bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Condition: Detrusor Hyperreflexia
MeSH terms: Reflex, Abnormal
Intervention: Oxybutynin transdermal system
Intervention description: 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
Intervention MeSH terms: Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of an anticholinergic drug treatment
      administered by transdermal patch to treat overactive bladder in adults who have spinal cord
      injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age at day of consent;

          -  Is a male, or is a non-pregnant non-lactating female who is either of
             non-child-bearing potential, or is using adequate means of birth control;

          -  Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury
             etiology;

          -  Has impairment based on the American Spinal Injury Association (ASIA);

          -  Use clean intermittent catheterization;

          -  Has urinary incontinence between scheduled catheterization;

          -  Capable of understanding and complying with the protocol.

        Exclusion Criteria:

          -  Have one or more treatable conditions, other than neurogenic bladder dysfunction, that
             may cause urinary incontinence or urgency;

          -  Have any medical condition that precludes their participation in the study, or may
             confound the outcome of the study;

          -  History of major lower urinary tract surgery, procedures;

          -  Has an active skin disorder, affecting TDS application site areas;

          -  Hypersensitivity to the investigational drug;

          -  Has participated in any study involving administration of an investigational compound
             within 30 days before this study.
Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Acthar Gel; Placebo
Intervention description: 80 Units Acthar Gel per 1 mL for subcutaneous injection; Matching placebo 1 mL for subcutaneous injection
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1: Single Group; Part 2: Parallel
Masking: Double (Participant, Investigator)
Masking description: Part 1: Open Label ; Part 2: Double-blind
Enrollment: 259.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Persistent disease activity

Summary:

      This is a 2-part study to examine the effect of Acthar Gel in adult participants with
      rheumatoid arthritis (RA) with persistently active disease even after receiving two other
      treatments intended to modify the disease.

      Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12
      weeks. After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for
      treatment response using the DAS28-ESR.

      Participants who have achieved low disease activity (LDA) will enter a double-blind
      randomized maintenance period (Part 2) and be randomized in a 1:1 ratio to receive either
      Acthar Gel or matching placebo for an additional 12 weeks.

      A single participant might be involved in the trial for as many as 32 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant, nonlactating female subjects

          -  Meets criteria for definite rheumatoid arthritis as defined by 2010 American College
             of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at
             screening

          -  Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug
             administration despite dual-DMARD treatment

          -  Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a
             stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit

          -  May also be on a stable dose of 10 mg or less of prednisone or other the dose
             equivalent of another corticosteroid for 4 weeks prior to study drug administration

        Exclusion Criteria:

          -  Has current rheumatoid disease or inflammatory joint disease other than RA

          -  Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA

          -  Has taken B-cell mediated therapies in the 6 months prior to screening

          -  Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication
             as per the United States (US) Prescribing Information for Acthar

          -  Has history of Type 1 or Type 2 diabetes

          -  Has any clinically significant infection
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Condition: Smoking Cessation; Depression
MeSH terms: Depression; Depressive Disorder
Intervention: varenicline; placebo
Intervention description: varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks; placebo tablets matched in appearance and dosage to varenicline tablets
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: smoking; smoking cessation; smoking cessation in depressed subjects

Summary:

      Patients with depression tend to have a higher prevalence of smoking as well as increased
      severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that
      demonstrated its efficacy and tolerability have not included subjects with depression. This
      smoking cessation study focuses on the depressed population and will assess the efficacy and
      safety of varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female cigarette smokers, 18-75 years, motivated to stop smoking and
             considered suitable for a smoking cessation attempt

          -  Smoked an average of at least 10 cigarettes per day during past year and over past
             month, and exhaled carbon monoxide (CO) > 10 ppm at screening

          -  Current or past diagnosis of MDD without psychotic features, either single or
             recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at
             least one of the following:

          -  On stable antidepressant treatment for MDD (stable dose for at least 2 months)

          -  Major depressive episode, using DSM IV TR, in the past 2 years successfully treated

        Exclusion Criteria:

          -  Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or
             other psychotic disorder, bipolar I disorder, bipolar II disorder.

          -  Subjects with antisocial, schizotypal, or any other personality disorder severe enough
             to compromise the subject's ability to comply with the study requirements..

          -  Current use of either bupropion or nortryptiline.
Comparative Efficacy of 4 Oral Analgesics
Condition: Pain
Intervention: Oxycodone/acetaminophen; Hydrocodone/acetaminophen; Codeine/acetaminophen; Ibuprofen/acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Oxycodone; Hydrocodone; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pain

Summary:

      The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of
      the comparative efficacy of 4 oral analgesics in the initial management of acute
      musculoskeletal extremity pain presenting to the ED.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complaint of acute pain of < 7 days duration

          -  Location of pain in one or more extremities defined as distal to and including the
             shoulder joint in the upper extremities and distal to and including the hip joint in
             the lower extremities;

          -  Radiologic evaluation is planned

        Exclusion Criteria:

          -  Inability to confirm reliable means of phone followup.

          -  Past use of methadone

          -  Chronic condition requiring frequent pain management such as sickle cell disease,
             fibromyalgia, or any neuropathy

          -  History of an adverse reaction to any of the study medications

          -  Opioids taken in the past 24 hours

          -  Ibuprofen or acetaminophen taken in past 8 hours

          -  Pregnancy by either urine or serum HCG testing

          -  Breastfeeding per patient report

          -  History of peptic ulcer disease

          -  Report of any prior use of recreational narcotics

          -  Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or
             ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's
             or Cushing's disease

          -  Taking any medicine that might interact with one of the study medications, such as
             antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications
             quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib,
             ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Esomeprazole; Placebo
Intervention description: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate; once daily
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: GERD; Esophageal Reflux; Gastro-Esophageal Reflux; Regurgitation; Gastric

Summary:

      The purpose of this research study is to compare the safety and effectiveness (how well the
      medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any
      medication) taken daily in relieving nighttime heartburn and problems sleeping in patients
      with gastroesophageal reflux disease (GERD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months
             or longer or any history of EE;

          -  Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per
             week;

          -  Prior to the run-in period, a history of sleep disturbances associated with GERD for 1
             month or more;

        Exclusion Criteria:

          -  Any condition other than GERD that is either the primary cause of, or a significant
             contributor to, the patient's sleep disturbance

          -  Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or
             anti-anxiety medication use that has not been stable (either in dose or regularity)
             for at least 3 months or is not expected to remain stable during the patient's
             participation in the study. Patients on a stable regimen, whose regimen is also
             expected to remain stable throughout the study, are eligible for participation;

          -  Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable
             acid modifying rescue medication is GELUSIL® during the run-in period. Only study
             medication and rescue medication (GELUSIL®) is allowed during the treatment period for
             treatment of acid mediated symptoms
Tranexamic Acid in Knee Joint Surgery
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Tranexamic Acid; Normal saline (0.9% NaCl)
Intervention description: Given intravenously or topically; Administered in all 3 groups
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tranexamic acid; enhanced recovery; arthroplasty; perioperative care

Summary:

      Total knee joint replacement surgery can lead to significant blood loss, which can affect
      recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of
      blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of
      debate. Growing interest in the topical application of TXA (directly into the surgical wound)
      has been suggested as an alternative way of administering TXA, and may demonstrate similar
      effectiveness as when it is given intravenously. Therefore, this multicentred, randomized
      controlled trial, aims to investigate the safety and effectiveness of both topical and
      intravenous administrations of TXA in total knee joint surgery. The investigators predict
      that both routes of administration will demonstrate similar results when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients at the participating sites on the waiting list for a unilateral total
             knee joint replacement

        Exclusion Criteria:

          -  Patients with a history or risk of thrombosis

          -  Active thromboembolic disease such as deep vein thrombosis, pulmonary embolism and
             cerebral thrombosis

          -  Subarachnoid haemorrhage

          -  Hypersensitivity to tranexamic acid or any of its ingredients.

          -  Refusal of blood products

          -  Colour blindness

          -  Complex hematologic disorders requiring manipulation

          -  Coagulopathy

          -  Pregnant and Lactating Women

          -  Anti-coagulant therapy pre-operatively within 5 days of surgery (warfarin, dabigatran,
             heparin)

          -  Severe renal failure (eGFR <29)
Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: N-acetylcysteine; Placebo
Intervention description: Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.; Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to determine whether pharmacological treatment with
      N-acetylcysteine improves central and peripheral cardiorespiratory control and physical
      capacity in COPD patients with mild-to-moderate airflow obstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio
             between forced expiratory volume in one second and forced vital capacity
             (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized
             clinical treatment as judged by the accompanying physician

        Exclusion Criteria:

          -  unable to perform all experimental procedures and/or provide informed consent;

          -  hospital admission in the previous 6 weeks;

          -  exercise training program in the previous 6 months;

          -  any condition that could interfere with the ability to exercise;

          -  diagnosed psychiatric or cognitive disorders;

          -  type I insulin-dependent diabetes mellitus;

          -  excessively over-weight (BMI>35kg/m²);

          -  other diagnosed cardiorespiratory disorders (e.g., chronic heart failure, peripheral
             artery disease).
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty
Condition: Total Knee Replacement
Intervention: Fondaparinux Sodium (Arixtra)
Intervention description: 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators hypothesize that Arixtra patients will be less likely to experience wound
      infection than patients who have received low-molecular weight heparin, coumadin or aspirin
      with mechanical compression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All primary unilateral TKA and THA cases will be included.

        Exclusion Criteria:

          -  Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral
             procedures will be excluded.
Study to Evaluate OXERVATE™ in Patients With Stage 1 Neurotrophic Keratitis
Condition: Neurotrophic Keratitis
MeSH terms: Keratitis
Intervention: cenegermin-bkbj
Intervention description: Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage 1 Neurotrophic Keratitis; Corneal Disease; Ocular Disease

Summary:

      This study is to evaluate the safety and efficacy of OXERVATE™ 0.002% (20 mcg/mL)
      cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥ 18 years.

          2. Patients with Stage 1 NK defined by the Mackie criteria

        Exclusion Criteria:

          1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.

          2. Have current or history of conditions that may confound the study data including but
             not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD),
             neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome.

          3. History of severe systemic allergy or severe ocular allergy (including seasonal
             conjunctivitis expected during the subject's participation in the trial) or chronic
             conjunctivitis and/or keratitis other than dry eye disease.

          4. Patients with severe vision loss with no potential for visual improvement in the study
             eye, in the opinion of the investigator, or if the subject is deemed legally blind.

          5. Ocular surgery or elective ocular surgery expected during participation in the trial.

          6. Patients with eyelid abnormality that may alter eyelid function including but not
             limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid
             syndrome.
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Condition: Normal Healthy Subject Population
Intervention: Zegerid®; Prilosec OTC®
Intervention description: capsule(20 mg omeprazole/sodium bicarbonate), single dose; Omeprazole-magnesium 20.6 mg, tablet, single dose
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on
      gastric acid suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal subjects who are 18-65 years of age;

          -  Non-childbearing potential females or those using birth control

        Exclusion Criteria:

          -  History of significant GI disease

          -  Any significant medical illness

          -  History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump
             inhibitors;

          -  Currently using GI medications

          -  GI disorder or surgery leading to impaired drug absorption