bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess:

        1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in
           pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years

        2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two
           sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets
           (excluding marking)

        3. the pharmacokinetics of sitagliptin and metformin following the administration of two
           sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged
           10 to 17 years.
    


Intervention name(s): Sitagliptin/metformin XR; Placebo; Metformin; Thyroid hormone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg).; Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings.; Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.; Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
Other intervention name(s): MK-0431A XR; Janumet XR
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating the Acute Effects of THC on Functional Brain Systems
Condition: Reward; Tetrahydrocannabinol; Endocannabinoids; Memory; Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether THC, the main psychoactive ingredient in
      cannabis, affects functional brain systems underlying memory and reward.
    

Detailed description: 
      Cannabis is by far the most frequently used illicit drug worldwide and has significant
      effects on memory. Further, cannabis has an addictive potential. These effects are mediated
      by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1
      receptors. These receptors are particularly highly expressed in brain regions involved in
      memory and reward. Therefore, in this study we will investigate the acute effects of THC on
      functional brain systems underlying memory and reward. We will visualize these effects using
      the latest non-invasive imaging technique: pharmacological MRI (phMRI).
    

Intervention name(s): Delta9-tetrahydrocannabinol (THC)
Intervention type(s): Drug
Intervention description(s): inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
Other intervention name(s): dronabinol, marinol, THC, tetrahydrocannabinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tetrahydrocannabinol; memory; reward; magnetic resonance imaging; endocannabinoids
Whole Milk Compared With Skimmed Milk and Effect on Lipids
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The aim of the project is to investigate the effects in humans of a daily intake of whole
      milk compared to skimmed milk primarily and secondarily respectively on:

        -  Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides

        -  Risk markers of diabetes type 2: plasma glucose and insulin
    

Detailed description: 
      This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no
      wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of
      a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet
      containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the
      appearance of the test foods cannot be concealed. The study subjects will receive the two
      test foods in random order, decided by draw of lots. Blood samples will be drawn on the first
      day of the period and in the end of the period for each 3 week-periods.
    

Intervention name(s): Milk type
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study
Condition: Liver Tumor; Hepatic Fibrosis
MeSH terms: Liver Neoplasms; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for
      staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors
      before hepatic resection, using resected tissue pathology as a reference standard.
    


Intervention name(s): two-dimensional shear-wave elastography (SWE)
Intervention type(s): Other
Intervention description(s): performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with liver tumor intend to hepatectomy
      
Keywords: shear-wave elastography; hepatic fibrosis; liver tumor
Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children
Condition: Developmental Delay; Child Development; Child Development Disorder; Global Developmental Delay; Infant Development; Motor Delay; Speech Delay; Communication Disorders; Development Delay
MeSH terms: Communication Disorders; Language Development Disorders; Developmental Disabilities
Study type: Observational

Summary: 
      This study aimed to provide the validity and reliability of the Indonesian ASQ-3
      questionnaires as a screening tool for developmentally delayed children aged less than one
      year old. This study was divided into 2 phases. The first phase (April-June 2018) included
      the transcultural adaptation of the ASQ-3 questionnaires for 2 to 12 months age groups from
      English to Indonesian. The second phase (July- September 2018) included a cross-sectional
      study of Indonesian ASQ-3 questionnaires for parents/caregivers of children aged 1-12 months,
      with 35 children in each age group by cluster sampling methods, in 2 district areas in East
      Jakarta.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Parents with children aged 1-12 months living in East Jakarta
      
Keywords: Developmental delay; developmental screening; Indonesian ASQ-3 questionnaire; validity; reliability
The Effect of Dairy and Non-Dairy Snacks on Food Intake, Subjective Appetite in Children
Condition: Food; Eating; Appetite
Study type: Interventional

Summary: 
      Dairy products have the potential to be healthy snack foods for children and are provided in
      a variety of food matrices. For instance, milk represents a fluid product, yogurt can be
      classified as a semi-solid food, and finally, cheese is the example of solid food. This
      experiment is aimed to examine the effect of dairy products with different food matrices on
      satiety and food intake in children. Dairy products will be compared with other non-dairy
      snacks popular among children including cookies and potato chips.
    


Intervention name(s): Potato chips; Greek yogurt; Cookies; Cheese; Milk
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Commercially available potato chips, 180 kcal; Commercially available Greek yogurt, 180 kcal; Commercially available cookies, 180 kcal; Commercially available cheese, 180 kcal; Commercially available milk, 180 kcal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Snacking; Food Intake; Satiety; Obesity
Supplementary Food on Prevention of Moderate Malnutrition in Children
Condition: Moderate Acute Malnutrition (MAM)
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study will evaluate the impact of a supplementary food (cookies) in preventing the risk
      of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.

      Children will be divided in two groups; one will received the cookie plus 12 educative
      sessions and the other just the educative program. The study will last 12 months
    


Intervention name(s): Nutritional cookie
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure
Condition: Deep Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Preserving pulpal vitality is a major challenge when excavating deep caries lesions without
      severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for
      indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus
      prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is
      a complementary examination which allows to estimate the depth of the carious lesion. In
      clinical practice, it is currently difficult to accurately measure this depth on preoperative
      radiographs. This lack of precision leads to a decrease in the effective capacity of the
      operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise
      and is not used as a diagnostic element.

      The aim of this study was to determine if the use of pre-operative retroalveolar radiographs
      can help to predict pulpal exposure risk.
    


Intervention name(s): pre-operative radiograph
Intervention type(s): Radiation
Intervention description(s): Three hundred and sixty pre-operative radiographs of deep carious lesions and a "contrasted" version of the same set have been screened and annotated by 4 evaluators. Annotations were placed at the dentino-enamel junction, at the floor of the carious lesions, and on pulp chamber wall. From these annotations, the ratios residual dentin thickness/ total dentin thickness were derived. First, inter-evaluator agreement and concordance were assessed. A logistic regression that accounted for measurement error was applied to precisely estimate the capacity of the ratio to predict exposure (reported as odds-ratio).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pre-operative radiographs of deep carious lesions treated with DECAT
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of the study is to determine if MEDI-551, when used in combination with
      salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine
      (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem
      Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
    


Intervention name(s): MEDI-551 2 mg/kg; Rituximab; ICE; DHAP; Autologous Stem Cell Transplant (ASCT); MEDI-551 4 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Drug
Intervention description(s): MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).; Rituximab at 375 mg/m2 will be administered via IV infusion 2 days before the start of Cycle 1 and on Day 1 of each cycle. The infusion time for rituximab will be 50 400 mg/hr, depending on subject's tolerance. Subjects will receive 3 cycles of Rituximab with Ice (R ICE) or Rituximab with DHAP (R-DHAP) unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).; ICE will be administered via IV infusion as follows: ifosfamide 5 g/m2 continuously for 24 hours with mesna on Days 2 and 3; carboplatin AUC=5 mg/mL x min [800 mg maximum) on Day 2; etoposide 100 mg/m2 on Days 1, 2, and 3) in 21-day cycles.; DHAP will be administered via IV infusion as follows: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m2 continuously for 24 hours on Day 1 of dosing cycle; cytarabine 2 g/m2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.; Subjects who achieve CR or PR will undergo stem cell harvest and autologous stem cell transplantation (ASCT) following standard institutional protocols.; MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
Other intervention name(s): Inebilizumab; Rituxan; MabThera; Inebilizumab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma, Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, B-Cell Malignancy, anti-CD19, monoclonal antibody, second line, ASCT, Refractory
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Condition: Abscess
MeSH terms: Abscess
Study type: Interventional

Summary: 
      Patients will be enrolled in a multi-center study to prospectively evaluate outcome after
      treatment for an uncomplicated skin abscess. All patients will receive incision and drainage
      and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium
      double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the
      dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion
      in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the
      emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome
      is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within
      30 days of treatment. Patients who are not improving at the following visit will then be
      treated with additional antibiotics or admission if needed. Data will be analyzed both by
      initial randomization and intention to treat. This serves as the pilot for the full placebo
      controlled randomized trial.
    


Intervention name(s): Septra
Intervention type(s): Drug
Intervention description(s): (800/125) PO BID X 7 days
Intervention MeSH terms: Trimethoprim, Sulfamethoxazole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: abscess; cellulitis; antibiotics; MRSA
Effects of Soy Protein/Soy Fiber on Measures of Satiety
Condition: Lack of Satiety
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ingestion of a bar containing either added
      soy protein or soy fiber or both, increases subjective and objective measures of satiety
      compared to a control bar.
    

Detailed description: 
      The study will use a randomized, double blind crossover design in which subjects act as their
      own control. Satiation will be assessed using a Motivation to Eat Questionnaire. Height and
      weight will be measured at the screening visit and weight alone at each subsequent visit.
      Prior to consumption of the test meal (breakfast) and at 15, 30, 60, 90, 120 and 150 min
      thereafter, subjects will complete a VAS Motivation to Eat Questionnaire. After subjects
      complete the first VAS motivation questionnaire, they will be given the test meal and
      instructed to eat this over a 15 minute period and fill out a palatability questionnaire. Two
      hours after the start of the test meal they will be taken to a private feeding room, where an
      ad libitum pizza lunch will be served with mineral water. Participants will be instructed to
      eat and drink as much as they desire until they are comfortably full. Subjects will be asked
      to fill out a final VAS Motivation to eat questionnaire 30 min after the start of the pizza
      meal.
    

Intervention name(s): Satiety
Intervention type(s): Other
Intervention description(s): Single consumption of snack bars to determine satiety and food intake at next meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: obesity; satiety; soy protein; soy fiber; control appetite; reduce food intake
Phototherapy Applied in Combination With Aerobic Training
Condition: Excessive Physical Exercise, Unspecified
Study type: Interventional

Summary: 
      Interventional
    

Detailed description: 
      Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model:
      Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes
      Assessor) Primary Purpose: Supportive Care
    

Intervention name(s): Active and Active Phototherapy; Active and Placebo Phototherapy; Placebo and active Phototherapy; Placebo and Placebo Phototherapy
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.; Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: sedentary lifestyle
The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy, safety, and cost-effectiveness of DWP14012 40 mg compared to
      esomeprazole magnesium enteric-coated tablets for the treatment of reflux esophagitis.
    


Intervention name(s): DWP14012
Intervention type(s): Drug
Intervention description(s): DWP14012 40mg
Intervention MeSH terms: Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment