Kornimate/medical-research-clean huggingface dataset:
covid-19 anticoagulation in children - thromboprophlaxis (covac-tp) trial

Conditions: Infection Viral; Thromboses, Venous; COVID-19

Summary: the purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of sars-cov-2 infection (i.e., covid-19).


Eligibility criteria:
inclusion criteria: 1. birth to \<18 years of age; and 2. positive nucleic acid test for sars-cov-2 within the past 7 days; and 3. hospitalized, \<72 hours post-admission; and 4. one or more signs and/or symptoms of covid-19 illness within the past 72 hours, as follows: 1. cough; or 2. fever (oral temperature \>100.4°f/38°c); or 3. chest pain; or 4. shortness of breath; or 5. myalgia; or 6. acute unexplained loss of smell or taste; or 7. new/increased supplemental oxygen requirement; or 8. acute respiratory failure requiring non-invasive or invasive ventilation; or 9. encephalitis. exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; or 2. clinical-relevant bleeding (see criteria under primary outcome, below) within the past 72 hours; or 3. platelet count \<50,000/µl within the past 24 hours; or 4. prothrombin time (pt) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; or 5. activated partial thromboplastin time (aptt) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; or 6. fibrinogen level \<75 mg/dl; or 7. severe renal impairment, as defined by estimated glomerular filtration rate (egfr) \<31 ml/min/ 1.73 m2, as calculated by the schwartz formula; or 8. parent or legally authorized representative unwilling to provide informed consent for patient participation.
hcv epidemiological survey in china rural area

Conditions: Hepatitis

Summary: the purpose of this study is to determine whether the morbidity of hepatitis c with chinese population.

hepatitis c virus (hcv) infection rate in china is about 3%, which means about 30 million patients. more importantly, many of those patients with chronic hepatitis c eventually develop cirrhosis and hepatocellular carcinoma(hcc).our survey found the rate of hepatitis c infection in northeastern china without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. this population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis c. we plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.

Eligibility criteria:
inclusion criteria: * aged from 20 to 65 exclusion criteria: * has history of decompensated liver diseases * has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs * has a history of autoimmune hepatitis * history of a severe seizure disorder or current anticonvulsant use * history or other evidence of a medical condition associated with chronic liver disease other than hcv which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) * patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dl (as may be seen with ribavirin therapy) would not be well-tolerated * history of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (tsh) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Keywords: predict hepatitis c virus metabolomics
open-label extension study for clcz696g2301 (paradise-mi)

Conditions: Post Myocardial Infarction

Summary: the purpose of this study is to collect long-term safety and tolerability data of lcz696 and to provide open-label lcz696 to eligible participants who completed clcz696g2301 study (paradise-mi) if lcz696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (cv) mortality and development of heart failure in participants enrolled in the paradise-mi study.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. participant received study treatment (either in lcz696 or ramipril treatment arm) in paradise-mi. 3. participant is safe to be enrolled in the extension study and may benefit from the treatment of lcz696 per investigator's clinical judgement. exclusion criteria: 1. participant with a known history of angioedema 2. history of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ace inhibitors, arb or nep inhibitors 3. symptomatic hypotension at screening 4. serum potassium \> 5.2 mmol /l (or equivalent plasma potassium value) at screening 5. known hepatic impairment (as evidenced by total bilirubin \> 3.0 mg/dl or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices 6. pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception 7. other protocol-defined inclusion/exclusion criteria may apply

Keywords: lcz696 open-label extension paradise-mi post myocardial infarction post heart attack clcz696g2301
biomarkers associated with postoperative cognitive dysfunction

Conditions: Delirium; Postoperative Cognitive Dysfunction; Cognitive Decline; Cognitive Impairment

Summary: loss of cognitive function after major surgery is a significant risk in older people. it can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. together these conditions are called post operative cognitive dysfunction (pocd). they can be acutely distressing for patients and are associated with other problems after surgery. the causes of post operative cognitive dysfunction are poorly understood. studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing pocd. research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with pocd. the project consists of a feasibility study to investigate markers that might predict people over 65 years old getting pocd. the first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (eeg): the investigators will identify which eeg patterns predict delirium within five days surgery. the second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. the investigators will establish if these can be used to predict having pocd up to one year after surgery and long term cognitive impairment up to 5 years after surgery.


Eligibility criteria:
inclusion criteria: * greater than or equal to 65 years of age * having elective non-cardiac surgery under general anaesthesia * anticipated to have at least 48 hours of inpatient admission * able \& willing to give informed consent exclusion criteria: * unable to participate in neurocognitive assessments * presence of delirium prior to surgery * contraindication to use of eeg electrodes (e.g. known allergy to a component of the electrodes) * known history of severe traumatic brain injury * learning disability specifically with a known structural brain lesion * known history of dementia * participants undergoing operations on the carotid artery

Keywords: electroencephalography delirium neurofilament light chain tau protein
phase 2 clinical proof-of-concept study of the cardioprotective properties of danegaptide in st segment elevation myocardial infarction

Conditions: Focus of Study is STEMI

Summary: this study explores the potential cardioprotective properties of danegaptide when administered to patients with st-segment elevation myocardial infarction.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * st-segment elevation myocardial infarction * acute onset of chest pain of \< 12 hours duration exclusion criteria: * pregnancy * known prior myocardial infarction in same area as present stemi, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure * contraindication for cardiac mri * inability to understand information or provide informed consent
multicentric comparative prospective study of the benefits and risks of biopsy prostate using transrectal or transperineal procedure for the prostate cancer diagnostic

Conditions: Patients With Suspected Prostate Cancer

Summary: the performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade. the first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. there is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. the first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. it would also reduce the risk of rectal bleeding. in addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate. there is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. the aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.


Eligibility criteria:
inclusion criteria: * patients with suspected prostate cancer with at least one of the following criteria met : 1. mri staging: t2 or t3a, 2. mri grading: pirads greater than or equal to 3 3. mri tumor volume greater than or equal to 0.5 cm3 e.patient without tumor lesion detected by prostate mri less than 3 months old with psa \> 4 ng/ml, or an observed suspicious induration to the rectal exam * voluntarily signed and dated written informed consents prior to any study specific procedure, exclusion criteria: * other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, * individuals deprived of liberty or placed under legal guardianship, * unwillingness or inability to comply with the study protocol for any reason. * patients without a health insurance

Keywords: transpérinéal transrectal biopsy prostate cancer
cdk4/6 inhibitor plus camrelizumab for pd-1 inhibitor refractory r/m npc

Conditions: Nasopharyngeal Carcinoma

Summary: because most patients with r/m npc have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of pd-1 inhibitor refractory patients. how to deal with the icis resistance is an urgent problem in clinical practice.


Eligibility criteria:
inclusion criteria: 1. had histopathologically confirmed nonkeratinizing recurrent/metastatic npc. 2. ecog performance status of 0 or 1. 3. progression after previous treatment with platinum-based dual-drug chemotherapy. 4. progression after previous treatment with pd-1 inhibitors. 5. experieced at least 1 line systemic therapy. 6. subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (recist) v1.1. 7. adequate organ function assessed by laboratory parameters during the screening period. 8. life expectancy more than 12 weeks. 9. able to understand and sign an informed consent form (icf). 10. able to swallow the pill. exclusion criteria: 1. recurrent lesions suitable for radical treatment (radiotherapy or surgery). 2. previous treatment over 3 lines. 3. prior use of cdk4/6 inhibitors. 4. patients with other malignancies. 5. patients with known or suspected autoimmune diseases including dementia and seizures. 6. multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction). 7. an excessive dose of glucocorticoids given within 4 weeks before enrollment. 8. complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids. 9. patients with active pulmonary tuberculosis (tb) receiving anti-tb treatment or who have received anti-tb treatment within 1 year prior to screening. 10. hiv positive; hbsag positive and hbv dna copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis c with blood screening positive (hcv antibody positive). 11. any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment. 12. women of childbearing age with a positive pregnancy test and lactating women.
comparison of sealing ability of mta and biodentine for repairing of furcal perforation in primary molars

Conditions: Tooth Injuries

Summary: * preservation of the primary teeth is a mandatory issue for maintaining the integrity of the normal dentition and functioning till the eruption of the successors. * furcal perforations may occur due to iatrogenic and non-iatrogenic causes. * despite the high successful outcomes in perforation repair with mta, there are some issues which prevent the clinicians from using it for many cases such as its very long setting time and its difficult manipulation. * biodentin could be used as an alternative to mta in reparative treatment procedures due to its ability to provide a hermetic seal and durable restoration and thus an optimal sealing is expected. * the importance of the trial lies in testing the sealing ability of biodentine using scanning electron microscope. biodentine has short setting time and is easier in manipulation than mta which are major needs when dealing with pediatric patients to be able to give best results in short time.

* by immediate diagnosis and sealing of furcal perforations in primary molar teeth with a biocompatible material, the prognosis is usually favorable. * mta has high clinical efficacy, but there were some drawbacks which made it difficult for the clinicians to use it in many cases. the major ones being very long setting time and difficult manipulation. * biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures. * 42 extracted primary molar teeth will be collected, sterilized and stored according to the occupational safety and health administration guidelines and regulations. * a standard access cavity will be prepared in each tooth using a diamond bur and non-end cutting bur in high-speed handpiece with water spray. a 0.5 mm round bur will be used to standardize the size of furcal perforation, and the furcal involvement will be made on the center of the pulpal floor. * after the furcal perforation, the blocks will randomly be divided into two groups * control group: mta group, using amalgam applicator the material will be carried and sealed in the furcation site. * intervention group: biodentin group,the material will be scooped and applied on the perforation site. * outcome : sealing ability measurement method : scanning electron microscope unit of measurement : µm

Eligibility criteria:
inclusion criteria: * freshly extracted discarded primary molars * primary molars with intact furcation ( no caries, no perforation, no resorption ) * physiologic root resorption not more than two-third of root length exclusion criteria: * exfoliated primary molars * primary molars with internal resorption * primary molars with extensive tooth decay of the crown * primary molars with discoloration * cracked tooth
oral forodesine hydrochloride (bcx-1777) in patients with recurrent or refractory t/nk-cell malignancies

Conditions: Recurrent or Refractory T/NK-cell Malignancies

Summary: primary objectives are to evaluate the safety profile and tolerability of oral bcx1777 in each cohort of patients with recurrent or refractory t/nk-cell malignancies and to evaluate pharmacokinetics (pk) of oral bcx1777.


Eligibility criteria:
inclusion criteria: * histologically documented with histopathological diagnosis from biopsy, t/nk-cell malignancies (who classification). precursor t-cell lymphoblastic leukemia/lymphoma (t-all/t-lbl) should be excluded in this study * a patient with recurrent, relapse or refractory t/nk-cell malignancies who has received at lease one chemotherapeutic regimen * age 20 or greater * eastern cooperative oncology group(ecog) performance status:0,1. * able to be hospitalized at least for 15 days from the first dose * in the case of subject with tumor cell rate of ≤25% in bone marrow, a patient who satisfies both of the following criteria. * neutrophil count: ≥1,200/mm3 * platelet count: ≥75,000/mm3 * in the case of ctcl, the tumor cell rate is handled as ≤25%. * adequate liver function: ast, alt ≤ 5.0 x upper limit of normal (uln) * adequate renal function: creatinine clearance (using cockcroft-gault formula) ≥ 50ml/min * life expectancy of at least 3 months * a patient who has given a written informed consent prior to the start of procedures proper to this study. exclusion criteria: -
frequency of sod1 and c9orf72 gene mutations in french als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of the study is to determine the frequency of mutations in the c9orf72 and sod1 genes in the incident population of als patients followed in the filslan centres

after obtaining free and informed consent for genetic characteristic tests, a blood sample will be taken during hospitalisation for diagnostic confirmation or during the quarterly multidisciplinary consultations planned for these patients in the classic follow-up set up within the als centres of the filslan network if the genetic status is not already known. this sample will be integrated into the standard management of als patients, which includes a neurological examination and paraclinical explorations, including a biological assessment. the patient will then be reviewed during the standard multidisciplinary follow-up consultations. information to the patient on his or her c9orf72 or sod1 genetic status will be included in the quarterly multidisciplinary consultations for the classic follow-up of als patients. it should also be noted that the data (alsfrs-r score, weight, fev) collected during the 6 and 12 month consultations will be processed for the purposes of this research. for patients included in the quarterly multidisciplinary consultations planned in the classic follow-up, if the genetic blood sample was taken during the initial hospitalisation for diagnosis, then it will not be repeated in the framework of the research. in this case, the genetic status of c9orf72 or sod1 will be available at the inclusion visit and the patient will receive specific information about his or her genetic status. consent for the research will nevertheless be obtained in order to have the patient's agreement to the processing of their health data for the purposes of the research at inclusion, 6 months and 12 months.

Eligibility criteria:
inclusion criteria: * adult aged ≥ 18 years old * als defined, probable or likely based on neurophysiological data according to airlie house criteria (brooks, 2000) * sporadic als or familial als defined by the existence of a case of als or ftd among first or second degree relatives of the patient included (byrne et al, 2011). * participant affiliated to a social security scheme * free, informed and signed consent for the examination of the genetic characteristics of the participant exclusion criteria: * all conditions mimicking als including motor neuropathies with multiple conduction blocks and all cases of als that do not meet the criteria of the airlie house classification. * patients who are cognitively incapable of signing the consent to participate in this study.

Keywords: blood sample genetic features
glyt-1 inhibitor treatment for refractory schizophrenia

Conditions: Schizophrenia; Treatment Refractory

Summary: the etiology of schizophrenia remains unclear in recent one decade, hypofunction of n-methyl-d-aspartate (nmda) receptor has been implicated in the pathophysiology of schizophrenia. hence, enhancing nmda neurotransmission was considered as a new approach for schizophrenia treatment. to date, refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue. however, the effect of nmda treatment in refractory schizophrenia is still unknown. therefore, the primary goal of this study is to investigate the efficacy and safety of nmda adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to nmda enhancers.

the etiology of schizophrenia remains unclear. in recent one decade, hypofunction of n-methyl-d-aspartate (nmda) receptor has been implicated in the pathophysiology of schizophrenia. hence, enhancing nmda neurotransmission was considered as a new approach for schizophrenia treatment. to date, there have been a few pilot studies exploring the efficacy of nmda enhancers as adjuvant therapy for schizophrenia, for instance, d-serine (an endogenous agonist of the nmda-glycine site). they were not only well-tolerated but also synergistic in improving positive, negative and cognitive symptoms in those receiving typical and atypical antipsychotics (except clozapine). refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. previous studies revealed that add-on treatment of d-serine or other agonists of nmda receptor failed to give significant benefits in such patients. the primary goal of this study is to investigate the efficacy and safety of glycine transporter(glyt)-1 inhibitor adjuvant therapy in refractory schizophrenia, and to identify the predictors for treatment response to nmda enhancers.

Eligibility criteria:
inclusion criteria: * fulfill the criteria of schizophrenia according to the diagnostic and statistic manual, fourth edition (dsm-iv). * poor response of clozapine treatment: a 12-week treatment of clozapine without satisfactory response: a severity score of clinical global impression scale(cgi)\>=4, a total score of positive and negative syndrome scale(panss)\>= 60, and a scale for the assessment of negative symptoms(sans)score of \>=40. the doses of clozapine remain stable for at least 12 weeks prior to their enrollment in this proposed study, * agree to participate in the study and provide informed consent. exclusion criteria: * current substance abuse or history of substance dependence in the past 6 months * use of depot antipsychotic in the past 6 months * serious medical or neurological illness * pregnancy * inability to follow protocol.

Keywords: n-methyl-d-aspartate receptor glycine transporter schizophrenia