bioihbjkbjnl/mcl2 huggingface dataset:
Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol
Condition: Esophagogastroduodenoscopy
Intervention: Lidocaine; Placebo
Intervention description: Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).; Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Esophagogastroduodenoscopy; Lidocaine; Propofol

Summary:

      The purpose of this study is to determine the efficacy of application of the anaesthesia
      topical pharyngeal with lidocaine in esophagogastroduodenoscopy under propofol´s sedation, in
      therms of dosage and side effect´s reduction overall.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient´s over 18 years old that received standard indication for sedated
             esophagogastroduodenoscopy (American Society of Gastrointestinal Endoscopy Guidelines)
             in our centre between the period of study.

        Exclusion Criteria:

          -  Patients under 18 years old

          -  Unable to obtain inform´s consent

          -  Emergency endoscopy

          -  Pregnant women

          -  Encephalopathy

          -  Well known allergic reaction to propofol, amide-anaesthesics, soy or eggs

          -  Methaemoglobinemia induced factor risks

          -  No previous or unknown fasting
Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis
Condition: Brain Ischemia
MeSH terms: Brain Ischemia; Intracranial Arteriosclerosis; Atherosclerosis; Ischemia
Intervention: Aggressive BP lowering; modest blood pressure lowering
Intervention description: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level; adjust the amount and number of antihypertensive drugs
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Blood Pressure; Atherosclerosis; Brain Ischemia

Summary:

      To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke
      patients with symptomatic severe intracranial atherosclerosis.

      Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between
      110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to
      modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with
      symptomatic severe intracranial atherosclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  acute symptomatic ischemic stroke having relevant lesion on DWI(Diffusion weighted
             image) MRI 7 days after and 42 days within onset.

          -  relevant stenosis(more than 50%) or occlusion from MCA(middle cerebral artery)(M1) to
             distal of ICA(internal carotid artery ) on MR(Magnetic resonance) angiogram or CT
             angiogram.

          -  mean systolic blood pressure>=140mmHg or taking antihypertensive drug on screening.

        Exclusion Criteria:

          -  taking more than 3 antihypertensive drugs and mean systolic blood pressure>=150mmHg on
             screening.

          -  history of recent thrombolysis but stenosis or occlusion remained after thrombolysis.

          -  evidence of orthostatic hypotension

          -  suspicious embolic cerebrovascular stenosis

          -  planned state of cerebrovascular surgery or angioplasty or stent 7 months within
             screening.

          -  severe stroke-NIHSS>=16

          -  mean systolic blood pressure>=200mmHg which is not able to control on screening.

          -  abnormal blood test finding (abnormal LFT(liver function test), anemia, renal
             insufficiency)

          -  pregnant or breast-feeding

          -  severe stroke sequela or medical problem

          -  suspicious secondary hypertension

          -  disease causing edema or significant ankle edema on screening.

          -  severe heart failure which correspond to NYHA (New York Heart Association )heart
             failure classification class III or IV.

          -  inappropriate condition determined by investigator

          -  Patient who do not have FLAIR image on or two months prior to screening.
Intraarticular Antibiotic in TKA
Condition: Antibotics in Cementless Knees
Intervention: Tobramycin Powder; Vancomyscin
Intervention description: Everyone gets tobramycin powder.; Everyone gets the vancomyscin powder.
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the intra-articular concentration of vancomycin and
      tobramycin after administration of vancomycin and tobramycin powder in primary cementless
      total knee arthroplasty and determine the serum concentrations of these antibiotics
      postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age over 18

          2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee
             osteoarthritis

        Exclusion Criteria:

          1. Diminished mental capacity

          2. Vancomycin allergy

          3. Tobramycin allergy

          4. Chronic kidney disease stage III and stage IV
Cannabinoids for Pain Control During Medical Abortion
Condition: Medical Abortion; Pain
Intervention: Dronabinol 5mg Cap; Placebo
Intervention description: Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain; Subjects randomized to placebo and ibuprofen 800mg for pain
Intervention MeSH terms: Dronabinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: Female
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Medical Abortion; Pain; Cannabis

Summary:

      The objective of this study is to determine if a synthetic cannabis derivative, dronabinol,
      in addition to ibuprofen, decreases maximum pain scores compared to ibuprofen and placebo in
      women undergoing medical abortion. Results of this study will help providers counsel patients
      regarding cannabis use during medical abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 21 years or older

          -  Consented for elective medical abortion

          -  Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound

          -  Able and willing to receive text messages via phone

          -  English speaking

          -  Able and willing to give informed consent and agree to the study terms

          -  Have assistance at home; no motor vehicle use while taking study medications

        Exclusion Criteria:

          -  Desires to continue pregnancy or currently breastfeeding

          -  Lack of access to cell phone and texting capabilities

          -  Prior participation in this study

          -  Early pregnancy failure

          -  Contraindications to the study medications: Marinol or marijuana derivatives, sesame
             oil, Ibuprofen

          -  Contraindications to medical abortion with Mifepristone or Misoprostol

          -  History of methadone, buprenorphine or heroin use within the last year

          -  History of a seizure disorder

          -  Used marijuana 5 or more days in the last week

          -  History of any adverse effects associated with prior use of recreational or medical
             marijuana products, or sensitivity/allergy to Marinol.
Travoprost 0.004% Versus Pilocarpine 1% in Patients With Chronic Angle Closure Glaucoma (CACG)
Condition: Angle-closure Glaucoma
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Intervention: Travoprost 0.004% (Travatan); Pilocarpine 1%
Intervention description: One drop in each eye, once daily at 9 AM; One drop in each eye, forth times daily at 7 AM, 11 AM , 4 PM and 9 PM for twelve (12) weeks
Intervention MeSH terms: Travoprost; Pilocarpine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IOP lowering efficacy; CACG

Summary:

      The purpose of this study is to demonstrate that the Intraocular Pressure (IOP) lowering
      efficacy of Travoprost Ophthalmic Solution 0.004% is superior to that of Pilocarpine 1% in
      patients with chronic angle-closure glaucoma (CACG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Chronic Angle Closure Glaucoma (CACG)

          -  21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM

          -  Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit

          -  Anterior chamber angle in which the trabecular meshwork is not visible for ≥180
             degrees in gonioscopy without indentation

          -  Peripheral anterior synechiae (PAS)

        Exclusion Criteria:

          -  Traumatic damage of the anterior chamber angle

          -  History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months

          -  Patients who cannot be safely discontinued from use of all ocular hypotensive
             medication(s) for 12 days to 14 weeks

          -  Visual Acuity ≥ 1.0

          -  Contact lenses wearer
Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Condition: Tobacco Use Cessation
Intervention: Varenicline Tartrate; Placebo
Intervention description: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.; Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary goal of this study is to compare efficacy of varenicline to placebo for cessation
      of use of smokeless tobacco.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female daily smokeless tobacco users aged 18 years and older, who are
             motivated to stop use of all tobacco products.

          -  Subjects must be daily users of nicotine containing smokeless tobacco and using
             smokeless tobacco on at least 8 occasions per day averaged over a week.

          -  Have used smokeless tobacco for at least 1 year prior to screening with no period of
             abstinence >3 months in the past year.

        Exclusion Criteria:

          -  Subjects using nicotine containing products (including smoking tobacco) other than
             smokeless tobacco for 3 months prior to screening.

          -  Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.

          -  Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.

          -  Subjects currently or within the past 12 months requiring treatment for depression or
             have a current or prior history of panic disorder, psychosis, bipolar disorder or any
             other serious mental illness.
Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
Condition: Bladder Outlet Obstruction
MeSH terms: Urinary Bladder Neck Obstruction
Intervention: Detrusitol 4 mg QD; Doxazosin 4 mg QD
Intervention description: Group 1; Group 2
Intervention MeSH terms: Doxazosin; Tolterodine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Lower urinary tract symptoms (LUTS); International Prostate Symptom Score (IPSS); Antimuscarinics; α-blockers

Summary:

      This study is a prospective randomized, open label, controlled, double arm, post-marketing
      study to compare the treatment efficacy of first-line antimuscarinics and α-blockers
      monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS)
      (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio
      (IPSS-V/S) ≤1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8)

          -  Patient or his/her legally acceptable representative has signed the written informed
             consent form

        Exclusion Criteria:

          -  Patients with severe cardiopulmonary disease and such as congestive heart failure,
             arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

          -  Patients with urinary retention, urodynamically proven detrusor underactivity or PVR
             ≥250 mL

          -  Patients with known active urinary tract infection, urinary stone or malignancy

          -  Patients with history of urethral injury or transurethral surgery for prostate or
             bladder

          -  Patients have laboratory abnormalities at screening including:

               1. Aspartate aminotransferase (AST) >3 x upper limit of normal range

               2. Alanine aminotransferase (ALT) >3 x upper limit of normal range

               3. Patients have abnormal serum creatinine level >2 x upper limit of normal range

          -  Patients with any other serious disease or condition considered by the investigator
             not suitable for entry into the trial

          -  Patients participated investigational drug trial within 1 month before entering this
             study

          -  Patients with major psychiatric illness or drug abuse

          -  Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase
             (5AR) inhibitor within 6 months
Does Deep Neuromuscular Blockade Improve Operating Conditions During Total Hip Replacements?
Condition: Arthropathy of Hip
MeSH terms: Joint Diseases
Intervention: Vecuronium 0.1 mg/kg; Vecuronium 0.2mg/kg
Intervention description: Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.; Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
Intervention MeSH terms: Bromides; Vecuronium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: The anesthesiologist will NOT be blinded, but the orthopedic surgeon performing the hip replacement surgery will be.
Enrollment: 116.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: neuromuscular blockade; sugammadex

Summary:

      During many surgeries, increased muscle tension makes it harder for the surgeon to expose the
      site of surgery and work within the incision. Neuromuscular blockade (NMB) drugs such as
      Vecuronium bind to neurotransmitter (acetyl choline) receptors at the neuromuscular junction,
      blocking their action and producing muscle relaxation. This muscle relaxation allows easier
      retraction of muscle tissues and manipulation of structures in the wound. Improved surgical
      conditions are likely to result in improved patient outcomes. While increased depths of NMB
      have been shown to optimize surgical conditions during intra-abdominal and retroperitoneal
      procedures, the impact of NMB depth has not been reported for orthopedic surgeries.1 To
      address this, we propose to study the effect of NMB depth on surgical conditions during total
      hip replacement (THR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Physical status 1-3

          -  age 50-75

          -  English speaking

          -  able to provide informed consent

          -  BMI equal to less than 30

          -  non-emergent THR by anterolateral minimally invasive non-cemented total hip
             arthroplasty

        Exclusion Criteria:

          -  Revision surgery

          -  Bilateral THR

          -  ASA 4+

          -  age less than 50 or greater than 75

          -  BMI greater than 30

          -  unable to provide informed consent

          -  women taking oral contraceptives (Sugammadex used for reversal interferes with their
             efficacy

          -  contraindications to general inhalation anesthesia (such as malignant hyperthermia)

          -  contraindications to NMB (known allergy to NMB)

          -  chronic kidney disease
Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults
Condition: Mental Health; Geriatrics
Intervention: donepezil; Placebo (cornstarch)
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Donepezil; Driving; Cholinesterase Inhibitors; Geriatric Psychiatry; Psychopharmacology; Aricept

Summary:

      The goal of the study is to assess the role of cholinesterase inhibitors in affecting the
      driving ability of cognitively intact seniors using driving simulators. We hypothesize that
      the use of a cholinesterase inhibitor for two weeks will be associated with improvement in
      safe driving behavior on a simulated driving task.
    

Eligibility criteria:

        Inclusion Criteria:

          -  valid Ontario driver's license

          -  active driver (greater than or equal to three times per week)

          -  written, informed consent

          -  lives in Toronto/Thunder Bay

          -  healthy

          -  Male between 65-75 years old

        Exclusion Criteria:

          -  cognitive impairment

          -  psychiatric history

          -  sleep disorder history

          -  substance abuse

          -  neurological history

          -  medical illness

          -  ophthalmological disease

          -  psychoactive medications

          -  contra-indications to Donepezil

          -  experience car/motion sickness
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
Condition: Cervical Cancer; Cervical Intraepithelial Neoplasia; Adenocarcinoma in Situ
MeSH terms: Uterine Cervical Dysplasia; Adenocarcinoma in Situ
Intervention: V501
Intervention description: HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1030.0
Sex: Female
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6,
      11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial
      neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Japanese females

          -  Not pregnant at Screening and agree to use effective contraception through Month 7 of
             the study

          -  Lifetime history of 0 to 4 male or female sexual partners

          -  No oral temperature ≥37.5 centigrade within 24 hours prior to injection

        Exclusion Criteria:

          -  Received a marketed HPV vaccine

          -  Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN

          -  Known history of positive test for HPV

          -  Known history of genital warts

          -  Received immune globulin or blood products within 6 months prior to first injection or
             plan to receive any through Month 7 of the study

          -  History of splenectomy, known immune disorders, or receiving immunosuppressives

          -  Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)