bioihbjkbjnl/mcl2 huggingface dataset:
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent
      Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW
      Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent
      meningococcal vaccine in the population with the highest incidence of disease.

      Objectives:

        -  To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different
           schedules and concomitantly with routine pediatric vaccinations.

        -  To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5
           different schedules and concomitantly with routine pediatric vaccinations.

        -  To describe the immunogenicity profiles of selected licensed pediatric vaccines
           (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or
           without MenACYW Conjugate vaccine.
    

Detailed description: 
      Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending
      on the assigned schedule in their randomized groups. All participants underwent safety and
      immunogenicity assessments according to the schedule for their assigned group.
    

Intervention name(s): Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined); M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live; Varicella Virus Vaccine Live; Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein); Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein); Rotavirus Vaccine; Hepatitis B Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 milliliter (mL), Intramuscular (IM) injection; 0.5 mL, IM injection; 0.5 mL, Subcutaneous (SC) injection; 0.5 mL, SC injection; 0.5 mL, IM injection; 0.5 mL, IM injection; oral; 0.5 mL, IM injection
Other intervention name(s): TetraMen-T; Pentacel; Varivax; Prevnar; Prevnar 13; RotaTeq/ROTARIX; Engerix-B/Recombivax-HB
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Infection; Neisseria meningitidis; Tetravalent Meningococcal Vaccine
Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the role of racial and socioeconomic disparities in coronary heart disease
      (CHD) mortality in the United States.
    

Detailed description: 
      BACKGROUND:

      Despite strong decreases in coronary heart disease (CHD) mortality over past decades, there
      is evidence that racial and socioeconomic disparities in CHD mortality are increasing. CHD
      surveillance efforts that examine trends within these population subgroups are an important
      first step in quantifying and reducing disparities. The Atherosclerosis Risk in Communities
      (ARIC) Study has monitored rates and trends in validated hospitalized myocardial infarction
      and fatal CHD among black and white adults aged 35 to 74 years in four U.S. communities since
      1989.

      DESIGN NARRATIVE:

      The study will expand the scope of ARIC surveillance by examining variations in the rates and
      temporal trends in CHD by socioeconomic status (SES), measured at the level of census tract.
      For CHD events already included in ARIC surveillance (1992-2002), addresses will be obtained
      from medical records and death certificates and geocoded so that they can be matched with
      identifiers for census based geographical areas. The ARIC study will contribute yearly
      updates of abstracted CHD events and addresses for subsequent years (2003-2005). Each event
      will be linked with census tract level SES indicators available from the 1990 and 2000
      censuses. This novel effort will permit an examination of disparities by SES in rates and
      trends in fatal CHD, hospitalized myocardial infarction, case fatality, use of invasive
      cardiac procedures and prescription of efficacious medication at time of hospital discharge.
      In addition, the extent to which racial disparities in CHD and associated treatments are
      explained by SES will also be explored.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Community surveillance of adults in four communities in the US
      
Keywords: Surveillance; coronary heart disease; neighborhood SES
Supporting Together Exercise and Play and Improving Nutrition
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition
      sessions for primary care patients aged 6 -12 years who are overweight or obese and who want
      to eat healthier and be more active.
    

Detailed description: 
      In addition to the group nutrition sessions, the investigators will give a Fitbit to each of
      a parent and child dyad, which will be used to track and motivate their activity. The
      investigators hypothesize an improvement pre-post in children's physical activity levels,
      self-efficacy and intentions for physical activity, self-reported consumption of fruits,
      vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened
      beverages and fast and snack-food, and television (TV)/ videos screen time
    

Intervention name(s): Group nutrition sessions; Fitbit
Intervention type(s): Behavioral; Device
Intervention description(s): The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).; Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
Other intervention name(s): Peer-led Group Sessions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Observational

Summary: 
      With the aim of evaluating the putative impacts of emotion related personality factors on
      physical and mental disease and the mechanisms of these impacts, 58 students were submitted
      to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken.
      The subjects were also submitted to several personality trait inventory, that evaluated
      respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of
      Personality.

      The moderating impact of these factors on the cortisol response were analysed
    


Observational model: Natural History
Time perspective: Other
Keywords: emotion; personality; social stress; appraisal
Positive Expiratory Pressure for the Treatment of Acute Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthma is a leading cause of emergency department (ED) visits for children. A novel way of
      treating asthma is the use of positive expiratory pressure (PEP). Positive expiratory
      pressure works by creating pressure in the lungs to keep airways open and to clear mucus from
      the lungs. PEP is already used in the treatment of asthma at the investigators institution,
      but studies evaluating the efficacy of PEP therapy in asthma exacerbations do not exist. This
      study plans to learn more about the use of PEP therapy in the treatment of asthma
      exacerbations in children in the emergency department. Specifically, the study aims to
      evaluate if PEP therapy reduces the severity of asthma exacerbations in children and if it
      reduces the need for additional therapies and admission to the hospital. This study will be a
      randomized control trial comparing children who receive standard therapy to those who receive
      standard therapy plus PEP therapy in the treatment of asthma exacerbations. Children age 2 to
      18 years presenting to the ED with moderate to severe asthma exacerbations will be included
      in the study. Reduction in clinical asthma severity will be measured by change in the
      Pulmonary Asthma Score (the respiratory severity score used at the investigators
      institution). The need for additional therapies and hospitalization will also be evaluated.
    


Intervention name(s): EzPAP; Standard Care
Intervention type(s): Drug; Other
Other intervention name(s): Positive Expiratory Pressure (PEP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus
Condition: Double Lumen Tube Intubation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided
      double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.
    


Intervention name(s): Neutral shape of bronchial tip; Bent shape of bronchial tip
Intervention type(s): Device; Device
Intervention description(s): Intubation is performed without transforming the shape of the bonchial tipof a double lumen tube.; Intubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Enhanced Linkage Maps From Family-Based Genetics Studies
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      To develop genetic maps for the genome-wide screening markers used by multiple investigators
      and to investigate map differences between sexes and different ethnic groups.
    

Detailed description: 
      BACKGROUND:

      Meiotic linkage maps are the foundation of both linkage and linkage disequilibrium studies
      for mapping disease genes. Despite the importance of precise maps, existing genome-wide
      linkage maps were built using only a small collection of pedigrees, and so have wide
      confidence intervals surrounding estimates of map distance. Incorrect marker order and map
      distances can have a profound effect on linkage analyses. Using a sex-averaged map instead of
      a sex-specific map biases the lod scores upward, markedly increasing the false positive rate.
      Since it is very costly to follow-up many false-positive results, there is a clear need for
      more precise and accurate sex-specific genetic maps. Accurate estimates of meiotic map
      distance cannot be obtained by any means other than by linkage analysis using genotype data.

      The study is in response to a Request for Applications entitled "NHLBI Innovative Research
      Grant Program" released in July, 2001. The purpose of the initiative is to support new
      approaches to heart, lung, and blood diseases and sleep disorders that use existing data sets
      or existing biological specimen collections whether obtained through National Heart, Lung,
      and Blood Institute support or not.

      DESIGN NARRATIVE:

      The genetic epidemiology study will build improved highly-precise sex-specific linkage maps
      utilizing thousands of individuals who have previously been genotyped. After filtering out
      obvious relationship and genotype errors, the study will incorporate methods that properly
      model for genotyping errors. In addition to creating precise maps for the scientific
      community, the study will also use these genotype data to study how recombination may vary
      between ethnic groups. The genotypes generated by the NHLBI Mammalian Genotyping Service are
      precisely the type of data required to produce more accurate maps. These data collections
      contain over 3,400 pedigrees with more than a 100-fold increase in information compared to
      that contained in the 8 CEPH families that have been used to construct current genome-wide
      linkage maps. The new maps will be made publicly available and the genotype data from the
      study will be accessible by the MAP-0-MAT linkage mapping server. In the future, the study
      will be broadened to incorporate genotype data from additional genotyping centers such as the
      Center for Inherited Disease Research (CIDR).
    

Observational model: Other
Time perspective: Other
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      The purpose of this study is to determine if long acting tolterodine confers more benefit
      than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12
      weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen
      confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms.
      Secondary outcomes were to assess if the addition of the other therapy to the treatment
      regimen conferred benefit at 24 weeks and 52 weeks.
    

Detailed description: 
      Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency,
      nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which
      urgency is the predominant symptom with or without urge incontinence and is usually
      accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome
      is treatment with anticholinergic medication as well as behavioral therapy. This method of
      treatment has demonstrated a 60% response rate as reported in the Cochrane Database of
      Systemic Reviews.

      In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a
      pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in
      post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women
      with this condition experience vaginal dryness, irritation, painful intercourse, as well as
      urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent
      urinary tract infections.

      Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the
      treatment of OAB symptoms
    

Intervention name(s): Extended Release Tolterodine LA; Intra Vaginal Estradiol Cream
Intervention type(s): Drug; Drug
Intervention description(s): Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks; 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
Other intervention name(s): Detrol; Estrace; Premarin vaginal cream
Intervention MeSH terms: Tolterodine Tartrate; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overactive bladder; urge leakage; nightime urination; incontinence; urinary frequency
Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury
Condition: Spinal Cord Injury at C5-C7 Level
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      16 persons affected by Cervical-SCI were recruited for the study and randomly assigned to the
      Control Group (CG) or to the Experimental Group (EG). Persons of the CG (n = 8) executed 20
      sessions of FES for the rehabilitation of hand functions (grasp or pinch), participants of
      the EG (n = 8) performed 20 sessions of FES and CBA in addition. The primary assessment was a
      modified version of Bimanual Activity Test (10 tasks); also, SCIM-II and measurement of
      grasping strength only in participants submitted to grasp rehabilitation were evaluated.
    

Detailed description: 
      Each participant followed twenty sessions of hand rehabilitation, three times per week. Each
      treatment, for both CG and EG, lasted about forty minutes.

      The FES devices chosen for this research stimulated "grasp" or "pinch" function: the NESS
      H200 (NESS Ltd., Ra'anana, Israel) was used if patient needed to improve the grasp functions,
      otherwise the Microstim (Microstim, Medel, Hamburg, Germany) was used to increase pinch
      functions. In order to provide FES, the five electrodes of NESS H200 were first humidified
      with warm water and then inserted in the right size place of the rigid splint worn by the
      patient, while Microstim was used with four standard electrodes, two for each muscle treated.
      In both case the stimulation was triggered by the therapist clicking a button (Table 1).

      The participants of CG received only FES to improve their manipulating skills without the
      interaction with objects, but only with the muscle contraction induced by the devices.

      The participants of EG executed FES and CBA treatment which means that during the stimulation
      they manipulated different tools. In particular, for the first ten sessions the participants
      were invited to manipulate specific objects: squares, rectangles and pyramids of different
      sizes; touch on plastic test tubes coated with materials of different consistency; these two
      exercises were performed both with open and closed eyes. Finally, for the last ten sessions
      the participants were asked to execute specific tasks, depending on person's life before the
      lesion.
    

Intervention name(s): FES+CBA; FES
Intervention type(s): Other; Other
Intervention description(s): The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy; The control treatment was formerly composed by 20 sessions of FES for the hand
Other intervention name(s): Functional Electric Stimulation, Cognitive Therapy; Functional Electric Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
Condition: Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction (DDI) study has been designed to investigate the effect of a
      moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major
      circulating active metabolite AC886.
    

Detailed description: 
      In vitro, quizartinib is metabolized primarily by CYP3A. Therefore, co-administration of
      quizartinib with CYP3A inducers may decrease quizartinib exposure. This study will assess the
      effect of a moderate CYP3A inducer efavirenz on the single dose (60 mg) quizartinib
      pharmacokinetics in healthy participants.
    

Intervention name(s): Efavirenz; Quizartinib
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose, 600-mg tablet; Single oral dose, 60 mg (2 x 30 mg) tablets
Intervention MeSH terms: Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib; CYP3A Inducer
Circadian Rhythms and Cardiovascular Risk
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to understand how behaviors and the effects of the body's
      internal clock (called the circadian pacemaker) affect the control of the heart and blood
      pressure.

      People with Obstructive Sleep Apnea (OSA) are hypothesized to have altered circadian
      amplitudes in certain key indices of cardiovascular (CV) and an abnormally advanced circadian
      phase in some of the same key indices of CV risk. The investigators hypothesize that such
      changes, taken together, may explain the different timing of heart attack and sudden cardiac
      death in OSA.
    


Intervention name(s): Forced Desynchrony
Intervention type(s): Behavioral
Intervention description(s): all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients
Condition: Infertility
MeSH terms: Infertility; Vitamin D Deficiency
Study type: Observational

Summary: 
      The role of vitamin D deficiency in female reproduction remains controversial. Early
      retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels
      on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two
      retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy
      rates with an effect mediated through the endometrium.

      Taking into account that knock-out experiments have shown that vitamin D receptor null mice
      not only experience uterine hypoplasia but also impaired folliculogenesis, it might be
      hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian
      reserve. This may be further supported by previous reports demonstrating that serum 25-OH
      Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced
      reproductive age.

      The aim of this study is to examine through a large set of prospectively recruited infertile
      women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted
      biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile women 18-43 years old undergoing IVF/ICSI
      
Keywords: Infertility