bioihbjkbjnl/mcl2 huggingface dataset:
is the Sclerostin Marker of Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Reviewed literature suggests that sclerostin will inhibit the bone formation and ultimately
      leads to chronic periodontitis. Estimation of Sclerostin levels in the serum of periodontitis
      patients before and after intervention could explore the effectiveness of therapy and also
      give a more detailed insight into its diagnostic and prognostic potential as a biomarker of
      periodontal disease.
    

Detailed description: 
      Advances during the last decade provided relevant information on the regulation of
      Sost/sclerostin and its mechanism(s) of action. Several stimuli have been reported to
      regulate Sost/Sclerostin expression, however how these factors interplay to regulate the
      expression of this gene in a spatiotemporal manner is unknown. Animal studies demonstrate
      that sclerostin is key for skeletal homeostasis, and required for the bone anabolic response
      to mechanical loading although appears dispensable for PTH-induced bone gain. The knowledge
      provided by preclinical investigations resulted in clinical trials based on the
      neutralization of sclerostin activity as a novel osteoanabolic therapeutic approach. It is
      now clear that sclerostin is capable of uncoupling bone formation and bone resorption, by
      inhibiting osteoblast function while stimulating osteoclast function, as the bone gain
      achieved by pharmacologic inhibition of sclerostin results from stimulation of osteoblast
      activity and inhibition of bone resorption. Furthermore, the recent observations show that
      activation of βcatenin in osteocytes increases bone resorption and Rankl production in a
      sclerostin-dependent manner. Anti-sclerostin therapy has shown beneficial skeletal outcomes
      in osteoporotic patients, however more recent evidence shows that the anabolic effects of
      this therapy attenuate with time and that after discontinuation BMD returns to pretreatment
      levels over time. The new evidence showing increased levels of Sost/sclerostin (and Dkk1)
      after activation of Wnt-βcatenin signaling suggest that sclerostin (and Dkk1) act as a
      negative feedback limiting bone formation stimulated by this pathway.

      In this study is there any alterations in sclerostin levels in serum response to periodontal
      therapy was checked. Periodontal therapy alters the inflammation pathway is a proven fact.
    

Intervention name(s): non surgical and surgical periodontal therapy
Intervention type(s): Other
Intervention description(s): scaling and root planing periodontal flap surgery
Intervention model: Sequential Assignment
Intervention model description: interventional prospective study
Masking: None (Open Label)
Primary purpose: Screening
Keywords: periodontitis; sclerostin; periodontal surgery; scaling and root planing
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
Condition: Therapeutic Treatment of Inhalation Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in
      healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months
      ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable
      female subjects) will receive a second dose of raxibacumab equal to that of the previous dose
      >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1
      and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab
      has been shown to provide improved survival in rabbit and monkey anthrax spore challenge
      studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival
      benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can
      occur more than once, especially in individuals who do not develop protective immunity.
      Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for
      the repeat administration of raxibacumab. The rationale of the study is to evaluate the
      immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval
      between dosing.
    


Intervention name(s): Raxibacumab
Intervention type(s): Biological
Intervention description(s): Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Monoclonal Antibody; Safety; Raxibacumab; HGS1021; Immunogenicity
Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance
Condition: Cardiac Surgery
Study type: Observational

Summary: 
      The aim of this study is to compare the sedation effects between remifentanil and
      dexmedetomidine in post-cardiac surgical patients who developed noninvasive ventilation (NIV)
      intolerance.
    

Detailed description: 
      This study is a prospective,observational,cohort study. Data of post-cardiac surgical
      patients who receives noninvasive ventilation (NIV) in the investigators' cardiac surgical
      intensive care unit are prospectively collected into a database for further analyzation since
      January 2018. Tolerance of NIV is estimated by a four-point NIV intolerance score system: A
      score of 1 indicates a comfortable and relaxed patient tolerating NIV; a score of 2 indicates
      mild intolerance with some discomfort and occasional grabbing at the NIV mask; a score of 3
      indicates moderate intolerance and discomfort with the NIV mask most of the time with
      frequent grabbing at the mask (sometimes pulling it off); and a score of 4 indicates severe
      NIV intolerance with agitation or/and an inability to leave the NIV mask in place.
      Participants who receives re-intubation will be recorded as 4 points. Application of
      remifentanil or dexmedetomidine will be initiated when a score of 3 or 4 was recorded,
      according to the intensivists' preference.Depending on the sedation regime applied, patients
      with NIV intolerance are divided into two groups: remifentanil group and dexmedetomidine
      group.The investigators will compare the two groups with the NIV intolerance score at
      15min,1, 3, 6, 12, 24, 48, 60 and 72 hours after the initiation of the sedation regime. The
      investigators will also compare the two groups with clinical outcomes such as NIV failure,
      tracheotomy rate, mortality, ICU length of stay etc.
    

Intervention name(s): Remifentanil; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): The noninvasive ventilation intolerated patients was sedated by remifentanil.; The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult cardiac surgical patients who receive NIV and develop moderate to severe
        intolerance (NIV intolerance score of 3 or 4) between January 2018 and December 2019 in our
        CSICU will be enrolled in this study.
      
Keywords: noninvasive ventilation; remifentanil; dexmedetomidine; cardiac surgery
RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
Condition: Severe Eosinophilic Asthma; Nasal Polyps
MeSH terms: Asthma; Nasal Polyps; Pulmonary Eosinophilia; Polyps
Study type: Observational

Summary: 
      The purpose of this observational study is to describe the population of patients with SEA +
      NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and
      asthma.
    

Detailed description: 
      In light of the increasing importance of comorbidities in driving choice for biologics in
      severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom
      the decision to start biologics was based on the presence of severe, uncontrolled asthma.
      This retrospective, observational study will describe the population of patients with SEA +
      NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and
      asthma.
    

Intervention name(s): FASENRA(benralizumab)
Intervention type(s): Other
Intervention description(s): This is a retrospective, observational study with secondary data collection utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis.
Intervention MeSH terms: Benralizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is SEA + NP patients on benralizumab.
      
Keywords: Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
Nutrition, Physical Performance & Fitness in Indian School Children
Condition: Physical Fitness; Nutritional Status
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of nutritional supplement on physical
      performance measures of apparently healthy school going children in India.
    

Detailed description: 
      Nutritional status may be important in achieving optimal physical performance. There is
      evidence of significant improvements in physical fitness, aerobic capacity and anaerobic
      threshold of children and adolescents with nutritional intervention, albeit in children with
      initial sub-optimal nutritional status. This may be of particular relevance in developing
      countries like India, where there is limited data on physical fitness and a wide-spread
      prevalence of concurrent micronutrient deficiencies even in apparently normal school age
      children. The present study therefore, is designed to assess the effect of a nutritional
      supplement on the physical performance measures of school going children. This is a
      randomized, double blind placebo-controlled study of three treatment groups (1 test, 1
      positive control (placebo) and 1 'no intervention') conducted in equal numbers of male or
      female children [ages 7-11] attending day schools in Bangalore. Subjects in the intervention
      (test and positive control) groups will receive study treatments (fortified or un-fortified
      nutritional powder) once a day for 4 months. The treatments will be administered under
      supervision on all school working days; for the weekend and other holidays, sachets will be
      provided for home consumption. At baseline and 4months, physical performance tests will be
      administered and blood sample drawn to assess nutritional status. Other selected outcome
      measures such as nutrition status and muscle strength/ endurance will also be assessed. It is
      hypothesized that after 4 months of intervention, children consuming fortified nutritional
      powder will have statistically significant improvements in physical performance/ fitness
      measures as compared to the two control groups.
    

Intervention name(s): Nutritional supplement; Placebo
Intervention type(s): Other; Other
Intervention description(s): Fortified nutritional powder; Un-fortified nutritional powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: physical performance; micronutrients; physical fitness; healthy children
D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals
Condition: Cocaine Use Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In summary, this pilot study will explore the use of an innovative pharmacologic approach to
      the treatment of substance dependence through the facilitation of extinction of response to
      cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this
      preliminary study, a controlled treatment trial will be planned. This novel approach could
      have implications for the treatment of multiple substance use disorders including
      methamphetamine, marijuana and opiate dependence.
    

Detailed description: 
      Cocaine dependence remains a serious problem in the US today and in spite of two decades of
      intense research, efficacious pharmacotherapeutic treatments have not been identified.
      Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related
      cues is likely to be involved in relapse. Emerging data supports the role of glutamate in
      extinction of associative learning in animal models of rear-conditioning and clinical studies
      of exposure treatment for anxiety disorders. A recent study demonstrated DCS acceleration of
      cocaine-induced conditioned place preference in rats. Exploration of DCS in facilitating
      extinction of response to drug-related cues in humans is needed. The proposed study will
      extend these innovative and promising findings from the basic science arena and anxiety
      disorders field in a proof of concept investigation of DCS facilitation of extinction of
      response to cocaine-related cues in a human laboratory paradigm.
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg DCS; Placebo
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: substance related disorders
The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile
Condition: Intrabony Periodontal Defect
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of citric acid on bone surface of infrabony defects when used
      for 30 seconds at ph 1 and 50% concentration before the application of bovine derived
      xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5
      different days during the first month after surgery and clinical and radiographic parameters
      were reassessed after 6 months
    

Detailed description: 
      Citric acid have been widely used to treat root surfaces of periodontally affected teeth in
      order to render it biologically suitable for fibroblast reattachment. however, systematic
      reviews showed no clinical significance when it was used as a root surface conditioner.
      Recently it was found in experimental studies that when citric acid was used on bone surface
      for a brief period, it increased bone formation and improved consolidation of grafted bone to
      bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50%
      concentration for 30 seconds before washing it off and then application of bovine derived
      xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by
      taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and
      radiographic parameters were taken after 6 months of follow-up
    

Intervention name(s): Citric acid; Control Test
Intervention type(s): Drug; Drug
Intervention description(s): Citric acid ph1, 50% concentration solution; Control group, xenograft was used to fill infrabony defects without treating bone surface
Other intervention name(s): Control
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Condition: HIV Infections; HIV-Associated Lipodystrophy Syndrome; HIV Lipodystrophy Syndrome; Lipodystrophy; Dyslipidemia; Osteoporosis; Osteopenia
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Osteoporosis; Bone Diseases, Metabolic; Lipodystrophy; Dyslipidemias; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to assess the prevalence of metabolic and physical abnormalities
      in HIV infected (via mother-to-child transmission) and uninfected children and youth.
      Metabolism, body composition, bone density, and other factors will be assessed in
      relationship to participants' exposure to highly active antiretroviral therapy (HAART).
    

Detailed description: 
      Despite advances in HIV care associated with HAART, many patients on HAART regimens develop
      physical and metabolic problems, including changes in body fat distribution (lipodystrophy),
      osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that
      protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and
      skeletal complications in HAART-treated patients. This study will compare HIV infected,
      HAART-treated children and youth and their uninfected counterparts to make connections
      between HAART, HLS, and skeletal and metabolic problems. The study is the first to address
      the prevalence and risk assessment of these complications in children, and will be useful in
      predicting long-term prognosis in HIV patients who use or have used HAART.

      There will be three groups in the study. Group 1 participants will be uninfected volunteers
      who will receive no protocol-specific treatment or other intervention. Vertically infected
      HIV patients in Groups 2 and 3 will continue their current HAART either on a
      non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening
      evaluations will be conducted within 30 days prior to study entry. Study evaluations may be
      completed at study entry or over the course of up to 3 study visits. All participants will
      undergo whole body and regional DEXA scans (to assess bone density), measurements to
      determine sexual maturity, and blood work.
    

Keywords: HIV-Associated Lipodystrophy Syndrome; HIV Lipodystrophy Syndrome; Treatment Experienced; Lipodystrophy; Dyslipidemia; Osteoporosis; Osteopenia
Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults
Condition: Social Isolation; Mental Status Change; Cognitive Impairment; Physical Activity; Quality of Life; Self-Perception
Study type: Interventional

Summary: 
      The purpose of this community-engaged project is to examine how taking part in different arts
      (dance & music), compared to control (no arts) affects older adults' Health-Related Quality
      of Life (HRQoL using the Short Form-20(SF) form), physical performance (Short Physical
      Performance Battery-SPPB), cognition (using the Montreal Cognitive Assessment-MoCA), social
      engagement (National Social Life, Health, & Aging Project-NSHAP survey), and perceptions of
      self (focus interviews).
    

Detailed description: 
      In this Randomized-Controlled-Trial, 60 adults (20/condition) will take part in 20, 45-minute
      sessions (ballroom dance, ukulele/guitar playing, or control- i.e. social conversation), 2
      times/week for 10 weeks.

      While the investigators know that arts participation improves function in older adults, exact
      effects of different arts programs on health outcomes remains unclear.

      The investigators plan to fill this gap by studying how different arts participation affect
      health outcomes.

      The overall aim is to study how arts engagement helps older adults remain active and
      influences physical, psychological, and emotional functioning.
    

Intervention name(s): Active Social Conversation
Intervention type(s): Other
Intervention description(s): Active Social Conversation
Other intervention name(s): Active Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dance; Music; Social Conversation
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine pediatric vaccinations in Spain.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7-valent Pneumococcal Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Pneumococcal; Pediatric; Vaccine
Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy
Condition: Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia); Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe); Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)
MeSH terms: Eclampsia; Pre-Eclampsia; Proteinuria; Albuminuria; Hypertension, Pregnancy-Induced; Hypertension
Study type: Observational

Summary: 
      The utilization of external cardiohemodynamic patient assessment, applying non-invasive
      stick-on contact patches to the mother's neck on either side and chest wall on either side,
      enables the practitioner to have information about the patient's cardiac function and
      vascular status beyond simply blood pressure and pulse. This information, once collected,
      should open the practitioner's eyes to better assess the patient's disease status and her
      response to therapy. We will use this information to compare the effectiveness of the two
      standard medications used for treatment of maternal high blood pressure.
    

Detailed description: 
      Pregnant patients with severe acute hypertension due either to superimposed preeclampsia,
      severe preeclampsia or severe gestational hypertension will be randomized to receive either
      of two antihypertensive agents (hydralazine or labetalol). Just before drug administration
      and immediately thereafter impedance cardiography of the patient will be undertaken and the
      results analyzed relative to the cardiac profile and the drug administered to reduce the
      severe hypertension.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous or parous patients with severe hypertension, a singleton gestation, gestational
        age greater than 20 weeks along who are admitted to the Wiser Hospital for Women and
        Infants at the University of Mississippi Medical Center.
      
Biospecimen description: 
      One tube of blood