Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and efficacy of neoadjuvant and adjuvant tiragolumab plus atezolizumab, with or without platinum-based chemotherapy, in participants with previously untreated locally advanced resectable stage ii, iiia, or select iiib non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: this study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (nsclc). the study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed stage ii, iiia, or select iiib (t3n2 only) nsclc of squamous or non-squamous histology * eligible for r0 resection with curative intent at the time of screening * adequate pulmonary function to be eligible for surgical resection with curative intent * eligible to receive a platinum-based chemotherapy regimen * measurable disease, as assessed by the investigator per response evaluation criteria in solid tumors (recist) v1.1 * availability of a representative tumor specimen that is suitable for determination of pd-l1 status * eastern cooperative oncology group (ecog) performance status of 0 or 1 * normal life expectancy, excluding lung cancer mortality risk * adequate hematologic and end-organ function * negative human immunodeficiency virus (hiv) test at screening * negative serology for active hepatitis b virus (hbv) and active hepatitis c virus (hcv) at screening key exclusion criteria: * nsclc with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or nsclc not otherwise specified * small cell lung cancer (sclc) histology or nsclc with any component of sclc * any prior therapy for lung cancer * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * active tuberculosis * significant cardiovascular disease * nsclc with an activating egfr mutation or alk fusion oncogene * known c-ros oncogene 1 (ros1) rearrangement * history of malignancy other than nsclc within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death * severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety * prior treatment with cd127 agonists or immune checkpoint blockade therapies, including anti-ctla-4, anti-pd-1, anti-tigit, and anti-pd-l1 therapeutic antibodies * treatment with systemic immunostimulatory agents * treatment with systemic immunosuppressive medication * pregnancy or breastfeeding
back to school covid-19 simulation study

Conditions: Covid19; Schools

Summary: this will be a prospective study simulating return to school for two full days prior to the start of the school year in september. volunteer students and teachers from six grade ranges will be recruited to participate in the study. in each grade range, there will be two classes that will participate, one that will be assigned to wear face masks/coverings at all times (experimental group/class) and the other that will not wear face masks/coverings at all times (control group/class). students will be randomized to either the masking at all times (experimental across all grades) or no masking (control across jk-grade 4) / masking only when physical distance can be maintained (control across grade 5-grade 12) class in their appropriate grade. personal behaviours and person-to-person interactions will be recorded using video cameras. in addition, a safe biological indicator will be applied to the hands to simulate potential asymptomatic infection in a subset of students. other students will have sanitizer applied so that students are blinded to who has the indicator. cameras will be used to document how the indicator moves throughout the classroom.

grade ranges will include 1) senior kindergarten (children who have just completed jk or sk in the 2019-2020 year), 2) grades 1-2, 3) grades 3-4, 4) grades 5-6, 5) grades 7-8 and 6) high school. a total of 14 teachers and up to 240 students will be recruited. final class sizes will be in accordance with ministry of education and public health guidelines.

Eligibility criteria:
inclusion criteria: • to be included in the study, students must have attended a structure learning environment during 2019-2020 school year and provide informed consent (student in grade 7 or older) or parental consent (sk - grade 6) and assent (if appropriate). to be included in the study, teachers must be certified teachers and provide informed consent to participate. exclusion criteria: * require additional resources or support beyond what can be provided by the single class teacher * have been exposed to an individual that has tested positive for covid-19 in the 14 days prior to the simulation * test positive for covid-19 in the 14 days prior to the simulation * have signs or symptoms of covid-19, as identified on the screening form (see screening form) before the simulations * travel outside canada in the last 14 days * known hypersensitivity or allergy to the biological indicator (fluorescein dye/glogerm)
red wine and ageing and atherosclerosis

Conditions: Coronary Disease

Summary: the investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length. the sample size has been calculated expecting that regular red wine ingestion would lead to a five year old younger vascular ageing indexes measured by carotid intimal media thickness, coronary artery calcium scores and leucocyte telomere length longer than those abstainers subjects at same age. the investigators hypothesized that regular wine consumers present less coronary lesion and coronary calcium score on coronary tomographic angiography, lower carotid intimal media thickness and higher mean telomere length due the benefice of wine.


Eligibility criteria:
inclusion criteria: * healthy male, from 50 years-old to 70 years-old. exclusion criteria: * asiatic or with manifest atherosclerosis disease

Keywords: wine aging atherosclerosis telomere tomography coronary vessels
single-center study on laparoscopic distal subtotal gastrectomy for advanced gastric cancer

Conditions: Stomach Neoplasms

Summary: laparoscopic distal subtotal gastrectomy with lymph node dissection for treatment of gastric cancer is popular in east asian countries. however, the long-term follow-up outcome based on randomized clinical trial (rct) is still rare. some studies indicated that laparoscopic distal subtotal gastrectomy with d2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. however, the application of it is still limited because of lack of solid evidence on the oncologic efficacy. nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 80 percent of all gastric cancer cases in china. before the clinical application of laparoscopic procedure for the treatment with curative intent to advanced gastric cancer located at the middle- or lower-third of the stomach, the oncologic efficacy must be verified.accordingly, the comparison of long-term outcome between laparoscopic and open distal subtotal gastrectomy with d2 lymphadenectomy for locally advanced gastric cancer based on a well designed rct is needed.


Eligibility criteria:
inclusion criteria: * age from over 18 to under 75 years primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy ct2-4a, n0-3, m0 at preoperative evaluation according to the ajcc cancer staging manual seventh edition expected curative resection through distal subtotal gastrectomy with d2 lymphadenectomy performance status of 0 or 1 on ecog (eastern cooperative oncology group) scale asa (american society of anesthesiology) score class i, ii, or iii written informed consent exclusion criteria: * women during pregnancy or breast-feeding severe mental disorder history of previous upper abdominal surgery (except laparoscopic cholecystectomy) history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging history of other malignant disease within past five years history of previous neoadjuvant chemotherapy or radiotherapy history of unstable angina or myocardial infarction within past six months history of cerebrovascular accident within past six months history of continuous systematic administration of corticosteroids within one month requirement of simultaneous surgery for other disease emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer fev1\<50% of predicted values
early exposure of medical students to night shifts: impact on well-being and anxiety

Conditions: Medical Students Well-being and Anxiety

Summary: this is an interventional study assessing the impact of 'shadowing night shifts' early during medical school, on the wellbeing and level of anxiety of a students during their first official night shifts.


Eligibility criteria:
inclusion criteria: * students of the class of 2021 at the faculty of medicine of saint joseph university in their fifth year (med 2). exclusion criteria: * student who has already been on call during internships in lebanon or abroad, as well as students in other medical years.
menstrual cycle maintenance and quality of life: a prospective study

Conditions: Amenorrhea; Menstrual Cycle; Breast Cancer

Summary: very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. no prospective study exists. the purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.


Eligibility criteria:
inclusion criteria: * non-institutional (community dwelling) woman of any race * between 18-45 years at the first screening visit * have regular menstrual cycles * diagnosed with invasive breast cancer stage i, ii, iii within the previous eight months * have physician agreement for patient participation exclusion criteria: * no menstrual bleeding cycles * psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance * previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer) * stage iv breast malignancy * residency outside united states * no telephone

Keywords: amenorrhea menstrual cycle breast cancer questionnaire 97-127
fludarabine, cyclophosphamide, and thalidomide in treating patients with angioimmunoblastic t-cell lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells. purpose: this phase ii trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic t-cell lymphoma.

objectives: primary * determine the response rate in patients with angioimmunoblastic t-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide. secondary * assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide. * determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide. * assess the progression-free and overall survival of these patients. * develop a detailed pathological description of the disease at presentation and at relapse. * assess the number of circulating clonal t cells at presentation and during thalidomide treatment. * screen for possible etiological viruses at presentation. * evaluate the evolution of ebv viral load during follow-up. outline: this is a multicenter study. patients receive oral or iv fludarabine and oral or iv cyclophosphamide once daily on days 1-3. courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months. lymph nodes, marrow, and peripheral blood will be collected periodically for research studies. after completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility criteria:
disease characteristics: * newly diagnosed angioimmunoblastic t-cell lymphoma * measurable disease (i.e., anatomically assessable) patient characteristics: * who/ecog performance status 0-2 * serum creatinine ≤ 2.5 times upper limit of normal (uln) * bilirubin ≤ 2.5 times uln * alkaline phosphatase ≤ 2.5 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception before, during, and after study treatment * no known seropositivity for hepatitis b virus, hepatitis c virus, or hiv * no active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy prior concurrent therapy: * no prior chemotherapy for angioimmunoblastic t-cell lymphoma

Keywords: angioimmunoblastic t-cell lymphoma
efficacy and olfactory network of electro-acupuncture for subjective cognitive decline: a multicenter randomized controlled trial and fmri study

Conditions: Subjective Cognitive Decline (SCD)

Summary: subjective cognitive decline (scd) is the early diagnosis and treatment window period of alzheimer's disease (ad), and the identification of scd individuals who will progress to ad (pscd) is a research hotspot. based on olfactory fmri,previous studies have found that scd individuals showed damaged entorhinal neural circuits. after follow-up, the incidence of pscd increased by three times. but,the spatiotemporal characteristics of the entorhinal neural circuits and whether it has the value of individualized prediction and intervention target need to be further studied. thus, based on multi-center ambispective cohort study at home and abroad, we will (1) build a new paradigm of synchronous fmri-eeg olfactory task state oddball experiment, jointly representational similarity analysis, extract spatiotemporal characteristics of neural circuits damage, and discover and verify that the entorhinal neural circuits are vulnerable brain regions; (2) establish the middle fusion model of vulnerable brain region combined with the methods of olfactory task-fmri activation image generation, functional connectome gradient,etc.; then, establish late fusion multi-omics multi-task model combined with the new methods of molecularomics such as ultra-deep total proteomics and metabonomics proposed by the research group to accurately identify pscd; (3) carry out the precise intervention of image-guided "olfactory three-needle" acupuncture with the entorhinal neural circuits as the target. through clinical rct research and mouse model, the remodeling mechanism of vulnerable brain regions will be clarified.this project will provide the basis for early diagnosis and treatment of the ad risk population.


Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for scd diseases; 2. 55-79 years old; 3. ≥8 years of schooling; 4. right-handed; 5. sign the informed consent. exclusion criteria: 1. have received other antidepressant therapy or involved in other clinical trials in the previous 2weeks. 2. infarct located in the left dlpfc. 3. positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc., in the past. 4. other serious concomitant diseases (aphasia, severe edema, venous thrombosis, arteriosclerosis occlusion, diabetic vascular disease, peripheral neuropathy, spinal lesions, brain trauma, intracranial infection, brain tumors, etc.) or secondary diseases (heart, liver, renal failure, etc.). 5. infection around acupoints and/or intolerance to acupuncture manipulation. 6. mri or rtms contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).
cyslt1-r expression following allergen exposure in asthma and allergic rhinitis

Conditions: Asthma; Allergic Rhinitis

Summary: cysteinyl leukotrienes (cyslts) play an important role in asthma. cyslts exert most of their bronchoconstrictive and pro-inflammatory effects through activation of the cyslt1-r. as allergic rhinitis appears to be a predisposing factor in the development of asthma and as cyslt-receptors seem to be implicated in the first steps of asthma manifestations, we think it would be of interest to determine if the cyslt1-r is a key mediator in the progression from allergic rhinitis to asthma. we believe it would be interesting to study the expression of the cyslt1-r our goal is to assess baseline, as well as variations following allergen bronchoprovocations, in the expression of the cyslt1-r in mild asthmatic subjects compared with non asthmatic subjects with allergic rhinitis. our hypothesis is that there will be a higher baseline expression of the cyslt1-r in asthmatic subjects compared with allergic rhinitis subjects and that allergen bronchoprovocations will induce an increase in the expression of the cyslt1-r in both groups.

we will recruit mild allergic asthmatic subjects and non asthmatic subjects with allergic rhinitis. on a baseline visit, allergy skin prick tests, spirometry, methacholine bronchoprovocation and induced sputum (is) with differential leukocyte count will be obtained. in a second step, mild asthmatic subjects will undergo conventional bronchial allergen challenge. is will be obtained at 6h (corresponding to the late asthmatic response) and 24h following the challenge. the rhinitic subjects and asthmatic subjects will undergo a 4-day low dose allergen bronchial challenge as well as a nasal allergen challenge. sputum samples will be obtained following days 2 and 4 of the low dose challenge and one week later, and 24h following nasal challenge. induced sputum will be analyzed for differential cell count. total mrna will be extracted from is cells and used for rt-pcr.

Eligibility criteria:
inclusion criteria: * to have a positive reaction to one or more allergen on prick tests. * non smokers * no respiratory track infection for at least one month prior to the study. * asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment. * asthmatic subjects with a history of asthma of at least 6 months. * asthmatic subjects with pc20 methacholine lower or equal to 8 mg/ml. * allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past. * allergic rhinitic subjects with a pc20 methacholine higher than 16 mg/ml. exclusion criteria: * smokers or ex smokers less than 6 months or more than 10 pack-years. * asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
a phase iii open-label, multi-center, long-term extension study of depakote er in subjects who either completed or prematurely discontinued due to ineffectiveness from study m02-488.

Conditions: Migraines

Summary: the purpose of this study is to determine if long-term treatment, up to 1 year, with depakote er is safe in the reduction of occurrence of migraine headaches in adolescents.


Eligibility criteria:
inclusion criteria: * subject and subject's legal representative have voluntarily signed and dated an irb-approved informed assent form and an irb-approved informed consent form, respectively, before any study-specific procedures or tests are performed; * the subject was randomized into study m02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and * the subject is male or non-pregnant, non-lactating female exclusion criteria * female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives). * experienced a serious adverse event in study m02-488 which the investigator considered "possibly" or "probably related" to study drug; or * in the investigator's opinion, long-term treatment with depakote er for migraine prophylaxis is contraindicated. * for any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.

Keywords: migraines depakote er divalproex sodium
bracing and reconstruction of the anterior cruciate ligament for efficacy trial

Conditions: Anterior Cruciate Ligament Injuries

Summary: several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. a recent survey of the anterior cruciate ligament (acl) study group has shown that 53% of surgeons prefers functional bracing following acl reconstruction. currently, however, there is no clear consensus on whether functional bracing following acl reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to acl reconstruction without bracing.

given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts, there might be a role for functional bracing following quadriceps acl reconstruction. additionally, no studies to date have assessed the role of psychological readiness of return to sport, kinesiophobia and return to sport rates with and without functional bracing following acl reconstruction (aclr). the purpose of this randomized controlled trial is to assess the 2-year outcomes of psychological readiness, patient-reported outcome measures (proms), clinical stability, return to sport and failure rates following quadriceps autograft acl reconstruction with and without functional bracing in the postoperative phase in younger athletic patients and military patients with a higher risk of failure or not returning to sports or duty, respectively, in a randomized study: the bracing and reconstruction of the anterior cruciate ligament for efficacy trial (brace-trial).

Eligibility criteria:
inclusion criteria: * patients with unilateral complete acl injury * patients involved in sports and the desire to return to sports * patients undergoing quadriceps autograft acl reconstruction * must be 14 to 39 years old exclusion criteria: * multiligamentous knee injuries defined as two ligaments requiring surgical stabilization * concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction * concomitant femoral, tibial, or patellar fracture(s) * patients with significant osteoarthritis * concomitant ipsilateral knee dislocation or patellar dislocation * significant lower leg malalignment requiring correcting osteotomies * prior acl surgery, including contralateral knee * pregnancy during injury or surgery * unable to provide consent * prolonged use of prednisolone or cytostatics * comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation

Keywords: anterior cruciate ligament (acl) reconstruction postoperative bracing functional bracing