bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study were to compare the relative bioavailability of Duloxetine HCl delayed release
      capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed
      release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to
      monitor safety of subjects
    

Detailed description: 
      Open label, randomized, two period, two treatment, two sequence, crossover, balanced, single
      dose comparative oral bioavailability study in healthy, adult, human subjects under fasting
      conditions
    

Intervention name(s): Duloxetine; Cymbalta®
Intervention type(s): Drug; Drug
Intervention description(s): Duloxetine Delayed-Release Capsules 60 mg; 60 mg capsule of Eli Lilly and Company
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Default Genetics Referrals for Young-Onset Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators will perform a pilot implementation study of a default genetics referral
      process among patients with young-onset CRC diagnosed between ages 40 and 49.
    

Detailed description: 
      The incidence of young-onset colorectal cancer (CRC) - defined as a diagnosis of CRC prior to
      age 50 - has increased at alarming rates in recent years. Over 75% of cases occur in patients
      diagnosed between 40-49 years old, a group that is not traditionally included in young adult
      cancer initiatives tailored only to patients up to 39 years of age. Young age of CRC onset is
      a defining feature of hereditary CRC syndromes; as such, the National Comprehensive Cancer
      Network and American College of Medical Genetics and Genomics recommend germline genetics
      evaluations for all patients diagnosed with CRC under the age of 50. However, multiple
      studies have shown suboptimal rates and racial and socioeconomic disparities in
      guideline-recommended genetics evaluations.

      In this pilot implementation study, the investigators aim to develop, implement, and evaluate
      the effects of a default genetics referral process among patients with young-onset CRC
      diagnosed between 40-49 years old. The investigators hypothesize that by applying defaults,
      or pre-selected choices, to minimize the cognitive effort that patients and clinicians use to
      make decisions, default referrals will improve rates of genetics referrals while reducing
      existing racial and socioeconomic disparities. The investigators will implement this
      intervention at five academic and community hospitals within Penn Medicine that serve a
      racially, socioeconomically, and geographically diverse patient population. The investigators
      will use an automated electronic health record-based algorithm to identify eligible patients,
      after which default referrals for genetic risk evaluation will be made unless patients or
      their oncology clinicians opt out. The investigators will rigorously evaluate the impact of
      this default genetics referral process using mixed methods leveraging models and frameworks
      from the field of implementation science.
    

Intervention name(s): Default Genetics Referral Process
Intervention type(s): Behavioral
Intervention description(s): Patients and their oncology providers will be notified of their eligibility for a cancer genetics referral, with an option to opt out if they are not interested in proceeding. Everyone else will be automatically referred to their local hospital's cancer genetics program for contact and scheduling. Standard genetic counseling, testing, and results disclosure will take place, including usual methods of payment and insurance coverage for testing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
Condition: Sleep Apnea; Nasal Obstruction
MeSH terms: Nasal Obstruction
Study type: Interventional

Summary: 
      patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to
      reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and
      tonsillectomy. It will compare the amount of nasal congestion for each group with the idea
      that it will be less if treated with turbinate cauterization. Assessments from baseline to 6
      months post procedure will be compared between the two groups.
    

Detailed description: 
      To assess if inferior turbinate cautery improves nasal obstruction in children undergoing
      adenotonsillectomy.
    

Intervention name(s): turbinate cauterization
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nasal obstruction
Congenital Heart Adolescents: Program of Transition Evaluation Research
Condition: Congenital Heart Defects
MeSH terms: Heart Defects, Congenital
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the potential role of a cardiology clinic-based
      educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their
      parents, and to determine whether this intervention results in improved self-management
      skills (e.g., renewing medication prescriptions), teens having greater knowledge of their
      heart condition, and more teen and parent satisfaction with services. The results of this
      study will form the basis for a website that in turn may serve as an additional means of
      providing transition interventions. The results of this study may also be applicable to youth
      with other special health care needs.
    


Intervention name(s): Clinic-based Educational Intervention
Intervention type(s): Behavioral
Intervention description(s): This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Health Care Transition; Adolescent
Knowledge, Beliefs and Attitudes of Greek Physiotherapist About Pain Neuroscience Education
Condition: Chronic Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      An e-survey study will be carried out based on Checklist for Reporting Results of 52 Internet
      E-Surveys (CHERRIES)". The purpose of this study is to investigate the knowledge, beliefs and
      behaviour of Greek physiotherapists regarding the pain neuroscience education program (PNE)
      as an intervention in patients with chronic musculoskeletal pain.
    

Detailed description: 
      The main questions it aims to answer are:

      What physiotherapists know about a PNE program; What physiotherapists believe about the using
      of a PNE program in patients with chronic musculoskeletal pain? Whether and how often they
      use a PNE program in patients with chronic musculoskeletal pain? What are the barriers of
      using PNE in patients with chronic musculoskeletal pain?
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Physiotherapists with chronic musculoskeletal experience and clinical practice in Greece
      
Keywords: Pain Neuroscience Education; Chronic Musculoskeletal Pain
Safety and Efficacy of MET-3 in Obese Human Subjects
Condition: Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A pilot study to explore the metabolic effect and safety of a 3-week course of therapy with
      MET-3 in obese subjects
    

Detailed description: 
      This is an open label, single center, uncontrolled pilot study of 20 participants; each group
      will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants
      with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
    

Intervention name(s): MET-2
Intervention type(s): Biological
Intervention description(s): Ingestion of a novel human microbiome preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design is open label, single center, uncontrolled pilot study of 20 participants divided into 2 groups of 10; each group will receive a different dose of MET-3. Each group will have 4-6 females, 4-6 participants with BMI 30.0-34.9 kg/m² and the remainder with BMI 35-39.9 kg/m.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: human microbiota
Vitamin D Improves Clinical Manifestations in Asthmatic Children
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives: Evaluation of the effect of vitamin D supplemental therapy (VDST) on clinical
      manifestation of bronchial asthma (BA) as judged by The International Study of Asthma and
      Allergies in Childhood (ISAAC) questionnaire and estimated serum levels of immunoglobulin E
      (IgE).

      Patients & Methods: scores of ISAAC questionnaire and blood samples were obtained for
      estimation of serum IgE and 25-hydroxy VD (25-HVD) at booking time (T1) of 102 BA patients.
      VDST was provided as 2000 IU daily for 3 and 6 months for patients had moderate and mild HVD,
      respectively. At the end of 12-m after start of VDST (T2), ISAAC questionnaire and serum
      levels of 25-HVD and IgE were re-evaluated and the percentage of change was calculated.
    


Intervention name(s): Vit D
Intervention type(s): Drug
Intervention description(s): Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      single-ascending and multiple-ascending doses of ALZ002 DS.
    


Intervention name(s): ALZ002 DS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): JM17
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
Condition: Bowel Preparation Before Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate that investigation medication
      (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with
      regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An
      additional objective of this study is to collect subject's response to the acceptability and
      tolerability about bowel preparation and safety information.

      After bowel preparation, independent evaluator who is blinded to subject's treatment will
      evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600
      eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation
      to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's
      participation is expected to be maximally 4 weeks in study duration (up to 3-week screening
      period followed by one week post colonoscopy).
    

Detailed description: 
      The objective of this study was to demonstrate that investigational medication (Bowklean) is
      not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the
      overall quality of bowel preparation in subjects undergoing colonoscopy. It was designed to
      measure the number of subjects whose colons are cleansed successfully.

      The primary efficacy endpoint is the percentage of subjects that achieve excellent or good
      cleansing (success rate) in the Aronchick Scale.

      The secondary efficacy variables include:

        1. Proportion of successes (excellent, good, or fair) by individual colon segment
           (ascending, transverse, descending), which are assessed with the Ottawa scale6.

        2. Mean bowel preparation score assessed with Ottawa Scale by adding points for the
           cleansing of three parts of colon and points for amount of fluid in the bowel.

        3. Percentage of subject's responses to the acceptability and tolerability

      Safety was assessed at each clinic visit by evaluation of the following variables:

        1. Percentage of subjects occurred solicited event (nausea, vomiting, chest pain and
           dizziness) during the preparation.

        2. Percentage of subjects with treatment-emergent adverse events during the study period.
    

Intervention name(s): Picosulfate sodium, magnesium oxide, citric acid
Intervention type(s): Drug
Intervention MeSH terms: Picosulfate sodium; Magnesium Oxide; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison Between Provisional Versus Routine Kissing Balloon Technique After Main Vessel Crossover Stenting for Bifurcated Lesions.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      In the setting of single stent strategy for treatment of bifurcation, we investigate to
      compare simple strategy as "provisional final kissing balloon technique(fKBT)" to complex one
      as "routine FKBT", focusing on actual myocardial ischemia assessed by scintigraphy in 7-month
      and to examine optimal endpoint of side branch ostium.
    

Detailed description: 
      Final kissing balloon technique (FKBT) is effective and accepted technique for the treatment
      of bifurcation. However, in complex lesion or anatomy, much procedure-time and contrast media
      are needed to accomplish this technique. Recent FFR study for jailed side branch (SB)
      demonstrated that angiographic severe stenosis at SB ostium includes "pseudo-stenosis" and
      stent-deployment jailing SB without FKBT has comparable impact on clinical outcome with FKBT
      strategy. Considering simple technique for bifurcation, we sought to investigate to compare
      "provisional FKBT" with "routine FKBT", focusing on actual myocardial ischemia assessed by
      scintigraphy in 7 month and to examine optimal endpoint of SB ostium.
    

Intervention name(s): stent technique: Provisional fKBT; stent technique: Routine fKBT
Intervention type(s): Procedure; Procedure
Intervention description(s): Provisional use of fKBT only when SB flow is aggravated to TIMI0-2 after stenting for non-left main bifurcation.
Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.
Stent type: Everolimus-eluting stent only; Mandatory use of fKBT irrespective of SB flow after stenting for non-left main bifurcation. Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.
Stent type: Everolimus-eluting stent only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, observer-blinded, active-controlled Phase II study to
      evaluate the immunogenicity, safety and reactogenicity of the low dose (20μg) and high dose
      (40μg) of ReCOV, when administered as a booster to healthy adults aged 18 to 65 years who
      have completed two or three doses vaccination (prioritized two doses). Estimate 300
      participants.
    

Detailed description: 
      The study is a multicenter, randomized, observer-blinded, active-controlled trial. About 300
      eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV
      group, and the control vaccine [COVID-19 Vaccine (Vero Cell), Inactivated] group,
      respectively, stratified by age (18 to < 50 years, ≥ 50 to ≤ 65 years) and the duration since
      the last dose of primary vaccination (90~180 days, 181~365 days).

      All Participants will be observed for 30 minutes after study vaccination at study site if
      Participants will be asked to record solicited AEs within 7 days and unsolicited AEs within28
      days. After 28 days post the study vaccination，all participants will have 2 on-site safety
      follow-up Visits on Day 90 (±15days) and on Day 180 (±15days) after the study vaccination to
      collect serious adverse evens (SAEs), adverse events of special interest (AESIs). During the
      study period, they can spontaneously report any adverse events (AEs) they experienced at any
      time.
    

Intervention name(s): Recombinant two-component COVID-19 vaccine (CHO cell); COVID-19 Vaccine (Vero Cell), Inactivated
Intervention type(s): Biological; Biological
Intervention description(s): Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Milky-white suspension.Stratified precipitate may form which can be dispersed by shaking
Other intervention name(s): ReCOV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Condition: Obesity; Eating Disorders
MeSH terms: Weight Loss; Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to assess the effect of rimonabant compared to placebo on weight
      loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients
      with binge eating disorder.

      The secondary objectives are:

        -  to assess the effect of rimonabant on the number of binge episodes per week, to assess
           the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three
           Factor Eating Questionnaire (TFEQ),

        -  to evaluate the safety and tolerability of rimonabant over a period of 6 months.
    


Intervention name(s): rimonabant (SR141716)
Intervention type(s): Drug
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: binge eating; eating disorders; obesity
Blood Glucose Response to Meals of Varying Glycemic Index in Youth With Type 1 & 2 Diabetes
Condition: Type 1 Diabetes; Type 2 Diabetes; Impaired Glucose Metabolism
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Research to date suggests that the selection of lower glycemic index foods, that is, foods
      provoking a slower, more sustained blood sugar response, may result in improved glycemic
      control in youth with diabetes. However, there is currently insufficient data to support
      practice recommendations. The purpose of this pilot study is to test the blood glucose
      response to low and high glycemic index meals in youth with diabetes using continuous blood
      glucose monitoring, and to determine whether the effect of glycemic index differs by regimen
      or diagnosis. In this pilot study up to 42 youth with type 1 diabetes or impaired glucose
      metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will
      participate in 5 days of continuous blood glucose monitoring during which they will receive
      both low and high glycemic index meals. Children will be provided with 1 full day of low
      glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in
      randomized order. Each of these test days will be preceded by a standard evening meal and
      snack. Continuous blood glucose monitoring will also be conducted during regular food intake
      ad libidum away from the clinic, as well as during one day of instructed low glycemic meals
      at home. All food intake, insulin, and blood glucose self-monitoring will be recorded. While
      in the clinic, measures of satiety and acceptability of the food will also be obtained. Data
      analysis will include indices of blood glucose levels and variability.
    


Intervention name(s): Diet; Standard diet
Intervention type(s): Behavioral; Other
Intervention description(s): Whole-foods, low glycemic index diet; Standard diet meeting American Diabetes Association guidelines
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Children; Adolescents; Diet; Glycemic index