bioihbjkbjnl/mcl2 huggingface dataset:
Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
Condition: Acute Diarrhea; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of probiotic yogurt in acute watery
      diarrhea in children. The investigators will compare the effect of two different probiotics
      products.
    

Detailed description: 
      Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood,
      considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a
      probiotic who reduces the number of days of hospitalization and also de the severity.

      Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who
      are between 10 months and 3 years old with acute non-dysenteric diarrhea.

      Methods: A randomized clinical trial, controlled, double-blind. The investigators will have
      two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt
      presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ;
      the parameters of evaluation are going to be the number of diarrhea stools by day, number of
      vomiting episodes, hours with fever, nutritional and immunization state.
    

Intervention name(s): Probiotic yogurt; Placebo probiotic
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.; Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
Other intervention name(s): Florestor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute diarrhea; probiotics; children
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting
      condition.
    

Detailed description: 
      Objective of the study is to compare and evaluate the single-dose oral bioavailability of
      Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India
      and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb
      Company, USA in normal, healthy, adult, human subjects under fasting condition.

      Total duration of the study was of 17 days from the day of admission of first period till the
      end of second period.

      Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical
      Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be
      housed in the facility till 36.00 hours post-dose blood sample collection in each of the two
      periods.

      A gap of 14 days was kept as wash out between each consecutive dosing period.
    

Intervention name(s): Metformin Hydrochloride Extended-Release Tablets USP 750 mg; GLUCOPHAGE®XR
Intervention type(s): Drug; Drug
Intervention description(s): Metformin Hydrochloride Extended-Release Tablets 750 mg once a day; GLUCOPHAGE®XR 750 mg once a day
Other intervention name(s): Test Product; Reference product
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel
      is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies,
      cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes
      the backbone upon which to improve upon. Thus, the primary objective of this study is to
      determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone
      based on safety and tolerability in men with chemorefractory metastatic castration-resistant
      prostate cancer (CRPC).
    


Intervention name(s): tasquinimod; tasquinimod 0.25 mg; 0.5 mg; tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tasquinimod 0.25 mg continuously; tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated; tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Acute Hyperglycaemia on Brain in T1D
Condition: Hyperglycemia; Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hyperglycemia
Study type: Interventional

Summary: 
      The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20
      years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and
      hyperglycaemic state. During both MRI, the participants are going to preform Flanker test,
      Tower of London test and Spatial memory test. The investigators are going to evaluate the
      response of inflammation markers and oxidative stress marekers in blood during
      hypreglycaemia.
    

Detailed description: 
      The study is going to include 20 patientswith T1D. The group of patients is going to be
      homogeneous. The inclusion criteria are going to be: duration of T1D approximately 5 - 10
      years, age between 10 and 24 years, without associated clinical complications of T1D, similar
      value of HbA1c and BMI within the normal range (depending on the percentile for age and sex),
      treatment with an insulin pump. Only the patients who are going to give written consent to
      participate in the form "Declaration of conscious and free consent" are going to be included.

      All selected clinical data to determine the phenotypic characteristics of the patient will be
      obtained from available medical records or. at their regular outpatient reading.

      After 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp.

      During hyperglycemia a sample of venous blood for the evaluation of oxidative stress,
      inflammatory response and the expression of non-coding RNA is going to be drawn.

      Subjects will have 1H-MRS in hyperglycaemic and euglycaemic state and evaluation of executive
      function (using psychological tests) is going to be preformed. For 1H-MRS, the MRI of the
      head in order to obtain anatomical data is going to be preformed at first .
    

Intervention name(s): hyperglycaemic clamp
Intervention type(s): Other
Intervention description(s): 2h hyperglyceamic clamp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Pharmacokinetics of Oral Controlled-ileocolonic-release Nicotinamide (CICR-NAM)
Condition: Safety Issues; Pharmacokinetic
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, randomised, placebo-controlled phase I trial with single-ascending and
      multiple-ascending dose to evaluate safety and pharmacokinetics of oral
      controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to immediate-release
      nicotinamide and placebo in healthy subjects and in patients with inflammatory bowel
      diseases.
    

Detailed description: 
      Nicotinamide (NAM) has been implicated in the restoration and maintenance of a healthy gut
      microbiome. Conventional NAM formulations are designed for systemic NAM supplementation and
      therefore release NAM in the stomach and upper small intestine for maximum absorption. In
      contrast, the novel CICR-NAM tablets (controlled-ileocolonic-release nicotinamide) start
      releasing in the lower small intestine for topical delivery of NAM to the microbiota and the
      mucosa in the ileum and colon, also leading to a reduced systemic exposure. This clinical
      Phase I trial investigates the safety and tolerability of CICR-NAM in single- and
      multiple-ascending doses (1, 2 and 4 g). At the beginning of the trial, single-dose
      pharmacokinetics (PK) of 1 g of conventional immediate-release NAM and CICR-NAM are compared.
      At the end of the trial, patients with inflammatory bowel diseases (IBD) receive a medium
      multiple dose (2 g for 4 weeks) to compare their exposure, PK and safety data with those of
      healthy subjects at the same dose level.
    

Intervention name(s): controlled-ileocolonic-release nicotinamide (SAD/MAD/MD); Immediate-release nicotinamide (SAD); Placebo controlled-ileocolonic-release nicotinamide (SAD/MAD); Placebo Immediate-release nicotinamide (SAD)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD); single-ascending dose (SAD); single- and multiple-ascending dose (SAD/MAD); single-ascending dose (SAD)
Other intervention name(s): CICR-NAM (SAD/MAD/MD); ImR-NAM (SAD); no active substance; no active substance
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Nicotinamide; Inflammatory Bowel Disease
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
Condition: Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated
      Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single
      intramuscular injection.
    

Detailed description: 
      This was a multi-center, randomized, double-blind, active-controlled study.

      Before initiation of any protocol-specific activities, written informed consent was obtained
      from each patient and their legally acceptable representatives (consent of the legally
      acceptable representative was required for children younger than 10 years of age, and for the
      some sites, for children younger than 7 years of age). Subjects who met all of the
      eligibility criteria after screening assessments as specified in the protocol, were
      randomized into the test group or the comparator group in a ratio of 5 to 1 according to the
      pre-generated site-specific randomization table, and received a single dose or two doses of
      the study vaccine. The investigator performed the efficacy (immunogenicity) and safety
      assessments throughout the study. Efficacy data were collected at Visit 1 (prior to
      vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for
      safety assessment, subjects and their legally acceptable representatives were instructed to
      record any treatment-emergent adverse event in Patient Diary cards.

      For all randomized subjects, blood sample was obtained prior to vaccination, and the study
      vaccine 0.5mL or 0.25mL was administered to the deltoid muscle or anterolateral thigh muscle.
      For children aged from 6 months to <9 years of age who had not been previously exposed to
      influenza virus or had not previously received influenza vaccine, another dose of the study
      vaccine was administered 4 to 5 weeks after the first dose. Blood samples were collected 4 to
      5 weeks after the last dose of the study drug for the assessment of antibody titer. All
      subjects were followed for 6 months after the last dose of the study drug for the safety
      assessments, and Month 6 follow-up visit was the end-of-study visit.
    

Intervention name(s): IL-YANG FLU Vaccine Prefilled Syringe INJ.; VAXIGRIP Prefilled Syringe INJ.
Intervention type(s): Biological; Biological
Intervention description(s): IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL; VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine
Cervical Length on Pregnancy Termination
Condition: Pregnancy Loss
Study type: Observational

Summary: 
      Cervical length is used as a parameter to predict cervical insufficiency and onset of labor.
      However, its role in predicting abortion induction is unclear.To investigate the impact of
      cervical length measurement and fetal viability on second trimester pregnancy termination
      duration in nulliparous pregnant women.
    

Detailed description: 
      Cervical length and fetal viability were evaluated prior to second trimester pregnancy
      termination due to various indications. nulliparous pregnant women through 13 and 26
      gestational weeks in whom pregnancy termination was conducted within 72 hours after admission
      were included in the study. The subjects were grouped into two groups according to fetal
      viability.
    

Intervention name(s): cervical length measurement
Intervention type(s): Procedure
Intervention description(s): cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.
      
Keywords: Cervix; Length; Viability; prostaglandin; Termination
A Study to Compare Pharmacokinetics of GB1211
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, Randomized, Three-period, Crossover Study to Compare the
      Pharmacokinetics of GB1211 upon Dosing a Capsule under Fasting Condition and a Tablet under
      Fasting and Fed Conditions in Healthy Volunteers
    

Detailed description: 
      This is relative bioavailability and food effect study to enable further clinical development
      of a tablet formulation of GB1211.
    

Intervention name(s): GB1211
Intervention type(s): Drug
Intervention description(s): Hard tablet or capsules for oral use
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Iron Overload in Pediatric Oncology Patients
Condition: Iron Overload
MeSH terms: Iron Overload
Study type: Observational

Summary: 
      The purpose of this study is to evaluate for iron overload in pediatric oncology and
      transplant patients who have completed their treatment between one to ten years ago.
    

Detailed description: 
      Long term survivors of childhood cancer, are a distinct group requiring specific follow-up in
      order to enhance their quality of life. Studies have shown that many of these patients will
      go on to develop chronic issues within different organ systems. Because of the iron burden of
      the frequent transfusions required to care for these patients, iron overload may indeed be
      one of the problems these survivors potentially face. Research primarily in thalassemia and
      bone marrow transplant patients who were extensively transfused has shown that iron overload
      can have a significant impact on their overall health. Complications from increased iron
      burden can include growth retardation, gonadal dysfunction, hypothyroidism, impaired glucose
      metabolism, cardiac arrhythmias and failure, hepatic fibrosis and cirrhosis, and increased
      susceptibility to infections. However all of these conditions related to iron overload can be
      prevented with the use of either phlebotomy or chelation therapy. Based on this knowledge,
      our objective is to determine if pediatric oncology and transplant patients heavily supported
      with transfusions develop consequential biochemical and clinical evidence of iron overload.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients one to ten years post chemotherapy for Ewing sarcoma, osteosarcoma,
        rhabdomyosarcoma, AML, or neuroblastoma and patients post-transplant for any malignancy.
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir
      and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels
      of each other when given separately and together. This is a phase I, open-label, prospective,
      three phase, pharmacokinetic study.
    

Detailed description: 
      Phase I (study day 1 - 14):

        -  14 healthy volunteers with a documented negative HIV-1 antibody test during screening
           procedures will be enrolled.

        -  On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed
           dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood
           sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.

        -  This will be followed by a wash-out period.

        -  As steady state pharmacokinetics of ribavirin are not reached for several weeks, single
           dosing pharmacokinetics will be assessed in this study

      Phase II (study days 15 - 19):

        -  On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend
           for safety visits and witnessed dosing during this phase.

        -  Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached,
           subjects will attend for a 12 hour detailed pharmacokinetic visit where following
           witnessed administration of raltegravir 400 mg without food, blood sampling will be
           drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment
           of raltegravir plasma exposure.

      Phase III (study day 20):

      • Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This
      will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn
      at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
    

Intervention name(s): Ribavirin; Raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): 800mg once daily; 400mg twice daily
Other intervention name(s): Copegus
Intervention MeSH terms: Ribavirin; Raltegravir Potassium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers
The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective pilot study designed to suggest differences in the immunologic response
      to the seasonal influenza vaccine in people with regular vaccination history compared to
      those vaccinated less regularly. Participants will receive one dose of the Food and Drug
      Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will
      be collected at standard time points. The duration of the study for each participant will be
      approximately 1 month.
    

Detailed description: 
      This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old,
      inclusive, who are in good health and meet all eligibility criteria. The study is designed to
      evaluate differences in the immunologic response to the seasonal influenza vaccine in people
      with regular vaccination history compared to those vaccinated less regularly.

      Participants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their
      vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm
      A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will
      receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal
      influenza vaccine. The duration of the study for each participant will be approximately 1
      month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month
      follow-up period following vaccination.

      The study has two primary objectives; to evaluate the antibody response to the influenza
      vaccine in people who are vaccinated regularly and those vaccinated less regularly; the
      second is to evaluate circulating follicular helper T cells (TFH) in people who are
      vaccinated regularly and those vaccinated less regularly.
    

Intervention name(s): 2016-2017 Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccination