bioihbjkbjnl/mcl2 huggingface dataset:
Peer-Based Skills Training to Enhance Teen Weight Loss
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To evaluate the efficacy of peer-based skills training to enhance weight control and improve
      psychosocial functioning in overweight adolescents.
    

Detailed description: 
      BACKGROUND:

      The prevalence of obesity in children, adolescents, and adults has increased significantly
      over the last two decades. Adolescents who are obese are at great risk for remaining obese
      into adulthood. Given the difficulty of treating adult obesity, intervening with adolescents
      before they reach adulthood is critical. Decreasing obesity during adolescence provides an
      opportunity to prevent the continuance of pediatric onset obesity into adulthood. There are
      well-established weight control interventions for children between 8 and 12 years of age.
      However, treatment findings with overweight adolescents are not as robust and are difficult
      to replicate. One potential limitation of existing weight control interventions for
      adolescents is the minimal attention given to the peer group as an active component of
      treatment.

      The study was in response to an initiative issued by the National Institute of Diabetes and
      Digestive and Kidney Diseases and entitled "Innovative Approaches to the Prevention of
      Obesity". The resulting grant was later reassigned to the National Heart, Lung, and Blood
      Institute.

      DESIGN NARRATIVE:

      A total of 119 adolescents between the ages of 13 and 16 years and between 20 and 80%
      overweight were randomized to one of three treatment conditions: (1) cognitive-behavioral
      treatment (CBT); (2) cognitive-behavioral treatment with the addition of peer-based skills
      training (CBT + PBST); or 3) standard care (SC). The cognitive-behavioral intervention
      consisted of 16 weekly sessions followed by four monthly maintenance sessions. Adolescents
      randomized to CBT + PBST received the cognitive-behavioral treatment as well as an intensive
      32 session peer-based intervention. The peer-based intervention combined problem-solving
      therapy with principles from Outward Bound to address self-reliance, social competence and
      physical self-worth. One way analyses of variance was conducted at the end of treatment and
      at 6-months after the end of treatment to compare the three groups on initial reduction in
      percent overweight and maintenance of decreases in percent overweight at follow-up. Analysis
      of variance was also used to compare the three groups on measures of social functioning,
      self-esteem, physical activity level, and physical self-worth.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the randomised part of the study is to investigate the efficacy and safety
      of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug
      naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic
      patients with insufficient glycaemic control. For the open-label part of the study the
      objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic
      patients with very poor glycaemic control for 24 weeks
    


Intervention name(s): BI 1356; BI 1356 + metformin; Bi 1356 + metformin; Metformin; metformin; matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): BI 1356 high dose tablet, once daily; BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily; BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily; Metformin 500 mg tablet, twice daily; metformin 1000 mg tablet, twice daily; matching placebo
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
Condition: Fluid Shifts; Body Fluid Compartments
Study type: Interventional

Summary: 
      This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device
      called Body Composition Monitor (BCM) which measures the body composition (i.e. the water
      content of the body).

      Specifically, the investigators will evaluate the use of BCM for correct detection of
      intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we
      will test the change over time of the volunteers´ volume status after an intravenous fluid
      therapy.
    

Detailed description: 
      Technically assisted assessment of volume status may be useful to direct fluid
      administration.

      As a prerequisite the investigators will test a recently developed whole-body bioimpedance
      spectroscopy device to determine fluid status in volunteers after an intravenous fluid
      therapy.

      The correlation of infused fluid and change of the fluid status measured with Body
      Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.

      Using a three-compartment physiologic tissue model, BCM determine total body fluid volume
      (TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as
      surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and
      reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz
      through the entire patient via 4 electrodes placed on the wrist and ankle.

      Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After
      randomisation into one of two treatments the volunteer will receive either an iv isotonic
      fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour or
      no fluid therapy. At the second study day the volunteer will obtain the opposite treatment.

      We will perform BCM measurements every 10 minutes before, during and after the treatment for
      6 hours or until the BCM results return to baseline. The results are stored on a BCM patient
      card automatically.

      The main objective of this study is to detect the administered iv fluid in the extracellular
      compartment respectively in FO, TBV and ICV.

      Secondary outcome parameters include the change over time of ICV, ECV, TBV and FO after the
      iv therapy at the study day "Fluid Therapy".
    

Intervention name(s): Elo-mel® (Fresenius Kabi Austria); Body Composition Monitoring
Intervention type(s): Drug; Device
Intervention description(s): an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.; BCM measurements every 10 minutes for 6 hours.
Other intervention name(s): BCM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Bioimpedance Spectroscopy, Body Composition Monitor, Fluid Therapy
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part study will assess the effect of formulation and food on the pharmacokinetics of
      Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study.
      Participants will receive single doses of Indoximod base or salt formulation, in the fasted
      or fed state. Part 2 is a randomized single ascending dose study of indoximod salt
      formulation to characterize the PK profile and determine the safety and tolerability of each
      dose in healthy male volunteers.
    


Intervention name(s): Indoximod base formulation; Indoximod HCL (salt) formulation; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indoximod
Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous
      administration in 4 different quadrants of the abdomen for treatment of opioid use disorder
      (OUD). Injection locations are rotated to minimize irritation. Having 1 or more alternate
      injection sites is desirable for patients who may be taking SUBLOCADE for extended durations,
      based upon clinical response.

      The primary objective of this study is to assess the relative bioavailability of
      extended-release buprenorphine when administered at alternative injection locations (test
      treatments), in comparison to the abdomen (reference treatment).
    


Intervention name(s): Buprenorphine Extended-Release Injection
Intervention type(s): Drug
Intervention description(s): Administered as a subcutaneous injection.
Other intervention name(s): SUBLOCADE®
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medicine for opioid use disorder (MOUD)
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Condition: CML, CML-CP,MMR,TKI
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line
      treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.

      Randomized,Open Label,Control
    


Intervention name(s): Flumatinib 600mg qd; Imatinib 400mg qd
Intervention type(s): Drug; Drug
Intervention MeSH terms: Imatinib Mesylate; Flumatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Condition: Lupus Erythematosus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is a clinical trial of administering mesenchymal stem cell secretome to lupus
      patients.
    

Detailed description: 
      This research is experimental. The study was conducted on 30 SLE patient subjects. the
      treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th,
      5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA
      antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were
      collected. Statistical test with paired difference test with p < 0.05
    

Intervention name(s): Secretome; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mesenchymal stem cell secretome obtained from Kalbe Pharma Company; NaCl 0,9% infusion
Other intervention name(s): Messenchymal stem cell Concitioned Media; NaCl 0,9% infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Messenchymal Stem Cell Secretome; Lupus
Differential Diagnosis of STA-PSV in Thyrotoxicosis
Condition: Thyrotoxicosis; Peak Systolic Velocity of Superior Thyroid Artery; Thyroiditis; Graves Disease
MeSH terms: Graves Disease; Thyroiditis; Thyrotoxicosis; Systolic Murmurs
Study type: Observational

Summary: 
      Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their
      clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold
      standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake
      is limited for its availability in china and easily influenced by medicine or food contained
      iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of
      thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily
      varied by operator subjective judgement. This study is focus on the role of peak systolic
      velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods:
      Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two
      clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic
      velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below
      the low value of normal range. Graves disease is defined as the typical symptoms of graves
      disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as
      lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver
      operator curve(ROC) to evaluate its diagnosis value
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
Brain, Brainstem, and Spinal Cord fMRI
Condition: Neck Pain; Chronic Pain
MeSH terms: Chronic Pain; Neck Pain
Study type: Observational

Summary: 
      New advances in medical imaging have allowed for the measurement of brain activity related to
      chronic pain. In addition to the brain, the investigators aim to use functional magnetic
      resonance imaging to investigate pain processing in the brainstem and spinal cord in healthy
      subjects and chronic neck pain patients. The information gained from this study will increase
      the investigators understanding of how chronic pain is encoded in the nervous system and
      assist in developing more effective treatment strategies.
    

Detailed description: 
      The experimental design is an observational (non-interventional) cross-sectional clinical
      study. The principal goal of the proposed research is to utilize functional magnetic
      resonance imaging to further investigate and characterize pain-related neural activity at the
      level of the brain, brainstem, and spinal cord in healthy subjects and chronic neck pain
      patients. Healthy subjects and chronic neck pain patients will be recruited and participate
      in a single session of data collection. For both the healthy and chronic neck pain groups,
      painful thermal stimuli will be applied over the skin of the upper extremity while whole
      brain, brainstem, and cervical spinal cord functional images are acquired (on separate
      scans). For the chronic neck pain group, additional scans (brain, brainstem, and cervical
      spinal cord) will be acquired while the subjects rate their spontaneous chronic neck pain.
    

Intervention name(s): Functional Magnetic Resonance Imaging
Intervention type(s): Other
Intervention description(s): Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects and chronic neck pain patients recruited from the community
      
Keywords: Brain; Brain Stem; Spinal Cord; Neurophysiology; Magnetic Resonance Imaging
Inpatient Screening Mammography for Non-adherent and High Risk Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The investigators propose to pilot a program that will evaluate the feasibility of an
      inpatient screening mammography for non-adherent and high risk hospitalized women age 52-74
      admitted to the medicine services at Johns Hopkins Bayview Medical Center and Howard County
      General Hospital. The two key activities include: inpatient breast care education with
      educational handouts and offering inpatient screening mammography. Inpatient screening
      mammography will be offered to non-adherent (last screening mammogram more than 24 months
      ago) and high risk (Gail 5-year risk of breast cancer 1.6 or greater) women. This pilot
      program will thus evaluate the feasibility of an inpatient screening mammography as an
      innovative approach to increase breast cancer screening among non-adherent and high risk
      women.
    


Intervention name(s): Screening mammography
Intervention type(s): Other
Intervention description(s): The purpose of the study was to evaluate the feasibility of securing inpatient breast cancer screening mammograms for non-adherent hospitalized women prior to hospital discharge.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Breast Cancer Screening; Mammography
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the pain relieving effect of a single-dose of a novel ibuprofen
      formulation to placebo and two formulations of standard ibuprofen in the treatment of
      post-surgical dental pain following "wisdom" tooth (third molar) removal.
    


Intervention name(s): Novel Ibuprofen; Standard Ibuprofen; Standard Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single-dose of novel ibuprofen (equal to 400 mg ibuprofen); Single-dose of standard ibuprofen (400mg); Single-dose of standard ibuprofen (400mg); Single-dose of placebo
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain following third molar extraction
Study In Patients With Dyslipidaemia
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Study in patients with dyslipidaemia.
    


Intervention name(s): GW677954
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dyslipidaemia
Efficacy of Banhasasim-tang on Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and
      safety based on the rate of adverse event or laboratory findings of Banhasasim-tang
      administrated three times a day orally on functional dyspepsia.
    

Detailed description: 
      Banhasasim-tang

        1. Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis
           Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis
           Rhizoma) of old oriental prescriptions for dyspepsia.

        2. Usually having used for dyspepsia in asia

        3. Need for correct clinical information by RCT
    

Intervention name(s): Banhasasim-tang; Corn-starch granules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study; This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.
Other intervention name(s): Brand names : Bansasin granules; Corn-starch granules with herb decoctions flavor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Functional dyspepsia; Banhasasim-tang; Gastrointestinal Symptom score; Visual Analogue Scale; Functional Dyspepsia-related Quality of Life; Electrogastrography
Parent Supported Weight Reduction in Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a nutrition and physical activity education
      program for families of overweight or obese adolescents with Down syndrome is more effective
      when behavioral lifestyle change strategies are added.
    

Detailed description: 
      Children with intellectual disabilities, including Down syndrome (DS), are as likely to be
      overweight than their typically developing peers. The consequences of childhood obesity
      include increased risk for Type-2 diabetes, orthopedic problems, sleep apnea, elevated
      cardiovascular risk and menstrual irregularities. Research indicating a high prevalence of
      overweight, obesity, low fitness levels and other health problems among adults with DS
      suggest the need for more attention to health promotion among adolescents with DS, which has
      been limited to date. Educational interventions in nutrition and physical activity have not
      been tested through randomized clinical trial with families of adolescents with DS; nor have
      behavioral "lifestyle change" interventions based on Social Cognitive Theory. Among typical
      populations, the addition of training in behavior and lifestyle change to education-alone
      interventions increasingly is being seen as critical in helping to promote long-term weight
      loss and weight maintenance. The hypothesis of this study is that a parent supported weight
      reduction (PSWR) intervention that combines behavioral strategies with nutrition and activity
      education (NAE) will be more effective in reducing overweight in adolescents with DS than a
      program that provides NAE alone or a Wait-List (WL) control.
    

Intervention name(s): Parent Supported Behavioral Intervention; Nutrition/Activity Education (NAE)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.
Other intervention name(s): lifestyle modification; behavior modification; behavior therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; behavioral intervention; family based; weight loss