bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback
Condition: Physical Activity; Health Behavior
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention on
      reducing sedentary behavior and increasing physical activity among adolescents and to
      investigate the engagement in the exergame. This will be compared in three groups: an
      intervention group that will receive a tailored exergame; an active control condition that
      will receive a non-tailored exergame; and a passive control condition that receives no
      intervention.
    

Detailed description: 
      The aim of this study is to investigate the effectiveness of the 'SmartLife' intervention
      with tailored feedback on sedentary behavior and physical activity among adolescents and to
      investigate the engagement in the exergame. One intervention group will receive a version of
      the exergame that tailors feedback. This means tailored feedback will be based on data from a
      sensor which is integrated in a T-shirt and paired to the game. The active control group will
      receive a different version of the game, that does not provide tailored feedback.

      Both groups will be compared to investigate their level of engagement in the game. A passive
      control group will be included that will be asked to continue their daily routines as usual.
      All three groups will be compared to determine the effectiveness of the 'SmartLife'
      intervention on physical activity and sedentary behavior.
    

Intervention name(s): 'SmartLife' with tailored feedback; 'SmartLife' without tailored feedback; No game
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 'SmartLife' game with tailored feedback: mobile exergame with tailored feedback. Feedback will be based on accelerometer data from a sensor that is integrated in a T-shirt. The sensor captures individually calibrated accelerometer data and is paired with the mobile exergame. Depending on the physical activity intensity of the player, the game challenge and feedback adapts individually in real-time.; 'SmartLife' without tailored feedback: mobile exergame without tailored feedback. The mobile exergame will not be paired to any sensor. The participant can play the mobile game, yet, will not receive any real-time feedback or adjustment in the game on physical activity intensity.; Passive control: School classes will be asked to continue their daily life as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clustered randomized controlled trial/parallel assignment
Different school classes will be allocated to one of the three groups: 1) intervention group with a game based on tailored feedback, 2) active control group with a game not using tailored feedback, 3) passive control group (waiting list group).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; sedentary behavior; serious game; exergame; behaviour change techniques; tailored feedback
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans
Condition: Traumatic Brain Injury (TBI); Suicidal Behavior
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Suicide
Study type: Observational

Summary: 
      This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The
      purpose of this research is to find out more about the issues related to these conditions.
      This study seeks to explore the relationship between executive dysfunction and suicidal
      behavior in an outpatient population.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        outpatient veterans with a history of traumatic brain injury
Safety, Tolerability and Pharmacokinetics of GSK3923868 Inhalation Powder in Healthy Participants and Stable Asthmatics
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Respiratory Aspiration; Asthma; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and
      pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in
      both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo
      controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868
      capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in
      participants with asthma (Part C). The duration of study participation for each part A, B and
      C will be 11, 9 and 8 weeks, respectively.
    


Intervention name(s): GSK3923868; Matching placebo; Monodose RS01
Intervention type(s): Drug; Drug; Device
Intervention description(s): GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.; Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.; Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part A will be a single ascending dose escalation study consisting of two sequential cross-over cohorts (Cohorts 1 and 2) in healthy participants. Part B is a repeat dose study consisting of two parallel cohorts (Cohort 3 and 4) in healthy participants. Part C is a repeat dose study consisting of one cohort (Cohort 5) in participants with asthma.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First time in human; Stable asthmatics; GSK3923868; Inhalation powder; Phosphatidylinositol 4-kinase beta
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
Condition: Diabetes Mellitus, Type 2; Metabolic Syndrome X
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objectives of the current study are to establish the safety and clinical
      proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and
      features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or
      metformin in combination with a sulfonylurea agent.
    

Detailed description: 
      Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed
      study.
    

Intervention name(s): NC-503 (eprodisate disodium); placebo
Intervention type(s): Drug; Other
Intervention description(s): capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks; Dosage: 4 capsules BID for 26 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type II diabetes; Metabolic syndrome
A Prospective Trial of Ayurveda for Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk
      factors in patients with coronary artery disease.
    

Detailed description: 
      Patients with established coronary artery disease will be treated with 90 days of Ayurvedic
      therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness,
      weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at
      baseline and after 90 days of therapy.
    

Intervention name(s): Ayurveda
Intervention type(s): Other
Intervention description(s): Ayurveda includes meditation, yoga, breathing exercises, herbs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spectral Dynamics and Speech Understanding by Hearing Impaired People
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The purpose of this program of research is to understand the perception of the dynamic
      spectral properties of speech by hearing-impaired listeners, with the long-term goal of
      improving speech understanding by these individuals in adverse listening conditions. The
      proposed research compares the performance of normally-hearing and hearing-impaired listeners
      on measures of speech understanding in the presence of different types of signal distortion
      and speech understanding of signals with enhanced spectral dynamics. A computational model
      based on the amount of potential information available in speech will be used to quantify
      differences in speech intelligibility due to hearing status and stimulus characteristics.
    

Detailed description: 
      This is a behavioral study of human auditory perception. Each experiment in this study
      involves prospective data collection from three types of listeners. The experimental
      listeners will be people with sensorineural hearing loss and the control listeners will
      either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will
      be simulated through the use of a spectrally-shaped broadband noise. The tasks of the
      subjects in this study involve either listening to synthesized sounds over earphones while
      seated comfortably in a sound-treated booth, and making responses indicating the subject's
      auditory perception of these sounds by touching specific areas on a touch-screen terminal;
      or, listening to recorded, acoustically modified syllables, words, or sentences over
      earphones and making responses indicating the subject's identification.
    

Intervention name(s): Acoustic distortion of speech
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hearing; Hearing Loss, sensorineural; Speech Perception
Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease
Condition: Asthma; Chronic Obstructive Pulmonary Disease; Healthy
MeSH terms: Asthma; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This clinical trial will include healthy volunteers, COPD patients and asthmatic patients who
      will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.
    

Detailed description: 
      Two types of measurements will be performed with each of the three evaluated gases:

        -  pulmonary function measurements at rest to establish the resistance to airflow in a
           reproducible way, including the measurements of Inspiratory Capacity (IC), Forced
           Expiratory Volume in 1 second (FEV1), Forced Expiratory Flows (FEF) at different lung
           volumes (25 to 75% of the vital capacity), and Forced Vital Capacity (FVC),

        -  Tidal Volume (TV) measured at rest and during light cycling exercise. The results of
           this study should be useful to evaluate the extent of influence on gas concentration,
           since none of the previous trials have been performed with He/O2 65:35, as well as the
           extent of influence on the lung disease, since none of the previous trials have been
           performed with asthmatic patients at various disease stages.

      The working hypothesis is that when using He/O2 mixtures 78:22 and 65:35, the flow resistance
      decreases as compared to medical air because low density helium replaces nitrogen, thus
      resulting in a lower workload of breathing for asthmatic and COPD patients. For patients with
      reduced pulmonary function, this difference might result in greater Inspiratory Capacity.

      That is why Inspiratory Capacity will be measured as primary efficacy criterion, but also
      Tidal Volume and other pulmonary function parameters on 3 types of subjects/patients :

        -  healthy volunteers,

        -  patients with moderate and severe persistent asthma,

        -  patients with moderate and severe COPD.
    

Intervention name(s): spirometer
Intervention type(s): Device
Intervention description(s): According to the randomisation order, the appropriate medical gas cylinder with the pressure regulator will be connected to a humidifier to avoid the inhalation of very dry gas; the humidifier will be connected to the breathing bag; the flow of the medical gas will be adjusted individually for each subject/patient by the valve of the pressure regulator.
Other intervention name(s): ergospirometer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: evaluate Inspiratory Capacity (IC) measured by spirometry
Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Condition: Cannabis; Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Marijuana use is a major problem among veterans and non-veterans. A patient's use of
      marijuana while engaged in psychotherapy treatment may affect their memory and, therefore,
      limit their ability to benefit from treatment. This study is designed to test a new
      pharmacotherapy, modafinil, which has the potential to improve memory functioning in
      marijuana using individuals.

      We hypothesize that modafinil treatment will decrease ratings of drug liking and improve
      cognitive measures, especially episodic memory.
    

Detailed description: 
      The impairment of episodic memory in marijuana abusers has important treatment implications.
      Since many treatments, including cognitive-behavioral therapy, strongly utilize episodic
      memory, marijuana use during treatment may lead to diminished treatment outcomes. In
      addition, lessened response inhibition may lead to elevated rates of drug relapse while in
      treatment. Consequently, a treatment which will improve episodic memory and response
      inhibition may lead to improved treatment outcomes in marijuana users. One such treatment is
      modafinil.This study will be a 4 session within-subjects, double-blind, crossover study
      evaluating the impact of modafinil (400 mg/day) on the cognitive, subjective, and
      physiological effects of marijuana. Across 4 sessions, subjects will be randomly assigned to
      receive either oral placebo, modafinil (400mg), dronabinol (15mg), or dronabinol and
      modafinil. Outcome measures will include physiological, cognitive, and subjective drug
      effects.

      Currently this study complete and has been published.
    

Intervention name(s): drug condition
Intervention type(s): Drug
Intervention description(s): Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
Other intervention name(s): Marinol, Provigil,
Intervention MeSH terms: Dronabinol; Modafinil
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cannabis Abuse; Cannabis Dependence; Cannabis-Related Disorder; Marijuana Dependence; Marihuana Abuse
Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients
      with gastrointestinal signs of GVHD that were treated with teduglutide.
    

Detailed description: 
      Preliminary studies have showed that Glucagon-like peptide 2 (GLP-2) has regenerative and
      protective effects on the gastrointestinal tract after bowel injury. It induces positive
      effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation,
      etc. One of the target organs from GVHD is the GI tract, and since patients suffering from
      GI-GVHD experience intestinal disorders like loss of mucosal epithelial integrity, diarrhea
      accompanied by strong abdominal pain that can lead to food inanition, the investigators
      therefore aimed to examine the outcome of patients suffering from SR-GI-GVHD that are treated
      with the GLP-2 analogue, Teduglutide. The investigators will determine the outcome of each
      patient by monitoring the gastrointestinal signs like diarrhea frequency, intestinal
      absorption measured by serum-albumin concentrations and GI histology, specifically the number
      of Paneth cells before and during teduglutide treatment.
    

Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): Treatment of patients with SR-GI-GVHD with teduglutide
Intervention MeSH terms: Teduglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Neuroimmune Effects of Alcohol Using Free Water Imaging
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study examines the effects of moderate alcohol intake on the brain, the immune system,
      and cognition.
    

Detailed description: 
      The study involves a within-subjects, pre/post design to assess the effects of a moderate
      dose of alcohol on immune biomarkers, neurobiological measures, and cognitive functioning.
      The study recruits healthy adults (ages 21-45) from the community to complete the
      experimental protocol. Participants complete magnetic resonance imaging scans, blood sample
      collection, and cognitive testing in the context of alcohol consumption.
    

Intervention name(s): Ethanol
Intervention type(s): Drug
Intervention description(s): Moderate alcohol consumption
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Bilingual Family Literacy Program Pilot
Condition: Language Development; Literacy; Health Behavior
Study type: Interventional

Summary: 
      This study will examine the feasibility of implementing a virtual bilingual health-focused
      family literacy program.
    

Detailed description: 
      "Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses
      anticipatory guidance on important health routines to introduce critical language and
      literacy skills to young Latino children entering Kindergarten and their families.

      The objectives of this study are 1) To assess the feasibility of implementing the bilingual
      family literacy program online via video conference by collecting information on family
      attendance and participation, 2) To examine the acceptability of the program, and 3) To
      explore preliminary effects of the program on the family health and language routines as well
      as child language and literacy skill acquisition.
    

Intervention name(s): Online Family Literacy Program
Intervention type(s): Behavioral
Intervention description(s): Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Language development; Health routines; Literacy
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in
      patients with osteoarthritic pain of the knee. The most painful knee joint will be identified
      as the index joint at screening, and this joint will be used for all pain assessments
      throughout the study.
    


Intervention name(s): PF-04136309; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval.; Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PF-04136309 CCR2 osteoarthritic pain knee; phase 2 placebo multicenter double-blind placebo-controlled
Plethysmographic Waveform for Monitoring the Quality of Cardiopulmonary Resuscitation
Condition: Cardiopulmonary Arrest; Cardiopulmonary Resuscitation; Return of Spontaneous Circulation; Pulse Oximeter Plethysmographic Waveform
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early
      cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation
      (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early
      identification ROSC is very important. Now there is no an easy, non-invasive and real-time
      method to monitor the quality of CPR. In this study the investigators hypothesis the pulse
      oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR
      to the physicians.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        emergency room sample of multi-centers
Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
Condition: Lung Neoplasms; Pulmonary Surgical Procedures; Surgical Staplers; Tissue Adhesives; Chest Tubes
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the efficacy of FORESEAL with stapling alone or
      associated with tissue sealant or glue in terms of air leakage duration after lung resection
      for cancer.

      Hypothesis: to show a significant difference of 1 day in the average duration of air leakage
      between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).
    

Detailed description: 
      Air leaks continue to be the most common complication after pulmonary resection even using a
      stapling device. Double chest tubes after lobectomy is a well established method for drainage
      of the pleural cavity to allow adequate expansion of the remaining lung.

      FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a
      absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention
      of air leakage after pulmonary resection with stapling device. It acts as a suture
      reinforcement as well as a sealant thanks to its jellification.

      Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of
      this study is to compare the efficacy of FORESEAL with stapling alone or associated with
      sealants.

      This is a multi centre, prospective controlled and randomised clinical study.
    

Intervention name(s): FOREseal; Stapling
Intervention type(s): Device; Device
Intervention description(s): a pair of alginate sleeves for linear cutting staplers used in lung surgery; Stapling alon or associated with sealants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Absorbable implants; Humans; Alginates; Pneumonectomy/methods; Pneumonectomy/instrumentation; Surgical Stapling; Thoracic surgery; Tissue Adhesives; Prospective studies