Kornimate/medical-research-clean huggingface dataset:
magnetic resonance elastography (mre) of uterine fibroids

Conditions: Uterine Fibroids

Summary: the purpose of this study is to gain additional information regarding use of magnetic resonance elastography (mre) for uterine fibroid characterization. in this study, the investigators will use a new noninvasive technology, mre, to further characterize the elastic properties of the uterine fibroids. to date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with magnetic resonance guided focused ultrasound (mrgfus). in this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (mre), to further characterize the elastic properties of the uterine fibroids. this information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. it is known that some fibroids with increased t2-signal on magnetic resonance imaging(mri) can be more difficult to treat. this information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.

this is a single-site, non-randomized pilot study to determine whether magnetic resonance elastography (mre) can be optimized for clinical use as part of the patients routine clinical imaging and to correlate with mr signal characteristics of the uterine fibroid. mre is performed at the end of the examination after the standard magnetic resonance imaging protocol. aims: specific aim 1: to acquire magnetic resonance elastography images on women who have a clinically ordered pelvic magnetic resonance imaging (mri) for uterine fibroids. specific aim 2: to examine the correlation between mre stiffness values and mr t2 signal characteristics for uterine fibroids. for a subset of patients going on to surgery correlation with pathology can also be performed. this study will seek to determine whether mre can be performed in the pelvis on a routine clinical basis as well as correlating the mre findings with magnetic resonance signal characteristics. there are no additional risks to the patient and no additional cost to the mri exam.

Eligibility criteria:
inclusion criteria: 1. women able to give informed consent 2. women having uterine imaging exclusion criteria: 1. women currently pregnant 2. allergy to either gadolinium or iodinated contrast 3. severe claustrophobia 4. weight in excess of 250 pounds

Keywords: uterine fibroids uterine leiomyomas mr elastography mri (magnetic resonance imaging) symptomatic uterine fibroids
safety and immunogenicity study of the recombinant human bovine reassortant rotavirus vaccine in healthy indian infants

Conditions: Rotavirus Infections

Summary: a randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of live attenuated tetravalent (g1-g4) bovine-human reassortant rotavirus vaccine \[brv-tv\] administered to healthy indian infants concurrently with other standard epi vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of brv-tv (containing the vp7 serotypes g1, g2, g3, and g4) administered orally to healthy indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard epi vaccines would be generally well tolerated and immunogenic.


Eligibility criteria:
inclusion criteria: * healthy infants 6-8 weeks of age of either sex; * born after a gestational period of 36-42 weeks with birth weight \>2 kg; * father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (icf); * parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up. exclusion criteria: * history of congenital abdominal disorders, intussusception, or abdominal surgery; * known or suspected impairment of immunological function; * known hypersensitivity to any component of the rotavirus vaccine; * prior receipt of any rotavirus vaccine; * fever, with an oral temperature ≥38.1oc (≥100.5of); presumably measured by study staff? * history of known rotavirus disease, chronic diarrhea, or failure to thrive; * baseline level of alt or ast \>2.5 times the upper limit of normal; * clinical evidence of active gastrointestinal illness (infants with gerd can participate in the study so long as this condition is well controlled with or without medication); * receipt of any im, oral, or iv corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study); * infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, hiv infection, leukemia, lymphoma, hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); * infants testing positive for hbv, hcv, or hiv infection; * prior receipt of a blood transfusion or blood products, including immunoglobulins; * any infants who can not be adequately followed for safety by telephone and/or a home visit; * any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
maternal reflective functioning during the transition to motherhood

Conditions: Pregnancy; Primiparous Women

Summary: the goal of this clinical trial is to learn about maternal reflective function (mrf) during the transition to motherhood. the main questions it aims to answer are: does mrf mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship. participants will: answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth). intervention group will participate in an online short intervention to enhance mrf.

using this trial, the investigators will be able to better understand rather mrf moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. using rct design we will be able to understand mechanism of change.

Eligibility criteria:
inclusion criteria: * pregnant women in 27-30 weeks pregnant in enrollment * speak read and understand hebrew * has a connection to internet and zoom platform. * ready to participate in a group workshop exclusion criteria: * women who can\&#39;t participate in a online workshop due to physical or mental health difficulties.

Keywords: pregnancy primiparous women anxiety depression stress mentalization reflective function
exercise training and endothelial function in type 1 diabetes

Conditions: Type1diabetes

Summary: endothelial dysfunction and vasoreactivity disorders are early subclinical complications of type 1 diabetes (t1d). in a preventive setting, in t1d patients still free of complications, the research of non-pharmacological interventions to improve endothelial function appears fundamental. in this randomized controlled trial, the effects of exercise training on endothelial function will be evaluated in t1d adults. secondary objectives are to evaluate the exercise training effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity and their possible neurometabolic consequences. an improvement in vascular function, particularly endothelium-dependent, as well as in neurometabolic profile, through this non-pharmacological strategy is expected


Eligibility criteria:
inclusion criteria: * covered by social security * with a t1diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications. exclusion criteria: * type 1 diabetes diagnoses for less than 1 year * mody diabetes, mitochondrial diabetes or type 2 diabetes * presence of macrovascular and/or microvascular diabetic complications (retinopathy, nephropathy, neuropathy ,...) * obesity (body mass index \> 30 kg/m² * smokers * hypertension * disabling painful discomfort for trunk, upper or lower limb movements * active chronic disease or in remission (excluding type 1 diabetes) * head trauma in the past

Keywords: type 1 diabetes endothelial function exercise training physical activity
gait training in patients with burn injury

Conditions: Burns; Gait Training; Physical Functions

Summary: twenty-four individuals with burn injury will be included in this study. participants with burn injury will evaluate with the following assessment tools: demographic datas; age, gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle). will be recorded via gaitrite system.

twenty-four individuals with lower extremity burn injury will be included in this study. participants will be included if they are aged of 18-50, able to walk independently at least 10 meters. participants will be divided in two groups; intervention and control groups. intervention group: standart rehabilitation program and gait training on the overground will be applied. conntrol group:standart rehabilitation program and gait training on the treadmill will be applied. rehabilitation program will applied by physiotherapist during the acute hospitalization. standart rehabilitation will include active range of motion exercises, functional mobility, balance activities. participants will evaluate with the following assessment tools: demographic datas; age, gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. gaitrite system for gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle), timed up and go test (tug) for dynamic balance and six minute walk test (6mwt) for exercise capacity, will be used. these evaluations will be made twice; initial (admission) and final (discharge).

Eligibility criteria:
inclusion criteria: * participiants who have lower extremity burn injury and able to walk independently 10 meters exclusion criteria: * f there is a medical condition that prevents the ambulance of the individual and oxygen is needed for ambulance, participants will be excluded.

Keywords: burn injury gait physical function
maximizing yield of the fecal immunochemical test for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is a leading cause of cancer death in the united states. screening for crc reduces crc mortality, yet rates of screening in the united states remain low. fecal occult blood testing (fobt) has an established positive balance of benefit and risk, is the least expensive, and is the preferred method for nearly half of patients. a newer fecal screening test, the fecal immunochemical test (fit), offers significant improvements over the fobt. it is easier to use and is more sensitive at detecting both crc and precancerous adenomas than the fobt. the oc-micro fit is of particular interest because it is highly sensitive and specific and it is the only fit test approved in the us that can be processed in an automated manner. thus, the oc-micro is an optimal method for use in mass screening programs to improve community crc-screening rates. however, prior studies of oc-micro suffer from several limitations: they were conducted in populations not optimal for assessing screening performance in average risk patients in the u.s. and the studies did not clearly establish optimal number of samples required and cut-points for test positivity. therefore, the overall goal of my-fit is to capitalize on the highly integrated and extensive electronic medical record system of the study site to collect two separate sets of data that, when synthesized, will provide a thorough picture of the comparative patient adherence to, sensitivity, specificity, and costs of different protocols for using the oc-micro fit. specifically, among kpnw members aged 50-75 who are at average risk for colorectal cancer (crc) and who are due for crc screening (n=78,000), the investigators propose to: 1. compare the sensitivity, specificity, positive predictive value, and negative predictive value for colorectal cancer and advanced adenoma (advanced neoplasia) between a single-sample fit (1-fit) and a two-sample fit (2-fit) using varying cut points for a positive test (n=2100). 2. compare patient adherence to completion of a 1-fit versus a 2-fit protocol (n=3000). 3. assess and compare cost per screen for a 1-fit versus a 2-fit protocol, and the cost per advanced neoplasia detected in a 1-fit versus a 2-fit protocol (using varying cut points for a positive test) (n=78,000). answering the above questions will provide a much-needed strong evidence base for a best-practice, cost-effective method of using the oc-micro fit to screen for crc in a general u.s. population.


Eligibility criteria:
inclusion criteria: * eligible for standard kpnw automated telephonic colorectal cancer screening reminder and have indicated on the call that they wish to screen with fit. exclusion criteria: * kaiser permanente members less than 1 year. * currently on the kaiser permanente center for health research do not call list.

Keywords: colon rectal cancer screening fit fecal
impact of spa treatments on the consumption of care in children

Conditions: Respiratory Disease; Otorhinolaryngologic Diseases; Dermatologic Disease

Summary: children represent 1.2% of the spa population in france. spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. the benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures. few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. moreover, no real-life study of a large sample of children seems to have been conducted in this area. the present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.


Eligibility criteria:
inclusion criteria: * children living in france at the time of the study * 'pomme' cohort : children included at birth and 'egb' cohort : children from birth to 15 years-old exclusion criteria:

Keywords: drug consumption
study of the safety and pharmacology of gdc-0980 in combination with paclitaxel with or without bevacizumab in patients with locally recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: this is an open-label, multicenter, phase ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of gdc-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * locally recurrent or metastatic breast cancer, not amenable to resection with curative intent * for arm c: overexpression of her2 * eastern cooperative oncology group performance status of 0 or 1 * adequate hematologic and organ function * evaluable or measurable disease per recist (response evaluable criteria in solid tumors) * female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study exclusion criteria: * prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer * prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment * history of type 1 or type 2 diabetes requiring regular medication * history of clinically significant cardiac or pulmonary dysfunction * history of malabsorption syndrome or other condition that would interfere with enteral absorption * any condition requiring full-dose anticoagulants * leptomeningeal disease as a manifestation of cancer * active infection requiring iv antibiotics * active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of \<= 10 mg/day of prednisone * known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis * known hiv infection * known untreated or active cns metastases * pregnancy, lactation, or breastfeeding * major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment for arm b: * uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment * evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment * history of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab * serious, non-healing wound, active ulcer, or untreated bone fracture * proteinuria
incidental cancer in familial adenomatous polyposis

Conditions: Cancer

Summary: colectomy is life-saving in patients with familial adenomatous polyposis (fap) because cancer development is inevitable in individuals with this disease. in this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for fap. prophylactic colectomy should be performed in patients with fap, as colorectal cancer transformation is inevitable in these individuals. the possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

colectomy is life-saving in patients with familial adenomatous polyposis (fap) because cancer development is inevitable in individuals with this disease. in this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for fap. the files of patients diagnosed with fap who underwent surgery in our clinic between 2010 and 2020 were retrospectively reviewed. definitive surgery was performed in patients with histopathological malignancy identified in colonoscopic biopsies in the preoperative period, while prophylactic surgery was performed in patients without malignancy. the incidence of incidental malignancy in histopathological specimens from patients who underwent prophylactic colectomy was determined. prophylactic colectomy should be performed in patients with fap, as colorectal cancer transformation is inevitable in these individuals. the possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

Eligibility criteria:
inclusion criteria: * diagnosed with familial adenomatous polyposis exclusion criteria: * did not receive surgical treatment * data deficiencies

Keywords: familial adenomatous polyposis colectomy rectum cancer adenoma
phase 2 trial of cp-751,871 and docetaxel in advanced breast cancer

Conditions: Breast Cancer

Summary: this study will assess the effectiveness of cp- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. the effectiveness will be measured by progression-free survival duration. patients will be followed for 2 years from the date of randomization.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (stage iv) of locally recurrent disease not amenable to curative resection or radiation therapy (stage iiib). * her-2negative breast cancer or unknown her-2 status. * at least 1 measurable lesion as defined by recist. * ecog status 0-1 * adequate bone marrow, hepatic and renal function. * left ventricular ejection fraction of greater than or equal to 50%. * willingness to discontinue hormonal therapy. exclusion criteria: * any previous chemotherapy for advanced disease. * prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization. * symptomatic brain metastases. * prior anti-igf-1r based investigational therapy. * peripheral neuropathy greater than grade 2.

Keywords: key words: docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;her-2 negative; stage iiib or iv breast cancer.
effects of short-term atorvastatin treatment on vaccination efficacy in nonresponder persons to hepatitis b vaccine

Conditions: Hepatitis B; Vaccination Failure

Summary: the purpose of this study is to determine whether short-term atorvastatin can increase the immunity response to hepatitis b vaccination in vaccine nonresponders.

20 person of vaccinated individuals who have hbsab\<10 after 3 dose hepatitis b vaccination who called nonresponders will be randomly allocated in 2 groups. one group receive short-term atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis b vaccine and then immunity response will be measured.

Eligibility criteria:
inclusion criteria: * previous 3 dose hepatitis b vaccination * negative hbc ab * negative hbs ag * hbs ab less than 10 in eliza exclusion criteria: * positive serologic evidence of hepatitis b infection * chronic use of atorvastatin * immunosuppressive disease

Keywords: vaccination failure nonresponder hepatitis b virus atorvastatin immunization against viral hepatitis