Kornimate/medical-research-clean huggingface dataset:
the effect of puppet show on pain and fear during subcutaneous injection in children with leukemia

Conditions: Pain, Acute; Fear

Summary: this study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.

before and during subcutaneous injection administration to the children in the study group there will be a puppet show. no distraction method will be applied to the children in the control group and the clinical a subcutaneous injection will be administered in accordance with the routine. pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.

Eligibility criteria:
inclusion criteria: * child \ 7 years old * medically unstable (dehydration, septic shock, sedation) * children who are being treated for leukemia in the pediatric hematology service will be included in the study. exclusion criteria: * not exposed to any other interventional procedure before (same day) subcutaneous intervention * not expressing any pain before subcutaneous intervention * heart rate to be within age-appropriate limits * wong-baker pain rating scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago) * having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment) * the child and family do not know turkish
the effect of cocoa on platelet function profiles in patients

Conditions: Platelet Dysfunction

Summary: the effects of chocolate on cardiovascular health are still a matter of debate. it can potentially favor cardiovascular health through the antioxidative effects of cocoa ingredients, such as polyphenols (present in dark but not white chocolate).

epidemiologic studies have shown inverse associations between dietary polyphenols (present in dark chocolate and cocoa) and mortality from coronary heart disease. however, the basis for this protective association is uncertain. food polyphenols such as in cocoa reportedly have antioxidant properties and decrease platelet function in vitro. the goal of the present study was to investigate whether the beneficial antioxidant effect of polyphenol-rich cocoa can induce an improvement of endothelial and platelet function in patients with stable coronary artery disease with known platelet hyperreactivity.

Eligibility criteria:
inclusion criteria: 1. patients with stable coronary artery disease. 2. patients \> 18y of age. exclusion criteria: 1. patients with t2dm. 2. patients who already ingest any cocoa-based products.

Keywords: platelet dysfunction cocoa polyphenol
machine learning assisted electrochemical profiling to provide early identification of bloodstream infections pathogens

Conditions: Bacteremia Sepsis

Summary: in the context of a bacteremia, although significant progress has been made in speeding up pathogen identification once a blood culture bottle turns positive, few cost-effective solutions have been proposed to improve the earlier stages of the process-specifically, from blood collection to bottle positivity. the investigators propose that transport time could be leveraged to grow and identify bacteria, enabling faster access to actionable results through innovative technologies. this project aims to develop a bacterial identification database by analyzing the electrochemical profile of bacteria growing within the blood culture bottle, using machine learning.


Eligibility criteria:
inclusion criteria: * patient requiring a blood culture sample as standard of care procedure * body weight \> 50 kg * patient for whom the collection of 2 to 4 additional blood culture bottles is feasible, depending on venous access * patient who has not objected to participation in the project exclusion criteria: * patient protected under the french public health code (pregnant or breastfeeding women, patients under guardianship or curatorship, hospitalized under constraint, or deprived of liberty) * patients with ongoing antibiotic treatment at the time of sampling

Keywords: rapid identification positive blood culture electrochemical profiling machine learning artificial intelligence bacteremia database
early detection of polyps and colon cancer by fluorescence imaging - a dose-finding study

Conditions: Colorectal Cancer

Summary: patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (hal) prior to colon inspection. blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. different hal doses will be tested to find the optimal image conditions. tolerability measurements will be performed to ensure patient safety.

colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. the sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily missed, are often not recognised. fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete. in this study hexaminolevulinate (hal) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient safety assessments. both standard white light and blue light (fluorescence) inspection will be performed.

Eligibility criteria:
inclusion criteria: * patients with suspicion of colorectal cancer * written informed consent * data protection consent * 18-85 years exclusion criteria: * liver cirrhosis * hepatitis * abnormal liver function * porphyria * patient non-compliance * coagulation disorder * contraindication to colonoscopy * pregnancy and lactation * participation in another study
optimisation of disease management in patients with epithelial ovarian cancer in france

Conditions: Ovarian Epithelial Cancer

Summary: no structured organization for ovarian first line management emerges in france. management across france seems to depend on regional contexts. regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. these different templates present a major problem in identifying differences, costs and benefit. to deal with this issue the investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. this study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of french territories.


Eligibility criteria:
inclusion criteria: * ovarian epithelial cancer initially diagnosed in 2012 * age \> 18 years old * residency in france (rhône-alpes region, district of calvados and cotes d'or) * first-line ovarian epithelial cancer exclusion criteria: * relapsed ovarian epithelial cancer * non epithelial ovarian cancer
miracle of life study

Conditions: Preterm Labor; Preterm Birth; Preterm Birth Complication; Preterm Premature Rupture of Membrane; Preeclampsia; HELLP; Gestational Hypertension; Gestational Diabetes Mellitus in Pregnancy; Small for Gestational Age at Delivery; Intrauterine Growth Restriction

Summary: the goal of this observational study is to develop and validate cell-free rna-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. the main question it aims to answer are: 1. can cell-free rna-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. what is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, ppv, npv, tpr)?

this is a multi-center, prospective, observational cohort study, that involves the collection of blood samples from pregnant people during their second trimester of pregnancy. maternal plasma is isolated from blood samples and subjected to transcriptome and other multi-omic analyses. in conjunction with blood sample collection, extensive clinical data are collected about the pregnancy including any pregnancy complications (e.g., preterm birth, preeclampsia) that may have arisen during pregnancy. biological markers and clinical data are combined to develop and validate mirvie's investigational predictive test.

Eligibility criteria:
inclusion criteria: 1. subject is willing and able to provide written informed consent. 2. subject is willing and able to provide up to 40 ml of blood via venipuncture and comply with all other study procedures. 3. subject is a pregnant female before 22 weeks of gestation 4. subject is at least 18 years of age exclusion criteria: 1. estimated due date (edd) via 1st or 2nd ultrasound, date of last menstrual period (lmp), or in-vitro fertilization (ivf) implantation date is not available 2. subject is pregnant with multifetal gestation (e.g., twins) 3. subject is planning to deliver via home birth
decreasing medication errors by caregivers using a health literacy intervention

Conditions: Medication Administration; Medication Errors

Summary: giving medications to children can be confusing; studies have shown that caregivers make dosing administration errors up to 50% of the time. there are many reasons that there are so many errors, including the fact that dosing for children is based on their weight, liquid medications come in many different forms, and caregivers often give medicines using kitchen teaspoons and tablespoons. caregivers who have difficulty reading have even more difficulty understanding medication instructions. we are developing and testing a web-based educational module to teach caregivers how to give medications. we are focusing on the pediatric emergency department because we know that this population has low literacy levels, and that many antibiotics are prescribed in this setting. we anticipate that those caregivers that view the interactive module will have increased knowledge on how to give medications once they get home.

dosing error rates of home administration of medications to children have been reported to be as high as 50%. contributing to this error rate are the complexity of pediatric weight-based dosing, confusing formulations of liquid medications, and a reliance on non-standardized dosing tools such as kitchen teaspoons and tablespoons to administer medications. families with low health literacy are at particular risk for medication administration errors. health literacy promoting interventions to improve medication administration such as dissemination of a pictogram-based medication list have been shown to work for common over-the-counter medications such as acetaminophen, but their effect on administration practices for common medications prescribed in the pediatric emergency department (ped) has not been evaluated. of the 50,000 patients seen in the ped each year, approximately 85% of patients are discharged with a prescription for medication. this makes the ped an ideal setting to implement a health literacy intervention to reduce medication administration errors at home. the investigators are proposing to conduct a randomized controlled trial of an educational module focused on how to administer antibiotics at home and test whether there is an improvement in care practices.

Eligibility criteria:
inclusion criteria: caregivers of: * patients aged 2 months to 8 years * patients triaged to emergency severity index (esi) level 4 or 5 in the pediatric emergency department. * patients with at least one prescription for a liquid, tablet or ointment antibiotic. exclusion criteria: caregivers of: * patients in need of immediate care. * patients hospitalized.

Keywords: medication administration medication errors health literacy pediatric emergency department web-based education
comparison of repaglinide and metformin combination tablet versus repaglinide and metformin as separate tablets in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal. the trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (williams design). the trial participant will receive one single dose of each trial product in varying order.


Eligibility criteria:
inclusion criteria: * willing to sign informed consent before initiating any trial related procedures * bmi: 19.0-25.0 kg/m2 * fasting plasma glucose: 3.9-6.1 mmol/l * trial participant is judged to be in good health on the basis of their medical history, physical examination, ecg, and routine laboratory data exclusion criteria: * any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease * clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening * any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial * currently a smoker (more than one cigarette per day or equivalent) * use of grapefruit or grapefruit juice within 7 days of trial product dose administration * blood donation, surgery or trauma with significant blood loss (400 ml) within the last 2 months prior to trial product dose administration * recent history (within the last 2 years) of drug or alcohol abuse * known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions * subject has taken an investigational drug in another clinical trial within the last 4 weeks. * recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints * history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant
the marvin chatbots to provide information for different health conditions

Conditions: HIV Infections; Breast Cancer; Pediatric Emergency Medicine

Summary: this research is a continuation of a usability study with the marvin chatbot. the investigators aim to adapt the marvin chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. the investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.

from 2020, the principal investigator's team has developed an innovative chatbot named minimal antiretroviral interference (marvin), for people with hiv. the primary objectives with this master protocol are to: 1) develop or adapt the marvin chatbots for different healthcare contexts through co-construction; 2) evaluate the global usability of individual chatbots in their respective use scenarios with a small sample of research participants; 3) evaluate the implementation and user outcomes (e.g., fidelity, appropriateness) of individual chatbots in their respective use scenarios with a larger sample of research participants. this includes also documentation of factors that inhibit or enhance the utilization of the chatbots and outcomes; and 4) establish and evaluate, through the previous objectives, different partnerships with research participants and research team members to co-construct chatbots that will respond to their needs and encourage continued use of the tool.

Eligibility criteria:
inclusion criteria for all objectives: * being 14 years or older; * being fluent in english and/or french; * being able to understand the requirements of study participation and provide informed consent during the duration of the study; * having access to a smartphone, tablet, or computer at home/at workplace; * having access to an internet connection at home or data plan on their device. inclusion criteria specific to objectives 2 and 3: * accept to use a facebook messenger-based chatbot; * accept to use or create a personal facebook account; * accept facebook's privacy and data security policies. exclusion criteria: * not meeting the inclusion criteria * any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)

Keywords: chatbot intelligent conversational agent co-construction adherence antiretroviral therapy mhealth implementation science care breast cancer hiv self-management adaptive platform trial design telehealth digital health artificial intelligence pediatric emergency medicine patient and stakeholder engagement pediatric infection large language models
kidney function in patients with bladder exstrophy

Conditions: Classic Bladder Exstrophy; Renal Function; GFR; Proteinuria

Summary: patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.


Eligibility criteria:
inclusion criteria: * all patients with classic bladder exstrophy treated and followed in pediatric urology clinic in dana children hospital and outpatient clinic exclusion criteria: * no

Keywords: classic bladder exstrophy renal function gfr proteinuria
wireless assessment of respiratory and circulatory distress - continuous glucose monitoring

Conditions: Hypoglycemia; Perioperative Complication

Summary: the applicant and research team partners have over the last years developed the ward project (wireless assessment of respiratory and circulatory distress), using wireless continuous monitoring of vital signs in high-risk patients undergoing major abdominal surgery. an important perioperative indicator not currently included in the ward project is continuous glucose monitoring (cgm), which may not only predict and identify hypo- and hyperglycemia, but also utilize the information from variations in blood glucose in combination with other changes in vital signs to predict surgical complications in all patients. the current study involves the inclusion of 80 patients, scheduled for major abdominal, orthopedic or vascular surgery, to be monitored with cgm in addition to the currently measured vital signs. the project is a prospective, observational, clinical study, describing and analyzing variations in perioperative blood glucose levels and vital signs, and the relation to adverse clinical outcomes. patients scheduled for elective surgery will preferentially be recruited at the preoperative assessment at a maximum of 30 days before surgery. cgm and monitoring of the remaining vital sign modalities will commence on the day of surgery. patients admitted for acute surgery will be recruited preoperatively and cgm as well monitoring of the remaining vital sign modalities will commence as soon as possible. the patients will be monitored with cgm for up to 10 days and with the remaining modalities for up to 5 days or for all modalities until discharge or withdrawal of consent.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted to rigshospitalet or bispebjerg hospital for major abdominal surgery (e.g. colonic resections, gastrectomy, hepatic resection etc.) or major orthopedic surgery (e.g. hip-fracture, hip and knee-arthroplasty) or major arterial vascular surgery (e.g. aortic aneurysm, iliac or femoral bypass etc.) * estimated duration of surgery ≥1 hour and at least one expected overnight stay postoperatively and ● type 1 diabetes (clinically defined: insulin initiated at diabetes onset and treatment with multiple doses of insulin or continuous subcutaneous insulin infusion) (n=20) or ● type 2 diabetes treated with insulin (clinically defined: treatment with diet or oral antidiabetic drugs for at least 6 months before insulin was started) (n =20) or ● type 2 diabetes treated with oral antihyperglycemic drugs and/or glp-1 analogs (n=20) or ● no diabetes mellitus (excluded by an admission hba1c \<48 mmol/mol) (n=20) exclusion criteria: * patient expected not to cooperate with study procedures. * patient allergic to plaster or silicone. * patients with impaired cognitive function (assessed by a mini mental state examination \[mmse\] score \<24) * patients admitted for palliative care only. * previous or currently scheduled for pancreatectomy (complete or partial) * patients with pacemaker or implantable cardioverter defibrillator (icd) device
nebulised hypertonic saline to decrease respiratory exacerbations in neuromuscular disease or neurodisability

Conditions: Neuromuscular Diseases; Neurodevelopmental Disorders; Cerebral Palsy

Summary: research aim: this study investigates whether a 12-month treatment with hypertonic saline (salty water) can reduce antibiotic use in individuals with neuromuscular disease or cerebral palsy who frequently experience chest infections due to difficulty clearing mucus from their airways. methodology: participants will be randomly assigned to receive nebulised hypertonic saline (7% salt in water) or normal saline (0.9% salt in water). the study is open-label as both participants and researchers are aware of the treatment, necessary due to the differing tastes of the solutions. two centers, royal brompton hospital in london and queens medical centre in nottingham, will conduct the research. before starting the treatment, participants will undergo various assessments, including questionnaires to measure quality of life and treatment satisfaction, sputum/throat swab collection, lung clearance index, forced oscillation technique, electrical impedance tomography, and lung ultrasound. once these assessments are completed, participants will take the assigned treatment at home, administered twice daily for 12 months, with monthly follow-ups regarding difficulties and chest infections. after 12 months, the treatment will cease, and participants will repeat the assessments. significance: this research will provide valuable insights into the efficacy of nebulised hypertonic saline for individuals with neuromuscular disease or cerebral palsy, potentially aiding both patients and doctors in making informed treatment decisions. dissemination: the study's findings will be shared through publication in scientific journals and presentation at conferences.


Eligibility criteria:
inclusion criteria: * diagnosis of nmd or neurodisablity by a physician independent of the study, on standard criteria. * age 5 years and above, including adults. * must be able to tolerate nebulised 6% hypertonic saline. * must have a history of at least one respiratory exacerbation requiring antibiotic treatment with or without the need for hospitalisation in the 12 months prior to recruitment. exclusion criteria: * patients with additional diagnosis, for example, cf, but those with aspiration and/or bronchiectasis secondary to respiratory complications of nmd will be included. * patients who are already prescribed daily hs in any concentration (i.e, 3%, 5%, 6%, 7%) will be excluded, but those who are on daily ns or have hs prescribed as part of their escalation plan (i.e., prn) will be included.

Keywords: hypertonic saline saline nebulised