bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237; Tiotropium; Placebo to NVA237; Placebo to tiotropium; Salbutamol
Intervention description: NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI); Tiotropium 18 μg once daily delivered via HandiHaler® device.; Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).; Placebo to tiotropium once daily delivered via HandiHaler® device; Used as resuce medication
Intervention MeSH terms: Glycopyrrolate; Albuterol; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to further figure out differences of glycopyrronium bromide
      compared to tiotropium in early bronchodilation measured by a comprehensive assessment of
      lung function that includes hyperinflation and specific airway resistance in patients with
      moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 years

          -  Patients with moderate to severe COPD defined by a post-bronchodilator Forced
             Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and
             a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Patients who have a clinically significant laboratory abnormality at run-in

          -  Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or
             bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732)
             or urinary retention. (BPH patients who are stable on treatment can be considered).

          -  Patients with any history of asthma

          -  Patients with pulmonary lobectomy or lung volume reduction surgery or lung
             transplantation

          -  Patients receiving medications in the classes listed in the protocol as prohibited.

        Other protocol-defined inclusion/exclusion criteria may apply
Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Amiodarone
Intervention MeSH terms: Amiodarone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: amiodarone; atrial fibrillation; surgical procedures, thoracic

Summary:

      The investigators hypothesize that the medication amiodarone decreases the incidence of
      atrial fibrillation (AF) following non-cardiac open-chest surgery. Their specific aims are
      to:

        -  Determine the effectiveness of amiodarone for the prevention of AF following non-cardiac
           open-chest surgery;

        -  Determine the influence of the prevention of AF following non-cardiac thoracic surgery
           on post-surgical duration of stay in the Intensive Care Unit (ICU); post-surgical
           duration of stay in a hospital unit that employs cardiac monitoring; and duration of
           post-surgical hospital stay; and

        -  Determine the safety of amiodarone for the prevention of AF following non-cardiac
           open-chest surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females over the age of 40

          -  Scheduled to undergo pneumonectomy or lobectomy

        Exclusion Criteria:

          -  History (hx) of atrial fibrillation

          -  Prior severe side effects from amiodarone

          -  Elevated liver enzymes >3 times the upper limit of normal (UNL)

          -  QTc interval > 450 ms

          -  Receiving class Ia or class III antiarrhythmics
Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts
Condition: Tobacco Use Disorder; Smoking; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Intervention: bupropion; varenicline; motivational emails
Intervention description: bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks; varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks; brief motivational emails, sent weekly for 12 weeks
Intervention MeSH terms: Bupropion; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 893.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; Bupropion; Varenicline; Population-level; Mass distribution; Drug Therapy

Summary:

      Bupropion and varenicline are indicated for smoking cessation. The objectives of this study
      are two-fold: (1) to explore the logistic feasibility of distributing bupropion and
      varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada
      and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in
      Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who
      smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will
      enroll via the study website, visit their physician to receive a prescription for bupropion
      or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison
      group. All participants will receive weekly motivational emails for 12 weeks. Abstinence
      measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of
      eligible participants who were able to confirm an appointment with a physician to receive the
      prescription will be also measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, at least 18 years of age, resident of Ontario, smoke at least 10
             cigarettes per day, had smoked daily for at least the past 3 months, had smoked at
             least 100 cigarettes in their lifetime and intended to quit smoking in the next 30
             days.

        Exclusion Criteria:

          -  history of brain injury or seizure(s); pregnancy, lactation or risk of becoming
             pregnant; allergy or sensitivity to bupropion or varenicline; current use of monoamine
             oxidase inhibitors (MAOIs), thioridazine, varenicline or buproprion; severe liver
             impairment; or history of anorexia and /or bulimina.
Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix™
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3054.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      A study to investigate the incidence of influenza and influenza-related complications, in
      adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female age 50 years or older at the time of the first vaccination.

          -  non-childbearing female

          -  Availability to follow up by phone

          -  Subjects with residence status allowing free mixing with general community

        Exclusion Criteria:

          -  Use of non-registered products

          -  Pregnancy

          -  Hypersensitivity to a previous dose of influenza vaccine

          -  Acute disease at the time of enrolment/vaccination.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine

          -  Any contra-indication to intramuscular administration of Fluarix™

          -  For subjects enrolled in the immunogenicity subset only: administration of
             immune-modifying drugs within 7 days prior to the vaccination
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Condition: Strabismus; Delirium on Emergence; Pediatric Disorders
MeSH terms: Delirium; Strabismus; Emergence Delirium
Intervention: Dexmedetomidine; Placebo
Intervention description: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes; intraoperative dose of intravenous placebo
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 1 Year
Maximum age: 7 Years
Healthy volunteers: No
Keywords: strabismus; pediatric; emergence delirium; precedex/dexmedetomidine

Summary:

      This study is trying to see if using precedex pre-operatively prevents emergence delirium in
      pediatric (ages 1-7) patients undergoing strabismus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA physical status of I or II

          -  male or female, aged 1-7

          -  has no significant lab abnormalities

        Exclusion Criteria:

          -  ASA physical status of III, IV or V

          -  Presence of medicated behavioral disorder

          -  Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational
             anesthetics are contraindicated.

          -  Parental refusal
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Condition: Multiple Sclerosis; Constipation
MeSH terms: Multiple Sclerosis; Sclerosis; Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg twice daily for 21 days.; matching placebo twice daily for 21 days.
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Constipation; Multiple Sclerosis Associated Constipation

Summary:

      The purpose of the study is to assess how safe and effective the drug Lubiprostone is in
      people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation.
      Lubiprostone is approved by the FDA for the treatment of two common types of constipation in
      adults, chronic idiopathic constipation and irritable bowel syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multiple Sclerosis

          -  Chronic Constipation defined as < 3 spontaneous bowel movements per week by history
             and confirmed by diary during the 14 day washout period.

          -  Women of child-bearing potential must agree to use adequate birth control.

        Exclusion Criteria:

          -  history of other clinically significant medical or psychiatric disorders or suicidal
             ideation.

          -  Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation
             prior to dosing that include nausea, vomiting, abdominal pain or distention.

          -  Subjects with a positive urine pregnancy test prior to dosing.

          -  Medication changes within one month prior to visit one.

          -  Corticosteroid use within 2 months prior to visit one.

          -  Age<18.

          -  Known intolerance to lubiprostone.

          -  Inability to perform any required study procedures.
Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.
Condition: Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Antibiotic local prophylaxis with medicated calcium sulfate beads; Classical parenteral antibiotic prophylaxis
Intervention description: Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection; Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial. Study participants are randomly assigned to one of two groups: the experimental group receiving the Calcium sulfate beds with antibiotics and a comparison group (control) which receives a conventional prophylactic therapy.
Masking: Single (Participant)
Masking description: No participant will know during the study in which group will be assigned.
Enrollment: 87.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Periprosthetic Joint Infection; Prophylaxis; Joint Replacement; Calcium Sulfate Beads

Summary:

      To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in
      patients with non-modifiable risk factors that will undergo a hip or knee joint replacement,
      comparing with a control group.

      To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in
      patients undergoing hip or knee joint replacement with non-modifiable risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with fracture or osteoarthrosis of the hip or knee that require treatment by
             joint replacement.

          -  patients who have any of the Non-Modifiable Risk Factors prior to surgery or during
             transoperative period.

          -  Patients entitled to the ISSEMyM (Instituto de Seguridad Social del Estado de Mexico y
             Municipios)

        Exclusion Criteria:

          -  Patients that lose their validity of institutional rights and do not follow up

          -  Patients who die during the study due to other causes not related to the orthopedic
             procedure.

          -  Patients who do not have any of the risk factors for periprosthetic infection

          -  Patients allergic to vancomycin or ceftriaxone.
Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia
Condition: Deep Extubation
Intervention: Desflurane with remifentanil; Desflurane
Intervention description: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil; During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
Intervention MeSH terms: Remifentanil; Desflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      It has been reported that deep extubation can reduce cardiopulmonary complication against
      endotracheal tube extubation during emergence from general anesthesia. The investigators
      hypothesized that using desflurane with target controlled infusion of remifentanil is more
      effective than using desflurane alone during deep extubation. The purpose of this study is to
      evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing)
      during emergence from general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20-60

          -  patients undergoing elective surgery take more than an hour

          -  Under general anesthesia using an LMA

          -  ASA I,II

        Exclusion Criteria:

          -  Patients on CNS depressants

          -  Chronic opioid use

          -  Corticosteroid

          -  Pregnant patients

          -  Full stomach

          -  Morbidly obese (BMI >35kg/m2)

          -  Hepatitis B

          -  Hepatitis C

          -  Coronary artery disease

          -  Liver disease

          -  Renal disease

          -  Seizure disorder

        Dropout criteria:

          -  Need for reintubation due to breath holding

          -  high ETCO2 during self ventilation (ETCO2>50)

          -  Surgeon or patient request
Rheumatological Evaluation of Anastrozole and Letrozole as Adjuvant Treatment in Post-menopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: letrozole
Intervention description: 2.5 mg daily by mouth for 6 months
Intervention MeSH terms: Letrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: breast cancer; adjuvant treatment in post menopausal women; letrozole; arthralgia-myalgia

Summary:

      This study will evaluate whether patients who are intolerant and discontinue anastrozole due
      to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking
      letrozole
    

Eligibility criteria:

        Inclusion Criteria:

          1. Postmenopausal women with HR+ early stage breast cancer at the time of initial
             diagnosis. For study purposes, postmenopausal is defined as:

               -  Age ≥ 50 y and amenorrheic for 12 or more months.

               -  Age ≥ 50 y and amenorrheic for 3 or more months after receiving adjuvant
                  chemotherapy.

               -  Age < 50 y and amenorrheic for 12 or more months.

               -  Prior bilateral oophorectomy.

               -  Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per
                  local institutional standards.

               -  Age > 55 y and prior hysterectomy.

          2. Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry
             when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3
             (NCI-CTCAE V3) arthralgia-myalgia.

          3. Hormone receptor-positive tumors as defined by institutional standards.

          4. ECOG performance status of 0, 1, or 2

          5. Consent to participate in the trial. -

        Exclusion Criteria:

          1. Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding
             chest wall recurrence with no evidence of systemic disease.

          2. Recent history of pain associated with non-traumatic bone fracture.

          3. Pain requiring chronic use of analgesics (due to any reason).

          4. History of rheumatological disease except osteoarthritis.

          5. Prior hormonal therapy with AIs other than anastrozole.

          6. Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other
             than Estring®, Vagifem® or low dose estrogen vaginal cream.

          7. Concomitant disease which significantly affects quality of life.

          8. Patient unable to complete self administered questionnaire.

          9. Patients unable to sign consent form.

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Intervention: naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol
Intervention description: NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
Intervention MeSH terms: Acetaminophen; Dexamethasone; Naproxen; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: naproxen sodium; codeine phosphate; dexamethasone; pain; temporomandibular joint

Summary:

      Temporomandibular disorders (TMDs) are one of the most common muco-skeletal disorders, seen
      in the dental clinics. Many factors work together to initiate or aggravate the condition, so
      it is a multifactorial disorder. The etiology of TMDs may be a result of parafunctional
      habits such as clenching and bruxism, acute trauma to the jaw, trauma from hyperextension
      e.g. after a long dental treatment, joint laxity, psychological distress, occlusal disharmony
      like presence of high crown or free-end saddle leading to joint instability or systemic
      diseases such as Rheumatoid arthritis or Osteoarthritis. The aim of this study was to
      evaluate the effects of naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, and
      naproxen sodium on pain in patients complaining from temporomandibular pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Without a systemic disease,

          -  Not used any medication in the last week

          -  Have a habit of clenching and / or grinding teeth, individuals with normal
             preoperative results, suffering with pain and / or limitation of the mouth opening in
             the temporomandibular region

        Exclusion Criteria:

        Individuals who smoke

          -  Have a parafunctional habits (except for squeezing and grinding teeth)

          -  Pregnant and breastfeeding individuals

          -  Allergies to study medicines

          -  Do not use their medications / use different drugs and non-follow-up