Kornimate/medical-research-clean huggingface dataset:
multiparametric magnetic resonance imaging (mri) in medullary sponge kidney

Conditions: Medullary Sponge Kidney

Summary: background : medullary sponge kidney disease is a congenital disorder caracterised by tubular ectasia and cystic dilatation of the collecting ducts in the pericalyceal region of the renal pyramids, which can lead to nephrolithiasis and frequently associated with impaired tubular function such as distal renal tubular acidosis. the disease knowledge is limited, especially about origin, diagnosis, and physiopathology of the disease. the disease is associated with impaired tubular function such as distal renal tubular acidosis, hypocitraturia, hypercalciuria, which suggest altered kidney medulla function. multiparametric mri may provide further informations about the physiopathology and help in earlier diagnosis of the medullary sponge kidney. objective : the aim of this study is to test the hypothesis that early kidney medulla function alteration in medullary sponge kidney can be detected and characterised with multiparametric mri. we are expecting to see in medullary sponge kidney a decreased oxygenation content in bold mri (blood oxygenation level dependent magnetic resonance imaging), and decreased adc (apparent diffusion coefficient) value in the medulla. design : a monocentric prospective case/control study will be conducted in adults with medullary sponge kidney. controls are adults patients with glomerular filtration rate \> 60 ml/min/1.73m2 without kidney stone attending a renal exploration. after a screening visit, patients included will be evaluated on one day with lithiasis assessment and measurement of glomerular filtration (urinary collection of the last 24 hours, urine sample, blood sample) and they will perform multiparametric magnetic resonance imaging of the kidneys.


Eligibility criteria:
inclusion criteria: * medullary sponge kidney attending medical consultation * patients with glomerular filtration rate \> 60 ml/min/1.73m2 without kidney stone * consent signed * effective contraceptive method for women * affiliated to social insurance scheme exclusion criteria: * kidney transplant * polycystic kidney diseases * chronic kidney disease (gfr \< 60 ml/min/1,73m² ) * mri contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non mri-compatible) * weight\> 130 kg * pregnancy * legal protection measure (guardianship, curatorship) * deprived of liberty by a judicial or administrative decision * subject participating in another research that may interfere with the research and including an exclusion period still in progress at inclusion

Keywords: medullary sponge kidney kidney stone multiparametric mri medullary function
ssc-covid in patients after covid-19

Conditions: Secondary Sclerosing Cholangitis; COVID-19

Summary: analysis of occurrence of ssc-covid in sars-cov-2-patients after the first wave of covid-pandemic

in central europe, the first wave of sars-cov-2 peaked in april 2020 and ended in june 2020. our tertiary care center, the university hospital of tübingen is located in a first-wave sars-cov-2 hotspot area that had the second highest 7-day incidence in germany on march 31, 2020, exactly at the peak of the first wave in germany (205.9/100,000, www.rki.de; the peak daily incidence in tübingen was 179/100,000 on march 25, 2020). in this period, 249 patients were hospitalized for or with sars-cov-2 infection. to gain fast knowledge about the new disease, a covid-19 patient registry was established at our center, including all patients admitted to tübingen university hospital for or with sars-cov-2 infection and retrospectively collecting routine clinical data. after hospitalization, patients were followed up in the outpatient clinic of our department, the department of gastroenterology, hepatology, gastrointestinal oncology, geriatrics and infectious diseases. subsequently, several patients with secondary sclerosing cholangitis (ssc) after covid-19 (ssc-covid) were recognized in our center, either from our own cohort, or referred to our center due to the need for further treatment of end-stage liver disease including liver transplantation. ssc is a cholangiopathy estimated to be rare in icu patients with an incidence of 1/2000 icu patients. pathogenesis has not been fully deciphered, but a combination of ischemic injury and increased bile toxicity during critical illness is suspected. this imposes acute damage on the biliary system, that, if not resolving early or spontaneously, may lead to the vicious circle of gradually destruction of the biliary tree over time, well known to hepatologists and endoscopists.

Eligibility criteria:
inclusion criteria: * post-covid19-patients with required hospitalization during the first wave of covid-19-pandemic * patients controlled at the university ambulance for follow-up exclusion criteria: * children and patients younger than 18 years
study of efficacy of digital cognitive behavioral therapy with wearable device for insomnia

Conditions: Insomnia

Summary: the purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (cbt)-based wearable integrated digital therapeutics for insomnia patients

the investigators intend to conduct a single-arm clinical trial. following voluntary consent during the screening visit, participants will undergo screening procedures. the screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the mini international neuropsychiatric interview (mini), columbia suicide severity rating scale (c-ssrs), etc. participants who meet the selection criteria and do not meet the exclusion criteria will use the dtx app for 8 weeks. surveys conducted after app installation (insomnia severity index (isi), patient health questionnaire-9 (phq-9), generalized anxiety disorder 7-item scale (gad-7), and a sleep environment questionnaire) will serve as the baseline. during the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (se), sleep onset latency (sol), wake after sleep onset (waso), etc. for the experimental group, assessments as per the protocol will be conducted at baseline (visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (visit 2).

Eligibility criteria:
inclusion criteria: 1. individuals aged 19 to 65 years old 2. dsm-5 insomnia disorder patient 3. isi ≥11 4. capable of using mobile device and application exclusion criteria: 1. currently on non-pharmacological treatment for insomnia (ex. cbt-i, light therapy, oriental therapy for insomnia) 2. sleep disorders diagnosis other than insomnia (ex. obstructive sleep apnea, sleep behavior problem, restless leg syndrome) 3. progressive and active medical conditions 4. received continuous psychotherapy such as cbt, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months 5. major psychiatric illness as assessed through mini 6. suicide risk as assessed through c-ssrs 7. having occupational risk due to sleep restriction 8. shift workers 9. phq-9 of 20 or above 10. individuals who have actually slept less than an average of 5 hours per night over the past month 11. pregnant women or individuals planning pregnancy during the clinical trial period
validation of the gocheck kids® eye screeningtest in infants in flanders

Conditions: Amblyopia; Infant

Summary: the aim is to validate the new gocheck kids application as automatic eye screener for preschool children (\<3 years of age) at 'child and family' agency. sensitivity, specificity, positive and negative predictive value of the gocheck kids screening tool are the endpoints of this study.

comparison of the results of the gocheck kids application on iphone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Eligibility criteria:
inclusion criteria: * gocheck kids (gck) evaluation at child and family agency at the age between 11-16 months. exclusion criteria: * allergy for the used cycloplegia cyclopentolate 0.5%. * any history of ocular surgery * the time window between gck measurement and the complete eye examination may not exceed 2 months. * the parents or legal representatives of the child do not understand or speak dutch, french or english.

Keywords: eye screening
cerebral morbidity after radiation therapy for brain tumors

Conditions: Brain Tumor; Cognitive Impairment; Radiation Toxicity

Summary: this study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (rt) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. all types of brain tumours apart from glioblastoma will be included.

rt to brain tumours causes cognitive dysfunction. the extent of rt induced changes in cognitive function and radio-sensitivity of the brain is unknown. rt with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. there is modest knowledge on which parts of the brain we need to spare, to prevent cognitive dysfunction. the study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in denmark. the patients will do patient reported outcome (pro) and undergo neuropsychological assessment with standardized tests: they will do this prior to rt treatment and ½, 1, 3 and 5 years afterwards. the pro's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. the standardized tests are: trail making test (tmt); hopkins verbal learning test (hvlt); controlled oral word association test (cowat) - animals and s; coding and digit span from wais-iv; paced auditory serial addition test (pasat). the correlation between cognitive scores and rt dose-volume parameters to specific areas in the brain will be tested. this study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.

Eligibility criteria:
inclusion criteria: * 18 years or older and danish speaking. * performance status who 0-2 * capable of cooperating on testing * tumor histology (who 2016 classification) of the following types: anaplastic astrocytoma (idh mutant), diffuse astrocytoma (idh-mutant), gemistocytic astrocytoma (idh mutant), diffuse astrocytoma (nos), oligidendroglioma, meningioma, medulloblastoma (nos), pituitary adenoma, other brain tumours including skull base sarcomas exclusion criteria: * glioblastoma * performance status 3-4

Keywords: brain tumor cognitive function radiation therapy hippocampus
long-term evaluation of the efficacy and safety of splentis for the treatment of primary apical pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: this prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using splentis via the vaginal route in primary uterine prolapse

women who undergo hysteropexy with splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. the primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. furthermore, a detailed report about adverse events will be included.

Eligibility criteria:
inclusion criteria: * non-fertile women * primary symptomatic uterine descent pop-q≥2 * scheduled apical pop repair with splentis * willing and able to participate at study visits and to sign informed consent exclusion criteria: * fertile women * recurrent apical prolapse * women with post hysterectomy vaginal vault prolapse * patients with active or latent infection of the vagina, cervix or uterus * patients with previous or current vaginal, cervical or uterine cancer * previous, current or planned pelvic radiation therapy * known allergy to polypropylene.

Keywords: apical pelvic organ prolapse transvaginal repair mesh augmented repair sacrouterine ligament fixation
effects on colesevelam hc1 (welchol®) on insulin sensitivity in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to test whether welchol (colesevelam hc1) improves blood sugar control in patients with type 2 diabetes by making their own insulin work more efficiently.

single-center, randomized, parallel, double-blind, placebo controlled, 8-week trial in subjects with type 2 diabetes mellitus. two parallel treatment groups include double-blind colesevelam or placebo. a screening period may be up to 18 weeks to withdraw non sulfonylurea antidiabetic treatment or withdraw or adjust sulfonylurea antidiabetic treatment. to evaluate hepatic and peripheral insulin sensitivity, subjects will undergo a two-step hyperinsulinemic-euglycemic clamp with a tritiated glucose infusion at pre randomization and after 8 weeks of treatment. to evaluate oral glucose absorption, subjects will undergo two oral glucose tolerance tests (ogtt) at pre randomization, one without colesevelam and one with colesevelam, and one ogtt at the end of the treatment period..

Eligibility criteria:
inclusion criteria: subjects meeting the following criteria at the screening visit will be eligible to participate in the trial: * have given written informed consent * ages 18 to 75 years, inclusive * diagnosis of type 2 diabetes mellitus of at least 3 months duration * hba1c 7.0- 10.0%, inclusive * antidiabetic treatment may include oral agents; all antidiabetic agents must be withdrawn before randomization * women may be enrolled if they are not pregnant (negative serum βhcg at the screening visit), are not breast-feeding, and do not plan to become pregnant during the trial. in addition, they must either have had a hysterectomy or tubal ligation at least 6 months before signing informed consent, be post-menopausal for 1 year, or practicing an acceptable method of birth control. an acceptable method of birth control may be oral, injectable or implantable hormonal contraceptives, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. abstinence, partner's use of condoms, and partner's vasectomy are not acceptable methods of contraception * bmi 25 - 45 kg/m sq, inclusive exclusion criteria: subjects are excluded from participation in the study if any of the following criteria apply: * type 1 diabetes mellitus or history of diabetic ketoacidosis * treatment with lipid or blood pressure lowering therapy that has not been stable for three months before randomization * treatment with welchol, cholestyramine or colestipol for hyperlipidemia within the last 3 months * treatment with thiazolidinediones * history of dysphagia, swallowing disorders, or intestinal motility disorder * serum triglyceride \>500 mg/dl at visit 1 * serum ldl-c \<60 mg/dl at visit 1 * any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest * use of any investigational drug within 30 days before randomization * chronic treatment with oral corticosteroids * history of hyperthyroidism and/or treatment with thyroid hormone/ levothyroxine
tacticath contact force ablation catheter study for atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the toccastar study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. subjects will be randomized for treatment with either the tacticath catheter or another ablation catheter with no contact force sensing capability. patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic af between the two study arms. additional measures of treatment success including quality of life, recurrence of asymptomatic af and procedural efficiency will also be studied. a second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.

it has been hypothesized that the ability to create durable lesions during radiofrequency (rf) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (paf). lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. in this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of paf will be randomized for treatment with either a device incorporating contact force sensing or one without. to be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. in both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. the study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.

Eligibility criteria:
inclusion criteria: * symptomatic paf refractory to at least one class i-iv antiarrhythmic drug * minimum one documented paf episode \>30 sec duration within prior 12 months * minimum three paf episodes during prior 12 months * 18 years or older exclusion criteria: * persistent or long-standing persistent af * four or more cardioversions in prior 12 months * mi, cabg or pci within preceding 3 months * left atrial diameter \> 5.0 cm * lvef \< 35% * nyha class iii or iv * previous left atrial ablation procedure * previous tricuspid or mitral valve repair surgery

Keywords: paroxysmal atrial fibrillation atrial fibrillation radiofrequency ablation pulmonary vein isolation ablation catheter rf contact force sensing contact force contact force assisted ablation
observation of benefits for patients implanted with a hearing implant of the company cochlear

Conditions: Hearing Loss

Summary: the purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company cochlear over a period of 2 years post treatment. assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.

the clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss. clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform. the registry is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company cochlear. patients are approached for registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent. monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.

Eligibility criteria:
inclusion criteria: * post-lingually deafened adults and adolescents who are newly implanted and prior to first switch-on of their external device * unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company cochlear® * children 10 years or older and in accordance with local regulations and product labelling * mentally capable to respond to self-administered assessment scales * willingness to participate and sign the patient informed consent form exclusion criteria: * individuals excluded from participation in a registry according to national or local regulations

Keywords: cochlear® hearing implants
esomeprazole for prevention of upper gastrointestinal symptoms associated with continuous use of nsaids

Conditions: NSAIDs; Upper GI Symptoms

Summary: this study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. the primary variable was to assess theefficacy of esomeprazole 40 mg orally qd (e40) or esomeprazole 20 mg orally qd (e20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper gi symptoms associated with nsaid use, including cox-2 selective nsaids, in patients receiving daily nsaid therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent. * completed the sh-nen-0003 study with relief of upper gi symptom. relief is defined as "last 7 days with a diary assessment of none or minimal, but allowing up to 2 days to be rated as mild during the 7-day period". * a clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily nsaid treatment for at least 6 months. daily nsaid treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include cox-2 selective nsaids, multiple nsaids, and high-dose nsaids. * daily nsaid treatment dose and type: * must have been stable for at least 9 weeks prior to inclusion * are expected to remain stable for the duration of the study. * must be administered orally. if more than one type of nsaid treatment is used, at least one type must be administered orally. * hp negative on histology performed at baseline endoscopy in the study shnen-0003. exclusion criteria: * discontinuation from study sh-nen-0003 * pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation. * pain, discomfort or burning in the upper abdomen not associated with the use of nsaids, including cox-2 selective nsaids. * pregnancy or lactation. women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.