bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Compumedics "Somfit" Device
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      To study whether Somfit is substantially equivalent to an existing approved device (i.e.
      Compumedic's Grael System) to assist in elucidating sleep disorders.
    

Detailed description: 
      Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and
      sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of
      chronic health conditions. Given the importance of good quality sleep and its critical role
      in overall well-being, there is a need for regular monitoring and assessment of sleep quality
      in individuals. However, current technologies will only allow for this to be performed in
      sleep clinics and with the help of full polysomnography (PSG) systems which require the
      patients to spend a night at the clinic with several wired electrodes connected to their
      scalp. This will cause discomfort for the patients in a long run. To solve this problem,
      Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring
      system with code name of "Somfit" which can be used in the comfort of patients' home. The aim
      of this study is to validate Somfit for home based sleep studies.
    

Intervention name(s): Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
Intervention type(s): Device
Intervention description(s): Data were recorded overnight by both devices simultaneously
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        30 volunteers were invited to participate in this study. 15 participants will be selected
        among healthy volunteers, by advertising to the general public. The remaining 15 will be
        among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their
        routine treatment.
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily
      (based on change in HbA1c from baseline to 24 weeks) when administered in combination with
      mealtime insulin lispro.
    

Detailed description: 
      This trial is a multicenter, open-label, randomized, parallel-group trial in patients with
      Type 1 Diabetes Mellitus (T1DM) comparing the efficacy and safety of Mylan's insulin glargine
      with that of Lantus®.
    

Intervention name(s): Mylan's insulin glargine; Lantus®
Intervention type(s): Drug; Drug
Intervention description(s): All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.; All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selegiline Patch for Treatment of Nicotine Dependence
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of
      this study is examine whether selegiline, given in the form of a skin patch, is effective in
      stopping smoking.
    

Detailed description: 
      Most smokers relapse following smoking cessation treatment. More effective smoking cessation
      therapies are needed to prevent the high rates of relapse. Selegiline is a selective
      inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with
      levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA)
      levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used
      as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic
      transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has
      interesting implications for the treatment of nicotine dependence because brain DA systems
      may play a key role in the mediation of reward learning behavior. Previous research suggests
      that the brains of living smokers show a 40% decrease in the level of MAO B relative to
      nonsmokers or former smokers. The purpose of this study is examine whether selegiline,
      administered in the form of a skin patch, is effective for smoking cessation.

      Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline
      patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8
      weeks. Participants will be stratified by gender to evaluate the role that gender plays in
      moderating smoking cessation treatment. Study visits will take place once each week for 30 to
      45 minutes, and will include adverse events monitoring, biochemical verification of smoking
      status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine
      response to treatment.
    

Intervention name(s): Selegiline; matching placebo
Intervention type(s): Drug; Other
Intervention description(s): 6mg/24 hrs for 8 weeks; placebo/24hrs for 8 weeks
Other intervention name(s): EMSAM; Placebo
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin D Supplementation in Wheelchair Indoor Athletes
Condition: Vitamin D Deficiency; Spinal Cord Injury; Drug Effects; Dietary Supplements; Physical Education and Training/Methods
MeSH terms: Spinal Cord Injuries; Vitamin D Deficiency
Study type: Interventional

Summary: 
      There is a high prevalence of vitamin D deficiency in Switzerland. In indoor-athletes as well
      as wheelchair users, vitamin D deficiency occurs even more often. It is well established that
      vitamin D deficiency has a negative effect on health. However, vitamin D supplementation in
      individuals with a vitamin D deficiency has a positive effect on muscle performance. In
      recently published studies with able-bodied subjects, it has been shown that a normal vitamin
      D level (>75nmol/L) can only be achieved with a high-dose supplementation of vitamin D.

      The aim of this study is to examine the effect of vitamin D supplementation on exercise
      performance in wheelchair athletes with vitamin D deficiency . All participants with a
      vitamin D deficiency are assigned to the intervention group and treated with 6000 IU of
      vitamin D3 daily over a period of 12 weeks. All participants who have a normal vitamin D
      level will receive placebo treatment (control group). The physical performance is measured
      three times at baseline, after six weeks and 12 weeks. The measurements include a Wingate and
      a dynamometer test.
    


Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.; alcohol-based solution 1.3ml daily over a period of 12 weeks.
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vitamin D; Exercise Performance; Wheelchair Athletes; Indoor sports; Wingate; Isokinetic Dynamometer
Pharmacokinetics of Misoprostol With Titrated Oral Administration
Condition: Hypotonic; Labor
Study type: Interventional
Phase: Phase 1

Summary: 
      The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral
      misoprostol.
    

Detailed description: 
      The primary outcomes measures of the study are the area under the curve of serum
      concentration of misoprostol acid against time up to 240, 360 and 480 minutes.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): 20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
Other intervention name(s): cytotec
Intervention MeSH terms: Misoprostol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: misoprostol, pharmacokinetics
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Condition: Intercritical Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if once-daily treatment with colchicine, compared
      to placebo, is effective in preventing gout flares in patients who are initiating therapy
      with allopurinol.
    


Intervention name(s): Colchicine (Colcrys®); placebo; allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily 0.6 mg colchicine dosing for 16 weeks; daily placebo dosing for 16 weeks; background therapy
Intervention MeSH terms: Colchicine; Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gout
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Condition: Spinal Cord Injury; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Normally, nerve fibers carry electrical impulses through the spinal cord, providing
      communication between the brain and the arms and legs. In people with spinal cord injury,
      some fibers may be destroyed at the site of injury, while others remain connected but do not
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as
      bladder control, bowel function and sexual function. The study will also examine the possible
      risks of taking Fampridine-SR.
    


Intervention name(s): Fampridine-SR; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 25mg bid (twice daily); Placebo
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: spinal cord injury; muscle spasticity
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
Condition: Estrogen Replacement Therapy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the bioavailabity of three new investigational combination
      formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
      formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in
      women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe
      dryness, itching, and burning, in and around the vagina; and to help reduce your chances of
      getting osteoporosis (thin weak bones). The purpose of this study is to determine if these
      new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as
      Prempro in healthy postmenopausal women.
    


Intervention name(s): conjugated estrogens/progestin (MPA)
Intervention type(s): Drug
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP); Progestins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Straumann Bone Ceramic Versus BioOss in Sinus Elevation
Condition: Jaw, Edentulous, Partially; Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss; Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is
      a need for bone augmentation in the posterior upper jaw. 9 months later the bone formation is
      evaluated. The patients are followed for 3 years.The study hypothesis is that the SBC is not
      worse than BioOss.
    

Detailed description: 
      Straumann Bone Ceramic (SBC) and BioOss will be used as bone grafting materials when there is
      a need for bone augmentation in the posterior upper jaw. The bone grafting materials will be
      placed into the sinus cavity,(a routine procedure), one material randomly at each side and a
      micro-implant will be inserted simultaneously. 9 months later the micro-implant is removed
      and a regular Straumann SLActive implant is inserted. The micro-implant is evaluated
      histologically. The site is evaluated every 12 months for 3 years in regards to clinical
      measurements. The study hypothesis is that the SBC is not worse than BioOss.

      Study design: Prospective, randomized, open, controlled, single center, split mouth

      Study population: 11 male and female patients at an age of between 18 and 80 years, affected
      by edentulism of both lateral-posterior maxilla and presenting two pneumatized maxillary
      sinuses and necessitating rehabilitation with implant-supported prostheses will be recruited
      in the study and treated by means of maxillary sinus floor augmentation and delayed implant
      placement.
    

Intervention name(s): Straumann Bone Ceramic; BioOss
Intervention type(s): Device; Device
Intervention description(s): Granules applied once during surgery; Granules that are applied once during surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone grafting; sinus elevation; sinus augmentation
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to test whether or not the rate and extent of absorption of oxycodone
      from a proprietary controlled-release formulation is significantly affected by
      co-administration of alcohol compared with controlled conditions (when the formulation is
      administered with water). The primary pharmacokinetic parameters are the peak concentration
      of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area
      under the plasma concentration-time curve (AUC).
    


Intervention name(s): Test formulation administered with water; Test formulation administered with 20% ethanol; Test formulation administered with 40% ethanol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of 20 mg of test formulation with 240 mL of water; single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water; single dose of 20 mg of test formulation with 240 mL of 40% ethanol
Other intervention name(s): ALO-02 20 mg; ALO-02 20 mg; ALO-02 20 mg
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; oxycodone; ethanol interaction; healthy volunteers
Coronary Sinus Pressure and Microvascular Disease
Condition: Microvascular Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      MACCHUS is a randomized, single-center, controlled, cross-over interventional study in which
      coronary artery resistances will be measured at baseline and during temporary occlusion of
      the coronary sinus.
    

Detailed description: 
      The aim of this study is to test whether an increase in coronary sinus pressure leads to a
      change in coronary microvascular resistances in patients with angina pectoris and with an
      indication to measurement of microvascular function as per clinical guidelines.

      All patients with a clinical indication for the assessment of microvascular function will be
      invited to participate and will sign the informed consent at least 24 hours before the study.
      Patients with an index of microvascular resistances >25 (i.e. evidence of microvascular
      dysfunction) will undergo study-specific procedures in the same session (i.e. no additional
      invasive procedure is required for the study).

      Study-specific procedures include the repetition of the assessment of microvascular
      resistances at rest and during coronary sinus occlusion. Coronary sinus occlusion will be
      achieved by inflating a balloon sized to ~70% of the diameter of the coronary sinus. Since
      the implantation of a coronary sinus reducer is a therapeutic option for this type of
      patients, also this procedure (inflation of an undersized balloon in the coronary sinus)
      provides clinically relevant information (sizing of the vessel, effect on microvascular
      resistances and feasibility of the intervention).

      The primary goal of the study is to study the effect of coronary sinus occlusion on
      microvascular resistances at rest and during hyperemia.
    

Intervention name(s): Swan-Ganz catheter placed in the coronary sinus - deflated; Swan-Ganz catheter placed in the coronary sinus - inflated
Intervention type(s): Device; Device
Intervention description(s): A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be kept deflated during sham intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.; A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be inflated to obtain coronary sinus occlusion during the active intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a single-center, cross-over randomized trial to investigate the effect of coronary sinus occlusion on microvascular resistances.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Sonoelastography to Predict Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      Large-to-massive rotator cuff tears accounts for 30% of all rotator cuff tears. These
      problems can be solved by surgeries, but only part of them can be completely repaired. The
      prognosis for partial repair is worse than complete repair, so evaluating the possibility of
      complete repair is so important that it will affect the decision of treatment. More and more
      recent researches focused on using magnetic resonance imaging (MRI) for evaluation of fatty
      infiltration of rotator cuff muscles to predict the reparability of large-to-massive rotator
      cuff tears. However, the availability of MRI is not that good as ultrasound, so some
      researchers are starting to use ultrasound to predict the reparability of large-to-massive
      rotator cuff tears. Because it is hard to observe the tissue quality through the general
      ultrasound, many researchers use sonoelastography to evaluate the tissue elasticity and
      viability. This aim of this study is to:

        1. check the reliability of sonoelastography.

        2. associate the findings of sonoelastography to the results of MRI.

        3. build a predictive model for the reparability of large-to-massive rotator cuff tears.
    


Intervention name(s): Sonoelastography
Intervention type(s): Diagnostic Test
Intervention description(s): This diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly. Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography and the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity at the center point of each quadrant.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigator will enroll participants with diagnosis of large-to-massive rotator cuff
        tears who will receive surgical repairs later, and sonoelastography and MRI are necessary
        for preoperative evaluation.
      
Keywords: large-to-massive rotator cuff tears; reparability; sonoelastography; magnetic resonance imaging