bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial of A Pacifier-Activated Music Player
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Neonatal intensive care unit infants are at high risk for oromotor difficulties including
      poor coordination of sucking swallowing and breathing. These feeding difficulties often
      result in prolonged hospitalization, with increased physiologic stressors and poor growth. In
      preliminary studies, Pacifier Activated Lullaby (PAL) use showed potential increased oromotor
      skills and decreased length of hospitalization.

      The investigators propose to test the hypothesis that a week-long PAL intervention can
      improve feeding skills and decrease stress compared to standard of care parental interactions
      in infants in the late preterm period. The investigators also hypothesize that these
      improvements will result in shorter hospital stays and increased growth in the intervention
      group.

      Our study design is a prospective randomized controlled trial design of 94 infants
      (Post-conceptional ages 34-36 weeks). The 47 intervention-group infant/mother dads will
      receive a book library with one lullaby book and record her voice to the PAL, which the music
      therapist will then administer in 15-minute sessions for 5 consecutive days. The 47
      participants in the control group will receive the same library but no recording will be made
      or PAL used. Outcomes measured will include time to full oral feeds, suck rate and
      efficiency, salivary cortisol levels before and after intervention, daily growth parameters
      and nutritional data, and hospital length of stay.
    

Detailed description: 
      Objectives: We conducted a randomized trial to test the hypothesis that the mother's voice
      played through a pacifier-activated music (PAM) player during nonnutritive sucking would
      improve the development of sucking ability and promote more effective oral feeding in preterm
      infants.

      Methods: Preterm infants between 34 0/7 and 35 6/7 weeks postmenstrual age, including those
      with brain injury, who were taking at least half their feedings enterally and less than half
      orally, were randomly assigned to receive 5 daily 15-minute sessions of either PAM with
      mother's recorded voice or no PAM, along with routine nonnutritive sucking and maternal care
      in both groups. Assignment was masked to the clinical team.
    

Intervention name(s): Pacifier-Activated-Lullaby system (PAL).
Intervention type(s): Device
Intervention description(s): Pacifier-Activated-Lullaby system (PAL).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neonatal Intensive Care Unit (NICU); Music therapy; Premature infant; Oral feeds; Non-Nutritive Sucking; Suck rate; Suck efficiency; Contingent music; Mother's voice
Aerobic Versus Combined Exercise and Diastolic Dysfunction
Condition: Diastolic Dysfunction; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Thirty-two stable patients with chronic heart failure participated in an exercise
      rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic
      and strength training (COM). Before and after the program, they underwent a symptom-limited
      maximal cardiopulmonary exercise testing and serial echocardiography evaluation examining the
      indices of diastolic dysfunction (DD).
    

Detailed description: 
      Thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, EF: 32 ± 8%, 88 %
      men) participated in an exercise rehabilitation program. They randomly assigned to aerobic
      exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen
      uptake, as stratified randomization criteria. Before and after the program, they underwent a
      symptom-limited maximal cardiopulmonary exercise testing (CPET) and serial echocardiography
      assessment to evaluate peak oxygen uptake (VO2peak), peak workload (Wpeak), DD grade, right
      ventricular systolic pressure (RVSP) and EF.
    

Intervention name(s): aerobic exercise; combined exercise
Intervention type(s): Other; Other
Intervention description(s): exercise training rehabilitation (aerobic exercise with/without strength training); exercise training rehabilitation (aerobic exercise with/without strength training)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diastolic dysfunction; exercise training
Evaluation of Two Hand Hygiene Products in ICUs
Condition: Hand Hygiene Effectiveness
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the immediate antimicrobial efficacy and persistence of two hand
      hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on
      hands using the hand print method. It is hypothesized that the product containing
      Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in
      less bacterial growth on the hand print plates. In addition, environmental monitoring for
      cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas
      using Rodac plates and adenosine triphosphate tests.
    

Detailed description: 
      Crossover study with 50 Health care workers using each product with a minimum of 3 days in
      between. Products will be applied twice as per manufacturer's instructions for a Healthcare
      Personnel Handwash followed by immediate hand print. Persistent hand prints will be collected
      after exposure to environmental contaminants in the common areas. Hand prints will also be
      collected from one hand of 60 patients cared for by a participating Health Care Worker and
      gloved hand of Health Care Worker. All media contain neutralizers to inactivate active
      ingredients in each product and on surfaces. Each hand print plate's area of growth will be
      measured for Colony Forming Units using computerized software.
    

Intervention name(s): hand antiseptic with CHG and alcohol; Alcohol hand sanitizer foam
Intervention type(s): Drug; Drug
Intervention description(s): HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.; Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day
Other intervention name(s): Avagard CHG Hand Antiseptic with Moisturizers; Purell Advanced Instant Hand Sanitizer Foam; Purell Instant Sanitizer Foam
Intervention MeSH terms: Ethanol; Anti-Infective Agents, Local; Hand Sanitizers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antimicrobial; efficacy; hand; hygiene; bacteria
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
Condition: Tooth Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The study is intended to verify through clinical measurement that the NUPRO Sensodyne
      Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended
      relief up to 28 days.
    

Detailed description: 
      It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate
      sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
    

Intervention name(s): NUPRO Classic Prophy Paste; NUPRO Sensodyne Prophy Paste with Novamin with fluoride.; NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Intervention type(s): Device; Device; Device
Intervention description(s): Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.; Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the safety and tolerability of the following doses of atogepant
      (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg
      BID for the prevention of episodic migraine and will characterize the dose/response
      relationship.
    


Intervention name(s): Atogepant; Placebo-matching Atogepant
Intervention type(s): Drug; Drug
Intervention description(s): Atogepant capsule.; Placebo-matching atogepant capsule.
Other intervention name(s): AGN-241689
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Wear-Time Trial for Self-Fitting Hearing Aid
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      This document describes a clinical validation study for a double-blind repeated-measures
      comparative study of the Great Nordic (GN) self-fitting method to a validated
      audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device
      intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover
      wear-time field trial will be conducted. The focus of the study is on the validity of the
      self-fitting process used to select appropriate frequency-gain characteristics for the GN
      Self-fitting Hearing Aid, and the safety and effectiveness of the device.
    


Intervention name(s): Hearing aids
Intervention type(s): Device
Intervention description(s): Earbud style hearing aids fit to both ears
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Planning for SUCCESS
Condition: HIV
Study type: Interventional

Summary: 
      Planning for SUCCESS (Sustained, Unbroken Connections to Care, Entry Services, and
      Suppression) is a project to improve the connection to community care for HIV infected
      persons leaving Fulton County Jail or Atlanta City Detention Center in Atlanta.

      Hypothesis: Participants who receive the intervention will be more likely to link to medical
      care after jail release than similar participants who do not receive the intervention.

      Rationale and objective: This project aims to make sure HIV positive persons leaving jail
      maintain medical care. Case managers will use strength based case management and phone
      texting technology to improve release's connections to care in the community.

      This study will have extensive tracking of outcomes. The key outcome will be whether HIV
      infected participants receiving an intervention experience suppression of their viral load
      after release from jail . The investigators wish to demonstrate the ability to recruit
      participants into the SUCCESS intervention and repeatedly check community medical records to
      see how well their infection is being controlled after they linked to care. Investigators
      also want to conduct a survey at baseline, 3 months and 12 months.

      Investigators will compare the viral load of participants receiving the intervention to
      participants passing through the jail who do not receive the outcome.
    


Intervention name(s): Strength Based Case Management
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; jail; detainee; Linkage and Retention; Treatment as Prevention; Strength Based Case Management; releases
Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.
Condition: Dental Restoration Failure of Marginal Integrity
Study type: Interventional

Summary: 
      clinical performance of short fiber reinforced resin composite versus indirect nanohybrid
      resin composite onlay restorations in complex proximal cavities of molar teeth will be
      evaluated over one year.
    

Detailed description: 
      Resin composite materials have been rapidly developed in the latest few years. Direct resin
      composite restorations become the golden standard for restoring intracoronal cavities. While
      for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic
      restorations in most situations being more esthetic and conservative with lower cost (Rocca &
      Krejci, 2007).

      Indirect resin composite onlays usually are lab processed in two appointments but it can be
      made in one appointment through CAD/CAM technology or by flexible model technique (semidirect
      technique).

      These restorations offer more control on the proximal contacts and the anatomic form over the
      direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses
      are decreased and become limited to the width of the luting space. Annual failure rate (AFR)
      of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).

      One of the advancement in resin composite technology is the evolution of short fiber
      reinforced resin composite (SFRC) material that allows making a direct onlay restoration
      possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).

      This material is made to be used as a dentine substitute in the high stress-bearing areas. It
      is covered by a conventional resin composite filling to act as the enamel replacement this
      combination gives us a kind of biomimetic restoration.
    

Intervention name(s): Ever X Posterior
Intervention type(s): Other
Intervention description(s): Resin composite restoration can be made as a direct onlay
Other intervention name(s): Short fiber reinforced resin composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Short fiber reinforced resin composite; Nanohybrid resin composite; Indirect resin composite restoration
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
Condition: Cystic Fibrosis; Anemia, Iron-Deficiency
MeSH terms: Cystic Fibrosis; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Fibrosis
Study type: Interventional

Summary: 
      This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks
      increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic
      anemia.
    


Intervention name(s): Ferrous sulfate 325mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks; Matching placebo capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystic fibrosis; Iron; Hepcidin; Anemia; Erythropoiesis
Study of the Natural Variation in Strokevolume
Condition: Stroke Volume Variation
MeSH terms: Stroke
Study type: Observational

Summary: 
      We would like to investigate the natural variation in the strokevolume of the heart. At the
      same time we would like to find out the minimal number of heart cycles necessary to discover
      a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal
      Doppler.
    

Detailed description: 
      We would like to investigate the natural variation in the strokevolume(SV) of the heart. At
      the same time we would like to find out the minimal number of heart cycles necessary to
      discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal
      Doppler.

      Also we will compare the variation in SV both before and after the patients have been fluid
      optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus.
      The equipment used, will be the CardioQ from Deltex medical.
    

Intervention name(s): Esophagus Doppler monitoring; Fluid optimization
Intervention type(s): Procedure; Procedure
Time perspective: Prospective
Keywords: Stroke volume; SV variation; Esophagus Doppler; Goal Directed Therapy
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The intensification with maraviroc in recently HIV-1-infected patients of a preferred
      gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could
      accelerate the decay of the HIV-1 reservoir in latently infected cells established early in
      HIV-1 infection.

      This could provide further insight into this area, decrease the size of latent reservoir, and
      translate into clinical benefits for patients.
    

Detailed description: 
      A reservoir of latently infected cells established early in infection may be involved in the
      maintenance of viral persistence despite continuous highly active antiretroviral therapy
      (HAART). This is likely to represent the major barrier to virus eradication in patients on
      successful combination antiretroviral therapy.

      The majority of the viruses in the latent reservoir use CCR5 receptor during entry.

      More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated
      antiretroviral therapy early in infection have been demonstrated. The treatment of acute
      infection may set the stage for subsequent attempts at eradication. To achieve this, more
      potent antiretroviral therapy and/or more potent antilatency therapies may be needed.

      In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell
      membrane, nor does not require intracellular processing in order to exert its activity. In
      addition, there is no cross-resistance between entry inhibitors and agents that act on
      intracellular targets.

      Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses
      tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment
      intensification in HIV-1 infected patients with a recent HIV-1 infection.
    

Intervention name(s): Raltegravir; Maraviroc; Tenofovir/Emtricitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Raltegravir 400 mg every 12 hours; Maraviroc 300 mg every 12 hours; Tenofovir/Emtricitabine 300/200 mg every 24 hours
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maraviroc; CCR5 antagonists; Primary HIV Infection; HIV-1 reservoir; eradication; treatment naive
Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study is designed to evaluate the preliminary effectiveness and safety of a digitally
      based multidomain intervention in patients with MCI. In addition, a portion of cognitively
      normal subjects and caregivers of patients with MCI will also be recruited as an exploratory
      cohort. We hope that the digital platform will improve the overall cognition and quality of
      life in patients with MCI.
    

Detailed description: 
      3 groups of participants will be recruited. For the participants in the MCI (group A) and
      cognitively normal subjects (group B), they will be provided with a digital tablet and a
      wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1
      hour) for 10 weeks to be completed at home. The wearable device will be used to track and
      collect physiological data.

      For the caregivers of the patients with MCI (group C), they will be asked to complete a
      questionnaire during screening visit and follow-up visit, and to use the caregiver app during
      the intervention period.
    

Intervention name(s): Digitally based multidomain intervention
Intervention type(s): Device
Intervention description(s): Education (5-10 mins). This session is to educate patients on instrumental activities of daily living such as the importance of companionship, medication, finance, home, travel, and kitchen safety. The content will be delivered using video and text-based material in English.
Physical Activity (10 mins). This session includes activities such as brisk walking and yoga. Participants will be allowed to choose their preferred exercise option from the menu.
Reminiscence Therapy (20 mins). This session includes recollection of events using directed questions, and a collection of photos from the past. Participants will be asked to share about any aspect related to the given topics using text or audio.
Cognitive Games (20 mins). Participants will be asked to play games using their fingers to control characters on the screen to achieve goals. These games are designed to train different cognitive abilities, including attention, memory, executive functioning, and processing speed.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: This study comprises three study populations: patients with MCI, cognitively normal subjects, and caregivers of the patients with MCI.
Masking: None (Open Label)
Primary purpose: Treatment