bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Ketamine-propofol Combinations
Condition: Agitation; Postoperative Pain
MeSH terms: Psychomotor Agitation; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      ASA I-II 3-12 years old children participated to this study. All Participants will divide
      into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at
      anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of
      ketamine-propofol mixture with %67 of Mcfarlan dose regiment.

      In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia
      induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol
      mixture with %80 of Mcfarlan dose regiment.

      In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction.
      General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90
      of Mcfarlan dose regiment.

      After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU
      will be recorded. These data will be evaluated with statistically.
    

Detailed description: 
      ASA I-II, 3-12 years old children who will operate due to tonsillectomy and adenoidectomy.
      will be participated in to this study. All Participants will divide into the three groups. In
      Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction.
      General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of
      Mcfarlan dose regiment.

      In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia
      induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol
      mixture with %80 of Mcfarlan dose regiment.

      In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction.
      General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90
      of Mcfarlan dose regiment.

      McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion
      during second 15 minutes, 11 mg/kg/h infusion from 30 to 60 minutes, 10 mg/kg/h from 1 to 2
      h.

      Anaesthesia dept will be detect with BIS monitoring during operation. After than surgical
      operation recovery time, PAED scores, FLACC scores, staying time in PACU and extubation time
      will be record. At the end of the study, these data will be evaluated with statistically.
    

Intervention name(s): Ketamine-propofol mixture
Intervention type(s): Drug
Intervention description(s): Ratio of Ketamine-propofol mixture will be compare for every groups.
Other intervention name(s): ketofol
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects
Condition: Netherton Syndrome
MeSH terms: Netherton Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or
      standard of care currently exists for patients with NS. DS-2325a, a specific and potent
      inhibitor of kallikrein 5, is expected to treat NS by replacing a defective gene.
    

Detailed description: 
      This first-in-human study for DS-2325a will evaluate the safety, tolerability, and
      pharmacokinetics of single ascending doses of DS-2325a in healthy participants. DS-2325a will
      be evaluated after both subcutaneous (SC) injections and intravenous (IV) infusions, as it
      may have to be given intravenously to young patients and as loading dose.
    

Intervention name(s): DS-2325a; DS-2325a; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection (starting dose 30 mg); Intravenous infusion (starting dose 100 mg); Subcutaneous injection; Intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Netherton Syndrome; DS-2325a; Healthy Participants
Evaluation of Nasal Mucosal Permeability in Controls and House Dust Mite Allergic Rhinitis Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Recently, a critical role in the development of allergic rhinitis (AR) has been attributed to
      the nasal epithelium. The airway epithelium forms a physical barrier, protecting the nasal
      mucosa and underlying organs from damage from contact with exogenous particles. The nasal
      epithelial barrier is primarily determined by the integrity of the airway epithelium, in
      which epithelial cells are connected to each other by complex network structures like tight
      junctions (TJs), ultimately sealing off the paracellular space. TJs consist of different
      transmembrane proteins including occludin, tricellulin, the claudin family, and junctional
      adhesion molecules. TJ form intercellular homodimers/heterodimers between neighboring cells.
      Scaffold adaptor proteins like cingulin and the zonula occludens family connect the
      transmembrane proteins to the actin cytoskeleton.

      Disturbed TJ function can facilitate the entrance of foreign pathogens and antigens into the
      submucosal layer, giving raise to allergic sensitization via increased access of allergens to
      the dendritic cells and/or inducing persistent inflammation via activation of mast cells and
      other inflammatory cells residing in the upper airways. Chronic disorders like allergic
      asthma, inflammatory bowel disease and atopic dermatitis have been linked to defective or
      altered TJ function. Recently, an impaired epithelial barrier function was found in patients
      with chronic rhinosinusitis with nasal polyps (CRSwNP), suggesting changes in TJ arrangement
      in the nasal cavity. CRSwNP presents a similar inflammation of the sinonasal cavities as
      found in AR patients, i.e. a Th2 cytokine driven inflammation with tissue eosinophilia.
      Nevertheless, the role of TJs and its regulation has not been investigated in AR.
    


Intervention name(s): healthy controls; AR patients without medication; AR patients with use of nasal corticoid spray
Intervention type(s): Other; Other; Other
Intervention description(s): biopsy of nasal mucosa for healthy controls; biopsy of nasal mucosa for allergic rhinitis patients without allergy medication; biopsy of nasal mucosa for allergic rhinitis patients with use of nasal corticoid spray
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Online Rheumatological Rehabilitation Education in Intern Physiotherapy Students
Condition: Learning Problem
Study type: Observational

Summary: 
      The aim of the study is to investigate the effect of online rheumatological rehabilitation
      training on readiness, clinical decision making and perceived self-efficacy in intern
      physiotherapy students. In the study, online rheumatological rehabilitation training is
      planned. Online rheumatological rehabilitation training will be video-based via the Edpuzzle
      application and interactively via the zoom application. Online trainings are planned for
      15-person intern physiotherapy student groups 4 days a week, 2 hours a day, for 4 weeks on a
      case-based basis. In the study, readiness, clinical decision making and perceived
      self-efficacy levels will be evaluated in intern physiotherapy students before and after
      online rheumatological rehabilitation training.
    


Intervention name(s): Rheumatological rehabilitation training
Intervention type(s): Other
Intervention description(s): Online rheumatological rehabilitation training is planned. Online rheumatological rehabilitation training will be video-based via the Edpuzzle application and interactively via the zoom application. Online trainings are planned for 15-person intern physiotherapy student groups 4 days a week, 2 hours a day, for 4 weeks on a case-based basis. With the Edpuzzle application, videos will be prepared for 10 different rheumatological diseases. In each video, a case with rheumatic disease will be introduced, evaluations made from a physiotherapy perspective and their results will be included. Before the lesson, students will watch the video defined for them every day from the application called Edpuzzle, answer the questions and plan a disease-specific assessment and treatment program according to the directions in the video. Then, the assessment and treatment programs prepared by a group of 15 people through the zoom platform will be discussed during the lesson.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Intern physiotherapy students taking the Rheumatology Internship course at Istanbul
        University Cerrahpaşa Faculty of Health Sciences, Physiotherapy and Rehabilitation will be
        included in the study. In the 2020-2021 academic year, 60 intern physiotherapy students who
        took the Rheumatology Internship course will be included. Consent will be obtained from all
        participants with a voluntary information form on google forms.
      
Keywords: Learning management
Effect of Indomethacin on the Progression of Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is determine whether indomethacin is able to retard disease
      progression in patients with mild to moderate Alzheimer's disease.
    

Detailed description: 
      Previous research indicates that inflammation plays a role in the pathogenesis of Alzheimer's
      disease (AD), and nonsteroidal anti-inflammatory drugs (NSAIDs) may retard the progression of
      the disease.

      Comparison(s): Cognitive decline of patients with mild to moderate AD receiving the NSAID
      indomethacin, compared to cognitive decline of patients with mild to moderate AD receiving
      placebo, during a one-year period.
    

Intervention name(s): indomethacin
Intervention type(s): Drug
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dementia; Inflammation; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Drug Therapy
Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of a tetravalent dengue vaccine
      TetraVax-DV TV005 in adults 50 to 70 years of age with no history of previous flavivirus
      infection.
    

Detailed description: 
      Dengue viruses (DENV) are widespread in most tropical and subtropical regions of the world.
      There are four serotypes of dengue virus (DENV-1, DENV-2, DENV-3, and DENV-4); each can cause
      dengue infection. Infection with dengue viruses can range from mild illness to
      life-threatening disease. TetraVax-DV TV005 (also referred to as TV005) is a live attenuated
      recombinant tetravalent dengue virus vaccine developed to protect against all four dengue
      virus serotypes. The purpose of this study is to evaluate the safety and immunogenicity of
      TV005 in adults 50 to 70 years of age with no history of previous flavivirus infection.

      Participants will be randomly assigned to receive a subcutaneous injection of either TV005 or
      placebo at study entry (Day 0). After receiving the injection, participants will record their
      temperature 3 times a day through Day 16. Additional study visits will occur on Days 4, 6, 8,
      10, 12, 14, 16, 21, 28, 56, 90, and 180. Visits will include a physical examination and blood
      collection.
    

Intervention name(s): TetraVax-DV TV005; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Contains 10^3 plaque-forming units (PFUs) of rDEN1Δ30, 10^4 PFUs of rDEN2/4Δ30(ME), 10^3 PFUs of rDEN3Δ30/31-7164, and 10^3 PFUs of rDEN4Δ30; administered by subcutaneous injection in the deltoid region of the upper arm; Administered by subcutaneous injection in the deltoid region of the upper arm
Other intervention name(s): TV005
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Vaccine
Research Study Examining Nerve Block for Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve
      block, which is a procedure involving an injection of a small amount of a local anesthetic
      next to a nerve to the skin, causing an area of skin to become numb. We have also noticed
      that light sensitivity goes away quickly after a nerve block. We would like to see how
      quickly this happens and how long the benefit of nerve block lasts. We are interested to see
      if these effects are due to the injection itself or due to the lidocaine.

      A subject may be asked to participate in this study if a subjects physician has planned for a
      subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a
      spinal nerve located at the back of the head) as part of a subjects routine preventive
      treatment for migraine today.
    


Intervention name(s): Greater Occipital Nerve Block
Intervention type(s): Procedure
Time perspective: Prospective
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
    

Detailed description: 
      This is an open-label follow up study to evaluate the safety for the subjects with
      ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

      ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells.
      Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as
      vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can
      enhance wound healing and regeneration of new tissue, finally may provide a new option in
      treating a Diabetic Foot Ulcer.
    

Intervention name(s): ALLO-ASC-DFU
Intervention type(s): Biological
Intervention description(s): ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer.
This study is a follow-up study without intervention.
Other intervention name(s): Allogenic adipose-derived mesenchymal stem cells
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of
        ALLO-ASC-DFU-101.
Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor
Condition: Spinal Cord Stimulation
Study type: Interventional

Summary: 
      To assess lead migration rates using different methods of securing leads during Spinal Cord
      Stimulation trial period.

      Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent
      implantation. Trial lasts less than a week, which gives the patient an opportunity to assess
      the effectiveness of the treatment.
    

Detailed description: 
      Lead migration has been a known issue/complication with spinal cord stimulation. Lead
      migration during the trial period can alter the success of a trial. There is no one way of
      securing the leads to the skin.

      Our endeavor was to look at different modes of securing the leads to the skin during the
      trial period and present their respective lead migration rates. The three methods are

        1. suturing the leads using 2.0 mono-filament nylon to the skin,

        2. suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106)
           attaching them to the skin,

        3. non- suture.

      In all three groups copious amounts of benzoin and steri-strips will be used.

      Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will
      be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray
      was taken and compared to the fluoroscopy pictures taken at the time of lead placement.
    

Intervention name(s): Suture; Lead Anchor
Intervention type(s): Device; Device
Intervention description(s): Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.; Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.
Other intervention name(s): 2.0 Mono-filament nylon suture; 2.0 Mono-filament Nylon suture & Lead Anchor (St.Jude Medical Co) model-long, No# 1106
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Trial of Gemcitabine and Cisplatin in Patients With Inoperable Biliary Tract Carcinomas
Condition: Biliary Tract Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in Korean
      patients with biliary tract (bile tracts of the gallbladder or liver) cancer.
    


Intervention name(s): gemcitabine; cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to assess whether participants with traumatic brain
      injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in
      magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to
      assess the safety and tolerability of glyburide compared to placebo in participants with TBI.
      The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan
      /MRI abnormalities, reduction of mortality and or improvement of function or physiology,
      incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady
      state concentrations of glyburide in TBI participants.
    

Detailed description: 
      This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired
      by Biogen.
    

Intervention name(s): Glyburide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the Treatment Arm.; Administered as specified in the Treatment Arm.
Other intervention name(s): RP-1127; glibenclamide; glybenclamide
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use
Condition: Drug Overdose
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 1

Summary: 
      Overdose with potential deadly outcome is a serious problem among opioid abusers, not least
      in Norway. The annual death toll from overdose is about 250, twice the annual death toll from
      traffic accidents. Those who inject heroin or other opioids are considered to have the
      highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid
      antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood
      vessel. Administration of naloxone via the nose has been suggested as an alternative for use
      by emergency teams and possibly also bystanders. This is not only an easier way to give
      naloxone, but would also eliminate the risk for needle stick injuries and blood
      contamination. A pilot study in this hospital has shown no significant side effects or
      adverse reaction. While significant benefits are expected from developing an adequately
      formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal.
      Therefore this preclinical study in healthy volunteers will be undertaken.
    


Intervention name(s): nasal naloxone
Intervention type(s): Drug
Intervention description(s): one puff in one nostril with the subject is lying down
Intervention MeSH terms: Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emergency Treatment; Morphine Derivates; Heroin; Antidotes; Administration, Intranasal