bioihbjkbjnl/mcl2 huggingface dataset:
Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
Condition: Diabetic Gastroparesis; Idiopathic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric
      emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by
      scintigraphy.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4)
      receptor agonist and is being tested to treat people who have diabetic or idiopathic
      gastroparesis and who previously reported delay in stomach emptying. This study will look at
      the gastric emptying time of solids in people who take TAK-954 or placebo.

      The study will enroll approximately 41 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the four treatment groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK-954 0.1 mg

        -  TAK-954 0.3 mg

        -  TAK-954 1 mg

        -  Placebo (dummy inactive solution) - this is a solution that looks like the study drug
           but has no active ingredient.

      This single center trial will be conducted in the United States. The duration of treatment is
      3 days and the overall period of evaluation is up to 28 days. The participants will be
      contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another
      follow-up phone call for women of childbearing potential (Days 38 to 43).
    

Intervention name(s): TAK-954; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-954 IV infusion.; TAK-954 placebo-matching IV infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
A Dose-ranging Study of Fluticasone Furoate (FF)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIb, multi-centre, stratified, randomised, double-blind, double-dummy,
      parallel-group, placebo and active controlled study in children aged 5-11 years with
      persistent uncontrolled asthma. Subjects meeting all of the inclusion criteria and none of
      the exclusion criteria at the screening visit (Visit 1) will enter a four week run-in period
      during which time they will continue their current medications. Visit 2 will occur two weeks
      into the run-in period to allow a review of compliance with daily diary and run-in
      medication. At Visit 3 (end of run-in/randomization visit), subjects meeting the eligibility
      criteria who remain uncontrolled despite baseline therapy will be stratified based on pre
      screening inhaled corticosteroid (ICS) use. Once stratified, subjects will be randomised to
      the treatment phase of the study where they will receive one of five treatments for 12 weeks.
      Approx 1200 subjects ages 5 to 11 will be screened to achieve 575 randomized for a total of
      115 randomized/evaluable subjects per treatment arm. Subjects will attend on-treatment visits
      at 2, 4, 8 and 12 weeks (Visits 4, 5, 6 and 7 respectively). A follow-up contact will be
      performed one week after completing study medication. All subjects must attempt spirometry
      measurements at Visits 1 and 3. For all subjects, a timed 24-hour urine collection for
      urinary cortisol and creatinine excretion will be performed prior to randomization at Visit 2
      and within 7 days prior to Visit 7. All subjects must perform PEF daily between visits 1 and
      7. The primary endpoint will be change from baseline in pre-dose (i.e. dosing trough) PM PEF
      from patient hand held electronic daily diary at Endpoint (Endpoint is defined as the mean
      over the last 7 days of treatment). Safety assessments include adverse events, oropharyngeal
      examinations, clinical chemistry, urinary cortisol, and vital signs.
    


Intervention name(s): Fluticasone Furoate; Fluticasone Propionate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): current asthma medicine; Fluticasone propionate; placebo
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fractional Resurfacing Device for Treatment of Acne Scarring
Condition: Acne; Scar
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to evaluate the safety and effectiveness of a new
      investigational laser device for treatment of acne scarring, for improvement in the
      appearance of surface texture and topography (recessed or uneven surfaces).
    

Detailed description: 
      Thirty subjects between two research locations with an acne scar severity score greater than
      4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved
      10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at
      1 month and 3 months post-treatment.

      Post-treatment responses evaluated are immediate erythema, immediate edema, and any other
      immediate responses. Evaluations are conducted immediate post treatment and one week
      post-treatment. Key safety data include the severity scoring of post-treatment responses, as
      well as by photodocumentation.

      The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at
      follow-up visits one and three months post-treatment. Key safety data include the incidence
      rates and severity scoring of side effects, as well as by photodocumentation
    

Intervention name(s): 10,600 nm fractional carbon dioxide laser system
Intervention type(s): Device
Intervention description(s): 1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
Other intervention name(s): Fraxel Re:pair laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acne vulgaris; scarring; laser
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
Condition: Arterial Occlusive Disease; Ulcers; Ischemia; Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether intramuscular injections of NL003 into the
      calf is safe and effective in the treatment of critical limb ischemia
    

Detailed description: 
      Management of CLI process consumes a significant amount of healthcare resources,and the new
      therapeutic approaches are required.

      Hepatocyte growth factor (HGF) has been shown to be a potent angiogenic growth factor
      stimulating the growth of endothelial cells and migration of vascular smooth muscle cells.
      Because of its pluripotent capabilities, increasing the availability of HGF in ischemic
      tissues to achieve therapeutic angiogenesis has been a growing area of research.

      This study will use NL003, which is a DNA plasmid that contains novel genomic cDNA hybrid
      human HGF coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723. As
      there are currently no approved drugs that can reverse CLI and as most patients have
      exhausted surgical and endovascular intervention options, inducing angiogenesis in the
      affected limb with NL003 may result in an increase in tissue perfusion, which, in turn
      improve wound healing, reduce pain and improve limb salvage rates.
    

Intervention name(s): NL003; NL003; NL003; Normal Saline
Intervention type(s): Genetic; Genetic; Genetic; Other
Intervention description(s): Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003); Day 0: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 14: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 28: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections); Day 0: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 14: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 28: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections); Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections )
Other intervention name(s): HGF plasmid; pCK-HGF-X7; HGF plasmid; pCK-HGF-X7; HGF plasmid; pCK-HGF-X7; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HGF; Gene; Critical Limb Ischemia
Couple & Family Contexts
Condition: Behavior and Behavior Mechanisms
Study type: Observational

Summary: 
      The purpose of this study is to understand the factors that lead to adolescent sexual risk
      behavior by investigating both the family contexts and romantic relationships that influence
      adolescent couples' decision-making.
    

Detailed description: 
      In the United States, inner-city African American and Latino youth are vulnerable to the
      negative consequences of sexual risk behavior. Despite the fact that sexual risk behavior is
      a dyadic behavior, almost all of the social-cognitive theories emphasize individual-based
      variables to explain behavior. Little research has studied both members of an adolescent
      couple or has used measures from each member to predict future sexual activity of that dyad.
      The overall aim of the present study is to identify explanatory models of couple sexual risk
      behavior among a sample of unmarried, non co-habiting Latino and African American high
      school-aged dyads that are romantically linked. In addition, the present research also will
      study the parents of adolescent couples. In doing so, the present research will apply
      theories of cognition, emotion and emotion regulation, and a new theory of parental
      monitoring to the study of adolescent sexual risk behavior among couples.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Latino and African American adolescents currently involved in romantic relationships who
        reside in the Bronx, New York.
      
Keywords: adolescent couple decision-making; parenting practices; sexual risk behavior
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The overall aim of this study is to develop and test a psychodynamic Internet--delivered
      psychological treatment for patients with social anxiety disorder and compare its efficacy to
      a waiting list.
    

Detailed description: 
      Participants with social anxiety disorder (MINI telephone interview) will be recruited via
      mass media and randomly allocated to psychodynamic Internet--delivered psychological
      treatment or to a waiting list control condition.
    

Intervention name(s): Psychodynamic Internet Treatment; Waiting list
Intervention type(s): Behavioral; Other
Intervention description(s): Psychodynamic Internet Treatment for patients social anxiety disorder; Waiting list, where participants wait for delayed treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Test; psychodynamic; Internet-delivered psychodynamic treatment; patients with social anxiety disorder
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Our project is a 24-month longitudinal randomized controlled trial that aims to investigate
      the myopia development after topical application of 0.01% atropine in children with either
      fast or slow myopia progression classified according to their initial electro-retinal
      responses. This will help elucidate the effectiveness of using low concentration atropine for
      myopia control in children with different myopia progression rates.
    


Intervention name(s): Atropine (0.01%); Artificial tear
Intervention type(s): Drug; Drug
Intervention description(s): tropical application; tropical application
Intervention MeSH terms: Atropine; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Myopia; Myopia control; Atropine; Electroretinogram; Multifocal Electroretinogram
Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
Condition: Cytokine Release Syndrome
MeSH terms: COVID-19; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of the study is to evaluate the safety and tolerability of open-label ST266
      given to subjects with confirmed COVID-19 infection through IV administration once a day of 5
      consecutive days.
    

Detailed description: 
      This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
    

Intervention name(s): ST266
Intervention type(s): Biological
Intervention description(s): 1X ST266
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19
Psychometric Evaluation of the Traditional Chinese Version of Resilience Scale-14
Condition: Resilience of Hong Kong Adolescents
Study type: Observational

Summary: 
      This study will aim to translate the original RS-14 (English version) into traditional
      Chinese. It will then test the psychometric properties of the newly translated RS-14 to
      examine its factorial structure using both exploratory factor analysis (EFA) and CFA.
    

Detailed description: 
      Mental health problems in adolescents reflect a global problem that is becoming more
      prevalent in Hong Kong. In Hong Kong, there is a significant change in family structure to
      small nuclear families. Children receive more attention and may even be overprotected by
      parents. Also, parents' great expectations for high academic achievement also contribute to
      the increase in mental health problems among adolescents in Hong Kong. The Polytechnic
      University and the Christian Family Service Centre conducted a mental health survey study of
      12,518 Form 1 to Form 7 pupils from 2011 to 2014. Of the respondents, 62.1% demonstrated
      slight to very serious depression symptoms. Evidence has shown that depressive symptoms
      predict suicidal tendencies among adolescents.

      Resilience effectively prevents the development of mental health problems and is associated
      with positive mental health outcomes in adolescents. Assessing resilience in adolescents is
      therefore crucial for developing a thorough understanding of their responses to stress and
      adversity. The literature reports various instruments used to assess resilience, such as the
      Connor-Davidson Resilience Scale (CD-RISC) and the Resilience Scale (RS). And translated
      version of RS-14 is also developed because of linguistic and cultural differences.

      The proposed study will aim to translate the original RS-14 (English version) into
      traditional Chinese. It will then test the psychometric properties of the newly translated
      RS-14 to examine its factorial structure using both exploratory factor analysis (EFA) and
      CFA. Furthermore, using the newly validated RS-14, a survey will be conducted to assess the
      resilience level of a large sample group of Hong Kong Chinese adolescents.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Form 1 students (Grade 7, 12 to 13 years of age) from six secondary schools across three
        major districts (Hong Kong Island, Kowloon and the New Territories) will be randomly
        selected and invited to participate in the proposed study.
Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
Condition: Impaired Fasting Glucose; Prediabetes
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the effect of 8 weeks of treatment with
      colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the
      acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes
      (impaired fasting glucose).
    

Detailed description: 
      Colesevelam is a bile acid sequestrant that was initially approved for treatment of patients
      with dyslipidemia. Subsequently it was observed that patients with type 2 diabetes receiving
      this medication had improved glucose control. However, the mechanism(s) by which it lowers
      glucose concentrations has not been determined.

      Glucose metabolism is enhanced following oral nutrient ingestion by the action of the
      incretin hormones. The two major incretin hormones are the peptides glucagon-like peptide-1
      (GLP-1) and glucose-dependent insulinotropic peptide (GIP), which are released from the
      intestinal tract wall in response to a meal. Of these two peptides, GLP-1 appears to be more
      important in regulating glucose metabolism. In the presence of elevated plasma glucose, GLP-1
      promotes insulin release from the ß-cells of the pancreas. GLP-1 also suppresses glucagon
      release, and thereby inhibits hepatic glucose output. Administration of GLP-1 by infusion or
      by subcutaneous injection has been shown to improve glucose tolerance in type 2 diabetic
      patients.

      The purpose of this study is therefore to determine in a cohort of individuals with
      prediabetes, who have an elevated fasting plasma glucose and are at increased risk of
      developing type 2 diabetes, whether the glucose lowering properties of colesevelam occur by
      it improving insulin sensitivity, islet ß-cell function or both. Further, by assessing the
      effect of colesevelam on incretin hormone release, it will be possible to determine whether
      any improvement in islet ß-cell function is due to enhanced incretin stimulation.
    

Intervention name(s): Colesevelam; placebo
Intervention type(s): Drug; Other
Intervention description(s): colesevelam HCl 3.75 g once daily orally with the evening meal; tablet (s) orally given with evening meal
Other intervention name(s): colesevelam HCl
Intervention MeSH terms: Colesevelam Hydrochloride
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Impaired Fasting Glucose; PreDiabetes
Recurrent Low Back Pain:Linking Mechanisms to Outcomes
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine if trunk neuromuscular control strategies are
      changed by therapeutic exercises emphasizing core stabilization.

      Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in
      function and pain will have significantly improved trunk motor control strategies.

      Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be
      tested using a known group method demonstrating:

        -  no significant change in motor control measures within the untreated, healthy control
           group.

        -  significant changes within the low back subjects who demonstrate clinically meaningful
           improvements.
    

Detailed description: 
      A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region
      is an important finding in a large number of patients with recurrent and chronic low back
      pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor
      control in individuals with low back pain, the neuromuscular strategies underlying these
      alterations have not been satisfactorily characterized. The aims of this study are to(1)
      identify which neural control strategies are altered following a rehabilitation program that
      emphasizes trunk control and stability using a motor learning approach and (2) provide
      preliminary evidence of a link between hypothesized mechanism and effectiveness for programs
      designed to improve trunk control.
    

Intervention name(s): Core Stabilization
Intervention type(s): Other
Intervention description(s): The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.
Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.
Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced.
Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic physical therapy clinic community
      
Keywords: low back pain; clinical instability; neuromuscular control; core stabilization; physical therapy