Kornimate/medical-research-clean huggingface dataset:
effect of fasting on hypoglycemic counterregulation in type 1 diabetes

Conditions: Hypoglycemia; Type1diabetes

Summary: iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (t1d). in a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. in the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with t1d will be determined.

because patients with type 1 diabetes (t1d) are required to estimate and administer their own insulin requirements, they frequently overestimate their needs. this often leads to debilitating insulin-induced hypoglycemia, which is the number one barrier to the safe, effective management of glycemia in this population. in addition to the difficulty estimating one's own insulin requirements after a meal, counterregulatory hormone responses to hypoglycemia are impaired in patients with t1d, thereby reducing hepatic glucose production (hgp) and increasing the depth and duration of the hypoglycemic episode. the discovery of ways by which counterregulatory responses to hypoglycemia can be improved in people with t1d is a priority. in previous experiments, it was observed that fasting reduces counterregulatory hormone secretion in healthy humans during insulin-induced hypoglycemia, thereby reducing hepatic glucose production (hgp). therefore, the studies proposed herein will determine the effect of fasting on hypoglycemic counterregulation in people with t1d. it is hypothesized that fasting will diminish the hormonal and hepatic responses to insulin-induced hypoglycemia. each subject will undergo two trials; one where they eat an isocaloric breakfast and lunch prior to an insulin-induced hypoglycemic challenge and a second one during which they remain fasted prior to the hypoglycemic challenge. this study design will allow assessment of the relationship between fasting and the counterregulatory responses to insulin-induced hypoglycemia in a population that is particularly vulnerable to low blood sugar.

Eligibility criteria:
inclusion criteria: * males and females of any race or ethnicity * non-obese (bmi \< or = to 30) * have a diagnosis of type 1 diabetes * c-peptide negative exclusion criteria: * pregnant women * cigarette smoking * taking inflammation-targeting steroids (e.g., prednisone). * taking medications targeting adrenergic signaling (e.g., beta-blockers, bronchodilators). * hematocrit less than 33%. * presence of hiv or hepatitis (due to their deleterious effects on the liver). * the presence of cardiovascular or peripheral vascular disease. * the presence of neuropathy, retinopathy or nephropathy. * a detection of the presence of any other disease or condition by one of the study doctors, that would be expected to confound the responses to insulin-induced hypoglycemia or make participation in the study dangerous to the individual.

Keywords: glucagon hepatic glucose metabolism liver glycogen
correlation between prostate-specific membrane antigen positron emission tomography and arterial spin labeling perfusion imaging in glioblastoma

Conditions: Glioblastoma

Summary: evaluating the relationship between prostate-specific membrane antigen positron emission tomography and arterial spin labeling perfusion imaging, and the correlation with prostate-specific membrane antigen expressed on glioblastoma microvascular.


Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent glioblastoma; * adult (≥18 years old); exclusion criteria: * the patient has a serious underlying disease or mental illness and is unable to cooperate with the imaging examination; * have received systematic chemotherapy; * the image data is of poor or incomplete quality; * pregnant women;

Keywords: prostate-specific membrane antigen arterial spin labeling
vt cryoablation system post-market clinical follow-up (pmcf) study

Conditions: Ventricular Tachycardia

Summary: the pmcf is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the adagio vt cryoablation system in the treatment of recurrent ventricular tachycardia.

this vt post-market clinical follow-up (pmcf) study continues collecting additional information about the adagio medical vt cryoablation system in real world clinical settings.

Eligibility criteria:
inclusion criteria: * ic 1 male or female the ages of ≥ 18 years * ic 2 planned ablation procedure according to the indication for use of the adagio vt cryoablation system * ic 3 subject willing to comply with study requirements and give informed consent * ic4 subject has or will be receiving an icd prior to hospital discharge exclusion criteria: * ec 1 in the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the adagio vt cyroablation system as indicated in the device instructions for use (ifu) * ec 2 subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor * ec 3 any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)

Keywords: monomorphic ventricular tachycardia vt cryoablation
obtaining and storing wound debridment samples for immediate or future wound-related scientific study

Conditions: Wound

Summary: debridement samples being collected for future or immediate research purposes.

inclusion criteria 1. the subject must have a full thickness wound. 2. the subject must be a candidate for sharp debridement. 3. the subject must be 18 years of age or older 4. the subject must be mentally competent as determined by the principal investigator. exclusion criteria 1. the subject may not be currently incarcerated or pregnant. * nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Eligibility criteria:
inclusion criteria: * the subject must have a full thickness wound. * the subject must be a candidate for sharp debridement. * the subject must be 18 years of age or older * the subject must be mentally competent as determined by the principal investigator exclusion criteria: * the subject may not be currently incarcerated or pregnant. * nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Keywords: study of debridement tissue for research purposes. open wound
efficacy, safety and tolerability of agomelatine in the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will assess efficacy, safety and tolerability of agomelatine (ago178) 25 mg and 50 mg in patients with major depressive disorder (mdd). this study includes an 8-week double-blind phase and a 52-week open-label phase.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, single or recurrent episode, according to dsm-iv criteria * ham-d17 total score \> or = 22 at screening and baseline * cgi-severity score \> or = 4 at screening and baseline * only patients who complete the core protocol are eligible to participate in the open-label extension phase exclusion criteria: * history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder * any current axis i disorder other than major depressive disorder which is the focus of treatment * substance or alcohol abuse in the last 30 days, dependence in the last 6 months * concomitant psychotropic medication, including herbal preparations and melatonin * psychotherapy of any type * female patients of childbearing potential who are not using effective contraception other protocol-defined inclusion/exclusion criteria may apply

Keywords: agomelatine, major depressive disorder, mdd, depression
dense red blood cells in sickle cell children

Conditions: Sickle Cell Disease

Summary: quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the creteil pediatric cohort.

an association between red blood cell density and hemolytic parameters, and clinical manifestations has been demonstrated in adults with sickle cell anemia. this factor has not been studied in children. the identification of predictive biomarkers of disease severity, especially of specific pediatric complications (cerebral vasculopathy, splenic sequestration, dactylitis) would be useful for optimal care of the children and early intensification red blood cell density might be one of these prognostic factors.

Eligibility criteria:
inclusion criteria: * age: 18 months-18 years * patient with sickle cell disease namely ss, or s / beta0 or s / beta + * patient regularly followed in the pediatric cohort of the chi creteil * patient hospitalized for an annual check-up * with or without intensification by hydroxycarbamide * patient who haven't been transfused within 3 months * whose parents have given their informed consent * patients insured to the french social scheme exclusion criteria: * sickle cell sc disease * having received an allogeneic bone marrow transplantation * under regular transfusion program * having received a transfusion within 3 months

Keywords: erythrocytes sickle cell disease
adaptative radiotherapy to decrease xerostomia in oropharynx carcinoma (artome)

Conditions: Oropharynx Cancer

Summary: standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs. adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment. artix study (nct01874587) entitled "phase iii trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used. artome study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). clinical data from artix study will be used for artome study.


Eligibility criteria:
inclusion criteria: * locally advanced non-metastatic carcinoma of the oropharynx limited to t3 and t4 (whatever the n) and n2-n3 (whatever the t)(ajcc stage iii-iv) * age ≥ 18 years and ≤ 75 years * performance status (who ≤ 2) * renal, hepatic and cardiovascular functions allowing systemic treatment administration * adapted stomatologic care * signed informed consent form * membership or beneficiary of a national insurance scheme exclusion criteria: * both parotids totally included in the target volume * stages t1 or t2 with positive node disease n1 * neoadjuvant chemotherapy * exereses of primitive tumor and/or nodes * history of other cancer within 5 years (except for basocellular epithelioma and cervical) * previous neck radiotherapy * platinum salts, 5fluorouracile (5fu) agents or cetuximab chemotherapy * unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia) incompatible with study participation * patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion. * patient already recruited in another biomedical research ( non interventional study is authorized) * pregnant or breast feeding patients * patient deprived of liberty, under tutorship, guardianship or placed under judicial protection * patient is deemed incapable of giving informed consent * patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.

Keywords: adaptative radiotherapy xerostomia medico-economic assessment
evaluation of the precursor-m+® in cin2

Conditions: Cervical Intraepithelial Neoplasia Grade 2

Summary: the goal of this observational study is to to evaluate the accuracy and sensitivity of precursor-m+ on a post-aliquot of liquid-based cytology (lbc) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of cin2. the precursor-m+® assay is a multiplex real-time methylation specific pcr test that identifies the level of promotor methylation of the host cell genes fam19a4 and mir124-2, known biomarkers associated with cervical carcinoma and transforming cin in cervical cells. to evaluate the clinical course of cin2 at 2 years after the first diagnosis, with an interval evaluation at 6 months. after enrolment, women will be divided into two groups: "active surveillance" and "immediate treatment". in the first group, clinical outcomes to be assessed, in relation to the precursor-m+ result at baseline, will include regression to \<cin2, persistence of cin2, and progression to cin3+. in the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of cin2+ recurrence based on the precursor-m+ result at baseline.


Eligibility criteria:
inclusion criteria: 1. age at diagnosis of 18 years or older; 2. histological confirmation of cin2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (leep) and laser conization; 3. known hpv test result at baseline; 4. ability to understand and sign the informed consent; 5. written informed consent given. exclusion criteria: 1. unknown hpv test result at diagnosis; 2. vulnerable patients.
efficacy and safety of mgso4 as tocolytics compared to ritodrine in preterm labor

Conditions: Preterm Labor

Summary: ritodrine is the conventional and the only approved tocolytics in korea(by kfda), although it was withdrawn from the us market more than 10 years ago. as already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. when such complications of ritodrine appears, clinicians consider of using mgso4 as substitute, but its use is off-the-label yet in korea. facing this discrepancy, the investigators want to compare the efficacy and safety of mgso4 with ritodrine and prove that mgso4 is not inferior to ritodrine as tocolytics. for the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in ritodrine group or mgso4 group. then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.


Eligibility criteria:
inclusion criteria: * gestational age of 24+0 to 34+6weeks * singleton and twin pregnancies * preterm labor with more than 4 times of uterine contraction for 20 minutes or more than 8 times for 1 hour on external tocography * cervical dilatation of 0 to 3cm and cervical ripening more than 25%, or cervical length in sonography below 2cm exclusion criteria: * triplet etc * preterm premature rupture of membrane * cervical dilatation more than 3cm * history of cerclage operation during this pregnancy * placenta previa * severe hypertensive diseases in pregnancy * history of administration of any tocolytics 12 hours before enrollment * fever more than 38.0'c
efficacy and safety of recombinant human endostatin in non-small cell lung cancer with leptomeningeal metastasis

Conditions: Leptomeningeal Metastasis

Summary: the purpose of this study is to observe the clinical effect and safety of recombinant human endostatin in non-small cell lung cancer with leptomeningeal metastasis


Eligibility criteria:
inclusion criteria: 1. age over 18 years old 2. pathologically proven non-small cell lung cancer 3. karnofsky performance status ≥ 40 4. lm diagnosis was based on the detection of malignant cells in the csf, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced mri . 5. no severe abnormal liver and kidney function; 6. patients have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. evidence of bleeding diathesis or serious infection 2. serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) 3. pregnant or lactating women

Keywords: recombinant human endostatin non-small cell lung cancer with leptomeningeal metastasis
a real-world study to evaluate the effectiveness of deucravacitinib in adults with plaque psoriasis in france (rephlect)

Conditions: Psoriasis

Summary: the purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis


Eligibility criteria:
inclusion criteria: * ≥18 years of age * physician-reported diagnosis of moderate to severe plaque psoriasis * be newly initiating deucravacitinib * do not object to participate exclusion criteria: * currently participating in or planning to participate in an interventional clinical trial * previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial

Keywords: psoriasis
evaluation of intra-abdominal fat in patients with type 2 diabetes using a non-invasive method

Conditions: Obesity; Type 2 Diabetes; Metabolic Syndrome

Summary: the main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a bmi range between 20-45 kg/m2


Eligibility criteria:
inclusion criteria: * established type 2 diabetes * age 18 - 80 * body mass index (bmi) between 20-45 kg/m2. * willing to undergo laboratory and anthropometric assessments. exclusion criteria: * the study will not include women who are pregnant, or are not using reliable birth control methods or who they think that they might be pregnant due to potential risk of fetal affection. * subjects with known malignancy, treated or untreated will be excluded (except treated skin melanoma). * subjects with major psychological problems or a major eating disorder will be excluded. * subjects with heart pacemaker or any other electronic devices attached to their body will be excluded. * subjects with confirmed type 1 diabetes or positive anti gad antibodies test will be excluded

Keywords: visceral fat waist circumference bioelectrical impedance metabolic syndrome obesity type 2 diabetes
frequency of axial spondyloarthropathy among patients suffering from fibromyalgia

Conditions: Fibromyalgia; Ankylosing Spondylitis

Summary: fibromyalgia syndrome (fms) is a non - inflammatory condition characterized by the presence of chronic, widespread musculoskeletal pain and tenderness; fms is considered to be the result of increased processing of pain by the central nervous system. axial spondyloarthropathy is the hallmark of ankylosing spondylitis (as), an inflammatory joint disease involving the axial spine, the sacroiliac joints as well as peripheral joints. although fms and as differ vastly in their pathogenesis, a considerable clinical overlap may exist between these conditions. both disorders typically cause chronic nocturnal back pain and disturbed sleep may accompany either condition. in addition,the investigators have previously described an increased prevalence of (secondary) fms among female as patients. this overlap may have important clinical implications since the presence of comorbid fms may lead to increased severity results on commonly used instruments in the evaluation of disease activity in as, such as the basdai and basfi . recently, the assessment of spondyloarthritis international society (asas) has published updated classification criteria for axial spondyloarthropathy. these criteria, which are summarized in table 1, are based on the evaluation of patients suffering from chronic back pain with an age of onset of less than 45. objective: the objective of the current study is to evaluate the prevalence of axial spondyloarthropathies among fms patients, utilizing the new asas criteria.


Eligibility criteria:
inclusion criteria: patients fulfilling american college of rheumatology criteria for classification of fibromyalgia: * widespread pain lasting over three months * tenderness in at least 11 of 18 points exclusion criteria: * patients with known inflammatory joint disease prior to the study * patient not able to give informed consent * pregnant women
smoking cessation program with cbt and mindfulness audio support: a randomized controlled trial

Conditions: Smoking Cessation; Tobacco Dependence

Summary: this protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. one method provides only cbt text messages (group a), while the other combines cbt text with mindfulness audio (group b). the study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation. this study investigates the effects of two different smoking cessation interventions: (1) cbt text-based program alone (group a), and (2) cbt text combined with mindfulness audio (group b). the primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.

design: a randomized controlled trial (rct) will be used to compare the outcomes of the two intervention groups. setting: the study will be conducted online. participants will access the cbt text materials through a dedicated platform and the mindfulness audio via a compatible device. recruitment will be done through social media, community outreach, and online advertisements.

Eligibility criteria:
inclusion criteria: * who smoke at least 5 cigarettes per day. * express a desire to quit or reduce smoking. * who has the ability to access and use the provided digital materials. exclusion criteria: * those currently enrolled in other smoking cessation programs. * individuals with severe psychiatric disorders that may interfere with participation. * those without access to the necessary digital devices.
interest of a 30 minutes' intermittent work exercise test in patients with chronic obstructive pulmonary disease: cardiac and pulmonary functions

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.


Eligibility criteria:
inclusion criteria: * copd patients (male and female) with moderate obstruction (fev1/cv\<60%) exclusion criteria: * acute respiratory disease * any type of cardiac disease

Keywords: pulmonary arterial pressure copd cardiac output pulmonary and cardiac functions pulmonary arterial pressure measurements