bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK
      Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged
      20-64 years.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The
      sections impacted are study design and outcome measures
    

Intervention name(s): Influenza investigational vaccine GSK2340274A
Intervention type(s): Biological
Intervention description(s): Two intramuscular injections on Day 0 and Day 21, respectively
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza infection; GSK Biologicals' influenza vaccine GSK2340272A
Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of potential irritation (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd Delicata (new fragrance of Dermacyd)
    


Intervention name(s): lactoserum
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Point of Care Clotting Tests in the OR Versus Standard Laboratory Clotting Tests
Condition: Coronary Artery Bypass Grafting
Study type: Observational

Summary: 
      The purpose of this study is determine the agreement of point of care (POC) clotting tests
      (INR and aPTT) by the POC device by Hemochron Jr versus standard laboratory clotting tests
      (INR and aPTT) in patients undergoing elective cardiac surgery.
    

Detailed description: 
      The study is a correlation between POC Hemochron Jr INR and aPTT with the standard.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patient undergoing elective on pump CABG
      
Keywords: coagulation; INR; aPTT; point of care; laboratory; CABG; surgery
Can Transcutaneous Electrical Acupoint Stimulation Improve the Quality of Recovery After Thyroidectomy?
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      The effect of transcutaneous electric acupoint stimulation (TEAS) on the quality of recovery
      in patients undergoing thyroidectomy surgery remains unclear. Therefore, the investigators
      conducted this prospective, randomized, double-blind study to verify the hypothesis that
      pre-operative TEAS could improve the quality of recovery (QoR) after thyroidectomy surgery.
    

Detailed description: 
      Transcutaneous electric acupoint stimulation (TEAS) is a form of non-invasive electrical
      stimulation that produces a perceptible sensation via electrodes attached to the skin. It has
      no risk of infections and can potentially be applied by medical personnel with minimal
      training. Clinical trials have demonstrated that TEAS reduces the consumption of
      intra-operative anesthetics and general anesthesia related side-effects.
    

Intervention name(s): the Hans electronic acupuncture apparatus
Intervention type(s): Device
Intervention description(s): TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
SAP Depleter Dose Assessment Study in Patients
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to provide safety information on the ligand, GSK2315698A. The
      pharmacokinetics and pharmacodynamics of the ligand will be determined together with the
      differences in routes of dose administration, namely the tolerability between intravenous
      versus subcutaneous dose administration. The study will be carried out in patients with
      systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid
      protein (SAP) will be measured.
    

Detailed description: 
      This study is an open label, dose characteristic study assessing safety and pharmacokinetic
      and pharmacodynamic considerations of GSK2315698A. GSK2315698A is a ligand known to bind to
      serum amyloid protein (SAP), a key component of an anti-SAP approach to the treatment of
      systemic amyloidosis. Safety assessments will include adverse events, vital signs, ECGs and
      other relevant clinical laboratory tests. Dose administration routes will also be determined
      focusing on the tolerability of intravenous dose administration versus subcutaneous. The
      study aims to recruit up to 30 patients with a medical diagnosis of systemic amyloidosis.
      Subjects will be asked to attend 2 dosing sessions, each session will involve an intravenous
      infusion of GSK2315698A over 48 hours followed by a single subcutaneous dose in session 1 and
      up to 3 subcutaneous doses in session 2 to be administered over a 24 hour period.
    

Intervention name(s): GSK2315698
Intervention type(s): Drug
Intervention description(s): Intravenous infusion for approximately 48hours followed by subcutaneous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase 1; Patient; Systemic Amyloidosis; Amyloidosis
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of
      GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and
      co-administered with other routine paediatric vaccines in infants in The Gambia. Two
      formulations containing different doses of pneumococcal antigen and two different schedules
      will be tested in infants.
    

Detailed description: 
      There will be two cohorts in the study: Cohort 1 (children aged 2-4 years) and Cohort 2
      (infants aged 8-10 weeks), and two steps in the study, Step 1 and Step 2. Step 1 will consist
      in a safety evaluation of the GSK Biologicals' pneumococcal vaccine 2189242A (GSK 2189242A or
      10PP vaccine). Before evaluating the two formulations of the 10PP vaccine in infants (Cohort
      2), safety and reactogenicity of the highest dose formulation of this vaccine will be
      evaluated in children (Cohort 1). Prevnar 13™ will be used as a control. In the second step
      of the study, Step 2, two investigational formulations of the 10PP vaccine will be tested in
      infants (Cohort 2) as regards immunogenicity, reactogenicity and safety. Both formulations of
      the 10PP vaccine will be evaluated according to the Expanded Programme on Immunization (EPI)
      schedule i.e. a 2, 3, 4 months vaccination schedule, using licensed Synflorix™ and Prevnar
      13™ vaccines as comparators. The higher dose (HD) formulation of the 10PP vaccine will be
      also evaluated according to the 2, 4, 9 months vaccination schedule using licensed Synflorix™
      vaccine as comparator. The study in infants will also assess the immune responses to routine
      vaccines when co-administered with the candidate pneumococcal vaccine, using licensed
      Synflorix™ and Prevnar 13™ vaccines as comparators.
    

Intervention name(s): Pneumococcal vaccine GSK 2189242A (LD formulation 1); Pneumococcal vaccine GSK 2189242A (HD formulation 2); Synflorix™; Prevnar13™; Tritanrix™-HepB/Hib; Polio Sabin™; M-Vac™; Stamaril™
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Orally; Intramuscular injection; Intramuscular injection
Other intervention name(s): 10PP; LD Formulation; 10PP; HD Formulation
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Haemophilus influenzae; Streptococcus pneumoniae; The Gambia; immunogenicity; nasopharyngeal carriage; infants; safety; Pneumococcal vaccine; children
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will look at what happens to the level of protection against hepatitis B (HB)
      disease if a 'helper' gel is applied to the skin over the injection site of a small dose of
      hepatitis B vaccine.
    


Intervention name(s): Resiquimod gel; Resiquimod gel; Resiquimod gel
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator; 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.; 3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.
Other intervention name(s): HPV vaccine - Gardasil; HPV vaccine = Gardasil; HPV vaccine = Gardasil
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Topical Immune Modulator; resiquimod gel; Hepatitis B booster response; Vaccine Evaluation; Prevention of Hepatitis B disease
PK, Dose Proportionality, Food Effect And Repeat Dose Study Of Rosiglitazone XR In Healthy Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The present pharmacokinetic study is designed to further characterise the pharmacokinetics of
      the RSG XR formulation and aims to assess dose proportionality, strength equivalence, the
      food effect and the pharmacokinetics after repeat dosing.
    

Detailed description: 
      The present pharmacokinetic study is designed to further characterise the pharmacokinetics of
      the RSG XR formulation manufactured in Crawley and aims to assess dose proportionality,
      strength equivalence, the food effect and the pharmacokinetics after repeat dosing. The study
      aims to enroll sufficient number of subjects to ensure 48 subjects complete Study Part 1 (6
      period crossover design) and a further 12 subjects complete Study Part 2 (repeat dosing).
    

Intervention name(s): Rosiglitazone XR
Intervention type(s): Drug
Intervention description(s): Rosiglitazone extended release formulation
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rosiglitazone XR; Pharmacokinetics; Strength Equivalence.; Alzheimers Disease; Repeat dose; Dose proportionality
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of
      sotagliflozin and its metabolite in healthy male and female subjects.

      Secondary Objectives:

        -  To assess total 24 hour urinary glucose excretion (UGE) after 400 mg sotagliflozin alone
           and in combination with mefenamic acid in healthy male and female subjects.

        -  To assess the safety and tolerability of sotagliflozin alone and in combination with
           mefenamic acid in healthy male and female subjects.
    

Detailed description: 
      The expected duration of the study is approximately 59 days per subject, including 2-28 days
      of screening, treatment period 1 of 7 days, treatment period 2 of 8 days, at least 7 days of
      wash-out period, and an end of study visit, which is between 14-21 days after the last dose
      of sotagliflozin.
    

Intervention name(s): Sotagliflozin (SAR439954); Mefenamic acid
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: capsule
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Mefenamic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional

Summary: 
      The investigators examined the efficacy of nefopam in patients undergoing kidney
      transplantation.
    

Detailed description: 
      Drug combination are frequently used to relieve postoperative pain. Nefopam can inhibit
      serotonin, dopamine, and norepinephrine reuptake through central mechanisms. Several studies
      have demonstrated analgesic efficacy of nefopam in the postoperative period. The purpose of
      this study is to ascertain the analgesic effect and tolerance of intravenous nefopam in
      combination with fentanyl based patient-controlled analgesia after kidney transplantation.
    

Intervention name(s): Normal saline; Nefopam
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours; Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Gustatory Evoked-related Potentials in Humans
Condition: Gustatory Evoked Potentials
Study type: Observational

Summary: 
      Taste perception plays an important role in maintaining nutritional balance. Gustatory evoked
      potentials (GEP) can be detected in response to an intermittent stimulation of the gustatory
      receptors by a primary flavour. GEP are non invaisve, painless and safe.

      The aims were to establish a reliable recording of GEP in Humans and to determine
      physiological variations of the gustatory evoked cerebral activity, by recording gustatory
      evoked potentials in different physiological situations (different intensities of taste
      solutions, after feeding or fasting, with different taste...). Healthy volunteers were
      included in this study. GEP were recorded in 9 cortical sites by EEG sensors (10/20 system),
      in front of the primary and the secondary gustatory cerebral areas, referenced against ear
      lobes.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy young volunteers
Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is being undertaken to evaluate responses to seasonal influenza vaccine in older
      adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that
      infects many people, but does not usually cause disease in the individual unless they are
      immunocompromised i.e. their immune system is not working well such as in the case of HIV
      infection. CMV is believed to have infected up to 80% of individuals in the age group we will
      be looking at in our study and we are interested in whether this infection affects their
      responses to vaccination.
    

Detailed description: 
      Human cytomegalovirus (HCMV) is an important pathogen or disease-causing virus, which can
      result in disease in the unborn child as well as in individuals whose immune systems are not
      working properly such as those with HIV or who are receiving some treatments for cancer,
      where the body's ability to fight infection is not as good as in healthy people. HCMV infects
      the majority of the population, yet rarely causes overt disease which would limit the
      capacity of the host to transmit HCMV to others. This virus is thought to be millions of
      years old and because of this we think that it has evolved over time to become very efficient
      at evading the immune system. This means it has become very efficient at moving through the
      human population and resulting in humans devoting more immunological resources to controlling
      this virus than to any other. Recent studies have reported that the immune system does work
      less efficiently in older people, especially in elderly patients with CMV antibodies compared
      to age matched controls who did not have CMV antibodies.

      It is well recognized that responses to vaccination are generally lower in older populations
      compared to children, so they may be thought to be immunologically in a suboptimal position.
      It is proposed that this may be as a result of diversion of key factors in the immune system
      to address CMV infection, the incidence of which increases with age. This study will allow
      assessment of responses to licensed seasonal influenza vaccine with respect to age and CMV
      status and will provide baseline information as a proof of principle on which a larger study
      will be designed.
    

Intervention name(s): Fluarix
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza Vaccine; CMV
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in
      subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of
      brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects
      with moderate to severe plaque psoriasis.
    

Detailed description: 
      Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects
      and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of brodalumab.
      Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
    

Intervention name(s): Brodalumab
Intervention type(s): Drug
Intervention description(s): Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
Other intervention name(s): AMG 827
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as
      tablet or solution over 12 days to healthy male participants. Researcher want to study how
      the body absorbs, breaks down and excrete the new drug, also when given together with a test
      meal. In addition the study will investigate changes that take place in the body when
      BAY2328065 is given together with another drug.
    


Intervention name(s): BAY2328065 LSF; BAY2328065 tablet; Placebo LSF; Placebo tablet; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg/mL LSF (liquid service formulation), orally; 50 mg tablet, orally; Matching Placebo LSF, orally; Matching Placebo tablet, orally; 1 mg per day, orally
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be performed in 2 study parts. Each participant will take part in one study part only.
Bridging part: This will be a single-center, randomized, open-label cross-over part with 3 study interventions, 3 intervention periods and 2 intervention sequences.
Multiple dose escalation part: This will be a single-center, randomized, placebo-controlled, double-blind, parallel group multiple dose escalation part.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary:

      To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of
      glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared
      with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on
      HbA1c in patients with type 2 Diabetes Mellitus (DM)

      Secondary: To compare the following parameters in two treatment arm

        -  Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)

        -  Response rates in terms of HbA1c, FPG

        -  Patient compliance

      Safety:

        -  episodes of hypoglycemia

        -  adverse events

        -  laboratory values including hematology blood chemistry and urinalysis

        -  vital sign and physical examination
    


Intervention name(s): Glimepiride
Intervention type(s): Drug
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment