bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing
      endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
      important in children who often are suffering from nutritional deprivation which retards
      their growth.

      The key objectives are to:

        1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
           the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
           weight, and pediatric quality of life survey.

        2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
           active Crohn's Disease.

        3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma
           opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
    

Detailed description: 
      The present proposal is designed as double-blinded placebo controlled study involving 30
      children between 6-17 years of age with active Crohn's disease. Children will be treated with
      either naltrexone or placebo for the first 8 weeks then all subjects will receive active
      naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks
      after completion of the active drug for safety and to assess Crohn's activity. Low dose
      naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10
      years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg.
      Half of the subjects in the first 8 weeks will be randomized to placebo which will be either
      capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form.
      Children are eligible who are not of child-bearing potential or are using two means of
      effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least
      31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or
      radiographic tests.
    

Intervention name(s): Naltrexone; Placebo, sugar pill
Intervention type(s): Drug; Other
Intervention description(s): Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks; Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
Other intervention name(s): Revia, Vivitrol; sugar pill
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; pediatric; Crohn's Disease; naltrexone; LDN; IBD; Inflammatory bowel disease
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
Condition: Subcutaneous Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will be an open-label and single course study to assess the safety,
      tolerability, PK and metabolite profile of CBL-514.
    

Detailed description: 
      This is a Phase 2 study to evaluate the safety, tolerability, PK and metabolite profile of
      CBL-514 injection at the maximal use dosage.

      This Phase 2 study has an open-label and single course design. A total of 10 adult
      participants, composed of 5 females and 5 males, will be enrolled in a single cohort. Each
      participant will receive a single course of treatment with CBL-514 800 mg on the abdomen
      (administered as multiple subcutaneous injections) on Day 1 only.
    

Intervention name(s): CBL-514
Intervention type(s): Drug
Intervention description(s): CBL-514 800 mg (unit dose: 2.0 mg/cm^2)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
    


Intervention name(s): darbepoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: darbepoetin alfa; anemia; cancer patients; chemotherapy
Neural Correlates of Stress Reduction
Condition: Stress; Psychological Stress; Life Stress; Emotional Stress; Social Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study will identify neural mechanisms associated with changes in emotion regulation
      following participation in stress reduction programs.
    


Intervention name(s): Stress Reduction
Intervention type(s): Behavioral
Intervention description(s): We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose
      combination in comparison to the single unit formulations
    


Intervention name(s): Hydrochlorothiazide; Telmisartan; Telmisartan/HCTZ FDC
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of TAK-861 in Participants With Narcolepsy Type 1
Condition: Narcolepsy Type 1
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including
      excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in
      the study across North America, Europe and Asia Pacific.

      The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this
      treatment period the participant will have the option to participate in a separate, long-
      term extension study during which all participants will be treated with TAK-861.
    

Detailed description: 
      The drug being tested in this study is called TAK-861. This study will look at the effect of
      TAK-861 on improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS)
      and number of cataplexy episodes.

      The study will enroll approximately 100 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the five treatment groups which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK-861 Dose 1

        -  TAK-861 Dose 2

        -  TAK-861 Dose 3

        -  TAK-861 Dose 4

        -  Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
           no active ingredient

      This multi-center trial will be conducted worldwide. The overall time to participate in this
      study is up to 23 weeks. Participants will make multiple visits to the clinic during the
      treatment period and then will either enroll in a long-term extension study in which all
      participants will receive TAK-861 or have 2 final visits 7 and 28 days after last dose of
      study drug for follow-up assessments.
    

Intervention name(s): TAK-861; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-861 tablets; TAK-861 placebo matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Drug Therapy
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
Condition: Urinary Tract Infections; Bacterial Pneumonia; Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia; Urinary Tract Infections; Soft Tissue Infections; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in
      pediatric patients with urinary tract infections, skin infections, or community-acquired
      pneumonia.
    


Intervention name(s): MK0826, ertapenem sodium /Duration of Treatment: 14 Days; Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ceftriaxone; Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Two Types of Non-invasive Erector Spinae Muscle Taut Band Therapy in University Students With Low Back Pain
Condition: Low Back Pain; Trigger Point Pain, Myofascial
MeSH terms: Myofascial Pain Syndromes; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific low back pain can be caused by the presence of active trigger points in the
      muscles of the lumbopelvic region. Trigger points are defined as hypersensitive points within
      a taut band of a musculoskeletal system that cause pain during contraction, stretching, or
      stimulation of said muscle. If these points are active, they can trigger referred pain, local
      tenderness, and vegetative responses. There is scientific evidence of the improvement of the
      treatment of these points through non-invasive manual techniques. The objective of this study
      will be to determine the effect of Strain Counterstrain and Myofascial Induction techniques
      in subjects with low back pain secondary to the presence of active trigger points in the
      lumbopelvic region. Hyperexcitable myofascial trigger points located within a taut band of
      skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The
      scientific data refer to an immediate improvement in the symptoms of these active points
      treated with manual therapy. Based on these factors, the objective of the study is to
      determine the effect of the combined therapy of the Strain Counterstrain technique and
      Myofascial Induction in participants with the presence of an active trigger point in the
      erector spinae muscle.
    

Detailed description: 
      The treatment will last a total of 15 minutes accompanied by a baseline assessment and after
      10 minutes of the intervention in 2 experimental groups and a placebo group, of no-pain
      positioning. In addition to basic indices and scales of low back pain and disability caused
      by low back pain, it is intended to measure flexibility, range of motion, proprioception and
      cognition through software with sensors of the latest technology when representing reliable
      results in differences between techniques.
    

Intervention name(s): Jones Group (Strain Counterstrain); Myofascial Induction Group; Placebo Group
Intervention type(s): Other; Other; Other
Intervention description(s): No pain positioning technique with diaphragmatic breathing; Myofascial Induction technique on the lumbar fascia; No pain positioning of participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Rehabilitation; Treatment; Active Trigger Point
Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the
      morning for up to 14 days to heart failure patients with volume overload that does not show
      adequate response to other diuretics such as loop diuretics in order to investigate the
      effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy
      of tolvaptan during the treatment period will also be investigated.
    


Intervention name(s): Tolvaptan; Placebo of tolvaptan
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral administration of one tolvaptan 15 mg tablet in the morning; Once-daily oral administration of one placebo tablet in the morning
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; Volume overload; Tolvaptan; loop diuretics
Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Hemoglobinuria, Paroxysmal
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study was to evaluate the pharmacokinetic (PK) and
      pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for
      pediatric and adolescent participants with PNH.
    

Detailed description: 
      This was an open-label, multi-center study of eculizumab administered to approximately 6 to 8
      pediatric and adolescent participants aged 2 to 17 years with PNH. There were 3 periods in
      this study (screening, treatment, and post-treatment) with the treatment period having 2
      dosing phases (induction and maintenance). If all screening criteria were met, the
      participant was eligible to enter the treatment period of the study after receiving Neisseria
      meningitidis (N. men), Streptococcus pneumoniae (S. pneumo), and Haemophilus influenzae (H.
      influ) vaccinations at least 14 days prior to first dose of study drug, or was vaccinated and
      received treatment with appropriate antibiotics until 14 days after the vaccinations.
      Participants received eculizumab intravenously (IV) based on their weight. Eculizumab was
      administered via an IV infusion at a rate of 5 to 10 milliliters (mL) per kilogram (kg) per
      hour (hr) (mL/kg/hr) for at least 25 minutes. The planned duration of treatment was 12 weeks
      with a 4-week induction phase and an 8-week maintenance phase. At the Investigator's and
      parents/legal guardian's discretion, participants who completed this study with eculizumab
      could continue treatment with commercially available eculizumab (Soliris®) and were followed
      in the Soliris® PNH Registry. Participants who stopped study participation before study
      completion or who did not continue with Soliris® treatment at the completion of the study
      were followed for 8 weeks and monitored for signs and symptoms of serious hemolysis.
    

Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): 5 mg/mL solution in 5% Dextrose
Other intervention name(s): Soliris®
Intervention MeSH terms: Eculizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alexion; Eculizumab; Paroxysmal Nocturnal Hemoglobinuria; PNH; Soliris
Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old
Condition: Chickenpox
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a cross-over, open-label, single-group study. The study subjects were children 12
      months to 12 years of age who will be vaccinated with a single dose. The duration of
      follow-up for safety evaluation and immunogenicity (on a small group) is 6 weeks (+ 2 weeks).

      The main target:

      • Evaluating the safety of live attenuated Varicella vaccine [Oka / SK], lyophilized powder
      and solvent for subcutaneous injection (SKYVaricella inj.) in healthy Vietnamese children
      from 12 months to 12 years, with a single injection.

      Secondary target:

      • Assess the immunogenicity of live attenuated Varicella vaccine [Oka / SK], lyophilized
      powder and solvent for subcutaneous injection (SKYVaricella inj.) in a small group of healthy
      Vietnamese children from 12 months to 12 years, with a single injection.
    

Detailed description: 
      The Safety of Skyvaricella Injection:

        -  The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash
           (disseminated) between 1 and 6 weeks after vaccination

        -  The incidence and severity of events (local and systemic) within 30 minutes after
           vaccination

        -  The incidence of expected systemic and local adverse events within 7 days after
           vaccination

        -  The incidence of serious adverse events and Unexpected adverse events within 6 weeks
           after vaccination The Immunogenicity of Skyvaricella Injection: seroconversion rate by
           Fluorescent antibody to membrane antigens (FAMA) test 6 weeks after investigational
           vaccination
    

Intervention name(s): Skyvaricella Injection
Intervention type(s): Biological
Intervention description(s): The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection.
The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chickenpox; varicella-zoster virus; varicella vaccine
Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity in children is a serious disease that is associated with increased mortality and
      decreased life expectancy. A simple tool used to assist in controlling portions (and
      therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance
      and/or loss. The purpose of this study is to assess the efficacy of a family intervention
      using a portion control tool to help control weight in obese children. The investigators
      hypothesize that the use of portion control tools by the parents and child will result in a
      greater decrease in the child's BMI over a 6 month period compared with the control group.
    

Detailed description: 
      This study is a randomized controlled trial designed to assess the efficacy of a portion
      control tool to help improve body mass index in obese children over a 6 months period. This
      study will also assess whether this weight control strategy results in improvement of blood
      pressure, waist circumference, and biomarkers of obesity including plasma visfatin,
      adiponectin, fasting lipid profile and apolipoprotein B, liver function tests and fasting
      insulin and glucose. Both the intervention and the control group will receive a one hour
      session of standard dietary counseling from a registered dietician at baseline regarding
      healthy eating habits, appropriate portion sizes and the Canada Food Guide. The duration of
      this study will be 6 months. Baseline measurements will be taken at the initial visit and
      again at 3 months and 6 months. Each participants' height and weight will be measured, and
      BMI will be calculated. Waist circumference and blood pressure will also be measured. A blood
      sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin,
      and glucose levels. Measurement of plasma visfatin and adiponectin levels using ELISA will be
      carried out.
    

Intervention name(s): Nutrition counseling + portion control tool; Nutrition counseling
Intervention type(s): Other; Other
Intervention description(s): Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool; Nutrition counseling with registered dietician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Children; Dyslipidemia; Hypertension
Vaccination Coverage Amongst Children/Young People Attending the PED
Condition: Vaccination/Immunisation Status
Study type: Observational

Summary: 
      In the United Kingdom (UK), most childhood vaccinations are given in the community, although
      uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance
      offers an opportunity to check the vaccination status of children and young people (CYP) and
      all parents/carers should be asked about this routinely. Those not up-to-date with
      vaccinations could then be signposted to existing services or perhaps offered a vaccine in
      the PED.

      CYP attending the PED may also have lower vaccination coverage than their peers, so may
      benefit even more from interventions to increase uptake. However, recall by parents/carers is
      not always sufficiently accurate to identify those who have not yet received all their
      age-appropriate vaccinations. The most complete record of an individual's vaccination history
      is held within their primary care records. However, these records are often in a separate
      computer system that is inaccessible from the hospital's main computer system, although some
      information (including vaccination) may be accessed from within the hospital via a third
      system.

      This study aims to see if CYP attending the PED are under-vaccinated compared to their peers
      and assess the accuracy of parent/carer recall. The results of this study will then be used
      to inform recommendations for developing better ways to access accurate vaccination data
      during a PED consultation. If such a system existed, under-vaccinated children could be
      identified routinely during an attendance, and an intervention offered if appropriate. This
      would be particularly useful if there was an outbreak of a vaccine-preventable disease such
      measles.

      All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be
      invited to participate. CYP/their parent/carer will be asked to provide consent for their
      vaccination records to be accessed as well as being asked if the child/young person is
      up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Observational study
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and young people accessing PED
      
Keywords: Vaccination; Immunisation; Opportunistic; Child; Young person; Paediatric Emergency Department