Kornimate/medical-research-clean huggingface dataset:
eric acute stroke recanalization (eraser)

Conditions: Ischemic Stroke

Summary: to monitor the effect of the eric® device in combination with sofia™ distal access catheter on artery recanalization and on clinical outcomes in stroke patients using data from clinical routine application (eraser). to additionally evaluate the effect of the eric® device in combination with sofia™ distal access catheter on the final infarct volume as determined by advanced image postprocessing methods in the subgroup of patients with acute middle cerebral artery stroke (eraser+).

this is a prospective, international, single-arm, controlled, open label post-market, multicenter study to compare the safety and effectiveness of eric® device in combination with sofia™ distal access catheter in acute ischemic stroke patients using clinical routine data. patients who meet the imaging inclusion criteria for eraser will be included in the cohort where collected and additionally analyzed data will be compared to a historical patient cohort (referred to as eraser imaging =eraser+). all other patients will be included in a registry (referred to as eraser), where clinical information will be collected. the overall study duration is expected to be 18 months. the expected duration of each subject's enrolment is approximately 90 days. subjects will be followed with assessments at 90 days post stroke. the basic concept of eraser+ is the use an infarct prediction algorithm that has been trained on a large dataset of historical imaging data of patients treated with iv tpa, apply it to the pre-treatment imaging and compare its predictions with the actual outcome.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke with nih-ss score of 8-25 * ctp/ mrp \<4.5h after symptom onset completed * cta/ mra confirms m1-occlusion * groin puncture estimated \<6h after stroke onset * intended usage of eric® as first device in combination with sofia™ distal access -catheter (secondary bail-out with other devices allowed) exclusion criteria: * mca \>1/3 abnormal in dwi or cbv (aspects ≤ 7, \>100 ml) * pre stroke mrs ≥ 2 * necessity of ipsilateral internal carotid artery (ica) angioplasty * age \<18 years

Keywords: stroke clot retrieval system recanalization
increased dose of icotinib in advanced none small cell lung cancer patients after routine gefitinib therapy

Conditions: Non-small Cell Lung Cancer

Summary: to evaluate the efficacy and safety of increased dose of icotinib in advanced nsclc patients who progressed after gefitinib therapy.

this single center, single arm open label study is designed to assess the safety and efficacy of using high dose of icotinib (conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. the adverse events and adverse reaction are evaluated as well.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed local advanced or metastatic stage iiib/iv nsclc. * have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib. * at least one measurable lesion according to response evaluation criteria in solid tumors. * signed and dated informed consent before the start of specific protocol procedures. exclusion criteria: * allergic to icotinib. * gefitinib excepted, experience of anti-tumor monoclonal antibody or small molecular compounds therapy such as erlotinib or cetuximab. * severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
screening for atrial fibrillation in pulmonary embolism study -safe-pe study

Conditions: Atrial Fibrillation; Pulmonary Embolism

Summary: patients with newly diagnosed pulmonary embolism and high thromboembolic risk will be randomized to screening for atrial fibrillation or standard of care using intermittent ecg registration for at least two weeks.

patients included in the study might be referred for an ultrasound of deep vein thrombosis unless this has already been performed. blood will be drawn in a subset of patients to assess cardiac biomarkers, and stored in a biobank for further analysis of thrombotic biomarkers. if a computed tomography (ct) angiogram was used as diagnostic method for pulmonary embolism a radiologic review will be performed to assess presence of right atrium thrombus, with the reviewer will be blinded to the presence of atrial fibrillation (af). in addition, an echocardiogram of the heart will be performed. many patients with pulmonary embolism have prolonged symptoms of dyspnoea, and palpitations. these symptoms are also described in patients with atrial fibrillation. all participants will be asked to fill out a standardized quality of life (rand-36)-, and a symptoms questionnaire (modified european heart rhythm association symptom scale). upon inclusion all patients will be reviewed for factors predisposing to pe such as recent surgery, or illness requiring immobilisation within the past three months prior to index event. after inclusion patients will be randomised to screening for atrial fibrillation or standard of care. participants who get randomised into the screening arm will be screened for af using a validated, handheld ecg device at least twice daily for two weeks. participants who get af diagnosed during the study will be referred for appropriate cardiology follow-up and the anticoagulant therapy will be changed from a fixed time to continued (subject to yearly reviews). patients will then be followed for five years using the swedish death registry, and the swedish national patient registry, in combination with the national prescription registry for the outcomes.

Eligibility criteria:
inclusion criteria: * recent pulmonary embolism (within three months) fulfilling chads-vasc criteria for life-long oral anticoagulant therapy (2 points for men, and 3 points for women), or age \> 65 years exclusion criteria: * known diagnosis of atrial fibrillation contra-indication to oral anticoagulant therapy provoked pulmonary embolism in sub-segmental artery only active cancer therapy (on-going therapy, recent surgery or life-expectancy below 1 year)

Keywords: atrial fibrillation pulmonary embolism screening
individualized systems medicine functional profiling for recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: a study to determine the feasibility and safety of individualized cancer stem cell targeted therapy based on high-throughput functional profiling of fda/ema-approved drugs in patients with gbm that has recurred or progressed following standards-of-care (rt, tmz).

this protocol describes a prospective single-center phase 1 study to evaluate the feasibility and safety of a high-throughput drug sensitivity and resistance testing (hts) platform of individualized cancer stem cells (csc) to predict targeted therapies in patients with recurrence of gbm after standards-of-care. secondary outcome include efficacy of drug treatment. the underlying hypotheses is that treatment of patients based on functional profiling og autologous cscs using hts a) is feasible within an acceptable time window for clinical translation, b) safely delay disease progression and c) increase survival. there are increasingly published literature that strongly support the importance of a targeting csc to improve therapy and prevent tumor recurrence in gbm, as an additional strategy to improve the overall prognosis of patients.

Eligibility criteria:
inclusion criteria: * recurrence of histologically verified glioblastoma * adequate biopsy to generate enough live cells to allow functional screening * must be ambulatory with an eastern cooperative oncology group (ecog) performance status 0-1 * must be 18 to 70 years of age * adequate bone marrow, liver and heart function * must be competent to give consent * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to international conference on harmonization good clinical practice guidelines (ich gcp), and national/local regulations. exclusion criteria: * patients taking part in other clinical trials which could make inclusion or follow-up difficult * any reason why, in the opinion of the investigator, the patient should not participate

Keywords: functional screening personalized treatment
clinical outcome and or resource use of total knee arthroplasty using patient-specific or conventional instrumentation

Conditions: Gonarthrosis

Summary: compare or resource use and clinical outcome after total knee arthroplasty using patient-specific or conventional instrumentation.

the aim of this study was to compare or resource use and clinical outcome after total knee arthroplasty (tka) using patient-specific (psi) or conventional instrumentation. for this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (vas pain scale, oxford knee score, eq-5d) were assessed. cost per qaly (quality-adjusted life year) was assessed using the german drg reimbursement and the eq-5d. a total of 139 tka with psi or conventional instrumentation were included in three centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.

Eligibility criteria:
inclusion criteria: * painful, disabled knee joint resulting from osteoarthritis requiring primary tka * informed consent: patient has signed a "patient informed consent. * able and willing to undergo a preoperative mri scan (for psi cases) and full-leg, standing radiographs (all cases) * able and willing to follow instructions and complete follow-up * patient receiving zimmer nexgen solutions cr-flex (including gender solutions) exclusion criteria: * patient is skeletally immature * active infection (including septic knee, distant infection, or osteomyelitis) * severe hip arthrosis * neurological disorders (including, but not limited to parkinson's disease) * prior unicompartmental knee arthroplasty, tka, knee fusion or patellectomy * hip or knee ankylosis * either rheumatoid or post-traumatic knee arthritis * scheduled for simultaneous bilateral tka * indications of intra- and/or extra-articular deformations that would inhibit the use of psi guides * any metal within 150 mm of the joint line for the operative-side knee * knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination * an existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study * a female who is pregnant or lactating * current involvement in any personal injury litigation, medical-legal or worker's compensation claims * arterial disease or stents that would exclude the use of a tourniquet
safety and biological activity of vesatolimod in hiv-1 infected, virologically suppressed adults

Conditions: HIV-1 Infection

Summary: the primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly gs-9620) in hiv-1 infected virologically suppressed adults on antiretroviral therapy (art) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma hiv-1 rna.


Eligibility criteria:
key inclusion criteria: * hiv-1 infection * aged ≥ 18 years at pre-baseline/day -13 * on antiretroviral (arv) treatment for ≥ 12 consecutive months prior to pre-baseline/day -13 * the following agents are allowed as part of the current arv regimen: nrtis, raltegravir, dolutegravir, rilpivirine, and maraviroc * the following agents are not allowed as part of the current arv regimen: hiv protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine * a change in arv regimen ≥ 45 days prior to baseline/day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed * plasma hiv-1 rna \< 50 copies/ml at screening * documented plasma hiv-1 rna levels \< 50 copies/ml (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/ml) * unconfirmed virologic elevations of ≥ 50 copies/ml (transient detectable viremia, or "blip") prior to screening are acceptable. (if the lower limit of detection of the local hiv-1 rna assay is \< 50 copies/ml, the plasma hiv-1 rna level cannot exceed 50 copies/ml on two consecutive hiv-1 rna tests) * if art regimen is changed ≥ 60 days prior to pre-baseline/day -13, plasma hiv-1 rna \<50 copies/ml at pre-baseline/day -13 visit is required * no documented history of resistance to any components of the current arv regimen * availability of a fully active alternative arv regimen, in the opinion of the investigator, in the event of discontinuation of the current arv regimen with development of resistance * hgb ≥ 11.5 g/dl (males) or ≥ 11 g/dl (females) * white blood cells (wbc) ≥ 4,000 cells/μl * platelets ≥ 150,000/ml * absolute neutrophil count (anc) ≥ 1500 cells/μl * cd4 count ≥ 400 cells/μl * albumin ≥ 3.9 g/dl * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2 × upper limit of the normal range (uln) * estimated glomerular filtration rate ≥ 60 ml/min * no autoimmune disease key exclusion criteria: * hepatitis b surface antigen (hbsag) positive * positive anti-hbs antibody and negative hbsag results are acceptable * hepatitis c antibody (hcvab) positive * positive anti-hcv antibody and negative hcv polymerase chain reaction (pcr) results are acceptable * documented history of pre-art cd4 nadir \< 200 cells/µl * unknown pre-art cd4 nadir is acceptable * a new aids-defining condition diagnosed within 90 days prior to screening * acute febrile illness within 35 days prior to pre-baseline/day -13 note: other protocol defined inclusion/exclusion criteria may apply.
a prospective study to evaluate the suture pattern with the endomina suturing device for endoscopic sutured gastroplasty (esg).

Conditions: Obesity

Summary: advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery (1). endomina (endo tools therapeutics, gosselies, belgium) is ce mark device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of the device during a peroral intervention. it offers the possibilities of making transoral surgical full thickness sutures and may allow performing endoscopic therapeutic interventions, via a transoral route. a first trial including 11 patients assessed feasibility and safety of the technique (2). there were no complications and the short-term results were encouraging. then a multicentric efficacy study was conducted, including 51 patients (3). the results where ewl of 31% at one year and tbwl of 9% without complications. finally a randomized controlled study was done including 73 patients in a 2/1 randomized fashion with a crossover at 6 months. treated group was with the endomina device and controlled group was diet only. the follow-up was the same in each group. primary endpoint was to reach the asge guideline "difference between a control group and a treatment group of minimum 15%" (4). technique and suture pattern have evolved since the first study. the aim of this prospective evaluation is to compare different suture patterns and their mechanism of action.


Eligibility criteria:
inclusion criteria: 1. age between 18-64 years; 2. bmi between 30 to 40 kg/m² 3. must be able to comply with all study requirements for the duration of the study as outlined in the protocol. this includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, gastric emptying scintigraphy, satiety test, as well as laboratory investigations. 4. must be able to understand and be willing to provide written informed consent. 5. must have completed the multidisciplinary workup exclusion criteria: 1. achalasia and any other esophageal motility disorders 2. heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the new york heart association's class iii or iv functional capacity. 3. hypertension: uncontrolled hypertension during last 3 month 4. severe renal, hepatic, pulmonary disease or cancer; 5. gi stenosis or obstruction 6. pregnancy or breastfeeding or willing to become pregnant within study duration 7. history of gastric surgery (any type) 8. impending gastric surgery 60 days post intervention 9. history of weight changes (±5% tbwl) within the previous 6 months 10. placement/removal of an intragastric balloon in less than 6 months 11. currently participating in other study 12. hp positive

Keywords: endoscopy mini invasive
process of regulation in addictions: vulnerability emotional factors to craving

Conditions: Craving; Emotional Dysfunction; Self-Regulation, Emotion; Alexithymia; Cocaine Addict

Summary: the aim of this study is to have a better understanding of the relationship between self-controle difficulties (and more specifically the inhibition deficit in impulsivity), emotional regulation disorders such as alexithymia and craving.this study will be the first in france to specify the interactions between self-regulkation processes dysfunctions and emotional dysfunctions in craving.

the main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (dsm 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. to evaluate cocaïne craving,the questionnaire ccq-brief will be used.

Eligibility criteria:
inclusion criteria: * patient, men or women between 18 and 60 years-old * patient with a diagnosis of moderate to severe dependence (dsm 5) to cocaine with or without co-addictions to alcohol or psychostimulant. * patient on day-hospitalisation or full hospitalisation * patient affiliated or beneficiary to a social security scheme. * patient having signed the free and informed consent. exclusion criteria: * patient with psychiatric disorders psychosis type * patient with severe chronic somatic disease. * patient participating in another clinical study * protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision. * pregnant, breastfeeding or parturient woman. * patient hospitalized without consent.

Keywords: vulnerability
delivery during covid-19 pandemic: implications for obstetrics, maternal psychopathology, and mother-infant relationship

Conditions: Delivery; Trauma; Covid19

Summary: the coronavirus 2019 (covid-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. in this study, we aimed to evaluate the relations between the fear of covid-19 and postnatal depression symptoms.

this is a multicenter prospective cohort study of childbearing women during covid-19. participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. fear of covid-19 was evaluated using the validated fear of covid-19 scale and postnatal depression was evaluated using the epds. pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Eligibility criteria:
inclusion criteria: * women who delivered during the covid-19 pandemic at the site, since 01-march-2020 exclusion criteria: * women age 18 and below * gestational age under 34 weeks * intra uterine fetal demise * ante-partum fetal demise * maternal post partum death
dexmedetomidine for lisa procedure in preterm infants

Conditions: RDS

Summary: the investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during lisa procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.

information will be given to parents of preterm babies \ 0.30 on cpap pressure of at least 6 cmh2o) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. after the step of sedation lisa is performed. before/during and after the procedure pain will be assessed by the nips scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. babies will then be managed in usual nicu way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.

Eligibility criteria:
inclusion criteria: 1. preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: vlbwi 26-31+6and lbwi 32-36+6. 2. respiratory distress syndrome requiring surfactant therapy exclusion criteria: 1. need for emergency intubation in the delivery room 2. major congenital malformations (such as cardiopathies) 3. chromosomic abnormalities 4. fetal hydrops 5. hypercapnia: co2 \> 65 mmhg 6. pneumothorax 7. hemodynamic compromise

Keywords: rds lisa preterm sedation dexmedetomidine