Kornimate/medical-research-clean huggingface dataset:
ultra-low dose interleukin-2 for refractory chronic graft versus host disease

Conditions: Graft Versus Host Disease

Summary: the purpose of this research study is to determine the safety of il-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (gvhd). chronic gvhd is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. the donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. traditional standard therapy to treat chronic gvhd is prednisone (steroids). treatment options are limited, and it is thought that il-2 may help to control chronic gvhd.

* il-2 will be given daily through an injection under the skin for a period of 8 weeks. to determine the highest safest dose of il-2, the dose participants receive will increase as lower doses are determined to be safe. there will be three dose levels. * participants will be seen periodically while they are receiving il-2. physical exams and blood tests will be performed weekly for the first two weeks and then every other week until week 8.

Eligibility criteria:
inclusion criteria: * recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens * patients must be at least 180 days from the allogeneic stem cell transplantation procedure * steroid refractory cgvhd, defined as having persistent symptoms and signs of gvhd despite the use of prednisone for at least 4 weeks in the preceding 12 months without complete resolution of signs and symptoms. * stable dose of corticosteroids for 4 weeks prior to enrollment * no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment. * adequate bone marrow, renal and hepatic function as outlined in the protocol * 18 years of age or older * ecog performance status of 0-2 exclusion criteria: * ongoing prednisone requirement \> 1mg/kg/day (or equivalent) * exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment * concurrent ecp therapy within 4 weeks prior to enrollment * post-transplant exposure to any novel immunosuppressive medication within 100 days prior to enrollment * donor lymphocyte infusion within 100 days prior to il-2 therapy * active malignant disease relapse * active, uncontrolled infection * positive serologic test for hepatitis b or a positive serologic or nucleic acid test for hepatitis c * hiv seropositivity * life expectancy \< 3 months * pregnancy or lactation * inability to comply with il-2 treatment regimen * uncontrolled cardiac angina or symptomatic congestive heart failure * organ transplant (allograft) recipient

Keywords: chronic gvhd steroid refractory gvhd allogeneic stem cell transplantation
evaluating the brain's response to natural versus artificial sweetener in women who have had an eating disorder

Conditions: Eating Disorders

Summary: this study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders.

eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. anorexia nervosa and bulimia nervosa are examples eating disorders. people with anorexia nervosa do not eat enough in fear of becoming overweight, resulting in extreme weight loss. people with bulimia nervosa first binge by consuming hundreds or even thousands of calories within a very short time period and then purge by either vomiting or using laxatives. women are at a greater risk of developing the disorders, particularly when they are between the ages of 12 and 24. treatments for eating disorders typically include nutrition counseling, psychotherapy, and medication. to better understand eating disorders, this study will compare the brain's ability to distinguish between natural and artificial sweeteners in women with and without a history of eating disorders. all participants in this observational study will be administered a taste test to determine if they can consciously differentiate between a sugar solution and an artificially sweetened solution. participants may also perform several brief computerized tests, ranging from 3 to 10 minutes each, to evaluate thinking, memory, and information processing skills. participants who cannot tell the difference between the solutions will undergo a functional magnetic resonance imaging (fmri) scan, which will take pictures of the brain and blood flowing through the brain. prior to the scan, blood and urine collection may occur, and participants may complete two additional computerized tests. the scan will require 60 to 90 minutes to complete. during the scan, participants will hold two thin tubes in their mouth. at various intervals, these tubes will deliver 1 ml of liquid containing either sugar water or an artificial sweetener into each participant's mouth. a screen projection of abstract pictures will also be shown to each participant throughout the scan, either before the liquid is delivered or alone. this study will require a 6- to 9-hour time commitment. the results from this study may provide valuable information regarding anorexia nervosa and bulimia nervosa and may eventually lead to the development of new and better treatment options for these complex and serious disorders.

Eligibility criteria:
inclusion criteria: * right-handed * recovered from anorexia or bulimia nervosa at least 12 months prior to study entry * met dsm criteria for anorexia or bulimia nervosa at one time within 3 years prior to study entry exclusion criteria: * pregnant or breastfeeding * currently taking any medication (except birth control) * any current mental illness * any metal in body

Keywords: anorexia nervosa bulimia nervosa
phase 1/2 study of abo-101 in primary hyperoxaluria type 1 (redephine)

Conditions: Primary Hyperoxaluria Type 1 (PH1)

Summary: the goal of the redephine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of abo-101 in participants with primary hyperoxaluria type 1 (ph1). the trial will consist of 2 study periods. during the first study period, there will be 2 parts. in part a, adult participants will be treated with a single ascending dose to identify a recommended dose. in part b, pediatric participants will be treated with the recommended dose. following the first study period, participants will start study period 2, a long-term monitoring program to comply with local and national requirements.


Eligibility criteria:
key inclusion criteria for parts a and b * documentation of ph1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (agxt) gene (valid historical laboratory data will be reviewed and approved by the sponsor) * age at time of signing the informed consent/assent form: * part a: ≥18 years to ≤64 years * part b: ≥6 years to \<18 years * 24-hour uox ≥0.7 mmol/24 hours/1.73 m² * egfr ≥30 ml/min/1.73m² * weight ≤90 kg key exclusion criteria for parts a and b * confirmed diagnosis of primary hyperoxaluria type 2 or type 3 * history of a liver, kidney or combined liver/kidney transplant * currently on dialysis * participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering rna interference (rnai) or sirna therapy * female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)

Keywords: ph1 primary hyperoxaluria agxt crispr gene editing pharmacokinetics pharmacodynamics abo-101 redephine
completion of ost - a prospective study

Conditions: Opioid Dependence

Summary: only limited information on the process of completing long-term opiate substitution treatment (ost) with substances like methadone exist. furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). studies by nordt et al. (2004) or nordt \& stohler (2006) show an estimated rate of 10% of patients per year who terminate ost by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. it is state of the art that an indication for termination of ost has to be based on a common agreement between the patient and the doctor. furthermore, the patient should live in a stable social situation and the state of health had markedly improved. finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (vader et al. 2003). the main objective of the prospective and explorative study is the systematic description of the process of termination of ost. with a comparison between patients who complete ost regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of ost can be identified. patients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate ost during the next 12 months from the doctors' perspective can take part in the study. in addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). the questionnaires include state of health, well-being, social situation as well as drug and alcohol use. furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples). patients who will be successful in completing ost during the observational period will be compared with the remaining cases. finally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12.


Eligibility criteria:
inclusion criteria: * opioid dependence according icd-10 * minimum age of 18 years * in ost with methadone or levomethadone * expected or planned treatment completion during the next 12 months * informed consent to participate in the study exclusion criteria: * patients with planned hospitalisation during the next 12 months * patients who are likely or it is save to assume that they will be incarcerated or imprisoned during the next 12 months * disability to take part in the study or follow the study conditions

Keywords: opioid dependence opiate substitution treatment methadone completion termination
lymphatic organs and myocardium after myocardial infarction

Conditions: Myocardial Infarction; Myocardial Injury; Myocardial Inflammation

Summary: the adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. therefore, the involved lymphocytes represent a novel target for therapeutic interventions. however, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. multimodal imaging of the heart and immunologic organs might provide such information. recent retrospective analysis of patients after mi revealed enlarged mediastinal lymph nodes associated with increased cxcr4 radiotracer accumulation, thereby indicating that cxcr4 pet-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. these considerations are further fuelled by the fact that, within lymph nodes, cxcr4 is expressed almost exclusively on lymphocytes, whereas various other cell types express cxcr4 within the myocardium. this leads to the hypothesis that the size of mediastinal lymph nodes and their respective cxcr4 pet signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up. this prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (cxcr4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute mi. the combination of cardiac magnetic resonance (cmr), echocardiography, and positron emission tomography (pet) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective pet-derived cxcr4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.


Eligibility criteria:
inclusion criteria: * patients with acute myocardial infarction (stemi) who were treated with immediate catheterization * stable clinical course * male/female, above 18 years old exclusion criteria: * hemodynamic instablity \> 48 h after immediate catherization * known cad * known structural heart disease * multi vessel disease * nstemi * sarcoidosis * immunosuppressive therapy * acute inflammatory disease * no consent obtainable * contraindiations for cmr * impaired renal function * active cardiac implants, ferromagnetic implants * pregnancy, breast-feeding

Keywords: cxcr4 cmr lymphatic organs myocardial infarction
linking novel diagnostics with data-driven clinical decision support in the emergency department

Conditions: Inpatient Hospitalization, Intensive Care Unit Admission, Inpatient Mortality, Sepsis and Septic Shock

Summary: the primary objective of this study is to validate the use of an electronic clinical decision support (cds) tool, triagego with monocyte distribution width (triagego-mdw), in the emergency department (ed). triagego-mdw is non-device cds designed to support emergency clinicians (nurses, physicians and advanced practice providers) in performing risk-based assessment and prioritization of patients during their ed visit. this study will follow an effectiveness-implementation hybrid design via the following three aims (phases), to be executed sequentially: (aim 1) validate the triagego-mdw algorithm locally using retrospective data at ed study sites. (aim 2) deploy triagego-mdw integrated with the electronic medical record (emr) and perform user assessment. (aim 3) evaluate triagego-mdw in steady state with respect to clinical, process, and perceived utility outcomes.


Eligibility criteria:
inclusion criteria: adult patients receiving care at a study site ed exclusion criteria: none
effects of cetoleic acid on atherosclerosis (ketolinsyre's effekt på aterosklerose)

Conditions: Metabolic Syndrome

Summary: in this randomized controlled trial (rct) we want to study the effect of an oil with high concentrations of cetoelic acid (c22:n1-11) (intervention) compared to supplements with a low concentration of cetoleic acid (control), but with equivalent content of epa og dha, on plasma levels of epa and dha as well as atherosclerotic markers, glucose, c-peptide and triglycerides in a patient group with a metabolically unfavorable phenotype. our primary endpoints are changes in the concentration of epa and dha in plasma.

this is a randomized double-blinded controlled trial (randomized 1:1). study population: men and women 20-70 years with a metabolically unfavorable phenotype defined as: triglycerides \> 1.7 mmol/l and waist measurement \> 80 cm (women) and \> 94 cm (men). study design: * 3 weeks run-in-period where all participants consume control capsules every morning. * randomization intervention: control (1:1). all participants consume their capsules (control or intervention) for 4 weeks. the intervention oil is consists of an oil high in cetoleic acid and the control oil is low in cetoleic acid. both the intervention oil and the control oil are a mix of different oils; fish oils, olive oil, "high-oleic sunflower oil" and rapeseed oil so that the content of epa, dha and ala is similar in the two oils. power calculation and sample size: it was expected a difference of 15% in n-3 between the groups after the intervention (østbye et al. 2019, doi:10.1017/s0007114519001478). the level of significance was set to 5% (two-sided) and the power to 80%. a total of thirty-eight subjects were required to participate in the study, but a high dropout rate was expected (20%) and it was considered necessary to include a total of seventy (n=70) subjects (thirty-five per arm).

Eligibility criteria:
inclusion criteria: * triglycerides \> 1.7 mmol/l * waist measurement \> 80 cm (women) and \> 94 cm (men) exclusion criteria: * chronic disease (liver/kidney/metabolism) * ongoing active cancer treatment * excessive alcohol consumption (\>40g/day) * pregnant/breastfeeding or planned pregnancy during the intervention * high intake of fish (\>3 weekly meals) * level of free thyroxine (t4) and triiodothyronine (t3) outside reference ranges. * hypertension (≥ 160/ 100 mmhg) * total cholesterol \> 7.8 mmol/l * blood donation during the intervention period * difficulty following the protocol * smoking or sniffing * regular use (\> 1 day/week) of anti-inflammatory drugs * regular use of omega-3 supplements/cod liver oil * drug use other than stable use of statins, hypertension drugs (ca antagonists, diuretics and beta blockers). * hormonal treatment excluding stable use of thyroxine and birth control pills/contraceptive rod

Keywords: omega 3 fatty acids sustainability cetoleic acid very long monounsaturated fatty acid cardiovascular disease prevention antiinflammation
prevention of hepatitis b virus mother-to-child transmission by serovaccination.

Conditions: Hepatitis B

Summary: the prevalence of hbsag carriage in pregnant women varies in france, according to the native country, with highest rates in those originating from sub-saharan africa and asia (5 to 8 % in parisian area). the level of hbv-dna varies according to hbe status and geographical origin, and is strongly predictive of the risk of hbv mother-to-child transmission (mtct). it has been shown that the rate of vertical transmission (chinese study by yuan j et al) was 0 % in newborns to mothers whom hbv-dna was \ 108 copies/ml, despite hbig and vaccine at birth. thus, data are needed concerning the current practices about the prevention of hbv mtct in france, and their results.

this monocentre, observational study will include pregnant women whom hbv-dna is \> 105 iu/ml. hbv mtct rates will be evaluated, according to the level of hbv-dna in the women during the last three months of pregnancy and at childbirth (between 105 and 108 iu/ml, or \> 108 iu/ml), and according to the clinical practices of serovaccination in the participating center. the evaluation will be based on the rate of hbsag positivity in infants at 9 months, despite a correct immunization at birth. the rate of detectable hbv-dna will be also evaluated in infants at the same date.

Eligibility criteria:
inclusion criteria: * pregnant woman * whom hbs ag + * whom hbv-dna \>105 iu/ml exclusion criteria: * women who have to be treated for hbv hepatitis, (ast/alt \>2 uln without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)

Keywords: hbv mother-to-child transmission women with hbv dna > 105 i.u./ml france
colonoscopic probiotics infusion for functional gastrointestinal disease

Conditions: Functional Constipation; Irritable Bowel Syndrome; Probiotics; Colonoscopy

Summary: the purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. the study is a single-center, prospective, randomized, single-blind, controlled, cohort study. the invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. the invesitigators will randomize the included study subjects. the experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. the control group receive basic treatment and a single injection of normal saline through colonoscopy. the invesitigators will follow up the patients for 8-12 weeks. the primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. the secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.


Eligibility criteria:
inclusion criteria: * patients undergoing for colonoscopy * meet rome iv diagnostic criteria for functional constipation or irritable bowel syndrome * voluntarily participate in this clinical study and sign the informed consent. exclusion criteria: * use of probiotics or antibiotics within the past 4 weeks * history of intestinal surgery * history of severe liver and kidney disease * history of cardiovascular and cerebrovascular diseases * history of neuropsychiatric diseases * pregnant women or lactating women * allergic to any ingredients of the live bacteria tablet
vouchers vs. prizes for cocaine-dependent methadone patients - 2

Conditions: Cocaine Dependence

Summary: the purpose of this study is to compare voucher-based contingency management (cm) procedures to a lower-cost cm system that provides opportunities to win prizes. cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize cm, (c) standard treatment plus higher magnitude prize cm, or (d) standard treatment plus voucher cm. urine and breath samples are collected 2-3x/week for 14 weeks. follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.


Eligibility criteria:
inclusion criteria: * age \> 18 years * current dsm-iv diagnosis of cocaine dependence * received methadone treatment at the clinic for at least 3 months * on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration * submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months * english speaking * pass a brief quiz related to understanding of the informed consent form exclusion criteria: * have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) * have dementia (\<23 on the mini mental state exam; folstein et al. 1975) * are in recovery from pathological gambling

Keywords: substance abuse contingency management