Kornimate/medical-research-clean huggingface dataset:
karolinska-rennes (karen) prospective study of exercise stress echocardiography in heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: background: heart failure with preserved ejection fraction (hfpef) is common but not well understood. electrical dyssynchrony in systolic heart failure is harmful. little is known about the prevalence and the prognostic impact of dyssynchrony in hfpef. methods: we have designed a prospective, multicentre, international, observational study to characterize hfpef and to determine whether electrical or mechanical dyssynchrony affects prognosis. patients presenting with acute heart failure will be screened. inclusion criteria will be: acute presentation with framingham criteria for heart failure, left ventricular ef ≥45%, bnp \>100 ng/l or nt-probnp \>300 ng/l. patients will return in stable condition 4-8 weeks after the index presentation and undergo questionnaires, serology, ecg and dopplerechocardiography. thereafter, patients will be followed for mortality and heart failure hospitalization every 6 months for at least 18 months. sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography. conclusion: karen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in the hfpef. the ancillary study of the exercise stress echocardiography sought to improve our understanding of hfpef and generate answers to the question whether dyssynchrony could be a target for therapy in hfpef.


Eligibility criteria:
inclusion criteria: 1. acute presentation to the hospital with clinical signs and symptoms of hf, according to the framingham criteria \[19\]. 2. lvef ≥ 45% by echocardiography within the first 72 hours. the measurement will be carried out according to guidelines 3. bnp \>100 ng/l or nt-probnp \>300 ng/l. exclusion criteria: 1. evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease 2. known cause of right heart failure not related to left ventricular dysfunction 3. pericardial constriction 4. clinically significant pulmonary disease, as evidenced by requirement of current home oxygen 5. end-stage renal disease currently requiring dialysis 6. bi-ventricular pacemaker (crt). (patients who have a conventional pacemaker may be included) 7. anticipated or indication for cardiac surgery. (patients who have indication for surgery but may not undergo surgery because of some contraindication, for example age, may not be included). 8. anticipated percutaneous intervention on aortic stenosis. (patients who undergo other percutaneous intervention, for example pci, may be included).

Keywords: heart failure preserved ejection fraction diastolic dysfunction dyssynchrony echocardiography patients with acute heart failure clinically diagnosed bnp level > 100 ng / l or nt-probnp > 300 ng /l preserved left ventricular ejection fraction(lvef ≥ 45%)
craving and lifestyle management through mindfulness study

Conditions: Obesity

Summary: the purpose of this study is to determine whether a mindfulness-based stress reduction and mindful eating program will lead to reductions in abdominal fat and total weight and improve cell aging in overweight and obese women compared to a waitlist control group.

obesity is the largest growing epidemic, with about 65% of americans overweight (flegal, carroll et al. 2002). obesity, in particular, abdominal obesity, confers increased risk for a host of diseases, including hypertension, type 2 diabetes, and coronary heart disease, resulting in shortened life span (fontaine, redden et al. 2003). psychological stress is widely cited anecdotally as a factor that causes people to engage in overeating, and studies provide strong evidence that stress can promote obesity. stress induces selective preference of sweet, high-fat food and increases visceral fat depots. the telomere maintenance system (telomerase activity and telomere length)are markers of cellular aging and predict mortality (cawthon et al, 2003)and have been linked to both psychological stress and components of the metabolic syndrome. the proposed study adapts a program called mindfulness-based stress reduction (mbsr) that has been shown to be effective in a variety of other stress-related conditions. fifty overweight, pre-menopausal women at risk for the metabolic syndrome will be randomized in a 1:1 distribution to either a 3-month intervention to reduce stress and overeating \[craving and lifestyle management with mindfulness (calmm)\] or wait list control group. the primary outcome measures include amounts of abdominal fat, weight, and telomerase activity. data from this study are intended to provide pilot data for use in planning a larger randomized, controlled trial that will investigate the effects of the calmm intervention on the metabolic and psychological processes assessed in this pilot study.

Eligibility criteria:
inclusion criteria: * pre-menopausal * bmi (25 - 40) * weight \< 300 lbs. * negative urine glucose test exclusion criteria: * inability to provide informed consent * age \< 21 or menopausal as determined by self-report * dsm-iv diagnosis of an eating disorder * any substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention * factors that confound relations between stress and eating, including, drug abuse and use of medications containing corticosteroids. * diabetes * polycystic ovary syndrome * chd * breastfeeding (due to interference with stress hormone measurement) * non english speaker * pregnant as determined by pregnancy test at screening visit or planning to get pregnant in the next 6 months * previous mbsr training and/or current meditation, yoga, or other mind-body practice * initiation of new class of psychiatric medications in past 2 months. * currently on a weight loss diet

Keywords: obesity mindfulness based stress reduction mindful eating stress overnutrition nutrition disorders overweight body weight signs and symptoms
effect of immunepotent-crp on serum pro-inflammatory cytokines in mild to moderate covid-19

Conditions: COVID-19; SARS-CoV2 Infection

Summary: in this study, the effects of immunepotent-crp (i-crp), a dialyzable leukocyte extract (dle) derived from bovine spleen cells, on the levels of key inflammatory cytokines in outpatients with covid-19 were examined. i-crp has been previously studied for its ability to regulate the immune system in other conditions, such as cancer and sepsis. based on its potential to reduce harmful inflammation, the study aimed to determine if similar benefits could be observed in covid-19 outpatients.

outpatients with mild to moderate covid-19 symptoms and a confirmed sars-cov-2 infection were enrolled. these patients were randomly assigned to receive either immunepotent-crp (i-crp) or a placebo over a 14-day period. the study was double-blind, meaning neither the patients nor the researchers knew who was receiving i-crp or placebo, ensuring unbiased results. the main objective of the study was to measure changes in the levels of specific cytokines and chemokines in the blood-il-1β, il-6, il-10, tnf-α, ifn-α, ifn-γ, and il-8-which are key players in the inflammatory response linked to severe covid-19 cases. high levels of these molecules are associated with worse outcomes and more severe symptoms. additionally, other markers of inflammation and immune system activity, such as lactate dehydrogenase (ldh), high-sensitivity c-reactive protein (hs-crp), ferritin, and d-dimer, were measured, as these are commonly used to assess the severity of inflammation and risk of complications in covid-19 patients. throughout the study, outpatients were regularly monitored for symptoms, and their vital signs-such as oxygen levels and body temperature-were checked during home visits. blood samples were collected at different intervals to measure cytokine levels and the other included inflammatory markers. patients were also tested four times for the presence of the virus to determine their infection status during the follow-up period.

Eligibility criteria:
outpatients inclusion criteria: * laboratory-confirmed sars-cov-2 infection (by antigen or rt-qpcr test). * with mild to moderate symptoms of covid-19. * aged ≥ 18 years. * not participating in any other clinical study. * written informed consent duly signed. outpatients exclusion criteria: * undergoing any process of primary or secondary immunosuppression. * any autoimmune disease. * receiving chemotherapy. * history of lymphoma or any malignancy. * pregnancy or breastfeeding women.

Keywords: cytokine storm mild to moderate covid-19 inflammatory cytokines dialyzable leukocyte extract (dle) immunepotent-crp (i-crp)
long-term mortality post liver transplantation in the era of modern immunosuppression.

Conditions: Liver Transplant

Summary: liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. this study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a french multicenter cohort. this study does not interfere with patients' medical care. the study method involves collecting and analyzing only the essential data from patient records.

liver transplantation stands as the gold standard for treating decompensated chronic liver diseases and select cases of hepatocellular carcinoma. over time, post-transplant survival rates have shown consistent improvement, attributed to advancements in surgical techniques, refined immunosuppressive protocols, and enhanced comprehension of post-transplant complications. these developments have significantly mitigated the incidence of infectious, immunological, and neoplastic complications following transplantation. research indicates post-liver transplant survival rates of approximately 85% at one year, 68% at five years, and 50% at ten years. it is important to note that these statistics are based on patients transplanted in the 1990s, whose immunosuppression relied on a combination of cyclosporine, azathioprine, and corticosteroids. the field of immunosuppression has undergone substantial evolution, with an expansion in therapeutic options. these include the gradual replacement of cyclosporine a with tacrolimus, and the introduction of interleukin-2 receptor inhibitors, mycophenolate mofetil, and mtor inhibitors. these innovations facilitate more adaptable protocols, offering improved preservation of renal function and allowing for earlier discontinuation of corticosteroids. as a result, these new therapeutic options offer immunosuppression that is more tailored to each patient, with reduced long-term toxicity. the primary objective of this study is to investigate long-term mortality rates following liver transplantation and to identify the various risk factors contributing to mortality in these patients, with a particular focus on the current era of immunosuppression techniques. this investigation will be conducted within the framework of a french multicentric cohort study. the results of this study have the potential to enhance our understanding of long-term post-transplant mortality and to more accurately identify risk factors. this knowledge could inform the refinement of immunosuppressive treatments and post-transplant patient care protocols. the overarching aim of this research is to optimize the management of liver transplant recipients and ultimately prolong their survival.

Eligibility criteria:
inclusion criteria: * patients with liver transplant between 2008 and 2013 and follow up during 2008-2023 exclusion criteria: -

Keywords: mortality risk factors decompensated chronic liver diseases survival immunosuppression
a phase 1/2 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of bmn 351 in participants with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to test the safety and tolerability of bmn 351 in participants with duchenne muscular dystrophy (dmd) with a genetic mutation amenable to exon 51 skipping.

this is phase 1/2, open-label, multi-center study consisting of 2 parts to evaluate the safety and tolerability of bmn 351 at escalating doses in participants with duchenne muscular dystrophy (dmd) with genetic mutations amenable to exon 51 skipping. participants will be assigned to one of three groups called cohorts (cohort 1, 2 or 3). cohort 1 participants are further divided into cohort 1a and cohort 1b. in cohort 1a, 3 participants will receive increasing doses once every 2 weeks with a visit to assess safety measures collected the week after dosing prior to escalating doses of bmn 351. in part 2, the participants in cohort 1a will transition to once weekly dosing. the participants in cohort 1b, 2, and 3 will initiate low, medium, and high doses of bmn 351 and continue once weekly dosing at that same dose. the study will enroll approximately 18 participants.

Eligibility criteria:
inclusion criteria: * age 4 to 10 * diagnosis of duchenne muscular dystrophy with a specific genetic change amenable to exon 51 skipping * able to walk * not requiring assistance from a ventilator to breathe * currently on consistent doses of steroid treatment for the last 12 weeks exclusion criteria: * the participant will have some initial clinical labs and studies to assess baseline level of heart and lung function. * treatment with an exon skipping therapy within 12 weeks prior to the first visit. * any history of treatment with gene therapy
an imaging agent (fluorodopa f 18) with positron emission tomography/magnetic resonance imaging for assessing treatment response in patients with high-grade soft tissue sarcomas

Conditions: Recurrent Soft Tissue Sarcoma; Resectable Soft Tissue Sarcoma; Soft Tissue Sarcoma

Summary: this study evaluates the use of a new imaging agent called fluorodopa f 18 (18f-dopa) with positron emission tomography/magnetic resonance imaging (pet/mri) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas that are new or that have come back (recurrent). though there have been improvements in treatment options for soft tissue sarcomas, there is currently a need for a non-invasive way to determine a patient's potential benefit from receiving one of these treatments. 18f-dopa with pet/mri allows a patient's tumor to be visualized and their response to a given treatment assessed.

primary objective: i. determine the correlation between 18f-dopa pet/mri quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis. secondary objective: i. compare the changes in 18f-dopa pet/mri quantitative metrics between baseline (before radiotherapy \[rt\]) and after rt, but before surgery with percent tumor necrosis. outline: patients receive 18f-dopa intravenously (iv) and undergo pet/mri over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

Eligibility criteria:
inclusion criteria: * pre-eligibility - inclusion criteria: * age \>= 18 years * histological confirmation of newly diagnosed soft tissue sarcoma or recurrent soft tissue sarcoma \>= 1-year post-treatment * tumors \> 1 cm in diameter in largest dimension located midline within the torso or neck, retroperitoneal, or lower extremities * operable sarcoma, planning to receive surgery with or without neoadjuvant rt/chemotherapy at mayo clinic florida. systemic therapy is allowed during radiotherapy * provide informed written consent * willingness to participate in mandatory imaging studies at mayo clinic florida exclusion criteria: * post-eligibility - exclusion criteria: * 18f-dopa pet uptake deemed as unacceptable for quantitative assessment * unable to undergo an 18f-dopa pet/mri scan due to standard mri restrictions, such as for those with certain implanted devices, those who cannot fit inside the bore, or those with severe claustrophobia * any of the following: * pregnant women * nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception
assessment of adherence to gluten free diet in children and adolescents by detection of gluten in faecal samples.

Conditions: Celiac Disease in Children

Summary: to assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (gip). this will provide an objective measure for adherence.

the adherence to the gfd can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or cd serological screening tests showing decreasing levels of antibodies. however, none of these methods offer an accurate measure of dietary compliance. a novel method to monitor the adherence to the gfd by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin g12 antibody was described recently in the literature. gluten peptides, in particular peptides equivalent to the immunogenic - α -gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces. consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

Eligibility criteria:
inclusion criteria: * age 2-17 years. * either diagnosis of celiac disease or, in controls, no systemic disease or inflammation * for all groups parents will provide informed consent. exclusion criteria: ° children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.
effect of variceal eradication on portal circulation

Conditions: Portosystemic Collateral Veins

Summary: study the effect of variceal eradication on portal circulation, liver stiffness and child-pugh and meld scores in patients with liver cirrhosis.

portosystemic collateral circulation is a consequence of portal hypertension, which occurs in chronic liver disease and is responsible for numerous complications. gastric and oesophageal varices are two of common portosystemic collaterals, patients usually presented with hematemesis, melena, or both, ultimately 20% is the mortality during the first attack. although both band ligation and sclerotherapy are effective modalities of treatment in controlling acute variceal bleeding, in preventing future variceal bleeding as well as in eradicating varices with very few complications , their effects on portal circulation have raised concerns among hepatologist. information about collateral pathways is especially relevant when interventional procedures or surgery is indicated because inadvertent distribution of these vessels can cause significant bleeding. few studies pointed on development of new portosystemic collaterals post variceal eradication depending on abdominal computed tomography (ct ) compared to pre-variceal eradication as showed paraoesophageal varices, retro-gastric varices not visualized with endoscopy ,or large deep gastric collaterals that may increase risk for rebleeding. also, liver stiffness measurement and indirect markers of portal hypertension have been correlated with the severity of portal hypertension and have been used to predict the presence of varices, and there is rising question what about effect of variceal eradication on liver stiffness. the child-pugh and meld scores were significantly higher for patients with gastric variceal bleeding , and the question here is variceal eradication can improve child-pugh and meld scores or there is no effect.

Eligibility criteria:
inclusion criteria: * • age between 18 and 70 years old. * patient with documented liver cirrhosis undergoing either primary or secondary prophylactic variceal eradication. * liver cirrhosis with child-pugh score a and b. exclusion criteria: * • age less than 18 years. * have contraindications to computed abdominal ct-angiography (e.g. allergy to all suitable contrast agents, renal failure). * patients with history of recent significant bleeding varices. * previous history of variceal ligation, sclerotherapy, and tips operation. * patients with isolated gastric varices. * patients with hcc or other malignancies. * end-stage liver disease (child score more than 9). * patients with malignant portal vein thrombosis. * patients with non-cirrhotic portal hypertension. * patients refuse to participate in the study.
efficacy of therapy based on fecal molecular antimicrobial susceptibility tests for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: this study aims to evaluate the efficacy and safety of 14-day quadruple therapy based on fecal molecular antimicrobial susceptibility tests for the first-line eradication of h. pylori infection, thus, providing more evidence to inform the value of fecal antimicrobial susceptibility tests in the first-line treatment of h. pylori infection.

the eradication rate of h. pylori is decreasing year by year due to the occurrence of bacterial resistance, especially clarithromycin, one of the most widely-used antimicrobials against h. pylori. understanding antibiotic resistance before treatment may be the main determinant of the successful eradication of h. pylori. nevertheless, due to the invasive examination of sampling, the economy-benefit ratio, and the harsh cultivation conditions, traditional antimicrobial susceptibility test is rarely used before first-line eradication treatment in the real world. as an alternative, faster and simpler molecular methods applied to fecal samples obviate the need for endoscopy and provide the possibility to popularize the antimicrobial susceptibility tests catering to initial treatment. this study aims to explore the efficacy, safety, and economic benefits of the first-line therapy for h. pylori guided by fecal antimicrobial susceptibility tests.

Eligibility criteria:
inclusion criteria: participants enrolled should meet the following criteria: (1) participants aged 18-65 with no history of eradication treatment; (2) diagnosed as h. pylori infection by one or more of the following methodologies: gastric biopsy using histochemical staining, tissue culture, the 14c-urea breath test (ubt), the 13c-ubt, and/or fecal antigen; (3) were requested to undergo an endoscopy before the eradication treatment if they have alarm symptoms, a family history of gastric cancer or age over 40 years old without undergoing an endoscopy before; and (4) voluntarily participated in the clinical trial and have signed the informed consent. exclusion criteria: potential participants will be screened on the following exclusion criteria: (1) participants had a history of using antibiotics or bismuth within four weeks or acid inhibitor (including h2 receptor antagonist (h2ra), proton-pump inhibitor (ppi) or potassium-competitive acid blocker (p-cab)) within two weeks before inclusion; (2) had an active peptic ulcer with complications such as hemorrhage, perforation, or obstruction; (3) had a history of esophagectomy or gastrectomy; (4) had an allergy to any study drug; (5) were pregnant or breastfeeding; (6) had a history of alcohol abuse or drug addiction; (7) existence of mental illness; or (8) without self-judgment ability.