bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
Condition: Anesthesia of Mucous Membrane
Intervention: Pliaglis; Benzocaine; Articaine
Intervention description: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.; Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.; Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
Intervention MeSH terms: Lidocaine; Tetracaine; Carticaine; Benzocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The efficacy of the topical anesthetics will be determined by how much pain the patient felt
      (using a Heft-Parker pain analog scale) upon needle penetration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars

          -  Patients with healthy mucosal tissues, and who do not have pain on palpation at
             injection site

          -  Ability to use and understand a VAS score

          -  Ability to use and understand a VAS score

          -  No know allergies to topical anesthetics being used

        Exclusion Criteria:

          -  Allergy or other contraindications to topical anesthetics

          -  Allergy to epinephrine or local anesthetics

          -  Broken/unhealthy mucosal tissues and pain on palpation at injection site

          -  Patients needing endodontic therapy on maxillary anterior teeth

          -  Inability to consent to participate in the study

          -  Patients who have used analgesics within 6 hours of appointment time

          -  Pregnant and nursing women
Budesonide in Patients With Immune Mediated Enteropathies
Condition: Enteropathy; Celiac Disease; CVID Enteropathy; Collagenous Sprue; Autoimmune Enteropathy
MeSH terms: Celiac Disease; Intestinal Diseases; Collagenous Sprue
Intervention: Withdrawal of Oral Budesonide
Intervention description: The intervention arm will taper and stop budesonide therapy (withdrawal).
Intervention MeSH terms: Budesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open-label withdrawal of budesonide versus continued budesonide therapy in patients with immune-mediated enteropathies that have had symptomatic and histologic improvement
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers are trying to determine if withdrawal of budesonide therapy in patients with
      immune-mediated enteropathies doing well on therapy will result in worsening symptoms,
      histology, quality of life, and micronutrient/nutritional status when compared to continued
      therapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients will be recruited from the Division of Gastroenterology and Hepatology and
             the Mayo Clinic in Rochester, MN.

          -  Adult patients with immune mediated enteropathies who have had improvement in symptoms
             and histology on oral budesonide therapy.

        Exclusion Criteria

          -  Age <18 years

          -  Positive stool gluten testing in patients with refractory celiac disease

          -  Small bowel malignancy or history of small bowel malignancy

          -  Refractory celiac disease type 2

          -  Post-transplant lymphoproliferative disorder associated enteropathy

          -  No prior improvement in symptoms and histology with budesonide therapy

          -  Discontinuation of budesonide therapy prior to the trial

          -  Other concurrent systemic corticosteroids

          -  Other immune mediating medications, for example but not limited to azathioprine,
             6-mercaptopurine, cyclosporine, methotrexate, anti-TNF monoclonal antibodies, alpha-4
             beta-7 integrin inhibiting monoclonal antibody, interleukin 12/23 inhibiting
             monoclonal antibody, JAK inhibitors.
An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
Condition: IV Insertion Pain
Intervention: 1% lidocaine; bacteriostatic normal saline (BNS)
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: local anesthesia; intravenous catheter

Summary:

      The purpose of this study is to compare how well different anesthetic, or numbing, solutions
      injected under the skin work in reducing the discomfort associated with placing a catheter in
      a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been
      found to be effective in reducing discomfort when injected under the skin just prior to
      inserting the catheter. This study compares these two solutions, and will compare the
      discomfort that occurs both with and without using these solutions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients (aged 18 or older)

          -  admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)

          -  have a physician's order for an IV

          -  are able to speak, read and understand English

          -  referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization

        Exclusion Criteria:

          -  admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit,
             an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;

          -  history of a psychological disorder, as determined from the patient's chart;

          -  history of peripheral neuropathy, as determined by patient's chart;

          -  history of IV drug abuse, as determined from the patient's chart;

          -  decreased sensation in the arm or hands, as reported in the chart or by the patient;

          -  patient disorientation or confusion (i.e., unable to state person, place, time or
             unable to comprehend instructions for completing Visual Analog Scale);

          -  a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;

          -  veins that cannot be palpated and are difficult to visualize by VAST nurses;

          -  pregnancy;

          -  an order for the emergency insertion of an IV by the patient's doctor or assigned
             nurse;

          -  an IV insertion that requires the use of a catheter gauged 18 or larger

          -  severe vision impairment, as determined by the patient's inability to read the Visual
             Analogue Scale
Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery
Condition: Neuromuscular Blockade; Postoperative Complications
MeSH terms: Postoperative Complications
Intervention: Succinylcholine; Cisatracurium
Intervention description: Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.; Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Intervention MeSH terms: Cisatracurium; Succinylcholine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Open label drug administration. Outcomes assessor and care providers are otherwise masked.
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Postoperative Pulmonary Complications; Residual Neuromuscular Blockade; Cardiac Surgical Procedures

Summary:

      The investigators will conduct a prospective, randomized trial to assess the impact of
      neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory
      complications in cardiac surgical patients. The study will compare continual neuromuscular
      blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for
      cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring
             cardiopulmonary bypass

        Exclusion Criteria:

          -  Emergency surgery

          -  Extremes of age

          -  Previous cardiac surgery

          -  Clinical contraindications to succinylcholine or cisatracurium

          -  Anticipated difficult tracheal intubation

          -  Preoperative mechanical ventilation

          -  Preoperative pharmacologic/mechanical hemodynamic support
Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: telbivudine; tenofovir disoproxil fumarate
Intervention description: 600 mg film-coated tablets taken as 600 mg once daily; 300 mg tablets taken as 300 mg once daily
Intervention MeSH terms: Tenofovir; Telbivudine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety following the Roadmap
      Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg
      negative CHB patients. The data from the study should allow for the validation of the Roadmap
      concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative
      CHB patients. As part of a post-approval commitment to the European Health Authorities, the
      data will also be used to provide an optimized clinical treatment strategy for better
      clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from
      the study will contribute to a better scientific understanding, disease management and
      treatment of HBeAg negative CHB patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female, at least 18 years of age

        Documented compensated HBeAg negative CHB defined by all of the following:

          -  Detectable serum HBsAg at screening visit and at least 6 months prior;

          -  HBeAg negative at the screening visit with positive HBeAb;

          -  Serum HBV DNA > 2000 IU/mL Serum ALT level > 1×ULN and <10×ULN at screening visit;
             patient with normal ALT ≤1xULN at screening are eligible, with moderate liver
             inflammation or fibrosis, complensated liver sirrhosis, ALT level >1xULN wtihin last 6
             months

        Exclusion Criteria:

          -  Co-infected with HCV, HDV or HIV.

          -  Received treatment of nucleoside or nucleotide drugs at any time

          -  Received IFN or other immunomodulatory treatment within six months before Screening

          -  Pregnant or nursing (lactating) women

          -  Clinical signs/symptoms of hepatic decompensation

          -  History of myopathy, myositis or persistent muscle weakness

          -  history of clinical and laboratory evidence of chronic renal insufficency
Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Bacteriostatic Normal Saline; 1% Lidocaine
Intervention description: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.; A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Local anesthetic

Summary:

      The purpose of this study is to determine if creation of a skin wheel with bacteriostatic
      normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar
      level of anesthesia compared to 1% lidocaine. Participants will receive both types of
      anesthesia, in random order.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for an initial lumbar medial branch block

        Exclusion Criteria:

          -  Allergy to local anesthetics

          -  Fibromyalgia

          -  Inability to provide informed consent in English

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners
Clinical Evaluation of a New Aspheric Intraocular Lens.
Condition: Cataract
MeSH terms: Cataract
Intervention: Advanced Akreos Adapt in one operated eye.; Akreos Adapt in fellow operated eye.
Intervention description: Cataract surgery to implant the assigned IOL according to randomized schedule.; Cataract surgery to implant the assigned IOL according to randomized schedule.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 75.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study evaluates the visual performance and occurrence of posterior capsular
      opacification after implantation of a new aspherical intraocular lens compared with a control
      spherical lens of otherwise identical design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a clinically documented diagnosis of bilateral cataract (either
             cortical, nuclear, subcapsular or a combination) liable to benefit from standard
             cataract surgery.

          -  Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation,
             requiring a IOL power from 10 to 30 diopters.

        Exclusion Criteria:

          -  Patients with corneal damage.

          -  Patients with any anterior segment pathology for which extracapsular
             phacoemulsification cataract surgery would be contraindicated.

          -  Patients with any ocular pathology, other than the cataract, having repercussions on
             visual function:
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Brinz/brim vehicle; Prostaglandin analogue
Intervention description: Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Brimonidine Tartrate; Bimatoprost; Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering
      effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a
      prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of either open-angle glaucoma or ocular hypertension;

          -  Must sign an informed consent form;

          -  Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the
             same eye[s]) ≥ 19 and < 32 mmHg at 09:00.

          -  Willing and able to attend all study visits;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, breast-feeding, intend to become
             pregnant during the study, or not using adequate birth control methods to prevent
             pregnancy throughout the study;

          -  Any form of glaucoma other than open-angle glaucoma or ocular hypertension;

          -  Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in
             the protocol;

          -  Any other conditions including severe illness which would make the subject, in the
             opinion of the Investigator, unsuitable for the study;

          -  Other protocol-specified exclusion criteria may apply.
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Condition: Stroke; Upper Limb Spasticity
MeSH terms: Muscle Spasticity; Stroke
Intervention: Botulinum toxin type A; Placebo
Intervention description: Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.; Placebo administered intramuscularly in the targeted upper limb.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if early administration (i.e. within 12 weeks
      after stroke) of Dysport® 500 U injections may delay the appearance or the progression of
      upper limb symptomatic spasticity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 to 12 weeks after first ever stroke according to the World Health Organisation
             criteria (previous transient ischaemic attack or clinically silent infarct on
             computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as
             previous stroke)

          -  Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke

          -  Presence of spasticity:

               -  either symptomatic, based on symptomatic spasticity criteria (i.e. at least one
                  of the following items: impacted passive/active function, involuntary movements,
                  or pain ≥4 on a numeric pain rating scale [NPRS]), in addition to increased
                  muscle tone [Modified Ashworth Scale, MAS ≥2])

               -  or only increased muscle tone (MAS≥2)

        Exclusion Criteria:

          -  Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including
             prior local joint, tendon, and intrinsic muscle disorders) that could potentially
             interfere with assessment of spasticity in the primary targeted muscle group selected
             by the Investigator and in agreement with the subject

          -  Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides,
             aminoquinolines, cyclosporine, D penicillamine

          -  Previous surgery of the affected muscles/ ligaments/tendons

          -  Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple
             organ failure, hepatic renal failures, severe infections)
Massage for Pain Relief During the Active Phase of Labor
Condition: Pain
Intervention: Lumbosacral Massage
Intervention description: Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 46.0
Sex: Female
Minimum age: 15 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: labor; pain; massage

Summary:

      The objective of this research is to evaluate the effect of massage therapy as a resource for
      pain relief during the active phase of labor. The research will be of type randomized
      controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral
      Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups
      (lumbosacral massage) and control (routine maternity) and will be assessed before and after
      therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation
      will be performed by numerical category scale, Diagram Location of Pain and Pain
      Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction
      questionnaire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nulliparous

          -  literate

          -  A single fetus in vertex position

          -  Low-risk Pregnancy

          -  From 37 weeks of gestation

          -  Cervical dilatation from 4 cm with normal uterine dynamics in this phase

          -  Labor in early spontaneous

          -  No use of medications during the study period

          -  Absence of cognitive or psychiatric problems

          -  Intact membranes

          -  No risk factors associated

          -  You want to participate and signing the informed consent

        Exclusion Criteria:

          -  Use of drugs or any procedure that aims to relieve pain

          -  Intolerance to the application of massage therapy

          -  Presence of dermatological conditions that indicate against the application of massage
             therapy