bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children
Condition: Adverse Effect of Other General Anesthetics
Study type: Interventional

Summary: 
      Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating
      airway properties, rapid induction and emergence. However, it is associated with emergence
      agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a
      cause of stress to both caregivers and families. Various pharmacologic agents have been
      suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This
      study was designed to compare the effects of remifentanil and remifentanil combining
      alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.
    

Detailed description: 
      One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied.
      General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane.
      At the time of separation from parents, separation score was recorded. When the children have
      a separation score of three or four point, they received half dose of thiopental before going
      to the operation room. They randomly assigned to group S (sevoflurane alone) or group R
      (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane
      with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the
      end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration
      were checked every 15 minutes after induction of anesthesia. Time to extubation from
      discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia
      care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation
      scoring system was used to evaluate the incidence and severity of EA.
    

Intervention name(s): Sevoflurane; Remifentanil; Alfentanil; Thiopental; Rocuronium
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): Anesthesia of patients was maintained only with sevoflurane.; Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.; Anesthesia was maintained with both sevoflurane and continuous infusion of remifentanil. Alfentanil was administrated (5ug/kg) to patients 10 minutes before the end of surgery.; General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.; General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
Other intervention name(s): Ultiva; Pentothal sodium; Esmeron
Intervention MeSH terms: Remifentanil; Alfentanil; Thiopental; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of an Exercise on Serum Uncoupling Protein-1 Level and the Role of Uncoupling Protein-1-3826 A/G Polymorphism
Condition: Uncoupling Protein-1; Polymorphism, Restriction Fragment Length; Irisin
Study type: Interventional

Summary: 
      This study aims to determine the effect of an acute maximal exercise on serum uncoupling
      protein-1, irisin, interleukin 6 levels, and on blood lipid and lipoprotein concentrations.
      This study also evaluates the role of uncoupling protein-1-3826 A/G polymorphism on this
      eventual effect.

      Therefore, this study hypothesizes that:

      H01: Sedentary people and athletes' serum uncoupling protein 1, irisin, and interleukine 6
      levels are different before and after an acute maximal exercise.

      H02: Sedentary people and athletes' basal serum uncoupling protein 1 levels are associated
      with uncoupling protein 1-3826 A/G polymorphism.

      H03: Uncoupling protein 1-3826 A/G polymorphism has a modifying role in the effect of maximal
      exercise on serum uncoupling protein 1 levels.

      H04: Sedentary people and athletes' basal serum lipid and lipoprotein levels are associated
      with uncoupling protein 1-3826 A/G polymorphism.

      H05: Uncoupling protein 1-3826 A / G polymorphism has a modifying role in the effect of
      maximal exercise on serum lipid and lipoprotein levels.
    


Intervention name(s): Yo-Yo intermittent recovery test (level 1)
Intervention type(s): Other
Intervention description(s): The Yo-Yo intermittent recovery test (level 1) will be administered once.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Beige fat cell; Fat tissue; Athletes; Sedentary people; Irisin
Epigenetic Regulation of BDNF in Schizophrenia
Condition: BDNF, DNA Methylation, Suicide, Drug Responses.
MeSH terms: Suicide
Study type: Observational

Summary: 
      In this proposal, we will (1) detect the associations between BDNF and Trk B gene DNA
      methylation, histone modification, psychotic symptoms, obesity, suicide and antipsychotic
      drug responses in Taiwanese patients (2) discuss the possible mechanisms of epigenetic
      regulation of BDNF and Trk B in schizophrenia patients.
    

Detailed description: 
      A total 160 subjects (80 subjects every year, including 40 healthy controls and 40
      schizophrenia patients) will be recruited during a 2-year period. The first year, the
      baseline data of BDNF and Trk B DNA methylation, protein and mRNA levels in all subjects will
      be collected and the following 1 months data will also be collected in schizophrenia with
      antipsychotic drug treatments. The second year, the baseline data of BDNF and Trk B histone
      modification in all subjects will be collected.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be conducted in our clinical setting. By a semi-structured interview for
        DSM-IV criteria, total 160 subjectes (80 subjects every year, including 40 healthy controls
        and 40 schizophrenia patients with acute exacerbation) will be recurited during a 2-year
        period. The data of blood BDNF and Trk B DNA methylation and histone remodelling of all
        subjects will be collected.
      
Biospecimen description: 
      Blood
    
Keywords: schizophrenia, BDNF, DNA methylation, histone modification
3D Analysis of Root Canal Conformation
Condition: Endodontic Disease; Root Canal Infection
MeSH terms: Dental Pulp Diseases
Study type: Interventional

Summary: 
      Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file
      systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography
      and 3D reconstructions to measure canal volume increase, centering ability of the instruments
      and canal transportation in human premolars in vivo.

      Methodology Thirty human lower premolars were randomly divided into three groups, in which
      root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne
      Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by
      using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering
      ability of the instrument and canal transportation for each group. Statistical analysis was
      made for each variable to determine statistically significant differences between groups.
    


Intervention name(s): Root canal preparation
Intervention type(s): Procedure
Intervention description(s): Root canals from lower premolars with extraction indicated were prepared previous to being extracted with either the Reciproc Blue, the WaveOne Gold or the XP EndoShaper single-file techniques.
Other intervention name(s): Root canal instrumentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: root canal preparation; single-file preparation techniques; 3D reconstruction
Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders
Condition: Bladder and Bowel Disorder, Pediatric
MeSH terms: Intestinal Diseases; Respiratory Aspiration
Study type: Interventional

Summary: 
      Urination is a result of a complex neuro-muscular coordination which involves the action and
      arrangement of different parts of nervous systems as well as the muscular structure of the
      lower part of the urinary system. When there is an abnormal pattern in bladder and bowel
      habits without any known neuronal lesions, the condition is called bladder and bowel disorder
      (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to
      urinating much less than expected during the day.

      The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a
      beneficial basic and harmless form of treatment widely used for all children with BBD. SU
      involves explaining of the problem to the children and their parents by the doctors and
      educating them on proper voiding mechanisms, sitting, and standing positions as well as how
      and when to void.

      The purpose of this study is to explore the possibility of testing the additive effectiveness
      of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment
      to SU in children with BBD.
    


Intervention name(s): Diaphragmatic Breathing; Standard Urotherapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diaphragmatic breathing (DB); Bladder and bowel disorders (BBD); Autonomic nervous system (ANS); Heart rate variability (HRV); Deep breathing; Randomized controlled trial (RCT)
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
Condition: Cholestasis
MeSH terms: Cholangitis; Cholestasis; Liver Cirrhosis, Biliary; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672
      administration for the treatment of pruritus (itch) in participants with primary biliary
      cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of
      GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily).
      Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study
      has a prospectively defined adaptive design that will utilize interim data to further inform
      and potentially optimize the doses under investigation. Hence, additional dose regimen may be
      added during study. The total duration of a participant in the study will be up to 45 days of
      screening and 24 weeks of study including follow-up.
    


Intervention name(s): Placebo; GSK2330672
Intervention type(s): Drug; Drug
Intervention description(s): GSK2330672 matching placebo will be supplied as white film-coated tablets.; GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: linerixibat; PBC; itch; GSK2330672; GLIMMER; primary biliary cholangitis; pruritus
Alternative of Treatment in Obesity Hypoventilation Syndrome
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus
      continuous positive airway pressure (CPAP) and life style modification treatment in Obesity
      Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second
      phase) analyzed as a primary variables and percentage of dropouts for medical reasons and
      mortality as operative variables. As secondary variables: Measure functional and clinical
      improvement during sleep and wakefulness, quality of life, echocardiography and the incidence
      and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of
      apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of
      diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will
      be divided initially into two groups based on their apnea-hypopnea index (AHI) score, >=30
      and < 30, using conventional polysomnography. The AHI >=30 group will be randomized to CPAP,
      NIV or life style modification treatments. The AHI <=30 groups will be randomized to NIV or
      life style modification treatments. Treatment efficacy at the medium- and long-term will be
      analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime
      alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient
      between responders and non-responders to CPAP treatment, and the evolution of leptin levels
      in the four branches of the study. The role of apneic events in metabolic and biochemical
      alterations and endothelial dysfunction will be analyzed by comparing basal and
      post-treatment levels of related substances between groups, with and without significant AHI.
    

Detailed description: 
      The AHI >=30 group will be analyzed to CPAP, NIV or life style modification treatments for
      two mouths.Once an evaluation is done during this period, the life style modification
      treatment will be randomized with the NIV/CPAP treatment for a continuation of three years.
    

Intervention name(s): life style modification, noninvasive ventilation, CPAP
Intervention type(s): Device
Intervention description(s): life style modification, noninvasive ventilation, CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: sleep apneas; noninvasive ventilation; CPAP
Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
Condition: Laparoscopic Surgery
Study type: Interventional

Summary: 
      the study discussed the safety of new technique for primary port insertion in cases of
      previous abdominal and pelvic surgery
    

Detailed description: 
      the study discussed the safety of new technique for primary port insertion in cases of
      previous abdominal and pelvic surgery and comparing the new technique group (A) patients to
      already known technique called (Hasson's technique) group (B) patients
    

Intervention name(s): new laparoscopic access technique for group a; Hasson's technique for laparoscopic access in group b
Intervention type(s): Procedure; Procedure
Intervention description(s): new laparoscopic access technique through the epigastric region; Hasson's technique for laparoscopic access in group b
Other intervention name(s): new laparoscopic access technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.
Condition: Lymphocele; Lymphocele After Surgical Procedure; Endometrium Cancer
MeSH terms: Endometrial Neoplasms; Lymphocele
Study type: Interventional

Summary: 
      To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel
      matrix used and not used during pelvic lymph node dissection.
    

Detailed description: 
      Pelvic lymph node dissection is the most accurate staging tool to determine lymph node
      involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious
      morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study,
      conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application
      after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of
      thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.
    

Intervention name(s): Thrombi-Gel; Conventional Pelvic lymphadenectomy
Intervention type(s): Drug; Procedure
Intervention description(s): Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy; Conventional Pelvic lymphadenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by
      symmetric poly-arthritis usually involving the small joints of the hands and feet. In
      addition, various extra-joint manifestations may develop. Several immunomodulating agents
      have been attempted in the treatment of RA without achieving satisfactory results.
      Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases,
      which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose
      IL-2 could be a novel therapy in active RA patients. This clinical study will test the
      efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a
      single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the
      effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2
      (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).
    

Detailed description: 
      Each RA patients (n=47) with DAS>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX +
      Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously
      (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started)
      for 3 cycles. The end points were safety and clinical and immunologic response.
    

Intervention name(s): hrIL-2 active; hrIL-2 placebo; MTX; Folic Acid; Loxoprofen
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): hrIL-2 active (1 million U doses of hrIL-2s.c.injection); hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection); Methotrexate (oral administration); Folic Acid (oral administration); Loxoprofen (oral administration)
Other intervention name(s): Human recombinant IL-2; placebo
Intervention MeSH terms: Folic Acid; Loxoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of a New Apexification Method for Patients Presenting a Non Vital Immature Tooth
Condition: Dental Pulp Necrosis
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Pulp necrosis is one of the main complication of dental trauma. When it happens on an
      immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy
      called apexification is required to induce the formation of a calcified apical barrier
      allowing a permanent and hermetic root filling.The aim of this study is to compare the
      efficacy of a new apexification method using Mineral Trioxide Aggregate (MTA®) with the
      reference treatment based on calcium hydroxide repeated stimulations.
    

Detailed description: 
      36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the
      study (inclusion period: 12 months). These patients will be randomly divided into two groups:
      one treated with MTA®, and the other one with calcium hydroxide. For each patient, the total
      duration of the study will be 12 months. Recalls will be performed at 15 and 21 days and then
      at 3, 6 and 12 months to assess by clinical and X-ray exams the main success criterion:
      presence of a calcified apical barrier or not. Additional criterions such as presence of
      clinical symptoms or not, apical morphology and depth of this apical barrier will be
      observed. This randomised prospective therapeutic study will allow to assess the ability of
      MTA® inducing apexification of a non vital immature tooth. Furthermore, it will be possible
      to compare for both materials the kinetics of clinical symptoms disappearance and the
      morphology and depth of apices.
    

Intervention name(s): Mineral Trioxide Aggregate; Calcium hydroxide
Intervention type(s): Drug; Drug
Intervention description(s): Apexification treatment of the tooth with Mineral Trioxide Aggregate; Apexification treatment of the tooth with Calcium hydroxide
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Apexification; Pulp necrosis; Calcium hydroxide; MTA; pulp necrosis of an anterior immature tooth
Tolerability and Pharmacokinetics/-Dynamics of BIBT 986 BS in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg)
      BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood
      coagulation parameters
    


Intervention name(s): BIBT 986 BS - low; BIBT 986 BS - high; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Condition: Conjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of Zylet in
      comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of
      blepharoconjunctivitis in pediatric subjects.
    


Intervention name(s): loteprednol etabonate and tobramycin; loteprednol etabonate; Tobramycin; Vehicle of Zylet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.; Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.; Topical ocular administration of Tobramycin QID for 14 days.; Topical ocular administration of the vehicle of Zylet QID for 14 days.
Other intervention name(s): Zylet; Lotemax
Intervention MeSH terms: Loteprednol Etabonate; Tobramycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blepharokeratoconjunctivitis