Kornimate/medical-research-clean huggingface dataset:
initial efficacy study of supporting play, exploration, & early development intervention

Conditions: Infant, Premature, Diseases; Brain White Matter Disease Periventricular

Summary: the primary aims of this randomized controlled trial are to evaluate efficacy potential of speedi at enhancing reaching and play based problem solving compared to infants receiving usual care.

the primary aims of this randomized controlled trial are to evaluate efficacy potential of speedi at enhancing reaching and play based problem solving compared to infants receiving usual care. the secondary aim is to assess the efficacy potential of speedi to impact motor and cognitive development as assessed using commonly used clinical outcome measures. the exploratory aims are to assess the impact of speedi on parent child interactions and feeding skills. the findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of speedi.

Eligibility criteria:
inclusion criteria: * born extremely preterm (˂29 weeks of gestation) or 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt. * medically stable by 40 weeks of gestation, including being off ventilator support * live within 50 minutes of the hospital. * english speaking mother * mother willing and able to participate in the study with the infant subject exclusion criteria: * genetic syndromes or musculoskeletal deformities
prognostic biomarkers in patients with urothelial carcinoma

Conditions: Bladder Cancer

Summary: bladder cancer (bc) is a heterogeneous malignancy with dismal outcome.despite treatment, the 5-year overall survival rates for mibc are \<50%, with many patients unresponsive or inapt, necessitating biomarkers to select those most likely to respond or fit for treatment

in this study was assessed the associations among most frequently mutated genes and with clinicopathological features, as well as the prognostic significance of the presence of mutations in the top mutated and dna damage response (ddr) mutated genes in terms of overall survival (os). moreover, overall tumor-infiltrating lymphocytes (tils) density was measured, analyzed immunohistochemically the expression of pd-l1, the four mmr proteins (mlh1, msh2, msh6 and pms2) and tumor or stromal cd8+ cytotoxic t lymphocyte infiltrates and assessed their association with each other, top mutated genes and available clinicopathological parameters together with their role in prognosis.

Eligibility criteria:
inclusion criteria: * urothelial carcinoma located in bladder * patients treated with platinum regimens at the neoadjuvant . adjuvant setting * written informed consent for the use of biological material exclusion criteria: -

Keywords: next generation sequencing tp53 arid1a ercc2 braca2 dna damage response platinum sensitivity muscle invasive pd-l1 cd8 tils mmr
the effect of nurse practitioner led-care on quality of life in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. it may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. with an ageing population, increasing rates of af and limited access to specialists, new methods of care, like nurse practitioners (np) need to be assessed to meet patient specific needs and provide sustainable care. the objective of the project is to evaluate the effect of nurse practitioner-led care in people with af on their quality of life. the canadian healthcare system is overwhelmed, with increasing costs and wait times. contributing to these issues, is af is the most common arrhythmia accompanied with costly complications including stroke and heart failure. currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with af. unfortunately, there is limited access to their services. np's are nurses who have taken extra education at university to treat patients and prescribe medications. this research project involves an np who has specialized training in af patient management. by utilizing an np to provide care for patients with af, the investigators hope to improve patient's quality of life and satisfaction with care. this may also reduce complications of af.


Eligibility criteria:
inclusion criteria: * 18 years or older * documented non valvular atrial fibrillation * able to provide informed consent * able and willing to complete the study questionnaires on own or with assistance exclusion criteria: * referral is for atrioventricular node ablation or pulmonary vein isolation. * patients who have failed antiarrhythmic medications * patients with moderate to severe mitral or aortic valvular heart disease * clinically unstable atrial fibrillation * cannot or unwilling to attend follow-up appointments

Keywords: atrial fibrillation health related quality of life nurse practitioner sustainable models of healthcare patient satisfaction
indocyanine clearance rate and septic liver injury

Conditions: Sepsis

Summary: liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. as a measurement for liver function, plasma clearance rate of indocyanine green (pdr-icg) always decreased during the early phase of sepsis. so the investigators hypotheses include: pdr-icg is lower in sepsis patients than non-septic patients in icu; pdr-icg may be lower in abdominal sepsis patients than non-abdominal sepsis patients in icu; pdr-icg correlates with abdominal perfusion pressure; change of pdr-icg in early phase correlates with change of transaminase or bilirubin in late phase of sepsis.

liver injury is a complication of sepsis and septic liver injury has adverse impact upon the outcome. however, changes of transaminase or bilirubin are always not significant during the early phase of sepsis. as another sort of measurement of liver function, plasma clearance rate of indocyanine green (pdr-icg) always decreased during the early phase of sepsis. so the investigators hypotheses include: pdr-icg may be lower in sepsis patients than non-septic patients in icu; pdr-icg may be lower in abdominal sepsis patients than non-abdominal sepsis patients in icu; pdr-icg correlates with abdominal perfusion pressure; change of pdr-icg in early phase may correlate with change of transaminase or bilirubin in late phase of sepsis. through this study we also plan to calculate the range of abdominal perfusion pressure that can maintain normal pdr-icg and the range of pdr-icg that can maintain normal transaminase or bilirubin level in sepsis patients.

Eligibility criteria:
inclusion criteria: * for control group: the patient does not match the diagnosis criteria of sepsis before the operation; the operation was done in peritoneal cavity; the patient is transferred to sicu directly from surgical room or recovery room; the patient is anticipated to stay in sicu for more than 48 hours. * for study group: the patient matches the diagnosis criteria of sepsis; the patient is anticipated to stay in sicu for more than 48 hours. exclusion criteria: * pregnancy * age \< 18 years * the infection is purely caused by virus * obstruction of biliary tract, or acute cholangitis, or acute liver abscess, or active hepatitis, or hyperacute/acute liver rejection occurs during study period * hemorrhagic shock occurs during study period * asthma occurs during study period * acute coronary syndrome occurs during study period * continuing peripheral circulation dysfunction leads to refractory "low quality" during pdr-icg measurement * comorbidity of the bladder leads to impossibility to measure intra-abdominal pressure

Keywords: indocyanine green sepsis liver injury abdominal perfusion pressure
pilot study of treatment for subclinical amr (antibody-mediated rejection) in kidney transplant recipients

Conditions: Kidney Transplant Rejection

Summary: this is a pilot study to determine if extended release envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) amr (antibody mediated rejection) in kidney transplant patients. subjects will be randomized to either conversion to envarsus xr (extended release); or, to a standard of care regimen of plasma exchange/ivig (intravenous immunoglobulin)/rituximab treatments.

there is currently minimal data to guide treatment of mild graft damage in kidney transplant patients. some of the current therapies used often come with dangerous complications (infections, malignancies, etc.). this is a pilot study to determine if extended release envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) amr (antibody mediated rejection) in kidney transplant patients. the subjects will be randomized to either conversion from their current tacrolimus regimen to envarsus xr (a once a day, extended release version of tacrolimus); or, to a regimen of 5 plasma exchanges/ivig (intravenous immunoglobulin) treatments and one treatment with rituximab. subjects who are within their first year of transplant will visit their doctor monthly for regular tests and checks and then will have a kidney biopsy at 6 months. subjects who had their transplant over a year prior will see the doctor for tests and checks at 1, 3 and 5 months and then will have a biopsy of the kidney at month 6.

Eligibility criteria:
inclusion criteria: * adult (18+ years) recipients of kidney or kidney/pancreas transplants * willing to sign an irb (institutional review board)-approved consent and to comply with study requirements * dsa (donor specific antibodies) detected by sab (single antigen beads) screening with mfi ≥ 2000 * graft biopsy performed within prior 30 days * stable renal function defined by serum creatinine increase ≤ 30% over prior 6 months * subacute antibody-mediated rejection on biopsy defined by ptc + g + c4d ≥ 2 by banff 2013 criteria exclusion criteria: * kidney/liver or kidney/heart recipient * unwilling/unable to undergo screening biopsy * hiv (human immunodeficiency virus), hcv (hepatitis-c virus), or hbsag (hepatitis-b surface antigen) positive * active/untreated infection * acute cellular rejection with banff grade 1b, 2a, 2b on initial biopsy requiring ratg (rabbit anti-thymocyte globulin) therapy * pregnant or nursing females

Keywords: subclinical graft rejection amr (antibody-mediated rejection) ambr (acute antibody-mediated rejection) dsa (donor specific antibodies)
the impact of dementia and neurocognitive disorders on hypertension treatment in the elderly

Conditions: Neurocognitive Disorders; Dementia; Hypertension; Aged, 80 and Over

Summary: neurocognitive disorders and hypertension occur commonly with aging. while, by definition, older adults are at high cardiovascular risk, there is no guideline exist currently on blood pressure management of elderly hypertension. however, studies have shown that in aging adults, high blood pressure helps prevent against cognitive decline, and low blood pressure on antihypertensive drugs could accelerate it. this study aims at investigating if pharmacological treatment of hypertension in the very elderly is influenced by presence and severity of neurocognitive disorders. our research hypothesis is that the drug management of hypertension in patients 80 years of age or older more is all the less aggressive as the neurocognitive disorders are advanced.


Eligibility criteria:
inclusion criteria: * to be 80 years of age * with history of hypertension and/or on hypertensive drug(s) exclusion criteria: * legal protection measure.

Keywords: neurocognitive disorders dementia hypertension aged, 80 and over
plantar fascitiis: comparison of eswt and collagen hydrolyzed peptides

Conditions: Plantar Fascitis

Summary: patients suffering from plantar fasciitis were randomized into three groups: the first group underwent infiltration of collagen hydrolyzed peptides, the second one underwent the eswt treatment, the third one underwent a combination of the two treatments.

patients suffering from plantar fasciitis were randomized into three groups: the first group underwent infiltration of collagen hydrolyzed peptides, the second one underwent the eswt treatment, the third one underwent a combination of the two treatments. aim of the study was to consider any difference in the outcome of the three groups of patients. the nrs and the afas score were considered for the outcome measurement.

Eligibility criteria:
inclusion criteria: plantar fascitiis aged between 18 and 80 years old exclusion criteria: * previous surgery of the foot * contraindications to eswt
pharmacodynamic parameters of two different doses of cefepime

Conditions: Infection; Bacteremia; Pneumonia

Summary: pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the "susceptible" range. this study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.

this will be a non-interventional study in that the antibiotic and its dose will be chosen by the treating team not the investigators. patients on cefepime who have ventilator-associated pneumonia or bacteremia will be invited to participate in the study. blood samples will be taken to determine the pharmacokinetic profile of the drug. blood cultures will be repeated in patients with bacteremia to determine clearance of infection. a mini-bal will be repeated in patients with ventilator-associated pneumonia to determine clearance of pneumonia.

Eligibility criteria:
inclusion criteria: 1. adults of at least 18 years of age or older 2. culture proven ventilator associated pneumonia (vap) or bacteremia caused by a cefepime susceptible gram negative pathogen: * bacteremia is defined as at least one positive blood culture * vap is defined by at least 10,000 cfu/ml of an organism from a bronchoalveolar lavage sample 3. cefepime therapy (1 or 2 grams intravenously \[iv\] every \[q\] 8 hours or q 12 hours) initiated as part of standard of care exclusion criteria: 1. concomitant vap or bacteremia with a cefepime resistant organism 2. concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside 3. patients requiring surgical or interventional drainage of purulent collections 4. pregnant or lactating women 5. dialysis patients 6. contraindication to blood sampling 7. cystic fibrosis

Keywords: ventilator associated pneumonia
self-advocacy training for autistic college students at a public university

Conditions: Autism Spectrum Disorder

Summary: cases in autism spectrum disorder (asd) have dramatically risen over the past 30 years, with the current rate of 1 in every 44 (maenner et al., 2021) children born with the condition. much emphasis rests on the need for various interventions, practices, and therapies during childhood to improve quality of life and success across a variety of settings. nonetheless, as they age, all children advance through the education system and eventually leave the school system. consequently, it should not be surprising that these children must grow up and face realities after high school. for some, this may include residential placements, living at home with family members, or working part or full time. for others, this comes in the form of postsecondary education. however, many individuals with autism might not be prepared to handle the requirements future education entails. as stated in articles by chiang et al. (2012) and blackorby and wagner (1996), persons with disabilities, regardless of type, do not have successful transitions after high school compared to individuals without disabilities-even with having access to many resources in school and the community. barriers, therefore, exist that prevent successful outcomes for students with autism attending college and obtaining a postsecondary degree. thus, there is a need to identify strategies that can be effective in assisting autistic adults in postsecondary education to succeed, both academically and socially.

this study will utilize a concurrent multiple baseline design across participants with an embedded abcde design (or more specifically, an abacadae design). these components will be the four scenarios teaching self-advocacy skills based primarily on recognition of one's wants and needs and personal decision making. the four included scenarios will be a) requesting appropriate accommodations from disability services; b) requesting additional supports or services (daily living, social, etc.) from disability services; c) presenting accommodations to a professor; and d) meeting with disability services in the event a professor is not accommodating student needs. there will also be a pre-test/post-test comparison between scores on the self-advocacy questionnaire with data displayed in the form of a bar graph that will explore all four areas of self-advocacy: recognition of wants and needs, scheduling meetings, locating services, and personal decision making.

Eligibility criteria:
inclusion criteria: * students to be undergraduates enrolled at a university or community college * students must have a confirmed diagnosis of asd (either through an official diagnosis via documentation of the disability services or proof of self-diagnosis). exclusion criteria: * students who are not enrolled in college, do not have a confirmed diagnosis of asd, or who already demonstrate strong self-advocacy skills will be excluded from this study.

Keywords: self-advocacy
a phase 1 study to examine the pharmacodynamics of different azd1722 formulations

Conditions: Healthy

Summary: the study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of azd1722 in healthy male and female subjects taking omeprazole.


Eligibility criteria:
inclusion criteria: * healthy man or woman * body mass index between 18 and 29.9 kg/m2 exclusion criteria: * diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (gi) tract * any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk

Keywords: volunteers
comparison of the effect of mcfa and lcfa on postprandial appetite and lipemia

Conditions: Lipemia

Summary: the main objective is to investigate if foods high in coconut oil (mcfa) or palm oil (lcfa) have different impacts on postprandial blood lipid levels and appetite via a visual analog scale (vas).

postprandial lipemia has been recognized as a cardiovascular disease risk factor. the rate of postprandial triglyceride production and clearance in the blood, as well as the appetite, are influenced by the quality of the food consumed, such as the length of saturated fatty acids. the study will include 24 healthy adults ranging in age from 18 to 40 years old, of both sexes and it will be conducted at the university of jordan. the study will involve two experimental test days, each separated by at least a week of washout interval, and each test day will last for 6 hours. all subjects will be randomly assigned to one of the experimental meals using computer-generated tables. blood serum samples (2 ml) will be taken after an overnight fast and 2, 4, and 6 hours after eating the meals, and blood lipid profiles \[total cholesterol (tc), low-density lipoprotein cholesterol (ldl-c), high-density lipoprotein cholesterol (hdl-c), and triglyceride (tg)\] will be examined in a private lab. after that, participants will be allowed an ad libitum intake of standard meals. each meal will be weighed before and after it is consumed, with the amount of food ingested being calculated.

Eligibility criteria:
inclusion criteria: * age between 18-50 years * males and females * apparently healthy * fasting triglyceride (tg) \< 2.5 mmol/l or 222 mg/dl at the time of screening. * body mass index (bmi) in normal range (18.5-24.9). * stable weight for at least 3 months exclusion criteria: * consumption of lipid-lowering drugs or any medication that might affect appetite. * consumption of any supplement that may affect lipid metabolism or appetite on a regular basis for the past month. * regular consumption of two or more fish meals a week over the previous month. * a history of diabetes, gastrointestinal , liver disease, congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft or established atherosclerotic disease. * current smokers * pregnant , breastfeeding, postmenopausal or suffer from polycystic ovary syndrome (pcos) * athlete * being on a diet or lifestyle changes for the past month.

Keywords: postprandial lipemia
clinical registry of long-term dental outcomes in head and neck cancer patients

Conditions: Head and Neck Cancer; Dental Diseases; Osteoradionecrosis

Summary: the current study (orarad ii) will examine participants of the original cohort for a visit roughly 7 years after the start of rt. the primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

this is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (rt) modalities with curative intent, as part of clinical care for a head and neck cancer. five hundred and seventy-two participants were enrolled in the original study, orarad, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of rt. the current study (orarad ii) will examine participants of the original cohort for a visit roughly 7 years after the start of rt. the primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Eligibility criteria:
inclusion criteria: * enrolled in the original orarad study * willing to participate and comply with all study procedures exclusion criteria: * anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study (e.g., unable to obtain consent or unable to tolerate an oral examination).

Keywords: dental outcomes cancer registry