Kornimate/medical-research-clean huggingface dataset:
post-trial access for nipocalimab in participants with warm autoimmune hemolytic anemia (waiha)

Conditions: Warm Autoimmune Hemolytic Anemia

Summary: the purpose of this post-trial access (pta) program is to provide nipocalimab for the treatment of participants with warm autoimmune hemolytic anemia (waiha) who are experiencing clinical benefit after completing 28-weeks open-label extension in mom-m281-006 (nct04119050) study.


Eligibility criteria:
inclusion criteria: * participants demonstrate clinical benefit (improvement of hemoglobin from baseline) at the week 28 assessment in the open-label extension of the mom-m281-006 (nct04119050) study * participants does not have co-morbidities that would alter the risk-benefit of nipocalimab administration (determined by treating physician) * participants completed treatment in the 28-week open-label extension of the mom-m281-006 (nct04119050) study without receiving rescue treatment or discontinuation of the study prior to week 28 visit exclusion criteria: * participants have a serious or clinically significant infection (example: pneumonia, biliary tract infection, diverticulitis, clostridioides difficile infection) requiring parenteral anti-infectives and/or hospitalization * participants have a chronic infection (example: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or require chronic treatment with anti-infectives (example: antibiotics, antivirals)
a study of onartuzumab (metmab) in combination with mfolfox6 in patients with metastatic human epidermal growth factor receptor 2 (her2) negative gastroesophageal cancer

Conditions: Gastric Cancer

Summary: this randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (metmab) in combination with mfolfox6 in patients with metastatic her2-negative adenocarcinoma of the stomach or gastroesophageal junction. patients will be randomized in a 1:1 ratio to receive either onartuzumab (metmab) or placebo in combination with mfolfox6. patients may continue to receive onartuzumab (metmab) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.


Eligibility criteria:
inclusion criteria: * adult patients, 18 years of age and older * adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy * eastern cooperative oncology group (ecog) performance status 0 or 1 * life expectancy \>3 months * presence of tissue sample for immunohistochemistry assay of met receptor and her2 status (if unknown) * radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the response evaluation criteria in solid tumors (recist v1.1); patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial. * for women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin * for men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin * adequate laboratory values exclusion criteria: * her2-positive tumor (primary tumor or metastasis) * previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization) * prior treatment with investigational drugs that target the hepatocyte growth factor (hgf) or met pathway * history of other malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage 1 uterine cancer, and localized prostate cancer * receipt of an investigational drug within 28 days prior to study start * clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., crohn's disease) * significant history of cardiac disease * significant vascular disease * infection with human immunodeficiency virus, hepatitis b, or hepatitis c
niacin (+) laropiprant (tredaptive) re-examination study (mk-0524a-119)

Conditions: Hypercholesterolemia; Mixed Dyslipidemia

Summary: this survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (tredaptive) in usual practice in korea according to the new product re-examination regulations of the korean food and drug administration.


Eligibility criteria:
inclusion criteria: * participants who are treated with tredaptive tablet within current local label for the first time * participants with primary hypercholesterolemia or mixed dyslipidemia * participants who are treated with tredaptive for more than or equal to 24 weeks will be included in long-term surveillance * special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected. exclusion criteria: * participant who is treated with tredaptive tablet before contract and out of enrollment period * participant who has a contraindication to tredaptive tablet according to the current local label

Keywords: usual practice re-examination
the effect of medical clowns and topical anesthetic cream on pain and anxiety in children undergoing allergy skin tests

Conditions: Anxiety Disorder; Allergic Skin Reaction

Summary: allergy skin tests are occasionally associated with pain and anxiety in patients undergoing this procedure. the investigators intend to examine if medical clowns compared with local anesthetic cream can decrease these feelings in children.


Eligibility criteria:
inclusion criteria: * any child undergoing allergy prick skin test exclusion criteria: * children suffering from coulrophobia (phobia of clowns) * children with a known hypersensitivity to emla 5% cream * children who have undergone a painful medical procedure (surgery, dental procedures, blood drawing) over the past 3 months * children who, for medical reasons, must have their skin test performed on an area other than the volar aspect of the arm

Keywords: anxiety disorder due to allergy skin testing
accurate wifi-based localization of dementia patients for caregiver support:

Conditions: Dementia, Vascular; Alzheimer Dementia; Lewy Body Dementia With Behavioral Disturbance

Summary: in this phase ii sbir project we will enhance a wireless wifi-based insole that was designed and successfully tested during a phase i trial with elderly persons with dementia and their caregivers, and then investigate its efficacy in terms of caregiver activity, burden, and quality of life in phase ii. evaluation will use semi-structured interviews and participant observation data collected from professional and family caregivers of patients with moderate or mild dementia.

the efficacy of the activlink system offering localization information to improve caregiver will be evaluated in two studies. study 2a will use the insole system with dementia patients residing in skilled or memory care. data regarding caregiving activity will be collected from their paid professional care providers. study 2b will use participant localization data collected on 80 independently dwelling mild dementia patients. in this case data will be collected from their unpaid family caregivers. both studies will result in evaluating the efficacy of the wifi-based insole to provide caregivers with augmented patient awareness, helping to improve their immediate quality of life by reducing their direct burden of continuous oversight of their person in care.

Eligibility criteria:
inclusion criteria: persons with dementia resides in memory care or skilled nursing * moderate dementia (mmse of 10-18) * ambulatory (without or with cane, walker or wheelchair assist) * a legal proxy that can provide consent persons with dementia resides in independent living setting in community. * mild dementia (mmse of 19-25) * ambulatory (without or with cane, walker or wheelchair assist). * has a legal proxy that can provide consent. care partners * speaks english * be 21 years of age or over * has at least three times per week direct contact with person with dementia (pwd) * consents to participate in the study exclusion criteria: * is not fluent in written or spoken english * indicate an unwillingness to use the activlink * history of major mental illness for patient or caregiver
play long: the effect of sports and recreation participation for young children with physical disability

Conditions: Physical Disability; Quality of Life; Social Interaction; Health, Subjective

Summary: ten year longitudinal survey following children with disabilities who have participated in sports and recreation from a young age (5 to 10), and the parents of children who have participated in sports and recreation at a young age (5 to 10). these children will be followed for 10 years with surveys every 6 months, whether they are currently participating in sports and recreation activities or not. the purpose of this longitudinal study is to examine the effects of early participation in organized sports and recreation activities (s\&r) on self-reported health and health-related quality of life of children and youth (c\&y) with disabilities and their parent-reported social participation. this project will examine child and parent reported differences between: 1. c\&y with disabilities who participate in s\&r and those who have discontinued participation in s\&r programs 2. c\&y with disabilities who participate in sports vs. those who participate in recreation, and 3. c\&y with disabilities who participate in s\&r and normative data on c\&y with disabilities and those without disabilities.


Eligibility criteria:
inclusion criteria: * at the time of enrollment, the child must be between the ages of 5 and 10 and be participating in an adapted sports and recreation program. * at the time of enrollment, the parent must have a child between the ages of 5 and 10, who is participating in an adapted sports and recreation program. * children and parents who are enrolled in the study will continue to participate in the study for 10 years. exclusion criteria: * children who are younger than 5 or older than 10 will not be entered into the study, nor will parents whose children are younger than 5 or older than 10 be entered into the study. . * individuals who do not read and write in english will be excluded from the study. * children who are wards of the state, or in foster care will be excluded from the study.
leucine, mtor and athero

Conditions: Atherosclerosis

Summary: high protein low carbohydrate diets have become popular in recent years to help facilitate weight loss. it is controversial if these diets are associated with an increased risk of cardiovascular disease. recent work in mice has implicated monocytes/macrophages and mtor signaling as the culprit cell type driving the increased cardiovascular risk with high protein diets. we aim to build on this preclinical research by evaluating the effects of liquid meals with different protein and leucine (a potent mtor activator) contents on circulating human monocytes and platelets. study participants will be given either a low protein liquid meal, a high protein liquid meal, or a low protein liquid meal with additional leucine. blood will be collected from study participants just just prior to and for several hours after ingestion of the meals. activation of amino acid-dependent signaling pathways (particularly mtor) and downstream sequelae will be evaluated in the isolated monocytes and platelets.


Eligibility criteria:
inclusion criteria: * 18 years or older * able to drink milk-based liquid mixed meal exclusion criteria: * current pregnancy * allergies to meal ingredients * history of diabetes * history of heart disease * history of high blood pressure * history of stroke * history of cancer * history of organ transplant * taking rapamycin/sirolimus * taking torisel/temsirolimus * taking afinitor/everolimus * taking any statin medication
clinical trial to assess the pk/pd of yyd601 20mg after oral administration if healthy adult subjects (phase1)

Conditions: GERD

Summary: clinical trial to assess the pk/pd of yyd601 20mg after oral administration if healthy adult subjects (phase1)

to evaluate comparatively a characteristics and safety of the pk/pd of single/repeated oral administration yyd601 20mg and nexium tab 20mg and the effects of food influence the pk/pd of yyd601 20mg in a healthy adults.

Eligibility criteria:
inclusion criteria: * healthy volunteers of over 19 years old at the time of screening. * volunteers weighing over 50 kg with ideal body weight (ibw) between -20% \~ 20% * subjects don't have congenital or chronic disease and is without pathologic symptom or finding on medical exam. * subjects evaluated eligible for the study based on the screening test results such as laboratory tests including serology, hematology, blood chemistry and urinalysis, etc and electrocardiogram(ecg). * subejctys who signed on the written informed consent form and comply with study requirements after listening adn fully understanding the details of this study. exclusion criteria: * who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole. * who has genetic problem like fructose tolerance, glucose-galctose absorption, deficiency or sucrase-iso maltase deficiency. * medical history or evidence (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) that can affect absorption, distribution, metabolism and excretion of a given drug. * subject who has over 141mmhg or under 89mmhg of systolic pressure or over 95mmhg of diastolic pressure in vital sign or over 100 times/min of pulse rate. * who has active liver disease, (ast, alt, total bilirubin \> 2 x lnr), (bun, creatinine \>1.5 x lnr) or clinically abnoramal result at screening test. * creatinine clearance \< 80 ml/min (calcaulated by cockcroft-gault formula using serum creatinine) * history of gastrointestinal disease (e.g., crohns disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy) * treatments for peptic ulcer, esophageal disease, zollinger-ellison syndrome diagnosis therapy or clinically related histories within 3 months prior to the first dose. * positive 13c-urea breath test * a history of serious trauma within 4 weeks, or resection operation (exculding simiple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease.
nalysis of the periodontal microbiota in elderly subjects with and without alzheimer's disease: a case control study

Conditions: Periodontitis; Alzheimer Disease

Summary: the neurological disorders that accompany aging represent a major public health problem. the management of these diseases is a major medical and social priority. this project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. the mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. in addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. the final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * ge greater than or equal to 70 years old * patient (or trusted person) having read and understood the study information note and signed the informed consent form * membership in a social security scheme * for cases : diagnosis of possible or probable alzheimer's disease according to the dsm-v exclusion criteria: * presence of a neurodegenerative pathology (excluding alzheimer's disease for cases) * presence of a neurocognitive disorder (excluding alzheimer's disease for the cases) * patient with or having had any kind of cancer, including oral or aerodigestive tract * patients with or having had autoimmune diseases (hiv, hepatitis) * patients with inflammatory diseases (such as rheumatoid arthritis (ra) or gougerot-sjogren's syndrome (gsj)) * patients with severe haemopathy * patients with severe acute or chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, pulmonary, neuropsychiatric pathologies, judged by the investigator to be incompatible with the study, as all these pathologies may interfere with the results of the oral flora sampling * patients who have undergone oral surgery in the two months prior to sampling * patients treated with oral retinoids, bisphosphonates, oral anticoagulants or anticonvulsants * patients who have had anti-cancer or immunosuppressive chemotherapy within the last 6 months * patient who has had antibiotic or anti-inflammatory treatment in the last 4 weeks * a history of treatments (drugs and probiotics) taken in the month prior to sampling will be taken, as well as a record of toxic habits (tobacco, alcohol, other)
study evaluating the long-term safety of desvenlafaxine succinate sustained-release (dvs sr) in subjects with pain associated with diabetic peripheral neuropathy

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of the study is to learn if long-term treatment with dvs sr is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * outpatients who have completed double-blind treatment in study 322 (nct01050218) for dpn. subjects must have completed all scheduled evaluations, with no major protocol violations and no events that, in the opinion of the investigator, would preclude the subject's entry into the long-term open-label study. * women of childbearing potential must have a negative serum pregnancy test on day 91 of the short-term study. a woman of childbearing potential is one who is biologically capable of becoming pregnant. "biologically capable" includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. sexually active women participating in the study who are biologically capable of becoming pregnant must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. medically acceptable forms of contraception include oral contraceptives, transdermal, injectable, or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm. exclusion criteria: * presence of any new and/or clinically important medical condition that might compromise subject safety (including, but not limited to, significant changes in glycemic control). * pregnancy, lactation, or plans to become pregnant during the study. * use of prohibited treatments. * meets any of the exclusion criteria listed for study 322 (nct01050218).

Keywords: diabetic peripheral neuropathy
the effects of group cycling (spinning®) with knee osteoarthritis: a randomized control trial

Conditions: Knee Osteoarthritis

Summary: hypothesis: group cycling classes (spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis methods: patients with symptomatic knee oa will be randomized to active spinning® classes 2-3 per week or control group for 3 months. outcomes including gait speed, womac, koos, kos, and vas pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.


Eligibility criteria:
inclusion criteria: * symptomatic and radiographic knee oa exclusion criteria: * severe patella femoral knee pain that would make cycling difficult * medical condition which would prohibit an exercise program

Keywords: osteoarthritis knee exercise cycling
the impact of sodium and fructose on blood pressure and inflammation

Conditions: Blood Pressure; Inflammation

Summary: the goal of this study is to determine the impact of dietary sodium and fructose on blood pressure and inflammation in young healthy adults.

excess dietary salt is associated with an increased risk of cardiovascular diseases. some healthy adults have been determined to be more sensitive to dietary salt than others, which can result in a 10% or more increase of blood pressure. the mechanisms underlying salt sensitivity of blood pressure are not fully understood. previous research has suggested excess intake of added sugars, especially fructose, can increase salt sensitivity of blood pressure. chronic elevated consumption of salt and fructose independently have been shown to have damaging effects on the body, however, the combination of both salt and fructose has not been fully studied in humans. the purpose of this research study is to determine if increased dietary fructose consumption will stimulate salt-sensitive hypertension and induce proinflammatory cytokines through activation of the immune system. understanding how the body regulates blood pressure during times of elevated salt and fructose is important for determining cardiovascular risk in a population with normal blood pressure.

Eligibility criteria:
inclusion criteria: * normal blood pressure * males, females, minorities exclusion criteria: * high blood pressure * body mass index (bmi) of \> 30 kg/m2 * smokers or nicotine users * pregnancy