bioihbjkbjnl/mcl2 huggingface dataset:
The Satiating Effect of Eggs in Children
Condition: Appetite
Study type: Interventional

Summary: 
      This study will determine which breakfast (egg breakfast or bagel breakfast) has the most
      beneficial effect on appetite.
    

Detailed description: 
      Test Day 1 (about 4 hours)

        -  This is a fasting visit (nothing besides water 12 hours prior to visit)

        -  Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast)

           . He/she will be asked to eat all the food that is provided.

        -  He/she will be asked to rate the taste of the meal.

        -  He/she will be offered a pasta lunch.

      Test Day 2 (about 4 hours)

        -  This will be scheduled 1 week after Test Day 1

        -  This is a fasting visit (nothing besides water 12 hours prior to visit)

        -  The procedures for this visit are the same as for Test Day 1. Your child will be offered
           the breakfast that he/she did not receive at the last visit.

      The sequence of the 2 breakfasts will be randomly assigned to each child.
    

Intervention name(s): Egg Breakfast; Bagel Breakfast
Intervention type(s): Other; Other
Intervention description(s): Egg, Toast and Jelly; Bagel, Cream Cheese and Yogurt
Other intervention name(s): Egg; Bagel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.
Condition: Breast Cancer.
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to
      detect the margine of the breast tumoral tissue.
    

Detailed description: 
      Primary objective:

      Definition of the histological distribution (intravascular, extra vascular, in specific
      cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy
      tissues of breast cancer patients (and the potential of axillary lymph nodes found
      fluorescent).

      Secondary objectives:

      Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more
      specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.

      Analysis of the correlation between fluorescence and "margins" as defined operatively as
      tumor (microscopically by the pathologist).
    

Intervention name(s): Indocyanine Green
Intervention type(s): Drug
Intervention description(s): Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
Other intervention name(s): ICG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Prevalence of IL28B Polymorphism in Hepatitis C Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and
      host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at
      rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV
      genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT
      genotype at rs8099917 are associated with good treatment outcome. Asian populations have high
      prevalence of CC genotype in other studies, which can explain relatively good response to
      peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.
    

Detailed description: 
      The prevalence of different genotypes of IL28B polymorphism in the local population will be
      studied. DNA will be extracted from the whole blood sample of hepatitis C patients with
      genotype 1, 2 and 3 infection. It will be amplified by real-time PCR and subsequently
      analysed for the genotypes of IL28B SNPs.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hepatitis C patients with genotype 1, 2/3
      
Biospecimen description: 
      DNA extracted from whole blood sample will be used as template for real-time PCR
      amplification. It will be analyzed for the genotypes of IL28B SNPs (genotype CC/CT/TT for
      rs12979860 and TT/GT/GG for rs8099917).
    
Keywords: IL28B gene
Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
Condition: Postoperative Complications
MeSH terms: Paralysis; Postoperative Complications
Study type: Observational

Summary: 
      This study aims to establish the incidence of residual paralysis in patients following
      administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in
      most patients) during supraglottic airway insertion and correlate it with the duration of
      time from drug administration to arrival at PACU. The secondary aim is to compare the
      incidence of residual paralysis in patients who receive full doses of atracurium (per body
      weight) with those who receive mini-doses.
    

Detailed description: 
      Post-operative residual paralysis may be defined as the incomplete recovery of muscle
      function following intra-operative administration of neuromuscular blockers (NMBs). This
      condition is associated with many negative patient outcomes such as: increased risk of
      aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU)
      discharge, amongst others. Despite the increasing use of shorter acting agents, the
      prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used
      to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding
      airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal
      in clinical practice, there is a need to evaluate the incidence of residual paralysis in the
      patient population who have received mini-dose atracurium during the supraglottic airway
      insertion.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be picked from all patients who are going surgery at National
        University Hospital (NUH) during the period of data collection, and who are receiving
        supraglottic airway for their procedure. They must fulfil the inclusion and exclusion
        criteria.
      
Keywords: Supraglottic airway; Mini-dose atracurium; Postoperative residual paralysis
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
Condition: Malaria; Malaria Vaccines
MeSH terms: Hepatitis B; Malaria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study has been designed to support the indication of the candidate vaccine (also
      referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when
      administered as a primary vaccination integrated into an Expanded Program on Immunization
      (EPI) regimen to infants living in sub-Saharan Africa.
    


Intervention name(s): GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049; Engerix-B™ vaccine; Infanrix/Hib™ vaccine; Polio Sabin™ vaccine; Rotarix™ vaccine; Synflorix™ vaccine; Measles vaccine; Yellow fever vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.; Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.; Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection; Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.; Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.; Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.; Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.; Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Africa; Plasmodium falciparum; Malaria vaccine; hepatitis B; EPI
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the effect and breakdown of lysine administration, specifically
      examining whether it leads to increased plasma 2-AAA in healthy humans.
    

Detailed description: 
      The purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-AAA),
      which may influence the risk of diabetes. 2-AAA has been identified as a novel predictor of
      diabetes development in humans, identifying at-risk individuals before any detectable glucose
      abnormalities. 2-AAA is a naturally occurring metabolite in the body, and it has no known
      adverse effects at normal physiological levels. 2-AAA is generated in the body from the
      breakdown of lysine. Lysine is one of the twenty essential amino acids, meaning that it is
      essential for human function, but that our body cannot manufacture it. Thus, it is acquired
      from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily
      intake of 30 mg/kg/day. Amino acids are the building blocks of proteins, which are what allow
      our cells, organs and body to maintain structure and function. The investigators are
      interested in whether 2-AAA is increased in the body after consumption of lysine.
    

Intervention name(s): L-Lysine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 5g L-lysine in 50ml water, administered orally; Normal (0.9%) Saline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lysine
Preserving Muscle Mass and Function in Bedridden Older Adults
Condition: Bed Rest
Study type: Interventional

Summary: 
      The investigators propose that low-intensity exercise and supplementing daily meals with
      leucine or whey will independently and synergistically reduce the deleterious effects of
      inactivity on skeletal muscle and facilitate recovery during rehabilitation.
    

Detailed description: 
      The loss of muscle mass and function in older adults during bed rest is facilitated by
      defects in the regulation of muscle protein metabolism, including an impaired ability to
      mount an anabolic response to a mixed nutrient meal. The investigators propose that
      low-intensity exercise and supplementing daily meals with leucine or whey will independently
      and synergistically reduce the deleterious effects of inactivity on skeletal muscle and
      facilitate recovery during rehabilitation. Metabolic measures will include: a) nutrient and
      exercise-specific markers of translation initiation; b) skeletal muscle protein synthesis;
      and c) a novel breath test of glucose tolerance. Morphologic and functional measures will
      include: a) muscle mass and body composition; b) muscle strength and function; and c) motor
      activation. The investigators will test the following hypotheses in older men and women
      (65-80 years) during 7 days of bed rest followed by 7 days of inpatient rehabilitation:

        1. Inactivity-induced metabolic dysregulation will blunt the anabolic response to meals,
           facilitating a loss of lean muscle mass, glucose tolerance and functional capacity that
           is partially restored during rehabilitation.

        2. Supplementing daily meals with leucine or whey will maintain nutrient-stimulated
           translation initiation and preserve the anabolic response to meal ingestion. This will
           partially preserve lean muscle mass and function during bed rest and facilitate the
           recovery of functional and metabolic capacity during rehabilitation.

        3. Daily low-intensity exercise will preserve motor unit activation, stimulate the
           exercise-regulated signaling pathway and normalize the anabolic response to meal
           ingestion. This will partially preserve glucose tolerance, lean muscle mass and function
           during bed rest and facilitate rehabilitation.

      This translational project will provide mechanistic and practical insight into strategies to
      reduce the negative consequences of physical inactivity and promote rehabilitation in aging
      muscle. Our novel, minimally invasive and clinically interventions have direct application
      for older hospitalized patients at risk of accelerated muscle loss and diminished functional
      capacity.
    

Intervention name(s): Leucine; Exercise; Whey protein
Intervention type(s): Dietary Supplement; Behavioral; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Bed rest,
An Open-label, Parallel-group Study to Determine the Pharmacokinetics of a Single Dose of AFQ056 in Subjects With Renal Impairment Compared to Healthy Subjects
Condition: Mild Moderate; or Severe Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to characterize the pharmacokinetics and safety of AFQ056 in
      subjects with a different degree of renal impairment.
    


Intervention name(s): AFQ056
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal impairment,; pharmacokinetics,; safety
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that varenicline will be effective (compared with placebo) for smoking
      cessation when subjects are allowed to set their own quit date within the first 5 weeks of
      treatment.
    


Intervention name(s): placebo; varenicline
Intervention type(s): Drug; Drug
Intervention description(s): placebo tablet taken orally twice daily for 12 weeks; varenicline tablets, 1 mg taken orally twice daily for 12 weeks
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: smoking cessation; smoking treatment; patient self-selected quit date
Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study focusses on the evaluation of safety and tolerability of the XC8. The design of the
      study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of
      the product after receiving conclusion and recommendation for further continuation of the
      study from the Dose Escalation Committee.
    


Intervention name(s): XC8 (histamine glutarimide); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Histamine; Glutarimide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Double-blind; Randomized; Dose-escalating; Placebo-controlled; Phase I; Healthy volunteers; Bronchial asthma; Histamine glutarimide; EURRUS
Probiotic Formula and Infant Growth
Condition: Healthy
Study type: Interventional

Summary: 
      This is a growth study of full-term, formula-fed infants randomized to receive a partially
      hydrolyzed whey protein formula with and without probiotics for the first four months of
      life. It is hypothesized that there will be no difference in growth between the two groups.
    


Intervention name(s): Control infant formula; Test infant formula
Intervention type(s): Other; Other
Intervention description(s): partially hydrolyzed whey infant formula consumed ad libitum throughout study; partially hydrolyzed whey formula with probiotic
Keywords: full-term; formula-fed infants
Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football
Condition: Fractures in Children; Apophysitis; Muscle Strain; Ligament Injury; Tendon Injuries; Genetic Predisposition
MeSH terms: Genetic Predisposition to Disease; Wounds and Injuries; Tendon Injuries
Study type: Observational

Summary: 
      A total genotype risk score was generated based on the findings of previous research for
      non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture
      injury and apophysitis injury. This score was then compared with the incidence of injury
      between those with high, medium and low risk scores for each injury. The influence of
      different rates of growth, stages of physical maturation and loading exposure were then also
      included in the risk model to see if any interaction effects could be observed between
      genetic risk score and susceptibility to injury in different categories of growth, maturation
      and loading exposure.
    


Intervention name(s): Total Genotype Risk Score
Intervention type(s): Genetic
Intervention description(s): A total genotype risk score has been generated based on the results of previously observed genetic association studies
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Elite male football players aged 12-40
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, randomized, open-label study will evaluate the immune response to vaccines
      (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide
      vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine
      [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose
      of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
    


Intervention name(s): 23-PPV; 13-PCV Booster; Influenza Vaccine; KLH; OCR; TT Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Biological
Intervention description(s): The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).; The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).; The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).; KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).; OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.; The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
Other intervention name(s): RO4964913, PRO70769, rhuMAb 2H7
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy
Condition: Faecal Microbiota Transplantation (FMT); Diabetes Mellitus, Type 1; Gastrointestinal Neuropathy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A randomised, double-blinded and placebo-controlled intervention study. The study aim to
      evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a
      treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.
    

Detailed description: 
      Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to
      changes in gastric and intestinal motility. This change predisposes to an abnormal amounts
      and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and
      severely impaired quality of life. Transferal of intestinal microbiota from a healthy donor
      to a patient is called faecal microbiota transplantation (FMT). FMT may potentially change
      the bacteria in the gut and reduce gastrointestinal symptoms. However, FMT may also have
      potential side effects, especially in persons with autonomic neuropathy and delayed transit
      through the gut.
    

Intervention name(s): Faecal microbiota transplantation (FMT) capsules; Placebo capsules
Intervention type(s): Other; Other
Intervention description(s): The faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (~50 grams of original donor faeces).; The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a 8-week, randomised, double-blinded, placebo-controlled pilot trial of oral FMT versus placebo in patients with DM1 and severe GI neuropathy. The intervention period consists of a first 4 weeks where patients receive either FMT or placebo and a second 4 weeks where all patients receive FMT. The patients will undergo the investigations before and after each 4-week period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment