Kornimate/medical-research-clean huggingface dataset:
left atrial cryoablation enhanced by ganglionated plexi ablation in the treatment of atrial fibrillation

Conditions: Mitral Valve Disease; Coronary Artery Disease; Tricuspid Valve Disease; Aortic Valve Disease; Atrial Fibrillation

Summary: the aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.

the observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between july 2012 and december 2014. the patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. in all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of marshall.

Eligibility criteria:
inclusion criteria: * indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other) * concomitant paroxysmal, persistent, long standing persistent atrial fibrillation * signing of the informed consent exclusion criteria: * age below 40 and over 80 years of age * left ventricular ejection fraction below 25% * left atrium diameter over 60mm * permanent atrial fibrillation * polymorbidity (euroscore ii over 10) * emergency surgery * renal insufficiency (creatinine over 200 umol/l)

Keywords: atrial fibrillation left atrial cryoablation ganglionated plexi open-heart surgery
faecal immunochemical test and urine volatile compounds in adenoma detection

Conditions: Colorectal Cancer

Summary: bowel cancer can arise from polyps, which can become cancerous. polyps are little outgrowths within the lining of the bowel (similar to skin warts). depending on their size and their potential to become cancerous, they can cause bleeding. however, it is not known which polyps harbour cancerous potential. therefore, at present all patients undergo a colonoscopy (camera examination of the large bowel) in order to identify and remove any polyps. however, not all patients who undergo a colonoscopy will have polyps. moreover, colonoscopies are invasive and disruptive to patients, as they require bowel preparation. the aim of this study is to evaluate non-invasive stool and urine tests to identify patients who are at risk of polyps and if the polyps have the potential to become cancerous. this in turn, will significantly reduce the number of 'unnecessary' polyp surveillance colonoscopies with resultant benefits to both patients and the national health service (nhs).


Eligibility criteria:
inclusion criteria: * patients who are on a polyp surveillance programme and will be undergoing colonoscopy examination for polyp surveillance or patients who will be undergoing elective polypectomy through specialised polyp multi-disciplinary meetings. exclusion criteria: * participants who are unable to attend colonoscopy * under 18 years old * unable to provide informed consent for themselves to take part in this study
a research study looking at how oral semaglutide works in people with type 2 diabetes in mexico, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower participant's blood sugar levels. participants will get rybelsus® as prescribed by the study doctor. the study will last for about 8-10 months. participant will be asked to complete a questionnaire about how the participant will take rybelsus® tablets. participant will complete this questionnaire during the normally scheduled visit with the study doctor. participant will be asked to complete some questionnaires about diabetes treatment. participant will complete these questionnaires during normally scheduled visits with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available hba1c value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (v1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit' (v1) if in line with local clinical practice * treatment naive to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
characterization of potential biomarkers of eye disease and vision

Conditions: Eye Disease

Summary: characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at cec, aibili

this is a registry study. only patients followed under the clinical practice at aibili clinical trial centre, and with a signed informed consent form will be included. based on the clinical information collected under the clinical practice, and based on patients' characteristics, scientific questions will be raised and data will be collected and analysed accordingly. any procedure performed under clinical practice that may allow for the characterization of the disease and/or for the identification of potential biomarkers will be collected and analysed.

Eligibility criteria:
inclusion criteria: * any patient followed under the normal clinical practice at aibili clinical trial centre, and with a aibili signed informed consent form for data collection, imp. 11-7-2 "consentimento informado para tratamento de dados". exclusion criteria: * none

Keywords: eye imaging
prevalence of incontinence and risk factors in children with cerebral palsy

Conditions: Urinary Incontinence

Summary: this study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.

children with cerebral palsy (cp) (rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (ozturk, 2006). the incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population. incontinence in children is often treated with urotherapy. this is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (neveus, 2006). recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (mulders, 2010). despite the high prevalence of incontinence in children with cp the possible treatment strategies in this population are poorly investigated. far too often, urinary incontinence in children with cp is considered a normal, unavoidable and even a minor problem. aim: analyze (risk) factors influencing (in)continence in children with and without cp. possible parameters will be registered through questioning, measurement (uroflow combined with pelvic floor emg and postmictional residue) and retrospective analysis of the patient files. parameters will be compared between continent and incontinent children with and without cp. this comparison evaluates whether the same therapeutic strategies can be applied in incontinent children with and without cp.

Eligibility criteria:
inclusion criteria: * daytime urinary incontinence with or without enuresis and/or fecal incontinence (groups with incontinence) * no urinary or fecal incontinence (groups without incontinence) * cerebral palsy (groups with children with cp) * normal development (groups with children without cp) exclusion criteria: * isolated urinary tract infections * isolated enuresis * isolated dysfunctional voiding * isolated fecal incontinence * anatomical abnormalities * history of genitourinary or renal surgery * medication for incontinence during the last 3 months * pelvic reeducation during the last 6 months * other neurologic problems influencing continence

Keywords: cerebral palsy risk factors child urinary incontinence
prevention of hepatitis b virus vertical transmission by serovaccination and tenofovir during pregnancy

Conditions: Pregnancy; HBV

Summary: the risk of vertical hbv transmission is related to hbv dna level in pregnant women, around 30% in women with hbv dna above 1, 000 000 i.u/ml despite serovaccination of newborns. using tenofovir df during the last trimester of pregnancy allows to reduce the risk, but data from western countries are needed.

the prevalence of hbs ag carriage in pregnant women varies in france, according to the native country, with higher 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). the rate of vertical transmission (yuan j et al. j viral hepatitis 2006) was 0% in newborns to mothers with hbv dna less than 100,000 copies/ml and up to more than 40% in newborns to mothers with hbv dna above 8 log10 copies/ml, despite serovaccination at birth, thus justifying the use of tenofovir df during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in easl 2012 guidelines. data are needed concerning the results of this strategy in western countries, justifying this prospective study.

Eligibility criteria:
inclusion criteria: * pregnant women * positive for hbs ag * hbv dna above 100,000 i.u/ml exclusion criteria: * hiv co-infection * hdv co-infection * requiring, according to the physician's decision, a treatment for herself and not only to prevent hbv mtc transmission
early life intervention in pediatrics supported by e-health - smoke

Conditions: Smoking Reduction; Asthma in Children; Wheezing; Non-Communicable Disease; Life Style; Behavior, Smoking

Summary: unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (ncds). exposure to secondhand tobacco smoke in early life contributes to the development of specific ncds in children, i.e. asthma. early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. the aim of elipse-ii is to assess whether an ehealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .

elipse-ii represents a single-blind randomized controlled parallel-group clinical trial. in total, 160 children, \<6 years of age with exposure to second-hand smoke at home will be included. children will be recruited at the children's university hospital and in private practices in bern, and randomly (1:1) assigned to a control and intervention group. all participants receive treatment-as-usual (tau), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. the app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. the primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. secondary endpoints in elipse-ii include changes in parental smoking habits and effects of the intervention on infants' respiratory health. a further endpoint is acceptance and usability of the app.

Eligibility criteria:
inclusion criteria: * age: younger than 6 years * exposed to second-hand smoke at home (at least one parent smoking) * german speaking parent * all sex and ethnic backgrounds * signed informed consent form from parent * children live/grow-up in the same household as the parental participant * referred by a health care professional (e.g. physician, midwife, nurse, other professions) exclusion criteria: * participation in another study/trial targeting similar outcomes * participation in an active smoking cessation programme

Keywords: secondhand smoke children prevention ehealth
long - term follow up of sickle cell disease and beta-thalassemia subjects previously exposed to bivv003 or st-400.

Conditions: Blood and Lymphatic Diseases

Summary: primary objectives: long-term safety of bivv003 in participants with severe sickle cell disease (scd) and st- 400 in participants with transfusion-dependent beta-thalassemia (tdt) secondary objectives: * long-term efficacy of the biological treatment effect of bivv003 in scd * long-term efficacy of the clinical treatment effect of bivv003 on scd-related clinical events * long-term efficacy of the biological treatment effect of st-400 in tdt * long-term efficacy of the clinical treatment effect of st-400 in tdt

the total study duration is up to 15 years of follow-up post bivv003 and/or st-400 infusion.

Eligibility criteria:
inclusion criteria: * received treatment with bivv003 or st-400 in one of the parent studies (act16222, st- 400-01) or any future studies with bivv003 * capable of giving signed informed consent (and if applicable assent) exclusion criteria: * unable to comply with study visit schedule or study procedures * any other reason that, in the opinion of the investigator or medical monitor, would render the participant unsuitable for participation in the study the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Keywords: sickle cell disease (scd), beta-thalassemia (tdt)
different stimulation patterns to reduce muscle fatigue during fes

Conditions: Spinal Cord Injuries

Summary: the main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (fes) following spinal cord injury (sci).

functional electrical stimulation (fes) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications. the main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes. three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle. in addition, the muscle changes during different patterns of stimulation will be evaluated in this study.

Eligibility criteria:
inclusion criteria: * incomplete spinal cord injury * able to give informed consent * able to sit up in a chair exclusion criteria: * female subjects who are pregnant * significant history of autonomic dysreflexia * unable to give informed consent * individuals who have a cardiac history * individuals who have significant cognitive impairment * individuals with muscular abnormality * individuals who have significant contractures in the lower extremities * individuals who have a rash or infection at the site of electrode placement (gastrocnemius for both legs) * individuals who are hypersensitive to electrical stimulation * individuals who are presently involved in another study which has overlap with the methodology and/or outcomes of the studies

Keywords: functional electrical stimulation
multiple myeloma treated with thalidomide before autotransplant or with conventional chemotherapy and as consolidation/maintenance treatment in young and elderly patients : 3 randomized studies.

Conditions: Multiple Myeloma de Novo Treatment

Summary: the aim of the study was to evaluate efficacy and tolerability of thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with dexamethasone before autotransplant, and in elderly patients in combination with conventional chemotherapy and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.

my-tag : thalidomide as induction treatment before high dose therapy, in young patients my-dect : thalidomide as induction treatment with conventional chemotherapy, in elderly patients my-plat : thalidomide and dexamethasone at plateau-phase, after high dose therapy or conventional chemotherapy

Eligibility criteria:
inclusion criteria: * for my-tag(auto-transplant): age 18-65, multiple myeloma salmon-durie stage ii, stage iii and symptomatic stage i (lytic bone lesion or a 25 % increase of monoclonal protein) * for my-dect (conventional chemotherapy) : qge 66-80, multiple myeloma salmon-durie stage ii, stage iii and symptomatic stage i (lytic bone lesion or a 25 % increase of monoclonal protein) * for my-plat (maintenance at plateau-phase): patients treated in my-tag or my-dect with at least a minimal response (25 % decrease of m protein)3-6 months after autotransplant or last chemotherapy exclusion criteria: * for my-tag : age 66 or more, smoldering stage i multiple myeloma, previous therapy, plasma cell leukemia,creatinine \> 300 micromol/l, liver failure, anthracycline contra-indicated, thalidomide contra-indicated, corticosteroid contra-indicated * for my-dect : age \ 80, smoldering stage i multiple myeloma, previous therapy, plasma cell leukemia,creatinine \> 300 micromol/l, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated * for my-plat : no response or progressive disease, randomization \> 6 m since autotransplant or last chemotherapy, creatinine \> 300 micromol/l, liver failure, thalidomide contra-indicated, corticosteroid contra-indicated

Keywords: multiple myeloma, treatment, first line
study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (itp) who failed first-line treatment

Conditions: Immune Thrombocytopenia

Summary: this is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult itp patients who failed first-line treatment. the study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.


Eligibility criteria:
key inclusion criteria: * male or female participants aged 18 years and older with primary itp * participant received at least a first line therapy and had a history of response while on treatment * participant has loss of response, relapse or steroid dependency key exclusion criteria: * participants with secondary itp * participants with evans syndrome or history of myelodysplastic syndrome * participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy. * participants with history of solid organ transplant * participants with history of coagulation or bleeding disorders other than itp * participant received advanced therapy for itp or was splenectomized * pregnancy or nursing the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
blood glycan biomarkers in women with stage iv breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer. purpose: this research study is looking at blood glycan biomarkers in women with stage iv breast cancer.

objectives: * to profile serum glycan biomarkers in women with metastatic stage iv breast cancer, healthy controls, and patients with noncancer medical illness. * to determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment. outline: this is a multicenter study. blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (maldi) and fourier transform ion-cyclotron resonance mass spectrometry (ft icr ms) methods. blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. patients without cancer have a single sample collected.

Eligibility criteria:
disease characteristics: * patient or participant at the women's health clinic, the internal medicine clinic, or at the uc davis cancer center, meeting 1 of the following criteria: * diagnosis of stage iv metastatic breast cancer, receiving active treatment with chemotherapy, endocrine therapy, or targeted therapy * patients/participants without cancer * healthy control being seen for annual exams, meeting the following criteria: * no chronic disease * not on regular prescribed medications * patient without cancer being seen in the internal medicine clinic * hormone receptor status not specified patient characteristics: * menopausal status not specified * not pregnant or breast feeding * no other active cancer prior concurrent therapy: * see disease characteristics

Keywords: stage iv breast cancer