bioihbjkbjnl/mcl2 huggingface dataset:
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the concentration of antibody to the vaccine one year, three and five years
      after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine
      GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are
      presented in a separate protocol posting with NCT number =00454909) will be evaluated. The
      safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years
      post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612
      vaccine will also be evaluated.
    

Detailed description: 
      GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
      vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of
      age.

      The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3
      years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals'
      meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C,
      W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy
      adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a
      booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary
      vaccination will be evaluated.

      Another cohort of subjects (naïve control group) 15 to <31 years of age will be offered a
      dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve
      control group) and booster dose within the same study.

      This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol
      Amendment 2, May 2011.
    

Intervention name(s): Nimenrix; Blood sampling
Intervention type(s): Biological; Procedure
Intervention description(s): One dose, as intramuscular injection; Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
Other intervention name(s): Meningococcal vaccine GSK134612 (MenACWY-TT)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccine; Booster vaccination; Immunogenicity; Meningococcal disease; Safety
Efficacy and Safety of Natto Extract
Condition: Thrombosis; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Nattokinase is a potent fibrinolytic enzyme extracted from Natto. The objective of this study
      was to compare the efficacy of the natto extract taken by healthy volunteers, dialysis
      patients, and patients with cardiovascularrisk factors on the fibrinolytic factors and blood
      lipids. The study has two primary objectives: to evaluate the effect of oral intake of
      nattokinase in normal subjects, patients under dialysis, and patients of cardiovascular high
      risk group, and to compare the effect of oral intake of nattokinase among three groups.

      Fifteen subjects, 20-70 years, for each group will be enrolled to take the capsules of natto
      extract orally for 2 months. Fibrinolytic factors, vital signs and blood lipids for efficacy,
      and body weight, renal function and self-administered questionnaire for safety will be
      assessed at screening, 3, 7, 28, and 56 days after the initiation of intake, and 2 weeks
      after the cease of intake.
    

Detailed description: 
      This study will employ an open-label, parallel-group design. Adult men and women who meet the
      inclusion/exclusion criteria and give written consent to participate will be assigned to one
      of the three groups according to their condition: Group A- normal volunteers; Group B-
      patients under dialysis; Group C- patients of cardiovascular high risk group. Each group will
      enroll 15 subjects. After two to four weeks run-in period, subjects will be given nattokinase
      orally for 8 weeks, and will be asked to stop taking nattokinase for 2 weeks to evaluate the
      effect of long-term intake and cease of intake of nattokinase.

      Laboratory tests, including fibrinogen, T-PA, PAI-1, D-dimer, total cholesterol, LDL-C,
      HDL-C, and TG, vital signs and body weight will be evaluated at screening visit, 3 days, 1
      week, 4 weeks, 8 weeks, and 10 weeks (2 weeks after cease of intake) visits. Patient
      self-evaluation of tolerance and physical improvement will be assessed by a Patient
      Questionnaire at 3-day, and 1-, 4-, 8-, and 10-week visits. Each patient will be carefully
      monitored for the development of any adverse events (AE).
    

Intervention name(s): Natto extract (Nattokinase)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nattokinase; fibrinolytic factors; blood lipids; nutrimental supplement
A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with
      levodopa in Japanese participants with Parkinson's disease.
    

Detailed description: 
      This is a multicenter, open-label, long-term, phase 3 study to evaluate the safety and
      efficacy of long-term administration of TVP-1012 at 1 mg with levodopa in Japanese
      participants with Parkinson's disease.

      The study period consisted of a 2-week run-in period and a subsequent 52-week treatment
      period. Participants fulfilling the inclusion criteria and did not meet any of the exclusion
      criteria at the start of the run-in period (Week -2) and also at the end of the run-in period
      (Week 0) were enrolled in the study, and received 1 mg of TVP-1012 once daily for 52 weeks,
      in an unblinded manner, from the day after Week 0.
    

Intervention name(s): TVP-1012 1mg
Intervention type(s): Drug
Intervention description(s): TVP-1012 1mg Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
    

Detailed description: 
      It is generally accepted that HIV-infected pregnant women should receive treatment to prevent
      the transmission of HIV from mother-to-child.The (relative) contra-indications for the NNRTIs
      during pregnancy make a PI based regimen the most rational choice. Based on several
      experiences and investigations it is expected that saquinavir will play a role as a component
      of tripe drug regimens for HIV-infected pregnant women. Since the bid dose regimen of 1,000mg
      saquinavir and 100mg ritonavir is approved by the regulatory authorities and with the
      availability of a new 500mg tablet formulation of saquinavir,there is a need for a
      well-designed pharmacokinetic trial using the new 500mg saquinavir tablet formulation in the
      above mentioned dose.
    

Intervention name(s): Saquinavir and Ritonavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Saquinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antiviral activity as measured by the change in
      viral load from baseline in the 14 days following initiation of treatment with 4 different
      dose regimens of TMC310911 co-administered with ritonavir.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention) and randomized
      (study medication assigned by chance) study in treatment-naive human immunodeficiency virus
      type 1 (HIV-1)-infected participants (participants who had not been treated with a
      therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with
      an antiretroviral [ARV] medication indicated for the treatment of HIV-infection or ARVs for
      treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study
      approximately 32 participants will be enrolled and randomly assigned to receive 4 different
      dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The
      trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911
      (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of
      adverse events, clinical laboratory tests, vital sign measurements, physical examinations and
      electrocardiograms.
    

Intervention name(s): TMC310911 75 mg twice daily; TMC310911 150 mg twice daily; TMC310911 300 mg twice daily; TMC310911 300 mg once daily; Ritonavir 100 mg twice daily; Ritonavir 100 mg once daily
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.; TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14; TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14; TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14; Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14; Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
Intervention MeSH terms: Ritonavir; TMC-310911
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human immunodeficiency virus type 1; HIV-1; HIV-1 treatment-naive; TMC310911; Protease inhibitor; Ritonavir; Antiviral Activity; HIV Infections; Treatment Naive
A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3
      inhibitor, for treatment of subjects with active RA. This study will assess the clinical
      response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients
      with active RA. The study will also evaluate the safety and tolerability of VX-509 compared
      to placebo when administered for 12 weeks to subjects with active RA.
    


Intervention name(s): Placebo; VX-509; VX-509; VX-509; VX-509
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet, placebo b.i.d. for 12 weeks; tablets, 25mg b.i.d. for 12 weeks; tablet, 50 mg b.i.d. for 12 weeks; tablet, 100 mg b.i.d. for 12 weeks; tablet, 150 mg b.i.d. for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients
Condition: Efficacy and Safety of Mivacurium Chloride for Pediatric Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect and safety of mivacurium chloride in pediatric patients.
    


Intervention name(s): mivacurium chloride; midazolam; ketamine; propofol; Remifentanil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): intravenously injected during induction with the dose according to allocated group, and intravenously injected with the dose of 0.1 mg/kg when T1 recovers to 25% during period of maintenance.; Before induction: after moving into operating room, oral administration with dose of 0.5 mg/kg or mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children
Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg; mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children
Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg; Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min; Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
Other intervention name(s): mivacron
Intervention MeSH terms: Midazolam; Ketamine; Remifentanil; Propofol; Mivacurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients
      with constipation predominant irritable bowel syndrome (IBS-C).
    

Detailed description: 
      <Period I (double-blind period)> A multicenter, collaborative, double-blind, parallel
      comparative study is conducted using IBS-C patients as subjects to verify efficacy of ASP0456
      and examine the safety. After the 2-week bowel habit observation period, subjects satisfying
      the primary enrollment criteria are randomly allocated to either ASP0456 group or placebo
      group, and orally administered the drug or placebo once daily before breakfast for 12 weeks.

      <Period II (non-blind period)> A multicenter, collaborative, non-blind, non-controlled study
      is conducted to examine safety and efficacy of ASP0456 in long-term administration in IBS-C
      patients. After Period I, subjects satisfying the transfer criteria are orally administered
      ASP0456 once daily before breakfast for 40 weeks.
    

Intervention name(s): linaclotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration once daily; Oral administration once daily
Other intervention name(s): ASP0456
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP0456; constipation; linaclotide; irritable bowel syndrome (IBS)
Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of oxygen within the blood will be reduced in a controlled manner by
      reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive
      pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements
      from a laboratory blood gas analyzer.
    


Intervention name(s): LNCS DBI Sensor
Intervention type(s): Device
Intervention description(s): Noninvasive Measurement of SpO2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a
      chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood
      by controlling the amount of fat made by the liver and gut. Recent research suggests that
      insulin may work through the brain. The investigators hypothesize that preferential delivery
      of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats
      made by the liver and gut.
    

Detailed description: 
      Each subject will be studied twice 4-6 weeks apart in random order in this single blinded
      study. In study A they will receive a single dose of insulin 40 IU through nasal spray. In
      study B they will receive placebo. On the day of the study subjects will drink regular liquid
      nutrient formula to maintain a constant fed state. A pancreatic clamp (octreotide with
      replacement glucose, insulin and growth hormone) will be started at 7am. From 9am a regular
      infusion of a stable isotope tracer will be started together with nasal spray of either
      insulin/placebo. Regular blood samples will be drawn to assess lipoprotein kinetics.
    

Intervention name(s): Insulin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Insulin 40 IU, nasal spray, single dose; Placebo, nasal spray, single dose
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Lipoprotein; Apolipoprotein; Pancreatic clamp; Insulin; Nasal
Impact of Braun Anastomosis on Reduction in Delayed Gastric Emptying Following Pancreaticoduodenectomy
Condition: Periampullary Pathology Requiring Pancreaticoduodenectomy
MeSH terms: Gastroparesis
Study type: Interventional

Summary: 
      Pylorus preserving pancreaticoduodenectomy (PPPD) has been considered as only curative
      treatment modality for periampullary tumor. High mortality rates after PPPD have been reduced
      down to 1%. However, postoperative morbidities are still reported around 10 to 20 % even in
      high volume centers.The delayed gastric emptying syndrome(DGE) is one of major complications
      after PPPD. Many randomized control studies reported that pylorus preserving method was not
      related to the occurence of DGE. Thus,we assumed that large amount of biliary and pancreatic
      juice might affect DGE.

      With the aim to prove that the use of Braun anastomosis after PPPD can prevent DGE, the
      investigators started the recruitment of patients with a periampullary tumors to this
      clinical trial from february 2013 with the study hypothesis that patients with Braun
      anastomosis had less DGE than those who only got conventional PPPD.

      The investigators have calculated the number of patients necessaries to have statistical
      significant differences in 60 patients with a rate DGE expected to be higher than 30%.

      The study include all the patients that usually arrive to our surgery department and who are
      indicated to PPPD for the curative treatment of periampullary tumor.

      The study is randomized, double blind where the investigators and the patients do not know if
      the patients are in the Braun anastomosis group or not, and prospectively analyzed. All the
      clinical and laboratory or radiographic finds relative to the occurrence of DGE are recorded.
    


Intervention name(s): PPPD with Braun anastomosis; conventional PPPD
Intervention type(s): Procedure; Procedure
Intervention description(s): making communication between E-loop and A-loop (Braun anastomosis 30cm away from duodenojejunostomy, by using staple method) will be added to conventional PPPD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pylorus preserving pancreaticoduodenectomy(PPPD), Delayed gastric emptying syndrome(DGE), Braun anastomosis
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India
      and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,
      adult,human subjects under Fed conditions.
    

Detailed description: 
      Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose,
      oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Sirolimus tablets 2 mg
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Effects of Vaping Nicotine on Cognition in Young Adults
Condition: Nicotine Addiction; Vaping
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      To examine reward processing and cognitive control both with and without the influence of
      vaporized nicotine in young adults with no history of cigarette use using EEG and fMRI. The
      goal is to determine whether acute nicotine administration using a Juul device would impact
      functional correlates of reward and inhibitory control in people who commonly use juul
      devices.
    

Detailed description: 
      Aim 1: To examine reward processing both with and without the influence of vaporized nicotine
      in young adults with no history of cigarette use using EEG and fMRI. The goal is to determine
      whether acute nicotine administration using a Juul device would impact functional correlates
      of distinguishable reward processes (anticipatory and consummatory reward) in young adults
      who commonly use juul devices. Predictions are that juul use will have an impact on activity
      in the striatum, resulting in reduced activation in fMRI and smaller amplitudes in
      event-related potentials (ERP) in response to reward cues and reward feedback.

      Aim 2: To examine cognitive control both with and without the influence of vaporized nicotine
      in young adults with no history of cigarette use using EEG and fMRI. The goal is to determine
      whether acute nicotine administration using a Juul device would impact functional correlates
      of behavioral inhibition in young adults who commonly use juul devices. Predictions are that
      juul use will affect the inhibitory circuit, including the anterior cingulate and the
      dorso-lateral prefrontal cortex, resulting in decreased activation in these regions during
      fMRI and reductions in the FRN and P300 ERP responses in response to inhibitions and to
      commission errors. Predictions also include that inhibitory control behavior will be impaired
      after juul use.

      Aim 3: To establish feasibility of naturalistic use of vaping devices for nicotine
      administration and observing the effects in the laboratory.
    

Intervention name(s): Nicotine pod; Placebo pod
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine pods administered to individuals who use Juul; Nicotine-free pods administered to individuals who use Juul
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: vaping; nicotine; juul; inhibitory control; reward processing