bioihbjkbjnl/mcl2 huggingface dataset:
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo
Intervention description: QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily; Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149, cardiac function, ventricular enddiastolic volume, hyperinflated COPD patients

Summary:

      This mechanistic study is a single-center, randomized, double-blind, placebo-controlled,
      cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and
      lung function parameters in hyperinflated COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with airflow limitation indicated by a post-bronchodilator FEV1 <80% of the
             predicted normal value and a post-bronchodilator FEV1/FVC<0.7

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Able and willing to give written informed consent

          -  Hyperinflated patients with RVol>135% predicted

        Exclusion Criteria:

          -  Patients on LABA or LAMA treatment at Visit 1.

          -  History of one COPD exacerbation that required treatment with antibiotics, systemic
             steroids (oral or intravenous) or hospitalization 3 months prior to Visit 2.

          -  More than one COPD exacerbation that required treatment with antibiotics, systemic
             steroids (oral or intravenous) or hospitalization within 6 months prior to Visit 2.

          -  Patients who have clinically significant cardiovascular abnormalities, which could
             interfere with the assessment of the study treatment (such as but not limited to
             cardiac arrhythmias, heart failure with left ventricular ejection fraction <40% as
             determined by MRI scan, unstable ischemic heart disease, NYHA Class III/IV left
             ventricular failure, history of myocardial infarction 6 months prior to Visit 2)

          -  Patients with a known history or current atrial fibrillation to be confirmed by ECG.

          -  Patients with pacemaker, bypass or stent.

          -  Patients whose QTcF measured at Visit 3 is >450 ms for males and >470 ms for females

        Additional study-specific inclusion and exclusion criteria may apply
Pain Expectations in Subjects With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Modafinil; Gabapentin; Placebo
Intervention MeSH terms: Gabapentin; Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Osteoarthritis; Knee pain; Hip pain; Total Knee Replacement Surgery

Summary:

      The purpose of this research study is to test whether or not researchers can alter or change
      expectations on pain. The researchers will test whether there is an effect on the size of the
      pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee
      or hip or healthy subjects for comparison.

      One of 3 possible treatment groups will be administered to qualifying subjects: (1)
      gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a
      medication that is commonly used to treat people with narcolepsy (a disorder that causes
      people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill,
      that is not thought to have any effect on your disease or condition
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee or hip

          -  Adult (ages 18-80)

          -  Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with
             normal activity)

          -  American Society of Anesthesiologists physical status 1-3

          -  Healthy subjects without pain

        Exclusion Criteria:

          -  Pregnancy;

          -  Currently taking gabapentin

          -  Currently taking a narcotic prescription medication that is > 50 mg morphine
             equivalents/day

          -  Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction

          -  History of previous eye surgery

          -  Psychotic disorder or a recent psychiatric hospitalization
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Rectocele; Prolapse; Pelvic Organ Prolapse
Intervention: Bupivacaine; Placebo
Intervention description: At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sacrocolpopexy; rectocele repair

Summary:

      To determine if the injection of liposomal bupivacaine to laparoscopic port sites and
      rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant
      rectocele repair will result in decreased postoperative pain compared to injection of
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 years of age or older

          -  Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele
             repair under general anesthesia

          -  Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Allergy to bupivacaine

          -  History of drug/alcohol abuse

          -  Severe cardiovascular, hepatic, renal disease, or neurological impairment

          -  Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery

          -  Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs
             (NSAID)

          -  Administration of an investigational drug within 30 days before study

          -  Chronic pain syndromes

          -  Daily NSAID/opioid use

          -  Patients not undergoing general anesthesia

          -  Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or
             fistula repair
STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: FTY720
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6998.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; MS; Fingolimod; Gilenya; ECG; Bradyarrythmia; conduction abnormalities; first dose observation

Summary:

      This study evaluated bradycardiac events during first dose observation of fingolimod in MS
      patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with relapsing remitting MS.

          -  Patients with highly active disease despite a full and adequate course of treatment
             with at least one disease modifying therapy.

          -  Patients who had been previously on 2nd line therapies. It was understood that these
             patients satisfied the above mentioned criteria listed under a. in the past.

        This also included patients, who were previously treated with fingolimod (regardless of
        whether or not they had already been treated within the START study) but discontinued
        treatment due to medical reasons.

        - or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression
        in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions
        compared to a recent MRI).

        Key Exclusion Criteria:

          -  immunocompromised patients

          -  active infections

          -  pregnant or nursing women, women of childbearing potential unless using 2 reliable
             forms of contraception

          -  presence of malignancy (other than localized basal cell carcinoma of the skin).
Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Intervention: Colgate Cavity Protection toothpaste; Colgate Total toothpaste; Parodontax toothpaste
Intervention description: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.; 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste; 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
Intervention MeSH terms: Listerine; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this randomized, single center, parallel clinical research study is to
      evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste,
      Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and
      dental plaque in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects, ages 18-70, inclusive.

          2. Availability for the six-month duration ofthe clinical research study.

          3. Good general health.

          4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

          5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
             Silness Gingival Index.

          6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
             Plaque Index (Turesky Modification).

          7. Signed Informed Consent Form.

        Exclusion Criteria:

          1. Presence of orthodontic bands.

          2. Presence of partial removable dentures.

          3. Tumor(s) of the soft or hard tissues of the oral cavity.

          4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss
             of periodontal attachment or alveolar bone).

          5. Five or more carious lesions requiring immediate restorative treatment.

          6. Antibiotic use any time during the one month prior to entry into the study.

          7. Participation in any other clinical study or test panel within the one month prior to
             entry into the study.

          8. Dental prophylaxis during the past two weeks prior to baseline examinations.

          9. History of allergies to oral care/personal care consumer products or their
             ingredients.

         10. On any prescription medicines that might interfere with the study outcome.

         11. An existing medical condition which prohibits eating or drinking for periods up to 4
             hours.

         12. History of alcohol or drug abuse.

         13. Pregnant or lactating subjects.
POWER (Pulse Width Optimized Waveform Evaluation Trial)
Condition: Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Death
Intervention: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
Intervention description: Patients that are indicated for an ICD or CRT-D receive one of these devices.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ICD; Defibrillation; ULV; Tuned

Summary:

      The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT
      (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant
      based biphasic defibrillation waveforms. This comparison will result in identifying the
      optimal membrane time constant when programming the "tuned" defibrillation waveform.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a candidate for ICD/CRT-D implantation.

          -  Patient has a compatible transvenous defibrillation lead system.

          -  Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of
             ICD/CRT-D implant.

          -  Patient is able to tolerate ULV guided DFT testing.

        Exclusion Criteria:

          -  Patient has a mechanical valve in the tricuspid position.

          -  Patient has epicardial defibrillation electrodes.

          -  Patient is pregnant.

          -  Patient is less than 18 years old.
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Intervention: Rikkunshito; Rikkunshito placebo
Intervention description: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks; - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rikkunshito; Double blind; Functional dyspepsia (FD)

Summary:

      The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to
      placebo in Japanese subjects with Functional Dyspepsia (FD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  -Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled
             for the last 3 months with symptom onset at least 6 months prior to obtaining informed
             consent ii) Have not received upper endoscopy within the last 6 months prior to
             enrollment and do not have evidence of structural/organic disease iii) Must have one
             or more of the following symptoms:

               1. Bothersome postprandial fullness

               2. Early satiation

               3. Epigastric pain

               4. Epigastric burning

          -  At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale
             (bothersome postprandial fullness, early satiation, epigastric pain, epigastric
             burning) is ≥4, whereas heartburn is ≤3.

          -  Total score of depression-related symptoms on Hospital Anxiety and Depression Score
             (HAD) is ≤10.

          -  Type of visit: Outpatient

          -  Provides voluntary informed consent after receiving adequate explanation and
             demonstrates thorough understanding of the nature of the study.

        Exclusion Criteria:

          -  Confirmed ulcer (excluding scars) or malignant tumor in the upper GI

          -  Suspected organic lesions in the hepato-biliary-pancreatic regions such as
             cholelithiasis, hepatitis, pancreatitis

          -  History of upper GI resection

          -  Serious complications (liver, kidney, heart, or blood disease or metabolic disease)

          -  Less than a year since testing positive for H. pylori or have undergone a successful
             eradication therapy

          -  Use of prohibited medications

          -  Neuropsychiatric disorders

          -  Use of or planned use of any investigational drugs

          -  Unable to take drugs orally

          -  History of allergic reactions to Kampo medicines

          -  Pregnant or lactating women or those who are planning to conceive during the study
             period

          -  Deemed ineligible by principal investigator or sub-investigator
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide/timolol maleate fixed combination
Intervention MeSH terms: Timolol; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary open angle-glaucoma; Ocular hypertension; Pigment dispersion glaucoma

Summary:

      The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®
      from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment
             dispersion glaucoma in at least one eye (study eye).

          -  On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening
             Visit.

          -  IOP considered safe in both eyes in order to assure clinical stability of vision and
             optic nerve throughout the study period.

          -  Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each
             eye.

          -  IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on
             brimonidine/timolol fixed combination therapy.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of other primary or secondary glaucoma.

          -  History of ocular herpes simplex.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Corneal dystrophies.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either
             eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

          -  Intraocular conventional surgery or laser surgery in study eye(s) less than three
             months prior to Screening Visit.

          -  Risk of visual field or visual acuity worsening as a consequence of participation in
             the study, in the opinion of the investigator.

          -  Progressive retinal or optic nerve disease from any cause.

          -  Use of systemic medications known to affect IOP which have not been on a stable course
             for 7 days prior to Screening Visit or an anticipated change in the dosage during the
             course of the study.

          -  Pregnant or lactating.

          -  Other protocol-defined exclusion criteria may apply.
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Nitroglycerin
Intervention description: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal
      administration of Nitroglycerin. Aim of this prospective research study is to investigate
      equivalence on image quality after sublingual or transdermal Nitroglycerin administration
      (H0).

      Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Scheduled cCTA with contrast.

          2. Able to comprehend and sign the consent form.

        Exclusion Criteria:

          1. Known hypersensitivity to glyceryl trinitrate, and related organic nitrates.

          2. Acute circulatory failure associated with marked hypotension (shock).

          3. Conditions associated with elevated intracranial pressure, cerebral haemorrhage and
             head trauma.

          4. Closed-angle glaucoma.

          5. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil
             (Cialis), or vardenafil (Levitra) within the last 24 hours

          6. Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)

          7. Critical aortic stenosis

          8. Systolic blood pressure < 90 mmHg

          9. Pregnant or lactating female; premenopausal women with a positive urine pregnancy
             test.

         10. Age under 18

         11. Unwilling or unable to inform consent.