bioihbjkbjnl/mcl2 huggingface dataset:
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating
      and exhaustion, which may potentially allow many more people with multiple sclerosis to
      participate in and benefit from exercise. The design is double-blind, within-subject, with
      three arms: participants will receive one of three treatments at three separate study visits:
      aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.
    

Detailed description: 
      Persons with multiple sclerosis benefit from exercise, but many avoid it because of
      exhaustion and overheating. This randomized controlled trial (RCT) tests aspirin as a method
      to increase time to exhaustion for persons with MS, through its antipyretic mechanism.
      Participants will be seen at our laboratory for maximal exercise tests on three separate
      days. At each session, they will be given one of three treatments: aspirin, acetaminophen (a
      drug that is anti-inflammatory but not antipyretic, thereby allowing for isolation of the
      antipyretic action of aspirin), and placebo. Primary outcome is increased time to exhaustion,
      secondary outcome is reduced body temperature increase during exercise.
    

Intervention name(s): Aspirin 650mg Oral Capsule; Acetaminophen Tablet 650mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.; A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.; A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Other intervention name(s): Aspirin; Acetaminophen
Intervention MeSH terms: Aspirin; Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; aspirin; cooling; antipyretic
Locomotion Strategies of Low Back Pain Patients
Condition: Chronic Low-back Pain; Walking
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The biomechanical parameters studied in non-specific chronic low back pain patients in a
      locomotion task have so far focused on straight line walking. Although locomotion is
      primarily an automated action composed of repetitive patterns allowing movement from one
      place to another, walkers must respond to the environmental demands.These modifications show
      a flexible and adaptive approach to the constraints of the environment. In this study, we are
      particularly interested in a task of passage through a horizontal opening, similar to a
      doorway, which is a standardized task that has shown its interest in the study of
      perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and
      functional abilities of individuals, reflecting their action capacities.
    


Intervention name(s): Quantified analysis of walking during a task of passage through a horizontal opening
Intervention type(s): Other
Intervention description(s): Functional test that reproduce a task of daily living, similar to a doorway
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        NSCLBP patients who do their medical follow-up in medical center in France
      
Keywords: Low Back Pain; Psychomotor Performance / physiology; Walking / physiology*; Adult; Humans; Motion Perception / physiology*
Reducing Distress in Phase 1 Trial Caregivers: The P1-CaLL Study
Condition: Caregiver Distress
Study type: Interventional

Summary: 
      This study seeks to decrease distress in the lives of the caregivers who are helping cancer
      patients who have entered a phase 1 clinical trial.
    

Detailed description: 
      This study seeks to decrease distress in the lives of the caregivers who are helping cancer
      patients who have entered a phase 1 clinical trial. The P1-CaLL study uses a psychosocial
      intervention aimed at decreasing distress through the utilization of adaptive coping
      strategies (e.g., meditation, emotion-focused coping) and cognitive behavioral techniques.
      Caregivers will receive 4 weeks of stress-management sessions (over the phone). Then, they
      will be randomized to receive 4 more weekly sessions of either Cognitive Behavioral Therapy
      or Metta-Meditation (over the phone). Participants will receive tasks to complete each week.
    

Intervention name(s): Stress Management and CBT; Stress Management and Metta-Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stress Management will focus on:
Mind-Body Connection
Coping Skills
Communication
Social Support
Cognitive Behavioral Therapy will focus on:
Intro to CBT-Tracking Automatic Thoughts
Identifying Distorted Thoughts
Challenging Distorted Thoughts
Core Beliefs/Relapse Prevention; Stress Management will focus on:
Mind-Body Connection
Coping Skills
Communication
Social Support
Metta-Meditation will focus on:
Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk
Intro to Brief Loving-Kindness Meditation and Self-Care
Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism
Review/Plan for Future
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Depression; Cognitive Behavioral Therapy; Coping; Meditation; Anxiety
Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects
Condition: Obesity
MeSH terms: Overweight; Body Weight Changes
Study type: Interventional

Summary: 
      Regular breakfast consumption may help lower body weight reduce body fatness and improve
      cardiovascular disease risk factors. However, the best kind of breakfast to consume to
      achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress
      appetite, lower body weight and improve cardiovascular disease risk factors compared with a
      no-fiber breakfast.
    

Detailed description: 
      Participants will report to the hospital cafeteria between 0800 and 0900h following an
      overnight fast every weekday for 4 consecutive weeks. On arrival, participants will be
      provided will the allocated breakfast and will be given 15 min to consume all the foods
      provided. The oatmeal breakfast will consist of 80g dry oatmeal (Quaker Quick Oats) prepared
      with 120mL fat-free milk and 230mL water. The frosted flakes breakfast will consist of 62g
      frosted flakes and 160mL whole milk and 190mL water served on the side. The No-breakfast
      (control) will consist of only 350mL plain water. All participants will also receive 200mL
      decaffeinated coffee with 12mL non-dairy creamer and 1g packet of non-caloric sweetener. On
      Friday of each week participants will be provided with two portions of the breakfasts to take
      home at consume on the weekend days. On the first day of the intervention and weekly
      thereafter participants will complete 3hr subjective appetite ratings responses to the
      breakfast. Laboratory assessments including body weight, composition, blood pressure and a
      fasting blood sample will be collected before the start of the intervention and at the end of
      the intervention.
    

Intervention name(s): Oatmeal; Frosted Flakes; No Breakfast
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A breakfast consisting of oatmeal; A breakfast consisting of Frosted Flakes and milk; A breakfast consisting of plain water
Other intervention name(s): Quaker Quick Oats; Kelloggs Frosted Flakes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: breakfast; oatmeal; appetite; cholesterol
The Effect of Pure Prone Positioning Therapy for the Patients With Mild to Moderate Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Efficacy of Pure Prone Positioning (PPP) treatment in improving apnea-hypopnea index (AHI)
      and nocturnal oxygen saturation was investigated in mild to moderate Obstructive Sleep Apnea.
    

Detailed description: 
      Sleeping in prone position could be effective in the management of obstructive sleep apnea
      (OSA) by reducing the gravity effect on the upper airway and hence collapsibility. Pure prone
      positioning (PPP) consisted of a pillow mounted on a table designed to keep the subjects
      sleeping prone with the head extended in line with the body.
    

Intervention name(s): Pure prone positioning
Intervention type(s): Device
Intervention description(s): Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.
Other intervention name(s): Positional treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Prone positioning; Positional Treatment; Hypoxemia
Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to establish the therapeutic equivalence between the test
      (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference
      formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the
      Fluticasone/Salmeterol combination.

      The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover
      fashion.
    

Detailed description: 
      In case of inhaled products, it is not possible to follow the classic scheme, based on
      similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.

      For this reason, a pharmacodynamic study was designed in order to assess the therapeutic
      equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The
      test and reference Fluticasone/Salmeterol formulations will be compared in terms of their
      bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be
      the primary efficacy measure and will be measured in such a way that a similar time-dependent
      increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol
      formulations in patients with asthma. In terms of safety comparison, repeated measurements of
      adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG
      changes will enable the establishment of the similar safety profile of the test and reference
      Fluticasone/Salmeterol combinations.
    

Intervention name(s): Elpenhaler active - Diskus placebo
Intervention type(s): Drug
Intervention description(s): randomized, double-blind, double-dummy, 2-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol (500/50 μg) combination administered with Elpenhaler® (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.
Condition: Dilatation of Cranial Arteries; MMA, STA and MCA; Headache
MeSH terms: Headache; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim
      or placebo (isotonic saline) for 20 min.

      The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA
      circumference over several hours using a high resolution MRA technique in a randomized,
      double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized
      that levcromakalim induces dilatation of cranial arteries.
    

Detailed description: 
      Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim
      or placebo (isotonic saline) for 20 min.

      The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA
      circumference over several hours using a high resolution MRA technique in a randomized,
      double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized
      that levcromakalim induces dilatation of cranial arteries.

      MR imaging will be performed on a 3.0 Tesla Philips Achieva Scanner (Philips Medical Systems,
      Best, The Netherlands) using an eight-element phased-array receiver head coil. We will obtain
      repeated MRA measurements covering the MMA and MCA before and after levcromakalim/placebo
      infusion
    

Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.; Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind placebo-controlled study with healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      This study is to analyze the relationship between brain structure, the heart rate variability
      and the serum fatty acid component of the irritable bowel syndrome patients.
    

Detailed description: 
      Several studies showed that the gray matter and white matter of the brain related to the
      symptoms of irritable bowel syndrome patients.

      The investigators study is to analyse the relationship between thickness of cortex of
      irritable patients, the sympathetic tone and the serum fatty acid component of the irritable
      bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether
      the symptoms of irritable bowel syndrome are related to the thickness of cortex or
      inflammation status of the body.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Irritable bowel syndrome patients, Control
      
Biospecimen description: 
      Serum
    
Keywords: MRI; Heart rate variability; Fatty acid
The Safety and Tolerability of Engensis (VM202) in Patients With Charcot-Marie-Tooth Disease Subtype 1A (CMT1A)
Condition: CMT
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To assess the safety and tolerability of the investigational product (VM202) injected in the
      weakened lower limb muscles of CMT1A patients
    

Detailed description: 
      There are no therapeutic agents for CMT to date. Attempts were made to develop therapeutic
      agents, but efficacy could not be demonstrated in clinical studies. Most of the attempted
      developments for therapeutic agents targeted alleviating the symptoms of CMT1A by regulating
      the expression of PMP22. This study will use Engensis (VM202), which is a DNA plasmid that
      contains novel genomic cDNA hybrid human HGF coding sequence (HGF-X7) expressing two isoforms
      of HGF, HGF 728 and HGF 723. HGF has been thought of as an angiogenic factor, but it has been
      recently identified as serving the role of a neurotrophic factor. Moreover, it has been
      reported that it can contribute to muscle tissue regeneration by targeting on muscles.
      Considering the pathologic mechanism of CMT, the biological activity of HGF helps peripheral
      nerve regeneration, relieves muscle atrophy, and reduces pain, so it is highly likely to show
      a therapeutic effect for CMT.
    

Intervention name(s): Engensis (VM202)
Intervention type(s): Biological
Intervention description(s): Intramuscular injections
Intervention model: Single Group Assignment
Intervention model description: Single center, repeat dose, open label, phase I/IIA clinical study
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
Condition: Ultrasound; CT Scans; MRIs
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric
      population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS)
      for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.
    

Detailed description: 
      This study was designed to evaluate the safety of a continuous infusion of dexmedetomidine (1
      mcg/kg loading dose with 0.6 mcg/kg/hr initial maintenance dose and titrated between 0.2-1.0
      mcg/kg/hr) administered to subjects requiring non-intubated, spontaneous breathing, moderate
      to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures that are expected
      to take more than 30 minutes.
    

Intervention name(s): Dexmedetomidine; Midazolam; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1 - 1.0 mcg/kg/hr IV; 0.025 - 2 mg/kg IV; 0.5 - 3 mcg/kg IV
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Videolaryngoscope and Direct Laryngoscope in IOP Changes, Throat Pain, IT and Hemodynamic Variables
Condition: Intraocular Pressure; Intubation;Difficult
Study type: Interventional

Summary: 
      The aim of the study was to compare intraocular pressure, intubation time, throat pain and
      hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring
      endotracheal intubation
    

Detailed description: 
      INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the
      difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013
      (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases
      of difficult airway, glottic visualisation is obtained more easily and less airway trauma is
      seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3,
      and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a
      camera which is connected to a video screen monitor. In addition to passing soft tissues by
      visualisation, the camera is helpful in defining the glottic appearance (1).

      There are studies which have compared the hemodynamic response and increase in IOP in
      intubation using direct laryngoscope and various videolaryngoscopes and airway devices .
      However, to the best of our knowledge there is no study comparing the effect on the increase
      in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to
      compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the
      direct laryngoscope.
    

Intervention name(s): direct laryngoscope; videolaryngoscope
Intervention type(s): Procedure; Procedure
Intervention description(s): procedure entubatıon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: videolaryngoscope; intraocular pressure; Direct laryngoscope
The Poweroff Sleep Study
Condition: Sleep
Study type: Interventional

Summary: 
      The primary objective is to explore the relationship between experimental condition (placebo
      or PowerOff) and sleep quality between pre-study and post-study. In addition, volunteers will
      wear actigraphy watches that collect objective measures of sleep, such as total sleep time,
      and these data points will be compared pre- and post-study.
    


Intervention name(s): Placebo Capsule; POWEROFF Capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Composition of the placebo is 100% organic rice flour, manufactured at a facility New York State licensed to produce pharmaceuticals. Capsules will be instructed to commence on day 7 of the study after baseline appointment.; blend of California Poppy Aerial Part Extract, L-Cystine, L-Theanine,GABA (proprietary Phosphatidylcholine-Palmitic Acid-Oleic Acid Complex), 5-HTP, Magnolia Officinalis Bark Extract, Glycine, Melatonin with 0.5mg of Vitamin B6 (as pyridoxal-5-phosphate).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention