bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome
Condition: Gut Microbiome
Study type: Interventional

Summary: 
      This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food
      supplement containing a blend of microbial accessible carbohydrates on the diversity of the
      gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory
      biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits,
      and facial skin features will also be evaluated.
    

Detailed description: 
      The human body is home to trillions of microbes, which have been shown to play important
      roles in many aspects of human biology, such as immune function and metabolism. Research in
      this area has primarily focused on the role that dietary factors have in modulating the
      gastrointestinal (GI) microbiota with associated changes in host health parameters.
      Specifically, dietary microbiota accessible carbohydrates (MACs), which include compounds
      such as resistant starches and other dietary fibers that are typically resistant to
      digestion, have been shown to serve as a primary source of energy for the distal gut
      microbiota. Metabolism of MACs by the GI microbiota is important in shaping this microbial
      ecosystem. A Western diet, typically low in MAC content (e.g., dietary fiber), is associated
      with a marked reduction in microbial diversity and depletion of specific types of potentially
      beneficial microbes.

      Until only recently, the bulk of microbiota studies have been conducted in animals, and human
      studies on the GI microbiota have focused primarily on delineating the gut bacterial
      composition and corresponding changes in taxonomy in response to a particular dietary
      intervention (e.g., with prebiotics). Additionally, investigations on dietary factors
      influencing the skin (or scalp) and oral cavity microbiomes have only recently garnered
      attention. Human intervention studies that increase consumption of dietary MACs are needed to
      better understand how changes in the composition and function of these bacteria influence
      host parameters.
    

Intervention name(s): Dietary MACs; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All subjects will have a dose-escalation period when randomized to the active arm that will occur as follows:
Day 1: 1 scoop of product (morning, in the clinic)
Day 2: 1 scoop of product (morning)
Day 3: 2 scoops of product (morning and evening)
Day 4: 2 scoops of product (morning and evening)
Days 5-60: 3 scoops of product (morning, afternoon, evening)
Other Names:
Dietary fiber supplement; No Intervention for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, 2-period crossover study.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Microbiome; Gut; Skin; Fiber; Starch
Epidemiological Study of Post-operative Chronic Pediatric Pain.
Condition: Chronic Pain; Postoperative Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      This study aims to estimate prevalence and determine risk factors for chronic pain at 3
      months post-operative in pediatric surgery.
    

Detailed description: 
      Chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative
      because in the territory of the surgical procedure and does not exist before the operation,
      is common in adults. Its prevalence varies according to the surgeries between 10 and 50% of
      the operated adults. The factors potentially responsible for their occurrence are gradually
      being highlighted in the recent literature, which has made it possible to develop an
      appropriate analgesic management strategy.

      In pediatric surgery, acute pain has long been known and treated as early as possible using
      multimodal analgesic techniques. On the other hand, there are very few studies evaluating
      postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in
      adults.

      This study aims to estimate prevalence and determine risk factors for chronic pain at 3
      months post-operative in pediatric surgery.
    

Intervention name(s): Pain questionnaire
Intervention type(s): Other
Intervention description(s): Pain questionnaire, 3 months after surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children between the ages of 6 and 18, who are scheduled for surgery or video-surgery,
        scheduled or urgent, in the pediatric surgery department of the Bordeaux University
        Hospital. The main interventions concerned by this protocol are:

          -  Thoracotomies and thoracoscopies

          -  Cholécysctectomie

          -  Laparotomy and appendectomy

          -  Inguinal surgery (inguinal hernia and testicular ectopia)

          -  Orthopedic surgery

          -  Urologic surgery (hypospadias, circumcision and upper urinary tract surgery)
      
Keywords: Pediatrics
Green Vegetables and Women's Health
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups
      fruits and vegetables daily. However, at current intake levels, fruit consumption will have
      to improve by more than 100% and vegetable intake by 50% to meet this recommendation.
      Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are
      not considered. It is possible that improved fruit and vegetable intake will have beneficial
      health effects. For example, higher intakes of fruits and vegetables, and particularly
      cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated
      with lower rates of many degenerative diseases, including some cancers, yet this group of
      vegetables may continue to be under-consumed due to their strong flavors. A supplement made
      from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI)
      contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism
      in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the
      urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study,
      the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM
      whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy
      premenopausal women will be compared over an eight-week period. The investigators hypothesize
      that treatment with daily supplements will increase the 2:16 ratio as compared to daily
      consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting
      reduced breast cancer risk.

      In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin,
      lutein and lycopene with dietary carotenoid intake as measured by a food frequency
      questionnaire and body composition will be evaluated in healthy premenopausal women.
      Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues
      and their concentration in human blood reflects dietary intake of carotenoid-rich foods.
      Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual
      status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations
      may serve as a functional marker for chronic disease risk associated with excess body fat.
    


Intervention name(s): Broccoli and Brussels Sprouts; Cruciferous Complete; Placebo
Intervention type(s): Other; Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Phase I Safety and Immunogenicity Preventative Vaccine Trial Based on Recombinant Tat Protein
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study is directed at evaluating the safety profile (as a primary end-point) and
      the immunogenicity (as a secondary end-point) of the recombinant HIV-1 Tat vaccine in
      healthy, immunologically competent adult subjects without identifiable risk of HIV-1
      infection.
    

Detailed description: 
      The development of a vaccine against HIV/AIDS has been primary focused on the structural
      proteins (Env, Gag) of HIV-1 with the aim of inducing sterilizing immunity by blocking virus
      entry. Alternative approaches are focused on new vaccine strategies aimed at modifying the
      virus-host dynamic favouring the establishment of a long-term non-progressing disease status.
      Such strategies target regulatory proteins that are the first to be expressed after infection
      and are essential for viral replication, infectivity and pathogenesis. Thus, this approach
      may be effective for both preventive and therapeutic vaccination strategies.

      Being a very early viral regulatory protein necessary for viral gene expression, cell-to-cell
      virus transmission and disease progression, Tat represents a key target protein for the host
      immune response and an optimal candidate for such a vaccination strategy.

      Preclinical studies demonstrated that vaccination with a biologically active Tat protein is
      safe, elicits a broad and specific immune response and induces a long-term protection against
      infection. Cross-sectional and longitudinal studies in natural infection suggest that the
      presence of an anti-Tat humoral immune response correlates with asymptomatic infection and
      with a slower disease progression while the presence of CD8+ T cell responses to Tat
      correlate with early virus control both in humans and monkeys. Since the immunogenic regions
      of Tat are well conserved among the HIV-1 M group, a vaccine based on Tat may be used in
      different geographic areas of the world.

      The subjects were stratified in two Arms according to the administration route to receive 5
      intradermal or subcutaneous immunizations at 4 weeks intervals.
    

Intervention name(s): Biologically active recombinant Tat protein
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV; Tat protein; Preventative vaccine; Healthy volunteers; HIV-1/2 uninfected; HIV Preventive Vaccine
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double blind placebo controlled study of one hundred and four subjects which will
      be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone
      and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups.
      Each of the one hundred and four subjects will undergo baseline examination to include a
      sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and
      four subjects will then be randomly placed in one of the four groups.
    

Detailed description: 
      Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug
      (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone
      works better than either product alone. Twenty-six subjects will be randomized to a two week
      ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week
      ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week
      ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized
      to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active
      product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of
      ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four
      subjects and each subject will give a second blood sample for analysis. On the morning of the
      14th day of ingestion the final sleep questionnaires will be completed.
    

Intervention name(s): Trazodone; Sentra PM; Sentra PM and Trazodone (CoPack Kit Trazamine); Placebo trazodone and placebo Sentra PM
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): active trazodone and sentra pm-like placebo; Active Sentra PM and trazodone-like placebo; A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.; Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
Condition: Knee Osteoarthritis; Fibromyalgia
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether creatine associated or not to exercise
      training can improve physical performance in patients with knee osteoarthritis and
      fibromyalgia.
    


Intervention name(s): Creatine supplementation; Dextrose supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Power-velocity Muscle Characteristics During Ageing
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      The purpose of this project is to investigate the age-related differences in force-velocity
      muscle characteristics during isolated knee extensions variable in speed and load, during
      cyclic movements on a usual and recumbent bike variable in speed and velocity development and
      a functional test battery with healthy participants aged between 20-80 years.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        young (20-40y) middle-aged (40-60y) old (60-80y)
A Study To Evaluate A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Healthy Subjects Aged 11-17 Years Received Either Menacwy-tt Vaccine (Nimenrix(Registered)) Or Mencevax Acwy(Registered).
Condition: Meningococcal ACWY Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity, reactogenicity and safety of a booster dose of
      MenACWY-TT vaccine administered 10 years after healthy subjects aged 11-17 years received
      either MenACWY-TT vaccine (Nimenrix) or Mencevax ACWY
    


Intervention name(s): MenACWY-TT
Intervention type(s): Biological
Intervention description(s): Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Prebiotic FOS on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease
    

Detailed description: 
      To demonstrate that FOS increases counts of Faecalibacterium prausnitzii in faecal samples
      from Crohn's disease patients
    

Intervention name(s): FOS; Adalimumab
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years
      of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency,
      safety, and tolerability of the vaccine, and also look at the subjects' immune response to
      the vaccine.
    

Detailed description: 
      Serology for B5091008 was delayed due to discussions with the FDA on statistical analysis as
      well as delays attributed to the COVID pandemic.
    

Intervention name(s): Clostridium difficile vaccine; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Toxoid based Clostridium difficile vaccine; Normal saline solution
Other intervention name(s): 0.9% sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clostridium Difficile; vaccine
Fibromyalgia in Rheumatiod and Psoriatic Patients
Condition: Fibromyalgia, Secondary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      the study based on investigate for fibromyalgia among rheumatiod arthritis patient and
      psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices
      ....and its relation to serum Vitamin D level in those patients
    


Intervention name(s): Serum vitaminDlevel
Intervention type(s): Diagnostic Test
Intervention description(s): Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Those patient who diagnosed as rheumatiod arthritis and psoriatic arthritis..assess serum
        vitamin D level
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The design of this study will enable an extensive evaluation of safety, tolerability, and
      PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease
    


Intervention name(s): APL180; APL180; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Coronary heart disease; APL180
Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2)
Condition: Intestinal Failure
MeSH terms: Intestinal Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aim of this study is to determine whether oral citrulline administration
      enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism
      will be assessed using an intravenous infusion of stable isotope labeled leucine. The
      investigators hypothesize that citrulline supplementation will decrease leucine oxidation
      without altering proteolysis, and consequently stimulate protein synthesis.
    


Intervention name(s): Citrulline and placebo
Intervention type(s): Drug
Intervention description(s): After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nutrition, protein metabolism, stable isotopes, mass spectrometry, intestinal failure
Direct Pulp Capping in Primary Molars
Condition: Direct Pulp Capping
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide
      (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and
      evaluate overall success rate of direct pulp capping in primary molars.
    

Detailed description: 
      After informed consent, baseline clinical and radiographic assessment will be obtained and
      recorded in patient examination sheet.

      Participants who met the inclusion criteria were randomly allocated to two groups (n =
      26/group, N = 52 in total) according to the capping martials using the envelope randomization
      method.

      2 study groups according to capping material that will be used (Dycal or MTA) and each group
      will be divided to 2 subgroups according to site of exposure axial or pulpal.

      All patients were recalled and their treated molars were evaluated clinically and
      radiographically at 3months, 6months, 9months ,12months follow up periods.
    

Intervention name(s): Mineral trioxide aggregate (MTA); Hard setting Calcium Hydroxide (Dycal)
Intervention type(s): Other; Other
Intervention description(s): Materials for Vital Pulp Capping; Materials for Vital Pulp Capping
Other intervention name(s): BIO MTA; CERKAMED, Poland; Dycal; Promedica Urbical, Germany
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet. Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method. All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.
2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: primary dentition; MTA; Dycal; bioactive material; deciduous dentition; Direct pulp capping