bioihbjkbjnl/mcl2 huggingface dataset:
PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients
Condition: Sciatica
MeSH terms: Sciatica; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to see if the spine shows areas of inflammation using a specific
      type of imaging (pictures).
    

Detailed description: 
      The purpose of this study is to determine if inflammation around the spinal nerves can be
      identified using a radioactive tracer [11C] PBR28 and integrated PET/MRI scan for the purpose
      of better treating patients who have radicular lumbar pain with epidural steroid injections.
    

Intervention name(s): Radioactive dye; PET/MRI; Blood draw
Intervention type(s): Drug; Radiation; Other
Intervention description(s): The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).; All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.; Up to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers.
Other intervention name(s): [11C]PBR28; Integrated MR-PET 3 Tesla scanner (Siemens Biograph mMR).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Subject is currently diagnosed with lower extremity radicular/sciatica pain.

          2. Healthy subjects with no pain from the local community.
      
Biospecimen description: 
      A blood sample will be taken from healthy subjects only at Visit 1. The blood sample will
      genotyped. Genotyping will identify if the subject makes proteins that will bind the
      radioactive tracer.

      A blood sample will be drawn for Genotyping at Visit 2 from all subjects.
    
Keywords: Sciatica; PET scan; MRI; Inflammation; Epidural Steroid Injection (ESI)
A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of
      JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients
      with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD)
      therapy.
    

Detailed description: 
      This is a randomized (treatment assigned by chance, like flipping a coin), multicenter,
      double-blind (neither physician nor patient will know the treatment the patient receives),
      parallel-group (each group of patients will be treated at the same time) study. JNJ-40346527
      will be compared to a placebo, which is an inactive substance used to test whether a drug has
      a real effect. Patients will receive study medication for 12 weeks and will continue their
      permitted, stable DMARD therapy (methotrexate [MTX], sulfasalazine [SSZ], and/or
      hydroxychloroquine [HCQ]) through Week 12. A follow-up visit will occur 4 weeks after dosing
      is complete. The maximum length of patient participation will be 22 weeks, including a 6-week
      screening period. Other study visits will occur during the study, and patient safety will be
      monitored.
    

Intervention name(s): JNJ-40346527; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.; Form=capsule; route=oral use; twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy; Disease-modifying antirheumatic drugs
Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women
Condition: Eating Behavior
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the combined effects of sequential meal
      variety and portion size on food intake at a meal. Additionally, other individual
      characteristics will be examined for their influence on the effects of simultaneous variety
      and portion size on meal intake.
    


Intervention name(s): Sequential Variety; Single-Food; Small Portion; Large Portion
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 3 different foods served in 3 successive courses; 1 food served in 3 successive courses; Small meal portion size; Large meal portion size
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Brain Stimulation and Aphasia Treatment
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the changes in language processing of patients with
      chronic, post-stroke aphasia following the application of brain stimulation. The brain
      stimulation the investigators administer is called transcranial direct current stimulation
      (tDCS). It involves passing a weak electrical current through the brain between two
      electrodes in the form of damp sponges. One sponge will be placed over a specified area on
      the damaged left hemisphere, while the other sponge will be placed on the right scalp.
      Computer-controlled speech-language treatment will be administered during the application of
      tDCS.
    

Detailed description: 
      Stroke is the leading cause of adult disability in the United States. Approximately one-third
      of all strokes result in acute language impairment (aphasia), with approximately one-fifth
      suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic
      aphasia remains grim, as current behavioral treatment approaches usually offer only
      limited-to-modest benefit. Recent advancements in understanding the relationship between low
      current electrical brain stimulation and cortical plasticity suggest that the effect of
      behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct
      current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the
      effect of behavioral aphasia treatment. Based on these results as well as our other studies
      aimed at understanding how favorable brain plasticity correlates with positive treatment
      outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility
      design. Consistent with the goals of Program Announcement PAR-08-204 by the National
      Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether
      there is sufficient evidence of short term improvement in humans to justify a phase III
      trial."
    

Intervention name(s): Activa Dose II Real tDCS; Activa Dose II Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions); 20 minutes of sham stimulation per treatment day (15 total sessions)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aphasia; Brain; Stimulation; Communication; Stoke; Post; Phase II Clinical Trial; Treatment; tDCS; Fridriksson
Retrospective Study of Endoscopic Ultrasound (EUS) Guided Transmural Drainage of Post-operative Abdominal Collections
Condition: Post-surgical Intra-abdominal Collection
Study type: Observational

Summary: 
      This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided
      transmural drainage of post-operative collections during a 9 years period.
    

Detailed description: 
      All patients who underwent a EUS guided drainage of post-operative collection between 2002
      and 2011 in the endoscopy unit of Erasme hospital will be included for analysis. The study
      will focus on retrospective analysis of prospectively collected data. The technique is the
      same as the one used for pancreatic pseudocysts drainage. The technical success is defined as
      the ability to access and drain the collection by placement of transmural drain and/or
      stents. Treatment success (regression of collection) is defined as the resolution of the
      collection as shown on abdominal imaging (CT or MRI) in association with clinical resolution
      of symptoms at 8 weeks of follow-up.
    

Intervention name(s): EUS guided transmural drainage
Intervention type(s): Procedure
Intervention description(s): Puncture of the collection is done under EUS guidance using a linear echoendoscope (FG-3830UT, Pentax or Olympus GF-UCT140/180 or forward viewing scope (Olympus)) with a 19G echoTip needle or a cystotome (Cook Medical Inc.). Then a 0.035 guidewire is inserted in the collection and the hole is enlarged with a cystotome (Cook Medical) or a 6.5F diathermic sleeve (Endoflex) and sometimes if needed a 6-8mm CRE balloon (Boston Scientific) before stenting with one or two double pigtail plastic stents (Cook Endoscopy, Endoflex). A nasocystic drain was also put whenever needed. If only a single stent could be placed in the first attempt, a subsequent procedure is scheduled for insertion of additional stents after dilation of the tract. There isn't any specific drug given during the procedure.
Other intervention name(s): Echoendoscope (Pentax FG-3830UT; Olympus GF-UCT140/180); 19G echoTip needle (Cook Medical); Cystotome (Cook Medical); diathermic sleeve (Endoflex); CRE balloon (Boston Scientific); double pigtail stents (Cook Endoscopy, Endoflex)
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent EUS guided drainage of post-operative collections admitted
        between january 2002 and july 2011 for this treatment in the endoscopic department of a
        single academic center will be included for analysis.
      
Keywords: EUS; Endoscopic ultrasound; abdominal collection; post-operative; post-surgical
Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
Condition: Visual Function
Study type: Interventional

Summary: 
      The purpose of this study is to determine if there is a measurable change in visual function
      as a direct result of the application of osteopathic cranial manipulative medicine. The study
      will also attempt to determine whether any changes noted remain after withdrawal of the
      treatment.
    


Intervention name(s): Cranial Manipulation; Sham/Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.; A laying on of hands with no actual treatment being performed.
Other intervention name(s): Osteopathy in the Cranial Field; Osteopathic Cranial Manipulative Medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cranial manipulation; Visual function
Use of Activated Recombinant FVII in Spinal Surgery
Condition: Acquired Bleeding Disorder; Spinal Fusion
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in the United States of America (USA). The purpose of this clinical
      research trial is to understand how safe and effective Recombinant Activated FVII is for
      reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.
    


Intervention name(s): eptacog alfa (activated)
Intervention type(s): Drug
Other intervention name(s): activated recombinant human factor VII
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is comparing the effect of a long-acting insulin analogue (insulin 287) with
      insulin glargine (Lantus®) in subjects with type 2 diabetes. In addition, the study is
      looking at symptoms of low blood sugar, awareness of low blood sugar and the time and amount
      of glucose needed to recover from low blood sugar after injecting 2 and 3 times the basal
      dose of insulin 287 and glargine. The purpose of the study is to make a once-weekly
      injectable basal insulin treatment for people with type 2 diabetes. Participants will get
      insulin 287 as well as insulin glargine - which treatment any participant gets first is
      decided by chance. Insulin 287 is a new medicine; insulin glargine can already be prescribed.
      The study medicines will be in a pen, and must be injected with a needle in the thigh once
      per day (insulin glargine) or once per week (insulin 287). The study will last for minimum 3
      months and up to approximately 6 months. Participants will have 21 clinic visits and at least
      2 phone calls with the study doctor. The participants' health will be monitored carefully and
      blood samples will be taken at the clinic visits.
    


Intervention name(s): insulin icodec; Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks; Participants will receive daily s.c. injections of insulin glargine U100 for 12 days
Other intervention name(s): Insulin 287
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of
      different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of
      GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of
      GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612
      given alone and the immunogenicity of GSK134612 given with Fluarix™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Multicentre study with 5 treatment groups. Three groups will receive three different
      manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an
      experimental co-administration with Fluarix™, the control group will receive Mencevax™. The
      study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612
      vaccine. The study will be 'open' between the groups receiving GSK134612 and the group
      receiving GSK134612 + Fluarix™ and the Mencevax™ group.

      Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to
      vaccination and one taken 30 days later.
    

Intervention name(s): Meningococcal vaccine GSK134612; Mencevax™ACWY; Fluarix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One intramuscular dose; One subcutaneous dose; One intramuscular dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: immunogenicity; Meningococcal serogroups A, C, W-135 and/or Y disease; co-administration; meningococcal vaccine; lot-to-lot consistency; conjugate vaccine
Diet/Growth Factor Mechanisms of Gut Adaptation
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind randomized controlled study on the clinical and metabolic effects and
      underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth
      hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition.
      Clinical endpoints include ability to wean patients from parenteral feeding, metabolic
      endpoints include gut nutrient absorptive function and molecular endpoints include expression
      of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month
      study is performed, in part, in the General Clinical Research Center for inpatient stays and
      outpatient visits.
    

Detailed description: 
      This is a double-blind randomized controlled study on the clinical and metabolic effects and
      underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth
      hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition.
      Clinical endpoints include ability to wean patients from parenteral feeding, metabolic
      endpoints include gut nutrient absorptive function and molecular endpoints include expression
      of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month
      study is performed, in part, in the General Clinical Research Center for inpatient stays and
      outpatient visits.
    

Intervention name(s): recombinant human growth hormone; diet modification
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Turkish Version of Modified Child Dental Anxiety Scale
Condition: Behavior; Child, Only; Anxiety, Dental
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Background: The faces version of the Modified Child Dental Anxiety Scale (MCDASf) is less
      time consuming and an easy to understand tool for measuring dental anxiety. The aim of this
      study was to develop the Turkish version of MCDASf and to analyze its validity and
      reliability.
    

Detailed description: 
      The internal consistency reliability was determined by calculating Cronbach's alpha (n=300).
      Intraclass correlation coefficients (ICCs) were calculated for test-retest reliability
      (n=67). Construct validity was determined by comparing with the Venham Picture Test (VPT).
      The factor structure was examined using exploratory factor analysis (EFA). Confirmatory
      factor analysis (CFA) was used for the dimensionality. The cut-off points of the Turkish
      version of MCDASf were plotted using a receiver operating characteristic (ROC) curve.
    

Intervention name(s): Modified Child Dental Anxiety Scale (MCDASf)
Intervention type(s): Other
Intervention description(s): The MCDASf is self-reported dental anxiety measure effective among children aged 5-12 years.11 The scale has eight questions about 'going to the dentist generally,' 'having teeth examined,' 'teeth being scraped and polished,' 'injections in the gum,' 'fillings,' 'having a tooth taken out,' 'being put to sleep for treatment,' and 'having a mixture of gas and air that will help you feel comfortable for treatment but will not make you sleep.' The scores of each question ranged from 1 'relaxed' to 5 'very worried.' The scores are also represented by cartoon faces varied according to emotions and anxiety levels. The total scores can range from 8 to 40.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        children who presented for the first time to the Faculty of Dentistry in Rize
The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia
      obstetric deliveries because of the ability to use fewer drugs, a more direct experience of
      childbirth and the capability to provide excellent postoperative analgesia. However, the
      incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead
      to maternal and fetal morbidities. Certain interventions may reduce the incidence and
      severity of spinal anesthesia induced hypotension, including the use of vasopressors and
      intravenous pre- or co-hydration using different types of volume expanders; crystalloid or
      colloid solutions. Such interventions aim to increase maternal cardiac output, which is the
      key in attenuating the hypotensive response to spinal anesthesia.

      The primary purpose of this study is to compare the efficacy of intravenous prehydration
      (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid
      (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after
      spinal anesthesia.

      The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by
      employment of a minimally invasive technique based on arterial pulse contour analysis.
      Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary
      outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome,
      intraoperative side effects and maternal satisfaction scores.
    


Intervention name(s): Lactated Ringer's; HES 130/0.42
Intervention type(s): Other; Other
Intervention description(s): Balanced colloid solution
Other intervention name(s): Tetraspan® 6%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment