bioihbjkbjnl/mcl2 huggingface dataset:
Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain
Condition: Peer Group; Motivational Interviewing; Cognitive Behavioral Therapy; Alcohol Drinking in College
MeSH terms: Alcohol Drinking; Alcohol Drinking in College
Study type: Interventional

Summary: 
      A pilot randomized controlled trial was carried out. Fifty nursing students were randomly
      assigned either a 50-minute brief motivational intervention with individual feedback or a
      treatment-as-usual control condition. The intervention was delivered by undergraduate peer
      counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary
      outcomes for testing efficacy were alcohol use and alcohol-related consequences.
    

Detailed description: 
      Aims: To assess the potential efficacy and the feasibility of a peer-led brief alcohol
      intervention aimed to reduce the alcohol consumption in Spanish heavy nursing student
      drinkers.

      Methods: A pilot randomized controlled trial was carried out. Fifty nursing students were
      randomly assigned either a 50-minute brief motivational enhancement intervention with
      individual feedback (n=23) or a treatment-as-usual control condition (n=27). Both
      motivational interviewing and personalized feedback were delivered by undergraduate peer
      counsellors trained in Brief Alcohol Screening and Intervention for College Students
      (BASICS). Participants were assessed during their pledge year of university with a one-month
      follow-up. Primary outcomes for testing efficacy were alcohol use (quantity, heavy-drinking
      episodes, and peak blood alcohol concentration), and alcohol-related consequences.
      Quantitative data were analyzed using the U-Mann-Whitney and Wilcoxon test. Content analysis
      was used for measuring the feasibility of the program.
    

Intervention name(s): Peer-led BASICS
Intervention type(s): Behavioral
Intervention description(s): The peer-led BASICS session consisted in a face-to-face 50-minute motivational interview. In this meeting, the peer counsellor oriented the participant using a personalized graphic feedback sheet, with topics including participant's drinking pattern; level of intoxication; perceived and actual descriptive drinking norms, alcohol expectancies; drinking consequences; individual risk factors; financial costs; alcohol caloric consumption, and hours of exercise required to burn those calories, and protective behavioral strategies. Participants received a copy of the personalized feedback, a personalized BAC card, and a tips sheet.
BASICS facilitators were volunteer undergraduate nursing students from who attented a pre-training course and showed being competent to conduct BASICS-based motivational interview and knowledgeable about alcohol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Brief interventions; Motivational interviewing; Peer counsellors; College students; Alcohol; Counsellor behavior
Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer
Condition: Advanced Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral
      Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically
      confirmed malignant solid tumor refractory to standard therapy.

      Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and
      Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on
      day 29.

      Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of
      paclitaxel
    

Detailed description: 
      Besides the main objective, there are 3 other objectives as follows.

      To determine dose-limiting toxicity (DLT) Of Oraxol. To characterize the pharmacokinetics of
      HM30181A(pgp inhibitor), paclitaxel and its metabolites following oral administration of
      Oraxol.

      To evaluate anticancer activity of Oraxol.
    

Intervention name(s): Paclitaxel+HM30181
Intervention type(s): Drug
Intervention description(s): oral, 3times for 4weeks
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The investigators are asking subjects to take part in the Patient NAVIgation to Reduce
      Readmissions among Black Men with Heart Disease (NAVI-HF) research study. This research study
      will test how well trained laypeople working as patient navigators will help patients
      recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new
      program sponsored by funding from the National Institute of Minority Health and Health
      Disparities. People who enter into the study will work with a patient navigator to undergo
      the full program or work with a trained layperson to receive general education on heart
      disease treatment and prevention. The purpose of the study is to determine whether a patient
      navigation program will be effective in reducing the number of hospitalizations in the future
      for program participants. This study will enroll 416 participants from UAB.
    

Detailed description: 
      Therefore, in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart
      Disease (NAVI-HF) study, the investigators propose to recruit 416 AA men with Heart Disease
      receiving inpatient care at UAB Hospital and randomize them either to Heart Disease self-care
      education plus a patient navigator-delivered self-care plan (Education + PN arm) or to Heart
      Disease self-care education alone (Educational Control arm). The investigators will compare
      participant outcomes such as all-cause and Heart Disease readmission rates, Heart Disease
      self-care adherence as well as cost effectiveness across the two intervention arms. Our
      Specific Aims are:

        1. To assess the 30-day all-cause readmission rates among male African American Heart
           Disease patients receiving Heart Disease self-care education plus a patient
           navigator-delivered self-care plan versus Heart Disease self-care education alone

        2. To assess the Heart Disease self-efficacy and heart failure self-care adherence among
           male African American Heart Disease patients receiving Heart Disease self-care education
           plus a patient navigator-delivered self-care plan versus Heart Disease self-care
           education alone

        3. To evaluate the cost-effectiveness of Heart Disease self-care education plus a patient
           navigator-delivered self-care plan versus Heart Disease self-care education alone
    

Intervention name(s): Education + Patient Navigation; Self-care Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.; 208 patients randomized to self-care education alone.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hospital Readmissions; Patient Navigation
Effects of Augmented Reality on Humans
Condition: Physical Activity; Mental Status Change
Study type: Interventional

Summary: 
      Nowadays, augmented reality (AR) has gained attention but little is known concerning its
      repercussion in individuals when considering some mental and physiological aspects.
      Therefore, the aim of this study was to investigate the effects of AR glasses on some
      cognitive and physiological functions in an attempt to determine its safety for workers.
    

Detailed description: 
      Twelve volunteers were tested during two separate randomized sessions: one with AR glasses
      (ARGlass) and one in normal condition (Normal). Participants had two perform different tasks
      of a 90 minutes total duration. Before, during and after these tasks, two feet balance, one
      foot balance, precision balance, stroop and memory tests were performed. Also, heart rate and
      electromyographic activity of some muscles were recorded. Finally a survey was filled to
      determine, for example fatigue, pain or comfort.
    

Intervention name(s): Tasks
Intervention type(s): Device
Intervention description(s): Augmented reality device Real condition
Other intervention name(s): Workers tasks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: augmented reality; fatigue; muscle; heart rate; mental function
Opportunities for Food Reformulation
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to determine the independent and additive effects of food
      texture and energy density on food and energy intake compared to a control condition.
    

Detailed description: 
      Study design: The study has a 2x2 randomized crossover design. All participants receive 5
      treatments and are their own control.

      Study population: Healthy adults (n=75) between 18-55 years old with a BMI between 18.5-30
      kg/m2.

      Intervention: Participants will join 5 test days during which they receive, 5 test meals
      (lunch). The 5 test meals of this study are: 1.) low energy density, hard texture (slow
      eating rate) 2.) low energy density, soft texture (fast eating rate) 3.) High energy density,
      hard texture (slow eating rate) 4.) High energy density, soft texture (fast eating rate) 5.)
      Average energy density and medium hard texture (control). During eating and before and after
      eating the weight of the plate will be measured to determine intake. Additionally,
      participants will be recorded on video to determine eating behaviour (number of bites, chews
      and oral processing duration). The order in which participants will receive the diets will be
      randomized. The evening before and during each test day participants will keep a food and
      exercise diary.

      Main study parameters/endpoints: The main study outcomes are food and energy intake of each
      lunch meal. Secondary outcomes are, eating behaviour characteristics measured by video
      (eating rate (g/min and bites/min), number of chews (chews/bite and chews/gram), bite size
      (gram/bite), oral processing duration (seconds), appetite (hunger, fullness, desire to eat,
      desire to eat sweet, desire to eat savoury, prospective consumption) and sensory
      characteristics (liking (taste + smell), desire to eat the meal, expected satiation, sweet,
      savoury, smoothness, chewiness, thickness) of the meals. Additional outcomes are individual
      differences in microstructure of eating, appetite responsiveness, eating Behavior phenotype,
      interoceptive sensitivity and anthropometry measures. During the trial new technology to
      capture food intake and eating behavior will be validated which is also an outcome of this
      trial.
    

Intervention name(s): Food properties manipulation to alter eating behavior and food and energy intake
Intervention type(s): Behavioral
Intervention description(s): Food properties of commercially available food products
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The 5 conditions of this study are:
low energy density, hard texture (slow eating rate)
low energy density, soft texture (fast eating rate)
High energy density, hard texture (slow eating rate)
High energy density, soft texture (fast eating rate)
Average energy density and medium hard texture (control)
Masking: Single (Participant)
Primary purpose: Prevention
Physical Activity Behavioral Intervention in Obese Endometrial Cancer Survivors
Condition: Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies a physical activity behavioral intervention in obese
      endometrial cancer survivors. Learning about physical activity behavior while participating
      in a fitness class may help increase physical activity and improve the quality of life of
      obese endometrial cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the effect of a 12-week behavior/exercise intervention on moderate-vigorous
      physical activity (> 150 minutes) among ethnically diverse endometrial cancer survivors.

      SECONDARY OBJECTIVES:

      I. To determine the effects of a 12-week behavior/exercise intervention on body composition
      among ethnically diverse endometrial cancer survivors.

      TERTIARY OBJECTIVES:

      I. To determine the effects of a 12-week behavior/exercise intervention for ethnically
      diverse endometrial cancer survivors on physical function and quality-of-life.

      II. To determine the most important behavioral variables for predicting physical activity
      adherence.

      III. To determine the most significant facilitators and barriers to adherence during the
      12-week intervention.

      IV. To compare the thematic differences between high-adherence and low-adherence participants
      and qualitatively assess the strengths and weaknesses of the 12-week intervention.

      OUTLINE: Participants are randomized to 1 of 2 groups

      GROUP I: Participants partake in 30 minutes of group discussions regarding physical activity
      behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes
      warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises
      using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly
      for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of
      class for 12 weeks.

      GROUP II: Participants receive a handout indicating the importance of physical activity and
      improved nutrition for health outcomes. After 12 weeks, patients are invited to participate
      in the physical behavior intervention as in Group I.

      After completion of study, participants are followed up at 12 weeks.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): Participate in physical activity behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Web-based Preconception Health Education Tool
Condition: Reproductive Health
Study type: Interventional

Summary: 
      Strong evidence supports that preconception care, or care to optimize a woman's health health
      prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a
      broad range of topics, including: desire for pregnancy, obstetric history, nutrition,
      vaccinations, sexual health, chronic disease, substance abuse, mental health and
      contraception. Despite calls from public health organizations and experts in the field for
      universal access to preconception care, most US women do not receive any health counseling to
      prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is
      critical that routine primary care serve as a venue for the provision of this important
      service. From a patient's perspective, improving preconception health involves many health
      behavior changes. As such, patient engagement and education regarding preconception health
      must be a primary focus. Several preconception health promotion tools have been developed for
      patients to date; few are truly patient-centered and even fewer have been rigorously
      evaluated.

      This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health
      education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is
      truly innovative in two key ways:

        -  MyFamilyPlan is a web-based preconception health self-assessment. This will allow for
           the employment of skip logic to individualize the questionnaire and subsequent health
           recommendations for each patient.

        -  Recognizing that preconception care is relevant to all women "at risk" of pregnancy,
           MyFamilyPlan has been designed for utilization in a primary care setting.

      This preconception health education tool will be tested using a randomized controlled design.
      This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of
      preconception health issues in primary care encounters (primary outcome). It will also
      evaluate whether the intervention affects participant self-efficacy in planning a healthy
      pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will
      improve the quality of evidence for preconception health education tools. Should it
      demonstrate effectiveness, it will also result in a new tool that could be made more widely
      available to promote preconception health.
    


Intervention name(s): MyFamilyPlan
Intervention type(s): Behavioral
Intervention description(s): Web-based preconception health education tool (interactive self-assessment) - to be completed by patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Fiber Tolerability in Children Aged 3-7 Year
Condition: Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years
      old.
    

Detailed description: 
      The aim of the trial is to determine, using a dose escalation design, the digestive
      tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding
      to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the
      evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to
      7 years old.

      As it is an exploratory study there is no categorization between primary and secondary
      objectives.
    

Intervention name(s): Placebo (including Maltodextrin); Dose 1 - Promitor®; Dose 2 - Promitor®; Dose 3 - Promitor®
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Fiber tolerability; Children
Prevalence of Periodontal Diseases in IBD
Condition: Inflammatory Bowel Diseases; Periodontal Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Periodontal Diseases
Study type: Observational

Summary: 
      Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that
      they are correlated with numerous systemic diseases as : diabetes, chronic obstructive
      pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases
      have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's
      disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of
      periodontal disease. These diseases present common features : a high prevalence worldwide,
      multifactorial pathogenies with common mechanisms. To date, no study has linked activity of
      IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal
      diseases could be increased in patient presenting an active IBD
    

Detailed description: 
      The present study explores the prevalence of periodontal diseases regarding to the activity
      status of IBD (active versus non-active).

      Diseases activity will be assessed by HBI (Crohn's disease) or partial Mayo score (Ulcerative
      Colitis) associated with fecal calprotectin and/or CRP and/or inflammatory/ulcerative
      lesions.

      Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the
      international classification of periodontal diseases (Chicago 2017) and based on the
      decision-making algorithms by Tonetti and Sanz. A periodontal screening, socio-demographic
      data and clinical data will be collected. Then, oral mucosa dermatological manifestations
      relative to IBD, treatment need (ICDAS) and quality of life related to oral health (GOHAI)
      will be evaluated. These data will be collected by a periodontist.

      The principal hypothesis of this study is that the prevalence of periodontal diseases could
      be increased in patient presenting an active IBD.

      The primary objective is to evaluate if patients presenting active IBD present more stage III
      and IV periodontal diseases than non-active IBD ones.

      The second objectives are :

        -  to compare periodontal diseases, gingivitis and oral mucosa dermatological
           manifestations rates according to the diseases activity, the IBD type and the treatment
           used to treat IBD,

        -  to compare oral treatment need according to the activity and the type of IBD,

        -  to compare quality of life related to oral health according to the activity and the type
           of IBD
    

Intervention name(s): Periodontal screening
Intervention type(s): Other
Intervention description(s): Periodontal data collection (PPD, REC, CAL)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consulting for the management of Crohn's disease or Ulcerative colitis
Clinical Investigation of a New Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS
      Symfony Extended Range of Vision IOL.
    


Intervention name(s): TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; TECNIS Monofocal IOL, Model ZCB00
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment