bioihbjkbjnl/mcl2 huggingface dataset:
Investigating COVID-19 Vaccine Immunity in Children in the Melbourne Infant Study of BCG for Allergy and Infection Reduction
Condition: COVID-19; Vaccine Reaction; Immunization; Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising
      a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection
      Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to
      investigate the specific and heterologous effects of COVID-19 vaccination on immunity in
      children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus
      Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after
      their final Coronavirus Disease 2019 (COVID-19) vaccination.

      Venous blood samples will be collected at two study visits, at Murdoch Children's Research
      Institute (MCRI):

        1. Day 0 - baseline (day of COVID-19 vaccination #1), and

        2. Day 84 (28 days after COVID-19 vaccination #2).
    


Intervention name(s): Tozinameran
Intervention type(s): Biological
Intervention description(s): Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Other intervention name(s): COMIRNATY; BNT162b2 [mRNA]; Pfizer COVID-19 Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Intervention model description: This trial is a non-controlled single-arm post-marketing exploratory trial where the approved COVID-19 vaccine will be used to determine whether COVID-19 vaccination alters heterologous (non-COVID-19-specific) immunity in children.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Non-specific effects; COVID-19 vaccination; paediatric vaccination; heterologous immunity; mRNA vaccine
Dexmedetomidine Versus Propofol for Sedation During Awake Endotracheal Intubation
Condition: Sedation; Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the sedation effect of dexmedetomidine and propofol
      when they are both combined with midazolam and remifentanil during awake endotracheal
      intubation.
    

Detailed description: 
      Awake intubation is one of the best strategy guaranteed by the American Society of
      Anesthesiologists (ASA) guidelines for the management of patients with anticipated difficult
      airways. Hemodynamic stability, optimal intubating conditions, patients' comfort, amnesia and
      preservation of patents' spontaneous respiration are critical for awake intubation. Sedation
      is one of the key elements for this technique. Intravenous midazolam, propofol,
      dexmedetomidine and remifentanil are commonly used as sedatives during awake intubation.
      These agents are not preferred to be used alone but in combination with each other for the
      purpose of minimizing their respective side effects. The aim of this randomized controlled
      trial is to compare the safety and effectiveness of dexmedetomidine versus propofol for
      sedation during awake endotracheal intubation when they are both combined with midazolam and
      remifentanil.
    

Intervention name(s): dexmedetomidine combined with midazolam and remifentanil.; propofol combined with midazolam and remifentanil.
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.5 mcg/kg dexmedetomidine over 5 min via separate syringe pumps.; Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.33 mg/kg propoful over 5 min via separate syringe pumps.
Other intervention name(s): dexmedetomidine-midazolam-remifentanil; propofol-midazolam-remifentanil
Intervention MeSH terms: Midazolam; Dexmedetomidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Awake tracheal Intubation
Neurodynamic Mobilization and Foam Rolling
Condition: Exercise-induced Muscle Damage; Movement Disorders; Nerve Pain
MeSH terms: Movement Disorders; Neuralgia
Study type: Interventional

Summary: 
      The purpose of this study was to assess the acute effects of a single NM treatment session on
      DOMS and to compare them with those of one foam roller (FR) session. Following the damaging
      plyometric exercise bout, the participants were randomly assigned in a counter-balanced
      fashion to either a FR or NM treatment group; treatments were administered 48-h
      post-exercise. The dependent variables were recorded before the exercise, 48-h post-exercise
      before treatment, and immediately post-treatment.
    

Detailed description: 
      Currently, the foam-rolling massage is often used by athletes from many sports. However,
      there are a few studies on the effects of foam-rolling massage and they have conflicting
      results regarding the improvements in ROM and muscular performance. In contrast, neurodynamic
      mobilization (NM) is a manual therapy method used to assess and treat neuromuscular
      disorders. It includes gliding techniques and tensile techniques. Gliding techniques or
      "sliders" are intended to produce a sliding movement between neural structures and adjacent
      nonneural tissues. NM has been shown to reduce pain and soreness and improve ROM. However, no
      studies have investigated its effects after exercise-induced muscle soreness or DOMS.
    

Intervention name(s): Manual therapy
Intervention type(s): Other
Intervention description(s): The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a single NM treatment session on Delayed Onset Muscle pain (DOMS) and to compare them with those of one foam roller (FR) session
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain
An Experimental Study of Psychological Effect of School Based-Yoga on Low-Income School Children
Condition: Psychological Disturbance; Anxiety Disorder of Childhood
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Poverty is a common experience for many children and families in developing countries. Living
      in a poor or low-income household has been linked to poor health and increased risk for
      mental health problems than the general population. Previous studies link psychological
      well-being with yoga in adolescents and children. This study investigated the effects of a
      structured yoga program on psychological well-being in low-income school children.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): 30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients
Condition: Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary
      heart disease patients at high psychosocial risk.
    

Detailed description: 
      BACKGROUND:

      As medical treatments for coronary heart disease have become more sophisticated, they have
      also become more costly. Evidence concerning the effects of medical and rehabilitative
      therapies on post-myocardial infarction patients' quality of life, including return to work
      and to normal levels of functioning, has been mixed. At the same time. recent data suggest
      that psychosocial factors, such as social isolation and depression, are important predictors
      of morbidity and mortality in coronary heart disease patients. These studies suggest that
      interventions which provide psychological support to myocardial infarction patients may
      enhance both the psychosocial and physical recovery of these patients. To the extent that
      supportive interventions can be shown to impact favorably on survival and health-related
      quality of life in myocardial infarction patients, the human and financial costs associated
      with coronary heart disease can be reduced. The initiative originated in the Working Group on
      Psychosocial Interventions which met in June 1992.

      The initiative was given concept clearance by the October 1993 National Heart, Lung, and
      Blood Advisory Council. The Request for Proposals was released in September 1994.

      DESIGN NARRATIVE:

      The study design compared a psychosocial intervention group, in which patients were provided
      with social and psychological treatment designed to decrease social isolation and depression,
      with a standard medical care group. The combined endpoint was death and reinfarction,
      measured for up to 4.5 years following hospital discharge. Secondary endpoints included
      assessment of health quality of life (HQL).

      The protocol was approved in May 1996. Recruitment began in October 1996 and ended on October
      31, 1999 with 2,481 patients enrolled.
    

Intervention name(s): social support
Intervention type(s): Behavioral
Primary purpose: Prevention
Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study
Condition: Aortic Valve Calcification
MeSH terms: Aortic Valve Stenosis; Calcinosis
Study type: Observational

Summary: 
      This study seeks to compare aortic dimension changes during cardiac cycle in patients with
      and without aortic valve calcification and to evaluate its correlation with aortic valve
      calcium score in former group.
    

Detailed description: 
      The study population comprised 104 patients referred to three cardiac imaging centers for
      coronary multislice computed tomography, including 52 patients with aortic valve
      calcification as the study group and 52 subjects without evidence of calcification in their
      aortic valve, who served as a control group. Data were reconstructed at each 10% of
      RR-interval during the cardiac cycle and reconstructed images at 30-35% and 70-75% of R-R
      intervals were obtained, representing systole and diastole, respectively. For diastolic
      phase, in most cases images at 70% were acquired. Thereafter, acquired images were
      transferred to a single remote workstation for post-processing and subsequent off-line
      analysis.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients referring for coronary CT angiography
      
Keywords: Aortic annulus; Aortic calcification; Multislice computed tomography; Cardiac cycle
The Human Epilepsy Project
Condition: Focal Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Observational [Patient Registry]

Summary: 
      HEP is a five-year, prospective, observational study whose primary goal is to identify
      clinical characteristics and biomarkers predictive of disease outcome, progression, and
      treatment response in participants with newly treated focal epilepsy.
    

Detailed description: 
      Epilepsy is a serious disease. It affects approximately 2.4 million Americans, with a
      lifetime risk estimated at 3%. More than 181,000 Americans develop epilepsy every year, and a
      substantial proportion has seizures that cannot be controlled by available medications. For
      the vast majority of patients with epilepsy, we do not understand the biological basis of
      their disease; we do not know whether a given anti-epileptic drug (AED) will be effective;
      and we cannot predict the severity of the seizure disorder, the potential emergence of
      co-morbidities, or the likelihood of remission.

      The Human Epilepsy Project seeks to answer these unknowns by collecting high-resolution
      clinical information and treatment response, MRIs, EEGs, and blood and urine samples for
      biomarkers. A major outcome of the project is to create an open data repository of clinical
      information and biologic samples for future studies.

      HEP may have a transformative impact on epilepsy diagnosis and treatment by identifying
      critical clinical features and biomarkers at the onset of epilepsy that can be used to
      predict outcome and guide therapy. We hope to identify subsets of patients at high risk for
      pharmacoresistance who may benefit from more aggressive initial therapy and earlier
      consideration for surgical treatment. The existence of biomarkers that predict the likelihood
      of disease remission would dramatically affect treatment decisions and counseling for
      millions of patients.

      In addition to its impact on current clinical care, the data and specimens collected in HEP,
      including sequential neuroimaging, electrophysiology and metabolite profiles, and banked DNA
      for the purpose of future genomics studies, have the potential to provide new insights into
      the biological basis of focal epilepsy, which will advance our efforts to discover effective
      treatments and cures for this disorder.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Epilepsy/Neurology clinical centers
      
Biospecimen description: 
      whole blood, plasma, urine
    
Keywords: epilepsy; focal epilepsy
Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnoea; Excessive Daytime Sleepiness
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5
      parallel groups (dose-range).
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a relatively common condition and is estimated to affect 2
      to 4% of middle-aged adults

      The study medication BF2.649 tested here is a novel, highly potent, selective, orally active
      inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic
      transmission in the brain and increases wakefulness EDS is characterized by daytime
      somnolence and sudden sleep episodes. This problem has several consequences, e.g., an
      impairment of quality of life, an interference with activities of daily living and other
      handicaps in the management of social and family affairs.

      The primary endpoint of this study will be measured by the change in the well-validated
      Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire.
      The outcome is to get an impression about the level of the daytime sleepiness in several
      real-life situations.

      In this study, each patient will be treated during 2 weeks, and randomly assigned to one the
      5 arms (BF2.649 at one of the 4 possible dosages or placebo).

      The patient will then attend a end-of-treatment visit, in order to assess the particularly
      the ESS score.
    

Intervention name(s): BF2.649; BF2.649; BF2.649; BF2.649; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule per week during 2 weeks; 1 capsule per week during 2 weeks; 1 capsule per week during 2 weeks; 1 capsule per week during 2 weeks; 1 capsule per week during 2 weeks
Other intervention name(s): Pitolisant; Pitolisant; Pitolisant; Pitolisant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep disorder; Obstructive Sleep Apnoea; Excessive Daytime Sleepiness
Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC
Condition: Breast Cancer Metastatic
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the response rate of capecitabine and irinotecan combination therapy in patients
      with metastatic breast cancer
    

Detailed description: 
      This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in
      patients with metastatic breast cancer previously treated with anthracyclines and taxanes. Up
      to 44 qualified patients will be enrolled according to the exact single stage design.

      Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8)
      followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2
      twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2
      weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine
      doses are rounded to the nearest dose that could be administered with a combination of 500-mg
      and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and taken
      orally with water within 30 minutes after ingestion of food (breakfast or dinner).
    

Intervention name(s): Irinotecan plus capecitabine
Intervention type(s): Drug
Intervention description(s): Irinotecan 80 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period.
Capecitabine is administered orally at a dose of 1,000 mg/m2 twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2 weeks of treatment followed by a 1-week rest period).
Other intervention name(s): Crabcan; Xeloda
Intervention MeSH terms: Capecitabine; Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Patients With COPD
Condition: COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of the investigational drug is the most
      safe and effective for the treatment of COPD compared to the control drug
    


Intervention name(s): Formoterol Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Formoterol Fumarate; Formoterol
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of subcutaneously
      administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with
      moderate to severe non-proliferative diabetic retinopathy (NPDR).
    


Intervention name(s): AKB-9778; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous AKB-9778 15mg; Subcutaneous Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Condition: Pain
Study type: Interventional

Summary: 
      This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is
      effective at decreasing pain during intrauterine device insertion in nulliparous women.
    

Detailed description: 
      Intrauterine devices (IUDs) are among the most effective forms of reversible contraception.
      Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake
      of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of
      pain during insertion, as studies do demonstrate that nulliparous women experience more pain
      than parous women during IUD insertion. Studies evaluating various methods for pain control
      during IUD insertion have shown conflicting results, leaving the question unanswered as to
      what is the best method to decrease pain during IUD insertion.

      This study aims to evaluate a novel approach to pain control by having women self-insert
      lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome
      some of the barriers from other studies where there may not have been ample time for the
      lidocaine to take effect, while at the same time eliminating the need for women to have
      multiple speculum exams. Although this is a novel approach to administering an anesthetic, we
      believe women will be interested in any intervention that may potentially alleviate pain
      during IUD insertion.

      If this study does demonstrate that pain is decreased with self-inserted lidocaine compared
      to placebo gel, this will potentially eliminate one large barrier to nulliparous women
      receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is
      just one of the many steps necessary towards decreasing unintended pregnancy.
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravaginal insertion of 4mL 2% lidocaine gel; KY Jelly
Other intervention name(s): Lidocaine Jelly; Lidocaine Hydrochloride; K-Y Jelly; water based lubricant
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Intrauterine Device; Pain; Lidocaine