bioihbjkbjnl/mcl2 huggingface dataset:
Full Spectrum vs. Standard Forward-viewing Colonoscopy
Condition: Colon Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its
      possible additive contribution in the detection of important lesions, namely polyps and
      cancers, compared to the standard "forward-viewing" approach, with and without the addition
      of the right-colon retroflexion technique, in a series of patients undergoing back-to-back
      screening or surveillance colonoscopies in a randomized fashion.
    

Detailed description: 
      We changed the anticipated number of subjects enrollment for study: NCT02117674 from 120 to
      200 based on the following sample size estimation:

      Tandem colonoscopies studies results, show that novel endoscopic technologies detect about
      20% more adenomas than those conventional colonoscopy does (missed adenomas). Since FUSE
      colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional
      colonoscopy will detect one third of the missed adenomas that FUSE detects in a similar
      setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio
      of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is
      equivalent to a difference between two paired proportions of 14% which occurs when the
      proportion of detected missed adenomas during FUSE is 21% and the proportion of missed
      adenomas during conventional colonoscopy is 7%. During one year period before the study
      initiation, our colonoscopy performance quality data show that we detect a mean number of
      adenomas per patient equal of 0.7 in a population similar to the one recruited in our study.
      Therefore, 172 patients overall will be required to detect 120 adenomas. Given the
      uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and
      unexpected incomplete colonoscopies, we decided to recruit 200 patients.

      A more extensive description regarding the investigators study is provided in the following
      fields.
    

Intervention name(s): standard forward-viewing colonoscopy; full-spectrum colonoscopy; right colon retroflexion
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): examination of the colon with a conventional colonoscope; examination of the colon with full-spectrum colonoscope; examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other intervention name(s): conventional colonoscopy; fuse endoscopy; retroflexion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; adenoma detection rate; full spectrum colonoscopy; right colon retroflexion; feasibility
Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake
Condition: Satiety; Food Intake
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of mid-morning gel snacks on subjective
      appetite, glucose and insulin responses, and food intake in healthy weight young adults.
    

Detailed description: 
      23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass
      index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a
      control snack and four modified snacks containing whey protein, oats, coconut oil or
      maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12
      hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and
      orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the
      five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue
      scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60,
      90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at
      the same time VAS measurements were taken. Food intake was measured via ad libitum pizza
      lunch.
    

Intervention name(s): Control snack; Maltodextrin snack; Whey protein snack; Oat snack; Coconut oil snack; Snack skipping
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal); Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal); Isovolumetric (238.4g) gel snack with whey protein (201.8kcal); Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal); Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal); no snack
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adults; Snacks; Appetite; Blood glucose; Insulin
Validity Of Turkish Version Of ABC Scale In Diabetes Mellitus Patients
Condition: Diabetes Mellitus; Balance; Distorted; Evaluations, Diagnostic Self
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Activities-specific Balance Confidence (ABC) scale is a well-known tool to evaluate
      functional balance. Diabetic patients suffer more often from balance disorders than the rest
      of the population. The aim is to investigate the validity of the Turkish version of ABC short
      form in patients with diabetes mellitus (DM).
    

Detailed description: 
      Thirty patients with DM will be included according to the inclusion and exclusion criteria.
      All the participants will be evaluated by ABC form and Timed Up and Go Test (TUG). The
      Cumulative Illness Rating Scale (CIRS ) will be used for all the patients.

      ABC scale is a self-assessment test with 16 items that helps assess balance impairments and
      falling risk, and it also investigates how confident people are while they are in some
      specific activities both indoors, and outdoors. Total score changes between 0-100.

      The HbA1c values of all patients will be noted if a blood test will be performed in the last
      three months.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patient with diabetes mellitus
      
Keywords: balance; Diabetes Mellitus
Exercise Improve Sympathetic Modulation in Chronic Heart Failure Patients
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to verify the effects of exercise training on sympathetic
      modulation and arterial baroreflex control in patients with chronic heart failure.
    

Detailed description: 
      Retrospective study. Patients were recruited by database from Rehabilitation Unit of
      Cardiovascular Rehabilitation and Exercise Physiology of the Heart Institute (InCor). The aim
      of this study is to assess the effects of exercise training on sympathetic modulation and
      arterial baroreflex control in patients with chronic heart failure. The investigators studied
      twenty-six chronic heart failure outpatients, age 30 to 70 years, functional class II to III
      of New York Heart Association, left ventricular ejection fraction (LVEF) ≤40% and peak oxygen
      uptake (VO2) ≤20. The exclusion criteria were recent myocardial infarction or unstable angina
      (<3 months), heart failure duration (<3 months), permanent pacemaker dependence, atrial
      fibrillation, skeletal muscle abnormality (e.g., arthritis) and participation in a regular
      exercise program. They were assigned to 2 groups: Untrained (n=13) and trained (n=13).
    

Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): exercise training
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: Chronic heart failure; exercise training; Sympathetic modulation; arterial baroreflex control
Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery
Condition: Respiration Disorders
MeSH terms: Respiration Disorders
Study type: Interventional

Summary: 
      Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like
      restrictive pathology, which may persist for weeks to months postoperatively. This
      experimental aimed to investigate the efficacy of a positive end-expiratory pressure device
      on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients
      who underwent valve surgery.
    

Detailed description: 
      Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old,
      recruited from the national heart institute enrolled in this experimental. They were assigned
      into two matched groups: Experimental group consisted of 15 patients, received positive
      end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy
      (postural drainage, percussion, vibration, and deep breathing exercises). Control group
      consisted of 15 patients, received routine chest physiotherapy alone. The program continued
      for four weeks.
    

Intervention name(s): respiratory exercises
Intervention type(s): Other
Intervention description(s): Manual respiratory exercises versus respiratory exercises with pressure meter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients
Condition: Complication of Hemodialysis
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Observational

Summary: 
      A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable
      Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at
      various age range and both sexes are recruited to observe their access flow, access
      recirculation and cardiac function and assess their relationship.
    

Detailed description: 
      All patients recruited who met the inclusion criteria were investigated access flow, access
      recirculation and cardiac function(including cardiac output,cardiac index,central blood
      volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of
      HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session).
      The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time
      points.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All eligible participants are recruited according the inclusion and exclusion
        criteria.Their basis data are documented and the central hemodynamic condition are assess
        cross-sectionally and longitudinally.
      
Keywords: access flow; access recirculation; cardiac output; cardiac index; hemodialysis
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety and pharmacokinetics of
      maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with
      methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis
      (RA) showing an insufficient response to MTX.
    


Intervention name(s): TA-650 3 mg/kg; TA-650 6 mg/kg; TA-650 10 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.; 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.; 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.
Other intervention name(s): Infliximab; REMICADE; Infliximab; REMICADE; Infliximab; REMICADE
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA; Infliximab; TA-650; Remicade
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Condition: Extremely Low Gestational Age Newborn; Premature Infant
Study type: Interventional
Phase: Phase 2

Summary: 
      Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory
      protection against nosocomial infection in extremely premature infants. However, most of them
      could not proceed enteral feedings due to clinical instability in the first few days. Recent
      studies supports oropharyngeal administration as a potentially safe and effective delivery
      method for immunologic benefits and only small amount of colostrum could be administrated for
      immune therapy for extremely premature babies. The purpose of this study is to determine the
      beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in
      extremely low gestational age infants and evaluated the safety of this method to extremely
      premature infants in the first few days of life.
    


Intervention name(s): oropharyngeal administration of own mother's colostrum; oropharyngeal administration of sterile water
Intervention type(s): Other; Other
Intervention description(s): application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.; application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
Condition: Rhinitis Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objectives:

        -  To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the
           presence of pollutants is observed using an Environmental Exposure Unit.

        -  To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from
           seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust
           particulates.

      Secondary Objective:

      To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.
    

Detailed description: 
      The total study duration per subject is expected to last up to 4.5 months, depending on the
      timing of the screening visit.
    

Intervention name(s): Fexofenadine M016455; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Condition: Migraine; Acute Treatment of Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711)
      compared with placebo in the acute treatment of migraine as measured by Pain Freedom
      (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point
      numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an
      optimal dose to support the Phase 3 clinical trials.
    

Detailed description: 
      Intervention Model: Parallel Versus Comparator + Placebo
    

Intervention name(s): Rimegepant; Placebo; Sumatriptan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rimegepant capsules; Rimegepant placebo-matching capsules; Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Other intervention name(s): Imitrex®
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to assess the bioequivalence of the test product
      (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg
      based on the Cmax and Area Under the Curve (AUC) values of monomethyl fumarate (MMF)
      determined after a single dose under fasting conditions.
    

Detailed description: 
      This was a single-dose, open-label, randomized, 2-way crossover study, evaluating the
      comparative pharmacokinetics of the test product (MMF) versus the reference product (DMF)
      under fasting conditions. Fifty (50) healthy, adult male and non-pregnant female subjects
      were enrolled. Screening of subjects occurred within 21 days prior to the first dose.
      Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.

      In each period, subjects received a single oral dose of MMF 190 mg administered as two 95 mg
      delayed-release capsules (test product) or Tecfidera® 240 mg DMF delayed-release capsule
      (reference product), followed by blood sampling (including predose samples) up to 24 hours
      postdose for the determination of plasma concentrations of MMF. There was a washout period of
      2 days between the 2 doses.

      Safety was monitored throughout the study by repeated clinical and laboratory evaluations.
    

Intervention name(s): monomethyl fumarate 190 mg; dimethyl fumarate 240 mg
Intervention type(s): Drug; Drug
Other intervention name(s): BAFIERTAM; BLS-11; Tecfidera
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were randomized to 1 of 2 treatment sequences prior to the first dose.
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the safety and tolerability of single oral doses of
      NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the
      pharmacokinetic (PK) profile of NCO-48 Fumarate and its active metabolite, tenofovir (TFV),
      in healthy subjects following single oral doses and to evaluate the effect of food on the PK
      of a 30 mg dose of NCO-48 Fumarate in healthy subjects.
    

Detailed description: 
      This is a first-in-human, double-blind, placebo-controlled, randomized, ascending single oral
      dose study. NCO-48 Fumarate will be assessed in healthy subjects (6 groups of 8 subjects
      each). Subjects will receive a single oral dose of NCO-48 Fumarate or placebo capsules in 1
      or 2 periods, depending on the dose group, under fasting conditions (unless otherwise
      indicated) and will be followed for a 1-week observation period. Safety assessments will be
      performed and NCO-48 Fumarate and TFV PK will be assessed. The planned doses for this study
      are 2, 10, 30, 60, 120, and 240 mg. Each group of 8 subjects (Groups 1 to 6) will be
      randomized in a 3:1 ratio to receive either NCO-48 Fumarate or placebo (6 subjects to receive
      active drug and 2 subjects to receive placebo) as a single dose on Day 1 of Period 1 in the
      fasted state. A preliminary assessment of food effect will be conducted in Group 3. Subjects
      in Group 3 will receive study drug in Period 1 under fasted conditions and return after a
      minimum of 14 days to receive study drug under fed conditions. There will be a Screening
      Period of up to 30 days. All subjects (Periods 1 and 2) will be observed through the morning
      of Day 3 (48-hour post-dose assessment). Safety assessments and NCO-48 Fumarate and TFV PK
      sample collection (blood and urine) will occur during this time. Subjects will be discharged
      from the study site after the 48 hour assessments and return to the study site on Days 5 and
      7 (final visit) for follow-up procedures. After the Day 7 follow-up procedures for each
      group, evaluation of all safety and tolerability data collected during the period, and
      evaluation of any available PK data, the dose for the next group of subjects will be
      determined by the Safety Monitoring Panel (SMP).
    

Intervention name(s): NCO-48 Fumarate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NCO-48 Fumarate; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941
Condition: Healthy; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics
      and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male
      subjects.
    

Detailed description: 
      This will be a randomized, open-label, 3-way crossover design study to investigate the effect
      of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after
      administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will
      receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
    

Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): ipragliflozin
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1941; Food effect; Pharmacokinetics