bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      While there have been a considerable number of studies on the impact of additional vitamin D
      in the diets of hens on the resulting egg vitamin D content, the effect of consumption of
      such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been
      tested in a RCT.
    

Detailed description: 
      The aim of this study was to investigate the effect of consumption of vitamin D3 versus
      25-hydroxyvitamin D3 biofortified eggs on winter serum 25(OH)D in adults using a 8-wk
      randomized controlled trial. This research will provide new data on the potential of vitamin
      D enriched eggs as a food-based strategy for prevention of vitamin D deficiency.
    

Intervention name(s): Control eggs; Vitamin D3 eggs; 25-Hydroxyvitamin D3 eggs
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Control eggs containing no additional vitamin D beyond norm; Vitamin D3-biofortified eggs; 25-Hydroxyvitamin D3-biofortified eggs
Intervention MeSH terms: Vitamin D; Cholecalciferol; Hydroxycholecalciferols; Calcifediol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D-biofortified eggs; Vitamin D status; RCT
Early Feasibility Study of Zone-MPC and HMS With DiAs in the Outpatient Setting
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is a feasibility study of an artificial pancreas (AP) system with our previously
      validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov:
      NCT01929798) integrated into the Diabetes Assistant (DiAs) system.
    

Detailed description: 
      This is a feasibility study of an artificial pancreas (AP) system with our previously
      validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov:
      NCT01929798) integrated into the Diabetes Assistant (DiAs) system. The system will be
      evaluated on 2-3 subjects per site (n=6-9 subjects) for 2 weeks at 3 different sites (William
      Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN). Basal rates
      will be adjusted in a run-to-run manner by study physicians prior to the closed-loop phase
      for a maximum of 3 weeks. Subjects will then complete 2 weeks at home use of the Zone-MPC/HMS
      system using the DIAs platform for a closed-loop feasibility trial. The purpose of this pilot
      study is to establish that safe day-and-night use of the Zone-MPC/HMS system integrated into
      the DiAs is achievable in the home environment, to analyze and learn to improve upon the
      run-to- run optimization process, and to collect efficacy data to inform a future larger
      study.
    

Intervention name(s): CGM and Insulin Pump; Closed-Loop Control System
Intervention type(s): Device; Device
Intervention description(s): Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump; The devices that will be used in the Closed-Loop Control System include the following components:
DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas; Diabetes Mellitus, Type 1; Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Metabolic Diseases
A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
Condition: Rhinitis Allergic; Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243)
      versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms.
      Participants will receive either the sublingual grass tablet or a placebo tablet during the
      study. It is expected that those participants receiving the active sublingual grass tablet
      will have less hayfever symptoms and need less medications to treat hayfever symptoms during
      the grass pollen season.
    


Intervention name(s): Grass (Phleum pratense) pollen allergen extract; Placebo for SCH 697243
Intervention type(s): Biological; Biological
Intervention description(s): One dissolving tablet sublingually once daily; One dissolving tablet sublingually once daily
Other intervention name(s): SCH 697243
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A New Method To Measure Cervical Proprioception
Condition: Proprioception; Position Sense
Study type: Observational

Summary: 
      To evaluate cervical proprioception (CP), frontal plane target platforms defined Revel
      technique measurement commonly used as an alternative to the Cervical Range of Motion (CROM)
      device in laser measurements for the head repositioning accuracy (HRA) test. However, when
      evaluating CP, the plane where the movement of the atlanto-axial joint takes place is the
      horizontal plane. Therefore, the investigators aimed to investigate the validity and
      reliability of CP measurements conducted via AOS PropPoint® device on the horizontal and
      frontal platforms, and the investigators hypothesized that horizontal platform measurement is
      more reliable and valid than frontal plane measurement.
    

Detailed description: 
      It has been reported in a number of studies that methods utilizing laser are practical, easy,
      portable, and inexpensive in clinical use, a standardized and branded laser apparatus and
      system have not been identified. This has caused problems about whether the laser equipment
      used in the literature is valid and reliable in the evaluation of cervical proprioception
      (CP). Besides, the head repositioning accuracy (HRA) test, which was designed before for CP
      assessment and standardized with trigonometric equations, carries out measurements in the
      frontal plane. In addition, cervical rotation in the atlanto-axial joint occurs in the
      horizontal plane. Therefore, the investigators presume that evaluating the biomechanical
      motion occurring in the horizontal plane and transferring it directly to the horizontal plane
      will be more practical and reliable for practitioners.

      The subjects' HRA values were measured through AOS ProPoint® device in the horizontal and
      frontal platforms and also through the CROM device. Each measurement was repeated bilaterally
      three times, and they were averaged. To validate the measurement method, a comparison between
      the CROM device used as the gold standard and the measurement values was made. Test-retest
      and inter-rater reliability scores were calculated to evaluate the reliability of the
      horizontal measurement method.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample consist of volunteer, healthy participants.
      
Keywords: reliability; validity; cervical; proprioception; rehabilitation
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Condition: Uncontrolled Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3
      Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with
      Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
    

Detailed description: 
      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with
      uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a
      history of asthma exacerbations.

      Approximately 1140 subjects will be randomized globally. Subjects will receive tralokinumab,
      or placebo, administered via subcutaneous injection at the study site, over a 52-week
      treatment period.
    

Intervention name(s): Tralokinumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Lung Disease; Lung Diseases
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's
      Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in
      healthy, adult,human, male subjects under fasting conditions.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single
      dose, crossover bioequivalence study in healthy, adult, human, male subjects under Fasting
      conditions. 72 healthy male adults were enrolled. A washout period of 7 days was maintained
      between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was
      administered orally with 240 mL water in sitting posture, after an overnight fast of at least
      10 hours in each period. This activity was followed by a mouth check to assess compliance to
      dosing. The subjects were not allowed to lie down for the first two hours after dosing.
    

Intervention name(s): Mycophenolate Mofetil; Mycophenolate Mofetil
Intervention type(s): Drug; Drug
Intervention description(s): Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited; 250 mg capsules of Roche Laboratories Inc.
Other intervention name(s): Cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence; Mycophenolate Mofetil; crossover
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning
Condition: Insulin; Glucose Metabolism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of feeding frequency on glucose and
      insulin metabolism and substrate partitioning.
    


Intervention name(s): low feeding frequency (3x); High feeding frequency (14x)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 meals a day; 14 meals a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: feeding frequency; insulin metabolism; glucose metabolism; substrate partitioning
Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery
Condition: Postoperative Pain; Chest Pain; Coronary Artery Bypass; Sternotomy
MeSH terms: Pain, Postoperative; Chest Pain
Study type: Interventional

Summary: 
      Inadequate pain control after coronary artery bypass graft surgery increases mortality and
      results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to
      assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied
      transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores
      and decrease tramadol consumption better after coronary artery bypass graft surgery
    


Intervention name(s): Transversus Thoracic Muscle Plane Block; Parasternal Intercostal Plane Block
Intervention type(s): Procedure; Procedure
Intervention description(s): 40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space; 40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between pectoralis major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adult cardiac surgery; poststernotomy pain; transversus thoracic muscle plane block; parasternal intercostal block; behavioral pain scale; numeric rating scale
Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration
Condition: Small Fiber Neuropathy
MeSH terms: Small Fiber Neuropathy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effects of a nutritional supplement called nicotinamide riboside
      in preventing small fiber nerve degeneration that is experimentally induced by applying
      capsaicin to skin in otherwise healthy study participants. Furthermore, the effects on nerve
      regeneration will also be evaluated. The results will be compared to a placebo control drug.
    

Detailed description: 
      Small fiber neuropathy (SFN) is a type of peripheral neuropathy that affects the small
      unmyelinated fibers, including both somatic innervation of the skin and autonomic nerves.
      Although diabetes and prediabetes are the two most common causes, up to 50% of all SFN remain
      idiopathic. Currently there is no effective treatment that prevents it or reverses it through
      regeneration of nerve fibers.

      Recent advances in understanding the molecular machinery that mediates Wallerian degeneration
      (i.e. degeneration of nerve fibers after physical transection) showed that key molecular
      players in this pathway and nicotinamide (NAD+) metabolites play a similar role in
      degeneration of axons in a distal-to-proximal manner seen in many peripheral neuropathies
      including SFN. Pre-clinical studies have shown that rapid depletion of NAD initiates a
      cascade of molecular events that leads to axon degeneration and that supplementation of a NAD
      precursor, nicotinamide riboside (NR) can prevent this degeneration.

      In this study investigators plan to evaluate the ability of NR to prevent degeneration of
      small somatic sensory axons innervating the epidermis as well as its ability to promote
      regeneration of these same fibers in a human experimental model of nerve degeneration and
      regeneration. This experimental human model has been used previously to evaluate the rate of
      nerve degeneration and regeneration in several peripheral neuropathies and in healthy
      subjects.

      Since NR is available as a nutritional supplement, if successful, this research can lead to
      development of a therapy for a variety of peripheral neuropathies very rapidly.
    

Intervention name(s): Nicotinamide riboside; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration.; Placebo drug that looks like the experimental drug, nicotinamide riboside tablets.
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Cross-Over Broccoli Sprouts Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study hypothesis tested is that broccoli sprouts are effective at altering the urinary
      levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant
      phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study
      will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or
      sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the
      biomarkers.
    


Intervention name(s): broccoli sprouts extract
Intervention type(s): Dietary Supplement
Intervention description(s): Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sulforaphane; pharmacokinetics
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The researchers will investigate if brain insulin action influences peripheral insulin
      sensitivity in healthy humans.
    


Intervention name(s): human insulin as nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: whole body insulin sensitivity; insulin action in the brain
Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG
      somatropin, which administered once per week, compared with the daily used somatropin, and to
      evaluate the safety and possibility to replace daily used somatropin.
    


Intervention name(s): somatropin AQ; pegylated somatropin
Intervention type(s): Drug; Drug
Intervention description(s): somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period; Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection
Other intervention name(s): Somatropin injection; rhGH; PEG somatropin; PEG GH; pharmacokinetics; growth hormone deficiency
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegylated Somatropin; PEG-GH; Phase 1 study; Pharmacokinetics
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of
      ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain in Opioid-Tolerant Patients
      with Chronic Low Back Pain
    


Intervention name(s): ORAVESCENT Fentanyl Citrate
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or
      ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual
      inhibition lipid lowering regimens as part of their normal standard of care. This study
      assesses the percentage of patients who achieve LDL-C target goals and also evaluates the
      patient compliance to treatment.
    

Detailed description: 
      Retrospective medical chart review
    

Intervention name(s): Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
Intervention type(s): Drug
Intervention description(s): Ezetimibe 10 mg taken daily for 3 months
Other intervention name(s): SCH 58235
Intervention MeSH terms: Ezetimibe; Fenofibrate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III
        target to previous lipid lowering treatment, and have received dual inhibition therapy,
        such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least
        3 months
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine
      Gardasil in young women.
    

Detailed description: 
      Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of
      persistent HPV infections and precancerous lesions compared to the healthy population. The
      HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years.
      There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune
      dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE
      might prevent patients with SLE from developing an adequate immune response to the vaccine.
      Also, theoretically, the vaccine might induce a disease exacerbation or production of new
      autoantibodies.

      The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its
      effects on autoantibody profile in female SLE patients aged 9-26 years
    

Intervention name(s): Gardasil
Intervention type(s): Biological
Intervention description(s): 0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lupus