Kornimate/medical-research-clean huggingface dataset:
a long-term extension study to wa19926 (nct01007435) of tocilizumab in participants with early, moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this multicenter, open-label, single arm long-term extension of study wa19926 will evaluate the safety and efficacy of tocilizumab (roactemra/actemra) in participants with early, moderate to severe rheumatoid arthritis who have completed the wa19926 core study. eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.


Eligibility criteria:
inclusion criteria: * participants who complete wa19926 core study (visit at week 104 and two follow-up telephone visits) and who may benefit from study drug treatment according to the investigator's assessment * no current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit * receiving treatment on an outpatient basis * females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period exclusion criteria: * pregnant women * participants who have prematurely withdrawn from the wa19926 study for any reason * treatment with any investigational agent or cell depleting therapies since last administration of study drug in the wa19926 core study * treatment with an anti-tumor necrosis factor (tnf) or anti-interleukin (il)1 agent, or a t-cell co-stimulation modulator since the last administration of the study drug in the wa19926 core study * immunization with a live/attenuated vaccine since the last administration of study drug in the wa19926 core study * diagnosis since visit at week 104 of the core wa19926 study of rheumatic autoimmune disease other than rheumatoid arthritis * diagnosis since visit at week 104 of the core wa19926 study of inflammatory joint disease other than rheumatoid arthritis * evidence of serious uncontrolled concomitant disease or disorder * known active or history of recurrent infection * current liver disease as determined by investigator
interscalene brachial plexus block combined with suprascapular nerve block

Conditions: Rotator Cuff Injury

Summary: the investigators compared the results of sono-guided interscalene brachial plexus block (isb) combined with arthroscopy-guided suprascapular nerve block (ssnb) with those of isb alone within the first 48 h after arthroscopic rotator cuff repair.

forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. the 24 patients randomly allocated to group 1 received isb and ssnb; the remaining 24 patients in group 2 underwent isb alone. vas pain score, patient's satisfaction (sat) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. vas pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. sat was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. rebound of postoperative pain was confirmed if there had been an increase of vas pain score after postoperative 1 hour.

Eligibility criteria:
inclusion criteria: 1. definite rotator cuff tear on preoperative mri, which needed repair; 2. acceptance of arthroscopic surgery including rotator cuff repair; 3. \> 20 years old; and 4. acceptance of routine regional blocks and patient-controlled analgesia. exclusion criteria: 1. did not want arthroscopic rotator cuff repair; 2. stopped pca before 48 h postoperatively due to side effects; 3. history of shoulder operation or fracture; 4. concomitant neurological disorder around the shoulder; 5. conversion to open surgery from the arthroscopy; and 6. contraindication to the routine regional blocks in this study

Keywords: sono-guided interscalene brachial plexus block arthroscopy-guided suprascapular nerve block arthroscopic rotator cuff repair postoperative pain
a first-in-human study of parp1 selective inhibitor, imp1734, in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study will evaluate the preliminary efficacy of imp1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mcrpc) with deleterious/suspected deleterious mutations of select homologous recombination repair (hrr) genes.

this study will evaluate the safety, tolerability and preliminary efficacy of imp1734 as monotherapy in patients with recurrent, advanced/metastatic solid tumors. the study consists of 3 parts: dose escalation, dose optimization and dose expansion. in dose escalation (part1), the study will identify the maximum tolerated dose (mtd) or maximum achievable dose (mad) in solid tumor. in dose optimization (part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of imp1734. in dose expansion (part 3) the recommended dose escalation (rde) of imp1734 monotherapy will be evaluated in patients with recurrent, advanced/metastatic breast cancer, ovarian cancer and mcrpc with deleterious/suspected deleterious mutations of select homologous recombination repair (hrr) gene mutations.

Eligibility criteria:
key inclusion criteria * breast cancer; must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if hr+, * hgsoc or high grade endometrioid eoc, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease * mcrpc with ongoing adt, must have received nha and up to 1 prior line of taxane chemotherapy * age ≥ 18 years at the time of informed consent * eastern cooperative oncology group (ecog) performance status ≤1 * adequate organ function * life expectancy ≥ 12 weeks * should have evaluable disease as defined by recist1.1 and/or ca125 or psa * female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of imp1734 * deleterious or suspected deleterious germline or somatic mutations of select hrr genes * up to 1 prior line of parp inhibitor containing treatment key exclusion criteria: * any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of imp1734 * have received prior parp1 selective inhibitors * mean resting qtcf \> 470 ms or qtcf \< 340 ms * active or untreated central nervous system (cns) metastases and/or carcinomatous meningitis. * infections - an active hepatitis b/c infection * any known predisposition to bleeding * unable to swallow oral medications or have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability

Keywords: eik1003 eik1003-001 imp1734
comparison of epidemiology and clinical outcomes of influenza a & b cases in manitoba, canada

Conditions: Influenza

Summary: this study compares the epidemiology and clinical outcomes of laboratory confirmed influenza type a to type b following clinical diagnosis of influenza. multivariate models are used to assess the effects of influenza type on clinical outcomes while accounting for potential confounders.

annual epidemics of influenza are an important public health problem globally and in canada. each year, 10-25% of the canadian population become infected with influenza. most of these infections are typically asymptomatic or associated with a mild self-limiting illness. however, influenza can cause severe illness leading to hospitalization and death, especially among the very young, the elderly and among those with underlying chronic conditions. it has been estimated that on average about 4,000 influenza-related deaths occur in canada each year. in addition, the economic burden of influenza is significant because of the high direct costs associated with increased utilization of services and the indirect costs caused by school and work absenteeism. this project compares laboratory-confirmed cases of influenza a and b in terms of their epidemiology, and the overall and cause-specific incidence rates of important clinical outcomes including physician visits, hospitalization and death following clinical diagnosis of influenza cases in manitoba over the period from 1993 to 2008. the study assesses secular and seasonal trends in the incidence rates of influenza a and b cases in manitoba during the period of 1993-2008, to determine whether these rates vary for different subsets of the population defined by demographic (e.g., age group, gender), socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination, presence of chronic conditions, immune status) characteristics. the analysis by influenza type then compares the overall and cause-specific incidence rates of physician visits, hospitalization and death following the diagnosis of a laboratory-confirmed influenza. the effects of influenza type on clinical outcomes (e.g., hospitalization) are assessed with multivariate models while accounting for potential confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity, immune status) characteristics.

Eligibility criteria:
inclusion criteria: * any person who normally resides in manitoba and who has been continuously covered by manitoba health during the study period will be eligible for inclusion in the study. exclusion criteria:

Keywords: influenza influenza type a influenza type b hospitalization manitoba canada
the use of ultrasound to measure depth of thoracic epidural space

Conditions: Post Operative Trauma; Acute Pain

Summary: the purpose of the study is to evaluate the use of ultrasound scanning of the thoracic spine to define the point of insertion and the depth of the epidural space compared to the blind technique. the study hypothesis is the use of ultrasound will improve the success rate of epidural placement and may also decrease the rate of complications.


Eligibility criteria:
inclusion criteria: * patients 18 years and older having a thoracic epidural catheter * both male and female patients. exclusion criteria: * pediatric population \< 18 years of age * pregnancy * prisoners * absolute contraindication to thoracic epidural placement severe scoliosis or deformity, * patients with previous spine surgery or hardware implanted at level of epidural placement, * anticipated ventilation postoperatively for a period more that 24 hrs * lack of patient consent to enroll in the study

Keywords: post operative pain thoracic epidural acute pain ultrasound scanning of the thoracic spine
multi-parametric mri in patients of bladder cancer

Conditions: Muscle-invasive Bladder Cancer; Artificial Intelligence

Summary: accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. the investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(mri).

patients who underwent bladder mri were retrospectively collected at three centers between january 2013 and september 2023. the investigators first constructed a nnunet to segment causal region where muscle-invasive bladder cancer may occur. subsequently, the investigators explored a causal network based on a modified resnet3d-18 by striking a fine balance between nnunet awareness and a self-supervised learning (ssl) model, which steered model to emulate diagnostic acumen of expert in staging muscle-invasive bladder cancer at mri. model was trained in center 1, and independently tested in center 1, center 2 and center 3. ablation test was performed among all 13 ablation-test models using either single or multi-parametric mri. benefit was tested in six radiologists using vesical imaging-reporting and data system (vi-rads) versus network-adjusted vi-rads.

Eligibility criteria:
inclusion criteria: * urothelial carcinoma of the bladder confirmed by final histopathology ②received a standard contrast-enhanced 3.0t mpmri before surgery ③all tumors within patients included were resected and received pathologic examination separately exclusion criteria: ①absence of surgical interventions ②with inadequate image quality or with inadequate pathology for analysis
prophylactic iabp in high-risk patients undergoing cabg

Conditions: Myocardial Infarction; Coronary Artery Disease

Summary: due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (cabg) is increasing. the perioperative mortality in these patients is ≥ 5%. the perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. one of the central aspects is perioperative maintenance of hemodynamic stability. the use of prophylactic iabp is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. yet, it is an invasive procedure with potential complications. the planned trial should give an explicit answer, whether preoperative prophylactic iabp decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing cabg.


Eligibility criteria:
key inclusion criteria: hemodynamically stable high-risk patients before cabg, defined by the following criteria: * age \>18 years * isolated cabg planned * informed consent in trial participation given * any left ventricular functional impairment (regional wall motion abnormality or global lvef\<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography * elevated cardiac biomarkers (ck-mb \> 6% of total-ck, troponin i \> 3-fold of specific test reference) or myocardial infarction (nstemi or stemi) within the last 4 days. key exclusion criteria: * contraindications for iabp * cardiogenic shock * shock of any other cause * critical preoperative state according to euroscore ii-criteria * cardiac surgical procedure other than cabg planned * severe comorbidity with life expectancy \< 6 months * incapability of giving informed consent

Keywords: iabp iabc coronary artery disease prophylactic cardiac assist
covid-19 associated coagulopathy in egypt

Conditions: Coagulopathy

Summary: coagulopathy is one of the most significant prognostic factors in patients with covid-19 and is associated with increased mortality and admission to critical care. most commonly observed coagulopathy in patients hospitalized with covid-19 (covid-19-associated coagulopathy) is characterized by increased d-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (dic) compared to 0.6% of survivors.

studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.

Eligibility criteria:
inclusion criteria: * patients with covid 19 positive by rt- pcr exclusion criteria: * no exclusions

Keywords: hypercoagulable covid-19
a study of verve-102 in patients with familial hypercholesterolemia or premature coronary artery disease

Conditions: Heterozygous Familial Hypercholesterolemia; Premature Coronary Heart Disease

Summary: vt-10201 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of verve-102 administered to patients with heterozygous familial hypercholesterolemia (hefh) or premature coronary artery disease (cad) who require additional lowering of ldl-c. verve-102 uses base-editing technology designed to disrupt the expression of the pcsk9 gene in the liver and lower circulating pcsk9 and ldl-c. this study is designed to determine the safety and pharmacodynamic profile of verve-102 in this patient population.


Eligibility criteria:
inclusion criteria: * diagnosis of hefh or premature cad * females of non-childbearing potential or males exclusion criteria: * homozygous familial hypercholesterolemia * active or history of chronic liver disease * current treatment with pcsk9 inhibitor or prior treatment within specified timeframe * clinically significant or abnormal laboratory values as defined by the protocol

Keywords: verve-102 familial hypercholesterolemia coronary artery disease dose escalation gene editing base editing
multicenter efficacy study of recombinant human erythropoietin in acute ischemic stroke

Conditions: Infarction, Middle Cerebral Artery; Middle Cerebral Artery Stroke; Stroke, Acute

Summary: the purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.


Eligibility criteria:
inclusion criteria: * ischemic stroke in the middle cerebral artery territory * clearly defined time of onset * confirmed by mri (dwi, flair) * nih stroke scale ≥ 5 * age \> 18 years * treatment within 6h after onset of symptoms * informed consent by patient, relatives or independent physician * life expectancy \> 90 days exclusion criteria: * coma or precoma (level of consciousness ≥ 2 in nih stroke scale) * previous stroke within the same territory * intracranial or subarachnoidal hemorrhage * traumatic brain injury or brain operation within the last 4 weeks * neoplasia, septic embolism, infectious endocarditis * mri contraindications * renal failure (i.e. dependent on dialysis) * known malignant/life-threatening disease * known myeloproliferative disorder, polycythemia * known allergy or antibodies against erythropoietin * participation in other intervention trials * pregnancy

Keywords: stroke epo erythropoietin ischemia hypoxia antiapoptosis neuroprotection rtpa thrombolysis stroke, middle cerebral artery ischemic stroke in the middle cerebral artery territory
assessment of remote eeg monitoring (remi-eeg) in pediatric emergency and adult critical care units

Conditions: Epilepsy

Summary: the goal of this observational study is to compare clinical utility between remote eeg monitoring (remi) and conventional eeg in patients (6 and older) that are undergoing eeg recording in a hospital as part of their routine clinical care. the main question\[s\] it aims to answer are: * what is the concurrence of diagnosis made by epileptologist using remi and full-eeg signals. * what is the proportion of participants experiencing as seizure at the time of sensor placement, compared between remi sensor placement and full-eeg placement. participants will wear remi and conventional eeg electrodes at the same time.

epitel has developed epilog, a wireless wearable eeg sensor capable of transmitting eeg to a recording, display, and review platform called remi (remote eeg monitoring). epitel's remi platform consists of the remi tablet and four epilog sensors. the remi tablet requires connection to secure wifi access, and emergency department and intensive critical care's it to open access to http://remi.epitel.com. the four epilog sensors communicate directly with the remi tablet via bluetooth connection. remi synchronizes four epilog sensors placed by hospital emergency department (ed) or intensive care unit (icu) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. remi securely transmits eeg data to its cloud server where data are processed in near real time using persyst® mobile software. data can then be remotely reviewed by clinical team members. the objective of this protocol is to demonstrate clinical utility of the epilog eeg sensors with the remi monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in epilog sensor placement and use of the remi platform. all participants will have four epilog sensors placed, in addition to the standard of care full-eeg. the bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.

Eligibility criteria:
inclusion criteria: * clinical eeg has been ordered for suspected seizures * age 6 years or older exclusion criteria: * cannot undergo eeg recordings because of severe head or other injury that prevents eeg recording. * transferred immediately for an operation * hemodynamically unstable (sbp less than 90 mmhg) at time of eeg placement * inability to place four remi eeg sensors.
early response assessment of induction chemotherapy in acute myeloid leukemia patients using f-18 flt pet/ct

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to investigate whether f-18 flt pet/ct is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients.

assessment of treatment response in aml is very important to determine the next treatment. standard treatment of aml begins with induction chemotherapy. nccn guideline recommend to assess the treatment response via bone marrow examination approximately 7-10 days after completion of induction chemotherapy. however, the possibility of sampling error and risks of infection and bleeding are the limitation of bone marrow biopsy. f-18 fluorodeoxythymidine (flt) is a radiopharmaceutical for pet, reflecting the proliferation of the cell. f-18 flt is trapped after phosphorylation by thymidine kinase1, whose expression is increased in replicating cells. there have been several studies that reported f-18 flt pet could measure health and proliferation of the bone marrow. the aim of this study is to evaluate if f-18 flt pet/ct is suitable for early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia * must receive induction chemotherapy * 19 years old and over exclusion criteria: * no standard therapy * pregnancy
effect of perioperative hemodynamic optimization on the immune function parameters of peripheral blood monocytes after cardiac surgery

Conditions: Postoperative Wound Infection; Postoperative Outcome

Summary: cardiac surgery patients have a high risk to suffer from postoperative infections. some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. in studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. the aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.


Eligibility criteria:
inclusion criteria: * elective cardiac surgery patient undergoing cardiopulmonary bypass * signed informed consent exclusion criteria: * pregnant or breast feeding women * age \<18 years * pulmonary disease with an oxygenation index \<300mmhg * liver disease (\>child b) * hiv-infection * therapy with corticosteroids * condition after transplantation * preexisting infection before operation

Keywords: advanced hemodynamic monitoring goal-directed therapy cardiac surgery hemodynamic monitoring