bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the breadth of protection against meningococcal disease in humans
      immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®"
      manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate
      underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated
      bactericidal activity.
    

Detailed description: 
      Neisseria meningitidis causes meningitis and severe infections of the blood stream. The
      incidence of serogroup B meningococcal disease however is too low to conduct a randomized,
      controlled trial to determine the actual efficacy of the new serogroup B vaccines. Instead
      vaccine efficacy was inferred from serum bactericidal antibody responses using four test
      strains. However, because of strain variability of FHbp amino acid sequence (there are more
      than 800 sequence variants described) and strain variability of FHbp expression, bactericidal
      data on only four strains are unlikely to be sufficient to predict the actual strain coverage
      by the vaccine. There also are gaps in knowledge about the underlying mechanisms by which
      human antibodies to FHbp elicit complement mediated bactericidal activity. For example,
      binding of FH to FHbp is specific for human FH. Therefore in vaccinated humans the vaccine
      antigen is expected to form a complex with FH right after immunization. The investigators'
      hypothesis is that binding of human FH to the vaccine antigen skews the antibody repertoire
      to FHbp epitopes located outside of the FH combining site. The resulting antibodies would be
      expected not to inhibit binding of FH to the bacteria. This hypothesis will be investigated
      in Trumenba-immunized humans as part of studies in Aim 1 (and in future studies of
      recombinant human anti-FHbp Fabs that will be enabled by obtaining DNA from individual B
      cells, described in Aim 2).
    

Intervention name(s): Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)
Intervention type(s): Biological
Intervention description(s): All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.
Other intervention name(s): MenB-FHbp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Meningococcal Vaccines; Neisseria Meningitidis; Factor H-binding Protein
Transdermal Contraceptive Patch - Endometrial Effects Study
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study is to investigate the effects of the transdermal patch on the
      endometrium in healthy women who require contraception.
    


Intervention name(s): Ethinylestradiol/Gestogene (BAY86-5016)
Intervention type(s): Drug
Intervention description(s): 7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Intervention MeSH terms: Ethinyl Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fertility control; Contraception
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Condition: Anxiety; Preoperative Care; Pharmacokinetics; Emergence Delirium
MeSH terms: Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and
      reduce perioperative complications. The investigators would explore the sedative effects of
      dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and
      detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters
      are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min,
      60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each
      time point. The blood samples are detected by mass spectrometer. The aim of this study is to
      investigate appropriate administration time and route for DEX sedation.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): oral, intravenous and nasal administration of Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexmedetomidine
Effect of Connective Tissue Graft Position
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Aim: The aim of this study was to compare the root coverage and aesthetic results of CAF+ CTG
      positioned apical to the CEJ (CAF+CTG-ACEJ) with CAF+CTG positioned on the CEJ (CAF+CTG-CEJ)
      for treating isolated gingival recession defects.

      Methods: Thirthy-eight patients with Miller class I and II gingival recessions were enrolled.
      19 patients were randomly assigned to the CAF+CTG-ACEJ group or CAF+CTG-CEJ group. Clinical
      and aesthetical evaluations were made at 6 months.
    


Intervention name(s): Coronally advanced flap + connective tissue graft
Intervention type(s): Procedure
Intervention description(s): connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: connective tissue graft
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the present study is to determine if use of dietary supplement
      tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.
    

Detailed description: 
      The notion that cellular stress lowers insulin-induced vasodilation is largely founded on ex
      vivo studies and experiments in rodents. However, it remains unknown if maintenance of
      cellular function with the use of dietary supplement tauroursodeoxycholic acid enhances
      vascular function in humans. The investigators test the hypothesis that daily administration
      of this dietary supplement enhances vascular function, particularly, insulin-stimulated leg
      blood flow and glucose disposal.
    

Intervention name(s): Tauroursodeoxycholic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.; Taking daily placebo capsules for 4 weeks.
Intervention MeSH terms: Ursodoxicoltaurine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-blinded randomized crossover study
Masking: Single (Participant)
Primary purpose: Basic Science
Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine
      drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to
      determine the safety, tolerability, and cue reactivity effects of NAC in cocaine dependent
      individuals and non-dependent healthy controls.
    

Detailed description: 
      Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces
      cocaine-primed drug-seeking behavior in formerly cocaine dependent rats. The purpose of this
      study is to determine the safety, tolerability, and cue reactivity effects of NAC in cocaine
      dependent individuals and non-dependent healthy controls.

      Participants in this study will include 20 non-treatment seeking cocaine dependent
      individuals and 12 healthy, non-dependent controls. Participants will be recruited via
      word-of-mouth and advertisements. Cocaine dependent participants will undergo two 3-day
      hospital stays. Healthy controls will be followed throughout the study on an outpatient
      basis. All participants will be randomly assigned to receive either 600 mg of NAC or placebo.
      Medication or placebo will be administered twice each day. Participants will be evaluated for
      side effects throughout the study. After administration of the final dose of medication or
      placebo, participants will undergo cue reactivity testing. This will include a standardized
      protocol of slides demonstrating cocaine acquisition, use of cocaine, and cocaine-related
      paraphernalia. Before, during, and after cue reactivity procedures, standardized behavioral
      and cognitive scales will be used to assess cocaine craving, cocaine seeking, and subjective
      effects of the cocaine "high." The following week participants will be crossed over so that
      they will receive the other treatment. All study procedures will be performed a second time.
      Participants will be contacted during Week 3 in order to determine if any residual side
      effects or adverse events occurred from the medication and treatment.
    

Intervention name(s): N-Acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cocaine; treatment
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this trial we compare the effect of 2 closure techniques of the rectus sheath during
      cesarean sections on postoperative pain. One closure technique is double lock technique and
      the other is the conventional continuous non-locking technique.
    


Intervention name(s): lower segment cesarean section and double lock closure of rectus sheath; lower segment cesarean section and continuous non-locking closure of rectus sheath
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The goal of this project is to examine the physical activity and screen-time environment of
      licensed childcare centers before and after the enactment of new state regulations.
    

Detailed description: 
      Pause and Play will take a prospective observational epidemiological approach before and
      after enactment of new regulations. 10 childcare centers licensed in East Baton Rouge Parish
      will be randomly selected and standardized behavioral observation scales will be used to
      objectively quantify the physical activity and screen-time environment of the centers and the
      children's behaviors both in and outside the center. These assessments will be collected
      twice during the 2-year grant period to capture potential changes after the policies are
      implemented.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ten licensed DOE Class A or B childcare centers will be randomly selected from a list of
        all DOE licensed childcare centers in East Baton Rouge Parish (EBR)
      
Keywords: childcare center regulations; physical activity; sedentary behavior; screen-time behavior
Can RFID Technology Capture Stair Walking
Condition: Physical Activity; Blood Pressure
Study type: Interventional

Summary: 
      There are two main aims for this study:

        1. conduct a proof-of-concept study illustrating how radio-frequency identification
           technology can be used to document the timestamps and duration of stair walking
           (ascending and descending stairs), and detect if an individual is stationary in the
           stairwell.

        2. assess the association of a 4-min bout of self-paced stair walking with changes in blood
           pressure, mood, and perceived exertion.
    

Detailed description: 
      Objective, passive methods for measuring physical activity participation can minimize error
      associated with self-report bias and cognitive processing. This study will test the utility
      of radio frequency identification (RFID) for the measurement of stair walking within
      buildings. RFID readers will be placed at stairwell entrances on each floor. Participants
      will wear a RFID tag. As the participant walks past the different readers going up and down
      the stairs, the reader will log the date and time. The frequency and duration of time in the
      stairwell can be calculated, as can an estimated speed.

      There are known effects for blood pressure (hypotensive) and moodafter exercise. However, few
      studies have assessed this effect for short bouts (<10 minutes) of exercise. Participants
      will have their pre- and post-stair walking blood pressure measured to determine the
      hypotensive and mood enhancing effects of four minutes of stair walking at a comfortable
      pace. Participants also will rate the exertion level of four minutes of stair walking at a
      self-selected pace.
    

Intervention name(s): Stair Walking
Intervention type(s): Behavioral
Intervention description(s): Walking up and down stairs for four minutes at a comfortable pace
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Radio Frequency Identification Device
Bioavailability of Clotiazepam 5 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pivotal study will investigate the bioavailability in fasting women of 1 Tablet
      formulations containing Clotiazepam 5 mg.

      The Pivotal study will be performed at a single site with 30 subjects. Participants will take
      1 Tablet of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 7 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of

      Clotiazepam of 1 tablet formulation with Clotiazepam 5 mg and to demonstrate bioequivalence
      of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Tecnandina S.A., Ecuador.

        -  Reference Product: Rize [Trademark], product of Mitsubishi Tanabe Pharma, Japan.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters área under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours
      (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl
      estradiol will be determined.

      Participants will be confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 12 hours post dosing) during which pharmacokinetic
      (PK) blood samples will be obtained. 18 blood samples will be taken up to 24 hours after the
      administration in each period. Participants will return to the site to provide additional
      blood samples at 24 h and 34 h postdose.

      The washout period between the two study periods will be at least 7 days. The samples from
      each participant will be analyzed with 2 methods of highperformance liquid
      chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel
      and Ethinyl estradiol in plasma.

      The safety objective is to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Clotiazepam 5 mg Test Product Coated Tablets; Clotiazepam 5 mg Reference Product Coated Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Rize (Trademark)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Asthma Phenotypes in the Inner City
Condition: Asthma; Rhinitis
MeSH terms: Rhinitis; Asthma
Study type: Observational

Summary: 
      This is an epidemiologic, multi-center, cross-sectional study to define the phenotypic
      characteristics of Difficult-to-Treat asthma, among children between the ages of 6 to 17
      years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.
    

Detailed description: 
      Asthma is a complex, heritable disease that affects more than 11.2% of the U.S. population,
      which represents approximately 9 million children and 23 million adults. Although the
      underlying characteristics of asthma exist in virtually all patients, the clinical expression
      of the disease and response to treatment are highly variable.

      The purpose of this study is to identify characteristics that will discriminate
      Difficult-to-Treat from Easy-to-Treat asthma in a defined inner-city population adherent to
      study-directed asthma treatment and management.
    

Intervention name(s): Guidelines-based asthma and rhinitis/rhinosinusitis therapy
Intervention type(s): Drug
Intervention description(s): All participants receive standardized asthma and rhinitis treatment. Asthma and rhinitis medication regimens were based on 1.) the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report -3 (EPR-3) and 2.) the Rhinitis and its Impact on Asthma (ARIA) 2008 guidelines-derived treatment algorithms. References: 1.) J Allergy Clin Immunol 2007; Volume 120, Issue 5, Supplement s93-140. 2.) Allergy 2008; Volume 63, Issue Supplement s86, pages 7-160.
Other intervention name(s): asthma controller medications; rhinitis/rhinosinusitis controller medications
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Inner-city Asthma Consortium (ICAC) children with mild to severe asthma
      
Biospecimen description: 
      Participants had the option of having blood, RNA, and DNA stored for use in future research
      studies.
    
Keywords: asthma; rhinitis; difficult-to-treat asthmatic; phenotypes
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and
      shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often
      referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the
      medial border of the scapula.
    

Detailed description: 
      Dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and
      the rhomboid muscles, and results in a winged scapula. A winged scapula is where the scapula
      protrudes from the patient's back and can affect the ability to lift objects or pull and
      push. The winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as
      seen as injury or paralysis of the serratus anterior muscle.

      Dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain.
      The scapular winging may be subtle, and the symptoms are easily mistaken for other problems.
      A careful history and physical exam, along with a high index of suspicion, are necessary for
      accurate diagnosis and therefore appropriate treatment. Injection of the dorsal scapular
      nerve under ultrasound guidance can be diagnostic as well as therapeutic.
    

Intervention name(s): Depo medrol
Intervention type(s): Drug
Intervention description(s): local injection
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of the Treatment of Spider Angioma
Condition: Spider Angioma
MeSH terms: Hemangioma
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of the laser treatment for the treatment of spider
      angiomas.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser
      within the Cutera Excel V system for the treatment of spider angiomas.
    

Intervention name(s): KTP laser
Intervention type(s): Device
Intervention description(s): Dual Wavelength Laser Emitting 532 nm Laser Energy
Other intervention name(s): Cutera Excel V
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Best Practice Alerts in Cardiology Outpatient Clinics
Condition: Hypertension; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This quality improvement intervention seeks to implement two Best Practice Alerts (BPAs) for
      use in cardiology clinics while simultaneously evaluating the impact of each BPA- one for
      patients with uncontrolled blood pressure and one for patients with atrial fibrillation not
      on anticoagulation.
    

Detailed description: 
      Best Practice Alerts based will be created for hypertension and atrial fibrillation.
      Outpatient cardiology providers will be randomly allocated into one of three groups. The
      first group will receive the BPA for hypertension alone. The second group will receive the
      BPA for atrial fibrillation alone. The final group will receive both BPAs. The rate of blood
      pressure control for all patients and anticoagulation in patients with atrial fibrillation in
      each group will be evaluated prior to and after the implementation of the BPAs to determine
      the effect of the BPA.
    

Intervention name(s): Best Practice Alert based in the Electronic Medical Record
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research