bioihbjkbjnl/mcl2 huggingface dataset:
Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases
Condition: Diagnosis of Pleural Diseases; Medical Thoracoscopy
MeSH terms: Pleural Diseases; Disease
Study type: Interventional

Summary: 
      Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and
      medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus
      exists regarding which biopsy methods are appropriate for specific procedures.

      In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy
      using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle
      (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.
    

Detailed description: 
      The primary end point of this study was the determination of the sensitivity and the
      complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle
      pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.
    

Intervention name(s): CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy
Intervention type(s): Diagnostic Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Preoperative Operating Room Environment Presentation in Hypertensive Patients
Condition: Hypertension; Anxiety; Blood Pressure
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of preoperative operating room
      environment introduction on preoperative hypertension and blood pressure in hypertensive
      patients.
    

Detailed description: 
      Procedure to be Applied:

      In order to eliminate the other factors that cause essential HT, the patients' blood pressure
      due to HT should be controlled, the surgery will be planned as the first case in the morning
      and the patients will need 8 hours fasting period.

      Patients' gender, age, height, weight values, ASA scores, body mass index (BMI) values will
      be recorded. Hemodynamic parameters (blood pressure, heart rate and SpO2 values) will be
      recorded in the services of the patients, in the preop unit and in the operation room.
      Hypertension requiring intervention or additional medication will be excluded from the study.
      A randomized number of patients will be included in the study according to the results of
      power analysis.

      Introduction of the operating room environment (IORE): The procedure to be performed on the
      day of surgery will be simulated and accompanied by an anesthesiologist. The patient's
      hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the
      time of operation, between 16: 00-18: 00 hours prior to the operation, and will be brought to
      the operating room with a service nurse. The hemodynamic data of the patient will be measured
      in the preop unit and the patient will be taken to the operating room with anesthesia doctor.
      Here, in addition to the patient's hemodynamic data, the instantaneous state anxiety scale
      (ST-STAI) will be completed and the patient will be left in service again. The procedure will
      be similar to the process that the patient will experience on the operation day.
    

Intervention name(s): Group IORE
Intervention type(s): Behavioral
Intervention description(s): This group will undergo the IORE procedure before surgery (operation). On the day of surgery, the patient will be brought to the operating room by the anesthesiologist. Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room. The anxiety level in the operating room will be measured by the ST-STAI scale.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hypertensive patients; Introduction of operating room; Anxiety; Blood pressure
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Condition: Anesthesia; Adverse Effect; Reflex, Abnormal; Tinnitus, Spontaneous Oto-Acoustic Emission
MeSH terms: Tinnitus; Reflex, Abnormal
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on
      Stapes Reflex and Distortion Product Auto Acoustic Emission.
    

Detailed description: 
      This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes
      reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic
      emission are of considerable diagnostic significances in otolaryngology this are objective
      methods for the assessment of auditory function.
    

Intervention name(s): Dexmedetomidine; esmolol
Intervention type(s): Drug; Drug
Intervention description(s): 1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion; 500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion
Other intervention name(s): precedex; breviblock
Intervention MeSH terms: Dexmedetomidine; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine; esmolol; stapes reflex
Reliability of the Facial Wrinkle Scale in Japanese Subjects
Condition: Facial Rhytides
MeSH terms: Facies
Study type: Observational

Summary: 
      This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle
      Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.
    


Intervention name(s): No Intervention
Intervention type(s): Drug
Intervention description(s): No intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with facial lines
A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples
Condition: Control of Pregnancy; Prevention of Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom
      versus a standard natural rubber latex (NRL) condom.
    

Detailed description: 
      In this clinical investigation, a new PU male condom (test condom) will be evaluated against
      a marketed NRL male condom (reference condom). This clinical investigation will also evaluate
      the in-use tolerance of the test and reference condoms.
    

Intervention name(s): Polyurethane (PU) condom; Natural Rubber Latex (NRL) condom
Intervention type(s): Device; Device
Intervention description(s): A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.; A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The condom types will be tested in a 2-way cross-over design where couples will be randomised to use each of the 2 condom types in a defined order, according to the randomisation schedule.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The study was the non-interventional, retrospective study aimed to assess the effectiveness
      and safety of omalizumab in children with allergic asthma in China, and described patient
      profiles and treatment patterns of omalizumab in real-world practice.
    

Detailed description: 
      This non-interventional, retrospective study aimed to assess the effectiveness and safety of
      omalizumab in children with allergic asthma in China, and described patient profiles and
      treatment patterns of omalizumab in real-world practice. This study was designed to use
      secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect
      information such as demographics, clinical characteristics, treatment patterns,
      effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -<12
      years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for
      medical chart extraction.
    

Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
Intervention MeSH terms: Omalizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with allergic asthma treated with omalizumab from July 6, 2018 to September 30,
        2020 were identified for medical chart extraction
      
Keywords: Omalizumab,; allergic asthma,; children,; real-world study
The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
Condition: Malocclusion, Angle Class II; Retrognathism; TMJ
MeSH terms: Retrognathia; Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Patients with class II malocclusion and retrognathic mandibles will be treated using
      functional appliances and asses the remodeling that is expected to occur in the
      temporomandibular joint (TMJ) using cone-beam computed tomography (CBCT) images and we will
      register mandibular movements using electronic axiograph ( a specific apparatus used to
      record jaw movements in three dimensions).

      There are three groups :

        1. Activator Group

        2. Twin block Group

        3. Control Group with no treatment.

      Patients will be allocated to the three groups randomly.

      Data will be collected using three different approaches:

        -  CBCT images before treatment and 12 months after treatment

        -  Axiograph registrations before treatment and 12 months after treatment
    

Detailed description: 
      The main purposes of this project are:

        1. to evaluate the remodeling effects that would take place in the bone structures of the
           temporomandibular joint (TMJ) during functional treatment.

        2. to evaluate the possible change that may occur in mandibular movements following
           functional treatment.

        3. to evaluate the possible change in the spatial relationship between centric occlusion
           (CO) and centric relation (CR) following functional treatment
    

Intervention name(s): Activator; Twin Block
Intervention type(s): Device; Device
Intervention description(s): This appliance is constructed in one piece to guide the position of the mandible on closure; This appliance is constructed in two pieces to guide the position of the mandible on closure
Other intervention name(s): Andresen Appliance; Clark's appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children
Condition: Anxiety; Fear
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as
      well as future behavior related to dental problems in children. A common cause of such
      anxiety and fear is the procedural intervention that uses needles and syringes since a visual
      impact due to the needle acts as a deterrent to the child's cooperation during dental
      procedures. We therefore improvised the syringe such that it will camouflage the needle. We
      hypothesized that the use of this needle will alleviate the child's anxiety and therefore
      will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group
      randomized trial to test the efficacy of the camouflage syringe as compared to the
      conventional syringe in children.
    

Detailed description: 
      The present study was conducted with an aim to evaluate the efficacy of a needle-covering
      camouflage syringe as compared to the conventional syringe in reducing dental anxiety and
      fear in children. The study was carried out in 100 children who consecutively reported to the
      study center and were allocated to the camouflage syringe arm or conventional syringe arm
      using block randomization to ensure equal distribution across trial arms. The study assessed
      the degree of dental anxiety and fear using Venham's clinical rating scale in conjunction
      with rating scale for movement, crying and overall behavior and Venham's Picture Test. The
      study also assessed parental emotional stress status when the child underwent the injection
      procedure and the reaction of the child after going home by Parental Emotional Stress
      Questionnaire and Recall Questionnaire, respectively. The study used appropriate statistical
      methods to determine the efficacy of the camouflage syringe in reducing the anxiety and fear.
    

Intervention name(s): Camouflage syringe
Intervention type(s): Procedure
Intervention description(s): Dental anesthesia is administered using the camouflaged syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Condition: Infections, Fungal
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance
      doses over 3 days and compare it to the amount of voriconazole in the plasma.
    


Intervention name(s): voriconazole
Intervention type(s): Drug
Intervention description(s): Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Other intervention name(s): Vfend
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Voriconazole; Magnetic Resonance Spectroscopy
The Effect of Nocturnal Haemodialysis on Arterial Stiffness
Condition: End Stage Renal Disease; Arterial Stiffness
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Observational

Summary: 
      Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium
      which reduce blood vessel compliance. Although there is growing evidence that increased
      arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is
      unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating
      arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims
      of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on
      arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical
      and biochemical parameters.
    


Intervention name(s): Nocturnal Hemodialysis
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All participants are adult patients who are receiving maintenance dialysis at the North
        West Dialysis Service. Consecutive patients enrolled in the Nocturnal Haemodialysis program
        are invited to participate in the study
      
Keywords: arterial stiffness; artery; aortic pulse wave velocity; pulse wave analysis; augmentation index; end stage renal disease; nocturnal hemodialysis; extended hours of hemodialysis; cardiovascular; hemodialysis
GSK1349572 Drug Interaction Study With Efavirenz
Condition: Infections, Human Immunodeficiency Virus and Herpesviridae
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1349572 is an integrase inhibitor that is currently in Phase 2 clinical trials for the
      treatment of HIV infection. As GSK1349572 development progresses, it may be dosed with
      non-nucleoside HIV reverse transcriptase inhibitors (NNRTIs) including efavirenz (EFV,
      Sustiva). Efavirenz is a known inducer of CYP3A4. GSK1349572 is primarily metabolized via
      UGT1A1, however it also has a CYP component to its metabolism, thus a drug interaction
      between GSK1349572 and EFV is likely. A previous study showed that another NNRTI, etravirine
      which is also a known inducer of CYP3A and UGT, reduced GSK1349572 exposure significantly.
      GSK1349572 is not an inhibitor or inducer of CYP3A and is not expected to have impact on
      pharmacokinetics (PK) of EFV.

      This study will investigate the dose proportionality between single doses of 50mg and 100mg
      of GSK1349572 and will compare steady-state plasma PK, safety and tolerability of GSK1349572
      50 mg every 24h (q24h) with and without efavirenz 600 mg q24h. Approximately 12 subjects will
      receive a single dose of GSK1349572 100 mg (Treatment A) in Period 1 followed by a washout of
      greater than or equal to 6 days. In Period 2 subjects will receive GSK1349572 50mg q24h for 5
      days (Treatment B). Subjects will then be administered GSK1349572 50mg q24h in the morning in
      combination with EFV 600 mg q24h (Treatment C) in the evening for 14 days in Period 3. There
      will be no washout between Periods 2 and 3. Safety evaluations and serial PK samples for
      GSK1349572 will be collected during each treatment period. A follow-up visit will occur 7-14
      days after the last dose of study drug.

      This study will be conducted at one center in the US, with healthy adult male and female
      subjects.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): GSK1349572; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): GSK1349572 is an experimental drug under development for the treatment of HIV. It is in the class of integrase inhibitors.; Efavirenz is a drug that has been approved by the FDA for the treatment of HIV. It is in the class of non-nucleoside reverse trancriptase inhibitors.
Other intervention name(s): SUSTIVA. SUSTIVA is a registered trademark of Bristol-Myers Squibb
Intervention MeSH terms: Efavirenz; Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1349572; efavirenz; integrase; pharmacokinetics
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      The purpose of the study is to testify the efficacy of treating functional dyspepsia with
      acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on
      meridians, and gathering of meridian Qi is the key point."
    

Detailed description: 
      The purpose of the study is to testify whether acupuncture is effective for functional
      dyspepsia, through treating functional dyspepsia patient for a month, using different
      acupoints according to literatures of treating migraine with acupuncture, and using Itopride
      as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture
      effect is based on meridians, and gathering of meridian Qi is the key point."
    

Intervention name(s): acupuncture; Itopride
Intervention type(s): Other; Drug
Intervention description(s): Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.; Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.
Other intervention name(s): Itopride Hydrochloride Tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; meridian; acupoint
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications
Condition: Unstable Cervical Injury
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain,
      pin loosening and pin replacement.
    

Detailed description: 
      Halo Thoracic Orthoses (Halos) are used to immobilise unstable cervical fractures. The halo
      grips the skull via 4 pins. Pin loosening is a major complication of halo wear. Pin loosening
      is painful and can result in loss of control of the fractures. Treatment is required urgently
      and involves re-siting the pin.

      Comparisons: This study will compare two pin management practises with the aim to determine
      which is optimal to reduce the incidence of complications including pin loosening. Patients
      will be randomly allocated into 2 groups. The control group will receive treatment in
      accordance with current practise at The Alfred, the pins will not be re-tensioned throughout
      the treatment period. The alternative treatment group will have their pins re-tensioned
      fortnightly.
    

Intervention name(s): Halo pin re-tensioning; Placebo Re-tensioning
Intervention type(s): Procedure; Procedure
Intervention description(s): Re-tensiong every 2 weeks with torque driver. Pins are re-tensioned to 8lb/inch; Pts undergo re-tensioning procedure with torque driver set at zero to elicit the same clicking sensation with no tightening of the pin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Halo Thoracic Orthosis; Re-tension; Pin loosening
OC-01 (Varenicline) Nasal Spray and Dry Eye Signs and Symptoms in Daily Disposable Contact Lens Wearers
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a single center, prospective, randomized, controlled, double-masked, two-arm
      investigator-initiated study to investigate the efficacy of OC-01 (varenicline) nasal spray
      on the signs and symptoms of dry eye disease in daily soft contact lens wearers.
    


Intervention name(s): OC-01 (varenicline 0.6mg/ml) Nasal Spray; Placebo (vehicle) nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal delivery of OC-01 nasal spray twice daily (BID); Intranasal delivery of Placebo (vehicle) nasal spray twice daily (BID)
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment