bioihbjkbjnl/mcl2 huggingface dataset:
Extracellular Signal-Related Kinase Biomarker Development in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The purpose of this research study is to establish a way to help the development of targeted
      treatments in autism spectrum disorders. This may also help in early diagnosis of autism and
      may possibly predict severity. The study will compare subject's ERK (extracellular
      signal-related kinase) signaling to age- and gender-matched neurotypical controls and
      Intelligence quotient (IQ)-matched developmental disabilities.
    

Detailed description: 
      Autism Spectrum Disorder Subject Criteria:

      Inclusion Criteria:

        -  Diagnosis of autism spectrum disorder, based upon a clinical interview utilizing the
           Diagnostic and Statistical Manual-V (DSM-V)

        -  Age 3-25 years

        -  Stable dosing of psychotropic drugs for greater than or equal to 5 half-lives

      Exclusion Criteria:

        -  Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or
           other substance abuse based on Diagnostic and Statistical Manual-V criteria

        -  Use of lithium, riluzole or other known modulators of ERK activation

      Age-Matched Neurotypical Control Subjects:

        -  Age matched to the age of an Autistic Disorder Subject

        -  History of normal development

      IQ-Matched Control Subjects:

        -  Those subjects who are included in the study based on having an IQ and age that matches
           the IQ and age of an Autistic Disorder Subject who has an IQ less than 70

        -  All IQ-Matched Control Subjects will then also have an IQ less than 70
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects with autism will be recruited through the clinic population at Cincinnati
        Children's Hospital Medical Center. Recruitment of subjects will be conducted by notifying
        via, IRB approved electronic and paper ads, individuals with autistic disorder, their
        families, treating clinicians and agencies throughout the referral base of CCHMC and those
        within our existing clinical services, residential facilities, schools and group homes for
        the developmentally disabled.
      
Biospecimen description: 
      For the ERK activation assay, about 5 mL of whole blood is layered onto 3 mL Histopaque in a
      15 mL centrifuge tube, and centrifuged. The lymphocyte-containing cell layer is removed and
      transferred for washing. After a second wash, cells are resuspended and rested. They are then
      stimulated by addition of phorbol myristate acetate and sample aliquots are removed at short
      intervals, fixed and permeabilized. Fixed, permeabilized cells are stained by addition of
      Alexafluor488-labeled monoclonal antibody to phospho-ERK in the dark for 30 min. Washed,
      resuspended cells are analyzed in a Coulter flow cytometer.
Safety and Pharmacokinetics Study in Healthy Japanese Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of Part A, a randomized double-blind, single-ascending-dose study, and
      Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in
      healthy Japanese volunteers.
    

Detailed description: 
      Part A includes the following two dose regimen groups:

        -  25 mg dose regimen group: ABX464 25 mg or placebo

        -  50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12
           subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464
           (9 subjects) or its matching placebo (3 subjects).

      Part B includes the following two dose regimen groups:

        -  25 mg dose regimen group: ABX464 25 mg or placebo for 28 days

        -  50 mg dose regimen group: ABX464 50 mg or placebo for 28 days

      In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio,
      to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).
    

Intervention name(s): ABX464; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: ABX464 ABX464 is a new anti-inflammatory drug; Drug: Matching Placebo placebo matching with ABX464
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A: single-ascending-dose Part B: escalating multiple-dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
eLIFEwithIBD - Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease (Online)
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This study aims to test the acceptability and preliminary efficacy of an online intervention
      (eLIFEwithIBD) developed for people with inflammatory bowel disease (IBD). The eLIFEwithIBD
      intervention is an adaptation of the LIFEwithIBD program (delivered in an in-person group
      format; Trindade et al., 2021), being an ACT, mindfulness, and compassion-based intervention.
      The eLIFEwithIBD intervention comprises nine sessions focusing on education about IBD, the
      functioning of the mind, emotions, and fatigue; acceptance of internal experiences;
      willingness; emotion regulation; values clarification; committed action; mindfulness;
      compassion; and gratitude. These topics are addressed through videos with therapists, texts,
      and experiential exercises.
    


Intervention name(s): eLIFEwithIBD
Intervention type(s): Behavioral
Intervention description(s): eLIFEwithIBD program is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if CH-4051 is a safe and effective treatment for
      rheumatoid arthritis.
    

Detailed description: 
      Multi-center, multi-national, double-blind, randomized, active-controlled (MTX), 3-month
      study with 4 doses of CH-4051 (0.3 mg, 1.0 mg, 3.0 mg and 3.0 mg with 1mg of folic acid
      supplementation p.o. daily) compared to a "standard" dose of MTX at 20 mg per week with 1 mg
      of folic acid supplementation p.o. daily. This study will be conducted in two parts:

      Part A: Patients will be randomized to 0.3 mg CH-4051, 1.0 mg CH-4051 or MTX. Part B:
      Patients will not be randomized into Part B until the Data Monitoring Committee has reviewed
      safety data from the Part A when approximately 25 patients (10 patients in each CH-4051 dose
      groups and 5 patients in the MTX groups) have completed 3 months of treatment. At this time
      the DMC will make a recommendation whether or not to commence randomization to 3.0 mg
      CH-4051, 3.0 mg CH-4051 with 1.0 mg of folic acid.
    

Intervention name(s): CH-4051; Methotrexate (MTX); Folic Acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Different doses CH-4051 to be compared; 20 mg MTX weekly; 1 mg folic acid daily
Other intervention name(s): amethopterin; folate
Intervention MeSH terms: Folic Acid; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; MTX; CH-405; antifolates
Comparative Bioequivalence Study in Adult Patients Suffering From Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor Under Fed Conditions
Condition: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumor
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To characterize pharmacokinetic profile of test product compared to that of the corresponding
      reference product in adult patients, who are diagnosed to have Chronic Myeloid Leukemia &
      Gastrointestinal Stromal Tumor under Fed Conditions.
    

Detailed description: 
      To characterize pharmacokinetic profile of Imatinib Mesylate tablets EQ 400 mg base of Amneal
      Pharmaceuticals LLC, compared to that of the reference product - GLEEVEC® (imatinib mesylate)
      tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently
      receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.
    

Intervention name(s): Imatinib Mesylate Tablets, 400 mg; Imatinib Mesylate Tablets, 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.; Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with "400" on one side with score on the other side, and "SL" on each side of the score.
Other intervention name(s): Gleevec
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Letrozole Versus Clomifene Citrate for Ovulation Induction
Condition: Infertility; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of the study is to assess the efficacy of letrozole as an ovulation induction
      agent and to test the hypothesis that letrozole will generate better pregnancy rates with
      fewer multiple pregnancies and higher live birth rate than the current standard agent,
      clomifene citrate in anovular infertile women with polycystic ovarian syndrome.
    


Intervention name(s): Letrozole; Clomifene citrate
Intervention type(s): Drug; Drug
Intervention description(s): Starting daily dose 2.5 mg on menstrual cycles days 2 to 6, to be increased to 5 mg daily if there is no response to 2.5 mg; Starting daily dose 50 mg on menstrual cycles days 2 to 6, to be increased to 100 mg daily if there is no response to 50 mg
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anovulation; ovulation induction,; polycystic ovarian syndrome; clomifene citrate; letrozole
Behavioral Economics-Based Online Lifestyle Balance Program
Condition: Weight Reduction; Health Knowledge, Attitudes, Practice
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The objective of this project is to design a Behavioral Economics Based Online Lifestyle
      Balance Program that employs behavioral economics to engage and motivate adherence to an
      Internet-based program. The investigators compare the effects of two financial incentives on
      inducing weight loss: a direct financial incentive for weight loss and a financial incentive
      for health literacy.
    

Detailed description: 
      This project investigates whether participants in an online weight loss program can be
      induced to achieve weight loss using financial incentives. The study is a 3-arm randomized
      controlled trial (RCT) stratified by gender. The goal is to examine how overweight
      individuals respond to two different types of financial incentives. The first type of
      incentive, incentive for weight loss (IW), is a cash award of approximately $150 given for
      achieving 5% weight loss over 12 weeks. The second type of incentive, incentive for education
      (IE), is a $150 award for passing quizzes that test the participants' health literacy about
      weight loss and the techniques required for maintaining a healthy lifestyle. The
      investigators compare the effectiveness of IW to IE in promoting weight loss in overweight
      individuals and investigate whether the two incentives work equally well for men and women.
    

Intervention name(s): Incentive for Education; Incentive for Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A $150 "Incentive for Education" is given to the participants for passing at least nine quizzes by the end of the program; A $150 "Incentive for Weight Loss" is given to the participants for losing at least 5% of baseline weight by the end of the program
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 3-arm RCT (Control, Incentive for Weight Loss, Incentive for Education) stratified by Gender.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Weight Reduction; Health Literacy; Financial Incentives; Lifestyle Change
The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses
      compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical
      performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
    

Detailed description: 
      This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing
      study. Participants will be randomized to wear first lens pair for two weeks, and then
      crossover to second lens pair for two weeks.
    

Intervention name(s): stenfilcon A; etafilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Condition: Type B Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the safety and efficacy of the GORE
      Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute
      complicated type B aortic dissection.
    


Intervention name(s): GORE TAG® Thoracic Endoprosthesis
Intervention type(s): Device
Intervention description(s): Endoprosthetic Implant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute, Complicated Type B Dissection
A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single-dose, three-period, crossover, single-center
      comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult
      participants with a history of cigarette smoking. The participants will be admitted to the
      investigational clinic at least 38 hours before dosing and will remain domiciled until the
      completion of all study procedures at approximately 24 hours after dosing. Three toothpastes
      (one is commercial non-medicated non-nicotine containing chewing gum and other two are
      nicotine containing gums) will be provided across the 3 treatment periods. During each of the
      3 treatment periods, participants will be under supervision in a non-smoking area and will
      abstain from smoking.There will be a total of at least 7 days and not more than 10 days
      (clinical furlough period) between treatment periods. Twenty (20) blood samples will be
      collected for pharmacokinetic (PK) analysis at baseline and multiple time points following
      study drug administration. The trial duration will be approximately 49 days and up to 55 days
      from screening to study end including the screening period.
    


Intervention name(s): Treatment A: Nicorette 2 mg coated mint gum; Treatment B: Nicotinell 2 mg coated mint gum; Treatment C: Nicotinell 2 mg coated fruit flavor gum
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be administered with 2 mg coated mint gum of Nicorette; Participants will be administered with 2 mg coated mint gum of Nicotinell; Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than
      18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).
    

Detailed description: 
      This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice
      daily for 5 days [except Day 5 when only morning dose will be given]) study in pediatric
      subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1 month
      of the completion of the Screening Visit. The study will consist of three cohorts based on
      the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than 12 years
      and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric subjects with
      JIA will participate in the study ensuring a total number of at least 24 pediatric evaluable
      subjects completing the PK period.
    

Intervention name(s): CP-690,550; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5; CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5; CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing <30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5
Other intervention name(s): Tofacitinib; Tofacitinib; Tofacitinib
Intervention MeSH terms: Tofacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Arthritis; Pediatric; Tofacitinib; JIA
Ankle Kinesio Taping vs Mulligan's Mobilization With Movement
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to compare the effects of Kinesio taping and Mulligan's mobilization
      with movement technique on balance, muscle strength and flexibility in healthy ankles .
      Patients will randomly be divided into 4 groups: Kinesio taping (KT) group, sham Kinesio
      taping (SKT) group, Mulligan's mobilization with movement (MWM) group and sham mobilization
      with movement (SMWM) group . Kinesiotape will be applied both ankles as "Correction
      technique" in KT group, 'Posterolateral glide mobilization with movement' will be applied 10
      times to both ankles in MWM group. The evaluations will be repeated after waiting 45 minutes
      to reveal the effects of Kinesio taping and Mulligan mobilization with movement.
    


Intervention name(s): Kinesio-tape; Mulligan's mobilization with movement; Sham Kinesio-taping; Sham Mulligan's mobilization with movement
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Kinesiotape will be applied both ankles as "Correction technique".; 'Posterolateral glide mobilization with movement' will be applied 10 times to both ankles.; Sham Kinesio-taping technique will be applied both ankles.; Sham Mulligan's mobilization with movement technique will be applied both ankles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesio-taping; Mulligan; Mobilization; balance; ankle
A Study of LY3437943 in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 43
      weeks.
    


Intervention name(s): LY3437943; Dulaglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment