bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects
      with type 2 diabetes.

      Each subject will be randomly allocated to one of four treatment sequences. Each sequence
      will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High
      dose) and one single dose of Humalog® Mix25.

      Subjects will come to the clinical trial centre in a fasted state in the morning of each
      dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been
      terminated.
    

Detailed description: 
      Subjects will attend the study site in the morning in a fasted state and will be connected to
      an automated glucose clamp device. Prior to dose administration plasma glucose will be
      stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose or
      insulin. IMP administration will be done by an unblinded person by means of subcutaneous
      injections in the abdominal wall.

      Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30
      hours.

      The pharmacodynamic assessment will be based on the time course of glucose infusion rate
      (GIR) and plasma glucose.

      Plasma insulin concentrations will be measured using a specific validated bioanalytical
      method differentiating concentrations of insulin glargine, of its main metabolites
      insulin-glargine-M1 and insulin-glargine-M2, and of insulin lispro. Pharmacokinetic
      assessments will be based on total insulin concentration (insulin glargine + insulin
      glargine-M1 + insulin glargine-M2 + insulin lispro), on insulin glargine concentration
      (insulin glargine + insulin glargine-M1 + insulin glargine-M2), or on insulin lispro
      concentration.
    

Intervention name(s): Euglycemic clamp with BC Combo THDB0207; Euglycemic clamp with Humalog® Mix25
Intervention type(s): Drug; Drug
Intervention description(s): Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure.; Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure.
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Four-period crossover
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
Condition: Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Study type: Interventional
Phase: Phase 3

Summary: 
      The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented
      Relay, a novel program that engages and intervenes with individuals in the ED following an
      opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The
      proposed randomized controlled trial will evaluate the impact of Relay on preventing
      subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal
      opioid OD presenting to one of four participating EDs will be enrolled and randomized to one
      of two arms: 1) site-directed care (SDC) or 2) Relay-peer-delivered OD education and
      treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12
      months through interviews and administrative health data.
    

Detailed description: 
      Relay is a novel program that engages and intervenes with individuals in the ED following an
      opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay
      is delivered by trained peer navigators, who are DOHMH staff with lived substance use
      experience. Relay navigators provide counseling, linkage to services, and OD prevention
      education.
    

Intervention name(s): RELAY
Intervention type(s): Behavioral
Intervention description(s): Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trabectedin in Treating Patients With Advanced, Persistent, or Recurrent Leiomyosarcoma of the Uterus
Condition: Sarcoma
MeSH terms: Sarcoma; Leiomyosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with
      advanced, persistent, or recurrent leiomyosarcoma of the uterus.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the antitumor activity of trabectedin, as measured by frequency and duration
           of objective response, in patients with advanced, persistent, or recurrent uterine
           leiomyosarcoma.

        -  Determine the nature and degree of toxicity of this drug in these patients.

      OUTLINE: This is a nonrandomized, multicenter study.

      Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3
      weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a
      confirmed complete response may receive at least 2 additional courses.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
    

Intervention name(s): trabectedin
Intervention type(s): Drug
Intervention MeSH terms: Trabectedin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uterine leiomyosarcoma; recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma
Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Condition: ADD; ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Multicenter, Prospective, randomized, comparative and controlled study about the beneficial
      effects in behavior and brain connectivity of different dietary patterns in 100 children with
      ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.
    

Detailed description: 
      The investigators collect electroencephalogram (EEG), event related potentials (ERP) data,
      and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during
      study. They would only follow some nutritional recommendations based on increasing the amount
      of dietary protein and fast carbohydrates decrease. The duration of the study will be 6
      months, 3 months for recruitment and 3 months for dietary treatment.
    

Intervention name(s): BP22042013; Low carbohydrate diet
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.; the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
Other intervention name(s): Brain Proteins Supplements; 2000 Kilo-calories without Fast Absorbing Carbohydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: ADD; ADHD; Proteins; Dietary; Nutrition; QEEG; ERP; ICA
A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a safety and efficacy study evaluating a experimental treatment for cognitive
      deficits in adults with schizophrenia.
    

Detailed description: 
      This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-126 in treating
      cognitive deficits in subjects with a diagnosis of schizophrenia. Eligible subjects will take
      study drug as an add-on treatment to their ongoing antipsychotic treatment regimen.
    

Intervention name(s): ABT-126; ABT-126; ABT-126; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABT-126 Middle Dose; ABT-126 Low Dose; ABT-126 High Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia
A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic
      and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male
      Subjects
    


Intervention name(s): HCP1306; HGP0904; HGP0608
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet); Amlodipine 5mg(Norvasc); Losartan 100mg(Cozaar)
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Postural Insoles on Stability and Leg Muscular Activity
Condition: Postural Stability; Muscular Activity
Study type: Interventional

Summary: 
      Posturology allows to treat postural problems by using postural insoles, which will have an
      effect at the neurophysiological level. Pieces of 1 to 3 millimeters are inserted to
      stimulate specific receptors located on the sole of the foot, which will affect the muscular
      proprioception and modify the activation of the ascending muscle chains.

      The hypothesis of this work is based on the fact that the use of postural insoles with a 2
      millimeters metatarsal bar will influence the displacement of the center of pressure and the
      muscle activity of the leg when compared with a placebo insoles.

      Participants will be healthy subjects and will be divided into two groups, control and
      experimental. Subjects in the control group will be given a pair of flat insoles (placebo
      insoles) with 1.2 millimeters polyester resin. Those of the experimental group will be made
      the same insoles but they will include by thermal fusion a metatarsal bar of 2 millimeters
      polyester resin in the metatarsal zone corresponding to the 1st, 2nd, 3rd and 4th metatarsal
      head.

      Postural stability analysis will be performed with the force platform of the Biomechanics
      Institute of Valencia (IBV-Spain) and at the same time an electromyographic analysis in the
      dominant leg with a surface electromyograph system. Subjects will be assessed with their eyes
      open and closed under two situations, with footwear and with footwear and insoles.
    


Intervention name(s): Postural stability assessment with a force platform.; Muscular assessment with a electromyograph
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition.; The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Metatarsal Bar; Insoles; Postural stability; Electromyograph Activity
Teaching Academic Success Skills to Students With Autism Spectrum Disorders in Clinical Setting
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to
      Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF
      deficits.

      Aim 1: Use focus group methodology and advice from expert consultants to develop the TASK
      intervention targeting academic EF skills for middle school youth with ASD that is tailored
      to the unique needs of these individuals (e.g., content specific to ASD EF deficits,
      incorporate evidence-based teaching principles and methods for ASD).

      Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials to assess initial
      feasibility and efficacy.
    

Detailed description: 
      The goal of the study is to develop an academic EF intervention, Teaching Academic Skills to
      Kids (TASK), for high functioning (i.e., IQ score ≥80) middle-school youth with ASD and EF
      deficits.

      Aim 1: Develop the TASK intervention targeting academic EF skills for middle school youth
      with ASD that is tailored to the unique needs of these individuals (e.g., content specific to
      ASD EF deficits, incorporate evidence-based teaching principles and methods for ASD). A
      methodologically rigorous, well-integrated iterative and collaborative design process with
      input from multiple stakeholders, including school mental health professionals, teachers,
      parents, and youth with ASD, will be utilized.

      Aim 2: Examine the feasibility and acceptability of TASK in 3 open trials including the
      feasibility of: 1) implementing the measurement protocol, 2) operationalizing intervention
      delivery, 3) assessing both trained and untrained areas of functioning, 4) assessing whether
      improvements in academic EF skills (proposed mechanism of treatment) are related to
      functional educational outcomes (e.g., homework behaviors, grades), and 5) exploring the data
      for potential treatment moderators (e.g., gender, severity). It is hypothesized that TASK
      will be feasible, acceptable (attendance, satisfaction), and will result in improved academic
      EF skills associated with reduced academic impairment and homework problems.
    

Intervention name(s): Teaching Academic Skills to Kids
Intervention type(s): Behavioral
Intervention description(s): Group treatment
Intervention model: Single Group Assignment
Intervention model description: Open trial
Masking: None (Open Label)
Primary purpose: Treatment
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have
      shown promise as a treatment of fibromyalgia, but the drug required new formulation
      technology for bedtime use. The present trial was designed to assess the safety and efficacy
      of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
    


Intervention name(s): TNX-102 SL 2.8mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Other intervention name(s): Low dose cyclobenzaprine sublingual tablets; Placebo sublingual tablets
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; sleep
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Condition: Overactive Bladder With Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902
      24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with
      placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up
      to 48 weeks post-dose.
    


Intervention name(s): URO-902; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intradetrusor injection; intradetrusor injection
Other intervention name(s): hMaxi-K; pVAX/hSlo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: URO-902; hMaxi-K; pVAX/hSlo; Overactive Bladder; Urge Urinary Incontinence
Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will
      receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System
      standard transducer on one side of the face and a Ulthera System prototype simulines
      transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days
      post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and
      at each follow-up visit.
    

Detailed description: 
      This is a prospective, multi-center, split-face, randomized pilot trial to determine the
      clinical feasibility of the Ulthera System prototype simulines transducers, that is,
      transducers which deliver two lines of treatment simultaneously (at once), in comparison to
      the standard transducers which deliver a single treatment line, by collecting average pain
      scores in the treated regions, as well as efficacy and treatment efficiency data. There will
      be 3 study arms with each arm having 2 treatment groups. Enrolled participants will be
      randomized to one of two study arms, and one of two treatment groups within each study arm.to
      determine which side of the face will be treated with Ulthera System standard transducers and
      Ulthera System prototype simulines transducers and the energy level for treatment.
      Participants will receive one dual-depth treatment at 4.5 millimeter (mm) and 3.0mm depths.

      Clinical feasibility will be assessed based on comfort level of standard transducers versus
      simulines transducers by comparing average pain scores obtained during study treatment.
      Efficacy will be determined based on qualitative masked assessment of post-treatment
      photographs compared to pre-treatment photographs and quantitative eyebrow lift measurements.
      Patient satisfaction questionnaires will be obtained.
    

Intervention name(s): Ulthera Treatment at EL2; Ulthera Treatment at EL4
Intervention type(s): Device; Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.; Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy; Ultherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy®; Ulthera, Inc.
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to establish the bioequivalence of the test product
      (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012
      supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers.

      The secondary objectives of this study are to determine the safety and tolerability of the
      test product compared to the reference product, to estimate PK parameters of the test product
      and the reference product, and to estimate the intra-subject coefficient of variation (CV%)
      of the referenced product for both area under the plasma concentration curve (AUC) and peak
      plasma concentration (Cmax).
    


Intervention name(s): dimethyl fumarate - Reference form; dimethyl fumarate - Test form
Intervention type(s): Drug; Drug
Intervention description(s): single dose 240 mg; single dose 240 mg
Other intervention name(s): BG00012 Tecfidera®; BG00012
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pompe Telemedicine Developmental Study
Condition: Pompe Disease; Glycogen Storage Disease II
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Study type: Observational

Summary: 
      The primary purpose of this study is to:

        -  Document the developmental outcomes of individuals with Pompe disease treated with
           long-term enzyme-replacement therapy (ERT) through school-age (ages 6-18) using measures
           of cognitive functioning, academic skills, and speech and language abilities.

        -  Investigate possible cognitive processing speed weaknesses using BrainBaseline
           neurocognitive assessment software.

        -  Investigate the relationship between behavior and other developmental factors including
           speech and language ability and cognitive ability.

        -  Explore if the use of selected iPad applications may help strengthen cognitive
           processing speed in children with Pompe disease
    

Detailed description: 
      The study will last approximately 2-3 years. It includes 2-4 visits to Duke for developmental
      assessments. The baseline/year 1 visit may take place at Duke (may take 1-2 days) or remotely
      via iPad. The follow up 1/year 2 visit may take place at Duke (1-2 days) or remotely via an
      iPad, depending upon each child's particular situation.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is open to patients with classic Pompe disease.
      
Keywords: Pompe; Glycogen Storage Disease II; Telemedicine; Duke University Medical Center