bioihbjkbjnl/mcl2 huggingface dataset:
Four Arm Food Effect Study of Fenofibric Acid Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the single-dose pharmacokinetic
      profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat
      compositions on the rate and extent of absorption. Additionally, the safety and tolerability
      of this dose and regimen of fenofibric acid will be evaluated.
    

Detailed description: 
      The primary objective of this study is to determine the single-dose pharmacokinetic profile
      of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat
      compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese,
      non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single
      oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions
      each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will
      receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast
      of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal
      according to their randomization sequence. Subjects will fast for at least 4.25 hours after
      dosing in each of the four dosing conditions. Blood samples will be drawn from all
      participants before dosing and for 72 hours post-dose at times sufficient to adequately
      define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate
      the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and
      heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be
      monitored throughout the confinement portion of the study for adverse reactions to the study
      drug and/or procedures. All adverse events whether elicited by query, spontaneously reported,
      or observed by clinic staff will be evaluated by the Investigator and reported in the
      subject's case report form.
    

Intervention name(s): Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet; Fenofibric Acid 105 mg Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.; One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast; One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.; One 105 mg tablet administered after an overnight fast of at least 10 hours.
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits
Condition: Conduct Disorder; Oppositional Defiant Disorder
MeSH terms: Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to modify behavior therapy so that it is optimized for children
      with conduct problems and callous-unemotional traits by emphasizing reward components and
      de-emphasizing punishment components.
    

Detailed description: 
      Several studies have demonstrated that standard behavioral treatments do not appear to be
      sufficient for children with conduct problems (CP) and callous-unemotional (CU) traits. Other
      research suggests that children with CPCU are less responsive to punishments as evaluated
      using controlled laboratory tasks. Based on these two sets of findings, it was hypothesized
      that behavioral treatment modified to emphasize reward and de-emphasize punishments would be
      advantageous when used to treat children with CPCU. This hypothesis was tested in a treatment
      development study that had three phases. During phase 1, which occurred in 2010, the
      intervention was planned and treatment procedures and manuals were developed. During phase 2,
      which occurred in 2011, a pilot study was conducted in which the intervention was tested in
      an iterative manner in a group of 12 children with conduct problems and callous-unemotional
      traits. In phase 3, a larger trial was conducted using a cross over design, with one-half of
      participants getting standard behavioral treatment for four weeks followed by modified
      behavioral treatment for four weeks and remaining participants receiving treatments in the
      reverse order.Treatments were evaluated using parent ratings, counselor ratings, and
      frequency counts of behavior during treatments.
    

Intervention name(s): Reward-Emphasized Treatment; Standard Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized; Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Conduct problems; callous-unemotional traits; disruptive behavior disorders
A Study of NBL-012 in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to
      evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending
      doses (SAD) administered subcutaneously to healthy Chinese subjects.
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to
      evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously
      as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be
      intended for enrollment. The first dose will be sentinel group which will consist of 2
      subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects
      will be given a single escalating SC dose of NBL-01
    

Intervention name(s): NBL-012 Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a single subcutaneous injection; a single subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
fMRI and DTI of Cerebellar Responses to Pain in the Human Trigeminal System
Condition: Cerebellum and Pain in Healthy Volunteers.
Study type: Observational

Summary: 
      This K01 application is designed to prepare the applicant with the skills necessary to
      establish an independent research program on pain--related processing in the cerebellum.
      Although pain studies using functional imaging in humans consistently find cerebellar
      activation, the role of this structure during pain is unknown. In such studies, speculation
      regarding the cerebellum's function during a painful event is often influenced by its
      reputation as a coordinator of motor function, though animal studies have indicated that it
      may also modulate the neural encoding of noxious stimuli. The candidate has published work
      that indicates a functional dichotomy in the way the cerebellum responds to experimental pain
      in healthy subjects and neuropathic pain patients. This suggests that the cerebellum has been
      overlooked as a potential pain processing area, and research into this area could lend
      invaluable insight into the basic physiological circuitry involved with pain and its
      modulation.

      The hypothesis of this project is that the cerebellum serves as an integrator of aversive
      stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience
      that distinguishes the perception of pain from the appreciation of innocuous sensory
      stimulation. A human trigeminal model of experimental pain will be used, as all the
      pain---related circuitry involved can be imaged along with the cerebellum at the same time.
      The specific aims are (1) to map cerebellar activations related to sensory coding of noxious
      stimuli and to correlate functional activity with anatomical connectivity using functional
      magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish
      between pain and its anticipation based on cerebellar responses and connectivity; and (3) to
      determine whether physical pain and aversive images engage similar circuitry in the
      cerebellum. To accomplish these aims, the candidate will need to expand his background in
      fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become
      proficient in DTI analysis, and learn the white matter connectivity to and from the
      cerebellum. The research environment at McLean Hospital and the other affiliates of the
      Harvard Medical School system will provide the candidate with the resources to reach his aims
      within 4 years.
    


Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Healthy human volunteers
      
Keywords: cerebellum; fMRI; DTI; pain; heat; noxious; aversion; unpleasantness; anger; aversive stimulus; motor; human; image analysis; perception; central nervous system; sensory; somatosensory cortex; trigeminal system; white matter
Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Following a radical prostatectomy and lymph node sampling, eligible patients will undergo
      post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal
      therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3
      months for 2 times).
    

Detailed description: 
      After consent, laboratory and radiologic tests will be done and a baseline questionnaire will
      be completed. Participants will then be started on the protocol specific hormonal therapy for
      a total of 6 months. After 2 months of hormone therapy the participants will begin radiation
      therapy and concurrent docetaxel chemotherapy treatments.

      The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx)
      once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated
      radiation therapy (IMRT).

      Participants will receive docetaxel once a week for a total of 7 infusions with concurrent
      radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will
      be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the
      radiotherapy treatments.
    

Intervention name(s): Docetaxel; Radiation Therapy; Casodex and Zoladex (or Lupron)
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): 20mg/m2 IV weekly for 7 weeks; 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx; Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)
Other intervention name(s): Taxotere; Bicalutaminde; Leuprolide
Intervention MeSH terms: Docetaxel; Leuprolide; Goserelin; Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Asthma Control Test Guided Treatment in Chinese Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aimed to evaluate the effectiveness of Asthma Control Test (ACT) guided
      treatment compared with usual care in asthma subjects in China. It is designed to assist
      Chinese subjects and physicians improving adherence to the guidelines through the inclusion
      of the ACT in the patient's asthma management plan. This is a prospective, multicentre,
      cluster-randomized, open-label 24-week study. In this cluster-randomization design, each
      study center, considered as a cluster, will be randomized to either ACT guided treatment
      group or control group (usual care group). For the subjects who are recruited in the ACT
      centers, they will be treated based on the ACT score. If ACT score are equal to (=) 25 for
      more than equal to (>=) 3 months then the treatment will stepped-down; if ACT score >=20,
      less than (<) 25 or ACT=25 for <3 months then there will be no change and if ACT score less
      than (<=) 19 then the treatment will stepped-up. For subjects who are recruited in the
      control centers, they will be treated based on doctor's subjective judgment. Assignment to a
      treatment will not occur, as no treatment intervention is provided for this study. A total of
      528 asthma subjects are planned in the study. The randomization will be stratified according
      to the Tier of the hospitals (Tier 3 verses Tier 2).
    


Intervention name(s): ACT guided Routine Treatment; Routine Treatment
Intervention type(s): Drug; Drug
Intervention description(s): The ACT is a validated, short, easy to use, and self-administered instrument used to assess asthma control. Subjects in this group received routine treatment as per ACT score.; Subjects in the controlled treatment group will receive usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cluster Randomization; Peak Expiratory Flow; Forced Expiratory Volume; Standardized Asthma Quality of Life Questionnaire; Asthma Control Test
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
Condition: Asthma; Efficacy; Safety
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled,
      multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once
      daily by inhalation, in patients with mild to moderate asthma.
    

Detailed description: 
      This is a randomized, double-blind, multiple dosing (14 ± 1 days), placebo-controlled,
      incomplete block crossover, multi-center study to assess efficacy and safety of 3 dose levels
      of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.

      This multi-center study will be conducted at multiple sites in Europe. It is planned that
      approximately 48 patients with mild to moderate asthma will be randomized into the study
    

Intervention name(s): 800 μg AZD7594 once daily; 250 µg AZD7594 once daily; 58 µg AZD7594 once daily; Placebo once daily; Salbutamol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule; Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule; Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule; Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule; Inhalation as needed
Other intervention name(s): High dose of AZD7594; Medium dose of AZD7594; Low dose of AZD7594; Placebo; Rescue medication
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild to moderate asthma; FEV1; efficacy; safety
Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients
Condition: Intussusception
MeSH terms: Intussusception
Study type: Observational [Patient Registry]

Summary: 
      To determine risk factors associated with recurrent intussusception among pediatric patients
      who have undergone successful reduction at a tertiary care hospital.
    

Detailed description: 
      This is the prospective observational study. In this study, 78 patients,age <16 years with
      diagnosis of intussusception between June 2019 and April 2020 who had successful reduction
      with either hydrostatic reduction and/or operative reduction in Teaching Hospital were
      enrolled in the study. They were followed up to a period of 1 month for recurrence of
      intussusception. The recurrent cases were thus identified and various variables were compared
      between recurrent and non-recurrent cases by univariable and multivariable analysis.

      This prospective observational study was approved by the ethics committees of Institutional
      review board of Tribhuvan University, Institute of Medicine.

      A standard structured questionnaire was filled by interviewing the patient (if possible) and
      family members/relatives after taking informed written consent. The questionnaire documented
      the patient's age, sex, weight, duration of symptoms, presenting symptoms: abdominal pain,
      excessive cry, vomiting, lethargy, blood in stool, fever, palpable mass, constipation,
      diarrhoea ,location of mass, enlarged lymph nodes(LNs), blood counts and methods of
      reduction. Age of 2 years, weight of 12 kg and duration of symptoms of 48 hours was used to
      classify patients into two groups
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric population age less than 16 years old recruited undergoing recurrent
        intussusception with successful reduction followed up for 1 month.
      
Keywords: Hydrostatic reduction; Recurrence; Pediatrics
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Condition: Health Behavior
Study type: Observational

Summary: 
      Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will
      use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and
      vegetables to increase SCS in medical students. This will be an observational, non-invasive
      study examining skin carotenoid levels over time in individuals who have increased their
      intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will
      be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per
      day over an eight week period of time. Students will self-select their fruits and vegetables
      from a given list and will receive supermarket gift cards to offset the cost of the increased
      food. Students will be asked to follow their usual diet for one week. Then increase their
      intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then
      return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At
      the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6
      cups per day. SCS will be measured every two weeks during the 8-week intervention phase.
      Students will return to their usual diet for 2 weeks and SCS will be measured at the end of
      that 2-week period.
    

Detailed description: 
      Inclusion criteria:

        -  Medical students (any year) from Texas Tech School of Medicine

        -  BMI between 20-29

        -  Non-smoker, non-pregnant

      Exclusion criteria:

        -  Individuals suffering from a chronic disease such as diabetes, heart disease, or other
           metabolic disorder

        -  Pregnant women

        -  Smokers

        -  Individuals with BMI > or = 30 or < or = 19
    

Intervention name(s): Food-based intervention; increased fruits and vegetables
Intervention type(s): Other
Intervention description(s): 4-6 cups of fruits and vegetables daily for 8-weeks
Other intervention name(s): Whole-diet intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical students from Texas Tech University School of Medicine.
      
Keywords: Antioxidants; Carotenoids; Diet
Bilingualism: Validation Of "Avicenne's Elal"
Condition: Language
Study type: Observational

Summary: 
      The primary purpose is the validation of an instrument of the first language assessment. The
      second purpose is to study the impact of familial and transcultural factors on early
      bilingualism in migrant children born in France.
    

Detailed description: 
      The research aims to validate a language instrument of the first language in migrants'
      children born in France. For that purpose, the investigators have built an instrument made of
      three sets of items: comprehension, production and narrative production. Children are elected
      if: they are four to six years old, in the third class of nursery school and if their first
      language is unique, and, one of the three languages that the investigators define for the
      first step of validation: tamil, SONINKE, Arabic. The PROTOCOLE is composed with two parts:

        1. For children:

             -  An assessment for children in French with items extracted from the NEEL test

             -  An assessment of mother tongue with the ELAL of Avicenne

        2. For parents:

             -  A semi-structured interview.

      The data collected are:

      General DATA:

        -  Social and professional categories

        -  Economical status of parents

        -  The conditions of living

        -  Month and year of birth for the child

        -  The language used during the interview

      About the child:

        -  Age of language AQUISITION

        -  Languages mastering

        -  Language environment

        -  The place among siblings

        -  SCOLARISATION(DATA about cultural affiliations, representations of transmission,
           intra-familial relationship

      DATA about parental uses and representations of languages:

        -  Social and economical DATA in the country of birth

        -  Place of birth, languages

        -  uses of languages

        -  representations about languages
    

Intervention name(s): NEEL test; ELAL test; Interview
Intervention type(s): Other; Other; Other
Intervention description(s): An assessment for children in French with items extracted from the NEEL test; An assessment of mother tongue with the ELAL of AVICENNE; For parents of children include in the study: A semi -structured interview
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children are five to six years old, in the third class of nursery school and if their first
        language is unique, and, one of the three languages that we defines for the first step of
        validation: tamil, soninké, Arabic
      
Keywords: Bilingualism; Language; Evaluation transcultural; Intra Familial Relationship; Transmissions mother; Tongue french; Language tamil; Language arabic; Language soninke; Language cultural; Affiliations crossbreeding