bioihbjkbjnl/mcl2 huggingface dataset:
Effect Of 8-Week Online Fitness Intervention Health Related Fitness
Condition: Sedentary Behavior; Physical Inactivity; Body Image
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of 8-week online delivered
      exercise program on actual and perceived physical fitness components.
    

Detailed description: 
      Physical fitness is one of the leading concepts of health and well-being at all stages of
      life. In certain context, individuals tend to engage in prolonged sedentary behaviors, and
      these contexts are considered sedentary-promoting environments. These environments also
      detrimental on physical fitness and health. University students and office workers who
      predominantly engage in sedentary behaviors, such as prolonged sitting and computer-based
      work, have consistently shown associations with various aspects of diminished physical
      fitness. The online intervention protocols might be a good alternative for increasing fitness
      level for those who live or work in highly sedentary settings. Hence, the purpose of this
      study is to investigate the effectiveness of 8-week online delivered exercise program on
      actual and perceived physical fitness components. Specifically, body composition measured by
      DXA, upper body muscular strength, and flexibility are the main focus of this study.
      Moreover, physical self-perception is also a focus of this study.
    

Intervention name(s): Web-Based Physical Fitness Intervention
Intervention type(s): Behavioral
Intervention description(s): The exercise program has been designed according to the progressive overload method. Therefore, the volume of the exercise program increased as the weeks progressed. Exercise videos were uploaded to YouTube on Mondays, Wednesdays and Fridays send to participants via a message group to follow the program. The videos featured the experts' explanations of the movements for each exercise.. The equipment that the participants should use in the training sessions was selected from the materials available at home (eg., use of water bottles instead of weight dumbbells). The exercise sessions is divided into 3 parts: warm-up (2-4 min. average), main part (14-19 min. average), cool-down (3-5 min. average). The warm-up includes movements to increase the heart rate and warm up the muscles to be worked on for that session. The main part of the exercise program also included rest breaks when the participants were asked to move and stretch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with a conventional control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; Leisure Activities
Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The anticaries effect of fluoride is through the increase in fluoride presence and retention
      in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous
      studies showed that a preapplication of calcium (in a rinse) prior to administration of
      fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of
      fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium
      supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium
      supplements will increase calcium concentration in the oral fluids above baseline levels.
      Secondly, the calcium supplement with the highest calcium release will be tested before a
      fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared
      with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva
      will be collected to assess calcium and fluoride concentration.
    


Intervention name(s): Inactive supplement; Tricalcium phosphate supplement; Calcium carbonate supplement; Calcium citrate supplement; Inactive supplement and fluoride mouthwash; Calcium carbonate supplement and fluoride mouthwash; Calcium citrate supplement and fluoride mouthwash
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Chewable candy (negative control), chewed for 30 seconds.; Chewable tricalcium phosphate supplement, chewed for 30 seconds.; Chewable calcium carbonate supplement, chewed for 30 seconds.; Chewable calcium citrate supplement, chewed for 30 seconds.; A chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).; A calcium carbonate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).; A calcium citrate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Citric Acid; Sodium Citrate; Calcium; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Associations of Plasma Vanadium Concentrations With Gestational Diabetes Mellitus
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Background: Vanadium compounds have been shown to exert insulin-mimetic effects and thereby
      control glucose homeostasis. However, studies regarding the levels of vanadium and
      gestational diabetes mellitus (GDM) are limited and have inconsistent outcomes.

      Objective: The aim of this study was to investigate the association of plasma vanadium
      concentrations with gestational diabetes mellitus (GDM).

      Design: A hospital-based case-control study was carried out in urban Wuhan, China from August
      2012 to April 2015. Pregnant women who screened for GDM at the outpatient clinics of the
      Department of Endocrinology, Tongji Hospital were invited to participant in the study. The
      inclusion criteria were as follows: 1) age ≥ 20 and ≤ 43 years; 2) gestational age at GDM
      screening ≥ 24 weeks; 3) singleton pregnancy. The investigators excluded women who met any of
      the following items: history of diabetes (including but not limited to GDM), cardiovascular
      disease, cancer or other systemic diseases; pharmacologic treatment or dietary supplement use
      that might influence glucose or lipids metabolism; accompanied by other pregnancy
      complications; incomplete basic information. The diagnosis of GDM can be made if one or more
      glucose values are above the cut points of 5.1, 10.0 and 8.5 mmol/L at fasting, 1 and 2 h
      during a 75-gram oral glucose tolerance test (OGTT). Controls were randomly selected and
      individually matched to cases by age (± 2 years), gestational age (± 2 weeks) and parity.
      Finally, 252 GDM cases and 252 matched controls were selected in this study. All participants
      gave written informed consent before enrolling in the study. Fasting blood samples (≥ 8 h
      overnight fasting) were collected using anticoagulant tubes and centrifuged at 3000 rpm for 5
      min. Plasma were separated from blood cells and stored at -80 ℃ for further assay. Plasma
      vanadium concentrations were measured using inductively coupled plasma mass spectrometry.
      Conditional logistic regression and restricted cubic spline model were used to evaluate the
      associations between plasma vanadium and odds of GDM.
    


Intervention name(s): Plasma vanadium concentration
Intervention type(s): Other
Intervention description(s): Plasma vanadium concentrations were measured using inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700 Series, United States)
Intervention MeSH terms: Vanadium
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All the participants enrolled were Chinese women. They gave informed written consent to the
        study and did not take any medication known to affect glucose tolerance or insulin
        secretion before participation.
      
Keywords: Vanadium; Gestational diabetes mellitus
The Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the
      food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or
      5 mg under fasting and fed states in healthy male and female subjects
    


Intervention name(s): DA-8010 2.5mg (Fasting); DA-8010 2.5mg (Fed); DA-8010 5mg (Fasting); DA-8010 5mg (Fed)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Test drug l : DA-8010 2.5mg (Fasting); Test drug ll : DA-8010 2.5mg (Fed); Test drug llI : DA-8010 5mg (Fasting); Test drug lV : DA-8010 5mg (Fed)
Intervention MeSH terms: DA-8010
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prader-Willi Syndrome Macronutrient Study
Condition: Prader Willi Syndrome; Syndromic Obesity; Childhood Obesity
MeSH terms: Prader-Willi Syndrome; Obesity; Pediatric Obesity; Syndrome
Study type: Interventional

Summary: 
      The overall objective is to explore the mechanisms by which macronutrients regulate food
      intake and weight gain in Prader Willi Syndrome (PWS).

      Previous studies from the investigators' labs suggest that the increased appetite of PWS may
      be triggered or maintained by an increase in the levels of ghrelin, an appetite-stimulating
      hormone produced primarily by the stomach. This study will compare the effects of low
      carbohydrate diet versus low fat diet on levels of ghrelin, appetite suppressing hormones and
      markers of insulin sensitivity in patients with PWS.

      The investigators hypothesize that the low carbohydrate diet will suppress plasma active
      ghrelin and increase appetite-suppressing hormones to a greater degree and for longer
      duration than the low fat diet and will thereby reduce hyperphagia and increase satiety. The
      investigators also hypothesize that the low carb diet will improve hormonal and metabolic
      markers (fatty acids, amino acids and organic acids) of insulin sensitivity and inflammatory
      cytokine profiles of children with PWS.
    


Intervention name(s): Low Carbohydrate diet; Low Fat diet
Intervention type(s): Other; Other
Intervention description(s): Low carbohydrate diet: 15%carb; 65%fat; 20% protein; Low Fat diet: 65%carb; 15%fat; 20% protein
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Prader Willi syndrome; childhood obesity; ghrelin; appetite regulation
Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      In this study, the suitability of an infant formula with a modified content of protein and
      fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.

      Primary hypothesis to be tested is: an infant formula with a modified protein content is non
      inferior compared to a standard infant formula in respect to the growth of healthy term
      infants.
    


Intervention name(s): standard infant formula; modified infant formula; breast milk
Intervention type(s): Other; Other; Other
Intervention description(s): infants are fed a commercial formula; the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added; infants are breast fed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: fully formula fed; fully breast fed
The Effectiveness of Purposeful Exercises in Children Diagnosed With Special Learning Disabilities
Condition: Lack of; Attention, With Hyperactivity (ADHD); Specific Learning Disability
MeSH terms: Learning Disabilities
Study type: Interventional

Summary: 
      The aim of the study is to examine the effect of purposeful balance and coordination
      exercises on attention and quality of life in children diagnosed with special learning
      disabilities.
    

Detailed description: 
      The study was planned as a randomized controlled trial, and children aged 7-17 who were
      diagnosed with "Special Learning Disability" in a special education center in Kocaeli-Darica
      were included as a sample. Children were divided into experimental and control groups by
      randomization. In addition to the individual training program they received from the special
      training center, the experimental group was given goal-oriented balance and coordination
      exercises for 8 weeks, 2 days a week for 40 minutes. The control group continued only the
      individual training program. All participants and their parents were informed about the
      study, and an informed consent form was obtained from the participants and their parents. In
      order to collect data from the participants; "Leisure Time Activity Questionnaire for
      Children" to determine physical activity levels, "Quality of Life Assessment Questionnaire
      for Children" to determine their quality of life, "Bruininks-Oseretsky Motor Proficiency Test
      2 short form" to evaluate motor skills, "Burdon Attention Test" to measure attention level
      used. These tests and forms were repeated before starting the study and at the end of the
      study. Pre- and post-intervention data were statistically analyzed and compared.
    

Intervention name(s): exercise; control
Intervention type(s): Other; Other
Intervention description(s): In addition to the individual support training program, the exercise group was given a balance and coordination exercise protocol including 40 minutes, 2 days a week.
These exercises are:
It consisted of warm-up (10 minutes), purposeful balance and coordination exercises (20 minutes), and cool-down (10 minutes) exercises.
Balance and coordination exercises with purpose were created with a series of exercises based on copying the shape of the blocks on the cards placed at the beginning of a track consisting of stations at the end of the track. The stations were composed of "hopscotch station", "tandem walking station in one line", "bounce station", "bucketing ping pong balls station" and "eight running stations".; The control group continued only the individual support education program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In addition to the individual training program they received from the special training center, the experimental group was given goal-oriented balance and coordination exercises for 40 minutes, 2 days a week.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Liraglutide on Pancreatic Hormones and Its Size
Condition: Obesity
Study type: Interventional

Summary: 
      Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes
      and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly
      elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of
      these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas
      (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been
      found an increased risk of acute pancreatitis.

      Animal and cell studies have shown that the increased levels of amylase and lipase in the
      blood are not due to an inflammatory state but adaptive changes (volume increase) of the
      pancreas.

      The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate
      whether the increased levels of amylase and lipase in the blood of individuals treated with
      the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by
      measuring amylase and lipase before, during and after treatment with a GLP-1 receptor
      agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical
      Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any
      volumetric changes in the pancreas with high reproducibility.

      The scan will be centered on the pancreas, other organs are not evaluated why the study is
      not designed to detect any malignant findings in the pancreas or other organs.
    


Intervention name(s): Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Intervention type(s): Drug
Intervention description(s): Treatment with Liraglutide (3.0mg per day) for ~6 weeks
Intervention MeSH terms: Liraglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Amylase; Lipase; GLP-1
Pre-emptive Analgesics in Orthodontic Treatment
Condition: NSAID; Pain Management
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to determine if the preemptive use of a combination of acetaminophen
      and ibuprofen is more effective in reducing pain following orthodontic tooth movement when
      compared to the use of acetaminophen and ibuprofen alone.
    

Detailed description: 
      This study is designed to determine if the preemptive use of a combination of acetaminophen
      and ibuprofen is more effective in reducing pain following orthodontic tooth movement when
      compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic
      appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or
      acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain
      intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and
      while chewing paraffin wax during the following time intervals: immediately following drug
      administration, 6 hours after, the morning after, and the second morning after orthodontic
      treatment.
    

Intervention name(s): Acetaminophen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen gel capsule; Ibuprofen gel capsule
Other intervention name(s): Tylenol; Paracetamol; Advil
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients of the University of Washington Graduate Orthodontics Clinic
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pre-emptive analgesics; Acetaminophen; Ibuprofen
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
Condition: Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple
      ascending doses in participants with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage
      0 to 3 and who are carriers of the patatin-like phospholipase domain-containing 3 (PNPLA3)
      148M risk alleles.
    

Detailed description: 
      This study is a double blind, randomised, placebo-controlled, multi-centre study in
      participants with NASH and fibrosis stage between F0 (no fibrosis) and F3 (bridging
      fibrosis), and who are carriers of the PNPLA3 148M risk alleles.

      The study will comprise of:

        -  An optional Pre-Screening Visit may be completed to determine PNPLA3 genotype and
           collect minimal baseline data and participants who are carriers of the PNPLA3 148M risk
           allele(s) will continue the study and enter the Screening Period.

        -  A Screening Period with a maximum of 60 days.

        -  For participants in all Cohorts, the dosing period will be 8 weeks during which
           participants will be resident of the study site for Dose 1 and Dose 3. Dose 1 will have
           participants reside at the study site from the day prior to study intervention
           administration (Day -1) until at least 2 days after study intervention administration
           with discharge on Day 3. Dose 2 will be administered at the study site on Day 29 with no
           overnight stay. Dose 3 will have participants reside at the study site from the day
           prior to study intervention administration (Day 56) until at least 2 days after study
           intervention administration with discharge on Day 59.

        -  Each participant will be followed for approximately 15 weeks post last dose.

      The study will be performed at up to 30 study sites in the United States (US) and up to 5
      study sites in Mexico. Approximately 80 participants comprising of male and female
      participants of non-childbearing potential may be enrolled into the first 4 cohorts of this
      study in order to achieve a target of 56 to 64 evaluable participants.
    

Intervention name(s): AZD2693; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subcutaneous administration of AZD2693 multiple ascending doses in participants with NASH and who are carriers of the PNPLA3 148M risk allele(s).; Participants randomised to placebo will receive the corresponding dose volume of solution as participants receiving AZD2693 within the same cohort
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Obese; PNPLA3 148M Risk Alleles; Multiple Ascending Dose