bioihbjkbjnl/mcl2 huggingface dataset:
A Treat-to-target Strategy Using Pan-enteric Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
Condition: Inflammatory Bowel Diseases; Children, Only
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      This prospective, interventional study aims this to determine the efficacy and safety of a
      PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep
      remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
    

Detailed description: 
      This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric
      Crohn's Disease aims to evaluate:

        -  The ability of Pan-enteric capsule endoscopy (PCE) to assess MH and DR rates at three
           time points and to guide a treat-to-target strategy was the primary outcome sought.

        -  The efficacy of a "treat-to-target" strategy to MH and DR rates over 24 and 52 weeks was
           evaluated as a secondary outcome;

        -  Comparison between PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small
           Intestine contrast ultrasonography (SICUS) in evaluating intestinal inflammation.
    

Intervention name(s): Pan-enteric Capsule Endoscopy (PCE)
Intervention type(s): Device
Intervention description(s): Second generation of colon capsule endoscopy (Medtronic)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colon capsule endoscopy
Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to investigate the safety, tolerability, pharmacokinetics,
      and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral
      dosage form (tablets) without and with food.
    


Intervention name(s): Placebo; BI 207127 NA powder for solution; BI 207127 NA tablet
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
CRESTOR Athero Imaging Head to Head IVUS Study
Condition: Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing
      the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic
      disease burden as measured by intravascular ultrasound in patients with coronary artery
      disease.
    


Intervention name(s): Rosuvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): capsule, oral, once daily; capsule, oral, one daily
Other intervention name(s): Crestor; Lipitor
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery disease
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
Condition: Infant Development
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This single-group study will assess growth and tolerance of infants fed a post-discharge
      preterm infant formula containing a prebiotic.
    


Intervention name(s): Experimental Infant Formula
Intervention type(s): Other
Intervention description(s): Formula fed Ad libitum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Effects of an Employee Wellness Program
Condition: Obesity
Study type: Observational

Summary: 
      Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled
      in a fitness program consisting 90 days of a structured exercise program and dietary
      counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and
      absenteeism rates will be measured at 0, 90 days, in one year.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ochsner employees with a BMI greater than or equal to 30
Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending
      dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and
      150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12
      months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months
      will be enrolled into the study.
    

Detailed description: 
      The primary objective of this study is to assess the preliminary efficacy of up to three
      different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks The
      secondary objectives of this study are to assess the safety of up to three different dosage
      regimens of R788 as determined by ACR 20 responder rates at 12 weeks, and to assess the
      general clinical and laboratory safety evaluations throughout the study.
    

Intervention name(s): R788; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): R788 50 mg, 100 mg, or 150 mg PO bid; Placebo PO bid
Other intervention name(s): tamatinib fosdium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: R935788; Rheumatoid Arthritis; Syk Kinase
A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible
      dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable
      schizophrenia.
    


Intervention name(s): SKL15508; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension
      study will be to explore antibody persistence in children at approximately 40 months of age
      and to evaluate the safety, tolerability and immunogenicity of a booster dose of rMenB±OMV NZ
      administered to subjects at approximately 40 months of age. Antibody persistence will be
      subsequently measured at 18-20 months after these booster doses when the subjects are 60
      months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be
      recruited in the study to serve as a baseline comparator for assessing antibody persistence
      at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ.
      Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations , if
      they have not already received these vaccines prior to enrollment.
    


Intervention name(s): rMenB; rMenB+OMV NZ
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Pre-school; Meningococcal disease; Prevention; Vaccination
Acute Cigarette Evaluation Study
Condition: Smoking Behaviors
Study type: Interventional

Summary: 
      This single laboratory session pilot study will examine the acute effects of commercially
      available cigarettes on adult smokers' initial product perceptions, use, and exposure. Forty
      adult daily smokers will be randomized to smoke two study-supplied commercially-available
      cigarettes interspersed by 45 minutes, completing pre- and post-cigarette carbon monoxide and
      questionnaire measures.
    

Detailed description: 
      In some research studies, the investigators cannot tell participants exactly what the study
      is about before they participate in the study. Study tasks will be described in this document
      in a general way, but participants will not be told the real purpose of the study until after
      they complete the study. The purpose of this study is broadly to learn more about how people
      who smoke evaluate different types of commercial cigarettes. The investigators are interested
      in how the marketing and design of different products affect perceptions and smoking
      behaviors. This research may help inform the Food and Drug Administration (FDA) how best to
      regulate tobacco products in the future with the goal of improving public health.

      After completing the study, the investigators will explain why they are doing this study,
      what they are looking at, and address any other questions. Although the real purposes of the
      study will not be explained until after participants complete the study, there are no
      additional risks to those described in the study consent form.
    

Intervention name(s): Cigarette A; Cigarette B
Intervention type(s): Other; Other
Intervention description(s): Participants will be smoke a first type of blinded commercially available cigarette.; Participants will smoke a second type of blinded commercially available cigarette.
Other intervention name(s): Product; Product
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Single-session study utilizing a 2 x 2 mixed factorial design
Masking: Single (Participant)
Primary purpose: Prevention
Office Blood Pressure Measurement With an Automated Device
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The investigators plan to determine if the sequence of blood pressure measurements from the
      sitting position to the table and vice versa has an impact on the measurements.
    

Detailed description: 
      The investigators plan to measure blood pressure (BP) in 30 consecutive individuals
      presenting to the St. Elizabeth Boardman Family Health Center. The sample will include
      patients presenting for their scheduled appointment. Following informed consent (see attached
      informed consent form), the participants will be randomly assigned to one of two groups. In
      group A, the sequence of BP measurements will be table position (TP) followed by recommended
      chair position (RCP) and then, after a 30-minutes rest, the BP will be measured again in the
      reverse sequence, RCP then TP. In group B, the sequence will begin with BP measurements in
      the RCP then TP, followed by 30-minutes rest and then measurements will be repeated in the
      reverse order. The assignment of participants to groups A and B will be random. The BP will
      be measured twice in each of the positions described above, according the the accepted
      standard technique, using a digital blood pressure monitor, the OMRON HEM-907 XL.
    

Intervention name(s): BP measurement
Intervention type(s): Other
Intervention description(s): the BP will be measured in the chair position followed by the table position and also in the reverse sequence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Influence of Pilates-based Exercises on Postural Balance
Condition: Sedentary Lifestyle
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study of the behavior of the mechanisms of body balance with a workout based on the
      Pilates method can facilitate the development of more accurate rehabilitation approaches.
      However, there is still little scientific information on its effects on the locomotor system
      and it's necessary to search for new methods to evaluate its strategies more specifically.
      Thus, this study aims to determine whether an exercise program based on Pilates method has
      influence on the static and dynamic postural balance of sedentary adults. This is a
      randomized controlled trial, which will be developed with an initial sample of 20 subjects of
      both sexes, aged between 18 and 30 years, divided into two groups: a control group and an
      experimental group. Participants with physical activity time up to 150 minutes per week will
      be included, assessed by the International Physical Activity Questionnaire (IPAQ), and those
      who have no experience with the Pilates method. In the experimental group a workout program
      will be done for 6 weeks with individual classes including exercises based on the Pilates
      method, during 1-hour, twice a week. Assessments will be made prior and after the training
      program with anamnesis, anthropometric measurements and also the Balance Error Scoring System
      and the Star Excursion Balance Test Y to assess postural balance. During the tests and
      training program exercises the muscle activity of paraspinals and transversus abdominis will
      be analyzed using surface electromyography (sEMG), and body mass center displacement will be
      measured with a triaxial accelerometer positioned on the fifth lumbar vertebra. The data will
      be entered in a spreadsheet and statistically tested with SPSS software. The tests will
      include the comparison of means, association, correlation and effect size, which will be
      chosen according to the distribution of the data and will use the 5% significance level for
      all tests.
    


Intervention name(s): Pilates-based exercises
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Postural Balance
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Condition: Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the
      correction of anemia in participants with non-dialysis chronic kidney disease.
    


Intervention name(s): Roxadustat
Intervention type(s): Drug
Intervention description(s): Oral capsule
Other intervention name(s): FG-4592
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney; Chronic Kidney Disease; CKD; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Erythropoietin; Blood count; Predialysis; Pre-dialysis; Hb; Non-dialysis
Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient
Condition: Surgery
Study type: Interventional

Summary: 
      The caudal block is the most common technique for inguinal surgery. Increased use of
      ultrasound in regional analgesia techniques has been improved the practise of the peripheral
      nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative
      methods to the central blocks. The aim of this study is to compare analgesic efficiency of
      caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for
      bilateral inguinal hernia in pediatric patients
    

Detailed description: 
      In this prospective randomized study, pediatric patients between 1- 10 years old who were
      scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil
      randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or
      caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine
      as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe
      with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred
      intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen.
      Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic
      requirement, complications and parental satisfaction. Parents will be also called for
      analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation
      will be performed by a researcher whom does not know which participants belong to the caudal
      or ilioinguinal/iliohypogastric nerve block group
    

Intervention name(s): inguinal hernia surgery
Intervention type(s): Procedure
Intervention description(s): repair of inguinal hernia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, prospective, randomized, double-blind, parallel group,
      acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary
      therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes
      labialis), following five consecutive treatment days with five times daily topical
      administration.
    

Detailed description: 
      The primary endpoint of this study are:

        -  "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.

        -  Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).

        -  Safety and tolerability following five consecutive treatment days with five times daily
           topical administration.

      The secondary endpoints of this study are:

        -  Proportion of subjects with non - ulcerative herpes lesion.

        -  Time for herpes labialis recurrences

      Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream
      5% treatment, using measurements of the following variables:

        -  Physical examination,

        -  Vital Signs (HR, BP, Body temperature),

        -  Adverse events recording and

        -  Concomitant medications
    

Intervention name(s): ZEP-3 ointment 1.0%; Acyclovir cream 5%
Intervention type(s): Drug; Drug
Other intervention name(s): Zovirax
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Herpes labialis, Cold sores, ZEP-3 ointment
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone
      mineral density (BMD) in postmenopausal women with osteoporosis.
    

Detailed description: 
      Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the
      following treatment groups:

        -  Romosozumab 90 mg/mL

        -  Placebo 90 mg/mL

        -  Romosozumab 70 mg/mL

        -  Placebo 70 mg/mL

      After completing a 6-month treatment period, participants entered a 3-month follow-up period
      with an end of study (EOS) at month 9.

      For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single
      placebo group. For safety analyses, the data for placebo were presented separately for each
      group.
    

Intervention name(s): Romosozumab 90 mg/mL; Placebo 90 mg/mL; Romosozumab 70 mg/mL; Placebo 70 mg/mL
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).; Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.; Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.; Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
Other intervention name(s): AMG 785; EVENITY™; AMG 785; EVENITY™
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
    


Intervention name(s): Metformin; CJ-30001/CJ-30002
Intervention type(s): Drug; Drug
Intervention description(s): 1000~1500mg/day, 24weeks; 0.6/1500mg~0.9/1500mg/day, 24weeks
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment