bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project
Condition: Aging; Cognitive Function 1, Social
Study type: Interventional

Summary: 
      The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive
      training - that have been shown to be effective in promoting active and healthy aging. The
      objective is to study the molecular and neural mechanisms of these strategies to stimulate
      brain plasticity and improve brain health and cognitive functioning.
    

Detailed description: 
      It is a randomized controlled study with three intervention groups - physical, cognitive and
      combined - and a control group. The intervention is carried out over 3 months, with a
      frequency of 5 weekly sessions of 45 minutes each. Cognitive training is applied through a
      computerized program, physical training consists of a walking aerobic program, and combined
      training arises from the addition of the two previous ones.

      140 participants will undergo an exhaustive pre- and post-intervention evaluation that
      includes neuropsychological, neuroimaging, genetic and biochemical analysis before and after
      the intervention as well as physical and health status assessment.

      The present project aims to examine the independent and combined effects of exercise and
      cognitive stimulation in functional and structural brain plasticity, cognitive performance,
      emotional state and quality of life, and will determine the demographic and clinical factors
      that can modulate neuroplasticity. It will allow us to study the neurophysiological
      mechanisms by which the different types of intervention have an effect on the structure and
      functioning of the brain and cognition within an omics framework.
    

Intervention name(s): Physical exercise; Cognitive training; Combined training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The structured physical activity plan consists of a walking program with an initial progressive phase (first week: 30 minutes/session and second week: 45 minutes/session, with a Borg scale of perceived exertion between 9 and 10) and an improvement and maintenance phase (10 weeks, 45 minutes/session with a Borg scale of perceived exertion between 11 and 14).; We use a computerized cognitive training tele-medicine tool, designed by the Guttmann Institute: Guttmann Neuro Personal Trainer (PREVIRNET). Sessions will consist in activities of attention, memory and executive functions, also put in place progressively and parallel to the physical activity.; Subjects included in this group receive both types of intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparisons Of The Bioavailability And Pharmacodynamics Of Various Formulations Of MOA-728 In Subjects On Methadone
Condition: Metahdone-maintenance Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To determine the relative bioavailability of MOA-728, an investigational drug,
      administered orally in both the capsule and tablet formulations to methadone maintenance
      subjects.Secondary: To assess the pharmacodynamic effect of MOA-728 administered both orally
      and subcutaneously to methadone maintenance subjects using the oral-cecal transit time.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep Timing and Insulin Resistance in Adolescents With Obesity
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Observational

Summary: 
      This study examines the relationship between sleep timing and insulin resistance in
      adolescents with obesity. The investigators also aim to develop a physiologically-based
      mathematical model of adolescent sleep/wake and circadian interactions.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with obesity
A Novel Mouthwash Formulation CTP/BNZ With Mucus Adhesive Polymer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the local tolerability and the systemic availability
      of benzydamine, if any, after single and multiple dose treatment with the test formulation
      containing cetylpyridinium chloride 0.05% + benzydamine hydrochloride 0.15% + mucoadhesive
      polymer and with the reference formulation Tantum Verde Bocca containing cetylpyridinium
      chloride 0.05% + benzydamine hydrochloride 0.15% to healthy subjects , under fasting
      conditions, in two consecutive study periods.
    


Intervention name(s): Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer; Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%
Intervention type(s): Drug; Drug
Intervention description(s): Test product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose; Reference Product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose
Other intervention name(s): Tantum verde bocca
Intervention MeSH terms: Cetylpyridinium; Benzydamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase I; Local tolerability; Systemic Availability; Cetylpyridinium chloride 0.05%; Benzydamine hydrochloride 0.15%; Mucoadhesive polymer; Tantum Verde Bocca
Adaptation of High Activity Arthroplasty Score to Turkish
Condition: Arthropathy; Surgery--Complications; Physical Disability
MeSH terms: Joint Diseases
Study type: Observational

Summary: 
      The objectives of this study were the translation, cross-cultural adaptation, and assessment
      of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in
      patients with primary TKA.
    

Detailed description: 
      The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into
      Turkish and investigate its psychometric properties. For cross-cultural adaptation, two
      bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after
      the first assessment, the participants will complete the Turkish version of HAAS to evaluate
      test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The
      correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check
      the validity.
    

Intervention name(s): Assesment
Intervention type(s): Other
Intervention description(s): This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with a total or unicompartmental knee prosthesis.
The Comparison of Tricuspid Replacement and Repair in Patients With Combined Heart Valve Disease
Condition: Tricuspid Valve Regurgitation
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      Functional tricuspid regurgitation is common in patients with heart valve disease,
      replacement and repair both can correct this anomaly. However, there is no data to address
      which one can bring more benefits to these patients with combined heart valve disease. The
      investigators retrospectively review patients with two or more heart valve disease and
      functional tricuspid regurgitation, and assess its long term outcomes.
    

Detailed description: 
      we reviewed patients who admitted to our hospital due to combined heart valve disease, and
      underwent tricuspid valve replacement or repair from January,1998 to december,2009. we made a
      comparison between these two groups, in term of early results after operation and long term
      results.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with aortic valve and mitral valve diseases and functional tricuspid valve
        regurgitation underwent surgical operations from Nov., 1998 to Dec., 2009 in our institute.
      
Keywords: tricuspid valve regurgitation; replacement; repair; outcomes
Regional Non-comparative Prospective Study of the Impact of Gamma Knife Radiosurgery on Tremor in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis, chronic inflammatory disease of the central nervous system, affects
      approximately 100,000 peoples in France. It is the leading cause of disability in young
      adults. Tremor is a common symptom (25-58% of patients depending on the series) and can be
      particularly disabling. The drug treatments against tremor are ineffective or insufficient.
      Deep brain stimulation of the Vim (Small nucleus within thalamus) and stereotactic
      radiofrequency thalamotomy have shown their efficacy in this indication. However, in some
      cases these invasive procedures are impossible because of operational risk. Gamma knife
      thalamotomy can be an alternative choice. This procedure, less invasive, mainly because of
      the absence of craniotomy is used by several teams of international reputation for over
      fifteen years, with good to excellent results in essential tremor. The team of Marseille,
      which has an experience of 22 years in Gamma Knife radiosurgery has treated 250 patients with
      severe tremor (essential tremor or Parkinson's disease) by a unilateral thalamotomy with an
      improvement of 70% of functional scores.

      In the literature, no formal studies of the effect of Gamma Knife in Multiple Sclerosis (MS)
      tremor is reported. There are only a few cases without specific evaluation of the efficacy in
      this disease. Hence the importance of studying in detail the effects of this technique, which
      allows a precise and limited lesion volume. Using an isocenter of 4mm and a dose of 130 Gy
      radiation lesion obtained is limited to a volume of 200 to 500 mm3.

      The aim of this study is to assess through a minimally invasive technique with a
      circumscribed and reproducible lesion volume, the effect of thalamotomy on the particular
      tremor in multiple sclerosis with a prospective evaluation of its effects.

      Patients with MS with a disabling tremor will be included in the study. They will be assessed
      with neurological examination, quality of life scales, neuropsychological assessment,
      functional scores and cerebral MRI.

      This study will demonstrate the feasibility and effectiveness of Gamma Knife thalamotomy in
      MS patients with severe tremor.
    


Intervention name(s): Thalamotomy by gamma Knife radiosurgery
Intervention type(s): Device
Intervention description(s): The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to see the affects of the study medication called mixed
      amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The
      researchers also want to see if MAS-XR makes your child more or less likely to develop
      problems like acting out (i.e. periods of irritability, agitation, aggression).

      MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention
      deficit hyperactivity disorder (ADHD) in adults, children and adolescents.
    

Detailed description: 
      A 12-week prospective study of two groups of adolescents (ages 10-18 years) with attention
      deficit/hyperactivity disorder (ADHD); 1) ADHD adolescents with a first degree relative with
      bipolar disorder ("high-risk") and 2) ADHD adolescents without any first or second
      degree-relatives with a mood disorder ("low-risk"). Patients will be evaluated using
      diagnostic interviews and symptom ratings, will receive neuroimaging scans (fMRI, DTI, 1H
      MRS), and will then be assigned to treatment. Low-risk ADHD adolescents (n=60) will receive
      treatment with open-label mixed amphetamine salts-extended release (MAS-XR), which is
      approved by the United States Food and Drug Administration (USFDA) for the treatment of ADHD
      and is a commonly prescribed psychostimulant medication for adolescents with ADHD. High-risk
      ADHD adolescents will be randomized to double-blind treatment with MAS-XR (n=60) or placebo
      (n=60). Following initiation of treatment, the ADHD adolescents will have regularly scheduled
      visits during which symptom and tolerability ratings will be performed. Healthy subjects
      (n=60) will be recruited from the community and will not receive medication but will undergo
      magnetic resonance imaging (MRI) scans at the same intervals to assess normal variability in
      imaging parameters between time points as well as to adjust and interpret comparisons within
      patients (i.e., whether patient values are changing toward or away from those of healthy
      adolescents). Neuroimaging (fMRI, DTI,1H MRS) evaluations will be performed at baseline and
      Week 12 (or termination).
    

Intervention name(s): mixed amphetamine salts-extended release (MAS-XR); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MAS-XR is a psychostimulant medication composed of amphetamine and dextroamphetamine, has been systematically studied in adolescents with ADHD, and is FDA-approved for the treatment of ADHD in adolescents.; Pills with no medication in it
Other intervention name(s): AdderallXR
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: ADHD
Whole Exome Sequencing in Coronary Artery Ectasia
Condition: Coronary Ectasia; Coronary Aneurysm
MeSH terms: Aneurysm; Coronary Aneurysm; Dilatation, Pathologic
Study type: Observational

Summary: 
      The goal of this observational study is to assess the role of the whole exome sequencing
      (WES) application in patients with giant coronary artery ectasia (CAE) with a high-risk of
      genetic background.

      The main question it aims to answer are:

        -  the assessment of role of WES in CAE

        -  the detection of novel pathogenic mutations associated with CAE development
    

Detailed description: 
      Coronary artery aneurysm and ectasia (CAAE) is defined as a dilation of the coronary artery
      by at least 1.5 times compared to the adjacent segment. The incidence of CAAE is reported in
      0.3-5.3% of patients undergoing coronary angiography. Giant CAAE is a rare phenomenon
      characterized by a dilation of a coronary artery exceeding 2 to 4 centimeters and it was
      found only in 0.02% of patients undergoing coronary angiography.

      The most common etiology of CAAE is atherosclerosis, followed by Kawasaki disease, infectious
      septic emboli, connective tissue disease and arteritis. Iatrogenic causes are less common.

      There are few genetic reports on potential loci associated with CAAE. Meta-analysis of genome
      wide association studies performed in European and Japanese population of children with
      Kawasaki disease has identified ITPKC, FCGR2A, CASP3 and FAM167A genomic regions to be
      associated with susceptibility to develop CAAE. Furthermore, 9p21 variant has been linked
      with coexistence of coronary artery disease, cerebral artery aneurysms and aortic aneurysms,
      mainly due to suspected potential adverse vascular remodeling. Nevertheless, the direct
      association of specific genetic variants with CAAE formation, especially with those giants,
      has not been proven.

      Therefore, the investigators aim to assess the role of the whole exome sequencing (WES)
      application in patients with giant coronary artery ectasia (CAE) with a high-risk of genetic
      background.
    

Intervention name(s): Whole exome sequencing
Intervention type(s): Diagnostic Test
Intervention description(s): Bioinformatic analysis of raw WES data and variants prioritization were performed as previously described.
Reads were aligned to the hg38 reference genome sequence and visualized by Integrative Genomic Viewer.
Other intervention name(s): Genetic analysis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with extremely giant coronary artery ectasia (CAE) and positive family history.
      
Biospecimen description: 
      DNA from proband was obtained from peripheral blood and extracted using standard protocols.
    
Keywords: Coronary ectasia; Coronary aneurysm; Whole exome sequencing; Mutations
Fluvastatin in the Therapy of Acute Coronary Syndrome
Condition: Coronary Disease; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed
      shortly after or immediately when the coronary event occurs.
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Coronary disease; Myocardial infarction; Statins
A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Glucose control is necessary to avoid the immediate and long-term adverse effects associated
      with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important
      step to achieving glucose control. Data suggest that large proportions of adolescents and
      young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing
      and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to
      increased risk of medical complications over an individual's lifespan, necessitating novel
      interventions to improve self-monitored blood glucose testing and metabolic control in
      emerging adults with type 1 diabetes. The investigators treatment approach, which provides
      direct tangible reinforcement for objective evidence of behavior change, is efficacious in
      decreasing substance use, reducing weight, and improving medication adherence.

      The purpose of this project is to develop and pilot test an intervention based on behavioral
      economic principles for improving self-monitored blood glucose testing in young persons with
      type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they
      test, and a return text will inform them of reinforcer vouchers earned. The investigators
      will collect data on self-monitored blood glucose testing frequency and A1c levels preceding
      treatment initiation and throughout a 6 month treatment period. If promising, a randomized
      trial will lead to larger scale evaluations of reinforcement interventions alone, or in
      combination with multimodal treatment approaches, and it may be applied to other clinical
      issues such as adherence to continuous glucose monitoring. Importantly, this intervention can
      be administered remotely and in an automated fashion, allowing for widespread adoption if
      efficacious.
    


Intervention name(s): contingency management
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a voucher for each self-monitored blood glucose test completed during the target testing window, and a bonus amount for each day that 4 tests fall within the testing windows and are separated by more than 2 hours.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Hyaluronan in Embryo Transfer Media
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media
      and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer
      are incubated in a culture media containing high concentration of hyaluronan or low
      concentration of hyaluronan.

      Primary outcome: implantation and pregnancy rates
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients entering in vitro fertilization and embryo transfer treatment
      
Keywords: In vitro fertilization; Embryotransfer; Hyaluronan; Pregnancy rate; Implantation rate
Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology
Condition: Myopia; Orthokeratology
MeSH terms: Myopia
Study type: Observational

Summary: 
      The present research focused on the effect of the age for the corneal biomechanics of low and
      moderate myopia patients after wearing orthokeratology (OK lens). According to age, the
      included cases were divided into 3 groups. Through the analysis of corneal biomechanical
      parameters, further learn the influence of OK lens on the patient cornea. It would help
      ophthalmologist and optometrist find out the potential issue and reach a better control
      result.
    

Detailed description: 
      The present research focused on the effect of the age for the corneal biomechanics of low and
      moderate myopia patients after wearing orthokeratology (OK lens). According to age, the
      included cases were divided into 3 groups: Ⅰ (8-12 years old), Ⅱ (13-16 years old), Ⅲ (over
      16 years old). The OK lenses used in the present study are of the same design (Euclid Systems
      Orthokeratology; Euclid System, Herndon, VA, USA). The base line (Day 0) and different
      follow-up time point (Day 1, Week 1, Week 2, Month 1, Month 3, and Month 6) of dynamic
      corneal response (DCR) (including 19 items) of the patients derived by Corvis ST were
      collected. The difference between before and after wearing OK Lens and the changes of
      parameters among the three groups were both analyzed. And the correlation between axis length
      (AL) and the 19 parameters also was analyzed. Through the analysis of corneal biomechanical
      parameters, further learn the influence of OK lens on the patient cornea. It would help
      ophthalmologist and optometrist find out the potential issue and reach a better control
      result.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Myopia with orthokeratology lens and complete follow-up.
      
Keywords: Myopia prevention and control; Orthokeratology; Dynamic corneal response