Kornimate/medical-research-clean huggingface dataset:
study to evaluate the potential pharmacokinetic interaction and pharmacodynamic effects on renal parameters of bumetanide (1mg) and dapagliflozin (10 mg) when co-administered in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the potential pharmacokinetic (pk) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m², inclusive. bmi = weight (kg)/ \[height (m)\]² * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized and men, ages 18 to 45 exclusion criteria: * wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * current smoker or recent (within 1 month) history of regular tobacco use * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population * abnormal urinalysis at screening * glucosuria at screening * abnormal liver functions tests (alt, ast or total bilirubin \> 10 % uln) * presence of edema on physical exam * history of diabetes mellitus * history of heart failure * history of renal insufficiency * history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months * positive urine screen for drugs of abuse either at screening or before dosing * positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or hiv-1, -2 antibody * history of allergy to sglt2 inhibitors, bumetanide (or related compounds) * history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) * prior exposure to dapagliflozin within 3 months of day -1 * exposure to any investigational drug or placebo within 4 weeks of day -1 * use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to study drug administration * use of any other drugs, including over-the-counter medications within 1 week and herbal preparations, within 2 weeks prior to study drug administration * use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of study drug administration
intravitreal bevacizumab for age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of neovascular age related macular degeneration

the neovascular age related macular degeneration(amd) is a important cause of legal blindness in adults older than 50 years. currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. bevacizumab has been reported effective used as intravenous injection for amd. but serious side effects have been reported with the use of this drug in oncologic patients. the intravitreal use has been reported in limited case reports and safety and efficacy should be determined. the purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for amd

Eligibility criteria:
inclusion criteria: * age \>50 age related macular degeneration exclusion criteria: * moderate to severe cataract glaucoma intraocular surgery diabetes mellitus non controlled hypertension coronary artery disease

Keywords: macular degeneration angiogenesis antibodies
assessment of quality of life and outcomes in patients with primary renal cell carcinoma treated with sbrt

Conditions: Renal Cell Carcinoma

Summary: this is a multicenter, single arm phase ii study of stereotactic body radiation therapy (sbrt) for patients with medically inoperable primary renal cell carcinoma (rcc).

primary renal cell carcinoma (rcc) is a common malignancy in canada. the current standard of care for fit patients with localized rcc is surgical resection of the kidney (nephrectomy). rcc, however, affects predominately an older population with a median age at diagnosis of 65 years. surgery is often not an option for these patients due to existing co-morbidities, and in an increasing environment of shared decision making in healthcare, some patients decline surgical resection and seek less invasive alternatives. stereotactic body radiotherapy (sbrt) is a treatment approach that offers precise delivery of highly conformal radiotherapy to the tumour with minimal exposure to the surrounding normal tissues. sbrt is non-invasive and not limited by the size or location of kidney tumors like other ablative strategies. the worldwide experience of treating rcc with sbrt is growing and the results to date are promising. there is broader enthusiasm from both the radiation oncology and urology community to increase utilization of sbrt for rcc in non-surgical patients within the context of a well-designed prospective trial in canada. we will prospectively assess the efficacy, toxicity and impact on quality of life (qol) of sbrt in the treatment of inoperable rcc.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old * newly diagnosed rcc by biopsy (preferred) or radiologic evidence of growth on surveillance over two consecutive assessments (6-12 months) * primary lesion \>3 cm, or recurrent lesion following local ablative therapy * medically inoperable or patient who refuses surgery following assessment by experienced urologist, and discussed in a multidisciplinary setting * ecog 0-2 * written informed consent * participants must be able to understand the english-language or with the aid of a translator exclusion criteria: * primary lesion \>20cm * evidence of distant metastatic disease * previous abdominal rt in vicinity of kidney preventing definitive sbrt * history of major radiosensitivity syndrome * second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer) * currently pregnant or lactating
kidsheart and brain : early eeg surgery congenital heart disease predict onset of neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders; Congenital Cardiomyopathy

Summary: congenital cardiopathy are frequent malformations (1/100 birth). the progress of surgery permit a survival rate at the adult age of more than 90%. the long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (calmant, 2015). the impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults. the identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients. on the scientific plans, the identification of early markers on brain dammage on eeg should permit to better apprehend the physiopathologic mecanisms involved.

interest of early eeg on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence. congenital cardiopathy are frequent malformations (1/100 birth). the progress of surgery permit a survival rate at the adult age of more than 90%. the long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (calmant, 2015). the impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults. the identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients. on the scientific plans, the identification of early markers on brain dammage on eeg should permit to better apprehend the physiopathologic mecanisms involved.

Eligibility criteria:
inclusion criteria: * child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the chu of lille during the study period. * child with congenital cardiopathy with necessity to be operated before 1 year old. exclusion criteria: * child with no necessity of surgery before 1 year old. * medical history of cardiac surgery. * refusal of consent by the parents. * no social security. * child not operated on the chu of lille.

Keywords: eeg neurodevelopmental disorders congenital cardiomyopathy orality disorders
way to quit - comparative efficacy, acceptance and effectiveness of health incentive structures

Conditions: Tobacco Use Disorder

Summary: using the nih-funded way to health platform, the investigators will conduct this smoking cessation randomized controlled trial (rct) among cvs employees. the investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.

specific aim i: compare the efficacy and effectiveness of 4 financial incentive structures for improving "quit rates" (rates of prolonged smoking abstinence for 6 months): (a) individual financial rewards, (b) individual deposit contracts, (c) cooperative rewards, and (d) competitive deposit contracts h1: compared with usual care, all 4 incentive structures will increase quit rates significantly. h2: compared with individual financial rewards of equivalent size and schedule, individual deposit contracts, cooperative rewards, and competitive contracts will each increase quit rates significantly. h3: group-oriented structures will increase quit rates significantly more than individual-oriented structures. specific aim ii: compare smokers' acceptance of these 4 financial incentive structures for smoking cessation h4: uptake rates of reward-based structures will be higher than of structures involving deposit contracts. h5: uptake rates of group-oriented structures will be higher than of individual-oriented structures. specific aim iii: identify individual characteristics that modify incentive structures' efficacy and acceptance h6: incentives will promote relatively greater quit rates among participants with fewer substitute reinforcers. h7: incentives will promote relatively greater quit rates among participants with lower incomes. h8: higher-income persons will be relatively more likely to accept incentives requiring deposit contracts.

Eligibility criteria:
inclusion criteria: * active smoker of 5 cigarettes per day for at least 6 months; * at least 18 years old; * current full- or part-time employee of cvs or be a family member or friend of a current full- or part-time employee of cvs. exclusion criteria: * use a form of tobacco other than cigarettes while participating in the study (as this may influence biochemical testing); * are unable or unwilling to access the internet; * are unable to provide informed consent. * due to the web-based nature of this study, people without reliable computer and internet access will also be excluded.

Keywords: smoking cessation work-site incentives health behavior smoking
contrast-enhanced photon-counting detector ct (pcd-ct) for the local staging of rectal cancer

Conditions: Rectal Carcinoma

Summary: this study evaluates whether images taken using a photon counting detector ct scanner (pcd-ct) can determine the growth of rectal cancer as well as, or better than, mri for the management of patients with rectal cancer.


Eligibility criteria:
inclusion criteria: * adult patients 18 to 99 years of age * patients with proven rectal cancer clinically referred for staging pelvic mri and contrast-enhanced ct of the abdomen and pelvis (for evaluation of liver and peritoneal disease) * endoscopic or imaging report that tumor is 2 cm or larger * patients who are able and willing to sign the informed consent * negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient) exclusion criteria: * minors less than 18 years old * known mucinous adenocarcinoma (may not enhance well) * patient unable to provide written informed consent * pregnancy * estimated glomerular filtration rate (egfr) ≤ 60 * history of prior moderate or severe contrast reaction including unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis * any history of premedication prior to iodinated contrast * hip replacement/prosthesis * patients that consent to participation but do not undergo their clinically indicated mri scanning for any reason (e.g., bad iv, infiltration, reaction, change in indication)
copeptin in childhood epilepsy

Conditions: Epilepsy; Febrile Seizures; Children

Summary: in many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. there are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (fs), and that copeptin is predictive for complexity and relapse at least in fs. although long-term morbidity and mortality are both low in fs, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. copeptin may fill this gap by adding important diagnostic and prognostic information. eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.

background: copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (avp) and has gradually replaced avp in several clinical studies largely due to its structural and methodological advantages. copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. however, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children. working hypotheses: 1. circulating copeptin concentrations are increased after generalized seizures, including fs. 2. copeptin is predictive for complexity and relapse in fs. specific aims: 1. to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (fs), and in control children below six years without seizures. 2. to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (ph), base deficiency, and carbon dioxide), lactate, sodium, chloride, c reactive protein (crp), and prolactin.

Eligibility criteria:
inclusion criteria epilepsy-cohort: * all kind of seizures leading to presentation * age below 6 years inclusion criteria control-cohort: * fever without seizures caused by banal infections * age below 6 years exclusion criteria: * no blood required for medical reasons
dexmedetomidine for non-invasive ventilation after chest trauma

Conditions: Thoracic Injuries

Summary: crossover randomized controlled double blinded trial : * the primary endpoint is the duration of non invasive ventilation (niv) session (minutes) with dexmedetomidine (dex) or placebo. * secondary endpoints will be the sedation level as assessed by the richmond agitation sedation scale (rass), the number of interventions to allow the completion of niv session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during niv sessions, the comparison of blood gas measurements before and after niv sessions, the reproducibility of niv cycles. the side effects of dex will be notified.


Eligibility criteria:
inclusion criteria: * blunt chest trauma with thoracic trauma score\> 6, icu admission and spontaneous breathing exclusion criteria: * contra indication for niv or dexmedetomidine as specified by the french marketing authorization
disrupting sdoh to improve substance use and mental health outcomes for parents in rural regions

Conditions: Social Determinants of Health; Substance-Related Disorders

Summary: the study will evaluate the effectiveness of the just care for families program in preventing oregon department of human services (odhs)-involved parents in rural communities from escalating opioid and/or methamphetamine use and mental health disorders by disrupting the associated social determinants of health (sdoh). in addition, investigators will examine the impacts of sdoh on just care treatment and the associated costs from the perspective of provider clinics delivering just care. just care is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. just care involves treatment components, supported by ongoing purposeful engagement: (1) substance use treatment; (2) mental health treatment; (3) parent management training; (4) community building; (5) systems navigation; and (6) addressing basic needs.

this study provides multiple tests of the mechanisms by which just care for families disrupts the effects of lifetime social determinants of health (sdoh) on ultimate outcomes of preventing escalation of opioid and/or methamphetamine use and suicide (ideation, intention, attempts). just care for families 's effect on these outcomes is hypothesized to occur through two mechanisms of action: (1) improvement in malleable sdoh (direct targets of intervention) and (2) improvement in substance use and mental health problems (intermediate prevention outcomes). analyses will examine whether the effects vary as a function of non-malleable external, structural sdoh, such as community poverty and healthcare service availability. additionally, system dynamics will be used to examine patterns of influence between sdoh and just care for families intervention targets, case outcomes, and associated costs.

Eligibility criteria:
inclusion criteria: parents: * use or misuse of opioids in the last year, and/or any methamphetamine use in the last year * parent of a child, age 0-18 * current mental health symptoms * resident of participating county (lane, linn, benton, douglas, lincoln) * insured by oregon health plan (medicaid) * access to a computer or smartphone; or wireless/cellular connection if a device were to be provided; or reliable access to a landline to receive a brief weekly phone assessment in place of the digital assessment clinical staff: * clinician at a participating clinic * providing just care for families services to parents in the study at any point during study exclusion criteria:
bloodsafe ghana- iron and nutritional counseling strategy pilot study

Conditions: Iron-deficiency Anemia; Iron-deficiency

Summary: this pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (id) and iron deficiency anaemia (ida) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary donors that compares haemoglobin levels at 4 months among those with id or ida who receive iron supplementation to those without id or ida who do not receive iron supplementation. a structured questionnaire will be used to extract demographic characteristics. participants will be followed for a total of 6 months with study visits at 2, 4 and 6 months after the baseline assessments. blood draws for full blood count (fbc), peripheral film comment, malaria rapid diagnostic tests (rdt) and ferritin assessment will occur at baseline and all follow-up visits. in addition, we will use a qualitative approach to identify barriers and facilitators of blood donation and the use of dietary and iron supplementation strategies to address iron deficiency and/or anaemia. this will involve conducting focus group discussions during the last month of the intervention and key informant interviews. expected outcomes the expected outcomes of the study have been grouped into two, primary and secondary. primary outcome will be haemoglobin level after 4 months. secondary outcomes are a. change in haemoglobin levels b. diagnosis of id or ida at 4 months c. serum ferritin concentration after 4 months of intervention d. acceptability of iron supplementation among participants and stakeholders e. incidence of gastrointestinal adverse events f. incidence of suspected malaria or bacterial infections g. incidence of id and ida h. successful return (non-deferred) to the blood donor pool after intervention within 6 months of enrolment i. key barriers and facilitators of intervention implementation.


Eligibility criteria:
inclusion criteria: * males or females aged between 17 and 60 years who weigh at least 50kg. * pass pre-donation screening using the nbsg standardised donor screening questionnaire for medical conditions and lifestyle risks for transfusion transmissible infections * vital signs must meet the nbsg requirement for blood donation: systolic and diastolic blood pressures between 90-140 mmhg and 60- 90 mmhg, respectively; pulse rate between 50-100 bpm; non-contact forehead temperature not exceeding 37.5°c; meeting acceptable requirements for skin lesions, needle marks and physical appearance. * must be willing and able to give study consent or assent. * intend to remain in the study location/site during the entire length of the study. exclusion criteria: * persons who have used iron supplementation within the past one month. * participant reports having previously donated blood. * evidence for a tti at baseline among those who successfully donated. * evidence of malaria and helminthic infections at baseline * participants who have hb \<10g/dl at screening

Keywords: blood donation
the effect of jigsaw technique on childhood epileptic seizure management knowledge and attitudes of nursing students

Conditions: Jigsaw Technique; Epilepsy in Children; Nursing Student

Summary: the aim of this study is to examine the effect of the education given to nursing students with the jigsaw technique and traditional method on their knowledge and attitudes about childhood epileptic seizure management.

it is important for nursing students, future health professionals, to gain sufficient professional knowledge and positive attitudes about epileptic seizure management in order to improve the quality of care they provide to children with epilepsy. studies emphasize that the nursing education curriculum should focus more on education regarding epilepsy and epileptic seizures, and that different educational methods should be used to positively develop nursing students' knowledge and attitudes towards patients with epilepsy. one of the collaborative learning methods used in nursing education is the jigsaw technique. jigsaw technique is a student-centered and collaborative learning method that improves knowledge, skills and attitudes in nursing education.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study exclusion criteria: * not attending trainings and not filling out data collection forms