bioihbjkbjnl/mcl2 huggingface dataset:
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic
      types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also
      evaluating novel HPV vaccines formulations. This study will evaluate the long-term
      immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects
      who received the novel vaccine or the control vaccine administered in the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): CervarixTM; HPV investigational vaccine GSK568893A, different formulations
Intervention type(s): Biological; Biological
Intervention description(s): Subjects were administered three doses of HPV vaccine; Subjects were administered three doses of HPV investigational vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine
Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Recent clinical trials were developed to test the outcomes of skin closure with tissue
      adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel
      incision: both clinical outcomes such as blood loss, surgical site infection, length of
      postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar
      Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these
      different skin closure methods.

      Despite the available studies are often based on robust methodologies and appropriate
      assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean
      section, whereas data analyses published so far do not allow to draw a firm conclusion about
      repeated cesarean sections. Based on these elements, the aim of this study is to evaluate
      cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples
      in a selected population undergoing repeated cesarean section.
    


Intervention name(s): Staples; Tissue adhesive
Intervention type(s): Procedure; Procedure
Intervention description(s): Skin closure using surgical stapler.; Skin closure using 2-octylcyanoacrylate tissue adhesive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, prospective, randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean delivery; Cosmesis; Healing; Skin closure; Scar assessment scales
A Safety Study of PTI-125 in Healthy Volunteers
Condition: Alzheimer Disease, Early Onset; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending
      Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
    

Detailed description: 
      This was a Phase I, single center, randomized, double-blind, placebo-controlled, single
      ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of
      twenty-four (24) subjects were enrolled into the study in one of three dose cohorts. Each
      cohort contained eight subjects; six subjects received PTI-125 and two received placebo.
      Three doses of PTI-125 oral solution (50, 100, and 200 mg) or placebo solution were
      administered to respective cohorts.

      The study included a screening period (Day -28 to Day -1), an inpatient treatment period (Day
      0 through Day 4), and a follow-up visit (Day 7). Subjects reported to the clinic on the day
      before dosing and were randomized to receive either a single dose of orally administered
      PTI-125 or placebo. Each dose was administered following an overnight fast of at least 10
      hours.

      For each dose level, dosing was staggered such that two subjects (one active and one placebo)
      were dosed prior to the rest of the group. After a minimum of 24 hours and review of all
      24-hour safety assessments (electrocardiogram [ECG], a brief physical examination, vital
      signs, and laboratory assessments) an independent Data Safety Monitoring Board/Data
      Monitoring Committee (DSMB/DMC) determined whether the remaining 6 subjects were to be dosed.

      Pharmacokinetic blood samples were obtained prior to dosing and at specified intervals during
      the study (0-72 hours post-dose). Blood draws for laboratory testing were performed prior to
      dosing and at 24 hours post dose. After safety assessments of ECG, vital signs, and a brief
      physical exam at 72 hours, subjects were discharged from the clinic and returned 7 days
      post-dose for a final safety assessment.
    

Intervention name(s): 50 mg PTI-125; 100 mg PTI-125; 200 mg PTI-125
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PTI-125 50 mg Oral Solution; PTI-125 100 mg Oral Solution; PTI-125 200 mg Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Study type: Observational

Summary: 
      Chart review.
    

Detailed description: 
      A chart review will be completed on patients with multiple sclerosis to determine potential
      early characteristics that might be helpful in defining aggressive onset MS and predicting
      subsequent disease course and disability
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with MS.
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Condition: Uveitis, Posterior
MeSH terms: Uveitis; Uveitis, Posterior
Study type: Observational

Summary: 
      An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes
      Treated with a Fluocinolone Acetonide Intravitreal Implant
    

Detailed description: 
      This is a prospective, multicenter, open-label, single arm, observational evaluation of the
      corneal ECD change from baseline for subjects having the Retisert FA drug delivery system
      (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously
      unimplanted eye for at least 1 year.
    

Intervention name(s): Retisert; Fluocinolone Acetonide Intravitreal Implant
Intervention type(s): Device; Drug
Intervention description(s): Intravitreal Implant; Intravitreal Implant
Intervention MeSH terms: Fluocinolone Acetonide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the
        ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year
Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the
      differences between Macintosh size 3 and 2 blades, we will analysis the data collected from
      airway and intubation condition.
    

Detailed description: 
      Selection the most appropriate size of laryngoscope blade size could not only increased
      intubation successful rate at the first time but also decrease the incidence of tissue
      trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared
      with Caucasian people, Asian people are smaller and thinner especially in women. This study
      aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view
      and intubation rate.

      Female patients without known difficult airway will be enrolled and allocated into Macintosh
      blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification,
      mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane
      grade, intubation difficulty scale scores and associated teeth or tissue traumas will be
      recorded.
    

Intervention name(s): Macintosh size 2 blade; Macintosh size 3 blade
Intervention type(s): Device; Device
Intervention description(s): intubate with Macintosh size 2 blade; intubate with Macintosh size 3 blade
Intervention MeSH terms: Pyrithione zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intubation rate; Macintosh blade; Asian women; intubation difficulty scale
Maternal 25-hydroxy Vitamin D Level and Adverse Outcomes in Near Term and Full Term Neonates
Condition: Neonatal Outcome
Study type: Observational

Summary: 
      Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study.
      Maternal serum 25-OHD was measured by ELISA
    

Detailed description: 
      Eighty-eight pregnant women and their newborns were enrolled in a cross-sectional study.
      Maternal serum 25-OHD was measured by ELISA.Maternal 25 (OH) vitamin D measurement: Blood
      samples for determination of serum 25 (OH) vitamin D were collected by venipuncture and
      processed as follows: 3 mL blood were collected into plain tubes and allowed to clot for 30
      minutes, then it was centrifuged at 1500 round per minute for 15 minutes at room temperature
      and the serum was separated into clean, properly labeled tubes and stored at ≤ -20°C till
      assay. Serum 25 (OH) vitamin D level was assessed by Enzyme-Linked ImmunoSorbent Assay
      (ELISA) using DRG 25-OH Vitamin D (total) ELISA (DRG International, Inc., USA) according to
      manufacturer's instructions. Vitamin D deficiency is defined by 25(OH) D levels less than 20
      ng/d
    

Intervention name(s): Vaginal delivery; Cesarean Section
Intervention type(s): Procedure; Procedure
Intervention description(s): classic vaginal delivery; routine lower segment cesarean scetion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        88 full term neonates of both sexes born to 88 healthy women with a mean age was 27.0 ± 5.0
        years. Forty-one (46.6%) had normal vaginal delivery and 47 (53.4%) underwent cesarean
        section
MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
Condition: Type 2 Diabetes
MeSH terms: Pregnancy in Diabetics; Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is
      increasing evidence that in-utero exposure to maternal diabetes is associated with an
      increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need
      to reduce these increasing rates of obesity and diabetes in subsequent generations.

      The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded
      multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample
      size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin
      to a standard regimen of insulin in women with diabetes, on perinatal morbidity and
      mortality.

      The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment
      with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in
      adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2
      years of age.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Offspring of women with type 2 diabetes who participated in the MiTy trial during
        pregnancy.
      
Keywords: Diabetes; MiTy; Metformin in Women; Type 2 Diabetes Pregnancy
Effects of Dietary Fructose on Glucose and Lipid Metabolism in Healthy Human Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The increasing intake of fructose has been associated with an increase in obesity among US
      children and adolescents, but its "dose dependent" effects on insulin sensitivity and lipid
      metabolism has not been studied in detail. Methods: 36 healthy male adult human subjects will
      be included in this study. They will be randomly allocated into a low, moderate or high
      fructose, a moderate or high glucose and a sucrose diet for 3 weeks. In randomized order and
      with 4 week wash out intervals each subject will receive all six different diets. Three day
      food records will be used to measure total fructose and glucose intake. During the low
      fructose diet subjects will be instructed to avoid nutrients containing fructose aiming at
      consumption of less than 1g fructose/d. During the moderate fructose diet subjects will
      receive 3x13.3g of fructose or glucose, respectively. High fructose diet subjects will
      receive either 3x26.7g/d of fructose, 3x 26.7g/d of glucose or 3x 26.7g/d of sucrose in the
      form of three daily soft drinks taken together with the three main meals.

      75 g oral glucose tolerance testing will be performed and composite insulin sensitivity index
      will be calculated The presence of phosphorylated fructose metabolites in plasma will be
      measured by targeted LC-MS/MS. In addition, metabolite biomarkers in plasma will be screened
      by untargeted metabolite profiling using both LC-MS and GC-MS. In a subgroup of 10 subjects
      an euglycemic hyperinsulinemic clamp will be performed using [6,6- 2H2]glucose.

      Thus, the lipogenic potential of fructose in humans will be compared with isocaloric amounts
      of glucose. Particularly, the question whether lipogenic effects are continuously dose
      dependent or whether there is a lipogenic shunting and if yes, at what level of ingested
      fructose will be addressed.
    


Intervention name(s): Fructose
Intervention type(s): Other
Intervention description(s): Subjects consume different amounts of fructose, glucose and sucrose in a crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study of NPO-13 During Colonoscopy
Condition: Bowel Disease
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with
      moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed
      up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an
      independent committee using recorded video images. The study consists of a screening visit
      window, 1-day treatment phase and 1-week follow-up phase.
    


Intervention name(s): NPO-13: l-menthol
Intervention type(s): Drug
Intervention description(s): 20 mL/site
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Safety of an Infant Formula With Hydrolysed Protein in Term Infants
Condition: Growth
Study type: Interventional

Summary: 
      A multi-centre, randomised, double-blind, parallel-group, controlled, prospective,
      non-inferiority intervention clinical trial is performed to assess the safety and suitability
      of an infant formula manufactured from extensively hydrolysed protein by showing normal
      growth of healthy term infants during the first 120 days of life with an optional follow up
      until 180 days of life.
    

Detailed description: 
      Since many years the use of infant formulae manufactured from hydrolysed proteins are
      recommended for infants at risk for developing allergies if they cannot be exclusively
      breast-fed. Although the use of such formulae manufactured from hydrolysed protein is legally
      authorized according to the respective legal framework since many years (currently: Directive
      2006/141/EC), the safety of each hydrolysed protein has to be substantiated by additional
      clinical data according to new legal requirements (Del. Regulation (EU) 2016/127). This study
      is intended to generate clinical safety data: demonstrating adequate growth of infants fed a
      formula manufactured from hydrolysed protein in comparison to infants fed a formula
      manufactured from intact protein. As formula manufactured from hydrolyzed proteins is known
      to have beneficial effects on gastrointestinal comfort, it is also fed to infants not at risk
      for developing allergies. Therefore, this study additionally investigates the impact of
      hydrolysed protein on gastrointestinal tolerance.
    

Intervention name(s): Intervention Group: Infant Formula with hydrolyzed protein; Control Group: Infant Formula with intact protein
Intervention type(s): Other; Other
Intervention description(s): Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).; Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Safety; Growth; Weight Gain; Infant Formula; Infants
Study of the Effects of Intravenous Exenatide on Cardiac Repolarization
Condition: Healthy Adult Male and Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study
      Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and
      Female Volunteers
    

Detailed description: 
      This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.

      The Pilot Part of the study will be an open-label, non-randomized, single-treatment design in
      10 healthy male and female subjects to determine if an infusion regimen of a 6-h continuous
      IV infusion of exenatide will lead to a mean plasma steady state concentration of 500 pg/mL.

      The Core part of the study will be a double-blind (except for the use of open label active
      control moxifloxacin), randomized, placebo-controlled,3 period, 6-sequence, cross-over design
      in 72 healthy male and female subjects to evaluate whether exenatide at therapeutic and
      supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization
      (threshold value >10 msec).
    

Intervention name(s): Exenatide; Placebo; Moxifloxacin; Palonosetron
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 hour IV infusion (double infusion of 0.1250 mcg/kg/hour for 30 min followed by infusion rate (1X) of 0.0625 mcg/kg/hour for 5.5 hours).; 6 hour IV infusion.; 400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide; 0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide
Intervention MeSH terms: Exenatide; Moxifloxacin; Palonosetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Behavioral Self-Regulation
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine whether incorporating self-regulation
      training using daily weighing is efficacious within a behavioral weight loss program
      specifically targeting young adults.
    


Intervention name(s): self-regulation
Intervention type(s): Behavioral
Intervention description(s): The current study involves a behavioral weight loss intervention tailored specifically to young adults. All participants receive calorie and activity prescriptions as well as training in behavior modification. In addition, one group receives training in self-regulation techniques using daily weighing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study of Colistin Methanesulfonate Sodium
Condition: Infections, Pseudomonas
MeSH terms: Pseudomonas Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical study protocol for a single centre, randomized, double blind, placebo
      controlled, single and repeat dose study to investigate the safety, tolerability and
      pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in
      healthy Japanese male subjects.

      Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or
      placebo as a single dose and twice daily for 2.5 days by intravenous infusion.

      Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals
      after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),
      safety laboratory data, renal function and review of adverse events.
    


Intervention name(s): Colistimethate sodium; Saline
Intervention type(s): Drug; Drug
Intervention description(s): active; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment