bioihbjkbjnl/mcl2 huggingface dataset:
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
Condition: IUD Insertion
Intervention: Vaginal 2% Lidocaine; Surgical Lubricant Jelly
Intervention description: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly; Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain Management; IUD insertion

Summary:

      For intrauterine device (IUD) insertion, currently there are no standardized clinical
      guidelines for pain management. The investigators aim to explore whether adequate pain relief
      is possible through self-administered, non-invasive means alone. Reducing pain associated
      with IUD insertion may benefit patients and providers. When patients are comfortable during
      their procedure, it is likely the provider can more quickly and with fewer complications
      perform the insertion. The investigators propose to explore the effect of a locally applied
      vaginal lidocaine gel in place of the standard of care pain management, no intervention,
      prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

        Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at
        Stanford; English or Spanish speaking, and ability to give informed consent.

        Exclusion Criteria:

        Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen
        or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical
        lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of
        tampons.
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Condition: Acute Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Besifloxacin; Moxifloxacin solution
Intervention description: Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days; Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Intervention MeSH terms: Moxifloxacin; Besifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1161.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This is a study to investigate a novel drug candidate for the treatment of bacterial
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival
             discharge and redness in at least one eye.

        Exclusion Criteria:

          -  Pregnant or nursing females.

          -  Use of any antibiotic within 72 hours of enrollment.

          -  Any disease conditions that could interfere with the safety and efficacy evaluations
             of the study drug.

          -  Participation in an ophthalmic drug or device research study within 30 days prior to
             entry into this study.
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
Condition: Gouty Arthritis
MeSH terms: Arthritis, Gouty
Intervention: Canakinumab, ACZ885; Triamcinolone acetonide
Intervention description: Canakinumab and placebo matching to triamcinolone acetonide; Triamcinolone acetonide 40 mg and placebo matching to canakinumab
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout; Inflammatory gout; acute gout

Summary:

      The purpose of this pivotal Phase III study is to support the registration of canakinumab for
      the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by
      demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are
      contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout
      flares relieves the signs and symptoms and prevents recurrence of gout flares compared to
      triamcinolone acetonide 40 mg i.m.
    

Eligibility criteria:

        Inclusion criteria:

          -  Meeting diagnosis criteria for acute arthritis of primary gout.

          -  Start of acute gout flare within 5 days prior to study visit 1

          -  History of ≥ 3 gout flares within the 12 months prior to study start

          -  Evidence of contraindication (absolute or relative), or intolerance, or lack of
             efficacy for either NSAIDs and/or colchicines

        Exclusion criteria:

          -  Requirement for administration of antibiotics against latent tuberculosis (TB), e.g.,
             isoniazide

          -  Refractory heart failure (Stage D).

          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia

          -  Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout

          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
             acute inflammatory arthritis

        Other protocol-defined inclusion/exclusion criteria may apply
S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000
Condition: Colorectal Cancer; Precancerous Condition
MeSH terms: Precancerous Conditions
Intervention: Vitamin E; Selenium; Vitamin E placebo; selenium placebo
Intervention description: 400 IU daily by mouth for 7 - 12 years; 200 mcg daily for 7 - 12 years; 1 pill by mouth daily for 7 - 12 years; 1 pill by mouth daily for 7 - 12 years
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Selenium
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8094.0
Sex: Male
Minimum age: 50 Years
Maximum age: 120 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: colon cancer; rectal cancer; adenomatous polyp

Summary:

      RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on
      the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors
      predict a participant's response to treatment and help plan the best treatment.

      PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on
      colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Enrolled on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000

          -  Screened by lower endoscopy (i.e., sigmoidoscopy and/or colonoscopy) after
             randomization on SELECT trial

        PATIENT CHARACTERISTICS:

          -  Willing to sign an applicable medical records release form

          -  Willing to allow the release of tissue for central pathology review of resected polyps
             and endoscopic biopsies

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
Condition: Crohn's Disease; Colitis; IBD; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Colitis; Inflammatory Bowel Diseases
Intervention: Placebo SC; Placebo IV; Ustekinumab 90 mg SC q8w; Ustekinumab 130 mg IV; Ustekinumab 90 mg SC q12w
Intervention description: Placebo will be administered subcutaneously.; Placebo will be administered as a single Intravenous infusion at week 0.; Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.; Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.; Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1282.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ustekinumab; Stelara, Moderately to severely active Crohn's Disease; IBD, Crohn's; UNITI; colitis; IL-12; IL-23

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance
      regimens of ustekinumab administered subcutaneously to patients with moderately to severely
      active Crohn's disease who responded to treatment with intravenous ustekinumab in studies
      CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who received study agent at the start of study CNTO1275CRD3001 or
             CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:

          -  Patients who underwent a Crohn's disease-related surgery since the start of induction
             study CNTO1275CRD3001 or CNTO1275CRD3002

          -  Patients who started a protocol prohibited medication since the start of studies
             CNTO1275CRD3001 and CNTO1275CRD3002

          -  Patients with protocol-specified changes to their concomitant medications due to
             Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
             and CNTO1275CRD3002
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Condition: Cervical Preparation
Intervention: Mifepristone; osmotic dilators
Intervention description: 200 mg po 20-24 hours prior to the procedure; osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      In this study the investigators plan to compare mifepristone and misoprostol use to osmotic
      dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be
      given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2
      hours prior to abortion. Osmotic dilators are the method currently used in our institution,
      and are placed 24 hours prior to abortion. The primary outcome will be the length of the
      procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,
      participant's assessment of discomfort before mifepristone or dilators, discomfort during the
      abortion procedure, acceptability to participants, and acceptability to staff.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18-50 years of age undergoing surgical termination of pregnancy

          -  English or Spanish speaking

          -  Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by
             ultrasound dating

          -  Eligible for a dilation and evacuation abortion with local anesthesia and sedation

          -  Ultrasound for dating purposes done within the last two weeks

        Exclusion Criteria:

          -  Intrauterine infection

          -  Fetal demise

          -  Ruptured membranes

          -  Multiple gestation

          -  Uterine anomaly or significant distortion of the uterus with fibroids

          -  BMI greater than 45

          -  Inability to place osmotic dilators

          -  Active substance abuse or intoxication

          -  Adrenal failure, chronic corticosteroid use, anticoagulant usage

          -  Severe cervicitis, until treated and resolved

          -  Prior Cesarean section
Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)
Condition: Healthy
Intervention: Comparator: Varicella Zoster Virus Vaccine; Comparator: Varicella Zoster Virus Vaccine
Intervention description: Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose); Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 695.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compared the safety and tolerability profile of a higher potency investigational
      vaccine to that of the investigational vaccine at a lower potency dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy individuals 50 years of age or older with a history of chickenpox who have not
             had herpes zoster

        Exclusion Criteria :

          -  Preexisting conditions that might affect vaccine safety such as conditions that
             inhibit an immune response
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI1744) Low; Olodaterol (BI1744) High; Tiotropium 18 mcg; Placebo (for Olodaterol (BI1744)l); Placebo (for Tiotropium)
Intervention description: Low dose inhaled orally once daily from Respimat inhaler; High dose inhaled orally once daily from Respimat inhaler; 18 mcg inhaled once daily from HandiHaler; Placebo (olodaterol low and high dose) delivered by Respimat; Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is intended to characterize the lung function profile of BI1744 in Chronic
      Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function
      tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient
      will receive all four treatments.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients willing to participate with confirmed diagnosis of COPD

          -  40 years of age or older

          -  having a 10 pack year smoking history

          -  able to perform serial pulmonary function tests

          -  able to use both a Dry powder inhaler (DPI) and Respimat device

        Exclusion criteria:

          -  Significant other disease

          -  clinically relevant abnormal hematology, chemistry, or urinalysis

          -  history of asthma

          -  diagnosis of thyrotoxicosis

          -  paroxysmal tachycardia related to beta agonists

          -  history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure
             within 1 year

          -  active tuberculosis, cystic fibrosis, clinically evident bronchiectasis

          -  significant alcohol or drug abuse

          -  pulmonary resection

          -  taking oral beta adrenergics

          -  taking unstable oral steroids

          -  daytime oxygen

          -  enrolled in rehabilitation program

          -  enrolled in another study or taking investigational products

          -  pregnant or nursing women, women of child bearing potential not willing to use two
             methods of birth control

          -  those who are not willing to comply with pulmonary medication washouts
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR); Desvenlafaxine Succinate Sustained-Release (DVS SR); Placebo; Duloxetine 60 mg/day
Intervention description: 50 mg tablet, once daily dosing for 8 weeks; 100 mg tablet, once daily dosing for 8 weeks; Matching placebo tablets and capsules, once daily dosing for 8 weeks; 60 mg capsule, once daily dosing for 8 weeks
Intervention MeSH terms: Duloxetine Hydrochloride; Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 638.0
Sex: All
Minimum age: 18 Years
Keywords: MDD; Major Depressive Disorder; Depression

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS
      SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without
             psychotic features.

          -  Depressive symptoms for at least 30 days before the screening visit.

          -  Outpatient men and women at least 18 years of age.

        Exclusion Criteria:

          -  Significant risk of suicide based on clinical judgment, including common suicidal
             thoughts and suicide having been considered as a possible solution even without
             specific plans or intent.

          -  Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
             hypertension), ophthalmologic, neurologic, or any other medical condition that might
             confound the study or put the subject at greater risk during study participation.

          -  Current (within 12 months before baseline) psychoactive substance abuse or dependence
             (including alcohol), manic episode, posttraumatic stress disorder,
             obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic
             disorder; b) current (within 12 months before baseline) generalized anxiety disorder,
             panic disorder, or social anxiety disorder; c) presence (within 12 months before
             baseline) of a clinically important personality disorder as assessed during the
             psychiatric assessments.
Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS)
Condition: Non-Constipation Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Rifaximin; Placebo
Intervention MeSH terms: Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diarrhea; Rifaximin; IBS; Abdominal pain; Bloating

Summary:

      To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in
      providing adequate relief of IBS symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed IBS diagnosis per Rome II criteria for diagnosis of IBS.

          -  Colonoscopy within 2 years as part of IBS diagnostic evaluation.

          -  Has active symptoms of non-constipation IBS at baseline as measured by average daily
             scores for abdominal pain/discomfort, bloating, and stool consistency.

        Exclusion Criteria:

          -  Symptoms of constipation.

          -  History of other gastrointestinal diseases.

          -  Type 1 or 2 diabetes.

          -  Lactose intolerance not controlled by lactose-free diet.
Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)
Condition: Pulmonary Arterial Hypertension; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sitaxsentan; Placebo
Intervention description: Sitaxsentan = 100 mg tablet administered orally, once daily; Sitaxsentan Placebo = 1 tablet administered orally, once daily
Intervention MeSH terms: Sitaxsentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sitaxsentan; endothelin receptor antagonist

Summary:

      This protocol is for subjects with pulmonary arterial hypertension and is the first of 3
      studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective
      Assessment of Adding Sildenafil (SR-PAAS) program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by
             one of the following: idiopathic arterial hypertension (IPAH), primary pulmonary
             hypertension (PPH), familial pulmonary arterial hypertension (FPAH) or pulmonary
             arterial hypertension (PAH) associated with connective tissue diseases. Has WHO
             functional class III symptoms.

        Exclusion Criteria:

          -  Previous exposure to an endothelin receptor antagonist (ETRA) such as sitaxsentan,
             bosentan or ambrisentan.