bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric International Nutrition Study 2018
Condition: Pediatric Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      This is a multi-site study of how nutrition is delivered to critically ill patients in
      pediatric intensive care units (PICUs) around the world. Each site will include mechanically
      ventilated children in their respective PICUs and record the details of what type and amount
      of nutrition was received. These details will be compared to goals designated by the
      clinicians caring for each patient. Data will be entered in a secure online remote data
      capture tool and managed by the lead researchers in Pediatric Critical Care Nutrition at
      Boston Children's Hospital, Nilesh Mehta, MD and Lori Bechard, PhD, RD. Data will be analyzed
      to better understand how different types and amounts of nutrition impact important PICU
      outcomes such as length of stay, ventilator time, incidence of infections, and mortality.
    

Detailed description: 
      Specific aim 1: To examine the impact of energy and protein adequacy on clinical outcomes.

      Specific aim 2: To describe world-wide patterns of nutritional therapies in the
      PICU.environment: use of guidelines/use of adjuncts (acid suppression, motility,
      etc.)/glycemic control strategy/etc. To describe these practices in subgroups of: cardiac,
      surgical, medical, oncology/stem cell transplant patients in the PICU.

      Specific aim 3: To examine enteral nutrition practices, including timing, route (gastric vs.
      post pyloric), adjuncts, and enteral nutrition (EN) intolerance definitions, in PICU patients
      worldwide Specific aim 4: To examine the current practices around parenteral nutrition
      prescription during the first week of critical illness in the PICU; time of initiation (early
      vs. late), rationale, threshold for initiation.

      Primary predictor: nutritional adequacy (energy, protein) Secondary predictors: nutritional
      status, use of guidelines/site level indicators (location, staffing), use of adjuncts (acid
      suppression, motility, etc.), EN intolerance, subgroups (cardiac, surgical, medical,
      oncology/stem cell transplant), EN route/timing
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention - exposure is mechanical ventilation in PICU
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 1 month to 18 years of age, admitted to the PICU and requiring mechanical
        ventilation with an anticipated length of PICU stay of 3 days or more.
      
Keywords: Nutrition
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Condition: Healthy
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential disease preventive effects of β-glucans
      from oat and barley.
    

Detailed description: 
      Objective:

      The primary aim is to examine whether consumption of oat and two different barley β-glucans
      exhibits hypocholesterolemic effects and to understand the underlying mechanisms.

      Secondary aims are to investigate whether there are also effects on blood pressure, appetite
      regulation, insulin sensitivity, hemostasis, low-grade inflammation and the metabolic profile
      of different biological materials.

      Intervention:

      In each of the 4 intervention periods the participants drink a milk drink together with their
      three main meals for 21 days. This way they consume 5g β-glucan/d form either oat or barley
      in the three treatment periods, otherwise they maintain their habitual diet. They are not,
      however, allowed to eat any oat- or barley-containing products during the trial.

      At the beginning and at the end of each intervention period the participants' blood pressure
      is measured and a fasting blood sample is drawn.

      Further they collect feces for 72 hours and urine for 24 hours before and at the end of each
      intervention period.

      Before and at the end of each intervention period a 4-hour meal test is undertaken to measure
      their subject appetite sensation. Here at first a fasting blood samples drawn and thereafter
      the milk drink is served. Appetite sensation is assessed every 30 min for 4 hours. Also blood
      samples are drawn at 2 hours and 4 hours at the meal tests which takes place before each
      intervention period.

      At the subsequent "ad libitum" lunch meal the food intake is measured and then a final
      appetite registration is made.

      Furthermore participants make 4-d food records before and at the end of each intervention
      period.
    

Intervention name(s): no β-glucan; oat β-glucan; barley β-glucan; mutant-barley β-glucan
Intervention type(s): Other; Other; Other; Other
Intervention description(s): daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days; daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days; daily consumption of 5g β-glucan extracted from the barley-mutant mother "Bomi" in the form of milk drinks with the 3 main meals for 21 days; daily consumption of 5g β-glucan extracted from the high β-glucan barely mutant "lys. 5.f" in the form of milk drinks with the 3 main meals for 21 days
Other intervention name(s): "PromOat",Biovelop, Kimstad, Sweden
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: β-glucan; cholesterol; bile acids; blood glucose; appetite
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV
      gentotype-1 in chronically infected subjects and to further evaluate the safety profile of
      EDP239.
    


Intervention name(s): EDP239; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C infected subjects
Manual Lymphatic Drainage for Rheumatoid Arthritis
Condition: Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by
      inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive
      damage occurs in cartilage, bone and joints. This damage leads to severe functional
      limitations and deterioration in quality of life. Synovial tissues are the main site of
      involvement. Manual lymph drainage reduces the levels of inflammatory mediators associated
      with edema and pain in the acute phase. On the basis of this concept; Stimulating the lymph
      system and increasing circulation, removing biochemical residues, regulating sympathetic and
      parasympathetic system responses, and thus reducing edema and pain. The increase in cardiac
      parasympathetic activity measured after MLD also contributes to relaxation. In addition to
      the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the
      skin with the touches it contains. Gentle stimulation to the skin increases tactile input and
      closes the pain pathways. In addition, the superficial relaxation and warming provided by
      soft stimulation creates an effect on the autonomic nervous system and activates the
      parasympathetic system. The aim of this study is to evaluate the effect of manual lymphatic
      drainage on upper extremity functionality in individuals with rheumatoid arthritis.
    


Intervention name(s): manual lymphatic drainage; excersize
Intervention type(s): Other; Other
Intervention description(s): In addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients.; upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate
      Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B
    

Detailed description: 
      Un-randomized, open Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and
      pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with
      Chronic Hepatitis B

      20 subjects with Chronic Hepatitis B will be enrolled. 10 subjects will be assigned to group
      A and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg twice daily
      for 48 weeks. 10 subjects will be assigned to group B and receive Morphothiadine Mesilate
      Capsule 120mg and Ritonavir Tablet 100mg three times daily for 48 weeks.
    

Intervention name(s): GLS4; RTV
Intervention type(s): Drug; Drug
Intervention description(s): Subject in group A will receive Mesilate Capsule 120mg twice daily. Subject in group B will receive Mesilate Capsule 120mg three times daily.; Subject in group A will receive Ritonavir tablet 100mg twice daily.Subject in group B will receive Ritonavir tablet 100mg three times daily.
Other intervention name(s): Morphothiadine Mesilate Capsule; Ritonavir tablet
Intervention MeSH terms: Ritonavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy
Condition: Bariatric Surgery Candidate; Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly
      obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and
      assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice
      computer tomography.
    


Intervention name(s): sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Sleeve Gastrectomy; gastric reservoir; Multi-slice computer tomography
Pharmacokinetic Study of Belviq in Adult Korean Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, single-dose, dose escalation study (Phase I)
      to evaluate the tolerability and pharmacokinetics of Belviq in adult Korean volunteers.
    

Detailed description: 
      The volunteers are screened through medical history, physical exam, laboratory tests etc.
      within 4 weeks (-28d~-2d) prior to the day scheduled for taking the investigational product
      (1d). The final subjects determined eligible for this clinical trial through screening tests
      are randomized to the dose groups with Belviq 10 mg and 20 mg. Twelve subjects are assigned
      to each group (9 subjects to study drug and 3 subjects to placebo), and the study drug or
      placebo are administered to the corresponding administration group. The subjects are
      discharged on the morning of 4d after completing the set study schedule at 72 hours after
      administration. The subjects then visit for the final tests on the last out-patient visiting
      day. Belviq is progressed sequentially from the low-dose group to the high-dose group.

      The blood sampling time for the pharmacokinetic evaluation is as follows. Blood sampling for
      pharmacokinetic evaluation

      : Before administration(0), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 and
      72 h (17 times) after medication.
    

Intervention name(s): Belviq 10mg; Belviq 20mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Belviq 10mg single dose administration; Belviq 20mg single dose administration; Placebo single dose administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy, Volunteers
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section
Condition: Opioid Use; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus
      opioid
    

Detailed description: 
      Women will be approached priors to discharge from the hospital, if they meet inclusion
      criteria and consent for the study, they will be randomized to one of two possible analgesic
      regimens. They will be followed at 1-2 weeks and 4-6 weeks after discharge to assess pain
      level.
    

Intervention name(s): Ibuprofen; Acetaminophen; Norco
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NSAID; analgesic; acetaminophen plus opioid
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two parallel groups included, randomized to control analgesic regimen versus alternative analgesic regimen and followed prospectively.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postpartum
One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators
Condition: Thoracic Surgery With One-lung Ventilation
Study type: Interventional

Summary: 
      One-lung ventilation; organ protection; volatile anesthetics

      One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis
      will be tested in this study:

        1. Are inflammatory mediators increased in the re-ventilated lung after short-period
           pulmonary collapse?

        2. Does Sevoflurane influence the production of inflammatory mediators in the re-inflated
           lung? Therefore, this study will elucidate the potential protective effect of a volatile
           anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory
           compartment of the lung, i.e. the alveolar epithelium.

             -  Trial with immunomodulatory product / biological
    


Intervention name(s): Sevoflurane/propofol
Intervention type(s): Drug
Intervention description(s): Sevoflurane/propofol
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Physical Activity of Asthmatic Children
Condition: Physical Activity; Asthma; Child Development
MeSH terms: Asthma
Study type: Observational

Summary: 
      Physical activity is mandatory to the optimal development and health of children. The
      presence of asthmatic manifestations may influence the comportment of children and its family
      toward exercise and practice of sports. There no scientific argument to advice a reduction of
      physical activity in asthmatic children, but previous studies showed that physical activity
      is reduced in asthmatic children.

      The aim of this observational study is to evaluate the existing factors leading to this
      reduction of physical activity in asthmatic children and their families.
    

Detailed description: 
      Physical activity is mandatory to the optimal development and health of children. The
      presence of asthmatic manifestations may influence the behaviour of children and its family
      with a significant reduction of exercise and practice of sports.

      There no scientific argument to advice such a reduction of physical activity in asthmatic
      children.

      The aim of this observational study is to evaluate the existing factors leading to this
      reduction of physical activity in asthmatic children and their families.

      To evaluate the factors explaining this behaviour the investigator design an observational
      study, based on a questionnaire.

      The evaluation of the number of sujets to complete this study is 50 asthmatic children. The
      whole population will be considered as the same group. This study may be further completed by
      a comparative and new study including asthmatic and non-asthmatic children.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic cohort of the asthma clinic of the children hospital
A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated
Condition: Type II Diabetes Mellitus; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to look at the effect MEDI0382 has on blood sugar in people with type 2 diabetes and
      kidney problems and also to check that MEDI0382 is well tolerated.
    


Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.; Participants will receive SC placebo matched to MEDI0382 once daily for 32 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-Blind, Placebo-Controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; MEDI0382; Renal Impairment; Glucose concentration; Hemoglobin A1c
A Pharmacokinetic Study of Oral Deflazacort in Children and Adolescent Subjects With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterize the single-state and steady-state dosing of oral deflazacort in
      pediatric and adolescents subjects.
    

Detailed description: 
      This is an open label, single period study in 24 male DMD subjects consisting of children
      (ages 4-12, inclusive) and adolescents (ages 13-16, inclusive) with at least 12 subjects
      between the ages of 4-12 (children). Subjects taking maintenance corticosteroid therapy will
      be required to take their dose of corticosteroid 24 hours (± 2 hours) prior to the first dose
      of deflazacort on Day 1. Subjects receiving deflazacort as maintenance corticosteroid therapy
      must take their last dose at least 30 days prior to the first dose of deflazacort on Day 1.
      Concomitant corticosteroid therapy will be prohibited during the study while the subject is
      taking deflazacort. On Day 1, a single oral dose of deflazacort under fasting conditions will
      be administered in the CRU followed by blood sampling for plasma analysis of DFZ and
      21-desacetyl-DFZ for 8 hours. Following the 8 hour PK sample on Day 1, subjects will be given
      medication to take at home for once-daily, morning dosing on Days 2 through 7 (+2 days). On
      Day 8 (+2 days), subjects will return for a PK sample predose and an 8th oral dose of
      deflazacort under fasting conditions which will be administered in the CRU followed by PK
      sampling for 8 hours.

      Safety will be monitored throughout the study by repeated clinical and laboratory evaluations
      on Days 1 and 8 (+2 days). Subjects will be contacted via telephone approximately 7 days (± 1
      day) following study drug administration on Day 8 (+2 days) for a follow-up assessment to
      determine if any adverse event (AE) has occurred since the last study visit. Subjects who
      terminate the study early will be contacted if the Principal Investigator (PI) deems
      necessary.

      Subjects that complete this study or receive at least one dose of study medication will be
      eligible for an open-label extension study with deflazacort treatment conducted under a
      separate protocol.
    

Intervention name(s): Deflazacort
Intervention type(s): Drug
Intervention description(s): Oral deflazacort administered once daily at 0.9 mg/kg for eight days
Other intervention name(s): DFZ
Intervention MeSH terms: Deflazacort
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Adolescent; Deflazacort
In Field Performance of a Hearing Aid Transducer
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Study participants will be fit with previously released receiver-in-canal (RIC) hearing
      instruments. Participants will be asked to wear the instruments in their daily life for a
      minimum of 3 months, but have the option to continue to wear devices for six months.
    


Intervention name(s): Receiver-in-canal hearing instrument
Intervention type(s): Device
Intervention description(s): Receiver-in-canal hearing instrument
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
Condition: Irregular Sleep-Wake Rhythm Disorder
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted to determine the dose response of lemborexant (LEM) on the
      change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters,
      and circadian-rhythm related parameters. Following the eligibility screening period, eligible
      participants will be assigned at random to 1 of 4 doses of LEM or to placebo for 4 weeks.
      After a 2-week follow-up period, eligible participants may enter an open-label extension
      period for up to 30 months or until the program discontinuation.
    


Intervention name(s): Lemborexant 2.5 mg; Lemborexant 5 mg; Lemborexant 10 mg; Lemborexant 15 mg; Lemborexant-matched placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lemborexant 2.5 mg tablets; Lemborexant 5 mg tablets; Lemborexant 10 mg tablets; Lemborexant 5 mg and 10 mg tablets; Lemborexant-matched placebo tablets
Intervention MeSH terms: Lemborexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild to Moderate Alzheimer's Disease Dementia; sleep; circadian rhythms