Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of ibuprofen l-lysine solution in premature infants for treatment of pda

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of patent ductus arteriosus.

the ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. early treatment by intravenous ibuprofen l-lysine (iv ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. this study aims to determine the effect of early treatment with iv ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (pda) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.

Eligibility criteria:
inclusion criteria: * premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age; * non-symptomatic pda with evidence of ductal shunting documented by an echocardiogram (echo); * less than 72 hours of age at the time of randomization; * if infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria; * consent form signed by parent. exclusion criteria: * either major congenital malformations and/or chromosomal anomalies; * proven, severe congenital bacterial infection; * maternal antenatal nonsteroidal anti-inflammatory drug (nsaid) exposure \< 72 hours prior to delivery; * treatment with pharmacological replacement steroid therapy at anytime since birth; * unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 sd using volume and maximal vasopressor therapy as defined by the individual institution); * renal failure or oliguria defined as urine flow rate \< 0.5 ml/kg/hr in the 8 hours prior to randomization (anuria is acceptable if infant is in first 24 hours of life); * platelet count \< 75,000/mm 3; * clinical bleeding tendency (i.e. oozing from puncture sites); * expected survival less than 48 hours in the opinion of the attending neonatologist; * participation in other clinical intervention trials. exceptions may be made if approved by medical director or designee, rpd pharmaceutical department; * symptomatic pda as documented by 3 of the following 5 criteria * bounding pulse * hyperdynamic precordium * pulmonary edema * increased cardiac silhouette * systolic murmur or, in view of the neonatologist is deemed to have a hemodynamically significant ductus. * exposure to nsaids at any time since birth.

Keywords: patent ductus arterious
mobile cardiac telemetry and advanced multi-parameter monitoring in patients

Conditions: Cardiac Arrhythmia

Summary: to determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

the arrhythmia management system records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. these biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.

Eligibility criteria:
inclusion criteria: * subjects who require monitoring for non-lethal cardiac arrhythmias * subjects who have an indication for mobile cardiac telemetry (mct) monitoring * subjects 21 years of age or older exclusion criteria: * subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (icd), cardiac resynchronization therapy device, subcutaneous icd's, pressure monitors and loop monitors * subjects with wearable cardioverter defibrillator, holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time * subjects currently hospitalized * subjects with a skin condition preventing them from wearing the ams device * subjects who are non-ambulatory * subjects who are self-reporting to be pregnant * subjects participating in another study

Keywords: cardiac arrhythmia
maintenance treatment of iron deficiency in ibd patients

Conditions: Iron Deficiency; Inflammatory Bowel Disease

Summary: the aim of this study is to evaluate the treatment of iron deficiency in ibd patients.


Eligibility criteria:
inclusion criteria non-anaemic patients treated in the fergi-correction study (hb ≥12 g/dl female, ≥13 g/dl male), independent of ferritin value. females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication. exclusion criteria: chronic alcohol abuse (alcohol consumption \>20 g/day). presence of portal hypertension with oesophageal varices. history of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening. known hypersensitivity to ferinject®. history of acquired iron overload. myelodysplastic syndrome. pregnancy or lactation. known active infection, clinically significant overt bleeding, active malignancy. known chronic renal failure. surgery with relevant blood loss (defined as hb drop \<2 g/dl) in the 3 months prior to screening or planned surgery within the following 3 months. chronic liver disease or increase of liver enzymes (alanine aminotransferase (\[alt\], aspartate aminotransferase \[ast\]) \>3 times the upper limit of normal range. known human immunodeficiency virus (hiv)/acquired immunodeficiency syndrome (aids), hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. inability to fully comprehend and/or perform study procedures in the investigator's opinion. participation in any other interventional study (except correction study) within 1 month prior to screening. body weight \<35 kg. significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure nyha (new york heart association) grade iii or iv, or poorly controlled hypertension according to the judgment of the investigator.
preoperative gluteal muscle atrophy: a silent predictor of tha dislocation.

Conditions: Dislocation; Total Hip Arthroplasty; Muscle Degeneration

Summary: this study looks at how fat buildup in hip muscles relates to hip osteoarthritis and less favorable recovery after hip replacement surgery. while it is known that weak gluteal muscles might cause problems, it is not yet proven if this specifically leads to hip dislocation after surgery. the goal of this study is to compare fat buildup in gluteal muscles between patients who had a hip dislocation soon after surgery and those who did not.


Eligibility criteria:
inclusion criteria: * primary tha with preoperative ct-scan exclusion criteria: * malposition of acetabular implants outside the lewinneck safe zone, * neurological or cognitive disorders, * associated spinal pathologies (within the context of a hip-spine syndrome), * chronic alcoholism, * aseptic osteonecrosis, * revision surgeries, * late dislocations attributed to polyethylene wear, * replacement following post-traumatic coxarthrosis due to acetabulum injuries. * diameters of the prosthetic heads ≠ 32mm

Keywords: total hip arthroplasty muscle fatty degeneration ct gluteal muscles
the use of chinese herbal medicine and vitamin c by hospital care workers in hk to prevent covid-19

Conditions: COVID-19

Summary: this is a prospective randomized controlled trial study to explore whether the combination of chinese herbal medicine and vitamin c is effective and safe to prevent covid-19 transmission among health care workers in hong kong mobile cabin hospital governed by the hong kong hospital authority who have been caring for patients with covid-19. a total of 652 adults will be enrolled. eligible subjects who provide written informed consent will be assessed for inclusion/exclusion criteria. all participants are asymptomatic and test negative for sars-cov-2 at the study's commencement. subjects with major medical illness, renal insufficiency and hypersensitivity to chinese herbal medicine will be excluded. all participants will receive vitamin c (vc) supplementation and 28 packets of the herbal medicine free of charge and are advised to consume daily for 14 days. after written informed consent, the subjects will be included and randomly allocated to either chm+vc group or vc treatment.


Eligibility criteria:
inclusion criteria: 1. health care workers in hong kong mobile cabin hospital; 2. asymptomatic and test negative for sars-cov-2; 3. aged ≥18; 4. voluntarily signing a written informed consent form; exclusion criteria: 1. with major medical illness or renal insufficiency; 2. with hypersensitivity to chinese herbal medicine; 3. pregnancy or lactation.

Keywords: chinese herbal medicine prevention health care worker
calcium pyrophosphate deposition (cppd) disease

Conditions: Calcium Pyrophosphate Deposition Disease; Rheumatic Diseases

Summary: the goal of this clinical trial is to describe the transcriptomic and metabolomic profile of patients with chronic calcium pyrophosphate deposition (cppd) compared to those with acute cppd. the hypotheses are as follows : * it is hypothesised that there is a transcriptomic and metabolomic signature of cppd which explains why therapeutic responses to different anti-inflammatory treatments differ from one phenotype to another one * it is hypothesised that the acute and chronic clinical phenotypes of cppd have different clinical, biological and imaging characteristics, as well as a differing predisposition toward crystalline deposition and inflammatory pathway activation. the management of participants with chronic forms of the disease included in this research was modelled on the usual recommended management, including a biological workup, joint puncture, ultrasound and radiographic workup. double-energy ct scans and transcriptomic and metabolomic analyses on plasma are not routine tests.


Eligibility criteria:
inclusion criteria - acute forms of cppd: retrospective part of the study * cases included in the colchicort cohort (nct03128905), for whom this was the first acute episode of cppd inclusion criteria - chronical forms of cppd : prospective part of the study * patients affiliated to the french social security system * age ≥ 65 years * diagnosis of chronic cppd (recurrent acute or persistent arthritis), meeting acr/eular 2023,11 classification criteria after evaluation by a rheumatologist in the rheumatology department * progression of cppd rheumatism for at least 3 months and still active cppd rheumatism, defined by a visual analogue scale (vas) of disease activity ≥ 40 and/or presentation of at least 1 crisis over the last 3 months * glomerular filtration rate (gfr) in chronic kidney disease epidemiology (ckd epi collaboration) ≥ 30ml/min/1.73m2 * minimum time between the last intake of a crisis treatment and inclusion in the study, depending on their half-life, in order to not interfere with the results of the omics analyses: 2 weeks (nonsteroidal anti-inflammatory drugs per os (po) or intramuscular (im) or intravenous (iv); corticosteroids po or iv; colchicine po; anakinra subcutaneous (sc), 1 month (methotrexate po, tocilizumab sc), 3 months (canakinumab sc, tocilizumab iv) * signed written consent for study participation exclusion criteria - acute forms of cppd: * missing data concerning transcriptomic and metabolomic analyses. * opposition exclusion criteria - for chronic forms of cppd: * history of gout or presence of monosodium urate (msu) crystals on joint fluid, * cognitive decline (confusion and neurodegenerative diseases) * inability to provide informed consent and disease vas * patient under guardianship or curatorship

Keywords: calcium pyrophosphate deposition disease gene expression acute clinical phenotype chronic clinical phenotype metabolic expression
correlation between volume and pain in lower limbs lymphoedema

Conditions: Lymphedema, Lower Limb

Summary: the vascular physiotherapy department of the ucl university clinics of mont-godinne specializes in the physiotherapeutic management of lymphoedema. since 2018, an agreement has been established with inami to evaluate the effect of complex decongestion therapy on lymphoedema and its impact on patients' quality of life. one of the aims of the treatment is to reduce the volume of lymphoedema and the discomfort or even pain associated with it. more generally, pain can have a significant functional impact, especially when it becomes chronic. as pain is subjective and influenced by many factors, it is difficult to assess it. therefore it is interesting to consider psychosocial factors when assessing pain, in order to propose a global management approach. at mont-godinne, pain-related data is currently collected on a numerical scale from 0 to 10, using the lymph-icf questionnaire. moreover, in belgium, reimbursement for lymphoedema care in the form of pathology e or f is based mainly on volume measurements. the main aim of this study is to identify correlations between lymphoedema volume and pain related to lower limbs and to determine if pain could reduced when lymphoedema volume is decreased using current therapy. the second objective is collecting demographic data to assess the need for a comprehensive, specific and systematic approach to pain in the management of lymphoedema. to proceed this assessment, we have sought the opinion of the ethics committee regarding the anonymous collection of new data from patients treated via a medical history and the introduction of three validated questionnaires (brief pain inventory - short version, orebro musculoskeletal pain screening questionnaire (omspq) - short version and the dn4 scale) at d0 (start of complex decongestion therapy) and d4 (end of complex decongestion therapy). no interventions or measures other than those used in clinical practice will be added.


Eligibility criteria:
inclusion criteria: - adult patients with lymphoedema of one or both lower limbs diagnosed by three-stage lymphoscintigraphy, or clinically if it is medically impossible to perform three-stage lymphoscintigraphy for good reason. exclusion criteria: * patient under 18 years of age * pain not related to lymphoedema * inability to read and understand french to answer questionnaires * patient with infection of the lower limb(s)

Keywords: pain volume adult
evaluation of moleculight i:x as an adjunctive fluorescence imaging tool to clinical signs and symptoms for the identification of bacteria-containing wounds

Conditions: Wound

Summary: this is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. the moleculight i:x imaging device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).


Eligibility criteria:
inclusion criteria: * male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. dfu, vlu, pu, ssi) * 18 years or older exclusion criteria: * treatment with an investigational drug within 1 month before study enrolment * subjects with recent (\<30 days) biopsy of target wound * subjects with wounds that cannot be completely imaged by study device due to anatomic location * inability to consent * any contra-indication to routine wound care and/or monitoring
prevalence of fabry's disease in a population of patients with chronic pain

Conditions: Fabry's Disease; Chronic Pain

Summary: fabry disease is a rare inherited metabolic disorder that predominantly affects heart, kidneys and nervous system. fabry disease has been searched in series of patients presenting different isolated signs caused by the affection of one of these organs. acroparesthesias and chronic crises of pain of different origins are reported in the large majority of patients during the progression of the disease. moreover, this signs are frequently inaugurating the disease. the investigators have previously performed a preliminary single-center study which permitted to identify one female patient with fabry disease in a series of 147 consecutive patients with chronic pain tested. the investigators now propose to confirm the results of our preliminary study. the investigators plan to evaluate the prevalence of fabry disease in a series of 1000 patients suffering from chronic pains of undetermined aetiology and consecutively recruited.

fabry disease (fd) is a rare x-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. globotriaosylcéramide (gb3) deposits are observed in almost all tissues examined. signs of the disease appear earlier and are more severe in affected males than in females. myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. the availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. the prevalence of fd is estimated between 1/40,000 and 1/117,000. the frequency of fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. however, no data are available about the prevalence of fd in populations of patients suffering from chronic pains of unknown origin. the diagnosis of fd will be performed by standard procedures following international recommendations. these require the search for a deficiency of alphagalactosidase a activity on leucocytes in males and genetic analysis of the gla gene in females (germain et al. 2010). the patients in whom the diagnosis of fd is established during this study, will be call in for an additional visit in the investigating centre in order to confirm the diagnosis and propose suitable assessment and care.

Eligibility criteria:
inclusion criteria: * patients of both sex, * aged from 6 to 80, * with chronic pains of unknown aetiology including: acroparesthesias, and/or pain crises evolving more than 3 months, continued neuropathic evolving more than 3 months, and/or multiple pains evolving more than 3 months and/or recurrent abdominal crises of pain who come for a clinical visit in the pain centres of france. exclusion criteria: * chronic pain of known cause

Keywords: prevalence study fabry's disease chronic pain
real-time fmri neurofeedback for mild/moderate depression

Conditions: Depression Mild; Depression Moderate

Summary: the aim of the study is to compare the effects of the self-regulation (neurofeedback) of the fmri signal of the prefrontal cortex in depression to ones of more conventional non-pharmacological treatment, primarily, psychotherapy.

the study was devoted to the neural, clinical, and psychological effects of the rt-fmri neurofeedback for mild/moderate depression. recruited unmedicated patients suffering from depression were assigned either to the fmri neurofeedback (8 sessions of the left prefrontal cortex activity regulation) or to the active control group, i.e., a double dosage of cognitive-behavioral treatment or eeg neurofeedback (preliminary aborted). depression symptoms were measured at baseline, at mid-treatment, and at post-treatment points. some inventories of depression and related traits were also given. in the rt-fmri group, self-regulation learning was also estimated by means of the fmri signal change.

Eligibility criteria:
inclusion criteria: * a diagnosis of unipolar depressive disorder on icd-10 (f32, f33, f34.1) * sufficient self-regulation ability (verified with 3 sessions of alay eeg neurofeedback) exclusion criteria: * serious somatic, mental, or substance abuse problem other than depression * depression secondary to other mental or somatic conditions * psychotic features in depression or comorbid psychotic disorder * serious suicide risk * seasonal depression * receiving or planning to receive psychotropic medications * receiving cardiovascular medications * general mri exclusions * current pregnancy * iq\<70 (established with raven's progressive matrices) * previous experience with neurofeedback

Keywords: neurofeedback functional magnetic resonance imaging cognitive behavioral therapy
clinical trial of new single-use compact intermittent catheter

Conditions: Urinary Incontinence

Summary: the study is a randomised, single-blinded, controlled crossover study. the total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. visits 0 and 1 can be performed on the same day. visit 2 can be performed the day after visit 1. for visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. a sub-group of subjects (all enrolled subjects at dk sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and pvr. the total study duration for the individual subject will be up to 14 days.


Eligibility criteria:
inclusion criteria: * is female * is at least 18 years of age and has full legal capacity * has signed an informed consent form * has used clean intermittent self-catheterisation (cisc) (ch12 or ch14) for at least one month up to inclusion * is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying * has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study * has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator exclusion criteria: * is participating in any other clinical study during this investigation * has previously participated in this study * has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id) * is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris * has any known allergies towards ingredients in the investigational device * is pregnant * is breastfeeding