bioihbjkbjnl/mcl2 huggingface dataset:
Flavivirus Cross-priming Potential of IMOJEV
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional

Summary: 
      There is a pressing need for a better experimental system to understand flavivirus antibody
      responses, beyond dengue, to make sure the investigators are using current vaccines to
      greatest effect and to inform the development of next-generation vaccines. This study will
      use live chimeric JE vaccine IMOJEV® as a tool for flavivirus epitope discovery. This will
      allow experimental JEV infection using replication competent, live, attenuated virus as a
      model, in a setting where the flavivirus infection history of humans can be tightly
      controlled.
    

Detailed description: 
      This study will test the hypothesis that in previously flavivirus-exposed individuals, the
      antibody response is more broadly cross neutralising, and that this will lead to the
      identification of conserved virion surface epitopes that could be the target of second
      generation vaccines.

      Exploratory Primary Objectives/Specific aims:

        1. To establish a human model system of JEV infection in healthy adult volunteers using
           live attenuated JE vaccine IMOJEV®.

        2. To sort and sequence individual responding B cells (plasmablasts) after vaccination with
           IMOJEV®, and to generate human monoclonal antibodies to JEV.

        3. To generate JEV specific human monoclonal antibodies from the sequences derived in (2).

        4. To describe the development, specificity, cross-reactivity and function of the T cell
           response to IMOJEV®.

        5. To establish a sample bank for future work on cross-reactive and other responses to
           flaviviruses, flavivirus vaccines and other emergent viruses.

      Exploratory Secondary Objectives:

        1. To examine the specificity and cross-reactivity of the antibody response after JE
           vaccination, using serum and human monoclonal antibodies.

        2. To determine whether there are epitopes which can serve as the target of broadly
           cross-neutralising antibody responses.

      Experimentally the fine specificity and cross-reactivity of the antibody response will be
      studied by cloning antibodies from plasmablasts (B cells responding to the vaccine) that have
      been single cell sorted by flow cytometry then sequenced at one week post vaccine. These
      human monoclonal antibodies will then be mapped on to the surface of the virus particle using
      established approaches, and tested to look for cross-reactive antibodies. T cell responses to
      the vaccine will be studied using custom pools of synthetic peptides by ELISpot and flow
      cytometry.
    

Intervention name(s): IMOJEV
Intervention type(s): Biological
Intervention description(s): live attenuated Japanese encephalitis (JE) vaccine IMOJEV®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to learn about the safety and efficacy of pexacerfont in
      outpatients diagnosed with Generalized Anxiety Disorder
    


Intervention name(s): pexacerfont; escitalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks; Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks; Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Other intervention name(s): (BMS-562086)
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cingal Study for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to see if a single injection of Cingal into the knee provides
      safe relief of pain caused by osteoarthritis.
    

Detailed description: 
      This study compared three groups of subjects. Group One received a single injection of Cingal
      (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of
      Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.
    

Intervention name(s): Hyaluronic Acid and TH (Cingal®); Hyaluronic Acid (Monovisc®); Saline
Intervention type(s): Device; Device; Device
Intervention description(s): Injection into knee; Injection into knee; Saline placebo packaged to look identical to comparator syringes. Injection into knee.
Other intervention name(s): Cingal®; Monovisc®
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; Hyaluronic acid; HA Injection; Steroid Injection; Knee injection
Weight Bath Traction in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      It is typical of chronic low back pain that, after the first painful episode, is repeated at
      44-78% of patients. For acute lumbar pain, approx. 10-15% of them are converted into chronic.
      Conservative treatments are few studies done in the traction therapy. A large number of
      multicenter trials did not evaluate the effectiveness of underwater traction therapy.
    

Detailed description: 
      Goals are the followings:

        1. Is the beneficial effect of a weight bath comparable to a non-treated control group with
           respect to clinical parameters?

        2. How much does the quality of life change in an initial state and how much is it in
           comparison with the control group?
    

Intervention name(s): questionnaires
Intervention type(s): Other
Intervention description(s): Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are selected from on the Outpatients clinics of the Department of Rheumatology and
        Physiotherapy of Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
      
Keywords: Balneotherapy; Chronic low back pain; Controlled; Randomized trial; weight bath traction; follow-up
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The application of active warming to patients whether awake or under general anesthesia has
      been proven safe in numerous studies and it is common practice to use warmers. The warmers
      are commonly used with both the supplied blankets and also with hospital blankets.

      Subjects receiving standard care will not benefit from this study. Subjects in the
      investigational group may benefit in several ways:

        -  Increased comfort in the pre-operative period by being warmer

        -  Decreased incidence of mild hypothermia

        -  Possible decreased incidence of transfusion with less bleeding

        -  Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)

        -  Possible shorter stay in the PACU and overall Length of Stay (LOS)

        -  Possible decreased risk for surgical site infection
    


Intervention name(s): Bair Paws Patient Adjustable Warming System
Intervention type(s): Device
Intervention description(s): Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Other intervention name(s): Bair Paws Flex Gown
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypothermia; surgical site infection; opioid usage; blood loss; pain severity; anxiety; Length of Stay
To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of two Traclear 62.5 mg tablets
      and one HGP1206 125 mg tablet in healthy male volunteers.
    

Detailed description: 
      An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics
      and safety of Traclear 62.5 mg Tablets and HGP1206 125mg Tablet in Healthy Male Volunteers.
    

Intervention name(s): HGP1206; Traclear
Intervention type(s): Drug; Drug
Intervention description(s): One Bosentan 125 mg tablet; Two Bosentan 62.5 mg tablets
Other intervention name(s): Bosentan 125 mg; Traclear 62.5 mg
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo
      from scalp, to induce hair growth in male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp, plucked of hairs prior to excision, is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. The cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Vaccination With Peptides in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Unresectable Stage III or IV Malignant Melanoma
Condition: Malignant Melanoma With Metastasis
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess whether a vaccine containing a small fragment of the
      protein IDO, which may be present in cancer cells and cells of the immune system, is safe to
      use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant
      melanoma that has metastasized.
    


Intervention name(s): Vaccine consisting of a peptide derived from the protein IDO
Intervention type(s): Biological
Intervention description(s): All patients will receive seven vaccines containing IDOlong
Other intervention name(s): IDOlong
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
      inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis
      combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15
      months of age. The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    

Detailed description: 
      An open, controlled comparison of Havrix™ administered alone or with Infanrix™ and ActHIB.
      The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + Infanrix™ and ActHIB and 3)
      Infanrix™ and ActHIB followed by Havrix™ one month later.
    

Intervention name(s): Havrix™; Infanrix™; ActHIB™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 intramuscular injections, 6 months apart; 1 intramuscular injection; 1 intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A
Study of Antioxidants and Oxidants in Malnourished Children
Condition: Protein-energy Malnutrition; Kwashiorkor; Marasmus
MeSH terms: Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Interventional

Summary: 
      It is believed that the organs of severely malnourished children malfunction because harmful
      compounds called oxidants injure the tissues in these organs. In a healthy person oxidants
      are made harmless because another compound called glutathione neutralizes them. Glutathione
      is made from three amino acids that we get from the protein we eat in our food. We found that
      malnourished children were not making enough glutathione because they lacked one of these
      amino acids called cysteine. In this study we determine why malnourished children do not have
      sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich
      in cysteine during their treatment to determine whether they will make more glutathione. This
      in turn may make their organs recover faster. These findings will let us know whether
      malnourished children can recover faster if they are given more cysteine during the early
      phase of treatment.
    


Intervention name(s): sulfur amino acids
Intervention type(s): Dietary Supplement
Intervention description(s): Sixteen (16) children with edematous SCU will be randomly assigned to either a supplement of SAA or an isonitrogenous amount of alanine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: glutathione kinetics; oxidant damage; anti-oxidant capacity; oxidative stress; cysteine kinetics; severe childhood malnutrition
Symax International Study
Condition: Hip Osteoarthritis; Prosthesis Durability
MeSH terms: Osteoarthritis, Hip; Prosthesis Failure
Study type: Interventional

Summary: 
      The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip
      stem. The Symax stem design combines an anatomical anteverted proximal geometry with a
      straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA)
      coating for improved osseointegration to enhance load transfer and to minimize proximal bone
      loss. The distal part is treated with an anodization surface treatment in order to prevent
      distal bone apposition, which is expected to prevent distal loading and reduce proximal
      stress shielding. Aim of this study is to report mid-term clinical performance and evaluate
      whether the radiographic features are in line with the design principles of the Symax hip in
      an international clinical study with 5 years of follow-up.
    


Intervention name(s): Symax uncemented hip stem
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SensAwake™ Sleep Quality Trial
Condition: Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway
      pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns
      that differentiate between sleep and wake. Upon sensing that the patient is awake the device
      is able to reduce positive airway pressure PAP aiming to improve patient comfort which should
      result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA)
      and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology
      called SensAwake™. This requires experimental confirmation in a randomised controlled trial.
      Double-blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP
      modified by the addition of the SensAwake™ modification on consecutive nights in participants
      with moderate-to-severe OSA.

      A total number of 45 participants will be recruited from an OSA population, aged 18-65.
      Participants will consist of male and female patients diagnosed with moderate-severe OSA
      (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants,
      according to the protocol approved by the HREC, providing written informed consent will be
      enrolled into the study. Patients will be enrolled sequentially according to the
      randomisation list. Patients will be randomised to APAP or APAP with the addition of the
      SensAwake™ modification. The investigator and study staff will be blinded to the treatment of
      any participant.
    


Intervention name(s): SleepStyle 200 Auto Series with SensAwake; SleepStyle 200 Auto Series with out SensAwake
Intervention type(s): Device; Device
Intervention description(s): Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled; Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
Condition: Degenerative Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety
      of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody
      fusion.
    

Detailed description: 
      During one-level PLIF, bioactive glass-ceramic intervertebral spacer (Novomax) and titanium
      cage were inserted in the experimental group and control group, respectively. Bone fusion by
      simple radiography had angular deformity of less than 3 degrees and a potential of less than
      3 mm in flexion extension radiographs, and thin-section CT (<2 mm) was used to determine the
      combination between the vertebral endplate and the autogenous bone or bioactive glass-ceramic
      intervertebral spacer (Novomax) in the cage without any gaps or the part connected to bony
      trabecula as fusion, and both groups will be compared.
    

Intervention name(s): Bioactive Glass-Ceramic Spacer; Titanium cage
Intervention type(s): Device; Device
Other intervention name(s): Novomax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Weight Reduction on Immunity
Condition: Lymphocytes; Weight Loss; Viral Diseases; Immunity; Anti-obesity Agents
MeSH terms: Virus Diseases; Obesity; Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      This study included two groups of premenopausal healthy obese women. Experimental group
      underwent a weight loss program involved a low calorie diet plus anti-obesity drugs and
      moderate physical activity and control group underwent an ad libitum diet. At baseline and
      after a 10-15% weight loss lymphocyte subgroups were analyzed and compared between two group.
    

Detailed description: 
      TCD3 and NKC CD16/56 were decreased significantly. Hence this weight loss program impaired
      viral immunity
    

Intervention name(s): weight loss program
Intervention type(s): Combination Product
Intervention description(s): A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
Other intervention name(s): experimental
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Plyometric, Proprioceptive and Strength Exercises in Rugby Players.
Condition: Overhead Athletes
Study type: Interventional

Summary: 
      Introduction. Shoulder injury is the pathology that causes the longest downtime in rugby
      players, representing 66% of upper limb injuries in this discipline. The lack of strength,
      and instability are factors that predispose the athlete to suffer this type of dysfunction.
      The intervention of the study consists of a training program that counteract these
      dysfunctions.

      Aim. Assess the effectiveness of a program using plyometric, proprioceptive and strength
      exercises on 18-45-year-old rugby players to improve strength and stability.

      Study design. Clinical randomized, prospective, single-blind and trackable. Methods. The
      subjects included in two study groups, experimental and control, will be attributed a random
      order. The treatment will last 4 weeks, with 2 weekly sessions, of approximately 25 minutes
      each. The study variables will be strength, stability and functionality. A descriptive
      statistical analysis will be carried out calculating the main statistical characteristics.
      Through of a Kolmogorov analysis the normality of the sample will be assessed. A t-Student
      test for paired samples will be performed for the difference between the means of the
      dependent and independent variables. An analysis if variance (ANOVA) for repeated measures
      will be used to compare the means and checked to what extent the intra-subjects factors
      influence the dependent variables.

      Expected results. Improved shoulder strength, stability and functionality for the subjects on
      which the study is carried out.
    


Intervention name(s): exercises
Intervention type(s): Other
Intervention description(s): Those subjects included in the experimental group will receive an intervention through a program with plyometric, proprioceptive and strength exercises. The subjects included in the control group will not receive any intervention.
Other intervention name(s): Experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder; Strength; Stability; Functionality; Rugby.