Kornimate/medical-research-clean huggingface dataset:
engaged 2 study: experiences with mammography screening and breast density 2

Conditions: Breast Density; Breast Cancer Female

Summary: this trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider mri and/or chemoprevention to manage their breast cancer risk.

along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. although breast density is measured on routine screening mammograms, it is not typically communicated to patients. this is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. therefore,we have developed an intervention to support decision making about cancer risk management (mri and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.

Eligibility criteria:
inclusion criteria: * women, aged 40-69 * enrolled at group health * have had a negative mammogram as part of their routine care * either (a) an intermediate 5-year risk (\>1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense breasts utilizing the breast cancer surveillance consortium risk calculator (http://tools.bcsc-scc.org/bc5yearrisk/) * women must also have a valid email address. exclusion criteria: * not able to speak and read english * history of lcis * prior cancer diagnosis (including dcis) * known brca1/2 family mutation, or previous receipt of cancer genetic counseling * do not want to be contacted for research * have previously participated in intervention development activities * dis-enrolled from health plan between mammogram and start of recruitment.

Keywords: breast cancer breast density
single dose versus 24 hours antibiotic prophylaxis in reduction mammaplasty

Conditions: Plastic Surgery; Mammaplasty; Anti-bacterial Agents; Prophylaxis; Wound Infection

Summary: setting: translacional surgery graduation program - universidade federal de são paulo and hospital das clínicas samuel libânio - universidade do vale do sapucaí. background: breast reduction is one of the most performed plastic surgery procedures. antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. however, there is a lack of evidence to support its use. objective: to compare the influence of the use of prophylatic antibiotics as a single dose or for 24 hours on surgical site infection rates following reduction mammaplasty. methods: randomized trial of non-inferiority, with two parallel groups, double blinded. a total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. patients will be randomly allocated to group a, that will receive antibiotics only at the anesthesia induction (n=73), or to group b, that will receive antibiotics at the anesthesia induction and for 24 hours (n=73). none of the patients will receive antibiotics after hospital discharge. patients will be followed-up weekly, for 30 days, regarding surgical site infection. the centers for disease control and prevention criteria will be applied. a statistical analysis of the data will be performed.


Eligibility criteria:
inclusion criteria: * 18 and 60 years of age * body mass index (bmi) between 19 and 30 kg/m2 * breast hypertrophy according to the criteria of sacchini et al. and franco and rebello exclusion criteria: * patients who had previously undergone another surgical procedure of the breast * patients who have been diagnosed with a breast pathology * smokers * patients who had a child or breastfed within the last year * patients with uncontrolled comorbidities, such as arterial hypertension or diabetes * use of immunosuppressants * patients who had any infection during the follow-up period, requiring the use of antibiotics * patients who present any adverse effects due to the antibiotics during the study * patients who miss follow-up assessments * patients who withdraw their consent at any time
melodic intonation therapy for tone language speakers

Conditions: Dementia; Speech Therapy

Summary: one of the traditional therapies for restoring the ability of speech in aphasic patients is melodic intonation therapy (mit), in which everyday phrases are taught in a singing-like manner. the suggested mechanism for speech recovery is that because of the sharing of brain resources for language and music, the regions normally reserved for singing can be trained to help compensate the speech functions originally subserved by the damaged regions. however, this therapy has primarily been applied to speakers of non-tone languages, in which prosodic features carry a more important role than pitch features in conveying meanings. it remains unknown whether mit will be equally applicable for speakers of tone languages, in which pitch features likely play a more important role. another uncertainty concerns whether the efficacy of mit can be extended to patients with expressive speech impairment due to dementia. this pilot study aims to find out the efficacy of mit for speech-impaired dementia patients in different verbal tasks. the results of this study will provide preliminary empirical evidence to establish the utility of mit for cantonese speakers in hong kong.


Eligibility criteria:
inclusion criteria: * early to moderate stage dementia patient * normal hearing (hearing aid accepted) * non-fluent speech (max. score of fluency in cantonese aphasia battery spontaneous speech subtest = 6/10) exclusion criteria: * non-native cantonese speaker * illiterate * aphasic patients * subjects who receive other speech therapy during study

Keywords: melodic intonation therapy music tone language
effects of teriparatide or zoledronic acid treatment on bone in postmenopausal osteoporotic women

Conditions: Osteoporosis, Post-menopausal

Summary: the purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). after completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.


Eligibility criteria:
inclusion criteria: * ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2 years prior to trial entry) * free of severe or chronically disabling conditions other than osteoporosis that will impair ability to complete the trial * bone mineral density (bmd) t-score of at least -2.5 at the femoral neck, total hip, or lumbar spine (l1-l4, with at least 2 evaluable vertebrae), with or without atraumatic fracture or, * bone mineral density (bmd) t-score of at least -1.5 at the femoral neck, or total hip, or lumbar spine (l1-l4, with at least 2 evaluable vertebrae), and either 1 or more atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion of the investigator. nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs, humerus, clavicle, leg (femur, tibia, and fibula, excluding the ankle). * serum calcium, parathyroid hormone (pth), alkaline phosphatase must be within normal reference range exclusion criteria: * have an increased risk of osteosarcoma (bone tumor); this includes paget's disease of bone, a previous bone tumor, or radiation involving the skeleton * are allergic or cannot tolerate teriparatide or zoledronic acid or any of their ingredients or components * are allergic to tetracycline * have a history of exposure to tetracycline therapy in the 3 months prior to trial entry * have participated in a prior pth clinical trial or received prior treatment with teriparatide, pth, or other related medications * have a vitamin d level below 10 nanogram/milliliter (ng/ml) * have a condition that could possibly put one at risk for an adverse event due to the bone biopsy procedure (e.g. bleeding disorder) * have undergone two previous iliac crest bone biopsies (one in each iliac crest) * have taken any intravenous (iv) osteoporosis medication * have taken other oral osteoporosis medications and have not been off of them for a specific period of time before trial entry * have a history of certain cancers in the 5 years prior to trial entry * have active liver disease * have significantly impaired kidney function * currently have active or suspected diseases that affect the bones, other than osteoporosis * have active or recent history of significant gastrointestinal (stomach or intestinal) disorders * have been treated with certain glucocorticoids for more than 30 days in the past 1 year prior to trial entry

Keywords: osteoporosis teriparatide zoledronic acid histomorphometry bone biopsy postmenopausal
goserelin, flutamine, and radiation therapy in treating patients with locally advanced prostate cancer

Conditions: Prostate Cancer

Summary: rationale: patient abstract not available purpose: patient abstract not available

objectives: i. compare locoregional control, disease-free survival, and overall survival in patients with carcinoma of the prostate who are considered at high risk of relapse and receive long-term adjuvant zoladex (zdx) vs. no adjuvant treatment following neoadjuvant zdx/flutamide and radiotherapy. ii. compare sexual function in patients treated with these two regimens. outline: randomized study. arm i: neoadjuvant antiandrogen therapy and releasing factor agonist therapy plus radiotherapy. flutamide, flut, nsc-147834; and zoladex, zdx, nsc-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 mv (at least 6 mv preferred). arm ii: neoadjuvant antiandrogen therapy and releasing factor agonist therapy plus radiotherapy followed by adjuvant releasing factor agonist therapy. flut; and zdx; plus external-beam irradiation using equipment as in arm i; followed by zdx. projected accrual: 1,508 patients will be accrued over 2 years.

Eligibility criteria:
disease characteristics: histologically confirmed, locally advanced adenocarcinoma of the prostate, including: bulky primary tumors confined to the prostate (clinical stage t2c) primary tumors extending beyond the capsule (clinical stage t3-4) no common iliac or para-aortic nodal involvement regional lymph node involvement below the common iliac level allowed positive nodes on imaging studies must be biopsied by fna or surgical sampling psa no more than 150 (mandatory) no distant metastases patient characteristics: age: at least 50 performance status: karnofsky 70-100% hematopoietic: not specified hepatic: not specified renal: not specified other: no prior or concurrent second cancer except basal cell skin cancer no major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy endocrine therapy: no prior hormonal therapy radiotherapy: no prior radiotherapy surgery: no prior radical surgery for carcinoma of the prostate

Keywords: stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer
a study of galcanezumab (ly2951742) in adult participants with episodic migraine

Conditions: Migraine; Episodic Migraine

Summary: the purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. the study duration will be approximately 6 months.


Eligibility criteria:
inclusion criteria: * have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of international headache society international classification of headache disorders - 3rd edition guidelines (ichd-3 2018) exclusion criteria: * have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins * have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty. * evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders. * women who are pregnant or nursing * current use or prior exposure to any calcitonin gene related peptide (cgrp) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a cgrp antagonist (small molecule or antibody)
contrast-enhanced ultrasound scan for the estimation of tissue pressure in patients with breast cancer

Conditions: Breast Carcinoma

Summary: this clinical trial studies the use of contrast-enhanced ultrasound (ceus) in estimating tissue pressure in patients with breast cancer. diagnostic procedures, such as ceus, may help estimate tissue pressure noninvasively.

primary objective: i. to determine if the 3-dimensional (3d) subharmonic aided pressure estimation (shape) results can be used to estimate interstitial fluid pressures (ifps) in breast tumor and its surrounding tissue. secondary objective: i. to determine if the malignancy of breast tumor can be predicted by the 3d shape results. outline: patients undergo ultrasound without contrast. patients then receive perflutren lipid microspheres (definity) intravenously (iv) over 15 minutes and undergo ceus.

Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent form * be conscious, willing and able to comply with all study procedures and be available for the duration of the study * at least 21 years old * be scheduled for a breast biopsy (breast imaging reporting and data system \[birad\] 4, 4a, 4b, 4c or 5) * patient with an at least 1 cm mass located at \< 3 cm depth, approachable by 2.5 inch needle * be medically stable as determined by the investigator * if a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of definity exclusion criteria: * females who are pregnant or nursing * patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. for example: * patients on life support or in a critical care unit * patients with unstable occlusive disease (e.g., crescendo angina) * patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * patients with uncontrolled congestive heart failure (new york heart association \[nyha\] class iv) * patients with recent cerebral hemorrhage * patients who have undergone surgery within 24 hours prior to the study sonographic examination * patients with known hypersensitivity or allergy to any component of definity * patients with unstable cardiopulmonary conditions or respiratory distress syndrome * patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome.

Conditions: Short Bowel Syndrome

Summary: the primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with sbs-if.

this is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. eligible subjects would be those who were trial subjects of ta799-007 or ta799-013 trials.

Eligibility criteria:
inclusion criteria: 1. males and females with a diagnosis of sbs-if secondary to surgical resection of the small intestine, with colon-in-continuity (cic) or stoma, who were trial subjects of parent trials ta799-007 or ta799-013 2. able to give informed consent and agree to follow the details of participation as outlined in the protocol. exclusion criteria: 1. subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements. 2. any other reason judged not eligible by the investigator. 3. pregnancy or lactation

Keywords: short bowel syndrome sbs intestinal failure sbs-if
portable monitoring for diagnosis and management of sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: this multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

the study is a randomized, parallel group, unblinded, multicenter study that compares two approaches \[home-based, portable monitoring (pm) versus attended, laboratory-based polysomnography (psg) (lab)\] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (osa) and who have been referred to sleep medicine specialists at aasm-accredited sleep centers for evaluation and/or management. the study is designed to compare the utility of the two approaches (pm group vs. lab group) for the diagnosis and management of osa in adults. approximately 372 eligible adults will be randomized at screening to either the pm or lab arm (186 per arm), undergo baseline osa testing to confirm diagnosis and study eligibility, then receive positive airway pressure (pap) titration studies to determine the level of pressure needed to treat their osa. for qualifying participants, the titration study will be lab-based in the lab group and be home-based using a commercially available portable, automatic pap device (apap) in the pm group. all qualifying study participants will have access to study cpap equipment and supplies to treat their osa. primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting cpap treatment. study participants who complete all of their study visits will keep their cpap machine at the end of the study.

Eligibility criteria:
inclusion criteria: * intermediate to high probability of having osa based on an adjusted neck circumference \> 43 cm (17 inches) * presence of excessive daytime sleepiness (epworth sleepiness scale ≥ 12) apnea-hypopnea index \>= 15 on diagnostic testing to continue in study exclusion criteria: * severe chronic insomnia, other condition with \< 4 hrs of sleep per night * unstable medical conditions * major psychiatric diagnosis * unable to undergo home testing * concerns about unsafe driving * severe copd or restrictive lung disease * chronic narcotic use * alcohol abuse * history of cataplexy * moderate to severe restless legs syndrome symptoms * pre-existing diagnosis of sleep apnea * prior experience with positive airway pressure treatment of sleep apnea * anticipated upper airway surgery or gastric bypass surgery in 4 months * decisional impairment for consenting * hypoventilation syndrome, identified in the medical record * waking oxygen saturation \< 92%

Keywords: treatment positive airway pressure compliance cost effectiveness clinical trial
a pharmacist-led transitions of care program

Conditions: Chronic Disease

Summary: this study was to show the value of pharmacists in providing transitions of care to and improving health outcomes of uninsured populations. it also aimed to demonstrate the feasibility of implementing a transitions of care program in an indigent care clinic with limited resources. we hypothesized that a pharmacist-led transitions of care program will reduce 30-day hospital readmission rates among the uninsured discharged from a community hospital.


Eligibility criteria:
inclusion criteria: * aged 18 years old or older * uninsured * english speaking * discharged from east alabama medical center within the past 16 days exclusion criteria: * patients who did not show up for the first follow-up visit with the study pharmacist after being referred by the care coordinator at east alabama medical center

Keywords: transitions of care indigent population hospital readmission rates
safety and efficacy of palonosetron in preventing chemotherapy-induced nausea and vomiting

Conditions: Nausea; Vomiting; Chemotherapy

Summary: the purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. the study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in china.


Eligibility criteria:
inclusion criteria: * male or female, age ≥ 18 yrs and \<70 yrs with histologically or cytologically confirmed * malignant disease * naive or nonnaive to chemotherapy, with a karnofsky score of ≥ 60 * scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 \~ 80 mg/m2 on study day 1 * use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit * patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion * patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion * predicted life expectancy of ≥ 3 months * provision of written informed consent. exclusion criteria: * inability to understand or cooperate with study procedures * receipt of investigational drugs ≤ 30 days before study entry * receipt of other investigational drugs during the course of this study * seizure disorder or any condition requiring anticonvulsants, sedatives * cns malignancy or metastasis * ongoing emesis due to obstruction of digestive tract * emesis, retching, or grade 2 or 3 nausea 24 hrs before chemotherapy * moderate or severe nausea and vomiting after any previous chemotherapy * scheduled receipt of any chemotherapeutic agent with an emetogenicity level \>3 during study days 2-5 * scheduled receipt of radiotherapy of the upper abdomen or cranium on study days 2-5 * scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5 * contraindications to 5-ht3 receptor antagonists * contraindications to chemotherapy

Keywords: chemotherapy-induced nausea and vomiting acute delayed emesis antiemetics 5-ht3 receptor antagonist granisetron palonosetron