bioihbjkbjnl/mcl2 huggingface dataset:
MOTIONPOD (TM) Validation and Calibration Study
Condition: Energy Expenditure
Study type: Interventional

Summary: 
      In this study we propose 1) to develop a new multisensor monitoring system associating a
      tri-axial accelerometer and a magnetometer to measure physical activity in free-living
      adults, 2) to perform its calibration and assess its validity in a series of activity tasks
      in comparison with the measure of energy expenditure by indirect calorimetry as the criterion
      measure, and with existing physical activity monitors (cardiofrequencemetry and
      accelerometers used either alone or in combination). Briefly the subjects will perform a
      series of standardized activity tasks of different intensities and a 30-min free physical
      activity period while wearing 6 MOTIONPOD(TM) and different commercial activity monitors.
      Physical activity energy expenditure will be measured using a metabolic gas analyser.

      Data of the 30 first subjects will be used to develop new algorithms to identify the
      different activity tasks and to estimate the related energy expenditures. Data of the
      following 30 subjects will be used to validate the MotionPOD(TM) against indirect calorimetry
      and existing physical activity monitors
    


Intervention name(s): MOTIONPOD (TM) measures
Intervention type(s): Device
Intervention description(s): It is a study with a single arm. The MOTIONPOD TM measures are compared with simultaneous estimations obtained with the criteria measure (indirect calorimeter) and with existing activity monitors (heart rate monitor POLAR; different accelerometers - rT3 et Actigraph GT3X-, Actiheart, Sensewear Pro2 Armband) After physical fitness evaluation, different activity monitors are set up and the subjects perform a series of standardised activity tasks of different intensities, and well as a 30-min free activity period. Physical activity energy expenditure is measured at the end of each task using a metabolic gas analyser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Energy expenditure, physical activity, accelerometer, magnetometer, monitoring
Muscle Growth Following a Resistance Training Program in Men and Women Consuming Protein Supplements
Condition: Skeletal Muscle Growth
Study type: Interventional

Summary: 
      Soy and whey protein have different concentrations of leucine, an amino acid known to be a
      particularly potent simulator of muscle protein synthesis. The purpose of this study is to
      determine whether matching soy and whey protein supplements for leucine content instead of by
      total protein content would contribute to differences in strength increases and muscle growth
      in response to 12 wk of resistance training.
    


Intervention name(s): Whey protein supplement; Soy protein supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.; 26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects
Condition: AD
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201
      in healthy subjects.
    

Detailed description: 
      The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose
      limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose
      group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg
      Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects
      will be accepted into the protocol after review and providing voluntary written informed
      consent forms and completion of a comprehensive medical, physical examination, and routine
      laboratory assessment.
    

Intervention name(s): Donepezil Pamoate for Injection 17mg; Donepezil Pamoate for Injection 34mg; Donepezil Hydrochloride 5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.; A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.; A tablet of 5mg Donepezil Hydrochloride will be administered once.
Other intervention name(s): HHT201; HHT201; Aricept
Intervention MeSH terms: Donepezil
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
Condition: Prematurity; Late-onset Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized controlled trial (RCT) to evaluate the influence of different doses of
      vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and
      C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to
      assess its influence on clinical outcomes of these infants.
    

Detailed description: 
      Vitamin D has an important role in the regulation of both the innate and adaptive immune
      systems. There are very few studies of such roles in the neonatal population. It is
      potentially an attractive therapeutic agent for sepsis given its low cost and low risk of
      toxicity and side effects. There is no consensus regarding to the dose of vitamin D
      supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN
      have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The
      influence of different doses of vitamin D on immunological status and clinical outcomes of
      preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate
      the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of
      interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical
      evidence of late-onset sepsis we will also evaluate their safety and influence on clinical
      outcomes of these infants
    

Intervention name(s): High-dose vitamin D 3; Conventional-Dose Vitamin D 3
Intervention type(s): Drug; Drug
Intervention description(s): Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU; Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU
Other intervention name(s): High-dose cholecalciferol; Conventional-dose cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preterm; late-onset sepsis; Vitamin D; Dose; Interleukin-6; Tumor necrosis factor-alpha
Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products
Condition: Heat Effect
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is intended to determine the effect of heat and occlusion on oxybutynin
      products.
    

Detailed description: 
      This research study is intended to determine the effect of heat and occlusion on oxybutynin
      products. This study will use an oxybutynin patch and gel that have been approved by the Food
      and Drug Administration (FDA) and are already sold to customers in the United States; will
      not include any placebos.
    

Intervention name(s): oxybutynin; oxybutynin
Intervention type(s): Drug; Drug
Intervention description(s): patch; gel
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Actigraphs for Detection of Asymmetries
Condition: Hemiplegia; Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Observational [Patient Registry]

Summary: 
      In hemiplegia quantitatively measurement of the asymmetry in the use of upper limbs could
      overcome the limitation of many outcome measures in which scores are dependent on the
      experience and training of the therapist. The main aim of this study was to determine the
      validity of Actigraph GXT3+ to measure asymmetry in the use of the two upper limbs during the
      Assisting Hand Assessment (AHA) in children, adolescents and young with hemiplegia aged 5-19
      years, compared to age-matched typically developing subjects (TD).
    

Detailed description: 
      This study aims to validate the use of Actigraphs as an evaluation tool of the upper limb
      asymmetry in children / adolescents and young adults with typical development or hemiplegia.

      The validation involves two stages:

      The first stage, carried out in the clinical setting, provides the use of Actigraphs
      (Actigraph GXT3+ and in a subgroup also FitBit) during the administration of clinical tests
      which are usually performed for the evaluation of the manual dominance in individuals with
      hemiplegia but also suitable for those with typical development.

      This first phase will allow to compare the quantitative measures acquired by the actigraphs
      (e.g. the mean activity of each hand and the asymmetry index i.e. difference between the mean
      activities of the two arms) with those from clinical standardized measures.

      The second phase, carried out in a non-clinical setting, provides the use of Actigraphs
      (Actigraph GXT3+ and in a subgroup also FitBit) in a subgroup of subject involved in the
      first phase for a week in order to measure the asymmetry index during the activities of daily
      living.
    

Intervention name(s): Actigraph
Intervention type(s): Other
Intervention description(s): Actigraphs worn on wrists
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children, Adolescents and Adults with hemiplegia and age-matched controls with typical
        development
      
Keywords: Upper limb; Inertial sensors
The Comparative Study About the Effect of Vertebral Body Decompression Procedure
Condition: Osteoporotic Vertebral Compression Fracture
MeSH terms: Fractures, Compression
Study type: Interventional

Summary: 
      The purpose of this study is to compare the treatment efficacy between vertebral body
      decompression procedure and conservative treatment with non-inferiority design
    


Intervention name(s): Decompression; Conservative Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): vertebral body decompression in compression fracture; Conservative Treatment in vertebral compression fracture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vertebroplasty; Core decompression; Osteoporosis
Navigating Health Insurance Selection for IVF Benefits
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of an educational intervention on
      health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits.
      The investigators hypothesize that the intervention is acceptable and satisfactory and will
      result in increased health insurance literacy and utilization of IVF benefits.
    


Intervention name(s): Health insurance educational guide
Intervention type(s): Behavioral
Intervention description(s): The educational guide includes 4 content areas: 1) Definition of key insurance terms; 2) premiums, deductibles across the five 2023 health plans; 3) Summary of how premiums and deductibles can affect out of pocket costs; 4) Guide to finding in-network IVF providers and facilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infertility; IVF; health insurance
A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
Condition: Zygomatic Fractures
MeSH terms: Zygomatic Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      The study is a randomized controlled clinical trial, following the Consolidated Standards of
      Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal
      approach, conventional transconjuctival approach and the Y- modification of the
      transconjuctival approach in the management of zygomatico-maxillay complex fracture.
    

Detailed description: 
      The study is a randomized controlled clinical trial. Twenty-four patients with age range of
      20-50 years requiring open reduction and fixation of a fractured zygomatic complex were
      randomly divided into three equal groups according to the approach used:

      Group A: subtarsal approach group. Group B: conventional transconjuctival approach group.
      Group C: Y- modification of the transconjuctival approach group.
    

Intervention name(s): subtarsal approach; conventional transconjunctival approach; transconjunctival approach with Y- modification
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): surgical approach; surgical approach; surgical approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.
Condition: LUTS(Lower Urinary Tract Symptoms); Benign Prostatic Hyperplasia; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate and compare the pharmacokinetic characteristics
      and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and
      co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy
      male volunteers.
    

Detailed description: 
      A randomized, open-label, single dose, two-way crossover study.
    

Intervention name(s): JLP-1207; Solifenacin 5mg+Tamsulosin 0.2mg
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.; The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: α1-blockers; antimuscarinic agent
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Condition: Meningococcal Meningitis; Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, modified single-blind, randomized, parallel-group, multicenter,
      comparative trial in the United States designed to evaluate the immunogenicity and safety of
      two doses of Menactra vaccine administered alone, and concomitantly with other routine
      pediatric vaccines typically administered between 12 and 15 months of age.

      Primary Objective:

      To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.

      Secondary Objectives:

      Immunogenicity

        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
           Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.

        -  To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when
           Menactra vaccine is administered alone or concomitantly with PCV vaccine.

      Safety

      - To describe the safety profile within 7 and 30 days of each vaccination, and serious
      adverse events (SAEs) throughout the course of the study.
    


Intervention name(s): Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; ProQuad®; Menactra®; Prevnar®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Menactra vaccine; Meningococcal meningitis; Measles; Mumps; Rubella; Varicella virus; Haemophilus influenzae type b; Pneumococcal conjugate vaccine
Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To examine whether providing patients with a cue to the availability of pain medication
      affects patient satisfaction, patient anxiety, PCA efficacy, and safety.
    

Detailed description: 
      Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest
      PCA pumps can be programmed so that the button is backlit with a green light at the end of
      the lockout period, and the green light flashes when the medication is being dispensed. No
      studies have examined whether this type of visual cue would influence satisfaction or other
      patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and
      adolescents, and no studies have examined whether pediatric patients' perspectives would be
      similar to those of adults.
    

Intervention name(s): Patient-Controlled Analgesia pump with Cues; Patient-Controlled Analgesia pump without Cues; Morphine
Intervention type(s): Device; Device; Drug
Intervention description(s): The end of the lockout period will be cued via the PCA pump; The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.; Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Levels of Endocan in Umbilical Cord Blood Samples of Pregnant Females With Intrauterine Growth Retardation
Condition: Intrauterine Retardation
MeSH terms: Fetal Growth Retardation
Study type: Observational

Summary: 
      As a proteoglycan secreted from endothelial cells, expression, and secretion of endocan
      increases in the endothelium of several tissues secondary to inflammation. It can be regarded
      as an indicator of endothelial damage. Besides, it is both a target and a modulator of the
      vascular endothelial growth factor (VEGF) signaling pathway. Considering its action
      mechanisms, it can provide information about angiogenesis, inflammation, and vascular
      permeability.

      It is known that intrauterine growth retardation mainly occurs as a result of endothelial
      dysfunction and abnormal angiogenesis in the placenta. In previous studies, maternal serum
      endocan levels have also been shown to be increased in cases of preeclampsia, which is mainly
      characterized by placental dysfunction.So, we hypothesize that there may be an association
      between endocan levels and intrauterine growth retardation.
    

Detailed description: 
      Endocan is a proteoglycan that is closely associated with inflammation. Its levels increase
      in association with the severity of endothelial damage. Endothelial dysfunction and abnormal
      angiogenesis in the placental tissues are the main pathophysiological mechanisms leading to
      intrauterine growth retardation.

      It has been known that there was a significant association between maternal serum levels of
      endocan and preeclampsia. In cases with preeclampsia, increased serum levels of endocan in
      maternal blood samples has been reported.

      Intrauterine growth retardation is a situation in which endothelial dysfunction and abnormal
      angiogenesis are the leading disturbances. In fetuses with intrauterine growth retardation, a
      hypoxic environment secondary to uteroplacental insufficiency. In previous studies, increased
      levels of endocan in maternal blood samples have been shown. Although maternal blood can be a
      good reflector of situations both in fetuses and their mothers, measurement of endocan in
      umbilical cord blood samples may better represent the pathology in fetuses.
    

Intervention name(s): endocan in umbilical cord blood
Intervention type(s): Diagnostic Test
Intervention description(s): After taking blood samples from the umbilical cord, centrifugation is applied to all samples for 15 minutes at 1000 rpm. The serum samples with specific identification numbers are going to be stored at -80 °C. After completing the study group, all serum samples will be analyzed using human endocan ELISA kit for the measurement of endocan levels.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant females attending outpatient clinics of obstetrics in a tertiary hospital.
      
Keywords: intrauterine growth retardation; umbilical cord blood; proteoglycans; pregnancy outcomes