bioihbjkbjnl/mcl2 huggingface dataset:
Persons With Disabilities Generating Quality Metrics
Condition: Physical Disability; Chronic Mental Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      No standard way exists to measure the quality of medical care or independent living long-term
      services and supports provided to persons with disabilities. This project will: provide a
      broader picture of how consumers with disabilities define care and care quality; measure the
      value of using consumers' expertise in developing, collecting, and assessing quality
      measures; and use this information to assist One Care providers in improving care delivered
      to their enrollees
    

Detailed description: 
      The aims of the project are as follows:

        1. To work with persons with significant physical disabilities and serious and persistent
           mental illness to develop two new approaches to assess quality of care:

           Approach #1: We will survey enrollees about their experiences in One Care and their
           thoughts about the care they receive. This survey will also ask One Care enrollees about
           how they manage their care and what self-direction means to them. The survey will be
           called the Persons with Disabilities Quality Survey (PDQ-S), and it will be available in
           English and Spanish versions.

           Approach #2: Enrollees in One Care will provide information about their perceptions of
           care quality to a trained team of persons with disabilities who will report the
           information to One Care care teams. The goal of the activity is to support quality
           improvement in One Care through hearing the consumer's voice. This is called YES Health
           - Your Experience: Speak up for better health care.

        2. We want to test how providing consumer informed and consumer directed quality
           information to One Care providers affects One Care quality.

        3. We want to improve the ability of One Care enrollees to manage their own health care and
           to recognize and report quality problems
    

Intervention name(s): Survey; YESHealth
Intervention type(s): Other; Other
Intervention description(s): PDQS survey reports only; Arm 3: YESHealth and PDQS survey reports to providers
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control v Survey v YESHealth
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
LY353381 in Preventing Breast Cancer in Women With Hyperplasia
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of LY353381 may be an effective way to prevent
      the development of breast cancer in women who have hyperplasia.

      PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing
      breast cancer in women who have hyperplasia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for
           breast cancer.

        -  Determine if this drug modulates other potential surrogate endpoint biomarkers or drug
           effect biomarkers.

        -  Determine if cytologic improvement is associated with initial presentation of the
           various stratification factors.

        -  Determine whether cytology is correlated with other potential surrogate endpoint
           biomarkers or drug effect biomarkers and whether change in cytology is correlated with
           change in the other biomarkers.

        -  Monitor the effects of this drug in terms of quality of life and women's health.

      OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label
      study for both arms. Patients are stratified according to cytologic status (hyperplasia with
      atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2
      genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs
      postmenopausal), estrogen-receptor status, and participating center. Patients are randomized
      to one of two treatment arms.

        -  Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.

        -  Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms
           then receive oral LY353381 hydrochloride for an additional 6 months.

      Quality of life is assessed at baseline and then at 6 and 12 months.

      Patients are followed at 2 weeks and then annually for 5 years.

      PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3
      years.
    

Intervention name(s): arzoxifene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one tablet daily; matched tablet dialy
Other intervention name(s): LY353381
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: breast cancer
Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils
      that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo,
      or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.
    


Intervention name(s): AIN457; Placebo; prednisolone
Intervention type(s): Biological; Other; Drug
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ozone challenge; airway neutrophilia; induced sputum; Healthy volunteers
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese
      subjects compared with Caucasian subjects. The reasons for these potential differences are
      unclear. Therefore this study is being done to look at and compare how fluticasone furoate is
      processed by the body in healthy Caucasian, Japanese, Korean and Chinese subjects after
      inhaled and intravenous administration. The data obtained will be used to help in the
      clinical development of the drug in Japanese and other East Asian populations.
    

Detailed description: 
      Corticosteroids are a highly effective anti-inflammatory therapy in allergic conditions such
      as asthma and rhinitis. Fluticasone Furoate (FF) is a novel corticosteroid with potent
      glucocorticoid activity similar to fluticasone propionate and mometasone furoate. Phase II
      studies have shown FF to be an effective once daily inhaled steroid for asthma and it is
      being developed as a potential steroid component in a once daily combination with GW642444M,
      for once-daily administration for the maintenance treatment of asthma and COPD. FF is
      approved worldwide (including the US, EU and Japan) as an intranasal steroid for the
      treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™). Previous inter-study
      comparisons have indicated potentially higher systemic exposure to FF in Japanese subjects
      compared with treatment groups that recruited predominantly Caucasian subjects. The reasons
      for these potential differences are unclear. This study is being performed to evaluate and
      directly compare the PK and systemic PD effects of FF in healthy Caucasian, Japanese, Korean
      and Chinese subjects when delivered from the novel dry powder inhaler and intravenously. The
      data obtained will be used to facilitate clinical development of the FF/GW642444 combination
      in Japanese and other East Asian populations.
    

Intervention name(s): fluticasone furoate
Intervention type(s): Drug
Intervention description(s): Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).
A single intravenous dose of 250mcg FF given over 20 minutes (Day 1).
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; serum cortisol; pharmacodynamics; fluticasone furoate; healthy Caucasian, Japanese, Korean and Chinese subjects
Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or
      a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and
      their effect on blood glucose control, versus insulin glargine alone as active comparator in
      type 2 diabetes.
    

Detailed description: 
      Due to the different mechanisms of action of the long-acting insulin analog insulin glargine
      and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a
      promising approach to combine insulin glargine with either exenatide or sitagliptin for
      optimum control of fasting and postprandial blood glucose values. Thus, in the present study
      the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal
      insulin (insulin glargine) was investigated versus insulin glargine alone as active
      comparator in subjects with type 2 diabetes. Preexisting metformin was continued,
      sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose
      excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment,
      the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of
      subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting
      lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed.
      The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in
      period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the
      site and twice weekly telephone contacts.
    

Intervention name(s): insulin glargine + exenatide + preexisting metformin; insulin glargine + sitagliptin + preexisting metformin; insulin glargine + preexisting metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin; insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin; insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
Other intervention name(s): Lantus; Byetta; Lantus; Januvia; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Sitagliptin Phosphate; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes
Exploratory Study to Assess the Pharmacokinetics of AZD5985
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses
      of AZD5985 in healthy male volunteers
    


Intervention name(s): AZD5985; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.; Oral suspension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers
An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders
Condition: Spinal Disorder
MeSH terms: Spinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of
      NORSPAN® from baseline.

      And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)
      the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's
      overall satisfaction, and safety
    

Detailed description: 
      Upon providing written informed consent, subject will be screened in the study and assessment
      will be performed at that time such as safety laboratory assessments, physical examination,
      vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, pain and sleep
      questionnaire, physician's overall satisfaction and subject's overall satisfaction.

      If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient
      will receive treatment with NORSPAN®.

      Treatment with NORSPAN® will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper
      titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to
      the investigator's decision.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): 8weeks treatment with Norspan®(Buprenorphine)
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, single-dose, three-treatment, parallel group design PK comparability study of
      MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution
      (bevacizumab).
    

Detailed description: 
      Double-blind, single-dose, three-treatment, parallel group design PK comparability study of
      MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution
      (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment
      arm). After randomization, subjects will receive one of the following treatments: A single 1
      mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O,
      an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion
      of EU marketed Avastin® (1 mg/kg).
    

Intervention name(s): MYL-1402O; US marketed Avastin(R); EU marketed Avastin(R)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.; Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins; Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.
Other intervention name(s): Bevacizumab; Bevacizumab; Bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: safety; tolerability; immunogenicity; MYL-1402O; PK; Avastin®; biosimilarity; male
Physiological and Perceptual Effects of Music on Resting Metabolic Rate (RMR)
Condition: Metabolism
Study type: Interventional

Summary: 
      The objective of the study is to determine whether music has any effect on resting metabolic
      rate (RMR), which is the amount of energy expended at rest. There is currently conflicting
      research on how music affects RMR. One problem with RMR testing is that participants often
      fall asleep during the test. There can be a 5-10% difference in the metabolic rate between
      rest and sleep. If no change in RMR is observed, playing music during an RMR test could be a
      potential strategy to prevent participants from falling asleep. Participants will undergo RMR
      measurements while listening to no music, relaxing classical music, and self-selected
      classical music.
    


Intervention name(s): No Music; Relaxing Classical Music; Self-Selected Relaxing Music
Intervention type(s): Other; Other; Other
Intervention description(s): Participants lie supine on a table while no music is played.; Participants lie supine on a table while classical music is played.; Participants lie supine on a table while self-selected relaxing music is played.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain
Condition: Chronic Non-specific Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is
      featured by neck muscles contractures which lead to pain and reduction of cervical spine
      mobility. High intensity laser therapy has been shown to be an effective treatment to improve
      symothoms in patient with non-specific neck pain.

      The aim of this study is to assess the effects of a multi-wave locked system laser therapy in
      patient with non-specif neck pain.
    


Intervention name(s): Laser therapy; Sham laser therapy
Intervention type(s): Other; Other
Intervention description(s): Multiwave locked system laser therapy; Sham laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
FITLINE: Pediatric Practice-based Obesity Intervention to Support Families
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of this study is to investigate whether eight weekly telephone coaching sessions or
      materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year
      olds.
    

Detailed description: 
      The proposed five-year cluster randomized controlled pediatric practice-based trial will
      compare the effectiveness of two practice-based interventions on improving diet and physical
      activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric
      practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus
      Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same
      practice-based component, but only the family workbook materials mailed over 8 weeks, with no
      referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to
      either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and
      twelve parents and their children ages 8-12 with a body mass index (BMI) of > 85th percentile
      (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month
      follow-up.
    

Intervention name(s): Coaching; Materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.; The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity
Phase I Trial for Pharmacokinetic Characteristics of Factive 200mg Intravenous Formulation (Gemifloxacin 200mg) With Factive 320mg Tablet Formulation (Gemifloxacin 320mg)
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to compare the pharmacokinetic characteristics of Factive 200mg Intravenous
      Formulation (Gemifloxacin 200mg) with those of Factive 320mg Tablet Formulation (Gemifloxacin
      320mg) and to explore possibility of clinical use of the IV formulation.
    


Intervention name(s): Factive® Tab / Factive IV
Intervention type(s): Drug
Intervention MeSH terms: Gemifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part,
      single ascending dose and multiple dose cohort study of orally administered Norketotifen
      (NKT) in healthy subjects.
    

Detailed description: 
      Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10
      subjects will be enrolled in each cohort and will be randomly assigned to receive a single
      oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review
      all available safety data in a blinded manner following the completion of each cohort to
      determine the next dose level to be evaluated in the next cohort.

      Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned
      to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an
      adequate number of days to reach steady state (the number of days will be determined based on
      the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the
      SRT.
    

Intervention name(s): Norketotifen Oral Capsule (Cohort 1); Norketotifen Oral Capsule (Cohort 2); Norketotifen Oral Capsule (Cohort 3); Norketotifen Oral Capsule (Multiple Dose Cohort); Placebo Oral Capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose Norketotifen; Single dose Norketotifen; Single dose Norketotifen; Multiple dose Norketotifen; Placebo
Intervention MeSH terms: Ketotifen
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment