bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Immunogenicity Study of Inactivated EV71 Vaccine in Children
Condition: Enterovirus 71 Human
MeSH terms: Enterovirus Infections
Study type: Observational

Summary: 
      This study is designed to evaluate the long-term antibody titers of EV71 vaccine 4 and 5
      years after first dose vaccination for subjects at the age of 2 to < 6 years , and 3 to 5
      years after first dose vaccination for subjects at the age of 2 months to < 2 years
    

Detailed description: 
      This is an extension study of protocol CT-EV-21, to evaluate the long-term immunogenicity of
      EV71vaccine.

      The first study visit will be approximately 3 or 4 years after the administration of first
      vaccination of EV71 vaccine or placebo in CT-EV-21 study; 4 years after the first vaccination
      for subjects 2 to < 6 years of age (2b), and 3 years after first dose for subjects 2 months
      to < 2 years of age (2c and 2d).

      Subjects of 2b will remain in the study for approximately 12 months and will have 2 clinic
      visits; subjects of 2c and 2d will remain in the study for approximately 24 months and will
      have 3 clinic visits. Immunogenicity response against EV71 virus antigen at each visit will
      be assessed.
    

Intervention name(s): EV71 vaccine
Intervention type(s): Biological
Intervention description(s): EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have completed participation in study CT-EV-21
      
Biospecimen description: 
      Serum
    
Keywords: EV71 Vaccine
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion
Condition: IUCD Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal isonicotinic acid hydrazide administered before the
      levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and
      difficulty in insertion in adolescents and young women.
    

Detailed description: 
      Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
    

Intervention name(s): INH; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.; 3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blind randomized controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin
      and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and
      dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of
      valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK
      of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects
    


Intervention name(s): simvastatin; Dapagliflozin; simvastatin; valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 20 mg, Single Dose; Tablets, Oral, 20 mg, Single Dose; Oral, 40 mg, Single Dose; Tablets, Oral, 320 mg, Single Dose
Other intervention name(s): Zocor; BMS-512148; Diovan
Intervention MeSH terms: Dapagliflozin; Valsartan; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Up to now, only little research has been performed in tailoring treatment of patients with
      chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial
      intervention in patients with a moderate to high level of disability and in whom the
      contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).
      Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary
      rehabilitation settings but might also benefit from treatments based on these
      multidisciplinary rehabilitation treatment principles when provided by specifically trained
      primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the
      feasibility of a specifically for primary care physiotherapist developed biopsychosocial
      intervention ("Back on Track" intervention) in WPN3- classified patients, and to evaluate
      whether this "Back on Track" intervention results in a significant improvement in functional
      disability in this subgroup of patients.
    


Intervention name(s): Back on Track intervention
Intervention type(s): Other
Intervention description(s): A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Back Pain; Chronic Pain; Cognitive Behavioral Therapy; Primary Health Care; Physical Therapy
Effects of Fixed and Removable Space Maintainers on Periodontal Health and DMFT/Dft Values
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Observational

Summary: 
      Space maintainers are appliances that applied when primary teeth were lost prematurely
      because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 Space
      problems play an important role in practice of dentistry and also understanding of the dental
      development in the primary and mixed dentitions could help to intercept the malocclusion.The
      aim of this study is to evaluate the effects of applied space maintainers on periodontal
      health and dental status after teeth missing in pediatric dentistry clinic.
    

Detailed description: 
      The study was approved by the Ethics Committee of the Istanbul University Faculty of
      Dentistry (No:2014/8) and was carried out in agreement with the Declaration of Helsinki
      principles. This study conducted 104 patient whose age between the range of 4-15 years were
      chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space
      maintainers in Istanbul University Faculty of Dentistry Department of Pediatric Dentistry
      were followed between years of 2013-2014. Totally, four of the patients excluded due to
      systemically and genetically disorder.

      In primary and mixed dentition, dft index was used and in permanent dentition DMFT index was
      used. Longevity time in the mouth, the number of developing new caries were evaluated and
      DMFT/dft and plaque index were compared.
    

Intervention name(s): space maintainer
Intervention type(s): Other
Intervention description(s): Space maintainers are applied after the missing teeth in pediatric dentistry for protection of size of extracted area.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 patient whose age between a range of 4-15 years due to having early loss of teeth and
        were treated with fixed and removable space maintainers in Istanbul University Faculty of
        Dentistry Department of Pediatric Dentistry were included to this study.
      
Keywords: oral health; dental plaque; space maintenance
Mild Traumatic Brain Injury Discrimination
Condition: Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      Evaluation of the utility of a multi-modal assessment tool in distinguishing between
      individuals with and without a history of mild traumatic brain injury.
    

Detailed description: 
      This was a preliminary validational study of a multi-modal concussion assessment battery
      incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the
      Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC)
      analyses, 1) a subset of the most discriminating neuro-physiological assessment tests
      involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a
      balance score ratio sensitive to vestibular balance performance and two neurocognitive tests
      of response speed and memory/incidental learning, was identified, 2) the enhancement in
      discriminatory capability of detecting concussion-related deficits through the combination of
      the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust
      and readily implemented global scoring approach was demonstrated for both eye track and
      balance assessment tests. These results are significant in introducing a comprehensive
      solution for concussion assessment that incorporates an economical, compact and mobile
      hardware system and an assessment battery that is multi-modal, time efficient and whose
      efficacy has been demonstrated on a preliminary basis. This represents a significant step
      toward the goal of a system capable of making a dependable return-to-play/duty determination
      based on concussion likelihood.
    

Intervention name(s): Multi-modal assessment system
Intervention type(s): Device
Intervention description(s): Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Injury; Brain; Traumatic Mild; Mild Traumatic Brain Injury
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Condition: Thyroid Neoplasm; Goiter
MeSH terms: Thyroid Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in
      BABA endoscopic and robotic thyroidectomy.
    

Detailed description: 
      Diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain
      and reduce bleeding during procedures. The synergistic effect of ropivacaine with epinephrine
      can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic
      stability.
    

Intervention name(s): Ropivacaine with epinephrine injection; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.; 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
Other intervention name(s): Hanlim ropiva injection 7.5 mg/mL (20cc); Insurance code: A37804211; Jeil epinephrine injection 1 mg/mL (1cc); Insurance code: A04900341; CJ 0.9% Normal Saline injection 100cc; Insurance code: A11601752
Intervention MeSH terms: Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ropivacaine; Epinephrine; Endoscopy; Robotics; Thyroidectomy
Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy such as fludarabine use different ways to stop tumor
      cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to
      damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells
      that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells
      can reject the body's normal tissues. Donor lymphocytes that have been treated in the
      laboratory may prevent this.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy, total-body irradiation,
      peripheral stem cell transplantation, and lymphocyte infusion in treating patients who have
      stage IV melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the objective response rate in patients with metastatic melanoma treated with
           nonmyeloablative allogeneic peripheral blood stem cell transplantation with fludarabine
           and total body irradiation, followed by cyclosporine and mycophenolate mofetil, followed
           by donor lymphocyte infusion.

        -  Determine the disease-free and overall survival of patients treated with this regimen.

        -  Determine the toxicity of this nonmyeloablative conditioning regimen in these patients.

      OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -4 to -2
      and total body irradiation on day 0. Allogeneic peripheral blood stem cells are infused on
      day 0.

      Patients receive oral cyclosporine twice a day on days -3 to 35 and tapered until day 56 and
      oral mycophenolate mofetil 3 times a day on days 0-40.

      Patients with mixed chimerism and no graft-versus-host disease on day 56 receive donor
      lymphocyte infusion (DLI) over 30 minutes on day 65 unless there is evidence of increasing
      donor chimerism. DLI may be repeated every 65 days for up to 4 doses.

      Patients are followed weekly for 3 months, monthly for 6 months, every 6 months through year
      2, and then annually through year 5.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4 years.
    

Intervention name(s): therapeutic allogeneic lymphocytes; cyclosporine; fludarabine phosphate; mycophenolate mofetil; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Fludarabine; Fludarabine phosphate; Cyclosporins
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV melanoma; recurrent melanoma
Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Condition: Skin Diseases; Nail Diseases; Nails, Ingrown
MeSH terms: Skin Diseases; Nail Diseases; Nails, Ingrown
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators conducted a controlled, prospective randomized study to examine the
      antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
    

Detailed description: 
      The investigators conducted a controlled, prospective randomized study to examine the
      antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The
      investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and
      0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout
      the surgical procedure, and bacterial culture analysis was performed (positive culture rate,
      total inocula count, reduction of bacterial load, and identification of specific
      microorganisms).
    

Intervention name(s): Polihexanide
Intervention type(s): Drug
Intervention description(s): The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Intervention MeSH terms: Polihexanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Skin Diseases [C17.800]; Nail Diseases [C17.800.529]; Nails, Ingrown [C17.800.529.406]
Erythropoietin in Traumatic Brain Injury (EPO-TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical
      care patients with moderate or severe traumatic brain injury improves neurological function
      assessed at six months after injury.
    

Detailed description: 
      Many people who have a traumatic brain injury (TBI) - usually from a blow to the head such as
      in a vehicle collision or in a fall do not survive or, if they do, suffer from long-term
      disability. Previous studies have shown that about 1,000 people in Australia and New Zealand
      suffer a moderate or severe TBI every year. With current best available treatment and
      therapies many of these patients sustain loss of brain function and long term disability in
      varying degrees.

      When a patient sustains a traumatic brain injury there are two phases to the injury. First,
      the head-impact causes immediate damage to the brain. The secondary injury, which can evolve
      over hours or weeks, is a very complicated process. It involves many, linked, changes to the
      cells, brain chemistry, tissues or blood vessels that can destroy brain tissue. The treatment
      of brain injury focuses on trying to minimize the secondary injury and there is much research
      being done to try to find treatments that will prevent it.

      Erythropoietin (EPO) has recently emerged as a drug that may help reduce secondary injury and
      improve brain function. It has been found to offer some protection to the brain when brain
      cells are deprived of their normal oxygen supply causing cells to die or be impaired.

      The aim of this study is to determine if EPO reduces secondary brain injury and helps
      patients make a better recovery after traumatic brain injury. The investigators also plan to
      monitor the effect of EPO on the rate of deep vein thrombosis (DVT - blood clots in the large
      veins in lower extremity) in patients with moderate or severe TBI in the intensive care unit
      (ICU).

      Study Hypothesis:

      In patients with moderate (GCS 9-12) or severe (3-8) TBI, EPO therapy improves long-term
      neurological function assessed 6 months after injury.
    

Intervention name(s): Epoetin Alfa; Sodium Chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): 40,000 IU given as subcutaneous injection weekly up to 3 doses; 1 m/L given as subcutaneous injection weekly up to 3 doses
Other intervention name(s): Eprex; Normal Saline
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section
Condition: Hypotension; Pregnancy Related; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Spinal anaesthesia for elective caesarean section is associated with maternal hypotension,
      secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.

      Our objective, in this prospective single-centre observational study, was to assess the
      ability of change in systolic ejection volume after 45° passive leg raising to predict
      hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive
      Clearsight Device just before elective caesarean section in third trimester pregnant women.
    


Intervention name(s): Clearsight monitoring
Intervention type(s): Device
Intervention description(s): Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.
Other intervention name(s): Cardiac ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for
        elective ceasarean section
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of GSK2330811 in Healthy Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind (sponsor-open), placebo-controlled, single-center study
      involving Japanese participants. The purpose of the study is to assess the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity after a single
      subcutaneous (SC) dose of GSK2330811 in healthy Japanese participants. GSK2330811 is a
      humanized immunoglobulin G1 (IgG1) monoclonal antibody that binds and inhibits the action of
      Oncostatin M (OSM) and is being developed for the treatment of Crohn's disease (CD) and
      Systemic sclerosis (SSc). Participants will be randomized to receive either GSK2330811 (450
      milligram [mg]) or placebo in an approximate ratio of 7:3.
    


Intervention name(s): Placebo; GSK2330811
Intervention type(s): Drug; Drug
Intervention description(s): Placebo is 0.9 percent sodium chloride solution. It will be administered as SC injection to abdomen by study personnel. Three injections will be used to match active doses.; GSK2330811 will be available as SC injection 150 mg/mL.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel group study. Participants will be randomized to receive either GSK2330811 (450 mg) or placebo in an approximate ratio of 7:3.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2330811; Healthy participants; Japanese; Pharmacokinetics; Safety; Subcutaneous dose
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical pharmacology study is performed to evaluate the total systemic exposure and the
      lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in
      healthy volunteers.
    


Intervention name(s): CHF 5993 100/6/12,5 pMDI; CHF 5993 100/6/12,5 DPI Test 1; CHF 5993 100/6/12,5 DPI Test 2; CHF 5993 100/6/12,5 pMDI replicate; CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment