Kornimate/medical-research-clean huggingface dataset:
long-term remote ischemic preconditioning improves myocardial perfusion and prognosis of patients after cabg

Conditions: Coronary Disease

Summary: remote ischemic preconditioning (ripc) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.two large randomized controlled trials demonstrated a perioperative cardioprotective effect of ripc (reduced troponin levels), but did not find that a single preoperative ripc improved long-term outcomes of coronary artery bypass grafting(cabg).the effect of a single ripc before cabg may be too short. this study aims to investigate whether long-term ripc improved myocardial perfusion in patients 3 months and 6 months after cabg surgery , and to detect changes in blood vascular endothelial growth factor, nitrc oxide, adenosine，and endothelin-1, and to observe macce event rates at 12 months.

a total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group. experimental group 1: the patient underwent one ripc (four five-minute cycles of upper limb ischaemia and four five-minute pauses using a blood pressure cuff air vehicle to 200 mmhg) 1 hours before surgery, then normal surgery, and ripc was performed on the second day after surgery and every day after surgery, which lasted for 1 year. experiment group 2: patients underwent once ripc 1 hours before surgery, and then normal medical procedures were performed with no additional intervention. control group: patients did not receive any additional intervention. all patients were evaluated in three ways. first: 7days and 3 months after surgery , the quantitative examination of myocardial blood flow was conducted to observe the improvement of myocardial blood perfusion. second: the changes in the concentrations of vascular colorectal growth factor, nitrc oxide, adenosine, and endothelin-1. third, patients were evaluated for 6 months and 12months macce incidence (cardiovascular death, nonfatal myocardial infarction, unplanned revascularization, and stroke).

Eligibility criteria:
inclusion criteria: * three coronary artery lesions, cabg surgery was planned exclusion criteria: * the patients could not tolerate ripc; * peripheral vascular disease affecting upper limbs * acute myocardial infarction complicated with cardiogenic shock，in recent 30 days, * emergency cases * severe structural heart disease and severe arrhythmia ； * the uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmhg and 120 mmhg respectively; * severe liver, renal and pulmonary disease * mental disorder can't cooperate; * inability to give informed consent； * patients on glibenclamide or nicorandil, as these medications may interfere with ric * pregnant;
efficacy of subcutaneous sarilumab in hospitalised patients with moderate-severe covid-19 infection (sarcovid)

Conditions: Covid-19

Summary: the global health emergency created by the rapid spread of the sars-cov-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage covid-19 severe and critical manifestations affecting a wide population in a short period of time. clinicians are committed to do their best with a great uncertainty in this evolving crisis. off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. based in unpublished experiences in china, italy and spain, intravenous il-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. sarilumab is a human monoclonal antibody that binds membrane-bound and soluble il-6 receptors to inhibit il-6 signalling, licensed in a subcutaneous route administration.

sarcovid is an investigator-initiated monocentric randomised proof of concept study that aims to evaluate the efficacy and safety of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe covid-19 infection, compared to the current standard of care.

Eligibility criteria:
inclusion criteria: * age\> 18 years * laboratory-confirmed sars-cov-2 infection as determined by pcr or other validated commercial or public health assay * documented interstitial pneumonia requiring admission and at least two of the following: 1. fever ≥ 37.8ºc (tympanic) 2. il-6 in serum ≥ 25 ng / ml (in the absence of a previous dose of prednisone or equivalent\> 1 mg / kg) or pcr\> 5mg / dl 3. lymphocytes \<600 mm3 4. ferritin\> 300 mcg / l that doubles in 24 hours 5. ferritin\> 600 mcg / l in the first determination and ldh\> 250 u / l 6. d-dimer (\> 1 mg / l) * informed verbal or administration consent under urgent conditions, documented in the electronic medical record. exclusion criteria: * patients who require mechanical ventilation at the time of inclusion. * ast / alt values \> 5 folds upper normal limit. * neutrophil count below 500 cells / mm3 * platelet count below 50,000 cells / mm3 * documented sepsis or high suspicion by pathogens other than covid-19. * presence of comorbidities that according to clinical judgment could lead to an unfavorable result. * complicated diverticulitis or intestinal perforation. * current skin infection (eg, uncontrolled dermopiodermitis). * immunosuppressive anti-rejection therapy. * pregnancy or lactation. * previous treatment with tocilizumab or sarilumab. * patients participating in some other clinical trial for sars-cov-2 infection. * patients with known hypersensitivity or contraindication to sarilumab or excipients.

Keywords: covid sars-cov-2 coronavirus infections sarilumab il-6 receptor inhibitors
a study to investigate how effective, safe and tolerable the drug nbi-921352 is when used with anti-seizure medications in adults with focal onset seizures

Conditions: Focal Onset Seizure; Focal Onset Epilepsy

Summary: this study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of nbi-921352 versus placebo in adults with focal onset seizures


Eligibility criteria:
key inclusion criteria: 1. capable of providing consent and has completed the written informed consent. 2. male or female, 18 to 65 years of age, inclusive, with a body mass index (bmi) \< 40 kg/m\^2. 3. diagnosis of focal onset epilepsy according to the international league against epilepsy (ilae) classification of epilepsy (2017) at least 18 months before screening. 4. history of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (asm) for at least 18 months prior to screening. 5. treatment with at least 1 but not more than 4 asms for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study. 6. be able to keep accurate seizure diaries. 7. documented seizure frequency in the baseline seizure diary of ≥8 countable focal seizures during the 8-week seizure baseline period. key exclusion criteria: 1. history of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures. 2. presence or previous history of developmental and/or epileptic encephalopathy. 3. presence of seizure types other than fos. 4. status epilepticus within the last 12 months before enrollment. 5. any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the c-ssrs in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt. 6. multiple drug allergies or a severe drug reaction to an asm(s), including dermatological (eg, stevens-johnson syndrome), hematological, or organ toxicity reactions. 7. an implanted responsive neurostimulator system (rns).

Keywords: epilepsy focal seizure sodium channel voltage-gated alpha subunit nav1.6 inhibitor antiseizure medication asm antiepileptic drug aed partial seizure partial onset epilepsy
sti combined to valsalva maneuver for the diagnosis of left ventricular dysfunction in copd exacerbations

Conditions: Obstructive Chronic Bronchitis With Acute Exacerbation

Summary: the aim of this investigation was to assess the value of systolic time intervals (stis) as a method of detecting left ventricular dysfunction (lvd) in patients admitted to the emergency department for cute exacerbations of chronic obstructive pulmonary disease (aecopd) and whether stis measured under valsalva manoeuver (vm) could improve the distinction between patients with lvd and those without lvd.

we included patients admitted to the ed for aecopd. measurement of stis included electromechanical activation time (emat), left ventricular ejection time and emat/lvet ratio. these were performed at baseline and during the first strain phase of the vm using a computerized phono and electrocardiographic method. the diagnosis of lvd was determined on the basis of clinical examination, echocardiography and brain natriuretic peptide. the values of stis were compared between patients with and without lvd ; their diagnostic performance was assessed using the area under receiver operating characteristic curve (auc of roc).

Eligibility criteria:
inclusion criteria: * oxygen saturation (spo2) \<90%, * respiratory rate \>25c/min, * paco2 \> 6 kpa et ph\< 7.35. exclusion criteria: * neurological distress and hemodynamic instability * confusion, agitation * pneumothorax * non cooperative patients * refusal of consent

Keywords: aecopd left ventricular dysfunction valsalva maneuver systolic time intervals
proximal humerus fractures: a retrospective analysis

Conditions: Proximal Humeral Fracture

Summary: the purpose of this study is to evaluate preoperative objective measurements of patients with a proximal humerus fracture and operative objective measurements to determine if there is any effect to postoperative outcomes. patients who were 18 years old or greater at the time of open reduction, internal fixation surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria:
inclusion criteria: 1. english speaking 2. \>18 years of age 3. open reduction internal fixation surgical management of a proximal humeral fracture exclusion criteria: 1. non-english speaking 2. \<18 years of age 3. greater tuberosity fractures
single-cell insights into diabetic retinopathy mechanisms

Conditions: Diabetic Retinopathy

Summary: this study aims to uncover the cellular and molecular mechanisms of diabetic retinopathy through single-cell sequencing to identify new therapeutic targets. the study will collect retinal tissue samples from 3 patients with advanced proliferative diabetic retinopathy who underwent prosthetic eye implantation and 3 normal cadaver donors. additionally, aqueous humor, vitreous fluid, and plasma samples from patients with severe diabetic retinopathy requiring surgery and macular hole surgery patients without diabetic retinopathy will be analyzed using elisa, qpcr, and western blot. these experiments will validate sequencing results and explore the pathogenesis of diabetic retinopathy to identify potential treatment targets.

diabetic retinopathy is the leading cause of blindness among the working population worldwide. however, its pathogenesis is not fully understood, and effective prevention and treatment methods are limited. this study, initiated by shanghai first people's hospital, aims to explore the cellular and molecular mechanisms underlying its occurrence through methods such as single-cell sequencing, to identify new intervention targets. this study plans to collect retinal tissue samples from 3 patients each who underwent prosthetic eye implantation due to late-stage proliferative diabetic retinopathy blindness and from 3 normal cadaver donors at the ophthalmology department of shanghai first people's hospital for single-cell sequencing and bioinformatics analysis. additionally, samples of aqueous humor, vitreous fluid, and plasma will be collected from 30 patients with severe diabetic retinopathy requiring surgery and from 30 macular hole surgery patients without diabetic retinopathy. these samples will be subjected to experiments such as elisa, qpcr, and western blot to validate sequencing results, investigate the pathogenesis of diabetic retinopathy, and identify potential therapeutic targets.

Eligibility criteria:
inclusion criteria : * for the single-cell sequencing group: patients with advanced proliferative diabetic retinopathy (pdr) resulting in blindness or ocular atrophy, who voluntarily opt for enucleation and ocular prosthesis implantation surgery, and have no systemic or local contraindications to surgery. for the validation group: patients with severe pdr lesions requiring vitrectomy, and who also have no systemic or local contraindications to surgery. * patients who voluntarily agree to participate in this clinical trial and sign the informed consent form. exclusion criteria: * patients with severe systemic diseases such as autoimmune diseases or cancer
lymph node assessment using simultaneous 18f-fdg-pet and mri

Conditions: Head and Neck Cancer

Summary: the overarching goal of this study is to develop pet/mr techniques to accurately detect nodal metastases for surgical planning and assessment of treatment response.

patients (n = 30) with head and neck cancer who are scheduled for node dissection surgery are eligible. enrolled subjects will undergo one research pet/mr scan at the center for biomedical imaging (660 first avenue) within one week prior to the planned surgery. during the dissection, the locations of removed lymph nodes will be noted in terms of conventional neck lymph node levels. pet/mr data will be used for development of a combined kinetic model analysis of pet and mri data (aim 1). the final pet/mr findings will be compared with pathological evaluation results in order to assess the accuracy of pet/mr for detection of nodal metastases (aim 2).

Eligibility criteria:
inclusion criteria: patients with head and neck cancer who are scheduled for node dissection surgeries at nyu langone medical center or bellevue hospital are eligible. exclusion criteria: normal mri exclusion criteria will apply, including those on the following list. a standard mri safety form will be used to identify potential conditions warranting exclusion. * electrical implants such as cardiac pacemakers or perfusion pumps * ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants * ferromagnetic objects such as jewelry or metal clips in clothing * claustrophobia * history of seizures * diabetes in addition, patients with gfr \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.

Keywords: head cancer neck cancer mri pet
sg301 safety study in subjects with relapsed or refractory multiple myeloma and other hematological malignancies

Conditions: Relapsed or Refractory Multiple Myeloma; Hematological Malignancy

Summary: this is a phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of sg301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies

after a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of sg301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first. the study consists of a dose escalation phase (phase 1a) and a dose expansion phase (phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.

Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign the informed consent form (icf). 2. age ≥18 years. 3. eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2. 4. expected survival time of ≥3 months. 5. patients with histologically or cytologically confirmed hematological malignancies who are relapsed or refractory to or intolerant of standard therapies. for patients with multiple myeloma: should be relapsed or refractory multiple myeloma with measurable disease 6. adequate organ function 7. toxicity caused by prior anti-tumor therapy recovered to grade 0 to 1 (ctcae 5.0), except for alopecia, controlled grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders. 8. female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (hcg) test during screening period and must not be lactating. exclusion criteria: patient exclusion criteria: 1. presence of central nervous system metastatic lesions. 2. uncontrolled cardiac disease requiring treatment, congestive heart failure nyha iii or iv, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months. 3. active infection requiring antimicrobial therapy within 2 weeks prior to study drug administration. 4. patients with active viral hepatitis (any etiology) are excluded. 5. anticancer therapy within 5 half-lives or 2 weeks (whichever is longer) 6. primary refractory to previous anti-cd38 therapy. 7. major surgery within 4 weeks prior to study entry. 8. prior or concurrent malignancy within 2 years prior to entry, other than adequately controlled skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma. 9. any other condition that, in the opinion of the investigator, may lead to inappropriate participation in this study.
sensimed triggerfish discomfort during iop monitoring

Conditions: Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Summary: evaluation of the wearing discomfort (safety and tolerability) involved during iop monitoring with the senismed triggerfish, a sensor embedded in a telemetric contact lens


Eligibility criteria:
inclusion criteria: * patient is able to comply with the study procedure * patient is 18-80 years old * healthy subject or glaucoma patient * patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out * cylinder refraction of no more than +/- 2 diopters in the study eye * visual acuity of 20/80 or better in the study eye * ability of subject to understand the character and individual consequences of the study * for women with childbearing potential, adequate contraception exclusion criteria: * subjects wearing contact lenses within the last two years * subjects with contraindications for wearing contact lenses * history of refractive surgery * history of intraocular surgery in the last three months * severe dry eye syndrome * keratoconus or other corneal abnormalities * conjunctival or intraocular inflammation * pregnancy and lactation * simultaneous participation in other clinical trials
cxcr4 modified anti-bcma car t cells for multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. b-cell maturation antigen (bcma) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. this study aims to evaluate the safety and tolerance cxcr4 modified bcma car t cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. the efficacy of cxcr4 modified bcma car t will also be investigated.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 75 years old. 2. the expected survival ≥ 12 week 3. ecog ≤ 2 4. patients with multiple myeloma that never achieved mr (minor response) or received ≥ 1 line of standard therapy but tumor relapse 5. the liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease 6. venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection 7. patients can take effective contraceptive measures during the trial period and 1 year after the infusion 8. voluntary informed consent is given, agree to follow the trial treatment and visit plan exclusion criteria: 1. patients with other uncontrollable cancer 2. active hepatitis b, hepatitis c, or hiv infection 3. other uncontrolled active disease 4. patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases 5. patients with uncontrollable hypertension(≥ grade ii) 6. patients with history of uncontrollable mental illness 7. long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded) 8. unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment; 9. pregnant or lactating women; men or women who have a pregnancy plan within a year; the patients cannot guarantee effective contraceptive measures during the trial period; 10. patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment; 11. patients had other conditions that were not appropriate for the study determined by the researchers.