Kornimate/medical-research-clean huggingface dataset:
biomarkers for the prognosis of influenza in children

Conditions: Influenza

Summary: context: seasonal influenza affects 2.5 to 3 million people each year in france, resulting in 1500 to 2000 severe cases seen in intensive care units. the severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. viral, human but also environmental factors have been described as having an important role in determining this severity. several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. during influenza infection, the respiratory microbiota is significantly altered. in animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. in a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. this difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms. hypotheses : * the respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication) * the respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza originality: there are currently no clinical and / or virological markers to predict the clinical course of influenza infection. this study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. these prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.


Eligibility criteria:
inclusion criteria: * age \< 5 years * seen in an emergency department with influenza confirmed by a positive test (polumerase chain reaction, rapide antigen detection test). exclusion criteria: * presence of associated significant comorbidity (chronic respiratory, cardiac, neurological or metabolic pathology, prematurity, known immunodeficiency) * documented non-respiratory bacterial infection * no consent * patient not affiliated to a national health cover

Keywords: severe influenza biomarkers respiratory microbiome prognosis
genital ct treatment to pregnant women to prevent adverse pregnancy outcomes: a pilot rct

Conditions: Chlamydia Trachomatis Infection

Summary: this study aims to identify the relationship between genital c. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital c. trachomatis in pregnant women can reduce adverse pregnancy outcomes. approximately 200 pregnant women from nanhai hospital of southern medical university in guangzhou, china will be enrolled and randomized to the intervention or control group.

women recruited for the study will be randomized to the intervention or control groups. women in the intervention group will be tested in real time for c. trachomatis and neisseria gonorrhoeae. patients who test positive for either infection will be linked to physicians at the center for treatment. for the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. in the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. the endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn. qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. university of north carolina at chapel hill (unc) investigators will work with the nanhai hospital of southern medical university and staff at dermatology hospital of southern medical university to oversee the study.

Eligibility criteria:
inclusion criteria: 1. pregnant women on their first visit to the hospital (regardless of gestational age); 2. aged 18 or above; 3. agree to participate and sign an informed consent. exclusion criteria: 1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit; 2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension); 3. diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); women with a previous history of ct or ng and women with a prior adverse outcome will not be excluded. instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.
autoantibodies against human recombinant erythropoietin in myelodysplatic syndrome patients

Conditions: Myelodysplatic Syndrome

Summary: the purpose of this study is to verify the presents of autoantibodies in serums of mds serum patients who had an inadequate response or did not respond to recombinant human erythropoietin (rhuepo) treatment.

mds are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is associated with lowering quality of life and often requires blood transfusions. historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to recombinant human erythropoietin (rhuepo) treatment for dealing with the anemia. rhuepo treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. studies have shown presents of anti- rhuepo in blood serums which followed treatment of other diseases. these findings can indicate the possibility of the presence of antibodies in mds patients as well.

Eligibility criteria:
inclusion criteria: * followed up hematological patients * pateint recieving rhuepo treatment (except control group) * pateint signed informed consent exclusion criteria: * none

Keywords: mds autoantibodies erythropoietin autoantibodies in mds patients treated with epo
effectiveness of inactivated covid-19 vaccine of the first booster dose

Conditions: COVID-19

Summary: this is a retrospective test-negative case-control study of covid-19 vaccine (coronavac®) manufactured by sinovac research and development co., ltd.the main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with coronavac® against laboratory-confirmed symptomatic disease.

this is a retrospective test-negative case-control study in são paulo city, brazil . the covid-19 vaccine (coronavac® )produced by sinovac research and development co., ltd.the main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with coronavac® against laboratory-confirmed symptomatic disease.a total of 14000 subjects will be enrolled,including 7,000 positive cases and 7,000 test negative covid-19 cases the statistical analysis plan (sap) will include univariate (and, when required, multivariable) models of logistic regression.data will be recovered from three health surveillance information electronic health records (ehrs): 1. vacivida, comprising individual data for people vaccinated against sars-cov-2. 2. e-sus, mandatory report database for mild to moderate covid-19. 3. sivep-gripe, mandatory report database for severe cases of covid-19. all those rwd sources are available at the são paulo municipality centers for health surveillance.

Eligibility criteria:
inclusion criteria: * exposure group 1: adults (≥ 18 years of age) registered in the e-sus or sivep-gripe rwd source data from august 16th, 2021 through april 21st, 2022 and received a three-dose homologous vaccination with coronavac. specifically, ≥14 days after receipt of the third vaccine dose using a homologous regimen with coronavac. * exposure group 2: adults (≥ 18 years of age) registered in the e-sus or sivep-gripe rwd source data from august 16th, 2021 through april 21st, 2022, who received a two-dose vaccination with coronavac and did not receive any booster vaccine. specifically, ≥14 days after receipt of the second vaccine dose and before the third dose of coronavac. * exposure group 3: adults (≥ 18 years of age) registered in the e-sus or sivep-gripe rwd source data from august 16th, 2021 through april 21st, 2022, who received only one dose vaccination with coronavac and did not receive any other vaccine dose. specifically, ≥14 days after receipt of the first vaccine dose and before the second dose of coronavac. * non-exposure group: adults (≥ 18 years of age) registered in the e-sus or sivep-gripe rwd source data from august 16th, 2021 through april 21st, 2022, who were not vaccinated. no history of vaccination for any type of covid-19 vaccine, or \<14 days after receipt of the first vaccine of coronavac. exclusion criteria: * anyone who received other vaccines for the first doses. * anyone who received coronavac for the two initial doses but other vaccines for the booster (heterologous immunization). * subjects with incomplete vaccination history.
distal femur fracture nonunion - statistical analysis plan

Conditions: Femur Distal Fracture; Nonunion of Fracture

Summary: here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

see attached pdf.

Eligibility criteria:
inclusion criteria: * age \> 16 years * ao/ota type a or c distal femur fracture * fracture located on the metaphyseal area of the distal femur (square method) * operative treatment in the helsinki university hospital with a distal femur anatomic lateral locking plate * operative treatment within 1 month after trauma * operative treatment between years 2009 and 2018 exclusion criteria: * stress fracture * pathological fracture * an epicondylar or subchondral fracture * a ligament sprain in distal femur * treatment with a double-plating method or with both plate and nail * non-surgical treatment and patients who died before the treatment * treatment with an unconventional plate (other than distal femur plate) * patients whose follow-up criteria not fulfilled

Keywords: prediction distal femur fracture nonunion statistical analysis plan
outcomes allomap registry: the long-term management and outcomes of heart transplant recipients with allomap testing

Conditions: Cardiac Transplant Failure; Cardiac Transplant Rejection; Heart Diseases

Summary: the objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular allomap testing as part of allograft rejection surveillance.

the standard of care in adult heart transplant recipients has been to perform periodic endomyocardial biopsies for surveillance for rejection. because of the risks and discomforts associated with the biopsy procedure, a non-invasive test (allomap) based on gene-expression profiling of peripheral blood was developed and introduced in 2005 to identify heart transplant recipients who have a low probability of rejection at the time of protocol surveillance testing. the schedule of allomap surveillance testing has been derived from the customary timing of surveillance biopsies: e.g. at 1 to 2 month intervals for patients who are 6 and 12 post-transplantation, and at 3, 4 or 6 months after the first year post-transplantation. in the large multicenter image (invasive monitoring attenuation by gene expression profiling) 602 patients in the united states who had undergone cardiac transplantation at least 6 months prior were randomized 1:1 to either surveillance with routine biopsy or allomap testing. patients in both groups were also monitored with echocardiography. a primary outcome event was defined as an episode of rejection with hemodynamic compromise, graft dysfunction due to other causes, death or retransplantation. over a median follow-up period of 19 months, 297 patients who were monitored with allomap and 305 patients who underwent routine biopsies had similar 2-year cumulative rates of events (14.5% and 15.3%, respectively; hazard ratio with gene-expression profiling, 1.04; 95% confidence interval, 0.67 to 1.68). this outcomes allomap registry (oar) study is designed to collect similar clinical outcomes information as studied in image, in a larger cohort of patients (approximately 2000) followed for up to 5 years. at each routine clinic visit, key clinical features such as rejection surveillance management schedules, testing results (e.g. blood levels of immunosuppressive agents), and allomap scores will be collected. this larger and longer term follow-up dataset is intended to enable further elucidation, through analyses techniques such as multivariate cox proportional hazards models, of the surveillance management features which may be associated or contribute to the most favorable long term outcomes of the heart recipients.

Eligibility criteria:
inclusion criteria: * new and existing heart transplant recipients ≥ 2 months (≥ 55 days) post-transplant receiving post-transplant care at the enrolling centers for interim surveillance monitoring that includes allomap testing

Keywords: molecular diagnostics heart transplantation risk factors prognosis
clinical trial navigation to increase participation and diversity in cancer clinical trials

Conditions: Breast Carcinoma; Digestive System Carcinoma; Genitourinary System Carcinoma

Summary: this clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. despite this, only a small number of cancer patients participate in clinical trials. there are many different items that contribute to low clinical trial participation, including health-related social needs (hrsn) and financial burden. guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (guide), is a program that uses a trained clinical trial navigator, or "guide", to work with identified potential cancer clinical trial patients to help them recognize and remove hrsn and financial barriers preventing clinical trial participation. a clinical trial navigation intervention, like guide, may help increase participation and diversity in cancer clinical trials.

outline: patients are randomized to 1 of 2 arms. arm i: patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. patients receive ongoing access to the guide for up to 6 months. patients also receive standard of care (soc) supportive care services. arm ii: patients receive soc supportive care services.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * identified as potentially eligible for an open clinical trial by clinical trial pre-screening (operating in breast, gastrointestinal \[gi\], and genitourinary \[gu\] clinics) * have ≥ 1 health related social need, defined by * food insecurity, housing instability, transportation challenges, or financial instability documented in the supportive cancer care questionnaire in epic electronic medical record (epic), or * concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare, or unable to take time off work documented by clinical trial pre-screening (ctps), or * medicaid insurance documented in epic * able to speak english exclusion criteria: * unable to speak english * children, adolescents, and teens under the age of 18 years * patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (ct id): nct04960787 * patients refusing to sign health insurance portability and accountability act (hipaa) authorization
comparing the synergistic effect of caudal dexmedetomidine and propofol versus caudal dexmedetomidine only or propofol only in prevention of sevoflurane related emergence agitation in pediatric patients undergoing congenital inguinal hernia repair

Conditions: Sevoflurane Agitiion in Pediatric

Summary: evaluate the synergistic efficacy of propofol and caudal dexmedetomidine for postoperative ea in pediatrics aged from to 2 to 5 years maintained on sevoflurane inhalational anesthesia and scheduled for conginital inguinal hernia repair surgeries

eligibility and type of the study: this prospective randomized placebo-controlled double-blind study will be conducted after approval from the institutional ethics committee and obtaining written informed consent from parents of children scheduled for conginital inguinal hernia repair procedures under general anesthesia. this study will be conducted at pediatric surgery operating theatre, assiut university hospitals. sample size: drugs coding and randomization: patients will be randomly allocated into three equal groups with the help of a computer-generated table of random numbers to receive the study drugs. one anesthesiologist, not involved in the study procedure or data collection, will prepare the study drugs in identical coded syringes. access to these codes will be only available to one anesthesiologist who will prepare the syringes according to the study drugs used. to ensure double-blinding, the anesthetic technique and outcome data will be collected by an anesthesiologist not included in preparing study drugs or envelops coding. also the parents will be blinded to the drug grouping of their children.

Eligibility criteria:
inclusion criteria: * age 2-7 years * both genders * american society of anesthesiologists (asa) physical state i-ii * children undergoing sub-umbilical abdominal surgeries exclusion criteria: * guardians refusal * congenital anomalies at the lower spine or meninges * increased intracranial pressure * skin infection at the site of injection * bleeding diathesis * known allergy to any drugs used in this study * children with behavioral changes; physical or developmental delay; neurological disorder or psychological disorder. * children on sedative or anticonvulsant medication.

Keywords: sevoflurane dexmedetomidine propofol
oxaliplatin+gemcitabine vs capecitabine as adjuvant therapy for intrahepatic cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: to evaluate of adjuvant therapy using oxaliplatin and gemcitabine (gemox regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (icc) -- a randomized control study.

chemotherapy: gemox vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (rfs); second endpoint: overall survival after surgery (os).

Eligibility criteria:
inclusion criteria: * ecog ps≤1; * pathologically confirmed adenocarcinoma of bile duct; * r1 resection or r0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size \>5 cm, preoperative ca199\>200 u/ml. * postoperative liver function child pugh class a, leukocyte count\>1.5\*10\^9/l, platelet count\>100\*10\^9/l, serum alanine aminotransferase \<1.5\*uln * no tumor recurrence or metastasis on baseline examination * no history of radiotherapy or intervention therapy exclusion criteria: * hepatocellular carcinoma, mixed carcinoma of icc and hcc, or hilar cholangiocarcinoma * distant metastasis * prothrombin time \>14s * severe cardiopulmonary dysfunction * severe renal dysfunction * bone marrow suppression before the initiation of therapy * allergic to fluorouracil, gemcitabine, or platinum * gemcitabine was used in combination with radiotherapy

Keywords: gemox intrahepatic cholangiocarcinoma adjuvant therapy oxaliplatin gemcitabine capecitabine curative surgery
immunopathology of autoimmune hemolytic anemia

Conditions: Autoimmune Hemolytic Anemia

Summary: autoimmune hemolytic anemia (aiha) is an auto-immune disease mediated by specific antibodies targeting red blood cells. its pathogenesis is not completely understood, and the role of t cells have been rarely studied. the aim of this study is to compare the frequency of circulating t cells, t cell polarization and functions, notably regulatory t cells, during warm aiha by comparison to healthy controls. the role of treatments, such as steroids, will also be determined in patients with warm aiha.


Eligibility criteria:
inclusion criteria: * patients diagnosed with primary warm autoimmune hemolytic anemia (waiha) * secondary ahai (infections, hematological diseases, systemic diseases) * naive of treatment for hemolytic anemia or in relapse * older than 16 * able to understand written and spoken french * who have provided written informed consent * inclusion criteria for controls * persons without auto-immune disease, cancer or active infection. * older than 16 * able to understand written and spoken french * who have provided written informed consent exclusion criteria: * cold agglutinin disease * pregnancy * persons without national health insurance exclusion criteria for controls: * subjects treated with corticosteroids or immunosuppressants * pregnancy * persons without national health insurance
dose finding study of hp802-247 in venous leg ulcers

Conditions: Venous Leg Ulcer; Venous Stasis Ulcers

Summary: this is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. this research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of hp802-247, together with standard care, compared to placebo, plus standard care.


Eligibility criteria:
inclusion criteria: * provide informed consent. * willing to comply with protocol instructions, including allowing all study assessments. * have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus. * venous insufficiency confirmed by duplex doppler ultrasound examination for valvular or venous incompetence. * target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months. exclusion criteria: * women who are pregnant or lactating * therapy with another investigational agent within thirty (30) days of screening, or during the study. * a target ulcer of non-venous etiologies. * refusal of or inability to tolerate compression therapy. * therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the screening visit. * therapy of the target ulcer with topical growth factors within 1 week preceding the screening visit.

Keywords: venous leg ulcer (vlu) venous stasis ulcer (vsu) vlu vsu leg ulcer leg wound