bioihbjkbjnl/mcl2 huggingface dataset:
Cervical Cancer Screening Among Hispanic Women
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      In this study, 400 Hispanic women will be recruited and randomized to one of three
      interventions:

        1. Control (no change);

        2. A low-intensity information program, consisting of a video approach educating women on
           the importance of cervical cancer screening;

        3. A higher intensity program consisting of the video plus a 'promotora' or lay-community
           health educator led intervention at the participant's home to encourage cervical cancer
           screening.

      The investigators will compare which intervention is most effective in encouraging Hispanic
      women to undergo cervical cancer screening (Pap test)
    


Intervention name(s): DVD; Promotora
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening; Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Condition: Presbyopia; Refractive Error
MeSH terms: Presbyopia; Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort
      Plus® (DACP) MF contact lens using new objective measurements.
    

Detailed description: 
      In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3
      products in randomized order and used 1 product at a time for a duration of 5±1 days before
      switching to the next assigned product.
    

Intervention name(s): Nelfilcon A MF contact lenses (DACP MF); Nelfilcon A single vision contact lenses (DACP)
Intervention type(s): Device; Device
Intervention description(s): Multifocal contact lenses in Low, Medium, High Add
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: DACP MF; DAILIES AquaComfort Plus® Multifocal; presbyopia; visual performance
Provider and Peer Delivered Youth Smoking Intervention
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine whether a pediatric practice-based smoking
      prevention and cessation intervention increases abstinence rates among adolescents.
    

Detailed description: 
      The majority of adolescent smokers are interested in quitting and have attempted to stop with
      limited success. A recent review of cessation trials for adolescents has concluded that there
      are no proven programs to help teens stop smoking, but suggested interventions based on
      cognitive behavioral therapy and sensitive to stages of change appear promising. The American
      Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with
      adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive,
      practice-based smoking prevention and cessation intervention for adolescents delivered by
      pediatric providers and peer counselors in the context of routine care has the potential for
      assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.
    

Intervention name(s): Pediatric Practice-Based Smoking Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pediatric practice; Smoking cessation; Smoking prevention; Adolescents
Weight Regain Treatment Post-Bariatric Surgery
Condition: Obesity, Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for
      weight regain after bariatric surgery.
    


Intervention name(s): Behavioral Weight Loss (BWL); Early Responder: BWL continued; Early Non-responder: BWL continued with medication added
Intervention type(s): Behavioral; Behavioral; Combination Product
Intervention description(s): All participants will receive twelve weeks of BWL treatment.; Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.; Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Difficult Intubation and Anthropometric Measurement
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic
      measurements alone or in combination in predicting difficult intubation. The investigators
      hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are
      sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The
      investigators included the data of 170 patients (85 difficult intubation and 85 easy
      intubation) who underwent an abdominal surgery under general anesthesia. Patients in
      difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and
      gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal
      protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients.
      Anthropometric measurements were measured.
    

Detailed description: 
      To define the tongue protrusion tests, anatomic landmarks and horizontal lines were used. The
      first horizontal line (lower target line) was passing through the midpoint of the distance
      between stomion to mentum (mandible height) and the second horizontal line (upper target
      line) was passing through the midpoint of the distance from subnasal to stomion (upper lip
      height). The horizontal lines were drawn with an erasable marker pen on the each patient's
      face. In the sitting position, patients were asked to make maximal tongue protrusion upward
      (UMPT) and downward (DMPT) in anatomical neutral position. The inability of the tip of the
      tongue to reach to the target line was scored "1" and ability of the tongue tip to reach or
      pass the target line was scored "2
    

Intervention name(s): difficult intubation; easy intubation
Intervention type(s): Other; Other
Intervention description(s): Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.; Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Therapeutic Effects of Arch Support Insoles on Children
Condition: Normal Development
Study type: Interventional

Summary: 
      Using double blind, randomized controlled design to study the short-term therapeutic effects
      of customized arch support insoles on children
    

Detailed description: 
      A total of 45 children were enrolled. The children were randomized into two groups, including
      the study group (insoles group) and the control group (without insoles group).

      All participants in the insoles group were evaluated at baseline, that was before the
      customized arch-support insoles were prescribed. All the evaluations, including functional
      performance, physical function, and quality of life, were re-evaluated up to 12 weeks after
      the insoles wearing in the study group (insoles group).

      The control group were evaluated at baseline and up to 12 weeks.
    

Intervention name(s): MEI BIN insoles
Intervention type(s): Device
Intervention description(s): wearing insoles for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: therapeutic effects; insoles; children
Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults With Behaviorally Acquired HIV
Condition: HIV Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Papillomavirus Infections
Study type: Observational

Summary: 
      The proposed study is a substudy of ATN 106 and a cross sectional study intended to be
      conducted at each of the AMTUs newly participating in ATN III. The intent is to enroll all
      youth with behaviorally-acquired HIV who have enrolled in ATN 106. The study involves a
      review of the subjects' medical chart and a collection of an oral rinse sample.
    

Detailed description: 
      ATN 114 is a cross-sectional substudy of ATN 106. In addition to sharing data collected in
      ATN 106, an oral rinse sample along with the subject's self reported history and medical
      chart abstraction of HPV vaccination status and medical chart abstraction of a history of
      oral condylomata, oral dysplasia and oral tumor viruses will be collected in ATN 114.

      Recruitment is expected to last approximately one year, similar to the same timeframe for ATN
      106. Enrollment may be terminated earlier at the discretion of the ATN Executive Committee
      and/or the ATN 114 protocol team should ATN 106 also terminate enrollment early. Individuals
      who have agreed to participate in ATN 106 may be simultaneously approached at any clinic
      visit, or, for community-based sites, contacted directly for participation in ATN 114. Site
      staff may also contact individuals via phone, e-mail, or any other agreed-upon methods of
      communication. Site staff should try as much as possible to incorporate the study visit into
      a regularly scheduled clinic visit.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Behaviorally-acquired HIV-infected adolescents and young adults, ages 12-24, inclusive, who
        have enrolled in ATN 106.
Low Dose Ketamine VR Analgesia During Burn Care Procedure
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the research is to see whether a low dose of ketamine, a medication used to
      reduce pain, enhances the effectiveness of a virtual reality video game, which is used as a
      form of distraction from pain during a painful burn care procedure.
    

Detailed description: 
      This study is conducted in a hospital setting. It is a randomized controlled trial comparing
      the use of virtual reality distraction (VRD) and standard pain medications to the use of VRD,
      standard pain medications and a single low dose of ketamine as a means to reduce pain during
      a painful procedure in patients in the hospital.
    

Intervention name(s): Virtual Reality
Intervention type(s): Behavioral
Intervention description(s): The patient will receive virtual reality during a burn care procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Virtual Reality Ketamine
Transcutaneous Immunization With an Attenuated Listeria Monocytogenes Vector Vaccine
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This project is a pilot safety and immunogenicity study of transcutaneous vaccination with
      live attenuated Listeria monocytogenes BMB72 bacteria (actA/plcB-deleted, expressing
      influenza A nucleoprotein) and a cutaneous adjuvant, native purified cholera toxin.
      Transcutaneous vaccination is needle-less application of materials directly to the skin.
      Healthy adult volunteers (4 per group) will receive either:

        -  Saline (placebo)

        -  Cholera toxin adjuvant alone

        -  L. monocytogenes BMB72 bacteria alone

        -  L. monocytogenes BMB72 bacteria plus Cholera toxin adjuvant

      Vaccine solutions will be applied to the upper deltoid area under a standard Tegaderm
      dressing. Key primary endpoints include: safety as measured primarily by clinical findings
      (VS, cutaneous exams, and systemic reactions), and immune responses as measured by
      serological responses to L. monocytogenes, influenza A nucleoprotein, CT, and IFN gamma
      ELISPOT responses to listeriolysin and nucleoprotein peptides. Local skin immune responses
      will be evaluated by skin biopsy in subjects who agree to that (optional). The study will
      begin with 2 "roll-in" subjects receiving both L. monocytogenes and CT.
    


Intervention name(s): BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)
Intervention type(s): Biological
Intervention description(s): 1mL liquid contained in an adhesive skin patch
Other intervention name(s): Lot ELH072910
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Memantine for Epileptic Encephalopathy
Condition: Epileptic Encephalopathy, Childhood-Onset
MeSH terms: Brain Diseases; Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the potential benefit of memantine hydrochloride as treatment for
      children with epileptic encephalopathy using a double-blind placebo-controlled cross-over
      design.
    

Detailed description: 
      Memantine, a drug approved for Alzheimer's dementia, exerts its therapeutic effect through
      its action as a low to moderate affinity non-competitive (open channel) N-methyl-D-aspartate
      receptor (NMDA-R) antagonist, which binds preferentially to the NMDA receptor-operated cation
      channels. It blocks the effects of persistently elevated levels of glutamate that may lead to
      neuronal dysfunction. Memantine may also have anti-inflammatory effects. Memantine has been
      used off-label in children and adolescents with autism spectrum disorder, to improve the
      cognitive impairment.

      Epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of
      multiple etiologies, including genetic and inflammatory pathologies. Ion channels were long
      considered to be implicated in genetic epilepsy. Indeed one of the many possible causes of
      epilepsy is NMDA receptor dysfunction.

      In the present study, the investigators plan to investigate the potential benefit of
      memantine as a treatment for epileptic encephalopathy. A double-blind placebo-controlled
      cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks
      of placebo, with a 2-week washout period in between.
    

Intervention name(s): Memantine Hydrochloride 10 mg
Intervention type(s): Drug
Intervention description(s): Week #1: 5 mg id (am), 1 caps
Week #2: 5 mg bid (am and pm), 2 caps
Weeks #3-6: 5 mg am & 2x 5 mg pm, 3 caps
Weeks #7-8: Washout
Placebo
Week #9: id (am), 1 caps
Week #10: bid (am and pm), 2 caps
Weeks #11-14: 1 caps am & 2 caps pm, 3 caps
OR Placebo
Week #1: id (am), 1 caps
Week #2: bid (am and pm), 2 caps
Weeks #3-6: 1 caps am & 2 caps pm, 3 caps
Weeks #7-8: Washout
Memantine
Week #9: 5 mg id (am), 1 caps
Week #10: 5 mg bid (am and pm), 2 caps
Weeks #11-14: 5 mg am & 2x 5 mg pm, 3 caps
Other intervention name(s): PrSANDOZ MEMANTINE FCT10 mg Drug Identification Number (DIN) 02375532
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Monocentric, Off-Label Use, Randomized, crossover, Double-blinded Placebo vs Memantine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Memantine; N-methyl-D-aspartate receptor; Serum inflammatory; Seizure
Free Fatty Acids: Threshold Repeatability Study
Condition: Taste, Non-esterified Fatty Acids
Study type: Observational

Summary: 
      This study seeks to determine if non-esterified fatty acid (NEFA) taste detection thresholds
      change with repeated testing. Threshold testing for NEFA taste has been reported by a number
      of laboratories, including our own; however, these studies have reported data for only one
      testing occasion. The investigators seek to conduct repeated testing to measure the
      test-retest reliability of these methods. The investigators believe that with repeated
      exposure to NEFA, a person's sensitivity increases. The investigators are also testing the
      efficiency of testing by two methods (forced-choice ascending trial versus staircase).
      Additionally, the association between taste responses, diet and BMI will be explored.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants between the ages of 18 and 55 years of age from any ethnic background who are
        in good health and are available for the next three months will be recruited. Additionally,
        equal numbers of lean and overweight participants will be sought.
      
Keywords: taste; fat; threshold; sensitivity; human
Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerance of entinostat administered
      orally as a single agent in a weekly dosing schedule. Additionally, this study will
      characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced
      breast cancer. And to define the profile of adverse events, including laboratory parameters
      in these subjects
    


Intervention name(s): Entinostat; Exemestane
Intervention type(s): Drug; Drug
Intervention description(s): Given PO; Given PO
Other intervention name(s): MS-275; SDNX-275
Intervention MeSH terms: Exemestane; Entinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: entinostat; breast cancer
Daily Magnesium-treatment of Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The present study is part of a project titled 'Magnesium in asthma and chronic obstructive
      pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement
      will benefit patients with asthma and chronic obstructive pulmonary disease.

      The aim of this part of the project is to study the effect of a daily magnesium supplement
      for COPD-patients
    


Intervention name(s): Magnesium supplement (magnesium hydroxide/ -oxide); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS; 3 tablets of placebo daily for 12 weeks
Other intervention name(s): Mablet
Intervention MeSH terms: Magnesium Hydroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Daily magnesium supplement; EQ-5D
Context Aware Data Gathering Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Automated Insulin Delivery (AID) systems have now become an important standard-of-care for
      people with T1D and have demonstrated a reduction, but not elimination, of hypoglycemia
      during long-term studies. One limitation of current AID systems is that they have no
      knowledge about the context or environment that a person is currently experiencing.
      Contextual patterns can potentially improve the performance of an AID by recognizing
      environments or patterns of living that are related to changes in glucose. The team at OHSU
      is developing a context-aware glucose prediction algorithm that will capture context data
      from the patient both indoors and outdoors. This context data will be provided to the
      algorithm to allow for detecting contextual patterns that might relate to high or low
      glucose. The goal of this study will be the creation of a data set that will include
      contextual patterns along with glucose, insulin and physiological data.
    

Detailed description: 
      Subjects will be on study for 28 days. Sensor glucose, activity, exercise, insulin, indoor
      and outdoor contextual patterns and meal data will be collected during this time. Subjects
      will wear the Dexcom G6 CGM system and a physical activity monitor for the entire 28 days.
      Subjects will continue to use their own insulin pump. Subjects will be asked to also wear a
      MotioWear indoor/outdoor context-aware tracking tag and to install the MotioWear beacons
      within their home. Subjects will be randomized to complete either aerobic, high intensity
      interval training, or resistance exercise videos twice weekly at home during weeks 1 and 2
      and once during weeks 3 and 4. Subjects will also ingest a self-selected meal prior to these
      prescribed exercise sessions. Subjects will eat a high carbohydrate dinner once each week on
      the same day at the same approximate time of day (but not on the exercise days).

      Subjects will use the T1 DEXI mobile app created by OHSU to capture meal and exercise data
      along with photos of meals the day of exercise and the day after. While at home, subjects
      will check CBG before and after exercise, for symptoms of hypoglycemia, and for Dexcom G6
      alarms for sensor <70 mg/dL and >250 mg/dL.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: automated insulin delivery systems; Context patterns