bioihbjkbjnl/mcl2 huggingface dataset:
Digital Literacy Promotion
Condition: Language Development; Literacy
Study type: Interventional

Summary: 
      This study evaluates the effects of digital versus standard literacy promotion, as well as
      dialogic language behaviors and reading comprehension among infants when comparing the use of
      e-books to standard board books. Around half of the participants will receive standard board
      books at the 6, 9, and 12 month well visits, while the other half will receive digital
      e-books.
    

Detailed description: 
      This study has three main objectives. The first is to test the effects of digital versus
      standard literacy promotion by way of a randomized controlled trial design. The second aim is
      to explore the reading behaviors and reading activities between parents and their infants
      when comparing the use of e-books to standard board books. The third aim is to identify
      themes regarding dialogical reading behaviors among parents participating in the video
      sub-study.

      Participants will be stratified by clinic site and randomized to receive literacy promotion
      using 1) standard early reader board books or 2) digital electronic early reader e-books. We
      will recruit and consent one hundred eligible parent-infant dyads, with the infant being
      between 5 and 7 months of age at enrollment.

      In this intervention, parent-infant dyads randomized to the digital arm will receive
      developmentally appropriate e-books. Those randomized to the standard arm will receive
      developmentally appropriate board books. Participants will receive either the e-book or board
      book at the time of their 6, 9 and 12 month well visits. In addition to the books,
      parent-infant dyads in both arms will be provided information on the importance of early
      parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.

      The main outcome will be differences in Bayley-3 Composite scores between groups. Secondary
      aims include differences in StimQ Reading Subscale Scores and Edinburgh Postnatal Depression
      Scale Scores between groups.
    

Intervention name(s): Digital/E-Book Arm; Standard/Board Book Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Promotion of early reader digital e-book reading; Promotion of early reader board book reading
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be stratified by site and randomized 1:1
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Digital literacy; Reading
Ethyl Chloride for NPWT
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Negative pressure wound therapy (NPWT) has been shown to improve wound care outcomes for
      acute and chronic wounds as well as for surgical incision sites. We have found that patients
      report significant pain during dressing changes specifically with the removal of the clear
      adhesive drape. Upon review of the literature, there were multiple studies related to pain
      and the removal of the sponge (filler) but limited studies relating to the pain associated
      with the removal of the drape. The patient reported pain with drape removal has led to
      increased psychological stress and decreased compliance with the dressing change protocol.
      Application of a topical anesthetic to the drape during the dressing change has the potential
      to decrease the pain experienced by the patient. An FDA approved ethyl chloride spray is a
      topical anesthetic that can be sprayed onto the outer perimeter of the drape during the
      dressing change as a means to decrease pain. We hypothesize that the use of ethyl chloride
      spray will result in patients experiencing less pain leading to decreased psychological
      stress, improved compliance with dressing changes, and overall improved customer
      satisfaction.
    


Intervention name(s): Ethyl chloride; Tissue culture grade water
Intervention type(s): Drug; Other
Intervention description(s): Pressurized vapocoolant developed for acute, mild pain relief.; Pressurized water mist
Other intervention name(s): vapocoolant; Nature's Tears Eyemist
Intervention MeSH terms: Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Fecal Microbiota Transplant for Improvement of Metabolism
Condition: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota
      transplantation (FMT) transfers intestinal bacteria by a "stool transplant" from a healthy,
      lean person to a person with obesity.
    

Detailed description: 
      Multiple lines of evidence suggest that gut microbiota play an important role in regulating
      human metabolism. In this study, subjects will receive FMT capsules from lean metabolically
      healthy donors to study effects on body weight and insulin sensitivity. Subjects who
      participate will be randomized 1:1 to receive either active FMT capsules or placebo capsules.
      Subjects and providers will be blinded to treatment assignment. The study will last for 24
      weeks. Subjects will be asked to come to MGH for a baseline visit at week 0, return for 6
      weekly visits and come back at week 12. Major study outcomes include change in weight,
      insulin sensitivity, and body composition. Fecal samples will also be collected for
      intestinal microbiome analysis.
    

Intervention name(s): Placebo Capsules; FMT Capsules
Intervention type(s): Other; Biological
Intervention description(s): Placebo capsules contain powdered cocoa and gelatin; Capsules will be generated as per FDA-approved procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score (CADEPO)
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      The goal of this observational study is to make a statement concerning the identification of
      depressive symptoms at the time of the realization of the G8 score in patients over 75 with
      cancer and followed in oncology.

      The main question it aims to answer are:

        -  Compare the medical hetero-evaluation of depressive symptoms via the G8
           "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score

        -  Evaluate the number of patients over 75 treated with antidepressants

        -  Evaluate the proportion of patients with depressive symptoms according to the
           predisposing factors

        -  Compare the number of patients followed in oncogeriatrics over the period from
           01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023

      Participants will complete a self-questionnaire (GDS-15 score) as well as a socio-demographic
      sheet.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients over 75 presenting eligibility criteria and undergoing oncological treatment
        and coming for consultation in the Hôpital Nord Franche-Comté
Tramadol vs.Tramadol With Paracetamol
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      This study focused on to determine postoperative analgesic efficacy of tramadol compared to
      tramadol with addition of paracetamol after a lumbar disc surgery.
    

Detailed description: 
      Background:

      Despite developments in treatment of pain, the availability of new drugs or increased
      knowledge of pain management, postoperative pain control after different surgeries still
      remains inadequate.

      Aims:

      This study focused on to determine postoperative analgesic efficacy of tramadol compared to
      tramadol with addition of paracetamol after a lumbar disc surgery.

      Study Design:

      In this study we have randomized 60 patients into two treatment groups. In Group Tramadol
      patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr
      iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.

      Methods:

      Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale
      score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative
      period.
    

Intervention name(s): Tramadol; Paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): Tramadol iv; Paracetamol iv
Intervention MeSH terms: Acetaminophen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Acetaminophen; Tramadol; Discogenic pain; Lumbar Discectomy
Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs
Condition: Human Immunodeficiency Virus Positive or Negative
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV Seropositivity
Study type: Observational

Summary: 
      The purpose of this study is to understand the effects of decreased functioning of the testes
      or ovaries on mental performance in males and females using illicit drugs excluding
      marijuana.
    

Detailed description: 
      This research is being done to understand the effects of endocrine abnormalities,
      specifically hypogonadism (decreased functioning of the testes or ovaries) on cognitive
      (mental) performance in males and females using illicit drugs (excluding marijuana).
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        males and females 18-50 years old who have completed the 8th grade and are using drugs
      
Keywords: endocrine abnormalities; cognitive performance
Cannabinoids for Pain Control During Medical Abortion
Condition: Medical Abortion; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine if a synthetic cannabis derivative, dronabinol,
      in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in
      women undergoing medical abortion. Results of this study will help providers counsel patients
      regarding cannabis use during medical abortion.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled trial comparing pain levels in women
      undergoing medical abortion with one of two regimens: ibuprofen 800mg and a 5mg oral
      dronabinol versus ibuprofen 800mg and placebo given at the time of misoprostol
      administration. This study will include 62 women undergoing medical abortion. Women will be
      randomized to dronabinol 5mg oral versus placebo. The primary outcome will be maximum
      reported pain score within 24 hours of misoprostol administration.
    

Intervention name(s): Dronabinol 5mg Cap; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain; Subjects randomized to placebo and ibuprofen 800mg for pain
Other intervention name(s): Dronabinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Medical Abortion; Pain; Cannabis
Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers
Condition: Locally Advanced and Recurrent/Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy,response rate,time to treatment
      failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable
      and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern
      after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen
    

Detailed description: 
      In the treatment of metastatic breast cancer, paclitaxel followed by weekly HDFL has been
      shown to have a 55% response rate in anthracycline-resistant patient. Recently, regimen
      combining paclitaxel and moderately-high-dose 5-FU (1500mg/m2) has had response rate up to
      61.5% (including 23%CR) in a small group of gastric cancer patients (8 responders in 13
      patients). Thus, the sequential use of weekly paclitaxel followed by weekly HDFL regimen may
      become a new generation of chemotherapeutic regimen for the treatment of gastric cancer.
      Further study with a larger group of patients and further testing of possible schedules of
      administration are warranted.
    

Intervention name(s): Paclitaxel-HDFL
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Condition: Coronary Heart Disease, Graft Occlusion, Vascular
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Graft Occlusion, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety
      of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing
      elective or urgent coronary artery bypass (CABG) surgery. Patients will be randomized to
      receive either RO4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32
      weeks.
    


Intervention name(s): Placebo; RO4905417
Intervention type(s): Drug; Drug
Intervention description(s): iv infusion every 4 weeks, 32 weeks; 20 mg/kg iv infusion every 4 weeks, 32 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Neuromodulation on Verbal Fluency in Post-stroke Aphasia
Condition: Post-stroke Aphasia
MeSH terms: Stroke; Aphasia
Study type: Interventional

Summary: 
      This is a pilot study with a single active treatment arm. The study is designed to assess the
      efficacy of a portable, non-invasive neuromodulation system for the treatment of post-stroke
      aphasia. Both language and movement assessments will be made.
    


Intervention name(s): TNM(trademark) - thermoneuromodulation
Intervention type(s): Device
Intervention description(s): The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aphasia; stroke
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the effects of elagolix versus subcutaneous depot
      medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density
      (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.
    


Intervention name(s): Elagolix; Subcutaneous depot medroxyprogesterone acetate (DMPA-SC); Placebo to Elagolix; Placebo to DMPA-SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Provided as tablets for oral administration; Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.; Matching placebo tablets for oral administration; Matching placebo for subcutaneous injection in a pre-filled syringe
Other intervention name(s): NBI-56418; Orilissa™; depo-subQ provera 104™
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the QT/QTc Interval Between an Outpatient HIV-Infected Population on Antiretroviral Therapy and Two Large HIV-Negative Cohorts
Condition: QT and Corrected QT Intervals Prolongation in HIV Positive Subjects Treated With an Antiretroviral Regimen
MeSH terms: HIV Seropositivity
Study type: Observational

Summary: 
      This is a unicentric, two cohorts, observational transversal study.

      The purpose of this study is to compare the QT/QTc intervals of HIV positive subjects
      receiving an antiretroviral therapy and those without HIV in an ambulatory care setting.
    

Detailed description: 
      Primary objective:

      The primary objective is to compare the QT/QTc intervals of HIV positive subjects treated
      with antiretroviral therapy and followed at the ambulatory HIV clinic and the QT/QTc
      intervals of :

        1. an outpatient HIV negative population from the same health center pre-admission one-day
           surgical clinic.

        2. the large HIV-free korean population studied in the ECG-ViEW database.

      Secondary objectives :

        -  Evaluate the prevalence of QTc interval prolongation in the outpatient HIV positive
           population comparatively to the two HIV negative outpatient populations available from
           the one-day surgical clinic and the ECG-ViEW database.

        -  Evaluate risk factors associated with QTc interval prolongation in the outpatient HIV
           positive population compared to the outpatient HIV negative population and the
           population studied in the ECG-ViEW database.

        -  Compare the QT/QTc intervals and the prevalence of QTc interval prolongation of the
           outpatient HIV positive population currently on an antiretroviral regimen including a
           protease inhibitor versus those on an antiretroviral regimen without protease inhibitor.

        -  Compare the QT/QTc intervals among the outpatient HIV positive population treated with a
           protease inhibitor, in regard to the presence or the absence of certain genetic
           polymorphisms that may influence pharmacokinetic aspects of protease inhibitors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study is being conducted within the Centre hospitalier de l'Université de Montréal
        (CHUM). The recruited population was identified from the CHUM ambulatory care HIV clinic
        and an ECG registry composed of outpatient HIV negative subjects who were scheduled for a
        one-day surgery. The HIV positive outpatients on antiretroviral therapy will be recruited
        prospectively from March 2013 through August 2013. The outpatient HIV negative cohort will
        be recruited retrospectively according to a 10:1 ratio.
      
Biospecimen description: 
      10 mL whole blood in a purple Vacutainer EDTA tube
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the systemic exposure and bioavailability at
      steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in
      postmenopausal women with atrophic vaginitis.
    


Intervention name(s): Premarin® Vaginal Cream; Premarin® oral tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)
Condition: Nightmare
MeSH terms: Suicide
Study type: Interventional

Summary: 
      Youth suicide risk has increased 56% in the last decade, and suicide is the leading cause of
      preventable death in children and adolescents. Experiencing chronic nightmares doubles the
      risk of suicidal ideation in children and adolescents. Decades of research support that even
      when controlling for depression and insomnia, nightmares predict suicidality. Contemporary
      theories model nightmares as the mediating link between depression and suicide. Numerous
      studies examine the effect of nightmare-specific therapies on reducing suicide in adults, but
      none have examined whether nightmare therapies can reduce youth suicidality. The proposed
      pilot will evaluate the feasibility of the Cognitive Behavioral Therapy for Nightmares in
      Children paradigm (CBT-NC), recruiting and retaining children ages 6-17 who experience
      chronic nightmares. Utilizing a waitlist control (WL) model, participants (n=30) will be
      randomized after baseline assessment to either immediate treatment or a WL. Feasibility will
      be evaluated by examining retention through treatment (or WL) to post WL and post treatment
      assessments. Both groups will be evaluated before and after the treatment for suicidal
      ideation, sleep quality, and nightmare distress and frequency, in order to document
      improvements due to therapy. The proposed pilot will provide preliminary data about
      recruitment, retention, and allow for effect size calculations between groups. These results
      will be used to develop a larger treatment study that would ultimately evaluate the mediating
      effect of treatment for chronic nightmares on suicidality in children.
    


Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after a 5 week wait.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nightmares; Children; Trauma; CBT; Exposure; Relaxation; Rescripting; Cognitive; Behavioral; Therapy; Suicidality