bioihbjkbjnl/mcl2 huggingface dataset:
Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents
Condition: Smoking Prevention
Study type: Interventional

Summary: 
      This feasibility study evaluates acceptability and preliminary effectiveness of a digital
      health game as an intervention supporting tobacco-related health literacy in 10- to
      13-year-old early adolescents. One third of the study participants will receive the health
      game, on third a web page with similar content and one third will act as a control group
      without intervention.
    


Intervention name(s): Health game; Web page
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Health game intervention consists of 20 minutes guided training session with the health game at school and 2 weeks free usage of the health game via own smart phone or tablet computer during free time. The health game includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations. The visualized content is presented in a format of a game including tasks, rules, goals, rewards and opponents. There are also sound effects and background music included in the game.; Web page intervention consists of 20 minutes guided training session with the web page at school and 2 weeks free usage of the web page via own smart phone or tablet computer during free time. The web page includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations. The visualized elements are presented with pictures and video clips. These visualized elements do NOT contain game elements (NO activating tasks, rules, goals, rewards or opponents). The video clips contain sound effects, but no background music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Games; Adolescent; Health education; Smoking; Health literacy
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
Condition: Focal Onset Seizure; Focal Onset Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses
      of NBI-921352 versus placebo in adults with focal onset seizures
    


Intervention name(s): NBI-921352; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration; Matching placebo tablets for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; focal seizure; sodium channel; voltage-gated; alpha subunit; Nav1.6 inhibitor; Antiseizure medication; ASM; Antiepileptic drug; AED; partial seizure; partial onset epilepsy
Biomarkers in Post-Menopausal Women Receiving Flaxseed
Condition: No Evidence of Disease
Study type: Interventional

Summary: 
      This randomized clinical trial studies biomarkers in post-menopausal women receiving
      flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants
      receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine associations between the composition of the gut bacterial communities and
      baseline levels of the mammalian lignans and steroid hormones.

      II. To determine how variation in gut microbial community composition and in steroid hormone
      and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid
      hormones after exposure to a lignan-rich food (flaxseed).

      III. To determine how these associations differ by race (i.e., African American and European
      American women).

      OUTLINE: Participants are randomized to 1 of 2 treatment groups.

      GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet
      "washout" period of 8 weeks, patients crossover to Group II.

      GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period
      of 8 weeks, patients crossover to Group I.

      After completion of study treatment, participants are followed up for 30 days.
    

Intervention name(s): Clinical Observation; Flaxseed; Laboratory Biomarker Analysis; Questionnaire Administration
Intervention type(s): Other; Dietary Supplement; Other; Other
Intervention description(s): Participants maintain usual diet and undergo clinical observation; Given PO; Correlative studies; Ancillary studies
Other intervention name(s): FLAX SEED; Flour, Flaxseed; Linseed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gut microbiome; hormones; women; race; phytoestrogens
Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Observational

Summary: 
      Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged
      mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality .
      Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections,
      including bacterial infections, viral infections, and infections of other etiologies. Early
      initiation of adequate antibiotic therapy is the cornerstone in the treatment. However,
      overuse of antibiotics and prolonged duration of antibiotic therapy in patients with
      bacterial ARIs in the hospital and intensive care setting is associated with increased
      resistance for common bacteria, high costs, and adverse drug reactions.
    


Intervention name(s): Lung Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): We will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients having ventilator associated pneumonia (VAP) with positive sputum culture. VAP was
        considered if the onset occurred following intubation of the trachea for 48 h and the
        infection was absent before starting mechanical ventilation . Diagnosis of pneumonia was
        based on radiographic finding of pulmonary infiltrate; findings should be new and
        progressive and at least should satisfy two clinical criteria of the following: body
        temperature >38°C or <35.5°C; leukocyte count > 12,000 cells/mm3 or <4000 cells/mm3; and
        clinical evidence of pneumonia, such as purulent secretions and a decrease in oxygenation.

        Diagnosis of VAP was confirmed microbiologically by positive bronchial secretion cultures
Live Stream of Ultrasound in Prehospital Medical Care
Condition: Ultrasound
Study type: Observational

Summary: 
      Prehospital emergency ultrasound (PEU) is being increasingly used in different preclinical
      emergency systems across the world. Ultrasound examinations in emergency situations, however,
      remain challenging even in the hospital setting despite the availability of standardized
      approaches such as Focused Assessment with Sonography for Trauma (FAST). Preclinical
      circumstances further complicate the adequate execution of an additional diagnostic tool such
      as PEU on the scene or inside a medical emergency vehicle. Furthermore, rapid translation of
      ultrasound findings into meaningful therapeutic consequences is considerably demanding in an
      environment of limited resources. If focused PEU is correctly used and patients' condition
      allows emergency doctors a careful ultrasound examination, it is possible to differentiate
      life-threatening diagnoses. PEU should be implemented in the management of emergency patients
      affected by trauma, cardiac arrest/shock or respiratory problems. To date it is unclear
      whether PEU results in improved outcome.

      Some emergency cases present difficult challenges in the prehospital ultrasound examination.
      Portable devices designed for PEU suggest the possibility of increasing the use of ultrasound
      "in the field". However, to the investigator's knowledge, opportunities for real-time
      consultation with a second specialist including live transmission of the ultrasound picture
      are not being provided at any preclinical emergency facility.
    

Detailed description: 
      Aim 1:

      Feasibility of real time prehospital emergency ultrasound (PEU) transmission in a university
      affiliated preclinical emergency system.

      Aim 2:

      Identify obstacles for PEU transmission including a real time consultation of an ultrasound
      expert.

      Hypothesis:

      We expect that live streaming of emergency ultrasound images in order to allow a second
      opinion could improve diagnostics of life threatening conditions and help us to improve
      patients' safety by digital health. The use of PEU is feasible and safe.
    

Intervention name(s): Prehospital ultrasound
Intervention type(s): Other
Intervention description(s): Feasibility of real time PEU transmission in a university affiliated preclinical emergency system.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PEU should be implemented in the management of emergency patients affected by trauma,
        cardiac arrest/shock or respiratory problems.
      
Keywords: echocardiography; emergency medicine; telemedicine
Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Condition: Asherman Syndrome
MeSH terms: Gynatresia
Study type: Interventional

Summary: 
      This study was taken out to compare two mechanical devices (intrauterine balloon and
      Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine
      adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by
      randomly.
    

Detailed description: 
      Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both
      effective in the therapy for intrauterine adhesion.

      The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the
      uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while
      intrauterine device is removed two or three month later.

      The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and
      usually removed on the 7th day after surgery.
    

Intervention name(s): Intrauterine balloon; Intrauterine Contraceptive Device Plus Foley Catheter
Intervention type(s): Device; Device
Intervention description(s): After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.; After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.
Other intervention name(s): Cook balloon; Intrauterine Device Plus Foley Catheter
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intrauterine balloon; Intrauterine Device Plus Foley Balloon Catheter; Asherman Syndrome
The Effects of A Proprietary Spearmint Extract on Cognitive Performance
Condition: Mood; Cognitive Performance; Sleep
Study type: Interventional

Summary: 
      This study was designed to evaluate the chronic effects of a proprietary spearmint extract
      over 90 days of supplementation on aspects of cognitive performance (cognitive function and
      active reaction time), subjective mood, and sleep quality in healthy men and women.
    


Intervention name(s): Proprietary spearmint extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Water extracted spearmint extract; Microcrystalline Cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cognitive Domain: Speed; Cognitive Domain: Reaction Time; Cognitive Domain: Attention; Cognitive Domain: Executive Function; Cognitive Domain Memory; Sleep Quality; Sleep Efficiency
Infant Immunity Comparison of Breastfed and Bottlefed Infants
Condition: Infant Immunity Response and Immunoglobulin Diversity
Study type: Observational

Summary: 
      This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%)
      breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of
      life from birth until 12 month age. Visits - Subjects will be consented prior to delivery,
      visit 1. Subject will be seen if possible after delivery for instruction on stool collection
      and distribution of supplies, visit 2. Subject will be seen at 6 months of age post
      immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact
      via phone/email to collect information about feeding changes.
    

Detailed description: 
      Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6
      month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12
      months of age prior to their 12 month immunization. Additionally, stool samples will be
      collected within the first week of live and once monthly through 12 months of age.
      Breastfeeding mothers will collect breast milk once monthly at the same time as the stool
      specimen during the period of breastfeeding.
    

Intervention name(s): blood sample/ stool sample
Intervention type(s): Procedure
Intervention description(s): blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Pregnant women 18 years of age or older.

          -  Vaginal delivery

          -  Healthy, full-term babies.

          -  Willing to primarily (> 75%) breastfeed or exclusively formula feed for at least the
             first 4 months of life.

          -  Willing to follow the American Academy of Pediatrics' Immunizations guidelines.
      
Biospecimen description: 
      Four 2.6 ml ACD tubes will be collected . All blood will be processed for pyrosequencing,
      TBNK, CBC and differential, platelets, sera plasman and PBMC's. Stool samples
Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans
Condition: Obesity
Study type: Observational

Summary: 
      The investigators hypothesize that some of these changes in the reduced appetite after
      surgery may be due to alterations in taste. The aim is to compare obese patients before and
      after bariatric surgery (gastric bypass and banding) to define the reward value of sweet,
      fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.
    

Detailed description: 
      Severe obesity is associated with excessive food eating and appetite. Bariatric surgery (also
      known as 'obesity surgery' or 'weight loss surgery') is a well known treatment for severely
      obese individuals. The way in which these operations achieve weight loss is not fully
      understood. The investigators hypothesize that some of these changes in the reduced appetite
      after surgery may be due to alterations in taste. The aim is to compare obese patients before
      and after bariatric surgery (gastric bypass and banding) to define the reward value of sweet,
      fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with obesity attending a specialist obesity clinic and normal weight controls who
        are staff at Imperial College London
      
Keywords: Taste; bariatric surgery; food preferences; reward; progressive ratio task
Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures
Condition: Supracondylar Fracture; Morbidity
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Observational

Summary: 
      This study aims to investigate that performing supracondylar humerus fracture operations
      during daylight hours may have better results than performing them at night.
    

Detailed description: 
      Supracondylar humerus fractures are one of the most common traumatic fractures seen in
      children and their treatment usually requires immediate closed reduction and percutaneous
      pinning (CRPP). The presence of neurovascular complications associated with this fracture is
      considered an orthopedic emergency. For this reason, depending on the patient's operation
      time, the procedure should be performed at night under emergency conditions. Sleep
      deprivation, which is common in healthcare professionals, may affect patient safety due to
      disruptions in treatments and surgical procedures by reducing physician performance.
    

Intervention name(s): Closed reduction and percutaneous pinning (CRPP)
Intervention type(s): Procedure
Intervention description(s): Operated for supracondylar humeral fractures
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        paediatric population with supracondylar humeral fractures
      
Keywords: supracondyler humerus fracture; night time operation; sleep deprivation; closed reduction and percutaneous pinning; CRPP
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
Condition: Immune Response to Influenza Vaccine; Influenza A Virus Infection; Influenza B Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Herpesviridae Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the serologic and cell-mediated immune response to
      licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in
      children 5-17 years old. The effects of prior infection and or prior season vaccination will
      be examined. Children will be followed during the influenza season to identify
      laboratory-confirmed influenza (i.e. vaccine failure).
    

Detailed description: 
      All children will have baseline blood samples drawn and will then be vaccinated with licensed
      and approved influenza vaccines. Following the recommendation from the Advisory Committee on
      Immunization Practices, children 5-8 years old will preferentially receive live attenuated
      influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or
      inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed
      influenza vaccine will be excluded from the study.

      The children will have their blood drawn between 2 and 4 times total over the course of two
      months in order to test their immune response to the vaccine. Between approximately December
      and April, study participants will be contacted weekly to monitor for any new respiratory
      illnesses with cough, and if present, nasal and throat swabs will be collected to test for
      influenza.
    

Intervention name(s): LAIV; IIV
Intervention type(s): Biological; Biological
Intervention description(s): Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.; A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]
Other intervention name(s): FluMist; FluZone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immune response to influenza vaccine; PCR confirmed Influenza A virus; PCR confirmed Influenza B virus
Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream
Condition: Anti-aging
Study type: Interventional

Summary: 
      The aim of the study is to determine the efficacy of the investigational product "Cream " :

        -  on skin network after 56 days of daily application

        -  on biological parameters linked to cellular communication involved in senescence

        -  on sebum composition (metagenomics and metabolomics analysis)
    

Detailed description: 
      This study will be conducted as a monocentric, randomized (for side of product application on
      forearms), open trial.

      4 visits are planned:

        -  Visit 1 - Inclusion (D1)

        -  Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,

        -  Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this
           evaluation

        -  Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)

      For a subject completing the study, the theoretical investigational product application will
      be 56 consecutive days up to 59 days maximum.

      The study duration for each subject will be 67 days maximum.
    

Intervention name(s): Anti-aging cosmetic care product
Intervention type(s): Other
Intervention description(s): frequency of application: Once a day (in the morning)
modalities of application: Apply the cream on face (according to normal conditions of use) and on treated forearm, massage until complete penetration
area: The whole face, neck, neckline and one randomized forearm (external photo-exposed area) the other forearm is untreated
duration of investigational product application: 56 days (a window of + 72 hours is allowed)
quantity: 2 pressures of product for the whole face, neck and neckline and 1 pressure of product for the treated forearm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention