bioihbjkbjnl/mcl2 huggingface dataset:
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
Condition: Neonatal Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in
      Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers
      including those on tube feeding tube, diarrhea in children, prophylactics of pathological
      colonization in newborns including premature newborns, and improvement of immunity in
      newborns (mature and premature).

      The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for
      immunity improvement in preterm newborn infants
    

Detailed description: 
      Study design: open-labeled, controlled, parallel group, non-interventional 3-weeks-study with
      followed prospective observation during 1 week and 1 year follow-up period.

      Patients of group I take the probiotic Mutaflor orally in the dose 1 ml once a day during
      first week of life and three times per week during the second and third week of life.
      Patients of the group II don't take specific probiotic for immunity strengthening.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm newborns with gestational age of 35-36 weeks
      
Keywords: preterm newborn; neonatology; EcN; Nissle; Mutaflor; prophylaxis; infection
Sugars-containing Beverage and Food Intake in Children
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose is to determine the effect of sugars in solution on food intake and subjective
      appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food
      intake after all sugars-containing solutions will be decreased in comparison to the control
      solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and
      sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose
      or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60
      and 90 minutes.
    


Intervention name(s): water with Sucralose; water with HFCS; water with glucose; water with sucrose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: boys; obesity; glucose; sucrose; high-fructose corn syrup-55
Chewing and Swallowing Training Program in Coffin-Lowry Syndrome
Condition: Swallowing Disorder; Chewing Problem
MeSH terms: Deglutition Disorders; Coffin-Lowry Syndrome
Study type: Interventional

Summary: 
      This study will report the chewing and swallowing disorders of a Coffin-Lowry Syndrome (CLS)
      patient, and effects of chewing and swallowing training on chewing and swallowing function.
    

Detailed description: 
      Patients with CLS suffer from spinal deformities, nonconvulsive status epilepticus,
      obstructive sleeep apnea syndrome, pneumonia, stimulus-induced myoclonus, cases of falls,
      mechanical ventilation, restrictive lung disease. It was also reported that patients with CLS
      had problems with eating and feeding functions. However there is no study investigating
      chewing and swallowing functions of this patient population. Therefore, the investigators
      have three main purposes:

        1. To chewing and swallowing function in a boy with CLS diagnosis who was referred due to
           coughing during eating, long-lasting wheezing, sputum and inability to intake solid food

        2. To investigate the effects of two months of chewing and swallowing training program

        3. To present long term follow-up effects on chewing and swallowing function.
    

Intervention name(s): Chewing and swallowing rehabilitation
Intervention type(s): Other
Intervention description(s): A home based chewing and swallowing training program (CST) will be applied by an experienced physical therapist. The Functional Chewing Training will be used to improve chewing function which has five steps including positioning the child and food, sensory stimulation, chewing training and adjustment of food consistency to improve chewing function. To support hyolaryngeal elevation, laryngeal mobilization will be performed. Hyolaryngeal mobilization will be performed by moving hyolaryngeal complex in right, left and up directions manually.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ischemic Injury and Ischemic Preconditioning in Diabetes
Condition: Diabetes Mellitus, Insulin-Dependent; Ischemia-Reperfusion Injury
MeSH terms: Reperfusion Injury; Diabetes Mellitus; Diabetes Mellitus, Type 1; Ischemia
Study type: Observational

Summary: 
      In this proof-of-concept study, forearm vulnerability to ischemic exercise is studied in
      patients with type 1 diabetes mellitus with and without prior ischemic preconditioning (short
      period of ischemia that protects against subsequent ischemic exercise). Annexin A5
      scintigraphy is used to quantify subtle signs of mild and reversible forearm injury that
      results from ischemic exercise.

      The following hypotheses are tested:

        1. Patients with type 1 diabetes are not more vulnerable to ischemic injury as compared
           with previously studied healthy volunteers.

        2. Ischemic preconidtioning is still present in patients with type 1 diabetes. Depending on
           the validity of hypothesis 2, the effect of short pharmacological interventions are
           studied on vulnerability to forearm ischemia/reperfusion injury in the absence or
           presence of local forearm ischemic preconditioning.
    

Detailed description: 
      All patients will be studied in supine position after an overnight fast, while plasma glucose
      levels are monitored. In the first 8 patients intravenous insulin is administered as needed,
      to reach target glucose levels between 5-7 mmol/l. Patients will be subjected to 10 minutes
      of forearm ischemia (non-dominant arm), combined with handgripping at 50% of maximal force
      until exhaustion. Upon reperfusion, Tc-99m-HYNIC-Annexin A5 will be injected intravenously.
      Targeting of annexin A5 to thenar muscle and forearm flexor muscle will be quantified as the
      percentage difference in radioactivity between experimental and control side. This procedure
      will be performed twice (randomized cross-over design), with at least 2 week interval, either
      with or without 10 minutes ischemia followed by 10 minutes of reperfusion prior to ischemic
      exercise.

      Depending on the results of this study, substudies will be performed to study the effect of
      diazoxide (K-ATP channel opener, may mimic ischemic preconditioning), glibenclamide (K-ATP
      channel blocker, may inhibit ischemic preconditioning) or adenosine (infusion into brachial
      artery of non-dominant arm as a substitute for ischemic preconditioning).
    

Intervention name(s): Ischemic preconditioning; Forearm ischemic exercise; Annexin A5 scintigraphy; Diazoxide; glibenclamide; adenosine
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug; Drug
Intervention MeSH terms: Glyburide; Adenosine; Diazoxide; Annexin A5
Observational model: Defined Population
Time perspective: Other
Keywords: Diabetes; Ischemia; Annexin A5 scintigraphy
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis
Condition: Spondyloarthritis; Enthesitis; Anti-Tumor Necrosis Factor Drugs
MeSH terms: Spondylitis; Spondylarthritis; Enthesopathy; Necrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Biological therapies should be considered in patients with high disease activity despite
      nonsteroid antiinflammatory drug treatment. The first option among biological therapies is
      anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown
      that clinical and ultrasonographic enthesitis may improve as well as disease activity,
      quality of life and acute phase reactants. In this prospective study, we aimed to evaluate
      the clinical and ultrasonographic evaluation of enthesitis and to determine its response to
      anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the
      clinical and ultrasonographic evaluation of enthesitis and to determine its response to
      anti-TNF treatment in patients with SpA.
    


Intervention name(s): TNF Inhibitor
Intervention type(s): Drug
Intervention description(s): TNF inhibitors are widely used in patients with spondyloarthritis
Intervention MeSH terms: Tumor Necrosis Factor Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Coffee Consumption, the Gut Microbiome, and the Microbiota-Gut-Brain Axis
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential of coffee to act as a prebiotic to
      alter gut microbiota and improve mood, memory and cognitive performance.
    

Detailed description: 
      The aim of this study is to investigate the potential of coffee to act as a prebiotic to
      alter gut microbiota and improve mood, memory and cognitive performance. Additional gut-brain
      axis pathways-related parameters such as inflammation, short chain fatty acids and other
      metabolites production and physiological stress levels will be explored. Moreover,
      differences between caffeinated and decaffeinated coffee consumption will be investigated to
      determine whether observed effects are attributed to caffeine or other coffee components.

      To determine the mechanism of action underlying the beneficial effects of coffee, coffee
      drinkers abstained from coffee and caffeine for a 2-week washout period following the
      baseline visit. Coffee drinkers further underwent an intervention in which they consumed
      either 4 sachets (1.8 grams each) of instant caffeinated or decaffeinated coffee per day for
      3 weeks of using a double-blind, randomised, parallel design. Reaction time, socioemotional
      processing, visual and episodic memory, learning, and an attentional task were administered
      to measure cognitive performance. Self-report questionnaires on mood, behavior and lifestyle
      were administered and response to an acute stressor was assessed. Biological samples of
      saliva, urine, blood, and stool were collected to investigate microbiome-gut-brain-axis
      signaling.
    

Intervention name(s): Caffeinated coffee; Decaffeinated coffee
Intervention type(s): Other; Other
Intervention description(s): After 2 weeks of coffee abstinence (washout), participants who were coffee drinkers were randomly allocated to receive either 4 sachets (1.8g each) of caffeinated instant coffee per day for 3 weeks. Participants were blinded to coffee contents.; After 2 weeks of coffee abstinence (washout), participants who were coffee drinkers were randomly allocated to receive either 4 sachets (1.8g each) of decaffeinated instant coffee per day for 3 weeks. Participants were blinded to coffee contents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Coffee; Microbiome-gut-brain-axis; Prebiotic; Polyphenol; Cognition; Stress; Mood; Behavior; Inflammation; Gut Microbiota; Caffeine
Mode of Delivery on Newborn Hearing Test
Condition: Hearing Loss, Neonatal
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well
      known that false positivity increases cost and maternal anxiety and anxiety in the neonatal
      hearing screening. The effect of the type of delivery to hearing screening is not yet clear.
      The first automated mode of delivery of babies born in Turkey auditory brainstem response
      (SAD's), the authors aimed to evaluate the effects of the test results and false positive
      rate.

      newborns were evaluated with brainstem response test. The AABR test was performed before
      patients were discharged. Perinatal and neonatal variables and AABR test results were
      recorded retrospectively.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who gave birth in our hospital and who had a hearing test in their newborns
        will form the study group.
      
Keywords: Newborn Hearing Screening; Automated Auditory Brainstem Response; Mode Of Delivery
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase II open-label baseline-to-treatment trial was designed to evaluate the safety,
      tolerability and efficacy of orally administered atorvastatin in patients with
      relapsing-remitting multiple sclerosis (RRMS). Patients with at least one
      gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were
      eligible for the study. Patients are screened and enrolled in the outpatient clinic of the
      Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3
      monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg
      atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9
      compared to baseline. Secondary endpoints include other MRI-based parameters and changes in
      clinical scores and immune responses.
    


Intervention name(s): interferon beta treatment to add-on atorvastatin treatment; untreated to atorvastatin treatment
Intervention type(s): Drug; Drug
Intervention description(s): IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment); no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
Intervention MeSH terms: Interferons; Interferon-beta; Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Effects Of Treadmill On LPA, Sitting Time, and Cardiovascular Risk
Condition: Sedentary Lifestyle; Risk Factor, Cardiovascular
Study type: Interventional

Summary: 
      The purpose of this study is to:

        1. Evaluate the relative efficacy of a treadmill desk intervention on light physical
           activity and sitting behaviors at work over four weeks;

        2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular
           risk profiles (blood pressure, body weight, body fat percentage) over a four-week
           period.
    

Detailed description: 
      American workers spend 70-80% of their time at work sitting at a desk, working on a computer,
      talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in
      the workplace may not be sustainable as they require deliberate and dedicated time away from
      work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in
      contrast, do not interfere with daily tasks and productivity and require small but cumulative
      changes in posture and LPA throughout the workday.

      Sedentary behavior interventions in the worksite, including those conducted by our team, have
      shown promising effects. Studies that have used multi-level approaches targeting individual,
      social, and environmental factors have been most effective. The most robust environmental
      support has been the use of sit-stand workstations, providing distinct opportunities for
      workers to reduce sitting while maintaining productivity. However, treadmill desks may
      provide an even greater opportunity to both reduce sitting and increase LPA during the
      workday. Thus, a pilot study is required to test the efficacy of this approach to reduce
      sitting and increase LPA in the workplace.
    

Intervention name(s): Treadmill desk
Intervention type(s): Other
Intervention description(s): A standing height desk with a treadmill attached.
Other intervention name(s): ActiveStation Treadmill desks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A within-person, cross-over design will be used. Fifteen participants will take part in two conditions: 1) the treadmill desk: this intervention will ask participants to use a treadmill desk for a minimum of 30min per day for four weeks; and 2) the usual desk condition: participants will use their current workstation, as is, for four weeks. Participants will be randomly assigned to their initial intervention condition after baseline measures have been collected. In addition to the two condition months, there will be a one-week baseline period (to collected information on habitual activity level at work).
Masking: None (Open Label)
Primary purpose: Treatment
High-intensity Interval Training in Overweight/Obese
Condition: Obesity, Metabolically Benign
MeSH terms: Overweight; Obesity, Metabolically Benign
Study type: Interventional

Summary: 
      Purpose: The purpose of this study would be to evaluate the effects of interval training on
      cardiovascular health, lipid profile and body composition in overweight and obese men and
      women.

      A secondary purpose will be to compare lab based measurements of body composition
      [4-compartment model (4C)) with portable equipment [bioelectrical impedance spectroscopy
      (BIS) and ultrasound (US)]

      Participants: Seventy-six men and women (age 18-55 yrs; BMI 25-45 kg/m2) will be randomly
      assigned to a high-intensity short interval group (SIT), high-intensity long interval group
      (HIT) or a control group (CON). Procedures (methods): Participants will be assessed for peak
      oxygen utilization (VO2peak), blood lipids, glucose and insulin levels. Body composition will
      also be measured using a 4C model, as measured from dual energy x-ray absorptiometry (DEXA),
      air displacement plethysmography (BodPod), and BIS, in comparison to US values. Participants
      assigned to either training group will undergo 3 weeks of interval training, 3 days per week.
      SIT will complete 10 bouts of a series of 1 min cycling with 1 min rest periods at 90% of the
      power output obtained during VO2peak;in comparison HIT will complete 5 bouts of the same
      protocol: 2 min bouts with 1 min recovery at varying intensities of VO2peak (80-100% power
      output).
    


Intervention name(s): Interval training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
Condition: Diet Habit
Study type: Interventional

Summary: 
      The tree that produces the arbutus berry, the strawberry tree, scientific name Arbutus unedo
      L., belongs to the family of Ericaceae. It exists in almost all of Southern Europe in arid
      and siliceous lands, in woods and forests and is very common in Portugal.

      Known for its use in the production of liqueurs and brandy, the arbutus berry is a fruit that
      can be consumed in nature or incorporated in the preparation of other foods. Arbutus berry
      has been attributed some properties beneficial to health given its low caloric value and its
      high content of vitamin C and flavonoids, which is why it is considered a good source of
      antioxidants.

      Arbutus has a high carbohydrate content (70-80% dry weight) with a relevant fiber fraction
      (10-30%), constituting an interesting source of vegetable protein (1-9%) and lipids (2-3%).
      Given this interesting nutritional composition, the hypothesis is that a daily consumption of
      this fruit can have an impact in health outcomes such as microbiota modulation and an
      improvement of metabolic parameters.
    

Detailed description: 
      The main objective of this clinical trial is to evaluate the effect of including a daily
      consumption of arbutus berry on the composition and diversity of the intestinal microbiota.
      It is also intended to evaluate metabolic parameters to determine the impact of this
      intervention.

      Participants will consume 50g or 200g of arbutus berry daily for 4 weeks. This study aims to
      provide scientific evidence regarding the impact of arbutus berry consumption on intestinal
      microbiota and general health improvements.
    

Intervention name(s): arbutus berry
Intervention type(s): Other
Intervention description(s): consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day
Masking: None (Open Label)
Primary purpose: Other
Keywords: adipokines; arbutus berry; gut microbiota; inflammatory cytokines; short chain fatty acid; strawberry tree
Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer
Condition: Locally Advanced Malignant Neoplasm; Gastric Cancer
MeSH terms: Stomach Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic
      intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally
      advanced gastric cancer undergoing standard surgical resection. Patients will be treated with
      HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90
      minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed
      after resection but before anastomosis.
    

Detailed description: 
      Treatment Plan:

      Patients undergoing definitive resection for gastric cancer and meeting the eligibility
      criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin
      50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before
      anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents
      and will be obtained as marketed drugs.

      Outcome Measures:

      Patients will be followed for 90 days following surgery. All postoperative complications will
      be recorded and graded according to the modified Clavien-Dindo classification.

      Schedule for Follow Up:

      Trial-related patient assessments will be performed daily while the patient remains in the
      hospital for postoperative care, and then during postoperative clinic visits. The final
      postoperative clinic visit for evaluation of study outcomes and complications should occur
      between postoperative days 90 and 95 to allow for a cumulative assessment of the patient's
      perioperative complications, if any.
    

Intervention name(s): Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Intervention type(s): Drug
Intervention description(s): Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Other intervention name(s): HIPEC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment