Kornimate/medical-research-clean huggingface dataset:
assessment of visual acuity in patients with polypoidal choroidal vasculopathy and aflibercept treatment

Conditions: Polypoidal Choroidal Vasculopathy

Summary: polypoidal choroidal vasculopathy (pcv) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (amd). however, pcv response to anti-vascular agents differs from the response of typical amd. this study aims at describing the evolution of the best corrected visual acuity (bcva) in pcv patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).


Eligibility criteria:
inclusion criteria: * active polypoidal choroidal vasculopathy, * visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32) * age above 45 * no prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability * intravitreal injection of aflibercept is indicated by current clinical recommendations exclusion criteria: * simultaneous treatment with another anti-vegm agent * diabetic retinopathy * personal history of vitrectomy or uveitis * personal history laser photocoagulation and/or verteporphin phototherapy * tear in the pigmentary epithelium * chorioretinitis scar * macular atrophy in the pigmentary epithelium * treatment with corticosteroids * eye surgery less than 3 months before inclusion
a phase 1 study of syncar-001 + stk-009 without conditioning chemotherapy (lymphodepletion) in subjects with severe, refractory systemic autoimmune rheumatic disease

Conditions: Systemic Lupus Erythematosus; Lupus Nephritis; Systemic Sclerosis

Summary: this is a phase 1 study of syncar-001 + stk-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

syncar-001 + stk-009 is a 2-component human orthogonal (ho) il-2 receptor-ligand cell therapy consisting of (1) syncar-001, a cd19-directed chimeric antigen receptor t cell (car-t) co-expressing an engineered il-2 beta receptor (horb); and (2) stk-009, an engineered pegylated il-2 cytokine (hoil-2) selective for horb. this study is being conducted to evaluate the safety and efficacy of a single dose of syncar-001 followed by multiple subcutaneously administered doses of stk-009. no conditioning chemotherapy (lymphodepletion) will be administered. the study will follow a 3+3 design during dose escalation followed by dose expansion at the recommended phase 2 dose (rp2d).

Eligibility criteria:
general inclusion criteria: age ≥18 years at screening. sle inclusion criteria: 1. clinical diagnosis of sle according to the 2019 european league rheumatism eular/acr classification criteria. 2. subject must be positive for at least one of the following at screening: anti-dsdna (above the upper limit of normal \[uln\]); or anti-sm (above the uln); or anti-chromatin (above the uln). 3. subjects with active, severe, non-renal sle or subjects with active proliferative ln ssc inclusion criteria: 1. classified as ssc according to the acr/eular classification criteria. 2. diffuse cutaneous ssc (dcssc) or ssc-associated ild (ssc-ild; significant or progressive). general exclusion criteria: 1. history of or active central nervous system manifestations of autoimmune disease. 2. prior treatment with anti-cd19 adoptive t cell therapy, or any prior gene therapy product (e.g., car t cell therapy). sle exclusion criteria: 1. rapidly progressive glomerulonephritis. 2. end stage renal failure requiring dialysis or most recent renal biopsy with purely chronic lesions (class iii\[c\], iv-s\[c\], or iv-g\[c\]) if isolated renal disease. ssc exclusion criteria: 1. fvc \<50% of predicted or dlco \<40% of predicted. 2. pulmonary arterial hypertension (pah) requiring pah-specific treatment. other protocol-defined criteria apply.

Keywords: car t cd19-car t chimeric antigen receptor il-2
plasma melatonin and mortality after acute myocardial infarction

Conditions: Melatonin; Myocardial Infarction

Summary: pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection effects. melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and antilipaemic properties, which plays important roles in a variety of cardiovascular pathophysiologic processes. nocturnal melatonin levels decreased after ami, and lower serum melatonin concentrations after ami are associated with more heart failure and cardiac death and left ventricular remodeling. moreover in women with increased bmi, lower melatonin secretion is associated with higher risks of mi. early-morning blood collection is easier in clinical practice. therefore, the investigators carried out a cohort study to evaluate the prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial infarction (ami).


Eligibility criteria:
inclusion criteria: * consecutive patients of acute ami come to department of cardiology, 301 hospital (beijing, china),absent of cardiogenic shock, and survival for at least 24 h after percutaneous coronary intervention treatment. exclusion criteria: * patients with autoimmune diseases, collagen tissue diseases, drug addiction, radiotherapy, patients receiving immunosuppressive treatment, taking sedatives, antiepileptic drugs, tricyclic antidepressants or any medication known to influence melatonin metabolism, psychiatric sleeping disorders, shift workers, and subjects with jet-lag syndrome
the efficacy and safety of triple therapy of telmisartan/amlodipine/rosuvastatin

Conditions: Hypertension; Dyslipidemias

Summary: the goal of this study was to assess the efficacy and safety of fdc therapy with triple therapy of telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10mg in korean patients with both hypertension and dyslipidemia.

patients were randomly assigned to 2 groups: (1) triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) dual therapy (5mg of amlodipine and 10mg of atorvastatin). after 8 weeks of treatment, the change in mean sitting systolic blood pressure (mssbp) and the percent change in ldl-c between 2 group, will be compared.

Eligibility criteria:
inclusion criteria: * 145 mmhg ≤ mssbp ≤ 190 mmhg * triglycerides \< 500 mg/dl * ldl-c ≤ 250 mg/dl exclusion criteria: * ssbp ≥ 20mmhg and sdbp ≥ 10mmhg * symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia * history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (new york heart association functional class iii and iv) * hypersensitivity to telmisartan or rosuvastatin * history of angioedema after treatment with angiotensin-converting enzyme inhibitors or arbs; creatinine phosphokinase levels ≥3 times the upper limit of normal * estimated glomerular filtration rate ≤30 ml/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal * potassium levels \>5.5 mmol/l; or any diseases that could affect the results of the study.
use of hyperbaric oxygen therapy to treat covid-19 patients with respiratory distress

Conditions: Covid19

Summary: investigate whether hyperbaric oxygen therapy treatment can become a viable treatment option for covid-19. if successful, providers will be able to provide future covid-19 patients with mild-to-moderate respiratory distress hyperbaric oxygen therapy in order to help avoid mechanical ventilation

using the monoplace hyperbaric oxygen chambers we will be providing covid- 19 positive patients with mild-to-moderate distress 100% oxygen at 2.0 ata for 90 minutes on consecutive days for a total of up to 5 treatments. a comparison will be made using a historical cohort not receiving hbot. data will be collected to determine whether or not hbot is of any benefit to covid-19 positive patient with mild-to-moderate respiratory distress. study group: provide 100% oxygen at 2.0 ata for 90 minutes on consecutive days for a total of up to 5 treatment to covid-19 patients meeting inclusion criteria control group: any covid-19 positive patient meeting study inclusion criteria that does not receive hbot (historical) the control group is further defined as patients who were previously treated for covid-19 at morton hospital that did not receive hyperbaric oxygen therapy. this will require accessing medical records to obtain patient information to establish the historical control data metric. study outcome measures: * time to normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or abg w/pa02 greater than 60mmhg on air) * mortality * days free of invasive mechanical ventilation

Eligibility criteria:
inclusion criteria: * verified covid-19 infection * patient w/02 dependence of less than or equal to 6 liter/min to maintain pulse ox greater than or equal to 92% or arterial gas w/pa02 greater than 60mm hg exclusion criteria: * not diagnosed w/covid-19 infection * pregnancy * dnr or other restrictions in escalation of level of care * contraindication for hbo * blood pressure parameters which are deemed unstable by clinical team * patients who require continuous ecg and/or continuous blood pressure monitoring, and with arterial lines * patients requiring rewarming * patients requiring any kind of invasive catheter/pressure monitoring * patients requiring continuous support of intravenous medication * minor subject (less than 18 years old) * refusal to participate * signs of respiratory decompensation requiring intubation and mechanical ventilation * 02 dependence greater than or equal to 6l/minute to obtain sa02 greater than or equal to 92% or abg w/pa02 \>60mmhg
a study to evaluate the safety and efficacy of biib104 in participants with cognitive impairment associated with schizophrenia (cias)

Conditions: Cognitive Impairment Associated With Schizophrenia

Summary: the primary objective of the study is to evaluate the efficacy of biib104 in participants with cias, using the working memory domain of the matrics consensus cognitive battery (mccb). the secondary objectives of this study are to evaluate the safety and tolerability of biib104 in participants with cias, and to evaluate the efficacy of biib104 in participants with cias on measures of cognition, functioning, and psychiatric symptomology.


Eligibility criteria:
key inclusion criteria: * otherwise healthy participant with a diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), diagnosis of schizophrenia of at least 2 years' duration as confirmed by the mini-international neuropsychiatric interview (mini) 7.0.2 for psychotic disorders. * evidence of stable schizophrenia symptomatology ≥12 weeks (e.g., no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of schizophrenia symptoms). * participants must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for ≥8 weeks prior to baseline/day 1, including concomitant psychotropic medication. doses of background atypical antipsychotics should be within the recommended dose range listed in the approved product labeling of the country where the study is being conducted. * sci-panss: no more than moderate-severe rating (score ≤5) on delusions, hallucinatory behavior, grandiosity, suspiciousness / persecution, and hostility (i.e. panss, positive symptom items p1, p3, p5, p6, p7); or unusual thought content (g9); and no more than a moderate rating (score ≤4) on conceptual disorganization (p2). key exclusion criteria: * participation in a trial using any component or version of the matrics consensus cognitive battery (mccb) or the university of california, san diego (ucsd) performance-based skills assessment test within the previous 6 months. * participation in cognitive remediation therapy within 6 months prior to randomization. * screening mccb working memory domain t-score ≥60. * current dsm-5 diagnosis of schizoaffective disorder on the mini 7.0.2 for psychotic disorders. * current dsm-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and/or generalized anxiety disorder on the mini 7.0.2 for psychotic disorders. * lifetime dsm-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, and/or binge-eating disorder on the mini 7.0.2 for psychotic disorders. * meets the dsm-5 diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of screening on the mini 7.0.2 for psychotic disorders interview. * dsm-5 diagnosis of intellectual disability (intellectual developmental disorder). note: other protocol defined inclusion/exclusion criteria may apply.
occupational therapy fatigue management-based intervention for metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8

Summary: this clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). many patients diagnosed with cancer experience cancer-related fatigue. these patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives. occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs. fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens. this trial may help patients address and reduce their fatigue.

primary objective: i. to determine if an occupational therapy (ot)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (bfi) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma. secondary objectives: i. to determine if an ot-based intervention can improve pain ratings. ii. to determine if an ot-based intervention can improve indices of depression. iii. to determine if an ot-based intervention can improve indices of anxiety. iv. to determine if an ot-based intervention can maintain a reduced level of fatigue beyond the period of intervention. outline: patients participate in ot sessions weekly for 3 weeks over 30 minutes each. patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.

Eligibility criteria:
inclusion criteria: * aged 18 and over. * sufficiently fluent in english. * cytologically or pathologically verified diagnosis of renal cell carcinoma (rcc). * evidence of metastatic disease. * clinician assessed prognosis of greater than or equal to six months. * patients who are undergoing immunotherapy treatment (with a checkpoint inhibitor) for advanced kidney cancer who have grade 1 or 2 fatigue based on physician assessment at the time of study entry. * willing and independently able to provide consent.
clinical validation of stool dna-based sdc2 methylation test for colorectal cancer detection

Conditions: Colorectal Cancer; Polyps; Other Cancers; Healthy

Summary: pivotal trials of sdc2 methylation biomarker test in stool dna to estimate clinical sensitivity and specificity in detection of colorectal cancer.

the purpose of this study is to validate the clinical performance of earlytect colon cancer test which is measuring syndecan 2 methylation status in stool dna to detect crc. syndecan 2 (sdc2) is a newly developed methylation biomarker for colorectal cancer diagnosis. methylation status of sdc2 gene in stool dna is determined by methylation specific qpcr. sensitivity and specificity will be determined by comparing stool dna test from healthy subjects, crc patients, and other group including polyps and other diseases.

Eligibility criteria:
inclusion criteria: * sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information * the crc patient who has not any treatment (surgery, chemotherapy, or radiation) * non-crc patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months * all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be crc with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not crc, 4) schedule to receive colonoscopy and additional confirmation test for crc with agreement to provide the test results. exclusion criteria: any one of below can be applicable; * the patient information is not complete and/or does not satisfy inclusion criteria * the sample information is not complete and/or does not satisfy inclusion criteria * the crc patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment * non-crc patient who received any chemotherapy within the last 6 months * the patient who has limited ability or are vulnerable to accept clinical trial agreement * the patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician

Keywords: syndecan 2 methylation biomarker colorectal cancer earlytect colon cancer test
effectiveness of biofoam® surgical matrix to improve hemostasis during liver resection

Conditions: Hemorrhage

Summary: the present randomized controlled trial evaluates the efficacy and safety of biofoam® surgical matrix in patients undergoing elective liver resection. in contrast to other topical agents, the surgical adhesive biofoam® surgical matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications. the primary objective of this trial is to show that time-to-complete hemostasis can be reduced using biofoam® surgical matrix as compared to the conventional approach.

hepatic resection is the primary therapy for various hepatobiliary disorders. advances in preoperative imaging, surgical technique, and perioperative management have markedly improved outcomes and extended the indications for hepatic resection within the past three decades. however, liver resection remains associated with substantial morbidity and mortality of up to 60% and 10%, respectively. the outcome of patients undergoing hepatic resection is closely linked to the amount of intraoperative blood loss. hemorrhage from the resection surface contributes significantly to the amount of blood loss. in addition, bile leakage from the resection surface presents a persistent clinical challenge. in fact, bile leakage remains the most frequent complication after hepatic resection with an incidence of 5 - 25%. various topical agents have so far been suggested to facilitate hemostasis with the ultimate aim to improve perioperative outcome. however, none of these agents has so far gained wide acceptance, possibly due to their impractical method of application. furthermore, these 'hemostatic agents' have been primarily designed to improve hemostasis and showed no effect on perioperative complications and in particular the incidence of bile leakage. the present randomized controlled trial evaluates the efficacy and safety of biofoam® surgical matrix in patients undergoing elective liver resection. in contrast to other topical agents, the surgical adhesive biofoam® surgical matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective hepatic resection * age equal or greater than 18 years * informed consent exclusion criteria: * previous treatment with biofoam® surgical matrix * known sensitivity to materials of bovine origin * known sensitivity to glutaraldehyde * abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyreoidism) * minimally invasive procedure planned * impaired mental state or language problems * expected lack of compliance

Keywords: liver resection
short-course radiotherapy followed by capox and ivonescimab for locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: this study is a single-arm, prospective, phase ii clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(tme) surgery in patients with advanced rectal cancer.

studies included a screening period (no more than 28 days after participants signed informed consent form to 28 days before first dose), treatment (receiving appropriate treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death or study end, whichever occurs first), and follow-up (including safety follow-up and survival follow-up). eligible subjects will receive short-course radiotherapy (scrt), pelvic 25gy/5f/1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: ivonescimab 20 mg/kg, intravenous infusion every 3 weeks (q3w), plus capox (capecitabine: 850-1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), q3w. neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and tme surgery was performed 4 weeks after the end of neoadjuvant therapy (r0 surgery was performed). patients can choose to enter the organ preservation observation; if the efficacy after preoperative chemoradiotherapy is evaluated as clinical complete remission (ccr) and the patient strongly refuses surgery, the patient should be informed of the risk of recurrence and ask the patient to sign a rejection of surgery. medication safety is assessed and, depending on the severity of adverse events (aes) and drug relevance, investigators will take steps to ensure subject safety. after surgery (or patients who strongly refuse surgery) there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.

Eligibility criteria:
inclusion criteria: * ecog score of 0-1; * histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis * tumor distance from anal verge ≦10cm * at least one high-risk criterion defined by pelvic mri: ct stage \>t2 (tumor invades intrinsic muscularis propria by more than 5 mm); extramural vascular invasion; cn2; involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); lateral lymph node short diameter ≥5mm * enough organ function exclusion criteria: * with known msi-h or dmmr * multiple primary adenocarcinomas * history of pelvic radiotherapy * previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-pd-1 antibody, anti-pd-l1 antibody, anti-ctla-4 antibody, etc.), immune checkpoint agonists (e.g., icos, cd40, cd137, gitr, ox40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.