Kornimate/medical-research-clean huggingface dataset:
prevention of celiac disease in skåne

Conditions: Celiac Disease in Children

Summary: this study aims to investigate the impact of being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children. this is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.

the primary hypothesis to be tested is that a strictly gluten free diet during the first three years of life with a slow introduction of gluten during the follow-up period will induce tolerance to gluten. a similar hypothesis is tested if a daily supply of two different lactobacillus (lb) strains can suppress an inflammatory response to gluten in the intestine by stimulating regulatory t-cells and reduced permeability of gluten peptides in the intestine. the secondary hypothesis tested is that celiac disease can not be prevented, but the onset of the disease will be delayed in children returning to a gluten-containing diet after the intervention period (gluten free diet) or probiotic treatment) during the first three years of life. the intervention period is 3 years and the follow-up period is further 4 years. the primary aim is to study the proportion of children who develop celiac disease autoimmunity and progression to celiac disease by the age of 3 years. secondary aim is to study the proportion of children who developed celiac disease at the age of 7 years.

Eligibility criteria:
inclusion criteria: * children screened positive for human leucocyte antigen (hla) dr3-dq2/dr3-dq2 * children must be enrolled to the study by 4 months of age (before gluten consumption has started). exclusion criteria: * congenital chronic disorder where intervention with diet or probiotics may be affected. * written consent from both caregivers are missing

Keywords: coeliac disease celiac disease autoimmunity
pediatric relapsing polychondritis : diagnosis and management in a french retrospective study

Conditions: Relapsing Polychondritis

Summary: the incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level. without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. however, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision. existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. different therapeutic lines have been introduced over the years and a better understanding of the pathology. more recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. data on the evolution under therapy in children are thus still poor. complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided. the aim of the study is to describe french practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.


Eligibility criteria:
inclusion criteria: * minor subject aged 1 to 17 years * diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022. * subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. exclusion criteria: * subject (or his parents) having expressed his (their) opposition to participating in the study * associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Keywords: polychondritis relapsing polychondritis pediatric relapsing polychondritis
calquence cll rr japan pms_japan post-marketing surveillance (pms) study - all patient investigation

Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)

Summary: to understand the incidence of adrs of calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting

to understand the incidence of adrs of calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting. this investigation will be conducted for application for re-examination specified in article 14-4 of the pharmaceutical affairs law. in addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.

Eligibility criteria:
inclusion criteria: patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product - exclusion criteria: none -
analgesic efficacy of a multiport versus uniport flexible catheter for labor epidural analgesia

Conditions: Labor Pain

Summary: the purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery

multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication it is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification i-iii parturients * mixed parity * estimated gestational age of at least 37 weeks * singleton gestation * cephalic presentation * spontaneous or induced labor exclusion criteria: * body mass index (bmi) \> 45 kg/m2 * prior cesarean section * multiple gestation * fetal abnormality * use of chronic analgesic medication * local anesthetic allergy * coagulopathy or anticoagulation * infection at epidural insertion site * spinal deformity other than mild scoliosis * uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition

Keywords: epidural catheter epidural analgesia labor epidural analgesia analgesic efficacy multiport epidural catheter uniport epidural catheter flexible epidural catheter
comparison of transanal irrigation and glycerol suppositories in treatment of low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Summary: the study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major low anterior resection syndrome (lars).

transanal irrigation (tai) is used as a second-line treatment following unsuccessful personalised conservative treatment (pct) of lars. however, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as tai. thus, the aim of this study is to compare the effect of tai with a glycerol suppository in patients suffering from major lars. the study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with tai to treatment with glycerol suppositories. patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with tai or glycerol suppositories. primary endpoint will be assessed by the end of week twelve.

Eligibility criteria:
inclusion criteria: * patients electively treated for rectal cancer with a low anterior resection. * unsuccessful pct after at least 4 weeks of treatment for lars (lars score \>29 at evaluation). * at least 3 months after surgery (including reversal of a temporary loop-ileostomy). * age \>= 18 years * ability to understand written and spoken language actual for the including site (due to questionnaire validity). exclusion criteria: * former use of tai * prior systematic use of rectal emptying aids * anastomotic stenosis * history of anastomotic leakage * current metastatic disease or local recurrence * ongoing oncological treatment * postoperative radiotherapy for rectal cancer * previous or current cancer in other pelvic organs than the rectum * underlying diarrhoeal disease * inflammatory bowel disease * dementia * spinal cord injury, multiple sclerosis, parkinson's disease or other significant neurologic disease assessed to be a contributory cause to lars symptoms. * inability of patient to use tai * inability and unwillingness to give informed consent * pregnancy or intention to become pregnant during the trial period

Keywords: low anterior resection syndrome transanal irrigation glycerol suppositories
pfo transcatether occlusion long-term outcomes national group (prolong) registry

Conditions: Patent Foramen Ovale; Stroke, Cryptogenic; Transient Ischaemic Attack Due to Embolism; Atrial Fibrillation New Onset

Summary: patent foramen ovale (pfo) has been associated with cryptogenic stroke and transient ischemic attack (tia) in young adults. evidence from randomized clinical trials (rct) has shown that transcatheter pfo closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals. however, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-pfo closure lifespan for these individuals. consequently, it is imperative to gather more extensive long-term follow-up data among pfo closure recipients the prolong (pfo transcatether occlusion long-term outcomes national group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter pfo closure, with the aim of assessing the long-term (\>10 years) efficacy and safety of this procedure.

the prolong (pfo transcatheter occlusion long-term outcomes national group) is an observational, retrospective, multicenter registry. it includes 1,360 subjects who underwent transcatheter patent foramen ovale (pfo) closure between 1999 and 2013 at 12 italian high-volume centers. patients will have at least 10 years of follow-up post-procedure. the primary objectives of the study are to evaluate the long-term clinical effectiveness of pfo closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events. secondary objectives include the incidence of new-onset atrial arrhythmias, the presence and severity of residual shunts, the incidence and severity of migraine symptoms, and bleeding events.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * confirmed patent foramen ovale (pfo); * transcatheter patent foramen ovale (pfo) closure with an occluder device; * pfo closure procedure performed between 1999 and 2013. exclusion criteria: * age \< 18 years; * previous surgical or transcatheter pfo closure; * patients without follow-up data available.

Keywords: patent foramen ovale stroke, cryptogenic stroke transient ischemic attack atrial fibrillation interventional cardiology
evaluation of novel lung function parameters in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD; Obstructive Ventilation Disorder; Pulmonary Emphysema

Summary: current guideline-based criteria defining copd do not meet the challenges set by the complex pathophysiology of the disease. the investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of copd.


Eligibility criteria:
inclusion criteria: * known or suspected copd * known or suspected obstructive ventilation disorder * pulmonary healthy controls exclusion criteria: * pregnancy * inability to participate
extrinsic and intrinsic factors in atopic dermatitis upon systemic immune modulation

Conditions: Atopic Dermatitis

Summary: currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. however, not all patients who suffer from atopic dermatitis respond similarly to this treatment. pattern recognition of immune cells (pri) is an efficient method to screen patients to allow a more personalized therapy. the main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. this allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.

a better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis. the pri is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. this facilitates the identification of meaningful t cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment. peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the t cells. therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers. patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating dupilumab treatment). the blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.

Eligibility criteria:
inclusion criteria: * age 18 and above * diagnosis of atopic dermatitis for ≥1 year * inadequate response to treatment with topical medications * confirmed dupilumab treatment exclusion criteria: * age below 18 * known or suspected allergy or reaction to any component of the dupilumab formulation * known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of ad * severe conjunctivitis or blepharitis

Keywords: dupilumab pattern recognition immune cells
bone marrow derived mononuclear cells for ischemic cardiomyopathy

Conditions: Heart Disease

Summary: this is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an icd-crt. it is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an icd-crt device as an adjunct to crt and usual drug treatment.


Eligibility criteria:
inclusion criteria: * chronic left ventricular dysfunction (ejection fraction \ 15% of lvef 3 months after crt-device implantation * wall motion dysfunction of any territory * left bundle branch block * patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ace-inhibitors, at1 blockers and/or lipid lowering agents for at least 30 days before crt implantation exclusion criteria: * patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy * with relevant valvular disease; * aneurysma of the anterior myocardial wall or myocardial wall thickness of \< 5 mm, * with overt heart failure, other than ischemic cardiomyopathy, * with history of stroke and/or transient ischemic attack (tia), * with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system; * with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment; * with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against x-ray or contrast agent and, pre-malignant and malignant disease) * atrial fibrillation with average heart rate \>70 bpm * pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment; * with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results; * patients with a chronic or acute hiv-, hbv-, hcv-infection; * improvement of more than 15% of lvef 3 months after crt-device implantation * patients who have a icd implantation for secondary prophylactic indication. these patients show a history of resuscitation, vt or syncope. * patients who are currently participating in another investigational drug or device study

Keywords: chronic ischemic heart disease
research protocol: glaucoma treatment adherence and persistence

Conditions: Primary Open Angle Glaucoma

Summary: the investigators are studying motivational interviewing (mi). mi is a counseling method to help people adopt healthy behaviors. the investigators will test whether mi improves patients' accurate use of glaucoma eye drops. the investigators will train eye clinic staff called glaucoma educators to use mi. up to 250 patients at 3 clinics will be recruited. all patients will receive their usual eye care. based on chance, some patients will also be supported by a glaucoma educator. the groups will be compared on medication adherence using micro-electro-mechanical system(mems). mems are electronic bottle caps that track when a medication bottle is opened. patients will be aware that their medication use is tracked. the groups will also be compared on treatment value, outcomes, and cost. the investigators will also collect data on variables that may predict medication adherence.


Eligibility criteria:
inclusion criteria: * community-dwelling adults with primary or secondary open-angle glaucoma, and * a current prescription for monotherapy topical glaucoma medication. exclusion criteria: * patient-reported inability to administer eye drops that cannot be addressed successfully through in-person instruction at the clinic, * cognitive impairment at a level that would in the judgment of the referring physician interfere with study participation, * referring physician's determination that glaucoma surgery is likely within the next 6 months, * any active medical, psychological, or substance use disorder that would in the referring physician's judgment significantly interfere with study participation (e.g., comorbid congestive heart failure (chf) resulting in a recent hospitalization; active psychosis due to uncontrolled bipolar disorder; etc.), or * no visual field test within the past 6 months (data required for the randomization approach described below).

Keywords: adherence glaucoma motivational interviewing
multifactorial risk assessment for breast & ovarian cancer risk detection

Conditions: Adnexal Mass; Germline BRCA1 Gene Mutation; Germline BRCA2 Gene Mutation; Hereditary Breast and Ovarian Cancer

Summary: the objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.


Eligibility criteria:
key inclusion criteria: * female subject * 18 years of age or older cohort a specific inclusion criteria: • diagnosed with a pelvic mass cohort b specific inclusion criteria: * diagnosed with a pelvic mass * undergoing genetic testing through our commercial offering cohort c specific inclusion criteria: • subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic dna mutation) associated with ovarian cancer. exclusion criteria: * n/a