bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety and Immunogenicity of rDEN3Δ30, a Live Attenuated Monovalent Dengue Virus Vaccine
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Infection with dengue viruses is the leading cause of hospitalization and death in children
      in many tropical Asian countries, and the development of a dengue vaccine is a top health
      priority. This study will evaluate the safety and immunogenicity of a live attenuated
      monovalent dengue virus vaccine (rDEN3Δ30) in healthy adults with no history of previous
      flavivirus infection.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated
      monovalent dengue virus vaccine (rDEN3Δ30) in healthy flavivirus-naive adults.

      Participants will be randomly assigned to receive the rDEN3Δ30 vaccine or placebo at Day 0.
      Study visits will occur on Days 2, 4, 6, 8, 10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits
      will include physical examinations and blood collection. All participants will record their
      temperature 3 times a day from Day 0 through Day 16. Some participants may be admitted to the
      clinic for an inpatient (overnight) stay during the first 16 days of the study.
    

Intervention name(s): rDEN3∆30; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 10^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm; Administered by subcutaneous injection in the deltoid region of the upper arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
Evaluation of Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of Neramexane Mesylate in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 (single dose)

      Primary parameters

        -  Area under the plasma concentration curve from zero to infinity [AUC0-inf] and observed
           maximum plasma concentration [Cmax] of Japanese and Caucasian subjects for each dose
           group

        -  If at least 20% of the Japanese or of the Caucasian subjects have an area under the
           plasma concentration curve extrapolation [AUCextrap%] >20% relative to AUC0-inf for one
           of the dose groups area under the plasma concentration curve from zero to the last
           measurable concentration [AUC0- tz] becomes primary parameter for Japanese and Caucasian
           subjects for all of the dose groups. In this case AUC0-tau will become a secondary
           parameter

      Secondary parameters and derived values from statistical analysis

        -  Dose proportionality and linearity in Japanese subjects

        -  Ratios (Japanese vs. Caucasian subjects) of AUC0-∞ and Cmax for each dose group

        -  Dose normalized AUC [AUC0-inf,norm], dose normalized Cmax [Cmax,norm], AUC0- tz, time of
           occurrence of Cmax [tmax], apparent terminal half life [t½], mean residence time [MRT],
           apparent (oral) total plasma clearance [CLtot/f], apparent volume of distribution during
           the terminal disposition phase [Vz/f], AUCextrap%, apparent terminal disposition rate
           constant [λz], weight corrected AUC0-inf, weight corrected AUC0-tz, weight corrected
           Cmax, weight corrected CLtot/f, cumulative amount of excreted Neramexane into urine
           [Ae0-tz], fraction of orally administrated drug excreted into urine [fe/f], renal
           clearance [CLR] and apparent non-renal clearance [CLNR/f]

        -  Safety and tolerability

      Other parameters

        -  Pharmacogenetics

        -  Amount of N-OH Neramexane excreted in urine [Ae0-tz] if a validated method will be
           available at the time of analysis

        -  Metabolite determination (N-OH Neramexane) in plasma and urine, optional (may be
           analyzed and evaluated if a validated method will be available at the time of analysis)

        -  Endogenous creatinine clearance [CLCR], amount of excreted creatinine into urine per
           hour [AeCR,hr]

        -  Evaluation of further metabolites will be described in detail in the Statistical
           Analysis Plan
    


Intervention name(s): Neramexane
Intervention type(s): Drug
Intervention description(s): single and multiple dose, tablets, oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients
Condition: Cancer; Brachytherapy
Study type: Interventional
Phase: Phase 2

Summary: 
      Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the
      preoperative procedure.

      In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for
      patients treated for prostate cancer The goal of the study is to demonstrate the added value
      of hypnosis during a brachytherapy detachment by improving the comfort of the patient.

      The investigators want to evaluate the contribution of hypnosis during brachytherapy
      detachment by quantifying the anxiety and pain felt by the patient during the procedure.
    


Intervention name(s): formal hypnosis; Kalinox
Intervention type(s): Other; Drug
Intervention description(s): patients will have brachytherapy detachment under Kalinox and formal hypnosis; patients will have brachytherapy detachment under Kalinox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; hypnosis; care management
Conservative Versus Non-conservative Treatment for Severe Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of the conservative (pulpectomy)
      versus non-conservative treatment (tooth extraction) of primary molars affected with severe
      dental caries associated to oral health-related quality of life, anthropometric and clinical
      outcomes.
    

Detailed description: 
      Treatment: evaluate two interventions for treating severe dental caries in primary molared of
      preschool children.

      SAMPLE: preschool children aged 3 to 5 years with severe dental caries (SDC) in primary
      molars. SDC will be indicated by the Pufa index. The Pufa index records the presence of
      severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing
      to root fragments (u), fistula (f) and abscess (a). Children with pufa-score > 0 in primary
      molars will be included in the study. All children aged 3 to 5 years, who sought dental
      screening at the Dental School, University of São Paulo (USP) in August to October 2013 can
      be initially eligible.

      CLINICAL GROUPS RANDOMLY ASSIGNED:

        -  Group A: Conservative treatment represented by pulpectomies + teeth restoration with
           composite resin crown.

        -  Group B: Dental extraction

             -  Treatment of carious teeth with pufa score =0 will receive dental fillings (01
                occlusal surface affected: ART; 02 surfaces affected: composite resin; ≥ 03
                surfaces affected: composite resin crown).

             -  One operator (specialists in paediatric dentistry) blinded to the outcomes will
                carry out the treatments.

      FOLLOW-UP: 4, 8 and 12 months.

      OUTCOMES: All outcomes will be assessed by a single person interviewer/examiner blinded to
      the oral treatments groups.

        1. Oral Health-Related Quality of Life:

             -  Brazilian SOHO-5

             -  Brazilian ECOHIS

        2. Anthropometric measures:

             -  Weight-for-age Z-score (WAZ)

             -  Height-for-age Z-score (HAZ)

             -  BMI-for age Z-score (BAZ)

        3. Dental anxiety (Facial Image Scale).

        4. Dental pain (Wong-Baker Scale)

        5. Problems in the developing occlusion: loss of space
    

Intervention name(s): Conservative treatment: pulpectomy and composite resin crown; Non-conservative treatment: Tooth extraction
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Quality of Life; Pulpectomy; Tooth extraction
Examining the Effects of Diet on Health With an Online Program
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a pilot, designed to provide data regarding the feasibility and acceptability of
      conducting such a study on a larger scale. The present study is a randomized controlled
      clinical trial comparing two programs to help people manage diabetes and lose weight, one
      using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and
      the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle
      modifications. Intervention content will include information about nutrition (American
      Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group,
      emotion regulation, positive affect, and mindful eating strategies.
    

Detailed description: 
      Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment
      groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our
      main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose
      levels and tied to diabetes severity).
    

Intervention name(s): Behavioral: Low Carbohydrate, Ketogenic Diet; American Diabetes Association Diet; Mindfulness and Positive Affect Skills
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; obesity; mindful eating; positive affect; low carbohydrate; ketogenic; diet
Strategies to Enhance the Experience of Exercise
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study aims to test the effect of three cognitive strategies to affect individuals'
      subjective experience of cardiovascular exercise. Participants will be randomly assigned to
      one of three strategies to use while exercising, both during an in-person session and
      self-directed two week exercise period.
    


Intervention name(s): Mindfulness; Distraction; Self-monitoring
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will use mindfulness techniques while exercising; Participants will distract themselves while exercising; Participants will use associative attentional focus while exercising
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double-blind placebo-controlled study comparing different doses of
      bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is
      15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose
      of study drug.
    

Detailed description: 
      This study will enroll 150 moderately severe to severe Alzheimer's disease subjects. Subjects
      will be randomly assigned 1:1:1 to treatment with two different doses of bryostatin 1 or
      placebo. The primary analysis will take place after 12 weeks of treatment (7 doses).
    

Intervention name(s): Bryostatin 1; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.; The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Other intervention name(s): bryostatin
Intervention MeSH terms: Bryostatin 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nursing Management of Irritable Bowel Syndrome (IBS) 2008
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is test the efficacy of a comprehensive self-management therapy to
      decrease abdominal pain/discomfort and improve quality of life in patients with irritable
      bowel syndrome (IBS) compared to IBS patients receiving their usual care.
    


Intervention name(s): Usual Care (Control Group); Comprehensive Self-Management (CSM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Cognitive Therapy; Abdominal Pain; Quality of Life
Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives
Condition: Contraceptive Usage; Metabolic Syndrome; Body Weight Changes
MeSH terms: Metabolic Syndrome; Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during
      five years follow-up
    

Detailed description: 
      Were eligible for the study 489 Women, followed in Federal University of São Paulo Family
      Planning Service, who used the same contraceptive method during five year of follow-up,
      According to the service protocol, the patients, after had participated of a orientation
      group about contraceptives methods, elected one of them. After that, if the choice had been
      according to the eligibility criteria of World Health Organization, it was approved by a
      gynecologist.

      The contraceptive methods available were the intrauterine device (IUD) oral contraceptives,
      including combined pills and progestin-only formulations, and depot medroxyprogestereone
      acetate.

      The study consisted in the evaluation of their medical records of weight, BMI, Blood
      pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and
      in the comparison of the differences of these data between the contraceptive methods.
    

Intervention name(s): Intrauterine device; Combined Oral Contraceptive; Progestin-only pills; Depot-Medroxyprogestereone Acetate
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): Use of Intrauterine device during the follow-up period; Use of combined oral contraceptive during the follow-up period; Use of progestin-only pills during the follow-up period; Use of depot-medroxyprogesterone acetato during the follow-up period
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Contraceptives, Oral; Contraceptives, Oral, Combined; Progestins
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women in menacme, users of the same contraceptive hormonal (combined oral contraceptives,
        progestin-only pills and depot-medroxyprodestereone acetate) and non-hormonal contraceptive
        methods (IUD) during five years
      
Keywords: contraception; Body mass index; Metabolic Syndrome; obesity
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents
Condition: Attention Deficit Hyperactivity Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a single site, double-blind, randomized, placebo-controlled parallel group
      design. this study is designed to directly examine the efficacy of a single daily dose of
      atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with
      ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency
      (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and
      child-reported evening settling difficulties, as measured on the evening subscale items of
      the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional
      actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime
      sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and
      morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version;
      provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT);
      executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life
      (CHQ).
    


Intervention name(s): atomoxetine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will then be randomized (at Visit 2) to receive either atomoxetine or placebo for 4 weeks (Treatment Period); study drug will be titrated individually according to tolerability and efficacy (measured by ADHD-RS and CGI-I) completed at Visits 3, 4, 5, and 6) at 7-10 day intervals to a maximum dose of 1.8 mg/kg.; placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention deficit hyperactivity disorder; insomnia; atomoxetine
75 or 150 mg Clopidogrel Maintenance Doses Following PCI (ISAR-CHOICE-2)
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test whether an increase of the maintenance dose of
      clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced
      platelet aggregation
    

Detailed description: 
      In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300
      to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in
      a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6
      hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic
      therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is
      administered. The 600 mg loading dose has been shown to be safe and effective in preventing
      thrombotic events following coronary stent implantation. Recently, it was shown that in
      patients with stable angina and administration of the 600 mg loading dose at least two hours
      prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further
      reduction of the incidence of thrombotic events. In contrast to a number of investigations
      with different loading doses, no trials have been performed comparing different clopidogrel
      maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in
      patients already on chronic clopidogrel therapy (75 mg/day) results in an additional
      significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet
      aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose
      in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of
      platelet aggregation.
    

Intervention name(s): Clopidogrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): after PCI; after PCI
Other intervention name(s): Iscover; Plavix; Iscover; Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests
Condition: Healthy; Adults
Study type: Observational

Summary: 
      The human foot is a complex structure, which serves functions such as support and mobility.
      These functions are accomplished through the deformation of the arch, which is controlled by
      intrinsic and extrinsic foot muscles. The intrinsic muscles have an important role in dynamic
      stabilization of the foot due to their structurally short force levers and small diameters.
      There are many studies reporting that foot intrinsic muscle weakness is directly related to
      pathologies such as structural or functional toe deformities, pes planus, hallux valgus,
      plantar fasciitis .Therefore it is essential to evaluate the strength of these muscles in an
      objective and reliable way.
    

Detailed description: 
      Two different methods are used in measuring muscle strength via a Hand Held Dynamometer; the
      "break test" and the "make test" . During these tests, the examiner and subject play opposite
      roles. During the make test, the subject applies maximal force against the examiner and the
      position is maintained by the examiner. During the break test, the subject holds the position
      of the muscle being evaluated and the examiner pushes until the subject's maximal force is
      overcome. In the two tests, force is applied differently; the dynamometer receives different
      amounts of force, and different results may be generated. Therefore, the aim of this study
      was to compare the reliability of intrinsic foot muscle strength assessment with break and
      make test in healthy young subjects.
    

Intervention name(s): Muscle Strength Assesment-Make Test; Muscle Strength Assesment-Break Test
Intervention type(s): Other; Other
Intervention description(s): For the make test, the examiner applies resistance in a fixed position and the person being tested exerts a maximum effort against the dynamometer and examiner. The examiner is only required to sustain an isometric contraction and read the highest value on an Hand Held Dynamometer.; For the break test, the examiner applies resistance sufficient to overcome the maximum effort of the person being tested and cause the subject's joint to move in the opposite direction, which results in an eccentric contraction. During this test the limb must move at a constant velocity while the person being tested is asked to achieve a maximum contraction. In addition, the examiner must read the force output reading at the exact time the subject's limb begins to move from the Hand Held Dynamometer.
Other intervention name(s): Make Test; Break Test
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sedantary healthy individuals who do not have any orthopedic/neurologic lower extremity
        problems.
      
Keywords: Make and Break Test; Strength assessment; Hand held dynamometer; Intrinsic foot muscles