bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Condition: Serogroup B Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to
      lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with
      routine infant vaccines.
    


Intervention name(s): Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1); Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2); Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3); Infanrix Hexa; Menjugate; Prevenar
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): One dose of rMenB Lot concomitantly with the routinely administered infant vaccines; One dose of rMenB concomitantly with the routinely administered infant vaccines; One dose of rMenB concomitantly with the routinely administered infant vaccines; Routine vaccination; One dose of the routinely administered infant vaccines + MenC vaccine; Routine vaccination
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: infant; Meningococcal disease; prevention; vaccination
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Condition: Primary Dyslipidemia; Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg
      daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed
      dyslipidemia.
    


Intervention name(s): pitavastatin; pravastatin
Intervention type(s): Drug; Drug
Intervention description(s): pitavastatin 4 mg once daily (QD); Pravastatin 40 mg once daily (QD)
Other intervention name(s): Livalo
Intervention MeSH terms: Pravastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the clinical outcomes after coronally advanced flap
      technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of
      single gingival recessions. For this blinded randomized controlled clinical trial, 40
      patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will
      selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters
      evaluated will be probing depth, clinical attachment level, gingival recession height, height
      and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45
      days, 2, 3 and 6 months after surgery.
    


Intervention name(s): Coronally Advanced Flap; Mucograft
Intervention type(s): Procedure; Device
Other intervention name(s): Porcine collagen matrix for soft tissue regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival recession/surgery; Collagen/therapeutic use; Root coverage; Treatment outcome
Effect of Different Supralottic Airway Devicess on Optic Nerve Sheath Diameter
Condition: Intracranial Pressure Increase; Supraglottic Airway Device; Optic Nerve Sheath Diameter
MeSH terms: Intracranial Hypertension
Study type: Observational

Summary: 
      Direct laryngoscopy and tracheal intubation are associated with increases in intraocular
      pressure (IOP), intracranial pressure (ICP), heart rate (HR), and blood pressure. The use of
      supraglottic airway devices (SADs) are known to be beneficial in overcoming the disadvantages
      of laryngoscopy and tracheal intubation, especially ocular and pressure stress responses. In
      recent years, it has been reported that ultrasonographic measurement of optic nerve sheath
      diameter (ONSD) can be used in the diagnosis of increased ICP. The aim of our study is to
      compare the effects of Proseal laryngeal mask airway (pLMA), Suprem laryngeal mask airway
      (sLMA) and I-gel on hemodynamic response and ONSD during insertion in adult patients.
    


Intervention name(s): pLMA: PROSEAL LARYNGEAL MASK, sLMA : SUPREMA LARYNGEAL MASK, I-jel =I-GEL
Intervention type(s): Other
Intervention description(s): a SAD was inserted by all anaesthetists participating in the study had at least 3 years experience of airway management and were experienced with both the pLMA, sLMA and I-jel. Inadequate ventilation after two attempts was considered a failed placement, and these patients were excluded, while the practitioner was freed to use an alternative airway device.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        90
      
Keywords: Supraglottic airway device; hemodynamic response; optic nerve sheath diameter
Treatment for the Mental Health Impact of Killing in War
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The goal of this project is to test the feasibility, acceptability, and efficacy of a
      treatment module addressing the mental health and functional impact of killing in the war
      zone.

      The investigators will enroll between 12-20 Veterans who have killed in war and have been
      diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy
      of the six-session treatment. Veterans will be randomized either to the treatment or to the
      waitlist control group.
    


Intervention name(s): Impact of Killing CBT Treatment
Intervention type(s): Behavioral
Intervention description(s): Treatment will include six, one hours sessions with a licensed clinical psychologist or an advanced postdoctoral fellow under the close supervision of a licensed psychologist.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Combat veterans
      
Keywords: PTSD; Veterans; Killing; Military
Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block
Condition: Radius Fractures
MeSH terms: Radius Fractures
Study type: Interventional

Summary: 
      Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized
      regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in
      which the neural cluster formed by the trunks or divisions of the brachial plexus is situated
      superolateral to the subclavian artery (SA).

      In many approaches, corner pocket approach [deposit local anesthetic (LA) at the intersection
      of the SA, neural cluster, and the first rib] and cluster approach (direct deposit LA into
      the neural cluster after penetration of the sheath of brachial plexus) has been well known
      methods. And single or multiple injection techniques has been used with the above approaches.
    

Detailed description: 
      In clinical practices, the investigators observed that the neural cluster was shown
      differently every person on the ultrasound image. Some neural cluster is shown as a typical
      round cluster of grapes lateral to the SA, in which, any approaches of US-SCBPB can be
      possible and good success rates are anticipated. But in many cases, neural cluster was shown
      in part lateral or superolateral to the SA like slightly-hated SA on the ultrasound image,
      and it passes posterior to the SA when the probe follows the path of the neural cluster along
      the SA. In that case, corner pocket approach is hard to apply due to the position of the
      neural cluster far away from the first rib, cluster approach increases chance of lopsided
      spreading of the LA, and multiple injection is also hard to apply due to narrow-shaped neural
      cluster. Therefore, we hypothesized that double injection in different plane (we call this
      new approach as a 2 plane-2 injection approach) would achieve an effect of a
      "tridimensionally administered LA", which is presented like shortening the onset time or
      increasing rate of all four nerves block compared with the existing cluster approach (the
      investigators call this as an 1 plane- 1 injection approach in this study).
    

Intervention name(s): Stimuplex insulated needle; lidocaine mixed with epinephrine
Intervention type(s): Device; Drug
Intervention description(s): 2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time.
1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL.; 2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once.
Other intervention name(s): (D Plus B.Braun); 1.5% lidocaine mixed with 1:200,000 epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: brachial plexus block; nerve stimulator; ultrasound
Non-invasive Brain Stimulation for Auditory Verbal Hallucinations in Schizophrenia
Condition: Auditory Verbal Hallucinations; Schizophrenia
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      The current study investigates the basic principles that underlie the efficacy of
      transcranial direct current stimulation for chronic auditory verbal hallucinations in
      schizophrenia in a multimodal design.
    


Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): active vs. sham tDCS left hemisphere
Other intervention name(s): device: neuroConn tDCS PLUS device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Non-Invasive Brain Stimulation and Substance Use
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The will investigate the feasibility and effectiveness and initial efficacy of non-invasive
      transcranial alternating current stimulation (tACS) on distress tolerance and inhibitory
      control among treatment seeking substance users.
    

Detailed description: 
      Disruptions in inhibitory control (IC) and distress tolerance (DT) are implicated in the
      development and maintenance of substance use disorders. Findings suggest that differential
      DLPFC engagement during affective and cognitive processing, and in particular, distress
      tolerance, in substance use disorder may be malleable, providing a promising intervention.
      Modulating neural oscillations with non-invasive, safe brain stimulation by targeting regions
      such as the DLPFC may provide an avenue to improve distress tolerance and inhibitory control
      in SUD. Transcranial alternating current stimulation (tACS) may be a particularly promising
      approach as it is a safe and non-invasive method of electric stimulation that has the
      potential to effectively modulate neural network and circuit dynamics, more closely aligning
      with a network-based conceptualization of affective and cognitive processesThis study will
      test the effects of tACS on distress tolerance and inhibitory control among treatment-seeking
      adults with substance use disorder.
    

Intervention name(s): Transcranial Alternating Current Stimulation at 10 Hz; Transcranial Alternating Current Stimulation at 40 Hz; Active sham transcranial alternating current stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity; Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity; Active sham (placebo)
Other intervention name(s): tACS at 10 Hz; tACS at 40 Hz; Active sham
Intervention MeSH terms: Dihydrotachysterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tACS; Brain Stimulation; Transcranial Alternating Current Stimulation; Substance Use
Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way,
      crossover study comparing the Test (T) and Reference (R) products following subcutaneous
      administration. Subjects will be randomly assigned to one of two treatments sequences (TR or
      RT).

      All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol
      requirements and procedures will be followed within each group.
    

Detailed description: 
      The current study design was prepared to assess and compare the PK, PD, safety, tolerability
      of the Adello biosimilar candidate, TPI-120 and the US-licensed reference product, Neulasta®
      after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover
      design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD
      parameters are baseline-corrected AUEC0-t and Emax for ANC.

      This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way,
      crossover study comparing the Test (T) and Reference (R) products following subcutaneous
      administration. Subjects will be randomly assigned to one of two treatments sequences (TR or
      RT).

      All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol
      requirements and procedures will be followed within each group.
    

Intervention name(s): PEG-rhG-CSF; Neulasta (PEG-rhG-CSF)
Intervention type(s): Drug; Drug
Intervention description(s): PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule; PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule
Other intervention name(s): PEGFILGRASTIM; PEGFILGRASTIM
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acclimatization of Healthy Subjects During a Stay at 3200 m
Condition: Effects of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at
      3200 m.
    

Detailed description: 
      This study evaluates the effect of 3 weeks altitude acclimatization on sleep related
      breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek,
      Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude
      clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.
    

Intervention name(s): Altitude exposure
Intervention type(s): Other
Intervention description(s): Participants will stay for 3 weeks at an altitude of 3200 m
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; acclimatization; sleep; hypoxia
Assessment of Pain, Anxiety and Efficiency of NumBee Compared to Traditional Local Anesthetic Syringe
Condition: Dental Phobia; Dental Anxiety; Anesthesia, Local; Needle Phobia
MeSH terms: Anxiety Disorders; Phobic Disorders
Study type: Interventional

Summary: 
      The study was conducted among a group of dental patients aged (6-8 years old) of both genders
      to assess the following variables in the needleless interparliamentary anesthesia (NUMBEE)
      compared to traditional local anesthesia:

        1. Pain perception.

        2. Pain related behaviors.

        3. Dental anxiety

        4. Anesthetic efficiency.

        5. Patient acceptance and preference
    

Detailed description: 
      The prevalent phobia of needles and the associated rise in dental anxiety when using the
      traditional needle method of LA infiltration, the development of needle-free alternatives for
      local anesthetics became an urgent necessity. The NumBee (BioDent, Simi Valley, CA) is a new
      gadget that promises less pain administration of local anesthetic without the use of a
      hypodermic needle. It is a tiny metal cannula with a silicone-like covering that is used for
      intraligmentary injection without penetrating the periodontal ligament. This study was
      performed due to the lack of sufficient research on NumBee and since it meets a number of
      exceptional criteria, including being able to anesthetize just one tooth without having to do
      so for the entire alveolar dental nerve and having a needleless design that may be more
      appealing to children than the distressing appearance of traditional dental syringes.
    

Intervention name(s): dental syringe ( NumBee); Traditional dental syringe
Intervention type(s): Device; Device
Intervention description(s): assess the capability of NumBee to reduce anxiety and pain during injection; compare the level of anxiety of the traditional dental syringe and the Number dental syringe
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Keywords: Dental anxiety; Pain perception; Anesthetic efficiency
The Use of LMA-Proseal and Endobronchial Blocker for One Lung Anesthesia, Case Series
Condition: Anesthetic Technique; One-lung Ventilation
Study type: Observational

Summary: 
      An observational pilot study to determine the success rate of using LMA Proseal in conjuction
      with endobronchial blocker to provide one-lung anesthesia for thoracic surgery.
    

Detailed description: 
      The use of LMA has gained popularity secondary to benefits confirmed by many literatures.
      However, LMA is rarely used in thoracic surgery. To enable one-lung ventilation, the LMA need
      to be used with bronchial blocker. The use of this combination has been reported as a rescue
      technique in special clinical scenarios, i.e. patient with difficult airway. When used in
      patient with difficult airway, the LMA will be inserted until proper ventilation achieved,
      then endobronchial blocker will be subsequently placed through the LMA into the selected main
      bronchus. The success rate of the the bronchial blocker placement via properly placed LMA has
      never been studied. This pilot study was designed to evaluate the success rate, the quality
      of lung collapsed, the dislodgement or other associated problems including some minor
      complications i.e. postoperative dysphagia, sore throat hoarseness of voice.
    

Intervention name(s): Bronchial blocker (Coopdech, Arndt); LMA-ProsealTM
Intervention type(s): Device; Device
Intervention description(s): Using bronchial blocker with LMA
Other intervention name(s): Coopdech; Arndt
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA class I-III patients age 18-75 years scheduled for thoracic surgery that required
        one-lung ventilation
      
Keywords: LMA; Bronchial blocker
Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the
      PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus
      RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg
      in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of
      tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest
      dose, the same has been selected for the study.
    


Intervention name(s): Tocilizumab
Intervention type(s): Drug
Intervention description(s): Tocilizumab is a recombinant human monoclonal antibody of the immunoglobulin G1 subclass, directed against the IL-6 ligand specific receptor. By preventing the binding of IL-6 to its receptor, tocilizumab inhibits the biological activity of IL-6. Tocilizumab was approved by the US Food and Drug Administration (4 mg/kg with an increase to 8 mg/kg based upon clinical response) for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to one or more tissue necrotizing factor (TNF) antagonist therapies. Tocilizumab is currently approved in 95 countries for the treatment of adult onset moderate to severe rheumatoid arthritis.
Other intervention name(s): ACTEMRA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Tocilizumab