Kornimate/medical-research-clean huggingface dataset:
multi-marker index for the risk assessment of sepsis in the emergency department (mindset)

Conditions: Sepsis

Summary: the purpose of the study is to procure blood samples from patients ≥18 years of age who present to the emergency department (ed) with at least two of the diagnostic criteria for sepsis. samples obtained upon enrollment will be used for future testing of the triage sepsis panel and other biomarkers.

this is a multi-center, prospective specimen procurement study. the samples will be used for future testing of the triage sepsis panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the emergency department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the icu. approximately 700 patients presenting to the emergency department (ed) with at least two of the symptoms or signs of sepsis will be enrolled in this study. the day of enrollment is defined as study day 0. enrolled patients who are discharged to home will be contacted by telephone on study days 3, 14 and 28 to assess their clinical status. patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points). each patient will also be contacted on study day 14 and on or after study day 28 to assess the duration of hospital stay and mortality through days 14 and 28.

Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * presenting to the emergency department (ed) for evaluation and who can be enrolled within 6 hours of initial ed evaluation * exhibiting two or more of any diagnostic criteria for sepsis * willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on study days 3, 14, and 28 exclusion criteria: * age \< 18 years * participation in any interventional clinical study within the previous 30 days * status-post cardiac arrest (within the past month) * moribund or with active "do not resuscitate" or "comfort care only" status * prisoners or other institutionalized or vulnerable individuals * already a hospital in-patient * unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for day 3, 14, and 28 status assessments if discharged
study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ignx001

Conditions: Peanut Allergy

Summary: the goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ignx001 in peanut-allergic adults and older adolescents.


Eligibility criteria:
key inclusion criteria: * history of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years). * peanut specific ige level ≥ 1 kua/l. * positive peanut spt with wheal diameter ≥ 5 mm. key exclusion criteria: * history of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to screening. * current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study. * current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance sc aeroallergen immunotherapy.
role of irisin/fndc5 (rs3480) single nucleotide polymorphism in breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most frequent cancer in women worldwide. its incidence is increasing but mortality has decreased in a considerable way due to the combined effect of early detection and improvement in treatment . irisin is encoded by the fndc5 gene, whose expression is controlled by the peroxi- some proliferator activated receptor gamma coactivator 1 alpha (pgc-1α). pgc-1α is a transcriptional co-activator which does not bind directly to dna. studies indicated that the estrogen-related receptor alpha (errα) could be a factor that plays a role in pgc-1α binding to dna. errα is encoded by the esrra gene and is an orphan nuclear receptor, which has two domains. one of them allows the interaction with dna, and the second one with a ligand. the errα structure is similar to that of the estrogen receptor alpha (erα), but this receptor does not bind to natural estrogens. errα interacts with a canonical sequence of the estrogen response elements (erre). errα and erα could compete with each other to bind to similar dna elements. together, errα binds to dna, in complex with pgc-1α, to regulate the activity of genes such as fndc5 . ca15-3, a high molecular weight glycoprotein (300-450 kda), is produced by the epithelial ducts and acinic breast cells and is then secreted in milk normally. it has been widely used for the prediction of bone metastases in patients with breast cancer .


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer exclusion criteria: * • history of other tumors.
pioglitazone, body composition,insulin sensitivity and protein metabolism in esrd

Conditions: ESRD

Summary: non diabetic patients on renal replacement therapy are prone to changes in body composition with an increase in visceral fat and muscle wasting all favoured by the insulin resistant state. malnutrition is associated with a worst prognosis in these patients. glitazones are the most powerful insulin sensitisers available in clinical practice which also have anti-inflammatory properties. their use has been associated with significant and favourable changes in body fat distribution in type 2 diabetic subjects. experimental studies suggest that glitazones may attenuate muscle wasting in renal failure. the goal of this study was to examine in non diabetic esrd patients the effects of pioglitazone on inulin sensitivity and protein metabolism as determined by the hyperinsulinemic euglycemic clamp and on changes in body composition as determined by anthropometric measurements, dual energy x-ray absorptiometry (dexa) and ct-scan determined changes in abdominal visceral and sub-cutaneous fat.


Eligibility criteria:
inclusion criteria: non diabetic individuals with esrd, on hemodialysis or peritoneal dialysis for at least 3 months. consent form signed - exclusion criteria: no infectious complication 3 months prior to entry in the study. -

Keywords: body composition insulin sensitivity protein metabolism pioglitazone
diclofenac vs. ropivacaine for cesarean section

Conditions: Cesarean Section

Summary: a prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following cesarean section performed via a pfannenstiel incision.

study objective: to assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound infusion. design: prospective, randomized, double-blind, placebo-controlled study. setting: large referral hospital. patients: 75 women recovering from cesarean section performed via a pfannenstiel incision. interventions: on completion of the surgical procedure, a 15 cm 19g infusion catheter (painfusor™, baxter) will be placed below the fascia. according to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25). * in group control water for injection will be administered. * in group ropivacaine 0.2 % ropivacaine will be administered. * in group diclofenac diclofenac (300 mg/240 ml of water for injection) will be administered. during the first 6 postoperative hours, a co-investigator will administer "rescue" analgesia (10 ml bolus of infusion drug or rescue morphine). thereafter, the catheter will be connected to an elastometric pump (lv 10 infusor, baxter) filled with either water for injection, ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection). the fluid will be administered as a constant infusion rate (10 ml/hr). continuous wound infusion will be continued for the subsequent 18 postoperative hours. during this 18 hour period, subcutaneous morphine 4 mg will be administered on patient request for additional analgesia. measurements and main results: the following parameters will be assessed and recorded: 1. demographic data 2. surgical milestones(anesthetic time, surgical time etc). 3. incidence of failed intrathecal anesthesia 4. vas for pain every 15 min during first 6 postoperative hours 5. time to first pain (intrathecal anesthesia to vas \> 60 mm) 6. number of infusion events (10 ml and 5 ml) 7. rescue morphine administration during first 6 postoperative hours. 8. subcutaneous morphine administration during subsequent 18 postoperative hours. 9. vas for pain. 10. the incidence of nausea and vomiting. 11. patient satisfaction at 24 hours, postoperatively.

Eligibility criteria:
inclusion criteria: * patients undergoing cesarean section exclusion criteria: a history of clinically significant disease: * cardiovascular * pulmonary * hepatic * renal * neurologic * psychiatric * metabolic disease

Keywords: ropivacaine diclofenac local anesthetic instillation
an open-label study to evaluate the absorption, metabolism, and excretion of [14c]-telotristat etiprate in males

Conditions: Carcinoid Syndrome

Summary: to evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite lx1033.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 30 to 65 years of age. * male subjects and their partners must agree to use an adequate method of contraception * historically able to produce a minimum of 1 bowel movement every day on most days exclusion criteria: * female subjects * use of any medication or supplement within 5 days prior to dosing * radiation exposure exceeding 5 millisieverts (msv) in the last 12 months or 10 msv in the last 5 years * current smokers or the use of cigarettes within 90 days prior to screening * history or renal disease or abnormal kidney function * history of hepatic disease * acute diarrhea or constipation within 7 days of dosing * positive urine glucose at screening

Keywords: absorption metabolism excretion
european management platform for childhood interstitial lung diseases - child-eu register and biobank

Conditions: Lung Diseases, Interstitial; Pulmonary Alveolar Proteinosis; Pulmonary Eosinophilia; Pulmonary Fibrosis; Respiratory Distress Syndrome, Newborn; Child

Summary: generation of a common european database and biobank continous assessment and implementation of guidelines and treatment protocols establishment of a large observational cohort of child patients determination the value of outcomes used in child assess treatment variations used, deliver data from defined protocols and linked outcomes

objective 1: generation of a common european database and biobank. the existing national programmes to collect data on child in three countries (france, germany, uk) will enable the consortium to swiftly adapt current frameworks to a functionally appropriate pan-european web-based database and biobank. importantly, compatibility with ongoing united states child data base developments will be factored in. objective 2: continuous assessment and implementation of guidelines and treatment protocols. our standards working group will convene regularly. initial tasks will establish (a) specific diagnostic pathways, including detailed protocols for gathering clinical information, blood testing, imaging and pathology ("best practice checklist"); (b) international panels of clinicians, geneticists, radiologists and pathologists who will review every diagnosis to quality control the data; and (c) detailed protocols for follow up to generate natural history data. objective 3: recruitment of a carefully characterized cohort of child patients. european wide recruitment and interdisciplinary critical peer review of all diagnoses submitted from across europe is imperative. each case will be given a diagnosis independently; if no firm diagnosis is possible, we will review the case periodically as new information becomes available. during the first year of the study, clinicians´ decisions according to local practice and outcomes will be independently monitored and assessed. objective 4: determine the value of outcomes used in child. we will systematically optimize and clarify the relative weight of a large spectrum of single and composite clinical outcomes (using both clinician and carer scoring), sequential limited chest ct (to minimise radiation exposure), lung function testing, histopathological categorization of lung biopsies, serum markers and genetic tests. variability, reproducibility and the effects of training on reading images will be investigated. objective 5: assess treatment variations used, deliver data from defined protocols and linked outcomes. this project will analyse in detail treatment and outcomes within and between subjects using data collected. analysis of the collected data will enable us to support the definition of trial protocols planned in the future.

Eligibility criteria:
inclusion criteria: * all children with suspected or * verified diagnosis of ild or * masquerading as ild and * those with rare localized parenchymal lung diseases exclusion criteria: * other indication as inclusion criteria

Keywords: ild; child
early nutrition in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: the aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate ap. patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. biochemical tests and pain severity will be evaluated.

prospective, randomized study. research in the adult population shows that early enteral feeding in acute pancreatitis (ap) both oral and via the feeding tube is safe, shortens the length of hospital stay, prevents the multi organ failure (mof) and reduces mortality. the pediatric population lacks prospective data concerning refeeding modes in ap. the aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate ap. patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. biochemical tests including crp, amylase, lipase and proinflammatory cytokines levels and zonulin level as well as severity of pain will be assessed again in the second, the third and the fifth hospital day.

Eligibility criteria:
inclusion criteria: * ap diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria: * abdominal pain of pancreatic origin * radiologic findings supportive of ap on imaging * amylase or lipase levels elevation three times above the upper limit of normal * mild or moderate ap mild ap: ap without organ failure, local or general complications moderate ap: ap that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening * no contradictions to enteral treatment * informed consent from the parents or legal guardian and from the patient if older than 16 years exclusion criteria: * severe general condition * severe ap * kidney insufficiency, cardiac insufficiency * diabetes type 1 * cystic fibrosis * contraindications to enteral feeding * lack of required informed consent
quantification of cerebral perfusion by contrast-enhanced ultrasound during neonatal heart surgery

Conditions: Heart Defects, Congenital

Summary: transcranial contrast-enhanced ultrasound for evaluation of cerebral blood flow during pediatric cardiac surgery. this study is aimed as a feasibility study prior to conducting a lager prospective clinical trial including neurologic and developmental outcome measures.

the cerebral perfusion of infants with congenital heart defects is a critical determinant during cardiac surgery. the majority of these interventions is performed during deep or moderate hypothermia (25-32°c) with reduced blood flow of the heart-lung-machine (hlm). assuming a symmetrical anatomy of the cerebral arteries (c. willisii) a single vessel (t. brachiocephalicus) is then supplying the cerebral blood flow. using contrast-enhanced ultrasound the cerebral blood flow will be assessed during cardiac surgery interventions.

Eligibility criteria:
inclusion criteria: * neonates and infants ≤ 4 month (open fontanelle) * proper ultrasound conditions/window * appropriate general and neurologic state of health * written consent of both parents/guardians * availability of trained sonographer (medical doctor) exclusion criteria: * absence of trained sonographer (medical doctor) * intolerance against sonovue® (bzw. sulphur hexafluoride) * missing signed consent * reduced or inappropriate general and neurologic state of health * preexisting cerebral injury

Keywords: ceus tceus contrast enhanced ultrasound perfusion cerebral perfusion sulphur hexafluoride sonovue
rapid histologic assessment for stereotactic breast biopsy: enhancing early detection with miniature mass spectrometry and ai

Conditions: Breast Cancer

Summary: breast cancer is the leading cancer among taiwanese women, and it is the second leading cause of cancer-related deaths in women. the five-year survival rate for early-stage breast cancer (stage 0 to ii) is over 90%, significantly better than the survival rates for stage iii and stage iv breast cancer, which are approximately 70% and 25%, respectively. as a result, breast cancer screening and early diagnosis have always been of great importance. breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation. however, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. for the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer. the investigators use a special technique-paper spray ionization miniature mass spectrometry (psi-mms). according to preliminary research, with the assistance of ai, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. the investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.


Eligibility criteria:
inclusion criteria: * those who come for receiving vacuum-assisted stereotactic breast biopsy exclusion criteria: * those who cannot or are unwilling to sign the informed consent.

Keywords: breast cancer breast biopsy miniature mass spectrometry artificial intelligence
brazilian reality of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage; Hepatocellular Carcinoma Stage I; Hepatocellular Carcinoma Stage II; Hepatocellular Carcinoma Stage III

Summary: national, multicenter, retrospective, non-randomized observational study (real world evidence-rwe) with the purpose of analyzing the epidemiological profile of hepatocellular carcinomas (bclc a, b or c), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).

hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide. prognosis strongly depends of the underlying liver disease, tumor-specific characteristics such as tumor load, extrahepatic spread and portal vein branch thrombosis, as well as access to treatments. the brazilian reality of hepatocellular tumor clinical presentation varies widely and the management profile, treatments adopted and response rates are little described. taking into consideration the heterogeneity of health services in reference centers in brazil, knowing the epidemiology profile and treatment of these tumors is of paramount importance to improve care for patients, deepen the knowledge in these diseases and foster for the generation of new regional researches. the primary objective of this study is to determine and describe the epidemiological profile of hepatocellular carcinoma bclc (barcelona algorithm of liver cancer) stages 0, a, b and c of patients followed in brazilian reference oncology centers, within the last 6 years (between 2017 to 2022). the secondary objective is to describe the treatment and endpoints patterns of 2 disease cohorts: early disease (bclc 0, a and b) and advanced disease (bclc c).

Eligibility criteria:
inclusion criteria: * male and female; * above 18 years old; * hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging); exclusion criteria: * fibrollamelar carcinoma, hepatoblastoma, intrahepatic cholangiocarcinoma, neuroendocrine tumors or other less common types of liver tumors; * patients with incomplete staging data; * patients with only 1 visit to the participating site healthcare service, with loss to follow-up prior to the second visit to the participating site healthcare service; * previous treatment for hepatocellular carcinoma in another institution; * treatment with investigational drugs in a clinical trial.

Keywords: hepatocellular carcinoma; rwe
study of treatment free remission in patients with chronic myeloid leukemia in chronic phase

Conditions: CML

Summary: the principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (cml) in deep molecular response after stopping tyrosine kinase inhibitor (tki) treatment. the second aim is to characterize the immunological status of patients with cml at the time of tki interruption and then at 3 months after the interruption.

argentina stop trial is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase chronic myeloid leukemia (cml) in deep molecular response after stopping tyrosine kinase inhibitor (tki) primary objective: - to identify the proportion of patients who continue on major molecular response after discontinuing treatment with tki. secondary objectives: * to characterize the immunological status of patients with cml at the time of interruption and then at 3 and 12 months after the interruption. tertiary objective: to evaluate the pharmacoeconomic impact of interrupting the treatment.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. patients with a diagnosis of cml bcr-abl positive in cp treated with approved tki (imatinib, nilotinib or dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep mr with 1st line tki, which never presented criteria for treatment failure. 3. age ≥ 18 years 4. ≥ 4 years of treatment with imatinib, nilotinib or dasatinib. 5. achievement of mr 4.5 in a standardized laboratory (bcr-abl1 is ≤ 0.0032%). 6. evidence of mr 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart. 7. evidence of typical quantifiable bcr-abl1 transcript (b3a2 \[e14a2\] and / or b2a2 \[e13a2\], typical isoforms of p210). exclusion criteria: 1. patients who previously discontinued tki and demonstrated recurrence of the disease. 2. patients with failure to any tki at any time. 3. patients who presented accelerated phase or cml in blast crisis at any time. 4. patients with atypical transcript not quantifiable by rt qpcr 5. bcr-abl mutation detected at any time during the course of the resistant disease

Keywords: discontinuation