bioihbjkbjnl/mcl2 huggingface dataset:
Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty
Condition: Nerve Block; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca
      compartement block [FICB] group or quadratus lumborum block [QLB] group). In the FICB group,
      ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine)
      is performed on the ipsilateral surgical side at the end of surgery. In the QLB group,
      ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is
      done on the ipsilateral surgical side at the end of surgery. A standardized multimodal
      analgesic regimen is used for postoperative pain control. The total use of opioids including
      patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours
      after surgery. The amount of opioids used is compared by conversion to oral morphine
      equivalent dose. Pain score at rest and movement during postoperative 24 hours, time to first
      request for analgesics, the incidence of side effects, patient satisfaction for pain control
      at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge
      readiness, and hospital length of stay are compared.
    


Intervention name(s): fascia iliaca compartement block; quadratus lumborum block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.; Ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
Other intervention name(s): FICB; QLB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study on Improved Dynamic Myocardial Perfusion With Less Effective Radiation Dose in CT (SIMPLE CT)
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Among the current myocardial CT perfusion techniques, dynamic CT perfusion technique is most
      advantageous in obtaining information on myocardial blood flow and volume. However, dynamic
      CT perfusion technique involves higher radiation dose than static CT techniques. Patients
      have to take a breath hold during 30 seconds with current dynamic CT perfusion protocol. If
      patients cannot hold their breath, anterior or inferior myocardium might be excluded due to
      limited scan coverage of a 128-slice dual-source CT scanner.

      Reduction of scanning duration of dynamic CT perfusion may not only reduce radiation
      exposure, but also make patients more comfortable. Therefore, the investigators intended to
      propose a modified scan protocol with shorter scan duration and compare diagnostic accuracy
      of a modified scan protocol with the current scan protocol.
    

Detailed description: 
      The aim of this study is to compare the diagnostic performance of adenosine-stress dynamic
      myocardial CT perfusion using a reduced dynamic scan duration with perfusion protocol of
      30-second scan duration for the detection of myocardial perfusion defect and significant
      coronary artery stenosis.

      This trial is a single center, prospective, randomized trial designed to compare diagnostic
      performances and radiation doses between two protocols with 30-second or 21-second dynamic
      scan durations. A total of 120 symptomatic patients will be randomized to dynamic CT
      perfusion protocols with 30-second or 21-second scan duration. They will also undergo 1.5-T
      MRI and invasive coronary angiography as reference standards for the assessment of myocardial
      perfusion and coronary artery stenosis. The primary end point of the study is to compare
      diagnostic performances between two CT protocols of dynamic CT perfusion. The secondary
      endpoint of this study is to compare radiation doses and image qualities of two scan
      protocols.
    

Intervention name(s): Myocardial CT perfusion
Intervention type(s): Procedure
Intervention description(s): Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Myocardial ischemia; Coronary artery disease; Myocardial CT perfusion; Modified scan protocol; Diagnostic performance; Radiation dose
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3361237 and any side
      effects that might be associated with it when given to participants with systemic lupus
      erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The
      study will last up to 26 weeks and may include up to 17 visits to the study center.
    


Intervention name(s): LY3361237; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      Thirteen hospitals in China will participate in the study, which aims to provide data on
      transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and
      late-preterm neonates, and develop an hour-specific TcB nomogram.

      The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal
      hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up
      for hyperbilirubinemia in newborns.
    

Detailed description: 
      Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left
      untreated, it can have devastating consequences including cerebral palsy and hearing loss. It
      is therefore critical to be able to identify the newborns at risk for severe
      hyperbilirubinemia.
    

Intervention name(s): Transcutaneous bilirubinometry
Intervention type(s): Device
Intervention description(s): Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Term or late-preterm newborn infants from thirteen hospital in China were recruited.
      
Keywords: Hyperbilirubinemia; Neonatal; Transcutaneous Bilirubin
Comparison of Two Methods of Bronchial Methacholine Provocation
Condition: Bronchial Hyperreactivity; Bronchial Asthma
MeSH terms: Asthma; Bronchial Hyperreactivity
Study type: Interventional

Summary: 
      This study is meant to compare two routine diagnostic approaches in patients with bronchial
      asthma. Patients are challenged with methacholine in order to measure their bronchial
      response. We compare the evaluation of the effects of incremental concentrations versus
      incremental dosages.
    

Detailed description: 
      Bronchial methacholine challenge is well established in asthma diagnostic and research
      purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step
      dilution schedule. The Viasys APS system enables a feasible and less time consuming
      provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR)
      the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine
      should be compared.
    

Intervention name(s): Bronchial methacholine provocation; Bronchial methacholine provocation
Intervention type(s): Procedure; Procedure
Intervention description(s): A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine); A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
Other intervention name(s): DeVilbiss nebulizer; Viasys APS nebulizer
Intervention MeSH terms: Methacholine Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PC20 FEV1; PD20FEV1; bronchial hyperreactivity; bronchial asthma
New Technologies in the Management of Lumbopelvic Pain
Condition: Low Back Pain; Rehabilitation; Exercise
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Lumbopelvic pain represents one of the leading causes of disability and pain in the world
      population. It is estimated that 84% of the world's population will suffer from lumbar pelvic
      pain in their lifetime. This high prevalence causes it to be classified as a public health
      problem.

      Traditional primary care measures have failed to reduce the prevalence, recurrences and costs
      of this pathology. In the search for treatments focused on reducing public spending, the
      concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge
      on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and
      respiratory diseases. It has been suggested that the use of this instrument could help
      improve the patient's quality of life at the biopsychosocial level.
    


Intervention name(s): therapeutic exercise
Intervention type(s): Other
Intervention description(s): As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin.
The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group.
On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application.
On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks.
At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
Condition: Development
Study type: Observational

Summary: 
      The goal of the study is to determine whether there are age-, diet- and genetically-related
      differences in the perception of sweeteners, both nutritive and non-nutritive.
    

Detailed description: 
      This is an observational 3-day study of children between the ages of 7 and 14 and their
      mothers. A variety of psychophysical methods determined liking for each of the sweeteners and
      saliva samples were obtained for genotyping of taste receptor genes. Anthropometric and
      dietary intake measures were also collected.
    

Intervention name(s): sweeteners
Intervention type(s): Other
Intervention description(s): Participants tasted a variety of nutritive and nonnutritive sweeteners
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy children and adults living in the Philadelphia area
      
Biospecimen description: 
      Salivary samples obtained for genotyping of taste receptor genes
    
Keywords: Sweet Taste; Psychophysics; Genetics; Diet; Age; Nonnutritive Sweetener
Conscious Sedation for Outpatient Colonoscopy
Condition: Conscious Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are
      distressful for most patients. This raises the attention for using different sedation
      regimens aiming at maintaining optimal sedation level with maintained airway and stable
      haemodynamics all through the procedure. The present study was scheduled to investigate the
      sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
    

Detailed description: 
      Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups.
      In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v.
      dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h,
      titrated according to the sedation score, till the end of the procedure. In the PR group,
      propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance
      infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute
      then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion
      rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased.
      If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5
      μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of
      0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics,
      end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient
      and colonoscopist satisfaction and side effects will be recorded.
    

Intervention name(s): Dexmedetomidine; Propofol; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dexmedetomidine sedation; propofol sedation; Remifentanil sedation
Other intervention name(s): dexmedetomidine infusion; propofol infusion; Remifentanil infusion
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
NEWTON: Aflibercept Injection for Previously Treated Macular Edema Associated With Central Retinal Vein Occlusions
Condition: Macular Edema With Central Retinal Vein Occlusions
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the effect of Intravitreal Aflibercept Injection
      (IAI) on previously treated Central Retinal Vein Occlusions (CRVOs) with other Anti-VEGF
      agents.
    

Detailed description: 
      This prospective, open-label, single-center, nonrandomized, investigator-sponsored clinical
      study seeks to investigate the visual outcomes of a treat and extend dosing regimen of
      intravitreal aflibercept injection for macular edema following CRVO. All patients will
      receive IAI 2 mg at baseline and Week 4. If the pre-defined extension criteria are met at the
      4-week visit, and at any follow up visit, the patient will receive a mandated treatment, and
      the next visit will be extended by two weeks. If the extension criteria are not met on a
      follow-up visit, the treatment interval will be continued to be reduced by 1 week. If
      criteria are still not met despite treatment at the reduced interval, treatment will be
      administered as usual and follow up interval will continue to be reduced by 1 week until the
      criteria are met or a 4-week interval is reached. Treatment of IAI is rendered at every
      visit.
    

Intervention name(s): Aflibercept (2.0 mg)
Intervention type(s): Drug
Intervention description(s): Intravitreal Aflibercept (2.0 mg)
Other intervention name(s): Eylea; VEGF Trap-EYE
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular Edema; Central Retinal Vein Occlusion; CRVO; Aflibercept; VEGF Trap-Eye; Eylea; Ranibizumab; Bevacizumab
Multiple Sclerosis Rehabilitation Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The effects of routine rehabilitation in MS patients versus no rehabilitation.
    

Detailed description: 
      Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing
      input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with
      a "control" group on the waiting list for rehabilitation intervention. Duration of
      intervention is 6 weeks.
    

Intervention name(s): Physiotherapy; Occupational therapy; Speech pathology
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mulitple Sclerosis; MS
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate
      to severe glabellar lines are enrolled and those who are judged to be eligible for this study
      will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the
      glabellar lines. The investigational product is administered once, maintaining double-blind
      for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by
      comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.
    


Intervention name(s): PROTOXIN; Botox®
Intervention type(s): Biological; Biological
Intervention description(s): Botulinum toxin Type A; Botulinum toxin Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glabellar Lines; Botulinum toxin; Botulinum toxin type A
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine
Condition: Chickenpox
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the occurrence of adverse events, seroconversion rate
      and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.
    


Intervention name(s): Live Attenuated Varicella Vaccine
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study
Condition: Tracheal Intubation; Laryngoscopy
Study type: Interventional

Summary: 
      Forces applied on soft upper tissues by different laryngoscope blades during direct
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to
      the patients. The aim of this study is to compare the force and pressure applied to soft
      tissue in order to achieve the same glottis view comparing direct laryngoscopy and
      videolaryngoscopy in vivo.
    

Detailed description: 
      Forces applied on soft upper tissues by different laryngoscope blades during direct
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to
      the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic
      changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.

      In order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of
      an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes
      alignment, thereby reducing the detrimental effects above mentioned.

      The aim of this study is to measure the minimal force exertion to achieve not only glottis
      view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in
      patients with normal airway conditions. Furthermore, The investigators measured the following
      parameters: pressure distribution upon the blade; time required to visualize the glottis;
      time required to complete oro-tracheal intubation.
    

Intervention name(s): Forces applied by laryngoscope
Intervention type(s): Procedure
Intervention description(s): Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Force; Pressure; Intubation; laryngoscopy
A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen (C4-V3
      peptides) formulated in mineral oil containing mannose mono-oleate (IFA) in HIV-1 uninfected
      volunteers. To evaluate the humoral and cellular immune responses to the C4-V3 peptides as
      measured by the induction of 1 or more of the following: neutralizing antibodies to HIV-1 MN
      and RF, cross-neutralizing antibodies to primary isolates of HIV-1, HIV-1 antigen-specific
      lymphoproliferation, CD8+ and CD4+ cytotoxic T lymphocyte (CTL) activity specific for HIV-1
      gp120 or V3 peptides corresponding to the vaccine strains of HIV-1, induction of HLA-B7 and
      HLA-A2 restricted CD8+CTLs, and induction of HIV-specific DTH responses.

      The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120
      loop shared by approximately 80% of North American HIV-1 strains. Because of the critical
      role that this region plays in generating anti-HIV sequences, it is hypothesized that the
      test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive
      neutralizing antibodies in the majority of recipients.
    

Detailed description: 
      The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120
      loop shared by approximately 80% of North American HIV-1 strains. Because of the critical
      role that this region plays in generating anti-HIV sequences, it is hypothesized that the
      test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive
      neutralizing antibodies in the majority of recipients.

      Twenty-eight volunteers are randomized to receive two 0.5 ml injections of C4-43 peptides in
      IFA or placebo (IFA alone) administered intramuscularly at 0, 1, 6, and 12 months. At least
      50% of all volunteers (6 per Groups I and II; 2, Group III) must be HLA-B7 phenotype.
    

Intervention name(s): HIV-1 C4-V3 Polyvalent Peptide Vaccine
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: HIV Antibodies; HIV Envelope Protein gp120; Drug Carriers; Hypersensitivity, Delayed; AIDS Vaccines; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; HIV Seronegativity; Neutralization Tests; Mineral Oil; Oleic Acids; Mannose; HLA-B7 Antigen; HLA-A2 Antigen; HIV Preventive Vaccine