Kornimate/medical-research-clean huggingface dataset:
prevention of arrhythmia device infection trial (padit)

Conditions: Arrhythmia

Summary: the goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce cied infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. all antibiotics used are approved for use and readily available.

this is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. patients will not be randomized. centres will be randomized to one therapy and then cross over to the next after 6 months. at one year they will randomize again and then cross over for the final time at 18 months. during each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure. ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). a third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. received one of the following procedures: 1. a second or subsequent procedure on the arrhythmia device pocket: icd, pacemaker, crt-p, crt-d generator and/or lead replacement 2. pocket or lead revision 3. system upgrade (insertion or attempted insertion of leads) 4. new cardiac resynchronization therapy device implant (pacemaker or icd) 3. patient is not known to have device infection at the time of the surgery

Keywords: arrhythmia device procedure antibiotics infection cluster
efficacy and safety of intravenous + oral vs. oral amiodarone in preventing recurrence after catheter ablation in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: this study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (af) recurrence after catheter ablation in patients with persistent atrial fibrillation. using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \[sr\], long-term recurrence \[lr\], and patient quality of life), and safety (adverse drug reactions). subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. this study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.


Eligibility criteria:
inclusion criteria: * participants aged ≥18 years; * first-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days); * symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class i or iii antiarrhythmic drug; * participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent. exclusion criteria: * those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy; * life expectancy \< 12 months; * severe liver or kidney dysfunction; * allergy to amiodarone components; * pregnant or breastfeeding women; * contraindications to amiodarone (e.g., blood pressure \< 90/60 mmhg; bradycardia \< 55 bpm, second- or third-degree av block, or sick sinus syndrome); * thyroid disorders, such as hyperthyroidism or hypothyroidism.
effectiveness of family-based intervention for youn persons with eating disorders

Conditions: Eating Disorders

Summary: this research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ed), treated in a generic specialist child and adolescent mental health service. the first choice of treatment is outpatient family-based treatment (fbt), which has documented effect for anorexia nervosa and bulimia nervosa. however, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. further, treatment effectiveness for children and adolescents in a danish naturalistic setting has never been examined.

the overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care. research questions: 1. which patient and family characteristics predict faster recovery from ed in childhood and adolescence? 2. which patient and family characteristics predict intensification of treatment in the forms of day hospital or full hospitalization? 3. at which time point can recovery be predicted based on information from initial assessment and/or assessment during the course of treatment? 4. which patient and family characteristics (e.g. patterns of comorbid symptoms) are common in those not responding well to treatment within each diagnostic category? 5. how many young patients migrate between ed diagnoses, and what characterizes these patients? 6. studies on treatment effectiveness for ednos in children and adolescents are still lacking. hence, an important research question of this study is whether family based treatment for ednos is effective and is perceived as helpful by patients and families? in addition, the project will seek to answer the following: 7. is treatment effectiveness in the capital region of denmark (buc) comparable to published results from other countries in the same age group?

Eligibility criteria:
inclusion criteria: * begin treatment for eating disorder exclusion criteria: * lack of informed consent

Keywords: eating disorders, adolescents
two investigational drugs in the prevention of airway constriction brought on by exercise in participants with asthma (0476-911)

Conditions: Exercise Induced Asthma

Summary: the purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Eligibility criteria:
inclusion criteria: * 6-14 year old children with a history of asthma for at least 12 months * must demonstrate airway constriction brought on by exercise exclusion criteria: * is taking any medications that are not allowed in the study
phase iii trial to assess efficacy and safety of cetuximab for the treatment of chinese participants with head and neck cancer

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: this trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (scchn) as the first-line treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of scchn * recurrent and/or metastatic scchn, not suitable for local-regional treatment * presence of at least 1 measurable lesion according to recist version 1.1 * signed written informed consent before any trial-related activities are carried out * eastern cooperative oncology group (ecog) performance status of 0 or 1 * other protocol-defined inclusion criteria could apply exclusion criteria: * prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization * surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry * previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor * nasopharyngeal carcinoma * known central nervous system metastasis and/or leptomeningeal disease * medical or psychological condition that would not permit the participant to complete the trial or sign informed consent * legal incapacity or limited legal capacity * other protocol-defined exclusion criteria could apply
comparing the impact of mindful interoceptive mapping and mindful breathing on pain and opioid use

Conditions: Pain, Chronic; Opioid Use

Summary: this is a single site, two-arm, parallel group randomized clinical trial comparing the effect of two mindfulness-based interventions (mindful interoceptive mapping vs. mindfulness of the breath) on opioid-treated chronic pain patients' pleasant/unpleasant sensation reports and opioid use.


Eligibility criteria:
inclusion criteria: * (1) men/women ≥18 years of age, * (2) current chronic low back pain condition determined by physician assessment (e.g., icd-10 codes m54.5, m54.4, m54.3), * (3) reporting pain ≥3 on 0-10 scale with opioid medication, and * (4) long-term opioid pharmacotherapy (\>3 months of use). exclusion criteria: * (1) formal mindfulness training (e.g., mbsr/mbrp), * (2) current cancer diagnosis, * (3) psychosis, suicidality, and moderate/severe substance use disorder in the past year as assessed with the mini, and * (4) unstable illness, as judged by a physician, that may interfere with treatment.
correlation of visual and motor deficits in stroke patients

Conditions: Stroke

Summary: this is a prospective study of patients with stroke with accompanying motor and visual deficits. there will be patients' evaluations at 2 time points at the acute and subacute period after the stroke. statistical correlation of the improvement of their deficits will be conducted


Eligibility criteria:
inclusion criteria: acute phase stroke patients with motor and visual deficits exclusion criteria: previous stroke, neurologic disease or visual deficit

Keywords: course of motor and visual rehabilitation improvement of deficits stroke patients
comparison of misoprostol and pge2 gel for induction of labour in women with premature rupture of membranes at term

Conditions: Premature Rupture of Membranes at Term

Summary: induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal pge2 gel induction.


Eligibility criteria:
inclusion criteria: * premature rupture of membranes at 37 or more weeks * single live fetus in cephalic presentation exclusion criteria: * women in labour * women with contraindication of induction of labour * women with previous caesarean section or uterine surgery

Keywords: premature rupture of membranes induction of labour with misoprostol induction of labour with pge2 gel
translation and implementation of the dutch vvas score in clinical practice

Conditions: Vertigo

Summary: the aim of this study is to translate and introduce a cross-cultural adaptation of the visual vertigo analogue scale (vvas). e. dannenbaum et al developed the vvas in order to diagnose visual vertigo (vv). vv is dizziness caused by visual stimuli such as scrolling through a computer screen or walking through crowds of people or supermarket aisles.

the visual vertigo analogue scale (vvas) was developed by e. dannenbaum et al in 2011 to diagnose visual vertigo. it is a nine-item analogue scale in which the subjects can rate their symptoms' intensity. the symptoms can be categorized as none (0), mild (0.1-40), moderate (40.01-70), or severe (70.01-100). the vvas is already available in english and french but a dutch version does not yet exist. in this study, we would like to translate and introduce a cross-cultural adaptation of the vvas into dutch for use with vestibular patients in belgium.

Eligibility criteria:
inclusion criteria: * all patient with chronic vertigo (\>3 years) will included * interpretation of the vvas is be possible * 18-75 year exclusion criteria: * unable to read dutch * single episode of vertigo * \> 75 year * minors * when no interpretation of the vvas is possible (e.g. too young, dementia)

Keywords: vertigo epidemiology visually induced dizziness chronic vertigo
transmural healing definition in crohn's disease (trench 1)

Conditions: Crohn Disease

Summary: multicenter prospective cross-sectional study of cd patients, its aim is the construction of an objective and reproducible system for evaluation of transmural healing in crohn's disease (cd). primary objective : objective definition of depth or grade of transmural healing in relation to radiologic signs observed during magnetic resonance enterography (mre) in cd

number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist). recruitment period : 2 years primary endpoint : objective definition of depth or grade of transmural healing in relation to radiologic signs observed during magnetic resonance enterography (mre) in cd secondary endpoints : * to analyze intra- and inter-observer variability of radiological findings. * to analyze intra- and inter-observer variability of th definitions in cd.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * patient diagnosed with cd for more than 6 months with histological confirmation available in his medical record. * indication for mre based on routine clinical practice validated by the treating physician * any cd treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab...), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate...). * the subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study. * a subject can be enrolled into the study only if the grade of th (assessed by the lrp) corresponding to the subject is not already fulfilled. exclusion criteria: * pregnancy during the study * people unable to give consent (because of their physical or mental state) * absence of written consent * ulcerative colitis or unclassified ibd * specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy. * less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve) * severe obstructive symptoms * symptomatic intra-abdominal abscess * contraindication for mri * isolated perianal disease without luminal location * mre images of poor quality, based on previously defined criteria

Keywords: ibd cd
time-dependent change in the retention force of the implant overdenture

Conditions: Edentulous Jaw

Summary: this descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at marmara university faculty of dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.


Eligibility criteria:
inclusion criteria: * 50-65 years old, * volunteer to participate in the study, * upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture exclusion criteria: * pregnant or lactating women * those who do not want to sign the consent form, * patients with a history of malignancy, radiotherapy, or chemotherapy * patients whose maxilla was rehabilitated with implant overdenture * more than 2 implants for lower jaw implant overdenture

Keywords: dental prosthesis, implant-supported
combination of intravitreal ranibizumab with or without macular laser photocoagulation for me secondary to brvo

Conditions: Branch Retinal Vein Occlusion; Ranibizumab; Laser Photocoagulation

Summary: to investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (me) secondary to branch retinal vein occlusion (brvo) in long term.

to investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in chinese patients with visual impairment in me due to brvo. the result of the trial will be used to support new therapy in the brvo in china.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. male or female chinese patients ≥ 18 years of age with brvo 3. visual impairment due to me secondary to brvo in at least one eye with bcva score between 73 and 24 and at least 24 letters in the other eye exclusion criteria: 1. pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception 2. stroke or myocardial infarction less than 3 months prior to screening visit 3. renal failure or creatinine levels \> 2.0 mg/dl 4. uncontrolled hypertension 5. active ocular infection or intraocular inflammation in any eye 6. neovascularization of the iris or neovascular glaucoma in any eye 7. history of uveitis or vitreomacular traction in any eye 8. treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye 9. glaucoma or intraocular pressure (iop) ≥ 24 mmhg in study eye 10. active proliferative diabetic retinopathy in study eye 11. use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (vegf) antagonism drugs within 6 months prior to baseline visit 12. prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye 13. history of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening 14. history of vitrectomy in study eye 15. other protocol defined inclusion /exclusion criteria may apply

Keywords: laser photocoagulation ranibizumab branch retinal vein occlusion vascular endothecial growth factor
effect of prone position on oxygen, blood gas, and respiratory parameters in intensive care patients with covid-19-induced ards

Conditions: COVID - 19; ARDS (Acute Respiratory Distress Syndrome)

Summary: this randomized controlled trial aimed to investigate the effect of the prone position on oxygen saturation, arterial blood gas parameters, and respiratory rate in intensive care patients diagnosed with covid-19-induced acute respiratory distress syndrome (ards). a total of 90 patients (45 in the prone positioning group and 45 in the control group) were included. the intervention group received a 30-minute prone positioning procedure, while the control group received standard icu care. data were collected using a demographic information form and clinical monitoring of respiratory and blood gas parameters across six time points over two days.

this randomized controlled trial investigated the short-term physiological effects of prone positioning in intubated intensive care patients diagnosed with covid-19-induced acute respiratory distress syndrome (ards). a total of 90 patients were included, with 45 in the experimental group and 45 in the control group. patients in the experimental group were placed in the prone position for 30 minutes on two consecutive days, while the control group received standard icu care without prone positioning. oxygen saturation (spo₂, sao₂), arterial blood gas parameters (po₂, pco₂, ph, lactate, sodium), and respiratory rate were measured at six time points to evaluate the effectiveness of the intervention. the study was conducted in the general and intermediate intensive care units of a public hospital in eastern turkey, which was designated as a covid-19 treatment center during the pandemic. the study's primary objective was to determine whether prone positioning could improve oxygenation and respiratory efficiency in critically ill patients with covid-19-related ards. secondary outcomes included changes in blood gas and metabolic parameters. the results suggested that prone positioning had a beneficial impact on oxygen saturation and respiratory rate without causing adverse changes in blood gas chemistry. the study was ethically approved and conducted in accordance with the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * age 40 years or older * admission to an intensive care unit (icu) * confirmed diagnosis of covid-19 * developed acute respiratory distress syndrome (ards) due to covid-19 * intubated at the time of enrollment * provided informed verbal and written consent (or consent provided by legal representative) exclusion criteria: * significant hearing or vision impairments affecting communication * cognitive impairment or inability to understand instructions * patient died during the course of the study * early discharge from intensive care before completion of all measurements * non-intubated patients whose level of consciousness could not be monitored

Keywords: ards covid-19 nursing blood gas values prone position
diagnosis predictive modle for dense density breast tissue based on radiomics

Conditions: Breast Diseases; Artificial Intelligence; Dense Breast Density; Predictive Cancer Model

Summary: it is a prospective, observational cohort study of patients with dense breast tissue. the study was based on the radiomics and other clinicopathological information of patients to establish the diagnostic system for breast disease by using artificial intelligence.


Eligibility criteria:
inclusion criteria: * female patients with dense breast density tissue * digital breast tomosynthesis was performed * breast ultrasound examination was performed * pathologic examination of breast lesions was performed exclusion criteria: * incomplete clinicopathologic data * female patients with fatty glands of the breast