bioihbjkbjnl/mcl2 huggingface dataset:
Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia
Condition: Hypertriglyceridemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hypertriglyceridemia; Syndrome
Study type: Interventional

Summary: 
      Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of
      intestinal triglyceride rich lipoproteins in patients with isolated fasting
      hypertriglyceridemia.

      The objective of this study is to compare the serum apoB48 rate after a standardized load
      test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.
    

Detailed description: 
      Two major studies in 2007 showed that the occurrence of myocardial infarction and death was
      more frequent in subjects with the highest "non-fasting" triglycerides level. This is an
      important point that supports the hypothesis that the development of atheromatous lesions
      also depends on "remnant" of triglyceride-rich lipoproteins (TRL) products such as
      chylomicrons in the intestine. The elevation of triglycerides in postprandial period depends
      on the intestinal production of TRL that can be excessively increased as has been shown in
      diabetes. Accordingly, it is necessary to distinguish between hepatic and intestinal
      production of TRL in hypertriglyceridemic patients particularly during postprandial period.
      TRL contain a single molecule of apolipoprotein B (apoB), apoB100 when produced by the liver
      or apoB-48 when they are produced by the gut. It is well known that apo B100 is the
      lipoprotein of the VLDL which is increased in hypertriglyceridemia. But preliminary works
      showed that fasting concentrations of apoB48 were correlated with triglycerides in some
      hypertriglyceridemic patients. These results suggest an intestinal part in fasting
      triglycerides levels. It therefore appears that the liver and intestine contribute to
      hypertriglyceridemia, but the intestinal part is not established particularly in isolated
      hypertriglyceridemia. The detection of abnormalities in the production of LRT would consider
      intestinal bowel as a target organ for the initiation of specific lipid-lowering therapy.
    

Intervention name(s): Postprandial test
Intervention type(s): Other
Intervention description(s): Postprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. This post prandial test is the same in the two study groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Postprandial test; Metabolic syndrime; HTG
The Effect of Yogurt Containing BB12 on Children's Health and Child Care Absenteeism
Condition: Children's Health and Growth; Childcare Absenteeism
Study type: Interventional

Summary: 
      The aim of our study is to assess the effect of daily consumption of yogurt containing
      probiotic bacteria BB12 on the health and growth of healthy children 12-48 months of age in
      out of home child care.
    


Intervention name(s): Yogurt drink with probiotic bacteria BB12; Placebo
Intervention type(s): Other; Other
Intervention description(s): Probiotic yogurt dairy drink with Bifidobacterium Lactis and prebiotics. One bottle a day for 16 weeks.; Vanilla flavored dairy drink. One bottle a day for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotics; Children; Child Care Center; Nutrition; Health promotion
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      High bone turnover with the bone resorption exceeding bone formation is a major mechanism of
      postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach
      for the prevention. The Objective of the current study was to determine the short-term
      efficacy of once-weekly low dose alendronate in the prevention of bone loss in early
      postmenopausal Korean women with moderate bone loss via bone turnover markers.

      This study was a 12-week, randomized, double-blind clinical trial compared the effects of
      placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg
      and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with
      lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji
      University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline
      phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at
      baseline and 12 weeks after treatment.
    


Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention description(s): Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
Other intervention name(s): Bisphosphonate
Intervention MeSH terms: Alendronate; Diphosphonates
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoporosis; alendronate; bone marker
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications,
      but is difficult to achieve, despite the administration of escalating doses of oral
      antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients
      eventually require insulin which usually is added when glycemic control with a regimen of
      oral antidiabetic agents becomes suboptimal.

      The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine
      and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly
      controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient
      who may benefit more by the single treatment.

      This an open-label, randomized, parallel, 36-week comparative study was performed between
      January 2007 and March 2008 at a single centre.
    

Detailed description: 
      Patients were randomized to either NPL (Lilly) or glargine (Lantus, Aventis) to be
      administered subcutaneously at bedtime. Both insulin formulations consisted of cartridge
      containing 3 ML of either insulin preparation. Oral antihyperglycemic agents were continued
      at the prestudy dosages. No dietary advice was given beyond reinforcement of standard
      guidelines. The initial bedtime insulin dose was 10 IU for all patients with the goal to
      achieve a target FPG of < 100 mg/dL in both groups. The insulin dose was titrated weekly
      according to daily self-monitored fasting blood glucose measurements that provide values
      corresponding closely to laboratory measurements of plasma glucose. The patients were taught
      to increase their insulin dose by 2 IU if FPG was greater than 100 mg/dL, and by 4 IU if FPG
      was greater than 180 mg/dL on three consecutive mornings. Before the start of insulin
      therapy, and at weeks 12, 24 and 36, blood was withdrawn for measurements of full blood
      counts, electrolytes, creatinine, liver enzymes and lipids. Insulin doses, self-monitored
      plasma glucose (SMPG), and any events associated with signs or symptoms of hypoglycaemia were
      recorded in diaries.
    

Intervention name(s): NPL insulin; Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose 10 IU bedtime and then titration; 10 IU bedtime and then titration
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bedtime insulins; Poorly controlled type 2 diabetes; Glycemic control; HbA1c
GWAS in a Small Group of Metabolically Healthy Obese White Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a GWAS pilot study that aims to identified possible candidate genes associate to
      obesity by exploring single nucleotide polymorphism (SNP) in a small group of obese ,
      metabolically healthy white adults, matched with lean, white adults , metabolically healthy.
      The investigators hypothesize that the careful phenotyping of the subject sand matching with
      increase the power to find SNP significantly associate with obesity (as defined by BMI).
    

Detailed description: 
      Between 60%-70% of the risk of obesity appears to be heritable. Unfortunately, the exact
      genes involved have been difficult to identify. New technologies now exist to help
      researchers discover obesity susceptibility genes. One of these technologies is the
      Affymetrix Genome-Wide Human SNP (single nucleotide polymorphism) Array 6.0 chips. SNPs are
      individual base pair differences in genes of different individuals, and they are the main
      source of human genetic diversity. The "chips" are thumbnail-size silicon surfaces that
      contain copies of hundreds of thousands of SNPs of the human genome (in this case around
      900,000). SNP chips allow researchers to screen thousands of genes in a single experiment and
      compare genes of subjects with a particular disease or condition with unaffected control
      subjects. The investigators study utilizes SNP chips to compare the genetic profiles of obese
      subjects (N = 20, body mass index > 35 kg/m2) without common obesity-related co-morbidities
      such as diabetes mellitus or hypertension with well matched, lean controls (N = 20, body mass
      index 18-25 kg/m2). This is a pilot study intended to explore the following: 1) possible
      associations between obesity and previously unidentified obesity susceptibility genes; 2)
      associations between known obesity genes and obesity risk in subjects without obesity-related
      metabolic co-morbidities; and 3) how well our genetic data conform to other studies in
      similar populations as a way of assessing if the investigators have identified a
      representative cohort of obese subjects.
    

Intervention name(s): GWAS
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol
      blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal
      microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace
      analysis) and fecal microbiota composition (assessed by next generation sequencing).
    


Intervention name(s): Placebo; Flavonoids; Flavonoids+Prebiotics
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): A combination of maltodextrins and red and blue food colors.; A combination of blueberry extract, black current extract, and black rice extract.; A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Package of Interventions After Recovering From Moderate Acute Malnutrition
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Children who recover from moderate acute malnutrition in Malawi remain at high risk for
      relapse or death in the year following recovery. This cluster-randomized trial will evaluate
      a package of affordable, safe, proven interventions specifically targeted to this population
      of children in an attempt to decrease their risk of relapse or death following recovery from
      moderate acute malnutrition. These children will be followed for a year following recovery to
      assess rates of relapse and mortality.
    


Intervention name(s): Lipid Nutrient Supplement; Sulfadoxine-pyrimethamine; Albendazole; Zinc; Insecticide-treated bednet
Intervention type(s): Dietary Supplement; Drug; Drug; Drug; Other
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Moderate Acute Malnutrition
Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture
Condition: Venipuncture; Pain; Anxiety; Fear
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Venipuncture is one of the most common stressful procedures in children. Managing pain and
      fear of venipuncture procedure recommended strongly because it may change children's memory
      for procedural pain and the subsequent acceptance of later health care painful interventions.
      Prior painful experiences can reduce the acceptance of later health care, hence making it
      more difficult for both patients and nurses.

      There was clear evidence that the distraction method is the most performed as a psychological
      technique performed to decrease venipuncture-related pain and distress and supporting its
      efficacy in children.

      The aim of this study to investigate the effectiveness of TICK-B on children's pain and
      anxiety during venipuncture procedure.
    

Detailed description: 
      Note:

      The first registration number for the protocol of Ph.D. was approved as 10092019-6 on 10th
      September 2019 It approved the grant to publish the result as 20072020-3 on 23, August,
    

Intervention name(s): Trace Image and Coloring for Kids-Book (TICK-B)
Intervention type(s): Other
Intervention description(s): A collection of pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, multiple doses, crossover clinical study to compare the pharmacokinetic
      characteristics and the safety between administration of BR9003 and BR9003A in healthy adult
      subjects. Within each period, randomized subjects will be taken 2 dosing regimens of
      administrating BR9003 once a day for six days or BR9003A twice a day for six days.
    

Detailed description: 
      *Study Objective: After repeated administration of BR9003 2mg and BR9003A 1mg for healthy
      adult volunteers, the pharmacokinetic properties and safety are evaluated.

        -  Target number of subjects for enrollment (randomization):

           24 subjects in total (2 sequence groups(A or B), 12 subjects per sequence group)

        -  Investigational Product

             1. Control drug: BR9003A 1mg

             2. Test drug: BR9003 2mg

        -  Regimen

             1. Control group: Administration of BR9003A 1mg twice a day for six days

             2. Test group: Administration of BR9003 2mg once a day for six days
    

Intervention name(s): BR9003 2mg; BR9003A 1mg
Intervention type(s): Drug; Drug
Intervention description(s): After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003 tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it.; After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003A tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it. Another BR9003A tablet will be administered orally with water 150mL around 20:30 after dinner between 18-19:00.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iranian Intensive Care Unit (ICU) Glutamine Study
Condition: Trauma Patients in ICU
Study type: Interventional

Summary: 
      This is a double-blinded placebo-controlled block randomized study in intensive care patients
      comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of
      clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS)
      and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum
      inflammatory mediators will be compared.
    


Intervention name(s): Glutamine 0.5 g/kg/day; Glutamine 1 g/kg/day; Enteral Nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Glutamine 0.5 g/kg/day; Glutamine 1 g/kg/day; Ordinary Enteral Nutrition
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Digital Method for Measurement of Palatal Asymmetry in Twins
Condition: Identity, Body; Palate; Deformity
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the digital palatal model as a possible tool of human
      identification.
    

Detailed description: 
      In this research, the investigators investigate the individual characteristics of the human
      upper and lower dentition and palate. The investigators use digital dentistry, record the
      data using an intraoral scanner, and store the extracted open source file format on a secure
      cloud-based server. Data validation is repeated annually. By comparing the initial and
      control digital samples, the investigators draw conclusions about the usability of the
      extracted information. The aim of the study is to develop a method and data storage protocol
      that will allow the patient data to be used years or decades later to replace or restore lost
      information.
    

Intervention name(s): Intraoral scanning and data acquisition
Intervention type(s): Device
Intervention description(s): Intraoral scanner data acquisition, 3 scans are taken for each participant. Data will be exported from dedicated software (Planmeca, Romexis) and imported into GOM surface analysis software. Sample comparisons and sample preparation are performed here. The results are collected in excel spreadsheets and analyzed in SPSS statistical software.
Intervention model: Single Group Assignment
Intervention model description: Intraoral scanner (Planmeca Emerald) data acquisition, 3 scans are taken for each participant. Data will be exported from dedicated software (Planmeca, Romexis) and imported into GOM surface analysis software. Sample comparisons and sample preparation are performed here. The results are collected in excel spreadsheets and analyzed in SPSS statistical software.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Human identification; Palate morphology; Intraoral scanner; Digital dentistry
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the relative pharmacokinetic properties and the tolerability and
      safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after
      single-dose administration.
    

Detailed description: 
      10 Japanese and 10 Caucasian healthy male and female subjects in a one to one male to female
      ratio will be included in the study. Japanese and Caucasian subjects will be matched for body
      weight.
    

Intervention name(s): ACT-128800
Intervention type(s): Drug
Intervention MeSH terms: Ponesimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ACT-128800; Safety; Tolerability; Pharmacokinetics
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody
      adalimumab as an effective therapy for maintaining clinical response in pediatric
      participants with Crohn's disease (CD) and to gather long-term safety and tolerability data
      in this population. Participants were allowed to enroll in the study if they participated in
      and successfully completed Study M06-806 (NCT00409682) through Week 52.
    


Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Participants who enrolled into the study from blinded therapy in Study M06-806 received open-label (OL) therapy at a dose dependent on their body weight. Participants weighing ≥ 40 kg received 40 mg of adalimumab every other week (eow), and those who weighed < 40 kg received 20 mg of adalimumab eow. Starting at Week 8, participants who had a disease flare may have been switched to every week (ew) treatment at the same dose of adalimumab received while on eow treatment. Participants who enrolled from OL therapy in Study M06-806 continued to receive the same dose they were receiving (i.e., 40 mg ew or 20 mg ew) at the Week 52 visit of Study M06-806. Adalimumab dose could have been decreased to the next lower treatment level for those with body weight changes. Participants who responded to treatment may have also had their dosage frequency decreased from ew to eow dosing, as well as a decrease in dosage.
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; adalimumab
Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640
      tablets in the Chinese healthy population.
    

Detailed description: 
      This study is designed as a single-center, randomized, single-blind, placebo-controlled,
      single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The
      next dose should be tested only if the previous dose has demonstrated to be safe and
      tolerated, and each subject will receive either the experimental drug or a placebo only once.
    

Intervention name(s): TVB-2640; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day.; Oral, matching number of placebo Tablets with active arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment