bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of AMALS in Treating Language Impairment in Children
Condition: Language Disorder
MeSH terms: Language Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this proposal is to examine the efficacy of a manualized treatment intervention,
      AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate
      semantic, morphological, and syntactic aspects of language in preschool children with
      language impairment. This study will target preschool children with language impairment
      living in a region characterized by nonmainstream dialects.

      Questions driving this work are:

        1. Will children participating in the AMALS treatment exhibit greater semantic,
           morphological, and syntactic complexity on multiple outcome measures at the completion
           of the intervention compared to a Discrete Trial Approach (DTA) group?

        2. Will these gains be maintained at one-month follow up?

        3. What is the impact of dialect on dependent variables, specifically morphosyntactic
           abilities?

      To answer these questions a randomized clinical trial will be conducted comparing AMALS, an
      integrated approach to treatment, with DTA, an additive approach to therapy. In this study
      rather than restrict the ethnic and cultural backgrounds of this population, children's use
      of dialect will be uniquely identified and examined.
    


Intervention name(s): AMALS; DTA
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Addressing multiple aspects of language simultaneously; Discrete Trial Approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
Condition: Facioscapulohumeral Muscular Dystrophy (FSHD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and efficacy of Losmapimod in treating patients with
      Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.
    

Detailed description: 
      This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,
      multicenter study designed to evaluate the efficacy and safety of losmapimod in treating
      patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks. Patients will
      participate in this study for approximately 53 weeks. This will include a 4-week screening
      period, a 48-week, placebo-controlled treatment period and a 7 day safety follow-up period.
      Patients must have a confirmed diagnosis of FSHD1 and genetic confirmation must be obtained
      prior to the screening MRI and baseline muscle biopsy. Patients will be randomized to receive
      15 mg of losmapimod or placebo twice daily given as two 7.5 mg tablets per dose by mouth; for
      a total of 4 pills or 30 mg daily for 48 weeks. All patients will be asked to attend the
      study clinic for each scheduled visit.

      The primary endpoint of the study is to evaluate the efficacy of losmapimod in inhibiting or
      reducing expression of DUX4, as measured by a subset of DUX4-regulated gene transcripts in
      skeletal muscle biopsies of FSHD patients. Secondary endpoints include evaluation of the
      safety and tolerability of losmapimod, the plasma concentrations of losmapimod, levels of
      losmapimod in skeletal muscle and losmapimod target engagement in blood and skeletal muscle
      in FSHD patients.
    

Intervention name(s): Losmapimod; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): This study includes a 48 week treatment period. Patients will receive Losmapimod 15 mg twice daily given as two 7.5 mg tablets per dose by mouth; for a total of 4 pills or 30 mg daily. The study drug should be taken with food and the date and time of each dose taken recorded in the subject diary.; This study includes a 48 week treatment period. Patients will receive Placebo twice daily given as two 7.5 mg tablets per dose by mouth; for a total of 4 pills or 30 mg daily. The placebo tablets are identical to the Losmapimod tablets. Placebo should be taken with food and the date and time of each dose taken recorded in the subject diary.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized, double-blind, placebo-controlled, 48-week parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FSHD, FSHD1; Muscular Dystrophies; Muscular Dystrophy; Facioscapulohumeral Muscular Disorders; Musculoskeletal Diseases; Neuromuscular Diseases
Ketorol Gel in Gonarthrosis and Low Back Pain
Condition: Gonarthrosis; Low Back Pain
MeSH terms: Osteoarthritis, Knee; Osteoarthritis; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparative clinical study of Ketorolac tromethamineand Ketoprofen gel in patients with
      Gonarthrosis and Low back pain.
    

Detailed description: 
      This is a Comparative evaluation of therapeutic efficacy and safety of use of drug Ketorolac
      tromethamine gel and drug Ketoprofen gel , as an agent of local symptomatic therapy in
      patients with diseases of musculoskeletal system with associated pain syndrome in outpatient
      conditions.

      The study includes patients with moderate pain syndrome in gonarthrosis and lower back pain
      (LBP).

      The sample size of 240 was calculated for the main efficacy variable - mean pain intensity
      according to the visual analogue scale (VAS) in 10 days of therapy.

      Patients who subjected to inclusion into the study and had signed informed consent will be
      distributed into the study groups depending on established diagnosis: Gonarthrosis group and
      LBP group.
    

Intervention name(s): Ketorolac Tromethamine; Ketoprofen
Intervention type(s): Drug; Drug
Intervention description(s): Ketorolac tromethamine gel 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days; Ketoprofen gel 2.5% for external application Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Gonarthrosis; Low Back Pain; Ketorolac Tromethamine; Ketoprofen
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effect of erenumab on medication-specific
      treatment satisfaction.
    


Intervention name(s): Erenumab
Intervention type(s): Drug
Intervention description(s): Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
Other intervention name(s): AMG 334
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Migraine; Chronic Migraine; Episodic Migraine; Erenumab
Effect of Remimazolam on Motor Evoked Potential
Condition: Spine Disease
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      This study was planned to investigate the degree of effect of remimazolam on MEP compared to
      propofol when monitoring the motion-inducing potential (MEP).
    


Intervention name(s): Propofol; Remimazolam Besylate
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia induction and maintenance with propofol 60 minutes later, change the maintenance drug to remimazolam; Anesthesia induction and maintenance with remimazolam 60 minutes later, change the maintenance drug to propofol
Other intervention name(s): Remimazolam Besylate; Propofol
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Digital Cognition in Multiple Sclerosis
Condition: Multiple Sclerosis; Cognitive Decline
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
Study type: Interventional

Summary: 
      A DIGITAL THERAPEUTIC TO IMPROVE THINKING IN MULTIPLE SCLEROSIS

      WHO: 65 participants with a confirmed diagnosis of Multiple Sclerosis (MS)

      WHY: Purpose of the study is to compare the effect of 2 tablet-based brain training digital
      tools on important components of thinking (cognition).

      WHAT: Complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and
      use one of two brain training tools on an iPad in your home, for 25 minutes a day, 5 days a
      week, for 6 weeks.

      WHERE: UCSF WEILL INSTITUTE FOR NEUROSCIENCES (675 Nelson Rising Lane, San Francisco, CA)
    

Detailed description: 
      The purpose of this study is to begin to test a brain training video game in people with
      Multiple Sclerosis (MS).

      Visit 1. After informed consent, you will complete a series of questions about your
      functioning and mood. You will then complete a series of tests (vision, hand tapping,
      walking). Then, you will complete a set of thinking tests. The first set will be paper and
      pencil. The second set will be on a tablet or a computer. You will use your study code to
      sign into these tools and you won't provide any personal details for the digitized tests.

      Finally, you will complete the "cognitive training tool". There are two versions of this
      digital, iPad based tool, which takes about 25 minutes to complete and is designed to be
      entertaining. You will be randomized into 1 of 2 groups: each group will play a version of
      the brain training game. You will not be told what group/game type you were randomized into.
      You will be given the tablet with the game on it to take home, and to practice this game 5
      times a week for 6 weeks.

      Visit 2. After the 6 weeks of at-home training, you will then come back to the research study
      unit to do a repeat of the initial visit (with physical and cognitive assessments). At this
      study visit, you will also be returning the iPad.

      Visit 3. You will then return 8 weeks after Visit 2, to do a repeat of the assessments.

      You will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).
    

Intervention name(s): Tablet-based Game
Intervention type(s): Device
Intervention description(s): Tablet-based game aimed at improving processing speed and attention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Changes in Pulse Wave Transit Time and Its Variability After Placement of Interscalene Brachial Plexus Block
Condition: Interscalene Brachial Plexus Block
Study type: Observational

Summary: 
      Pulse wave transit time (PWTT) increases due to decreased arterial vascular tone resulting
      from sympathetic blockade caused by regional anesthesia. Its oscillation (PWTT variability)
      also contains information on the interaction between autonomic nervous system and the
      cardiovascular system. The changes in PWTT and its variability have not been investigated in
      patients receiving interscalene brachial plexus block (ISBPB). It was hypothesized that ISBPB
      increases PWTT and reduces low frequency power of PWTT variability.
    


Intervention name(s): Interscalene brachial plexus block
Intervention type(s): Procedure
Intervention description(s): Using a linear ultrasound transducer connected to an ultrasound machine, the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery. The transducer is moved cephalad to visualize the 5th to 8th cervical (C5 to C8) nerve roots located between the anterior and middle scalene muscles. Using an in-plane technique, a block needle is inserted close to a nerve root in a lateral-to-medial direction. The needle is moved to place 0.75% ropivacaine around each nerve root. The C8 nerve root is blocked first, and the C5 nerve root is blocked last. After blocking the four cervical nerve roots, ropivacaine is placed in the intermuscular plane between the sternocleidomastoid and scalene muscles to block the supraclavicular nerves. A total of 26 ml of 0.75% ropivacaine is used for the interscalene brachial plexus block (6 ml per nerve root and 2 ml for the supraclavicular nerves).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary university medical center
The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block
Condition: Erector Spinae Plane Block; Local Anesthetic; Thoracotomy; Postoperative Analgesia
Study type: Interventional

Summary: 
      It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency
      of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods
      have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA),
      thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane
      block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided
      TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as
      ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial,
      easy to access, and less likely to have complications. In addition, ESPB application is
      increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose
      of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the
      literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing
      local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed
      with USG in patients who underwent thoracotomy.
    


Intervention name(s): Same blocks with different local anesthetic volume
Intervention type(s): Procedure
Intervention description(s): Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Environmental Opportunities and Barriers on Physical Activity, Fitness, and Health in Hispanic Children in Wisconsin
Condition: Obesity, Diabetes, Nutrition, Physical Health
MeSH terms: Obesity
Study type: Observational

Summary: 
      This is a pilot community-based research study to examine the effects of specific
      environmental and social factors on physical activity, fitness, and health of middle school
      Hispanic children living in an inner-city community.
    

Detailed description: 
      Our primary hypothesis is that the disparity between a community's potential for physical
      activity and nutrition, and the realized fitness and health of its children, can be
      attributed to specific environmental and social factors. "Built environment" studies to date
      have measured potential for physical activity but have not looked at how social factors
      mediate an individual's activity within a particular environment. The unique aspect of this
      proposal is the development of a model that explains how physical, social, cultural, and
      nutritional SEM layers interact to create gaps between potential and realized physical
      activity. This project will utilize novel technologies to:

        1. identify and analyze characteristics of the social and built environment that inhibit or
           enhance physical activity and healthy nutrition;

        2. determine the direction and extent of influence of these variables on children's
           activity, nutrition, and health;

        3. gather ideas from students, parents, and school staff to inform a potential health
           campaign to reduce and prevent obesity in the community.

      To address these goals and demonstrate a causal relationship between physical activity and
      the social-nutritional factors within a built environment, the following specific
      objectives/aims are being addressed:

      Specific Aim 1: Assess the built environment for energy requirements of movement, nutrition
      options, suitability for outdoor physical activity, and for children's actual physical
      activity and energy expenditure within those environments.

      Specific Aim 2: Assess the impact of children's social environment on movement and nutrition
      choices within the built environment.

      Specific Aim 3: Conduct a quantitative assessment of children's fitness, obesity, and
      indicators of metabolic health.

      Specific Aim 4: Develop a quantitative model from Specific Aims 1-3 that describes the causal
      relationships among children's physical health, community "healthfulness," and other
      mediating factors such as attitudes, perceptions, and behavior.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Middle - school age children in grades 5-8
      
Keywords: Obesity, diabetes, hispanic, physical activity, nutrition
Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments
      x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle
      correction having not worn contact lenses on the day of the visit.
    


Intervention name(s): etafilcon a Test 1; etafilcon A Test 2; etafilcon A Test 3; Control
Intervention type(s): Device; Device; Device; Other
Intervention description(s): 1-DAY ACUVUE® MOIST; 1-DAY ACUVUE® MOIST for ASTIGMATISM; 1-DAY ACUVUE® MOIST MULTIFOCAL; Bare Eye
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Relative Efficacy of Vitamins D2 and D3 in Adult Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the
      same dose of vitamin D3.
    


Intervention name(s): vitamin D2; vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study Supplement; Study Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D2; vitamin D3; ergocalciferol; cholecalciferol; vitamin D status; To determine relative potency of vitamins D2 and D3 under conditions of continuous administration; To determine change in vitamin D content of subcutaneous fat after 12 weeks' administration
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This is a pragmatic, single-blinded randomized trial of improving adherence to dietary
      interventions in patients with MS who are receiving monthly natalizumab infusions.
    

Detailed description: 
      MS affects at least 400,000 people in the US alone, and its incidence has increased in the
      past 50 years, likely due to changing environmental risk factors. Recent research suggests
      that diet may be a critical factor in the development of MS. The "Western diet", high in
      sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune
      system, altering gut bacteria, and changing metabolism.

      Studying patients with MS who are overweight and obese may be relevant as obesity can cause
      chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification
      represents an interesting potential therapy for MS, particularly calorie restriction and
      fasting, which have been associated with reduced markers of inflammation. In addition to
      these direct effects, weight optimization may lead to improvements in MS-related symptoms,
      like fatigue, and overall quality of life.

      This is a single-blinded randomized trial of adherence to a dietary intervention in patients
      with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of
      technology may help patients with MS adhere to a calorie restricted diet. It will also
      evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A
      second part of the study will evaluate if shortening the period during the day in which
      people consume their typical food amounts leads to improvements in patient-reported outcomes.
    

Intervention name(s): Frequent Patient Interaction; Timing Restriction; LoseIt! Smartphone Application
Intervention type(s): Other; Behavioral; Device
Intervention description(s): Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.; Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.; Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: calorie restriction; weight loss
Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People
Condition: Overweight
MeSH terms: Overweight; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this research study is to learn more about how our body produces sugar, breaks
      down fat for fuel, and makes insulin (the major hormone that controls the production of blood
      sugar and fat breakdown) during a 24-hour day and how body fat and muscle are involved in
      these processes.
    

Detailed description: 
      The purpose of this study is to determine whether there are diurnal differences in
      postprandial beta-cell function and hepatic insulin sensitivity and the factors that
      influence these metabolic functions, including insulin signaling, adipose tissue and systemic
      inflammation, nicotinamide phosphoribosyltransferase (NAMPT)-mediated nicotinamide adenine
      dinucleotide(NAD) biosynthesis, and sirtuin (silent mating type information regulation 2
      homolog 1 (SIRT1)) in overweight human subjects.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of female subjects of all races and ethnic groups.
        Participants will be recruited by reviewing our database of research subjects containing
        thousands of research study volunteers and by St. Louis metro area postings.
      
Biospecimen description: 
      Blood samples, adipose tissue samples and muscle samples
    
Keywords: Overweight