Kornimate/medical-research-clean huggingface dataset:
multi-modal imaging and artificial intelligence diagnostic system for multi-level clinical application

Conditions: Diabete Mellitus; Diabetic Retinopathy

Summary: this study is to build an multi-modal artificial intelligence ophthalmological imaging diagnostic system covering multi-level medical institutions. we are going to evaluate this system in an evidence-based medicine view, taking diabetic retinopathy as an example. and clinical diagnostic criteria will be made based on this multi-modal artificial intelligence imaging diagnostic system. the study is designed as a cross-sectional study involving 1,000 normal individuals, 1,000 diabetes patients without ocular complications, and 1,000 with diabetic ocular complications. statistical analysis of the diagnostic sensitivity and specificity of the artificial intelligence system will be made, and roc curve wil be draw.


Eligibility criteria:
inclusion criteria: group a(normal individuals): meet all the items 1 \~ 5 below 1. no familial or hereditary retinopathy; 2. no history of ocular trauma and / or history of ocular disease (except for mild to moderate refractive errors and / or age-related cataracts); 3. no drug use history that may cause side effects of retina (such as chloroquine, hydroxychloroquine, chlorpromazine, rifampin, etc.); 4 binocular diopter ≤ ± 6.00d; no systemic diseases that may affect the retina. group b(diabetes patients without ocular complications): meet any of 1 to 3, and both 4 to 5 items 1. diagnosed with type 1 diabetes for more than 5 years; 2. diagnosed with type 2 diabetes patients; 3. diagnosis of gestational diabetes patients; 4. without systemic disease that may affect the retina except for diabetes; 5. meet the standards of 1 to 4 items. group c(patients with diabetic ocular complications): meet with any of 1 to 3, and all 4 to 6 items 1. diagnosed with type 1 diabetes for more than 5 years; 2. diagnosed with type 2 diabetes patients; 3. diagnosis of gestational diabetes patients; 4. meet the guidelines for diagnosis and treatment of diabetic retinopathy in any stage of diabetic retinopathy and / or diabetic macular edema. 5. without systemic disease that may affect the retina except for diabetes; 6. a group to meet the criteria for 1 to 4 items. exclusion criteria: 1. refractive pathway is turbid, so that fundus image can not be clearly photographed; 2. with other fundus diseases and / or other diseases that seriously affect the visual function; 3. any eye infection, such as conjunctivitis, keratitis, scleritis, endophthalmitis, acute and chronic dacryocystitis, or eye injury; 4. serious systemic diseases such as diabetes, hypertension, heart failur,renal failure; 5. can not cooperate with the examiner due to mental or other reasons.

Keywords: diabete mellitus diabetic retinopathy artificial intelligence
upper extremity versus lower extremity accessory access sites during transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: the goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation. the main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach: * is associated with less clinically relevant access site-related bleeding complications. * is associated with a shorter time to mobilization after tavi. * is associated with a shorter duration of hospitalization. * has the same early safety outcomes at 30 days post-tavi. participants will be subject to the usual care surrounding a tavi procedure but will also will be asked to fill out two questionnaires before and after tavi: * quick disabilities of the arm, shoulder and hand (quick dash) * lower extremity functional scale (lefs) researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.


Eligibility criteria:
inclusion criteria: * patients must be \> 18 years old. * written informed consent is obtained from all patients. * planned for transfemoral tavi procedure. exclusion criteria: * inability to obtain informed consent. * contra-indication for brachial or femoral vein access (temporary pacemaker access site). * contra-indication for radial or femoral artery access (diagnostic access site). * use of a cerebral embolic protection device (cepd) if this requires an additional (arterial) access site.

Keywords: transcatheter aortic valve replacement coronary angiography hemorrhage hospitalization pacemaker
txa127 for the treatment of severe covid-19

Conditions: COVID-19

Summary: the purpose of this study is to determine if administration of angiotensin-(1-7) (txa127) prevents acute kidney injury and deterioration into multi-organ failure in patients with severe covid-19. participants will undergo a 10-day treatment with either placebo or study drug. the drug will be administered intravenously for 3 hours once each day for 10 days consecutively.

corona virus disease 2019 (covid-19) has been associated with severe respiratory and multiorgan failure. research shows that covid-19 reduces levels of angiotensin-converting enzyme-2 (ace-2), an enzyme that converts angiotensin ii to angiotensin 1-7 (known as txa127). covid-19 reduces levels of ace-2 and therefore angiotensin 1-7 and as a result, angiotensin ii levels are going to be increased. many clinical observations in covid-19 have shown the high incidence of acute kidney injury that may be due to excessive levels of angiotensin ii. the investigators hypothesize that administration of angiotensin (1-7) replaces levels of ace-2 in covid-19 and thereby ameliorates deterioration of multi-organ failure and specifically acute kidney injury.

Eligibility criteria:
inclusion criteria: * severe covid-19: adult patients admitted to the hospital through the emergency department (ed) requiring oxygen therapy (any level) to maintain oxygen saturation (sao2) \> 90% * covid positive by polymerase chain reaction (pcr) on hospital admission * hospitalized patients aged 18 years or greater exclusion criteria: * pre-existing chronic kidney disease * new use of or change in dose of ace-inhibitors or angiotensin receptor blocker (arb) within the last 6 months * acute kidney injury at the time of enrollment defined as either increase pf serum creatinine by more than 50% or 0.3 mg/dl above baseline or estimated creatinine clearance (by mdrd) of less than 60 ml/min (if no baseline serum creatinine available) * pregnant and breastfeeding women * contraindicated medications: new use or change of medications from start of trial (start of an ace inhibitor or arb within 6 months of trial).

Keywords: covid-19 multi-organ failure acute kidney injury
tissue and blood biomarkers from patients with stage iii or stage iv melanoma treated with ipilimumab with or without sargramostim

Conditions: Melanoma (Skin)

Summary: rationale: studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. it may also help doctors understand how well patients respond to treatment. purpose: this research trial studies tissue and blood biomarkers in patients with stage iii melanoma or stage iv melanoma treated with ipilimumab with or without sargramostim.

objectives: * to compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (gm-csf) and patients receiving ipilimumab alone. * to determine the effects of the addition of systemic gm-csf to ipilimumab on effector immune function in patients with metastatic melanoma. * to determine the effects of the addition of systemic gm-csf to ipilimumab on regulatory immune function in patients with metastatic melanoma. * to determine the effects of the addition of systemic gm-csf to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma. outline: serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by ihc, rt-pcr, flow cytometry, elispot assays, and elisa.

Eligibility criteria:
disease characteristics: * diagnosis of measurable unresectable stage iii or stage iv melanoma * treated with ipilimumab with or without sargramostim on clinical trial ecog-e1608 * primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues patient characteristics: * ecog performance status 0 or 1 prior concurrent therapy: * see disease characteristics

Keywords: stage iiic melanoma stage iv melanoma recurrent melanoma
therapy optimization trial for the treatment of relapsed or refractory brain tumors in children

Conditions: Recurrent Brain Tumors; Supratentorial PNETs; Medulloblastomas; Ependymomas

Summary: the purpose of this study is to improve overall survival while maintaining a good quality of life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas, supratentorial pnets, ependymomas who grade ii and iii). response to different chemotherapy options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a multimodal therapy will be assessed. progression-free, overall survival and toxicity will be evaluated additionally.

parts of the study: p-hit-rez-2005: a trial for the treatment of relapsed pnets (medulloblastomas,supratentorial pnets) e-hit-rez-2005: a trial for the treatment of relapsed ependymomas (phase ii-study with temozolomide) phase ii-study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed pnets and ependymomas with subarachnoid tumor manifestation (window study)

Eligibility criteria:
inclusion criteria: disease characteristics * histologically confirmed medulloblastoma, cerebral pnet or ependymoma * refractory or relapsed disease * measurable disease by mri or detection of tumor cells in cerebrospinal fluid patients characteristics * performance status ecog ≥ 3 or karnofsky status ≥ 40% * life expectancy ≥ 8 weeks hematological: * absolute leukocyte count ≥ 2.0 x 10\^9 /l * hemoglobin ≥ 10g/dl * platelet count ≥ 70 x 10\^9/l renal: * creatinine no greater than 1.5 times unl * no overt renal disease hepatic: * bilirubin less than 2.5 times unl * ast and alt less than 5 times unl * no overt hepatic disease pulmonary: * no overt pulmonary disease cardiovascular: * no overt cardiovascular disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled infection prior concurrent therapy * more than 2 weeks since prior systemic chemotherapy * more than 4 weeks since prior radiotherapy * no other concurrent anticancer or experimental drugs examinations required * examination of lumbar csf * cranial and spinal mri within 14 days prior to start of treatment

Keywords: brain tumor relapse children etoposide intraventricular temozolomide
minimally invasive versus open liver resection for patients with colorectal cancer liver metastases

Conditions: Colorectal Liver Metastasis

Summary: to examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

the minimally invasive procedure contain laparoscopic or robotic surgery

Eligibility criteria:
inclusion criteria: * patients were diagnosed with colorectal cancer liver metastases * without extra-hepatic liver metastases * age were within 18-75 yeas * the numbers of metastases more than 3 * the maximal tumor size of liver metastases more than 10 cm exclusion criteria: * liver metastases were unresectable.

Keywords: colorectal liver metastasis minimally invasive surgery robotic surgery laparoscopic surgery
a trial to evaluate the efficacy and safety of tnm001 for the prevention of lower respiratory tract infection caused by respiratory syncytial virus in infants

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (pk), neutralizing antibody and antidrug antibody (ada) response for tnm001 in infants entering their first rsv season.

this study adopts an adaptive seamless dose selection design and consists of two parts: part 1 is a phase 2b dose ranging trial which will support to determine the dose for part 2, the phase 3 trial. the study population includes early and mid-term preterm infants \[gestational age (ga)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day ga), with or without congenital heart disease (chd) or premature infants chronic lung disease (cld). a total of approximately 2250 infants will be randomized 2:1 to receive either tnm001 or placebo. all subjects will be followed for 240 days after dosing. this study will be conducted in appropriately 50 sites in china.

Eligibility criteria:
inclusion criteria: * 1. early and mid-term preterm infants (\<35 weeks 0 day ga) and late preterm infants or full-term infants (≥35 weeks 0 day ga) under 1 year of age, with or without congenital heart disease (chd) or premature infants chronic lung disease (cld)，who are entering their first rsv season at the time of screening. exclusion criteria: * 1. any fever (\> 38.0°c) or acute illness within 7 days prior to randomization * 2. history of rsv infection or active rsv infection prior to, or at the time of, randomization * 3. drug medication prior to randomization or expected to be treated by medicines during the study period. * 4. currently receiving or expected to receive immunosuppressive therapy during the study period. * 5. renal impairment or hepatic dysfunction * 6. nervous system disease or neuromuscular disease * 7. prior history of a suspected or actual acute life-threatening event * 8. known immunodeficiency including hiv, mother with hiv infection unless the child's infection has been excluded. * 9. known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period. * 10.receipt of rsv vaccine or mab
molecular pituitary imaging using 18f-fet pet

Conditions: Pituitary Adenoma

Summary: the goal of this single centre pilot study is to explore whether 18f-fluoro-ethyl-tyrosine pet (fet-pet) yields comparable findings to 11c-methionine pet (met-pet) for the localisation of pituitary tumours.

up to 20 patients with pituitary adenomas (pa) who have previously undergone 11c-methionine pet (met-pet) as part of routine clinical care will undergo 18f-fluoroethyltyrosine pet (fet-pet). patients with newly diagnosed pa or residual/recurrent pituitary tumours following previous treatment will be eligible for recruitment to the study. quantitative and qualitative analyses will be performed to assess whether met-pet and fet-pet yield comparable findings in patients with newly diagnosed or recurrent pa.

Eligibility criteria:
inclusion criteria * participant is willing and able to give informed consent for participation in the study * male or female, age 18 or above * presence of pituitary adenoma suspected on the basis of clinical/biochemical and/or radiological findings * previous 11c-met-pet/ct exclusion criteria * inability to give informed consent * pregnancy or suspected pregnancy * inability to lie supine for 30-60 minutes * patient body habitus above scanner dimensions * known allergy to intravenous radiographic contrast agents

Keywords: molecular pituitary imaging functional pituitary imaging 18f-fet pet
cytokine clearance with cytoabsorbant device during cardiac bypass

Conditions: Myocardial Ischemia; Heart Valve Diseases

Summary: investigators are planning a single center pilot randomized controlled trial to assess the potential of a cytoadsorbant filter (cytosorb®, germany) to remove cytokines from the blood during cardiac surgery. investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications \[≥ 1 among: age \>75 years old, double valvular replacement, complex surgery with expected cpb time \>100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level \>120 mcmol/l) or chronic heart failure (lvef \<35%)\]. patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded. eligible patients will be approached, consented and enrolled in the trial. patients will then be randomized to either receive conventional cpb (control arm) or cpb plus cytosorb (intervention arm). the target population is 30 patients (15 per arm). for this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for il-2, il-6, il-10 and tnf alpha at baseline (pre-operatively), on icu admission, as well as 6 and 24 hrs post cpb. secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, icu and hospital length of stay as well as in-hospital mortality. recruitment period should span from may 2016 to april 2017.


Eligibility criteria:
inclusion criteria: * patients planned for elective cardiac surgery requiring cpb and (≥1 among): * age \>75 years' old and / or * double valvular replacement and / or * complex surgery with expected cpb time \>120 min and / or * redo cardiac surgery and / or * pre-op chronic renal failure (gfr\<30 ml/min) and / or chronic heart failure (lvef \<40%) exclusion criteria: * end stage renal disease (dialysis dependence) * emergency procedure * active infectious endocarditis * off-pump procedure planned * non steroidal anti-inflammatory treatment in the previous 7 days * corticosteroids administration in the previous 7 days * no informed consent * enrolment in another conflicting study
virtual reality for parkinson's disease

Conditions: Parkinson Disease; Virtual Reality Therapy; Functional Magnetic Resonance Imaging

Summary: parkinson's disease (pd) is one of the most common neurodegenerative disease. bradykinesia, tremor, resting tremor and postural instability are the main motor characteristics of this disease. as the disease progresses, mobility, walking, balance are reducing, the risk of falls is increasing and patients become functionally dependent. along with these symptoms, cognitive functions are also disturbed. the most commonly distorted cognitive functions are executive functions such as planning and reasoning, working memory, episodic memory, attention and visual-spatial skills. pharmacological and surgical treatments are used in parkinson's disease. pharmacologic treatment has a proven effect on motor symptoms, but since there is no approved pharmacologic treatment which has a direct effect on cognitive functions, recent studies suggest non-pharmacological treatments to improve cognitive function. physiotherapy is also accepted among non-pharmacological treatments. conventional physiotherapy focuses on optimizing patient independence and safety, focusing on hinting strategies, cognitive movement strategies and exercises utilizing transfers, posture, upper extremity function, balance (and falls), gait, physical capacity and (in)activity. virtual reality (vr) technology, a promising commonly used new rehabilitation tool, is a treatment method that can be used as one of the non-pharmacological treatment methods in parkinson's disease. in order to understand how neuronal network dysfunction in the parkinson's disease leads to clinical symptoms, both the component elements and the interconnections within these networks need to be examined in greater detail. studies of resting state-fmri (rs-fmri) use correlation of activation of brain regions and time series fluctuations between brain regions to give information about connectivity in brain. the purpose of this study is to investigate the therapeutic effects of virtual reality on motor and cognitive symptoms of pd. furthermore, the investigation of possible effects of this effect on neuroplasticity through functional brain networks is our other objective. this study will be the first study to evaluate the plasticity effect of virtual reality application with rs-fmri in parkinson's disease.


Eligibility criteria:
inclusion criteria: * to be 50 years old and older * clinical diagnosis of pd within the -framework of brain bank criteria * getting a stable antiparkinsonian medication at least for the last 1 month (or the treatment has not changed) exclusion criteria: * having a story of unstable medical condition * history of head trauma, stroke, or exposure to toxic substances * implying parkinson plus syndromes in neurological examinations; pyramidal, cerebellar examination findings, gaze paresis, autonomic dysfunction * being diagnosed with dementia

Keywords: fmri virtual reality therapy exercise therapy
phase ii study of forodesine in subjects with chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: to evaluate the effectiveness and safety of forodesine in cll patients

to investigate the efficacy (complete response \[cr\] + partial response \[pr\]) of forodesine in treating subjects with cll who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.

Eligibility criteria:
inclusion criteria: 1. age 18 years and older 2. diagnosis of cll established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria. 3. subjects with rai stage iii or iv, or earlier stage requiring therapy as determined by the 1996 national cancer institute -working group (nci-wg) criterion 4. primary resistant (no cr or pr) or progressive disease after response to at least one prior treatment regimen or treatment naïve subjects who meet at least one of the following criteria. 1. age \>65 years 2. eastern cooperative oncology group (ecog) performance status of 2, 3, or 4 3. inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician. 5. ecog performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen). 6. willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy. 7. all investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug. exclusion criteria: 1. pregnant or nursing. 2. unable or unwilling to sign consent. 3. severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy. 4. active serious infections that are not controlled by antibiotics. 5. ecog performance status \>2 (except for treatment naïve subjects where ecog performance status 0, 1 or 5 is excluded). 6. inadequate renal function: creatinine \> or equal to 2.0 unless related to the disease. 7. inadequate liver function: bilirubin \> or equal to 3.0; transaminases \> or equal to 3.0 times the upper limit of normal unless related to the disease. 8. known positive test for human immunodeficiency virus (hiv). 9. subjects with known hepatitis b and/or hepatitis c active infection.