of care. this practice potentially comes at the cost of inducing delirium due to poor sleep which can result in numerous adverse outcomes. this study hopes to identify the impact of eliminating overnight neuro-checks and prioritize sleep and rest. we hypothesize that increased emphasis on sleep will reduce the incidence of delirium and thereby improve the deleterious effects of delirium such as prolonged length of stay and increased likelihood of being discharged to a facility. a quality improvement project was undertaken to at musc to begin to understand the impact of eliminating overnight neuro-checks. this project was focused on patients on the inpatient stroke service, admitted to 9 east. starting in october 2022, the stroke team would identify patients who were medically and neurologically stable and place an order to discontinue overnight neuro-checks. incidence of delirium, los, nihss, and mrs were compared using data from 4 months prior (june-september 2022) and 8 months after initiation of the project. compared to pre-intervention, there was a reduction in patients who were delirious from 34-24% and a reduction in average length of stay by 1.5 days. this preliminary data suggests a positive impact of the intervention. there was no change in nihss at discharge or the mrs at discharge suggesting there was no negative impact on the patient's neurologic function by eliminating overnight neuro-checks. the data collect from this preliminary study is exciting, however, warrants more a more scientific evaluation. the proposed study will be a randomized control trial that will help answer these questions more definitively.

Eligibility criteria:
inclusion criteria: * admitted with acute stroke age greater or equal to 18 years old medical and neurologic stability for discontinuation of neuro-checks, determined by the stroke service np and attending physician (no uncontrolled fluctuation in vital signs, seizure like activity or worsening neurologic function) ability to give informed consent, or identifiable surrogate decision maker exclusion criteria: surgical hemorrhagic stroke subarachnoid hemorrhage medical or neurologic instability pregnancy inmates
efficacy of intralesional triamcinolone and 8% topical pirfenidone for treatment of keloid scars

Conditions: Keloid

Summary: the aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. the duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. the estimated number of persons to be recruited and randomized for the study is 102.

individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. the interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. the scar size will be measure at weeks 12, 24 and 52.

Eligibility criteria:
inclusion criteria: * keloids size equal or major than 1 cm * keloids less than 5 years old * keloids in trunk exclusion criteria: * keloid with a surgical indication * hypertrophic scars * scars after burn wounds * pregnancy * lactation * use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication * known hypersensitivity for triamcinolone or pirfenidone * severe comorbidity not controlled * inflammatory acne * diabetes mellitus * hypertension * renal, hepatic or respiratory failure * topical treatment 4 weeks before recruitment * previous treatment with intralesional steroids

Keywords: keloid scar
effects of different protocols of physical training on levels of muscle strength and functional capacity

Conditions: Peripheral Arterial Disease

Summary: introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients.

study aim: to assess three methods of physical training (strength training, aerobic training and electrical stimulation training) in muscle strength, functional capacity and life quality of patients with peripheral obstructive arterial disease

Eligibility criteria:
inclusion criteria: * diagnosis of pad and ic. * age from 40 to 80 years. * stage i and ii of fontaine. * symptoms of intermittent claudication for at least 3 months with resting brachial index ≤ 0.90 in 1 or 2 legs exclusion criteria: * critical ischemia in one of the lower limbs. * moderate or severe ulcers in one of the lower limbs. orthopedic problems that prevent exercise or evaluation. * participation in other studies with rehabilitation. * decreased arterial hypertension. * decompensated diabetes

Keywords: peripheral arterial disease, training