bioihbjkbjnl/mcl2 huggingface dataset:
Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this pilot feasibility study is to provide continued CGM access to youth with
      type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with
      type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if
      CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and
      to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to
      evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose
      metrics and patient reported outcomes (PROs). The investigators will pilot and refine a
      program to test the hypothesis that CGM start and continuation in youth with T2D is feasible
      and then evaluate glucose metrics and PROs.
    


Intervention name(s): Continuous Glucose Monitor; Patient Reported Outcome Questionnaires
Intervention type(s): Device; Other
Intervention description(s): Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care; Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia
Condition: Multiple Sclerosis; Fatigue; Insomnia
MeSH terms: Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assesses the safety, tolerability, and efficacy of suvorexant in multiple
      sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment
      period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects
      will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either
      suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater
      improvement in sleep, as measured by symptom rating scales, compared to placebo.
    

Detailed description: 
      The target enrollment number is 30 people with multiple sclerosis who meet inclusion
      criteria. After informed consent is given, potential subjects will be screened to ensure they
      meet eligibility criteria. Subjects who meet eligibility criteria will complete baseline
      assessments and will then be randomized to receive 2 weeks of treatment (Treatment Period 1)
      with either suvorexant or matching placebo (1:1). The initial dose of suvorexant will be 10
      mg at bedtime, with optional titration to 20 mg after 5-7 days. Study drug will be dispensed
      by an independent research pharmacist, keeping both study staff and the subject blinded. All
      subjects, whether in placebo or active arm, will receive a wearable sleep monitor to be worn
      for 7 days at baseline, and during both treatment periods. All subjects will keep 7-day sleep
      diaries at baseline and during each study period. At the end of Treatment Period 1 (2 weeks),
      subjects will undergo efficacy assessments with repeated clinical scales. Subjects will then
      go through a 1-week open-label off-drug washout period. Subjects will then be crossed over
      into the alternate treatment group, which will once again be double-blinded; those on active
      treatment (suvorexant) in Treatment Period 1 will be switched to placebo, and those on
      placebo in Treatment Period 1 will be switched to active treatment. Treatment Period 2 will
      also be 2 weeks long, and at the end of this, subjects will undergo final assessment with
      clinical scales.
    

Intervention name(s): Suvorexant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See detailed information in associated Arm Description.; Sugar pill manufactured to mimic suvorexant 10 mg tablet.
Other intervention name(s): Belsomra; Sugar pill
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized cross-over trial of suvorexant and placebo for people with multiple sclerosis (MS), insomnia and fatigue
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Fatigue; Insomnia; Suvorexant; Belsomra; Sleep disorder; Sleep
Evaluation and Treatment of Patients With Lung Disease Not Participating in Research
Condition: Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      This study was developed in order for the professional-staff at the Pulmonary-Critical Care
      Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their
      skills and increase their understanding of lung diseases.

      The study will permit PCCMB staff members to evaluate and treat patients with lung disease
      who do not meet the criteria for other research studies.
    

Detailed description: 
      The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain
      their clinical skills and to enhance their clinical knowledge. The purpose of this protocol
      is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet
      the criteria for existing research protocols.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pulmonary disease who do not meet the criteria for existing research
        protocols.
      
Keywords: Teaching; Pulmonary Disease; Routine Testing; Medically Indicated; Pulmonary Function Test
Internet-delivered CBT for Asthma-related Anxiety: Feasibility
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a study to investigate acceptability and feasibility of a novel protocol on
      exposure-based CBT for asthma-related fear delivered over the Internet (Internet-CBT).
    

Detailed description: 
      Asthma is one of the most common chronic diseases around the world, with a high prevalence of
      anxiety disorders. In a prior study (ClinicalTrials.gov ID: NCT03158194) a protocol for
      exposure-based CBT was developed for asthma-related anxiety. The aim of the current study is
      to evaluate acceptability and feasibility of our protocol for asthma-related fear when
      delivered over the Internet (Internet-CBT). The plan is to include 30 participants that will
      all receive the intervention in this uncontrolled feasibility study.
    

Intervention name(s): Internet-CBT for anxiety-related asthma
Intervention type(s): Behavioral
Intervention description(s): The specific assignments in the intervention will be based on individual behavior analysis for each participant.
Intervention model: Single Group Assignment
Intervention model description: This is an uncontrolled feasibility study with one arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Anxiety; Stress
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Condition: Menopause; Climacteric Syndrome; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The study collected retrospective data from the assumption of combined natural molecules in
      menopausal women with metabolic syndrome
    


Intervention name(s): inositol, phytoestrogens, cocoa polyphenols
Intervention type(s): Dietary Supplement
Intervention description(s): myo-inositol, soy isoflavones and cocoa polyphenols
Intervention MeSH terms: Inositol; Phytoestrogens
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women in menopause exhibiting at least three of the diagnostic criteria for metabolic
        syndrome
Functional Electrical Stimulation for Hemiplegic Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how a functional electrical stimulation (FES) device
      worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy
      walk and perform other functional activities.

      The investigators expect to find that wearing the functional electrical stimulation device
      will improve walking and other functional activities of children with hemiplegic cerebral
      palsy. Participants will be trained in use of the device and will be required to wear it
      daily for 3 months. Each participant will be evaluated before beginning the intervention and
      after completing the intervention. This study will provide important information regarding
      the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
    


Intervention name(s): FES neuroprosthesis to dorsiflexors on affected leg
Intervention type(s): Other
Other intervention name(s): Bioness L300
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemiplegia, cerebral palsy, neuroprosthesis, children
Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)
Condition: Infection With Human Papillomavirus
Study type: Interventional
Phase: Phase 4

Summary: 
      Six identical female twins aged 9-13 years will participate. One sib of each twin pair will
      be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will
      be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will
      be taken (the first prior to vaccine administration, the second and third 7 days after dose 2
      and 3, respectively). The blood samples will be used to determine: 1) the magnitude the
      anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of
      these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3)
      plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and
      eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments
      in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells
      induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of
      monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light
      (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either
      Cervarix or Gardasil will be examined.

      The duration of the study is approximately 187 days. Five study visits will take place, over
      a time period of 6.5 months, followed by a telephone call after 12 months.

      The purpose of the study is to learn more about the molecular mechanisms underlying the
      cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the
      aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).
    


Intervention name(s): cervarix; Gardasil
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses will be given, one on Day 0, one on Day 30 and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm; 3 doses will be given, one on Day 0, one on Day 60 ± 2 days and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm
Other intervention name(s): GSK's commercially available bivalent HPV types 16 and 18 recombinant vaccine containing AS04 adjuvant (Cervarix®); Merck's commercially availably quadrivalent HPV(types 6, 11, 16, 18) recombinant vaccine containing amorphous aluminiumhydroxyphosphate sulphate adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine
      citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of
      Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting
      conditions.
    

Detailed description: 
      Detailed Description : The study was conducted as an Open label, balanced, randomized,
      two-treatment, two-sequence, two period,single-dose, crossover oral bioequivalence study of
      Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories
      Limited, India and Advil@PM, of Wyeth Consumer Healthcare, USA., in normal, healthy, adult,
      human subjects under fasting conditions. A total number of forty (40) subjects were enrolled
      in the study and all the subjects completed both the periods of the study.
    

Intervention name(s): Ibuprofen and Diphenhydramine Citrate
Intervention type(s): Drug
Intervention description(s): Ibuprofen and Diphenhydramine Citrate 200mg/38mg Caplets
Other intervention name(s): Advil PM
Intervention MeSH terms: Diphenhydramine; Promethazine; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence,Ibuprofen Diphenhydramine Citrate,Crossover
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to assess the immune (antibody) response and safety of a Seqirus split
      virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US
      licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric
      population 6 months through 59 months of age.
    


Intervention name(s): Seqirus Quadrivalent Inactivated Influenza Vaccine; Comparator Quadrivalent Inactivated Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.; The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
Other intervention name(s): Seqirus QIV; Comparator QIV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Color-dependent Melatonin Suppression
Condition: Melatonin
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of complex, broad-band spectra light on
      the production of melatonin in humans.
    


Intervention name(s): Light - standard; Light - alternate
Intervention type(s): Device; Device
Intervention description(s): Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution; Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      This study was to investigate the comparison among acute effects of various aerobic exercise
      on symptoms in allergic rhinitis patients.
    

Detailed description: 
      Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a
      crossover design in which each participant was given three types of exercise: running,
      cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time.
      Physiological variables, lung function variables, allergic rhinitis symptoms variables, and
      cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The
      dependent variables between pre-test and post-test were analyzed by a paired t-test. The
      dependent variables between groups were analyzed by independent t-test. One way repeated
      measures ANOVA was used to compare the variables among exercise. Differences were considered
      to be significant at p < 0.05.
    

Intervention name(s): Running; Cycling; Swimming
Intervention type(s): Other; Other; Other
Intervention description(s): The participant perform running on treadmill at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.; The participant perform cycling on cycle ergometer at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.; The participant perform swimming at moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p < 0.05.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinits; Cytokines; Aerobic exercise; Rhinitis symptoms
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Condition: Urinary Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and tolerability of fesoterodine
      following once daily long-term treatment in Japanese pediatric neurogenic detrusor
      overactivity (NDO) subjects.
    

Detailed description: 
      This is a Phase 3, multi-center, open-label long-term extension study in Japanese NDO
      subjects who participated and completed in the precedent Study A0221047 which is a 24 weeks,
      randomized, open label study, to investigate the safety and tolerability of fesoterodine.

      This study consists of a 28-week open-label treatment period followed by a 4-week follow-up.
      In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the
      fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1
      year treatment data.
    

Intervention name(s): Fesoterodine PR 4 mg; Fesoterodine PR 8 mg; Fesoterodine BIC 2 mg; Fesoterodine BIC 4 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fesoterodine 4 mg tablet once daily for 28 or 40 weeks; Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks; Fesoterodine BIC 2 mg tablet once daily for 28 weeks; Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Intervention MeSH terms: Fesoterodine
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurogenic detrusor overactivity; fesoterodine; Japan
Mobile Health Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass
      index decrease at 15 months compared to traditional management in obese adolescents.
    

Detailed description: 
      Childhood obesity continues to be a key challenge in France. The unit is facing a high demand
      with limited resources, moreover despite an intensive program of care with a
      multidisciplinary dedicated team, the impact on weight loss is moderate.

      The hypothesis is to ameliorate results by using distance monitoring in maintenance phase.

      After a traditional intensive period consisting in a weekly family-based multidisciplinary
      intervention, patients are randomized in two arms, traditional or distance follow-up.

      Traditional follow-up is based on face-to-face multidisciplinary consultations every three
      months.

      The distance monitoring is based on a mobile application dedicated to food behavior change
      and physical activity, with weekly self-monitoring, goal setting, physical activity and
      healthy eating support, monthly weight assessment. Pre-programmed feedbacks "motivational
      strategies" are included.

      After one year of follow-up, adolescents are evaluated for weight loss, compliance and
      quality of life. The two groups will be compared.

      The question is can mobile apps help to monitor and promote healthy lifestyle in obese
      adolescents.
    

Intervention name(s): traditional follow_up; distance follow-up "new technologies"
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multidisciplinary support with educational face to face family based intervention at 6, 9 and 12 months after inclusion.
Two days of a complete medical check at 9 and 15 months; Multidisciplinary support with long distance monitoring "Mobile apps".
Two days of a complete medical check at 9 and 15 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: obesity; children; adolescents; new technology; mobile health; chronic disease