bioihbjkbjnl/mcl2 huggingface dataset:
Clarithromycin Resistant Tailored Therapy
Condition: Peptic Ulcer; Helicobacter Pylori Infection
MeSH terms: Peptic Ulcer
Intervention: 23S rRNA point mutation test of Helicobacter pylori; UBT test & Gastroenterology with biopsy c silver stain
Intervention description: mutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention; UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 924.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Peptic ulcer; Helicobacter pylori; Clarithromycin; 23S rRNA; Resistance

Summary:

      1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin
           is one of the main causes of failure of eradication. 23S rRNA point mutation of
           Helicobacter pylori is associated clarithromycin resistance

        2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment
           regimens containing a proton pump inhibitor and combination of two antibiotics
           (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate
           Helicoabacter pylori more successfully

        3. Material & methods The investigators enroll patients diagnosed with peptic ulcer,
           endoscopically. Helicobacter pylori is documented with Urea breath test or silver
           staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S
           rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation,
           the investigators consider as resistance to clarithromycin and choose the treatment
           regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no
           mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin,
           clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare
           eradication rate with conventional treatment,proton pump inhibitor, amoxicillin,
           clarithromycin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 - 75 years old

          -  Peptic ulcer (gastric ulcer, duodenal ulcer)

          -  Helicobacter pylori positive

        Exclusion Criteria:

          -  Major comorbidities

          -  Pregnancy

          -  History of Helicobacter pylori eradication

          -  History of gastric surgery or other cancers, except to endoscopic treatment due to
             gastric lesion
Allergic Rhinitis Changes the Sinus Microbiome
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: QNASL; Placebo nasal spray
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that treatment with QNASL will reduce nasal mucosal
      inflammation induced by the allergy season and prevent the changes in the microbiome caused
      by the allergy season.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 55 years of age.

          2. Two year history of seasonal allergic rhinitis.

          3. Positive skin test to grass and/or tree antigen.

        Exclusion Criteria:

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Subjects treated with systemic steroids during the previous 30 days.

          4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom
             or Opticrom during the previous 30 days.

          5. Subjects treated with oral antihistamine/decongestants during the previous seven days.

          6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants
             during the previous 3 days.

          7. Subjects treated with immunotherapy and are escalating their dose.

          8. Subjects on chronic anti-asthma medications.

          9. Subjects with polyps in the nose or a significantly displaced septum.

         10. Upper respiratory infection within 14 days prior to study start.
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin
Condition: Healthy
MeSH terms: Tissue Adhesions
Intervention: ChloraPrep; DuraPrep
Intervention description: The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule; The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to find out if presurgical antiseptic preparations affect how
      well surgical drapes adhere to skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is willing to sign the Research Consent form

          -  Healthy male or female subjects ages between 18 - 65

          -  Subject has agreed to be and appears to be compliant with requirements of the study

          -  Subject has a back (the product application site) of sufficient size, free of
             blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples

          -  Subject is willing to have the back clipped or shaved if it has excessive hair

        Exclusion Criteria:

          -  Sensitivity/allergy to adhesive products (e.g. medical tapes)

          -  Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl
             alcohol (IPA), or chlorhexidine gluconate (CHG)

          -  Allergy to seafood

          -  History of psoriasis dermatitis, or any skin condition that might be exacerbated by
             the action of removing adhesive materials

          -  Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on
             the subject's back

          -  History of diabetes

          -  Subject is currently pregnant or thinks she may be pregnant or is nursing

          -  Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy

          -  Subject is taking antihistamine medication

          -  Subject has been using moisturizers or other skin contact materials on the test sites
             for 24 hours prior to the start of the study

          -  Subject has a back problem that prohibits him or her from lying face downward for
             approximately 2 hours
A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
Condition: Influenza; Common Cold
MeSH terms: Influenza, Human; Common Cold
Intervention: Paracetamol; Phenylephrine; Ascorbic Acid
Intervention description: Present in both test and active comparator; Test product; Test product
Intervention MeSH terms: Acetaminophen; Ascorbic Acid; Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma
      faster than standard paracetamol tablets. The study will also assess the gastrointestinal
      transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is
      postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a
      greater early exposure compared to standard paracetamol tablets. In addition, the
      pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.
    

Eligibility criteria:

        -  Healthy male volunteers

          -  Body mass index between 18.0-29.9 kg/m^2
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Sumavel DosePro; Sumatriptan
Intervention description: Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration; subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Intervention MeSH terms: Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: migraine; treatment satisfaction

Summary:

      The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel
      DosePro to treat their moderate to severe migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of 2 to 6 migraine headaches per month

          -  Migraines should have been present for at least 1 year with age at onset of migraine
             less than 50 years

          -  History of 24 hours of freedom between migraine attacks

          -  Current users of triptan medications

          -  Able to distinguish interval or other non-migrainous headaches from typical migraine

          -  General good health

        Exclusion Criteria:

          -  History or symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral
             vascular syndromes

          -  Significant underlying cardiovascular diseases including uncontrolled hypertension

          -  Hemiplegic or basilar migraine

          -  History or diagnosis of severe hepatic or renal impairment

          -  History of epilepsy or seizure or other serious neurologic condition

          -  History of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its
             components or similar drugs including sulphonamides

          -  History of scleroderma (systemic sclerosis)

          -  Pregnant or breastfeeding

          -  Use of contraindicated prescription medications, monoamine oxidase inhibitors (MAO-A),
             selective serotonin reuptake inhibitors, or lithium agents
Advancing Tobacco Use Treatment for African American Smokers
Condition: Smoking Cessation
Intervention: Chantix; Placebo
Intervention description: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.; Health education counseling will be provided to all participants.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; quit smoking; smoking treatment

Summary:

      The purpose of this study is to examine whether or not providing Chantix (varenicline) will
      help African American smokers quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-identified African American

          -  Smokes ≥ 1 cigarette per day (cpd)

          -  Smoke on ≥ 25 days of the past 30 days

          -  Functioning telephone

          -  Interested in quitting smoking

          -  Interested in taking 3 months of varenicline

          -  Willing to complete all study visits

        Exclusion Criteria:

          -  Renal impairment

          -  Evidence or history of clinically significant allergic reactions to varenicline

          -  A cardiovascular event in the past month

          -  History of alcohol or drug dependence in the past year

          -  Major depressive disorder in the last year requiring treatment

          -  History of panic disorder, psychosis, bipolar disorder, or eating disorders

          -  Use of tobacco products other than cigarettes in past 30 days

          -  Use of pharmacotherapy in the month prior to enrollment, including prior use of
             varenicline

          -  Pregnant, contemplating getting pregnant, or breastfeeding

          -  Plans to move from Kansas City during the treatment and follow-up phase

          -  Another household member enrolled in the study

          -  Evidence of current severe major depressive disorder or suicidal ideation
Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Intervention: Galantamine; Donepezil
Intervention description: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.; Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.
Intervention MeSH terms: Donepezil; Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Cholinesterase Inhibitors; Elderly; Stroke; Cognition

Summary:

      This study will evaluate the effectiveness of treatment with acetylcholinesterase inhibitors
      in improving cognitive function and overall rehabilitation in elderly stroke survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke
             (cardiovascular accident)

          -  Stroke was within 30 days of being admitted

          -  Medically stable

          -  Presence of memory and/or attentional impairments and evidence that these impairments
             were not present or were less severe prior to the stroke (assessed via interview with
             family)

          -  Approval by individual's attending physician at the rehabilitation hospital

        Exclusion Criteria:

          -  Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid
             neuropsychiatric assessment

          -  Currently experiencing a major depressive episode (unless treated and in partial
             remission, assessed using the Primary Care Evaluation of Mental Disorders)

          -  Current psychosis or mania

          -  History of substance or alcohol abuse or dependence within three months of study entry

          -  Currently taking a cholinomimetic drug

          -  Medical condition with known sensitivity to donepezil (e.g., slower than normal heart
             rate, supraventricular cardiac conduction defects, severe asthma or obstructive
             pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if
             not on acid-blocking agent)

          -  Informed that taking donepezil is medically inadvisable

          -  Current use of any anticholinergic medication (e.g., for bladder spasm)
Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
Condition: Pruritus; Nausea/Vomiting
MeSH terms: Pruritus; Vomiting
Intervention: Ondansetron; Placebo Comparator
Intervention description: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.; This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study drug (ondansetron/placebo) will be masked for all but the pharmacist
Enrollment: 46.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: intrathecal morphine

Summary:

      This is a prospective randomized, double-blind, placebo-controlled study to compare the
      incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV
      ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group,
      where pruritus and PONV are treated with PRN only medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  3-17 years

          -  weight </= 100kg

          -  scheduled for urologic or orthopedic procedure necessitating intrathecal morphine

          -  ability to use verbal or pictorial pain assessment tools and techniques

          -  informed consent and (if applicable) assent

        Exclusion Criteria:

          -  Inability to use verbal or pictorial pain scoring scales

          -  hypersensitivity to selective 5-HT receptor antagonists

          -  diagnosed congenital long QT syndrome

          -  severe hepatic impairment

          -  pregnancy or nursing mothers
Study of the Effect of Fluticasone Furoate Nasal Spray on Spring Allergy Eye Symptoms
Condition: Allergic Conjunctivitis to Tree Pollen or Grass Pollen
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Fluticasone furoate nasal spray; Placebo nasal spray
Intervention description: 2 sprays each nostril every morning for 2 weeks; 2 sprays each nostril every morning for 2 weeks
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Rationale and objectives:

      Fluticasone furoate nasal spray (Veramyst) has been shown to improve ocular symptoms when
      used for the treatment of seasonal allergic rhinitis during the ragweed pollen season.
      Although this is the only published report of an intranasal corticosteroid shown to
      effectively treat ocular symptoms, the mechanism has not been delineated. Furthermore, the
      tears of patients with allergic conjunctivitis are known to have increased concentrations of
      cytokines and allergic mediators.

      The objective of this study is to determine if the positive effects of Veramyst nasal spray
      on ocular symptoms is via the inhibition of allergic mediators in the eyes. The investigators
      will conduct a double blind placebo controlled trial to determine if Veramyst nasal spray
      decreases the amount of allergic mediators in the tears of subjects randomized to Veramyst
      nasal spray versus placebo. The investigators will also compare the subjects' symptoms to the
      amount of allergic mediators detected in their tears.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a documented history of allergic rhinitis and conjunctivitis due to tree pollen and /
             or grass pollen for two allergy seasons

          -  positive skin prick test to tree and / or grass

        Exclusion Criteria:

          -  glaucoma

          -  cataracts

          -  acute or chronic sinusitis

          -  asthma

          -  chronic obstructive pulmonary disease

          -  physical nasal obstruction

          -  pregnant or breastfeeding

          -  have had a viral or bacterial infections within 2 weeks of the study commencement

          -  receiving allergen immunotherapy

          -  have used inhaled corticosteroids within 14 days prior to the study

          -  have used systemic corticosteroids within 30 days of the study

          -  travel outside of the geographic area during the 2 week study period

          -  use of contact lenses during the study period

          -  use of artificial tears during the study period

          -  use of eyewash irrigation during the study period

          -  use of lubricants during the study period
Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
Condition: Cataract
MeSH terms: Cataract
Intervention: One-Piece Tecnis Multifocal IOL; One-Piece Tecnis monofocal IOL, Model ZCB00
Intervention description: One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.; Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens
      (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general
      postoperative outcomes of the One-Piece Tecnis Multifocal lens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bilateral cataracts and otherwise healthy eyes

          -  visual potential of Decimal 0.8 in each eye

        Exclusion Criteria:

          -  any medications affecting vision

          -  any chronic disease/illness that would affect risk to subject or outcomes of the study

          -  any ocular pathology/abnormalities that may affect visual outcomes or confound study
             results

          -  desire for monovision