bioihbjkbjnl/mcl2 huggingface dataset:
Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study
Condition: Prevention of Hyperglycaemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within
      the body and eventually lead to the development of type 2 diabetes. Previous research by this
      group has shown that an apple polyphenol extract reduced hyperglycaemia following a
      high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of
      the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory
      polypeptide concentrations following a mixed carbohydrate test meal.
    

Detailed description: 
      Introduction:

      Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins,
      oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a
      diet that will allow more gradual rises in blood glucose levels after meals. Fruit
      polyphenols may help to limit the glucose excursion following a high carbohydrate meal.
      Previous research by this research group has demonstrated that 1200 mg of apple polyphenols
      (Appl'In™) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma
      glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal
      enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport
      activity. The literature also suggests that foods rich in polyphenols exert beneficial
      effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and
      vascular function.

      Study design:

      A randomised, controlled, double-blind, cross-over study will be conducted. Four matched test
      drinks will be consumed in random order on separate study visits immediately before a
      mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple
      polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP,
      GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four
      hour urine samples will be collected for analysis of urinary polyphenol metabolites and
      glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated
      via addition of 1.5 g paracetamol into the test drink.
    

Intervention name(s): Apple polyphenols; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Drinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Polyphenol; Apple; Fruit; Hyperglycaemia; Metabolic
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence as well as rate and extent of absorption of
      vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported
      vildagliptin tablet in Chinese healthy volunteers.

      This trial is not recruiting patients in the United States,
    


Intervention name(s): Vildagliptin (LAF237)
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; safety; LAF237; vildagliptin; Chinese; healthy subjects
Effect of Lyophilized Cornus Mas L. on Anthropometric and Biochemical Parameters in Metabolic Associated Fatty Liver Disease Patients
Condition: Fatty Liver Disease; Obesity; Liver Fat
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of lyophilized Cornus mas L. fruit powder
      with/without diet therapy on biochemical parameters and anthropometric measurements in
      patients with metabolic associated fatty liver disease.
    

Detailed description: 
      The main purpose of this study is to determine the efficacy of the lyophilized dried powder
      form of cornelian cherry (Cornus mas L.) grown in our country on nutritional status and
      biochemical parameters in patients with metabolic-associated fatty liver disease.

      Sub-objectives of the study;

        -  Determination of the effect of cornelian cherry on blood glucose, and lipid parameters,
           and liver enzymes.

        -  Determination of anti-inflammatory, antidiabetic, and antioxidant effects of cornelian
           cherry in metabolic fatty liver patients.

        -  Determination of the effect of cornelian cherry on anthropometric measurements.

      The aim of this study is to compare the anthropometric measurements and biomarkers of
      patients with metabolic-associated fatty liver disease as a result of the consumption of
      powdered cornelian cherry (Cornus mas L.) that has been freeze-dried at -55 degrees with a
      Lyophilizer device for 8 weeks.
    

Intervention name(s): Diet; Cornus mas L.(Cornelian Cherry)
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Patient in "Diet Group" and "Cornus mas L. and Diet Group" will be given a personalized diet and be followed up by a dietician.; Patients in "Cornus mas L. Group" and "Cornus mas L. and Diet Group" will receive 30 g/day freeze-dried Cornus mas L. fruit powder supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic associated fatty liver disease; Cornus mas L.; diet treatment; nutrition therapy; anthropometric measurements
The Effect of Daily Exercise Program on Bone Mineral Density and Cortisol Level in Preterm Infants
Condition: Osteopenia of Prematurity
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      ABSTRACT Objective: This randomized controlled double-blinded experimental study was carried
      out to determine the effects of daily exercise program on bone mineral density and cortisol
      level in preterm infants with very low birth weight matched for birth weight, gestation week,
      and gender.

      Study design: The study was performed with preterm infants hospitalized in the neonatal
      intensive care unit of a tertiary hospital. Ethical committee approval, institutional
      permission, parental written consent were obtained. Daily exercise program was implemented in
      preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10
      minutes. Before and after the study the following were evaluated in preterm infants in the
      exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone
      mineral density, serum biochemical parameters and cortisol levels.
    

Detailed description: 
      Objective: This randomized controlled double-blinded experimental study was carried out to
      determine the effects of daily exercise program on bone mineral density and cortisol level in
      preterm infants with very low birth weight matched for birth weight, gestation week, and
      gender.

      Study design: The study was performed with preterm infants hospitalized in the neonatal
      intensive care unit of a tertiary hospital. Ethical committee approval, institutional
      permission, parental written consent were obtained. Daily exercise program was implemented in
      preterm infants in the exercise group for 30 days, once a day, and continuing for 7-10
      minutes. Before and after the study the following were evaluated in preterm infants in the
      exercise and control group: anthropometric measurements, tibia speed of sound (SOS) for bone
      mineral density, serum biochemical parameters and cortisol levels.
    

Intervention name(s): Daily Exercise
Intervention type(s): Procedure
Intervention description(s): Daily Exercise Programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterm infants with very low birth weight (VLBW); bone mineral density; cortisol; exercise
Predictive Value of pCLE Findings in Pediatric IBD
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Studies over the past two decades have convincingly demonstrated the role of barrier
      dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that
      optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess
      mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be
      predictive of disease relapse in adult IBD patients. The purpose of the current study is to
      determine the predictive value of pCLE findings in pediatric IBD patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients with IBD from all over Russia, treated from IBD in our Center
      
Biospecimen description: 
      Optical biopsy
    
Keywords: IBD; Pediatrics; pCLE
A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to evaluate the effects on QT/QTc Interval of TS-142 in Healthy Adult
      Subjects
    


Intervention name(s): TS-142; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period; Single dose of moxifloxacin 400 mg in the morning under fasting in each period; Single dose of TS-142 placebo in the morning under fasting in each period
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gut Microbiota and Proteins Intake
Condition: Healthy
Study type: Interventional

Summary: 
      Gut microbiota are involved in the regulation of mammalian metabolic pathways through
      host-microbiota metabolic, signaling, and immune-inflammatory interactions that
      physiologically connect the gut, liver, brain, and other organs. Correlation of these
      metabotypes with gut microbial profiles facilitates deciphering inherent host-microbe
      relationships.

      Microbiome sequencing have generated novel insights into the role of gut microbial
      composition in health and disease, but are limited in addressing the microbial contribution
      to host metabolism and the gut microbial dysbiosis in disease.

      This is an exploratory trial, aiming to examine how gut microbial conditions determine
      response to dietary challenge by measuring urine, plasma and stool metabolites resulting from
      metabolism of protein, polyamines and bile acids in combination with stool bacterial
      composition. The focus of this trial is to evaluate impact of protein based food challenges,
      based on cross-over design of two diet challenges of animal and vegan protein sources.
    


Intervention name(s): Animal-based protein diet; Vegan-based protein diet
Intervention type(s): Other; Other
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut microbial; response; to protein-based; diet; challenges; population
Gingivitis Treated With Chlorhexidine 0.12% Mouthwash in Young Adults
Condition: Age Problem
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of this study will evaluate the effectiveness of 0.12% chlorhexidine solution as an
      anti-inflammatory agent and reducing the presence of biofilm in young adults.
    

Detailed description: 
      Thirty patients with gingivitis ages 18 to 30 year with a probing depth of at most 3 mm and
      at least 20 teeth will be selected and evaluate at baseline and after 4 weeks.
    

Intervention name(s): 0.12% chlorhexidine
Intervention type(s): Procedure
Intervention description(s): the patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
Other intervention name(s): Saline Solution
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty patients with gingivitis ages18 to 30 year with a probing depth of at most 3 mm and at least 20 teeth will select and evaluate at baseline and after 4 weeks. The periodontal clinical parameters will verify: plaque index (PI), gingival index (GI) and Simplified Oral Hygiene Index (OHIS). After evaluation of the clinical parameters, the patients will randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gingivitis; Periodontal treatment
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Our primary goal is to conduct a pilot study of the effects of a new potential strategy for
      youth substance abuse prevention - science-based drug education integrated into the high
      school science curriculum. Through this pilot study we propose to: (1) demonstrate that this
      new strategy shows promise, and (2) estimate the effect size for the intervention.
    

Detailed description: 
      NIDA, in recent years, has put resources into summarizing and synthesizing cutting-edge
      medical and basic science research discoveries about the short-term and long-term effects of
      drug use on the developing brain. One outcome of this results was the production of a
      science-based drug education program entitled "The Brain: Understanding Neurobiology Through
      the Study of Addiction." This is a 5-lesson module for high school science classes that
      teaches about brain structure and function, how drugs affect and change the biology and
      chemistry of the brain, how addiction occurs in the brain, and that addiction is a chronic,
      recurring disease. However, the effect of receipt of this program on students' substance use
      knowledge, attitudes, perceived risk of harm, and behavior has not been systematically
      evaluated to date.

      The specific aims of this project are:

        1. To evaluate the effects of receipt of the curriculum on specific cognitive contributors
           to substance use including a)students' knowledge about the short- and long-term effects
           of substance use on the brain; b)perceived risk of harm from substance use; and
           c)intention to use substances in the next 3 months.

        2. To evaluate the effects of the intervention on actual substance use behavior. We
           hypothesize that the effectiveness of this approach may be modified by the students'
           level of prior and current substance use, with the effect being stronger among those who
           have not already initiated use, or among those who have very low use. Therefore, we will
           specifically examine whether the intervention a)prevents substance use initiation among
           students who had no previous use, b)stops use among students with low lifetime use, and
           c) reduces use among those with higher levels of use.
    

Intervention name(s): drug prevention curriculum
Intervention type(s): Other
Intervention description(s): Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Substance abuse
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at how two different forms of semaglutide reach and stay in the blood
      after injection. None of the two forms of semaglutide have been approved by the authorities
      to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants
      will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will
      get the medicine as an injection under the skin of the belly using a pen-injector. The type
      of pen-injector is different for the two forms of semaglutide. The study staff will teach
      participants how to inject the medicine. Participants will take an injection once a week and
      will get a total of 21 injections of study medication. The study will last for about 27-30
      weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits,
      participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop
      the study if the study doctor thinks that there are risks for their health. Women cannot take
      part if they are pregnant, breast-feeding or planning to become pregnant during the study
      period.
    


Intervention name(s): Semaglutide
Intervention type(s): Drug
Intervention description(s): Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Condition: Healthy Volunteers; Norovirus, Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to select the optimal formulation of the norovirus vaccine from
      different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant
      (3-O-desacyl-4'-monophosphoryl lipid A) for further development.
    

Detailed description: 
      The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like
      particle (VLP) vaccine adjuvanted with aluminum hydroxide and with or without monophosphoryl
      lipid A (MPL). The norovirus vaccine is being tested to assess different formulations of the
      vaccine that will then be further developed.

      This study will look at the number of antibodies to norovirus formed in people who take
      different formulations of the norovirus vaccine. The study will enroll approximately 420
      patients. Participants will be randomly assigned (by chance) to one of fourteen treatment
      groups-which will remain undisclosed to the patient and study doctor during the study (unless
      there is an urgent medical need).

      All participants will receive a vaccination on Day 1 and Day 28 of the study. Some treatment
      arms will receive one dose of the norovirus vaccine and some arms will receive two. In order
      to keep the treatment arms undisclosed to the patient and the doctor, those randomized to the
      one dose groups will receive a dose of Hepatitis A vaccine on Day 1 followed by the norovirus
      vaccine 28 days later. Participants will be asked to record any symptoms that may be related
      to the vaccine or the injection site in a diary card for 7 days after each vaccination.

      This multi-centre trial will be conducted in Belgium. The overall time to participate in this
      study is up to 393 days. Participants will make 6 visits to the clinic, and will be contacted
      by telephone twice for follow-up assessments.
    

Intervention name(s): Hepatitis A Vaccine; Norovirus Bivalent VLP Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Hepatitis A Vaccine IM injection; Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Other intervention name(s): Havrix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Norovirus, vaccination
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Condition: Obstructive Sleep Apnea of Adult
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The study is designed as a prospective, open-label, multicentre, non-randomized, single arm
      treatment study to assess the safety, performance and initial efficacy trends of the GenioTM
      System in patients with Obstructive Sleep Apnoea (OSA).
    


Intervention name(s): Genio(TM) bilateral hypoglossal nerve stimulation system
Intervention type(s): Device
Intervention description(s): Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to assess the safety/tolerability and efficacy (by
      evaluating changes in pulmonary vascular resistance [PVR] and pulmonary blood volume [PBV])
      of MK-3475 in participants with pulmonary hypotension associated with chronic obstructive
      pulmonary disease (PH-COPD). The primary hypothesis is that 28 days of MK-5475 treatment is
      superior to placebo treatment in reduction of PVR.
    

Detailed description: 
      Part 1 of this study will assess safety, tolerability, and PK of MK-5475 compared to placebo.
      Part 2 will assess safety, tolerability, PK, and changes in PVR and PBV of MK-5475 compared
      to placebo.
    

Intervention name(s): MK-5475; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-5475 32 µg, 100 µg, 195 µg, 360 µg or 380 µg administered as dry powder inhalation according to randomization; Placebo administered as dry powder inhalation according to randomization
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment