bioihbjkbjnl/mcl2 huggingface dataset:
Brain Correlates of Self-Focused Processing
Condition: Social Phobia; Body Dysmorphic Disorder
MeSH terms: Phobia, Social; Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether neuroimaging-based markers of maladaptive
      self-focused processing are better predictors of treatment response to cognitive-behavioral
      therapy than behavioral markers.
    

Detailed description: 
      First, the investigators propose to identify the neural correlates of self-focused
      processing. The investigators will assess baseline resting state connectivity within the
      default network, as well as regional brain activation using a well-validated event-related
      fMRI task that manipulates self-focused processing in patients with body dysmorphic and
      socially anxious symptoms, compared to healthy controls. This clinical sample was selected
      because such patients display heightened self-focused attention, and sampling individuals
      across these symptom dimensions will ensure greater variability on this dimension of
      maladaptive self-focused processing. Second, the investigators will examine the neural
      correlates of self-focused processing as a predictor of treatment response. Neuroimaging data
      will be acquired from patients with body dysmorphic and socially anxious symptoms during two
      scan sessions, before and after 12 weeks of individual cognitive behavioral therapy, and
      compared with healthy controls scanned twice at a 12 week interval. Finally, the
      investigators will compare the prediction of treatment response between neural measures and
      behavioral measures of self-focused processing. The investigators will assess the behavioral
      correlates of self-focused processing using a self-reference effect paradigm, and assess
      their relation to treatment response. If the investigators hypotheses are borne out, the
      investigators will have new targets for treatment, a method to identify promising candidates
      for treatment, and sensitive surrogate markers of treatment response.
    

Intervention name(s): Cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Twelve weekly sessions of individual cognitive-behavioral therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention; Cognitive behavioral therapy; Neuroimaging
Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)
Condition: Heart Diseases; Cardiovascular Diseases; Atherosclerosis; Hypertension; Diabetes Mellitus; Coronary Arteriosclerosis
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To document cardiovascular disease and cardiovascular disease risk factors among 1,200 Native
      Alaskans who are members of approximately 40 families.
    

Detailed description: 
      BACKGROUND:

      There are many compelling reasons to study heart disease in the Native Alaskans. These Eskimo
      villages are remote and isolated. The traditional lifestyle is being eroded by mechanization
      and a westernized diet. There has been relatively little outside genetic influence and they
      are, like the American Indians of the lower 48 states, beginning to show a marked
      acceleration in the prevalence of atherosclerosis and coronary artery disease.

      DESIGN NARRATIVE:

      The study is a family-based, cross sectional study. Recognized and emerging risk factors and
      prevalent cardiovascular disease are documented in each individual through a standardized
      interview, physical exam, laboratory measurements, carotid ultrasound, ECG, and a review of
      centralized medical records. Assays will be made of contemporary samples and serum specimens
      stored at the Anchorage Center CDC antedating this study (10 to 20 years ago) for specific
      markers of inflammation and serologic responses. Through a ten-centimorgan genetic map,
      attempts will be made to find specific genes that relate to cardiovascular disease.

      The study uses standard methods to assess risk factors relating to lipid metabolism,
      hypertension, and diabetes mellitus. Importantly, the study also uses state-of-the-art
      methods for detection of infectious disease exposure, specifically to C. pneumoniae,
      cytomegalovirus, and other infectious agents hypothesized to play a role in atherogenesis. A
      case-control age-matched design is used to analyze the infectious disease burden.
Functional Electrical Stimulation for Production of Artificial Cough
Condition: Spinal Cord Injuries; Paralysis
MeSH terms: Spinal Cord Injuries; Paralysis
Study type: Interventional

Summary: 
      The purpose of the present study is to assess the utility of abdominal muscle stimulation to
      provide large positive airway pressures and expiratory airflow thus simulating cough.
      Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory
      complications such as atelectasis, respiratory tract infections and respiratory failure.
    

Detailed description: 
      Cough is a complex defensive respiratory reflex mechanism necessary for the clearance of
      respiratory secretions and foreign materials. In patients with chronic bronchitis, previous
      investigations have found that the cough mechanism is the most effective measure to enhance
      mucous clearance from the lung.

      Patients with cervical and thoracic spinal cord injuries have suffered a loss of the major
      portion of their expiratory muscles. Consequently, they are unable to generate significant
      positive intrathoracic airway pressures or airflow and have a markedly increased risk of
      developing pulmonary infections. Mechanical methods have been developed to enhance cough
      production. However, these have resulted in only marginal increases in airway pressure.

      Preliminary studies in our laboratory in animal experiments and those of others in humans
      have suggested that the abdominal muscles can be stimulated directly by surface electrodes.
      The purpose of the present study, therefore, is to assess the utility of abdominal muscle
      stimulation in quadriplegics and paraplegics to simulate cough. A range of stimulus
      parameters and electrode locations will be assessed to determine optimal stimulus paradigms.
      Airway pressure and expiratory airflow will be used as indices of cough effectiveness. If
      successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully
      reduce the incidence of respiratory complications such as atelectasis and infection in spinal
      cord injured patients.
    

Intervention name(s): Placement and use of the device
Intervention type(s): Procedure
Intervention description(s): Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Safety of Nailner Brush 2in1 in Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      Evaluate the effectiveness of Nailner Brush 2-in-1 in the treatment of onychomycosis based on
      the blinded evaluation of the percentage of healthy nail surface after 6 months of treatment
      compared to baseline.
    


Intervention name(s): topical treatment
Intervention type(s): Device
Intervention description(s): Topical application of Nailner brush 2in1 for toenail onychomycosis
Intervention model: Single Group Assignment
Intervention model description: Topical application of Nailner brush 2in1 (medical device) for the treatment of toenail onychomycosis
Masking: None (Open Label)
Primary purpose: Treatment
Compare the Effects of Agility and Cycling Exercise Training on Mobility and Balance in PD and Healthy Old Adults
Condition: Healthy; Movement Disorders; Parkinson Disease; Condition
MeSH terms: Parkinson Disease; Movement Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to compare the effectiveness and specificity of agility and
      cycling exercise training on balance and mobility outcomes in PD and age and gender matched
      healthy controls. The hypothesis is that due to being profoundly deconditioned, agility and
      cycling will be similarly effective in PD but agility will be more effective then cycling in
      healthy old adults, in improving mobility and balance.
    


Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): Healthy cycling group: The group participates in 5 weeks of intensive cycling therapy.
Healthy xbox group: The group participates in 5 week intensive xbox therapy Healthy controll group: The group does not take any kind of therapy. PD group: We have already analyzed the results of our group, and we will compare their results with the results of healthy groups.
Other intervention name(s): Healthy cycling group; Healthy xbox group; PD group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: balance; postural controll; motor controll; posturgraphy; quality of life
The CARO Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      A controlled dietary intervention study will be carried out based on the stable isotope
      method the investigators have developed to quantify both the absorption of beta-carotene and
      its bioconversion to retinol in oil and in a mixed diet. For 6 weeks the participants will
      consume 2 capsules/day, 7 days/week with each capsule containing 50-mg [13C10] beta-carotene
      and 50-mg [13C10] retinyl palmitate. For three weeks they will consume a diet with high
      levels of beta-carotene in vegetables and fruits and for the other 3 weeks they will consume
      a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra
      amount of beta-carotene in oil. Samples of blood and faeces will be taken.

      The study hypothesis is that the absorption of beta-carotene in oil in comparison with the
      absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators
      want to measure the influence of the food matrix of vegetables and fruits on the absorption
      of beta-carotene in healthy humans on a western diet.
    


Intervention name(s): absorption and conversion of beta-carotene in human gastrointestinal (GI) tract
Intervention type(s): Behavioral
Intervention MeSH terms: Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vitamin A; beta Carotene; diet; nutrition; nutritional requirements
Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The aim of this study is to investigate the relationship between grip endurance, disability
      of upper extremity and quality of life in patients with rheumatoid arthritis.
    

Detailed description: 
      Upper extremity functions affect the quality of life at different levels in patients with
      rheumatoid arthritis (RA). In the current literature; it has been shown that grip endurance
      is associated with upper limb functions. However, there is no study investigating the
      relationship between grip endurance and quality of life in patients with RA. The purpose of
      this study is to investigate the relationship between grip endurance, disability of upper
      extremity, and quality of life in patients with RA.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population of the study consists of RA patients.
      
Keywords: Grip Endurance, DASH, Quality of Life, Rheumatoid Arthritis.
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
Condition: Clostridium Difficile Infection; Diarrhea
MeSH terms: Infections; Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to
      elderly individuals at risk of exposure to Clostridium difficile because of impending
      hospitalization or residence in a care facility.

      Primary Objectives:

        -  To describe the safety profile of subjects in each of the study groups.

        -  To describe the immune responses elicited by toxoid A and toxoid B of subjects in each
           of the study groups.

      Observational Objective:

        -  To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
    

Detailed description: 
      Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™
      vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I
      will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different
      vaccination schedules using one of these formulations.

      Participants will be followed up for safety and immunogenicity; stool samples will also be
      provided in case of diarrhea.
    

Intervention name(s): Clostridium difficile toxoids A and B (Low-dose with adjuvant); Clostridium difficile toxoids A and B (Low-dose without adjuvant); Clostridium difficile toxoids A and B (high-dose with adjuvant); Clostridium difficile toxoids A and B (high-dose without adjuvant); Placebo: 0.9% normal saline; Clostridium difficile toxoids A and B (high-dose with adjuvant); Clostridium difficile toxoids A and B (high-dose with adjuvant)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular on Days 0, 7, and 30; 0.5 mL, Intramuscular on Days 0, 7, and 30; 0.5 mL, Intramuscular on Days 0, 7, and 30; 0.5 mL, Intramuscular on Days 0, 7, and 30; 0.5 mL, Intramuscular on Days 0, 7, and 30; 0.5 mL, Intramuscular on Days 0, 7, and 180; 0.5 mL, Intramuscular on Days 0, 30, and 180
Other intervention name(s): ACAM-CDIFF™ vaccine; ACAM-CDIFF™ vaccine; ACAM-CDIFF™ vaccine; ACAM-CDIFF™ vaccine; 0.9% normal saline; ACAM-CDIFF™ vaccine; ACAM-CDIFF™ vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clostridium difficile infection; Diarrhea; Pseudomembranous colitis; Clostridium Difficile Toxoid Vaccine; ACAM-CDIFF™ vaccine
Glucocorticoid-induced Osteopenia in Children
Condition: Crohn's Disease; Nephrotic Syndrome
MeSH terms: Crohn Disease; Nephrotic Syndrome; Nephrosis
Study type: Observational

Summary: 
      The purpose of this study is to characterize the skeletal deficits and risk factors for
      impaired skeletal development in children requiring glucocorticoid therapy.

      We will compare the bone health of children treated with prednisone for nephrotic syndrome
      (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually
      responds to prednisone and is not characterized by pathologies that can impact on bone. In
      contrast, CD is treated with prednisone, but is independently associated with poor growth and
      maturation, nutritional deficiencies and inflammation. Due to the differences in the
      diseases, this comparison will allow us to distinguish between the prednisone-related and
      disease-related effects on bone in the two disease states.
    

Detailed description: 
      Prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. Studies
      have shown that this drug decreases bone formation, decreasing bone density and bone
      thickness in children. Prednisone induced osteopenia, or low bone density, can be worsened by
      the effects of the underlying disease, such as delayed growth and maturation, malnutrition,
      and increased bone resorption (removal) by inflammatory compounds. The combined effects of
      decreased bone formation and increased resorption may be particularly detrimental to the
      growing skeleton.

      Subjects will include 15 newly diagnosed NS patients, 60 patients with pre-existing NS, 90
      patients with newly diagnosed CD, 45 patients diagnosed within the last two years and 200
      healthy controls of similar age, gender and ethnicity. Participants will visit the Children's
      Hospital of Philadelphia (CHOP) three times over a 12-month period for assessment of bone
      mineralization and turnover, fracture history, dietary calcium intake, physical activity,
      growth, body composition, muscle strength and glucocorticoid exposure.
    

Time perspective: Prospective
Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the
      evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated
      with GA and in healthy controls.
    

Detailed description: 
      The primary aim of this study is to explore whether treatment with Copaxone may decrease
      accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on
      optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a
      reference population of healthy controls.

      The secondary objective of this study is to investigate the effect of GA on total macular
      volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the
      24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by
      Expanded Disability Status Scale (EDSS).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing remitting multiple sclerosis Healthy controls without known
        neurological problems.
      
Keywords: OCT; Copaxone; Multiple sclerosis; relapsing-remitting
A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration
Condition: Type 2 Diabetes Mellitus(T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacokinetic parameters of
      saxagliptin and metformin in healthy male Chinese subjects.
    

Detailed description: 
      A Single-centre, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the
      Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration of the
      Individual Components in two cohorts of Healthy Chinese Subjects under Fed Conditions
    

Intervention name(s): Saxagliptin 5 mg; Metformin XR 500 mg; Mertformin XR 2 x 500 mg; Komboglyze XR 5/500 mg; Komboglyze XR 5/1000 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Saxagliptin oral tablet 5mg, single dose; Metformin XR oral tablet 500 mg, single dose; Metformin XR oral tablet 2 x 500 mg, single dose; oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose; oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 2 diabetes, Saxagliptin, Metformin,Fixed dose combination tablet, Bioequivalence, pharmacokinetic, safety, tolerability
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CHI-915 in Healthy Participants
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-phase, randomized, double-blind, placebo-controlled, within-participant
      crossover study to assess the safety, tolerability, PK, and PD of five oral doses of CHI-915
      versus placebo in healthy adult participants ages 18-55 years.
    


Intervention name(s): THCv
Intervention type(s): Dietary Supplement
Intervention description(s): THCv in MCT oil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The is a two-phase, within participant crossover study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Use of Critical-Care Pain Observation Tool and Bispectral Index for Detection of Pain in Brain Injured Patients
Condition: Intensive Care; Brain Injuries
MeSH terms: Brain Injuries; Pain
Study type: Observational

Summary: 
      Brain injured patients are at high risk of pain due to the illness itself and a variety of
      nociceptive procedures in intensive care unit. Since the disorder of consciousness, speech,
      and movement, it is usually difficult for them to self-report the presence of pain reliably.
      The Critical-Care Pain observation Tool (CPOT) has been recommended for clinical use in the
      critically ill patients when self-report pain is unavailable. Besides, it seems that the
      bispectral index (BIS), a quantified electroencephalogram instrument, can be used for pain
      assessment along with the CPOT tool in some nonverbal critical ill patients (e.g., intubated
      and deep sedation). However, the validity and reliability of CPOT and BIS for pain assessment
      in brain injured patients are still uncertain so far. So the aim of this research is to
      investigate the value of CPOT and BIS for pain evaluation in this specific patient group.
    


Intervention name(s): Critical-Care Pain Observation Tool (CPOT)
Intervention type(s): Diagnostic Test
Intervention description(s): The CPOT includes 4 behaviors: (1) facial expression, (2) body movements, (3) compliance with the ventilator, and (4) muscle tension. Each behavior is rated from 0 to 2 for a possible total score ranging from 0 to 8.
Other intervention name(s): Bispectral Index (BIS)
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with brain injury and artificial airway