bioihbjkbjnl/mcl2 huggingface dataset:
Rapid Maxillary Expansion for Residual Pediatric
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical
      Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after
      adenotonsillectomy.
    

Detailed description: 
      Cure rate of pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment
      adenotonsillectomy is 50-80%. Treatment alternatives are scarce, poorly effective and based
      upon low scientific evidence. This means one out of five patients will remain exposed to the
      well-known neurocognitive, behavioral and quality of life adverse effects of disease.

      Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion,
      has recently shown promising results in the treatment of pediatric OSAS based upon its effect
      on craniofacial and upper airway growth, usually limited in these patients.

      The investigators propose a randomized, prospective, controlled trial in patients with
      Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the
      treatment success rate avoiding morbimortality associated to disease persistence during
      childhood and development during adult life.
    

Intervention name(s): Standard clinical practice; Standard clinical practice + Rapid Maxillary Expansion
Intervention type(s): Procedure; Device
Intervention description(s): Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.; Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children´s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Anatomical and Functional Macular Changes in Retinal Detachment
Condition: Rhegmatogenous Retinal Detachment
MeSH terms: Retinal Detachment; Dissociative Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the correlation between morphologic changes in the
      outer retina and visual function after successful repair of rhegmatogenous retinal detachment
      with macula off.
    


Intervention name(s): Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)
Intervention type(s): Device
Intervention description(s): Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with successful repair of rhegmatogenous retinal detachment after macula off and
        minimum 6 month follow-up after surgery
      
Keywords: Retina; Rhegmatogenous retinal detachment; Macular detachment; Spectral domain OCT; Microperimetry
Neural Functioning Underlying Anxiety and Its Treatment (The INSULA Study)
Condition: Generalized Anxiety Disorder; Panic Disorder; Anxiety Disorders
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional

Summary: 
      This study will examine the effects of cognitive behavioral therapy on brain function in
      people with anxiety disorders.
    

Detailed description: 
      Anxiety disorders are characterized by excessive and irrational fears of common situations
      that impair normal functioning. Neuroimaging allows researchers to examine brain functioning
      as people are presented with tasks that provoke or model anxiety. Neuroimaging research
      suggests that anxiety is moderated by a neural circuit involving three parts of the brain:
      the amygdala, the insula, and the prefrontal cortex (PFC). Increased activation of the
      amygdala and insula is associated with high anxiety, although activation of the PFC is
      thought to reduce anxiety. Cognitive behavioral therapy (CBT) is the only type of
      psychotherapy with strong evidence for effectively treating panic disorder (PD) and
      generalized anxiety disorder (GAD), but it only works about half the time. This study will
      use neuroimaging to examine when and how CBT affects brain functioning in people with PD and
      GAD. The long-term goals of the research are to develop neuroimaging as a diagnostic tool, to
      use neuroimaging to predict treatment response, and to understand which changes in brain
      functioning are related to successful treatment.

      Participation in this study will last approximately 3 months. Four groups of participants
      will be recruited: healthy controls and people with PD, GAD, or social phobia (SP). All
      participants will undergo functional magnetic resonance imaging (fMRI) scanning-a measure of
      brain functioning-at the first visit. During the fMRI scan, participants will be asked to
      perform computerized tasks that involve responding to images. This will be the only visit
      that the healthy controls and people with SP complete; their inclusion in the study
      establishes a comparison point for the brain scans of the other participants. People with PD
      and GAD will then be asked to complete 10 sessions of CBT over a 10- to 14-week period. After
      3 months, these participants will again undergo fMRI scanning. At 3 and 6 months after the
      completion of CBT, these participants will be asked to complete follow-up questionnaires
      about their anxiety.
    

Intervention name(s): Cognitive behavioral therapy for anxiety
Intervention type(s): Behavioral
Intervention description(s): 10 sessions delivered over the course of 14 weeks and aimed at reducing pathological behaviors and patterns of thought
Other intervention name(s): CBT; Behavior Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognitive Behavioral Therapy; Functional Brain Imaging; Psychotherapy; Treatment; Brain Imaging
AT278 and NovoRapid® in Glucose Clamp Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross
      over study in a glucose clamp setting. The study compares the pharmacodynamic,
      pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with
      type 1 diabetes.
    


Intervention name(s): AT278; NovoRapid
Intervention type(s): Drug; Drug
Intervention description(s): Concentrated rapid acting insulin aspart; Rapid acting insulin aspart
Other intervention name(s): NovoLog
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients
Condition: Pediatric Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in
      pediatric cancer patients undergoing open nephrectomy
    

Detailed description: 
      -  Sixty patients will be included in this prospective randomized study. The patients will
           be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group
           (group T, n =30).

        -  All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be
           performed to group erector spinae plane block
    

Intervention name(s): Bupivacaine Hydrochloride; Tramadol hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): The patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the L3 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. then injecte bupivacaine hydrochloride; Patients in group Tramadol will intravenously administrate dose of 1 mg/kg/8hr tramal to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic
Other intervention name(s): erector spinae block; opioid group
Intervention MeSH terms: Tramadol; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
Condition: Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of
      famitinib malate in healthy adult subjects.

      The secondary objective is to evaluate the safety after famitinib malate alone or combined
      administration with omeprazole in healthy adult subjects.
    


Intervention name(s): famitinib、omeprazole
Intervention type(s): Drug
Intervention description(s): famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15.
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Intervention model description: This is a single-arm, open-label and fixed-sequence drug interaction study.
Masking: None (Open Label)
Primary purpose: Basic Science
Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation
      following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.

      II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following
      CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna,
      antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow
      transplantation.

      Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG
      receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients
      are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate.

      All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.
    

Intervention name(s): anti-thymocyte globulin; cyclophosphamide; cyclosporine; mesna; methotrexate; methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Methylprednisolone; Cyclophosphamide; Methotrexate; Cyclosporins; Antilymphocyte Serum
Primary purpose: Treatment
Keywords: aplastic anemia; hematologic disorders; rare disease
Effects of Posterior Parietal Cortex and Cerebellum Anodal tDCS on Ankle Tracking Visuomotor Adaptation
Condition: Transcranial Direct Current Stimulation
Study type: Interventional

Summary: 
      Motor adaptation is guided by state estimation, a dynamic prediction of the interaction
      consequences between body and environment in the sensorimotor system. Previous studies have
      shown that the posterior parietal cortex (PPC) and cerebellum are potential candidates for
      state estimators. However, neither direct evidence linking neural substrates of state
      estimation and motor adaptation nor the differences in state estimation in these two brain
      areas was presented. A comparison of neuromodulation effects over PPC and cerebellum in motor
      adaptation tasks could provide direct evidence to solve the knowledge gap.

      Objective: This study aims to provide direct evidence to link state estimation and motor
      adaptation, and the neuromodulation effects of PPC and cerebellum in motor adaptation by
      using anodal transcranial direct current stimulation.
    

Detailed description: 
      This was a single-blind, sham-controlled study. All participants were randomized to the PPC,
      cerebellum, and sham stimulation group. The ankle tracking system was used to record the
      ankle tracking visuomotor task during the motor learning phase, motor adaptation phase, and
      motor re-adaptation phase. Normalized root-mean squared error (RMSE) and RMSE reduction rate
      were measured as the performance outcome. A 20-minute atDCS at 2 mA anodal tDCS was given
      during the motor adaptation phase. The immediate effect and after effect of tDCS were seen in
      the motor adaptation phase and motor re-adaptation phase, respectively.
    

Intervention name(s): Transcranial direct current stimulation (Anodal); Transcranial direct current stimulation (Sham)
Intervention type(s): Device; Device
Intervention description(s): 20-minutes, 2 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes; 20-minutes, 0 mA anodal tDCS delivering through two 5 cm x 7 cm electrodes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Transcranial Direct Current Stimulation
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics
Condition: Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on
      the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.
    


Intervention name(s): Simvastatin/PF-03882845
Intervention type(s): Drug
Intervention description(s): Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DDI; pharmacokinetics
Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to
      subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who
      identify themselves as heavy digital devices users (at least 6 hours of digital device use
      per day).
    


Intervention name(s): Verofilcon A contact lenses
Intervention type(s): Device
Intervention description(s): Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
Other intervention name(s): Precision1™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EXercise Training for Reducing Anxiety in First-Time Inmates
Condition: Anxiety State
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at
      evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time
      prisoners with elevated anxiety symtpoms
    


Intervention name(s): exercise training
Intervention type(s): Behavioral
Intervention description(s): 6 weeks of physical exercise training. 3 sessions per week. Session duration : 40 minutes. Self-regulated exercise intensity using Borg's ratings of perceived exertion (RPE)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the persistence of bactericidal antibodies
      in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study
      (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate
      Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay
      (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In
      addition the response one month post an additional dose of Novartis MenACWY will be measured
      by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
    


Intervention name(s): MenACWY-CRM
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Toddlers; Children; Persistence; Boost
PEMF: an Adjunct Therapy for Anterior Uveitis
Condition: Anterior Uveitis; Iritis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis; Iritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a medical device (ActiPatch) that emits a low
      frequency pulsed electromagnetic field (PEMF) will benefit patients with anterior uveitis.
      Anterior uveitis (aka iritis) is an inflammatory disease involving the front segment of the
      eye. This is a common cause of a painful red eye, and ActiPatch has been shown to be
      effective in treating tissue inflammation. The conventional treatment of iritis typically
      involves frequent administration of topical steroids which have their own inherent risks
      (development of cataracts and/or glaucoma). The purpose of this study is to determine if
      ActiPatch therapy can be used to shorten the length of time and/or quantity of steroids
      administered.
    

Detailed description: 
      Iritis is an inflammatory disease focused in the anterior chamber of the eye. The
      inflammation inside the eye can lead to a number of conditions that ultimately effect vision.
      These can include glaucoma, posterior synechiae, cystoid macular edema, and cataract. The
      standard treatment for the disease is drug therapy centered around the administration of
      corticosteroids. These are administered in the form of eye drops, and if necessary
      periocular/intraocular injections, or/and by systemic oral/IV administration. Unfortunately,
      the treatment with corticosteroids can similarly induce severe side effects including
      glaucoma and cataract formation. ActiPatch is a medical device that emits a low frequency
      pulsed electromagnetic field. This device has been shown to reduce inflammation and pain in a
      number of conditions, eg blepharoplasty (eyelid surgery). ActiPatch is FDA approved for use
      after blepharoplasty to reduce swelling, inflammation and pain. The treatment is not
      invasive, does not require additional medication, and side effects from ActiPatch and other
      PEMF devices have not been reported. The potential benefit of treating uveitis with ActiPatch
      is the potential to reduce the time and/or amount of steroid administration. This would
      benefit patients by reducing the risk of unwanted side effects of the corticosteroid
      treatment.

      The benefit to society would be an improved treatment for anterior uveitis.
    

Intervention name(s): PEMF; PEMF Placebo
Intervention type(s): Device; Device
Intervention description(s): ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.; Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: PEMF; iritis; anterior uveitis
An Evaluation of the Energy Expenditure From Wii Fit Games
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      The purpose of this study is to provide energy expenditure data on Wii Fit / Wii Fit Plus
      games as compared with resting and treadmill walking/running.
    

Detailed description: 
      Increasing physical activity and, consequently, increasing energy expenditure and reducing
      obesity are among the highest public health priorities in the U.S. because physical
      inactivity negatively affects a wide variety of medical conditions (e.g., metabolic
      syndromes, cardiovascular disease). Research has shown that a major contributor to physical
      inactivity is the sedentary behavior induced by increased use of computer and video games.
      However, some of the newer generations of game consoles such as the Nintendo Wii market their
      product for its physical activity promoting features. Nintendo's recent release of Wii Fit /
      Wii Fit Plus uses a balance board and is the first game in which whole-body movements closely
      mirror that of the actual activity. As the use of these gaming systems may be more enjoyable
      modes of promoting physical activity than the traditional treadmill exercise, respondents may
      in turn exercise more regularly and for longer periods of time. To the best of the
      investigators' knowledge, no studies exist that demonstrate the energy expenditure of the Wii
      Fit / Wii Fit Plus among adults, or the Wii Fit / Wii Fit Plus compared to other forms of
      aerobic exercise such as walking and running. This study will provide preliminary data for
      future external grant applications comparing the energy expenditure of different physical
      activity conditions employing cutting-edge interactive physical activity promoting technology
      among adults. The potential contributions of the Wii Fit / Wii Fit Plus to promote healthy
      behaviors by being an alternative form of physical activity may be particularly informative
      for people who are unable to meet the national public health recommendations due to personal,
      health, safety or environmental concerns.
    

Intervention name(s): Wii Fit
Intervention type(s): Device
Intervention description(s): This is a randomized, crossover study to evaluate the energy expenditure associated with Wii Fit games. After the baseline resting energy expenditure assessment, each participant complete the following physical activities on separate days in a random order, (1) 30-minute Wii Fit Aerobics Free Run, (2) 3 bouts of Wii Fit Aerobics (Advanced Step, Super Hula Hoop, and Rhythm Boxing in a random order) each lasting 10 minutes, and (3) 30-minute treadmill running/walking.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: video games; energy expenditure; physical activity; exercise physiology