bioihbjkbjnl/mcl2 huggingface dataset:
Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Cognitive behavioral therapy (CBT) is a well-documented and effective method for the
      treatment of children and adolescents with anxiety disorders. Lately there has been an
      increase in the development and use of internet-based CBT programs (ICBT), as a means to
      reduce costs and enhance accessibility of psychological interventions. ICBT has proven
      efficacious towards adults with anxiety disorders. Research in the field of ICBT with
      children and adolescents is still in its infancy though and to date, no program targeting
      anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this
      study is to investigate the efficacy of a newly developed internet-based treatment program
      for adolescents with anxiety disorders. The effect will be examined in a randomized
      controlled trial comparing ICBT to a wait-list control condition.
    

Detailed description: 
      Within the context of a research and teaching clinic at the Department of Psychology and
      Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary
      anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month
      wait-list control condition or a treatment condition.

      The treatment consists of an internet-based self-help program for adolescents with anxiety
      disorders called 'Chilled Out', based on material from the well-established manualised
      group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules
      of approximately 30 minutes each distributed over a 14-week period. The program is
      interactive using a combination of different media (text, audio, illustrations, cartoons, and
      videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for
      adolescents to manage their anxiety. In addition, the adolescent will receive a limited
      amount of therapist support calls.

      Participants (youth and parents) are assessed with semi-structured diagnostic interviews and
      self-report measures before treatment, after 14 weeks (post treatment) and 3 months after
      treatment (follow-up).

      Participants are assessed at pre, post and 3-month follow up.
    

Intervention name(s): ICBT
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have
      little effect in one person but a large effect in another. Understanding mechanisms of
      altered response to treatment could aid treatment selection and assist the design of new
      medications with lower nonresponse rates.

      This study will examine the physiological mechanisms and potential clinical/biomarker
      predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering
      medication and answer fundamental methodological questions for the future study of variation
      in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy
      for up to 2 weeks with assessment of baseline characteristics and glycaemic response.
      Participants will then enter an optional extension where they receive sulphonylurea or DPPIV
      inhibitor therapy in crossover fashion.
    

Detailed description: 
      Participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an
      optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with
      Gliclazide (DPP-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second
      treatment with a 2 week wash-out period in between.

      Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in
      clinical practice and potential predictors of this, as well as whether a very brief period (1
      week) of treatment withdrawal is a valid assessment of an individual's response to therapy.
      Part 2 will allow comparison of the approach in part one with response to the same treatment
      in a trial setting and will allow assessment on whether response is consistent across
      therapies with different mechanisms of action.
    

Intervention name(s): Gliclazide 80mg OD; Sitagliptin 100mg OD
Intervention type(s): Drug; Drug
Intervention description(s): Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.; Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.
Other intervention name(s): DPP-IV inhibitor; sulphonylurea OD
Intervention MeSH terms: Sitagliptin Phosphate; Gliclazide; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
Condition: Total Knee Arthroplasty
Study type: Observational

Summary: 
      To determine whether specialty training or high volume of operative experience is associated
      with better clinical outcome and quality-of-life scores.
    

Detailed description: 
      Primary total knee replacements are becoming a commonly performed procedure. Many general
      orthopaedists can perform large numbers of such surgeries. Thus, we aim to find out if there
      is value of having surgeons with AR fellowship training to perform primary total knee
      arthroplasty. This has an implication in the direction of the training of future AR surgeons
      and in the distribution of operative cases.
    

Intervention name(s): Specialty training for knee surgeons
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients seen at Singapore General Hospital who require total knee arthroplasty
      
Keywords: outcome; quality of life; total knee arthroplasty; clinical outcome scores post total knee arthroplasty; quality of life scores post total knee arthroplasty
Conversion Rate of (TST) Tuberculin Skin Test and Quantiferon-TB Gold In Tube Assay in Health Care Workers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and
      Quantiferon-TB Gold In tube assay in health care workers.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        health care workers who performed TST or Quantiferon-TB Gold In tube assay before
      
Biospecimen description: 
      whole blood for perfoming Quantiferon-TB Gold in tube assay
    
Keywords: latent tuberculosis in health care workers
Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the effect of multiple doses BI 1356 given
      once daily in the estimated highest therapeutic dose of 5 mg until steady state on the
      pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of
      1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg
      being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was
      investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in
      combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD
      1750 were determined at steady state of BI 1356 when given alone or in combination with
      glyburide.
    


Intervention name(s): BI 1356; Glyburide; BI 1356 + Glyburide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Glyburide; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Wearing Personal Protective Equipment (PPE) on CPR Quality in Times of the COVID-19-pandemic
Condition: Cardiopulmonary Resuscitation; Personal Protective Equipment
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Background The significant risk of transmission of SARS-CoV-2 to healthcare staff mandated
      changes to Basic and Advanced Life Support (BLS and ALS) guidelines. As advised by the
      European Resuscitation Council (ERC), healthcare staff should put on airborne-precaution
      personal protective equipment (PPE) before starting chest compressions and/or airway
      interventions, as a minimum an FFP3 mask (FFP2 or N95 if FFP3 not available), eye and face
      protection and long-sleeved gown. However, wearing FFP3 masks has been shown to highly impair
      cardiopulmonary exercise capacity and the effect of wearing PPE on the quality of
      cardiopulmonary resuscitation is not known. The aim of this project is therefore to to
      investigate whether wearing PPE has an effect on the quality of chest compressions.

      Methods The study forsees a simulated CPR scenario on manikins. Study participants are lay
      rescuers and members of the rescue organization Croce Bianca. Each participant will perform 5
      sequences consisting of 2 min of chest compressions altered by 2 min of no chest compressions
      (break), as recommended by the current ERC guidelines. The participants will perform the
      described CPR sequence two times in a cross-over design with randomized order, once while
      wearing PPE and once without wearing PPE. Between the two CPR sequences (i.e. with and
      without PPE) a break of 60 min for recovery will be given. During both CPR sequences, the
      quality of chest compressions will be measured.
    


Intervention name(s): Personal protective equipment (PPE); No Personal protective equipment (PPE)
Intervention type(s): Device; Device
Intervention description(s): Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown); Standard CPR without wearing PPE
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
Condition: Blood Glucose Response
Study type: Interventional

Summary: 
      The aim of this study is to investigate second meal effects of a wholegrain cereal product on
      blood glucose response. The wholegrain cereal product will be consumed in the evening and
      blood glucose analyzed after a standardized breakfast meal the following morning.
    


Intervention name(s): Reference Product; Wholegrain product Dose A; Wholegrain product Dose B; Wholegrain product Dose A, cut kernels
Intervention type(s): Other; Other; Other; Other
Intervention description(s): This intervention is based on white rice.; This wholegrain intervention contains whole cereal kernels.; This wholegrain intervention contains whole cereal kernels.; This wholegrain intervention contains cut cereal kernels.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Correct Tip Position of Central Venous Catheters
Condition: Central Venous Catheter; Internal Jugular Vein; Radiography; Subclavian Vein Injury
Study type: Observational

Summary: 
      Patients, ages between 18-70 years, who require central venous catheter will be enrolled for
      the study. Central venous catheter will be inserted using patient's height formula by
      Seldinger technique. Anterioposterior chest radiography will be used to assess the correct
      tip position. Catheters that are below the carina more than 1 cm, will be pulled back for
      repositioning. Catheters that are above the carina more than 1 cm, will be changed by another
      catheter. The investigators aim to evaluate the formula for correct tip positioning for
      central venous catheters
    

Detailed description: 
      Central venous catheters are used for fluid infusion, nutrition, blood transfusion,
      hemodynamic monitorization in both intensive care unit and operating room. The superior vena
      cava and right atrium (SVC-RA) junction is considered the optimal position for central venous
      catheter tip. Carina corresponds to the SVC-RA junction on chest radiograph. Catheter tips, 1
      cm above and 1 cm below the carina are considered as the correct position. 18-70 years old
      patients will be enrolled for the study. Central venous catheters will be inserted via
      internal jugular vein or subclavian vein using patient's height formula by Seldinger
      technique. Postprocedural (within 6 hours) chest radiograph will be used to evaluate the
      correct tip position from the Picture Archiving and Communication System. This formula was
      described by Peres. If the tip of the catheter is below the carina more than 1 cm, it will be
      pulled back for repositioning. If the tip of the catheter is above the carina more than 1 cm,
      another catheter will be inserted. The formula is height (cm)/10 for right internal jugular
      vein, height(cm)/10-2 for right subclavian vein, height(cm)/10+4 for left internal jugular
      vein and height(cm)/10+2 for left subclavian vein. Number of the correct and incorrect
      position of central venous catheter tips will be noted.

      The investigators aim to evaluate the reliability and efficiency of Peres' formula for the
      correct tip position.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in intensive care unit and operating room who require a central venous catheter
        (right or left-sided) will be enrolled for the study.
      
Keywords: central venous catheter insertion; Peres' formula; correct tip position; carina
Montelukast Use in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Montelukast is widely used in patients with asthma. Several preclinical data suggest that it
      could be repositioned as novel strategy for managing rheumatic patients by decreasing
      inflammatory mediators.

      Considering the probable enhanced antiarthritic effects of montelukast; it could be
      hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who
      remain poorly controlled despite initial optimal guidelines directed medical treatment.
      Therefore, this study aims to evaluate the potential added benefits of montelukast use in
      conjunction with csDMARDs in RA patients with moderate and high disease activity.
    


Intervention name(s): Montelukast; Placebo; Conventional DMARDs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Montelukast 10 mg oral tablet once daily for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2; Oral tablet once daily; methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
Condition: Chronic Kidney Disease; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to summarize the percentage of participants achieving
      age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus
      in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on
      dialysis, following 8 weeks of treatment with lanthanum carbonate.
    


Intervention name(s): Lanthanum Carbonate; Calcium Carbonate
Intervention type(s): Drug; Drug
Intervention description(s): Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.; Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
Other intervention name(s): SPD405
Intervention MeSH terms: Calcium Carbonate; Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
Condition: Healthy; NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effect of itraconazole, a strong
      inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A,
      CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of ASC41, a THR beta agonist tables in
      healthy subjects. The PK, Safety and Tolerability of ASC 41 in Subjects with NAFLD will also
      be evaluated. Approximately 24 subjects including 16 healthy volunteers (HVs) and 8 subjects
      with NAFLD will be enrolled. This study consists of 3 cohorts.
    

Detailed description: 
      This multiarm study in HVs and subjects with NAFLD is designed to further characterize the
      PK, safety and tolerability of ASC41. Part I of the study will assess the effect of
      itraconazole and phenytoin on the single-dose PK of ASC41 in HVs. Part II of the study will
      evaluate the PK, safety and tolerability of a single dose of ASC41 in subjects with NAFLD.
      The pharmacokinetics of ASC41 and its metabolite ASC41-A will be assessed in both parts I and
      II. The secondary objective of the study is to characterize the safety and tolerability of
      oral ASC41 in subjects in the U.S. with NAFLD and in HVs. Approximately 24 male and female
      participants will be enrolled. This study consists of 3 cohorts.
    

Intervention name(s): ASC41; Itraconazole; Phenytoin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5mg/tablet; 200mg/capsule; 300mg/capsule
Intervention MeSH terms: Itraconazole; Phenytoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; NAFLD; DDI (Drug-Drug Interaction); Itraconazole; Phenytoin; THR beta agonist; ASC41
Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in
      non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low
      dose, high dose, and placebo control group.
    


Intervention name(s): HL tablet; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide
      following subcutaneous (SC) administration of 10 mg teduglutide.

      Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A
      further objective is the description of the PK of teduglutide following SC administration of
      10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy
      subjects.
    

Detailed description: 
      Pharmacokinetic study.
    

Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): 10 mg, one-time subcutaneous
Intervention MeSH terms: Teduglutide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Renal impairment; Renal impairment study
Single-Dose Phase 1 Study of TAK-792
Condition: Healthy Male Adults Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability profile of TAK-792
      when administered as a single oral dose in healthy Japanese and Caucasian male participants.
    

Detailed description: 
      This study will be double-blind and placebo-controlled to avoid subjective bias in the
      assessment of safety and tolerability of TAK-792. Sentinel dosing will be used in the first
      cohort (cohort 1) to ensure adequate safety and tolerability evaluation prior to
      administering TAK-792 to the remainder of participants within the cohort. The dose escalation
      to the next cohort for Cohorts 2 to 6 will occur after full review of safety and tolerability
      of the current cohort, and available pharmacokinetic data up to 24 hours in the preceding
      cohorts. The planned dose levels are 30, 100, 250, 500, 750 and 1250 mg, to be administered
      in the morning after a fast of at least 10 hours.
    

Intervention name(s): TAK-792 30 mg; TAK-792 30 mg placebo; TAK-792 100 mg; TAK-792 100 mg placebo; TAK-792 250 mg; TAK-792 250 mg placebo; TAK-792 500 mg; TAK-792 500 mg placebo; TAK-792 750 mg; TAK-792 750 mg placebo; TAK-792 1250 mg; TAK-792 1250 mg placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TAK-792 30 mg was administered in the morning after a fast.; TAK-792 30 mg placebo was administered in the morning after a fast.; TAK-792 100 mg was administered in the morning after a fast.; TAK-792 100 mg placebo was administered in the morning after a fast.; TAK-792 250 mg was administered in the morning after a fast.; TAK-792 250 mg placebo was administered in the morning after a fast.; TAK-792 500 mg was administered in the morning after a fast or after breakfast.; TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.; TAK-792 750 mg was administered in the morning after a fast.; TAK-792 750 mg placebo was administered in the morning after a fast.; TAK-792 1250 mg was administered in the morning after a fast.; TAK-792 1250 mg placebo was administered in the morning after a fast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment