bioihbjkbjnl/mcl2 huggingface dataset:
Reducing Transphobia Among Adolescents Through a Brief Video Intervention
Condition: Transgenderism; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purposes of this new study are to test among adolescent viewers the utility of brief
      video-based interventions to:

        1. reduce transphobia;

        2. reduce depression-related stigma and increase likelihood of treatment-seeking; and

        3. examine the role of viewer's sex (male / female / non-binary), race (Black vs
           non-Black), and sexual orientation (straight vs LGBQ) as independent factors on the
           outcomes of interest.
    

Detailed description: 
      Intervention videos will each be of ~100-second duration and feature four underage
      professionals (ages 16) acting as simulated patients. All videos will focus on an empowered
      presenter with depression sharing their personal story regarding depression. They will
      describe how social supports from family, friends, and community, as well as professional
      help assisted them in overcoming symptoms of the illness, as well as how being transgender
      may have had an impact on it. The four actors will include two males (one trans, one cis) and
      tow females (one trans, one cis).

      Assessments will occur at baseline and post-intervention, and will include:

        1. Demographics (baseline only);

        2. Primary outcome:

           a. Attitudes toward Transgender Men and Women (ATTMW) scale.

        3. Secondary outcome:

             1. Transgender attitudes: feelings thermometer, modeled after Norton et al 2013.

             2. Depression-related stigma (Depression Stigma Scale [DSS]);and

             3. Help-seeking (General Help-Seeking Questionnaire [GHSQ]).

      For each of study we intend to randomly assign ~1,000 individuals aged 14-18 as follows:

      Randomized, in equal proportions, and stratified by sex and race, to view one of four
      ~100-second videos:

        1. Transgender male;

        2. Cis-gender male);

        3. Transgender female;

        4. Cis-gender female.
    

Intervention name(s): Short videos
Intervention type(s): Behavioral
Intervention description(s): Intervention videos will each be of 90-second duration and feature four underage professionals (ages 16) acting as simulated patients. All videos will focus on an empowered presenter with depression sharing their personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of their illness. The actors will include a transgender male, a cis-gender male, a transgender female, and a cis-gender female.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Hands on - a Hand Care Guide in Systemic Sclerosis
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional

Summary: 
      Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to
      apply a home based hand care guide in patients with SS and to evaluate its response regarding
      hand pain, function, strength and mobility.
    

Detailed description: 
      Introduction: Hands are commonly affected in Systemic sclerosis (SS). Skin thickening,
      Raynaud phenomenon, digital ulcers and cutaneous calcinosis may result in pain, disability
      and claw deformity. Strategies to improve hand function are recommended since its diagnosis
      and throughout the treatment. Unfortunately hand care assistance is not often available. The
      objective of this study was to developed a brief guide about hand care and home-based
      exercises to be applied in our outpatient clinic.

      Methods: A brief program , with instructions about the disease and home-based exercises will
      be applied in a group patients with Systemic Sclerosis (SS) during the period of 12 weeks.
      Hand function (Cochin Hand and Functional Scale), disability (HAQ-Scleroderma), quality of
      life (SF-36 hand pain (visual analogue scale), grip and pinch strength, hand mobility (delta
      finger) will be assessed in the first appointment and after twelve weeks.
    

Intervention name(s): Handbook
Intervention type(s): Other
Intervention description(s): The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile
Condition: Metabolism Disorder; Insulin Sensitivity; Obesity, Pediatric
MeSH terms: Insulin Resistance; Metabolic Diseases; Pediatric Obesity
Study type: Interventional

Summary: 
      Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide
      interindividual variability after exercise training explored mainly in adults but not in
      children. Thus, is yet unknown what baseline health status as well as the influence of what
      health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of
      subjects who experienced a non-change/worsened response after training in some metabolic
      outcomes) after exercise training in school children.
    


Intervention name(s): High Intensity Training (HIT) + Resistance Training (RT); Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.; Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Theory of Meleis on Women's Adaptation to Motherhood and Perceptions of Newborn Baby
Condition: Newborn; Prenatal Care; Nursing Caries
Study type: Interventional

Summary: 
      A randomised control trial will made to determine the effects of nursing care based on
      Meleis's Theory of Transition on Adaptation of Women to Motherhood and their Perception of
      New-born Infant
    

Detailed description: 
      Transition to motherhood, being one of the most important life incidents in the lives of
      women embodies the transition of role from a known situation to an unknown one. Being a
      special period in which women hold the role of motherhood together with the birth of the
      child; try to adapt the new role and reform relationship with the family members at the same
      time, transition to motherhood is a progressive period experienced by many women. Transition
      of woman to motherhood in a healthy manner will positively affect developing trust, achieving
      healthy communication with the infant, adapting to new lifestyle and fulfilling her
      responsibilities. Thus, transition to motherhood is quite significant both for mother and
      other family members and the new-born infant and needs to be discussed.

      It is aimed in this research that effects of nursing care based on Meleis's Theory of
      Transition on Adaptation of Women to Motherhood and their Perception of New-born Infant shall
      be tested.

      It will tested the hypotheses that there is no difference between the intervention and
      control groups of pregnant women after the intervention in terms of adaptation to pregnancy,
      adaptation to the postpartum period and newborn perception.
    

Intervention name(s): Structured education and follow-up
Intervention type(s): Other
Intervention description(s): The women in the intervention groups will administer a seven-session intervention program in addition to the routine care they will receive.
The training including preparation practices for the transition with the mother, which is planned to last for 7 weeks encompassed providing the women with an educational programme that were created to increasing women's adaptation to motherhood and perceptions of newborn baby
Nursing-recommended follow-up and physical examination of the pregnant woman will be performed at 28th and 34th week of pregnancy. In addition, postpartum and newborn follow-up, and mother-newborn physical examinations will be performed at the postpartum period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nursing care; Prenatal; Newborn; Postpartum; Theory; Transition
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
Condition: To Determine Bioequivalence Under Fasting Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability of Kali and Ortho-McNeil's
    

Detailed description: 
      To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with
      Ortho-McNeil's Ultracet tablets 37.5mg/325mg
    

Intervention name(s): Tramadol APAP; Ultracet
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 37.5mg/325mg, single dose; Tablets, 37.5mg/325mg
Other intervention name(s): Ultracet; Tramadol APAP
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence, Tramadol APAP, fasting
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study evaluates the families' and health care professional's experience from using a web
      based support system including mobile applications for self-monitoring weight and physical
      activity. Changes in BMI standard deviation score are compared between usual care (control)
      and usual care with complementary web-based support system (intervention).
    

Detailed description: 
      In this study children with obesity were randomized to either usual care according to regular
      routine (control group) or to usual care plus a web-based support system (intervention
      group). The system is based on a smartphone application connected to a scale and an activity
      measuring wrist-band. Data is automatically transferred from the accessories to the
      smartphone, where data is presented graphically. The data is transferred to the clinic for
      support. The system is developed for communication between the clinic and family. The
      randomization was done at the start of individual treatment and lasted for 6 months.
      Investigators studied the families and health care professional's experience of using the
      web-based support system as well as changes in BMI standard deviation score in the control
      and intervention group.
    

Intervention name(s): CLOSS; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Usual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online.; Usual care. The child and parent(s) at regular visits to the nurse at the clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile Health, Self-Monitoring, Behavioural Treatment
Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
Condition: TTR Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy male and female volunteers will investigate the safety and tolerability
      of three increasing oral doses of tafamidis
    


Intervention name(s): Tafamidis; Tafamidis; Tafamidis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 240 mg, solution, single dose; 480 mg, solution, single dose; TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; pharmacodynamic
Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
Condition: Surgery
Study type: Interventional

Summary: 
      Treating pain, just as treating other medical conditions, depends on accurate assessment of
      patient's condition. When assessing pain, as other subjective symptoms, the challenge is
      twofold because the assessment is dependent on patient's understanding and use of the scale,
      all the more so in children

      So far, attempts to improve pain assessments have been focused on the development and
      refining pain scales. No emphasis has been placed on improving patient's ability to report
      their pain. Our purpose is to evaluate a training program designed to improve the quality of
      children's post-surgical pain intensity reports.

      After receiving Helsinki approval, eligible children and their parents will signed
      informed-consent. After surgery, the children, their parents, and the department nurses will
      assess children's pain intensity. Immediately after the nurse assessment, parents will assess
      their child's pain (blindly and independently) and the children will report their pain on
      four different pain scales.

      Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be
      invited to participate. Children in the experimental group will be exposed to a training
      program, developed for this study, aimed to teach and train how to report pain. The control
      group will receive the standard pre-surgical instructions.
    


Intervention name(s): Animation clips; Instructions
Intervention type(s): Other; Other
Intervention description(s): The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies; Routine preoperative preparations, which included a section on pain assessment instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Modification and Evaluation of the Educational Mobile Games Heroes of Knowledge in Children
Condition: Math Knowledge
Study type: Interventional

Summary: 
      The goal of the proposed research is to adapt and rigorously evaluate educational mobile
      games, designed as a downloadable mobile apps to be played on smartphones or tablets.
      Investigators will be partnering with Yogome for this project. Yogame is a company dedicated
      to creating educational games that aim to reinforce knowledge acquired in school and help
      children learn new things in an entertaining and fun way.
    

Detailed description: 
      This study will modify and evaluate the Heroes of Knowledge (HoK) games, beginning with the
      Math Heroes game which was designed to be played for up to 8 hours. Other games in the HoK
      series may be included in this process if they are fully developed and available for testing.
      In testing the efficacy of the Math Heroes game, children will play the game for 1-1.5 hours
      per week, 2-3 times per week, for 2-4 weeks (to accumulate 6-8 hours of game play). The game
      has been designed to target math knowledge skills identified by the Common Core Standards for
      Mathematics (2012).
    

Intervention name(s): Heroes of Knowledge; Attention/Time Control Game
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will play their assigned game(s) on a tablet computer for 1-1.5 hours, 2-3 times per week for 2-4 weeks (to accumulate 6-8 hours of gameplay).; Participants will play their assigned game(s) on a tablet computer for 1-1.5 hours, 2-3 times per week for 2-4 weeks (to accumulate 6-8 hours of gameplay).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Prevalence of Molar Incisor Hypomineralization Among Children Treated With Asthmatic Drugs Early in Their Lives
Condition: Molar Incisor Hypomineralization; Asthma in Children
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia; Asthma
Study type: Observational

Summary: 
      The aim of this study is to assess the prevalence of molar incisor hypo mineralization among
      children who have been treated with asthmatic drugs during the first three years of life.
    

Detailed description: 
      The term Molar incisor hypo mineralization (MIH) was first introduced in 2001 as a
      developmental disorder of enamel characterized by hypo mineralization -of systemic origin -
      affecting the enamel of first permanent molars (PFM) ,frequently associated with affected
      permanent incisors.

      The prevalence of MIH varies widely, ranging from 2.4 % to 40.2% in different populations.
      This wide variation may be due to differences in diagnostic criteria and methodologies used
      by the authors. Concerning the etiology of MIH it is mostly related to pre natal, perinatal,
      and post natal illness.

      Asthma and asthmatic drugs have been proposed to be one of the etiological factors of
      MIH,Internationally, the mean prevalence of pediatric asthma is 10%.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        children aged from 8 to 12 years old with fully erupted first permanent molar and permanent
        incisors, who have been treated with any type of asthmatic drugs during their first three
        years of life.
      
Keywords: MIH; asthmatic drugs
Comparison Study of Lay Person Finger Stick Versus Blood Draw
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger
      Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood
      taken from the arm vein).
    

Detailed description: 
      This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger
      Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood
      taken from the arm vein). The information and data obtained will be used to finish
      development of a convenience kit that allows doctors to provide their patients a method to
      have their blood tested for clinical laboratory tests in the convenience of their home
      without having to visit the doctor's office or clinic.
    

Intervention name(s): A1c, Self-collection, Blood sample
Intervention type(s): Device
Intervention description(s): This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
Other intervention name(s): HomeAccess A1c Kit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients
Condition: Cancer of Head and Neck; Cancer; Radiation-induced Xerostomia; Dry Mouth
MeSH terms: Head and Neck Neoplasms; Xerostomia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether continuous use of edible, gel-based
      artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms
      of dry mouth and improve quality of patients' saliva.
    


Intervention name(s): Gel-based artificial saliva
Intervention type(s): Other
Intervention description(s): Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth.
Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks.
Other intervention name(s): Oral moisturizing jelly
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Flexible Dose Titration Add-on Study to Treat Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Depressed patients will receive 6 weeks of citaloprma (20-40mg) therapy. Subjects who have an
      inadequate response (partial or non-responder) will be randomized to receive either
      mecamylamine (5-10mg) or placebo added to their citalopram for a further 8 weeks.
    

Detailed description: 
      This is a double blind, randomized, placebo controlled, parallel group, flexible dose
      titration, add-on study. Male or female subjects aged 18-70 years suffering from Major
      Depressive Disorder according to DSM-IV, with a HAMD-17 score greater than 21 and a
      CGI-Severity of Illness score greater or equal to 4, will be started on open labeled
      citalopram treatment. The dose of citalopram may be increased form 20mg to 40mg over a six
      week period, depending on investigator assessment of tolerability and efficacy. At the end of
      this treatment, subjects with a HAMD-17 score greater or equal to 14 and a CGI-Severity of
      Illness score greater or equal to 4 will be considered as partial or non-responders and will
      be entered into the double blind phase of the study. Subjects will be randomized to either
      mecamylamine or placebo for a further 8 weeks. Citalopram medication will remain constant
      while mecamylamine (or placebo) can be increased from 5.0 to 7.5 to 10.0mg based on
      investigator assessment of tolerability and efficacy.

      Plasma samples for citalopram assay will be collected at the start and end of the double
      blind phase to exclude any mecamylamine effect being due to a drug:drug interaction.

      Approximately 500 subjects will be entered into the open-label phase of the study and
      approximately 160 into the double blind phase. The study will be conducted in India and the
      USA.
    

Intervention name(s): Mecamylamine
Intervention type(s): Drug
Intervention description(s): 2.5mg mecamylamine Hcl, tablet form taken twice a day (total of 5.0mg). For 7.5 mg dose group, 2 tablets taken morning, one tablet evening. At 10.0mg, 2 tablets taken twice daily.
Other intervention name(s): Inversine
Intervention MeSH terms: Mecamylamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; Depression; Mecamylamine; Add-on Therapy; Major Depressive Disorder