Kornimate/medical-research-clean huggingface dataset:
he4 in the diagnostic approach of endometrial cancer in patients with postmenopausal bleeding

Conditions: Endometrial Neoplasms; Postmenopause; Uterine Hemorrhage; Cancer Biomarker; CA 125 Antigen

Summary: this study aims to explore the sensitivity of an innovative marker, he4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

endometrial cancer is the most common pelvic gynecological cancer in france, ranking 5th among cancers in women in terms of incidence. the most frequent symptom is post-menopausal bleeding and is one of the primary reasons for consultation in gynecological emergencies. the diagnosis of endometrial cancer is made by histological analysis of endometrial tissue taken during a surgical intervention. the latter is mostly reassuring. these interventions are often performed in mild situations and there is currently no element to be sufficiently reassuring to avoid surgery. at present, there is no biological marker used in current practice. in the population of patients with post-menopausal bleeding requiring surgical exploration for diagnosis, the pathology results are often reassuring. these procedures could have been avoided, especially as these patients often have numerous co-morbidities and these surgeries are therefore more risky. the appearance of a new tumour marker could be useful in the management of these patients and avoid many unnecessary and risky surgeries this study aims to explore the sensitivity of an innovative marker, he4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

Eligibility criteria:
inclusion criteria: * patient with postmenopausal bleeding * patient requiring hysteroscopy or hysterectomy * no objection from the patient to participate in the study exclusion criteria: * non-menopausal patient * patient under guardianship, curatorship or deprived of her freedom * patient with proven metastases on imaging * patient with a macroscopically suspicious cervix * patient presenting an ovarian cyst or an associated adnexal pathology * patient contraindicated for surgical treatment (therefore not eligible for pathological analysis) * patient who has already been treated with hormone therapy for breast cancer * patient who has already had surgery for this pathology, with a contributing anatomopathological result (we will therefore include patients who would not benefit from an operative hysteroscopy after performing a cornier® pipelle that does not allow a positive result)

Keywords: endometrial cancer human epididymis protein 4 he4 ca125 post-menopausal bleeding
study evaluating the effects of neratinib after adjuvant trastuzumab in women with early stage breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed her-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility criteria:
inclusion criteria: * stage ii through iiic her-2/erbb-2 positive breast cancer with node positive disease. * been treated for early breast cancer with standard of care duration of trastuzumab. * could have been treated neoadjuvantly but have not reached pathologic complete response. exclusion criteria: * positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry. * history of heart disease. * corrected qt (qtc) interval \>0.45 seconds * history of gastrointestinal disease with diarrhea as the major symptom.

Keywords: her-2/erbb-2 positive breast cancer breast cancer adjuvant therapy neratinib hki-272 nerlynx pb-272
transcranial direct current stimulation (tdcs) and hallucinations in schizophrenia

Conditions: Schizophrenia; Auditory Hallucinations

Summary: the purpose of this study is to determine whether trans direct current stimulation (tdcs) is effective in the treatment of auditory hallucinations in schizophrenia.

the project will investigate the use of a novel technique, transcranial direct current stimulation (tdcs) in the treatment of patients with schizophrenia. tdcs permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect. using anodal \& cathodal tdcs the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. the investigators plan to apply tdcs such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a french center (hospital le vinatier, sponsor of the study) and 30 in tunisia (laboratory "vulnerability to psychosis" (pr gaha) à monastir).

Eligibility criteria:
inclusion criteria: * schizophrenia according to diagnostic and statistical manual - dsm-iv * auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs) * medication resistance according to kane et al., 1988 * age between 18 and 50 years old * informed consent exclusion criteria: * concomitant major and unstable medical or neurologic illness * pregnant
postoperative pain therapy with hydromorphone using tci-pca

Conditions: Postoperative Pain

Summary: treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery


Eligibility criteria:
inclusion criteria: * written informed consent * age between 40 and 85 years, both genders * scheduled for elective cardiac surgery involving thoracotomy and subsequent icu stay exclusion criteria: * administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery * administration of hydromorphone in the period between screening and surgery * severe hepatic or renal impairment in medical history * bmi ≥35 kg/m² * asa ≥4

Keywords: therapy
the effect of different dose of ketamine with low dose rocuronium in children

Conditions: Inguinal Hernia

Summary: rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. for outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. for better intubating condition, ketamine can be used. however, appropriate dose of ketamine with low dose rocuronium is not established yet. this study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.


Eligibility criteria:
inclusion criteria: * asa class i, ii exclusion criteria: * upper respiratory infection within 14 days * anticipated difficult intubation
biomedicines and bacterial translocation in spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the aim of this project is to evaluate the effect of anti-tnf and anti-il17 biotherapies on bacterial translocation in patients with nsaid-resistant axial spondyloarthritis.

axial spondyloarthritis is a common inflammatory rheumatic disease and its management is based on the use of nsaids and biotherapies (anti-tnf and anti-il17 antibodies). its pathophysiology involves the digestive mucosa. the colon of patients with spondyloarthritis is the site of asymptomatic inflammation. this inflammation results from dysbiosis, which is responsible for activation of innate immunity linked to bacterial translocation phenomena. dendritic cells are then activated and the immune response is polarized towards the il23/th17 axis. this translocation is secondary to an increase in colonic permeability. the increase in digestive permeability allows translocation of bacteria or bacterial fragments, primarily lipopolysaccharide (lps). some proinflammatory cytokines (tnf, ifnγ, and il23) cause an increase in digestive permeability. il17 produced in the digestive mucosa has two different effects. indeed, two types of colonic t cells produce il17: regulatory t helpers 17 producing il10 and il17 and inflammatory t helpers 17 producing il17 and ifnγ. the investigators hypothesize that biotherapies decrease bacterial translocation. they suspect a lesser effect of anti-il17 compared to anti-tnf because of the potential inhibition of treg17 lymphocytes.

Eligibility criteria:
inclusion criteria: * axial spondyloarthritis (2009 asas criteria) * nsaid arm: responding to any class of nsaid and not likely to initiate biotherapy * anti-tnf/anti-il-17 arms: need to introduce a biomedical drug according to current recommendations (objective signs of inflammation, i.e. mri sacroiliitis or increased crp, and failure of two nsaids of different classes) exclusion criteria: * ibd already diagnosed by a gastroenterologist or suspicion of ibd (bloody diarrhea) * previous exposure to a biomedical drug (anti tnf or anti il 17). * antibiotic use in the 3 months prior to inclusion * contraindications for treatment with anti-tnf or anti-il17 (for all patients)

Keywords: bacterial translocation
initial hemopurification strategy for acute paraquat poisoning in adults

Conditions: Poisoning

Summary: hesapp is a single-center, non-blinded, parallel-group randomized controlled trial studying the hemopurification strategy for acute paraquat(pq) poisoned patients. the intervention to be investigated include hemodialysis (hd), hemoperfusion (hp), combined hemoperfusion-hemodialysis concurrent therapy (hp-hd) and conservative therapy. the object of the present trial is to investigate whether hemopurification therapy can reduce mortality compared with conservative therapy.

patients diagnosed with acute paraquat poisoning in the emergency room of the first affiliated hospital of zhengzhou university would be stratified according to their urine dithionite test results and randomly assigned to four different groups: hd, hp, hp-hd and control (conservative therapy) group for different treatment. arterial blood gas test, complete blood count, coagulation function, liver function, pancreatic function, urine dithionite test, renal function and chest radiographs would be closely monitored during treatment. primary endpoint is 28-day mortality. secondary endpoints include (1) survival time (from the time of pq ingestion to the time of death), all-cause mortality at the 3rd, 7th and 60th day; (2) rate of necessary oxygen uptake and rate of mechanical ventilation; (3) in-hospital length of stay and icu length of stay; (4) apache ii score and pss score; (5) rate of general complications, such as respiratory failure, acute kidney injury (aki), acute liver failure, pancreas function abnormality and multiple organ failure (mof); (6) rate of intervention related complications, such as catheter placement related complications, thrombocytopenia and deep venous thrombosis; (7) rate of adverse events, which include unexpected death, severe hemorrhage or edema, unplanned extubation, coagulation in the extracorporeal circulation, blockage of cartridge, incorrect pipe connection, etc.

Eligibility criteria:
inclusion criteria: * suspected paraquat ingestion history (intended or accidental), which is confirmed by positive urine dithionite result (light blue, navy blue and dark blue). * arriving at the er within 24 hours after pq digestion. * no known current pregnancy or lactation. * absence of cardiac arrest after poisoning, and no previous or present history of chronic kidney disease, chronic liver disease, respiratory failure, copd, asthma, heart failure, pancreatic disease, acute coronary syndrome (acs) or stoke. * no known combined ingestion with other poisons or alcohol. * no previous blood purification treatment prior to admission. * no known participation in other medical trials. * agreement on informed consent. exclusion criteria: * patients who are unable to comply with the procedures of the present trial, including those who change therapy or withdraw treatment. * patients who develop severe allergic response to hp materials. * patients who do not receive intervention within 4 hours after admission in reality.

Keywords: renal dialysis hemoperfusion paraquat
contribution of oncogenetics in breast cancer in reunion epidemiology of breast cancer in reunion: study of the reunion mutation on brca2

Conditions: Breast Cancer; Genetic Disease; BRCA2 Mutation

Summary: in mainland france, breast cancer is the most common cancer in women, with an estimated incidence of over 58,000 new cases. even if breast cancer is a cancer with a good prognosis, it is responsible for more than 12,000 deaths per year (first cause of death by cancer in women in france). breast cancer is a multifactorial disease, which results from the interaction between environmental, lifestyle, hormonal and genetic risk factors. in reunion, more than 400 cases of breast cancer are diagnosed annually. as in mainland france, it is by far the most common cancer in reunionese women, and its incidence continues to increase significantly since the age-standardized incidence rate increased by 28% between 2007 and 2017 to establish at 64.2/100,000 ap. two studies carried out in patients carrying mutations in the breast-ovary predisposition genes in reunion, showed that more than 50% of patients carrying brca mutation have a mutation specific to the reunion population on the brca2 gene. these two studies, which confirm the genetic specificities of reunion already described in other pathologies (mucoviscidosis or friedreich's ataxia), suggest that this mutation could have a significant frequency in patients with breast cancer. thus, evaluating the prevalence of this mutation in patients with breast cancer in réunion would make it possible to adapt the indications for access to the oncogenetics consultation and the associated preventive measures


Eligibility criteria:
inclusion criteria: * domiciled in reunion at the time of the diagnosis * who is diagnosed with a first breast cancer (in situ or invasive) confirmed by anatomopathological examination during the inclusion period or who is diagnosed with a second breast cancer (in situ or invasive) confirmed by pathological examination during the inclusion period, contralateral to the first or at least 5 years after remission of the first * having agreed to participate in the study; * affiliates or beneficiaries of a social security scheme exclusion criteria: * carriers of breast lymphoma, * minor patients or patients under guardianship or curatorship

Keywords: reunion
safety and efficacy of nateglinide in patients with type 2 diabetes already taking insulin glargine, metformin and/or pioglitazone or rosiglitazone

Conditions: Type 2 Diabetes

Summary: this study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.


Eligibility criteria:
inclusion criteria: * male/female, age 18-78 inclusive * type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening * hba1c 7.0-8.5% inclusive * fasting plasma glucose \<240 mg/dl at screening * body mass index 22-41 kg/m2 exclusion criteria: * pregnant or nursing * other investigational drugs within 30 days of screening * treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione * history of type 1 diabetes * abnormal kidney function * history of acute diabetic complications * congestive heart failure requiring treatment * myocardial infarction, coronary artery surgery, stroke within 6 months of screening * liver disease, liver enzymes more than 3 times upper limit of normal * fasting triglycerides \>700 mg/dl within past 12 weeks * acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data * treatment with corticosteroids * blood donation within past 12 weeks other protocol-defined inclusion/exclusion criterial may apply.

Keywords: type 2 diabetes, fasting glucose, postprandial glucose, blood sugar, hba1c, insulin, glargine, metformin, thiazolidinedione
tulsi consumption and its effects on cognition, stress and anxiety

Conditions: Cognitive Change

Summary: tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. a randomised placebo-controlled clinical trial.

ocimum sanctum or holy basil, commonly called tulsi is a traditional indian herb. it is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. stress and an inability to perform at a required level of cognition can induce anxiety. this study is looking at the effects of daily consuming tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 18 and 50 years, providing written informed consent. exclusion criteria: subjects who meet the following criteria * education level below 8th grade of schooling * unable to read or understand english or having no working knowledge of english * known history or neurological conditions that can affect cognition * known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study. * a chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption * any history or psychiatric disorders - currently on treatment or treated in within the last 12 months * any characteristic that makes the investigator uncomfortable to include the subject in the study.
lung allograft rejection gene expression observational (largo) study

Conditions: Graft Rejection; Lung Disease

Summary: the objective of the largo study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with the study endpoints. the primary objective is to use gene expression profiling of peripheral blood mononuclear cells to differentiate between the absence and presence of acute cellular rejection. the secondary objectives are to use other genomic and proteomic technologies to analyze rna and protein in blood samples in relation to related clinical conditions. the overall goal is to apply novel molecular insights in the development of non-invasive molecular diagnostic tests for lung transplantation.

largo is a prospective, multi-center, international observational study with participating centers in the united states, canada and europe. the target enrollment for study completion is 2,100 subjects. at each study visit, blood specimens are collected from subjects, processed and stored in the sample archive, with corresponding patient information entered into the clinical database. the analysis plan for each study objective includes a defined sample selection protocol that stipulates the inclusion and exclusion criteria for both patients and samples, and also the required number of blood specimens for the molecular analyses to achieve statistical significance. the diagnosis and treatment of acute cellular rejection remains a clinical management priority that is currently based on transbronchial biopsy. gene expression profiling is a technology based on molecular biology that measures changes in the rna levels of different genes expressed by circulating mononuclear cells in the peripheral blood. a key goal of the project is to use gene expression profiling to differentiate between the absence and presence of lung allograft acute cellular rejection, with the aim of using this novel information to develop a non-invasive diagnostic testing alternative.

Eligibility criteria:
inclusion criteria: * lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period exclusion criteria: * none

Keywords: allograft rejection biopsy gene expression pulmonary lung transplant
china obstetrics and gynecology journal club

Conditions: Language Disorders

Summary: the purpose of this study is to determine if an intensive journal club based on articles and materials provided on the journal obstetrics and gynecology website improves written and spoken comprehension of medical english in a population of chinese medical professionals.

this will be a randomized educational trial of an intensive journal club compared to a self study journal club (1:1 randomization). randomization will take place after baseline. the population will consist of 50 medical professionals at heilongjiang university in harbin china, who agree to participate in an 8 week educational intervention. this study will assess the impact of applying english for specific purposes(esp) pedagogy to foreign medical education and specifically evaluate learning in the field of obstetrics and gynecology(ob-gyn). esp is a subdivision of a wider field, language for specific purposes(lsp), defined as the area of inquiry and practice in the development of language programs for people who need a language to meet a predictable range of communicative needs. esp emphasizes teaching language in context and designs a curriculum around the results of a needs assessment, to more accurately determine which language skills are of priority: listening, reading, speaking, and writing. part of the theory behind esp suggests that being able to use the vocabulary and structures that students learn in a meaningful context reinforces what is taught and increases motivation. further, findings from a study by okamura (2006) that examined how learners succeed in mastering scientific discourse in english showed that they focused on reading academic texts in their field to learn typical writing patterns. this is as opposed to junior learners who focused on mastering the english language by reading english texts written by authors from a breadth of fields. this application of esp thus reflects how content-specific source articles could serve as rhetorical models and suggests that source articles are able to mediate scholarly writing and learning within the zone of proximal developmental; that is, learners are simultaneously gaining new content knowledge while increasing their skill base. the proposed intervention is to design an esp curriculum for medical professionals, specifically ob-gyn physicians and researchers at a chinese medical university, based on the journal club format and source articles. the study will quantitatively assess the impact of this model on student's esp language comprehension as well as determine the necessity of the traditional "facilitator" role for a journal club whose purpose is to foster language literacy in non-english speaking universities.

Eligibility criteria:
inclusion criteria: * chinese medical professional exclusion criteria: * english speaking fluency * non-chinese speaking medical professional

Keywords: comprehension verbal learning writing testing