bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Methods to Facilitate Rapid Sequence Intubation
Condition: Intubating Condition
MeSH terms: Disease
Study type: Interventional

Summary: 
      In this study, methods which are known for facilitating rapid sequence intubation or
      accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine
      pretreatment, large dose rocuronium and priming.
    

Detailed description: 
      Patients are pretreated with Mg, ketamine, or priming dose Roc. Two groups do not receive
      pretreatment, but are given Roc 0.6 mg/kg or 0.9 mg/kg.
    

Intervention name(s): Magnesium Sulfate; Ketamine; rocuronium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.; patients receive ketamine 0.5 mg/kg 2 min before Roc injection.; Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
Intervention MeSH terms: Magnesium Sulfate; Ketamine; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Rocuronium; magnesium; priming; ketamine; intubation
Association of Processing Speed Dysfunction and Brain Functional Abnormality in ECTS
Condition: Epilepsy, Rolandic
MeSH terms: Epilepsy; Epilepsy, Rolandic
Study type: Observational

Summary: 
      Epilepsy with centrotemporal spikes (ECTS) is the most common epilepsy syndrome in children.
      Language impairment has been widely investigated in patients with ECTS, but little is known
      about the cognitive dysfunction of processing speed and its neuroimaging mechanism.
    

Detailed description: 
      OBJECTIVE To investigate the processing speed dysfunction in patients with ECTS, and the
      associated brain functional abnormality using functional magnetic resonance imaging (fMRI)
      and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET).

      DESIGN, SETTING, AND PARTICIPANTS This study prospectively enrolled ECTS patients (n = 28)
      from June 2019 and June 2021. Twenty age- and gender- matched healthy children and another
      twenty children with extracranial tumors were enrolled as controls. Patients with ECTS and
      healthy controls underwent neuropsychological testing and fMRI examination. In addition, ECTS
      patients and children with extracranial tumors underwent 18F-FDG PET examination.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with childhood epilepsy with centrotemporal spikes
      
Keywords: Processing speed; Epilepsy; Positron emission tomography; Functional magnetic resonance imaging
CYP2D6 Pharmacogenetics in Risperidone-Treated Children
Condition: Psychiatric Disorders; Neurodevelopmental Disorders
MeSH terms: Mental Disorders; Problem Behavior; Neurodevelopmental Disorders
Study type: Observational

Summary: 
      Risperidone is an important medication used to treat children with psychiatric illnesses or
      neurodevelopmental disorders, such as autism. Despite excellent symptom control, the
      potential for side effects is worrisome. Treating these disorders is difficult because not
      everyone responds the same way to the same risperidone dose. One reason for this is genetic
      differences in how people break down the drug. Understanding these differences will help
      clinicians choose a dose and better predict the response so patients will be treated
      successfully with a lower risk for side effects. This study will research these genetic
      differences in children with psychiatric or neurodevelopmental disorders. Hypothesis: The
      inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and
      clinical response in patients with psychiatric or neurodevelopmental disorders is associated
      with identifiable pharmacogenetic factors, such as CYP2D6 single nucleotide polymorphisms
      (SNPs).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will include up to 41 risperidone-treated children and adolescents with
        psychiatric or neurodevelopmental (ND) disorders who participated in one of two previous
        risperidone pharmacokinetics investigations.

        To have a larger sample of poor metabolizer subjects, we plan to enroll at least 8
        additional subjects who are on stable treatment with risperidone, and perform risperidone
        pharmacokinetics analyses. Prospectively enrolled subjects (n = 8) will be CYP2D6 poor
        metabolizers and will include White / Caucasian subjects, of any socioeconomic status, and
        will be recruited from inpatients or outpatients at Cincinnati Children's Hospital
      
Biospecimen description: 
      DNA from blood, buccal swab, or saliva
    
Keywords: Psychiatric disorders; Neurodevelopmental disorders; Autism; Risperidone; Pharmacogenetics; Pharmacokinetics
Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients
      with knee or hip osteoarthritis (OA).
    

Detailed description: 
      This trial was a 12 weeks' randomized, double-blind, placebo-controlled study. The study was
      approved by the Institutional Review Board of Chung Shan Medical University hospital, and
      signed informed consent was obtained from each patient. Sixty patients of osteoarthritis of
      knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years;
      primary osteoarthritis in at least 1 knee or hip, verified; at least moderate pain during 2
      weeks before random assignment to treatment, as identified by the Western Ontario and
      McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.

      Primary outcome measures were WOMAC at week 12.

      Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality
      of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of
      osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.
    

Intervention name(s): JING CEIH SHERN YUAN EXTRACT PILL
Intervention type(s): Drug
Intervention description(s): Oral use, 3#BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
Condition: Psoriasis and Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral
      dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting
      condition
    


Intervention name(s): Apremilast 30 mg Tablets; Otezla 30 mg film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Each film-coated tablet contains 30 mg of apremilast; Each film-coated tablet contains 30 mg of apremilast
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,
      efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and
      premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
    

Detailed description: 
      This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group,
      efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and
      premenarchal female subjects 6 to 11 years-old diagnosed with SAR.

      This study will consist of the following:

      Screening, Single-blind Placebo Run-in period, Double-blind Treatment period (during this
      period, subjects will be randomized to double-blind treatment with either ciclesonide nasal
      aerosol 37 mcg or 74 mcg or placebo for 2 weeks of treatment) and Follow-up. The total
      duration of subject participation will be approximately 2 months.
    

Intervention name(s): Ciclesonide nasal aerosol 37 mcg; ciclesonide nasal aerosol 74 mcg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg; ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg; Placebo - one actuation per nostril
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis; Ciclesonide; Ciclesonide Nasal Aerosol
Birth Cohort Study for Respiratory Infections
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Observational

Summary: 
      The primary objectives are to evaluate relationship between nasopharyngeal microbial
      colonization and the occurrence of AOM or pneumonia in infants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Blood samples, clinical samples for bacterial and viral isolates
Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma
Condition: Rhinitis; Allergic, With Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study is to test whether individualized homeopathic medicines can produce
      any significant effect beyond placebo in treatment of allergic rhinitis and/or induced
      bronchial asthma
    

Detailed description: 
      A prospective, single-blind (subject), randomized, placebo-controlled, parallel group,
      interventional clinical trial is being conducted on 100 participants (subjects 50, control
      50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at
      Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal.
      This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with
      placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1
      year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for
      independent and consequent variables will be done to test for bias. Parametric or
      non-parametric tests will be employed as per distribution of data at the end of the trial.
    

Intervention name(s): Individualized homeopathic medicines; Placebo
Intervention type(s): Other; Other
Intervention description(s): 5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year; Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water
Other intervention name(s): Placebo: distilled water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Interleukin; Immunoglobulin; Homeopathy; Allergic Rhinitis; Asthma
Malnutrition and Outcome in Hospitalized Children in Europe
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Malnutrition in children has even more severe consequences on disease course and long-term
      health than malnutrition in adults. According to prior studies, malnutrition affects about
      15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and
      Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are
      inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines
      do not address assessment of and screening for childhood malnutrition. Therefore, a large
      number of affected children are not adequately diagnosed.

      One aim of this study is to assess the prevalence of malnutrition and patients at risk for
      malnutrition among at least 2700 hospitalized children mainly across Europe. In addition
      criteria to link anthropometric measurements and the prediction of outcome, i.e. length of
      hospital stay, shall be established. A further goal then is to establish agreed,
      evidence-based criteria for malnutrition in children with the purpose of leading to an
      agreed, evidence-based screening tool for paediatric malnutrition in developed countries.
      This tool shall include a set of simple questions, based on previously suggested tools.
      Thereby this study will provide a strong basis for implementing evidence-based nutritional
      interventions in paediatric patients by harmonisation of diagnostic criteria for childhood
      malnutrition in developed countries.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be performed in hospitalized children attending general paediatric wards.
        The network comprises at least 13 teams from at least 11 countries. A total of 2700
        patients will be recruited.
      
Keywords: Malnutrition; children; Hospital Stay; Screening Tools; Anthropometry
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open label, single dose, two-way crossover clinical trial to investigate the
      pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil
      administered in healthy male volunteers
    


Intervention name(s): Dutasteride 0.5 mg; Tadalafil 5 mg; YY-201
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose; single dose; single dose
Intervention MeSH terms: Tadalafil; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dutasteride; Tadalafil
A Clinical Trial to Evaluate Efficacy and Safety of Two Different Formulations of Topical Calcipotriol in Patients With Mild to Moderate Plaque Psoriasis
Condition: Mild to Moderate Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a Phase III, multicentre, randomized, observer blind, parallel group, three
      arms, controlled clinical trial to evaluate the efficacy and safety of topically applied
      Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g,
      Sandoz and placebo in patients with mild to moderate plaque psoriasis
    

Detailed description: 
      Total 278 patients with mild to moderate plaque psoriasis were randomized into the study.
      Study medications were applied twice daily for 8 weeks of study duration.

      Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.

      Primary objective of this study is to assess the therapeutic equivalence of
      Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g,
      Sandoz based on PASI score.
    

Intervention name(s): Calcipotriol/AKVANO, 50 μg/g cutaneous solution; Calcipotriol Ointment 50 micrograms/g; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Topical spray formulation containing Calcipotriol 50 μg/g. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.; Topical Ointment formulation containing Calcipotriol 50 micrograms/g. Twice daily treatment by applying on a psoriasis affected area for 8 weeks.; Topical spray formulation containing Vehicle of test formulation. Twice daily treatment by spraying on a psoriasis affected area for 8 weeks.
Intervention MeSH terms: Calcitriol; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Condition: Bankart Lesion
MeSH terms: Bankart Lesions
Study type: Interventional

Summary: 
      The aim of this study was to prospectively evaluate the efficacy of an accelerated
      rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time
      anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.
    

Detailed description: 
      Traditional rehabilitation regimes post arthroscopic stabilization commonly stipulate a
      period of immobilization of between 2 weeks and 6 weeks.This is apparently embedded in
      practice and is reportedly based on tissue healing times. However early mobilisation would
      allow good clinical results in terms of clinical outcome, return to play data and recurrence
      rates.
    

Intervention name(s): Accelerated rehabilitation; Delayed rehabilitation
Intervention type(s): Other; Other
Intervention description(s): advances in arthroscopic surgery have resulted in biomechanically stronger repairs that might allow for accelerated rehabilitation protocols and hence faster return to daily living activities and scapular control; Patients were not allowed to start rehabilitation programme first three weeks after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: bankart repair; accelerated rehabilitation; shoulder
Probiotics and Intestinal Microbiome in Preterm Infants
Condition: Microbial Colonization
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The gut microbiome plays a significant role in balancing the inflammatory system in the
      immature gut. A breakdown in this balance with altered colonization of the microbiota in very
      low birth weight (VLBW) preterm infants is associated with increased feeding intolerance,
      necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial
      populations and decrease intestinal disease in preterm infants. There is limited data linking
      clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI
      tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW
      preterm infants.

      Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the
      other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison
      of stool microbiome analysis and the incidence of feeding intolerance and time to reach full
      feeds in the two groups will be made.
    


Intervention name(s): Florababy
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotic supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Effects of Aerobic Exercise on Occupational Burnout
Condition: Burnout Syndrome
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the impact of regular aerobic exercise on
      psychopathology, cortisol secretion, BDNF, sleep, cognitive performance, and psychological
      functioning in people suffering from professional burnout. Pre- and postassessments after 12
      weeks of training will be performed.
    


Intervention name(s): aerobic exercising
Intervention type(s): Behavioral
Intervention description(s): All participants take part in an aerobic exercise training program with a total weekly energy expenditure of 17.5 kcal/kg/week over the entire 12-week intervention period. The dose of exercise is determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM, American College of Sports Medicine, 2000). All trainings take place at a local public gym under supervision of previously trained exercise coaches from the Institute of Exercise and Health Sciences of the University Basel. Participants can choose between different training devices for cardiovascular training. Energy expenditure is assessed using the values of burned calories provided by the training devices based on age, weight and training performance. Heart rate is monitored during all training sessions with chest belt heart rate monitors (Polar®) to ensure training below the anaerobic threshold with heart rates between 60 - 75 % of the maximum heart rate.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
Condition: Pain; Edema; Trismus
MeSH terms: Trismus
Study type: Interventional

Summary: 
      The main aim of the study is to investigate the pre-emptive effect of dexamethasone and
      diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the
      extraction of third molar.
    

Detailed description: 
      The surgery of third molar is usually associated with important post-surgical sequelae. The
      damage caused to tissue and bone may result in considerable pain, edema and trismus. The
      symptoms start gradually, peaking in 2 days after the extraction. The use of medications such
      as dexamethasone and diclofenac associated to codeine may support the prevention of
      post-surgical pain. This clinical trial aim compare the the pre-emptive effect of
      dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited
      mouth opening at the extraction of third molar.
    

Intervention name(s): Dexamethasone; Diclofenac Sodium associated with Codeine
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8 mg; Diclofenac Sodium 50 mg associated with Codeine 50 mg
Other intervention name(s): Dexamethasone Acetate
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Diclofenac; Codeine; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain measurement; edema; trismus