bioihbjkbjnl/mcl2 huggingface dataset:
Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a
      GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults
      aged between 18 and 60 years.
    

Detailed description: 
      The protocol posting has been updated to reflect changes due to an amendment to the protocol
      (addition of an exclusion criterion). The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain); H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.; Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.; Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza Vaccine
Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
Condition: Healthy Volunteers; Atopic Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and
      multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in
      healthy subjects and in subjects with atopic disease.
    

Detailed description: 
      The study will be divided into 2 parts. Part A will be an open-label, parallel group, BA
      study evaluating 4 once-weekly doses of IV XmAb7195 or SC XmAb7195 in healthy subjects. Each
      of 5 treatment groups will consist of 6 subjects. Part B will commence following the
      completion of Part A and will be a randomized, double-blind, placebo-controlled, MAD study
      evaluating 4 once weekly doses of SC XmAb7195 in healthy subjects and/or subjects with atopic
      disease. Each treatment group will consist of 8 subjects randomized 3:1 to XmAb7195:placebo
      Subjects in both parts of the study will be followed for at least 28 days after their last
      dose.
    

Intervention name(s): XmAb7195; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; atopic
Comparison of Erector Spinae Plane Block and Intravenous Analgesic in Nefrectomy
Condition: Regional Anesthesia Morbidity; Nephrectomy
Study type: Interventional

Summary: 
      The efficacy of erector spinae plane block versus intravenous analgesics compared relate to
      the morphine consumptions
    

Detailed description: 
      Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with
      a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group.
      All patients will premedicated. then esp will applied to one group before surgery at the
      preoperative care unit by the same anesthesiologist. The other group will receive intravenous
      tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous
      morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses
      every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is
      responsible of all pcas' in the hospital was recorded the variables of these patients in the
      service
    

Intervention name(s): erector spinea plane block administered preoperative open nephrectomy; intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg
Intervention type(s): Procedure; Procedure
Intervention description(s): erector spinae plane block applied in this group before open nephrectomy; intarvenous analgesic administered in this group for analgesia end of the open nephrectomy
Intervention MeSH terms: Acetaminophen; Tramadol; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: nefrectomy; erector spinea plane block
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
Condition: Scars
Study type: Interventional

Summary: 
      Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of
      scars.
    


Intervention name(s): 755nm Alexandrite Laser with handpiece 2; 755nm Alexandrite Laser with handpiece 1; 755nm Alexandrite Laser with handpiece 3
Intervention type(s): Device; Device; Device
Intervention description(s): Focusing energy on skin; focusing energy at skin surface; Focusing energy on skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
A First Human Study of a Ferroportin Antibody
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the following in healthy participants: 1)
      LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the
      body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system
      reactions to LY2928057.
    


Intervention name(s): Placebo; LY2928057
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous placebo dose.; Single intravenous dose.
Other intervention name(s): Ferroportin antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Anemia
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of this trial is to assess the efficacy and safety
      of liraglutide in the paediatric population in order to potentially address the unmet need
      for treatment of children and adolescents with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.; Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, open-label, randomized,two-way crossover,
      propofol-controlled, two-stage study evaluating the safety and
      pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV single
      loade dose plus maintenance dose of HSK3486 emulsion for injection in healthy subjects.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h.; First-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy/Safety of Cilnidipine Plus Valsartan Versus Valsartan in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate of efficacy and safety of cilinidipine plus
      valsartan and valsartan alone in patients with essential hypertension inadequately controlled
      on valsartan monotherapy
    


Intervention name(s): valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg
Intervention type(s): Drug
Intervention MeSH terms: Valsartan; Cilnidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER
Condition: Immediate Implant Soft Tissue Healing
Study type: Interventional

Summary: 
      Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to
      promote tissue healing and soft tissue quality after placement of immediate implants.
    


Intervention name(s): Platelet Rich Fibrin; Diode laser
Intervention type(s): Biological; Device
Intervention description(s): for the preparation of PRF, A well-trained professional nurse drew 10ml of patient blood from the antecubital vein and transferred it to a test tube without anticoagulant. The blood sample was immediately centrifuged for 10-12 minutes at 3000 rpm. L-PRF was ready to use after centrifugation.
PRF membrane was put over the implant and slightly tucked under the soft tissue periphery, then held in place with a figure-of-8 suture by 0.5 proline suture; A 980 nm diode laser device (BIOLASE) was applied in a circular motion to the blood formed at the socket orifice at a power of 1W for 1 minute with a continuous wave mode, the application was done without touching the pooling blood and with a non-activated tip of the fiber optic.
The laser application cycle was repeated 3-5 times to yield a stable fixed blood clot covering the dental implant with no oozing blood from its periphery.
Other intervention name(s): PRF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Various studies in animal and humans have shown a potential beneficial effect of probiotics
      consumption on allergy. However few studies exist that document their efficacy for upper
      airways allergies such as allergic rhinitis. The objective of this study is to investigate
      the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics
      (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed
      out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a
      randomized, double-blind study, based on two 4-weeks cross-over periods of product
      consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical
      parameters of NPT as well as systemic and nasal immunological markers are compared before and
      after each treatment.
    


Intervention name(s): probiotic; probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
Condition: Unilateral Primary Osteoarthritis of Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an
      estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans
      will be affected by the disease. Despite the relative good track record of total knee
      replacement, it remains a biomedical device that can fail over time. A recent study looking
      at the current mechanisms of total knee replacement failures, listed polyethylene wear and
      osteolysis around implants. The material used for polyethylene insert as well as the
      conformity of articular surface of implants has been modified to decrease wear. While
      introducing modularity, the usage of metal backing in tibial base plates became obvious as it
      offered better stress distribution to the proximal tibial bone. However, it introduced other
      modes of failures. Micromotion has been demonstrated between the metal backing and the tibial
      liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision.
      Factor influencing the surgeon's choice of implant include: reproductibility and longevity of
      results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of
      elasticity of the tibial base plate has a direct effect on periprosthetic bone biology.
      Studies have described a significant decrease in postoperative Bone mineral density (BMD),
      adjacent to the implants, after total knee replacement. No study, to our knowledge, has
      looked at BMD in vivo after total knee replacement comparing different tibial base plate
      designs. Direct effect of changes in design on overall implant survival can be studied with
      randomized clinical trials isolating specific variables. No randomized clinical trial has
      looked at tibial insert stiffness and modularity, and it effect on bone density changes,
      synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study
      variables, one would aim at randomizing an homogenous patient population undergoing total
      knee arthroplasty with implants of similar articular geometry designs with different tibial
      insert modularity and stiffness.
    

Detailed description: 
      Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all
    

Intervention name(s): Total knee arthroplasty
Intervention type(s): Device
Intervention description(s): Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Other intervention name(s): NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer); NexGen Option Stemmed (Titanium) modular tibia (Zimmer).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; trabecular metal; bone mineral density
TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM
Condition: Glioblastoma Multiforme (GBM)
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose-escalation study that will assess the safety and determine the maximum
      tolerated dose (MTD) of mibefradil dihydrochloride, a partially selective T-type calcium
      channel blocker, combined with hypofractionated radiation therapy (RT) in subjects with
      recurrent glioblastoma multiforme (GBM).
    

Detailed description: 
      Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day
      until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is
      reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4
      divided doses per day for 17 consecutive days to the MTD. The MTD will be determined
      according to dose-limiting toxicities (DLTs) graded using the Common Terminology Criteria for
      Adverse Events version 4.0. Radiation therapy (RT) consists of 5 fractions of 600 centigray
      (cGy) each, delivered over 2 consecutive weeks for a total dose of 3,000 cGy, using
      stereotactic, intensity-modulated radiation therapy (IMRT).

      The primary endpoint of the study is to determine the MTD of mibefradil dihydrochloride when
      given with concurrent hypofractionated RT. Secondary and tertiary endpoints include
      evaluating the efficacy of mibefradil dihydrochloride and RT in terms of progression-free
      survival (PFS) and overall survival (OS), and to perform translational research on resected
      tumor tissue.
    

Intervention name(s): Mibefradil with Radiation
Intervention type(s): Drug
Intervention description(s): Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD.
This will be given concurrently with hypofractionated radiation therapy.
Other intervention name(s): mibefradil; mibefradil dihydrochloride; Posicor; hypo fractionated radiation; intensity modulated radiation; IMRT
Intervention MeSH terms: Mibefradil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bilateral; Flank Study With Crown Cooling Insert
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the
      flank using an applicator with and without the Crown Cooling Insert.
    

Detailed description: 
      This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore
      applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.
    

Intervention name(s): The ZELTIQ CoolSculpting System
Intervention type(s): Device
Intervention description(s): The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Barrow Nasal Inventory Survey
Condition: Pituitary Tumors
MeSH terms: Pituitary Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery.
      This type of surgery is conducted for pituitary and skull base tumors. There is no published
      data on trauma to the nose during surgery and how it impacts nasal functioning. The
      investigators propose to develop a survey and administer it to patients before and after
      surgery to learn about their perception of nasal functioning.
    

Detailed description: 
      A 9-item patient survey (the ASK Nasal Inventory) focusing on the most common postoperative
      complaints, such as crusting, sinusitis, pain, and ease of breathing, was developed by the
      anterior skull base team at the Barrow Neurological Institute. Content was validated in
      structured patient interviews by four subject-matter experts with both endonasal and control
      groups. Eligible patients for the control group included patients undergoing any
      neurosurgical procedure requiring anesthesia that did not involve the endonasal corridor,
      such as spinal decompression procedures, craniotomies for trigeminal neuralgia, and shunting
      procedures. This survey was self-administered pre- and 3 months post-surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neurosurgery and endocrinology clinic
Anesthesia and Lymphocytes Apoptosis
Condition: Anesthesia
Study type: Interventional

Summary: 
      Most researches revealed that volatile anesthetic sevoflurane has a more marked
      cardioprotective effect against ischemia compared with intravenous agent propofol.However,
      propofol has been suggested to be more benefit for attenuation of surgery-induced
      immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB
      surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol
      and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating
      lymphocytes.
    


Intervention name(s): Sevoflurane; Propofol; combine of sevoflurane and propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration); anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion); anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: troponin I; creatine kinase mb; hospital days; lymphocyte apoptosis; intensive care unit days