bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China
Condition: Polio; Vaccine Reaction
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a
      booster vaccination in children aged 4 years who were previously immunised with different
      sequential immunization history by Sabin IPV and bOPV, and to observe the antibody
      persistence three years after different primary sequential immunization with Sabin IPV or
      bOPV at age 2, 3 and 4 months.
    

Detailed description: 
      This is a continuous study of preliminary trial (Immunogenicity of three sequential schedules
      with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang,
      China: NCT03147560) . The investigators will follow up previous participants at age 4 years
      old with different primary sequential immunization schedules at age 2, 3 and 4 months:
      sIPV-bOPV-bOPV , sIPV-sIPV-bOPV , or sIPV-sIPV-sIPV, and give the 4th doses of polio vaccine
      with Sabin IPV or bOPV. A pre-vaccination blood sample is taken for polio antibody
      determinations. Sabin IPV will be administrated for participants in the previous Group 1
      (sIPV-bOPV-bOPV), and Sabin IPV or bOPV will be given for participants in the previous Group
      2 (sIPV-sIPV-bOPV) and Group 3 (sIPV-sIPV-sIPV) after they were randomly divided into two
      subgroups. At least two active surveillance visits, during which staff visited the
      participants s at home (on days 3 and 30) will required after vaccination to collect adverse
      reaction data. Parents or legal guardians were instructed to contact investigators if they
      observed any possible vaccine-related adverse events or important medical events (such as
      serious illness, physical disability, or death). The second blood sample will be collected
      28-60 days after the booster vaccination. The investigators will asess the immunogenicity by
      seroconversion rate and seropositivity after the booster vaccination, and evaluate the
      antibody persistence using seropositive rate and GMT in participants before the booster
      vaccination. Safety will assessed with the occurrence of adverse events reported across the
      study groups.
    

Intervention name(s): vaccinated with Sabin IPV; vaccinated with bOPV
Intervention type(s): Biological; Biological
Intervention description(s): the 4th dose of polio vaccination; the 4th dose of polio vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Antibody persistence; Safety; Sabin IPV; bOPV
Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of modified pilates exercises on neck
      pain, deep neck flexor muscles edurance, joint position sense and functionality in patients
      with chronic neck pain.
    

Detailed description: 
      50 individuals with Chronic Neck Pain not working will be included to our study. We will
      evaluate pain (with visual analog scale), deep neck flexors' endurance (with cranio-cervical
      flexure test using the pressure stabilizing feedback device), cervical range of motion and
      cervical proprioception (wit cervical range of motion device). Besides we will conduct a
      questionnaire (neck disability index) to get further knowledge about their functionality.
      Participants will be randomly allocated 2 groups consisting of 25 participants and these 2
      groups will receive different interventions. Modified Pilates Exercise Group (MPEG) will be
      involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week
      in the presence of a physiotherapist. The Control Group (KG) will receive daily routine
      advises to prevent neck pain and they will be asked about to apply these advises and not to
      make other changes in their life. The evaluations will be repeated and analyzed 2 times,
      pre-treatment and 6 weeks after treatment , and the effectiveness of the modified pilates
      exercises will be examined in the chronic neck pain. Our hypothesis is ''Modified pilates
      exercises have a positive effect on neck pain, range of motion, deep neck flexor muscles,
      joint position sense and function in patients with chronic neck pain.''
    

Intervention name(s): modified pilates exercise; daily life advises
Intervention type(s): Other; Other
Intervention description(s): modified exercises from original pilates exercises.; they will be given daily life advises to prevent neck pain
Other intervention name(s): daily routine advises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; pilates; modified pilates; chronic neck pain
Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders
Condition: Auditory Processing Disorder, Central; Stroke
MeSH terms: Auditory Perceptual Disorders; Stroke; Language Development Disorders
Study type: Interventional

Summary: 
      This study aimed to evaluate long term benefits in speech reception in noise, after daily 10
      week use of an assisting listening device (personal frequency-modulates systems) , in
      non-aphasic stroke patients with auditory processing deficits.
    

Detailed description: 
      Stroke can affect all levels of the auditory pathway. Approximately one in five stroke
      survivors report severe difficulties when listening to speech-in-noise, despite normal
      hearing, attributed to abnormal processing of sounds within the brain, and these individuals
      are more likely to experience communication difficulties in poor acoustic environments, The
      patient with significant auditory deficits and functional limitations may require a range of
      rehabilitation and remediation approaches. Several studies conclusively demonstrate
      substantial improvements in speech recognition in noise when using personal
      frequency-modulated (FM) systems. These devices are used to improve speech perception in
      noise in adults with neurological disorders including stroke with good immediate benefits.
      However, the long-term benefits of FM systems in stroke patients has not been studies. In
      this research study the investigators aimed to investigate the long term benefits in speech
      reception in noise in non-aphasic stroke patients and measure the potential improvement in
      unaided speech in background noise performance after 10 weeks.
    

Intervention name(s): personal frequency modulated systems
Intervention type(s): Other
Intervention description(s): patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks
Other intervention name(s): FM systems
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from
      prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype
      extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg
      extended release tablet of BMS-663068.
    


Intervention name(s): BMS-663068
Intervention type(s): Drug
Intervention description(s): BMS-663068
Intervention MeSH terms: Fostemsavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Efficacy of Preseasonal Omalizumab Treatment
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the
      allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be
      divided into two kinds, perennial AR and seasonal AR (SAR).

      In recent years, biologics have become promising drugs for allergic diseases. The efficacy
      and safety of Omalizumab in treating SAR have been well proven by previous studies. However,
      the efficacy in preseasonal treatment for SAR has not yet been studied before.
    


Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prebiotic Effects on Glucose Tolerance
Condition: Diet Prevention of Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The primary purpose of this project is to evaluate effects in healthy humans on glucose
      tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues
      are to investigate effects of the test foods on subjective appetite variables, mood variables
      and gut microbiota composition. The test food products will be consumed in the evening and
      test variables will be determined the next morning. The study will apply a randomized
      crossover study design.
    


Intervention name(s): Cereal based products
Intervention type(s): Other
Intervention description(s): The cereal products are made from common Swedish cereals.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study design. Healthy young adult volunteers.
Masking: Single (Participant)
Primary purpose: Prevention
Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery
Condition: Horner's Syndrome
MeSH terms: Horner Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial
      plexus blocks in the patients undergoing arthroscopic shoulder surgery.
    

Detailed description: 
      This study aims to compare supraclavicular brachial plexus block to interscalene brachial
      plexus block with regard to degree of sensory and motor blockades, side effects and
      complications of the blocks, and frequency of intraoperative analgesics or antihypertensives
      use.
    

Intervention name(s): Supraclavicular block; Interscalene block
Intervention type(s): Other; Other
Intervention description(s): Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.; Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Supraclavicular brachial plexus block; Interscalene brachial plexus block; Arthroscopic shoulder surgery
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the longterm impact on cardiovascular morbidity and
      mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight
      and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated
      cardiovascular risk receiving usual care, and compare outcome against glimepiride.
    


Intervention name(s): linagliptin; glimepiride; linagliptin placebo; glimepiride placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): linagliptin tablets 5mg QD; glimepiride over-encapsulated tablet 1-4 mg QD; linagliptin placebo; glimepiride placebo
Intervention MeSH terms: Glimepiride; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Properties and Clinical Performance of Zirconia-based Dental Ceramics
Condition: Dental Restoration Wear
Study type: Interventional

Summary: 
      The objectives of this study are to determine the clinical performance of zirconia-based
      dental prostheses and their related properties.
    

Detailed description: 
      Zirconia has been used in dentistry since 2000 for constructing fixed partial denture. Its
      advantages are high fracture resistance, excellent biocompatibility, moderate opacity, etc.
      Because the increase in demand for more esthetic restoration, zirconia becomes more popular
      for use as a core material for all-ceramic systems. Its properties have been investigated
      extensively in many in vitro studies. However, clinical performance of zirconia-based
      restorations would require a period of time before the results can be assessed. Currently,
      there are not much results regarding clinical performance of zirconia-based prosthesis and
      more information are required for future research.
    

Intervention name(s): ceramic crown
Intervention type(s): Other
Intervention description(s): Zirconia
Other intervention name(s): Zirconia
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: crowns; ceramics
Parent Skills Training for Families of Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The study is focused on helping parents master the basic intervention skills and evaluate the
      effectiveness of this parental training style for children with autism spectrum disorder in
      China.
    

Detailed description: 
      The investigators designed a set of parental training curriculum about early intervention.

      The curriculum consists of three units: (1) Delivery of theoretical intervention knowledge
      and analysis of successful training cases; (2) Commenting and making suggestion on
      parent-child interaction videos; (3) Demonstration of intervention skills and practice .The
      contents of the curriculum involved setting up an environment, developing objectives (verbal
      communication, non-verbal communication, social interaction, imitation, fine motor skills,
      etc.), designing activities, dealing with challenging behavior. This study will help parents
      master the basic intervention skills(how to set up an environment, develop objectives, design
      activities, deal with challenging behavior, etc) . At last the investigators will evaluate
      the effectiveness of this parental training style for children with autism spectrum disorder
      in China.
    

Intervention name(s): Parent skills training
Intervention type(s): Behavioral
Intervention description(s): Parents of children with autism spectrum disorder attend the parental training course once a week, and there was a total of eight courses with each course lasting 3 hours
Other intervention name(s): PST
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Inflammatory Markers in LARC Patients
Condition: Locally Advanced Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Introduction: In locally advanced rectal cancers (LARC), TNM staging is far from optimal. We
      aimed to investigate the value of previously described circulating biomarkers as predictors
      of prognosis.

      Methods: Retrospective analysis of 245 LARC patients diagnosed between January 2010 and
      December 2022, who underwent neoadjuvant chemoradiotherapy and surgery at two centers. A Cox
      regression and Kaplan-Meier analysis were performed.
    


Intervention name(s): Inflammatory markers
Intervention type(s): Diagnostic Test
Intervention description(s): analysis of inflammatory scores
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        as in inclusion criteria
Multi-frequency Bioelectrical Impedance for Estimating Total Body Water by Deuterium Dilution
Condition: Total Body Water Assessment
Study type: Observational

Summary: 
      SPECIFIC AIM:

      Determine the validity of the Biospace bioelectrical impedance devices compared to deuterium
      water (D2O) measurements.

      HYPOTHESIS:

      The Biospace Body Composition Analyzers are valid tools for measuring total body water and
      body composition.
    


Intervention name(s): observation
Intervention type(s): Other
Intervention description(s): no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: multi-frequency; bioelectrical impedance; body composition; hydration
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of the drug product at
      each dose level.
    


Intervention name(s): Botulinum toxin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
      lead over time to cervical cancer in women . This study will evaluate the immunogenicity and
      the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.
    

Detailed description: 
      Study participants will receive either HPV or hepatitis A vaccine, study duration will last
      for 7 months and involve a total of 4 visits.
    

Intervention name(s): HPV-16/18 L1/AS04
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Condition: Parkinson Disease; Depression
MeSH terms: Parkinson Disease; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the
      brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the
      brain (nerve cells) to control and harmonize muscle movements. Consequently, the main
      manifestations of the disease affect movement and include tremor, muscular rigidity, slowness
      in performing movements and loss of balance.

      However, the disease affects also other, non motor functions and may cause other disorders,
      such as depression. Depression may be a reaction to the disability caused by the disease, but
      many studies show that depression is more common in PD than in other chronic debilitating
      illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is
      also used in brain circuits involved in the experience of pleasure, and loss of pleasure in
      daily physical or social activity is one of the key manifestations of depression.

      The objective of the study is to assess whether pramipexole, at doses approved for the
      treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in
      PD patients.

      Also data on the safety of the product in the disease will be collected.
    


Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dopamine agonist
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment