bioihbjkbjnl/mcl2 huggingface dataset:
Effects and Safety of Different Dose of Bambuterol on Chinese COPD Patients
Condition: COPD
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period
      followed by three treatment periods of 21-days each performed in patients with COPD. Patients
      will be randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and
      placebo).
    

Detailed description: 
      Patients with COPD who meet the inclusion criteria will enter the 7-days washout baseline
      period. After the baseline period, patients will be randomly assigned to one of the following
      treatment sequences:

        -  Sequence I: bambuterol 10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -
           washout (7 days) - placebo (21 days);

        -  Sequence II: bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) - washout (7
           days) - bambuterol 10mg (21 days) ;

        -  Sequence III: placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout
           (7 days) - bambuterol 5mg (21 days).

      During the treatment period patients will record their adverse events and use of rescue
      medication (Ipratropium bromide) in a diary. At each visit, pulmonary function tests will be
      performed. At V2, V4 and V6, forced expiratory volume at one second (FEV1) and forced vital
      capacity (FVC) are measured at following times: immediately before tablet treatment, and at
      0.5, 1, 2, 3, 4, 6, 9, 12hrs after administration of tablets, FEV1 and FVC area under curve
      (AUC) 0~12 hours will be analyzed. At V1, V3, V5 and V7, and FVC are measured a time in the
      morning. Peak expiratory flow rate (PEFR) is measured by Mini-Wright peak flow meter in the
      morning before treatments. All other data will be evaluated as safety status, and monitoring
      of adverse events.
    

Intervention name(s): bambuterol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days.
Other intervention name(s): Bambec, KWD-2183
Intervention MeSH terms: Bambuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: efficacy; safety; Bambuterol tablets; COPD
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.
    

Detailed description: 
      The goal of this study is to obtain baseline information on serum and cerebrospinal fluid
      (CSF) relaxin levels in patients with MS, as well as to further study RXFP-1 receptor binding
      affinity for RLX in patients with active and clinically stable MS.
    

Intervention name(s): Blood Draw; Lumbar Puncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will provide a serum sample for research.; Patients will have a lumbar puncture to obtain CSF.
Other intervention name(s): Spinal tap; LP
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected MS undergoing a lumbar puncture for diagnosis, patients with stable
        MS willing to participate in the study, and patients without MS having a lumbar puncture as
        part of their non-MS disease management will be invited to participate in this study.
      
Biospecimen description: 
      Patients will provide blood and cerebrospinal fluid for use in this research.
    
Keywords: Multiple Sclerosis; MS; Relaxin
A+ Asthma Early Intervention in Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This project will evaluate the effectiveness of a Head Start-based early intervention for
      designed to improve asthma management skill and practices of parents, pre-school children and
      Head Start staff.
    

Detailed description: 
      BACKGROUND:

      While increased asthma morbidity and mortality have been observed across all ethnicities,
      results from several studies have found that asthma morbidity has increased
      disproportionately in low-income African American children. Elementary school-based asthma
      education programs have shown promise in improving asthma management, and reducing asthma
      morbidity in this high-risk population, however, the fastest growing asthma risk is
      associated with children young than six. By elementary age many parents and children with
      asthma have well-established patterns of inappropriate asthma management that may be
      difficult to change. To date, no research has examined the impact of early intervention for
      asthma management in low-income, high-risk children.

      DESIGN NARRATIVE:

      Head Start sites will be randomized to either a minimal intervention control group or the A+
      Asthma early intervention program designed to educate and assist Head Start teachers and
      family service coordinators to: optimize classroom management of asthma, educate, facilitate
      and reinforce appropriate parental medical and behavioral management of asthma, and instruct,
      model and reinforce early asthma knowledge and age-appropriate skills for preschool age
      children.

      The primary outcome that the study was designed to evaluate Head Start absences/days
      enrolled, determined by review of Head Start attendance records.

      The secondary outcomes specified in the protocol are health care utilization (emergency
      department visits, hospitalizations, primary care visits), asthma symptoms (restricted
      activity, symptom-free days, day and nighttime symptoms), asthma medications, parents'
      asthma-related quality of life, and parent, child and teacher asthma knowledge and management
      practices.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): A+ Asthma early intervention program
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and
      reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI
      tract. The most common symptoms associated with the effects of opioids are constipation and
      nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of
      long-term opioid therapy.

      The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with
      placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term
      opioid therapy for chronic noncancer pain.
    


Intervention name(s): Placebo; ADL5945 0.25 mg
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid therapy; constipation; chronic noncancer pain; mu opioid receptor antagonist; ADL5945; Opioid Induced Constipation
Deductive Reasoning and Math Learning Difficulty
Condition: Healthy
Study type: Interventional

Summary: 
      Most studies to date that have examined the factors underlying math achievement in children
      have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic
      numerical knowledge and recent behavioral studies suggest a relationship between math and
      deductive reasoning skills. The goal of this study is to determine the neural mediators of
      this relationship using functional magnetic resonance imaging. The investigators will ask
      children from 8 to 14 to complete a standardized math achievement test, and measure their
      brain activity while they process deductive arguments. The investigators will then correlate
      brain activity during reasoning to individual math skills to identify the brain regions in
      which activity during reasoning is modulated by math skill.
    


Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): All participants are scanned while evaluating deductive reasoning problems. Their math skill is also assessed.
Other intervention name(s): fMRI scanning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Longitudinal Endodontic Study of Apical Preparation Size
Condition: Chronic Apical Periodontitis of Pulpal Origin
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      This protocol is for a clinical trial evaluating the clinical success of root canal therapy
      performed on teeth with chronic apical periodontitis of pulpal origin with either large or
      small apical root canal preparation techniques.
    

Detailed description: 
      This randomized clinical trial will compare the clinical success of two commonly used
      techniques for performing non-surgical endodontic procedures on teeth with chronic apical
      periodontitis of pulpal origin. The first method, termed the "GT method" uses a commercially
      available rotary file system to instrument the root canal systems from the crown to the
      apical portion of the root. After completion of this technique, the apical portion of the
      root is prepared to the same standardized ISO size #20 in all roots (i.e., 0.2 mm
      cross-sectional diameter). The second method, termed the "Lightspeed method" uses a different
      commercially available rotary file system to shape the root canal systems from the apical to
      the crown portion of the root. After completion of this technique, the apical preparation is
      often larger in cross-sectional diameter than that observed after the GT method; however, an
      equally important distinction is that the Lightspeed method customizes the final
      cross-sectional diameter for each root canal system, and thus each root has a similar
      enlargement of apical preparation size due to proportionate removal of infected dentin at the
      end of the root. Although the Lightspeed method may result in reduced bacteria in the apical
      portion of root canal systems, there is no evidence to date that this effect improves
      clinical success rates. This study will test the hypothesis that the larger apical
      preparation size produced by the Lightspeed instrumentation system will produce a higher
      percentage of clinically successful treatments of teeth with apical periodontitis (AP) as
      compared to the GT method
    

Intervention name(s): Endodontic procedure with varied apical preparation size
Intervention type(s): Procedure
Intervention description(s): Comparison of two commonly used techniques for performing root canal treatment: 1) Lightspeed method 2)Buchannan method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Apical Periodontitis, Root Canal Therapy, Apical Preparation
Positron-Emission Tomography With Vesicular Monoamine Transporter Ligand ([18F]-DTBZ) In Healthy Elderly And Young Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      A total 25 healthy subjects will be included in this study. Subjects between 20 and 80 years
      of age may be eligible for this study. Candidates are screened with a medical history and
      physical examination, and blood test.
    

Detailed description: 
      The primary objective of this protocol is to assess the possible age-dependent decline in
      striatal 18F-DTBZ uptake of healthy subjects.

      This study is expected to be completed in a period of 2 years.
    

Intervention name(s): 18F-DTBZ AV-133
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-DTBZ AV-133 imaging
Genitourinary Symptoms With Levonorgestrel Releasing Intrauterine Systems
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The main purpose of the study was to evaluate the efficacy of Levonorgestrel Releasing
      Intrauterine devices (LNR-IUD) on genitourinary symptoms in patients with abnormal uterine
      bleeding. The patients were asked urogenital distress inventory (UDI) (which includes;
      irritative symptoms, stress symptoms, obstructive discomfort) and incontinence impact
      questionnaire (IIQ) (which includes; physical activity, travel, social/relationships,
      emotional health)questionnaires in the day of application LNR-IUD and six months later this
      procedure. Statistical analyse will be performed to evaluate the changes in this time period.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        15-55 aged women using levonorgestrel releasing intrauterine device for the treatment of
        menorrhagia or adenomyosis
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
Condition: Schizophrenia; Bipolar Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Maintenance of employment is dependent upon being able to successfully integrate into one's
      work setting. This can present a significant challenge to individuals with serious mental
      illness, as they typically exhibit impairment in their ability to accurately perceive and
      understand social exchanges. Presently the most established intervention is Social Cognition
      and Interaction Training (SCIT), a 12-week group intervention in which participants learn
      strategies to enhance emotion recognition and to assess the accuracy of their interpretation
      of social interactions. To enhance transfer of training gains to functional outcomes,
      participants will be paired with a social mentor to facilitate completion of homework and to
      ensure that skills are practiced outside of treatment (supported SCIT). The study will
      examine the impact of supported SCIT on social and work role functioning.

      The specific aims are:

        1. To assess the feasibility of providing supported SCIT to individuals with serious mental
           illness who are engaged in compensated work activity.

        2. To assess the impact of supported SCIT on social cognitive skills as well as work and
           social performance.

        3. To assess durability of intervention-induced change 3 months after the end of
           intervention.

      A single blind study will be conducted in which participants between 18-70 with serious
      mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned
      to 12 weeks of supported SCIT. Intervention will consist of one 2-hour small group training
      sessions and 30 minutes of individualized supported practice of skills with a treatment
      facilitator weekly. Feasibility will be assessed with attendance at group and individual
      sessions. Baseline, post-intervention (3-month), and follow-up (6-month) assessments will
      measure social cognitive abilities and functional outcomes. Potentially confounding variables
      such as symptom severity and outside treatment hours will also be assessed. It is
      hypothesized that supported SCIT will be completed by at least 75% of veterans. The
      intervention is predicted to improve social cognitive skills and social and work performance.
      Training gains are expected to be sustained 3 months after intervention.
    


Intervention name(s): Social Cognition and Intervention Training
Intervention type(s): Behavioral
Intervention description(s): A manualized group therapy that teaches social cognitive skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the phase 1b trial described here are to facilitate identification of assays and
      immune responses that could then be evaluated as correlates of risk and correlates of
      protection in efficacy studies and ultimately to provide leads for biomarkers of protection
      against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating
      the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).
    

Detailed description: 
      This study proposes to further evaluate the safety and immunogenicity of H4:IC31, H56:IC31,
      and BCG revaccination. The study will be conducted in previously BCG vaccinated healthy
      adolescents, and will entail a thorough immunogenicity evaluation of these regimens
      incorporating unbiased systems vaccinology approaches and novel assessments of baseline and
      elicited responses that may impact vaccine responses. A major goal for this study is to
      generate immunological data on a wide range of immune responses using a variety of approaches
      including validated assessments, unbiased strategies, and novel exploratory assays to
      increase the likelihood of detecting responses correlating with risk or protection in the
      prevention of infection study. Investigators contributing to the proposed study have
      participated in a correlates analysis for an HIV vaccine exhibiting modest efficacy in which
      2 correlates of risk were identified.

      An additional aim of this study is to explore factors affecting vaccine induced responses
      that may also impact efficacy. For example, it is hypothesized that exposure to environmental
      mycobacteria may alter protection provided by BCG vaccination. Reagents for evaluating levels
      of exposure to environmental mycobacteria are in development as part of a concurrent
      collaborative study. An exploratory objective for this trial is to apply these reagents to
      examine whether such exposures influence immune responses elicited by the study vaccine and
      regimens.
    

Intervention name(s): H4:IC31; H56:IC31; BCG; Control Sodium Chloride 0.9%
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): H4 contains Mtb antigens Ag85B and TB10.4; H56 contains Mtb antigens ESAT-6, and Rv2660c
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Validity and Reliability of the Polar M200 Activity Monitor
Condition: Healthy Persons; Fitness Trackers
Study type: Interventional

Summary: 
      The aim of this study will be to investigate the validity of a consumer available activity
      tracker (Polar M200) in free-living conditions to measure sedentary time.
    

Detailed description: 
      The aim of the present study is to evaluate the validity from a commercially available
      wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for
      long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be
      used for research purposes, but high-quality validation studies are needed. The aims of this
      study will be to assess validity of sedentary outcome measures of a Polar device during
      free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL
      Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary
      time in free-living conditions.
    

Intervention name(s): Polar M200
Intervention type(s): Device
Intervention description(s): Participants will have to wear the activity monitors (AP and Polar M200) for at least 7 days. Minutes spent in each activity type will be summed to a total day score. Participants will be instructed to do their regular daily life activities without limitation, but to note their main activity categories in an activity diary, with a main focus on cycling and participation in structured exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to provide an initial assessment of the safety, tolerability and
      efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.
    

Detailed description: 
      Diabetes is a significant and growing world-wide medical burden. Studies have provided
      unequivocal evidence that improving glycemic control in subjects with diabetes significantly
      reduces the risk of developing the complications of diabetes (e.g., retinopathy, nephropathy,
      and neuropathy). Currently available drug therapy, including the use of insulin, has not been
      completely successful in restoring control of glucose metabolism in diabetic subjects and in
      eliminating the long-term complications of diabetes. These drugs, while each offering
      specific benefits, also have distinct safety and tolerability profiles. Thus, there remains a
      need for agents with novel mechanism(s) of action.

      ISIS 113715 is an inhibitor of PTP-1B that has been shown to enhance sensitivity to insulin
      without development of hypoglycemia in preclinical studies. Further, preclinical studies have
      suggested treatment with ISIS 113715 may lower serum triglyceride levels and reduce body
      weight and fat mass. Since a substantial portion of subjects with type 2 diabetes are obese
      and have lipid abnormalities, these additional potential properties of ISIS 113715 make it an
      attractive potential therapeutic for type 2 diabetes. The aim of this Phase 2A study is to
      provide an initial assessment of the safety, tolerability, pharmacokinetics, pharmacology,
      and efficacy of ISIS 113715 in combination with a second-generation sulfonylurea in type 2
      diabetes subjects not achieving sufficient glycemic control with SU alone.
    

Intervention name(s): ISIS 113715
Intervention type(s): Drug
Intervention description(s): doses of 100 and 200 mg per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes