bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)
Condition: Glucose Transporter Type 1 Deficiency Syndrome; GLUT1 Deficiency Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine if an alternative energy source will impact brain
      metabolism in a disorder characterized by glucose metabolism failure in the brain.

      The central hypothesis tested in this investigation is whether circumventing impaired glucose
      metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors
      through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC)
      through alternative metabolic pathways.
    

Detailed description: 
      Triheptanoin, a nutritional supplement long used in other metabolic disorders and also added
      to foods and cosmetics, will be used to complement any diet that G1D patients may be
      receiving at enrollment with the exception of the ketogenic diet.
    

Intervention name(s): Triheptanoin
Intervention type(s): Drug
Intervention description(s): Triheptanoin is a 7-carbon medium chain triglyceride
Other intervention name(s): C7; Heptanoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: G1D; Glut1 Disorder; Glucose Transporter Type 1 Disorder; Glucose Transporter Type I Disorder
Diagnosis of Bladder Pain Syndrome / Interstitial Cystitis
Condition: Bladder Pain Syndrome; Interstitial Cystitis; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Cystitis; Cystitis, Interstitial; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      To identify new, simple and reliable biomarkers for bladder pain syndrome/interstitial
      cystitis (BPS/IC) for diagnosis of this disease.
    

Detailed description: 
      Collection and analyses of bladder biopsies, bladder washings, blood and urine samples of
      patients with bladder pain syndrome/interstitial cystitis (BPS/IC), overactive bladder
      syndrome (OAB) and bladder-healthy controls. Analyses include ELISA, RT-qPCR, DNA sequencing,
      and immunohistochemistry techniques. Differences between patient groups are statistically
      evaluated.
    

Intervention name(s): biopsy
Intervention type(s): Procedure
Intervention description(s): cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: BPS/IC; OAB
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if Dymista nasal spray is better and safer than
      placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.
    


Intervention name(s): azelastine hydrochloride and fluticasone propionate; Dymista vehicle
Intervention type(s): Drug; Drug
Other intervention name(s): Dymista; placebo
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Training After Transcatheter Aortic Valve Implantation
Condition: Aortic Valve Stenosis; TAVI; Transcatheter Aortic Valve Implantation; Rehabilitation
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      In this prospective, controlled trial, patient after TAVI will be randomized to either
      exercise training or usual care group.
    

Detailed description: 
      Patients after transcatheter aortic valve replacement (TAVI) are particularly old and
      severely deconditioned and are thus likely to benefit from cardiac rehabilitation programs.
      In this controlled trial, patients after TAVI will be randomized to either exercise training
      or usual care.

      The aim of our study is to compare the effect of exercise training vs. usual care on:

        1. exercise capacity

        2. vascular function

        3. parameters of heart failure, inflammation and homeostasis

        4. arrhythmogenic potential

        5. health-related quality of life
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Continuous exercise training 2 times per week for a period of 12 weeks.
Other intervention name(s): Rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise training
Micro Ribonucleic Acid (RNA) as Cholinergic Tone and Inflammatory Regulator in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      There is a reciprocal relationship between the central nervous system and the immune system.
      Stimulation of the vagus nerve results in secretion of acetylcholine (Ach) which decreases
      secretion of pro-inflammatory cytokines. Acetylcholine esterase is an enzyme that neutralizes
      Ach and thus, involves in regulation of Ach levels, and in the cholinergic tone and
      inflammatory state.

      MicroRNAs (miRs) are evolutionarily conserved, RNAs that regulate gene expression. The
      investigators hypothesized that miRs controlling systemic communication processes function in
      one tissue in response to signals (i.e. neuronal, hormonal or others) from another.

      Specifically, the investigators hypothesized that miRs control the inflammatory response in
      inflammatory bowel diseases through regulation of expression of messenger RNA of AchE.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients- inflammatory bowel disease patients under going colonoscopy controls- average
        risk patients without inflammation under going colonoscopy
      
Biospecimen description: 
      serum, colonic tissue, whole blood
    
Keywords: inflammatory bowel disease; micro RNA; cholinergic tone; inflammation
Evaluation of Inhaled Treatment in Sinusitis
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether inhaled corticosteroid (specially
      nebulized) could be a good alternative to oral corticosteroid and whether they are effective
      in the treatment of sinusitis
    


Intervention name(s): methylprednisolone; Budesonide; Budesonide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral 32mg/8d-16mg/4d-8mg/4d; Budesonide by metered dose inhaler; Budesonide by nebulization
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Budesonide; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Supervised Versus Home Based Exercises Neck and Low Back Pain Among Students Due to Quarantine During COVID-19
Condition: Musculoskeletal Pain
MeSH terms: COVID-19; Musculoskeletal Pain; Back Pain
Study type: Interventional

Summary: 
      This study investigates whether or not the stretching and strengthening exercises are
      effective both at home and under supervision for people suffering from neck pain from using
      equipment for online courses due to quarantine during COVID-19.
    

Detailed description: 
      The aim of this study is to investigate which regime is best to follow a recommendation, be
      it under the supervision of the therapist or at home with stretching and strengthening
      exercises. There was no study that could explain the effect of stretching and strengthening
      exercises as a comparison between a supervised and a home treatment plan for neck pain in
      students during quarantine due to Covid-19.This study examines whether or not the
      recommendations given are effective both at home and under supervision.
    

Intervention name(s): Supervised stretching and strengthening exercise; Home-based stretching and strengthening exercise
Intervention type(s): Other; Other
Intervention description(s): The structure of the supervised exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.; The structure of the home based exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.
Other intervention name(s): Rehabilitation following Supervised stretching and strengthening exercise; Rehabilitation following Home-based stretching and strengthening exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Pain; COVID-19; strengthening exercises; stretching exercises
Comparison Between Supraclavicular And Infraclavicular Approach For Right Subclavian Venous Catheterization
Condition: Central Line Complication
Study type: Interventional

Summary: 
      A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a
      larg central vein for a multitude of indications in major elective surgeries and ICU patients
      and now it's now with notable advance is the adjunct of ultrasound guidance, which has
      recently become the standard of care for CVCs placed in wanted site to decreases the
      complications
    

Detailed description: 
      A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a
      large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced
      until the terminal lumen resides within the inferior vena cava, superior vena cava, or right
      atrium.for a multitude of indications including; total parenteral nutrition administration
      dialysis, plasmapheresis , medication administration, hemodynamic monitoring and to
      facilitate further complex interventions such as transvenous pacemaker placement inserted
      with Seldinger's technique. A notable advance is the adjunct of ultrasound guidance, which
      has recently become the standard of care for CVCs placed in wanted site owing to associated
      decreases in complications e.g. arterial puncture, haematoma formation, pneumothorax,
      haemothorax and catheterization failure and an increase in first-pass success.
    

Intervention name(s): Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
Intervention type(s): Device
Intervention description(s): Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Strength Training for Chronic Low Back Pain Patients (IRMA20)
Condition: Musculoskeletal Pain; Low Back Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is common in the population and has great socioeconomic consequences for
      societies across Europe and the United States. About a third of working-age adults have
      frequent LBP, and for about 10% the pain becomes chronic with consequences for work and
      leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an
      intervention with few adverse events and positive outcomes on pain and function in adults
      with chronic pain. However, when scrutinizing the specific studies of the review there are
      large differences in adherence to the exercise interventions and consequently in the results
      obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.
    


Intervention name(s): Strength training; Usual care (control)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks; Will receive the usual care at the hospital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of topical application of
      IDP-108 versus vehicle in treating patients with onychomycosis.
    


Intervention name(s): IDP-108; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical application once a day for 48 weeks; Topical application once a day for 48 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety of long-term use of cetirizine dry syrup in children with various type
      of cutaneous disease accompanied on pruritus.
    


Intervention name(s): Cetirizine Dry Syrup
Intervention type(s): Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cetirizine; various type of cutaneous disease accompanied with Pruritus; pediatrics
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label study with 30-day run-in phase and adaptive design component to include more
      participants if deemed appropriate by investigators.
    

Detailed description: 
      This is a within-subject, controlled open-label study seeking to determine if PTC-589 can
      alter the biochemical signature of Parkinson's disease as assessed by peripheral blood
      biomarkers, central nervous system (CNS) biomarkers, and urine biomarker analysis. In
      addition, data on a number of disease-relevant clinical measures will be collected.
    

Intervention name(s): PTC-589
Intervention type(s): Drug
Intervention description(s): PTC-589 is a redox active molecule and will be provided in a 250 mg tablet formulation.
Other intervention name(s): (R)-Troloxamide quinone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; PD; EPI-589; EPI589
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and
      collecting outcome data on CLBP patients within the Veterans Affairs Community Based
      Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness
      (yoga) and without mindfulness (stretching class)
    

Detailed description: 
      The study will approach all new or existing patients within the chiropractic clinic between
      the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or
      equal to 3, who have no contraindications to active exercise. Patients will be queried as to
      interest and those interested will be consented. The investigators will recruit a total of 20
      patients. Patients will then be randomized to receive either an 8 week active exercise class
      with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching
      class). Both groups will have home exercise requirements and will be held accountable through
      the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS
      Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing
      and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8
      week intervention. Clinician open ended questionnaire will be given to both study clinicians
      at the end of the trial.
    

Intervention name(s): Yoga (stretching plus mindfulness); Stretching
Intervention type(s): Other; Other
Intervention description(s): Stretching plus mindfulness; Stretching alone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Condition: Neonatal Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants.
      Current treatments for the brain damaging complication of neonatal seizures are
      unsatisfactory.

      Monitoring for seizure detection will be tested at five (5) US sites and one (1)
      international site using the internet.
    

Detailed description: 
      This project aims to improve the treatment of neonatal seizures. Current treatments are
      poorly effective and have significant side effects.

      Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not
      approved for use in children less than 2 years of age.

      This study aims to obtain essential data regarding the efficacy and safety of LEV in this
      vulnerable and under researched population and simultaneously to develop EEG monitoring
      systems that facilitate seizure detection and research.

      Specific aims are:

        1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given
           as first line therapy.

        2. To obtain dose escalation data by studying the additional efficacy of a further dose in
           non responders.

        3. To obtain additional pharmacokinetic data to confirm findings from our previous
           pharmacokinetic study.

        4. To obtain further safety data of LEV in neonates.

        5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring
           in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising
           automated neonatal seizure detection algorithm.

      The study design is a phase 2b randomized blinded controlled study.
    

Intervention name(s): Intravenous levetiracetam; Intravenous phenobarbital
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.; Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.
Other intervention name(s): Keppra; phenobarbitone
Intervention MeSH terms: Levetiracetam; Phenobarbital
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seizures; Neonates; Anticonvulsants; Treatment; Levetiracetam; Phenobarbital
Evaluation of CPD MNV as an Aid in the Diagnosis and Risk Assessment of Sepsis (Protocol # Sepsis 1-14)
Condition: Sepsis, Severe Sepsis and Septic Shock
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      The investigators hypothesize that CPD parameters will provide improved prediction of sepsis
      compared to currently employed laboratory parameters. These studies hold the potential to
      shape practitioner guidelines and improve the timeliness and accuracy with which patients
      with sepsis are treated today.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Emergency Department
Treatment of Insomnia in Migraineurs
Condition: Insomnia; Migraine
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesized that treating insomnia in migraineurs, many of whom also have tension
      headaches, prolongs total sleep time to the extent that it decreases overall headache
      frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly
      affecting daytime functioning, which is hypothesized to improve as well with prolonged total
      sleep time.
    

Detailed description: 
      The objective of the study is to determine the effect of prolonging total sleep time in
      migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and
      functioning. The prolongation of total sleep time is accomplished by bedtime administration
      of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.
    

Intervention name(s): eszopiclone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg tablet every night at bedtime; 1 tablet every night at bedtime
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: insomnia; migraine; eszopiclone; insomnia in migraineurs