Kornimate/medical-research-clean huggingface dataset:
diagnostic performance of shear wave dispersive imaging in breast lesions: comparison with shear wave elastography

Conditions: Breast Diseases

Summary: human soft tissue such as breast tissue has viscoelasticity property. however, most ultrasound has only been measured for elasticity and viscosity has been neglected. shear wave elastography (swe) is a ultrasound technique that quantifies tissue elasticity. shear wave dispersion (swd) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. the goal of this retrospective study was to compare diagnostic performance between swe and swd to distinguish benign from malignant breast masses and to investigate additional role of swd. using histological diagnosis of breast lesions as a standard reference, quantitative indices of swe and swd were evaluated to diagnose breast cancer, and the diagnostic performance of swe and swd was compared.

this retrospective study was approved by our institutional review board, which waved the requrement for informed consent. the investigators obtained quantitative parameters of swe and swd of solid breast lesions before biopsy. the investigators measured average tumor elasticity and tumor-to-fat elasticity ratio on swe and average tumor dispersion and tumor-to-fat ratio and on swd from each breast lesion. diagnostic performance of swe and swd was compared using the area under the curve (auc), sensitivity, specificity, and accuracy.

Eligibility criteria:
inclusion criteria: * patients with histological results exclusion criteria: * patients without histological results
genocare: a prospective, randomized clinical trial of genotype-guided dosing versus usual care

Conditions: Colorectal Cancer; Pancreatic Cancer

Summary: this is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are ugt1a1 intermediate metabolizers (\*1/\*28) (heterozygotes) and usual ugt metabolizers (\*1/\*1). all patients will be assessed for ugt1a1 genotype at screening and those with intermediate or usual ugt1a1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed stage i-iv pancreas or stage iii-iv colorectal cancer who are planning to undergo treatment. * prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed. * age ≥ 18 years. * ecog performance status ≤ 1. * patients must have adequate organ and marrow function as defined below: * measurable or non-measurable disease. exclusion criteria: * patients who received prior treatment with irinotecan are excluded. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician. * pregnant women are excluded from this study. * patients who are not planned for treatment of their cancer.
propranolol versus prednisolone for treatment of symptomatic hemangiomas

Conditions: Hemangioma of Infancy

Summary: hemangiomas are relatively common lesions in infants. most go away spontaneously after one year of life and do not need treatment. others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. it appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. this study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.

infants with symptomatic hemangiomas will be enrolled. magnetic resonance imaging will be completed before starting medication if the extent of the hemangioma is not evident on clinical examination alone. infants will be randomized to receive either propranolol or steroids for 4-6 months. hemangioma response will be measured and compared monthly as will tolerability of the medications. additionally, urine specimens will be collected at each visit to determine if markers are present that can predict response to therapy. additionally, any hemangiomas that are excised will be examined for genetic markers to aid in predicting response to therapy.

Eligibility criteria:
inclusion criteria: * infants with symptomatic hemangiomas exclusion criteria: * asthma * diabetes * hypertension * hypotension * hypoglycemia * liver failure * previous treatment for hemangiomas

Keywords: hemangioma
longitudinal analysis and sample collection to evaluate pml risk host markers for pml risk host markers for pml risk

Conditions: Multiple Sclerosis

Summary: the purpose of the study is to develop an improved understanding of the long term pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended dosing, and collect additional samples to explore cell-based biomarkers of natalizumab treatment and pml risk.

the underlying etiology for the association of natalizumab therapy to an increase risk of progressive multifocal leukoencephalopathy (pml) remains unknown. it is possible that persistently high natalizumab levels lead to sustained immune-modulation or suppression resulting in an increased pml risk. since 2010 we have conducted three investigator initiated trials (iits) at our center to measure serum natalizumab concentration, lymphocyte alpha 4 integrin saturation, and other biomarkers to understand the association of these markers to pml risk. a number of the patients who participated in these clinical trials are still infusing. these studies have demonstrated that plasma natalizumab concentrations continue to rise over time with a plateau effect not yet clearly delineated. improved drug clearance in patients with higher body weight is described in the prescribing information. we have accumulated preliminary data suggesting that patients with lower body weight may be at higher risk for pml and that this may relate to higher drug concentrations and saturations seen in this group. dose extension may be a viable option to lower drug concentration (pharmacokinetic, pk) and saturation (pharmacodynamic, pd) in patients with lower body weight to potentially impact pml incidence. in addition to the pk/pd of natalizumab, host related biomarkers may allow for more specific pml risk stratification. further validation of these biomarkers is critical for our understanding of their utility.

Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. 2. must be enrolled in the touch prescribing program for tysabri® (natalizumab) prior to informed consent. 3. in the opinion of the principal investigator, must be able and willing to comply with all study directions 4. ≥ 18 years of age at the time of informed consent exclusion criteria: 1. in the opinion of the principal investigator, subject is unwilling or unable to comply with study directions. 2. subject who is pregnant, breastfeeding, or likely to becoming pregnant during the course of the study. women of child-bearing potential must be practicing an acceptable form of birth control. -

Keywords: multiple sclerosis immunological biomarkers observational relapsing remitting multiple sclerosis
effect of core engagement exercises and routine exercise therapy on low back pain in middle school children

Conditions: Low Back Pain

Summary: low back pain is defined as the region of pain between the lower ribs and hips. low back pain with respect to middle school children corresponds to the age where children and adolescents go to school for longer periods of time, having heavy bags, assuming poor postures while sitting for prolonged hours. poor posture, prolonged sitting and lack of physical activity results in back pain that leads to poor performance in school as well as attendance.

middle school children are the children of the age where they spend most of their hours sitting in school. low back pain often goes undiagnosed and unreported in children which persists and if left untreated, causes problems in later stages in life. low back pain is the region of pain from lower ribs to hips. children and teenagers often have lower back discomfort, which may be brought on by several conditions, including poor lifting skills, bad posture, and overuse injuries from sports or other physical activity. according to estimates, up to 50% of school-aged children may sometimes have lower back discomfort. the muscles that surround our spine are considered the "core" of our body. it is composed of the abdominal muscles on your front and sides, the erector muscles and gluteus. each and every one of these muscles must work together in order to enhance the stability of the spine. when muscles contract they create force and stiffness. it is the stiffness part that is important for stability. when the core fails to meet the stability demands placed on the body during a certain lift, parts of the spine will be overloaded with forces that increase injury risk and performance will suffer. for that, various warm up exercises, stretches and mobility exercises are performed so that the body can work as stable linked system that works efficiently as well.

Eligibility criteria:
inclusion criteria: * middle aged school children between age 9 and 14. * both male and female. * back pain of 2 or greater on nprs exclusion criteria: * structural observational deformity (kyposis, lordosis, scoliosis) * history of post spinal surgery * acute low back pain flare up * pain or any other injury of lower limbs
lt f-up study 16-20 yrs after vaccine dose of hepatitis b with/without hbig in newborns to hbeag+ mothers

Conditions: Hepatitis B

Summary: to evaluate the persistence of anti-hbs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007. no additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

the primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis b vaccine in healthy neonates of hbeag positive mothers if administered with or without a dose of hbig at birth. the current study describes the long term follow up of these subjects between y16 and 20 after primary vaccination.

Eligibility criteria:
inclusion criteria: * subjects who had received at least one dose of the study vaccine in the primary study * written informed consent obtained from each subject before each blood sampling visit exclusion criteria: * none

Keywords: hepatitis b immunoglobulin hepatitis b antibody persistence
evaluation of the safety and effectiveness of the akreos mi five-0 intraocular lens.

Conditions: Cataract

Summary: the objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the bausch \& lomb akreos mi five-o intraocular lens (iol). effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.


Eligibility criteria:
inclusion criteria: * subjects must have a clinically documented diagnosis of age-related cataract. * subjects must have clear intraocular media other than cataract. * subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction. exclusion criteria: * subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * subjects with diagnosis of degenerative visual disorder. * subjects who have any inflammation or edema (swelling) of the cornea. * subjects with immunodeficiency disorders. * subjects who have had previous intraocular surgery in the study eye. * subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture. * subjects with chronic use of systemic steroids or immunosuppressive medications.

Keywords: cataract extraction phacoemulsification
a single group study to evaluate the effects of a supplement on premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: this is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). during the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of pms, such as cramping or bloating. for the second and third menstrual cycles, participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on day 3 of their cycle. questionnaires will be completed at the following time points: * baseline * day 7 of their first cycle during the trial (after using the product prn during their period) * 4 days before their second period during the trial (after using the product prn for the previous month) * day 3 of their second period during the trial (after using the product for 7 days straight) * day 3 of their third period of the trial (after using the product for 7 days straight)


Eligibility criteria:
inclusion criteria: * female, aged 18-40 * self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings. * self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux * generally healthy - don't live with any uncontrolled chronic disease * has a menstrual cycle between 21 and 35 days in length * able to predict their menstrual cycle and timing of their menstruation exclusion criteria: * any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * current use of any blood thinning medication * anyone with known severe allergic reactions. * women who are pregnant, breastfeeding, or attempting to become pregnant * unwilling to follow the study protocol. * anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (pcos), premenstrual dysphoric disorder (pmdd), endometriosis, etc. * anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months
moderating the negative impact of abnormal screening mammograms

Conditions: Breast Cancer

Summary: this project evaluates the impact of chess-mammo by assessing participants' health information competence, psychological distress, and satisfaction with their doctor as measured by previously validated survey questionnaires.

the study consists of two parts. part 1 (focus groups) interviewed 11 women in total (6 diagnosed with breast cancer and 5 diagnosed with benign breast disease) reinforced the need for online information during the breast diagnostic process. the focus group reviewed online chess-mammo module and suggested minor changes to content. part 2 (evaluation) will enroll 130 women in study and compare one group (65 participants) who receives access to chess-mammo to another group of women (65 participants) who receive an email message containing screening mammography information. both groups in part 2 will be evaluated for health information competence, psychological distress, and patient satisfaction with physician through questionnaires. an evaluation of the group that accesses the chess-mammo website will be done. the reason for conducting part 2 of this study is to allow greater insight into the clinical application of a novel interactive cancer communication systems (chess-mammo) early in the diagnostic workup of breast cancer. by doing this project, we may achieve an important new way of implementing chess-mammo in the clinic.

Eligibility criteria:
inclusion criteria: to be eligible for the study, subjects must: * be females at least 18 years of age, * have had their screening mammogram performed at the uw breast center, * be able to read and write english at the 6th grade level (as shown by their, ability to understand the informed consent), * have access to a computer with internet capability. exclusion criteria: exclusion criteria: * illiterate * homeless

Keywords: diagnostic imaging breast screening breast cancer to be eligible for the study, subjects must: be females at least 18 years of age, have had their screening mammogram performed at the uw breast center, be able to read and write english at the 6th grade level (as shown by their, ability to understand the informed consent), have access to a computer with internet capability.
a study in healthy people to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food

Conditions: Healthy

Summary: this trial is conducted to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests. * age of 18 to 55 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m² (inclusive) * signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ich-gcp) and local legislation prior to admission to the trial further inclusion criteria apply. exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 45 to 90 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator further exclusion criteria apply.
a retrospective chart review to evaluate diagnosis and treatment of chronic migraine and headache

Conditions: Migraine Disorders; Headache

Summary: this study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months * eight (8) headache days per month for at least 1 of the preceding 15 months exclusion criteria: * not currently diagnosed with chronic migraine, headache or migraine * history of receiving botulinum toxin injections for the treatment of chronic migraine.
use of levemir® improves metabolic and clinical status in cystic fibrosis-related diabetes (cfrd)

Conditions: Cystic Fibrosis Related Diabetes

Summary: this is a study to find out if levemir® (a long acting or basal insulin) is safe and effective in treating cystic fibrosis related diabetes (cfrd).

cystic fibrosis (cf) related diabetes (cfrd) and glucose intolerance affects more than 50%-75% of teens and adults with cf. the 1998 north american cf foundation on cfrd categorized the disease differently than other types of diabetes: cfrd with fasting hyperglycemia (fh), cfrd without fh and transient cfrd. the outcome of this consensus conference was the use of insulin as the only recommended treatment of cfrd. although the conference report mandated treatment for cfrd with fh, treatment was not mandated for the other types of cfrd, the choice to treat was left to the clinician's discretion. however, insulin was the only recommended therapy for all types of cfrd. although some clinicians have used basal bolus regimens as the insulin management, many still use nph. given the need for cf patients to eat many frequent meals and snacks to maintain their weight, use of nph insulin rarely renders good glycemic control. a basal bolus regimen is much more physiologic and would allow good glycemic control even with frequent meals and snacks. to date, there are no studies documenting safety and efficacy of true basal insulin, or a basal bolus regimen. furthermore, protein catabolism and excessive muscle loss has been well documented in cf patients, both in those with and those without, glucose intolerance. studies by our group and others have documented that a major reason for the catabolism is resistance to insulin's anti-catabolic effects on protein turnover. thus, there is potential clinical benefit of improving muscle mass and general health by insulin treatment even for cf patients who do not have fasting hyperglycemia. a non-peaking basal insulin would be the only reasonable choice, yet studies are lacking. our overall goal is to study the safety and efficacy of levemirtm for the improvement of glycemic control of patients with cfrd. as a second goal, we will explore the ability of this basal insulin to improve protein catabolism and muscle mass. the study will be conducted as a six month trial.

Eligibility criteria:
inclusion criteria: * patients diagnosed with cfrd by oral glucose tolerance test (ogtt) who are medically stable. medical stability will be defined as: * no hospital admission for six weeks or more before the study * no oral or intravenous antibiotics for at least six weeks preceding the study (subjects will be allowed to use low doses of inhaled corticosteroids). exclusion criteria: * use of oral or intravenous corticosteroid medications within six weeks of the study. * evidence of clinically significant liver disease. * colonization with burkholderia cepacia. * colonization with aspergillus. * pregnancy. * medically unstable (stability defined above).