Kornimate/medical-research-clean huggingface dataset:
mealtime or post-meal dosing of urli in medtronic 780g hybrid closed loop system

Conditions: Type 1 Diabetes (T1D)

Summary: this is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (urli) used in a minimed 780g system hybrid closed loop system. subjects with type 1 diabetes mellitus (t1dm) already using a 780g hybrid closed loop system with urli will be included. after signing a remote digital informed consent, a baseline record of the minimed 780g system will be downloaded from the medtronic digital platform (carelink system \[1\]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary \[2\]. during the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. during the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary \[2\]. at the end of the intervention period- a carelink report \[1\] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences. 1. primary objective: to assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring. 2. secondary objective: to assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes ref: 1. carelink.medtronic.eu 2. nutratio.com.


Eligibility criteria:
inclusion criteria: participants must be 18 years of age or older (inclusive). diagnosed with type 1 diabetes mellitus (t1dm). already using the minimed 780g hybrid closed-loop system with ultra rapid lispro insulin (urli) for at least 2 months prior to study enrollment. able and willing to provide informed consent electronically. willing and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires. exclusion criteria: participants with a medical history of untreated active proliferative retinopathy. note: subjects with non-proliferative retinopathy may be included. subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment. severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.

Keywords: automated insulin delivery continuous glucose monitoring (cgm) glycemic control hybrid closed loop system insulin bolus lyumjev mealtime dosing medtronic 780g patient preferences postmeal dosing postprandial glycemia time in range (tir) type 1 diabetes mellitus (t1dm) ultra rapid lispro insulin (urli)
food effect and relative bioavailability study of oxycodone in healthy volunteers

Conditions: Healthy

Summary: to estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of pf-00345439 formulation k and to estimate its relative bioavailability compared to pf-00345439 formulation x in the fasted state in healthy volunteers

this study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of pf-00345439 formulation k in healthy volunteers. additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test pf-00345439 formulation k compared with the reference pf-00345439 formulation x under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in pf-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 18 and 55 years of age (inclusive). exclusion criteria: * evidence or history of clinically significant disease * positive urine drug test

Keywords: food effect pharmacokinetics bioavailability oxycodone management of moderate to severe pain
current and past sars-cov-2 infection and covid-19 in healthcare

Conditions: SARS-CoV 2

Summary: the sars-cov-2 pandemic and resulting covid-19 disease causes a substantial burden on healthcare systems. little is known about how the infection spreads within healthcare. in order to design control strategies, knowledge of the presence of viral nucleic acid and whether an immune response to the virus has been mounted is needed. the purpose of this study is to determine whether personnel and patients/clients in healthcare in region stockholm have a currrent sars-cov-2 infection or have had an infection. this information will be used to understand how the infection spreads in healthcare, to explore the association with sick-leave among personnel, and to plan high-quality and safe care. healthcare providers and organizations participating in the study from the greater stockholm region include the following: karolinska university laboratory, karolinska university hospital; intensive care unit, karolinska university hospital; scilifelab; kth royal institute of technology; roo home healthcare services (roo hemtjänst och vård); health care services stockholm county (slso); region stockholm; southern hospital (södersjukhuset); danderyd hospital; capio st göran hospital; södertälje hospital; tiohundra ab; ersta hospital, sweden; and st eriks eye hospital (st eriks ögonsjukhus).


Eligibility criteria:
inclusion criteria (all three criteria must be fulfilled): * healthcare personnel or patient/client of healthcare in stockholm county * age 18-99 * provided consent to participate in the study exclusion criteria: * no informed consent to participate provided * already confirmed with sars-cov-2 infection * already sampled for sars-cov-2 infection based on clinical presention but where the result has not been reported yet

Keywords: healthcare personnel screening virus antibodies sick leave covid-19
an anti-inflammatory diet effect on metabolic, inflammatory and immune status of obese younger adults

Conditions: Obesity

Summary: diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. the present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among young adults of the obese younger adults.

obesity pandemic presents a major challenge to chronic disease prevention worldwide. a low-grade chronic inflammation is associated with obesity and related cardiometabolic disorders, such as cardiovascular diseases, type 2 diabetes and some type of cancers. diet has a major role in the etiology of obesity, and there is a growing body of evidence suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade inflammation and thus the course of obesity-related chronic non-communicable diseases. the present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight loss, body composition, cardiometabolic risk factors and immune system response among younger adults. a nutritional intervention based on an energy-restricted anti-inflammatory diet will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein). the inflammatory potential of the diet will be assessed with the dietary inflammatory index®.

Eligibility criteria:
inclusion criteria: * adults age of 18 to 50 years * body mass index ≥ 30 kg/m2 * with or without obesity related complications exclusion criteria: * smoking * chronic hearth, renal and/or liver diseases, * active carcinoma or having carcinoma in last year * anti-inflammatory and/or immunosuppressive drugs intake * changing the existing medication therapy * persons older than 50 years * active infection and/or surgical procedure in last 3 months * nutritive allergy or intolerance to any anti-inflammatory diet constituent * pregnancy

Keywords: anti-inflammatory diet obesity low-grade inflammation cardiometabolic immunity
studies of biomarkers in different urodynamic diagnoses of female patients with lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms

Summary: urodynamic study is an objective method to evaluate female patients with lower urinary tract symptoms (luts). however, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with luts. therefore, it is necessary to find a simple and objective method to help in evaluating female patients with luts. several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. the aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with luts.


Eligibility criteria:
inclusion criteria: * all female patients (\> 20 years) with lower urinary tract syndrome. exclusion criteria: * female patients with tumor and stone were excluded.

Keywords: lower urinary tract symptoms biomarkers urodynamic studies
prevail-us: a study of pitavastatin 4 mg vs. pravastatin 40 mg in patients with primary hyperlipidemia or mixed dyslipidemia

Conditions: Primary Dyslipidemia; Mixed Dyslipidemia

Summary: randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(qd) vs. pravastatin 40 mg daily(qd) in subjects with primary hyperlipidemia or mixed dyslipidemia.


Eligibility criteria:
inclusion criteria: * male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent * plasma low-density lipoprotein cholesterol (ldl-c) ≥130 milligrams per deciliter (mg/dl) and ≤220 mg/dl and triglyceride (tg) levels of ≤400 mg/dl exclusion criteria: * homozygous familial hypercholesterolemia * any conditions which may cause secondary dyslipidemia * uncontrolled diabetes mellitus
allo bmt using matched related/unrelated donors with flubu and hicy

Conditions: Lymphoma; Multiple Myeloma; Leukemia; Myelodysplastic Syndrome

Summary: the purpose of this research is to find the most effective and least toxic way to prevent gvhd after bmt.

a person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (bmt). bmt has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (allobmt) however, a possible side effect of bmt is graft versus host disease (gvhd). gvhd occurs when cells of the donor's immune system, which are present in the bone marrow, attack the bmt recipient's normal tissue. prevention of gvhd is important for the success of the bone marrow transplant. this research is being done to find the most effective and least toxic way to prevent gvhd after bmt

Eligibility criteria:
inclusion criteria: * patients ages between 0 to and 65 years of age. * patient must have a genotypically hla-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor. * acute lymphocytic leukemia (all) in cr1 with high risk features * acute myeloid leukemia (aml) in cr1 with high risk features defined as: i. greater than 1 cycle of induction therapy required to achieve remission, ii. preceding myelodysplastic syndrome (mds) other than myelofibrosis, secondary aml iii. presence of flt3 mutations or internal tandem duplications, iv. fab m6 or m7 classification or adverse cytogenetics for overall survival such as those associated with mds, m6, m7 leukemia, or v. complex karyotype \[\> 3 abnormalities\] * acute leukemias in 2nd or greater remission * refractory or relapsed aml * aml transformed from mds * myelodysplastic syndrome (mds) beyond refractory anemia * chronic myeloid leukemia (cml) * chronic myelomonocytic leukemia * philadelphia-negative myeloproliferative disorder * relapsed chemotherapy-sensitive hodgkin's or non-hodgkin's lymphoma * multiple myeloma-stage iii exclusion criteria: * prior autologous or allogeneic stem cell transplant. * performance status greater than 2 * active infection. * inadequate cardiac function; arrythmias or symptomatic cardiac disease. * inadequate pulmonary function; fev1, fvc, dlco \<50% of predicted * inadequate serum creatinine clearance \<60 * inadequatebhepatic function * positive serology for hiv-1, 2 or htlv-1, 2. * pregnancy. female patient must have negative pregnancy test

Keywords: acute lymphocytic leukemia (all) acute myeloid leukemia (aml) acute leukemia refractory or relapsed aml myelodysplastic syndrome (mds) chronic myeloid leukemia (cml) chronic myelomonocytic leukemia hodgkin's lymphoma non-hodgkin's lymphoma philadelphia-negative myeloproliferative disorder hematologic malignancies transplantation busulfan fludarabine cytoxan bone marrow allogeneic related donor unrelated donor
beneficial effects of coenzyme q10 treatment on the mitochondrial dysfunction and oxidative stress associated to atherothrombosis developement in antiphospholipidid syndrome patients

Conditions: Coenzyme Q10 on Athero-thrombosis in APS Patients

Summary: the study will be performed on 50 aps (antiphospholipid syndrome) patients, which will be randomized to receive either coq10 (200mg/day) or placebo for one month. blood will be drawn at time 0 and at the end of the treatment. studies will be conducted in plasma and purified leukocytes from aps. design: 1) study of endothelial function: 2) analysis of changes operated on various prothrombotic/proinflammatory parameters and their associated intracellular signalling. 3) analysis of mitochondrial ultra structure and activity; mitochondrial antioxidant system characterization; expression levels and activity of transcription factors/proteins involved in oxidative stress (foxo 3, nfkb, nrf2), quantification of coq10 (coenzyme q10). 4) biomarkers of oxidative stress. 5) mirnas microarrays, rt-pcr validation and correlation/association studies. 6) induction of over-expression of mirnas of interest; luciferase constructs. 7)studies of methylation.


Eligibility criteria:
inclusion criteria: 1. patients who fulfilled sidney criteria for aps (antiphospholipid syndrome) (miyakis s et al., j thromb haemost 2006; 4:295-306) 2. age over 18 years 3. written informed consent exclusion criteria: 1. acute liver disease. 2. severe renal impairment 3. acute arterial or venous thrombosis episode in the last 3 months 4. pregnancy and breastfeeding
efficacy of a bilberry-based probiotic product on glucose tolerance and insulin resistance

Conditions: Insulin Resistance

Summary: the impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. the aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.


Eligibility criteria:
inclusion criteria: healthy adults with a bmi between 20-30 exclusion criteria: -
database of tissue samples to understand the inflammatory response after cardiac surgery

Conditions: Heart Diseases

Summary: the aim of this study is to collect non-individual related blood samples for the compelling of a unique database of tissue samples to understand the inflammatory responds after cardiac surgery on an on-going basis. this includes especially protein analyses and genetic testing for certain neurotransmitters in the blood and tissues to understand disease markers related to heart disease. the study is designed as an openly recruiting biobank with the purpose to later serve multiple study purposes. outcomes refer to protein analyses and genetic testing for neurotransmitters in the blood and tissues.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery exclusion criteria: * none.

Keywords: cardiac surgery tissue sample database inflammatory responds
predicting rectal adenoma with canceration and investigating mechanism based on multimodal mri and biochemical model

Conditions: Rectal Adenoma

Summary: in this retrospective study is to establish a diagnostic model for rectal adenoma canceration. the model will include multimodal comprehensive hr-t2wi morphological score, ivim functional imaging and radiomics features, and clinical indicators such as tumor markers, serum gelsolin protein and peripheral blood inflammatory cell ratio. it can be to provide accurate diagnostic information for patients before surgery, which is of great value for formulating personalized treatment plans and improving the prognosis of patients.

imaging tests is the main method for evaluating rectal mass, especially mri, which has been widely used in the preoperative diagnosis of rectal mass disease due to its very good soft tissue resolution. previous studies in our group found that hr-t2wi-based radiomics, hr-t2wi-based morphology, and ivim-based functional imaging can be used for the diagnosis of adenoma canceration. in addition to imaging, other tests, such as peripheral blood tests, can also reflect the development and progression of adenocarcinoma by counting tumor markers (colorectal tumor markers mainly cea, afp, ca199, ca724, ca50, ca242), inflammatory cell ratio (lymphocyte/c-reactive protein ratio, neutrophil/lymphocyte ratio, lymphocyte/monocytes ratio), and special types of proteins (such as coagulant protein).this study identifies the progression of adenoma to carcinoma by analyzing the combined cellular, morphological, and functional changes in adenoma carcinomas, with the expectation that multimodal co-diagnosis will improve the accuracy of clinical diagnosis.

Eligibility criteria:
inclusion criteria: 1. surgical resection 2. pathologically confirmed rectal adenoma or rectal adenoma with canceration 3. rectal mri examination including ivim-dwi, within two weeks before surgery exclusion criteria: 1. preoperative treatment 2. poor image quality, including intestinal gas or fecal artifact and ivim image fitting error 3. no surgical resection but colonoscopy 4. pathologically confirmed rectal cancer.

Keywords: rectal adenoma;canceration;magnetic resonance imaging radiomics
long-term prognosis of emergency aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: rupture of intracranial aneurysms can lead to extensive subarachnoid hemorrhage (sah), a potentially fatal neurological emergency with mortality rates ranging from 8 to 67%. at present, surgical clipping (sc) and endovascular coiling (ec) are two main treatments for aneurysmal subarachnoid hemorrhage (asah), in recent years, the improvements in surgical equipment and techniques have already greatly improved the postoperative safety of patients. however, considering individual differences between patients, some still at risk due to possible complications during hospitalization or after discharge from the hospital, it will no doubt generate a large healthcare burden. this prospective, observational clinical trial (longteam) is to improve the diagnosis and treatment effect and efficiency in this field, reducing mortality, medical costs, and medical burden, while opening up new avenues for interdisciplinary clinical practice and scientific research exploration.


Eligibility criteria:
inclusion criteria: * all patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry. exclusion criteria: * none
helmet noninvasive ventilation vs. high-flow nasal cannula in moderate-to-severe acute hypoxemic respiratory failure

Conditions: Respiratory Failure With Hypoxia

Summary: helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure. as compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. whether these physiological benefits are translated into improved outcome remains to be established. the investigators designed a randomized trial to establish whether first line treatment with helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.


Eligibility criteria:
inclusion criteria: acute-onset respiratory distress or flue-related symptoms moderate-to-severe hypoxemia (pao2/fio2\ 7.30 exclusion criteria: need for urgent endo-tracheal intubation exacerbation of asthma or chronic obstructive pulmonary disease documented pneumothorax clinical diagnosis of cardiogenic pulmonary oedema do-not-intubate order altered neurological status that requires immediate intubation and/or making the patient uncooperative thoracic or abdominal surgery in the previous 7 days recent head surgery or anatomy that prevent the application of helmet or optiflow to patient's face
screening of adolescent mental suffering

Conditions: Depression; Adolescent; Self-report Questionnaire

Summary: the primary purpose is to estimate the prevalence of depression and subsyndromal states among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they are another way of tracking this suffering, as they host many troubled teens at once for health problems and accidents sometimes iterative, reflecting their risk behaviour. secondary purposes are to assess the feasibility and desirability of a post-emergency medical consultation for adolescents who scored high on a self-administered questionnaire, and to assess the impact of this approach by later monitoring.

this is a multicenter longitudinal survey in three emergency centers in ile-de-france, with 2 periods of daily collection and comprehensive three weeks spread over one year, followed by a remote evaluation. the project is as follows: phase a : - evaluation of the prevalence: systematic execution of self-administered questionnaire by all adolescents consulting, night and day in each center. phase b : * for adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will be proposed within 15 days. * telephone survey, 12 months after the passage of emergency every teenager who completed self-administered questionnaire and presenting himself to the post-emergency consultation. this survey will aim to assess the psychological status of adolescents and the impact of any specific treatment.

Eligibility criteria:
inclusion criteria: * adolescents over the age of 13 to 17 years when passing emergency whatever the reason for consultation (surgical or medical, including attempted suicide or psychological problem) exclusion criteria: * young people not reading french.

Keywords: follow-up studies adolescent depressive disorder, major/diagnosis attempted/prevention & control self-report questionnaire emmergency department parental perception emergency