bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age
Condition: Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate
      immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new
      swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and
      adolescents. A booster dose will be administered 12 months after the first vaccination.
    


Intervention name(s): Monovalent A/H1N1 influenza vaccine
Intervention type(s): Biological
Intervention description(s): This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Pandemic influenza; Vaccine
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
Condition: Short Term Treatment of Insomnia
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon
      Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
    


Intervention name(s): Zaleplon
Intervention type(s): Drug
Intervention description(s): Short term treatment of insomnia
Other intervention name(s): Sonata
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia
Condition: Xerostomia; Head and Neck Cancers
MeSH terms: Xerostomia
Study type: Interventional
Phase: Phase 2

Summary: 
      Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of
      the most common side effect of radiation therapy among patients with HNC. Mouth dryness
      significantly impairs patients' quality of life (QOL).

      HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their
      beneficial effects in recent studies, we decided to design a randomized, controlled clinical
      trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation
      induced xerostomia
    


Intervention name(s): mixed powder of A. digitata and M. sylvestris; Hypozalix spray (artificial saliva)
Intervention type(s): Drug; Drug
Intervention description(s): Hypozalix spray (artificial saliva)
Other intervention name(s): Traditional Persian Medicine preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
Condition: Visual Performance
Study type: Interventional

Summary: 
      The objective of this study is to assess how various silicone hydrogel lenses perform when
      worn by subjects who are heavy digital device users.
    


Intervention name(s): Marketed Soft Contact lens; AIR OPTIX® AQUA; Biofinity®
Intervention type(s): Device; Device; Device
Intervention description(s): Replacement schedule every 2 weeks; Replacement schedule every 4 weeks; Replacement schedule every 4 weeks
Other intervention name(s): senofilcon A; lotrafilcon B; comfilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparıson Of PENG Block wıth Intra-articular And Quadratus Lumborum Block İn Primary Total Hip Arthroplasty
Condition: Hip Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      90 patients ASA I-III, undergoing Total hip arthroplasty (THA) under spinal anesthesia, will
      be randomly assigned into one of three groups, namely group A (n=30), where an PENG block,
      group B (N:30) where an inra-articuler, and group C (n=30) where Quadratus lumborum block
      will be performed preoperatively. All patients will receive a standardized postoperative
      analgesia regimen. NRS scores will be evaluated in static and dynamic conditions during the
      first 48 hours postoperatively.
    

Detailed description: 
      Total hip arthroplasty (THA) is the second most common joint replacement surgery, partly due
      to the aging population. The primary aim of this study is to compare the analgesic efficacy
      of Pericapsular nerve group (PENG) block with intra-articular and Quadrotus lumborum block
      (QLB). Regional anesthesia (RA), such as the recently described pericapsular nerve group
      (PENG) block, may provide additional analgesic benefit in this situation. Pericapsular nerve
      group (PENG) block is a new regional anesthesia technique to provide analgesia after hip
      fractures and hip arthroplasty. The aim of this single-center, double-blind, randomized
      controlled trial is to confirm the efficacy of PENG block for postoperative recovery after
      primary THA.

      Routine multimodal analgesia will be used for postoperative analgesia
    

Intervention name(s): Group A; Group B; Group C
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): PENG BLOCK; Intra-articular; Quadratus lumborum block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PENG block; intra-artikuler; Quadrotus lumborum block; Hip Arthropathy
The Effect of The 6 Week Online Exercise Program On Core Stability And Vertical Jump Performance In University Students
Condition: Exercise
Study type: Interventional

Summary: 
      The goal of this randomized controlled study is to examine the effect of the online exercise
      program on core stabilization and vertical jump performance and observe the relationship
      between physical activity levels and motivation. In addition, compare these parameters with
      the exercise group and control group. The main questions it aims to answer are:

      Does a 6-week online exercise program at university have an effect on core stabilization and
      vertical jump? Does exercise have an effect on motivation and physical activity level?
    

Detailed description: 
      Background: The importance of physical activity and exercise is increasing day by day. The
      aim of this study is to examine the effect of the online exercise program on core
      stabilization and vertical jump performance and observe relationship with physical activity
      levels and motivation.

      Methods: The study included 51 healthy volunteer students registered at Fenerbahçe University
      and actively continuing their education. Evaluations were made before the exercise program
      and at the end of the sixth week. All assessments and exercise program were conducted online.
      Two of Mcgill's trunk muscle endurance tests were preferred to evaluate core stability: Trunk
      extensor endurance test (TEET), bilateral side bridge endurance tests (SBET), and Prone
      Bridge Test (PBT) was preferred for flexor endurance. Vertical Jump (VJ) test was used to
      evaluate vertical jump height performance. The International Physical Activity
      Questionnaire-Short Form (IPAQ-SF) was used to determine the physical activity levels of
      individuals, and the Physical Activity Participation Motivation Scale (MSPPA) was used to
      measure their motivation to participate in physical activity.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): 6-week online exercise group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Core Stabilization, Vertical Jump, IPAQ-SF, MSPPA Exercise
Liothyronine (T3) for Bipolar Depression
Condition: Depression; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with
      bipolar disorder. In this study patients will be randomized to receive T3 or placebo.
    

Detailed description: 
      Bipolar affective disorder is a debilitating illness, and is characterized by depression
      episodes that dominates the longitudinal course and are most difficult to treat. Controlled
      trials with monotherapy mood stabilizers such as lithium and valproate show little to no
      efficacy and antidepressants may offer no additional efficacy. Recently there has been a
      growing interest in the use of quetiapine in bipolar depression. However, a successful
      treatment may take up to 8 weeks, and full remission is achieved in only 50% of patients.
      Thyroid hormone augmentation strategies have been used in unipolar depression with good
      results, but there is a paucity of its efficacy in bipolar depression (BD). To our knowledge
      there are no controlled studies regarding the efficacy of thyroid augmentation in BD. The
      present study proposes to evaluate the efficacy of T3 as an augmentation to treatment as
      usual in the treatment of BD. We plan to enroll patients with bipolar disorder I or II who
      are currently presenting with depressive symptoms. Patients will be randomized to 2 groups -
      liothyronine or placebo Results will provide information on the possible role of thyroid
      hormone augmentation in the treatment of patients with bipolar depression, and may contribute
      to alleviate the burden of this disabling condition.
    

Intervention name(s): Liothyronine (T3); placebo
Intervention type(s): Drug; Drug
Intervention description(s): liothyronine (T3) up to 50 micrograms a day; placebo
Other intervention name(s): cytomel (liothyronine)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; depression; treatment; randomized controlled trial
Biomarkers in Blood and Tissue Samples From Patients With Newly Diagnosed Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory
      may help doctors learn more about changes that occur in DNA and identify biomarkers related
      to cancer.

      PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients
      with newly diagnosed neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the expression of neuropeptide Y (NPY) and its receptors (Rs) in human
           neuroblastoma (NB) tissues.

        -  Determine whether BDNF/TrkB and TrkAIII stimulate expression of NPY and its Rs.

        -  Determine whether NPY mediates BDNF- and TrkAIII-induced NB proliferation and survival.

        -  Determine neurotrophins' angiogenic actions.

        -  Identify factors released from NB cells upon NPY stimulation (proteomics).

        -  Determine whether NPY upregulates expression of the identified proteins in NB and their
           Rs in endothelial cells (ECs).

        -  Test whether inhibition of the identified pathways reduces angiogenic activity of
           NB-conditioned media.

        -  Determine the mechanisms of NYP actions and signaling pathways.

        -  Test whether blocking NPY-Y2/Y5 pathway reduces NB growth and vascularization in vivo.

      OUTLINE: Archived tumor tissue and serum samples are analyzed for neuropeptide Y and its
      receptors (Y1, Y2, and Y5) expression, neuroblastoma prognostic factors (MYCN, TrkA, TrkAIII,
      TrkB, BDNF, and NGF), and angiogenic markers by real-time PCR, IHC, ELISA, radioimmunoassay
      (RIA), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography,
      tandem mass spectrometry, proteomic assays, and other assays. Results are then analyzed and
      compared with patients' clinical data, including stage of disease, its phenotype, prognostic
      markers, age and gender, and response to treatment.
    

Intervention name(s): RNA analysis; polymerase chain reaction; protein expression analysis; proteomic profiling; western blotting; enzyme-linked immunosorbent assay; immunohistochemistry staining method; laboratory biomarker analysis; liquid chromatography; mass spectrometry
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other; Other; Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.
      
Biospecimen description: 
      blood and tissue
    
Keywords: disseminated neuroblastoma; localized resectable neuroblastoma; localized unresectable neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma
Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Observational

Summary: 
      Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the
      pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after
      the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated.
      The investigators evaluated parameters related with MGD including lid margin abnormalities,
      meibomian gland expressibility and meibography before and after surgery.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for cataract surgery
      
Keywords: cataract surgery, meibomian gland dysfunction, meibum expressibility, meibography
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Condition: Exudative Macular Degeneration; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema
Study type: Interventional

Summary: 
      The purpose of this study is to measure biomarkers in the vitreous of patients undergoing
      Lucentis or avastin treatment.
    


Intervention name(s): Avastin; Avastin; Lucentis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.25 mg monthly for 4 months; 1.25 mg monthly for 4 months; 0.5 mg monthly for 4 months
Intervention MeSH terms: Bevacizumab; Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Vibration Impact on Parkinson's Tremor
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The primary purpose of this study is to test the safety, tolerability and efficacy of
      vibration (delivered by an experimental device called RMBand that is worn on the subject's
      arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This
      RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in
      persons with Parkinson's disease (PD).
    

Detailed description: 
      Participation will be completed in one visit at VCU Parkinson's and Movement Disorders
      Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale
      (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will
      be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part
      III will be repeated both during and after the therapy. Participants will be asked to provide
      feedback about the device, the therapy session and how they are feeling.
    

Intervention name(s): RMBand lower dose; RMBand higher dose
Intervention type(s): Device; Device
Intervention description(s): Light-weight portable device that delivers low dose vibration to the arm; Light-weight portable device that delivers higher dose vibration to the arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study
Condition: Transplantation
MeSH terms: Communicable Diseases; Infections
Study type: Observational [Patient Registry]

Summary: 
      The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective
      identification and collection of data of infectious disease complications in order to
      determine the epidemiology, risk factors, and outcomes of patients who receive solid organ or
      stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers. It is
      essential for the care and treatment of this population to employ a mechanism for
      investigators to centralize these datasets, using standardized definitions of infectious
      complications. This protocol outlines the procedures to be utilized in order to prospectively
      follow the diagnosis and treatment of infectious complications in transplant patients.
    

Detailed description: 
      Patients are approached at their transplant screening visit, if possible, or during their
      hospital stay (before or after transplant) in order to introduce the study and obtain
      informed consent for participation. A letter to transplant physicians will introduce this
      study. Data collection will begin immediately upon consent and continue for up to five years.
      The informed consent form specifically requests permission to contact the subject in the
      future to verify information or if the subject is lost to follow up by Transplant services.

      The Day of transplant will be considered day 0 for enrollment in this observational study.
      Data will be collected on clinical template forms completed by study team members, as
      infectious complications become apparent in either outpatient ID clinics or on the inpatient
      service. A member of the research team will complete data collection in the registry,
      maintained on the REDCap platform. In addition, patient electronic records will be reviewed
      every 3 months to identify and record infectious complications, treatments administered, and
      outcomes. During these intervals, subjects will be contacted by phone to review the same
      outcomes.

      Creation of the registry relies on use of standardized definitions to define infections. An
      electronic database has been constructed in the REDCap system, documenting subject
      demographics, transplant variables, infection variables, treatments administered, and overall
      outcomes, during each interim time period.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hematopoietic stem cell (bone marrow) and solid organ transplant patients
      
Keywords: Infection; Cohort; Prospective; Epidemiology; Outcome
A Study of the Effects of LY3372689 on the Brain in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study
      will be conducted in healthy participants and will last up to approximately 25 days after
      enrollment. Screening must be completed within 28 days prior to enrollment.
    


Intervention name(s): LY3372689; [18F]LSN3316612
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): Administered orally.; Administered IV.
Other intervention name(s): [18F]MNI-1068
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1359 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV
      doses of GMI-1359 in healthy adult subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending IV dose study
      conducted at one study center in the United States. Safety will be assessed throughout the
      study and serial blood samples and urine samples will be collected for the safety and
      pharmacokinetic assessment of GMI-1359.
    

Intervention name(s): GMI-1359; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subjects; Pharmacokinetics; Pharmacodynamics