Kornimate/medical-research-clean huggingface dataset:
contact aspiration versus stent retriever for recanalisation of acute stroke patients with basilar artery occlusion: the posterior circulation aster randomized trial protocol

Conditions: Basilar Artery Occlusion

Summary: acute ischemic stroke (ais) patients with basilar artery occlusion (bao) present a devastating, life-threatening prognosis. urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with bao although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). recently, a large retrospective study supports the interest of thrombectomy in this population . speed and grade of the recanalisation have a major impact on clinical outcome. favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (or=4.57, 95%ci=1.24-16.87, p=0.023). first pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome. thrombectomy with stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in bao patients (posterior circulation). contact aspiration (ca) is currently used in anterior large vessel occlusions (compass trial, lancet 2019), with similar rates of recanalization and favorable outcomes (boulanger m, 2019), as well as in bao patients . however, the benefit of ca compared to sr for the treatment of bao remains under debate with the superiority of first line ca compared to sr or no difference. available data are based on retrospective studies with no data from rct. in this context, a randomized controlled trial is needed to assess the benefit of ca versus sr.


Eligibility criteria:
inclusion criteria: age ≥ 18 years * ais with bao on non-invasive imaging (ct or mri) * eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms or of last time the patient was seen normal * being covered by a national health insurance * informed consent obtained from the patients/his proxy or following an emergency procedure exclusion criteria: * known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the symptomatic territory (basilar artery) * severe contrast medium allergy or absolute contraindication to use of iodinated products * clinical history, past imaging or clinical judgment suggesting intracranial stenosis of the basilar artery * pregnancy (urine or serum beta hcg test for women of child-bearing potential) * person deprived of liberty * patient benefiting from a legal protection (guardianship or curatorship)

Keywords: stroke basilar artery occlusion
a phase 3 telavancin staphylococcus aureus (s. aureus) bacteremia trial

Conditions: Bacteremia

Summary: this is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard iv therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (pcn), or cefazolin) in the treatment of subjects with complicated staphylococcus aureus (s. aureus) bacteremia and sa right-sided infective endocarditis (sa-rie).


Eligibility criteria:
inclusion criteria: * 18 years of age or older with at least one blood culture positive for s. aureus within 48 hours before randomization * at least one of the following signs or symptoms of bacteremia: * temperature ≥ 38.0°c * white blood cell (wbc) count \> 10,000 or \ 10% immature neutrophils (bands) * tachycardia (heart rate \> 90 bpm) * tachypnea (respiratory rate \> 20 breaths/min) * hypotension (systolic blood pressure \< 90 mmhg) * signs or symptoms of localized catheter-related infection * at enrollment, subjects must have either 1) known right-sided infective endocarditis by modified duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of s. aureus infection or 3) at least one risk factor for complicated bacteremia. exclusion criteria: * treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. exception: documented resistance to the prior systemic antibacterial therapy * presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment * presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator \[icd\]), permanent pacemaker, or cardiac valve support ring) * known or suspected left-sided infective endocarditis (lie), by modified duke criteria. note: right-sided infective endocarditis (rie) is permitted * known or suspected osteomyelitis or meningitis. note: evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. s. aureus pneumonia is permitted * confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against gram-negative pathogens

Keywords: bacteremia staphylococcus aureus
cellular immune responses in triple-negative breast cancer - high throughput immunogenetic studies

Conditions: Triple Negative Breast Cancer

Summary: this project introduces a novel methodology for the in-depth immunogenetic characterization of the tr gene repertoire in solid tumors, holding the promise to offer unprecedented insights into the tr anti-tumor specificity and the prognostic/predictive value of tr gene repertoire signatures.

the goal of this observational study is to address the role of t cells in the tumor microenvironment of tnbc. in detail, this study aims to: (i) explore the immunogenetic characteristics of the tr gene repertoire as informative prognostic/predictive biomarkers in tnbc (ii) identify immunogenic neoepitopes arising from common tumor-specific non-synonymous gene mutations, as well as the corresponding neoepitope-specific t cells (iii) describe, in single-cell resolution, the spatial organization of the intricate crosstalk between tumor cells and neoepitope specific-t cells, and (iv) delineate the functional properties of t cells within the tme. all the experimental results, regarding the tr repertoire features and the spatial organization of the tme, will be correlated with clinical outcome measurements (e.g. overall survival, progression time), which are available from the detailed patients medical record.

Eligibility criteria:
inclusion criteria: - confirmed tnbc diagnosis exclusion criteria: -

Keywords: t cells tumor-infiltrating lymphocytes next-generation sequencing t cell receptor spatial transcriptomics neoepitopes tr beta chain trb clonotypes trb gene repertoire cellular immunity
biological therapy with combination chemotherapy in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. combining chemotherapy with biological therapy may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage ii or stage iii colorectal cancer.

objectives: * assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer. outline: this is a three arm study. patients are randomized to receive either levamisole, alfa interferon, or no treatment. * arm i: patients receive levamisole po for 3 days every 2 weeks for 6 months before and after surgery. fluorouracil iv bolus and leucovorin calcium (folinic acid) iv over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery. * arm ii: patients receive alfa interferon-2a sc on 3 alternate days for a week before surgery and for 6 months after surgery. fluorouracil iv bolus and folinic acid iv over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery. * arm iii: patients undergo surgery followed by fluorouracil iv bolus and folinic acid iv over 1 hour on days 1-5 every 4 weeks for 6 cycles. patients are followed every 3 months for 2 years, then every 6 months. projected accrual: 350 patients per arm will be accrued for a total of 1,050 patients.

Eligibility criteria:
disease characteristics: * histologically confirmed stage t3-t4 n0 or t1-t4 n1-3 colorectal cancer * no evidence of residual disease after surgery * tumor located above peritoneal reflection * no distant metastases patient characteristics: age: * 75 and under performance status: * who 0-1 life expectancy: * not specified hematopoietic: * wbc at least 3500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin no greater than 2.0 mg/dl * sgpt less than 2 times upper limit of normal renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no serious cardiac ischemia other: * adequate metabolic functions * no prior neoplasm * no prior/concurrent illness * no insulin-dependent diabetes prior concurrent therapy: biologic therapy * no prior immunotherapy for the current cancer chemotherapy * no prior chemotherapy for the current cancer endocrine therapy * not specified radiotherapy * no prior radiotherapy for the current cancer surgery * not specified

Keywords: stage ii colon cancer stage iii colon cancer stage ii rectal cancer stage iii rectal cancer
utilizing free dna in embryo culture for pgt

Conditions: Chromosome Abnormalities; Genetic Diseases, Inborn; Mutation

Summary: in the way for developing and optimizing protocol to be used as non- invasive methodology used as routine testing for pgs. this protocol is to be adapted to replace the using of life embryo cells for genetic testing and aneuploidy study as well as for any type of genetic testing including single gene disorder or hla typing or study.

compare 100 embryos studied using ngs for chromosomal aneuploidies, and compare the results came from free media dna with this results.

Eligibility criteria:
inclusion criteria: * all abnormal/aneuploidy embryos rejected for embryo transfer. exclusion criteria: * all embryos had unsuccessful diagnosis with blastomere biopsy.

Keywords: pgs pgd free embryo dna ngs pgt pgt-a pgt-m pgt-hla
assessing the impact of the axomove therapy medical device on low back pain patients

Conditions: Low Back Pain

Summary: an evaluation study of the impact of the axomove therapy® medical device on subacute or chronic low back pain patients leaving rehabilitation centres to facilitate self-rehabilitation. a prospective, randomized, open-label, multicentre study whose main objective is to evaluate the effectiveness of the axomove therapy medical device on disability reduction (oswestry disability index score) patients with subacute or chronic low back pain requiring rehabilitation.


Eligibility criteria:
inclusion criteria: * patient aged 18-65 years, patients with subacute or chronic low back pain, day hospital follow-up (hdj) or weekday hospital with a planned return home within 2 weeks of the inclusion visit (j0), patient with common low back pain for at least 6 weeks before hospitalization, patient having a smartphone, tablet/ or computer (compatible with the technical requirements of the dm) and having the possibility to connect (via a telephone subscription or a wifi connection), patient agreeing to install the axomove therapy® application and agreeing to follow the study protocol, patient with physical, sensory and cognitive ability to use an application (digital tools) on a smartphone, tablet or computer and perform physical exercise programs, a patient who is a member of, or in receipt of, a social security scheme. exclusion criteria: * patients who are unable to understand, read or speak french, inability to receive informed information, a patient with a sensory, visual or tactile impairment that prevents the correct use of a smartphone, tablet and/or computer, or prevents the exercise from being carried out safely, patient with suspected or proven serious pathology such as recent vertebral fractures (less than 6 months), infection, malignant tumors and/or radiculopathy, patient with a history of rheumatic inflammatory disease, patient with true radiculalgia, patient with scoliosis \> 30°, patient with lumbar surgery in the past 12 months, pregnant patient, parturient or breastfeeding, patient under legal protection (guardianship, curatorship), a patient with a serious and/or uncontrolled illness that, in the opinion of the investigator, could result in unacceptable safety risks or compromise protocol compliance, for example: an active or uncontrolled infection.
cesarean scar evaluation using saline infusion sonography in women with previous pregnancy in scar

Conditions: Uterus; Scar

Summary: evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.

over the past few decades, cesarean delivery rates worldwide have risen considerably. the surgery may lead to deficient uterine scar healing, thinning of the myometrium and formation of cesarean scar defects or uterine scar niche. the prevalence of clinically relevant cesarean scar defects is unclear and has been reported between 20-88%, it is identified by using transvaginal ultrasound or saline-infused sonography in non-pregnant patients. women may be asymptomatic or present a wide gynecologic sequela including cesarean scar pregnancy, abnormal uterine bleeding, dysmenorrhea, chronic pelvic pain, infertility, and increased risk of complications during gynecologic procedures such as uterine evacuation and insertion of intrauterine device. cesarean scar pregnancy (csp) is defined as an early pregnancy implantation in the scar from a prior cesarean delivery. this pregnancy is implanted in a fibrous scar tissue and may lead to substantial risk for severe maternal morbidity such as adherent placenta, second or third trimester uterine dehiscence or rupture, severe maternal bleeding, and adherence to adjacent tissues. the prevalence of scar pregnancy is reported to be between 1:1800-2500 pregnancies, with increasing diagnosis in the last decade due to increasing use of transvaginal ultrasound early in pregnancy and possible increased physician awareness of this condition. the ultrasound criteria for csp have been redefined recently, and now propose transvaginal ultrasound as the imaging technique of choice at this early stage. in 2022, the niche task-force convened a delphi consensus to develop a standardized sonographic evaluation and reporting system for a csp in the first trimester. according to this consensus, csps were classified into three subgroups, subgroup a in which the largest part of the gestational sac protruded towards the uterine cavity, subgroup b in which the largest part of the gestational sac was embedded in the myometrium, and subgroup c in which the gestational was partially located outside the outer contour of the cervix or uterus. this sonographic classification has yet to be validated clinically. in the present report the investigators aim to evaluate the uterine cavity and potential cesarean scar defects or niche in women with history of csp using saline infused sonography. in the second stage of the research, we will classify the past cesarean pregnancies according to the new delphi criteria and examine correlation between the different csp subgroups and presence of cesarean scar defects.

Eligibility criteria:
inclusion criteria: * women with history of cesarean scar pregnancy exclusion criteria: * ongoing pregnancy * vaginal bleeding * active or suspected inflammation of genital tract including pelvic inflammatory disease * women engaged in unprotected intercourse * presence of intra-uterine device contraception
effects of a 4-week raw, plant-based diet on anthropometric and cardiovascular risk factors

Conditions: Hypertension; Elevated Cholesterol; Overweight and Obesity

Summary: this study evaluates the effects of a prescribed 4-week raw, plant-based dietary intervention in the treatment of excess body weight, hypercholesterolemia, and hypertension in the clinical setting.

plant-based diets have emerged in the literature as effective therapeutic strategies in the reduction of body weight, serum lipids and blood pressure. in addition, raw fruit and vegetable consumption has also been associated with the reduction of these clinical indicators. participants were instructed to follow a prescribed, raw, plant-based dietary intervention for four weeks. all animal products, including eggs and dairy, were excluded. cooked foods, free oils, soda, alcohol and coffee were also to be excluded. all meals and snacks were provided to the participants for the full duration of the intervention. emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. participants were not advised to alter their exercise habits. participants came to a total of 4 follow-up visits. a laboratory panel was obtained at baseline and at 4-weeks. a 24-hour recall was also conducted at baseline and at 4-weeks. anthropometrics, hemodynamics, and medication needs were assessed on a weekly basis.

Eligibility criteria:
inclusion criteria: * body mass index ≥25.0 kg/m\^2 * serum low-density lipoprotein cholesterol concentration ≥100 * systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 exclusion criteria: * tobacco use * drug abuse * excessive alcohol consumption (\>2 glasses of wine or alcohol equivalent per day for men or \>1 glass of wine or alcohol equivalent for woman) * current cancer diagnosis * estimated glomerular filtration rate \<60 mg/dl * clinically defined infection * mental disability * hospitalization \<6 months * previous exposure to plant-based diet
terumo aortic global endovascular registry

Conditions: Abdominal Aortic Aneurysm; Thoracic Aortic Aneurysm; Surgery

Summary: multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of ce marked and custom terumo aortic endovascular grafts.

post market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with terumo aortic endovascular stent-grafts in standard clinical practice.

Eligibility criteria:
inclusion criteria: * • minimum age as per local regulations * indication for aortic endovascular repair with an approved or ce marked by a regulatory body or custom-made terumo aortic endovascular graft * ability to provide informed consent o emergent cases (typically younger patients with traumatic injuries) are not excluded if there is irb/ec agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) * willingness to comply with the registry protocol * willingness to adhere to follow-up visits note: patients currently enrolled and actively participating within the treo registry (ip-0020-16) can have their data migrated from treo to the tiger registry where local ec approval has been obtained and the patient has been reconsented to tiger for longer follow-up. exclusion criteria: * • patient is unable or unwilling to comply with the study follow-up regime. * patient is contraindicated per the ifu, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure * patient is eligible to be enrolled in or is currently actively participating in the terumo aortic global fact clinical study (fact-001)
pegintron treatment of chronic hepatitis b e antigen-positive patients (p05170/mk-4031-327)

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to determine the efficacy and safety of two dosages of pegintron for treating hepatitis b e antigen (hbeag) positive chronic hepatitis b compared with the approved dosage, which is pegintron 1.0 microgram (mcg)/kg given once a week for 24 weeks. this study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. all subjects are followed for 24 weeks after their treatment ends.


Eligibility criteria:
inclusion criteria: * adults with chronic hepatitis b: * serum hepatitis b surface antigen positive for at least 6 months * serum hepatitis b e antigen positive * serum negative for hepatitis b surface and e antibodies * plasma hepatitis b virus deoxyribonucleic acid (dna) level greater than 20,000 iu/ml * alanine aminotransferase (alt) 2- to 10-times the upper limit of normal * compensated liver disease with certain minimum hematological and serum biochemical criteria exclusion criteria: * significant hepatic disease from an etiology other than hepatitis b virus * antiviral treatment for hepatitis within previous 6 months * history of severe psychiatric disease, especially depression * unstable or significant cardiovascular disease * prolonged exposure to known hepatotoxins such as alcohol or drugs * any condition that could interfere with the subject participating in and completing the study
bladder environment: microbiome oxygen relationship

Conditions: Urinary Incontinence; UTI's

Summary: the purpose of this study is to characterize bladder urinary oxygen tension (buot) in women whose urinary microbiomes contains at least one anaerobic bacterial species versus women whose urinary microbiomes do not contain anaerobes.

throughout the human body, microbial communities (microbiota) depend on their environment, including the level of oxygen (anaerobic vs. aerobic). recently published evidence documents the existence of a female urinary microbiota (fum) and provides evidence that the fum differ based on lower urinary tract symptoms, i.e. no bladder symptoms, urgency urinary incontinence, and urinary tract infection1-4. members of the fum include bacteria that require oxygen (aerobes), those that abhor oxygen (anaerobes) and those that thrive in both conditions (facultative anaerobes)5. this last group of microbes is known to consume low levels of oxygen to maintain an anaerobic environment. yet, virtually nothing is known about oxygen levels in bladder urine even though bladder urine oxygen tension may both affect and be affected by the fum. given the role oxygen levels play in other parts of the human body, the investigators request resources to investigate bladder urine oxygen levels. the study is designed to understand if buot levels differ in fums with and without at least one anaerobe, and if so, if there are any patient factors or urinary symptoms associated with certain buot

Eligibility criteria:
inclusion criteria: * age \> 18 * no indwelling urethral catheter * at least 50 ml of urine in their bladder as determined by the clinic's bladder scanner exclusion criteria: * non-english speaker

Keywords: oxygen tension female urinary microbiome urinary tract symptoms urine oxygen level