Kornimate/medical-research-clean huggingface dataset:
effectiveness of contrast-enhanced ultrasound

Conditions: Abdominal Injuries; Physical Abuse; Accidental Fall; Motor Vehicle Injury

Summary: the purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. the primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (ceus) compared to abdominal computed tomography (ct) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.

abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. the current gold standard imaging study is computed tomography (ct) with iv contrast, which is associated with radiation exposure. contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed. this is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal ct with iv contrast as part of their clinical care due to concerns for abdominal trauma. investigators will compare ceus results with those obtained by ct. investigators will additionally include retrospective data of children who underwent both abdominal ct and ceus as part of clinical care.

Eligibility criteria:
inclusion criteria for study ceus 1. males or females \< 8 years of age at time of enrollment 2. clinically stable (defined as not undergoing an emergent surgical procedure in the next hour) 3. abdominal ct ordered or obtained 4. iv in place exclusion criteria for study ceus 1. unable to obtain contrast-enhanced ultrasound within 72 hours after ct 2. history of allergic reaction to lumason, sulfa-hexafluoride lipid microsphere components, or other ingredients in lumason (polyethylene glycol 4000, distearoylphosphatidylcholine (dspc), dipalmitoylphosphatidylglycerol sodium (dppg-na) palmitic acid) 3. known congenital or acquired heart disease alternative inclusion and exclusion criteria for children who have undergone or are undergoing ceus as part of clinical care inclusion criteria: 1. males or females \< 8 years of age at time of ceus. 2. clinical team plans to perform ct or has performed ct as part of clinical care for abdominal trauma 3. clinical team plans to perform (or has performed) ceus as part of clinical care 4. date of ceus after january 1, 2015 exclusion criteria: none
prehospital use of ultrasound in undifferentiated shortness of breath

Conditions: Pneumonia; Pulmonary Edema; Dyspnea

Summary: this is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. the primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic b-lines in patients with undifferentiated shortness of breath at least 80% of the time in the prehospital environment using a portable ultrasound (u/s) device.

in the first phase of the study, a cohort of senior and supervisory paramedics will be recruited into the study. these paramedics would undergo didactic and hands-on training to learn how to operate the u/s machine, and obtain and interpret basic u/s images. the paramedics will then participate in video review sessions and spend time in the emergency department (ed) with the u/s team to get hands-on experience with patients. in the second phase of the study, paramedics will be staffing ambulances or fly cars in and around the greater new haven region and will respond to dyspnea calls. at each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. the paramedic will then use the portable u/s machine to look for the presence of either unilateral or bilateral b-lines indicating possible pneumonia (in the case of unilateral b-lines) or pulmonary edema (in the case of bilateral b-lines). the paramedic will then document the presence or absence of b-lines for each lung on the prehospital study sheet. the paramedic will then use the u/s to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.

Eligibility criteria:
inclusion criteria: - dyspnea and any of the following: * respiratory rate \> 20 * room air oxygen saturation \< 92% * accessory muscle use, tripod position, nasal flaring * exam with evidence of rales/rhonchi or wheezing * in acute respiratory distress on paramedic evaluation * any patient in acute respiratory distress with exclusion criteria: * trauma * burns * pregnancy * kussmaul respirations from metabolic acidosis * cheyne-stokes from increased icp (intracranial pressure), heart failure or cva * drowning

Keywords: lung ultrasound
use of the perinatal database and biologic tissue bank at the perinatology research branch (prb)

Conditions: Pregnancy; Premature Birth; Prenatal Care; Preterm Delivery; Preterm Birth

Summary: the purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. the samples have been gathered under the sponsorship and approval of the human investigations committees at yale university, wayne state university and pennsylvania hospital in the united states, the sotero del rio hospital, the hospital of the universidad de chile and the universidad catolica de chile , in chile. the investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. clinical information with patient identifiers is available for these samples and sonographic examinations.

the purpose of this application is to request permission to use a bank of biological specimens and clinical information collected by the investigators prior to their joining the intramural program. the samples have been gathered under the sponsorship and approval of the human investigations committees at yale university, wayne state university and pennsylvania hospital in the united states, the sotero del rio hospital, the hospital of the universidad de chile and the universidad catolica de chile , in chile. the investigators have generated a bank of amniotic fluid, maternal blood and urine, and fetal blood obtained at the time of delivery (from the umbilical cord and by cordocentesis), neonate s urine and sonographic examinations of the fetus, including echocardiography, stored on videotapes. clinical information with patient identifiers is available for these samples and sonographic examinations.

Eligibility criteria:
* not listed in protocol - samples only.

Keywords: pregnancy preterm birth preterm birth prevention prematurity pregnancy complications
a study of cusatuzumab plus azacitidine in japanese participants with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome who are not candidates for intensive treatment

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study is to determine the recommended phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in japanese participants with treatment naïve acute myeloid leukemia (aml) who are not candidates for intensive treatment.


Eligibility criteria:
inclusion criteria: * for acute myeloid leukemia (aml) participants: aml according to world health organization (who) 2016 criteria and fulfilling all of the following criteria:(a) more than or equal to (\>=) 75 years of age, or younger participants who are not eligible for or not willing to receive an intensive treatment (including stem cell transplantation) with curative intent and (b) previously untreated aml (except: emergency leukapheresis, low dose of cytarabine and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of cusatuzumab \[part 1\] or azacitidine \[part 2\]). all trans retinoic acid (atra) treatment for presumed acute promyelocytic leukemia (apl) is permitted but must be discontinued at least 1 day prior to the start of cusatuzumab (part 1) or azacitidine (part 2) * for myelodysplastic syndrome (mds) participants (only for part 2): mds according to who 2016 criteria and fulfilling all of the following criteria: (a) not eligible for or not willing to receive allogenic stem cell transplantation,(b) very high or high-risk mds according to revised international prognostic scoring system (ipss-r) and (c) previously untreated mds (except: transfusion and/or cytokine therapy including erythropoietin) * eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2 * must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * a woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hcg\]) or urine pregnancy at screening exclusion criteria: * acute promyelocytic leukemia (apl) with t (15;17), or its molecular equivalent promyelocytic leukemia retinoic acid receptor (pml rar alpha) * leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system * known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (example, mannitol, an excipient of azacitidine) * prior treatment with a hypomethylating agent for treatment of aml or mds * a diagnosis of other malignancy that requires concurrent nonsurgical treatment
an 8 week study looking at the efficacy, toleration and safety of ss-rbx for stress urinary incontinence.

Conditions: Urinary Incontinence, Stress

Summary: a study designed to assess the efficacy, toleration and safety of ss-rbx for the treatment of stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * clinically significant stress urinary incontinence exclusion criteria: * history or evidence of any relevant confounding urological or neurological disease
feasibility and accuracy of hybrid magnetic resonance and positron emission tomography with 18f-fluorodeoxyglucose in diagnosing cardiac sarcoidosis

Conditions: Cardiac Sarcoidosis

Summary: the purpose and objectives of the study is to establish the feasibility of the simultaneous pet/mr in patients with cardiac sarcoidosis, determine relationships between various imaging biomarkers like extracellular volume (ecv) and standardized uptake values (suv) from fdg-pet and to evaluate the diagnostic accuracy of the simultaneous method in comparison to the pet/ct and cardiac mri.

patients who meet the inclusion criteria and agree to the study will be recruited from the kirklin clinic and uab hospitals who will be undergoing fdg-pet/ct for cardiac study as part of their standard of care to diagnose cardiac sarcoidosis. mri and fdg-pet screening questionnaire will be completed. a chart review will be completed to obtain data from patient medical records pertaining to study including age, gender, race, weight, height, vital signs, social and family history, past medical history especially if there is any history of hypertension, diabetes, high cholesterol levels, heart failure or history of lung diseases, lab results including brain natriuretic peptide levels, creatinine, hemoglobin, coagulation parameters, results of stress test/left heart catheterization, prior echocardiography if available. the cmr will be done solely for research purposes. the patient will be in the pet/mri scanner for cardiac study only for 60-90 minutes, finally, multi-sequence, multi-planar cardiac mr images will be acquired to assess cardiac chamber size, regional wall motion abnormalities, ejection fraction, left ventricular perfusion(using gadolinium-based agent) and late gadolinium enhancement. the investigators will also conduct mri examinations on 5 healthy volunteers to establish cardiac mri protocol for the pet/mri scanner. these scans will not involve any fdg administration to the healthy volunteers. these will involve cardiac mri examinations to determine the feasibility and quality of mri scans with the new scanner.

Eligibility criteria:
inclusion criteria: 1.subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or biopsy proven extracardiac sarcoidosis and/or positive hrs criteria will be enrolled. exclusion criteria: 1. coronary artery disease 2. insulin dependent diabetes 3. claustrophobia 4. pregnancy/nursing 5. presence of pacemaker or automatic implantable cardioverter-defibrillator 6. impaired renal function (estimated glomerular filtration rate \<45 ml/min/1.73 m2) will be excluded. 7. inability to undergo pet/mri due to any other condition.
a clinical trial evaluating the safety and effectiveness of golimumab in patients with severe, persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.

golimumab is a type of tumor necrosis factor (tnf) inhibitor. tnf is a naturally occurring substance in the body and this substance may cause long-term inflammation. golimumab may help treat this disease by blocking the activity of tnf in the body and reducing the symptoms of severe, persistent asthma.this study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. the effect of subcutaneously (sc) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. about 200 patients will take part in the study at approximately 60 centers worldwide. participation in the study will last for about 42 weeks. the study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. patients eligible to take part in this study will be randomly placed into one of the following study groups: group 1: placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from week 0 through week 20. group 2: golimumab 100 mg from week 0 through week 20. this study is "blinded." this means that neither patient nor study doctor will know in which group a patient is placed. however, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time. patients will receive an injection (under the skin) of placebo (group 1) or golimumab 100 mg (group 2) every 4 weeks from week 0 through week 20.

Eligibility criteria:
inclusion criteria: * physician diagnosis of asthma for \>= 3 years and a diagnosis of severe, persistent asthma for \>= 1 year prior to screening * reversible airway obstruction * continuous treatment with high dose inhaled corticosteroids and long-acting beta2-agonist for at least 3 months prior to screening * at least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral) * score of \>= 2 points on the asthma control questionnaire (acq) at screening exclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd), cystic fibrosis, or other significant respiratory disorder * life-threatening asthma attack requiring intubation in the 6-month period prior to screening * steroid use at a dose \> 20 mg of prednisone at the screening visit * known malignancy or history of malignancy * previous exposure to anti-tnf therapies

Keywords: injections severe, persistent asthma
a study of galiximab + rituximab versus rituximab + placebo in follicular non-hodgkin's lymphoma (nhl)

Conditions: Lymphoma, Non-Hodgkin's

Summary: this is a phase iii, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular nhl. the purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular nhl. safety and pharmacokinetics (pk) of galiximab and rituximab will also be evaluated.


Eligibility criteria:
key inclusion criteria: key inclusion criteria: * aged \>= 18 years old at the time of informed consent. * histologically confirmed follicular grade 1-3a nhl. * relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. * bidimensionally measurable disease with at least 1 lesion \>= 2.0 cm in a single dimension. * acceptable hematologic, hepatic, and renal function parameters. * recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. key exclusion criteria: * follicular lymphoma grade 3b. * rituximab refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a ttp of less than 6 months). * cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosourea or mitomycin c). * prior lymphoma vaccine therapy within 12 months prior to study day 1. * prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1. * autologous bone marrow or stem cell transplant within 6 months prior to study day 1. * prior allogeneic transplant. * transfusion-dependent subjects. * another primary malignancy requiring active treatment (except hormonal therapy). * serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the investigator and/or the sponsor. * new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.

Keywords: relapsed nhl pharmacokinetics antibody safety galiximab efficacy rituximab refractory
effects of long-term treatment with nasally inhaled triamcinolone acetonide in children with allergic rhinitis

Conditions: Allergic Rhinitis; Allergy; Growth

Summary: seasonal/perennial allergic rhinitis (sar/par) is a common childhood illness. one of the leading therapies for the treatment of sar/par is intranasally inhaled corticosteroids (ics). one of the major long-term safety concerns is whether ics interferes with normal growth in allergic rhinitis children. recent evidence suggests that nasal ics may cause decreased growth. however, the effect of nasal ics on long-term growth and the attainment of final adult height is unknown. another potential systemic adverse effect of ics use is suppression of the hypothalamic-pituitary-adrenal axis function. the primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (taa) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.


Eligibility criteria:
inclusion criteria: * male/female aged 6-13 years of age * diagnosis of sar/par, with symptoms within the past 3 months * positive skin test to inhalant allergen with negative saline control * no previous use of intranasal inhaled, oral, iv or topical steroid use within past 6 months. * if the subject has asthma, only mild intermittent (per napp) guidelines treated with prn bronchodilator exclusion criteria: * screening height outside the 5th and 95th percentiles * history of abnormal growth * any other chronic condition beside allergic rhinitis or mild intermittent asthma * subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial. * subject with a known hypersensitivity to any active ingredients or excipents in the study medications * subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum) * subjects with a history of substance abuse, mental illness or retardation * subjects with a history or presence of glaucoma or posterior subcapsular cataract * subjects with nocturnal enuresis. * use of theophylline, intal/tilade or leukotriene modifiers.

Keywords: allergic rhinitis allergy growth
physical activity and basal metabolic rate in postmenopausal women

Conditions: Postmenopausal Metabolic Health

Summary: the primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (bmr) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. the investigators will measure bmr by indirect calorimetry and normalize it across subjects for body size (fat free mass) and level of aerobic fitness (vo2max). two groups will be compared: an intervention group (no previous participation in regular exercise, newly enrolled in this study's 16 week training program), and a long-term athlete group (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). a secondary aim is to generate an equation for the prediction of bmr from fat free mass in physically active postmenopausal women, to be applied to hypotheses in biological anthropology. the investigators expect to find at baseline that, controlling for fat free mass and vo2max, the long-term group will have significantly higher bmr than the intervention group. at 16 weeks the investigators expect no change in bmr for the long-term group, while bmr will have increased in the intervention group. at the same time, the investigators expect to find that after completing the training regimen, the intervention group will have bmr similar to that of the long-term athletes.


Eligibility criteria:
inclusion criteria: * naturally postmenopausal (i.e. non-surgically)/\> 1 year since last menstruation * fsh \> 30 miu/ml * estradiol-17β \< 25 pg/ml exclusion criteria: * smoker, abuser of alcohol/other drugs * hypo- or hyperthyroid (serum tsh \ 5.5 microu/ml, respectively) * underweight or severely obese (bmi \ 35 kg/m2, respectively) * weight instability within the past six months (±\> 5% of body weight) * hormone replacement therapy within the past six months * history of metabolic, respiratory or cardiovascular disease * high blood pressure * contraindication for maximal aerobic testing as determined by par-q questionnaire and physician's examination

Keywords: basal metabolic rate resting energy expenditure menopause physical activity metabolic syndrome