bioihbjkbjnl/mcl2 huggingface dataset:
Sero-epidemiology of Priority Arboviruses in French Guiana
Condition: Arbovirus Infections
MeSH terms: Arbovirus Infections
Study type: Interventional

Summary: 
      Dengue is an important public health problem despite the efforts of local health authorities
      to mitigate the impact of epidemics and the epidemiology of dengue evolved from an
      endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of
      chikungunya virus in the Americas was identified in Caribbean countries and territories
      including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had
      reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert
      regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in
      South America led to a rapid spread throughout South and Central America, reaching French
      Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and
      the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus
      have become social, political, and public health challenges that require specific and
      non-available immune status information.
    

Detailed description: 
      French Guiana is a 250,000 inhabitant's French overseas department located in South America,
      the epidemiology of arboviruses has recently evolved and marked by important outbreaks.

      Dengue remains an important public health problem despite the efforts of local health
      authorities to mitigate the impact of epidemics and the epidemiology of dengue evolved from
      an endemo-epidemic to a hyper-endemic state. In late 2013, the first local transmission of
      chikungunya virus in the Americas was identified in Caribbean countries and territories
      including French Guiana. Rapidly, more than 16,000 suspected local Health authorities had
      reported cases. In May 2015, the Pan American Health Organization (PAHO) issued an alert
      regarding the first confirmed Zika virus infections in Brazil. The emergence of Zika virus in
      South America led to a rapid spread throughout South and Central America, reaching French
      Guiana in December 2015. With the increasing frequency of epidemics related to arbovirus and
      the resulting health, social, and economic impacts of dengue, the surveillance of arbovirus
      have become social, political, and public health challenges that require specific and
      non-available immune status information.
    

Intervention name(s): Human Biological samples
Intervention type(s): Other
Intervention description(s): Blood sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and
      a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to
      evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous
      (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in
      a dose-escalation manner.
    


Intervention name(s): mRNA-6231
Intervention type(s): Drug
Intervention description(s): Sterile frozen liquid dispersion for injection
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mRNA-6231; Messenger RNA; Moderna
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this randomized study is to evaluate the impact of Optical frequency domain
      imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent
      (DES) as compared with Intravascular ultrasound (IVUS) guidance.
    

Detailed description: 
      Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging
      modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for
      achieving optimal stent deployment.

      The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous
      Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.

      We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine
      practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided
      PCI arm.

      Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12
      month after PCI.
    

Intervention name(s): OFDI; IVUS
Intervention type(s): Device; Device
Intervention description(s): OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI; IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
Other intervention name(s): LUNAWAVE; Fastview; Biolimus a9-eluting stent (Nobori stent); VISIWAVE; ViewIT; Biolimus A9-eluting stent (Nobori stent)
Intervention MeSH terms: Sirolimus; Umirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Optical Frequency Domain Imaging; Intravascular Ultrasound
Veteran Stress and Learning Study
Condition: Stress Disorders, Posttraumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a research study examining the use of two medications, Hydrocortisone and
      D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear
      responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder
      (PTSD). These responses will be tested using a fear learning and memory task administered by
      computer.
    


Intervention name(s): Hydrocortisone; D-Cycloserine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg/oral one hour prior to extinction task; 50 mg/oral one hour prior to extinction task; One hour prior to extinction task
Intervention MeSH terms: Cycloserine; Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Stress Disorders, Posttraumatic; Hydrocortisone; Cycloserine; Extinction, Psychological; PTSD; San Francisco
Information Processing at Sleep Onset and During Sleep in Patients With Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      Chronic insomnia is thought to occur as a result of hyperarousal. While there is a wealth of
      data to support this position, there is a lack of research to define how hyperarousal
      interferes with sleep initiation, maintenance, and the perception of sleep quality and
      quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information
      processing at sleep onset and during sleep. ERP measures of information processing have been
      well established in good sleepers; they have not been, however, applied to the problem of
      insomnia. The goal of the project is to examine the premise that the occurrence and severity
      of insomnia is fundamentally related to a neurobiologic preparedness to "attend to" and
      "identify" environmental stimuli. Following an extensive screening, patients with insomnia
      and good sleepers will participate in two experimental conditions, requiring that they spend
      four nights in the sleep laboratory over a two week period. ERP data will be gathered prior
      to, following, and during sleep.

      The ultimate objectives for this line of research are to determine 1) if insomnia is
      associated with a failure to inhibit information processing at sleep onset and/or during
      sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep
      is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions
      are functioning differently so as to give rise to information processing abnormalities, and
      4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia
      alters information processing abnormalities and/or the associated brain activity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community Sample
      
Keywords: Insomnia; Primary Insomnia; Good Sleepers; ERP
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the effect of chronic nighttime low oxygen
      saturations on selected body systems (liver) that break down drugs in children with
      obstructive sleep apnea syndrome (OSAS).
    

Detailed description: 
      The purpose of this study is to determine the effect of chronic intermittent nocturnal
      hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The
      specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2,
      N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to
      determine the effect of OSAS treatment on the activities of these enzyme systems.
    

Intervention name(s): Dextromethorphan; Caffeine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/kg (maximum 30 mg); Administered as 4 ounces of Coca-Cola
Intervention MeSH terms: Dextromethorphan; Caffeine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sleep apnea; phenotyping; cytochrome P450; drug metabolism; child
Safety of Acidform Lubricant in HIV-Uninfected Women
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Topical microbicides, substances that kill microbes, are being studied to prevent sexual
      transmission of HIV and other disease pathogens. In the future, topical microbicides may be
      applied vaginally to prevent both acquisition and transmission of HIV and other sexually
      transmitted infections (STIs). The purpose of this study is to compare the safety of daily
      applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection
      and assess the effect of a microbicide candidate on the natural immunity women have to STI
      pathogens.
    

Detailed description: 
      A new approach to HIV prevention currently being studied is the use of topical microbicides.
      This study will measure the mucosal response to daily intravaginal applications of Acidform
      lubricant and HEC gel in two groups of healthy women at low risk for HIV infection.

      The duration of this study for each participant is 3 weeks. Study participants will be
      randomly assigned to one of two study groups. Group 1 participants will apply Acidform
      lubricant twice daily for 14 consecutive days between menses. Group 2 participants will apply
      HEC gel for 14 consecutive days between menses.

      After screening and study entry, study visits will occur on Days 7, 14, and 21. Study entry
      will occur 2 to 6 days following the menses and within 45 days of screening. Medical and
      sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection,
      vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits.
      Cytobrush collection, vaginal swab, and cervical biopsy will occur at selected visits. All
      participants will be asked to complete a diary throughout the study; this diary will be
      reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a
      negative Pap smear result within the last year is not available.
    

Intervention name(s): Acidform Lubricant; HEC gel
Intervention type(s): Drug; Drug
Intervention description(s): 5 g application of acid buffered gel (pH = 3.5); 5 g application of hydroxyethylcellulose gel
Other intervention name(s): Amphora
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microbicide; HIV Seronegativity
Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
Condition: Wrinkles
Study type: Interventional

Summary: 
      Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands.
      Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained
      pre-treatment and at 90 days post-treatment
    

Detailed description: 
      Before Treatment:

      The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point
      Hand Grading Scale wil be evaluated by the Investigator in charge of assessment.

      Treatment:

      The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with
      20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand .

      Post-Treatment:

      All subjects will visit the Institution at12 weeks from the day of procedure, and will take
      photos of the back of the hands. Efficacy evaluation will performed by the Photographic
      Evaluator.
    

Intervention name(s): Ultherapy™ System
Intervention type(s): Device
Intervention description(s): Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: skin laxity; Ultherapy™ System; rhytids
Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse
Condition: Urinary Incontinence; Pelvic Organ Prolapse
MeSH terms: Urinary Incontinence; Enuresis; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time
      to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS
      protocol on time to mobilization and length of hospital stay in patients undergoing surgery
      for urinary incontinence and pelvic prolapse.
    

Detailed description: 
      ERAS protocols containing several preoperative, intraoperative and postoperative measures
      have been shown to improve recovery in terms of reduced pain, shortened time to ambulation
      and length of hospital stay in patients undergoing surgery. However, data concerning the role
      of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed
      to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence
      and pelvic prolapse.
    

Intervention name(s): ERAS Protocol; Conventional care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Preoperative measures:
Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication
Intraoperative measures:
Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids)
Postoperative:
Application of midthoracic, epidural anesthesia/analgesia Refraining from use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results; This group of patients will not receive the specific ERAS protocol but will receive conventional care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      A cross-sectional study of 350 medical student Universitas Indonesia from first grade until
      fifth grade was done during November-December 2016. This study used stratified randomized
      sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview
      was applied to all subjects.
    

Detailed description: 
      A cross-sectional study of 350 medical student Universitas Indonesia from first grade until
      fifth grade was done during November-December 2016. This study used stratified randomized
      sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview
      was applied to all subjects. A bivariate analysis was done to know the relationship between
      IBS and its related factors using chi-square, unpaired t-test, and their alternatives.
      Multivariate analysis was done using logistic regression test
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Medical student from first grade to fifth grade
      
Keywords: IBS, Rome IV criteria, anxiety
Glycaemic Response, Insulinaemic Response, GLP-1 and GIP Testing of Food Product Lines
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study was to compare the glycaemic response, insulinaemic response, GIP
      response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus
      using a single-blind, randomised, repeat measure, crossover design trial.
    

Detailed description: 
      The aims of this study were to examine:

        -  Phase I - the glycaemic response (GR) and insulinaemic response (IR) to:

             -  50 g available carbohydrate

             -  50 g available carbohydrate + protein (dose 1)

             -  50 g available carbohydrate + protein (dose 2)

        -  Phase II - the GLP-1 and GIP response to:

             -  50 g available carbohydrate

             -  50 g available carbohydrate + protein (dose 1)

             -  50 g available carbohydrate + protein (dose 2)

      A single-blind, randomised, repeat measure, crossover design trial was used to study the
      response following consumption of three meals: one reference meal (50 g available
      carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g
      available carbohydrate with protein dose 2). The study was conducted in two phases:

        -  Phase I: glycaemic response (GR), insulinaemic response (IR)

        -  Phase II: GLP-1 response and GIP response
    

Intervention name(s): 25 g Nutralys Pea Protein; 50 g Nutralys S85 Plus.; 50 g Glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus; To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .; To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomised, repeat measure, crossover design trial
Masking: Single (Participant)
Primary purpose: Basic Science
Effectiveness of Vibration and Standing Versus Standing Alone for the Treatment of Osteoporosis for People With Spinal Cord Injury.
Condition: Spinal Cord Injury.; Osteoporosis.
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to find out if standing and/or standing with vibration works for
      the treatment of osteoporosis for people with a spinal cord injury.
    


Intervention name(s): vibration and passive standing versus passive standing alone
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury.; Osteoporosis.; Standing.; Vibration.
The Second-Generation MCCG for Upper Gastrointestinal Tract.
Condition: Capsule Endoscopy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the clinical application of the second-generation MCCG
      with higher image resolution and frame rate for upper gastrointestinal tract compared with
      the first-generation.
    

Detailed description: 
      Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice
      for gastric examination. However, there still exist blind spots under MCCG, particularly in
      the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the
      main cause, MCCG still needs technical improvement. In addition, the gastric examination time
      under MCCG can be further optimized.

      Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to
      0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle
      improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective
      and stable information transmission method.

      This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects
      receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio
      of 1:1 before the procedure, the first-generation or the second-generation MCCG. After
      passage through the esophagus, the gastric examination and transpyloric passage of the
      capsule is conducted under magnetic steering, and then examination is continued in the small
      bowel under intestinal peristalsis.
    

Intervention name(s): the second-generation MCCG
Intervention type(s): Device
Intervention description(s): Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: SG-MCCG; Z-line visualization; Image quality; Gastric examination time; Manipulation performance