Kornimate/medical-research-clean huggingface dataset:
immunity against sars-cov2 in children and their parents / covid-19

Conditions: COVID-19 Infection

Summary: the purpose of this study is to provide data on the proportion of seroconverted children and their immune status. it will also provide insight into the number of children currently infected at each time point including healthy carriers. investigators will provide similar data on their parents in an ancillary study.

the fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of sars-cov2. to adapt the epidemy control, it is essential to study the immunoprotection of the general population. a crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. the serological study is essential in this context. the serologic test abbott will be used to study immunoprevalence. institut pasteur has validated test using neutralizing ab. cea will used a antibodies and antigen test.

Eligibility criteria:
inclusion criteria: for hospitalized children or consulting at hospital * any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at ap-hp or ch cayenne; or any child over 7 days old and under 17 years old with a positive pcr at home, with an attending physician in a participating centre * parent's agreement for blood, saliva and stool samples * optional parent's agreement for nasopharynx swab * optional parent's agreement for follow-up if pcr+ * with an health insurance for children with potential covid disease during the first wave * any child over 7 days old and under 17 years, seropositive during the first wave * or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to sars-cov2 * with an health insurance parent of the enrolled child * one parent of the enrolled child on ped-covid * agreement for blood and saliva samples * optional agreement for nasopharynx swab * optional parent's agreement for follow-up if pcr+ * with an health insurance for children sars-cov2 positive * any child less then 18 years old * infected by sars-cov2 * parent's agreement for blood, saliva samples * optional parent's agreement for nasopharynx swab * with health insurance for people living under the same roof of a child included in the study * any child or adult living under the same roof of a child sars-cov2 positive and included in the study * with health insurance exclusion criteria: for hospitalized children or consulting at hospital * child younger than 7 days * refusal of parent * refusal of child * no health insurance

Keywords: child covid-19 infection immune response healthy carrier
deep core muscles and biopsychosocial in asymptomatic adults and nsclbp

Conditions: Non-Spesific Chronic Low Back Pain; Aged

Summary: the goal of this observational study is to (1) investigate age effects on core muscles, sensorimotor system, psychosocial factors in asymptomatic adults across years of age; (2) explore the differences in biopsychosocial factors between asymptomatic adults and people with non-specific chronic low back pain (nsclbp); (3) study the correlations between biopsychosocial factors in people with nsclbp. the main questions it aims to answer : 1. are the core muscles, lumbar propriocpetion, and psychological measures altered as age increases? 2. do the core muscles, lumbar propriocpetion, functional performance, psychological measures, disability, and quality of life affected by nsclbp? 3. following (2), if so, are there correlations between the measured biopsychosocial factors, disability, and quality of life in people with nsclbp? researchers will compare between people with nsclbp and age-matched asymptomatic participants across years of age to see if the effect of age and effect of nsclbp existed in biopsychosocial factors. participants will 1. be observed by ultrasound image at the low back and abdominal areas to collect parameters related to trunk deep core muscles, such as changes in muscle thickness from resting state to contraction; 2. ungergo mri examination to acquire image of deep core muscles; 3. perform lumbar repositioning test which quantifies the lumbar proprioception; 4. perform timed up-and-go test and five-times sit-to-stand test, which are used as a measurement of physically functional performance; 5. fill out the psychosocial questionnaires including: patient-reported outcomes measurement information system short form depression 4a and anxiety 4a, pittsburgh sleep quality index, pain catastrophizing scale, fear-avoidance belief questionnaire, oswestry disability index, and heath survey short form-36.


Eligibility criteria:
inclusion criteria: * aged above 20 years old * non-specific chronic low back defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain. exclusion criteria: * history of surgery at the low back or lower extremity * neurological symptoms, such as numbness or tingling * not able to walk or stand independently * cancer * systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus * in pregnancy
a progressive resistance training program in patients with haemophilia

Conditions: Haemophilia

Summary: this study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia

the training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.

Eligibility criteria:
inclusion criteria: * diagnosis of haemophilia a or b * willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations * approval by their hematologist to participate in the exercise program * age between 18 and 60 years * informed consent signed. exclusion criteria: * the inability to attend exercise sessions at least twice a week for 6 consecutive weeks * non adherence to instruction on proper exercise technique * surgical procedures performed 6 weeks prior to or during the exercise program * participation in any other form of exercise, including rehabilitation, during the study; (5) changes in medication during the study * a major bleeding episode that posed a risk or prevented exercise * history of fviii inhibitor (titer ≥ 0.6 bu \[bethesda unit\]) or detectable fviii inhibitors at screening (titer ≥ 0.4 bu) * another haemostatic defect * need for major surgery * withdrawal of informed consent
quality of life after esophagectomy for cancer - step 2

Conditions: Esophageal Cancer; Quality of Life

Summary: background: a recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. the analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. the objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care. the study is divided into two steps. this is step 2. at hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. all the patients fill in the questionnaires qlq c30, oes18, inpat32 at 1 and 3 months after the surgical operation. primary end-points are the items dy (dyspnoea), ap (appetite loss) and ql2 of qlq c30. secondary end point is the item ea (eating) of oes18.


Eligibility criteria:
inclusion criteria: * age above 18 years old * scheduled for esophagectomy for cancer exclusion criteria: * age below 18 years old * incapability to autonomously fill in questionnaires * primary language not italian

Keywords: esophageal cancer quality of life
intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy

Conditions: Iron Deficiency Anemia of Pregnancy

Summary: this randomized controlled trial includes pregnant women with anemia. they are randomized to iv iron infusions or to oral iron supplementation. pregnancy outcomes are assessed.

this is a randomized controlled trial aimed at assessing whether iv iron administration (ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy. 140 patients will be randomized in a 1:1 ratio. patients in the iv iron group will receive two infusions of ferumoxytol, one week apart. patients in the oral ferrous sulfate group will receive medication to take at home during their pregnancy. patients will have iron studies performed at study entry, and again at presentation for delivery. cord blood will also be sampled for iron studies.

Eligibility criteria:
inclusion criteria: * maternal age \>/= 18 * singleton gestation * \>/=20 weeks gestation, \<37 weeks gestation * hemoglobin \<11g/dl and/or hematocrit \<33% * able to read/speak english or spanish exclusion criteria: * maternal age \<18 * multiple gestation * \<20 weeks gestation, \</= 37 weeks gestation * hemoglobin \>/=11g/dl and/or hematocrit \>/=33% * unable to read or speak english or spanish * incarcerated patients
safety study of shenfu (a chinese medicine injection) used in hospitals in china

Conditions: Shock; Coronary Heart Disease

Summary: this study was advocated by institute of basic research in clinical medicine, china academy of chinese medical sciences in october 2011. it was funded by china major scientific and technological specialized project for 'significant new formulation of new drugs'. shenfu is kind of chinese medicine injection used for treating shock and coronary heart disease in many chinese hospitals. the purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

safety surveillance on chinese medicine injection is an important problem that needs to be sorted out ,because in mainland china hospitals ,chinese medicine injection are used widely. population for taking medicine characteristics,the incidence rate of adr and other uncertain factors influence can not be found now. a registry study for shenfu injection safety surveillance with 20000 patients will be conducted from jan.2012 to dec.2015. eligibility criteria patients who will use shenfu injection in selected hospitals.

Eligibility criteria:
inclusion criteria: * patients using shenfu injection from 2012 to 2014
clinical performance evaluation of two frequent replacement silicone hydrogel multifocal contact lenses

Conditions: Presbyopia

Summary: the primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (lid210464) compared to the control contact lenses (aohg mf) after 30 days of wear.

subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).

Eligibility criteria:
key inclusion criteria: * able to understand and sign an informed consent form that has been approved by an institutional review board. * willing and able to attend all study visits as required by the protocol. * willing to stop wearing habitual contact lenses for the duration of the study. * currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. aohg mf wearers may be included. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator. * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator. * history of refractive surgery or planning to have refractive surgery during the study. * current or history of pathologically dry eye. * currently pregnant or lactating. * other protocol-specified exclusion criteria may apply.

Keywords: contact lenses multifocal
dacomitinib (pf-00299804) in advanced/metastatic squamous cell carcinoma of the penis

Conditions: Penile Neoplasms; Carcinoma, Squamous Cell

Summary: penile squamous cell carcinoma (scc) is a very rare disease and prognosis depends primarily on regional lymph-node involvement. despite the fact that cure can be obtained in patients with low metastatic load (pn1) by monotherapy, combination therapy is required for more advanced cases. medical treatment options only for advanced or metastatic penile scc are not very effective so far and the few chances for cure are solely dependent on multimodality treatment, either with surgery or radiation. based on the observation that the epidermal growth factor receptor (egfr) is almost invariably expressed in penile scc and assuming similarities to the scc of head and neck district, anti-egfr targeted monotherapy has been investigated with promising early results at istituto tumori milan and university of texas md andreson cancer center. these premises lend support to the use of the pan-her inhibitor dacomitinib for advanced or metastatic penile scc.


Eligibility criteria:
inclusion criteria: * patients must provide written informed consent * eastern cooperative oncology group performance status of at least 1 * cytologically or histologically proven diagnosis of scc of the penis * uni- or bidimensionally measurable disease as defined by recist v1.1 criteria * clinical stage n2-3 and/or m1 (tnm 2002) * locoregional relapse after prior major surgery/ies (either single or multiple) * no prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (vbm) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment * adequate bone marrow, liver and renal function exclusion criteria: * central nervous system (cns) metastases or leptomeningeal carcinomatosis * history of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities * previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated \> 5 years prior to study entry.

Keywords: molecular targeted therapy neoadjuvant therapy dacomitinib
feasibility and the effects of mindfulness-based stress reduction (mbsr) on college students

Conditions: Posttraumatic Stress Symptom

Summary: the goal of this retrospective control study is to learn about the effects of mindfulness based stress reduction (mbsr) intervention in military medical students' resilience, post-traumatic stress disorder symptoms (ptsd) and posttruamatic growth (ptg) etc. the main questions are aims to answer: 1. would mbsr intervention improve psychological resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth in military medical students？ 2. would mbsr intervention reduce anxiety, depression, and ptsd symptoms in military medical students？ 3. would the effects of mbsr intervention persist for at least one month in military medical students？ participants in the intervention group will complete 8-week of mbsr training while those in the control group will not. researchers will compare resilience, mindful attention awareness, satisfaction with life, and post-traumatic growth, etc. between the two groups.

recruitment for the study was done via broadcast email and posted notices online. 372 students filled out screening questionnaires and indicated their intention to participate the mindfulness based stress reduction (mbsr) course. we selected 120 students according to the participant criteria. of the 120 participants, 60 were randomly assigned to the mbsr or control groups. however, 8 participants were absent more than two courses in the mbsr group, and 24 participants did not complete the post-test. eventually, we enrolled 52 participants in the intervention group and 36 participants in the control group. we designed a questionnaire survey on the internet to collect data. two trained psychology teachers organized the survey at three time points: baseline (t0), the immediate postintervention (t1), and 1 month postintervention (t2). independent samples t-test and c2 analyses were used to test for possible group differences in demographic variables at baseline (t1). next, 2 (group) × 3 (time) mixed-model repeated-measure analysis of variance ( anova) was conducted to determine the effect of mbsr. effect sizes were reported as partial η² (ηp²) coefficients. to further interpret any time-by-group interactions, a series of t tests examined possible differences among baseline, post intervention and 1 month later after intervention.

Eligibility criteria:
inclusion criteria: * no regular meditation and yoga practice within the past 6 months; * no current psychiatric symptoms and physical contraindications to exercise; * the resilience scale scores were in the last 27% of the total 372 students. exclusion criteria: * unwillingness to participant the mindfulness class; * absence from 2 or more classes; * do not complete the pre-, post-test and follow-up psychological assessment.

Keywords: military medical students, mindfulness, resilience
implementation and outcome of minimally invasive pancreatoduodenectomy in europe:

Conditions: Pancreas Disease

Summary: a planned analysis of outcomes among consecutive patients after mipd from centers participating in the e-mips registry (2019-2021). main outcomes of interest were major morbidity (clavien-dindo grade ≥3) and 30-day/in-hospital mortality.

the european registry for minimally invasive pancreatic surgery (e-mips) is an e-ahpba endorsed registry with the aim to monitor and safeguard the introduction of mipd in europe. international multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (mipd) are lacking. a planned analysis of outcomes among consecutive patients after mipd from centers participating in the e-mips registry (2019-2021). main outcomes of interest were major morbidity (clavien-dindo grade ≥3) and 30-day/in-hospital mortality.

Eligibility criteria:
inclusion criteria: - data from all patients who underwent r-mipd and l-mipd between january 1st 2019 and december 31st 2021 were included exclusion criteria: * other pancreatic procedures * hybrid approaches (reconstruction phase open) * procedures with insufficient baseline data / missing primary outcome data.

Keywords: registry minimally invasive surgery robot-assisted laparoscopy pancreatoduodenectomy pancreatic surgery
surgery in the time of covid-19 pandemic

Conditions: Covid19

Summary: the ongoing coronavirus disease 2019 (covid-19) which started in china, was declared on the 11th of march as a global pandemic 2020 by the world health organization (who). governments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. the response was observed in the emergency departments and the number of patients who presented for non-covid issues drastically reduced. hospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions. part of that reorganization was reducing the surgical activity. the main focus was shifted to patients who are considered urgent and elective surgery were postponed. hence only surgical emergencies were maintained. many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic. whereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. this would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile. the investigators present initial data from four major hospitals in belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.


Eligibility criteria:
inclusion criteria: patients who had a surgical procedure since the start of the lock down in belgium due to the covid19 pandemic (16 of march 2020 to the 12 of april 2020). exclusion criteria: none
fish oil supplementation in late-life depression

Conditions: Late-Life Depression

Summary: to investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.

patients with late-life depression were reported cognitive impairment, especially in information-processing speed, working memory, attention and episodic memory, even after depressive symptoms subside and some of them further progress to dementia in two to four years. several epidemiological studies, fatty acid comparison studies, animal studies, and clinical trials found that omega-3 polyunsaturated fatty acids (pufas) were significantly associated with the major depression, cognitive decline in general population and alzheimer's disease. until now, there is no study investigating the effects of n-3 pufas on depressive symptoms and cognition in patients with late-life depression. thus, the aims of this study were to investigate whether fish oil supplementation, compared to placebo (olive oil), could have better effects on depression course and cognitive function in older people with major depression.

Eligibility criteria:
inclusion criteria: * an age range of 60 years old or over; * a previous diagnosis of major depressive disorder according to the chinese version of structured clinical interview for dsm iv-tr axis-i disorder; * depressive symptoms were stable for at least three consecutive weeks and the 17-item hamilton depression rating scale score less or equal to 10. * capacity to provide informed consent. exclusion criteria: * people with severe or acute medical illness ( such as metastatic cancer, brain tumor, decompensated cardiac, hepatic, or renal failure, or myocardial infarction or stroke) within the 3 months preceding the study. * those who had neurological disorders involving central nervous system, such as delirium, parkinson's disease, aphasia or multiple sclerosis) * prominent cognitive impairment, defined as the chinese version of mini-mental state examination score less than 17. * people with alcoholism, defined by a score of 8 or higher in male and of 6 or higher in female on the chinese version of the alcohol use disorders identification test (audit) questionnaire.

Keywords: late-life depression recurrence of depression cognition n-3 polyunsaturated fatty acids