Kornimate/medical-research-clean huggingface dataset:
the clinical efficacy and the changes of immune cells subsets with bioagents in ankylosing spondylitis patients

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(as), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (nsaids) or bioagents.

biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. the disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.

Eligibility criteria:
inclusion criteria: 1. patients who meet modified new york 1984 criteria for ankylosing spondylitis； 2. age ≥18 years and ≤ 65 years； 3. asdas ≥ 1.3； 4. concomitant drugs: use stable doses of nsaids alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (mtx), sulfasalazine (sasp), glucocorticoids. glucocorticoids can be injected locally after 12 weeks, nsaids keep stable for 12 weeks； 5. willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent. exclusion criteria: 1. patients with severe infections, tumors and damage to vital organs: * platelet counts(plt) \<80 x 10\^9 / l, or white blood cell (wbc) \<3 x10\^9 / l; * propionate acid aminotransferase (alt) or aspartate aminotransferase(ast) is two times higher than the upper limit of normal; * renal insufficiency: serum cr ≥ 176 umol / l; * pregnant or nursing women (breastfeeding) ; * patients has a history of malignancy (cure time in less than 5 years); * patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction; 2. patients with current or previous crohn's disease; 3. patients with current ulcerative colitis requiring immunosuppressive therapy; 4. any active infection active viral hepatitis includes hepatitis b virus (hbv), hepatitis c virus (hcv), human papillomavirus (hpv). active infections include small intestine herpes zoster virus (vzv), human immunodeficiency virus (hiv), syphilis or tuberculosis; 5. patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial; 6. patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.

Keywords: secukinumab adalimumab
the effects of a tele-health program

Conditions: Frailty; Old Age; Debility

Summary: frailty is a state of being vulnerable and functional disable due to age-related decline of multiple physiological systems, and is often associated with higher risk of falls, institutionalization, hospitalization, disability, dementia, and death. one of the best strategies to combat the burden of frailty is to promote physical activity in the aging population, especially to the older adults who are already in a frail condition


Eligibility criteria:
for older adults: inclusion criteria: * aged 60 or above * having level of frailty from "managing well" to "living with severe frailty" (clinical frailty scale score 3-7) -- hk-moca score 23 or less (add one point to people who had less than 6 year formal education and add 2 points to people who had no formal education) exclusion criteria: * currently receiving any kind of rehabilitation service * living with another older adult who is participating in the same study. for young adults: inclusion criteria: * aged 17 to 35 * having educational level of secondary 5 or above exclusion criteria: - having a full-time job

Keywords: technology device occupational therapy young adult frail older adults self-care
study to evaluate long-term safety, tolerability, and satisfaction with prucalopride in chronic constipation

Conditions: Chronic Constipation

Summary: objectives: to evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (cc).


Eligibility criteria:
inclusion criteria: 1. male and non-pregnant, non breast-feeding female outpatients at least 18 years of age. 2. patient completed the entire treatment period of one of the following studies: pru-usa-3, pru-usa-11, pru-usa-13, pru-usa-21, pru-usa-25, pru-usa-27 or pru-usa-28, or patient participated in the re-treatment study pru-usa-28 and did not qualify for treatment period ii after both washout periods. exclusion criteria: 1. patient with impaired renal function 2. patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. 3. female of childbearing potential without adequate contraceptive protection during the study. 4. patient who used an investigation drug other than prucalopride in the 30 days preceding the study.
strategies to reduce contrast medium in spectral ct pulmonary angiography

Conditions: Pulmonary Embolism

Summary: the purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in computed tomography pulmonary angiography (ctpa). 330 patients referred for ctpa are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. effects on the level and homogeneity of contrast enhancement are measured and compared between groups.

spectral detector ct facilitates large reductions in contrast medium in vascular ct examinations. to our knowledge, no studies have so far compared different strategies to inject this reduced contrast dose. the purpose of this study is to assess the effect of three different strategies to inject at reduced volume of contrast medium in computed tomography pulmonary angiography (ctpa). 330 patients referred for clinically indicated ctpa are randomized to receive either a low-concentration, a low-volume or a saline-diluted injection. all patients receive the same amount of iodine (140 mg/kg). effects on the level and homogeneity of contrast enhancement, image noise, contrast-to-noise-ratio and signal-to-noise-ratio are measured in the ct images and the results are compared between groups.

Eligibility criteria:
inclusion criteria: * inpatients and outpatients with kidney function (egfr) allowing for safe administration of contrast dose (as calculated with the omnivis calculator). * patients with clinical suspicion of disease of pe * referral to ctpa diagnosis, treatment planning or follow-up. * peripheral venous catheter (pvc) =/\< 18 g exclusion criteria: * contraindication to iodinated contrast medium * age \< 18 years * lack of informed consent * pregnancy

Keywords: pulmonary embolism spectral detector ct contrast medium
automated insulin for management of intrapartum glycemia

Conditions: Type 1 Diabetes (T1D); Pregnancy; Pre-Gestational Diabetes

Summary: the goal of this clinical trial is learn if automated insulin delivery (aid) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (t1d). the main questions this study aims to answer are * what are the neonatal glycemic outcomes with use of aid systems during labor/delivery? * do patients report higher birth satisfaction with use of aid systems during labor/delivery? * are glycemic parameters like time-in-range (tir) better with use of aid systems during labor/delivery? researchers will compare aid systems to intravenous (iv) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.


Eligibility criteria:
inclusion criteria: * known diagnosis of type 1 diabetes ≥ 1 year * current use of commercially available aid system ≥ 6 months * currently pregnant at ≥ 34 weeks * singleton pregnancy * english- or spanish-speaking exclusion criteria: * planned cesarean delivery * use of medications known to interfere with glucose metabolism * intrauterine fetal demise * physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare

Keywords: pregnancy intrapartum glycemic management neonatal hypoglycemia perinatal care diabetes in pregnancy
gabapentin for the reduction of radiation therapy induced pain during the treatment of oropharyngeal cancer

Conditions: Oropharynx Cancer

Summary: strategies to minimize and mitigate external beam radiation therapy related mucositis and pain during the treatment of head and neck cancer remain limited. the investigators hypothesize that gabapentin could be used to delay or reduce treatment-related pain, reliance on opioid medication, and improve the quality of life for these patients.

the specific aims of this proposed study include the following: * evaluate the reduction or delay of mucositis related pain and morbidity with the use of gabapentin in patients with stage iii or iv oropharyngeal squamous cell carcinoma undergoing definitive radiation with concurrent chemotherapy as part of their cancer management, compared to standard supportive side effect mitigation - using patient reported quality of life endpoints such as the patient-reported oral mucositis symptoms (proms) scale. * assess morphine-equivalent opioid use in both treatment arms by collecting the patient's narcotic use in the previous 24-hour period at each weekly evaluation during radiation treatment. * report on change in speech and swallow performance, as measured by the performance status scale (pss) for head and neck cancer patients * evaluate changes in weight from baseline throughout treatment between the two arms. * assess feeding tube requirements during treatment. * evaluate the adverse events associated with gabapentin. * evaluate the severity of radiation mucositis (grade 3-4, ctcae, v. 4)

Eligibility criteria:
inclusion criteria: * patients being treated with combination chemotherapy and radiation therapy daily for locally advanced (stage iii-iv) squamous cell carcinoma of the oropharynx. * age ≥ 18. * ecog performance status ≤ 1. * patients must provide study specific informed consent prior to study entry and be able to fill out toxicity and quality of life related questionnaires. exclusion criteria: * patients may not be receiving gabapentin, any other investigational agents, or other anticonvulsants. * patients with metastatic disease are excluded from this clinical trial. * patient with allergies or hypersensitivity to gabapentin. * patients receiving surgery as part of their definitive management. * patients who have received prior chemotherapy or radiation therapy. * patients unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily. * uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring iv antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, or psychiatric illness/social situations that would limit compliance with study requirements.
study of ultomiris® (ravulizumab) safety in pregnancy

Conditions: Ultomiris-exposed Pregnant/ Postpartum; Pregnancy; Paroxysmal Nocturnal Hemoglobinuria (PNH); Atypical Hemolytic Uremic Syndrome (aHUS); Generalized Myasthenia Gravis (gMG); Neuromyelitis Optica Spectrum Disorder (NMOSD)

Summary: the primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

this observational study will collect prospective and retrospective data in participants exposed to ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.

Eligibility criteria:
inclusion criteria: * female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified). * participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. if the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate). * willing to provide contact information for the participant. * willing to authorize hcp(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations. * diagnosed with an indication for which ultomiris is approved, based on hcp or medical records. * exposed to ultomiris at any point during the defined exposure window based on hcp or medical record documentation. (if exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure \[prior to conception as lmp+14 days, or during breastfeeding\].) * use of ultomiris per local product information (i.e., united states prescribing information \[uspi\] or summary of product characteristics \[smpc\]) exclusion criteria: * participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study

Keywords: ultomiris pregnancy pnh ahus gmg nmosd
discriminative validity of strain elastography of the supraspinatus tendon

Conditions: Elasticity Imaging Techniques; Tendinopathy; Rotator Cuff Tendinitis; Musculoskeletal Disease

Summary: this study aims at testing the discriminative validity of strain elastography in the normal and abnormal/pathological supraspinatus tendon due to tendinopathy

the case-control trial will include 96 participants. 48 of them diagnosed with supraspinatus tendinopathy by mri and 48 healthy subjects. in this study the investigators will compare the outcome of tissue elasticity measured by sonoelastography, with mri and conventional ultrasound. patients will be recruited through different radiology department and healthy volunteers will be recruited primarily through advertising in local newspapers and social media.

Eligibility criteria:
inclusion criteria: * body mass index \< 30 * symptomatic: positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins. * asymptomatic: no shoulder pain in the last year, negative on 5/5 clinical tests (full can, empty can, resisted external rotation, neers, hawkins). exclusion criteria: * shoulder-fracture, operation and luxation, known-neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondyloarthropathy and psychiatric disorders, pregnancy and inability to read and understand danish. biceps rupture, labrum lesions, supraspinatus tears (\> 1/3 of the vertical tendon height) and calcifications (\> 2 mm in length) (mri).
hypertension in families of african origin

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to investigate familial patterns of hypertension and related cardiovascular (cv) risk factors in the united states and nigeria.

background: it has been known for many years that african americans experience twofold higher rates of hypertension than do whites. the underlying biological mechanisms which lead to this differential are still not understood, however. despite widespread speculation that persons of african descent are genetically susceptible to hypertension, few direct studies have been carried out. rates of hypertension remain low in west africa, and this study will provide a contrast between populations of similar genetic background in a low versus high risk environmental setting design narrative: a total of 240 families were identified from completed community surveys in maywood, illinois and ibadan, nigeria. probands were ages 45-55 and equally divided between males and females. a minimum of five first-degree relatives were examined in each family to obtain information on the following variables: blood pressure (bp), obesity, urinary sodium and potassium, socioeconomic status and physical activity. in addition, plasma and dna were collected and stored for future studies of relevant physiologic intermediate phenotypes and candidate genes for hypertension in the two contrasting populations. these data provided the basis for examining familial aggregation of blood pressure/hypertension and related cv risk factors. three primary goals were addressed: 1) to determine whether the familial aggregation of blood pressure in black populations was influenced by the overall distribution of environmental factors at the population level, by contrasting the distribution of familial correlations of blood pressure and the familial aggregation of hypertension, in nigeria and the united states; to determine the significance of measured environmental correlates of blood pressure by comparing the magnitude of variance components for probands and relatives in each setting; and 3) to use path analysis to obtain estimates of genetic and cultural heritability of blood pressure, controlling for clustering environmental factors at the household level. plasma and dna samples collected in this study provided additional valuable resources for future molecular research. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
hepatectomy for early-stage hcc patients with csph

Conditions: HCC; Portal Hypertension

Summary: clinically significant portal hypertension (csph) can affect the surgical prognosis of early-stage (bclc stage a) hcc. an additional stage, such as the bclc stage a-b, can be considered.


Eligibility criteria:
inclusion criteria: hcc was diagnosed by two experienced pathologists in child-pugh grade a/b negative resection margin initial diagnosis of hcc in the patients exclusion criteria: distant transfer not hcc
tiotropium / respimat one-year study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to evaluate the long term effects of treatment with two doses of tiotropium delivered by the respimat inhaler in patients with copd.


Eligibility criteria:
growth and weight gain in elbw infants fed an exclusively human milk based diet with prolacta®

Conditions: Weight Gain; Human Milk; Preterm Infants; Extremely Low Birth Weight

Summary: preterm infants are susceptible to postnatal growth restriction. breast milk is the recommended source of nutrition for preterm infants. as preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth. due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (prolact+6 h2mf® prolacta, city of industry, california) has been developed. with this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (elbw, \<1000g birth weight) in comparison to bovine fortification.

preterm infants are susceptible to postnatal growth restriction. breast milk is the recommended source of nutrition for preterm infants. many positive short-term health effects like prevention necrotizing enterocolitis , effects on gut development and immunological issues are associated with breast milk feedings. the composition of breast milk usually meets the nutritional demands of term infants. as preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth and proper neurodevelopmental outcome. due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (prolact+6 h2mf® prolacta, city of industry, california) has been developed. this human milk fortifier contains more energy and protein than bovine milk fortifiers. so far, accurate data on growth and weight gain under an exclusive diet with human milk and the human milk fortifier prolact+6h2mf®are missing. with this study, the investigators want to evaluate the impact of a human milk based fortifier on weight gain in extremely low birth weight infants (elbw, \<1000g birth weight) in comparison to bovine milk based fortifier.

Eligibility criteria:
inclusion criteria: * preterm infants with a birth weight \<1000 g exclusion criteria: * congenital heart disease * major congenital birth defects * major inborn error of metabolism

Keywords: infant weight gain human milk fortifier preterm infants elbw infants
development of patient derived xenografts (pdx) in patients with breast cancer

Conditions: Breast Cancer; Residual

Summary: breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\>50%) risk of future life-threatening recurrences and death.

this study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. we will use the blood and tissue for future studies. these studies will try to find ways to treat future breast cancer patients. because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it. blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy. * surgically resectable disease following neoadjuvant systemic treatment. * at least one of the following must be true: 1. received at least 2 weeks of neoadjuvant endocrine therapy 2. received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging 3. began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by mri, ultrasound, or physical examination * provide written informed consent. * willing to return to enrolling institution for breast cancer surgery. * willingness to provide mandatory blood specimens for future research on breast cancer at mayo clinic. * willingness to provide mandatory tissue specimens for future research on breast cancer at mayo clinic. * willingness to provide mandatory tissue specimens for the generation of pdx and organoids to be used future research on breast cancer at mayo clinic. exclusion criteria: * ineligible for surgery. * history of prior malignancy \<3 years prior to registration. exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).