bioihbjkbjnl/mcl2 huggingface dataset:
Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
Condition: Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia
MeSH terms: Amblyopia; Strabismus
Study type: Interventional

Summary: 
      This study evaluates the effect of 3D movie viewing on stereopsis recovery in anisometropic
      and / or strabismus amblyopia and the satisfaction with the intervention.
    

Detailed description: 
      Amblyopia is a visual neurodevelopmental disorder associated, more frequently, with the
      presence of strabismus and anisometropia. It is clinically most important visual condition in
      childhood because, apart from refractive error, it is the most frequent cause of vision loss
      in children. It is a reversible condition that affects up to 5% of the population, and that
      is the result of an abnormal visual experience during the most sensitive period of visual
      development. Although amblyopia is expressed in the clinical practice as a reduction in
      visual acuity, it is also characterized by an altered stereoscopy. Generally, treatments for
      amblyopia focus on the recovery of visual acuity, and there are no treatments that focus
      mainly on the recovery of the altered stereopsis, so present and with an important functional
      impact.

      The aim of this study reviewing, analyzing and, if applicable, updating the current treatment
      model for amblyopia. On the one hand, to evaluate the effectiveness of viewing a 3D movie in
      the improvement of stereoacuity and the deviation, as well as visual acuity and sensitivity
      to contrast. Also, the correlation between them. On the other hand, to assess quantitatively
      the degree of satisfaction and acceptance of the participants and their families towards the
      intervention.

      A quasi-experimental study will be performed, without a control group, pre- and post-
      intervention in which subjects with refractive and / or strabismus amblyopia, that have been
      subjected to traditional treatment for amblyopia, will be selected. Variables of stereopsis,
      latent or manifest deviation, visual acuity and sensitivity to the contrast will evaluate
      previously and after the intervention.

      The sample will include subjects between 5 to 12 years old with a diagnosis of refractive and
      / or strabismic amblyopia.
    

Intervention name(s): 3D movie viewing
Intervention type(s): Other
Intervention description(s): 3D movie viewing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3D movies; Amblyopia treatment
Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other
      neurological disorders. In this research, the investigators are developing new tools to
      quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of
      the most common treatments, orthopaedic surgery. The results from this research will empower
      clinicians to identify patient-specific factors that contribute to impaired movement and
      improve treatment and quality of life.
    

Detailed description: 
      The long-term goals of this research are to quantify patient-specific changes in
      neuromuscular control in order to optimize treatment planning and improve mobility for
      individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to
      evaluate neuromuscular control before and after one of the most common treatments for
      individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific
      measures of neuromuscular control, based upon the framework of muscle synergies, can predict
      improvements in walking ability after surgery. Further, investigators will determine whether
      neuromuscular control changes after surgery and if these changes contribute to improvements
      in movement. To achieve these goal the investigators will implement and test new tools to
      quantify neuromuscular control which integrate clinical gait analysis and two computational
      techniques: synergy analysis and dynamic musculoskeletal simulation. This research will
      provide the foundation to use measures of altered neuromuscular control to inform treatment
      planning, develop alternative treatments, and improve mobility in CP and other neurologic
      disorders.
    

Intervention name(s): Single-event multilevel surgery
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with cerebral palsy, diplegia subtype, with mild or moderate impairment, Gross
        Motor Function Classification System (GMFCS) Levels I-III, between the ages of 6 - 18.
Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical trial is to asses the feasibility and the security of the
      intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic
      Lateral Sclerosis patients.
    

Detailed description: 
      Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis
      due to the continued loss of motoneurons that leads them to death in less than 5 years. No
      treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear
      cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps
      of trophic factors that keep the motoneurons functional. We have designed a phase I/II
      clinical trial to check the feasibility of this approach in humans.
    

Intervention name(s): Laminectomy and bone marrow stem cells transplantation; Autologous bone marrow cells collection
Intervention type(s): Procedure; Procedure
Intervention description(s): T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation; Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Bone marrow; Stem cells; Autologous; Safety
Epidemiologic Study of Reproductive Outcome in Women With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      OBJECTIVES: I. Evaluate whether pregnancy is an independent risk factor that affects disease
      activity in women with systemic lupus erythematosus.

      II. Evaluate whether maternal disease activity is a risk factor for adverse pregnancy
      outcome.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a case-controlled study. Intensive data collection begins when a
      patient becomes pregnant.

      Pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam,
      including the Systemic Lupus Activity Measure (SLAM). Assessments are scheduled every 3
      months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second
      trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at
      6 months postpartum. Visits 4 and 5 include an infant exam for growth and morphologic
      parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth.

      Patients not currently pregnant are randomly chosen to be followed as controls. These
      patients undergo a review of current pregnancy status and measures of disease activity,
      including SLAM, every 3 months for 5 visits.
    

Time perspective: Other
Keywords: arthritis & connective tissue diseases; immunologic disorders and infectious disorders; rare disease; systemic lupus erythematosus
Genomics of Chronic Renal Allograft Rejection (The GoCAR Study)
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      Doctors have had success preventing certain types of kidney transplant rejection by
      suppressing the immune system. However, an individual's genetic make-up and the strength of
      an immune response to a transplant may also determine whether a transplanted organ is
      rejected. The purpose of this study is to look at the genetic profile and immune response of
      people who have had kidney transplants and to correlate the findings with kidney transplant
      rejection episodes. Donor genetic profiles will also be studied and correlated with the
      recipient's information.
    

Detailed description: 
      New immunosuppressive drugs have improved short-term transplant survival but have not
      affected long-term transplant survival. Rejection is caused by both immunological and
      non-immunological factors from both the donor and the recipient. Although the exact cause of
      chronic rejection is not known, it is associated with the presence of C4d, a degradation
      product of the antibody response cascade, and the presence of circulating donor-specific
      antibodies (DSAs). The purpose of this study is to determine the role of cell- and
      antibody-mediated responses in chronic rejection of transplants, to determine the gene
      expression profile associated with the development of chronic rejection, and to determine
      whether variants of specific genes cause susceptibility to rejection.

      This is an observational study of people who will be receiving kidney transplants and
      participants will be followed for 2 years. Study visits for kidney transplant recipients will
      occur at study entry and at months 3, 6, 12, 18, and 24 after transplant. At these visits,
      adverse event assessment, rejection assessment, medication history questionnaire, and blood
      collection will occur. At some visits, a physical exam and a kidney biopsy will occur. Blood
      will also be collected from living kidney donors at the time of donation if both donor and
      recipient agree to be in the study. This study will be take place at 4 clinical sites: Mount
      Sinai School of Medicine, University of Wisconsin-Madison, Westmead Hospital, and
      Northwestern Memorial Hospital. Brigham and Women's Hospital and Massachusetts General
      Hospital will also participate in the study as central laboratories.
    

Intervention name(s): Kidney biopsy
Intervention type(s): Procedure
Intervention description(s): Kidney biopsy (recipients only) will be obtained for RT-PCR, microarray analyses and histology.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals receiving a kidney transplant and individuals who are donating a kidney
      
Biospecimen description: 
      Blood from both kidney donor and recipient and transplant kidney biopsy samples
    
Keywords: ELISPOT; RT-PCR; Luminex; Genomics
A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for
      the treatment of diabetic edema.
    


Intervention name(s): dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eye diseases; diabetic eye problems
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People
Condition: Obesity; Physical Activity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim of this study was to validate functions for estimating energy expenditure in
      controlled and free-living conditions. This method was based on accelerometry data acquired
      from smartphones worn in a trouser pocket. The developed functions have been compared to the
      estimations provided by three research devices named Fitmate, Armband and Actiheart.
    

Detailed description: 
      There is a growing interest in evaluating physical activity and energy expenditure (EE) to
      provide feedback to the user. The use of mass-market sensors such as accelerometers offers a
      promising solution for the general public due to the growing smartphone market over the last
      decade.

      Two previous studies allowed to propose a function named PredEE, which has been tested on
      normal-weighted volunteers.

      This EE estimation function has been tested and improved with data collected from 43
      overweight volunteers equipped with smartphones and two or three research sensors (Fitmate,
      Armband and Actiheart in controlled conditions, and Armband and Actiheart in free-living
      conditions). Research sensors' data serves as reference during the evaluation and improvement
      of the proposed function.

      This EE estimation function using the smartphone technology is dedicated to light- and
      moderate-intensity activities, and the investigators believe it can be a new way to help
      people controlling their daily physical activity level.
    

Intervention name(s): Controlled conditions; Free-living conditions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 13 volunteers in controlled conditions performed each of the nine activities several times according to the activity scenario: sitting, slow, normal and brisk walking, climbing and descending stairs (eight floors), standing, slow running and taking public transportation (tramway). The duration of each activity varied from 2 to 20 minutes.; The spontaneous activities of 30 volunteers were recorded in the free-living conditions for a full day selected either during the week or the weekend.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; energy expenditure; daily living physical activity; smartphone; accelerometry; prediction algorithm
Pediatric Cardiac Output Monitoring Observational Study
Condition: Pediatric ALL
Study type: Observational

Summary: 
      To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight
      system to intermittent thermodilution Swan-Ganz, in order to expand the indications of
      FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric
      population 12 to 18 years of age.
    


Intervention name(s): Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
Intervention type(s): Device
Intervention description(s): A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and Females, 12 to 18 years of age at the time of screening. Who presenting to
        Cardiac Catheterization Lab for right heart catheterizations.
      
Keywords: Hemodynamic Monitoring; Cardiac Output
Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children
Condition: Cuff Overinflation; Cuff Underinflation
Study type: Interventional

Summary: 
      Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a
      continuous or intermittent technique, cuff underinflation and overinflation are common
      increasing the risk of microinhalation and tracheal ischemia. All these complications are
      associated with high morbidity and mortality in ICU.
    

Detailed description: 
      In this study, the investigators will compare the duration of the period of under-inflation
      and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous
      monitoring of tracheal cuff pressure), in critically intubated children. This study aims to
      determine the effectiveness of the electronic device in the continuous monitoring of tracheal
      cuff pressure.
    

Intervention name(s): Electronic device (VBM©); Pneumatic device (Nosten©)
Intervention type(s): Device; Device
Intervention description(s): Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.; Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: tracheal cuff pressure; pediatric critical care
Prevention of Levodopa-induced Dyskinesias by Transcranial Static Magnetic Field Stimulation (tSMS)
Condition: Dyskinesia, Medication-Induced; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias; Dyskinesia, Drug-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized sham-controlled double-blind study to test the hypothesis that
      transcranial static magnetic field stimulation (tSMS) of the motor cortex improves
      levodopa-induced dyskinesias in patients with Parkinson's disease. Half of the patients will
      receive real tSMS treatment, the other half will receive sham treatment (placebo).
    


Intervention name(s): tSMS; sham
Intervention type(s): Device; Device
Intervention description(s): Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body.; A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain).
Other intervention name(s): MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain); MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Mindfulness-Based Stress Reduction Program (MBSR) in Risky Pregnants
Condition: Stress; Pregnancy, High Risk
Study type: Interventional

Summary: 
      Risky pregnant women need various physical and mental health needs, they need to be informed
      and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of
      one's attention on what is happening right now. A total of 100 pregnant women (50
      experimental, 50 control) are planned to be included in the study. Data will be collected
      with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version",
      "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the
      study, a stress reduction program (MBSR) based on mindfulness will be applied by the
      researcher to the pregnant women in the experimental group.
    

Detailed description: 
      Risky pregnancies are a situation that can negatively affect the health of the mother and the
      fetus, result in the loss of the baby, and bring about physical, social and mental changes.
      Mindfulness-based approaches have been used in solving both physical and mental problems in
      pregnant women and very positive results have been obtained. The aim of this study, which was
      carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on
      stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating
      appropriate intervention programs for high-risk pregnancies and contributing to the
      improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50
      control) are planned to be included in the study. Data will be collected with "Descriptive
      Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related
      Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress
      reduction program (MBSR) based on mindfulness will be applied by the researcher to the
      pregnant women in the experimental group.
    

Intervention name(s): Mindfullness Based Stress Reduction (MBSR) intervention
Intervention type(s): Behavioral
Intervention description(s): Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: prenatal attachment; Anxiety
Negative Postprandial Effect on Endothelium After a Not-healthy Meal in Type 2 Diabetes as Affected by Training
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether exercise reduces the postprandial effects of
      an unhealthy meal on heart function and endothelial function.

      Both healthy people and type 2 diabetes subjects will during three days either carry out two
      different sessions of exercise training or not before ingesting an unhealthy meal high in
      saturated fat and fast carbohydrates. The two different exercise training modes used are high
      intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise
      training in advance of an unhealthy meal will improve endothelial- and cardiac function in
      healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects
      on the endothelium more than MIT.
    


Intervention name(s): 47 min moderate intensity training; exercise healthy volunteers; control; no exercise training
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; endothelium; postprandial period