bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
Condition: General Anesthesia, Thoracic Epidural Anesthesia
MeSH terms: Aortic Dissection
Study type: Interventional
Phase: Phase 4

Summary: 
      We designed a study to determine whether a single dose of dexmedetomidine or thoracic
      epidural anesthesia combined with general anesthesia would provide hemodynamic stability,
      reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep
      quality in patients after thoracic surgery.
    

Detailed description: 
      We designed a prospective, single-blinded, randomized, and controlled study to determine
      whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with
      general anesthesia would provide hemodynamic stability, reduce stress hormone responses,
      inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic
      surgery.
    

Intervention name(s): general anesthesia combined with dexmedetomidine infusion; general anesthesia combined with TEA
Intervention type(s): Drug; Procedure
Intervention description(s): general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D); general anesthesia combined with TEA (Group E)
Intervention MeSH terms: Dexmedetomidine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine, thoracic epidural anesthesia
The Probiotic Study: Using Bacteria to Calm Your Mind
Condition: Anxiety; Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators seek to conduct the first open-label trial of probiotics in young children
      to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the
      feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the
      middle-lower GI tract. Self-report measures and a laboratory task will be collected from
      children, ages 9-13 years of age, and self-report measures from their primary caregivers
      prior to and following a 30-day probiotic administration. Children who score above cutoff in
      anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited
      sample size and the iterative nature of intervention development, criteria for success at the
      pilot phase are based primarily on clinical rather than statistical criteria. The study
      personnel will do their best to keep and ensure the privacy and confidentiality of our
      participants; however, some of the risks of this study may include psychological discomfort,
      legal risks, and loss of confidentially.
    


Intervention name(s): Lactobacillus rhamnosus
Intervention type(s): Drug
Intervention description(s): The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by the study Co-PI, Dr. Seed. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The treatment duration is 30 days.
Other intervention name(s): Culturelle Kids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and reactogenicity of GSK Biologicals' combined
      reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when
      given as a single injection to 6-10 year old children. Data that are available globally on
      the age group from four to six years of age will be used to bridge the age gap in this study
      and aid in the registration of the vaccine for children from the age of four years.
    

Detailed description: 
      A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM
      administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A
      single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will
      be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse
      events (during 4 days post vaccination), unsolicited adverse events (during 31 days post
      vaccination) and serious adverse event (during the trial period).

      This protocol summary was updated following an administrative change of adding the EudraCT
      number to this study.
    

Intervention name(s): Boostrix™
Intervention type(s): Biological
Intervention description(s): Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vietnam; Children; Reactogenicity; BoostrixTM; Safety; dTpa; Booster; Healthy
Study of Tibial Shaft Fractures in Children
Condition: Tibial Shaft Fractures in Children
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Tibial shaft fracture is one of the most common fractures in children and adolescents. It
      encompasses approximately 15 % of all long-bone fractures and is third behind only fractures
      of the femur and both bones of the forearm. (2). Although most authorities agree that closed
      tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no
      clear consensus as to when to allow weight bearing on the injured extremity. While most
      recent articles have recommended long-leg casts with the knee bent in flexion of 30-60
      degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less
      flexion, 0-5 degrees, to encourage early weight bearing.(5).

      The purpose of this randomized controlled prospective study is to determine if the position
      of immobilization of the knee influences the rate of healing, delayed union, and nonunion As
      well, we will assess if the type of immobilization affects the function of the patient during
      the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child
      self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a
      total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the
      tibia, with or without fracture of the fibula, will be included in the study
    


Intervention name(s): Long leg cast in full extension; Long leg cast with 45 degrees of flexion
Intervention type(s): Procedure; Procedure
Intervention description(s): Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity; Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tibia; shaft; fracture; children
Efficacy of Peppermint and Green Tea in Malodor
Condition: Bad Breath
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      Background:

      Herbal remedies can have the role of prevention and control of bad breath Since in the
      previous studies, therapeutic and antibacterial effect of green tea and peppermint had been
      proven .we studied and compared the effects of green tea and peppermint mouthwashes on
      halitosis.

      Materials and Methods:

      This single-blind clinical trial study with cross over design total of 88 volunteer dental
      students who complained bad breath and had organoleptic score (>= 2) and higher average test
      scores were enrolled. The students were divided randomly into two groups Green Tea -
      Peppermint were assigned. Organoleptic test in the baseline, on the 7 day, 14 and 21 measured
      after rinsing the mouthwashes .As well as the satisfaction of both plants on the last day was
      considered. Data analysis was performed using tests; Wilcoxon signed rank test, Mann Whithney
      u, GEE (Generalized Estimating Equation -ordinal logistic regression).
    


Intervention name(s): mouthwash
Intervention type(s): Other
Intervention description(s): mouthwash containing herbal peppermint or green tea
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: mouth wash , green tea , peppermint , bad breath
Effectiveness of Lung Sono in One-lung Ventilation
Condition: One Lung Ventilation
Study type: Interventional

Summary: 
      To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery
      with one-lung ventilation(OLV).
    

Detailed description: 
      One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better
      surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which
      might be preventable with adequate alveolar recruitment and positive end-expiratory
      pressure(PEEP). Alveolar recruitment has been performed with conventional methods without
      diagnostic tools in clinical setting.

      Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of
      lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in
      other surgeries, but not in thoracic surgeries with OLV.

      Thus, investigators designed a study to observe the effectiveness of ultrasound-guided
      alveolar recruitment in thoracic surgery with OLV.
    

Intervention name(s): Lung-sono guided
Intervention type(s): Procedure
Intervention description(s): The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.
In the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction.
During the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear.
Then, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: One lung ventilation; Lung ultrasound; Alveolar recruitment
Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of the study was to determine the efficacy of CDP870 in treating RA
      signs/symptoms in patients who were partial responders to MTX. Other purposes were to show
      additional efficacy without increased toxicity and the immunogenic response to CDP870 during
      combined CDP870 and MTX therapy.
    


Intervention name(s): CDP870
Intervention type(s): Drug
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CDP870; Certolizumab pegol
Music and Feeding in NICU
Condition: Feeding; NICU; Preterm Infants; Mozart; Weight Gain
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of classical music exposure on
      improved time to regain birth weight and improved feeding readiness in healthy premature
      infants in the NICU.
    


Intervention name(s): Music; No music.
Intervention type(s): Other; Other
Intervention description(s): This is the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Evaluate the Efficacy of RespireAidTM in Patient With Externally Contracted Seasonal Epidemic (外感時疫)
Condition: Respiration Disorders
MeSH terms: Respiration Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to learn about in the main objective of this study is to
      evaluate the clinical efficacy of the RespireAidTM (Tai-wan-Qing-Guan-Yi-Hao) to ease the
      symptoms of fever, sore throat, and cough, and the safety after treatment. Participants will
      Take 1 sachet(5g) 4 times daily. There is a comparison group: Researchers will compare
      placebo to see if RespireAidTM.
    

Detailed description: 
      This is a multicenter, parallel, double-blind, randomized, placebo-controlled study. A total
      of 258 male or unpregnant female outpatient subjects ≥ 18 years to ≤ 79 years of age will be
      enrolled into this study (dropout rate 10%). There will be 2 visits in this study. In Visit 1
      (Day 1), subjects who have the symptoms of fever, sore throat, and cough (match the
      definition in table 1 to 3 in protocol), by investigator's judgement will be recruited into
      the study. Subjects will be randomized into the RespireAidTM group or placebo group with
      allocation rate 2:1. Following to the clinical guideline of NRICM101, subjects in
      RespireAidTM group will take drug four times daily with 20g oral granule, administered for 5
      days. The subjects in placebo group received study drug with the same dose frequency. Other
      than study drugs, the rescue drug, acetaminophen, will be administered. If subjects have
      moderate or severe fever, sore throat, he/she could receive one rescue medication (500mg) per
      4 hours, up to 6 tablets in total in one day. Subjects will be educated how to use e-dairy.
      The dairy will be recorded the severity of fever, sore throat, and cough from baseline (Day
      1, before use of study drug) to Day 5. The efficacy endpoint will be the improvement of
      fever, sore throat, and cough, and the safety endpoint will be adverse events after
      treatment. The study and rescue drugs will be dispensed to subjects and the study staff will
      teach them how to receive medications. If subjects have persistent fever, unscheduled visits
      will be arranged to check whether or not they would be suitable to participate into this
      study.

      Adverse events will be recorded at Visit 2(Day 8), and the dairy with drug record will be
      checked.
    

Intervention name(s): RespireAid TM/placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Direction: Take 1 sachet(5g) 4 times daily
Indication: Externally contracted seasonal epidemic
Function: Relieving Exterior and Facilitating Lung, clear heat of lung, Wide chest and resolve phlegm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: RespireAid; Externally Contracted Seasonal Epidemic
Glucose Tolerance in Healthy Overweight Adults
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to compare the postprandial glycemic response of healthy overweight
      adults after consuming an amino acid drink mix versus a control drink.
    


Intervention name(s): Amino Acid Drink Mixture; Glucose drink
Intervention type(s): Other; Other
Intervention description(s): 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins; 22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Culture Medium on Embryo Quality
Condition: Embryo Development
Study type: Interventional

Summary: 
      The purpose of this study is to compare two culture media.
    


Intervention name(s): embryo culture medium
Intervention type(s): Other
Intervention description(s): comparison between two types of embryo culture medium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery
Condition: General Anesthesia; Elective Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the therapeutic equivalence, based on
      pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL
      (AstraZeneca), administered by target controlled infusion (TCI).
    


Intervention name(s): Propofol; Diprivan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Therapeutic Equivalence; Propofol
Investigation of Docosahexaenoic Acid (DHA) Metabolic Pathway in Human by Using 13C Labeled Molecules
Condition: Healthy Subject
Study type: Interventional

Summary: 
      The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway
      in human by using 13C labeled molecules.

      The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this
      research is to confirm that some lipidic forms are best carriers for the cerebral
      incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.
    


Intervention name(s): 13-C labeled AceDoPC-DHA; 13-C labeled TG-DHA; 13-C labeled PC-DHA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months; Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months; Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
The dose contains 50 mg 13C-DHA. The wash-out period is four months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: nutrition
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to assess the effect of severe renal impairment on the
      pharmacokinetics of lemborexant after a single-dose administration.
    


Intervention name(s): Lemborexant
Intervention type(s): Drug
Intervention description(s): oral tablet
Other intervention name(s): E2006
Intervention MeSH terms: Lemborexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe renal impairment; lemborexant; normal renal function; healthy participants; metabolites; E2006; pharmacokinetics
To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
Condition: Allergy to Pollen
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biological activity of Artemisia vulgaris
      allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Artemisia vulgaris allergen extract, together with a positive and
      negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol
      saline solution, respectively, will be tested in every patient in duplicate on the volar
      surface of the forearm.
    

Intervention name(s): Artemisia vulgaris
Intervention type(s): Biological
Intervention description(s): Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Other intervention name(s): Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pollen
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral
      tablets, patients experience withdrawal and cravings when the variable BPN levels in the
      blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is
      designed to provide 6 months of stable BPN blood levels. This study will test the safety and
      efficacy of Probuphine in the treatment of patients with opioid dependence.
    


Intervention name(s): Probuphine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 implants; 4 implants
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opioid dependence; opioid addiction; buprenorphine; methadone; heroin; implant; opioid withdrawal; opioid pain medication; suboxone
Bioequivalency Study of Meloxicam Tablets Under Fed Conditions
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam
      tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-inflammatory