Kornimate/medical-research-clean huggingface dataset:
assessment of psychological state of mothers of diabetic children aged 5 and under (in terms of depression, stress, coping , anxiety, fear of hypoglycemia) and influencing factors of this psychological state

Conditions: Depression

Summary: the incidence of type one diabetes is still rising, especially in children under 5 years old. mothers often are the primary caregivers of these children. to take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. this study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.


Eligibility criteria:
inclusion criteria: * mother of diabetic child aged 5 and under, followed-up in pediatrics department of besançon university hospital. exclusion criteria: * mother of diabetic child older than 5 years old

Keywords: diabetic children mothers
oct and microperimetry in patients with active neovascular armd (corfi)

Conditions: Choroidal Neovascularization, Visual Field, Visual Acuity

Summary: armd is the main cause of visual disability after 50 years old in france. patients with active neovascular armd are treated with intravitreal injections of antivegf. reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular oct but also on angiography when necessary). the aim of this study is to evaluate the link between active neovascularization found on oct and eye fixation quality measured with microperimetry in armd patients treated with antivegf. quality of eye fixation and exudative signs presents or not present on oct will be gathered at each consultation over the two-years follow-up for each patient. the mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered. in case no link will be found, for instance bad fixation quality without exudative signs on oct or good fixation stability despite exudative signs on oct, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.


Eligibility criteria:
inclusion criteria: * patients \> 50 years old, * with neovascular armd * who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antivegf more than 6 months ago) exclusion criteria: * other maculopathies * severe glaucoma with central visual field defect * diabetic patients * corneal, lens or vitreous opacities interfering in oct analysis * attention or comprehension deficit
retrospective observational cohort study of symbol cup dm 2

Conditions: Revision Total Hip Arthroplasty; Primary Total Hip Arthroplasty

Summary: this is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (tha) with a symbol cup dmr ha or a symbol cup dm cem hemispherical dual mobility acetabular implant. the purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.

description according to picos (patient, intervention, comparator, outcomes, study design) framework: patients: - adult men and women requiring a total hip arthroplasty intervention: - tha with symbol cup dmr ha or symbol cup dm cem hemispherical dual mobility acetabular implants. comparator: none outcomes: * safety 1: implant survival over 2-year follow-up. * safety 2: all adverse events, with focus on implant dislocation, infections, revision surgery * efficacy 1: harris hip score (hhs) at baseline and 1-year follow-up. * efficacy 2: modified hhs (mhhs) consisting of pain + functional subscores at baseline, 1-year and 2-year follow-ups. * efficacy 2: devane score at baseline, 1-year and 2-year follow-ups. * efficacy 3: charnley classification at baseline, 1-year and 2-year followups. study design: * single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 2 years prior to study start. * prospective 2-year follow-up letter and phone questionnaire.

Eligibility criteria:
inclusion criteria: * all patients with total hip implant using hemispheric dual-mobility symbol cup dmr ha or symbol cup dm cem * operation performed by the primary investigator * delay between index operation and march 1 2018 has reached 2 years exclusion criteria: * patient refusal to participate in the study * minors (age \< 18 years) * patients under guardianship

Keywords: total hip arthroplasty complex revision hemispherical dual-mobility acetabular cup safety efficacy implant survival prosthetic dislocation
efficacy of prompted voiding therapy in elderly hospitalized.

Conditions: Urinary Incontinence

Summary: this study evaluates effectiveness to apply prompted voiding in urinary incontinence and dependence patients admitted at functional recovery ward in a mid-stay hospital. this behavioural therapy is recommended in best practice guidelines, and it has good results in elderly living in the community or in nursing home but yet it has not shown his benefits in hospitalized elderly patients for a long time.

the increased level of chronic diseases, greater chances of survival and older people hospitalized, place the urinary incontinence (ui) problem in a priority position both in hospital and community care. guadarrama (public madrid health service) is a medium-stay hospital. it makes treatment to recover from acute disease and ui has 80% prevalence at admitted patients. main objective:to assess the efficacy of prompted voiding (pv) therapy for reverse of ui status in elderly patients hospitalized in a functional recovery ward. (frw) methods: experimental research pre/post-intervention, with 5 repeated measures data: baseline (preintervention); at discharge, at one, three and six months after discharge (post-intervention). sample size is 212 admitted patients in the frw with ui. prompted voiding intervention will be applied by nursing team following the procedure hospital approved and it will be individualized to each patient. main outcome: urinary continence (yes/no), others outcomes: amount and frequency of urine loss, type of incontinence pads; follow-up: urinary continence at one, three, and six months after discharge. applicability: incorporating prompted voiding therapy in ui patients care, encouraging global care, relevant implications for reduce the morbidity, improvement the quality of life, decrease health costs.

Eligibility criteria:
inclusion criteria: * onset of urinary incontinence less than 1 year (information extracted from the patient's medical history, or provided by the patient or family caregiver) * sign the informed consent. exclusion criteria: * patient with indwelling urinary catheters at admission * irreversible urinary incontinence by disease itself * moderate-severe cognitive impairment (pfeiffer's questionnaire \> 4) * patients with indication of water restriction. * patients who do not collaborate in prompted voiding therapy.

Keywords: aged therapeutics hospitalization nursing care rehabilitation prompted voiding
a study to investigate effectiveness of tirzepatide following initiation of ixekizumab in participants with active psoriatic arthritis and overweight or obesity in clinical practice (together amplify-psa)

Conditions: Psoriatic Arthritis; Overweight or Obesity

Summary: the main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe psa and obesity or overweight with at least 1 weight-related comorbidity. the study will last up to 12 months.


Eligibility criteria:
inclusion criteria: * have a diagnosis of active psoriatic arthritis (psa) as defined by a rheumatologist or other healthcare professional (hcp) experienced in treating psa. * body mass index (bmi) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to \<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). * who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide. * must be able to initiate tirzepatide (day 0) within 30 days of treatment decision (baseline or screening). exclusion criteria: * have currently received ixekizumab for more than 4 months or less than 2 months. * had any exposure to tirzepatide or other glucagon-like peptide-1 (glp-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide). * are currently enrolled in any other clinical study. * have a known hypersensitivity to any component of tirzepatide. * have a personal or family history of medullary thyroid cancer. * have multiple endocrine neoplasia type 2. * have type 1 diabetes mellitus. * have a history of chronic or acute pancreatitis at any time before screening. * have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment. * have a history of ketoacidosis or hyperosmolar state/coma. * have a history of severe hypoglycemia unawareness within the 6 months before screening. * have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.
combination therapy of antibody hu3f8 with granulocyte- macrophage colony stimulating factor (gm-csf) in patients with relapsed/refractory high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: the purpose of this study is to find out if an antibody called humanized 3f8 (hu3f8) combined with granulocyte- macrophage colony stimulating factor (gm-csf) is safe for treating neuroblastoma.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by a) histopathology (confirmed by the mskcc department of pathology), or b) bm metastases or mibg-avid lesion(s) plus high urine catecholamine levels. * patients must have high-risk nb (including mycnamplified stage 2/3/4/4s of any age and mycn-nonamplified stage 4 in patients greater than 18 months of age) and: * phase i: patients must have refractory or relapsed nb, resistant to standard therapy\*. \*for nb, standard therapy includes intensive induction chemotherapy, followed by a variety of consolidation or salvage therapies, depending on response. * phase ii: patients must have primary or secondary refractory disease in bm, defined as morphologic evidence of nb in bm and/or abnormal 123i-mibg uptake in osteomedullary sites, or patients patients in ≥ 2nd cr patients are in ≥2nd cr * patients must be older than 1 year of age. * prior treatment with murine and humanized 3f8 is allowed. patients with prior m3f8, hu3f8, ch14.18 or hu14.18 treatment must have a negative haha antibody titer. human anti-mouse antibody (hama) positivity is allowed. * white blood cell count ≥1000/ul (phase i only) * absolute neutrophil count ≥500/ul (phase i only) * absolute lymphocyte count ≥500/ul (phase i only) * platelet count ≥25,000/ul (phase i only) * no chemotherapy or immunotherapy for a minimum of three weeks prior to start of hu3f8 * women of child-bearing potential must be willing to practice an effective method of birth control while on treatment * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * existing major organ dysfunction \> grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of wbcs, rbcs, and platelets). * active life-threatening infection. * pregnant women or women who are breast-feeding. * inability to comply with protocol requirements, including pk studies and genetic studies (phase i only) * history of allergy to mouse proteins. * positive human anti-hu3f8 antibody (haha) titer

Keywords: bone marrow hu3f8 gm-csf 12-230
spontaneous preterm birth marker test

Conditions: Preterm Delivery

Summary: the prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. it defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. the understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. however, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. the early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. however, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.


Eligibility criteria:
inclusion criteria: * pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation. exclusion criteria: * subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.

Keywords: spontaneous preterm birth lipids biomarkers
t-wave alternans in dialysis patients

Conditions: Sudden Cardiac Death; End Stage Renal Disease

Summary: sudden cardiac death due to arrhythmia is the leading cause of death in end-stage renal disease (esrd) patients treated with hemodialysis (hd). as it is anticipated that the number of individuals with esrd will exceed 1.2 million in the next 20 years, sudden death in this population has enormous public health impact. research has shown that arrhythmic events are temporally associated with longer periods between hd with a three-fold risk of events in the 12 hours preceding the longest inter-dialysis interval. the exact cause of these findings is unknown.

the purpose of this study is to assess the degree of cardiac electrical instability at various times in the dialysis cycle. the hypothesis is that longer time intervals between hemodialysis results in sympathetic and electrolyte-induced alterations in ventricular repolarization that can be measured non-invasively using microvolt t-wave alternans (twa). this increase in cardiac electrical instability may serve as a link between the clinically observed periods of increased risk and the occurrence of sudden cardiac death.

Eligibility criteria:
inclusion criteria: * patients with chronic esrd who have been on hd for at least 3 months * subjects 18 to 90 years of age with one or more risk factors for coronary artery disease or sudden cardiac death, including diabetes, peripheral vascular disease, known coronary artery disease, or ejection fraction \< 40% by any imaging modality. exclusion criteria: * subjects unwilling or unable to give written informed consent. * patients unable to return for regularly scheduled dialysis treatments * atrial fibrillation or flutter at screening * major surgical procedure two months prior to enrollment * high grade heart block or a permanent pacemaker in situ * patients with known allergies to adhesive tape

Keywords: t wave alternans (twa) dialysis end stage renal disease sudden cardiac death t-wave alternans cardiac electrical instability sympathetic and electrolyte-induced alterations ventricular repolarization
lutetium 177lu-edotreotide versus best standard of care in well-differentiated aggressive grade-2 and grade-3 gastroenteropancreatic neuroendocrine tumors (gep-nets) - compose

Conditions: Neuroendocrine Tumors

Summary: the purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (prrt) with 177lu-edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (sstr+), neuroendocrine tumours of gastroenteric or pancreatic origin.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * histologically confirmed diagnosis of unresectable, well-differentiated gastroenteropancreatic neuroendocrine tumors (gep-nets). measurable site of disease per recist v1.1 (response evaluation criteria in solid tumors) using contrast computed tomography (ct) / magnetic resonance imaging (mri). * somatostatin receptor-positive (sstr+) disease. exclusion criteria: * known hypersensitivity to lutetium 177lu, edotreotide, dota (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin). * prior (peptide receptor radionuclide therapy) prrt. * any major surgery within 4 weeks prior to randomization in the trial. * therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization. * other known malignancies. * serious non-malignant disease. * renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments. * pregnant or breastfeeding women. * patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

Keywords: gastroenteropancreatic non-functional and functional gastroenteropancreatic neuroendocrine tumors (gep-net)
cognitive remediation for hiv-associated neurocognitive dysfunction

Conditions: HIV-associated Neurocognitive Dysfunction

Summary: this study is a validation study to document the acceptability of the revised plasticity-based adaptive cognitive remediation (pacr) program to patients with hiv-associated neurocognitive dysfunction (hand). the primary objective of this study is to evaluate the effects of the revised pacr program on the cognitive abilities (e.g., attention, executive function), functional status and quality of life of individuals diagnosed with hand. the secondary objective of the study is to collect relevant data to support a pre-investigational device exemption (ide) submission to the fda required before the pivotal randomized, controlled trial planned for phase ii.


Eligibility criteria:
1. participant is between 25-60 years of age 2. participant is hiv positive 3. participant has diagnosis of hiv-associated neurocognitive disorder (hand), mild neurocognitive disorder (mnd) and hiv associated dementia (had) 4. participant is fluent in english 5. participant is able to use an ipad and have access to wireless internet connection 6. participant does not have a history of other conditions (other that from hand), including mental illness, cancer, or other neurological conditions (multiple sclerosis, seizure disorder) 7. participant is not enrolled in another research study 8. participant does not have current or significant past history of substance abuse 9. participant does not have severe depression or other chronic psychiatric disorder (eg. schizophrenia or bipolar disorder)
towards personalized dosing of natalizumab in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: a prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.

our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable rrms patients treated with natalizumab. adult patients with rrms with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. before subsequent natalizumab infusions, serum concentrations will be evaluated. if the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. patients will get regular brain mri scans and clinical follow-up.

Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis (rrms) according to the mcdonald criteria, revised by polman 2010 * natalizumab treatment for 12 months or longer at inclusion. * an expanded disability status scale (edss) score of 0.0-6.0 at baseline. * natalizumab level of ≥15 μg/ml * written informed consent. exclusion criteria: * any ms disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment. * unable to undergo frequent mri. * the use of other immunomodulatory medication other than natalizumab.

Keywords: natalizumab
study to assess safety and performance of neola®, a novel lung monitoring device for neonates

Conditions: RDS of Prematurity; Preterm Birth; Lung Diseases

Summary: clinical pilot study to assess safety and performance of neola®, a novel lung monitoring device for neonates

the purpose of the study is to demonstrate that the device is safe and performs as intended under anticipated use conditions. the performance of neola will be evaluated in terms of ability to continuously measure and display the relative lung volume and absolute oxygen gas concentration on neonates. the results of this clinical investigation will provide further information for the design of a subsequent full-scale clinical investigation.

Eligibility criteria:
inclusion criteria: * preterm or term born neonates with gestational age between 28 and 40 weeks * post-natal age between 1 and 14 days * weight between 1000 g and 3000 g * signed informed consent prior to any study related procedures by the legal representatives of the patient * legal representatives are 18 years or older * legal representatives can absorb and understand the content of the informed consent form exclusion criteria: * known cardiopulmonary congenital anomalies * patients with trisomies or other chromosomal abnormality * patients not expected to survive * non-intact skin or other skin conditions (such as skin lesions) that do not allow the use of skin adhesives. (e.g., bullous impetigo, staphylococcal scalded skin syndrome, localized lesions of herpes simplex virus) * thorax curvature does not allow placement of the probe sets without air between the surface of the probes and the skin.

Keywords: gasmas spectroscopy gas absorption spectroscopy