bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema,
      and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized
      Split-Mouth Clinical Trial
    

Detailed description: 
      Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard
      practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and
      trismus frequently jeopardize patients' well-being after the extraction of third molars.
      Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction.
      Refrigerated serums were used to work with cold serum, and since the refrigerator temperature
      was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to
      assess the influence of saline irrigation at various temperatures (4°C, 25°C) on
      postoperative edema, pain, and trismus after the extraction of impacted third molars.

      Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third
      molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical
      trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other
      side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and
      facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to
      compare pairs, and a Wilcoxon signed-rank test was used to compare groups.
    

Intervention name(s): saline irrigation at various temperatures (4°C, 25°C)
Intervention type(s): Procedure
Intervention description(s): cold serum application
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: irrigation,; third molar surgery,; temperature,
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and
      benzoate after intravenous administration of TAK-123 in Japanese healthy adult male
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-123. TAK-123 is being tested in Japanese
      healthy adult men. This study will look at the PK, safety and tolerability of phenylacetate
      and benzoates of people who administered TAK-123.

      The study will enroll approximately 10 participants. All participants will be administered
      TAK-123 intravenously at the dose level of 3.75 g/m^2 of sodium phenylacetate and 3.75 g/m^2
      of sodium benzoate.

      - TAK-123 as 3.75 g/m^2 of sodium phenylacetate and 3.75 g/m^2 of sodium benzoate

      This single-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 8 days. Participants will make multiple visits to the clinic and be
      hospitalized for four days.
    

Intervention name(s): TAK-123
Intervention type(s): Drug
Intervention description(s): TAK-123 infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Observational

Summary: 
      The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases
      in participants who participated in study CYD23 (NCT00842530).

      The Objectives:

        -  To describe the incidence of virologically-confirmed hospitalized dengue cases.

        -  To characterize hospitalized dengue cases.

        -  To evaluate the occurrence of related and fatal serious adverse events (SAEs).
    

Detailed description: 
      This study was a passive surveillance of hospitalized dengue cases in participants who
      participated in study CYD23 (NCT00842530) where participants were initially randomized to
      receive 3 injections of either CYD dengue vaccine or control at 6 month intervals. Any SAE
      related to a study procedure or related to a previous injection from study CYD23, or any
      fatal SAEs (even if unrelated) were reported to the Sponsor.

      An Independent Data Monitoring Committee (IDMC) was also involved in the regular review of
      virologically-confirmed hospitalized dengue cases. Any fatal outcome or related SAE were be
      promptly reviewed by the IDMC.

      No study vaccinations were administered.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in study CYD23 (NCT00842530) who were hospitalized with dengue cases.
      
Keywords: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia
Condition: Retinoblastoma
MeSH terms: Retinoblastoma
Study type: Observational

Summary: 
      Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective
      ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear
      but may be attributed to an autonomic nervous reflex induced by catheterization of the
      ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia
      and catheter stimulation might be a support cause of these SCRE.

      Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma
      are prospectively included in this observational study. Endovascular procedures are performed
      under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium.
      SCRE are strictly pre-defined and included arterial hypotension, bradycardia and
      bronchospasm. SCRE are recorded and the factors influencing their occurrence are
      investigated.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children requiring superselective ophthalmic artery chemotherapy for retinoblastoma
The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction
Condition: Target Controlled Infusion (TCI); Thoracic Epidural Anesthesia; Block Level; Gastrointestinal Surgery
MeSH terms: Aortic Dissection
Study type: Interventional
Phase: Phase 4

Summary: 
      It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA
      with different block level on propofol concentration during general anesthesia induction.
    


Intervention name(s): 1% lidocaine; 2% lidocaine; 0.9% normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): epidural anesthesia with 1% lidocaine 10ml before propofol TCI; epidural anesthesia with 2% lidocaine 5ml before propofol TCI; epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Other intervention name(s): A; B; C
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: effect-site concentration; propofol; thoracic epidural anesthesia
Impact of a Mental Health Curriculum for High School Students on Knowledge and Stigma
Condition: Mental Disorders; Education Curriculum; Comparative Effectiveness Research; Early Intervention; Adolescents
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study examines the effectiveness of a school based mental health literacy intervention
      for high school students, on improving mental health knowledge and reducing stigma.
      Twenty-four high schools in the regional area of Ottawa, Canada were randomly assigned to
      either the curriculum or control condition at a two to one ratio. The educational curriculum
      was integrated within grade 11 and 12 Provincial "Healthy Living" courses, delivered by
      teachers, and replaced existing educational content on mental health.
    

Detailed description: 
      There is limited evidence and consensus on the effectiveness of school-based mental health
      educational programs, and no standardization for mental health education being taught in
      schools. This study examines the effectiveness of a school-based mental health literacy
      intervention for adolescents, on knowledge and stigma. A secondary objective was to determine
      the generalizability and applicability of an educational resource for mental health in high
      schools.
    

Intervention name(s): Curriculum; eLearning Follow-up
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A mental health educational resource delivered in the classroom by trained educators; An online mental health education module that students access individually
Other intervention name(s): The Curriculum Guide; online follow-up learning module
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Mental Health Knowledge; Stigma; Mental Health Literacy
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain
Condition: Irrigation Activation
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Irrigation activation in endodontics is considered now a very important step for the success
      of root canal treatment. In this study, the investigator will examine the effect of two
      recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in
      comparison with the conventional needle irrigation on irrigant penetration depth into root
      canals using radiopaque contrast media and digital radiography and on the postoperative pain
      after single-visit endodontic treatment using a visual analog scale.
    


Intervention name(s): Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation
Intervention type(s): Device
Intervention description(s): irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.
Masking: Single (Participant)
Primary purpose: Treatment
Intervention in a Small-scale Study of Game Based Cognitive Change Skills
Condition: Emotion Regulation
Study type: Interventional

Summary: 
      This activity will have the objectives of preliminary testing user satisfaction, the
      feasibility of the platform and its preliminary efficacy
    

Detailed description: 
      Preliminary efficacy will be tested in an emotion-regulation framework. Children included in
      this study will be allocated to play Level 4 of the REThink game on cognitive change or to no
      intervention Control condition. Children and adolescents in the intervention group will be
      distributed afterwards in two groups: with or without ecological momentary intervention (EMI)
      using the PsyPills app for following-up with the cognitive change ER personalized strategy
      reminder during a real exam situation. Outcomes considered will be stress reactivity (both
      subjective and physiological) using EMA before, during and after the test (Colombo et al.,
      2020), and cognitive change, namely irrational and rational beliefs, and reflective
      functioning improvements.
    

Intervention name(s): Rethink game; PsyPills
Intervention type(s): Behavioral; Behavioral
Intervention description(s): REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.; PsyPills is a mobile app designed to provide personalized psychological pills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: online therapeutic game; emotional problems; emotional regulation; children and adolescents
Non-invasive Identification of Preoperative Anaemia
Condition: Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      Approximately 20% of patients undergoing elective orthopaedic surgery are anaemic. When not
      identified and treated before surgery, this can lead to requiring blood transfusions, which
      brings additional expenses, time and inconvenience to the patient.It is recommended that
      preoperative assessment involves investigation and where possible, treatment of anaemia.

      The timescale between assessment and surgery makes it difficult to comply with guidelines
      without postponing surgery.

      This study will investigate adult patients scheduled for elective orthopaedic surgery, where
      a full blood count is to be taken as part of routine care. A paired non-invasive reading of
      their blood will be taken. It will be conducted at The Royal Infirmary, Edinburgh. This
      device is not in use within the department currently but has been given free of charge for
      the study. There are no restrictions placed on the device except that it is not accurate for
      measuring haemoglobin <8g.dL. Participant care will only be determined by results from the
      laboratory assay as per routine care, not the noninvasive device.

      The device is CE marked for haemoglobin determination. Masimo (manufacturer) have released
      results in the accuracy of their monitor but with very little other information, for example,
      study population or precision. This study aims to answer how accurate and precise
      non-invasive measurements are in patients scheduled for orthopaedic surgery (there are no
      studies with these results) and whether anaemia can be identified earlier in the patient
      pathway i.e. an anaemia screen at time of surgical listing, therefore leaving ample time for
      treatment and optimisation of care.

      The data from the study will not be shared with Masimo. There is ongoing work towards
      introducing and piloting a new pre-operative triage system where optimisable conditions e.g.
      anaemia are identified at the time of listing. This study would aid this work.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for elective orthopaedic surgery.

        Healthy volunteers will be recruited from The Department of Anaesthetics.
Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Condition: Spinal Cord Injuries; Anxiety; Stress; Tetraplegia
MeSH terms: Spinal Cord Injuries; Quadriplegia; Wounds and Injuries; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this research is to test the feasibility of an intervention using biofeedback
      to treat stress and anxiety among individuals with tetraplegia.

      The expected duration of participation in this study is about 5 hours over the course of
      about 5 weeks. Participants will be randomly assigned to either a biofeedback training
      intervention or a control group. After completing questionnaires, participants will undergo
      physiological monitoring for the purpose of measuring heart rate and breathing. Those
      assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while
      also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home.
      Those assigned to the control group will undergo 20 minutes of physiological monitoring twice
      a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each
      session is expected to last 30 minutes to allow for completion of questionnaires over the the
      phone prior to and following each training session.

      It is hypothesized that the biofeedback intervention will demonstrate high feasibility and
      compared to those in the control group, participants who receive the biofeedback intervention
      will attain greater pre-post reductions in both physiological and self-reported stress.
    


Intervention name(s): Psychophysiological monitoring; Biofeedback training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.; Traditional resonance frequency training with the Mindfield eSense Pulse smartphone application. Using visual feedback of real time parameters of HRV and the use of controlled breathing, participants are trained to reach a relaxed state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Exercise on Patients With Hemiparetic Stroke
Condition: Stroke; Hemiplegia; Cardiovascular Disease
MeSH terms: Stroke; Hemiplegia; Cardiovascular Diseases
Study type: Interventional

Summary: 
      This randomized trial investigates the hypothesis that regular aerobic exercise training
      using a task specific gait training modality will improve cardiovascular fitness, functional
      mobility, and reduce risk factors for recurrent cardiovascular events in chronic hemiparetic
      stroke patients, when compared to matched controls performing just stretching.
    

Detailed description: 
      The aims are to determine whether 6 months progressive graded treadmill training: 1) improves
      cardiovascular fitness levels and reduces the excessive energy demands of hemiparetic gait,
      as defined by oxygen consumption levels based on open circuit spirometry during peak and
      submaximal exercise ambulation tasks; 2) increases free living physical activity measured by
      portable kinematic recording devices and quantitative in vivo determination of energy
      expenditure using stable isotopes; and, 3) improves the cardiovascular-metabolic risk factor
      profile including measures of key endogenous fibrinolysis regulatory enzymes [plasma tissue
      plasminogen activator (t-PA) and its main circulating inhibitor (PAI-1)], fasting lipoprotein
      lipid profiles, blood pressure, and oral glucose tolerance and insulin responses.
      Measurements of body composition at baseline and after training will further determine the
      effects of aerobic exercise training on muscle mass and central obesity.
    

Intervention name(s): Treadmill Exercise
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Cerebrovascular Disorders; Exercise; Rehabilitation
A Study of LNK01001 Capsule in Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a
      twice daily oral LNK01001 dose A or LNK01001 dose B or matching placebo for 12 weeks.
    

Detailed description: 
      The study was to include a 12-week double-blind treatment period. Participants who met
      eligibility criteria were to be randomized in a 1:1:1 ratio to one of the three treatment
      groups.

      Group 1:LNK01001 dose A (Day 1 to Week 12) Group 2:LNK01001 dose B (Day 1 to Week 12) Group
      3: Matching placebo (Day 1 to Week 12)
    

Intervention name(s): LNK01001 Dose A; LNK01001 Dose B; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules taken orally; Capsules taken orally; Capsules taken orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin)
      compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in
      Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise
      therapy and metformin agent monotherapy.
    

Detailed description: 
      The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week
      open-label period (week 25-52). During the double-blind period, participants will receive 10
      mg or 25 mg dose of HSK7653, or linagliptin, and with matching placebo respectively. During
      the open-label period, all participants will receive 25 mg dose of HSK7653. All participants
      will receive a stable dose of metformin therapy in both the double-blind period and the
      open-label period.
    

Intervention name(s): HSK7653 10 mg Q2W; HSK7653 25 mg Q2W; Linagliptin 5 mg QD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.; HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.; Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment