bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of
      patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative
      period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

      Secondary objectives of the comparative period (24 weeks):

      >To assess the effect of insulin glargine in comparison with liraglutide on:

        -  HbA1c level

        -  Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the
           comparative period

        -  Percentage of patients whose HbA1c has increased at the end of the comparative period

        -  Fasting Plasma Glucose (FPG)

        -  7-point Plasma Glucose (PG) profiles

        -  Hypoglycemia occurrence

        -  Body weight

        -  Adverse events

      Objectives of the extension period (24 weeks):

      >To assess the effect of insulin glargine in patients not adequately controlled with
      liraglutide on:

        -  HbA1c level

        -  FPG

        -  7-point PG profiles

        -  Hypoglycemia occurrence

        -  Body weight

        -  Adverse events
    

Detailed description: 
      Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin
      glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow:

        -  A 2-week of screening period,

        -  A 24-week comparative period,

        -  A 24-week extension period (only for patients treated with liraglutide, not adequately
           controlled at the end of the comparative period),

        -  A 1-week follow-up period
    

Intervention name(s): Insulin glargine; Liraglutide; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 Units/mL solution for injection in a pre-filled SoloStar pen; 6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg); Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.
Other intervention name(s): Lantus®; Victoza®
Intervention MeSH terms: Metformin; Insulin Glargine; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
rTMS-induced Cumulative Pattern of sBDNF in Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study aims at investigating the neuroplastic potential and the possible factors
      affecting rehabilitation in chronic schizophrenia patients on stable medication, by
      investigating the cumulative pattern of serum BDNF representing the neuroplasticity in the
      brain, through quantitative stimulus such as rTMS.
    

Detailed description: 
      Subjects who have been enrolled for this study will take baseline evaluation for
      sociodemographic data and serum level of BDNF, plasma Prolaction, and magnesium, etc. And
      then, weekday regular stimulation through rTMS will be applied on DLPFC of brain. After the
      completion of stimulation for 2 weeks, the change or response of serum BDNF will be analyzed
      and compared.
    

Intervention name(s): CR Technology, TAMAS for repetitive TMS
Intervention type(s): Device
Intervention description(s): repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: rTMS-induced cumulative pattern of sBDNF
Vital Pulp Therapy to Treat Irreversible Pulpitis
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new
      endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference
      treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of
      human permanent molar teeth.
    

Detailed description: 
      In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and
      instrumentation of all canals was done. Canal preparation was conducted using a step-back
      technique. The working lengths were determined and confirmed by radiography. Sterile normal
      saline solution was used for intra-canal irrigation. Root canals were obturated with
      gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet
      in the pulp chamber, the access cavity was closed with Cavit.

      In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure
      of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by
      irrigating the cavity with sterile normal saline and application of small pieces of sterile
      cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of
      MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with
      Cavit.
    

Intervention name(s): One-visit root canal therapy; pulpotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.; Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.
Other intervention name(s): single-visit RCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Endodontics; CEM cement; Calcium enriched mixture; MTA; Root Canal Therapy; Pain; Pulpotomy; Human; Permanent; Molar teeth
Sodium Bicarbonate Supplementation in Athletes
Condition: Supplementation; Sport
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to verify the effect of 10-day sodium bicarbonate (NaHCO3) and
      placebo (PLA) supplementation on body composition, physical capacity, as well as
      concentrations of the selected biochemical blood markers in trained athletes, in a
      randomised, double-blind, placebo-controlled crossover trial.
    

Detailed description: 
      Sodium bicarbonate (NaHCO3) was proposed as an ergogenic agent, because it improves
      high-intensity and resistance exercise performance. Until now the major limitation to NaHCO3
      supplementation has been the gastrointestinal (GI) side effects. Therefore, this study aims
      to examine the effect of chronic, progressive- dose NaHCO3 ingestion on physical capacity,
      body composition and concentrations of the selected biochemical blood markers in trained
      athletes, in a randomised, double-blind, placebo-controlled crossover trial.
    

Intervention name(s): Sodium bicarbonate supplementation; Placebo treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crossfit; Sodium bicarbonate; Physical capacity
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
Condition: Immune Thrombocytopenia Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to assess the safety and tolerability of single
      rising doses of MK-8723 in healthy adult participants and adult participants with chronic
      immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in
      participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet
      response rate to MK-8723 in adult patients with chronic ITP is >50%.
    

Detailed description: 
      In Part 1 of the trial, safety and pharmacokinetics of MK-8723 will be evaluated in healthy
      participants. In Part 2 of the trial, safety, pharmacokinetics, and pharmacodynamics will be
      evaluated among participants with ITP. In Part 1, dose escalation will occur in up to 5
      serial panels of participants; each participant will receive a single intravenous (IV) dose
      of MK-8723 (or placebo). In Part 2, dose escalation will occur in up to 3 serial panels of
      participants with ITP; each participant will receive a single IV dose of MK-8723 (or
      placebo), once safety and tolerability of the corresponding dose is shown in Part 1.
      Amendment 3 specified a re-enrollment procedure for eligible participants in Part 2 to
      participate in more than one dosing panel.
    

Intervention name(s): MK-8723; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.; Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of an mHealth Colorectal Cancer Screening Intervention
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a multilevel mHealth intervention (mCRC)
      can increase the percentage of patients who receive colorectal cancer screening. The mCRC
      intervention will include a tablet-based patient education program, clinic protocols to
      facilitate the ordering of CRC screening tests, and electronic messaging with patients to
      promote screening. The investigators hypothesize that participants randomized to mCRC will be
      more likely to complete screening compared with those randomized to the control arm of the
      study. Additionally, the investigators hypothesize mCRC will increase several intermediate
      outcomes (such as knowledge, attitudes, beliefs, and test ordering) which will predict
      completion of screening. Lastly, the investigators hypothesize the mCRC intervention will add
      little to the overall cost of screening.
    


Intervention name(s): mCRC intervention; Healthy Lifestyles video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a multilevel intervention consisting of tablet-based patient education about CRC screening, post-visit patient electronic messaging, and clinic protocols to facilitate ordering of screening tests; a brief video about healthy lifestyle habits displayed on a tablet device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: colorectal cancer screening; computer-assisted instruction; mHealth; text message
α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D and Risk Factor for Pre-term Birth
Condition: Cervical Shortening; Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Effects of oral administration of a food supplement constituted by α-lipoic acid, magnesium,
      vitamin B6 and vitamin D in tablets of 1,2 g administered daily to women presenting risk
      factors for preterm birth (PTB). The aim is to reduce the rate of short cervix at 19-21 weeks
      of gestational age and consequently reduce the occurrence of PTB.
    

Detailed description: 
      The physiological course of pregnancy can be threatened by the onset of rhythmic and
      progressive uterine contractions, associated with a shortening and dilation of the cervix.

      These modifications occur as a consequence of inflammatory processes that involve important
      changes in the extracellular matrix of connective tissues. For this reason, in the event of a
      threat of preterm birth, the appropriate tocolytic therapies should be associated with
      interventions able to counteract morphological changes in the uterine cervix. Women
      presenting high or low BMI, presence of uterine myomas, metrorrhagia during the first
      trimester and hypertensive disorders are at risk for PTB. Current management practices remain
      profoundly various, without a therapeutic tocolytic strategy, especially because most of the
      first-line tocolytic drugs used present important side effects [8]. It is to be assessed
      whether a supplementation during pregnancy with minerals, vitamins, anti-inflammatory and
      anti-oxidant agents can avoid PTB in women with risk factors.

      ALA may interact synergistically with magnesium, vitamin B6 and vitamin D, limiting some of
      the main factors related to the risk of preterm delivery - probably via the inhibition of
      nuclear factor k beta (NF-kB)-signaling pathway - and reducing therefore the rate of uterine
      contractions.

      Moreover, the administration of ALA, magnesium, vitamin B6 and vitamin D have been
      demonstrated to be safe in pregnancy.

      The aim of the present study is to evaluate whether pregnant women presenting risk factors
      for PTB, treated with a combination of ALA, magnesium, vitamin 6 and vitamin D from 11-14
      weeks of gestational age, until delivery, could present a reduced rate of cervical shortening
      measured by transvaginal ultrasound (TVS) at 11-14 weeks and 19-21 weeks of gestational age.
    

Intervention name(s): Dav
Intervention type(s): Dietary Supplement
Intervention description(s): Daily oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric open label randomized controlled study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: alpha-lipoic Acid; vitamin D; cervical shortening; pretermbirth; food supplement
Integral Physiological Adaptations to Carbohydrate Periodization
Condition: Sleepiness; Fatigue; Feeding Patterns; Daytime Sleepiness, Excessive
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of long-term carbohydrate periodization
      protocols on sleep architecture, sleep quality, daytime sleepiness, physical performance,
      body composition, gut microbiome, and miRNA in healthy trained individuals.
    

Detailed description: 
      Athletic populations have been particularly susceptible to sleep inadequacies, experience
      several sleep issues, and fall below the age-specific sleep recommendations. However, it is
      well demonstrated that exercise does not impair sleep by itself, and furthermore, acute
      post-exercise nutrition could elevate the exercise-induced sleep-optimizing effect, with
      further benefits for the next physical performance. In line with these findings, in a
      metanalysis of clinical trials, it was shown that pre-bed carbohydrate availability resulted
      in significant alterations in sleep architecture. It is of utmost importance to highlight
      that throughout this metanalysis, it was revealed that no long-term nutrition intervention
      for sleep optimization has been studied yet. These data raise the question of whether a
      long-term carbohydrate periodization protocol could optimize sleep and alter gut function in
      a way that athletic performance will be also enhanced. This would allow elucidating further
      potential interrelations and biological pathways underlying these adaptations.
    

Intervention name(s): Evening LGI Carbohydrate Consumption Group; Evening HGI Carbohydrate Consumption; Evening NO-CHO Carbohydrate Consumption
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive in the evening food with low glycemic index; Participants will receive in the evening food with high glycemic index; Participants will receive in the evening a meal with no carbohydrates at all.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized controlled trial. The study is composed of three groups, differentiating on evening carbohydrate quantity and quality (glycaemic index) intake. The trial period will last for 1 month for all groups. Intervention includes lifestyle changes, targeting exercise, and diet. The design is parallel.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: sleep; Carbohydrate periodization; Dietary Intervention; Sports Nutrition; Chrononutrition; Chronobiology; Gut Microbiome; miRNA
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
Condition: Gut Microbiota; Skin Microbiota; Humoral Immune Responses; Severity of Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic
      dermatitis. In addition to balancing the gut microecology and promoting host immune defences,
      specific probiotics might further aid in controlling the microbial colonization of the skin,
      thereby reducing proneness to secondary infections which typically cause sustained symptoms.

      Thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a
      double-blind design to receive extensively hydrolysed casein formula (NutramigenR,
      Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG
      (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.

      Sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of
      the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at
      each study visit (at entry and one month and three months thereafter).
    


Intervention name(s): Casein hydrolysate added with LGG; Infants drink casein hydrolysate without LGG
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.; Infants drink extensively hydrolysed casein formula without added LGG
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; barrier function; gut; probiotics; skin
Topcon 3D OCT-1000 Optical Coherence Tomography System
Condition: Retinal Disease; Glaucoma
MeSH terms: Retinal Diseases
Study type: Observational

Summary: 
      The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve
      Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified
      predicate device. In addition, this protocol performs a comparison of the thickness
      measurement results from images collected and analyzed with the Zeiss Stratus OCT to images
      collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer
      for analysis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ophthalmology practice
A Mass Balance Study of LCB01-0371 After a Single Oral LCB01-0371 Dose With a [14C]LCB01-0371-microtrace
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are:

      • To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral
      LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
    

Detailed description: 
      This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm
      study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a
      minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as
      a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for
      evaluation of the primary objectives. Study subjects will be screened for eligibility to
      participate in the study within 28 days before dosing.
    

Intervention name(s): LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
Intervention type(s): Drug
Intervention description(s): To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
Intervention MeSH terms: Delpazolid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District
Condition: Physical Activity
Study type: Observational [Patient Registry]

Summary: 
      Fundamental movement skill is the precursor for physical activity in later life. Proficiency
      of Fundamental Movement Skills in Indian School Children is unknown. This observational trial
      shall tell us how proficient are our Udupi District Children.
    

Detailed description: 
      After IRC and IEC approval and approval from district educational officers, proper assent and
      consent will be given to the principal of the respective school.

      1-week prior to the study, parents will be explained about the study during parent meeting
      and even school leaving and opening times, a parent who visits the school to drop their
      children will be addressed.

      Children of age above 7 yr. will be explained the class about the study.

      Inform sheets will be distributed after conveying the information.

      Only the children who get an informed sheet signed will be included in the study.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children between age 5 to 10 years going to school in Udupi district, who will get consent
        sign from the parent will be included.
      
Keywords: FMS