bioihbjkbjnl/mcl2 huggingface dataset:
Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Myalgia
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on
           muscle pain of the calf caused by eccentric contractions

        2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by
           eccentric contractions

        3. Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the
           calf caused by eccentric contractions
    


Intervention name(s): Celecoxib, Ketoprofen; Ketoprofen
Intervention type(s): Drug; Drug
Intervention description(s): Ketoprofen in Transfersome® gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d.
Celecoxib, 200 mg, one capsule b.i.d.; Placebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Oral placebo, one capsule b.i.d
Intervention MeSH terms: Celecoxib; Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: muscle pain; model
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
Condition: Skin Aging
Study type: Interventional

Summary: 
      The objective of this POC clinical study is to evaluate the moisturising effects on fine
      lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks
      of twice daily application of the test product on participants presenting visible signs of
      ageing.
    

Detailed description: 
      Participants who meet all the inclusion/exclusion criteria will be randomised to one of three
      treatment groups: test product/positive control, test product/no treatment or positive
      control/no treatment at the baseline visit. Product application within treatment group will
      be further randomised to either the right or left side of the face. Participants will apply
      one of the assigned treatments to one side of the face (left or right) and another assigned
      treatment to the other side of the face as per the randomisation schedule. Participants will
      be instructed to apply the assigned treatments twice daily (morning and evening,
      approximately 8-12 hours apart) for 4 weeks (28 days).
    

Intervention name(s): Test product (Moisturising cream); Positive control (Commercial market place moisturising cream); No treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).; Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).; No treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER
      Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban,
      USA. Dosing periods were separated by a washout period of 8 days.

      Study Design:

      randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects
    


Intervention name(s): Torrent's Isosorbide Mononitrate 120 mg ER Tablets
Intervention type(s): Drug
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Screws Implantation Assisted With Mixed Reality Technology
Condition: Spine Degeneration
Study type: Interventional

Summary: 
      Prospective comparative study of Mixed Reality Technology（MR）assisted lumbar pedicle screws
      placement and traditional lumbar pedicle screws placement.
    

Detailed description: 
      In this study, the randomized controlled method was adopted to prospectively include the
      samples, and the differences in surgical procedures and efficacy were compared between the
      thoracolumbar pedicle screw implantation assisted by MR and the traditional thoracolumbar
      pedicle screw implantation, so as to provide a plan for clinicians to choose the surgical
      method.
    

Intervention name(s): Mixed Reality technology
Intervention type(s): Device
Intervention description(s): combine image with real body
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of
      MGA031 when administered according to 3 different MGA031 dosing regimens in children and
      adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All
      regimens will be administered as an addition to insulin and other standard of care
      treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce
      typical insulin requirements while maintaining relatively normal blood sugar levels.

      Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized
      monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics,
      Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.
    

Detailed description: 
      The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to
      Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and
      Adults With Recent-Onset Type 1 Diabetes Mellitus
    

Intervention name(s): Teplizumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Daily IV dosing for 14 days, repeated at Week 26; Daily IV dosing for 14 days, repeated at Week 26
Other intervention name(s): MGA031
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Randomized; Double Blind; Parallel Group; Controlled Clinical Trial
Long-term Effect of Moderate and Vigorous Exercise on Incident Diabetes in Obese Subjects
Condition: Type 2 Diabetes; Obesity, Abdominal
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Abdominal
Study type: Observational

Summary: 
      Our previous randomized controlled trial has recruited 220 subjects with central obesity and
      allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise
      groups. The purpose of our previous study was to investigate the effect of moderate and
      vigorous exercise on improvement of fatty liver. Those subjects will be followed up for
      incident diabetes at 2 year and 10 year since randomization. The subjects will be invited to
      participate in on-site visit at 2 and 10 year. Questionaire forms will be collected and
      fasting plasma glucose level and HbA1c were measured. The history of diabetes and
      anti-diabetic medication will be recorded. The incident diabetes will be evaluated.
    

Detailed description: 
      Our previous randomized controlled trial has recruited 220 subject with central obesity and
      NAFLD. Those subjects were allocated into non-exercise control, moderate exercise and
      vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise
      and vigorous intensity exercise, respectively. The exercise intervention lasted one year.
      Those three group subjects will be followed up and evaluated for incident diabetes at 2 year
      and 10 year since randomization. All the subjects will be invited to participate in on-site
      visit at 2 and 10 year. Questionaire forms will be collected and fasting plasma glucose level
      and HbA1c were measured. The history of diabetes and anti-diabetic medication will be
      recorded. The incident diabetes will be evaluated.
    

Intervention name(s): Non-exercise control; Moderate intensity exercise; Vigorous intensity exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12 month lifestyle education; 12 month moderate intensity exercise by brisk walk 30 min per day and more than 5 days per week.; 6 month vigorous intensity exercise on treadmill for 30 min per day and more than 5 days per week, and subsequent 6 month moderate exercise by brisk walk 30 min per day and more than 5 days per week.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants in our study included all subjects who had been enrolled in the previous
        randomized controlled trial.
      
Keywords: Type 2 Diabetes; Obesity
Central Mechanism of Manual Therapy for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examine the change of nervous system activity before and
      after spinal manipulation treatment program in people with low back pain.
    


Intervention name(s): Spinal Manipulation; Placebo Spinal Manipulation
Intervention type(s): Other; Other
Intervention description(s): The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.; The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Low Level Laser Therapy in the Dorsal Root Ganglion in the Treatment of Chronic Low Back Pain
Condition: Pain; Low Back Pain; Nociceptive Pain; Neuropathic Pain; Low Level Laser Therapy
MeSH terms: Neuralgia; Back Pain; Low Back Pain; Nociceptive Pain
Study type: Interventional

Summary: 
      Chronic axial low back pain is a public health problem and has a high socioeconomic impact.
      The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies
      responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level
      laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project
      is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and
      treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into
      three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a
      prone horizontal position under anesthetic monitoring. The intervertebral foramen between the
      second and third lumbar vertebrae will be accessed by percutaneous puncture guided by
      fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without
      vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact
      with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at
      42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber
      crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog
      scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to
      study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek,
      RNA isolation and ATP quantification. The data will be evaluated for normality and subjected
      to appropriate statistical analysis, in order to seek representation, as same as the level of
      significance of the studied samples.
    


Intervention name(s): Laser; Drug: Lidocaine; Radiofrequency
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.; 1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.; Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Level Laser Therapy; Low Back Pain; Diagnosis; Genetic; Clinical trial
Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The Researchers are trying to assess the effectiveness of a new ultrasound technique for
      non-invasive evaluation of liver fibrosis.
    

Detailed description: 
      Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting
      ultrasound liver tissue elastography measurements during participant breath holds.
      Participants fast for a minimum of four hours and are positioned lying on left side with
      knees slightly bent.
    

Intervention name(s): Mechanical Vibrations with Ultrasound Shear Wave Imaging
Intervention type(s): Device
Intervention description(s): Multiple miniature mechanical vibrators will be placed on the body surface of rib cage of the subject or introduced through an audio loudspeaker in contact with the subject's upper torso or through miniature vibrator attached to the ultrasound probe. Repeated ultrasound stiffness measurements will be made at different locations within the liver parenchyma while the mini vibrators introduce shear wave in the liver, similar to an MRE examination.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram
      (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in
      participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens
      will be evaluated.
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): VRAYLAR®
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Flu-Bu-Mel Conditioning Regimen for Myeloid Disease
Condition: Relapse Rate After Allo-HSCT
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing
      allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day
      melphalan
    

Detailed description: 
      For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing
      allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan
      3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY
      (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.
    

Intervention name(s): Flu-Bu-Mel
Intervention type(s): Drug
Intervention description(s): 5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D and Severe Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study of vitamin D is designed to assess both the safety and efficacy of potential doses
      (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short
      period of time (e.g. 4 weeks or less) compared to 200 IU/day.

      In children with vitamin D insufficiency or deficiency who are at risk for severe asthma
      exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000
      IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day)
      will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.
    

Detailed description: 
      Asthma is a major public health problem in the United States and worldwide. Severe disease
      exacerbations account for the majority of costs attributable to asthma in the United States.
      Vitamin D is an essential nutrient with significant immuno-modulatory effects. The
      observation that vitamin D insufficiency and asthma share risk factors such as urban
      residence, obesity, and African American ethnicity has generated significant interest in
      exploring a link between these two conditions.

      This is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and
      4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged
      children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D <30 ng/ml)
      and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on
      medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
Other intervention name(s): vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: asthma; vitamin D
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the prescription determined for a new daily
      disposable toric contact lens will be a good match to a prescription determined for an
      existing brand of lens.
    


Intervention name(s): etafilcon A toric contact lens with new wetting agent; etafilcon A toric contact lens
Intervention type(s): Device; Device
Intervention description(s): Investigational toric contact lens made of etafilcon A material with a new wetting agent.; Marketed toric contact lens made of etafilcon A material.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect Of Cognitive Training On Sportıve Performance
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to examine the changes in cognitive performance, coordination,
      anticipation time, proprioception and pass quality of cognitive-based neuromuscular
      exercises.
    

Detailed description: 
      The investigators think that with cognitive-based neuromuscular exercises to be applied to
      football players, concentration, reflexes, balance, coordination, anticipation time,
      proprioception and pass quality can be improved. Within the scope of the investigators'
      study,the investigators think that the positive effects of cognitive-based neuromuscular
      exercises on executive functions can positively affect athlete performance by contributing to
      rapid thinking, planning and implementation. In this way, footballers will be able to reach
      high performances on the field and will become more qualified athletes. In addition, it is
      predicted that the incidence of injuries in athletes will be minimized by improving the
      parameters such as anticipation time, balance, coordination, reaction time, and
      proprioception. If the effectiveness of the exercises is proven, it is aimed to contribute to
      the literature with objective and evidence-based results in order to include cognitive-based
      exercises in training programs, which are often overlooked in football training programs.
    

Intervention name(s): Exercise; Classic Training
Intervention type(s): Other; Other
Intervention description(s): Cognıtıve-based neuromuscular exercıses will be applied.; Classic match preparation training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the informed consent form will be divided into two groups, the control group and the study group, by simple random randomization. Experimental group cognitive based neuromuscular exercises + classical training; the control group will only do the classic training. A total of 8-week exercise program will be applied.
Masking: None (Open Label)
Primary purpose: Other
Keywords: cognıtıve-based neuromuscular exercıses; cognıtıve functıons; sportıve performance
Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The objective of this study is to further the understanding and application of 60Hz
      subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The
      investigators will achieve this through 2 study aims:

        1. Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using
           wearable sensors

        2. Develop machine learning models to predict optimal subthalamic deep brain stimulation
           frequency based on wearable sensors
    

Detailed description: 
      Gait disorder, which manifests as shuffling, reduction in speed, multistep turning, and/or
      freezing of gait (FOG), can arise later in the Parkinson's disease (PD) course and cause
      significant disability. Ultimately, patients are at risk for falls and can become socially
      isolated due to their mobility limitations. These symptoms tend not to respond to high
      frequency STN-DBS. However, lower frequency stimulation (60-80Hz) of the STN in treating gait
      disorder and/or freezing of gait has demonstrated benefit. This study potentially can expand
      knowledge of 60hz DBS while improving its utilization in combination with PD
      medications-enabling sustainable and possibly predictable therapeutic benefit.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Parkinson's Disease; Wearable Sensors