bioihbjkbjnl/mcl2 huggingface dataset:
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
Condition: Pneumonia; Meningitis; Otitis Media
MeSH terms: Otitis Media; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal
      vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the
      Telethon Institute for Child Health Research and the Department of Paediatrics, University of
      Western Australia will collaborate to examine very closely the safety of neonatal
      vaccination, particularly with regard to impact on the development of immunity and response
      to other vaccines given to infants. This study will also provide a unique opportunity for
      training of PNG and Australian scientists in both countries.
    

Detailed description: 
      In order to obtain the earliest possible protection against invasive pneumococcal disease,
      achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate
      vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol
      312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant
      schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule)
      or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4
      months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of
      age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed
      weekly for the first month of life and at regular intervals thereafter. There will be ongoing
      surveillance for respiratory and other diseases throughout the study. In addition to
      serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell
      cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety,
      particularly for neonatal PCV, immune responses to concomitant vaccines and viral and
      environmental antigens will also be examined as well as overall T-cell maturation.
    

Intervention name(s): Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Intervention type(s): Biological
Intervention description(s): Accelerated PCV vaccinaton.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Antibody responses; Cellular immunology; Th1/Th2 immune responses; Paediatric; Neonatal; Infectious diseases; Papua New Guinea
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722).
      The objectives are:

        -  To describe the antibody persistence to any antigen contained in the investigational
           DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose

        -  To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep
           B-PRP-T or Infanrix hexa™ vaccine.

        -  To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.
    

Detailed description: 
      All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in
      this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to
      receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

      Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T
      combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.
    

Intervention name(s): DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide; DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide; DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular each into the right and left deltoid muscle; 0.5 mL, Intramuscular each into the right and left deltoid muscle; 0.5 mL (each), Intramuscular each into the right and left deltoid muscle
Other intervention name(s): DTaP-IPV-Hep B-PRP~T vaccine; Prevenar™; Infanrix hexa™; Prevenar™; DTaP-IPV-Hep B-PRP~T combined vaccine; Prevenar™
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Pediatric combined vaccine; Invasive Hib infections
Risk Factors for Aortic Dissection in the Chinese Patients
Condition: Persistent Blood Flow in False Lumen of Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese
      patients.
    

Detailed description: 
      Aortic dissection (AD) is a life-threatening cardiovascular disease with high mortality.
      Without optimal treatment, approximately 50% of patients die within one week of the onset of
      symptoms, and 80% die within 2 weeks. With the change of life-style and the development of
      diagnostic technology, the incidence and detection rate of AD were increasing in China
      recently. However, the cause remains unclear. Studies showed that AD were associated with
      some risk factors, such as hypertension, connective tissue disease, iatrogenic injury, drug,
      pregnancy, etc. It is reported that two thirds patients with AD had a history of
      hypertension; 50% patients aged <40 years were accompanied with hereditary Marfan syndrome;
      13～19% had a familial history of aortic aneurysm or dissection. These epidemiological data
      were obtained from Caucasian population, however, such information was not available for the
      Chinese population. Moreover, epidemiological investigation was absent in China, and the
      assessment of risk factors for AD was mainly referred to the studies from developed
      countries. Therefore, the aim of our study was to evaluate epidemiological features of risk
      factors for AD in Chinese patients using 3045 individuals from the 15 major centers in China.
      We anticipated that this analysis would provide helpful information preventing and
      controlling AD in China.
    

Intervention name(s): observation
Intervention type(s): Other
Intervention description(s): Data were collected by a disigned form. Statistic software was used to analyze clinical data.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Between January, 2011 and December, 2012, we collected 3045 patients with AAD (1668 with
        type A and 1377 with type B) from 15 major centers in China as the case group. As the
        control group, 2760 patients without AD were obtained from the hospitalized patients in the
        same period.
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating
      the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal
      atrial fibrillation.
    

Detailed description: 
      Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be
      screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will
      then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.),
      followed by concomitant cardiac surgery. Subjects will be followed at 7 days, 30 days, 3
      months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or
      atrial tachycardia of 3 months following the index ablation procedure.
    

Intervention name(s): IOWA Approach Cardiac Ablation System
Intervention type(s): Device
Intervention description(s): Epicardial ablation using the IOWA Approach Cardiac Ablation System
Intervention model: Single Group Assignment
Intervention model description: Patients with paroxysmal atrial fibrillation undergoing cardiac surgery and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Cardiac Ablation System.
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
Condition: Seasonal Affective Disorder; Vitamin D3; Mental Health; Dietary Supplement
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than
      placebo in preventing depression symptoms among employees in health care
    

Detailed description: 
      Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun.
      Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D [25(OH)D], which
      is the storage form of vitamin D in the body, and then in the kidney into the steroid
      hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D [1,25(OH)2D].

      At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season.
      Half of Danes have low levels of [25(OH)D] in the blood and especially in the early spring
      months the levels of [25(OH)D] are low. In addition, Vitamin D3 is absorbed through the gut
      from vitamin D-rich food sources. But several studies show that it is not possible through a
      recommended diet, which consists of 300 g of fish per week to consume adequate amounts of
      vitamin D3.

      New research suggests link between vitamin D3 and brain function.In the Central Nervous
      System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes
      necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.

      In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive
      function, anxiety and depression.

      The objective of this randomized clinical trial is to investigate whether indoor employees,
      with tendency to depressive symptoms in the winter season, should be offered vitamin D3
      supplements during the Winter season, or it has no significance in relation prevent
      depressive symptoms.

      The study is carried out in the winter season in the Region of Southern Denmark for 12 weeks
      and offered to health service staff, who have a tendency for depressive symptoms in the
      winter season.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 70µg Vitamin D3, daily, 12 weeks; Placebo, daily, 12 weeks
Other intervention name(s): Active
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SPAQ; Sigh-SAD; Hamilton 29; Vitamin D3; p25(OH)D
Influence of a High Fat Breakfast in the Pharmacokinetics of UH-AC62MU in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Influence of a high fat breakfast in the pharmacokinetic profile of the 7.5 mg meloxicam
      rapid releases tablet
    


Intervention name(s): meloxicam rapid release tablet, 12mg, UH AC62MU
Intervention type(s): Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PACIFIC-FIT: Providing Adults Collaborative Interventions for Ideal Changes Focused Intervention and Tracking
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The pilot study will be a one group treatment program and will be utilized to refine the
      M+BWL program.
    

Detailed description: 
      The investigators have developed a new model for the treatment of obesity, which emphasizes
      the role of memory on food consumption in an overweight population.The pilot study will be an
      open label trial of a memory+behavioral weight loss (M+BWL) group treatment. The treatment
      will be administered in 14 group sessions over 16 weeks. The investigators will recruit
      adults with overweight and obesity and will assess them at baseline (prior to treatment),
      during treatment, post-treatment (immediately following treatment), and follow-up (3 months
      after treatment). Assessments will include body mass index (BMI), body composition, and binge
      eating over the course of treatment and follow-up. This study will contribute to the study of
      basic behavioral mechanisms and food intake, could provide a novel model for the treatment of
      obesity, and could inform clinical decision making regarding obesity treatment.
    

Intervention name(s): Memory + Behavioral Weight Loss
Intervention type(s): Behavioral
Intervention description(s): BWL and memory enhancement (M+BWL) will be integrated to capitalize on the strengths of both treatments. All participants will be taught general behavioral weight loss skills including to decrease caloric intake and increase physical activity, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss. The proposed M+BWL program provides memory interventions based on the literature, including eating attentively, memory of previous meal, memory skills for planning, effects of diet on memory and the relationship between memory and satiety. The M+BWL program will also utilize experiential learning during the group program such as practicing memory enhanced skills during eating.
Other intervention name(s): M+BWL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Overeating; Body Mass Index; Weight; Treatment; Cravings; Intervention; Behavioral Treatment
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on
      the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).
    


Intervention name(s): Natalizumab
Intervention type(s): Drug
Intervention description(s): As described in the treatment arm.
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been
        prescribed natalizumab under standard clinical care.
Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
Condition: Degeneration of Lumbar Intervertebral Disc
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The purpose of this clinical investigation is to evaluate the Aspen™ device compared to
      pedicle screw instrumentation for posterior fixation in the treatment of patients with
      degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to
      pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of
      fusion.
    

Detailed description: 
      This is a multi-center, prospective randomized clinical study to evaluate the clinical
      outcome of subjects with degenerative disc disease (DDD) (defined as back pain of discogenic
      origin with degeneration of the disc confirmed by history and radiographic studies) and/or
      spondylolisthesis utilizing either Aspen Spinous Process Fixation System or Pedicle Screws
      for supplemental posterior instrumentation as an adjunct to an anterior or lateral approach
      to lumbar interbody fusion.

      The primary hypothesis is that change in Oswestry Disability Index (ODI) of subjects in the
      study group (Aspen) will be non-inferior to the control group (pedicle screw
      instrumentation). The non-inferiority margin is pre-specified to be 10 ODI score points. If
      the non-inferiority is established, superiority of Aspen to the control will be tested.

      The study will involve up to 25 investigational sites. Enrollment is expected to take
      approximately 24 months. Subjects will be followed for 2 years, with the anticipated duration
      of the study being approximately 4 years from start to finish.
    

Intervention name(s): Aspen Spinous Process Fixation Device; Pedicle Screws
Intervention type(s): Device; Device
Intervention description(s): The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF); Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuro Linguistic Programming Pain Levels After Cesarean Delivery
Condition: Nursing Caries; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was conducted to determine the effect of Neuro-Linguistic Programming (NLP)
      application on post-cesarean section pain levels.
    

Detailed description: 
      The study was carried out between March 1 and June 1, 2021 with mothers who gave birth
      through cesarean section in the postpartum service of a maternity and children's hospital in
      the most populated city of Turkey, which is located in the west. The study data consists of a
      total of 76 individuals, including 38 in the experimental group and 38 in the control group.
      In the study, the effect size was calculated as 2.22. Accordingly, the power of the study,
      which was completed with 38 individuals in the control group and 38 in experimental group,
      had an effect size of 2.22, and used a significance level of 0.05, was calculated as 99.9%.
      The power analysis was conducted on the G*Power software package.
    

Intervention name(s): NEURO-LINGUISTIC PROGRAMMING (NLP)
Intervention type(s): Behavioral
Intervention description(s): ● One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was conducted by using a prospective randomized single-blind clinical trial model.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: NLP, cesarean section, postpartum, pain
Fitness, Hearing and Quality of Life in Older Adults With Hearing Loss. Walk, Talk and Listen for Your Life
Condition: Hearing Loss, Functional
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Functional
Study type: Interventional

Summary: 
      This study examines the effect of an exercise and health education/auditory rehabilitation
      and socialization intervention on functional fitness, hearing handicap and psychosocial
      distress measures in older adults with hearing loss.
    

Detailed description: 
      Hearing loss is associated with functional fitness declines and increased risk for isolation,
      dementia, depression, falls, hospitalization and premature mortality. No studies have
      determined the effect of an exercise intervention on these measures in older adults with
      hearing loss.

      After baseline assessment of function fitness and several psychosocial measures, 60 older
      adults with hearing loss will be randomized into a 10 week exercise, health education,
      socialization and auditory rehabilitation program or auditory rehabilitation alone. The
      exercise program consists of 3/4 of an hour strengthening and resistance training followed by
      30 minutes of group walking. The educational session content is determined by participants
      and is interactive and may include such topics as wills and probate, diabetes treatment,
      healthy exercise etc. The 3/4 of an hour auditory rehabilitation sessions are modified from
      an online program and will include interactive sessions on education about hearing and
      hearing devices/technologies, psychosocial support and enhancing communication skills.

      At the end of the 10 week intervention the assessments of functional fitness and psychosocial
      measures will be repeated. The group that was randomized to the auditory rehabilitation alone
      will then be offered the exercise program.
    

Intervention name(s): Exercise + health education+ auditory rehabilitation; auditory rehabilitation alone
Intervention type(s): Other; Other
Intervention description(s): comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation; 10 weeks of one hour per week of group auditory rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention