bioihbjkbjnl/mcl2 huggingface dataset:
The Compassion and Attention Longitudinal Meditation Study
Condition: Immune System Processes; Inflammatory Activation and Modulation; ANS Function
Study type: Interventional

Summary: 
      The increasingly widespread use of meditation for stress-related emotional and medical
      conditions highlights the urgent need to rigorously evaluate mechanisms through which the
      benefits of practice might be conferred. Primary challenges in this regard include evaluating
      dose response relationships between practice time and outcomes; clarifying whether
      physiological and behavioral effects of meditation derive primarily from non-specific aspects
      of training or result from specific meditation practices; and identifying molecular
      mechanisms by which meditation might affect physiological responses relevant to
      stress-related illness. Recent findings from a cross-sectional study by our group indicate
      that young adults who are randomized to, and practice, compassion meditation demonstrate
      reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a
      standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared
      to subjects randomized to an active control condition. However, as a result of the
      cross-sectional study design and lack of a meditation comparator arm, these results provide
      only partial insight into key issues outlined above regarding the role played by specific
      meditation procedures and/or practice time in observed physiological and behavioral outcomes.
      The primary hypothesis of the proposed work is that practicing a meditation procedure
      specifically designed to enhance empathic concern for others (i.e. compassion meditation)
      will optimize autonomic reactivity to psychosocial stress in a manner that results in
      diminished activation of peripheral inflammatory signaling pathways and reduced behavioral
      distress.
    


Intervention name(s): Cognitive-Based Compassion Training; Mindful Attention Training; Adult Health Education Curriculum
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University; Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.; Eight week training in health and wellness, using a curriculum developed specifically for this study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: inflammation; immune system; cytokines; meditation; compassion; attention
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
Condition: Cutaneous Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety
      and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with
      cutaneous warts.
    


Intervention name(s): CLS003; Furosemide; Digoxin; Vehicle topical
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Digoxin; Furosemide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of LEDs on Memory in TBI Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to investigate whether transcranial, high-intensity LED placed on
      the scalp can improve working memory in people who have sustained a concussion with lingering
      effects or a mild brain injury.
    

Detailed description: 
      This is a four month, outpatient, single center study investigating whether transcranial,
      high intensity LED applied outside the skull can improve frontal lobe executive function and
      working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or
      without mild posttraumatic stress disorder (PTSD), due to closed head injury.

      Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening
      test are administered. If the participant's neuropsychological screening test scores meet the
      Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion
      criteria, then he/she will be tested again on the tests that are part of the
      Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and
      during the week after the last LED treatment and again at one and two months after the last
      LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be
      treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED
      treatments will be administered.
    

Intervention name(s): MedX Health Phototherapy (light therapy)
Intervention type(s): Device
Intervention description(s): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mild traumatic brain injury; mild TBI; mTBI
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
Condition: Mass Balance Study
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral
           dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary
           excretion pathways in humans;

        -  To obtain radioactive metabolite profiles of human plasma, urine and feces , identify
           major metabolites of D-1553 and determine the major metabolic pathways and elimination
           pathways;

        -  To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of
           plasma TRA and investigate whole blood/plasma ratio for TRA.
    

Detailed description: 
      Primary Objectives:

        -  To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral
           dose of [14C] D-1553 in healthy subjects, and obtain radioactivity recovery and primary
           excretion pathways in humans;

        -  To obtain radioactive metabolite profiles of human plasma, urine and feces after a
           single oral dose of [14C] D-1553 in healthy subjects, identify major metabolites of
           D-1553 and determine the major metabolic pathways and elimination pathways;

        -  To quantitatively analyze the TRA in whole blood and plasma after a single oral dose of
           [14C] D-1553 in subjects, and obtain PK parameters of plasma TRA and investigate whole
           blood/plasma ratio for TRA.

      Secondary Objectives:

        -  To observe the safety of a single oral dose of [14C] D-1553 in healthy subjects;

        -  To quantitatively analyze the concentration of D-1553 and its metabolites (if
           applicable) in plasma using the validated LC-MS (liquid chromatography-mass
           spectrometry)/MS method and obtain the pharmacokinetic (PK) parameters of D-1553 and its
           metabolites (if applicable) in plasma.
    

Intervention name(s): [14C] D-1553
Intervention type(s): Drug
Intervention description(s): [14C] D-1553 (approximately 400 mg/80 μCi)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Condition: CerebroSpinal Fluid (CSF) Leak; Chronic Otitis Media; Otospongiosis; Otosclerosis; Pulsatile Tinnitus; Cholesteatoma
MeSH terms: Tinnitus; Otitis Media; Otosclerosis; Cholesteatoma
Study type: Interventional

Summary: 
      The study objective is to compare the CBCT images generated by the CS 9300 to those generated
      by conventional CT.
    

Detailed description: 
      The study objective is to compare the CBCT images generated by the CS 9300 to those generated
      by conventional CT. It proposes a direct comparison of diagnostic image quality between the
      CS 9300 and CT for the ability to view and confirm ENT disorders.
    

Intervention name(s): Radiation
Intervention type(s): Radiation
Intervention description(s): Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Intervention model: Single Group Assignment
Intervention model description: Predicate CT Scan and Investigational Cone Beam Scan
Masking: None (Open Label)
Primary purpose: Diagnostic
Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells
      and either kill them or deliver tumor-killing substances to them without harming normal
      cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel,
      and trastuzumab in treating patients who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in
      combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast
      cancer. II. Determine the response rate of these patients to this treatment regimen. III.
      Determine the median time to treatment failure in these patients with this treatment regimen.
      IV. Determine the incidence of cardiac toxicity in these patients with this treatment
      regimen. V. Assess the quality of life in these patients.

      OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab
      (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2;
      and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in
      the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive
      escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The
      MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
      toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is
      assessed at baseline and after 3 courses of treatment.

      PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation
      portion of this study. A total of 28-41 patients will be accrued for the phase II portion of
      this study.
    

Intervention name(s): trastuzumab; capecitabine; paclitaxel
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Paclitaxel; Capecitabine; Trastuzumab
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
Condition: Genital Herpes
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Observational

Summary: 
      The purposes of this study are:

        -  To determine the accuracy of commercially available serologic assays in diagnosing
           patients with herpes simplex virus type 2 (HSV-2);

        -  To assess the sensitivity and specificity of the commerical assays using HSV-2 western
           blot as the "gold standard" in a diverse patient population;

        -  To develop testing strategies and recommendations for screening asymptomatic populations
           for HSV-2.
    

Detailed description: 
      The purposes of this study are:

        -  To determine the accuracy of commercially available serologic assays in diagnosing
           patients with herpes simplex virus type 2 (HSV-2);

        -  To assess the sensitivity and specificity of the commerical assays using HSV-2 western
           blot as the "gold standard" in a diverse patient population;

        -  To develop testing strategies and recommendations for screening asymptomatic populations
           for HSV-2.

      We will evaluate the assays in diverse populations:

        1. STD clinic population

        2. Men who have sex with men, with high prevalence of HIV infection

        3. Pregnant women

      The study will inform the development of testing strategies:

        1. Combine commercial tests to optimize positive predict value (PPV) and negative predict
           value (NPV)

        2. Increase cutoff values to increase PPV

        3. Understand factors associated with false positive results that may include HSV-1
           infection, pregnancy status, HIV infection, and age/race etc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will comprise of diverse ethnic and racial populations derived from 3
        Health and Human Services Regions and recruited from different type of clinics: 1) STD
        clinics 2) Prenatal clinic 3) Health clinic for gay men
      
Biospecimen description: 
      Serum specimens
    
Keywords: HSV-2; HSV-1; Sensitivity; Specificity; Testing algorithm; Test evaluation
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females
Condition: Infections, Papillomavirus
Study type: Observational

Summary: 
      This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK
      Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as
      per the regulations of the Korean Food and Drugs Administration (KFDA).
    


Intervention name(s): Cervarix.; Data collection
Intervention type(s): Biological; Other
Intervention description(s): Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.; All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy female subjects aged between and including 10 to 25 years who receive Cervarix®
        according to the current practice of Korean doctors.
      
Keywords: Post-marketing surveillance; Human papillomavirus; Korea; Safety; Prescribing Information
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)
Condition: Heterozygous Familial Hypercholesterolemia (HeFH)
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effects of anacetrapib (MK-0859) on low-density
      lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with
      heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying
      therapy.
    


Intervention name(s): Anacetrapib; Placebo for anacetrapib
Intervention type(s): Drug; Drug
Other intervention name(s): MK-0859
Intervention MeSH terms: Oxazolidinones; Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
My Body is Fit and Fabulous at School Phase II
Condition: Overweight, Childhood
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      "My Body is Fit and Fabulous" (MyBFF@school) program was designed specifically for overweight
      and obese school children in order to help them control their BMI and body fat. MyBFF@school
      is a multi-faceted obesity intervention program that incorporated physical activity,
      nutrition and psychology modules.
    

Detailed description: 
      "My Body is Fit and Fabulous" (MyBFF@school) is a school-based, cluster randomised controlled
      trial (C-RCT) study that primarily aimed to evaluate the effectiveness of MyBFF@school
      program on overweight and obese school childrens' BMI for age (BMI z-score) and body fat
      percentage at 3 and 6 months post intervention. Primary and secondary schools in the central
      region of Peninsular Malaysia were randomised to either intervention or control school via
      systematic random sampling method. The selected intervention schools underwent MyBFF@school
      programme that consisted of physical activity, nutrition and psychology modules, whereas the
      control schools followed the standard national school curriculum.
    

Intervention name(s): MyBFF@school
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
Condition: Metabolism and Nutrition Disorder; Obesity; Obstructive Sleep Apnoea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nutrition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in North America. The aim of the trial is to investigate the effect
      of liraglutide in obese subjects with sleep apnoea.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise; Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: OSA
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD
      (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated
      with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to
      moderate pain associated with osteoarthritis of the knee in adults.
    

Detailed description: 
      The primary objective of the study is to compare the efficacy of ThermoProfen™ against two
      other experimental treatments.

      The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may
      or may not include ketoprofen and that may or may not provide heat.
    

Intervention name(s): ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System); Placebo Matrix/CHADD Patch; Ketoprofen matrix/placebo CHADD Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Transdermal patch applied to the knee for 12 hours daily.; Transdermal patch applied to the knee for 12 hours daily.; Transdermal knee applied to the knee for 12 hours daily.
Other intervention name(s): Matrix Transdermal Ketoprofen CHADD System; Placebo patch with heating system; ketoprofen matrix with no heat
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference
      to CONCERTA® in pediatric subjects diagnosed with ADHD.
    

Detailed description: 
      This is a phase III, randomized, double-blind, multi-center, parallel-group,
      placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of
      MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in
      pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).
    

Intervention name(s): Methylphenidate Transdermal System; Placebo; Concerta
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA; The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA; The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other intervention name(s): MTS; Sham treatment; Methylphenidate HCL
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)