bioihbjkbjnl/mcl2 huggingface dataset:
Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
Condition: Burn Injury
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this study is to determine if burn injured patients who receive blood
      transfusions in the operating room have better outcomes when given transfusions at a set
      ratio (1:1)of PRBC to FFP.

      Traditionally, patients that need blood transfusions during surgery are given mostly packed
      red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of
      FFP to PRBC.

      In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC
      during the operative period.

      The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of
      1:4 will result in a(n)

        1. decrease in the amount of blood transfused in the operating room

        2. decrease in the amount of blood transfused during hospitalization

        3. improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and
           Fibrinogen in the operative period (from operation start to 12 hours post operatively)
           and at 24 hours postoperatively

        4. decrease the hospital length of stay, lung dysfunction, infections, and mortality
    

Detailed description: 
      The hypothesis of the study is that the use of a fresh frozen plasma/packed red blood cells
      (FFP/PRBC) ratio of 1:1, compared to a ratio of 1:4 during operative excision of >20% TBSA
      will: result in a decrease in the amount of blood transfused in the operating room, a
      decrease in the amount of blood transfused during hospitalization, an improvement in
      coagulation parameters (PT/PTT, INR) in the operative period (from operation start to 12
      hours postoperatively) and at 24 hours postoperatively, and a decrease in hospital length of
      stay, lung dysfunction, number of infections, and mortality.

      The primary objective of the study is to determine if aggressive correction of intraoperative
      coagulopathy during burn excision and grafting results in improved outcomes.
    

Intervention name(s): Treatment
Intervention type(s): Other
Intervention description(s): Blood product transfusion at a ratio of 1:1 FFP to PRBC or 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FFP; PRBC; Burn
Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Condition: Sleep Apnea, Obstructive; Tonsillitis
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with
      modified retractor is used compared to use of an endotracheal tube (ETT) and non modified
      retractor is used.
    

Detailed description: 
      The laryngeal mask airway (LMA)is a device used to secure the airway of patients during
      general anesthesia. This device is routinely used for anesthesia in elective head and neck
      surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be
      studied as it pertains to operative times and cost.

      The child will be randomized into either the LMA group or the ETT group.
    

Intervention name(s): ETT with non modified retractor; LMA with modified retractor
Intervention type(s): Procedure; Other
Intervention description(s): adenotonsillectomy; LMA with modified retractor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenotonsillectomy
Measurement of Fibroid Volume and 2D, 3D US
Condition: Gynecology
MeSH terms: Leiomyoma
Study type: Observational

Summary: 
      Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual
      myomas volume after surgical removal, to clinically test the validity and usability of 3D
      ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the
      reliability of different ultrasound methods to measure volume of uterine fibroids.
    


Intervention name(s): ultrasound
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        44
Does Repetitive Electroconvulsive Therapies Affect Propofol Induction Dose ?
Condition: Physiatrics; Electroconvulsive Therapy
Study type: Interventional

Summary: 
      Electroconvulsive therapy has been used for many years for different types of physiatric
      diseases. General anesthesia is used during the procedure. Different anesthesiologists use
      different regimens. The duration of seizure is important in this procedure. The investigators
      evaluated the relationship between the dose of propofol and the number of electroconvulsive
      therapy and duration of the seizure.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: propofol; electroconvulsive therapy; anesthesia
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
Condition: Keratoconjunctivitis; Ocular Surface Disease
MeSH terms: Keratoconjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult
      volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific
      enzyme (Dihydroorotate Dehydrogenase).

      The study was amended and now includes patients with ocular surface inflammation.
    

Detailed description: 
      In this prospective, single-centre, double blind (within each cohort), placebo controlled,
      randomised study, safety and tolerability of PP-001 eye drops is assessed in healthy, adult
      volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). PP-001
      is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with
      anti-inflammatory properties.
    

Intervention name(s): PP-001; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PP-001 eye drops; Placebo eye drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of 48-week treatment with
      Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
    


Intervention name(s): Clevudine
Intervention type(s): Drug
Intervention MeSH terms: Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if the use of antidepressant medication in depressed
      patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it
      improves depressive affect.
    

Detailed description: 
      episodes of arrhythmia remain present even after icd implantation, this is specially true in
      depressed patients. it is hypothesized that improving mood state by means of an
      antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of
      appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the
      drug itself or an indirect effect of improving anxious and depressive affect. the mood and
      anxiety state are measured with the HADS scale
    

Intervention name(s): mirtazapine; mirtazapine
Intervention type(s): Drug; Drug
Intervention description(s): mirtazapine 15 mg daily tablets; 15 mg daily
Other intervention name(s): mirtazapine 1500 mtz; remeron 1569 rem
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open-label, randomized two-way cross-over study to determine if cefixime 200
      mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200
      mg/5 mL suspension reference formulation. Study will be conducted in 28 healthy adult
      subjects under fasting conditions. There will be two treatment periods and each subject will
      participate in both periods. The washout period between both treatment periods will be 7-14
      days. Subjects will be randomized to either of treatment sequences of reference followed by
      test or test followed by reference to receive a single dose of test or reference formulation
      on Day 1 in each treatment period. The study will last for 5 to 7 weeks.
    


Intervention name(s): Test formulation A; Reference formulation B
Intervention type(s): Drug; Drug
Intervention description(s): Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.; Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single dose; Oral suspension; Bioequivalence; Cefixime; Two-way crossover
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535
      compared to a placebo in patients with active Ulcerative Colitis.

      Depending on their response, participants will be offered the investigational medication for
      up to one year after the study's completion at select sites.
    


Intervention name(s): OPC-6535 Tablets (drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ulcerative Colitis
Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea
      co-administered with metformin to glyburide/metformin combination tablet. It is expected that
      safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and
      metformin.
    


Time perspective: Prospective
Keywords: Change from baseline of HbA1c after 16 weeks of treatment; Change from baseline of FPG after 16 weeks of treatment; Change from baseline of diabetes self-care scale by patient on drug administration after 16 weeks of treatment
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies
      sleep. No one has studied how pediatric patients perform with it and how accurate it is in
      measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA)
      questionnaire completed by parents and Fitbit® together and evaluate how they perform against
      the polysomnography (PSG).
    


Intervention name(s): Fitbit; OSA questionnaire; Polysomnography
Intervention type(s): Device; Other; Diagnostic Test
Intervention description(s): Wearable activity & sleep tracker.; Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).; All participants will be undergoing a sleep study as part of their clinical care.
Other intervention name(s): Sleep study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC)
Condition: no Condition
Study type: Interventional
Phase: Phase 1

Summary: 
      Study primary Objective:

      - To evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of
      N-acetyl-cysteine 600 mg uncoated tablets vs. N-acetyl-cysteine 600 mg film-coated tablets
      (NAC) in healthy male and female volunteers.

      Study secondary objectives:

        -  To describe the pharmacokinetic (PK) profile of NAC in plasma after single dose
           administration of NAC 600 mg uncoated tablets vs. NAC 600 mg film-coated tablets;

        -  to collect safety and tolerability data after single dose administration of NAC 600 mg
           uncoated tablets vs. NAC 600 mg film-coated tablets.
    

Detailed description: 
      This is single centre, single dose, open, randomised, cross-over, two-stage bioequivalence
      study to compare two different oral formulations of NAC.

      The study has been conducted in healthy volunteers of both genders, in one single dose of
      both formulations.

      The initial 48 subjects were sufficient to satisfy the study objectives on the basis of the
      ad interim preliminary bioequivalence test. The study was then considered as concluded and
      the second stage did not take place.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): The product was administered according to the randomisation list and cross-over design, with 150 mL of still mineral water under fasting conditions on study day 1 of periods 1 or 2 at 8:00±1 h.
Other intervention name(s): Fluimucil uncoated tablets
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers
Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM)
      five elements music therapy improving quality of life for patients with advanced cancer, as
      well as establishing the standard operating procedures (SOP) for it.
    

Detailed description: 
      Design: As randomized controlled trial (RCT) with un-blinded design will be done.
    

Intervention name(s): music
Intervention type(s): Other
Intervention description(s): Experimental Group one : Listening TCM five elements music therapy（TCMMT）based on conventional therapy in China.
Experimental Group two: Listening western music based on conventional therapy in China.
Control Group: no music therapy will be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: advanced cancer; TCM five elements music therapy; quality of life (QOL)
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers
Condition: Diabetes; Diabetic Foot Ulcer; Non-healing Wound
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a prospective, open-label trial focused on assessing the safety and
      tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU).
      Because the focus is on safety rather than efficacy, a standard of care comparator is not
      included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects
      with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a
      single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU
      following a 10-14 day run-in period. Any subjects requiring additional treatment will receive
      protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will
      occur with a minimum of one week between each subject.
    


Intervention name(s): ExpressGraft-C9T1 Skin Tissue
Intervention type(s): Biological
Intervention description(s): ExpressGraft-C9T1 skin tissue is provided as a suturable, biologically-active, circular skin tissue with a fully-stratified epithelial compartment comprised of human keratinocytes (NIKSC9T1) and a dermal compartment containing fibroblasts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perception of Illness Turkish Validity and Reliability Study
Condition: Perception of Disease
MeSH terms: Rheumatic Diseases
Study type: Observational

Summary: 
      In chronic diseases such as rheumatic diseases, it is important to direct the treatment of
      the disease and to evaluate the disease perception in terms of the course of the disease. As
      a result of this study, this questionnaire, which will help us gain information about the
      perception of the disease specific to rheumatic diseases, will be translated into Turkish.
    

Detailed description: 
      Disease perception is the cognitive aspect of the disease state. Although they experience the
      same disease in a certain period of their lives, the methods of meeting the disease and
      coping with the disease differ. Patients try to explain their illnesses in the light of their
      personal experiences, knowledge, values, beliefs and needs. People create cognitive models to
      explain and predict events in the outside world. Patients also develop similar patterns of
      symptoms of transient or long-term disease. Leventhal et al. suggested that patients formed
      their own coping mechanisms with these cognitive models and developed the self-regulation
      theory. According to this theory, people create schemas about illness and life-threatening
      situations in their minds with the information presented to them from concrete and abstract
      sources. These cognitive models also include beliefs about treatment and control of the
      condition.

      The World Health Organization (WHO) has classified more than 200 musculoskeletal diseases,
      the most common being rheumatoid arthritis and osteoarthritis. The biopsychosocial model has
      been drawing attention in rheumatological rehabilitation in recent years. This model
      acknowledges that the experiences and symptoms of the disease are affected by biological,
      psychological and social factors. The dysfunction is not only related to the severity of the
      disease, but also to how the disease is perceived. The patient's beliefs and perceptions
      about his illness show how the illness affects him both physically and emotionally. Disease
      perception is based not only on symptoms but also on disease-related consequences, concerns,
      and past illness experiences of the patient. Recent studies emphasize the importance of
      disease perception in explaining the difference in treatment outcomes in chronic diseases,
      including rheumatic diseases.

      It was planned to determine the validity and reliability of the Disease Perception Scale in
      Rheumatic Diseases due to the importance of treatment in rheumatic diseases and the
      evaluation of disease perception in terms of the course of the disease.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren
        Syndrome, Systemic Lupus Erythematosus
      
Keywords: rheumatic diseases, perception of illness
Cat-PAD Follow on Study
Condition: Cat Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis and/or asthma.

      The purpose of this optional observational follow-on study is to further evaluate
      rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who
      completed all dosing visits in study CP005 approximately one year after the start of
      treatment.
    

Detailed description: 
      Subjects who completed all dosing visits and the post treatment challenge (PTC) in study
      CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4
      visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be
      performed 3-10 days later.
    

Intervention name(s): Placebo; Cat-PAD Dose 1; Cat-PAD Dose 2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.; No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.; No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject previously randomised in study CP005 and completed all dosing visits and the PTC
      
Keywords: Cat allergy; Rhinoconjunctivitis