bioihbjkbjnl/mcl2 huggingface dataset:
Opioid Laws and Pediatric Use
Condition: Burns; Knee Injuries; Opioid Use; Pain
MeSH terms: Knee Injuries
Study type: Observational

Summary: 
      The legitimate need for opioid medications for acute pain management in pediatric trauma
      patients is recognized, however, the high dose and duration of opioid drugs prescribed by
      medical providers has been associated with an increased risk of opioid abuse and chronic use
      by patients. The overarching goal of application is to assess opioid use and outcomes of
      pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large
      academic pediatric medical center before and after Ohio opioid prescription rules for acute
      pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days
      post-treatment.
    

Detailed description: 
      This study has a prospective and retrospective component. Phase 1 involves a retrospective
      chart review will be performed among pediatric patients undergoing burn care or knee
      arthroscopy at our institution to determine a whether there was a reduction in prescribed
      opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period
      (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017,
      to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn,
      n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods.

      Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee
      arthroscopy procedure to assess the association of opioid prescribing, consumption and amount
      of left-over medications, and pain control status after 90 days. This phase will include 100
      patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.
    

Intervention name(s): Opioid Use 90-Days Post Treatment
Intervention type(s): Behavioral
Intervention description(s): Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain
Intervention MeSH terms: Analgesics, Opioid
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients (age 0-18 years) treated at our institution for either a burn injury or
        knee arthroscopy procedure and received an opioid prescription.
      
Keywords: Burns; Knee Arthroscopy; Opioid; Pain; Chronic
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics
      (the study of the way a drug enters and leaves the blood and tissues over time), and
      pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different
      doses in combination with two standard therapies commercially available for chronic (lasting
      a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.
    

Detailed description: 
      This is a Phase 2a, open-label (all people know the identity of the intervention),
      multicenter trial (conducted in more than one center) in participants with chronic genotype 1
      HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment
      phase up to 48 weeks depending on participants' individual virologic response, and a
      follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir
      treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and
      participants will continue on standard therapy only. Participants will be randomly assigned
      to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8
      hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated
      interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard
      doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response,
      viral breakthrough, partial response, early viral kinetics and sustained viral response.
      Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety
      will be monitored throughout the study duration.
    

Intervention name(s): Telaprevir; Peg-IFN-alfa-2a; Peg-IFN-alfa-2b; Ribavirin (RBV) tablet; Ribavirin (RBV) capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oval tablets containing 375 mg of telaprevir for oral administration.; Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.; Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.; Tablets containing 200 mg RBV for oral administration.; Capsules containing 200 mg RBV for oral administration.
Intervention MeSH terms: Ribavirin; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Peginterferon alfa-2a; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Genotype 1; Telaprevir; Treatment-naïve; VX-950-C208; VX-950-TiDP24-C208
A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers
Condition: Irritation Potential of Topic Agent
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I single-site study to evaluate the irritation potential of topically applied
      ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201
      GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six
      (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to
      complete the study. The test articles will be applied to the upper back of the subjects
      during the study, and the placement of the test articles will be randomized. Abraded skin
      will be induced using sequential tape stripping.
    


Intervention name(s): ATx201 Gel 2%; ATx201 Gel 4%; Positive Control; Negative Control; ATx201 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2% active gel; 4% active gel; Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP; Water for Injection, USP; matching placebo gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the assignment of the test articles to the test sites will be randomized. Each "arm" is a different patch of skin on the same study participant
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if an otic formulation is safe and effective in
      treating middle ear infections in patients with ear tubes.
    


Intervention name(s): Moxidex otic solution; Ofloxacin otic solution; Tympanostomy tubes
Intervention type(s): Drug; Drug; Device
Intervention description(s): 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days; 5 drops into the infected ear(s) twice daily (morning and evening) for 10 days; Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Other intervention name(s): FLOXIN
Intervention MeSH terms: Ofloxacin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute otitis media; Tympanostomy tubes
Phase I Study of OPC-61815
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on
      QT/QTc interval in healthy male subjects
    


Intervention name(s): OPC-61815 16mg; OPC-61815 32mg; Moxifloxacin; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): OPC-61815 16mg will be intravenously administered once a week.; OPC-61815 32mg will be intravenously administered once a week.; 400mg tablet will be administrated once a week.; Placebo will be intravenously administered once a week.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents
Condition: House Dust Mite Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of different doses of
      sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust
      mite-associated allergic rhinitis.
    


Intervention name(s): SLIT tablets of HDM allergen extracts
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: House Dust Mite Allergic Rhinitis; Phase I; House Dust Mite Allergen Extract
Effective Communication to Improve Decision Making About Health Care Plans
Condition: Health Literacy; Health Insurance; Health Services Accessibility
Study type: Interventional

Summary: 
      The overall goal of the study is to better understand how communication strategies can help
      people make decisions about health insurance plans.

      This study aims to:

        -  (Aim 1) Examine currently uninsured individuals' understanding of terminology and
           details of health insurance plans;

        -  (Aim 2) Apply three recommended strategies for communicating information about health
           insurance plans;

        -  (Aim 3) Test the effects of these strategies in a randomized experiment.
    

Detailed description: 
      First, this study will examine people's understanding of health insurance plan terminology
      and details through qualitative interviews with 50 uninsured individuals. These responses
      will then lead to the development of three communication strategies to improve understanding
      of health insurance plans: 1) plain language, 2) plain language plus visual displays and 3)
      plain language plus narratives.

      The strategies will the be pilot tested with 30 individuals to assess readability, clarity of
      language, and layout. The revised communication strategies will be tested with 280
      individuals in a randomized experiment. Individuals will be randomly assigned to either a
      plain language condition alone, a plain language + visual displays condition, and a plain
      language + narrative condition.
    

Intervention name(s): Plain Language; Plain Language + Visuals; Plain Language + Narratives
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Health insurance; Health services accessibility; Decision making; Health literacy
A Pharmacokinetics Study of AF-130 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, single centre, single (Part 1) and multiple (Part 2) dose escalation study
      in healthy male subjects.
    

Detailed description: 
      Part 1 is a double-blind, placebo-controlled, randomised single dose design in up to 64
      healthy male subjects. Part 1 will consist of Groups 1 to 6, each comprising 8 subjects
      (total of 48 subjects). There will be an option to enrol 2 additional groups (8 subjects in
      each of Groups 7 and 8) to assess alternative dose levels. Subjects will be randomised to
      receive active or placebo in the fasted state.

      Part 2 is a double-blind, placebo-controlled, randomised, multiple ascending dose design in
      up to 45 healthy male subjects. Part 2 will consist of Groups 9 to 11, each comprising 9
      subjects (total of 27 subjects). There will be an option to enrol 2 additional groups (9
      subjects in each of Groups 12 and 13) to assess alternative multiple dose levels. Part 2 will
      not commence before completion of Groups 1 to 3 in Part 1. Subjects will be randomised to
      receive active or placebo in the fasted state. The planned dosing regimen is once per day
      however, this may be modified to twice per day depending on emerging pharmacokinetic data
      from Part 1.
    

Intervention name(s): AF-130; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): AF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days; AF-130 matching placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Robotic and Conventional Hand Therapy After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are
      often not effective in restoring full function of the upper limb. Specifically, many
      individuals remain with weakness in the hand, preventing its return to full use.

      Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such
      as the InMotion2, have been shown to be useful in restoring some motor function in the upper
      limb. However, most existing devices designed to be used with the upper limb have primarily
      been developed to treat the shoulder, elbow and wrist. They have not specifically addressed
      hand function.

      Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide
      rehabilitation for patients with neurological or orthopedic deficits in hand function.
      Initial clinical testing has demonstrated the practicality of using this device in a
      population of stroke survivors, although further research is needed to better understand the
      usefulness of the Amadeo device as compared with conventional rehabilitation methods. The
      purpose of this study was to compare results of training with the Amadeo device or training
      with conventional therapies.

      A total of 28 subjects from two separate sites participated in the study and underwent
      baseline testing of upper limb motor and sensory performance and function. Subjects were then
      assigned to one of two treatment groups with a 50:50 chance of being in either group. One
      group underwent training with the Amadeo device and the other group underwent training with
      conventional therapy. All training sessions were 60 minutes in duration, three days/week for
      eight weeks (24 total sessions). Subjects were reassessed on completion of the training
      program.
    


Intervention name(s): Amadeo Hand Robot Device; Conventional Therapy
Intervention type(s): Device; Other
Intervention description(s): This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.; This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Diacerein on Insulin Secretion in Diabetes
Condition: Type 2 Diabetes Mellitus; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)
      inhibition with diacerein administration on insulin secretion and metabolic control of
      drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

      Hypothesis. Diacerein administration improves insulin secretion and metabolic control of
      drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

      Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.
      Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A
      metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well
      as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion
      and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15
      days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed
      rank and Mann-Whitney U test.
    


Intervention name(s): Diacerein; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Diacerein
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Overweight; Obesity
Do Common Physical Tests Predict Injury or Performance
Condition: Lower Extremity Musculoskeletal Injury
MeSH terms: Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Field tests are convenient, simple tests that serve as estimates of components of athletic
      performance like power speed, and agility. It is thought clinically, that those who do best
      at these tests will perform the best in their sport and/or be the least likely to get
      injured. The converse is also thought to be true. The objective of this study is to
      administer field tests to athletes at the beginning of each season and then follow athletes
      over several years, tracking their injuries and their performance statistics. In this way,
      the investigators can determine if the clinical supposition is true and that the results of
      field tests are associated with injury or performance
    

Detailed description: 
      11 physical performance tests were examined to determine their ability to predict injury
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        college age, varsity, division 1 athletes
Myotonic Dystrophy Type 1 and Resistance Exercise
Condition: Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the response after one bout of moderate-heavy
      resistance exercise in patients suffering from Myotonic Dystrophy type 1. There is still
      doubt about if these patients could benefit from resistance exercise, or if this mode of
      exercise is detrimental to their mobility and health. We aim to monitor the subjects during
      the recovery phase and investigate recovery in several ways.
    

Detailed description: 
      Myotonic dystrophy type 1 (DM1) is an autosomal, dominantly inherited, muscular disease and
      the most common muscular dystrophy amongst adults. The disease is characterized by
      progressive myopathy and myotonia, first evident in the distal parts of the body: calves and
      forearms, further progressing towards proximal parts. A recent review by Voet and co-workers
      (2013) concludes that exercise is safe for DM1-patients, and based on our current knowledge,
      DM1-patients should be able to gain positive adaptations from exercise. However, the
      physiological outcomes of an exercise stimulus are not well studied in this population and
      because of alterations in important Ca2+ handling systems the recovery processes might be
      significantly different from healthy muscles.

      The aim of this study is to investigate the acute responses to moderate-heavy resistance
      exercise in DM1-patients. We aim to establish a timeline for recovery of muscle strength,
      measured as maximal voluntary contraction. In line with this, we want to investigate if any
      muscular damage has occurred with both direct and indirect measures, and possible mechanisms
      leading to muscle damage, i.e. impaired Ca2+ handling.
    

Intervention name(s): Moderate-Heavy Resistance Exercise
Intervention type(s): Other
Intervention description(s): Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.
Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Resistance exercise; Recovery; Muscle protein synthesis; Muscle protein breakdown; Muscle function