bioihbjkbjnl/mcl2 huggingface dataset:
Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin
      sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not
      adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a
      placebo and active treatment group for comparison.
    


Intervention name(s): Rivoglitazone; Pioglitazone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Placebo and active control dose response study of rivoglitazone in type 2 diabetics
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Condition: Hygiene
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove the absence of photo irritation and photo sensitivity potential of the product
      Dermacyd Femina.
    


Intervention name(s): Lactic acid (Dermacyd Femina)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
Condition: Vaccine for Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate
      the safety, immune response and consistency of immune response of three consecutively
      manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both
      inclusive). The immune response of NmCV-5 will also be statistically compared against a
      licensed conjugate vaccine against ACYW (Menactra).

      A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three
      age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group
      subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The
      NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different
      lots (Lot A, B & C) of NmCV-5.

      All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day
      1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at
      Day 85.
    


Intervention name(s): NmCV-5; Menactra
Intervention type(s): Biological; Biological
Intervention description(s): The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration.
The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine.
The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule.; The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery
      temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the
      standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma
      multiforme.
    


Intervention name(s): Temozolomide; Radiotherapy
Intervention type(s): Drug; Radiation
Other intervention name(s): Temodal; Temodar; SCH 052365; Irradiation; radiation therapy
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
Condition: Substance Withdrawal Syndrome; Opiate Addiction; Opiate Dependence
MeSH terms: Syndrome; Opioid-Related Disorders; Substance Withdrawal Syndrome; Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative exposures of lofexidine and its major
      metabolites in subjects seeking buprenorphine dose reduction.
    

Detailed description: 
      This is a Phase 1, open-label, inpatient study in male and female subjects seeking at least a
      4 mg reduction of their buprenorphine maintenance dose. The purpose of this study is to
      assess the relative exposures of lofexidine and its 3 major metabolites in subjects tapering
      from buprenorphine maintenance treatment. Lofexidine is an alpha-2 adrenergic agonist under
      development for the treatment of acute withdrawal from short-acting opioids.
    

Intervention name(s): lofexidine administration in subjects seeking buprenorphine dose reduction
Intervention type(s): Drug
Intervention MeSH terms: Lofexidine; Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: substance withdrawal syndrome; opiate addiction; opiate dependence; opioid withdrawal syndrome; buprenorphine
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if revaccination with pneumococcal vaccine
      (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese
      adults. The primary hypothesis being tested is that the geometric mean concentration of
      antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after
      revaccination will be superior to that before revaccination in Japanese adults who received a
      primary vaccination at least 5 years before revaccination.
    


Intervention name(s): PNEUMOVAX™ 23
Intervention type(s): Biological
Intervention description(s): PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Powerball System in People With Multiple Sclerosis
Condition: Neurologic Disorder; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Sclerosis
Study type: Interventional

Summary: 
      There is a high percentage of impairment in the upper limbs (UL) in patients with multiple
      sclerosis (MS), being muscle strength and hand dexterity a determining factor for the
      preservation of functional activities, constituting the basis of independence and quality of
      life. The aim of this study is to determine the effects of a training protocol on UL muscle
      strength, through the NDS-Powerball® system, in combination with conventional physiotherapy,
      during 8 weeks in terms of muscle strength, coordination, fatigue, functionality and quality
      of life in people with MS.
    


Intervention name(s): NDS-Powerball®,; Conventional treatment
Intervention type(s): Device; Other
Intervention description(s): Rehabilitation using the Powerball system; Rehabilitation by conventional treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      All study participants will receive both warfarin and a study drug called evacetrapib. The
      main purpose of this study is to look at how much warfarin gets into the blood stream and how
      long it takes the body to get rid of warfarin when given both with and without evacetrapib.
      Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots
      when given with evacetrapib by measuring the time it takes for blood to clot and comparing it
      to an average of the international normalized ratio (INR). INR measures the time it takes for
      blood to clot and compares it to an average.

      The study will last approximately 5 weeks, not including screening.
    


Intervention name(s): Evacetrapib; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Other intervention name(s): LY2484595
Intervention MeSH terms: Warfarin; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
Condition: Digestion; Gut Microbiota
Study type: Interventional

Summary: 
      This is a non-randomized, single-arm, open-label, prospective interventional study using a
      commercially available starter infant formula in healthy term formula-fed infants with a
      parallel group of healthy term breast-fed infants as reference group. Approximately 120 male
      and female infants (60 per group) who are 3-28 days old and are exclusively or predominately
      formula-feeding or breastfeeding will be enrolled.
    

Detailed description: 
      Breastmilk contains an abundance of structurally diverse compounds having important
      physiologic roles. These include glycoproteins which are biologically active and involved in
      infant gut, immune and brain development (Jiang and Lönnerdal 2016).

      The overall purpose of this study is to study the effectiveness of a term infant formula rich
      in glycoprotein (formula-fed group) on gastrointestinal tolerance, and gastrointestinal
      health in healthy term infants compared to a breast-fed reference group. We hypothesize that
      there will be comparable gastrointestinal tolerance in formula-fed and breast-fed and that
      fecal bifidobacteria changes in early infancy in the formula-fed group are similar to that of
      breast-fed infants.
    

Intervention name(s): Commercially Available Starter Infant Formula
Intervention type(s): Dietary Supplement
Intervention description(s): Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: gut tolerance; gut microbiota; gut immunity
Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
Condition: Cherry Angioma
MeSH terms: Hemangioma
Study type: Interventional

Summary: 
      The primary objective of this study is to determine whether laser treatments over 6 weeks
      using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are
      effective in patients with cherry angiomas as observed by a physician provider and the
      subject.

      The investigators hypothesize that the two laser treatments will be an effective tool for
      treating cherry angiomas. The investigators aim to compare these modalities to
      electrodessication, as all three modalities are considered the current standard of care.
      Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.

      In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the
      AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of
      care, electrodessication.
    


Intervention name(s): Electrodessication; Pulsed dye laser (PDL); potassium titanyl phosphate (KTP)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Treatment applied to a third of the torso at each study visit.; Laser treatment applied to a third of the torso at each study visit.; Laser treatment applied to a third of the torso at each study visit.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.
Condition: Allergy
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus
      placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.
    


Intervention name(s): Fexofenadine HCI
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release
      capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity
      Disorder (ADHD).
    

Detailed description: 
      This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, 2-arm,
      parallel-group, flexible dose trial assessing the efficacy and safety of SPN-812 (Viloxazine
      extended-release capsules; 200-600 mg) as monotherapy for the treatment of adults 18-65 years
      old with Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Intervention name(s): Placebo; SPN-812
Intervention type(s): Drug; Drug
Intervention description(s): Placebo will be administered once daily; SPN-812 will be administered once daily and compared to Placebo
Other intervention name(s): PBO; Viloxazine extended-release capsules
Intervention MeSH terms: Viloxazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention-Deficit/Hyperactivity Disorder (ADHD), Adult ADHD,
Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
Condition: Colic; Gastrointestinal Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri
      (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo
      orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white
      blood cell receptors and inflammatory cytokine profiles will be measured.
    

Detailed description: 
      Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR),
      which has traditionally been used for the establishment and maintenance of a well-functioning
      gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea
      associated with GI-tract infections. The oil drops contain a dietary supplement of
      Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10^8 live organisms) by
      mouth daily for 60 days. Daily administration will include 5 drops (5x10^8) of L. reuteri or
      placebo daily for two months. During this time,circulating peripheral blood mononuclear cell
      (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine
      production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be
      completed identifying changes in fecal microbiota. Inflammation in the gut will also be
      assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4
      months observation, for a total of 6 months. There will be 7 required visits, during which,
      we will assess safety and immune system effects.
    

Intervention name(s): L. reuteri; Sunflower Oil
Intervention type(s): Biological; Biological
Intervention description(s): The oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops.; As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops.
Other intervention name(s): BioGaia Drops; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L. reuteri; Cytokines; Toll like receptors; Healthy Adults; Probiotics
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
      lead over time to cervical cancer in women . This study will compare the immune response
      induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the
      manufacturing process.
    


Intervention name(s): Cervarix™
Intervention type(s): Biological
Intervention description(s): GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      Motor Function Measure (MFM) is a validated tool assessing the motor function of
      neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure
      (MFM) training sessions, there is still an inter-individual variability in the items' scoring
      procedure, depending for example on the subjectivity of the therapist.

      Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated
      by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact
      Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger
      on each standardized cases. The reproducibility of these 3 items could be improved with the
      use of a digital tablet and the development of a software allowing to computerize the scoring
      procedure. The second interest is to implement directly the MFM data in the MFM base.

      The hypothesis is that the difference of scoring of these 3 items between digital tablet
      versus paper completion is enough low to use indifferently each completion in patients with a
      neuromuscular disease.
    


Intervention name(s): Items completion
Intervention type(s): Other
Intervention description(s): Patients will complete his Motor Function Measure in the usual way, except items 18, 19 and 22 which will be completed twice: once using conventional material and once on a digital tablet.
The order of completion between conventional material or digital tablet will be allocate randomly.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with neuromuscular disease
A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
Condition: Pharmacokinetics; Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in
      healthy adult male subjects as the dose to be investigated in a thorough QT
      interval/corrected QT interval (QT/QTc) study.
    

Detailed description: 
      A dose escalating study to determine the tolerability and pharmacokinetics (PK) of a
      supra-therapeutic dose of Androxal, up to 250 mg, in healthy adult male subjects as the dose
      to be investigated in a thorough QT interval/corrected QT interval (QT/QTc) study.
    

Intervention name(s): Androxal; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg Androxal, 250 mg Androxal separated by at least 7 days; Placebo, single dose
Other intervention name(s): Enclomiphene citrate; Sugar pill
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment