bioihbjkbjnl/mcl2 huggingface dataset:
Addition to Infant Formula of 2-fucosyllactose (2-FL)
Condition: Growth of Infants
Study type: Interventional

Summary: 
      OBJECTIVES:

      Primary:

      The primary objective is to determine whether the mean weight gain over a 16-week interval
      starting on or before 14 days of life differs between infants fed one of two infant formulas
      as their sole source of nutrition: a commercial formula using a canola l fat blend (Control,
      E23) or the same formula containing the human milk oligosaccharide (Test (HMO)
      2-fucosyllactose (2FL). Mean weight gain also will be compared to that of a concurrently
      enrolled reference group of exclusively breastfed infants.
    

Detailed description: 
      METHODOLOGY/ STUDY DESIGN: This study is double blinded-randomized controlled trial with two
      arms and a reference breast fed group. The experimental variable is the composition of infant
      formula fed to healthy term infants for a period of 16 weeks upon entering the study as their
      sole source of nutrition. The formulations are a commercial control (Control, NPS-E23); and
      the control formula containing the human milk oligosaccharide (HMO) 2-fucosyllactose (2FL) at
      1g/L (HMO, NPS-E23XA).

      Infants will be enrolled on or before 14 days of age and fed a study assigned formula for 16
      weeks. Weight, length and head circumference will be measured at baseline and 2, 4, 6, 8, 12
      and 16 weeks of study entry. Formula volume will be recorded for a three-day period before
      each visit. Fecal samples will be obtained at baseline (convenience samples) and at week 16
      for all subjects and analyzed for microbial populations. Buccal cheek cells of all infants,
      and mothers of breast fed infants, obtained by swab at week 16 will be genotyped for FUT2.
      Information on adverse events and new/change of medications will be collected at in person
      visits and by telephone interviews between in-person visits.

      NUMBER OF SUBJECTS: It is estimated that approximately up to approximately 200 subjects will
      be enrolled in the formula groups to obtain up to approximately 65 evaluable per protocol
      subjects in each group. As non-randomized reference group of approximately 85 breastfed
      infants will be enrolled to obtain approximately 65 evaluable infants.
    

Intervention name(s): sole source nutrition
Intervention type(s): Other
Intervention description(s): Infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of
      the study is to describe the immunogenicity and safety of the trivalent cell culture-derived
      influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.
    

Detailed description: 
      Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the
      immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from
      sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety,
      solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28
      days post-vaccination are assessed and reported. The serious adverse events are collected
      during 6 months post-vaccination.
    

Intervention name(s): NBP607; Agrippal S1
Intervention type(s): Biological; Biological
Intervention description(s): For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL); For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as
           a new capsule formulation and as the original formulation of oral solution, after a
           single oral dose of 400 mg under fed condition in healthy volunteers.

        2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers.

        3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian
           volunteers.
    

Detailed description: 
      TG-2349 oral solution has been investigated in a phase I/IIa study (study number: TG-2349-01)
      in healthy volunteers and patients with chronic hepatitis C (CHC) infection. The study
      demonstrated that TG-2349 was safe and well-tolerated when given to healthy volunteers at
      single oral doses up to 800 mg, and at five-consecutive daily oral doses up to 600 mg.
      Co-administration of TG-2349 with food resulted in a significant increase in bioavailability,
      and therefore concomitant food intake with dosing is recommended.

      To further advance the clinical development of TG-2349, a new capsule formulation was
      developed to replace the current TG-2349 oral solution. The objectives of this study (study
      number: TG-2349-02) are to evaluate the PK and relative bioavailability of TG-2349, given as
      a new capsule formulation and as the original formulation of oral solution, after a single
      oral dose of 400 mg under fed condition in healthy volunteers, and to evaluate the safety,
      tolerability, and ethnic differences of the TG-2349 capsule formulation.
    

Intervention name(s): TG-2349 as the original formulation; TG-2349 as a new capsule formulation
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose under fed condition; single oral dose under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Background:

      Laparoscopic colorectal surgery has been shown by randomized trials to be associated with
      better short-term clinical outcomes when compared with open surgery. However, in a
      traditional perioperative care setting, the reduction in hospital stay following laparoscopic
      surgery in these trials was modest. Fast-track perioperative programs have been introduced in
      the West to optimize perioperative factors to reduce the physiological/psychological stress
      of open colorectal surgery. However, few studies have evaluated the impact of fast-track
      programs on the outcomes after laparoscopic colorectal surgery.

      Objective:

      To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing
      laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track"
      perioperative program.

      Design:

      Prospective randomized trial.

      Subjects:

      One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection
      of non-metastatic colonic and upper rectal cancer will be recruited.

      Interventions:

      Patients will be randomized to a "traditional" or a "fast-track" perioperative program.

      Outcome measures:

      Primary outcome: total postoperative hospital stay, including hospital stay of patients who
      are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters
      (including systemic cytokine response and cell-mediated immune function), morbidity and
      mortality, quality of life, and medical costs.
    


Intervention name(s): Fast-track perioperative program; Traditional perioperative program
Intervention type(s): Other; Other
Intervention description(s): Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization; Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic surgery
Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
Condition: Women Who Have Experienced Trauma
Study type: Interventional

Summary: 
      Objectives: We aimed to (1) develop a caring program for health promotion among women who
      experienced trauma and (2) evaluate its effect on post-traumatic stress, depression,
      health-promoting behaviors, and self-esteem.

      Methods: We conducted a quasi-experimental study using a group pre-test/post-test design.
      Data were collected from 14 women recruited from a self-sufficiency support center for
      sexually exploited women who experienced trauma, during December 2019-May 2020. Participants
      were assessed at pre-test, post-test, and at a one-month follow-up. We analyzed changes in
      outcome variables over time using repeated-measures analysis of variance and paired t-tests.
    


Intervention name(s): Health Promotion Nursing Intervention
Intervention type(s): Other
Intervention description(s): A one-on-one program was conducted over six sessions, with each session ranging from 60 to 120 minutes. The caring program for health promotion included the following concepts: understanding the self; sharing traumatic events and negative emotions; re-framing the meaning of traumatic events; identifying thoughts and physical and emotional responses; developing health-promoting activities; and maintaining a positive attitude during the process of change .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
Condition: Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second
      booster to healthy 6 year-old children .

      Secondary objectives:

        -  Additional immunogenicity assessments.

        -  To describe the safety profile of a single dose of REVAXIS® or DT-Polio®
    


Intervention name(s): REVAXIS®; DT-Polio®
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of : Diphtheria, Tetanus and Poliomyelitis
Investigation of the Effect of Toilet Training Given to Children
Condition: Toilet Training
Study type: Interventional

Summary: 
      In the study, it was aimed to examine the factors affecting the toilet training of children
      aged 18-36 months who have no problems in social-emotional development and the effect of
      professional support on the toilet training process.
    

Detailed description: 
      Toilet training studies in Turkey and analyzes of bladder, bowel control and training
      completion times in these studies are limited. In this study, training processes were
      examined separately, and the factors that were not studied frequently until today were
      investigated. Also the effects of the professional support provided to children who did not
      have problems in social-emotional development on the process were examined.
    

Intervention name(s): Toilet training
Intervention type(s): Behavioral
Intervention description(s): As the training model, Brazelton's child-oriented toilet training method was taken as the basis in study group. In addition, literature studies on toilet training in Turkey were scanned and the final form of training to be given to mothers was created. In the control group, families manage training process themselves.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Toilet training; Social-emotional development; Child
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of the test formulation
      of mesalamine suspension rectal enema with the reference formulation in healthy, adult
      subjects.
    


Intervention name(s): Mesalamine
Intervention type(s): Drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Mesalamine
Transitional Telehealth Home Care: REACH
Condition: Congenital Heart Disease; Post Cardiac Surgery
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The investigators want to determine if additional, increased contact with infants and
      families discharged to home after cardiac surgery improves infant and parent outcomes as
      compared to usual care.
    

Detailed description: 
      The investigators want to compare videoconferencing (SKYPE or FACTIME) and a monitoring
      system called Buddy Check is helpful. Buddy Check is a web-based tool using speech and
      internet technology to maintain contact with the health care team.

      Infants are randomized to usual care or the intervention which uses automated daily phone
      calls and 2 virtual home visits each week. Weights, oxygen levels, and amount of food taken
      are obtained by the primary caregiver (parent) daily and sent via automated phone call, text
      message or email messages based on primary caregiver's desired.
    

Intervention name(s): Daily Messages, Virtual Home Visits; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
Daily messages requesting weight, intake, pulse ox and pulse are automated
Virtual home visits occur twice weekly where the investigators see the infant and families.; Usual care as defined by by the Cardiology Department.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Congenital Heart Disease; Neonates and infants; Telehealth; Virtual Home Visits
ARTEMIS Synovial Markers in Arthritis Childhood
Condition: Septic Arthritis; Juvenile Idiopathic Arthritis
MeSH terms: Arthritis, Infectious; Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The aim of this study is to find markers that could differentiate infectious and inflammatory
      arthritis. The investigators want to find markers by differential analysis by compare
      synovial fluids of septic and inflammatory arthritis. The investigators will use for this
      analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The
      investigators will use one marker or a score with biological and clinical data to
      discriminate arthritis of infectious and inflammatory etiology.
    


Intervention name(s): Articular punction, salivary samples, blood sample
Intervention type(s): Procedure
Other intervention name(s): Proteomic analysis; Cytokine dosage; Monocyte
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Arthritis; septic; Juvenile idiopathic arthritis; diagnosis; proteomic; cytokine; monocytes
An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate safety and efficacy of varenicline tartrate in helping people quit smoking
    


Intervention name(s): Varenicline tartrate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Resistance Training in Patients With Diabetic Neuropathy
Condition: Diabetes Mellitus, Type 2; Polyneuropathy Diabetes; Diabetes Complications; Diabetic Peripheral Neuropathy; Muscle Weakness; Fall Patients
MeSH terms: Muscle Weakness; Peripheral Nervous System Diseases; Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
Study type: Interventional

Summary: 
      This is a population-based study of type 2 diabetes patients with and without neuropathy
      recruited from the Danish National Type 2 Diabetes cohort (DD2).

      Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain,
      muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural
      instability increasing the risk of frequent falls and thereby increased morbidity and
      mortality. Thus, diabetic neuropathy is associated with significant disabilities having major
      impact on activities of daily living and quality of life.

      The effects of resistance training on neuropathy symptoms, muscle strength and muscle
      structure in patients with and with diabetic neuropathy will be examined.
    

Detailed description: 
      Perspective: The studies will likely improve the understanding of diabetic neuropathy and the
      relation between risk of falls in patients with and without motor dysfunction. The results
      may enable new and more precise recommendations for exercise in diabetic patients with
      diabetic neuropathy. In addition, the results may lead to a better understanding of the
      mechanisms underlying the effects of training. The improvement of motor function may lead to
      improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes
      patients, resulting in lower morbidity and mortality.
    

Intervention name(s): 12-week resistance training
Intervention type(s): Other
Intervention description(s): Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: International, randomized controlled training trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry
Condition: Measurement of Pupil Diameter
Study type: Observational

Summary: 
      Null hypothesis (HO): There will be no difference in pupillometry readings when using any of
      the maintenance anesthetic techniques within subjects.

      Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the
      anesthetic technique
    

Detailed description: 
      Postoperative visual loss resulting from a surgical procedure not performed on the eye is a
      devastating outcome for the patient and poorly understood by the medical community. It is
      potentially a preventable complication. Diminished blood supply to the optic nerve, affecting
      both the anterior or posterior portions of the optic nerve, is the most common cause of
      postoperative visual loss. Other, less common causes include occlusion of the retinal artery
      and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual
      loss increases in patients undergoing cardiopulmonary bypass and prone spine surgery.
      Although the etiology of post-operative visual loss is unknown, it is thought to be
      multifactorial, and several potential risk factors have been identified, including degree of
      low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood
      loss, prolonged duration of surgical time and increased pressure in the eye associated with
      positioning. To date studies have focused on the mechanism associated with the visual loss.
      We would like to focus on the feasibility of using a monitor which may signal loss of visual
      function intraoperatively.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Pupillometry; Sevoflorane; Propofol
Antithrombin III Concentrate After Liver Transplantation
Condition: Liver Transplant; Complications
Study type: Interventional

Summary: 
      This study was designed to demonstrate more effective administration method of AT-III in
      immediate post-liver transplantation period.
    

Detailed description: 
      Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the
      immediate post-liver transplantation period without clear evidence regarding the optimal dose
      or administration scheme.

      The investigators retrospectively analyzed the clinical data from the patients who received
      liver transplantation and developed pharmacokinetic model of AT-III in the previous research.
      According to this study, optimal AT-III activity level will be well-maintained with smaller
      dose with continuous infusion than with intermittent infusion which is widely accepted way of
      administration currently.

      A prospective study was planned to show the more effective manner of AT-III concentrate
      administration after liver transplantation.
    

Intervention name(s): Antithrombin III, continuous infusion; Antithrombin III, Intermittent infusion
Intervention type(s): Drug; Drug
Intervention description(s): Antithrombin-III is administered continuously; Antithrombin-III is administered intermittently
Other intervention name(s): Antithrombin III, human; Antithrombin III, human
Intervention MeSH terms: Antithrombins; Antithrombin III
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antithrombin III; liver transplantation; administration method; dosage