bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Personality Characteristics and Psychological Capital Factors on the Leadership of Pediatric Clinical Nurses
Condition: Pediatric Nursing; Leadership
Study type: Observational

Summary: 
      Survey Methods In this study, a questionnaire on nursing leadership and influencing factors
      was distributed online through Wenjuanxing, an online questionnaire platform. The nursing
      department and the head nurse of the department where the questionnaire was to be distributed
      were first contacted and they agreed, and the researcher joined each department's nurses'
      WeChat group, distributed the questionnaire QR code, and explained the inclusion and
      exclusion criteria and the method of completing the questionnaire, emphasizing that the
      questionnaire was filled in anonymously. Nurses in each department were given 24 hours to
      participate in the response (the response time was around 30 minutes).

      Quality Control The selected nursing leadership questionnaire, EPQ-RSC scale and
      psychological capital questionnaire all had good reliability and validity; the inclusion and
      exclusion criteria and the method of completing the questionnaire were explained by the
      researcher to the participated nurses; questionnaires that were not filled out completely or
      filled out with obvious regularity, and those with L scores greater than 60 on the
      personality trait scale were considered invalid and were excluded; the data were checked by
      two people after collection.

      Statistical methods SPSS 22.0 was used for statistical analysis. Continuous-type data were
      described using the mean ± standard deviation ( ), and single-sample t-test was used for
      those satisfying normal distribution. Count data were described using frequency and
      composition ratios. Dichotomous logistic regression was used to analyze the factors
      influencing the leadership of pediatric clinical nurses; P<0.05 was considered a
      statistically significant difference when not specifically stated.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        nurses from 4 medical institutions in Hunan Province
Exercise Intervention for Bone Tumor Patients
Condition: Bone Sarcoma
MeSH terms: Osteosarcoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proGait-study is a two-arm exercise intervention study for AYA-patients with lower
      extremity tumor endoprosthesis in the follow-up care. This clinical trial will investigate
      the effects of an 8-week personalized multi-modal exercise intervention of lower extremity
      muscles on gait quality in adolescents and young adults with cancer diagnosis beginning at
      least 12 months after endoprosthesis implantation.
    

Detailed description: 
      The main objective of the proGait-study is to investigate the effects of an 8-week
      personalized, partially supervised exercise program for lower extremity muscles on gait
      kinematics of adolescents and young adults, who are in follow-up care after cancer treatment
      and at least 12 months after endoprosthesis implantation. This randomized controlled trial
      will include n=20-30 patients. Patients will be randomly assigned to the intervention or
      control group. Patients in the intervention group will perform two supervised exercise
      sessions in week one and two. In the following weeks, they will perform in a mix of
      supervised and unsupervised exercise sessions to introduce the patients into independent
      exercise. Both groups receive recommendations for individual lower extremity exercise.
      Secondary aims of this interventional study are to evaluate functional mobility, knee range
      of motion and patient-reported outcomes including QoL and fatigue.
    

Intervention name(s): Exercise therapy; Information
Intervention type(s): Behavioral; Other
Intervention description(s): 8 weeks personalized, multi-modal exercise with focus on lower extremity; Initial consultation with recommendations for general physical activity
Brochure with exercise recommendations.
Other intervention name(s): physical activity intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: exercise; lower limb endoprosthesis; pediatric oncology; gait quality; 3D gait analysis
Study of Sequential Perfusion of Liver Grafts to Prevent Nonanastomotic Biliary Strictures After Liver Transplantation
Condition: Liver Transplantation; Transplant Recipient
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      The study was designed to investigate whether, compared with conventional sole perfusion with
      high-viscosity solution of University of Wisconsin (UW), sequential perfusion of liver grafts
      with low-viscosity and high-viscosity preservation solutions could further decrease the
      incidence of nonanastomotic biliary strictures (NAS) after liver transplantation.
    

Detailed description: 
      The exact etiology of nonanastomotic biliary strictures (NAS) with a patent hepatic artery
      after liver transplantation remains unclear so far. Microangiopathy is strongly suspected to
      be involved in the etiology, so sufficient flushing of peribiliary plexus (PBP) which
      directly nourishes the donor biliary tree may be pivotal to prevent NAS with a patent hepatic
      artery.

      Solution of University of Wisconsin (UW solution) is a standard for liver graft flushing, but
      accused of high viscosity and hyperaggregation effect on erythrocytes by ingredient
      hydroxyethyl starch as well as initial vasoconstriction by high potassium content, which
      together constitutes a hindrance to solution penetration and thorough flushing of liver
      microcirculation including PBP. Several studies have revealed the relationship of high
      viscosity of UW solution with the development of NAS.

      The investigators, therefore, have hypothesized that sequential perfusion with low-viscosity
      and high-viscosity preservation solutions might improve the patency of PBP in contrast with
      conventional sole perfusion with high-viscosity UW solution, and as a result, the incidence
      of NAS with a patent hepatic artery after liver transplantation would be significantly
      decreased.
    

Intervention name(s): sequential perfusion with ipv Ross solution and UW solution; sole perfusion with UW solution
Intervention type(s): Procedure; Procedure
Intervention description(s): Totally 6 L of ipv Ross solution were initially infused (aortic: portal=1:1), followed by 2 L of cold UW solution infusion (aortic: portal=1:1).; Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
Intervention MeSH terms: Insulin; Allopurinol; Adenosine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: orthotopic liver transplantation; preservation solution; peribiliary plexus; nonanastomotic biliary strictures; primary non-function
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Statin therapy has been shown to efficiently reduce mortality in patients with coronary
      artery disease and myocardial infarction, partially as a result of the lipid-lowering
      properties of statins. However, especially the pleiotropic effects of statins, e.g. their
      anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of
      patients with chronic heart failure that are limited in their exercise capacity due to
      alterations of the skeletal muscle and peripheral endothelial dysfunction.

      Aim of this trial is therefore to assess the effects of three months of rosuvastatin
      treatment on markers of inflammation and oxidative stress in the skeletal muscle and the
      blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients
      with severe chronic heart failure.
    

Detailed description: 
      A total of 40 patients with severe chronic heart failure are prospectively randomized to
      either 3 months of rosuvastatin or placebo treatment.

      Before and after the intervention period maximal exercise capacity is measured by
      ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound.
      Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for
      inflammatory markers, measures of oxidative stress and vasculogenesis. Blood samples are
      assessed with regard to markers of inflammation and oxidative stress as well.
    

Intervention name(s): rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic heart failure; rosuvastatin; endothelial function; skeletal muscle
Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will provide an initial assessment of the safety, tolerability and
      pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to
      healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled,
      inpatient, sequential-group study conducted under fasting conditions at a single
      investigational site. Each subject will participate in only 1 dose group and will receive
      only 1 dose of test article.
    


Intervention name(s): NSA-789; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Healthy
The Relationship Between Muscle Morphology and Muscle Strength
Condition: Skeletal Muscle Ultrasound; Isometric Muscle Strength
Study type: Observational

Summary: 
      The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is
      an unresolved problem especially during the rehabilitation process. The aim of this study is
      to correlate morphological parameters assessed with muscle ultrasound and isometric muscle
      strength to establish an objective progression parameter for rehabilitation therapies.
    


Intervention name(s): Siemens Acuson Antares ultrasound
Intervention type(s): Device
Intervention description(s): skeletal muscle ultrasound of the musculus quadriceps, on two different days, two observers
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        outpatients or inpatients of the institute of physical medicine and rehabilitaion
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Active treatment, dose-blinded extension study evaluating the safety and long term efficacy
      of sildenafil citrate in children with PAH.
    


Intervention name(s): Sildenafil citrate; Sildenafil citrate; Sildenafil citrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, subjects with body weight ≥8 - 20 kg: 20 mg 3 times a day (tid) subjects with body weight >20 - 45 kg: 40 mg 3 times a day (tid) subjects with body weight >45 kg: 80 mg 3 times a day (tid); Oral,10 mg 3 times a day (tid), only subjects with body weight >20 kg; Oral, subjects with body weight ≥8 - 20 kg: 10 mg 3 times a day (tid); subjects with body weight >20 - 45 kg: 20 mg 3 times a day (tid); subjects with body weight >45 kg: 40 mg 3 times a day (tid)
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children
Osteoarthritis Initiative (OAI): A Knee Health Study
Condition: Osteoarthritis; Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Knee osteoarthritis (OA) is the most common cause of disability in adults. The
      "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that
      will help researchers gather more information about the physical changes that occur prior to
      the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to
      examine people who have knee OA or are at high risk for knee OA; information will be used to
      better understand how to prevent and treat knee OA.
    

Detailed description: 
      Knee OA causes more health problems and medical expenses that any other form of arthritis.
      Symptoms of OA can range from stiffness and mild pain to severe joint pain and even
      disability. Previous research has shown that certain factors, such as knee pain, prior knee
      injury or knee surgery, OA of the hand, or obesity, may lead to knee OA. The OAI is a
      multicenter, observational study of knee OA that will collect information on potential
      biomarkers for OA and trends in OA onset and progression.

      The OAI will recruit and follow participants who have knee OA or are at high risk for
      developing knee OA for an eight-year period at one of four clinical centers. Blood and urine
      collection, magnetic resonance imaging (MRI), and X-rays will be completed at each of four
      annual follow-up visits. A questionnaire and physical examination at screening will assess
      for risk factors for the development and progression of knee OA. Levels of knee pain and
      physical disability will be assessed at study start and at each of the follow-up visits by
      questionnaire and examination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who have knee OA or are at high risk for developing knee OA
      
Biospecimen description: 
      Blood, urine
    
Keywords: Osteoarthritis; Knee Pain; Knee Health
Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label, non-randomised, single-dose study in 6 healthy male subjects.
      Subjects attended a screening visit within 28 days before drug administration. Subjects were
      admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a
      single oral administration of study drug in a fasted state on Day 1. Subjects were resident
      in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass
      balance cumulative recovery of >95% was achieved, or if a mass balance cumulative recovery of
      >90% was achieved and <1% was collected within 2 separate, consecutive 24 h periods. At
      specified times during the study period, blood samples were taken and urine and faeces were
      collected for PK analysis. Safety assessments were also performed.
    


Intervention name(s): [14C]-LC15-0444
Intervention type(s): Drug
Intervention description(s): A single oral administration of [14C]-LC15-0444 50 mg, containing 4.9 MBq [14C]. Subjects in the fasted state will receive the drug as a capsule, with 240 ml of water.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fingolimod Effect on Cytokine and Chemokine Levels
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study was to measure the serum levels of cytokines and chemokines
      that are known to increase during multiple sclerosis relapses.

      Cytokines are a broad and loose category of small proteins that are important in cell
      signaling.

      The second purpose of the study was to test the cytokine/chemokine changes measured in the
      3rd and 6th months on the efficacy parameters.
    


Intervention name(s): Fingolimod 0.5 mg
Intervention type(s): Drug
Intervention description(s): 66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: A 6-month, multicenter, prospective, interventional, single arm, open label study investigating the effects of fingolimod administered according to local label recommendations on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fingolimod,cytokine,chemokine,RRMS
The Possible Effects of Roflumilast on Obesity Related Disorders
Condition: Obesity; PreDiabetes
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism,
      insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.
    


Intervention name(s): Roflumilast; placebo
Intervention type(s): Drug; Drug
Intervention description(s): administration of roflumilast 500 mcg tablet once daily for 3 months.; administration of placebo tablet once daily for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacogenomics of Antiplatelet Response - II (PARes-II)
Condition: Atherothrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial is examining the effect of 4-week aspirin therapy on platelet
      transcriptome in persons at high-risk for myocardial infarction or stroke due to family
      history of early-onset coronary artery disease.
    

Detailed description: 
      Platelet aggregation can initiate thrombosis on ulcerated arterial plaques resulting in acute
      coronary syndrome (ACS). There is large variation in platelet aggregation between
      individuals. As the genetic message to the cell machinery is conveyed through its
      transcriptome, we hypothesize that much of the variability in platelet function can be
      explained by transcriptome changes including differences in gene or isoform expression,
      altered splicing events, or allele-specific expression. Moreover, aspirin modifies gene
      expression in several cells, but whether it also affects platelet transcriptome has not yet
      been studied. Our goal is to characterize the platelet transcriptome and identify genes that
      are up- or down-regulated after 4-week aspirin therapy. A major strength of our study is that
      it enrolls individuals from European Americans and African Americans and thus will have the
      ability to study similarities and differences between the two. The study will produce
      innovative comparative genomic/platelet phenotype data and will provide a potential
      pharmacogenomic and diagnostic template for the future discovery of novel antiplatelet
      regimens to prevent thrombosis-related cardiovascular disease events.
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): 81 mg daily for 4 weeks
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Platelet Transcriptome; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aspirin
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children
      and adolescents with drug-resistant epilepsy regarding seizure control, and to create a
      protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.
    

Detailed description: 
      The study is a prospective trial on the Modified Atkins Diet for children and adolescents
      with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the
      classical ketogenic diet, which is usually offered to this group of patients. Twenty patients
      between 2 and 18 years are included in the study, and the study period is 6 months. The study
      will be conducted at the National Centre for Child Epilepsy in Norway.
    

Intervention name(s): The Modified Atkins Diet
Intervention type(s): Other
Intervention description(s): The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
Other intervention name(s): Ketogenic diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Diet; the Modified Atkins Diet; Ketogenic diet
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Background Chronic inflammation in peripheral airways plays an important role in the
      pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished
      from other ICS because of its fine aerosol characteristics. As a result, there is a greater
      extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore,
      extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with
      asthma.

      Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone
      compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO)
      concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC),
      and conventional parameters.

      Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor
      diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from
      an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this
      study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters
      were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration
      of exacerbations and adverse effects. All parameters were recorded at baseline and after each
      treatment period.
    


Intervention name(s): extrafine HFA-beclomethasone; HFA-fluticasone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; non-invasive inflammometry; exhaled nitric oxide; exhaled breath condensate; paediatric; extrafine HFA-beclomethasone; HFA-fluticasone