bioihbjkbjnl/mcl2 huggingface dataset:
Light Sleep: Screen Use and Sleep Health
Condition: Glasses
Study type: Interventional

Summary: 
      The Phone Sleep Study is being done to find out whether wearing blue light-blocking glasses
      in the evening improves subsequent sleep. This is a 21-day study and participants will be
      asked to wear a sleep-monitoring "actiwatch", a heart tracker, and an activity monitor, as
      well as to provide screenshots of participants' smartphone's screen time app for three weeks.
      Participants will also be asked to wear a blood pressure cuff on their arm for three days
      during each week, for a total of nine days.
    


Intervention name(s): Blue light-blocking glasses; Glasses with clear lenses
Intervention type(s): Device; Device
Intervention description(s): Participants will be randomly assigned to wear either blue light-blocking glasses or glasses with clear lenses during the second week of the study. During the third week, participants will be assigned to wear the opposite pair of glasses.; Non-blue light-blocking glasses
Other intervention name(s): Swanwick Night Swannies; Swanwick glasses
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly assigned to wear either blue light-blocking glasses or glasses with clear lenses during the second week of the study. During the third week, participants will be assigned to wear the opposite pair of glasses. Sleep and wake behaviors are the primary study outcome.
Masking: Single (Participant)
Primary purpose: Other
Serum CTRP3 and RBP4 Levels in Obesity and Hypertension
Condition: Obesity; Hypertension
MeSH terms: Hypertension; Obesity
Study type: Observational [Patient Registry]

Summary: 
      Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines
      may play important roles in the pathogenesis of obesity, which are a link between obesity and
      obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4
      (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This
      study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and
      essential hypertension.
    

Detailed description: 
      Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly
      diagnosed obesity and essential hypertensive patients not taking anti-obese and
      antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All
      subjects were divided into two groups depending on body mass index (BMI), including NW group
      and obesity group, and then four subgroups were divided according to obesity and
      hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup
      (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup
      (OB-HTN).
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We consecutively selected 2100 Chinese subjects from the general population who had
        undergone medical check-ups at the Southwest Hospital Medical Center at the Third Military
        Medical University
Ultrasound Evaluation of OMT for Sacral Base Asymmetry
Condition: Manipulation, Osteopathic
Study type: Interventional

Summary: 
      This prospective, randomized, controlled trial is proposed to investigate the effect of OMT
      on sacral base asymmetry as assessed by ultrasound.
    

Detailed description: 
      The proposed prospective, randomized, controlled trial will investigate the effect of
      osteopathic manipulative treatment (OMT) on sacral base asymmetry as assessed by ultrasound.
      The study will be conducted between July 2016 - June 2017 with data collection planned for
      August and September 2016. Forty men and women ages 20 to 55 years with at least one or more
      episodes of LBP in the past two weeks will be recruited from the Kirksville area.
      Participants will be randomly assigned into two groups, control or OMT using a random number
      generator. Males and females will be randomized separately to ensure equal distribution into
      the two study groups. Demographics including sex, age, and body mass index (BMI) will be
      collected on all participants. All participants will complete a brief medical history
      questionnaire, receive an initial palpatory assessment of the sacral base asymmetry, and then
      an initial ultrasound evaluation of sacral base asymmetry. After the ultrasound assessment,
      the control group will wait in another room for approximately 30 minutes. Participants in the
      OMT group will receive OMT to address sacral base asymmetry after the initial ultrasound
      assessment. Following the treatment period for the OMT group, all participants will receive a
      second ultrasound assessment of sacral base asymmetry. The ultrasonographer will be blinded
      on whether the subject received an OMT or not. After the second ultrasound measurement, the
      participants in the control group will be offered an OMT treatment consistent with that of
      the OMT group.
    

Intervention name(s): OMT
Intervention type(s): Procedure
Intervention description(s): Osteopathic Manipulative Treatment to low back region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic Manipulation; Somatic Dysfunction; Musculoskeletal Ultrasound
miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
Condition: Vascular Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      To assess the expression of miRNA in patients with TAA, AAA in aneurysmatic tissue and to
      compare this expression with the healthy tissue in the same patient.

      In the same cohort, to asses the presence of miRNA in plasma and to compare with the control
      group.

      Over the period of three years,to follow subjects in order to assess if the presence of
      certain miRNAs speeds up or slows down the progression of disease.

      In patients with intracranial aneurysms to detect miRNA in plasma especially in patients with
      familial occurrence.
    

Detailed description: 
      MicroRNAs constitute a recently discovered class of non-coding RNAs that play key roles in
      the regulation of gene expression. Acting at the post-transcriptional level, MicroRNAs have
      been shown to be involved in a wide range of biological processes such as cell cycle control,
      apoptosis and several developmental and physiological processes including stem cell
      differentiation, hematopoiesis, hypoxia, cardiac and skeletal muscle development. In addition
      to their important roles in healthy individuals, microRNAs have also been implicated in a
      number of diseases including a broad range of cancers, cardiovascular and heart disease.
      Their different expression in aortic tissue in patients with aortic abdominal aneurysm and
      their association with the progression of the disease were confirmed. They represent the
      potential target for the treatment of the disease. MiRNA act as biomarkers showing the
      potential risk of the presence of TAA, AAA and intracranial aneurysm, for the prediction of
      TAA and AAA progression and for the discovery of new treatment possibilities.
    

Intervention name(s): ngs next generation sequencing
Intervention type(s): Diagnostic Test
Intervention description(s): the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study group will be made up of 50 subjects followed for the diagnosis of AAA or TAA and
        20 patients with intracranial aneurysm. The control group comprises 20 subjects in total
        and will be made up of patients who are treated for lipid metabolism disorder
      
Biospecimen description: 
      Aneurysmatic tissue, healthy tissue and blood
    
Keywords: miRNA
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Observational

Summary: 
      Following licensing of PoliorixTM in Korea, this study will collect safety data about the
      routine use of this vaccine in 600 children according to the regulations of Korean Food and
      Drugs Administration (KFDA).
    

Detailed description: 
      An open, multicentric, post-marketing surveillance study to monitor the safety and
      reactogenicity of GlaxoSmithKline Biologicals. Poliomyelitis vaccine (inactivated)
      -PoliorixTM., administered in Korean children as a primary vaccination in healthy subjects
      aged two to six months or as a booster vaccination in subjects aged four to six years.
    

Intervention name(s): Poliomyelitis vaccine (inactivated) -PoliorixTM
Intervention type(s): Biological
Intervention description(s): Deep intramuscular injections for the primary vaccination and booster vaccination.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Korean children between two and six months of age (primary vaccination) or between four and
        six years of age (booster vaccination) at the time of vaccination.
Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures
Condition: Supracondylar Humerus Fracture
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      Supracondylar humerus fracture are common upper extremity injuries in children accounting for
      over 400 fractures per year and approximately 25% of all fractures treated at Seattle
      Children's Emergency Department. Most of these fractures are treated with splints and casts
      though more than one-third undergo surgical fixation followed by casting. Healing is usually
      complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion
      begun. Though stiffness is often a problem after immobilization of adult elbow fractures,
      stiffness after pediatric elbow fractures is regarded as typically transient. This study
      addresses the question "Does early motion of the arm with physiotherapy promote the return of
      function and motion in patients with supracondylar humerus fractures?" The investigators will
      conduct a prospective randomized trial to determine the effect of six occupational therapy
      visits over a five week period of time on elbow function and mobility after supracondylar
      humerus fracture. The investigators will measure motion of the elbow and administer the child
      and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer
      this question.
    


Intervention name(s): Occupational therapy
Intervention type(s): Other
Intervention description(s): Participants in this arm will receive six sessions of occupational therapy in a 5 week period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
Condition: Failed Conscious Sedation During Procedure
Study type: Interventional

Summary: 
      Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the
      beginning of colonoscopy. MEI works by creating an electromagnetic field of very low
      intensity. By that the position of the endoscope can be displayed virtually on a monitor. The
      use of MEI has been shown to reduce the formation of loops and to ease the removal of
      existing loops during the investigation. Furthermore, as loops favour the occurrence of pain
      when the scope is moved forward, patients who underwent colonoscopy with MEI reported less
      pain at the end of the procedure.

      Sedation is used widely during colonoscopy for it has improved the tolerability of the
      investigation. Most of the patients demand for sedation. In Germany Propofol is recommended
      as the first-line sedative when endoscopy it is performed in an outpatient setting. The use
      of Propofol involves the danger of respiratory complications. One reason for the application
      of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if
      MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We
      therefore planned this prospective controlled trial.
    


Intervention name(s): Magnetic Endoscope Imaging (Scope Guide)
Intervention type(s): Device
Other intervention name(s): brand name: Scope guide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sedation; Colonoscopy; Propofol; Scope guide
Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety
      and tolerability of single and multiple twice daily doses of inhaled Aclidinium
      Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable
      moderate to severe COPD.
    

Detailed description: 
      Screening will be performed within 21 days of dosing on Day 1 at visit 2. Eligible
      participants will be admitted to the trial center the day preceding the first dosing (day
      -1).

      Participants will receive Aclidinium Bromide/Formoterol Fumarate 400/12 μg twice-daily
      (morning and evening) on Days 1 to 4. On Day 5 patients will receive the morning dose only.
      PK and safety assessments will be conducted at specific timepoints on Day 1 to Day 7.

      Participants will be discharged 48 h after the last administration of investigational product
      and completion of the 48-h PK sample collection and safety assessments on Day 7.

      A follow-up visit will be performed within 5 days of the last PK sample collection on Day 7.
    

Intervention name(s): Aclidinium Bromide/Formoterol Fumarate 400/12μg BID
Intervention type(s): Drug
Intervention description(s): Aclidinium bromide/formoterol fumarate 400/12μg administered by inhalation via the Genuair® multidose dry powder inhaler, twice daily (morning and evening) for 5 days
Intervention MeSH terms: Bromides; Formoterol Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
School-Age Children With Autism With Limited Expressive Language Skills
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This project will address a major challenge to the field of autism research: improving
      expressive communication in children with autism who have reached school age but have not
      acquired functional spoken language (non-verbal school aged children with autism; NVSACA).

      Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger
      site and follow-up testing but continue to have minimal functional spoken language will be
      participants in this study. After eligibility is established, participants will be randomly
      assigned to a baseline duration of one week, two weeks or three weeks before the start of
      active treatment. Once the baseline duration is completed, participants begin active
      treatment one hour of intervention three days per week in the participants' school setting.
      In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to
      improve the child's generalization of skills and teach parents the strategies implemented in
      their child's treatment. Post-baseline and post-treatment assessments will be completed in
      the lab at a time that is convenient for the participants' families.
    


Intervention name(s): Non-Verbal School Aged Children with Autism (NVSACA) Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention has 3 components:
One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; language; intervention; school-age
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mix 25 to Humalog® Mix 25 in Healthy Subjects
Condition: Clamp Study
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro mix 25
      (Insulin Lispro Mix 25 GEROPHARM vers. Humalog® Mix 25 Eli Lilly)
    

Detailed description: 
      A randomized duble blinded two-way crossover single-dose pharmacokinetics and
      pharmacodynamics study of Insulin Lispro Mix 25 (LLC "GEROPHARM", Russia) versus Humalog® Mix
      25 (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique
    

Intervention name(s): Insulin Lispro Mix 25; Humalog® Mix 25
Intervention type(s): Drug; Drug
Intervention description(s): insulin lispro biphasic in doses 0.4 ME/kg; insulin lispro biphasic in doses 0.4 ME/kg
Other intervention name(s): insulin lispro biphasic; insulin lispro biphasic
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Insulin Lispro
Text4Peds: Short Message Service Evaluating Medical Student Education
Condition: Education, Medical, Undergraduate; SMS
Study type: Interventional

Summary: 
      In this study, third year medical students on the pediatric clerkship will be randomized to
      receive either only written educational material (review journal articles) or written
      educational material plus daily text messages consisting of board style questions with online
      answers. The students' performance on the National Board of Medical Examiners (NBME)
      Pediatric Subject Evaluation will be compared between the two groups.
    

Detailed description: 
      In the last decade, the use of smartphone and text messaging (SMS) has increased
      significantly; during this time, text messaging has become the primary means of communication
      in some instances. Despite the popularity, text messaging and smartphones have been rarely
      utilized in the context of medical education. Few studies have been performed examining the
      effect of text messaging as an adjunct to traditional medical education. A previous study
      with the Saint Louis University (SLU) Pediatric Residency program, showed the feasibility of
      using text messaging to deliver medical information to pediatric residents through the
      Text4Peds program.

      This study aims to expand Text4Peds to third NBME Pediatric Subject Evaluation performance.
      The NBME Pediatric Subject Evaluation is a national, standardized pediatric knowledge based
      exam from the NBME taken by all medical students at the end of their pediatric clerkship.
    

Intervention name(s): Texting Group; Non Texting Group
Intervention type(s): Other; Other
Intervention description(s): See above in arm/group description; See above in arm/group description
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to a Texting Group or a Non-Texting Group using a random number generator. The texting group received a daily text message containing a board style multiple choice question. If the participant wanted immediate feedback, the message contained a link to a website containing the answer to the question along with an explanation, the source material, and a more complete clinical vignette. One hour after the initial text message was sent, a follow up "answer" text message was delivered. Text messages were sent 6 days per week (Monday through Saturday) at 2pm and 3pm. To minimize perceived impropriety, the non-texting group received access to the journal articles from which the content was derived, but did not receive any text messages or any of the synthesized material. The primary outcome was performance on the NBME Pediatric Subject Examination.
Masking: None (Open Label)
Primary purpose: Other
Performance and Safety Evaluation of an Intradermal Delivery Device
Condition: Injections, Intradermal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether an investigational vaccine delivery device
      (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the
      skin.
    


Intervention name(s): PATH ID Adapter
Intervention type(s): Device
Intervention description(s): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intradermal injections; Vaccination
The Study Of CT Scans and Echo Parameters in Patients With PAH
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive
      and non-invasive tests. The goal of the study is to correlate data from CT scans,
      echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The
      ultimate goal is to determine patterns of the PAH disease processes.
    

Detailed description: 
      The goal of our study is to correlate data from various non-invasive tests such as commuted
      tomography (CT) imaging, echocardiogram, Pulmonary Function Tests, and other laboratory tests
      along with hemodynamic measurements from Right Heart Catheterizations in these ILD patients
      with Pulmonary Hypertension, as well as all other pulmonary hypertension. The ultimate goal
      is to determine patterns of the PAH disease processes, as well as define optimal diagnostic
      modalities including in-hospital verses outpatient studies.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pulmonary Arterial Hypertension; Idiopathic Lung Disease
      
Keywords: Pulmonary Hypertension;; ILD;; CT Imaging;; Echocardiogram;; Hemodynamic measurements of RHC.; Pulmonary Function Tests