Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety of cd24-exosomes in patients with covid-19 infection

Conditions: SARS-CoV-2

Summary: this is an open-label phase i study, four dose escalation groups, to evaluate the safety of cd24-exosomes in patients with moderate/severe covid-19 disease. patients with moderate/severe covid-19 infection and factors predictive of a cytokine storm are recruited from the corona department of the tel aviv sourasky medical center (tasmc), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.

coronavirus disease 2019 (covid-19) is a highly transmissible disease in the community. the main cause of clinical deterioration that leads to death is the cytokine storm in the lung. cd24 is a small heavily glycosylated gpi-anchored protein. cd24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of t cells. hence, cd24 can negatively regulate inflammation. the treatment is a biologic therapeutic agent based on exosomes carrying cd24. the rationale for this treatment is that exosomes overexpressing cd24, isolated and purified from t-rex™-293 cells engineered to express cd24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. this enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events.

Eligibility criteria:
1. a covid-19 diagnosis confirmed with a sars-cov-2 viral infection positive polymerase chain reaction (pcr) test 2. disease severity: moderate/severe according to the following criteria (at least one clinical parameter and one laboratory parameter are required): 1. clinical and imaging-based evaluation * respiratory rate \> 23/ min and \< 30/min * spo2 at room air ≤94% and ≥90% * bilateral pulmonary infiltrates \>50% within 24-48 hours or a severe deterioration compared to imaging at admission 2. evidence of an exacerbated inflammatory process * ldh score \> 450 u/l * crp \>100 u/l * ferritin \>1650 ng/ml * lymphopenia \ 1 3. willing and able to sign an informed consent exclusion criteria: 1. age\ 85 years 2. any concomitant illness that, based on the judgment of the investigator is terminal 3. ventilated patient 4. pregnancy (positive urine pregnancy test \[women of childbearing potential only\]) or breastfeeding 5. unwilling or unable to provide informed consent 6. participation in any other study in the last 30 days

Keywords: sars-cov-2 severe acute respiratory syndrome coronavirus 2 covid-19 exosomes ards cd24 cd-24 exosomes
use of δivc for early diagnosis of ahf in aecopd

Conditions: Acute Decompensated Heart Failure; COPD Exacerbation

Summary: acute heart failure (ahf) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (aecopd). this association is frequently underestimated with regard to the difficulty of clinical diagnosis. the investigators expect that the application of the inferior vena cava collapsibility index (δivc)could be useful in this issue.

acute heart failure (ahf) is a common cause of copd exacerbation however its role is very often underestimated. until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the swanganz catheter has been stated as reference. other noninvasive diagnostic methods have been studied, such as systolic time intervals and valsalva maneuver, but their application still difficult in patients with copd exacerbation, especially in emergency department (ed) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the δivc for the early identification of ahf in patients presenting to the ed with acute copd exacerbation.

Eligibility criteria:
inclusion criteria: * patient with history of copd and admitted to the emergency departement for aecopd exclusion criteria: * impossibility to give consent to participate in the study, non consent patients * post traumatic dyspnea * instable hemodynamic or neurological status

Keywords: copd acute heart failure inferior vena cava ultrasound collapsibility index
normal and abnormal erp during tom and emotional conflicts in schizophrenia

Conditions: Schizophrenia

Summary: case-control comparison of clinical population, interventional and single-center research.

the main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. two groups of subjects are recorded : schizophrenic patients and healthy controls. visual reinforcement effect during theory of mind judgment is tested.

Eligibility criteria:
inclusion criteria: written informed consent french mother tongue schizophrenia diagnosis according to dsm-iv-r for the patient group exclusion criteria: coma history, epilepsy, head trauma with loss knowledge greater 10 min ect older than 1 month dsm-4 r criteria of toxic addiction in the last 6 months deafness or blindness scalp pathology intracranial implanted device
transgender observational performance

Conditions: Transgender Persons

Summary: the study will evaluate the sports capabilities of transgender women mainly in terms of muscular strength and aerobic capacity (vo2max). the control group will be composed of cisgender women and cisgender men with the same levels of physical activity.


Eligibility criteria:
inclusion criteria: * diagnosis of a transgender woman by the dsm-v or icd10. * gonadectomized and non-gonadectomized * initiation of androgen blockade and/or estrogen use after 12 years of age. * age range 18 to 50 years old. * bmi: 18.0 to 34.9 kg/m2. * well-trained individuals (ipaq very active) exclusion criteria: * current or previous morbidities that could interfere with strength or aerobic tests. * chronic illnesses and/or chronic medication use. * musculoskeletal limitations.

Keywords: transgender women oxygen uptake cardiac output muscle strength acute physical effort
a real-world study on patients of unresectable giant cell tumor of bone

Conditions: Giant Cell Tumor of Bone

Summary: this is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of chinese populations of surgically unsalvageable or severe post-surgery morbidity associated giant cell tumor of bone (gctb), collectively referred to as unresectable gctb, during 2013-2021 in three medical centers, serving as the external control for a single arm phase ib/ii trial on jmt103 treatment of gctb. 301 patients were enrolled and divided into 2 groups according to their actual previous exposures. group 1 (n=135) was denosumab group. group 2 (n=166) included two types of exposures other than denosumab: other anti-gctb drug therapies, or no therapy on gctb patients. the dosage, route, frequency and other administration methods was collected according to the actual previous treatment records. the primary outcome measure was the tumor response rate \[radiographic tumor response (cr/pr evaluated by icds or eortc criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline\]. the key secondary endpoint was the tumor response rate \[radiographic tumor response (cr/pr evaluated by icds or eortc criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline\]. other secondary outcome measures include: proportion of patients whose tumors was surgically resectable; median duration of tumor response (dor), disease control rate (dcr), and time to disease progression (ttp); and types and proportion of key adverse reactions.


Eligibility criteria:
inclusion criteria: * 1. both genders, aged 18 years or above; * 2. patients pathologically diagnosed of giant cell tumor of bone (gctb), and are surgically unsalvageable, or salvageable but surgery was associated with severe morbidity based on physician's judgement; * 3. for patients received denosumab or other anti-gctb medications, one of the two is required: imaging data (including x-ray, ct, mri or pet-ct) prior to and at least once followed to administration, or pathological data on surgically resected gctb; for patients with no medication, imaging data or pathological data on surgically resected gctb is required. exclusion criteria: * 1. no access to definite treatment information; * 2. bone metabolic diseases diagnosed before treatment: hypo-/ hyperparathyroidism, hypo-/hyperthyroidism, hypopituitarism, hyperprolactinemia, cushing syndrome, acromegaly, paget disease, etc; * 3. complication of malignant tumor receiving anti-tumor therapy.
a study of recombinant human erythropoietin beta (neorecormon) in anemic cancer participants treated with chemotherapy

Conditions: Anemia

Summary: this study will evaluate the efficacy and tolerability of subcutaneous (sc) or intramuscular (im) recombinant human erythropoietin beta (r-huepo) in participants with anemia and histologically or cytologically confirmed cancer.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmed cancer * participants who are treated with at least first line chemotherapy * hemoglobin less than (\<) 11 grams per deciliter (g/dl) * participants able to receive iron supplement, if necessary exclusion criteria: * history of hypersensitivity to active or inactive excipients of r-huepo * insufficient controllable hypertension * thalassemic syndromes * anemia caused by hematic loss * women who are pregnant or lactating
impact of sperm dna integrity on in vitro cycles

Conditions: Male Infertility; Unexplained Infertility; Abortion, Habitual

Summary: sperm dna integrity will be measured via the toluidine blue assay (tba) for patients undergoing in vitro fertilization (ivf); the study will determine correlations, if any, between ivf success and sperm dna integrity.


Eligibility criteria:
inclusion criteria: * couple undergoing ivf at the center for human reproduction * sperm sample given from partner (not a donor) exclusion criteria: * low sperm concentration (\<5 million/cc) * using a donor sample

Keywords: sperm dna integrity toluidine blue assay (tba) ivf outcome
fecal microbiota transplantation in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: fecal microbiota transplantation(fmt) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. this is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed adult patients with mild-moderate uc. the primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation,in newly diagnosed adult patients with mild-moderate uc. all processing will occur at the center for microbiome research at assaf harofeh medical center, under gmp conditions.


Eligibility criteria:
inclusion criteria: * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. women of childbearing potential will have a urine pregnancy test, which must be negative, on study day 1, prior to receiving fmt. men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after fmt. * ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool. * ability to swallow oral medications. exclusion criteria: * severe, uncontrolled ulcerative colitis. * patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. * delayed gastric emptying syndrome * known chronic aspiration * patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs) * pregnant and breast-feeding women * participants who are unable to swallow pills.

Keywords: ibd colitis fecal fmt microbiota transplantation
anticoagulation tracking intervention and evaluation

Conditions: Anticoagulation; Atrial Fibrillation; Atrial Flutter; Pulmonary Embolus/Emboli; Deep Vein Thrombosis; Stroke; Hypercoagulability

Summary: anticoagulants are a leading cause of acute injury from adverse drug events, leading to \~20,000 serious injuries reported to the food and drug administration per year and more than 220,000 emergency department visits annually. therefore, we propose to implement a health information technology (hit) population management tool at two distinct anticoagulation clinics that will allow the care team to assign and track tasks essential for timely patient monitoring. we will examine its effect on anticoagulation management outcomes through a randomized trial, hypothesizing that such interventions can be effective as well as cost-effective strategies to improve patient safety in the context of anticoagulation management services.


Eligibility criteria:
inclusion criteria: * adults (age ≥18 years) * those prescribed an anticoagulation medication at zuckerberg san francisco general hospital or university of california, san francisco health exclusion criteria: * minors (age\<18) * those not prescribed anticoagulation medication at zsfg or ucsf health
thailand hdv cohort

Conditions: HDV

Summary: there is very limited data of hdv in thailand. as both hdv and hiv can accelerate the hbv course and increased the risk of death, particularly, among those with low cd4 cells/count, therefore, hdv burden in this special population is unmet need. therefore, this study plans to perform a nationwide survey of the prevalence and predictor of hdv among people uses drugs (pwid) with and without hiv, hbv/hiv (msm vs non msm), hbv related cirrhosis. findinds from this study will provide the scientific community to understand how important hdv is among hbv patients, this could be used to develop strategies for hdv screening and treatment

the prevalence of hdv remains ill-defined, mainly for lack of appropriate testing and screening. as both hdv and hiv can accelerate the hbv course and increased the risk of death, particularly, among those with low cd4 cells/count, therefore, hdv burden in this special population is unmet need. this data will inform the guideline whether hdv screening among hbv/hiv is required. this study has plans to perform a nationwide survey of the prevalence and predictor of hdv among people uses drugs (pwid) with and without hiv, hbv/hiv (msm vs non msm), hbv related cirrhosis. this nationwide survey of hdv is collaboration between thai liver society, thai aids society, thai red cross aids research centre, faculty of medicine chulalongkorn university, and aids tb and sti control division, department of disease control, moph thailand. all findings will be shared and discussed to develop the national guideline for screening, treatment and care.

Eligibility criteria:
inclusion criteria: 1. male or female, aged 18 years and older 2. chronically-infected with hbv, as defined by: positive hepatitis b surface antigen hbsag) or hbv dna result with a subsequent positive hbsag or hbv dna result at least 6 months after first positive result 3. provide signed and dated informed consent form. exclusion criteria: non chronic hbv

Keywords: hbv hdv cirrhosis thailand
pregnancy subsequent to ventral hernia repair

Conditions: Hernia, Ventral; Pregnancy

Summary: we will examine the outcome of ventral hernia repair with subsequent pregnancy


Eligibility criteria:
inclusion criteria: * history of ventral hernia repair with subsequent pregnancy * born between january 1 1955 and january 1 1995 exclusion criteria: * registered in the danish hernia database with a non-valid id-number, i.e. non-danish resident.
hepcidin levels in periodontal health and disease

Conditions: Periodontal Diseases

Summary: periodontal disease refers to inflammatory disease of the periodontium caused by the host and/or pathogenic microorganisms. anti-inflammatory and pro-inflammatory cytokines play a role in the periodontal inflammation process. the aim of this study was to evaluate the levels of hepcidin, interleukin (il)-6, and il-10 levels in gingival crevicular fluid (gcf) and in serum samples obtained from individuals with periodontal inflammation.

the study included 90 individuals, who were divided into three groups: periodontally healthy (ph) (n=30); gingivitis (g) (n=30); and chronic periodontitis (cp) (n=30). gcf and serum samples were obtained from each individual, and samples were evaluated using elisa. statistical evaluation of the data was performed using the spss packet data program.

Eligibility criteria:
inclusion criteria: * systematically healthy patients. patients who did not receive any medication or periodontal treatment within the previous 6 months exclusion criteria: * individuals who smoked and women who were pregnant and/or lactating were excluded from the study

Keywords: periodontal diseases hepcidin elisa interleukin 6 interleukin 10
escitalopram neuroimaging supplement

Conditions: Body Dysmorphic Disorder

Summary: the purpose of this study is to find out more about the brain's response to selective serotonin reuptake inhibitor (ssris) treatment in people with body dysmorphic disorder (bdd). the investigators will use positron emission tomography (pet) and magnetic resonance imaging (mri) scans to look at brain activity in people with bdd before and after treatment with an ssri. the investigators hope that what is learned will allow prediction of whether someone will improve with ssri treatment.

the investigators have chosen to focus on five regions of interest, namely acc, ofc, caudate, amygdala and hippocampus. these are brain regions that have been previously associated with obsessive-compulsive, affective, and psychotic phenomena. the investigators will test for correlations between pre-treatment fdg brain images and subsequent ssri treatment outcome to identify potential predictors of treatment response. finally, the investigators will compare pre-treatment and post-treatment pet fdg studies as well as mri studies in bdd subjects to examine changes in these brain regions following treatment. the goals of the proposed research are to use fdg-pet and mri to identify predictors of treatment response to ssris in bdd and to determine changes in rcmrglu in bdd subjects following treatment with ssris.

Eligibility criteria:
inclusion criteria: * male or female. * from 18-64 years of age. * right-handed, by virtue of assessment with the edinburgh handedness inventory * capacity to render informed consent. * already enrolled in clinical study nct00149799. * must be an outpatient with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of bdd, as defined by dsm-iv criteria and by a bdd yale-brown obsessive-compulsive scale score greater than or equal to 24. exclusion criteria: * with serious medical illness or instability for which hospitalization may be likely within four months of entry into the study, or current renal insufficiency or diabetes. * any pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded. pregnancy status will be determined by administration of a blood beta-hcg test prior to each pet scan. * with recent or anticipated radiation exposure, which, combined with the exposure in the present study, will exceed allowable annual limits for the subject * with a history of hypersensitivity to any component of fdg * with specific comorbid psychiatric diagnoses (alcohol abuse or dependence within the past 3 months, bipolar disorder, psychosis, organic mental disorder, development disorder, borderline personality disorder, body image concerns accounted for primarily by an eating disorder or weight concerns). if subjects have another comorbid diagnosis, the bdd must be the primary concern. * mri- incompatibilities (for example, metal implants, pacemakers)

Keywords: bdd
tacrolimus treatment for refractory autoimmune cytopenia

Conditions: Autoimmune Hemolytic Anemia; Pure Red Cell Aplasia; Evans Syndrome

Summary: autoimmune cytopenia, including autoimmune hemolytic anemia (aiha), pure red cell aplasia (prca), evans syndrome (es), usually has good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependent on steroids to maintain an acceptable level of hemoglobin or platelets. the effects of the second line therapy are also not satisfactory and sometimes not available. the investigators aim to explore the efficacy and side-effect of tacrolimus for refractory autoimmune cytopenia.

tacrolimus binds fkbp12 with high affinity after entry into cytoplasm, suppresses calcineurin activity and prevents nuclear translocation of transcription factors such as nf-at that are involved in il-2 gene transcription. as a result, t-cell activation is inhibited with a subsequent reduction in the production of cytokines that include il-2, tnf-α, il-3, il-4, ifn-γ, il-6 and il-10; b-cell activation, class-switching and immunoglobulin production are also attenuated. reports on the use of tarcrolimus in the treatment of autoimmune cytopenia are anecdotal and describe therapy with a variety of drug dosages. the purpose of this study is to evaluate the effect of tacrolimus on patients with refractory autoimmune cytopenia, the side-effects will be documented and plasma concentration of tacrolimus will be monitor.

Eligibility criteria:
inclusion criteria: * refractory autoimmune cytopenia, including autoimmune hemolytic anemia, pure red cell aplasia, evans syndrome. * 18-80 years old. * no response or intolerant to first and second line therapies. * ecog performance status of 0-2 * written informed consent. exclusion criteria: * other diseases which might cause hematological abnormalities. * response and well tolerate to first or second line therapy. * patients who are under 18-year-old or over 80-year-old. * pregnant or lactating. * patients unwilling to or unable to comply with the protocol.

Keywords: tacrolimus refractory autoimmune cytopenia prospective study
risk perception of needlestick injury

Conditions: Needlestick Injuries

Summary: the purpose of this study is to determine the effectiveness of needlestick injury prevention module

after being informed about the study and the potential risk, participants were given written informed consent to be filled out and signed. agreed participants will receive a 1-week duration of educational intervention. the intervention only involved education and was less likely to cause injury or damage to the body.

Eligibility criteria:
inclusion criteria: 1. all house officer in government hospitals with house officer training programme 2. house officers must be among those who join housemanship program for minimum of 1 month duration exclusion criteria: 1. house officer who undergo attachment outside the training hospital 2. house officer that are not available during the data collection period or on long leave