bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Nerve Cross Section Area on Sensory Block Onset
Condition: Regional Anesthesia
Study type: Interventional

Summary: 
      The study aims to describe a correlation between the nerve cross section and the sensory or
      motor block onset time. Therefore, different nerve cross sections with their Motor and
      sensory onset times are compared in order to find a correlation.

      In the case of discovering a correlation, this could be translated into clinical practice,
      where a more tailored and individualized approach to performing peripheral nerve blocks would
      be possible, thus lowering the risks of adverse events occurring.
    


Intervention name(s): Dominant Arm; Non-dominant arm
Intervention type(s): Procedure; Procedure
Intervention description(s): The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.; The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Ultrasound-guided regional anesthesia
Safety of MenACWY-CRM Vaccination in Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      The purpose of this US FDA post-marketing commitment study is to evaluate the safety of
      MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance
      Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The
      pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies
      and include certain neurological, immunological, vascular, musculoskeletal and hematologic
      disorders. All events are collected retrospectively.
    

Detailed description: 
      This is an observational study, vaccines administration and data that is collected is only as
      part of routine clinical care. Vaccinated subjects are not actively recruited.

      Events of interest: Seizure, Aseptic meningitis, Bell's Palsy, Multiple Sclerosis,
      Guillain-Barre Syndrome, Acute disseminated encephalomyelitis, Cerebellar ataxia, Transverse
      myelitis, Brachial Neuritis, Hashimoto's disease, Systemic Lupus Erythematosis, Henoch
      Schonlein Purpura, New Onset Juvenile Diabetes Mellitus, Rheumatoid arthritis, Idiopathic
      Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome,
      Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic
      urticaria, Anaphylaxis, Meningococcal Disease, Suicide attempt.
    

Intervention name(s): MenACWY-CRM
Intervention type(s): Biological
Intervention description(s): MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is selected from the Health Maintenance Organization population of the
        Kaiser Permanente Southern California (KPSC) HMO in Pasadena, CA, USA.
      
Keywords: observational; serogroup A, B, Y, W; meningococcal meningitis; meningococcal vaccines; safety; MenACYW-CRM; post-marketing; adolescents
Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old
Condition: HIV Antibody Testing
Study type: Observational

Summary: 
      Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva
      as an alternative specimen for HIV testing has been explored. Today, very sensitive tests
      have been formulated and have been used for diagnosing HIV in adults and older children.
      OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as
      well test the saliva.

      Most studies done on the use of saliva have been carried out in adults and have produced very
      good results. However very few such studies have been done in children, especially infants.
      In adults, use of saliva has also highlighted the advantages of ease of collection and
      increased acceptability of testing.

      HYPOTHESIS OraQuick rapid test can detect antiHIV antibodies as well as the Abbott determine
      test and oral fluid testing is more acceptable than blood testing.
    

Detailed description: 
      BACKGROUND Serological identification of antibodies to Human Immunodeficiency virus (HIV) in
      blood is the most widely used method to screen for HIV infection. Use of oral fluid as an
      alternative to blood sample has been studies the past 20 years and extremely sensitive tests
      that are able to detect the very low quantities of antibodies found in oral fluid have been
      formulated and are currently being used. OraQuick rapid test, a combination, collection and
      testing device that uses both blood and oral fluid was approved for used by the U.S.A, FDA in
      2002 and has been tested in adults and older children.

      The value of oral fluid in screening for HIV infection in adults is now well established and
      has been used extensively in field survey and epidemiologic studies. However, these methods
      have not been studied in children in whom differences in test performance might be expected.
      Studies in adults have also highlighted the advantages of oral fluid testing, such as ease of
      collection and high degree of acceptability of testing. This would make oral fluid testing a
      good alternative for HIV screening in infants, a challenging population in which venipuncture
      is often difficult or unacceptable.
    

Intervention name(s): Abbott-rapid HIV antibody test; OraQuick Rapid HIV-1/2 Antibody test
Intervention type(s): Other; Other
Intervention description(s): Abbott will be used to test serum or whole blood; OraQuick for oral fluid HIV antibody testing
Intervention MeSH terms: Antibodies; Immunoglobulins; HIV Antibodies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children admitted to the University Teaching Hospital,Lusaka,Zambia with various illnesses
        and aged less than 18 months old
      
Keywords: HIV-1; HIV-2
Pupil Dilation for Treatment of IFIS
Condition: Intraoperative Floppy Iris Syndrome
MeSH terms: Mydriasis; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.
    

Detailed description: 
      This study explores the effects that medication can have on increasing pupil dilation. Pupil
      dilation size is important for operative eye procedures. Decreased pupil size is related to
      increased complication risks in eye surgery. By exploring novel pupil dilation techniques,
      there is a potential to counteract the effects of poor pupil dilation that is caused by
      medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome
      characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused
      by BPH medications. This study evaluates treatment methods targeting IFIS.
    

Intervention name(s): Brimonidine Tartrate
Intervention type(s): Drug
Intervention description(s): All subjects will apply brimonidine tartrate to one eye (right eye) only for the duration of study participation.
Other intervention name(s): "Eye Drops"
Intervention MeSH terms: Brimonidine Tartrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study in which all enrolled subjects will receive eye drops to only one eye. The alternative eye will serve as the control for efficacy.
Masking: None (Open Label)
Primary purpose: Treatment
GlutDigest - Pilot Study
Condition: Main Focus: Gluten and Starch Digestibility
Study type: Interventional

Summary: 
      This is a pilot, feasibility study to evaluate, test and optimize sample analysis procedures
      and protocols before the full-scale, crossover study is conducted.
    

Detailed description: 
      Two important factors can influence the proportions of gluten and starch that resist
      digestion: (1) enzyme availability and specificity and (2) the structural properties of the
      food. A complete evaluation of gluten digestion and of the impact of dietary supplements is
      difficult to conduct because it is not easy to obtain samples of digestive chime. The
      analysis of the ileal effluent of healthy ileostomy patients constitutes a non-invasive
      alternative to intubation techniques for the study of nutrient digestion and of the fate of
      probiotics in the small intestine.

      The main aim of this study is to test and optimize sample analysis protocols before
      conducting the full-scale, crossover study which will aim at evaluating the impact of two
      dietary supplements (Glutalytic® and DE111®) and of oatmeal properties on the digestion of
      gluten and starch and on the glycemic response.
    

Intervention name(s): Glutalytic®; DE111®; Meal A
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Glutalytic® capsule; DE111® capsule; Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Gluten; Starch; Digestive enzymes; Probiotics
Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision
Condition: Tramadol - Anesthetics- Child - Circumcision
Study type: Interventional

Summary: 
      After the consent of the local ethics committee and informed consent of the parents, we
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We
      collected 53 children in each group.
    

Detailed description: 
      After the consent of the local ethics committee and informed consent of the parents, we
      conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December
      2014, including one to eight year olds, ASA I or II and Programmed for circumcision.
      Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The
      children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV
      non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or
      saline serum at the same volume (G2: Group B or control). Postoperative analgesia was
      assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO
      hour at home, by the number of analgesic inThe hospital and at home, and by the time of the
      first demand analgesic.
    

Intervention name(s): Tramadol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.; Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.
Other intervention name(s): group BT; group B or control
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled and double blind assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: tramadol-penile block -circumcision surgery-anesthesia-child
Comparison of Plant and Animal Proteins on Amino Acid Concentrations
Condition: Healthy Resistance-Trained Males
Study type: Interventional

Summary: 
      The study purpose is to assess various protein blends, which differ in protein quality, and
      the impact on blood amino acid response in male subjects.
    


Intervention name(s): Animal Proteins (crossover); Plant-based protein blends type 1 (crossover); Plant-based protein blends type 2 (crossover); Plant-based protein blends type 3 (crossover)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design; Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in
      Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics,
      safety and tolerability of two different amlitelimab drug products (DPs) after administration
      of a single subcutaneus (SC) dose in healthy adult participants.

      Study details include:

      The study duration for a participant will be approximately 17 weeks. The study includes a
      screening period of up to 28 days, a 4-day institutionalization period, and a follow up
      period for approximately 89 days (9 visits).
    

Detailed description: 
      The study duration for a participant will be approximately 17 weeks
    

Intervention name(s): Amlitelimab DP1; Amlitelimab DP2
Intervention type(s): Drug; Drug
Intervention description(s): Injection solution 1
Subcutaneous; Injection solution 2
Subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-part, open-label study with 1 arm in Part 1 and a randomized, 2 arms parallel design in Part 2
Masking: None (Open Label)
Primary purpose: Other
Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection
Condition: Intraocular Pressure Change in Intravitreal Injection
Study type: Interventional

Summary: 
      To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular
      pressure rise after intravitreal injection.
    

Detailed description: 
      Acute intraocular pressure elevation after intravitreal injection of bevacizumab was
      proven.Acute intraocular pressure elevation most probably is volume related and long term
      intraocular pressure elevation relates to pharmacologic features of the medications which
      results in anatomic changes in the angle of anterior chamber.Numerous studies found an
      intraocular pressure elevation right after the injection and quick normalization within
      maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can
      result in irreversible visual loss especially in patients with critical remaining nerve
      fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to
      prevent or even shorten this time of intraocular pressure elevation? We tried in our study to
      find a suitable response for a question above, so we used several anti-glaucoma agents
      (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent
      acute intraocular pressure elevation right after intravitreal bevacizumab injection.
    

Intervention name(s): Timolol; Brimonidine; Acetazolamide; Mannitol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection; Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection; Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection; Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection; Artificial tears, 2 drops, 1-2 hours before intravitreal injection
Other intervention name(s): Timoptic; Alphagan; Diamox; Sham
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Mannitol; Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intraocular pressure, intravitreal injection, short term
Molecular Processes of the Relaxation Response in Older Adults
Condition: Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the molecular (nitric oxide) and biochemical
      (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR
      elicitation and which may counteract the effects of acute stress in the elderly.
    


Intervention name(s): Relaxation response
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of relaxation response training
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunological Measurement of Aspartate/Alanine Aminotransferase
Condition: Chronic Liver Disease and Cirrhosis
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Previous reports have suggested that ALT-immunoglobulin complex was increased according to
      the severity of the liver disease, and high concentration of mAST and this might indicate a
      severely damaged liver. Immunoassay might be useful as a screening method in the
      differ-ential diagnosis of liver fibrosis according to patients. In this study, the efficacy
      of immunoas-say in the prediction of liver fibrosis in patients with chronic hepatitis B
      (CHB) was evaluated.
    

Detailed description: 
      Enzymatic analysis of aspartate/alanine aminotransferase (AST/ALT) does not exactly represent
      the progression of liver fibrosis. Immunoassay for the AST (cytoplasmic [c] AST/mitochondrial
      [m] AST) and ALT (ALT1/ALT2) have been suggested as one of the alternatives for the
      enzy-matic analysis. We evaluated the efficacy of immunoassay in predicting liver fibrosis
      and in-flammation. A total of 219 patients with chronic hepatitis B (CHB) who underwent
      hepatic ve-nous pressure gradient (HVPG) and liver biopsy before antiviral therapy were
      recruited. Serum samples were prepared from blood during HVPG. The liver function test
      including enzymatic AST/ALT and immunological cAST, mAST, ALT1 and ALT2 were checked with
      sandwich ELI-SA immunoassay with fluorescence labeled monoclonal antibodies, and were
      compared with the METAVIR stage of live fibrosis and the Knodell grade of inflammation.
    

Intervention name(s): with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
Intervention type(s): Diagnostic Test
Intervention description(s): with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Between January 2007 and December 2010, patients with CHB, who simultaneously underwent
        HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were
        prospectively recruited.

        They are all admitted for the evaluation of CHB. Age: 20-70 Gender: both, Korean
      
Biospecimen description: 
      serum
    
Keywords: Chronic hepatitis B; Alanine Aminotransferase; Aspartate Aminotransferase
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether cyclosporine, added to methotrexate and steroid, increases the
      possibility of inflammatory management early in the disease; furthermore to investigate the
      possible steroid-sparing effect of cyclosporine in patients with recently diagnosed
      rheumatoid arthritis.
    

Detailed description: 
      Design: Multicentre, prospective, randomised, double-blind study with parallel design.

      Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6
      months of persistent synovitis).
    

Intervention name(s): Methotrexate; Intraarticular betamethasone; Cyclosporine/placebo-cyclosporine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Betamethasone; Methotrexate; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement
Condition: Aortic Valve Disease
MeSH terms: Aortic Valve Disease
Study type: Observational

Summary: 
      Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic
      valve replacement are extensively practiced in our institution. The primary disease process
      for which patients are referred remains aortic stenosis. But more and more, we met older
      patients with both aortic stenosis and other cardiac pathology (coronary artery disease,
      other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to
      significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths
      of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is
      however important to have medical data and statistics in order to better understand the
      factors influencing morbi-mortality and thereby to continue this improvement.
    


Intervention name(s): Aortic valve replacement
Intervention type(s): Procedure
Intervention description(s): Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patient operated for aortic valve replacement with or without associated cardiac
        surgery from 2009 in Dijon University Hospital