Kornimate/medical-research-clean huggingface dataset:
oncotipnet: multicenter study on risk factors and outcome in cancer pediatric patients admitted in italian picus

Conditions: Pediatric Cancer; Critically Ill

Summary: the study will describe characteristics of pediatric cancer patients admitted to italian picus and will analyze risk factors of picu admission, neurological outcome, and mortality. after a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 italian picus.

the study aim to evaluate: 1. characteristics of pediatric cancer patients admitted to italian picus 2. risk factors of picu admission, neurological outcome and mortality. inclusion criteria: age \<= 18 years, informed consent. exclusion criteria: informed consent not obtained. after a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (march 2021 - february 2021) gathering data from 15-20 italian picus. each center can decide whether to participate only in the prospective phase. data will be recorded in an electronic data collection form in red cap. the following variables will be collected: * demographic variables: age, sex, ethnicity; * tip pre-admission clinical variables and at the time of admission: basic diagnosis, comorbidity, hemopoietic stem cell transplantation (tcse) number and type, treatment phase, hla matching, graft versus host (gvh) and grade, veno-occlusive disease, venous occlusive disease * variables upon entering tip: pim3, popc score, organ failure cause and staging, high intensity treatments, high flow oxygen therapy, dialysis, inotropes or other, fluid overload, immunodeficiency * clinical variables during hospitalization: organ failure cause and staging, ventilation, modality, presence of pards and severity, need for inotropic support, sepsis and severity score (sofa), inotropes (vis score), arrest event cardiac, need for hfov, extra-corporeal membrane oxygenator, nitric oxide, dialysis, intracranial pressure monitoring, drugs used for sedation, development of withdrawal syndrome, development of delirium. considering the participation of 15-20 centers involving 20 patients in a year, the expected number is 600 patients considering the retrospective phase (optional, therefore some centers may not contribute) and the prospective phase. study sites will also take part to a survey designed to collect data in order to describe italian picus involved in providing care to cancer patients.

Eligibility criteria:
inclusion criteria: * age \<= 18 yeras * informed consent\* exclusion criteria: * informed consent not obtained\* * only for next prospective part of the study

Keywords: pediatric intensive care unit oncology
measuring synovial fluid components

Conditions: Knee Osteoarthritis

Summary: participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection. the synovial fluid will be analyzed for changes in components.

80 participants with grade 3 and 4 symptomatic knee osteoarthritis, with a visable effusion, will receive aspiration of 3 ml of synovial fluid from the suprapatellar pouch, followed by either injection with 10 ml of 12.5% dextrose, 10 cc hematopoietic stem cells, 10cc prp, or no injection into the suprapatellar pouch. they will then receive aspiration of 3 ml of synovial fluid at 2 days and either 7 days (for dextrose injected or no injection) or 14 days (stem cell and prp injected) days post injection. these synovial samples will be analyzed for a change in components.

Eligibility criteria:
inclusion criteria:≥ 6 months of knee pain with walking * ≥ 6/10 on a 0-10 point numerical rating scale * high grade medial compartment cartilage loss ( kellgren-lawrence grade 3 or 4) on plain weight bearing x-ray * exposed subchondral bone at 110 degrees of flexion by ultrasound examination * easily visible suprapatellar pouch with quads conttraction. exclusion criteria * current intake of nsaids or steroids * current anticoagulation therapy * inflammatory or post-infectious knee arthritis * systemic inflammatory conditions * knee flexion less than 100 degrees * knee extension less than 165 degrees * valgus or varus more than 15 degrees * any knee injection in the precedign 3 months * bmi more than 50 kg/ meter squared * gross synovial folds on ultrasound.
single-incision gasless endoscopic total thyroidectomy via subclavian approach versus open surgery for ptc

Conditions: Papillary Thyroid Carcinoma

Summary: historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. this study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (sca) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (ptc) retrospectively.

historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. this study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (sca) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (ptc) retrospectively.

Eligibility criteria:
inclusion criteria: * (1) thyroid neoplasm \&lt;3.0 cm; * (2) well differentiated papillary thyroid carcinoma. exclusion criteria: * (1) extrathyroidal extensions estimated in ultrasonography scan; * (2) enlarged lymph nodes in lateral neck compartment on palpation, or us scan; * (3) suspected distant metastases; * (4) previous history of neck radiation therapy and/or surgery.
first-line treatment of advanced bladder cancer randomized vs. gemcitabine ± vinflunine in patients ineligible to receive cisplatin-based therapy

Conditions: Bladder Cancer; Transitional Cell Carcinoma; Metastasis

Summary: the purpose of this study is to test an investigational drug, vinflunine (bms-710485), in combination with gemcitabine in patients with transitional cell carcinoma who cannot be treated with cisplatin. this study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic * ineligible for cisplatin-based therapy because of at least one of the following two medical conditions: * calculated creatinine clearance ≤60 ml/min: or * new york heart association classification stage iii-iv congestive heart failure * measurable disease documented by imaging with at least one uni-dimensional lesion * adequate performance status (ecog 0, 1, or 2) * men and women ≥18 years of age exclusion criteria: * patients in whom radiation or surgery is indicated * current neuropathy ≥ ctcae grade 3 * prior radiation to ≥ 30% of bone marrow * inadequate renal function: serum creatinine clearance ≤ 20 ml/min * prior allergy to any vinca alkaloid

Keywords: advanced or metastatic transitional cell carcinoma of the urothelium
efficacy and safety of opl-0301 compared to placebo in adults with post-myocardial infarction (mi)

Conditions: Myocardial Infarction

Summary: study opl-0301-201 is intended to generate efficacy and safety data of opl-0301 in participants with post-myocardial infarction (mi) left ventricular dysfunction (lvd)

opl-0301 is intended to address the disease state of post-myocardial infarction (mi) left ventricular dysfunction (lvd). mi is a manifestation of atherosclerotic coronary artery disease, the pathogenesis of which is closely associated with vascular and endothelial dysfunction, and inflammation. acute mi leads to acute lvd, which often persists, leading to poor cardiovascular outcomes. the therapeutic hypothesis is that these effects mediated by sphingosine-1 phosphate 1 (s1p1) receptor agonism with opl-0301 will reduce infarct size and benefit post-mi left ventricular function, thereby supporting improved cardiovascular outcomes in this patient population.

Eligibility criteria:
inclusion criteria: * are male or female between 18 and 90 years of age, inclusive, at the time of signing the informed consent * are hospitalized with acute st-elevated myocardial infarction (stemi), defined based on american heart association (aha)/american college of cardiology (acc) criteria * have cardiac troponin-i (ctni), cardiac troponin-t (ctnt) levels ≥10x upper limit of normal (uln) at least once during the index event of myocardial infarction exclusion criteria: * previous history of documented myocardial infarction * previous history of percutaneous coronary intervention (pci) within 6 months or coronary artery bypass graft surgery (cabg) or valvular heart surgery at any time prior to screening * previous history of documented chronic left ventricular dysfunction with ejection fraction (ef) \< 50% * previous history of decompensated heart failure * previous history of documented specific cardiomyopathy (including but not limited to hypertrophic cardiomyopathy (hcm), amyloid, sarcoid, etc.) * previous history of documented arrhythmias * are being treated with sphingosine-1 phosphate (s1p) modulators (fingolimod, siponimod, ozanimod, ponesimod)

Keywords: heart attack acute ischemic heart disease acute coronary syndrome st-elevated myocardial infarction left ventricular dysfunction
adherence, hiv-1 infection, resistance, and renal and skeletal adverse event in individuals taking truvada® for hiv pre-exposure prophylaxis (prep)

Conditions: HIV

Summary: this is an observational study of hiv-1 negative individuals who participated in demonstration projects or clinical studies and took daily emtricitabine/tenofovir disoproxil fumarate (ftc/tdf, truvada®) for pre-exposure prophylaxis (prep). all individuals were enrolled and followed as described in the parent prep demonstration project or clinical study protocol until study completion, hiv-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. in the protocols of the parent prep observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and hiv-1 infection status. adherence was determined by the specific ftc/tdf drug level measurement(s) outlined in the parent protocol. gilead had collected data from 21 global prep demonstration projects and clinical studies for over 7,000 truvada for prep users who had at least one measurement of adherence. data from the different contributing studies were pooled for statistical analyses by gilead.


Eligibility criteria:
inclusion criteria: * participants in an ftc/tdf for prep observational or clinical study * hiv-1 negative individual at the time of enrollment in a demonstration project or clinical study * participants with at least one measurement of tenofovir-diphosphate (tfv-dp) in dried blood spot (dbs) or tenofovir (tfv) in plasma exclusion criteria: * this is an observational study and will collect hiv-1 infection and resistance information along with renal or skeletal adverse events without intervention.

Keywords: hiv-1 truvada ftc/tdf pre-exposure prophylaxis prep adherence resistance
influence of the design of the transmucosal abutment on the periimplant bone level

Conditions: Peri-implant Marginal Bone Loss; Peri-implant Bone Level; Transmucosal Abutment Design; Peri-implant Bone Loss

Summary: the objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height

patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. the control group will receive conventional transmucosal abutments while the test group will receive tcp abutments, with a narrower design. results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.

Eligibility criteria:
inclusion criteria: * absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%. * absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit. * adequate bone quality available, allowing placement of mozo grau® implants inhex std quattro with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm. * natural teeth or implants with fixed restoration as antagonists. exclusion criteria: * systemic factors: * continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism. * history of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis. * physical disability that may interfere with proper oral hygiene. * use of any investigational medication or device within the previous 30 days to implant surgery in the study. * alcoholism or drug addiction * smoker of more than 10 cigarettes per day. * conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability. local factors: * history of local radiotherapy. * bruxism. * diseases that affect the oral mucosa, such as oral lichen planus. * untreated periodontitis. * persistent intraoral infection. * post-extraction alveoli not cured (less than 6 weeks after extraction).

Keywords: periimplant bone loss abutment design transmucosal abutment
effects of infrared laser moxibustion on cancer-related fatigue in breast cancer patients

Conditions: Cancer-related Fatigue

Summary: cancer-related fatigue (crf) is the most common and distressing symptom associated with tumor or cancer treatment that breast cancer survivors (bcs) experience.the investigators previously found the laser moxibustion was potentially efficacious for crf; however, more rigorously designed study is needed to confirm its benefit. the primary aim of this study is to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on crf. secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing symptoms such as among bcs experiencing crf.

the randomized, placebo-controlled, three-arm trial will be conducted to evaluate the efficacy of infrared laser moxibustion (ilm) and sham ilm (silm) compared to waitlist control (wlc) for moderately to severely fatigued bcs. the two intervention groups will receive real/sham infrared laser moxibustion on four acupoints (e.g. st36 (bilateral), cv4, and cv6) for 20 minutes each session for six weeks (two times per week). the primary endpoint is the change in fatigue scores from baseline to week 6 as measured by the chinese version of the brief fatigue inventory (bfi-c). our secondary aims are to compare the severity of comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere length) among the three groups.

Eligibility criteria:
inclusion criteria: * age between 18 years and 75 years * breast cancer survivors with a diagnosis of stage i-iiia * cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy) at least 12 weeks before the trial, with the exception of hormonal and trastuzumab therapy * complaint of fatigue starting on or after their cancer diagnosis,brief fatigue inventory score of ≥ 4 exclusion criteria: * severe anemia (platelet count \<60,000/μl,hemoglobin \<8 g/dl, or leukocyte count\<3000/μl) * abnormal findings in a thyroid function test (abnormal level of free thyroxine and thyroid stimulating hormone \ 5.1 μiu/ml) * having received acupuncture for any indication in the previous 4 weeks or having received acupuncture test within the past 6 months. * untreated major depressive disorder and suicidal ideations. * pregnant or planning to become pregnant

Keywords: infrared laser moxibustion cancer-related fatigue breast cancer
hypoglycemia associated autonomic failure in type 1 diabetes mellitus (dm)

Conditions: Type 1 Diabetes; Hypoglycemia Associated Autonomic Failure

Summary: exercise is a cornerstone of diabetes management. it helps reduce blood pressure, promote weight loss, lower insulin resistance and improve glucose and lipid (triglyceride and hdl-cholesterol) profiles. unfortunately, the benefits of exercise are often not embraced by diabetic individuals because of the fear of low blood sugar (hypoglycemia). my laboratory has demonstrated that autonomic nervous system (ans) counterregulatory failure plays an important role in exercise associated hypoglycemia in type 1 dm. ans responses are significantly reduced in type 1 dm and are further blunted by antecedent episodes of hypoglycemia. furthermore, there is a large sexual dimorphism of reduced ans responses during submaximal exercise in both type 1 dm and healthy individuals that is unexplained. accumulating data are demonstrating that serotonergic pathways can regulate ans discharge. generally, serotonergic pathways are inhibitory but both single and longer term administration of selective serotonin reuptake inhibitors (ssri's) such as prozac has been demonstrated to increase basal epinephrine levels and enhance baroreflex control of sympathetic nervous system (sns) activity. what is unknown is whether fluoxetine can also enhance sns responses and also override the large ans sexual dimorphism present during sub maximal exercise. therefore, the purpose of this study is to determine if the ssri fluoxetine (prozac) can improve sns responses during exercise.


Eligibility criteria:
inclusion criteria: * 32 (16 males, 16 females) healthy controls aged 18-45 yr. * 32 (16 males, 16 females) type 1 diabetic patients aged 18-45 yr. * hba1c 6-10.0% * has been diagnosed type 1 dm * no clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) * body mass index \< 40kg • m-2 exclusion criteria: * pregnant women * subjects unable to give voluntary informed consent * subjects on anticoagulant drugs, anemic or with known bleeding diatheses * subjects taking any of the following medications will be excluded: non-selective beta blockers, sedative-hypnotics, anticonvulsants, antiparkinsonian drugs, antipsychotics, antidepressants, mood stabilizers, cns stimulants, opioids, hallucinogens * subjects with a recent medical illness * subjects with a history of hypertension, heart disease, cerebrovascular incidents * current tobacco use

Keywords: exercise diabetes ssris
study of changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

patients with primary non-small cell lung cancer who received first chemotherapy in beijing chaoyang hospital affiliated to capital medical university were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.we will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. the correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Eligibility criteria:
inclusion criteria: * each period non-small cell lung cancer, which was confirmed by histopathology. patients has only lung cancer . * functional status score (ps) ≧ 70. * the first time for chemotherapy . * a written informed consent. exclusion criteria: * merging other tumors. * have autoimmune diseases. * aids

Keywords: non- small cell lung cancer; lymphocyte subsets
taiwan registry of endovascular thrombectomy for acute ischemic stroke

Conditions: Stroke, Ischemic

Summary: taiwan registry of endovascular thrombectomy for acute ischemic stroke is a multi-centers registration. it starts in jan 2019. the key items in the registration form include basic demographic profiles, past medical history, time of stroke onset, stroke severity (nih stroke scale), whether to have rt-pa treatment, pre-evt imaging, type of devices, status of recanalization, complication and other associated parameters for evt, and 3 months post stroke outcome. the study also includes a standardized imaging analysis for the quantification of the de-identified imaging data from participates. in summary, the registry will provide the valuable information for ais patients receiving evt in twain.

stroke is the second leading cause of death and third leading cause of disability worldwide. until recently, intravenous recombinant tissue-type plasminogen activator (r-tpa) was the only therapy that was proven to be effective for acute ischemic stroke (ais). however, the effect of rt-pa was limited in stroke patients with large artery occlusion. in 2015, there were five randomized controlled trials of endovascular therapy (evt) for ais. the significant positive results indicated an evolution of treatment for ais in selected patients. nevertheless, because previous evt trials recruited mainly caucasians as trial participants, little is known about racial differences in endovascular treatment. in taiwan, the ministry of health and welfare has approved the application of evt in ais and the national health insurance also started to pay the devices for evt in ais patients fulfilling certain conditions in recent years. therefore, it is important to have a prospective registration to evaluate the efficacy and safety in ais patients receiving evt in taiwan. taiwan registry of endovascular thrombectomy for acute ischemic stroke is a multi-centers registration. it starts in jan 2019. the key items in the registration form include basic demographic profiles, past medical history, time of stroke onset, stroke severity (nih stroke scale), whether to have rt-pa treatment, pre-evt imaging, type of devices, status of recanalization, complication and other associated parameters for evt, and 3 months post stroke outcome. the study also includes a standardized imaging analysis for the quantification of the de-identified imaging data from participates. in summary, the registry will provide the valuable information for ais patients receiving evt in twain.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke caused by intracranial large vessel occlusion * can be treated within 24 hours of stroke onset. * large vessel occlusion demonstrated by magnetic resonance imaging angiography (mra), computed tomography angiography (cta) or digital substraction angiography (dsa). * pre-stroke independence (modified rankin scale 0-2). exclusion criteria: * other cause of stroke, such as intracranial hemorrhage. * not underwent endovascular thrombectomy
entacapone augmentation for schizophrenia

Conditions: Schizophrenia

Summary: this study is testing the hypothesis that entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.


Eligibility criteria:
inclusion criteria: * predominantly negative symptoms * stable on ongoing antipsychotic treatment exclusion criteria: * acute psychotic exacerbation * suicidal ideation * uncontrolled systemic disease

Keywords: schizophrenia negative symptoms entacapone