bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain
Condition: Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Tapentadol has already been studied in adults. This study is needed to find out if tapentadol
      works and is safe to use in children and adolescents with long-term pain.
    

Detailed description: 
      During the first 2 weeks of the study (Part 1), participants were given either tapentadol or
      morphine prolonged-release (PR) tablets. Assignment was done randomly (like tossing a coin).
      The participant and the caregiver knew which medication the child was taking. The primary
      endpoint was based on data collected in Part 1 of this study.

      If eligible and willing, participants from Part 1 could enter a 12 month follow-up period
      (Part 2). In Part 2 of this study, participants were either treated with tapentadol PR
      tablets or entered observations arms where they were not treated at all or with standard of
      care.
    

Intervention name(s): Tapentadol prolonged release; Morphine prolonged release
Intervention type(s): Drug; Drug
Other intervention name(s): Palexia®; Nucynta®; Yantil®
Intervention MeSH terms: Morphine; Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There were 2 arms in Part 1: Randomization was carried out in blocks and in a 2:1 ratio (tapentadol PR to morphine PR). Participants were stratified using interactive response technology: by age group (6 years to less than 12 years and 12 years to less than 18 years, at the second visit [Allocation Visit]) so that at least 25% of participants were in the younger age group, and by underlying pain condition (cancer/non-cancer-related pain).
There were 4 arms in Part 2: The investigators/participants decided if participants from Part 1 switched to or continued on tapentadol PR (tapentadol arm) or if they received no treatment/standard of care treatment if needed (2 direct observation arms following treatment in Part 1 and 1 observation arm after initial treatment with tapentadol in Part 2).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; opioid
Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal transcranial direct current stimulation
      (tDCS) amplitude and electrode montage that is both safe and efficacious
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique
      that can modulate cortical excitability of targeted brain regions. Various studies have
      investigated tDCS use in stroke patients with motor impairments (cumulatively about 200
      cases). Although these studies are mostly "proof of concept" with small sample size, they do
      suggest that tDCS may improve motor function. However these two questions have not been
      addressed systematically:

        1. What is the optimal current for stroke patients?

        2. What is the optimal tDCS electrode montage for stimulation?

      This proposal lays the scientific foundation for systematic application of tDCS in stroke
      recovery research by progressively increasing tDCS currents and montages that are both safe
      and efficacious in population with stroke.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages
Other intervention name(s): tdcs
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; tDCS
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has two parts. Each participant will receive a daily injection of insulin
      peglispro during one treatment period and a daily injection of insulin glargine during the
      other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures
      to look at how the body uses or stores fats while taking each study drug.
    


Intervention name(s): Insulin Peglispro; Insulin Glargine
Intervention type(s): Biological; Biological
Intervention description(s): Daily doses administered SC.; Daily doses administered SC.
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.
Condition: Influenza Disease
MeSH terms: Influenza, Human; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II, open label, is designed as a seasonal study to support annual strain update
      evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation
      of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic
      diseases
    


Intervention name(s): Adjuvanted influenza vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; influenza vaccine; adjuvanted influenza vaccine; subunit influenza vaccine; surface antigen
Training Effects on Skeletal Muscle Fatty Acid Metabolism
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      We are interested in how skeletal muscle processes fat and how this may affect insulin
      resistance. This is an important question since insulin resistance predates and predicts type
      2 diabetes. We know that if pharmaceutical grade fat is infused into people, they develop
      insulin resistance. Likewise, we would like to infuse pharmaceutical grade fat into trained
      subjects, believing that trained subjects will have less insulin resistance, less decline in
      muscle energy function, and less accumulation of fat metabolites than untrained subjects. For
      comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of
      trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the
      same as pharmaceutical grade fat infusion without the fat component.
    

Detailed description: 
      We are interested in how skeletal muscle processes fat and its effect on insulin resistance.
      This is an important question since insulin resistance predates and predicts type 2 diabetes.
      We know that if pharmaceutical grade lipid is infused into people, they develop insulin
      resistance. Thus, we would like to infuse pharmaceutical grade lipid into trained subjects,
      believing that trained subjects will develop less insulin resistance, less decline in muscle
      energy function, and less accumulation of fat metabolites than untrained subjects. For
      comparing the effects of the pharmaceutical grade fat infusion, we will also have a group of
      trained and untrained subjects given a control (glycerol) infusion. Glycerol is basically the
      same as pharmaceutical grade lipid infusion without the lipid component.

      Three visits will be required. The first visit will involve measurement of fitness. A second
      visit will involve measurement of insulin resistance. The third visit will involve an
      inpatient stay, with a six hour infusion either the lipid or glycerol. Three muscle biopsies
      (before, during and after) will be take in conjunction with the infusion.
    

Intervention name(s): 20% lipid infusion; glycerol
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 ml/min for 6 hours; glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Other intervention name(s): Intralipid; triglyceride infusion; lipid infusion; fat infusion; Control infusion; glycerol infusion
Intervention MeSH terms: Soybean oil, phospholipid emulsion; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: insulin resistance; lipid metabolism; lipid infusion; glycerol infusion; skeletal muscle; diabetes
The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System)
Condition: Meniscectomy; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized,
      interventional clinical trial to test the hypothesis that the NUsurface implant is superior
      to the non-surgical standard of care in treating the target population.The rationale for
      performing this clinical study is to gather clinical data to evaluate the safety and
      effectiveness of the NUsurface device compared to the Standard of Care.
    

Detailed description: 
      The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain
      that have had a previous partial medial meniscectomy.

      Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization
      into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS
      (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation
      Committee) forms will be used to provide a comprehensive evaluation of the patients'
      pre-intervention and post-intervention condition including activity levels, pain, swelling,
      locking, stability, support, sports activity, and quality of life assessment.
    

Intervention name(s): NUsurface® Meniscus Implant; NSAID's and Non-surgical Treatment Options; Intra-Articular Injections with Corticosteroids; Intra-Articular Injections with Hyaluronic Acid (HA)
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.; Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise; Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).; Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NuSurface; Meniscus; Prosthesis; KOOS
Bioavailability of Phenolic Compounds in Bread
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The consumption of wholemeal cereals has been associated with the reduction of several
      chronic diseases. The mechanisms behind these protective effects may be linked, besides
      dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly,
      hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the
      highest concentration of ferulic acid, principally contained as monomeric form and diferulic
      acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of
      the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary
      excretion of phenolic metabolites in humans fed with two different kind of a commercial
      bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the
      pharmacokinetics of the main phenolic compounds was also evaluated by measuring the
      circulating metabolites in plasma samples.
    


Intervention name(s): Bread
Intervention type(s): Other
Intervention description(s): In each arm subjects consume bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Phenolics; Aleurone; Bioavailability; Pharmacokinetics
Peripheral Metabolic Effects of Somatostatin
Condition: Acromegaly; Growth Hormone Deficiency; Diabetes
MeSH terms: Acromegaly
Study type: Interventional

Summary: 
      The aim of this study is to investigate peripheral effects of Somatostatin on glucose
      metabolism and growth hormone (GH) signalling in healthy men. Eight subjects will be
      enrolled. The hypothesis is that Somatostatin infusion reverses insulin resistance caused by
      GH.
    


Intervention name(s): Somatostatin
Intervention type(s): Drug
Intervention description(s): 4 h of 150 microgram infusion
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: GH signalling; insulin resistance; somatostatin; acromegaly
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The intent of this study is to demonstrate that single doses of the Final Market Image (FMI)
      ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are
      bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are
      coadministered as individual tablets in healthy adults.
    


Intervention name(s): Ezetimibe; Ezetimibe/atorvastatin 10mg/10mg FDC; Atorvastatin 10mg; Atorvastatin 80mg; Ezetimibe/atorvastatin 10mg/80mg FDC
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).; Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).; Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).; Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).; Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
Other intervention name(s): Zetia; SCH 900068; Lipitor; Lipitor; SCH 900068
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperlipidemia; statin; Ezetimibe; Zetia; Atorvastatin; Lipitor
Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Interventional

Summary: 
      This study will determine the effectiveness of initiating a high-dose inhaled corticosteroid
      (ICS) or a leukotriene receptor antagonist (LTRA) in addition to an inhaled beta2-agonist
      (albuterol) at the onset of respiratory tract illness (RTI)-associated symptoms in increasing
      episode-free days among young children with recurrent severe wheezing.
    

Detailed description: 
      Acute Intervention Management Strategies (AIMS) is a randomized, double-blind, double-dummy,
      placebo-controlled parallel comparison study that will compare the effectiveness of three
      treatments, when given at the onset of RTI-associated symptoms, in increasing the proportion
      of symptom-free days over the entire treatment period of the 5- to 9-month study. There will
      be a 2-week period to qualify and characterize participants, who at that time will have no
      lower respiratory tract symptoms other than mild cough. A total of 244 participants will be
      randomized to one of three treatment groups and followed for the remainder of the
      fall-winter-early spring season. Participants will receive one of the following treatment
      regimens for 7 days, at the first sign of RTI-associated symptoms: 1) active ICS plus placebo
      LTRA plus albuterol inhalation treatments four times daily; 2) active LTRA plus placebo ICS
      plus albuterol inhalation treatment four times daily; or 3) placebo ICS plus placebo LTRA
      plus albuterol inhalation treatments four times daily.
    

Intervention name(s): Inhaled Corticosteroid (Budesonide); Leukotriene Receptor Antagonist (Montelukast Sodium); Inhaled Albuterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive inhaled corticosteroid for 7 days, at the first sign of RTI-associated symptoms.; Participants will receive leukotriene receptor antagonist for 7 days, at the first sign of RTI-associated symptoms.; All participants will receive inhaled albuterol treatments four times a day.
Intervention MeSH terms: Budesonide; Albuterol; Montelukast; Leukotriene Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Wheezing; Respiratory Tract Illness
Comparison of Dry Needling and Thera Gun Treatment on Trapezius Muscle Active Trigger Points.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Comparison of dry needling and Thera Gun on treatment of Active trigger points of trapezius
      Muscle, pain threshold and Range of motion of neck.
    

Detailed description: 
      Chronic neck pain related to the myo-facial systems from local muscle fiber contractions
      referred to "myo-facial trigger points" (MTrPs).MTrPs are highly sensitive spots that lie in
      the skeletal muscle, and are diagnosed with mechanical pressure, they can also develop as
      referral pain in a specific pattern. Although MTrPs are found in all muscle groups, they are
      more prevalent in the upper quarter postural muscles, especially the upper trapezius muscle.

      Data will be collected from both gender patients having active trigger points in trapezius
      muscles. Then patients will be divided randomly into two groups. All patient will be given
      conventional treatment and then group A will be given treatment with Thera Gun and group B
      will be given dry needling treatment and then will compare effects of both.

      To date, a wide range of physical therapy interventions have been suggested to address MTrPs
      including manual therapies (massage, stretching, myofascial release), electrotherapy
      modalities (surface heat, ultrasound, Transcutaneous Electrical Nerve Stimulator and laser
      therapy) and invasive techniques such as dry needling (DN) but none of study is done on the
      effectiveness of facial gun in decreasing pain intensity and increasing range of motion and
      none of study compare the effect of Dry needling with facial gun. So, this study will
      determine the effect of facial gun on pain intensity and range of motion and compare that
      effect with dry needling.
    

Intervention name(s): Facial Gun; Dry Needling
Intervention type(s): Other; Other
Intervention description(s): Vibration massage applied for five Minutes directly on the trigger point; For dry needling the outer skin should be clean with alcohol and the taut band should be placed between thumb and index finger. Without damaging any nerve or artery the needle is passed though the muscle into the trigger point and breaking it to relief pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trapezius Trigger Points; Range of motion; Pain threshold; Thera Gun; Dry Needling
Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to
      Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in
      Preparation for Evaluation in Adults with COVID-19
    

Detailed description: 
      This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to
      Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in
      Preparation for Evaluation in Adults with COVID-19

      64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo.
      4 sentinel subjects (one per cohort 1, 2 ,3 and 4 ) will be treated in an open-label manner
      to confirm the safety of each dose sequentially. 40 subjects will be randomly assigned (3:1)
      to either active or placebo. For the last 2 cohorts, a total of 20 healthy volunteers will be
      enrolled to receive multiple doses of UNI911 INHALATION.
    

Intervention name(s): UNI911 inhalation 1% and intranasal spray 1%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Niclosamide is a broad spectrum, host tageting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide 1% solution is administered as inhalation by nebulization and intranasal by a nasal spray.; The placebo formulation contains the vehicle. The solution is administered in the same way as the active drug. Placebo was only administered for cohorts 1-5.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other