bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the improvement in airway inflammation in children with asthma non-invasively with
      exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg
      daily.
    

Detailed description: 
      Comparisons will be made before and after 2 week therapy of nebulized budesonide in children
      not on prior anti-inflammatory medications.
    

Intervention name(s): Nebulized Budesonide; Nitric Oxide Analyzer
Intervention type(s): Drug; Device
Intervention description(s): Pulmicort Respules 0.5mg/2cc; Niox NO analyzer
Other intervention name(s): Pulmicort Respules 0.5mg/2ml nebulized; Niox NO analyzer
Intervention MeSH terms: Budesonide; Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
Condition: Cosmetic Techniques
Study type: Interventional

Summary: 
      The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved
      neuromodulators on facial lines, wrinkles and animation. Participation is available to women
      who have never had a cosmetic procedure above the malar region nor a treatment with a
      neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3
      (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order
      to determine their baseline dimensions. Imaging will be repeated post injection to determine
      change over time.
    

Detailed description: 
      This study is a randomized controlled trial in which patients will be randomly assigned into
      one of four groups: those receiving onabotulinumtoxinA (Botox, Allergan, Irvine, California),
      abobotulinumtoxinA (Dysport, Ispen Biopharmacueticals Inc.Cambridge, MA), incobotulinumtoxinA
      (Xeomin, Raleigh, NC) or prabotulinumtoxinA (Jeuveau, Evolus, Newport Beach, California).
      Each patient will receive FDA approved dosages in which they are assigned in to treat rhytids
      within the glabella, as per FDA approved indications. All injections will be performed by a
      blinded single trained physician according to a preset injection plan per FDA approved
      administration guidelines. Prior to injection patients will be imaged with 3-dimensional
      photogrammetry. All pre-procedure images will be evaluated for absolute strain performing two
      types of facial animation: 1) relaxed, and 2) frowning. Subjects will return Day 3, 30, 90,
      and 180, post intervention for re-imaging with the same expressions. Strain will be
      calculated using the same metrics.
    

Intervention name(s): Onabotulinumtoxina for Injection; Abobotulinumtoxina for Injection; IncobotulinumtoxinA for Injection; PrabotulinumtoxinA for Injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): cosmetic injection into the glabella area (eyebrow area); cosmetic injection into the glabella area (eyebrow area); cosmetic injection into the glabella area (eyebrow area); cosmetic injection into the glabella area (eyebrow area)
Other intervention name(s): Botox; Dysport; Xeomin; Jeuveau
Intervention MeSH terms: Botulinum Toxins, Type A; incobotulinumtoxinA; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial in which patients will be randomly assigned into one of four groups
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: minimally invasive procedures; neurotoxins; cosmetic; Botox; eyebrow area; glabella; Dysport; Jeuveau; Xeomin; forehead; cosmetic injections; facial rejuvenation; wrinkle reduction
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis
Condition: Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a
      5-week dosing period in patients with osteoarthritis.
    


Intervention name(s): Extended-Release Hydrocodone/Acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets BID; 2 tablets BID
Other intervention name(s): ABT-712; hydrocodone/acetaminophen extended release
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain associated with osteoarthritis
Glycemic Response in Adults With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized crossover design with oral nutrition supplement interventions.
    

Detailed description: 
      This will be a randomized crossover design with two oral nutrition supplement interventions.
      The subjects will be randomized to one of two interventions on two separate study days, one
      week apart.
    

Intervention name(s): Balance oral nutritional drink - control; Balance oral nutritional drink - test
Intervention type(s): Other; Other
Intervention description(s): Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.; Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.
Masking: Single (Participant)
Primary purpose: Supportive Care
Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy
Condition: Child; Osteotomy
Study type: Interventional

Summary: 
      The iliac crest is one of the most commonly used bone graft sources, especially in pediatric
      pelvic osteotomy operations for developmental dysplasia of the hip (DDH) and
      Legg-Calve-Perthes disease. In this study, we aimed to identify the effects of inner side and
      two-sided approaches for iliac crest bone harvesting on post-surgery ilium growth in
      children.
    

Detailed description: 
      Autogenous bone grafting is still the gold standard and most effective method for treatment
      of non-union and bone defects due to congenital disease and infection. Despite the
      development of bone engineering, none of the allogeneic bone products can match the
      osteoinductive, osteoconductive, and immunogenic properties of autogenous bone. The iliac
      crest is one of the most harvested sites other than the fibula, ribs, and ulna. An iliac
      crest bone graft (ICBG) can supply a larger amount of cortical and cancellous bone than
      grafts from other donor sites. Pelvic osteotomy is widely used for treating developmental
      dysplasia of the hip (DDH) and Legg-Calve-Perthes disease. Tricortical structural bone such
      as that in the ilium is needed to stabilize the pelvis after osteotomy, and the anterior and
      posterior iliac crest are the two most used graft donor sites. When surgery is planned in the
      prone position, such as that for posterior spinal fusion, surgeons generally prefer to adopt
      the posterior approach for ICBG procedures. In supine position surgeries such as pelvic
      osteotomy for DDH or Legg-Calve-Perthes disease, surgeons prefer the anterior approach for
      ICBG procedures. There are many studies on iliac bone growth and complications after ICBG
      procedures. Most of the studies demonstrated good outcomes and few complications. However,
      according to our literature review, none of the previous studies used the iliac bone for
      transplantation in pelvic osteotomy. In this study, we compared the results between an inner
      table harvest site and an inner-outer table harvest site for ICBG used to maintain stability
      in pelvic osteotomy.
    

Intervention name(s): two-sided approaches for iliac crest bone graft
Intervention type(s): Procedure
Intervention description(s): Only one side of the ilium was exposed when surgery.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pelvic osteotomy; developmental dysplasia of the hip; iliac crest bone graft
Analgecine for Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in
      patients with low back pain for 3 months after surgical treatment. It is a randomized,
      placebo-controlled, double blind, multi-center phase III clinical trial. Patients with
      chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and
      70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are
      divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with
      Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4
      measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required
      to score their pain with pain VAS and to have regular blood, urine, and renal/liver function
      tests. The changes of the pain VAS at day 21 are compared between groups.
    


Intervention name(s): Analgecine; Neurotropin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Analgesic drug under test; Analgesic drug as positive control; Blank tablet as placebo.
Intervention MeSH terms: Neurotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The investigators hypothesize that treatment with non-invasive spinal decompression reduces
      discogenic low back pain (LBP), decreases visual analog pain scale scores, increases
      activities of daily living and decreases medication use.
    


Intervention name(s): DRX9000
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pain Management Clinic
Cannabinoid Modulation of Pain
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to test the effects of cannabinoids on pain response using a
      variety of human experimental pain models.
    


Intervention name(s): Thermal; Electrical; Capsaicin; THC; THC; Placebo
Intervention type(s): Other; Other; Other; Drug; Drug; Drug
Intervention description(s): Thermal sensation/pain testing; Electrical sensation/pain testing; Intradermal Capsaicin; Active THC (0.01 mg/kg) administered over 10 minutes; Active THC (0.03 mg/kg) administered over 10 minutes; Control: small amount of alcohol with no THC, administered over 10 minutes
Other intervention name(s): Delta-9-tetrahydrocannabinol; Delta-9-tetrahydrocannabinol
Intervention MeSH terms: Dronabinol; Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Cannabis; THC; Pain
Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)
Condition: Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the cholesterol lowering safety and effectiveness of
      two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high
      triglycerides).
    

Detailed description: 
      The duration of treatment is 48 weeks.
    

Intervention name(s): MK0653, ezetimibe; Comparator: fenofibrate monotherapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe; Fenofibrate
Primary purpose: Treatment
Keywords: Mixed hyperlipidemia (high cholesterol and high triglycerides)
Biological Aspects of Depression and Antidepressant Drugs
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will be measuring changes in depressive symptoms over a 7 week time period.
      Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or
      Desipramine.
    


Intervention name(s): paroxetine; Desipramine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine; Desipramine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Depression
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising
      doses in healthy Asian male volunteers.
    


Intervention name(s): Placebo; BI 655064
Intervention type(s): Drug; Drug
Intervention description(s): Solution for subcutaneous (s.c.) injection.; Solution for subcutaneous (s.c.) injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oxidation-reduction Homeostasis in Cognitive Impairment Patients After Stroke
Condition: Oxidative-reduction Homeostasis; Post-stroke Cognitive Impairment
MeSH terms: Stroke; Cognitive Dysfunction
Study type: Observational

Summary: 
      Cognitive impairment after ischemic stroke can affect not only the social adaptation ability,
      but also affect the comprehensive rehabilitation of patients. The damage of cognitive
      impairment after ischemic stroke is not lower than the body function defect after stroke.
      Many studies have shown that oxidative stress is one of the pathophysiological mechanisms of
      ischemic cerebrovascular disease. Many studies have reported that the oxidative-reduction of
      cells plays an important role in the life activities of organisms, affecting the health,
      aging and death of the organism. In the recent years, some scholars have suggested that
      post-stroke cognitive impairment may be related to oxidative-reduction homeostasis of the
      body, but the relevant evidence is lacking and needs to be further explored. Therefore, the
      purpose of this study is to explore the effect of oxidation-reduction homeostasis on
      cognitive impairment in patients with ischemic stroke, and provide a theoretical basis for
      the prevention and treatment of cognitive impairment after ischemic stroke.
    


Intervention name(s): No intervention has been conducted
Intervention type(s): Other
Intervention description(s): It is an observational study, and no intervention has been conducted
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.
A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
Condition: Small for Gestational Age Infant
Study type: Interventional
Phase: Phase 2

Summary: 
      To preliminary assess the efficacy and safety of recombinant human growth hormone injection
      on the treatment of small for gestational age (SGA), and determine the best dose.
    


Intervention name(s): Somatropin Injection low dose group; Somatropin Injection high dose group
Intervention type(s): Biological; Biological
Intervention description(s): 0.23mg/kg /wk，inject for seven divided doses; 0.46mg/kg /wk，inject for seven divided dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Renaparin® in Kidney Transplantation
Condition: Delayed Graft Function
MeSH terms: Delayed Graft Function
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and tolerability of Renaparin in adult patients receiving a
      deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the
      patient group will receive a kidney treated with Renaparin, while the other half of the
      patient group will receive a kidney treated with placebo.
    

Detailed description: 
      Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem
      after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in
      patients being put on dialysis in the immediate time-period after transplantation. In the
      longer perspective DGF is associated with increased risk of graft failure, thus decreasing
      the efficacy of the kidney transplantation.

      Renaparin is a new product under development for the prevention of DGF in association with
      kidney transplantation. The product binds to the kidney vascular endothelium and its
      pharmacological effect is based on a local and effective presentation of heparin. Renaparin
      is administered ex vivo to the kidney by adding it to the preservation solution during
      Hypothermic Machine Perfusion (HMP) prior to transplantation.
    

Intervention name(s): Renaparin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation; 50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and
      β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal
      bronchodilation after inhalation dosing via two validated mechanisms in one molecule.

      The study will consist of three parts:

      Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability
      and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366

      Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability
      and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366

      Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single
      dose of CHF6366 in an active and placebo controlled design
    


Intervention name(s): CHF6366; Placebo CHF6366; umeclidinium bromide and vilanterol trifenatate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: CHF6366 (Part 1 - SAD) Single doses of CHF6366 at each period (for up to 3 periods per subject)
Drug: CHF6366 (Part 2 - MAD) Once daily doses of CHF6366 for 7 days
Drug: CHF6366 (Part 3) Single dose of CHF6366; Drug: Placebo (Part 1 - SAD) Single doses of placebo matching CHF6366 at each period (for up to 3 periods per subjects)
Drug: Placebo (Part 2 - MAD) Once daily dose of placebo matching CHF6366 for 7 days
Drug: Placebo (Part 3) Single dose of placebo matching CHF6366; Part 3 Single dose
Intervention MeSH terms: Bromides
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 alternating cross-over design
Part 2 parallel group design
Part 3 3-way cross-over design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intraoperative M-Entropy Measurements
Condition: General Anesthesia
Study type: Observational

Summary: 
      The purpose of this study is to learn more about an Entropy monitor that the anesthesiologist
      will be using.
    

Detailed description: 
      Depth of anesthesia monitors are increasingly used in clinical anesthesia practice.
      Bispectral Index (BIS) and M-Entropy are examples to these devices, both of which are
      available at our institution. Both BIS and M-Entropy use a unilateral, single channel of EEG
      to derive a number indicating the anesthetic depth. These devices have similar disposable
      skin probes that can be applied on either side of the forehead. Since the depth of anesthesia
      for an individual is the same over the whole brain cortex at a given point in time, BIS
      numbers obtained over the left and right side of the forehead should agree. The same should
      be true for M-Entropy as well.

      A recent study, however, showed that two separate BIS probes, applied over the left and right
      forehead of the same patient at the same time, can give significantly different numbers. This
      has not been studied for M-Entropy. BIS and M-Entropy use different mathematical algorithms
      that process the raw EEG signal to compute a numeric value. Therefore, it is possible that
      M-Entropy may show different results in a similar study setup.

      The aim is to investigate the same-patient reproducibility of M-Entropy by monitoring and
      recording Entropy variables over both the left and the right side of the forehead of patients
      under general anesthesia.
    

Intervention name(s): study cases
Intervention type(s): Device
Intervention description(s): Application of a second M-Entropy probe on the forehead of the patient, which will happen in the OR along with the application of other monitors immediately before induction of general anesthesia.
Other intervention name(s): M-entropy module (Datex-Ohmeda S/5 EntropyTM Module)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that are scheduled to have surgery under general anesthesia for which an
        intraoperative M-Entropy monitoring is planned. Suitable candidates will be identified by
        speaking to the attending anesthesiologists working at OU Presbyterian hospital.
      
Keywords: M-Entropy