Kornimate/medical-research-clean huggingface dataset:
assessment of pharmacokinetics of a single oral dose of vimovo in healthy adult volunteers

Conditions: Juvenile Idiopathic Arthritis

Summary: this is an assessment of pharmacokinetics of a single oral dose of vimovo in healthy adult volunteers.

a phase i, open-label, single-center study to assess the pharmacokinetics of a single oral dose of vimovo (250 mg naproxen/20 mg esomeprazole)in healthy adult subjects

Eligibility criteria:
inclusion criteria: * healthy male and female subjects aged 18 to 55 years * capable of understanding and complying with the clinical study protocol * body mass index (bmi) of 19 to 30 kg/m2 and weight of 50 to 100 kg exclusion criteria: * previous enrollment in the present study * receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study * female subjects with a positive urine pregnancy test

Keywords: juvenile idiopathic arthritis pharmacokinetics vimovo fasting state amount of vimovo in the blood taken on empty stomach
vaccine health literacy related text message reminders to increase receipt of second dose of influenza vaccine for young, low income, urban children

Conditions: Influenza

Summary: influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. low-income, urban children may be at particular risk of not receiving two doses. while traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.


Eligibility criteria:
inclusion criteria: * parenting adult of child age 6 months through 8 years * child receives care at study site (visit in last 12 mths) * child received influenza vaccine and needs a second this season * parent has cell phone has text message capability * parent speak english or spanish * can read text messages exclusion criteria: * parent does not speak english or spanish * parent does not have cell phone with text messages

Keywords: influenza text message vaccination
collateral effects of pandemics - care for informal caregivers

Conditions: Bereavement

Summary: the study is a workpackage in the german research consortium collpan. the study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.it will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics.

a scoping literature review will compile evidence on informal caregiver burden during and after the pandemic (pubmed, psychinfo, cochrane database). the aim of the review is to gain knowledge on frequency, severity, source and circumstances of care givers' burden and to identify research and supportive gaps. the study will recruit family members and care givers of patients with covid-19 or long-covid as well as bereaved family members and care givers of patients who have died during the pandemic in order to assess severity of burden. recruitment will be done in collaboration with the german association of undertakers and the federal association for bereavement care. family members and caregivers will be asked to complete a survey with instruments on bereavement burden (pg- 13), distress (phq-9; gad-7) and care giver symptoms (ipos; midos-2). the survey will be available online (using soscisurvey platform) or as a paper and pencil version. survey participants will be invited to in-depth interviews. recruitment of 200 participants each for caregiving of covid-19 patients and bereaved family members will be targeted. interviews are planned with 30 participants in each group or until saturation is reached. based on findings, recommendations on interventions to support family care givers will be developed

Eligibility criteria:
inclusion criteria: * having cared for a patient with covid-19 in the first year of the pandemic (march to december 2021) exclusion criteria: * not fluent in german

Keywords: informal caregiver burden
cbt group for adolescents with adhd: a randomized controlled trial

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is the first randomized controlled study that tests the efficacy of a cognitive-behavioral group therapy (cbt) on adolescents with adhd who were in pharmacological treatment but still presented persistent symptoms.

a multicenter, randomized rater-blinded controlled trial was carried out in a sample of 119 adolescents (15-21 years) and was conducted between april 2012- may 2014. patients were randomly assigned to 12 group manualized cognitive-behavioural group therapy sessions (n=45) or a waiting list control group (n=44). primary outcomes were assessed by a blind evaluator (adhd rating scale, clinical global impression scale for severity, global assessment functioning) before and after treatment as well as by self-report and parent informant ratings.

Eligibility criteria:
inclusion criteria: * dsm-iv adhd diagnosis * age between 15 and 21 years * stabilized doses of medication for adhd for at least 2 months prior to the study * agreement not to seek out any other psychiatric or psychological treatment during the study. exclusion criteria: * affective disorders * anxiety disorders * psychotic disorders * personality disorders * substance use disorders in the past 6 months * pervasive developmental disorder * patients with an iq lower than 85 * patients receiving concurrent psychological interventions.

Keywords: cognitive-behavioral therapy, adolescents, adhd.
impact of gerd on daily life (nis)

Conditions: GERD

Summary: the aim of this study is to gather epidemiological data in a population of gerd patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).


Eligibility criteria:
inclusion criteria: * patients with erosive esophagitis (endoscopical findings according to the los angeles classification; grade a-d) currently not treated with a proton pump inhibitor, for whom the general practitioner (gp) has decided to initiate or change the treatment for gerd

Keywords: gerd esophagitis ppi
immunological follow-up after sars cov2 vaccination in kidney transplant recipients

Conditions: Kidney Transplant Recipients

Summary: the investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against sars-cov-2. the study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. these patients will be vaccinated as part of routine care with a cov-2 sars vaccine licensed in france. in this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against sars cov-2 and the specific cellular response of sars cov-2 by quantiferon and in vitro lymphocyte stimulation assays.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older * patient vaccinated against sars-cov-2 as part of routine care * kidney or pancreatic kidney transplant * transplantation for more than 3 months * subject affiliated to a social protection health insurance * subject able to understand the objectives and risks of the research and to give signed and dated informed consent exclusion criteria: * history of anaphylactic shock or known allergy to peg * known history of covid or positive covid serology in the 3 months prior to vaccination * contraindication to an intramuscular injection * impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...) * subject under safeguard of justice * subject under guardianship
cardiorenal interactions during treatment of acute decompensated heart failure: diuretics versus ultrafiltration

Conditions: Acute Decompensated Heart Failure

Summary: the cruf trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of acute kidney injury (aki).


Eligibility criteria:
inclusion criteria: * \>18 years old * severe systolic heart failure with ejection fraction \<40% * and hospitalisation for decompensated heart failure * and new york heart association (nyha) iii or iv * and 1 of the following: * jugular vein distension\>6cm * tissue doppler mitral annulus lateral\>12 or medial\>15 * chest x-ray: pulmonary edema or pleural effusion exclusion criteria: * need for inotropic or vasopressive agents * use of intravenous (iv) contrast media * acute coronary syndrome * need of dialysis * severe co-morbidity * contra-indications for anticoagulation * pregnancy

Keywords: acute decompensated heart failure ultrafiltration diuretics aki
renal cell carcinoma microenvironment discovery project

Conditions: Renal Cell Carcinoma

Summary: this study will obtain tumor samples from nephrectomy specimens in a multi-regional fashion and subject them to integrated genomics, proteomics, pathological, and radiological assessment. the goal is to better understand the the molecular basis for how various cells within the tumor microenvironment act in a coordinated manner to facilitate tumor progression and therapy resistance. our ultimate aim is to leverage this data resource to identify novel therapeutic targets and biomarkers to improve the clinical management of this disease.

this study is an observational prospective trial where renal cell carcinoma samples are isolated from nephrectomy specimens in a multi-regional manner and subjected to an integrated genomic, proteomic, pathological, radiological assessment to provide a detailed morphological and molecular view of the rcc microenvironment. the major genomics technologies used to examine tumour specimens include single cell rna sequencing including nuclear (nucseq) and epitope sequencing (citeseq). additionally, bulk rna/dna sequencing, targeted mutational profiling, and imaging mass cytometry will be performed. these technologies will determine mutational and gene/protein expression profiles of various heterogeneous cell populations within the tumour microenvironment, including cancer, immune, and supporting cells. this will allow identification of mutations and abnormal expression patterns within individual cells, that will be used to infer targetable vulnerabilities and biomarker signatures.

Eligibility criteria:
inclusion criteria: * nephrectomy * primary or metastatic disease * any histology of renal cell carcinoma exclusion criteria: * na

Keywords: renal cell carcinoma genomics single-cell microenvironment immunotherapy neoplasms, glandular and epithelial neoplasms by histologic type kidney neoplasms urologic neoplasms urogenital neoplasms neoplasms by site kidney diseases urologic diseases
protein and phospholipid analysis of hdl in patients with very high serum levels of hdl-c

Conditions: Hyperlipidemia

Summary: coronary heart disease (chd) is the single leading cause of death in the united states . serum cholesterol is known to have a direct impact on a number of human diseases through a variety of mechanisms. this is particularly true of cardiovascular disease. measurement and manipulation of serum cholesterol has become a primary focus of primary care physicians and cardiologists when attempting to reduce risk of heart disease.

clinical investigations have shown that lowering the "total serum cholesterol" levels result in a significant reduction of coronary artery disease and myocardial infarctions . thus, interventions to lower the "total serum cholesterol" are commonly employed by medical professionals - this includes behavioral modifications (exercise, dieting, and weight loss) and pharmacological interventions. investigation has shown that clinical outcomes do not only rely on "total serum cholesterol". "total serum cholesterol" is comprised of multiple subtypes - most notable are "hdl cholesterol" and "ldl cholesterol". analysis of the data has shown that high levels of ldl cholesterol predict higher rates of cardiovascular events, while high levels of hdl cholesterol are actually predictive of significantly less cardiovascular events. these effects are independent of other cardiovascular risk factors . the mechanism by which ldl cholesterol results in heart disease has been intensely investigated and elucidated. numerous drugs are now approved and utilized by physicians to lower the ldl cholesterol of patients to prevent primary and secondary cardiovascular disease. epidemiological data show that low levels of hdl-c place individuals at higher risk for coronary artery disease while high levels of hdl-c actually decrease an individual's risk . the mechanism behind this risk reduction remains unclear and is likely multi-factorial. furthermore, some data suggests that while hdl-c is important in risk reduction, it is not necessarily the measured serum level of hdl-c, but also the composition, oxidation state, metabolism of the hdl-c that determines an individual's cardiac risk . understanding of this mechanism could lead to potential therapeutic targets as well as clinically relevant diagnostic testing.

Eligibility criteria:
inclusion criteria: * age \> 18 years. * serum hdl-c \> 100 mg/dl. exclusion criteria: * significant history of smoking. * diabetes mellitus. * severe hypertension. * age \> 65 years

Keywords: hyperlipidemia hdl-c low density lipoprotein
safety of dialysate sodium individualization in hemodialysis patients with intradialytic hypotension

Conditions: Hemodialysis; Hypotension

Summary: low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. in this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. we hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.

hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (hd). sodium balance is important in mediating both processes. recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less hd-related symptoms, and better blood pressure control. in this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. in this protocol, we will recruit 7 hypotension-prone subjects. we will use an open-label cross-over design with randomized blocks. after a 3-week baseline period where pre-hd serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/l) or individualized dialysate sodium (same concentration as the average pre-hd serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). the remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. clinical information, pre/intra/post-hd blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on hd sessions during the 4 weeks of intervention.

Eligibility criteria:
inclusion criteria: * hemodialysis patients with intradialytic hypotension exclusion criteria: * atrial fibrillation * bilateral upper extremity arteriovenous access * average plasma sodium \>139

Keywords: renal dialysis hypotension dialysis solutions
a quit smoking study using smartphones

Conditions: Smoking Cessation; Smoking; Nicotine Dependence

Summary: the objective of this research is to determine whether smartphone games show promise for helping smokers increase their chances of quitting. the central hypothesis is that smokers who have access to smartphone games during their quit smoking attempt will smoke fewer cigarettes and report less craving than will smokers without such access.


Eligibility criteria:
inclusion criteria: * being age 18 or older; * being able to read and write english; * being willing and able to learn how to use a smartphone if they have not used one before; * smoking 10 or more cigarettes per day for the past 6 months; * having an expired carbon monoxide rating of 6 ppm or greater; * not having been diagnosed with or treated for schizophrenia, psychosis or bipolar disorder in the past 10 years; * being willing to make a quit attempt in 2 weeks; * agreeing to attend clinic visits, receive coaching calls, and complete brief smartphone assessments; * planning to remain in the area for at least the next 2 months; * using the following alternative tobacco products (a pipe, full sized cigars, snuff or chew) no more than two times a week over the past month; * being willing to stop using electronic cigarettes (e-cigarettes) for the 6 weeks they are in the study; * not currently taking bupropion, wellbutrin, or zyban; * if currently using nicotine replacement therapy or varenicline, agreeing to use only study medication for the duration of the study; * being willing and able to use the nicotine patch; * never having had a serious skin reaction or other allergic reaction to the nicotine patch; * not pregnant, trying to conceive, or nursing; * if a woman of childbearing potential, agreeing to use or having their partner use an acceptable method of birth control during a 2 month period (1 month of nicotine patch and 1 month after). (acceptable methods of birth control include: abstinence, condoms, diaphragm, birth control pills or injectable contraceptive \[e.g., depo-provera\], an intrauterine device, hysterectomy, tubal ligation, sterilization, vasectomy, or being more than 2 years post-menopausal.) * participants need to report playing video games for no more than 60 minutes a day. * although participants can play console games, they need to be willing to not play any mobile games for 6 weeks during the study if they are asked to do so. * participants need to report being willing to stay in the study even if they are not at first successful in quitting smoking. * they need to report that they have a way to get to the clinic. exclusion criteria: * they will be excluded if in the last 4 weeks they have been hospitalized for any of the following: a stroke, heart attack, congestive heart failure, or an abnormal electrocardiogram.

Keywords: smoking cessation smoking nicotine
blood flow path reconstruction in rectal cancer

Conditions: Rectal Cancer; Surgery; Image

Summary: 89 patients with distal sigmoid and rectal cancer were referred in our observation and underwent ms-cta between june 2020 and march 2022. we classified the distribution of lca and confirmed whether there exists amca (accessory middle colic artery). then we planned blood flow path based on the classification of lca branches before operation. high ligation was applied in regular radical surgery. during operation, we carefully protect the bifurcation of ascending and descending lca. then we compared the planned blood flow path with the actual postoperative blood flow path to verify the mechanism we proposed previously.


Eligibility criteria:
inclusion criteria: * (1) patients with distal sigmoid colon and rectal cancer; (2) ctnm stage was confirmed to be i-iii on mri or ct; (3) laparoscopic anterior resection (lar) was performed. exclusion criteria: * (1) the starting time of arterial phase scanning is earlier； (2) the anatomic structure is not clear; (3) no enhanced ct after operation (only 5 cases).
a dose ranging study to investigate the efficacy and safety of sb-742457 in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to find out if sb-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate alzheimer's disease. sb-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable mild-to-moderate alzheimer's disease as determined by the nincds-adrda and dsm-iv criteria with an mmse score of 12-24. * subjects and their caregivers must provide informed consent prior to study entry. * adequate blood pressure and laboratory values. exclusion criteria: * females of child-bearing potential. * have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin b12 deficiency or thyroid deficiency. * subjects taking medication for alzheimer's disease or centrally acting agents which might impact study outcomes. * subjects taking agents for which there is a theoretical risk of interaction with sb-742457. * subjects with known hypersensitivity to sunlight or seizures.

Keywords: alzheimer's disease cognition global functioning symptomatic b-742457