bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
Condition: Infant; Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to
      allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as
      Prevenar®.

      Primary Objective:

      To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers
      at 11-18 months of age.

      Secondary Objectives:

        -  To describe the incidence rate of severe fever within four days post-vaccination

        -  To describe the antibody responses to all antigens in a subgroup of subjects at baseline
           and post-vaccination.
    


Intervention name(s): DT5aP-IPV-Hib 5-component Pertussis vaccine; DT3aP-HBs-IPV
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): Pediacel™; Infanrix® hexa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus influenzae type b; Hepatitis B
Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This single center, comparative design study will be used to investigate the efficacy of an
      experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity
      (DH) after short term use compared with a standard fluoride dentifrice.
    

Detailed description: 
      This will be a single center, three day, randomized, examiner blind, two treatment arm,
      parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected
      test teeth), controlled study, in participants with at least two sensitive teeth that meet
      all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at
      baseline (pre-treatment), post-treatment and after 3 days twice daily brushing.
    

Intervention name(s): stannous fluoride; sodium monofluorophosphate
Intervention type(s): Drug; Drug
Intervention description(s): 0.454% w/w stannous fluoride containing 1100ppm of fluoride; 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of a Specific Spice on Energy Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to examine whether a specific spice is capable of affecting
      energy metabolism.

      Since chili and other spices have been shown to increase energy expenditure and in some cases
      also affect energy intake/appetite compared to placebo, the investigators expect that the
      specific spice may actually increase energy expenditure and potentially also decrease
      appetite - although not to a large degree.
    

Detailed description: 
      Several pungent food ingredients, such as chili, and also other bioactive food ingredients,
      e.g. green tea, have been shown to be able to increase energy expenditure and fat oxidation
      during the hours following a meal containing the bioactive ingredient. Furthermore, we will
      also look at the subjects own feelings of appetite and thereby examine whether the appetite
      is affected by the spicy food, since a few studies have suggested an effect of bioactive
      ingredients on appetite/energy intake. We expect to see some small effects on these
      parameters.
    

Intervention name(s): Mustard (dijon); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The specific spice added to a brunch meal; Placebo added to a brunch meal
Intervention MeSH terms: Mechlorethamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Thermogenesis; Meal-induced thermogenesis; Energy expenditure; Fat oxidation; Carbohydrate oxidation; Bioactive ingredient; Spice
STHLM3 - Prostate Cancer Diagnostic Trial
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for
      prostate cancer can substantially reduce the proportion of men referred to biopsy whilst
      maintaining sensitivity for aggressive prostate cancer
    


Intervention name(s): STHLM3
Intervention type(s): Diagnostic Test
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral
      administration.
    

Detailed description: 
      This is a single center, double-blind (neither the researchers nor the participants know what
      treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend
      treatment [with no drug in it] that is compared in a clinical trial with a drug to test if
      the drug has a real effect), randomized (study medication assigned to participants by
      chance), single-ascending dose study. The study consists of a screening phase, an in-clinic
      treatment phase, and a follow-up phase. The study duration for each subject will be
      approximately 5 weeks from screening (Day -28 to Day -3), in-clinic period (Day -2 to Day 4)
      to follow up visit (Day 8). Participants will receive a single oral dose of JNJ-42847922 or
      placebo in 3 cohorts. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42847922, 5 mg; JNJ-42847922, 20 mg; JNJ-42847922, 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.; Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.; Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.; Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42847922
Effects of Chronic Energy Drink Consumption on Cardiometabolic Endpoints
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Many people use energy drinks (EDs) regularly, but the overall health concerns are still
      unknown. There are many energy drink products that contain a mixture of caffeine and other
      energy-boosting ingredients and supplements which can affect parameters related to the heart,
      blood pressure and blood glucose. Several previous studies have shown that energy drinks may
      affect heart rhythm and blood pressure significantly. As energy drinks are sugar-sweetened
      beverages, long-term use may also affect the body's metabolism, including cholesterol, blood
      sugars, and weight.

      The purpose of this study is to learn if drinking energy drinks everyday may affect a
      person's cardiometabolic health.
    

Detailed description: 
      The popularity of energy drinks (EDs) have increased over the last few decades due to their
      purported benefits as mental and physical performance enhancements. While caffeine is a major
      ingredient in most EDs (ranging from 80 mg to 500 mg per drink), they may also contain
      various supplements, such as guarana, taurine, ginseng, B vitamins, gluconolactone, yohimbe,
      carnitine, and bitter orange, as well as high amount of sugar (ranging from 25-50 grams). The
      United States Food and Drug Administration (FDA) has cited that a daily intake of 400 mg
      caffeine (approximately 4-5 cups of coffee) in adults is generally safe and not associated
      with dangerous, negative effects. The Substance Abuse and Mental Health Services
      Administration reported a doubling of emergency department visits involving EDs from 10,068
      visits in 2007 to 20,783 visits in 2011. Commonly reported adverse reactions include
      insomnia, nervousness, headache, tachycardia, and seizures. Currently, the health effects of
      long-term ED use remain unknown.

      This study is a proof-of-concept, prospective trial that aims to evaluate the effects of
      chronic ED consumption on cardiometabolic parameters in a healthy population. Subjects will
      consume two cans (16 oz.) of an energy drink daily for 4 weeks. The study will assess any
      changes in blood pressure (BP), electrocardiographic (ECG) parameters, blood glucose,
      cholesterol, weight, body mass index (BMI), and body fat composition before and after
      consuming EDs for 4 weeks.
    

Intervention name(s): Commercially-Available Energy Drink
Intervention type(s): Dietary Supplement
Intervention description(s): Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Energy Drink; Blood Pressure; Arrhythmia
The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery
Condition: Ecchymosis
MeSH terms: Ecchymosis
Study type: Interventional

Summary: 
      Arnica montana is a homeopathic drug that is made in accordance with the official methods of
      the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic
      surgeons throughout the world, although there is no study proving its benefit after
      rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the
      amount of bruising and the intensity of the bruising after surgery. Photographs of the
      subject's face will be taken and used to analyze bruising after rhinoplasty surgery in
      subjects who receive Arnica montana and compare them to photographs of subjects who take a
      placebo (sugar pill).
    

Detailed description: 
      Subjects will receive either oral arnica montana or placebo without any identifying labels or
      markers on the drugs.

      During the post-operative period, the patients will be seen back in surgery clinic on
      post-operative days 3, 7 and 10. During the first two visits, the subject will receive
      routine post-operative care with no difference from patients not enrolled in the study. This
      includes routine sets of photographs. The participant will then return for a third
      post-operative visit lasting under ten minutes only for study photos using the left and right
      "three-quarters" view. Again, the subject will hold a measurement marker so length
      measurements can be made, and this marker will be held under the ear to not interfere with
      the routine cosmetic analysis of the photographs. The digital photographs will be used to
      analyze the bruising for the study. The ratio was calculated by dividing the number of pixels
      of bruised area over number of pixels of standard area.
    

Intervention name(s): Arnica montana; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take twelve pills by mouth three times a day over four days.; Subjects will take twelve pills by mouth three times a day over four days.
Other intervention name(s): Sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ecchymosis; bruising; rhinoplasty; nose job; arnica; arnica montana
Stress Urinary Incontinence of Sporting Teenager
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Physical activity and sport are beneficial to the cardiovascular system, the musculoskeletal
      system and many chronic pathologies. The High Authority of Health (HAS) recommends a regular
      practice. However, depending on the discipline and level of practice, it may be responsible
      for traumatic injuries, degenerative musculoskeletal injuries, overtraining, eating disorders
      or cardiovascular events. It also promotes urinary stress incontinence, by increasing
      intra-abdominal pressure in some situations.

      The prevalence of urinary leakage in the athlete depends of the practiced physical activity.
      A classification of the sports activities can be carried out according to the risk of
      increased pressures on the pelvic floor:

        -  high-risk sports: trampoline (10.17), acrobatic gymnastics, aerobics, athletics (jumping
           hedges, heights, triple jump), horse riding, basketball, volleyball, handball, martial
           arts;

        -  moderate-risk sports: tennis, skiing ...

        -  low risk sports: walking, swimming, cycling, rollerblading, golf ... In sports, urinary
           incontinence also depends of the practiced movements (jumps, abdominal exercises ...),
           and the occurence of sports activity. This disorder has even become one of the concerns
           of federal sports authority (INSEP).

      However, there is no data regarding stress incontinence of sports teenagers found n the
      literature on
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sporting Young Girl
      
Keywords: adolescent sports
Exercise and Brain Stimulation for Post-stroke Depression
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This project will assess the effects of aerobic exercise training (AET), repetitive
      transcranial magnetic stimulation (rTMS) or their combination on depressive severity as well
      as locomotor function in persons with post-stroke depression (PSD). Both AET and rTMS are
      established stand-alone treatments for non-stroke related depression, though neither has been
      adequately studied post-stroke. Furthermore, substantive research indicates that AET improves
      post-stroke locomotor function, thus offering a novel approach for treating PSD as well as an
      established vehicle to study the effects of PSD on response to rehabilitation.

      The purpose of this project is to determine the impact of AET, rTMS and their combination
      (AET+rTMS) treatments on post-stroke depressive symptoms and locomotor function so as to
      guide the development of a future clinical trial. A total of 40 depressed post-stroke
      subjects will be randomly assigned to one of four groups 1) AET; 2) rTMS; 3) combined AET and
      rTMS (AET+rTMS) or 4) control (sham rTMS) group (n=10 per condition; equally distributed with
      mild and moderate MDD). Further, an additional 10 non-depressed post-stroke subjects will
      complete 8 weeks of AET so as to allow us to determine the effects of PSD on response to
      training (Aim 2). Training (AET, rTMS and AET+rTMS) will take place over an 8-week period,
      three times per week on non-consecutive days. Measures of depression (HRSD17) as well as
      self-selected walking speed (SSWS) will be performed prior to the initial treatment session
      of each week as well as 8 weeks following cessation of treatment. Additional measures of
      locomotor function (walking endurance and amount of daily community stepping) will be
      assessed prior to training (pre), following 4 weeks of training (mid), upon completion of 8
      weeks of training (post) as well as 8 weeks following cessation of training (follow-up),
      allowing determination of the efficacy (and persistence) of training on these outcomes.
    


Intervention name(s): Aerobic exercise; Repetitive transcranial magnetic stimulation
Intervention type(s): Behavioral; Other
Intervention description(s): treadmill aerobic exercise; 3 sessions per week, 40 minutes per session; Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
Other intervention name(s): rTMS
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo
      in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety:
      There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus
      and both will be well tolerated.
    


Intervention name(s): Acetaminophen 1000mg
Intervention type(s): Drug
Intervention description(s): Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
Other intervention name(s): Tylenol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Delayed onset muscle soreness; DOMS
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an active control, randomized study to investigate the safety, tolerability and PK of
      repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM)
      (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy
      adult participants.
    


Intervention name(s): Cabotegravir sodium (Oral Lead In); Cabotegravir 400 mg/mL; Cabotegravir 200 mg/mL; Topical non-steroidal anti-inflammatory drug; Topical steroid; Placebo creams/gels; Recombinant human hyaluronidase PH20 (rHuPH20)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): CAB will be available as 30 mg tablets for oral administration.; CAB 400 mg/mL will be available for administration by IM injection or SC Injection.; CAB 200 mg/mL will be available for administration by IM injection or SC Injection.; Non-steroidal anti-inflammatory drug will be available for topical application; Steroid will be available for topical application; Placebo creams/gels will be available for topical application; rHuPH20 will be available for administration by SC Injection
Intervention MeSH terms: Cabotegravir; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants will receive repeat doses of long-acting CAB 400 mg/mL or CAB 200 mg/mL at four-weekly (Q4W) interval in Part 1 and at 12-weekly (Q12W) interval in Part 2.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cabotegravir; Long-Acting Injection; Pharmacokinetics; Safety; Tolerability
Skin Maturation in Premature Infants
Condition: Premature Birth of Newborn
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The skin barrier lipids will be lower in premature infants than in full term infants and will
      become normal over 3-4 months after birth. The higher skin pH in premature infants will be
      related to an altered lipid composition which will change as the skin acidifies.
    

Detailed description: 
      Premature infants have a poor epidermal barrier with few cornified layers, putting them at
      significant risk for increased permeability to external agents, skin compromise, high water
      loss and infection. While the skin develops rapidly after birth upon exposure to the dry
      environment, the ontogeny of the skin maturation and the time to a fully functional and
      protective stratum corneum (SC) barrier is largely unknown. The impact of a poor skin barrier
      on nosocomial infections and the morbidity associated with prematurity is not well defined.
      The purpose is to evaluate skin barrier maturation in premature infants compared to full term
      infants. The skin barrier lipids will be lower in premature infants than in full term infants
      and will become normal over 3-4 months after birth. The higher skin surface acidity in
      premature infants will be related to an altered lipid composition which will change as the
      skin acidifies.

      Full thickness skin samples will be collected from premature and full term infants during the
      time of medically necessary surgical procedures for genomic/transcriptomics analyses. The
      gene profiles will be compared to the corresponding biomarker profiles to determine the
      relationship between genes and gene expression products, i.e., biomarkers. The
      genomic/transcriptomics, biomarker, instrumental and clinical assessments will be examined
      for relationships and compared between premature and full term cohorts.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants and parents of infants who are patients at Cincinnati Children's Hospital Medical
        Center Neonatal Intensive Care Units including premature and full-term infants
      
Biospecimen description: 
      Full thickness tissue samples are to be collected from subjects who undergo surgery as part
      of their care and for whom a sample of tissue can be collected.
    
Keywords: premature infant; neonate; skin maturation; stratum corneum maturation; ontogeny of neonatal skin maturation; sunflower oil; effect of Vitamin B3 on premature skin maturation; skin acidity; stratum corneum barrier integrity; stratum corneum lipid composition; stratum corneum biomarkers; stratum corneum cytokines; stratum corneum structural proteins