Kornimate/medical-research-clean huggingface dataset:
comparison of whole breast screening ultrasound and contrast enhanced mammography for supplemental breast cancer screening

Conditions: Breast Cancer Screening

Summary: breast tumors are often detected on mammography but may be harder to see in women with dense breasts. this is why screening breast ultrasound is sometimes used as another test in women with dense breasts. ultrasound has been shown to detect additional cancers that are not seen on regular mammography. contrast enhanced digital mammography (cedm) is a fda approved form of mammography. it is essentially a routine digital mammogram performed after iodine dye (the same that is used with ct scans) is injected into a vein in the arm. like screening ultrasound, cedm has been shown to detect breast cancers that are not seen on a regular mammogram. the purpose of this study is to compare whether cedm or screening breast ultrasound is better at detecting cancer. both will be done in this study and compared to one another.


Eligibility criteria:
inclusion criteria: * women scheduled for screening wbus and a screening ffdm on the same day or within the following 30 days of each other * women scheduled for screening cedm alone * women scheduled for wbus and screening cedm on the same day or within 30 days of one another exclusion criteria: * age \< 30 years old * male patients * patients with any clinical breast symptoms (palpable mass, nipple discharge, etc) * patients with known diagnosis of breast cancer * patients with any breast surgery or biopsy within 90 days prior to the study * patients who have had a lumpectomy for breast cancer within 18 months prior to the study * patients who are thought to have a breast mri within 1 year prior to the study * patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)

Keywords: ultrasound enhanced mammography 14-240
evaluation of physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker

Conditions: Pacemaker; Physical Activity

Summary: the aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker compared with their healthy peers.

studies in children with heart diseases suggest that physical activity levels are reduced relative to their peers, which in turn increases cardiovascular risk factors and cardiac rhythm problems. to the best of our knowledge, physical fitness and objectively measured physical activity levels of children with a pacemaker have not been studied. the aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with a pacemaker compared with their healthy peers. investigators enrolled clinically stable pediatric patients and used the echocardiogram to evaluate cardiac functions of all patients. physical fitness was assessed using the munich physical fitness test (mft). the sensewear armband metabolic holter device was used to record the physical activity level for consecutive 7 days.

Eligibility criteria:
inclusion criteria: inclusion criteria of the pacemaker group: * permanent pacemaker * being 7-18 years of age * able and willing to complete the informed consent process * able to walk and co-operate exclusion criteria: exclusion criteria of pacemaker group: * unstable medical condition * to have severe neurological, severe orthopedic problems * to have severe heart failure and another systemic disease or acute infection * down syndrome * the control group will consist of healthy subjects.

Keywords: pediatric pacemaker physical activity physical fitness
sleephelsinki! circadian sleep regulation in adolescence

Conditions: Sleep Disorder Circadian Rhythm, Delayed Sleep Phase Type

Summary: adolescence associates with alterations in sleep-wake organization, such as later circadian phase preference. simultaneously external pressures, such as evening-driven social activities increase. these may lead to delayed sleep phase, which may cause serious problems for waking up at socially accepted times, and absenteeism from the school may follow. this project aims at tracking risk factors for later circadian regulation problems, characterizing interconnections of biological, psychological and behavioural mechanisms that maintain or induce poor sleep regulation in adolescence, and building a cost-effective, theoretically-based sleep intervention for adolescents with delayed sleep phase. this randomized control trial capitalizes on a new population-based cohort of 16-17-year olds.


Eligibility criteria:
inclusion criteria: * late bedtime several times per week exclusion criteria: * chronic disease that affects sleep. ongoing therapeutic treatment relationship if considered overlapping by the participant

Keywords: adolescent population-based social jetlag intervention bright light motivation circadian regulation behavioral change
impact of a sexological follow-up on the sexual function in patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy

Conditions: Cervix Cancer; Vaginal Cancer

Summary: prospective, monocentric study evaluating the impact of a nurse-led sexological follow-up on sexual function in patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy. the study procedure will consist of nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy. evolution of female sexual function and vaginal symptoms will be done through clinical examinations and completion of quality of life and female sexual function questionnaires during radiation oncologist consultation and/or nurse-led sexological consultations until one year after end of brachytherapy. study participation of each patient will be 12 months.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. woman diagnosed with cervix or vaginal cancer, for whom a treatment by radiotherapy and brachytherapy has been decided 3. patient receiving for the first time an utero-vaginal or vaginal brachytherapy at "institut universitaire du cancer de toulouse - oncopole" 4. easter cooperative oncology group (ecog) performance status ≤ 2 5. all patients are eligible, regardless of their relationship status (in couple or not), their sexual orientation, and their hormonal status 6. patient willing to give informed consent before the study and before performing any study-related procedures 7. patient affiliated to a social health insurance in france exclusion criteria: 1. patient not understanding the french language 2. patient for whom surgical treatment and brachytherapy has been decided 3. any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule 4. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice

Keywords: cervix cancer vaginal cancer sexual function brachytherapy radiotherapy
head injury retrieval trial

Conditions: Head Injuries, Closed

Summary: the study hypothesis is that advanced interventions as provided by a physician at an accident scene will decrease the death rate and the rate of severe disability in survivors of severe head injury. extended interventions by advanced level prehospital providers may include rapid sequence intubation (rsi) airway management, blood transfusions, surgical procedures, etc.

a randomised, controlled trial examining prehospital management of persons with severe blunt head injury, in the sydney region. treatments examined will be the current system consisting principally of paramedic management (standard care) compared with management by a retrieval team lead by a consultant anaesthetist, emergency physician or intensive care specialist. patients for inclusion in the study will be identified by a paramedic screening all "000" calls to the ambulance service and identifying persons likely to have severe head injury. the principal outcome measure will be their degree of disability measured at 6 months post injury.

Eligibility criteria:
inclusion criteria: * glasgow coma scale score of 3 to 8 due to blunt trauma as measured at the accident scene by the first prehospital team to arrive at the site. exclusion criteria: * penetrating trauma * age less than 16 years * no more than 5 casualties at the scene

Keywords: head injuries prehospital advanced interventions
bpa levels relationship with ivf/icsi outcomes in low ovarian reserve

Conditions: Infertility Low Over Reserve; IVF; Infertility, Female

Summary: the relationship between bpa elevation in urine, blood, and follicle fluid and embryo quality, ivf/icsi outcomes.


Eligibility criteria:
inclusion criteria: * patients who underwent ivf due to low ovarian reserve * patients provided urine, blood, and follicle fluid (ff) samples on the oocyte retrieval day * patients who did not smoke or use alcohol * patients did not work in the plastic industry exclusion criteria: * patients who underwent ivf due to unexplained infertility or tubal factor or male factor indications * patients diagnosed with endometriosis * patients with freeze-all cycles * patients having previous ovarian surgery * women with metabolic disease (such as hypertension or diabetes mellitus) * patients with a known genetic problem (male or female)
the use of statins following a left atrial catheter ablation procedure to prevent atrial fibrillation

Conditions: Atrial Fibrillation; Arrhythmia; Inflammation; Endothelial Dysfunction

Summary: to investigate whether statin therapy utilizing the drug lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation (af) following a left atrial ablation procedure. we further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower c-reactive protein (crp) values in the blood.

although pharmacologic therapy is the traditional mainstay of therapy for af, curative therapy has recently become possible. there is growing evidence that inflammation may be involved in the pathogenesis of af. crp, a sensitive marker of systemic inflammation, is increased in patients with af compared with patients in sinus rhythm. elevated crp levels are associated with increased likelihood of new onset af and with recurrence of af after successful cardioversion. clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against af. 125 eligible patients with af, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure. patients will have baseline lipids, crp, endothelial function tests and quality of life (qol) surveys compared with testing at 3 months post ablation.

Eligibility criteria:
inclusion criteria: * patients \> or = to 18 years of age * clinically indicated left atrial ablation procedure for atrial fibrillation exclusion criteria: * known malignancy * known inflammatory disease * surgery or trauma or myocardial infarction in the previous month * known contraindication to statin therapy * elevated liver enzymes above two times the upper limit of normal * patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization

Keywords: atrial fibrillation arrhythmia pulmonary vein isolation left atrial catheter ablation inflammation endothelial dysfunction
textured insoles and foot massage in individuals diagnosed with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to determine and compare the effects of using textured insoles and plantar massage on balance in patients with rheumatoid arthritis. patients diagnosed with rheumatoid arthritis will be divided into two groups. in the first group the patients will be given plantar massage; in the second group, both plantar massage will be applied and the patients will use textured insoles in their indoor and outdoor activities. plantar massage will be applied by the physiotherapist 3 days a week for 6 weeks; textured insoles will also be used for 6 weeks. all patients will be asked to complete the questionnaires, which assessed foot functionality, physical activity levels and quality of life. after each patients completed the questionnaire, the physiotherapist will perform plantar sensory and balance assessment. all assessments will be made before, after and 8 weeks after treatment.

in the solution of balance problems in rheumatoid arthritis (ra), successful results can be obtained with the correct sensory inputs from the sole of the foot. even after 5 minutes of application with plantar massage, which is one of these methods, it has been observed that there is an improvement in balance reactions. textured insoles are also one of the methods used to improve balance with the right sensory input. both methods increase cutaneous receptor activity and ankle proprioception by providing increased afferent information; as a result of these effects, postural sway decreases, balance can be achieved on a narrower support surface, and postural control increases. although the positive effects of plantar massage and textured insoles on balance are known, there are no studies in which these methods are used in ra patients. in our study, we aimed to determine and compare the effects of plantar massage, which provides short-term afferent input, and the use of textured insoles, which provide long-term afferent input, on balance in ra patients. for these purposes, plantar massage will be applied to one group, and plantar massage will be applied to the other group and textured insoles will be used. in this way, the effects on the balance will be observed and compared.

Eligibility criteria:
inclusion criteria: * 18-65 years old * being diagnosed according to the american college of rheumatology (acr)/eular 2010 rheumatoid arthritis diagnostic criteria exclusion criteria: * having an orthopedic or neurological disease that may cause balance and sensory impairment * using drugs that may cause balance and sensory disorders * having undergone lower extremity surgery * having a neurological problem that may cause hearing or vision impairment * having a communication problem * having a history of major psychiatric illness

Keywords: plantar massage textured insoles balance rheumatoid arthritis
ccc project - atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to develop and implement quality improvement programs for the treatment of atrial fibrillation (af) in china based on the successful experience of the aha-get with the guidelines program. this program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * hospitalized patients with discharge diagnosis as atrial fibrillation in 150 tertiary and 100 secondary hospitals. exclusion criteria: none
zinc and bone turnover study in adolescent females

Conditions: Bone; Growth; Osteoporosis

Summary: the purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment.

significant accomplishments have been achieved with respect to our understanding of calcium and vitamin d and skeletal health, yet a body of scientific evidence has also identified understudied nutrients that have potential for reducing the burden of osteoporosis. zinc has important roles in bone metabolism and there are indications from animal and human studies that beyond correcting skeletal and growth impairments under deficiency conditions, supplementation with zinc may have a bone health-promoting role. it has been postulated that the action of zinc on bone metabolism is partially mediated by insulin-like growth factor one (igf-i). prior to undertaking a long-term bone trial, a short-term zinc supplementation trial is proposed to first determine if zinc alters intermediate markers of bone metabolism in healthy, early pubertal females (9-10.5 years of age). we hypothesize that healthy females receiving 24 mg zinc /day over 4 weeks will have elevated serum markers of bone formation and plasma growth factors compared to those receiving placebo. we further hypothesize that the differences between the zinc and placebo groups will vary by race. to test these hypotheses, we will screen early pubertal females to assure similar maturational status and conduct a 3-week, randomized, double-blind, placebo-controlled trial with a zinc supplementation (zinc sulfate; n=80) and a placebo (n=80) arm. the groups will be further divided by race (non-hispanic white and non-hispanic black; n=40 per group). the specific aims are to determine if early pubertal females supplemented with zinc compared to those receiving placebo will have: 1) greater increases in markers of bone turnover favoring bone formation; 2) greater increases in plasma igf-1 and igfbp-3; and 3) changes in bone turnover markers, igf-1 and igfbp-3 that differ by race. in addition, anthropometric measures, maturity offset, sexual maturation, erythrocyte superoxide dismutase activity, ceruloplasmin, dietary intakes and physical activity will be determined. findings from this study will provide preliminary evidence of whether supplementation with zinc is a viable nutrition strategy to improve biochemical indices of bone turnover and growth factors in young females. moreover, the results will help determine if a long-term clinical bone trial is warranted to more definitely assess the potential for supplemental zinc to reduce the risk for osteoporosis.

Eligibility criteria:
inclusion criteria: * healthy * female * ages 9-11 * pre-menarchal * caucasian or african american exclusion criteria: * menses * disease known to affect bone * drugs known to affect bone * vitamin/mineral supplements

Keywords: zinc bone adolescents growth
erythropoietin and pediatric cardiac surgery

Conditions: Congenital Heart Defect

Summary: lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. we hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury. this randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. a medicine already used in humans, erythropoietin, may protect the heart and brain of children born with heart defects during their surgical repair. in a rabbit model, erythropoietin did protect the hearts. we hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury. for this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects, will be divided into four groups. two groups will be children whose usual blood oxygen level is low because of their heart defect; the other two will be children with normal blood oxygen levels. each child will be randomized to receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their surgery. erythropoietin's protective function will be measured after surgery by: (1) amount of medication required to support heart function, (2) how well the heart pumps blood as seen by echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) icu stay and (7) hospital stay. heart tissue will be collected during surgery to determine how erythropoietin protects heart cells. statistical tests including anova will test for similarities and differences among the groups on the measures of protection from injury. note - the study design was edited after the fda released a warning about the use of erythropoietin. only acyanotic patients were recruited therefore only 2 study groups are included.

Eligibility criteria:
inclusion criteria: * age 6 weeks to 18 years * requiring open heart surgery for congenital heart defect -parents able to speak english and document informed consent - exclusion criteria: * received erythropoietin within past 30 days * previous adverse reaction to erythropoietin or to albumin * history of neurological disorder -laboratory evidence of kidney or liver dysfunction -

Keywords: erythropoietin congenital heart surgery
medium-term health coaching and life-long monitoring in diabetes mellitus

Conditions: Diabetes Mellitus Type 2

Summary: evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. in addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility criteria:
inclusion criteria: * t2dm diagnosed \> 3 months prior to the enrollment * hba1c \>= 6,5 % * capability of filling questionnaires by their own language * being able to use the devices provided * being cognitively able to participate exclusion criteria: