bioihbjkbjnl/mcl2 huggingface dataset:
Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
Condition: Propofol Overdose of Undetermined Intent
MeSH terms: Hypersensitivity; Drug Overdose
Study type: Observational

Summary: 
      The induction dose of propofol is generally determined based on patients' characteristics,
      underlying disease, general condition, and also by clinician's experiences. However, It is
      difficult to anticipate and objectively calculate an adequate dose of propofol for every
      patient considering the variability of an individual's response to propofol. If there is a
      specific pattern in EEG prior to induction of anesthesia that can provide information about
      the patient's susceptibility to propofol, every induction may be performed far more smoothly
      with a precisely optimized dose of propofol for each patient. The study is to find a
      relationship between the pre-induction EEG pattern of adult patients and their sensitivity to
      propofol.
    


Intervention name(s): Propofol; EEG monitoring
Intervention type(s): Drug; Device
Intervention description(s): The dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients.; The processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution.
Intervention MeSH terms: Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia
Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM
      patients treated with metformin and sulfonylurea.
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days; Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type II diabetes mellitus; metformin; sulfonylurea
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Condition: Prolonged Air Leak; Lung Resection
Study type: Interventional
Phase: Phase 3

Summary: 
      The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection
      procedures remains unproved. The investigators hypothesize that one of the main reasons for
      that is the heterogeneity of previously studied populations. Since currently the risk of
      postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to
      investigate the effect of routine application of a novel tissue sealant in patients selected
      on the basis of a high risk of PAL estimated before surgery.
    


Intervention name(s): Hemopatch; standard preventive measures
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention PAL Prolonged Air Leak (PAL); Lung Resection; Thoracic Surgery; Post-operative Thoracic Air Leak
Reduction of Post-operative Endodontic Pain
Condition: Post Operative Endodontic Pain
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the effect of intraligamentary injection of Lornoxicam on the intensity of
      post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.
    

Detailed description: 
      sixty qualified samples (initial estimate which will be come more accurate after the pilot
      study on 6 patients) will be divided randomly in three groups which all of them will have an
      inferior Alveolar injection and before the beginning of the treatment the primary group will
      receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of
      Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in
      mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection
      but actually there is no substance injected ,making the patient believe that there was an
      injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis
      (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.
    

Intervention name(s): Lornoxicam; normal saline; no injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection; PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection; inject nothing after inferior alveolar injection and before root canal therapy
Other intervention name(s): Xefo; (904111)
Intervention MeSH terms: Lornoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: In the patients with symptomatic Irreversible Pulpitis
Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults
Condition: Cognitive Function
Study type: Interventional

Summary: 
      An acute, randomized, placebo controlled, double blinded crossover study in health subjects.
      Participants will complete 4 intervention arms in random order consisting of a placebo
      control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with
      a fruit extract, and a low does phenolic beverage. The primary objective of the study is to
      assess the effects of the phenolic compounds, at two different levels, alone and in
      combination with a fruit extract, on mood and cognitive performance during extended periods
      of cognitively demanding task performance.
    


Intervention name(s): Phenolic Beverage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Two doses of metformin with 12 hour interval

        -  low dose group (375/250 mg)

        -  high dose group (1000/1000mg)
    

Detailed description: 
      A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between
      different metformin dose groups.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing
      two different strategies in the treatment of grade III and IV hemorrhoids: transanal
      hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.
    

Detailed description: 
      Transanal hemorrhoidal dearterialization (THD)‪ uses a specially developed anoscope combined
      with a Doppler transducer to identify the hemorrhoidal arteries. A suture ligation is
      performed to effectively decrease the blood flow to the hemorrhoidal plexus. In case of
      redundant prolapse, the prolapsed mucosa is lifted (mucopexy). THD procedure is performed
      without any incisions or removal of the hemorrhoidal tissue and moreover the suture line is
      above the dentate line, so post-operative pain and morbidities seem to be minimized in these
      patients. This technique differs from Ligasure hemorrhoidectomy, which focuses on excising
      the hemorrhoidal tissue.

      This prospective, randomized, multicenter and controlled trial compares post-operative pain,
      morbidities, quality of life, fecal incontinence and recurrence rate in patients treated for
      grade III and IV hemorrhoids with THD with mucopexy versus Ligasure hemorrhoidectomy.
    

Intervention name(s): Transanal hemorrhoidal dearterialization + mucopexy (THD).; Ligasure™ hemorrhoidectomy; THD anoscope and doppler; Ligasure Vessel Sealing
Intervention type(s): Device; Procedure; Device; Device
Intervention description(s): Using an anoscope combined with a Doppler transducer the hemorrhoidal arteries are identified and ligated to decrease the blood flow to the hemorrhoidal plexus. In order to reduce hemorroidal prolapse a mucopexy is performed.; Excisional hemorroidectomy performed with Ligasure™; An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure; A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhoids grade III and IV; transanal hemorrhoidal dearterialization; hemorroidectomy; THD; LigaSure
Health Effects of Oat Bioactives (Betaglucan) in Human
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate health effects of oats and oat derived components, in
      human intervention studies, with the purpose to build new knowledge for development of
      cardiometabolic protective foods.
    

Detailed description: 
      The overall goal is to increase the knowledge which can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on cardiometabolic test markers of oat and oat based product. The new
      knowledge will form a base for the development of oat based food products with added health
      values.
    

Intervention name(s): Effects of Oat and Oat Components on Cardiometabolic risk variables
Intervention type(s): Dietary Supplement
Intervention description(s): Oat and oat bioactive components consumed as breakfast meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?
Condition: Anxiety; Overactive Bladder; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Retention
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Retention; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Anxiety Disorders
Study type: Observational

Summary: 
      This study will look at how pre-test anxiety levels affect the reproducibility of symptoms
      during routine urodynamic testing in women. Urodynamics is a test that assesses the function
      of the lower urinary tract, including the bladder.
    

Detailed description: 
      The results of urodynamic tests often determine treatment for patients, which may include
      bladder retraining, medication and/or surgery. Thus, it is important for the results of
      urodynamics to be accurate and representative of the patient's symptoms outside of the
      clinic.

      Pre-test anxiety levels in women undergoing urodynamics will be measured using a validated
      questionnaire HADS (Hospital anxiety and depression scale). The patient, prior to their
      routine urodynamics test, will fill out this self-administered questionnaire.

      Reproducibility of patient symptoms will be measured using a non-validated quantitative
      bladder test assessment. The patient will fill out this self-administered quantitative
      bladder assessment after their urodynamics test.

      The pre-test anxiety and symptom reproducibility variables will be correlated against each
      other to assess whether there is correlation between the two. A Spearman Rho test will be
      used to assess the strength of the relationship.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only patients referred for urodynamics for the first time will be asked to consider being
        included in the study. Minimum of 30 participants to be included. Recruited via obstetric
        and urogynaecology clinics.
      
Keywords: Anxiety; Urodynamics; Symptom reproducibility; Lower urinary tract symptoms; Women
Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence parameters of esomeprazole capsules
      20 mg (test product) vs. esomeprazole capsules 20 mg (reference product) under fasted
      conditions.
    

Detailed description: 
      This will be a single center, single dose, single-blind, randomized, two-sequence, two-period
      crossover, bioequivalence study in healthy adult participants with at least a 7-day washout
      period. The study will consist of an ambulant screening day within 28 days prior to first
      product administration and two study periods.
    

Intervention name(s): Esomeprazole 20 mg Delayed-Release Capsules; Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)
Intervention type(s): Drug; Drug
Intervention description(s): Esomeprazole 20 mg delayed-release capsules will be given as one capsule once daily as oral administration.; Esomeprazole 20 mg delayed-release capsules (Nexium 24HR) will be given as one capsule once daily as oral administration.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Psychoeducational Program "BalancingMySwing" for Patients With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The psychoeducation BalancingMySwing (BMS) program has been developed manually and its
      feasibility has been tested in our previous study. This 3-year research project aimed to
      further examine the immediate and lasted effects of BMS program for BD, and to assess its
      knowledge dissemination and the transferability of its evidence-based practice across
      multiple sites.
    

Detailed description: 
      The psychoeducation BalancingMySwing (BMS) program has been developed manually and its
      feasibility has been tested in our previous study. This 3-year research project aimed to
      further examine the immediate and lasted effects of BMS program for bipolar disorders (BD),
      and to assess its knowledge dissemination and the transferability of its evidence-based
      practice across multiple sites.

      During the first 2 years, a randomized controlled trial was conducted. Patients diagnosed
      with BD were recruited and 104 patients were randomly assigned to treatment as usual (TAU) or
      to 8 BMS sessions. A battery of three outcome indicators-social rhythm, illness perception,
      and symptom severity-were used to examine the effects of the two groups at baseline, after
      intervention, and every 3 months until half year. In addition, a pre- and post-test
      quasi-experimental study combined with qualitative design was used to assess the
      translational feasibility of BMS and to explore related barriers and facilitators of
      implementing BMS in clinical settings in the third year. Nurses from 4 Hospitals received the
      BMS training, and patients with BD received the BMS translated in practice were recruited.
    

Intervention name(s): Psychoeducational Program "BalancingMySwing"
Intervention type(s): Behavioral
Intervention description(s): Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing" group psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment as usual (TAU); and Psychoeducational Program "BalancingMySwing"
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; depression; manic; illness perception
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Condition: Healed Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to
      Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis
      confirmed by endoscopy following oral administration once daily(QD) for 6 months.
    

Detailed description: 
      This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be
      randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
    

Intervention name(s): Tegoprazan 25mg QD; Lansoprazole 15mg QD
Intervention type(s): Drug; Drug
Intervention description(s): Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.; Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
Condition: Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
Study type: Interventional

Summary: 
      Intraocular pressure is significantly increase during robot-assisted laparoscopic radical
      prostatectomy which is performed in a steep trendelenburg position at prolonged timeds of
      pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in
      intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.
    


Intervention name(s): Dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: DEXMEDETOMIDINE; intraocular pressure
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
Condition: Dermatitis, Atopic; Rosacea; Acne Vulgaris; Sensitive Skin
MeSH terms: Dermatitis, Atopic; Dermatitis; Acne Vulgaris; Rosacea; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial
      cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne,
      cosmetic intolerance syndrome).
    


Intervention name(s): Non-marketed Cosmetic Facial Cleanser
Intervention type(s): Other
Intervention description(s): Participants will apply non-marketed cosmetic facial cleanser on cleanse facial skin, twice daily for 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Objective Evaluation of Ocular Surface Lubricants in Two Environments
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.
    

Detailed description: 
      This study will objectively evaluate ocular surface lubricants in subjects with dry eye
      syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms,
      although objective data is not available. The investigators seek to objectively evaluate the
      effectiveness of two lubricants and compare the results to a saline eye drop (control).

      The investigators will assess the lipid layer before and after the administration of three
      products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal"
      environment. Subsequently the investigators will change the environment to one that causes
      the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and
      greater air flow) and perform the before and after drop administration measurements with the
      same three products in the same eye as the first environment.
    

Intervention name(s): B & L Soothe Lubricant Eye Drops; Liposic EDO; OcuFresh Eye Wash
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eye Drop; Eye Drop; Saline drop
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Dry Eye; tear film; lipid; tear volume; environmental chamber; thermal imaging