Kornimate/medical-research-clean huggingface dataset:
comparison of technics for determination of epstein-barr virus serological diagnosis

Conditions: EBV

Summary: this study compared the performance of three automated immunoassays, architect (abbott), immulite (siemens) and liaison (diasorin), for epstein-barr virus (ebv) serology. ninety-one serum samples collected in amiens university hospital were analyzed for the presence of viral capsid antigen (vca) igg and igm and epstein-barr nuclear antigen (ebna) igg. the agreement between the three assays was calculated for each marker individually and for determination of the ebv profile, based on interpretation of the combination of these three ebv markers.

this retrospective study was conducted on 91 samples collected between 2014 and 2015 for which ebv diagnosis was requested. the serological diagnosis of ebv infection was performed in the amiens university hospital virology laboratory (france). the median age of patients was 34 years (mean: 38 years, range: 3-82 year) with a sex ratio of 50%. sixteen of the 91 samples concerned children (\<15 years). this study compared the performance of three automated immunoassays, architect (abbott), immulite (siemens) and liaison (diasorin), for epstein-barr virus (ebv) serology. ninety-one serum samples collected in amiens university hospital were analyzed for the presence of viral capsid antigen (vca) igg and igm and epstein-barr nuclear antigen (ebna) igg. the agreement between the three assays was calculated for each marker individually and for determination of the ebv profile, based on interpretation of the combination of these three ebv markers.

Eligibility criteria:
inclusion criteria: * patients with ebv diagnosis * age between 3 and 82 years exclusion criteria: * patient \<3 years * patient \> 82 years

Keywords: epstein-barr virus infectious mononucleosis
parafunctional habits and temporomandibular disorder in adolescents

Conditions: Temporomandibular Disorder; Adolescent Behavior

Summary: the disorders that affect the temporomandibular joint (tmj) are responsible for the diverse symptoms. objective: to evaluate whether or not the relationship between signs or symptoms of tmd and presence of harmful habits. the investigators evaluated 244 adolescents enrolled in public school . the investigators used the questionnaire for selection of orofacial pain and temporomandibular disorders, recommended by american academy of orofacial pain to assess the presence or absence of signs and symptoms of tmd.

for the assessment of signs and symptoms of tmd and parafunctional habits, 244 adolescents between 10 and 20 years of age and enrolled in a municipal school system were analyzed. the participants were submitted to the self-explanatory questionnaire for screening recommended by the american academy of orofacial pain for the determination of orofacial pain and tmd. this questionnaire is made up of ten guided questions with yes or no responses to the most frequent signs and symptoms of orofacial pain and tmd. according to the academy, three or more affirmative responses are an indication of tmd. patient history and a detailed clinical exam were performed for the assessment of the presence or absence of parafunctional habits. the frequency of signs and symptoms was analyzed and the data were described based on gender and age. the spss 12.0 program was used for the statistical analysis and the data were treated using the chi-square test.

Eligibility criteria:
inclusion criteria: * age: 10 to 20 years old exclusion criteria: * no signing a term of informed consent

Keywords: temporomandibular disorder adolescents
a phase ii study on dose optimization of fruquintinib in elderly mcrc patients refractory to standard treatment（dofemcrc）

Conditions: Colorectal Cancer

Summary: a phase ii study on dose optimization of fruquintinib in elderly metastatic colorectal cancer patients refractory to standard treatment.

this is a prospective, multi-center, single arm, phase ii study. in this study, the low-dose initial dose incremental optimization scheme was used in the first cycle in patients ≥65 years old who need to receive fruquintinib. the aim is to observe the safety, tolerability and efficacy of fruquintinib in elderly patients with mcrc refractory to standard treatment. the correlation between the efficacy, toxicity and geriatric evaluation of fruquintinib will also be analysed.

Eligibility criteria:
inclusion criteria: 1. 65 years and older; 2. histologically or cytologically confirmed unresectable metastatic colorectal cancer refractory to or unfit for standard therapies; 3. ecog ps 0-1; 4. at least 4 weeks after the last anti-tumor therapy (chemotherapy, radiotherapy, biotherapy or hormone therapy) and more than 3 months after operation treatment before enrollment; 5. life expectancy ≥ 3 months; 6. cooperative in observation of adverse events and curative effect; 7. no other anti-tumor concomitant treatment (including steroid drugs); 8. adequate organ and bone marrow functions; 9. at least one measurable lesion(s); 10. signed the written informed consent and completed the geriatric questionnaire (g8 screening form) at the time of enrollment. exclusion criteria: 1. active upper gastrointestinal ulcer, obvious vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc which may affect drug absorption, distribution, metabolism, or clearance; 2. evidence of central nervous system metastasis; 3. one of the following complications: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure; 4. abuse of alcohol or drugs; 5. less than 4 weeks from the last clinical trial; 6. previous treatment with vegfr inhibitors; 7. severe uncontrolled disability with concurrent infection; 8. proteinuria ≥ 2 + (1.0g / 24hr); 9. uncontrollable gastrointestinal bleeding; 10. arterial / venous thromboembolic events such as cerebrovascular accident (including transient ischemic attack) occurred within 12 months before the first dose; 11. acute myocardial infarction, acute coronary syndrome or coronary artery bypass grafting occurred within 6 months before the first dose; 12. fracture or wound that has not been cured for a long time; 13. coagulation dysfunction, bleeding tendency or receiving anticoagulation treatment; 14. congenital or acquired immune deficiency (such as hiv infection), or active hepatitis (hbv dna ≥ 103copies / ml after regular antiviral therapy); 15. patients who are not suitable for the study judged by the researchers.
healthy environments study (heros)

Conditions: Health Behavior; Childhood Obesity

Summary: obesity is a multi-dimensional problem that has roots in infancy and tracks into adulthood. obesity is represented disproportionately among children and families from low socioeconomic and minority backgrounds, particularly in rural areas that have limited access to food, activity, and health-related services. there is a need for culturally-tailored, effective interventions that can positively impact the environments (home, preschool, community) in which young children grow and develop their eating and activity behaviors. developing family interventions, particularly for families with limited resources, requires improving caregivers' health literacy and home food/activity environments, and also requires tailoring to accommodate the realities of stressful and unpredictable family settings. the overall objective of this proposed heros study (healthy environments study) is to develop a companion, technology-based, interactive family intervention that will promote healthy lifestyles for young children in both head start and family settings.

this intervention study will test the impact of the intervention through a quasi-experimental staggered implementation pilot design. the aims will test whether the implementation of a parent-child interaction intervention, focusing on eating and activity behaviors, will improve children's eating behaviors, motor performance and parent-child interactions in these domains. this project seeks to answer the following research questions: 1. do children participating in the family-based intervention demonstrate enhanced pa and eating behaviors? * hypothesis 1.1: children receiving the family-based intervention will have higher pa levels and enhanced motor skills compared to children in the control group. * hypothesis 1.2: children receiving the family-based intervention will demonstrate enhanced eating behaviors compared to children in the control group. 2. can the home environment be improved by parents' self-monitoring of food availability and electronic devices; and the application of mindful parenting strategies? * hypothesis 2.1: evaluation of food items in the home and electronic devices in the child's bedroom will demonstrate a more positive home environment of participants receiving the family-based heros intervention. * hypothesis 2.2: parents will report more positive parent-child interactions after receiving the family-based heros intervention.

Eligibility criteria:
inclusion criteria: * adults who identify as the primary caregiver of a child enrolled in a head start or preschool center ; * caregivers who report their child is without disability, illness, or disorder that would significantly affect dietary or activity behaviors (e.g., diabetes, cerebral palsy); * participants who communicate in either english or spanish language. exclusion criteria: * caregivers with children who have a disability, illness, or disorder that would significantly affect dietary or activity behaviors.

Keywords: early childhood mindful parenting family intervention picky eating motor development diet quality physical activity
study of jyp0015 in patients with advanced solid tumors harboring specific mutations in ras

Conditions: Solid Tumor; Pancreatic Ductal Adenocarcinoma (PDAC); Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC)

Summary: evaluate the safety and antitumor activity of jyp0015 in adults with specific ras mutant advanced solid tumors.

this is a phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics (pk), and clinical activity of jyp0015 in adult patients with advanced solid tumors harboring specific ras mutations. the study consists of two parts: * phase 1 (dose escalation) - evaluates the safety, tolerability, and pharmacokinetic profile of jyp0015 monotherapy, preliminarily assesses efficacy, and determines the recommended dose (rd) for further evaluation. * phase 2 (indication expansion) - explores the therapeutic potential of jyp0015 monotherapy at the rd across four predefined cohorts: 1. pancreatic ductal adenocarcinoma (pdac) 2. non-small cell lung cancer (nsclc) 3. colorectal cancer (crc) 4. other advanced solid tumors phase 2 will assess both efficacy and safety within these cohorts. jyp0015 is a potent, orally bioavailable pan-ras inhibitor that selectively targets the active (on) form of wild-type and mutant ras across all three isoforms-hras, nras, and kras.

Eligibility criteria:
inclusion criteria: 1. histologically or pathologically confirmed solid tumors with ras mutation via molecular tests. 2. patients with ras mutation who have disease progression or intolerance after adequate standard treatment 3. eastern cooperative oncology group (ecog) performance status in 0 or 1 4. adequate organ function exclusion criteria: 1. presence of central nervous system (cns) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable. 2. gastrointestinal (gi) disorders that may interfere with drug administration/absorption, including but not limited to: dysphagia or inability to swallow tablets， malabsorption syndrome，refractory nausea, vomiting, or diarrhea，chronic gi diseases (e.g., crohn's disease, ulcerative colitis) 3. congestive heart failure with new york heart association (nyha) functional class ≥ii or left ventricular ejection fraction (lvef) \<50%. 4. any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: alcohol or substance abuse，concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment)， familial or social circumstances that may affect patient safety, compliance, or study data collection.

Keywords: pdac nsclc crc
pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate formulation in the paediatric population

Conditions: Monosymptomatic Nocturnal Enuresis

Summary: patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. in treatment resistant enuresis, this dose is doubled: those patients take 240mcg once daily. a pilot study performed at our department showed a correlation between weight and plasma concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to the pediatric patient (older than 6 years). this study will investigate the pharmacokinetics (pk) and pharmacodynamics (pd) of desmopressin in young children, less than 8 years old. additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary concentration testing will be evaluated


Eligibility criteria:
inclusion criteria: * children with an uro- and/or nephropathy who need an urinary concentration test or children with monosymptomatic nocturnal enuresis (based on nocturnal polyuria) with treatment failure on desmopressin tablet * otherwise healthy children (on medical history and physical examination) * parents or legal guardian of the child signed the informed consent form * age: between 6 months and 8 years * minimum weight: 8 kg exclusion criteria: * diabetes insipidus * renal failure (egfr\<60ml/min/1,73m²) * current urinary tract infection * syndrome of inappropriate antidiuretic hormone secretion * heart failure * clinical significant medical conditions (renal, hepatic, gastro-intestinal, pulmonary, cardiac, endocrinologic) that might interfere with the clinical endpoints * sensitivity to desmopressin or excipients of the oral lyophilisate formulation * use of antibiotics, diuretics or other drugs that can influence diuresis (tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine). * use of drugs that influence intestinal motility (such as loperamide) * anomalies of the mouth that might interfere with the intake / absorption of the medication

Keywords: desmopressin paediatrics urinary concentration test
validity of computed guided technology in proper placement of intermaxillary fixation screws in mandibular fractures

Conditions: Mandibular Fractures

Summary: a randomized clinical study that aims to assess the validity of the use of computer guided technique in the proper placement of imf screws in mandibular fractures

fractures of the facial skeleton involving the teeth bearing segments can lead to disruption of the dental occlusion, and difficulties with speech and mastication. the temporary fixation of opposing jaws is called maxillomandibular fixation and is usually secured through placement of imf screws and wires. the correct placement of imf screws can be challenging. such planning may make use of radiographs and computed tomography scans. knowledge of safe zones in the facial skeleton for screw placement through the use of pre-operative 3-dimensional planning may prevent some of the cited complications. the use of a custom made surgical guide for imf screw placement has the potential to reduce operation time, optimize screw position, and minimize injury to dental roots and important anatomical structures. aim: the aim of this study is to assess the use of computed guided technique in the proper placement of imf screws in mandibular fractures. materials and methods: this clinical study will be conducted on 20 patients who will be equally and randomly distributed into 2 groups: group a: 10 patients will be treated with 3d guided placement of imf screw. group b: 10 patients will be treated with conventional placement of imf screws. to assess the accuracy of imf screws placement in each group.

Eligibility criteria:
inclusion criteria: * patients suffer from recent mandibular fractures that requires fixation * dentulous patients * medically fit for surgery (asa i and asa ii) exclusion criteria: * edentulous patients * patient with bone pathosis * patients with primary and mixed dentition * pathologic mandibular fracture

Keywords: mandible fracture fixation screws
post-operative urinary retention (pour) in thoracic surgery patients receiving prophylactic tamsulosin

Conditions: Thoracic Diseases; Urinary Retention

Summary: post-operative urinary retention (pour) in thoracic surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of pour.

post-operative urinary retention (pour) is one of the most common post-operative complications encountered by most surgical specialties. the incidence of pour can vary from five to 70%. post-operative urinary retention is a prevalent complication. patients who undergo thoracic surgery have greater urinary retention rates compared to others. data on effective methods to reduce the risk of pour in this high-risk group are limited. all subjects who meet inclusion and exclusion criteria will be invited to participate. there will be no randomization. all will receive tamsulosin in the pre operative period.

Eligibility criteria:
inclusion criteria: * all male patients \>=60 years old who undergo inpatient thoracic surgery for major resections. exclusion criteria: * - prisoners * adults unable to consent * end stage renal disease on hemodialysis * indwelling urinary catheter * child-pugh class c hepatic failure * usage of the following medications prior to surgery: strong cyp 3a4 inhibitors, strong cyp2d6 inhibitors, other alpha-adrenergic blocking agents, pde5 inhibitors, and cimetidine * patients known to be cyp2d6 poor metabolizers * history of prostatectomy or cystectomy * patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin hcl or any component of flomax capsules, hypersensitivity to sulfonamides. history of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks
a study to assess the pharmacodynamic effects of sage-217 in healthy adults using an insomnia model

Conditions: Healthy

Summary: this study will assess the pharmacodynamic effects of sage-217 in approximately 42 healthy adult subjects using an insomnia model.

subjects are expected to complete treatment periods 1, 2 and 3, followed by an optional open-label administration of sage-217 for pharmacokinetic purposes (treatment period 4). this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits * subject is a healthy, ambulatory volunteer * subject meets sleep qualification criteria exclusion criteria: * subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders * subject has worked a night shift or flown \>1 time zone within 30 days prior to screening
my personalized breast screening

Conditions: Breast Screening

Summary: mypebs is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers. women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. the main study endpoint will be measured at the end of the four years of intervention. furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival


Eligibility criteria:
inclusion criteria: 1. female (whether born female or not) 2. aged 40 to 70 years old (inclusive) 3. willing and able to comply with scheduled visits, laboratory tests, and other trial procedures 4. able to provide written informed consent obtained prior to performing any protocol-related procedures 5. sufficient understanding of any of the languages used in the study 6. affiliated to a social security/national healthcare system exclusion criteria: 1. personal history of breast carcinoma, either invasive or ductal carcinoma in situ (dcis) 2. prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation 3. known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of brca1/2, palb2, tp53 or equivalent 4. history of bilateral mastectomy 5. recent abnormal breast finding under work-up (clinically suspect lesion or bi-rads 4 or 5 image) 6. psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up 7. women who do not intend to be followed-up for 4 years

Keywords: standard breast screening - risk-based screening program
effect of carvedilol versus metoprolol on glycemic control in patients with type ii diabetes and hypertension

Conditions: Hypertension

Summary: evaluation of the effect of two different antihypertensive treatments on control of glucose in type ii diabetic patients with high blood pressure


Eligibility criteria:
inclusion criteria: * patients at screening must be insulin producing type ii diabetics (c peptide positive). * patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure) * patients must be on a stable regimen of ace (angiotensin converting enzyme) / arb (angiotensin receptor blocker) treatment alone or in combination with other treatments. * patients must be on stable antidiabetic regimen (drug treated or diet alone). * patient''s laboratory result for hba1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone). exclusion criteria: * patients using beta-blocker therapy.

Keywords: hypertension beta-blockers type 2 diabetes