bioihbjkbjnl/mcl2 huggingface dataset:
Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 3

Summary: 
      determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg)
      plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient
      from the societal perspective over one year.
    

Detailed description: 
      Prospective double blinded randomized controlled study Will be carried out at Ain-Shams
      university hospital Method: - After approval of the research ethics committee of Ain shams
      University and obtaining consent from each patient, 100 patients newly admitted to the
      intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College
      of Chest Physicians (ACP) *will be randomized by the clinical pharmacist using a
      computer-generated randomization sequence with a block size of four into two groups.

      Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign
      guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be
      treated according SSCG plus simvastatin.

      Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.

      Secondary Outcome Measures:

        -  Requirement and length of renal replacement therapy, vasoactive agent support or
           mechanical ventilation

        -  Total ICU length of stay.(LOS)

        -  Number of patients alive 3, 6, and 12 months

        -  Incremental cost effectiveness ratio
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
Other intervention name(s): Zocor 40 mg
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study of Two Formulations of LY3074828 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
      into the blood stream and how long it takes the body to get rid of LY3074828 when given as
      different formulations. The tolerability of LY3074828 will also be evaluated and information
      about any side effects experienced will be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 12 weeks, not including screening.
    


Intervention name(s): LY3074828; LY3074828; Auto-injector (AI); Prefilled syringe (PFS)
Intervention type(s): Biological; Drug; Device; Device
Intervention description(s): Administered SC; Administered SC; AI to administer LY3074828; PFS to administer LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Soluble Epoxide Hydrolase Inhibition and Insulin Resistance
Condition: Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; PreDiabetes; Obesity
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test how soluble epoxide hydrolase (sEH) inhibition with
      GSK2256294 affects tissue sEH activity and insulin sensitivity.
    

Detailed description: 
      We will test the hypothesis that soluble epoxide hydrolase (sEH) inhibition with GSK2256294
      improves insulin sensitivity using the gold-standard, hyperinsulinemic-euglycemic clamps,
      with stable isotope dilution to assess hepatic gluconeogenesis. We will assess
      insulin-stimulated vasodilation in the forearm using plethysmography and in the renal
      vasculature using para-aminohippurate (PAH, IND#133828) clearance. We will obtain adipose and
      muscle tissue before and after clamp to assess insulin signaling in these tissues.

      Subjects are randomized to treatment with the sEH inhibitor GSK2256294 (10mg/day) or matching
      placebo for one week. On the seventh day of drug treatment, subjects will report to the CRC
      in the morning after an overnight fast to undergo a hyperinsulinemic-euglycemic clamp with
      adipose tissue biopsies.

      During the Hyperinsulinemic-euglycemic clamp, insulin will be infused for 2 hours at low dose
      (20 mU/m2/min) and 2 hours at high dose (80 mU/m2/min) to assess insulin sensitivity. The
      Glucose Infusion Rate (GIR) will be adjusted to maintain glucose near 95 mg/dL. The average
      GIR during the final 30 minutes of the high dose period will be used as the measure of
      insulin sensitivity.

      After completion of the study day, subjects will undergo a seven-week washout from study drug
      and then receive the opposite drug for one week. On the seventh day of treatment they will
      report to the CRC after an overnight fast and repeat the study day protocol.
    

Intervention name(s): GSK2256294; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Drug will be taken daily by mouth for 7 days.; Placebo will be taken daily by mouth for 7 days.
Other intervention name(s): GSK2256294 10mg oral capsule; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Arm 1 and 2 are crossover arms
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the blood
      glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects
      with type 2 diabetes.
    


Intervention name(s): insulin degludec/insulin aspart; insulin degludec/insulin aspart; insulin degludec/insulin aspart; biphasic insulin aspart 30; biphasic insulin aspart 30; biphasic insulin aspart 30
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.4 U/kg body weight injected subcutaneously (under the skin) once; 0.6 U/kg body weight injected subcutaneously (under the skin) once; 0.8 U/kg body weight injected subcutaneously (under the skin) once; 0.4 U/kg body weight injected subcutaneously (under the skin) once; 0.6 U/kg body weight injected subcutaneously (under the skin) once; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Condition: Low Milk Supply
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Domperidone in those
      mothers who are identified as having difficulty with breast milk production to meet the
      nutritional needs of their infant in the neonatal intensive are unit hospitalization setting,
      and to determine how it should be considered in the care of mothers and their preterm infants
      without causing undesirable effects to either the mother or infant.
    

Detailed description: 
      It is widely acknowledged that recent perinatal and neonatal technological advances (eg.
      assisted ventilation, surfactant, antenatal corticosteroids) have greatly enhanced the
      survival rate of very low birth weight and extremely low birth weight infants. A compelling
      body of evidence now exists to suggest that use of breast milk to feed preterm infants during
      initial hospitalization positively impacts their neurodevelopment during early childhood and
      beyond. In order to provide breastmilk, mothers of preterm infants have to begin to produce
      and mechanically express milk. However, these mothers are often faced with challenges in
      maintaining an adequate volume that will meet their infants' nutritional needs, as well as
      declines in production after several weeks despite a myriad of measures designed to assist in
      production. The primary hypothesis for this study is that Domperidone, through its
      pharmacologic action on increasing prolactin levels, will assist mothers experiencing
      inadequate breast milk production in increasing breast milk volumes to a level identified as
      being sufficient for continued pumping in the hospitalization period.
    

Intervention name(s): Domperidone maleate; Placebo Tablet; Domperidone maleate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): domperidone maleate tablet 10 mg orally three times daily for 28 days; placebo tablet 10 mg orally three times daily for 14 days; domperidone maleate tablet 10 mg orally three times daily for 14 days
Intervention MeSH terms: Domperidone; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breastmilk; domperidone; preterm
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Observational

Summary: 
      The Sutent® Observational Study is being proposed to assess the real-world usage patterns and
      effectiveness and tolerability of treatment of Indian patients with advanced renal cell
      cancer with Sutent®. Generation of such information is expected to aid everyday clinical
      decision-making by Indian doctors and will add to the body of generalizable evidence.
    

Detailed description: 
      The assignment of the patient to Sutent® treatment is not decided in advance by this
      noninterventional study protocol, but falls within current practice. The decision to
      prescribe Sutent® is clearly not driven by the decision to include the patient in this
      study.The sample size for this study is not based on statistical considerations. It is
      expected that a minimum of 100 patients will be enrolled in the study by the end of the first
      year and the data collected would be adequate to fulfill the observational objectives of the
      study.The study will be initiated at 10 sites across India during the 1st year. The study may
      be expanded with the addition of new sites during the 2nd year.
    

Intervention name(s): Non Interventional
Intervention type(s): Other
Intervention description(s): Sutent capsule, once daily administered per the locally approved product information.
Other intervention name(s): Observational
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory
        settings prescribed Sutent® will be eligible for the study.
      
Keywords: Advanced renal cell Cancer; Non interventional study; Renal Cancer; Sutent; Metastatic; Advanced Renal Cell Carcinoma
Hemodialysis and Wanting for Protein-rich Foods
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      A study conducted in the laboratory revealed the existence of a "window" during which
      patients with renal failure appreciate the protein-rich foods. This period, located
      immediately after the dialysis, is likely related to the purification of plasma products
      resulting from protein catabolism. It therefore appears necessary to understand the
      mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone),
      leptin (anorectic hormone) and plasma amino acids.
    

Detailed description: 
      In 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at
      11:00 am), a day without hemodialysis and another day after the hemodialysis:

        -  Hunger sensation,

        -  Olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2
           protein-rich foods) and 2 non-alimentary products,

        -  Food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6
           carbohydrate- and 6 protein-rich foods),

        -  Two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin
           as well as plasma amino acids.

           24 healthy subjects are also evaluated in order to compare the results from patients to
           those of control subjects.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        hemodialysis centers of Clinique Drevon, Dijon, France la Breuchillière, Saint Apollinaire,
        France University Hospital, Dijon, France Macon Hospital, Macon, France
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
Condition: Partially Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm
      diameter implant in a Chinese population by evaluation of marginal bone level alteration,
      implant stability and implant survival in the posterior mandible up to 3 years after loading.
      Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
    


Intervention name(s): OsseoSpeed™ TX
Intervention type(s): Device
Intervention description(s): OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV
Condition: Human Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomised clinical trial aims to determine whether an immunization schedule comprising
      two doses of Gardasil administered six months apart is non-inferior to a schedule comprising
      three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18
      infections that persist for at least six months, up to ten years after the initial
      vaccination.

      The study hypothesis is that the two-dose schedule would offer similar protection as that of
      a three-dose schedule against persistent HPV-16/18 infections.
    


Intervention name(s): Quadrivalent HPV vaccine
Intervention type(s): Biological
Intervention description(s): One dose of Gardasil administered in the intervention group
Other intervention name(s): Gardasil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Platelet Count（PC）/Spleen Diameter(SD) Ratio to Predict the Variceal Haemorrhage in HBV Cirrhotic Patients in China
Condition: Platelet Count/Spleen Diameter Ratio; Child-Pugh Classification
Study type: Observational

Summary: 
      To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese
      patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.
    

Detailed description: 
      Esophageal variceal bleeding remains the leading cause of acute mortality in patients with
      cirrhosis. Using noninvasive parameters for high-risk variceal haemorrhage may reduce the
      need for endoscopies. The ratio of platelet count/diameter of the spleen (PC/SD ratio) is the
      principal noninvasive predictor of esophageal varices. This was an analytical cross-sectional
      study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between
      January 2013 and August 2015. This study is to validate the PC/SD ratio to identification of
      those patients with high bleeding risk and selection for prophylactic treatment.
    

Intervention name(s): Platelet count/spleen diameter ratio
Intervention type(s): Other
Intervention description(s): Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated
Other intervention name(s): PC/SD ratio
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HBV cirrhotic patients in China
      
Keywords: Platelet count/spleen diameter ratio; China
Metabolic and Neurofunctional Responses to Breakfasts
Condition: Feeding Behaviors; Lack of Satiety; Attention Deficit and Disruptive Behavior Disorders
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This study aims at assessing the effects of glucose and different types of breakfast on
      metabolic and neurofunctional responses in healthy individuals.

      Twelve healthy subjects, on a stable diet, in a randomized-crossover fashion, received either
      a 50 g glucose load (control) or one of these breakfast:

      B1: milk (125ml) and cereals (30g); B2: milk (220ml), apple (200g) and cream chocolate filled
      sponge cake (30g); B3: milk (125ml), bread (50g), apple (150g) and hazelnut cream chocolate
      (15g). Prior and upon completion of each tolerance test, an EEG was performed to measure
      frontal P300-evoked potentials.
    


Intervention name(s): Glucose; Milk & Cereals; Milk, apple & snack; Milk, apple & bread w/ cream; EEG_pre; EEG_post
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Device; Device
Intervention description(s): 50g of glucose dissolved in 250 to 300ml of water was drunk. Prior and upon completion of each glucose tolerance test, an EEG was performed.; A breakfast (B1) including a glass of milk (125ml) and 30 g-corn flakes was consumed. Prior and upon completion of each tolerance test, an EEG was performed; A breakfast (B2) including a glass of milk (220ml), an apple (200g), a cream chocolate filled sponge cake (30g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.; A breakfast (B3) including a glass of milk (125ml), an apple (150g), bread (50g, hazelnut chocolate cream (15g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.; Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials; Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ghrelin; breakfast meal; P-300
The Effects of Ergonomics Awareness Education and Exercise
Condition: Ergonomics; Telerehabilitation; Musculoskeletal System Disorder; Quality of Life
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study aims to determine the effects of asynchronous and synchronous exercises, which are
      added to ergonomics awareness education, on musculoskeletal disorders, physical activity and
      quality of life.
    


Intervention name(s): Asyncronized Exercise; Syncronized Exercise
Intervention type(s): Behavioral; Procedure
Intervention description(s): This group will be informed about ergonomics and protective exercises for the musculoskeletal system with an online seminar.; This group will be informed about ergonomics and protective exercises for the musculoskeletal system with an online seminar. Then, participants will complete the 6 weeks of exercise training at an online video conference program two times a week under the physiotherapist's supervise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gender in Face-Voice Integration
Condition: Healthy
Study type: Interventional

Summary: 
      Bayesian models of perception represent a promising approach to describe information
      processing by the brain. Predictive coding hypothesizes a process in which top-down
      expectations are continuously compared across multiple hierarchical levels with bottom-up
      sensory inputs and the differences or error signals are propagated in a bottom-up direction.
      The investigators hypothesize that strong expectations, are best investigated in expert
      processes such as face and voice recognition in humans. Individuals in complex social systems
      need to extract socially relevant information in a fast and efficient manner; hence, the
      majority of humans constitute face, voice and gender experts. Nevertheless, linking such
      combined abilities to brain activity with regards to the predictive coding hypothesis has not
      been attempted.Our results suggest asymmetric contributions of visual and auditory signals to
      the gender classification task. This sensitive psychophysical procedure is implemented in a
      decoding approach using fMRI and multi-voxel pattern analysis (MVPA). The investigators plan
      to test whether cortical areas implicated in processing auditory and visual gender signals
      show similar asymmetries.
    


Intervention name(s): fMRI study
Intervention type(s): Other
Intervention description(s): Functional brain activations of face-voice processing during a gender task
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fMRI, perception, face-voice processing