Kornimate/medical-research-clean huggingface dataset:
endobarc-s study: "endovascular branched stent-grafts for aortic arch pathologies in spain"

Conditions: Thoracic Aortic Aneurysm; Thoracic Aortic Dissection; Stent-Graft Endoleak; Stent-Graft Stenosis; Intramural Hematoma; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases

Summary: the endobarc-s post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (nexus stent-graft system®, relay branch® or zenith arch branch graft®), with proximal landing at zone 0. the secondary objective is to evaluate the safety and clinical performance of the studied devices.

in this study patients will be observed, who receive a branch stent graft systems (nexus stent-graft system®, relay branch® or zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. the devices will be implanted at the discretion of the treating physician. participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (nexus stent-graft system®, relay branch® or zenith arch branch graft®). informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. the period of data collection will be approximately 60 months from the index procedure for each patient. source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. complete dicom image files of the ct scans will be sent to the corelab for independent evaluation.

Eligibility criteria:
inclusion criteria: * patient is between 18 and 90 years old * patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (nexus stent graft system©, relay® branch or zenith arch branch graft®, with proximal landing at zone 0. * patient must be available for the appropriate follow-up times for the duration of the study * informed consent signed. exclusion criteria: * patient less than 18 years old or more than 90 years old. * patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium) * patient has systemic infection or suspected systemic infection * patient has thrombocytopenia (platelet count \< 150000/µl) * patient has untreated hyperthyroidism * patient has a progressive or untreated malignancy. * patient is pregnant or breastfeeding. * patient has a life expectancy of less than 1 year. * not informed consent signed

Keywords: aorta thoracic aortic aneurysm thoracic aorta dissection endovascular repair
co-sér: serological analysis and viral neutralization in people with a documented covid-19 infection

Conditions: SARS-CoV Infection; Immune System Disorder

Summary: in light of the current coronavirus disease 2019 (covid-19) pandemic, the investigators want to better study the immunological characteristics of severe acute respiratory syndrome-coronavirus 2 (sars-cov2) infections in adults. the investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with sars-cov2. by collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. the investigators will evaluate the quality of the antibodies and their neutralising capacity. in a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 ml) of, in case of insufficient b-cells, a leucapheresis (after consent of the patient). these antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies. aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use. after the completion of the study, the samples will be stored for 30 years with consent of the participants.


Eligibility criteria:
inclusion criteria: * evidence of prior covid-19 infection, documented by polymerase chain reaction (pcr) or antibody testing (igg based) exclusion criteria: * known pregnancy at the time of screening * patient is on immunosuppressive therapy or was treated with immunosuppressive therapy during the last 6 months * inability to give informed consent or absence of legal representative who can give informed consent.

Keywords: immunology sars-cov2 antibodies
volume deficit prior to surgery

Conditions: Hypovolemia; Surgery

Summary: it is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery. the investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.

intravascular volume optimization has shown to improve outcome after surgery. in minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. patient scheduled for minor surgery are included. after the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. stroke volume is obtained by esophageal doppler technique which is a minimally invasive method. the volume estimated for optimization is considered as the functional volume deficit. in the healthy subjects the probe will be placed in the awake subject. a standardized meal and fluid intake secures that the subjects are in a non-fasting state.

Eligibility criteria:
inclusion criteria: * planned minor or medium sized surgery exclusion criteria: * oesophageal pathology * age \>90 yr or \< 18 yr * alcohol abuse, * insulin dependent dm

Keywords: minor surgery volume optimization volume deficit epidural anesthesia
sublingual versus vaginal misoprostol in medical treatment of second trimestric missed miscarriage

Conditions: Miscarriage

Summary: the aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage

in women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.

Eligibility criteria:
inclusion criteria: * all women above 18 years of age * between 13-26 weeks of gestation. * pregnancy is confirmed by a pregnancy test or ultrasound scan. * missed abortion * normal general and gynecological examination. exclusion criteria: * hemodynamically unstable. * suspected sepsis with temperature 38 °c. * concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, * respiratory illnesses, recent liver disease, or pruritus of pregnancy. * presence of intrauterine contraceptive device (iucd). * suspect or proven ectopic pregnancy. * -failed medical or surgical evacuation before the presentation. * known allergy to misoprostol.

Keywords: miscarriage sublingual vaginal misoprostol
serum visfatin and serum vaspin in patients with hepatocellular carcinoma on top of liver cirrhosis

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) has a global importance due to its high rate of progression and high mortality rates. significant risk factors for the development of hcc are metabolic syndrome, obesity and type 2 diabetes mellitus(t2dm). dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis \& due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with hcv-related liver cirrhosis with and without hcc on top.

despite improvements in hcc therapy, the prognosis for hcc patients remains poor due to a high incidence of recurrence. early diagnosis can significantly improve the overall survival of hcc patients. however, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. for instance, the gold standard marker alpha-fetoprotein (afp) has a false negative rate up to 40% for early stage of hcc. it is worthy to mention that the level of afp was reported in a normal range of 25% of patients with advanced hcc. as such, afp has been excluded from being a marker for the diagnosis of hcc by practice guidelines of the american association for the study of liver diseases (aasld) and confirmed by other studies. these discrepancies suggest the need of discovering new reliable diagnostic markers for patients with hcc. an improved understanding of the pathogenesis of hcc development would facilitate the development of more effective outcomes for the diagnosis and treatment of hcc at earlier stages.

Eligibility criteria:
inclusion criteria: * the diagnosis of chc will be based on positive hcv antibodies by enzyme-linked immunosorbent assay(eliza)\& hcv rna by polymerase chain reaction ( pcr) for more than 6 months. the diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. the diagnosis of hcc will be based on the typical features of dynamic imaging by triphasic ct with or without elevated serum alpha-fetoprotein (afp) . exclusion criteria: * - co-infection with hbv. * presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (psc), primary biliary cholangitis (pbc), wilson's disease, fatty liver disases with metabolic syndrome \&drug induced liver disease. * patients diagnosed with other malignancies. * patients with history of prior local or systemic hcc-specific treatment.
cognitive remediation in schizophrenia

Conditions: Schizophrenia; Psychosis

Summary: the aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (crt) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses. cognitive deficits are a problem for many people with schizophrenia. this study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

the aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (crt) that focuses on working memory training in a sample of community based patients with schizophrenia. pre and post neuropsychological assessment and magnetic resonance imagery (mri) will be used to determine the effects of cr training on 1. neuropsychological performance 2. brain structure using voxel-based morphometry (vbm) 3. brain function using functional mri (fmri) 4. social and occupational functioning the cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.

Eligibility criteria:
inclusion criteria: * schizophrenia * history of psychosis * subjective difficulties with memory or concentration * aged 18-60 years exclusion criteria: * history of head injury resulting in loss of consciousness * substance misuse in the last 3 months

Keywords: schizophrenia psychosis cognitive deficits
screening for covid-19 in teachers, childcare educators, pupils and preschoolers

Conditions: SARS-CoV-2

Summary: the main objectives of this study are 1. to establish the prevalence of sars-cov-2 in schools and kindergartens in the state of mecklenburg-vorpommern in autumn and winter 2020/2021 2. to monitor the future spread of the disease by assessing serological responses to sars-cov-2 in teachers and childcare educators over time

detailed description: this study aims to collect information on teachers and childcare educators as well as on pupils and preschoolers in the state of mecklenburg-vorpommern over a 5 month period, 5 study visits per participant are planned. at each visit, nasal/throat swabs (for pcr testing) will be collected and participants will be asked to fill in a questionnaire (asking for sars-cov-2 risk factors, perceived risk, and impact of the pandemic on their quality of life). in adults, additional blood samples (for sars-cov-2 antibody testing) will be collected at the first and the last study visit. this will help to gain a better understanding of viral load and antibody development over time. the remaining blood samples will be stored in a repository for future research. the study is part of a modular sars-cov-2-research programme of the university medicine greifswald.

Eligibility criteria:
inclusion criteria: * see cohort descriptions * willing to have blood samples stored for future research exclusion criteria: - none

Keywords: serology antibody formation epidemiology
clinical trial to evaluate the efficacy and safety of 'gla5pr glars-nf1 tab.' in peripheral neuropathic pain

Conditions: Pain of Mononeuropathy

Summary: a multi-center, randomized, double-blind, parallel, active-controlled phase iii clinical trial to evaluate the efficacy and safety of 'gla5pr glars-nf1 tab.' and 'pregabalin' in peripheral neuropathic pain


Eligibility criteria:
inclusion criteria: * both male and female who are over 19-year-old * patient whose pain scale is 4\~9 * patient who has pain of mononeuropathy exclusion criteria: * patient whose ccr is \<60ml/min * patient who has other pain which is not from mononeuropathy * patient who is going to have an operation during this study * patient who has abnormal ecg
chemotherapy-related toxicity, nutritional status and quality of life

Conditions: Toxicity Due to Chemotherapy; Cancer Cachexia; Metastatic Colorectal Cancer; Quality of Life; Dietary Modification

Summary: determine whether nutritional support with high protein ons in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

other endpoints: * to determine whether high protein ons influence on the nutritional status * to determine whether high protein ons influence on the quality of life * to determine whether high protein ons influence on the performance status * to determine high protein ons tolerability / ons intake compliance

Eligibility criteria:
inclusion criteria: * histological confirmed diagnosis of crc in clinical stage iv * successful qualification to chemotherapy * performance status at least 80% according to karnofsky scale and \<2 according to who/ecog scale * cancer-related asymptomatic precachexia diagnosed * absence of contraindications to oral nutrition and practicable realization of oral nutrition * absence of severe, decompensated concomitant diseases * signed informed consent for the participation in the study exclusion criteria: * diagnosis of a malignant neoplasm in clinical stage i-iii * disqualification from oncologic treatment * cancer cachexia or cancer anorexia-cachexia syndrome * poor performance status * contraindications to oral nutrition or to high protein nutrition * regular nutritional support at the moment of qualification to the study * patient incompliance at the moment of qualification to the study
insulin pre-treatment for steroid-associated hyperglycemia in pregnant diabetic patients

Conditions: Hyperglycemia in Pregnant Diabetic Patients

Summary: our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control. our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.


Eligibility criteria:
inclusion criteria: 1. pregnant women with gestational or pre-existing diabetes admitted to the university of minnesota 2. must be 18 years or older 3. must speak english, spanish, or somali 4. patients must receive steroids for fetal lung maturity as part of their hospital course exclusion criteria: 1. pregnant women with type 1 diabetes, or type 2 diabetes with evidence of end-organ disease 2. pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy
perampanel for status epilepticus prophylaxis post-cardiac arrest

Conditions: Heart Arrest; Seizures; Status Epilepticus

Summary: brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. the investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (pcarse) prevention after cardiac arrest.

more than 500,000 americans have a cardiac arrest every year and 100,000 survive to hospital admission. brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. seizures with or without muscle jerks, i.e. myoclonic seizures, are the most common seizure type after a cardiac arrest. despite being common, seizures are usually refractory to treatment (post-cardiac arrest refractory status epilepticus) and the vast majority of patients with this diagnosis die. we are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for pcarse prevention after cardiac arrest. perampanel is a non-competitive ampa glutamate receptor antagonist approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, however there are no randomized trials in critically ill cardiac arrest patients at risk for seizures. this medication has been used for the management of refractory status epilepticus, including status epilepticus post-cardiac arrest. we will randomize patients to placebo or perampanel after admission to the intensive care unit. the study's primary outcome will be the incidence of severe adverse events. secondary efficacy and safety endpoints include incidence of seizures and pcarse, seizure frequency, time to seizure control, number of anti-seizure medications necessary for seizure control, duration of treatment with anesthetics for seizure control, and time to coma awakening. this study will help determine the safety and feasibility of primary seizure prophylaxis after cardiac arrest.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * non-traumatic, out-of-hospital cardiac arrest * comatose on admission - defined as not following commands * return of spontaneous circulation (rosc) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or ems (emergency medical services) witnessed arrest) * admission to the intensive care unit at zuckerberg san francisco general hospital exclusion criteria: * acute cerebral hemorrhage or infarction * pregnancy * prisoner * severe kidney function impairment with creatinine clearance inferior to 30 ml/min * severe liver impairment with liver function tests five times above the upper limit of normal * electrographic or electroclinical seizures diagnosis using american clinical neurophysiology criteria confirmed by an epileptologist after cardiac arrest

Keywords: heart arrest seizure status epilepticus prophylaxis
comparing efficacy and safety of tacrolimus with steroids or monoclonal anti-il2r antibody in hepatitis c virus (hcv) positive liver transplant patients

Conditions: Hepatitis C; Liver Transplantation

Summary: this is an exploratory study to evaluate the impact of eliminating steroid administration upon viral hcv load at 12 months measured by quantitative serum hcv-rna determination in patients transplanted for hcv cirrhosis.

a comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (mab) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Eligibility criteria:
inclusion criteria: * patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for hcv-cirrhosis are eligible for the study. * patients receiving a cadaveric liver transplant with compatible abo blood type can be included. exclusion criteria: * recipient of multi-organ transplant * recipient of an auxiliary graft * patient is receiving abo incompatible graft * patients requiring immunosuppressive treatment * patients requiring ongoing corticosteroid therapy. * patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. * patient or donor is known to be hiv positive. * patient is allergic or intolerant to study medication * patient is pregnant or breast-feeding. * patient has been previously enrolled in this study

Keywords: tacrolimus liver transplantation immunosuppression adult treatment outcome
synovial sarcoma registry / biospecimen repository

Conditions: Synovial Sarcoma

Summary: the purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. the future research will involve various types of genetic testing. participants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.

this study will enroll patients with a diagnosis of synovial sarcoma. following consent, demographic, clinical, treatment and outcome data will be collected from an interview and/or online survey. this will include a request for contact information for the subject's treating hospitals/physicians and a release of records request to obtain medical records. at approximately 6-12 month intervals for up to 10 years after initial diagnosis and/or relapse, subjects and/or their treating hospitals may be contacted to provide updates on treatment and outcomes. tumor samples may be collected from residual material obtained during clinically indicated procedures occurring before or after consent to this study. no additional material will be collected or procedures performed solely for the purpose of this study. blood may be collected at the participant's local institution at the time of a clinically indicated blood draw and/or saliva or a buccal swab may be collected as a germline sample and for analysis of circulating free dna (cfdna) and/or circulating tumor cells (ctcs). genetic testing may be performed on tumor and germline samples submitted by subjects. results will only be returned if deemed clinically significant.

Eligibility criteria:
inclusion criteria: 1. males or females of any age 2. reported diagnosis of synovial sarcoma 3. informed consent from subject (aged ≥18 years) or parent/guardian exclusion criteria: 1. individuals with sarcomas that do not fit the definition of those considered for this registry 2. individuals who are unwilling to participate 3. individuals who are unwilling or unable to provide written consent

Keywords: registry biorepository sarcoma oncology cancer rare tumor