bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Steroids and Oxymetazoline in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Fluticasone furoate; Placebo Fluticasone furoate; Oxymetazoline; Placebo Oxymetazoline
Intervention description: 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm
Intervention MeSH terms: Fluticasone; Xhance; Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis
      medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to
      faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of
      fluticasone furoate alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 55 years of age.

          2. History of perennial allergic rhinitis.

          3. Positive skin test to dust mite, dog, cat or indoor mold antigen.

          4. And a combined nasal morning and evening score of ≥4 for nasal congestion in the day
             preceding entry

        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 of study start.
UW-CTRI Triple Medication Smoking Cessation Study
Condition: Smoking
Intervention: Varenicline; Nicotine Transdermal Patch; Nicotine Mini
Intervention description: Standard FDA approved 12 weeks of treatment with Varenicline; Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch; Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: medication tolerability

Summary:

      This study will focus on enhancing future smoking cessation treatment effectiveness by
      piloting a potentially more powerful combination of three FDA-approved pharmacotherapies:
      varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment
      (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design
      of future studies that would use this combination treatment as a cessation tool within the
      chronic care arsenal of treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >17 years;

          -  >=5 cigarettes/day for the previous 6 months;

          -  alveolar CO >= 6 ppm; able to read, write and speak English;

          -  planning to remain in the intervention catchment area for at least 4 months; not
             currently taking bupropion or varenicline;

          -  if the participant is currently using NRT, s/he agrees to use only study medication
             for the duration of the study;

          -  free of medical contraindications to NRT and varenicline; and,

          -  if participant is a woman of childbearing potential, using an approved method of birth
             control during treatment.

        Exclusion Criteria:

          -  Current diagnosis of/treatment for psychosis or bipolar disorder;

          -  suicidal ideation within the past 12 months; any history of suicide attempts; *
             significant hepatic or renal impairment; history of significant allergic reactions to
             varenicline or any type of NRT in the past;

          -  use of any investigational drugs in the previous 30 days. -
Trichomonas Vaginalis Recurrence Among HIV+ Women
Condition: Trichomonas Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Trichomonas Infections
Intervention: Metronidazole
Intervention description: 2 gm single dose versus 7 day 500 mg BID dose
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 270.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the 2 gram single dose of metronidazole is as
      effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among
      HIV-infected women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18 years or older

          -  HIV-positive

          -  TV positive by either wet preparation or culture

          -  ability to refrain from all alcohol use for 24 hours before and after taking oral
             metronidazole

          -  willing to take metronidazole treatment

        Exclusion Criteria:

          -  pregnant

          -  incarcerated

          -  previously enrolled

          -  currently taking disulfiram

          -  alcoholism or known liver damage

          -  medical contraindications to metronidazole

          -  treated with metronidazole within the previous 14 days

          -  requires treatment for B.V. per Amsel's criteria
Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
Condition: Chronic Constipation
MeSH terms: Constipation
Intervention: prucalopride; PEG 3350
Intervention description: One 2 mg tablet orally administered on Day 1; 13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).
Intervention MeSH terms: Prucalopride; Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor
      activity in subjects that are chronically constipated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic constipation

          -  Male or female ages 18-75 years

          -  Non-pregnant, non-lactating female

        Exclusion Criteria:

          -  Drug-induced constipation

          -  Subjects suffering from secondary causes of chronic constipation, such as:

          -  Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia,
             pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these
             are controlled by appropriate medical therapy.

          -  Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless
             these are controlled by appropriate medical therapy

          -  Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular
             accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis,
             hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord
             injury, Chaga's disease, or major depression

          -  Surgery.

          -  Subjects with insulin-dependent diabetes mellitus

          -  Rectal evacuation disorder/outlet obstruction

          -  Subjects with intestinal perforation or obstruction

          -  Severe renal impairment

          -  Subjects with a history of alcohol or drug abuse

          -  Subjects with lactose intolerance

          -  Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine,
             neurological or psychiatric disorders
Morphine Added to Ropivacaine for FICB for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine, Morphine; Ropivacaine, Saline
Intervention description: Morphine added to ropivacaine for fascia iliaca compartment block; Normal saline added to ropivacaine for fascia iliaca compartment block
Intervention MeSH terms: Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      prospective, randomized double blinded study to investigate the effects of morphine as an
      adjuvant to ropivacaine on FICB
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing elective femur surgery under spinal anaesthesia

               -  Age group (18-65 years)

               -  ASA physical status I and II

        Exclusion Criteria:

          -  • Not willing to participate in the study

               -  Other painful co-morbidities (neuropathies)

               -  Allergy or any contraindication to study medication

               -  Psychiatric disorder

               -  Coagulopathy

               -  Infection at the site of the block

               -  Use of other modes of anaesthesia or analgesia besides spinal anaesthesia.
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Intervention: SRP + Injectable Platelet-Rich Fibrin; SRP + placebo
Intervention description: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing; Saline application during scaling and root planing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: split mouth design
Masking: Single (Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: periodontitis; therapy; Platelet; Rich; Fibrin; Nonsurgical

Summary:

      Current treatments of periodontitis have limited efficacy since they fail to suppress
      microorganisms satisfactorily over time. The aim of present study was to investigate whether
      there are differences between initial treatment of chronic periodontitis (SRP) and SRP in
      conjunction with injectable platelet-rich fibrin (i-PRF) application.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A minimum of 6 teeth per quadrant;

               -  A minimum of 2 teeth in each quadrant with a probing depth (PD) ≥5 mm;

               -  Bleeding on probing (BOP) had to be at ≥40% tooth sites;

               -  No involvement of furcation;

               -  Good general health.

        Exclusion Criteria:

          -  Periodontal therapy within last 12 months;

               -  Having surgical therapy;

               -  Use of antibiotics over the last 6 months;

               -  Ongoing drug therapy that might have an impact on the clinical signs and symptoms
                  of periodontitis;

               -  Pregnancy or nursing;

               -  Current and former smokers.
The Effect of Anticholinergics on Cognitive Function in the Elderly
Condition: Mental Competency; Urinary Bladder, Overactive; Cognitive Function
MeSH terms: Urinary Bladder, Overactive
Intervention: Trospium Chloride; Placebo
Intervention description: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
Intervention MeSH terms: Trospium chloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: Female
Minimum age: 50 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COGNITIVE FUNCTION; OVERACTIVE BLADDER; [C23.888.942.343.780]

Summary:

      Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of
      this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a
      group that also has a higher baseline risk of cognitive dysfunction. Our objective is to
      evaluate the effect of an anticholinergic medication on cognitive function in elderly women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 50 or older

          -  Diagnosis of OAB (ICS definition)

          -  English literacy

          -  Ability to swallow oral medication

          -  Cognitive ability to give consent

        Exclusion Criteria:

          -  Dementia/Depression/Delirium

          -  Current anticholinergic use (requires 2 week washout period)

          -  Current cholinesterase

          -  Urinary or gastric retention

          -  Severe decreased gastrointestinal motility

          -  Uncontrolled narrow-angle glaucoma

          -  Myasthenia gravis

          -  Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery
Condition: Arthroscopic Knee Surgery
Intervention: IV ibuprofen; IV ketorolac
Intervention description: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.; 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds
Intervention MeSH terms: Ibuprofen; Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: knee surgery, arthroscopy; orthopaedic, orthopedic surgery

Summary:

      The intent of this study is to assess the analgesic efficacy of IV ibuprofen when
      administered at induction of anesthesia. Results from this pilot study will be used to design
      and determine the appropriate statistical power for a larger, multi-center randomized study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for knee arthroscopy

        Exclusion Criteria:

          -  Inadequate intravenous (IV) access.

          -  History of allergy or hypersensitivity to any component of ibuprofen or other NSAIDs,
             aspirin (or aspirin related products), opioids or cyclooxygenase-2(COX-2) inhibitors.

          -  Less than 18 years of age.

          -  Use of analgesics less than 8 hours prior to surgery.

          -  Patients with active, clinically significant anemia.

          -  History or evidence of asthma or heart failure.

          -  Pregnant.

          -  Recent history of chronic non-steroidal anti-inflammatory drug (NSAID) or opioid use.

          -  Inability to understand the requirements of the study, be willing to provide written
             informed consent (as evidenced by signature on an informed consent document approved
             by an Institutional Review Board [IRB]), and agree to abide by the study restrictions
             and to return for the required assessments.

          -  Refusal to provide written authorization for use and disclosure of protected health
             information.
Study of Arm and Putter Movement in Golfers With Golfer's Cramp
Condition: Occupational; Cramp(s)
MeSH terms: Muscle Cramp; Spasm
Intervention: Propranolol; Opal Device; Science and Motion PuttLab (SAM); Surface Electromyography EMG
Intervention description: Single oral dose of 10 mg propranolol; The Opal Device (APDM, Inc.) will be used to measure wrist movement.; The SAM will be used to study putter stroke movement and ball movement.; The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Occupational; Cramp(s)

Summary:

      The investigators will investigate golfers with visual evidence of an involuntary movement
      while putting before and after treatment with a low dose of propranolol.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age 18-75

          -  Complaint of golfer's cramp/yips

          -  Visual evidence of a movement disorder during putting

          -  Able to complete 80 putts during the session

        Exclusion criteria:

          -  Contraindication to treatment with propranolol

          -  Movement disorder not when putting
An Open-Label Preference Evaluation of BLI800
Condition: Colonoscopy
Intervention: BLI800
Intervention description: BLI800 Bowel Preparation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patient experience ratings of BLI800 in adult
      patients undergoing colonoscopy.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication

          -  18 to 85 years of age (inclusive)

          -  If female, and of child-bearing potential, is using an acceptable form of birth
             control

          -  Negative urine pregnancy test at screening, if applicable

          -  In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Primary Exclusion Criteria:

          -  Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon

          -  Subjects with ongoing severe, acute inflammatory bowel disease

          -  Subjects who had previous significant gastrointestinal surgeries

          -  Subjects with known severe renal, hepatic or cardiac insufficiency

          -  Subjects undergoing insulin therapy for any indication

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration

          -  Subjects undergoing colonoscopy for foreign body removal and/or decompression
Sitagliptin in Combination With Metformin and Sulfonylurea
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin
Intervention description: Sitagliptin 100 mg by mouth once daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: sitagliptin; type 2 diabetes; combination therapy

Summary:

      This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in
      comparison to thiazolidinediones as the third-line oral agent, in patients with type 2
      diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18-75

          -  Type 2 diabetes

          -  At least 3 months of treatment with maximum tolerated doses of metformin and a
             sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) >7.0%)

          -  Able to comply with all scheduled visits and requirements of the protocol

        Exclusion Criteria:

          -  Any contraindications to the use of metformin or a sulfonylurea agent

          -  Extreme hyperglycemia or symptoms of polyuria or polydipsia

          -  Current or previous chronic use of insulin (other than for treatment of gestational
             diabetes)

          -  History of confirmed (or clinical suspicion of) type 1 diabetes mellitus

          -  Episodes of symptomatic hypoglycemia averaging greater than once per day

          -  Estimated glomerular filtration rate (eGFR) < 60 mL/min

          -  Subjects with active hemolytic anemias or hemoglobin variants that render the
             measurement of HbA1c unreliable

          -  History of any clinically significant hepatic, cardiovascular (including the use of
             digoxin), or other major systemic disease that may make the use of sitagliptin unsafe,
             or otherwise make the interpretation of the data difficult.

          -  Female subjects of childbearing potential who are sexually active and not using a
             reliable form of contraception

          -  Current pregnancy or lactation.

          -  Subjects who will likely require or initiate therapy with drugs that may interfere
             with glucose metabolism during the course of the study.

          -  Subjects who are in another investigational study or have received another
             investigational medication within 30 days of study entry

          -  Subjects who are unable or unwilling to give informed consent, comply with all
             components of the study protocol, attend all scheduled follow-up visits, or present
             other barriers that would make the implementation of the protocol unusually difficult.