bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
Condition: Oral Feeding Outcomes; Growth; Length of NICU Stay
Study type: Observational

Summary: 
      The specific aim of this pre-post trial is to compare data regarding oral feeding, length of
      stay, and growth outcomes of 100 NICU infants to these same outcomes following the
      implementation of a developmentally supportive, infant driven feeding program with the NICU
      staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding
      program on a second sample of 100 NICU infants at Children's Memorial Hospital.

      The specific research questions considered in this study are:

        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically
           fragile infants in the NICU at discharge and at 3 months post-term?

        2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile
           infants in the NICU at discharge and at 3 months post-term?

        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile
           infants in the NICU?

        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU
           staff evaluations and communications related to managing oral feedings with medically
           fragile infants?
    


Intervention name(s): SOFFI
Intervention type(s): Other
Intervention description(s): NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.
Other intervention name(s): Supporting Oral Feedings in Fragile Infants
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Convenience sample of NICU infants discharged home prior to the implementation of the SOFFI
        will be compared to a convenience sample of NICU infants discharged home following the
        implementation of the SOFFI.
      
Keywords: Supporting Oral Feeding in Fragile Infants (SOFFI); Infant Oral Feeding; Infant Growth; Preterm infant oral feeding; Preterm infant growth; Neonatal Intensive Care Unit (NICU)
Easypod United States User Trial
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will help to determine whether an injection log on a recombinant human growth
      hormone (rhGH) delivery device improves subjects' adherence with injection schedules.
      Adherence will be compared between a group of subjects who are aware of the injection log on
      the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™
      injection log. It is the study hypothesis that subject non-adherence rate is different for
      those who are aware of the injection log capability versus those who are unaware of the
      injection log capability. Subject perception will also be evaluated by comparing the ease and
      convenience of use and subject preference for the easypod™ compared to two other rhGH pen
      injection devices.
    


Intervention name(s): easypod; easypod
Intervention type(s): Device; Device
Intervention description(s): Subjects is aware that the device records injection information that can be viewed by user; Subjects is not aware that the device records injection information that can be viewed by user
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination
Condition: Rumination Disorders
MeSH terms: Rumination Syndrome
Study type: Interventional

Summary: 
      Rumination syndrome is characterized by effortless recurrent regurgitation of recently
      ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a
      previous study we showed that rumination is produced by an unperceived, somatic response to
      food ingestión. After having identified the key mechanisms of rumination, we developed an
      original EMG guided biofeedback technique with specific targets for correction, based on
      EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the
      potential effectivity of this treatment. In a subsequent study this technique was validated
      by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of
      a simplified biofeedback technique not requiring EMG-guided control.
    

Detailed description: 
      Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the
      biofeedback group, patients will be instructed to control muscle activity, whereas in the
      placebo group patients will not. In each patient 3 sessions will be performed over a 10-day
      period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination
      events by questionnaries administered daily for 10 days) will be measured before and after
      treatment.
    

Intervention name(s): Biofeedback; Placebo
Intervention type(s): Behavioral; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
Condition: Obesity
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is whether an inspiratory muscle training protocol would be
      associated with an improvement in of the diaphragm mobility, an increase in pulmonary
      function values , gain strength and endurance of respiratory muscles and improving quality of
      life.
    

Detailed description: 
      Few studies have investigated the effects of an inspiratory muscle training in obese patients
      on the diaphragmatic mobility and thickness. Obesity, especially morbid, triggers changes in
      the respiratory system, which can affect the work activities and daily life of individuals
      with this multifactorial syndrome. These functional changes in mechanical ventilation may be
      linked to weakness and poor respiratory muscle strength, so by promoting rehabilitation of
      these muscles can minimize the losses that come with obesity
    

Intervention name(s): Threshold; Sham Threshold
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Obesity; Diaphragm; Inspiratory muscular training
Psychotherapy for Depressed Mothers of Psychiatrically Ill Children
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The current proposal is a randomized, controlled, clinical trial to evaluate the
      intergenerational impact of treating depressed mothers whose children suffer from psychiatric
      disorders.
    

Detailed description: 
      This study will compare a psychotherapy for mothers that targets factors known to be
      associated with the intergenerational transmission of psychiatric disorders to a nonspecific
      psychotherapeutic control condition. It will evaluate outcomes in both children and mothers.
      A modified form of interpersonal psychotherapy for depression, IPT-MOMS, specifically
      addresses maternal depressive symptoms, maternal interpersonal functioning, and mother-child
      communication, all factors that contribute to psychiatric illness in youth (Swartz et al.,
      2006). This application proposes to recruit mother-child dyads, both of whom suffer from
      psychiatric illness, randomly assign mothers to nine sessions over 3 months of either
      IPT-MOMS (N=105) or brief supportive psychotherapy (BSP; N=105), and evaluate the impact of
      acute maternal treatment on child and maternal outcomes at 3, 6, 9, and 12 month follow-up.
    

Intervention name(s): Interpersonal Psychotherapy for Mothers (IPT-MOMS); Brief Supportive Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed nine sessions. In addition to standard IPT techniques, IPT-MOMS includes a specific focus on the challenges associated with managing a child who suffers from psychiatric problems.; Interventions will be administered during the 3 Month Acute Randomized Phase and will consist of nine individual 45-minute sessions conducted over the course of three months. Treatment cannot exceed 9 sessions. Brief supportive therapy (BSP) is a manualized form of supportive psychotherapy which emphasizes reflective listening and elicitation of affect (Markowitz et al., 2008). Therapists are instructed to allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathic comments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interpersonal Psychotherapy; Depression; Mothers
TEOSYAL® PureSense Redensity [I] Injection Using MicronJet® Needle in the Treatment of Crow's Feet Wrinkles
Condition: Crow's Feet Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the feasibility and acceptability of a TEOSYAL®
      PureSense Redensity [I] injection using MicronJet® needle in the treatment of crow's feet
      wrinkles.

      It is a monocentric, open-blind, prospective, pilot study. 3 injections sessions spaced with
      an interval of 3 weeks. The last visit will be performed 3 weeks after the last injection.

      Only, one group of 15 healthy volunteers will be included.
    

Detailed description: 
      TEOSYAL® PureSense Redensity [I] is a viscoelastic gel of non-cross-linked hyaluronic acid
      that is sterile, non pyrogenic, colourless and of non-animal origin and contains 0.3% by mass
      of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two syringes
      pre-filled with Teosyal® PureSense Redensity I. The volume of each syringe is shown on the
      cardboard box as well as on each syringe. Teosyal® PureSense Redensity I is indicated for the
      prevention of wrinkles and rehydration of the neck, neckline, face and in particular the
      crow's feet wrinkles.

      The MicronJet® needle is a 3 micro-needle (0.6 mm of length) device that is mounted on a
      standard syringe in the same manner as a conventional needle. The MicronJet® needle is used
      to inject liquid substances, allowing for controlled intradermal delivery in any procedure
      which requires administration of substances to the dermal compartment.

      For the first time, the TEOSYAL® PureSense Redensity [I] will be injected using the medical
      device MicronJet® in the superficial wrinkles.
    

Intervention name(s): TEOSYAL® PureSense Redensity [I]/MicronJet®
Intervention type(s): Device
Intervention description(s): According the instruction of use, 3 injections of TEOSYAL® PureSense Redensity [I]will be performed all the 3 weeks. The used needle will be the MicronJet® microneedles for product injection. And the last visit (of control) will be performed 3 weeks after the last injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic acid; MiconJet needle
The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children
Condition: Raman Spectroscopy; Children, Only
Study type: Interventional

Summary: 
      Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks
      significantly increased skin carotenoid levels as compared to children who consumed a placebo
      juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy
      breakfast food alternative, was developed by Utah State University researchers.

      Objective: To determine the effect and response of a carotenoid-rich baked product on change
      in skin carotenoid levels among children.

      Design: A six week randomized controlled trial. Participants/setting: Participants were
      children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention:
      Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid
      baked food or control (n=25) who consumed a baked food with no carotenoids. Children were
      asked to eat the designated portion of the assigned food once a day for six weeks. Skin
      carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in
      Raman intensity counts. Participants were asked to maintain their diet and completed a food
      frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were
      returned to clinic, counted, and recorded.

      Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6
      weeks.

      Statistical analysis performed: Repeated-measures ANOVA was used to assess the group
      differences in Raman counts.
    


Intervention name(s): Feeding trial
Intervention type(s): Other
Intervention description(s): Children were asked to eat the designated portion of the assigned food once a day for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students
Condition: Healthy
MeSH terms: Plague
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of correct tooth cleaning and use of
      fluoride toothpaste after school lunch and before going to bed on primary school children's
      plaque reduction and tooth cleaning skills.
    

Detailed description: 
      Taking the school as a unit, the participants are children in grades three to six of
      elementary schools under the jurisdiction of Chiayi County, with a total expected sample size
      of 400 people.

      Through class teaching, the Shelley method of brushing teeth is taught, and flossing
      instruction is added to senior grades to improve students' teeth cleaning skills. They also
      use fluoride toothpaste with a concentration of more than 1000PPM to clean teeth after lunch
      at school and before going home to go to bed. School children were tested for plaque before
      and after using fluoride toothpaste, collected plaque control index, filled out a
      self-administered tooth cleaning skills and self-efficacy questionnaire, and tracked changes
      in the six weeks after use.

      Professional dentists and researchers will go to school to conduct dental plaque testing and
      fill out the first questionnaire for students. They will also use fluoride toothpaste after
      lunch at school and before going home to go to bed. Together with correct tooth cleaning
      methods, at 6 weeks Afterwards, the dental plaque test will be carried out again and the
      second questionnaire will be filled out. Each filling in of the questionnaire will take about
      ten minutes.
    

Intervention name(s): 1450ppm Fluoride toothpaste; 1000Pppm Fluoride toothpaste
Intervention type(s): Other; Other
Intervention description(s): 1450ppm Fluoride toothpaste; 1000Pppm Fluoride toothpaste
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: children; Health Education; brushing technique; dental plaque
A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This is a prospective, longitudinal, controlled study of cognitive function and fatigue in
      patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In
      addition to following each patient over time (i.e. acting as their own control), a separate
      control group will consist of patients with early stage CRC (Stage A or B) who have had
      surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients
      with stage C CRC who have declined chemotherapy.

      Also included is a smaller sub-study of patients with limited metastatic CRC who are treated
      with more toxic chemotherapy

      To compare changes in cognitive function, as compared to baseline assessment, of patients
      with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive
      function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients being treated for Colorectal cancer at participating centres
XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and
      tolerability of increasing doses of XC8 after single and repeated oral administration in
      healthy volunteers. The volunteers received the study drug once, and then continued daily
      intake for 14 days after a 6-day break.

      The primary objective of the study was to evaluate the safety and tolerability profile for
      XC8 after single and multiple administration based on the frequency and severity of adverse
      events and changes in vital signs, laboratory results, electrocardiography and results of the
      physical examination.

      The secondary objective of the study was to assess pharmacokinetics of XC8.
    

Detailed description: 
      One Russian center was approved for participation in this study. One center was initiated.
      Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening,
      single administration, multiple administration and follow-up.

      All eligible subjects were randomized into the study in appropriate cohort groups
      sequentially.

      Cohort 1 - XC8 or Placebo 2 mg once and then daily 14 days after a 6-day break; Cohort 2 -
      XC8 or Placebo 10 mg once and then daily during 14 days after a 6-day break; Cohort 3 - XC8
      or Placebo 50 mg once and then daily during 14 days after a 6-day break; Cohort 4 - XC8 or
      Placebo 200 mg once and then daily during 14 days after a 6-day break.

      The decision regarding increasing of the study drug dose for a subsequent cohort was made by
      the Data Safety Monitoring Committee on the basis of preliminary safety results assessment.

      A total of 20 volunteers received XC8 (2 mg, 10 mg, 50 mg or 200 mg) and a total of 8
      volunteers received the placebo during the study participation. The follow-up period lasted
      for 4 weeks.
    

Intervention name(s): XC8; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Histamine glutarimide
Intervention MeSH terms: Histamine; Glutarimide
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 4 doses of XC8/placebo (2 mg, 10 mg, 50 mg and 200 mg) were used in the study.The duration of exposure to the study drug was 15 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 14 days at the step of multiple administration.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; Phase I; Histamine glutarimide; PHARMENTERPRISES
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes;
      thus it is important to identify patients at risk and to develop strategies and tools to
      increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of
      Insulclock® - small electronic device to help track date, time and dosage of the last
      injection, type of insulin used and temperature, with an alarm system to prevent insulin
      omissions and mistiming.
    

Detailed description: 
      Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence
      to insulin regimens is reported in up to two-third of patients with diabetes; thus it is
      important to identify patients at risk and to develop strategies and tools to increase
      adherence to prescribed insulin regimens. This study will evaluate the efficacy of
      Insulclock® - small electronic device to help track date, time and dosage of the last
      injection, type of insulin used and temperature, with an alarm system to prevent insulin
      omissions and mistiming. The Insulclock's real time memory and alert system are likely to
      improve treatment adherence, patient's satisfaction, and quality of life measures, which may
      improve glycemic control in insulin treated patients with Type 2 Diabetes.
    

Intervention name(s): Insulclock with feedback; Insulclock without feedback
Intervention type(s): Device; Device
Intervention description(s): Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.; Not feedback on insulin administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: At midpoint (week 12), patients will be converted to the alternate arm (cross-over design).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncontrolled Type 2 Diabetes; Insulclock; Electronic device; Alarm system