bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of AMG 557 in Subjects With Lupus Arthritis
Condition: Lupus Arthritis, Systemic Lupus Erythematosus
MeSH terms: Arthritis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose
      study that will enroll approximately 40 systemic lupus erythematosus subjects with active
      lupus arthritis.
    


Intervention name(s): AMG 557; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.; Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus
Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
Condition: Evidence Based Practice
Study type: Interventional

Summary: 
      This study aims to test the impact of an empirically derived implementation strategy-under
      real-world conditions and across multiple child service systems-on successful adoption and
      sustainment of two evidence-based programs that address adolescent substance abuse: Treatment
      Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and
      Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for
      this study utilize "technology-based approaches" for "implementing large-scale change."
      Leveraging previous data focused on developing and testing the 8-staged Stages of
      Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy
      (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase
      and testing the SIC-CS to support the adoption of new evidence-based programs.
    


Intervention name(s): SIC Coaching
Intervention type(s): Behavioral
Intervention description(s): Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Identification of Null Allelic Variant of CYP2C8 In A Korean Population
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic
      population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.
    

Detailed description: 
      Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream
      region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct
      sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8*11
      using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses
      and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was
      conducted in 7 healthy subjects with CYP2C8*1/*1 and 2 with CY2C8*1/*11.
    

Intervention name(s): Rosiglitazone; CYP2C8 genotype
Intervention type(s): Drug; Genetic
Intervention description(s): single oral administration of 4mg of rosiglitazone; CYP2C8*11.
Other intervention name(s): Avandia; avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP2C8; genetic polymorphism; rosiglitazone; Korean
Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following
      distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract
      infection and complications.
    

Detailed description: 
      The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the
      occurrence of urinary tract infections (UTIs) and complications. However, even though
      prophylactic antibiotics are used by some pediatric urologists, to date there has been no
      evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications.
      This is a prospective, randomized trial involving children undergoing distal or mid-shaft
      hypospadias repair. Subjects randomized into a group taking prophylactic dosages of
      antibiotics and a group not receiving post-operative antibiotics.
    

Intervention name(s): Septra
Intervention type(s): Drug
Other intervention name(s): Bactrim; Sulfamethoxazole/trimethoprim
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Antibiotic Prophylaxis
Development of Reward Processing in Prenatally Exposed Adolescents and Young Adults
Condition: Pre-natal Cocaine Exposure; Risk-Taking
Study type: Observational

Summary: 
      Reward processing will be examined in prenatally exposed emerging adults in a longitudinal
      design. Participants will be followed for one year to see if neural markers of reward
      processing prospectively predict risk-taking behavior.
    

Detailed description: 
      This cohort will be drawn from a pre-existing cohort of individuals recruited as part of an
      already existing study, and who have been followed since birth. Reward processing will be
      measured in two temporally close testing sessions involving two methodologies,
      electrophysiology and fMRI. Information will also be collected pertaining to experimental and
      problematic drug use, as well as information about mood, at the recording sessions. Drug use
      and mood information will then be collected once again in quarterly follow-up sessions for
      one year. The goal is to examine if PCE status and reward processing are risk factors for
      problematic drug abuse and risky behaviors in emerging adulthood, and if these factors
      interact to increase such risk.
    

Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): Observation of neural markers of reward processing
Other intervention name(s): EEG
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emerging adults in this study will be drawn from a sample of 359 individuals who have been
        participating in a longitudinal study of the effects of PCE on physical, social, cognitive
        and emotional development. Children and their mothers who were exposed to drugs other than
        cocaine were also enrolled, as were non-drug exposed controls. Prenatal drug exposure
        status was ascertained at time of recruitment via a detailed interview that covered
        lifetime substance use and use in the past 30 days, as well as a urine screening of mother
        and infant and meconium toxicology. The sample from which participants will be recruited
        consists of 81% African American, 6.5% Hispanic and 12.5% Caucasian children, all of who
        come from the greater New Haven area. The sample was recruited at birth over a 5-year
        period.
      
Keywords: substance abuse
Photoallergy Potential of Dapsone Gel in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential of dapsone gel and its vehicle to cause a
      photoallergic reaction after repeated application and irradiation to the skin of healthy
      volunteers under controlled conditions.
    


Intervention name(s): dapsone gel; dapsone gel vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Patches containing dapsone gel will be applied to the skin.; Patches containing dapsone gel vehicle will be applied to the skin.
Intervention MeSH terms: Dapsone
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Blood Propofol Concentrations in Children During Spinal Surgery
Condition: Spine Deformities; Idiopathic Scoliosis; Neuromuscular Dystrophy
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      During major spinal surgery evoked potential monitoring is performed to detect spinal cord
      damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile
      anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with
      propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an
      automated drug delivery system which administers propofol to achieve a desired blood
      concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous
      studies. The TCI model also provides a real time predicted blood concentration to facilitate
      the anaesthetist to adjust the target concentration of propofol.

      The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a
      relatively small number of patients, by a "best fit" relationship between blood levels,
      infusion rates and other factors (such as age and weight). Several factors make it possible
      for a wide discrepancy between the predicted and the true blood concentrations. This
      difference can be higher in children compared to adults. Also blood loss and administration
      of large volumes of intravenous fluids can affect the blood concentrations. This study aims
      to identify the difference between the predicted and true blood concentrations by using
      Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major
      spinal surgery under TIVA.
    


Intervention name(s): Pelorus 1500; Propofol 2% (Diprivan 2%, Astra Zeneca UK)
Intervention type(s): Device; Drug
Intervention description(s): a bedside blood propofol measurement device
Other intervention name(s): Sphere Medical, UK
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Keywords: Children
n-3 Fatty Acid Infusion and Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this experimental study is to investigate whether an acute lipid infusion
      added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2
      diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids.
      Furthermore other effects on intermediary metabolism are tested for.
    

Detailed description: 
      Evidence indicates that n-3 fatty acids exert several beneficial effects. However, the
      effects of marine n-3 fatty acids on intermediary metabolism have not been completely
      elucidated. In a previous study of a high intake of marine n-3 fatty acids during 9 wk we
      demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat
      oxidation in subjects with type 2 diabetes. These results question the use of high doses of
      n-3 supplements in type 2 diabetes. It is not known to what extent such effects in type 2
      diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether
      short term intravenous administration has other effects.
    

Intervention name(s): Intralipid +/- Omegaven
Intervention type(s): Dietary Supplement
Intervention description(s): Intralipid®: the 500 ml 20% Intralipid will be infused during a hyperinsulinemic clamp. Infusion rate will increase from 50 to 100 ml/hour the first 30 min and then continue at 100 ml/hour for the next 210 min, infusion duration 240 min (4 hours) in all.
Intralipid® + Omegaven®: In the 500 ml 20% Intralipid 100 ml will be replaced by 100 ml 10% Omegaven and infused during the hyperinsulinemic clamp as described for Intralipid only. Heparin (0.4 U/kg/min) will be added to both lipid emulsions.
Content of marine n-3 fatty acids in 100 ml Omegaven will be 1.25-2.82 g EPA and 1.44-3.09 g DHA (seasoning variations of n-3 fatty acids in fish oil).
Other intervention name(s): Fresenius Kabi, ATC main group B05B A 02; Intralipid Vnr 42 79 55; Omegaven Vnr 55 25 54
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Intralipid; Omegaven; fish oil; hyperinsulinemic isoglycemic clamps; C-peptide glucagon test; indirect calorimetry; F2-isoprostanes
MUSIDORE PED Study
Condition: Pain Management; Music Therapy
Study type: Interventional

Summary: 
      The aim of this study is to measure the efficacy of music during a painful procedure in
      pediatric intensive care unit.

      Music therapy has real effects on the pain level already proven in adults units. Our
      objective is to apply this technic to children. The investigators will evaluate this technic
      during cleaning care which is daily procedure for each stable patient and wich may be painful
      in this population.
    

Detailed description: 
      Pediatric intensive care units may be anxious places. A lot of painful and stressful
      procedures are done every day. A simple care such as a simple cleaning care may become
      painful or uncomfortable.

      Usually those situation require the use of painkillers. For several years, new approaches are
      used in order to decrease the pain level without medication such as hypnosis or music
      therapy. Music therapy proved efficacy to reduce pain in different procedures and is
      currently used in adult intensive care units in order to decrease anxiety and pain.

      One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm
      variations following the U scheme, to relax patients.

      This program will be evaluated in our department and the investigators will study the effects
      on the pain level during a cleaning care .

      The patients will be evaluated during two consecutive cleaning cares. One with and the other
      without music therapy. The investigators will compare the variation of the FLACC scores
      (before and during cleaning care ) to show a difference between both methods. The order (with
      or without) will be randomized. The patient will be his one control.
    

Intervention name(s): Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
Intervention type(s): Device
Intervention description(s): Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pediatric Critical ill care or intensive care; anxiety; pain
English as a Second Language Health Literacy Program
Condition: Health Literacy; Language
Study type: Interventional

Summary: 
      This research is using a Community-Based Participatory Action Research (CBPAR) approach to
      design, implement, and evaluate English as a Second Language health literacy classes for
      Hispanic adults to reduce lead exposure.
    

Detailed description: 
      This Community-Based Participatory Action Research (CBPAR) aims to:

        1. Develop a community-based participatory English as a Second Language (ESL) health
           literacy curriculum for lead exposure that can be used in other locations or programs.

        2. Determine the outcomes of the curriculum, including changes in knowledge about lead,
           access to health resources, and health behavioral changes to reduce lead exposure.

        3. To evaluate the implementation of the ESL health literacy curriculum.

      This research focuses on ESL health literacy classes provided to Hispanic adults to reduce
      lead exposure. This research will use a pilot test with a pre-post test design. The program
      will last for 8 weeks; with weeks 1 and 8 as the assessment weeks. The curriculum uses
      pedagogies that move participants from health literacy as functional skill to health literacy
      as social practice where knowledge is used for empowerment and meaningful change. The goals
      of this research are to demonstrate increased health literacy knowledge, improved health
      behaviors, increased access to health services, and improved English language proficiency for
      Hispanic residents of Flint in relation to lead exposure prevention.
    

Intervention name(s): ESL Health Literacy Classes
Intervention type(s): Behavioral
Intervention description(s): The intervention will last 8-weeks, and the first and last classes will be devoted to survey assessments. Participants will be asked to reflect on their health knowledge and behaviors, and how they have changed since starting the program. The curriculum administered during the classes will use pedagogies for health literacy as a practice. It will focus on skills needed to learn about lead exposure in the ESL classroom: (1) vocabulary; (2) grammar; and (3) identifying risk factors, symptoms and preventive strategies. A focus on health literacy as practice will include personal engagement using language in context: (1) role-play interactions about lead exposure prevention; (2) discussing views about risk, and how to talk about it with peers and family members; (3) identifying sources of reliable health information; and (4) learning to ask for support and resources.
Intervention model: Single Group Assignment
Intervention model description: A pilot trial will be used: study participants will be registered and placed into the program on a first-come, first-served basis. This will result in a study assessing correlation rather than causation.
Masking: None (Open Label)
Primary purpose: Prevention
Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
Condition: Abdominal Abscess
MeSH terms: Abscess; Abdominal Abscess
Study type: Observational

Summary: 
      Increasing radiation exposure by medical examinations is getting more concerns. For optimal
      medical imaging, reducing radiation exposure with preservation image quality is important.
      One of the solutions is use of iterative recontruction of CT examination. In this study, the
      investigators aimed to investigate the clinical feasibility of ultralow dose abdominopelvic
      CT with iterative reconstruction in patients with intraabdominal abscess. Patients with
      intrabdominal abscess usually undergo multiple CT examinations to evaluate treatment
      response. Therefore, ultralow dose CT can reduce unnecessary radiation exposure in these
      patients.
    


Intervention name(s): ultralow dose abdominopelvic CT
Intervention type(s): Other
Intervention description(s): In the patient cohort with abdominal abscess, ultralow dose abdominopelvic CT will be performed as a follow-up protocol. Ultralow dose CT has approximately 80~90% reduced radiation dose compared to standard dose CT.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected abdominal abscess from a tertiary care clinic.
Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Labor is the process where the cervix is prepared to allow the baby to pass from the uterine
      cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental
      vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is
      passively dilated in response to uterine contractions consists of the second stage in which
      the mother passes the baby through the vagina and the third stage, the exit of the placenta.

      In the first stage of labor, pain is caused by uterine contractions and pressure on the
      cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal
      wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added
      to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve
      roots.

      In this study, we aimed to investigate the effects of dural puncture epidural analgesia
      versus combined spinal-epidural analgesia with epidural volume extension on labor variables.
    


Intervention name(s): Epidural; Intrathecal+Epidural
Intervention type(s): Drug; Drug
Intervention description(s): 2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural; 10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment