bioihbjkbjnl/mcl2 huggingface dataset:
Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      Postoperative ileus is generally referred to as the transient impairment of bowel motility
      after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting
      constipation and distension.

      The potential complications of prolonged POI include increased postoperative pain, increased
      nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral
      intake, delay in postoperative mobilization, prolonged hospitalization, and increased
      health-care costs. The estimated economic impact of POI in the United States is $7.5 billion
      per year, excluding the expenses of work loss.

      In view of these complications and economic burden a number of pharmacologic and
      non-pharmacologic strategies have been adopted by the doctors all over the world to reduce
      the burden of postoperative ileus.These programs involve transverse or curved surgical
      incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and
      postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.

      The use of gum chewing has emerged as a new and simple modality for decreasing POI. And
      reviews have concluded that there is consistent benefit for patients from gum chewing after
      the intestinal surgery; colonic surgery and gynecological surgery.

      This study is based on the hypothesis that postoperative gum chewing is beneficial in
      prevention of postoperative ileus after reversal of ileostomy.
    


Intervention name(s): Sugar Free Chewing Gum
Intervention type(s): Other
Intervention description(s): 'Extra' sugar free gum will be used as an intervention. Patients will be required to chew a gum for 30 min at intervals of 6 hours for first 48 hours post operatively or until they pass flatus.
Other intervention name(s): 'Extra' Sugar Free Gum
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine if standard and investigational tests used to
      help diagnose and treat food allergies can provide information that will be useful in
      determining the cause of dyspepsia and helpful in designing a treatment plan. The study will
      also determine if there is a connection between positive allergy tests and inflammation in
      the upper abdomen.
    

Detailed description: 
      Recurrent abdominal pain is the most common type of pain in school age children and young
      adolescents. Over 80% of these children have pain in the upper abdomen which is diagnosed as
      functional dyspepsia (FD). Many of these children are also found to have eosinophilic
      duodenitis (ED). ED is a type of inflammation in the lining of the gastrointestinal tract
      characterized by an increase in eosinophils. An increase in intestinal eosinophils is a
      finding also seen with food allergy upon exposure to the offending antigen. The presence of
      intestinal eosinophilia in ED would suggest an allergic mechanism may be involved in the
      generation of pain and other symptoms associated with ED. Endoscopy and biopsy are used to
      aid in the identification of ED, which often is followed by elimination diets and food
      challenges to identify the offending allergen. This approach is both invasive (due to
      endoscopy) and cumbersome (due to the complexity and restrictiveness of the elimination
      diet). The value of screening for food hypersensitivities in children with ED has not been
      well characterized despite the theoretical links between food hypersensitivities, gut
      inflammation, and symptoms of dyspepsia. The current study will determine if standard and
      investigational tests used to evaluate food hypersensitivity have the potential to be used as
      biomarkers to direct treatment of children with ED.
    

Intervention name(s): in vitro and in vivo allergy testing
Intervention type(s): Device
Intervention description(s): Patch Test: food to be tested is suspended in sterile saline, placed on the skin of the back using a Finn Chamber secured with surgical tape and left in place for 48 hours.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: abdominal; stomach; dyspepsia; food allergy
A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
Condition: Healthy Term Babies
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives: To evaluate the safety; efficacy; bone mineral metabolism & immunity changes of
      the use of Metlin & Metlos added to the Infant Formula Study Design: Randomized, double
      blind, clinical, controlled trial, in 600 full-term infants of 15 ± 7 days randomized to
      recive formula with probiotics + Metlin + Metlos; formula with probiotics + Metlin; Formula
      with probiotics + Metlos; formula only with probiotics or formula without probiotics and
      prebiotics; having a totally breast feed group as control.). Outcomes variables were
      frequency of stools; bowel intolerance manifestations (abdominal distension, flatulency,
      regurgitations, vomiting); report of dermatological problems like eczema; changes on the
      intestinal microbiota; lipids profile (cholesterol, triglycerides, lipoproteins associated to
      cholesterol); anthropomorphic profile and somatic growth ( weight gain, stature, arm mean
      circumference, skin folds); bone mineral metabolism (high-speed bone ultrasonography); and
      changes in the immunity (changes in the concentrations of salivary IgA and the frequency of
      respiratory events suggestive of infection)]. Statistical analysis was made with STATA Ver.
      11.0 for Mac. Safety and efficacy variables, were compared by Chi squared in the case of
      categorical variables or by ANOVA or Kruskall Wallis for the numeric variables. When
      convenient, a covariates adjustment was done by ANOVA or by multiple lineal regressions for
      continuous numerical outcomes or logistic regression for categoric outcomes. In all the
      hypothesis tests the p significant value of <0.05 were used.
    


Intervention name(s): Infant Formula; Exclusively breast milk; Metlin+metlos+Lactobacillus GG; Metlin + Lactobacillus GG; Metlos + lactobacillus GG; Lactobacillus GG
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Only Infant Formula without Lactobacillus, Metlin OR Metlos; Children non randomized which mothers decided to feed them with exclusively breast milk; A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG; A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG; A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG; An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: term babies
Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to determine the bioequivalence of Minocycline formulations
      after administration of single doses to normal healthy subjects under fed conditions. These
      data were to be evaluated statistically to determine if the products meet bioequivalence
      criteria.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing
      minocycline 100mg tablets of Ranbaxy with Minocin 100mg capsules of in healthy, adult, human,
      subjects under fed conditions.

      A total of 24 non-smoking subjects (17 men and 7 women) were included in this study, of which
      24 finished the study according to the protocol.
    

Intervention name(s): Minocycline 100mg Tablets
Intervention type(s): Drug
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequiavlence Minocycline Tablets
Absolute Bioavailability Of Bosutinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period
      crossover study in healthy subjects.
    


Intervention name(s): Oral Bosutinib; Intravenous infusion of bosutinib
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of 500 mg oral bosutinib; a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bosutinib; absolute bioavailability
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
Condition: Spinal Cord Injury; Neurogenic Bladder
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effects upon the bladder of electric
      stimulation of the leg's tibial nerve in people with acute spinal cord injury with an
      intervention called transcutaneous tibial nerve stimulation (TTNS).
    

Detailed description: 
      In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects
      which respond to TTNS will be identified as seen on urodynamic studies (USD). Then,
      responders will be invited to participate in a randomized control trial of a 2-week protocol
      of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder
      changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.
    

Intervention name(s): Transcutaneous Tibial Nerve Stimulation; Control
Intervention type(s): Device; Device
Intervention description(s): 10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.; 10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: electric stimulation; urodynamic study
Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk
Condition: Obesity; Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks
      will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with
      high cholesterol and obesity.
    

Detailed description: 
      This is a multi-site, randomized, controlled, parallel group food study designed to examine
      the health benefits, specifically glucose tolerance, insulin sensitivity and LDL-cholesterol
      in overweight individuals with a high waist circumference and elevated LDL-cholesterol.
      Recruitment will consist of approximately 102 overweight participants (n= 51 participants per
      site, at 2 sites located in Winnipeg and Toronto) with high waist circumference and elevated
      LDL-cholesterol.
    

Intervention name(s): Cooked Lentils; Potato-Based Foods
Intervention type(s): Other; Other
Intervention description(s): Consume food items containing one serving of (0.3 cups) of cooked lentils per day for the first 5 days, followed by one serving of (0.6 cups) of cooked lentils per day 5 times per week (equivalent of 3 cups cooked lentils per week) for the remainder of the 12-week schedule.; Control - Consumption of one serving per day of potato-based foods in matrices similar to those containing lentils in the same 12-week schedule, including the smaller serving size for the first 5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Overweight; Obese; Obesity; Cholesterol; Hypercholesterolemia; LDL-Cholesterol
Fruquintinib Food Effect and Proton Pump Inhibitor Study
Condition: Drug Interaction; Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this is to evaluate the effect of food and the effect of a proton pump
      inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
    

Detailed description: 
      This study will be a single center, open label, 3-period, randomized 2-sequence study
      conducted with 14 healthy male or female subjects. The study will consist of a Screening
      Phase (Screening and Day -1), a Treatment Phase (Periods 1, 2, and 3), and an End of Study
      (EOS) Phase. For Periods 1 and 2, subjects will be randomized into 1 of the 2 treatment
      sequences, with all subjects then moving to the same treatment in Period 3.

      Periods 1 and 2: 14 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 possible
      treatment sequences:

        -  Fed/Fasted: fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on
           Day 15

        -  Fasting/Fed: fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on
           Day 15

      Period 3: all subjects will take rabeprazole 40 mg orally once daily in the morning from Day
      23 to Day 29. On the morning of Day 29, all subjects will take rabeprazole 40 mg orally
      without food one hour before taking a fruquintinib 5 mg oral dose. Subjects will continue to
      fast until lunch.
    

Intervention name(s): fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole; fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15.
40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.; fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15.
40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.
Other intervention name(s): HMPL-013; rabeprazole 40 mg; HMPL-013; rabeprazole 40 mg
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development
Condition: Contraception; Newborn; Child Development; Growth
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess whether there is change in the growth and development of newborns
      whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48
      hours of delivery compared with those with standard implant insertion (6 week postpartum).
    


Intervention name(s): early insertion; conventional insertion
Intervention type(s): Drug; Drug
Intervention description(s): Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum.; Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 6 week of delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: etonogestrel-implant; newborn; growth; Child Development
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate
      cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate
      cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more
      effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.

      PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy
      to see how well they find prostate cancer compared with a placebo and ultrasound-guided
      biopsy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided
           targeted biopsy in detecting prostate cancer.

        -  Determine the detection rate of prostate cancer with targeted biopsy using
           contrast-enhanced ultrasound combined with dutasteride.

        -  Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs
           systematic biopsy in diagnosing clinically significant prostate cancer.

        -  Determine the reduction in post-biopsy bleeding after dutasteride in these patients.

        -  Determine the cost effectiveness of this regimen in these patients.

      OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients
      are randomized to 1 of 2 arms.

        -  Arm I: Patients receive oral dutasteride once daily on days 1-14.

        -  Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in
           both arms undergo blood collection and contrast-enhanced (perflutren protein-type A
           microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler
           imaging, and power Doppler imaging are performed. Biopsies are then performed; first up
           to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.

      After completion of study procedures, patients are followed at 1 day.

      PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
    

Intervention name(s): dutasteride; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Masking: Double
Primary purpose: Diagnostic
Keywords: prostate cancer
Nutrient Supplementation Influences Mitochondria Adaptation
Condition: Performance; Nutrition; Protein
Study type: Interventional

Summary: 
      Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block
      randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO
      or CHO and matched in pairs for gender, age, VO2max, training and performance status. The
      PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate
      beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO
      group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre
      and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6
      km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).
    


Intervention name(s): PROTEIN-CARBOHYDRATE; CARBOHDYRATE
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PRO before and PRO-CHO after training; CHO before and after training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: block randomized controlled intervention
Masking: Single (Participant)
Primary purpose: Other
U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study is being conducted to obtain safety, efficacy, and satisfaction data on the
      combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent
      Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate
      or severe acne will be asked to apply the commercially available, over-the-counter products
      Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating
      Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.
    

Detailed description: 
      This open-label, multicenter, study is being conducted to obtain safety, efficacy, and
      satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which
      includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5%
      Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of
      moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years,
      inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment
      (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all
      3 study products as part of a complete acne treatment system; no reference therapy or control
      group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl
      Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning
      and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic
      Acid) each evening over an application period of 12 weeks.
    

Intervention name(s): acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
Intervention type(s): Other
Intervention description(s): over the counter acne system
Intervention MeSH terms: Benzoyl Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the time-course of the antiproteinuric effect of renin inhibition
      with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established
      nephropathy.
    


Intervention name(s): Aliskiren
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Time course; antiproteinuric; blood pressure; lowering effect; initiation of renin inhibition; Aliskiren in Type 2 diabetes; incipient and/or established nephropathy