bioihbjkbjnl/mcl2 huggingface dataset:
Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and
      treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck
      tumors.
    

Detailed description: 
      The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus
      salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis
      (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can
      effectively prevent and treat radiation-induced oral mucositis and whether it will cause
      adverse events in patients undergoing radiotherapy.

      Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge
      three times daily from the beginning to the end of RT. After using the lozenges, the patients
      should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.

      Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral
      probiotic are beneficial in preventing and treating oral mucositis in patients undergoing
      radiotherapy.
    

Intervention name(s): Streptococcus salivarius K12; Streptococcus salivarius K12 simulants
Intervention type(s): Drug; Drug
Intervention description(s): The patients in intervention group were treated with Streptococcus salivarius K12 lozenges three times a day after gargling from the first day of radiotherapy up to 1 week after the end of treatment. Streptococcus salivarius K12 is dissolved in the mouth and then swallowed.; Patients in control group were treated with Streptococcus salivarius K12 simulants, and its use method and use time are the same as intervention group.
Other intervention name(s): OralBiotic BLIS K12 (NOW Foods, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: head and neck squamous cell carcinoma; nasopharyngeal carcinoma; oral mucositis; Streptococcus salivarius K12
Family Routines - Healthy Families
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the proposed study, Family Routines - Healthy Families, is to examine the
      feasibility and acceptability of a parenting/family routine intervention program for parents
      of young children, ages 2-5, with type 1 diabetes.
    

Detailed description: 
      The intervention in Family Routines - Healthy Families contains an established and effective
      parent skills training curriculum called "The Incredible Years," uniquely integrated with a
      newly developed family evening routine component e.g., family dinner time and evening
      routine, to promote improved metabolic control. The investigator will assess outcomes during
      and at one week post intervention. Outcome measures will include family routine, specifically
      the time between the dinner and bedtime glucose check, parent bedtime decision making, and
      child overnight glucose control. In addition, parental quality of life and receptiveness to
      the intervention will be assessed.
    

Intervention name(s): Parenting classes
Intervention type(s): Behavioral
Intervention description(s): Parenting Classes:The Incredible Years curriculum
Intervention model: Single Group Assignment
Intervention model description: This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes
Mask Usage and Physical Performance During COVID-19 Pandemic in Geriatrics
Condition: Exercise Capacity; Geriatric; Mask
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      In the COVID-19 pandemic, the use of masks in daily life has become an important issue. The
      most important measure taken to prevent contagion is the use of masks. The aim of the study
      is to determine the effects of surgical masks used in every moment of life on physical
      performance in elderly individuals.
    

Detailed description: 
      Physical performance measurements were carried out by a physiotherapist using the Senior
      Fitness Test (SFT). Participants were informed about the procedure of the test. All
      participants performed two evaluation sessions by the SFT with and without using a surgical
      mask. The participants were randomly selected to perform the test whether with or without the
      surgical mask at first. The sessions were held at least 24 hours apart to prevent fatigue.
    

Intervention name(s): Senior Fitness Test
Intervention type(s): Diagnostic Test
Intervention description(s): Senior Fitness Test, simple and easy to use, was used to evaluate physical performance.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals over the age of 65
      
Keywords: Mask Usage; Geriatrics; Exercise Capacity; Physical Performance; Senior Fitness Test
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      The investigators wish to study the effect of retaining potassium. The participants have
      essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The
      participants will ingest tablets for 28 days before being examined. We will perform a 24
      hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we
      also examine the patient using a SphygmoCor.
    

Detailed description: 
      Purpose of the study is to examine the effect of amiloride and spironolactone on

        1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),

        2. Pulsewave velocity, augmentation index central bloodpressure,

        3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and

        4. Ambulatory bloodpressure
    

Intervention name(s): Spironolactone; Placebo; Amiloride
Intervention type(s): Drug; Other; Drug
Intervention description(s): 1 tablet twice a day for 28 days; 1 tablet twice a day for 28 days; 1 tablet twice a day for 28 days
Intervention MeSH terms: Amiloride; Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Blood pressure, PWV, HRV, PWV, potassium
Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations
Condition: Measles; Mumps; Rubella
MeSH terms: Measles; Rubella; Mumps
Study type: Interventional
Phase: Phase 4

Summary: 
      Whether the lower immunogenicity of the mumps component obtained in clinical studies with the
      MMR in Brazil, due to the multidose presentation. Investigations were made on factors that
      could interfere with immunogenicity of mumps component, as the kits used for the immunoassay
      method, and potency of the vaccine, but no explanation was found. This study aimed to
      investigate the hypothesis that the lower immunogenicity of the mumps component of the MMR
      Bio-Manguinhos vaccine, is due to the multidose presentation.

      The Main objetctive is evaluate the immunogenicity of MMR after one dose in children 12 to 23
      months of life, comparing the performances multidose vial (10 doses per vial of vaccine
      produced in Bio-Manguinhos/Fiocruz through technology transfer from GlaxoSmithKline
      Laboratory - GSK) and single dose vial (1 dose per vial of vaccine produced by GSK).
    

Detailed description: 
      Study Design

      This is a clinical trial Phase IV, randomized, single-blind, with two arms:

        -  MMR (TV) combined measles, mumps and rubella vaccine produced in Bio-Manguinhos, applied
           to healthy children 12 to 23 months. Multidose presentation, only from one batch.

        -  MMR (GSK-TV), produced by GlaxoSmithKline, the same age. Monodose presentation, only
           from one batch.

      Locations of the study

        -  CMS Heitor Beltrão - Tijuca

        -  CMS Milton Fontess Magarão - Engenho de Dentro

        -  CMS Waldyr Franco - Bangu
    

Intervention name(s): MMR Vaccine
Intervention type(s): Biological
Intervention description(s): Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Measles; Mumps; Rubella
A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients
Condition: Type 2 Diabetes; Obesity
Study type: Interventional

Summary: 
      The objectives of this feasibility study are to evaluate the safety and functionality of the
      TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on
      trends of HbA1c, blood glucose and body weight changes.
    

Detailed description: 
      This is a prospective multi center, non-randomized, treatment only clinical trial with up to
      thirty (30) obese with type 2 diabetes subjects. The study is designed to demonstrate that
      use of the rechargeable TANTALUS II IPG is safe and that it functions as designed.

      Subjects will undergo an approximately two week baseline screening process. Eligible subjects
      will undergo device implantation. This will be followed by therapy initiation approximately
      one week after implantation. The device will then be activated to automatically deliver
      gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in
      for a safety monitoring period of 18 months following the therapy period.
    

Intervention name(s): rechargeable TANTALUS II
Intervention type(s): Device
Intervention description(s): Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obese,; Diabetes
Macular Pigment and Glare Disability
Condition: Vision, Entoptic
Study type: Interventional

Summary: 
      The purpose of this study is:

      I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50
      subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.

      II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin
      supplementation) will result in significantly improved visual performance under disability
      glare conditions.

      III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will
      result in significantly reduced photostress recovery times.

      IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will
      result in improved contrast enhancement.
    

Detailed description: 
      The following measurements will be taken, before and after supplementation with lutein and
      zeaxanthin:

      Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress
      recovery times chromatic contrast sensitivity.
    

Intervention name(s): 12 mg Lutein + Zeaxanthin; Visually identical placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year; Visually identical placebo, taken once daily for one year
Other intervention name(s): FloraGlo lutein + OptiSharp zeaxanthin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms: nutritional supplement vs. placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: macular pigment; glare disability; lutein; photostress; chromatic contrast sensitivity
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Condition: Liver Fibrosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar
      to metavir F2/F3, Ishak 2/3/4) are randomly assigned in a 1:1 ratio. One arm is entecavir
      alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus
      pegylated interferon (peg-IFN) for 1 year, entecavir for another additional 0.5 year.
      Patients will be assessed at baseline, at every six months for blood count, liver function
      test, HBVDNA, AFP, prothrombin time, thyroid function, liver ultrasonography, and Fibroscan.
      The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5
      years after initial therapy.
    


Intervention name(s): entecavir; Peg-IFN
Intervention type(s): Drug; Drug
Intervention description(s): antiviral therapy; antiviral and antifibrosis therapy
Other intervention name(s): entecavir dispersible tablets; Pegasys
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; Liver fibrosis; Regression; Efficacy
Repeated Controlled Human Hookworm Infection
Condition: Necator Americanus Infection
MeSH terms: Infections; Communicable Diseases; Hookworm Infections; Ancylostomiasis
Study type: Interventional

Summary: 
      Twenty-four healthy hookworm-naive volunteers will be exposed to 50 L3 Necator americanus
      larvae for a maximum of three times.
    

Detailed description: 
      Twenty-four volunteers will be allocated equally into three groups (i.e. group A, B, C).
      Group A, B, and C will have one, two, and three infections respectively. Every infection will
      be performed with 50 L3 Necator americanus larvae. Group A will receive infection at week 4
      only. Group B will be infected at week 2 and week 4. Group C will be infected at week 0, 2
      and 4. To maintain blinding, group A and B will receive mock infections with water at week 0
      and week 0 and 2 respectively. The interval between each CHHI is 2 weeks. Before every
      infection, the safety will be assessed by a review of adverse events data with a local safety
      monitor.

      Sixteen weeks after the last infection (week 20), all volunteers will be offered treatment
      with a 3-day regimen of albendazole to abrogate infection. Volunteers with average egg counts
      >250 eggs per gram will be asked if they would be willing to keep their infection for a
      maximum of two years (chronic donors). No more than four volunteers will be selected to be
      chronic donors. Six months after the last infection (or after the last donation for the
      chronic donors) volunteers will undergo their last visit.
    

Intervention name(s): 50 Necator americanus L3 larvae; 100 Necator americanus L3 larvae; 150 Necator americanus L3 larvae
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1x50 Necator americanus L3 larvae; 2x50 Necator americanus L3 larvae; 3x50 Necator americanus L3 larvae
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo-controlled, dose-escalation trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: hookworm; controlled human infection model
Safety, Tolerability, and Pharmacokinetics of Single Doses of APN1125 in Healthy Normal Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      APN1125 when administered as single doses to healthy adult subjects.
    

Detailed description: 
      The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect
      of food upon pharmacokinetics of a single dose of APN1125 in healthy adult volunteers.
    

Intervention name(s): APN1125; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): APN1125 orally at ascending doses; Matching Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity
Condition: Pediatric obésity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effect of realizing an exercise right before
      or right after a meal of on energy intake, appetite feelings and food reward in adolescents
      with obesity.
    

Detailed description: 
      The present study will compare the nutritional response to the realisation of an acute
      exercise right before or right after lunch in adolescents with obesity. 18 adolescents with
      obesity will be asked to randomly complete three experimental sessions: i) one control
      session (rest); ii) one session with an acute exercise realized right before lunch; iii) one
      session with an acute exercise realized right after lunch. Their ad libitum energy intake
      will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed
      at regular intervals and their food reward in response to the lunch will also be assessed.
    

Intervention name(s): CON; EX-MEAL; MEAL-EX
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; Condition with an acute exercise set right before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right before ad ad libitum lunch meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.; . condition with an acute exercise set right after lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right after an ad libitul buffet meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
Other intervention name(s): control condition without exercise / rest condition; Condition with an acute exercise set right before lunch; Condition with an acute exercise set right after lunch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appetite control; obesity; adolescents; exercise timing
The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine the type and degree of inflammatory parameters in
      peripheral blood of asthma patients compared to analysis of induced sputum.

      115 asthma patients visiting the outpatient clinic of the University Medical Center will be
      included. Blood samples are obtained and sputum induction is performed.

      Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by
      changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained
      from induced sputum
    

Detailed description: 
      Asthma is a heterogeneous disease and can be classified by level of control, disease severity
      and the inflammatory phenotype. However, these different domains overlap and classification
      of patients according to these characteristics has caused confusion in the literature.
      Concerning the inflammatory phenotype international consensus is present regarding the
      diagnostic power of induced sputum. This methodology is, however, difficult to implement in
      general practice. Local inflammation is associated with a complex combination of systemic
      pro- and anti-inflammatory signals that induce changes in responsive leukocytes. These
      changes can be used as read-out for type and degree of inflammatory disease. Hypothesis: This
      will facilitate the diagnosis of inflammatory phenotypes in asthma, as general application of
      induced sputum is not feasible.

      Goals

        1. To investigate whether analysis of antibodies directed against active Beta-1 and
           Beta-2-integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the
           diagnosis of eosinophilic asthma as compared to analysis of sputum eosinophilia.

        2. To evaluate the applicability of antibodies against active β1/β2-integrins and FcγRII in
           symptomatic asthma patients as a test to diagnose eosinophilic and neutrophilic asthma.

        3. To determine specific protein profiles in serum of asthma patients by proteomics for the
           development of a diagnostic test.

        4. To evaluate the effectiveness of this new test in comparison with FeNO.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthma patients between the age of 18 and 75, visiting outpatient respiratory clinic of the
        University Medical Centre in Utrecht, The Neterlands.
      
Biospecimen description: 
      Leukocytes in peripheral blood, serum samples for protein profiling and sputum samples.
    
Keywords: Asthma; Inflammation; Phenotype; Sputum