Kornimate/medical-research-clean huggingface dataset:
lipid variability--influence of stress

Conditions: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia

Summary: to investigate the variability of lipids and specifically the effects of stress on serum triglyceride levels, total cholesterol, hdl, and ldl in a 2.5 year epidemiological study.

background: while researchers had documented some of the behavioral contributors to fluctuation in individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention had been given to psychosocial stress. early reports utilizing accountants, race car drivers, and air traffic controllers provided some uncontrolled data associating stress with cholesterol increases. yet, no empirical research on stress that concomitantly examined other related influences was available. this paucity of data was probably due to lack of objective measures of stress and difficulty in measuring lipid subfractions. design narrative: based on the results of their pilot study, and their research observations, the investigators predicted significant positive associations between stress level and triglycerides. a total of 228 public accountants (148 men and 80 women to provide comparable power between the sexes) were recruited from the greater birmingham, alabama area. participants were evaluated monthly for 18 months, across three stressful and non-stressful work intervals (i.e., tax seasons). the investigators also collected data (during this same time frame) to closely monitor the following variables that affect lipids: dietary intake (including alcohol, caffeine, total calories, total fat, saturated fat, and dietary cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status and menstrual stage among the women. additionally, a substudy presented a unique opportunity for them to investigate the relation between stress and triglyceride-rich lipoproteins in the formation of foam cells. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
phase iv long-term maintenance study of aripiprazole in the treatment of irritability associated with autistic disorder

Conditions: Irritability Associated With Autistic Disorder

Summary: the purpose of this study is to determine whether pediatric participants with irritability associated with autistic disorder who have responded to aripiprazole treatment will experience a relapse significantly later when continuing therapy with aripiprazole than will participants who receive placebo

phase 1: single blind/ phase 2: double blind

Eligibility criteria:
key inclusion criteria: * male or female children or adolescents, 6 to 17 years of age, inclusive, at the time of the baseline visit * meets current diagnostic criteria of the diagnostic and statistical manual-of mental disorders iv-text revised for autistic disorder and displays behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems. diagnosis of autistic disorder will be confirmed by the autism diagnostic interview-revised. * participant or designated guardian or caregiver is able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator. * demonstrates behaviors such as tantrums, aggression, or self-injury or a combination of these problems * an aberrant behavior checklist irritability subscale score ≥18 and a clinical global impressions severity score ≥4 at the screening and baseline visits. * mental age of at least 24 months key exclusion criteria: * treatment resistant to neuroleptic medication, based on lack of therapeutic response to 2 different neuroleptics after treatment for at least 3 weeks each. * previous treatment with aripiprazole for at least 3 weeks duration at an adequate daily dose, without demonstrating a clinically meaningful response. * lifetime diagnosis of bipolar disorder, psychosis, or schizophrenia, or a current diagnosis of major depressive disorder * diagnosis of pervasive developmental disorder-not otherwise specified, asperger's syndrome, rett's syndrome, childhood disintegrative disorder, or fragile x syndrome * history of neuroleptic malignant syndrome * at significant risk for suicide based on history or routine psychiatric status examination * a seizure within the past year * history of severe head trauma or stroke * history or current evidence of any unstable medical conditions that would expose the patient to undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial * weight lower than 15 kg * known allergy or hypersensitivity to aripiprazole or other dihidrocarbostyrils * history of a clinically significant low white blood cell count or a drug-induced leukopenia/neutropenia * any other medically significant abnormal laboratory test or vital sign result or electrocardiogram finding
evaluation of transperineal us in stress incontinence

Conditions: Stress Incontinence, Female

Summary: stress urinary incontinence (sui) has an observed prevalence of between 4%and 35%.identified risk factors are aging, obesity and repeated pregnancies and deliveries. urodynamic remains the gold standard for diagnosis in the past years. trans labial ultrasound appears to have a good role in diagnosing stress incontinence

a comparative observational cross sectional study will be conducted . the symptom, or "subjective indicator of disease," of sui is described as "the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing." 1 stress urinary incontinence (sui) has an observed prevalence of between 4% and 35%. it's a social problem that causes hygienic problem that s distressing for females. urodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it's not done routinely in all cases of urinary incontinence according to the nice guidelines 2 translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.

Eligibility criteria:
inclusion criteria: females between 20-75 years old * -women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic. exclusion criteria: * -known to be diabetic * urge incontinence or mixed type * voiding dysfunction * neurological problems * open suprapubic wound * previous surgery for pop(pelvic organ prolapse) or incontinence * suspicion of pelvic malignancy
heraeus microdttect lyon pilot studyprosthetic joint infections (pjis)

Conditions: Chronic PJIs

Summary: prosthetic joint infections (pjis) are one of the main causes of implant failure after joint arthroplasty. identification of the causal organism is crucial for successful treatment. however, microbiological diagnosis of pjis remains a challenge notably because bacteria are embedded in biofilm adhered to the material. recently, dithiothreitol (dtt) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis. in this study, the investigators evaluate the interest of a commercial device using dtt, the microdttect system (heraeus, hanau, allemagne), for the diagnosis of low-grade chronic pjis compared to the conventional culture of periprosthetic tissue (ppt) samples.

prosthetic joint infections (pjis) are one of the main causes of implant failure after joint arthroplasty. identification of the causal organism is crucial for successful treatment. however, microbiological diagnosis of pjis remains a challenge notably because bacteria are embedded in biofilm adhered to the material. recently, dithiothreitol (dtt) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis. in this study, the investigators evaluate the interest of a commercial device using dtt, the microdttect system (heraeus, hanau, allemagne), for the diagnosis of low-grade chronic pjis compared to the conventional culture of periprosthetic tissue (ppt) samples.

Eligibility criteria:
inclusion criteria: adult patients with painful prosthesis or prosthesis loosening \<10 years * without mechanical explanation, * without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation), * without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture). exclusion criteria: patients with painful prosthesis or prosthesis loosening * with mechanical explanation, * or with clinical evidence of infection (fistula, abscess, discharge, local inflammation), * with a previous microbiological diagnosis

Keywords: bone and joint infection biofilm joint arthroplasty implant failure prosthetic joint infection dithiothreitol
peru decentralized hiv care

Conditions: HIV

Summary: the purpose of this study is to understand the processes by which hiv care is decentralized, an evidence-informed strategy to improve retention in hiv care, in peru. decentralization of hiv services has not been evaluated using experimental designs and urban decentralization studies of hiv are uncommon, so this study will lend important insights for future decentralization efforts in peru and other countries.

aim 1: using the delphi method, to create guidelines to identify: 1) criteria for transferring patients between hub and spoke and for initiating treatment in primary health clinics (phcs); and 2) the most important quality health indicators (qhis) needed to be assessed at phcs to improve retention in care (ric) and viral suppression (vs). aim 2: to identify the barriers and facilitators to decentralized hiv care from patients and clinicians in secondary health centers (shcs) and phcs in peru, where hiv is concentrated in key populations and treated primarily in shcs. findings will guide a hub and spoke decentralized care model to facilitate decentralized hiv care. aim 3: using a step-wedge design with 4 hub/spokes (4 shcs + 165 phcs), the investigators will conduct a type 2 hybrid implementation trial using to assess the extent to which decentralized services are adopted and scaled-up in phcs over 24 months of observation using niatx (network for the improvement of addiction treatment) combined with echo (extension for community healthcare outcomes)-like tele-education to develop and enhance a hub and spoke model. the implementation outcomes will include the proportionate increase of people with hiv (pwh): a) treated in phcs; b) retained in care; and 3) achieving vs. adoption by phcs to accept pwh, fidelity to niatx and echo, and concordance with decentralization guidelines will also be assessed. the focus of this registration is aim 3.

Eligibility criteria:
inclusion criteria for aim 3: survey of phc and shc clinicians (n=330): * currently employed at a phc or shc that is participating in the study. provide consent for participation. continuing professional development (n=825): * currently employed as a nurse or physician who fulfilled the echo training requirements survey of phc leadership (n=165): * currently serving as the leader of a phc.

Keywords: hiv care
researching the effect of exercise on cancer

Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage I Colorectal Cancer; Stage II Colorectal Cancer; Stage III Colorectal Cancer

Summary: researchers think that exercise may be able to prevent cancer from coming back by lowering ctdna levels. the purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctdna found in the blood. during the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctdna levels) will be found. each level of exercise tested will be a certain number of minutes each week. once the best level of exercise is found, it will be tested further in a new group of participants. all participants in this study will have been previously treated for breast, prostate, or colorectal cancer.


Eligibility criteria:
inclusion criteria: * postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following: ° high-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for phase 1a) * stage 3 or * ctdna positive ° high-risk breast cancer * residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (nact), * estrogen receptor (er), and/or progesterone receptor (pr) positive and her2 negative, * cps-eg score ≥ 3, * cps-eg score ≥2 w ith ypn+, or * recurrence score ≥ 25 * no evidence of disease * age ≥ 18 * interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy * non-exercising (i.e., \< 30 minutes of moderate and \< 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry) ° if ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the pi. * cleared for exercise participation as per screening clearance via par-q+ * willingness to comply with all study-related procedures exclusion criteria: * enrollment onto any other interventional investigational study except interventions determined by the pi not to confound study outcomes * any other current diagnosis of invasive cancer of any kind * distant metastatic malignancy of any kind * any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Keywords: breast cancer prostate cancer colorectal cancer exercise ctdna 20-378 memorial sloan kettering cancer center
dose-escalation study of ly573636-sodium and liposomal doxorubicin in patients with advanced solid tumors

Conditions: Solid Tumors

Summary: the goal of this study is to determine the dose of ly573636-sodium (hereafter referred to as ly573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment. the study consists of a dose escalation phase to the maximum tolerated dose (mtd) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin.


Eligibility criteria:
inclusion criteria: * you must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy * you must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option * you must have measurable disease or non-measurable disease as defined by the response evaluation criteria in solid tumors (recist) * you must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dl) (30 g/l) * you must have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * you must have tumor progression after receiving standard/approved chemotherapy * you must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures * women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception * your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory * ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant) * ovarian patients in the confirmation phase must have measurable disease by recist * ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy exclusion criteria: * you cannot have received other investigational drugs within the last 28 days * you cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections * you cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis * you cannot currently be receiving warfarin (coumadin®) therapy * you cannot have known positive test results in human immunodeficiency, hepatitis b surface antigen or hepatitis c antibodies * you cannot have a history of cardiac disease or clinical evidence of congestive heart failure * ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease * you cannot currently be receiving amiodarone, quinidine, propofol, and clozapine * if you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after ly573636 administration
objective and subjective outcomes of a trifocal iol in eyes with different al

Conditions: Cataract; Presbyopia; Lenses, Intraocular; Myopia; Satisfaction

Summary: this prospective cohort study enrolled patients with implantation of a trifocal iol. only one eye of each patient was enrolled. eyes were devided into three groups according the axial length (al), including the short al group, the control group and the long al group. manifest refraction, uncorrected and distance-corrected visual acuity at different distances, contrast sensitivity, aberrations and iol decentration were measured three months after surgery. spectacle independence, adverse photic phenomena, overall satisfaction and life quality were assessed with a questionnaire.


Eligibility criteria:
inclusion criteria: * inclusion criteria were patients older than 40 years with significant bilateral or unilateral cataract seeking spectacle independence, with the al between 21.00 to 30.00 mm, the prediction of postoperative corneal astigmatism less than 1.0 diopters (d), the angle kappa less than 0.50 mm, the corneal spherical aberration less than 0.5 μm and the corneal higher order aberration less than 0.5 μm. exclusion criteria: * exclusion criteria were eyes with serious intraoperative complications, irregular corneal astigmatism, corneal scarring, uveitis, glaucoma, pseudoexfoliation syndrome, macular degeneration or other retinal impairment, amblyopia or patients having difficulties with examinations or 3 months' follow-up.

Keywords: cataract presbyopia intraocular lens axial length satisfaction
contribution of genetics, non-invasive methods and neuropsychology in focal cryptogenic epilepsies

Conditions: Epilepsies, Partial; Epilepsy Intractable

Summary: patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. among them, about 30% are drug-resistant. the implementation of of high-field magnetic resonance imaging resolution, the new next generation sequencing techniques,and innovative non-invasive neurophysiological methods (electroencephalogram-functional magnetic resonance imaging and high density-electroencephalogram) could provide a superior identification of the epileptogenic zone and therefore an increased access to epilepsy surgery. despite this, patients with cryptogenic epilepsy require more frequently invasive methods of presurgical study and they have more unfavorable results than patients with lesions detectable on magnetic resonance imaging. within this context, the study is aimed at integrating the neurophysiological, radiological, neuropsychological and genetic aspects of patients with focal cryptogenic epilepsy in order to evaluate their surgical eligibility,sparing invasive methods.

the investigators foresee study duration of 36 months and the enrollment of about 20-25 patients, affected by cryptogenic epilepsy with onset during pediatric age (0-18 years), not only to identify the cause of epilepsy and the epileptogenic zone, but also to define in a non-invasive manner, the patient's possible eligibility for surgical therapy. innovative neurophysiological methods, such as combined electroencephalogram-functional magnetic resonance imaging recording and high resolution electroencephalogram, in addition to 7 tesla brain magnetic resonance imaging (available through the imago7 non-profit foundation), neuropsychological studies and genetic tests through next generation sequencing allow an advanced pre-surgical study free from the risks and discomforts caused by invasive methods. the systematic use of these diagnostic approaches will implement the knowledge and skills of the teams and it will stimulate their use in the clinical daily practise, especially for pediatric patients. in addition to that, the investigators would like to analyse descriptive indications relating to the diagnostic sensitivity of the combined electroencephalogram-functional magnetic resonance imaging recording, high density-electroencephalogram and 7 tesla magnetic resonance imaging in the identification of the epileptogenic zone, in patients with cryptogenic focal epilepsy.

Eligibility criteria:
inclusion criteria: * focal epilepsy, onset during pediatric age (\<18 y) * drug resistance * unknown cause * brain magnetic resonance imaging negative exclusion criteria: * epilepsy with good therapeutic control * focal symptomatic epilepsy * age limits onset (\> 18 y)
r4power: an online resilience program for adolescents

Conditions: Depression; Anxiety

Summary: the study will evaluate the r4power program, an online intervention designed to teach adolescents coping and problem-solving skills.

this study examines the feasibility of a 10-lesson web-based intervention, the r4power program, and its effectiveness in preventing symptoms of depression and anxiety. the r4power program teaches cognitive and problem-solving skills covered in classroom based interventions, including the penn resiliency program, that have been found to reduce or prevent symptoms of depression in children and adolescents. this study examines whether adolescents can benefit from learning these skills through a computer (rather than classroom) intervention. adolescents in grades 6 through 8 who participate in this study will be assigned to one of two conditions: an intervention group that will complete the r4power program during the first year (r4power1), or a waitlist control group that will complete the r4power program the following year (r4power2). students will complete the 10-lesson program over the course of twelve weeks. they will learn and practice cognitive skills (recognizing the link between their thoughts and feelings, identifying thinking traps, challenging their negative beliefs) and problem-solving skills (assertiveness, relaxation and distraction, overcoming procrastination, and decision making). adolescents who participate in this study will be followed for one year, and their coping responses and symptoms of depression and anxiety will be assessed at four points: at the beginning of the study (baseline) and at follow-up assessments approximately 4, 12 and 16 months after baseline.

Eligibility criteria:
inclusion criteria: * 6th-8th grade students attending participating school or adolescents aged 11-15 living in greater philadelphia area * access to high speed internet connection (at home, school, or another location) exclusion criteria: * below 6th grade reading level, as reported by parents

Keywords: adolescent child computer depression resilience