Kornimate/medical-research-clean huggingface dataset:
a study of flt3-ligand levels in sjögrens syndrome

Conditions: Sjogrens Syndrome

Summary: the study aims to correlate levels of flt3-ligand in cerebrospinal fluid (csf) and serum to markers for inflammation and degeneration in patients with primary sjogrens syndrome.

the study aims to correlate levels of flt3-ligand in csf and serum to markers for inflammation and degeneration in patients with primary sjogrens syndrome.

Eligibility criteria:
inclusion criteria: * fulfill the acr-criteria for primary sjogrens syndrome, * age above 18 years old exclusion criteria: * other cns-disease

Keywords: flt3-l csf
impact of different types of physical activity in patients with chronic inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Exercise Therapy

Summary: this is a prospective interventional study. the investigators will include patients in clinical remission who are on stable treatment. these ibd patients will be followed to analyze the effects of physical activity on their inflammatory disease. different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.there will also be a control group that does not initially benefit from a specific physical activity program. however, this group will be integrated into one of the other two groups after the 10-week follow-up. all three groups will perform the same baseline tests. these will be of different types: physical tests, biological tests and quality of life questionnaires.


Eligibility criteria:
inclusion criteria: * patients in remission defined by a harvey bradshaw index 5 in crohn's disease (cd) and a clinical mayo 3 with no sub-score \>1 in ulcerative colitis (rcuh) with stable treatment, without corticosteroid for 4 months. * patients accepting the study protocol exclusion criteria: * patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs. * patients with more than 3 hours of sports activity per week * pregnant, pregnant or nursing patients
exercise and genes in obese (ego)

Conditions: Obesity

Summary: regular exercise has several positive health effects including increased physical fitness and muscle mass. it is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. whether high-intensity exercise (hie) is associated with improved health related quality of life in severely obese patients remains unknown. this phd-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (mie) programme or a 24 week high-intensity exercise (hie) programme. the investigators main hypothesis is that patients randomised to the hie-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the mie-programme. in addition, the investigators hypothesise that the hie-group will achieve a better health related quality of life than the mie-group after treatment. the investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. if the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.


Eligibility criteria:
inclusion criteria: * treatment seeking weight stable morbidly obese patients (bmi ≥ 40 kg/m2 or bmi 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient obesity center, vestfold hospital trust, will be informed about this rct . exclusion criteria: * uncompensated heart failure * recent myocardial infarction or stroke (\<½ years) * severe arrhythmia or heart failure * unstable angina pectoris * renal failure * pregnancy * severe eating disorders * active substance abuse * being on a diet * taking medication known to affect appetite or metabolism (including thyroxin).

Keywords: exercise and genes in obese (ego)
study investigating the efficacy of crenolanib with chemotherapy vs chemotherapy alone in r/r flt3 mutated aml

Conditions: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Summary: this is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory aml subjects with flt3 activating mutation.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of aml according to world health organization (who) 2016 classification 2. presence of flt3-itd and/or d835 mutation(s) 3. subjects must be primary refractory or relapsed to 1st line intensive treatment for aml or refractory or relapsed after second line of treatment for aml 4. age ≥ 18 years and ≤ 75 years 5. adequate hepatic function 6. adequate renal functions 7. ecog performance status ≤ 3 exclusion criteria: 1. known clinically active central nervous system(cns) leukemia 2. severe liver disease 3. known, active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) 4. prior anti-leukemia therapy within the 14 days prior to randomization. prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
effects of physical activities on the expression of nrf2 and nf-kb hemodialysis patients

Conditions: Chronic Kidney Disease; Hypertension; Diabetes

Summary: oxidative stress and inflammation are cardiovascular risk factors in patients with chronic kidney disease (ckd) undergoing hemodialysis (hd). nuclear transcription factors play roles in the coordinated expression of genes involved in inflammation, such as nuclear factor kappa b (nfkb) that increase the cytokines synthesis and nuclear factor erythroid 2-related factor 2 (nrf2) that increase the transcription of genes encoding enzymes of phase ii detoxifying and antioxidant enzymes. the aim of this study was to evaluate the effects of resistance exercise program on the expression of transcription factors nrf2 and nf-kb in hd patients.

this study included 44 patients on regular hd program which 25 patients (54.5% women, age 45.7 ± 15.2 years and time on dialysis, 71.2 ± 45.5 months) composed the exercise group and 19 patients (61.5% women, age 42.5 ± 13.5 years and time on dialysis, 70.1 ± 49.9 months) the control group. the exercise program was performed during hd sessions, 3 times a week (36 exercises sessions). peripheral blood mononuclear cells (pbmc) were isolated and processed for expression of nrf2, nf-kb and nadph quinone oxidoreductase 1 (nqo1) by quantitative real-time polymerase chain reaction. antioxidant enzymes activity (catalase-cat and glutathione peroxidase-gpx), high-sensitivity c-reactive protein (hs-crp) and nitric oxide (no) products were assessed using an enzyme-linked immunosorbent assay (elisa).

Eligibility criteria:
inclusion criteria: * inclusion criteria were age \>18 years * without any motor skill disorders, arteriovenous fistula for vascular access in the upper limb and patients on maintenance dialysis for at least 6 months. exclusion criteria: * patients with autoimmune diseases, cancer, infectious diseases, acquired immunodeficiency syndrome, uncontrolled hypertension, unstable angina, malignant arrhythmias, pregnant, lower limb amputee, history of stroke, neurological or cardiovascular disease (moderate-intensity physical activity is not routinely recommended) * taking catabolizing drugs * under regular exercise * smokers * patients who complied with \<75 % of the training were excluded.
dynamic magnetic resonance imaging (mri) for lung tumor motion and lung function (gcc 0943)

Conditions: Lung Cancer

Summary: radiation treatment for each patient with cancer is designed based on ct scans. we know that tumors in the chest and abdomen move when you breathe. because of this, there can be differences between planned treatment and the treatment actually delivered to the body. usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. this can damage healthy parts of the body because the exact location of the tumor is unknown. magnetic resonance imaging (mri) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of x-rays or other radiation. the research doctors are studying to see if the position of a tumor can be tracked using mri scans and tracking sensors placed on the skin. mri scans and the tracking system used to calculate the location and position of the tumor are both fda approved technologies. the research doctors will also use the mri scans to evaluate any changes in your lung function during and following your radiation treatments. in this study the participant will undergo a series of mri scans with and without contrast dye. this study is being funded through grants from the national institutes of health (nih).

in this protocol, we seek to assess whether tumor motion can be inferred using dynamic mri and external surrogates. we propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic mri and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic mri with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.

Eligibility criteria:
inclusion criteria: * patients 18 years old or older * patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers. exclusion criteria: * pregnant or breast-feeding women are excluded. negative serum or urine pregnancy test prior to study entry is required. once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives (birthcontrol pill), intrauterine devices (iuds), contraceptive implants under skin or contraceptive injections and condoms with foam. * patients with kidney disease of any severity or on hemodialysis. * patients who have metallic dental fillings or other metallic implants. * patients with known allergies to gadolinium-based contrast agents. * patients who have difficulty lying flat on their back for extended periods of time will be excluded
effects of dipeptidyl peptidase-4 (dpp-4) inhibition on hormonal responses to macronutrient ingestion

Conditions: Healthy; Type 2 Diabetes

Summary: the regulation by dpp-4 inhibition after ingested of different individual macronutrients is not known. therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a dpp-4 inhibitor (sitagliptin).

meal ingestion releases gut hormones which stimulate insulin secretion. a most important gut hormone is the incretin hormone glucagon-like peptide-1 (glp-1). glp-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (dpp-4). inhibition of dpp-4 therefore increases the concentration of active glp-1 after meal ingestion, which augments insulin secretion. how this process is regulated after ingested of different individual macronutrients is not known. therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a dpp-4 inhibitor (sitagliptin).

Eligibility criteria:
inclusion criteria: * healthy men * age 20-30 years * bmi 20-30 kg/m2 exclusion criteria: * any disease * any medication

Keywords: glp-1 insulin secretion macronutrients
a phase 3 clinical trial to evaluate the efficacy and safety of hcp1303 capsules

Conditions: Benign Prostatic Hyperplasia

Summary: the main objective of this study is to evaluate efficacy and safety of hcp1301 capsule in patients with benign prostatic hyperplasia and erectile dysfunction

a multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of hcp1303 capsule

Eligibility criteria:
inclusion criteria: * at visit 1 1. ≥50 age 2. bph(benign prostatic hyperplasia) + total ipss(international prostate symptom score) ≥ 13 3. abnormal erectile function ≥ at least 3months based on screening date * at visit 2 1. total ipss ≥ 13 exclusion criteria: 1. history of hypersensitivity to tamsulosin or tadalafil 2. history of allergy for sulfonamide 3. psa (prostate specific antigen) ≥4ng/ml
inflammation and cell maturation in preterm delivery placentas - in vitro and in vivo effect of progesterone

Conditions: Obstetric Labor, Premature

Summary: the aim of this study is to investigate the in vitro and in vivo effect of progesterone on immature myeloid cells (imc), inflammation characteristics and maturation into dendritic cells (dc).


Eligibility criteria:
inclusion criteria: * placentas from term and preterm deliveries * singleton pregnancy * consent to participate exclusion criteria: * pregnancies with obstetric complications * multiple gestation * maternal illness or fetal malformation known pre-delivery
developing and evaluating interventions to reduce inappropriate prescribing of antibiotics in primary care

Conditions: Antibiotic Prescribing by GPs for URTI

Summary: 1. do paper-based and web-based intervention modelling experiments (the methodology we are developing) identify the same predictors of gp behaviour regarding prescribing of antibiotics for upper respiratory tract infections? 2. can a web-based ime system provide trialists with richer and more predictive information upon which to base the development of behavioural change interventions than paper-based ime systems?

the nhs needs effective quality improvement interventions to be put into clinical practice, which requires effective behaviour change interventions. intervention modelling experiments (imes) are a way of exploring and refining an intervention before moving to a full-scale trial. they do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting gps with a clinical scenario about making a treatment decision. earlier imes have been paper-based, which limits what can be done in the simulation. web-based imes provide the potential for better clinical simulations, which have the potential to lead to better interventions. the current proposal will run a full, web-based ime involving 250 gps that will advance the methodology of imes by directly comparing results with an earlier paper-based ime. moreover, the web-based ime will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing in primary care. reducing inappropriate prescribing of antibiotics in general practice is a national priority; indeed, antibiotic use is increasing in the uk and scotland's prescribing is second highest amongst uk administrations. more effective behaviour change interventions are needed and this proposal will develop one such intervention and a system to model and test future interventions. this system will be applicable to any situation in the nhs where behaviour needs to be modified, including interventions aimed directly at the public.

Eligibility criteria:
inclusion criteria: * gps in scotland. exclusion criteria: * unable to obtain both an email address and a postal address for the gp.
postpartum hypertension study

Conditions: Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Pregnancy-Induced Hypertension in Postpartum; Hypertensive Emergency

Summary: the purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.

hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. in order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. the objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.

Eligibility criteria:
inclusion criteria * patients admitted to labor and delivery (l\&d) with blood pressure (bp) in severe range, defined as a systolic ≥160 mm hg and/or diastolic ≥110 mm hg * postpartum, immediately to 6 weeks postpartum * with a prior diagnosis of chronic hypertension (not on medication) or hypertensive disorder of pregnancy exclusion criteria * they may not have previously had exposure to either study medication within the previous 24-hour period. * patients with a known atrial-ventricular heart block or moderate to severe bronchial asthma will be excluded, or other contraindication to receiving either study medication

Keywords: hypertension hypertensive emergency postpartum preeclampsia
cohort study of patients treated for peripheral arterial occlusive disease

Conditions: Peripheral Arterial Obstructive Disease

Summary: peripheral arterial occlusive disease is associated with a high risk of cardiovascular events. the critical ischemia stage represents the most severe stage of peripheral arterial occlusive disease, associated with decubitus pain and / or foot ulceration. the severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. in these patients, the rate of amputation and mortality at 1 year can reach 20%. therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis. in the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. with the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. the hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease. the objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with peripheral arterial occlusive disease supported by endovascular revascularization in the vascular medicine department of the ghpsj.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient with intermittent / intermittent claudication / arterial ulcer / mixed ulcer / critical ischemia / acute ischemia, whose need for a revascularization procedure in the patient's medical management was discussed and confirmed as a multidisciplinary staff between 1st november 2013 and september 2018 * endovascular revascularized patient * francophone patients exclusion criteria: * patients under guardianship or curatorship * patients deprived of their liberty * patients who oppose the use of their data for this research
comparative evaluation of the efficacy of intraoral cryotherapy versus intracanal cryotherapy on postoperative pain

Conditions: Postoperative Pain

Summary: the aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis


Eligibility criteria:
inclusion criteria: systemically healthy patient (asa i or ii). mandibular first molar teeth with: * preoperative sharp pain and symptomatic apical periodontitis * absence or slight widening in the periodontal ligament (pdl). * vital response of pulp tissue to cold pulp tester (ethyl chloride spray) . * positive response to percussion test exclusion criteria: 1. medically compromised patients. 2. pregnant women. 3. patients reporting bruxism or clenching. 4. patients allergic to ciprofloxacin or metronidazole. 5. teeth associated with acute periapical abscess and/or swelling. 6. greater than grade i mobility or pocket depth greater than 5mm. 7. size of periapical radiolucency is greater than 8 mm. 8. no restorability: hopeless tooth. 9. immature teeth. 10. radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
evaluation of vx 445/tez/iva in cystic fibrosis subjects 6 through 11 years of age

Conditions: Cystic Fibrosis

Summary: this study will evaluate the pharmacokinetics (pk), safety, tolerability, efficacy, and pharmacodynamic effect of vx-445, tezacaftor (tez), and ivacaftor (iva) when dosed in triple combination (tc) in cystic fibrosis (cf) subjects 6 through 11 years of age with f/f and f/mf genotypes.


Eligibility criteria:
key inclusion criteria: * homozygous or heterozygous for f508del mutation (f/f or f/mf genotypes) * forced expiratory volume in 1 second (fev1) value ≥40% of predicted mean for age, sex, and height. key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status. * solid organ or hematological transplantation. other protocol defined inclusion/exclusion criteria may apply.