bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Pressure Controlled Ventilation on the Pulmonary Mechanics in Prone Position Using the Wilson Frame: A Comparison With Volume Controlled Ventilation
Condition: Herniation of Lumbar Vertebral Disc
MeSH terms: Hernia
Study type: Interventional

Summary: 
      Prone position in spinal surgery can increase airway pressure and decrease dynamic lung
      compliance by a frame used for postural stabilization. Also, it can increase hemodynamic
      instability such as reduced blood pressure by aggravating cardiac index.

      Former study shows pressure controlled ventilation on the pulmonary mechanics can improve
      alveolar use and oxygenation than volume controlled ventilation. The latter one means
      controlling a patient's breathing completely through tidal volume and set breathing rate.
      This could be useful for the patients not possible to breath by themselves because it
      guarantees the perfect breathing.

      The pressure controlled ventilation is used when there is a possibility to change a patient's
      environment. The pressure will be maintained steadily, but volume and flux will be changed.
      That means through the pressure already set, the whole breathing will be maintained from the
      beginning to end. If a patient's resistance is increased, the volume will be decreased even
      though the way of blood pressure control is same. However, the tidal volume per minute can be
      controlled somewhat and barotrauma can be decreased by controlling respiratory rate. Through
      this study, we are expecting the pressure controlled ventilation in prone position can
      improve lung mechanics and oxygenation.
    


Intervention name(s): volume control; pressure control
Intervention type(s): Procedure; Procedure
Intervention description(s): Volume controlled ventilation of tidal volume 10 ml/kg; Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Developing a Discrimination Model to Diagnose ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      To combine several brain imaging techniques to develop a new diagnostic test to help with
      earlier diagnosis of amyotrophic lateral sclerosis.
    

Detailed description: 
      Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant
      obstacle to making a timely intervention to help patients suffering from this fatal disease.
      We envision a future in which neuroimaging techniques will be a critical tool in the
      diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in
      identifying central nervous system metabolite and cellular alterations in ALS. We propose an
      innovative approach to combine complementary advanced MRI techniques to interrogate brain
      chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a
      clinically relevant discriminatory disease model.
    

Intervention name(s): MRI(magnetic resonance imaging)
Intervention type(s): Diagnostic Test
Intervention description(s): Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes.
      Subjects will be administered insulin to induce a low normal glycemic state and will then
      receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center
      (CRC) or comparable setting.
    

Detailed description: 
      This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients
      ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days
      before dosing to determine eligibility before enrollment to the treatment phase.

      The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a
      low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given
      a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects
      ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of
      G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be
      monitored for 90 and 180 minutes post-dosing, respectively, at all visits.

      A follow-up phone call as a safety check will be conducted 3 - 14 days following
      administration of the final dose.
    

Intervention name(s): Glucagon
Intervention type(s): Drug
Intervention description(s): 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Other intervention name(s): G-Pen (glucagon injection)
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be the first time PF-07258669 is administered to humans. The purpose of the
      study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following
      administration of single oral doses to healthy adult participants.
    


Intervention name(s): PF-07258669; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined; Matching placebo will be prepared as an oral solution and/or suspension given in each cohort
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-07258669; first in human; melanocortin-4 receptor; MC4R; healthy participants; safety; tolerability; pharmacokinetics
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy,
      safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin
      resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in
      combination with Atorvastatin

      Total participation for each patient is approximately 16-17 weeks, which may include up to a
      2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up.
      During the run-in period patients taking statins, statin combination or Zetia will undergo a
      'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their
      same diet prior to entering the study). They will be asked to defer initiating any weight
      loss diets or meaningful changes in their activity level until after they have completed the
      study. Once randomized into the double blind study, patients will visit the clinic every two
      weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the
      double-blind study medication will be discontinued. Patients will attend a follow up visit
      two weeks after their final dose for safety evaluation.
    

Detailed description: 
      Total participation for each patient is approximately 16-17 weeks, which may include up to a
      2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up.
      During the run-in period patients taking statins, statin combination or Zetia will undergo a
      'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their
      same diet prior to entering the study). They will be asked to defer initiating any weight
      loss diets or meaningful changes in their activity level until after they have completed the
      study. Once randomized into the double blind study, patients will visit the clinic every two
      weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the
      double-blind study medication will be discontinued. Patients will attend a follow up visit
      two weeks after their final dose for safety evaluation.
    

Intervention name(s): Placebo; MBX-8025; MBX-8025; Atorvastatin; MBX-8025; MBX-8025
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 capsules, once a day for 8 weeks; 2 capsules, once daily for 8 weeks; 2 capsule, once daily for 8 weeks; 2 capsules, once daily for 8 weeks; 2 capsules, once daily for 8 weeks; 2 capsules, once daily for 8 weeks
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; Hyperlipidemia; HDL; LDL; Triglycerides; Dyslipidemia
Beneficial Bacteria Treatment for Autism
Condition: Gastrointestinal Problems; Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label clinical trial to investigate a combination therapy for treating
      gastrointestinal problems in children with autism spectrum disorders.

      The combination therapy includes beneficial bacteria.
    

Detailed description: 
      This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of
      a combination therapy to treat gastrointestinal problems in children with autism spectrum
      disorders.

      It involves a combination therapy including beneficial bacteria.
    

Intervention name(s): oral Vancomycin; MoviPrep; Prilosec; human fecal material; processed, frozen administered orally; human fecal material; processed, frozen; administered orally and rectally
Intervention type(s): Drug; Drug; Drug; Biological; Biological
Intervention description(s): an antibiotic; a bowel cleanse; a stomach acid suppressan; human fecal material; processed, frozen, administered orally; human fecal material; processed, frozen; administered orally and rectally
Intervention MeSH terms: Vancomycin; Omeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children
Neurocognitive Exercise Program for Children With Attention Deficit and Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The effects of Neurocognitive Exercise Program (NEP) on ADHD symptoms and executive functions
      in children with Attention Deficit and Hyperactivity Disorder (ADHD) will be investigated
      using The Conners parent rating scale-revised short (CPRS-RS), Stroop Test, Wisconsin test
      and Y-Balance test.
    

Detailed description: 
      The effects of Neurocognitive Exercise Program (NEP) on ADHD symptoms and executive functions
      in children with Attention Deficit and Hyperactivity Disorder (ADHD) will be investigated.

      Material and Methods: Twenty-nine boys (14 ADHD, 15 Healthy Controls) between 7 and 13 years
      of age will be recruited in the study and The Conners parent rating scale-revised short
      (CPRS-RS), Stroop Test, Wisconsin test and Y-Balance test will be performed . All tests and
      measurements will be performed for ADHD group before NEP, after NEP, 6 months and 12 months.
      The control group will be evaluated only once.
    

Intervention name(s): Neurocognitive Exercise Program
Intervention type(s): Other
Intervention description(s): Neurocognitive Exercise Program (NEP) is defined as a multimodal exercise program including different motor coordination exercises and cognitive tasks. Exercise progression is performed from easy to difficult, and consist of simple and complex tasks. Different sports equipment (such as different sizes of balls, racket, tulle, pilates ball, eye band, rope, etc.) is used in motor coordination exercises where multiple extremities can be used in NEP. These materials are used during different exercises including cross-limb movements, throwing, jumping, walking, involving different cognitive tasks. The cognitive task used and the degree of difficulty of the task are provided by different visual (colored cards, numbered cards, gestures, etc.) or auditory (keywords, ring signal, etc.) signs. For example, showing a red card might indicate throwing a ball with the left hand, while showing a blue card indicates throwing a ball with the right hand and walking forward
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
Condition: Small-cell Lung Cancer; SCLC; Small Cell Lung Cancer Limited Stage
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional

Summary: 
      The Investigators are looking to compare standard treatment for the management of small cell
      lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in
      patient survival) with cranial sparing PCI. Although standard of care PCI is successful in
      patient survival it also has neurologic side-effects. The Investigators are hoping the
      cranial sparing PCI has the same positive survival results with the added benefit of lowering
      neurological side-effects.
    

Detailed description: 
      The standard of care in management of small cell lung cancer consists of chemotherapy plus
      thoracic radiation followed by prophylactic cranial irradiation (PCI) based on a randomized
      trial that demonstrated a significant improvement in overall survival (OS) with PCI.
      Unfortunately radiation therapy to the brain is associated with neurocognitive toxicity,
      which may be at least in part related to radiation induced injury to neural progenitor cells
      in the hippocampus. Both human and animal data suggest an inverse relationship between
      radiation dose to the hippocampus and performance on neuropsychological testing. We
      hypothesize that hippocampal sparing PCI will allow improved performance on tests of short
      term memory and executive function compared to a historical control (RTOG 0212) receiving the
      same dose of conventional PCI. The primary objective of this study is to evaluate performance
      on the Hopkins Verbal Learning Test-Revised for delayed recall at 6 months following
      hippocampal-sparing PCI relative to the historical control. Secondary objectives are to
      estimate: 1) composite cognitive function following hippocampal-sparing PCI relative to the
      historical control and 2) the rate of metastases in the hippocampus at 2 years following
      hippocampal-sparing PCI. The long term goal of this research is to reduce the long term
      sequelae of radiation therapy for both primary and metastatic brain tumors.
    

Intervention name(s): Hippocampal-sparing Prophylactic Cranial Irradiation
Intervention type(s): Radiation
Intervention description(s): Hippocampal-sparing Prophylactic Cranial Irradiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prophylactic Cranial Irradiation; PCI; Hippocampal-sparing irradiation
ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
Condition: Tetraplegia; Spinal Cord Injury; Brachial Plexus Injury; Muscular Dystrophy; ALS; Brainstem Stroke
MeSH terms: Muscular Dystrophies; Spinal Cord Injuries; Paralysis; Quadriplegia; Brain Stem Infarctions; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this research study is to demonstrate that individuals with upper limb
      paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis
      and brain stem stroke can successfully achieve direct brain control of assistive devices
      using an electrocorticography (ECoG)-based brain computer interface system.
    

Detailed description: 
      Brain-computer interface (BCI) technology aims to establish a direct link for transmitting
      information between the brain and external devices, offering a natural and rich control
      signal for prosthetic hands or functional electrical stimulators (FES) to re-animate
      paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity
      using electrodes implanted on the surface of the brain. Each participant will undergo testing
      of the ECoG direct brain interface for up to 29 days. Participants will learn to control
      computer cursors, virtual reality environments, and assistive devices such as hand orthoses
      and functional electrical stimulators using neural activity recorded with the ECoG sensor.
    

Intervention name(s): Implantation of ECoG sensors on the brain surface
Intervention type(s): Device
Intervention description(s): One ECoG sensor will be implanted over the motor cortex of study participants
Other intervention name(s): brain-computer interface; neuroprosthetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Electrocorticography; Tetraplegia; Spinal cord injury; Brainstem stroke; Neuroprosthetic; Brain-computer interface; Direct brain interface; Neural activity; Motor cortex
Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male
      adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous
      injection.
    


Intervention name(s): GC1102; JW normal saline
Intervention type(s): Biological; Other
Intervention description(s): Description: GC1102 IV bolus injection during 10~ 30 seconds.
Amount: group1-3ml, group2-5ml, group3-8ml
Subject number: group1-8, group2-8, group3-8
Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times); Description: Normal saline IV bolus injection through 10~ 30 seconds.
Each 3 subjects of this placebo comparator group will match with group 1,2,3 respectively. Placebo comparator subjects in each group will be treated with same condition of each group(group 1, group 2, group 3) except being administered JW normal saline.
Subject number: 9
Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
Other intervention name(s): Hepabig_Gene; saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Physical Activity on the Brain in Parkinson's Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether exercise improves cognitive and motor
      functions in Parkinson's disease. To test this hypothesis, the researchers study general
      brain functions in subjects with PD during a 6-months exercise program.
    


Intervention name(s): stationary bike exercise; aerobic
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Condition: Major Depressive Disorder
MeSH terms: Seizures; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This two-center, between-subject, randomized, double-masked study (n=20) will provide the
      first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast
      the therapeutic properties and side effects of two forms of MST in patients in a major
      depressive episode (MDE).
    


Intervention name(s): Magstim Theta; Thymatron System IV
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
Condition: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study will be to evaluate the drug-drug interaction potential
      of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral
      administration of CCX168 to healthy participants.
    


Intervention name(s): CCX168; Midazolam; Celecoxib; Itraconazole; Rifampicin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Itraconazole; Rifampin; Celecoxib; Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal diseases; Atypical hemolytic uremic syndrome; Immunoglobulin A nephropathy; Complement 5a receptor (C5aR); Complement
Sodium Nitrate to Improve Blood Flow
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigators recently showed that tadalafil restores functional sympatholysis in patients
      with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD
      via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also
      be restored by sodium nitrite- which is an indirect nitric oxide donor.
    


Intervention name(s): Sodium nitrate
Intervention type(s): Dietary Supplement
Intervention description(s): Sodium nitrate will be ingested orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Becker; dystrophy; sympatholysis