Kornimate/medical-research-clean huggingface dataset:
care bundle containing chlorhexidine dressing on port catheter and central venous catheters

Conditions: Pediatric Cancer

Summary: in order to provide treatment in pediatric hematology-oncology patients, in some cases a central venous catheter is required in children. the most important situation to pay attention to when using a central venous catheter is "central line-associated bloodstream infections". these infections are infections that develop after admission to the hospital and are not in the incubation period at the time of admission, or although they usually develop in the hospital 48-72 hours after hospitalization, they can sometimes appear after discharge. central line-associated bloodstream infections significantly increase morbidity and mortality. in this context, the effect of using a care bundle containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients was examined.

this study was designed as a prospective, cross-sectional, and randomized controlled study to examine the effect of a care package containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients. hypotheses of the research h1: care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related bloodstream infections. h2: care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related complications. randomization a stratified randomization scheme was used to distribute the sample into groups. stratification randomization was made according to port catheter stay duration, age group, hematological/oncological cancer type and hematopoietic stem cell transplantation unit / pediatric hematology and oncology clinic.

Eligibility criteria:
inclusion criteria: * the child is receiving inpatient treatment at the hematology and oncology unit and hematopoietic stem cell transplantation unit * the child has a diagnosis of hematological or oncological cancer * the child's age range is between 1 and 17 * having a port catheter inserted and no early complications have occurred * the child agrees to participate in the study voluntarily * the parent agrees to participate in the study voluntarily * obtaining the consent form from the child and parent * he has been in the hospital for more than 48 hours exclusion criteria: * have a systemic infection.

Keywords: care bundle chlorhexidine pediatric cancer catheter-related bloodstream infections
study of human adipose tissue (loshat)

Conditions: Weight Change, Body; Weight Loss; Weight Gain; Lipolysis; Adipose Tissue; Human; Obesity; Type 2 Diabetes Mellitus

Summary: the investigators will study the influence of initial fat cell size/number and adipose function (in particular lipolysis) on weight development over very long time periods (years). by comparing investigations of fat biopsies or blood samples obtained at baseline, the investigators will determine the association between adipose morphology/function and changes in weight or development of metabolic complications (e.g. metabolic syndrome, glucose intolerance, type 2 diabetes, dyslipidemia and hypertension).

the investigators will ask all subjects that have previously been examined at the investigators laboratory (from 1992 and forward) in studies of adipose tissue function if they are interested to participate in a new study. previously obtained results from examinations of adipose tissue, anthropometric measurements and blood samples will be used as baseline. in addition, saved blood samples and samples from old fat biopsies can be re-investigated in some cases. the new investigation includes a questionnaire that the subjects can answer by mail or email. in addition, anthropometric measurements and blood pressure determination will be performed at a primary health care center and blood samples will be collected for analysis of fasting glucose, hba1c and lipids. information regarding all previously investigated subjects will also be collected from several swedish national patient registries such as the patient register, prescribed drug register and cause-of death register.

Eligibility criteria:
inclusion criteria: * previously participated in examinations at the investigators laboratory and donated adipose tissue. * previously participated in examinations at the investigators laboratory and donated blood samples that can be used to estimate lipolysis with a formula. exclusion criteria: * decline to participate after invitation. * severe psychiatric disease. * type 1 diabetes * participants that have undergone bariatric surgery will be exluded in the primary analysis but will be analyzed separately in a secondary analysis for all above mentioned outcomes.
correction of anterior open bite with skeletally anchored extrusion arch

Conditions: Anterior Openbite Malocclusion

Summary: this study will aim to evaluate the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite (aob).

this study will be a prospective clinical study. all the patients will be treated with 0.022 inch slot roth metal brackets. orthodontic bands will be cemented to the maxillary first molars. both maxillary and mandibular teeth, will be sectionally leveled and aligned with superelastic ni-ti archwires. a buccal stiff sectional wire from the first molar to the canine will be added for anchorage reinforcement. extrusion will be done by inverting a 0.017 × 0.025-inch connecticut intrusion archwire and inserting it in the molar auxiliary tubes upside-down and miniscrew will be tied to the molar bands to act as additional indirect anchorage.

Eligibility criteria:
inclusion criteria: 1. patients with a class i or a mild class ii dental relationship. 2. all permanent teeth are erupted except the third molars. 3. mild to moderate open bite is present. 4. normal or minimally increased facial height. 5. low lip line. 6. no or mild crowding. exclusion criteria: 1. patients with skeletal open bite. 2. posterior cross bite. 3. trauma to the maxillary incisor. 4. patients in need to extraction due to sever crowding.
investigation of the passage of antiviral antibodies from mother to child

Conditions: Pregnant Woman; Adult Patient

Summary: infections remain a major cause of neonatal morbidity and mortality worldwide. at birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. passive immunity by transplacental transfer of maternal antibodies is therefore of major importance in the first weeks and months of life before their own vaccination or until this period of immunological vulnerability has passed. some factors are known to affect transplacental passage of antibodies but these have generally been studied in small series and many other parameters have not yet been investigated. the transmission rate of antibodies, particularly neutralizing antibodies, remains little explored, as well as the difference in transfer between antibodies induced by vaccination and those induced by natural infection, or the influence of maternal factors such as multiple pregnancy, other infections and treatment of these infections. a better identification and understanding of the factors that can affect transplacental transfer of maternal antibodies is crucial for optimization of vaccination strategies and close monitoring of particularly vulnerable newborns.

the investigators aim to include 4050 patients and collect a maternal at delivery cord blood sample. the aim of the investigators is to measure and compare ratio of transplacental transfer of maternal anti-virus antibodies according to the mode of acquisition of immunity (post-vaccination, or post-natural or mixed infection), gestational age at birth (\ 37 wg) for several virus (hepatitis b virus, varicella zoster virus, rubella virus, measles, influenza virus, mumps virus, sars-cov-2, cytomegalovirus, herpes simplex virus 1 and 2, respiratory syncitial virus, parvovirus b19, htlv). the investigators also aim to identify factors likely to influence negatively or positively transplacental transfer of maternal antibodies as maternal age, maternal ethnic origin, parity and gestation, sex of the newborn, maternal chronic or acute infection/disease occurring during pregnancy; birth weight, vaccine boost carried out during pregnancy (etc.) will also be studied.

Eligibility criteria:
inclusion criteria: * women over 18 years old ; * pregnant patient (single or multiple pregnancy) ; * gestational age at the time of inclusion \> 22 weeks of gestation ; * patient affiliated or entitled to a french social security scheme ; * patient who expressed a non-objection to participate in the study. exclusion criteria: * misunderstanding of the french language; * participation in another interventional trial of category 1. participation in category 2 research, with minimal risks and constraints, will be left to the discretion of the investigator; * patient under curatorship or guardianship ; * patient's refusal to participate in the research.

Keywords: transfer placenta antibody virus
clinical value and efficacy index of lymphadenectomy for thoracic escc

Conditions: Esophageal Cancer

Summary: the goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. the main question\[s\] it aims to answer is: * provide a basis for accurate staging and the relationship between os and lymph node dissection


Eligibility criteria:
inclusion criteria: 1. pathologic findings proved escc (8th ajcc/uicc stage t1b-4an0-3m0) 2. underwent esophagecomy (two-field or three-field ln dissection) 3. the primary tumor was thoracic escc exclusion criteria: 1. located outside the thoracic 2. patients underwent salvage or r1/r2 esophagecomy 3. the number of resected lymph nodes (rlns) less than 15 4. with neoadjuvant therapy(nt) or salvage chemoradiotherapy(scrt)
dental hygiene and peri-implant tissues homeostasis ancillary study

Conditions: Peri-Implantitis

Summary: peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. recent discoveries have identified increased release of titanium (ti) particles around implants as being associated to peri-implantitis. in this ancillary study to the dental hygiene and peri-implant tissues homeostasis trial the objective is to determine potential triggers of increased ti dissolution from the implant surface and the mechanisms by which ti dissolution products amplify peri-implant inflammation. results from this study will determine whether there is a differential response to ti particles across individuals, which may alter susceptibility to peri-implantitis.


Eligibility criteria:
inclusion criteria: * is the subject ≥ 25 years of age? * does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of \> 2mm? * is the subject committed to the study and the required follow-up visits? exclusion criteria: - is the subject immune compromised? is the subject diabetic? does the subject take steroid medication? does the subject regularly use non-steroidal anti-inflammatories? is the subject pregnant or intending to become pregnant during the duration of the study? has the subject had previous implantoplasty? did the subject take any antibiotics in the last 3 months?

Keywords: implant titanium dental
medium vs low oxygen threshold for the surfactant administration

Conditions: Respiratory Distress Syndrome

Summary: the aim of this study will be to assess the better fraction inspired oxygen (fio2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (rds) randomized to receive exogenous surfactant at 25% or 35% of fio2 threshold. the pulmonary gas-exchanges will be evaluated by oxygen saturation (spo2) to fio2 ratio (sfr) and will be used to define the better fio2 threshold for the surfactant treatment.

exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (rds) and has been associated with reduced severity of respiratory distress and mortality. the 2019 european guidelines for neonatal rds treatment suggest as the threshold of inspired oxygen (fio2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. to date, the optimal fio2 threshold for surfactant administration remains unclear. in this single-center, randomized, phase 4 trial, preterm infants (gestational age\<32 weeks) with rds will be randomized to receive exogenous surfactant at 25% or 35% of fio2 threshold. according to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by intubation-surfactant-extubation (insure) / less invasive surfactant administration (lisa) methods in infants who will not remain intubated. the method used for the surfactant administration will be at the discretion of the caring physician.

Eligibility criteria:
inclusion criteria: * gestational age less than 32 weeks; * diagnosis of respiratory distress (rds); * need for ventilatory support; * written informed consent. exclusion criteria: * congenital malformations; * genetic disorders; * perinatal asphyxia. * neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.

Keywords: rds surfactant threshold oxygen preterm infant
pilot trial of an online personalised normative feedback intervention to reduce drinking

Conditions: Alcohol Consumption

Summary: unhealthy alcohol consumption is common in the uk and causes tremendous harm to the individual, as well as harm to others. a significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. however, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. one such promising intervention uses online personalised normative feedback (pnf) which compares a person's drinking with others in the general population of the same age and sex. pnf interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. multiple trials have demonstrated that providing pnf to people with unhealthy consumption reduces their alcohol use . while several uk websites do provide feedback on assessment of risk (e.g., down your drink introductory section, alcohol change uk), there appears to be no online intervention that provides pnf for unhealthy alcohol consumption. the major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (rct) in which 1,318 participants recruited from the prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a pnf report, and b) those in a no intervention comparator group. participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the pnf feedback and will be asked to think about how useful they would find each of them. follow-up assessment will occur at 1 and 6 months post-randomisation. the project is described as a pilot because it is a preliminary evaluation of the pnf intervention in a uk context.


Eligibility criteria:
inclusion criteria: typically consume 14+ standard uk alcohol units per week willingness to complete a 6-month follow-up survey 18 years of age or older
a phase i safety, pharmacokinetics and pharmacodynamics study of recombinant factor viia in adult patients with hemophilia a or b

Conditions: Hemophilia

Summary: this study will assess the pharmacokinetics and pharmacodynamics of rhfviia at three dose levels. the results will help identify the most optimal doses to take forward to the phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhfviia.


Eligibility criteria:
inclusion criteria: 1. be male with a diagnosis of moderate or severe congenital hemophilia a and/or b (with or without inhibitors) 2. be 18 years or older, up to and including 75 years of age 3. be capable of understanding and willing to comply with the conditions of the protocol 4. have read, understood and provided written informed consent exclusion criteria: 1. have any coagulation disorder other than hemophilia a or b 2. have a body weight \>105 kg (231 lb) 3. be immuno-suppressed (i.e., the patient should not receive systemic immunosuppressive medication \ 200/µl) 4. have a known allergy or hypersensitivity to rabbits 5. have platelet count \<100,000/ml 6. have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal) 7. have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 24 hours of the time of study drug administration 8. have received a factor vii or fviia containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration 9. have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study 10. have a clinically relevant hepatic (hepatic enzymes \>3 times the upper limit of normal) and/or renal impairment (creatinine \>2 times the upper limit of normal) 11. have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, have an arterial stent in place or have clinically significant atherosclerotic disease (e.g., angina pectoris, peripheral vascular disease) 12. use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration 13. have an active malignancy (those with non-melanoma skin cancer are allowed) 14. have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
french prospective, observational cohort study of patients with fabry disease treated with migalastat

Conditions: Fabry Disease

Summary: this is a noninterventional cohort study to evaluate the effects of migalastat, on long-term safety, effectiveness, and quality of life (qol) in patients with fabry disease.

occurrence of key indicators of safety and effectiveness will be evaluated, such as cardiac, cerebrovascular and renal events, and overall survival. the study is designed to provide effectiveness and safety data by q2 2023 which will cover a period up to 5 years after the migalastat launch date. this will involve a retrospective data collection up to migalastat initiation (for patients already receiving migalastat) and a prospective follow-up from 1 to 3.5 years (depending on the time of enrollment) in migalastat-treated patients with fabry disease who have a gla mutation amenable to migalastat. all visits will be scheduled and conducted according to the clinical site's standard of care. standard of care is defined as a diagnostic and customary clinical treatment/practice process that a clinician chooses according to their clinical judgement for a fabry disease patient. there are no study- required visits, tests or clinical assessments.

Eligibility criteria:
inclusion criteria: * patients with fabry disease aged 16 years or older * egfrckd-epi \> 30 ml/min/1.73 m2 * treated with migalastat, or who are starting migalastat upon enrollment * patients with fabry disease and/or parents/guardians (when applicable) who are able to understand and have provided a signed non-opposition form. * equipped with a web connection via a computer or tablet exclusion criteria: * patients who are participating in a clinical trial of any investigational medicinal product or device at the time of enrollment. * patients already included in the present study
imaging assessment of diastolic function

Conditions: Congenital Heart Disease

Summary: diastolic function is poorly studied in children with congenital heart disease. this is mainly due to the lack of validated techniques. cardiac mri offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. the main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. overall there is a lack of studies correlating different echocardiographic and mri parameters of heart function in pediatric populations with congenital or acquired heart diseases. this study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. this study hypothesizes the following: * atrial enlargement is a marker of chronic increase in filling pressures and 3d echo might be the best method for follow-up. * cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. this is related to changes in cardiac mechanics influencing diastolic parameters. especially the influence on twisting and untwisting will be studied. * regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact


Eligibility criteria:
inclusion criteria: * all patients with tetralogy of fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac mri will be eligible. * informed consent exclusion criteria: * lack of informed consent * need for general anesthesia * similar contraindications as for a clinical mri study apply.

Keywords: pediatrics congenital heart disease diastolic function echocardiograph mri