bioihbjkbjnl/mcl2 huggingface dataset:
Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: indacaterol; placebo
Intervention description: delivered via single-dose dry-powder inhaler; delivered via single-dose dry-powder inhaler
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Indacatarol; placebo; crossover; patient perception

Summary:

      This is a phase IV study of indacaterol 75 μg single-dose compared to placebo in
      moderate-severe COPD patients with breathing symptoms to assess time to patient's perception
      of onset of effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization in the 6 weeks prior to screening

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]
             Guidelines, 2008) and:

               -  Smoking history of at least 10 pack-years

               -  Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40%
                  of the predicted normal value

               -  Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

               -  Breathing symptoms that interfere with daily activities

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization in the 6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients who require oxygen therapy for chronic hypoxemia, are receiving
             bronchodilators or other medications for COPD that are dosed once daily, are unable to
             follow instruction on rescue albuterol use during the study, or are at risk
             deterioration of COPD with study procedures. Patients with concomitant pulmonary
             disease

          -  Patients with a history of asthma

          -  Patients with uncontrolled diabetes mellitus

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

        Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Bimatoprost 0.03%; travoprost 0.004%; latanoprost 0.005% eye drops
Intervention description: bimatoprost 0.03%, 1 drop nightly for 3 months; travoprost 0.004% eye drops, 1 drop nightly for 3 months; latanoprost 0.005%, 1 drop nightly for 3 months
Intervention MeSH terms: Bimatoprost; Travoprost; Ophthalmic Solutions; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate hyperemia and ocular surface tolerability in patients on
      prostaglandin analogues
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are
             allowed) or ocular hypertension

        Exclusion Criteria:

          -  Known contraindication to latanoprost, bimatoprost or travoprost

          -  Uncontrolled systemic disease

          -  Active ocular disease other than glaucoma or ocular hypertension

          -  Pregnant or lactating women or women of childbearing potential NOT utilizing a
             medically acceptable form of birth control
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Condition: Asthma
MeSH terms: Asthma
Intervention: Seretide; Flixotide
Intervention description: Seretide; Flixotide
Intervention MeSH terms: Fluticasone; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: asthma; exacerbation; persistent; bronchial hyperresponsiveness; mild; GINAII

Summary:

      An 18 months randomised double-blind study with two parallel arms with start dose of inhaled
      SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be
      up-titrated until well controlled is achieved, After 6 months the treatment continues without
      changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that
      the combination therapy with SERETIDE controls mild persistent asthma better than inhaled
      corticosteroids(FLIXOTIDE) alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to give informed consent.

          -  Males or females aged 18-70.

          -  Able to understand and complete dairy cards.

          -  Mild persistent asthma according to GINA. In addition, at randomisation subjects were
             required to have: 1. Day time symptoms more than once a week but not every day. 2.
             Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4. PC20 <8mg/mL

        Exclusion Criteria:

          -  Change to regular asthma medication in 4-weeks prior to visit 1.

          -  Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.

          -  Lower respiratory tract within 4 weeks of Visit 1

          -  Received investigational study drug within 4 weeks of visit

          -  Smoking history of >10 pack years of more.

          -  Serious uncontrolled disease.

          -  Medical conditions or medications known to affect the assessments or endpoints.

          -  Evidence of alcohol or drug abuse.

          -  Known pregnancy or planned pregnancy.

          -  Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or
             lactose.

          -  Previous enrollment in the study
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services
Condition: HIV Prevention
Intervention: emtricitabine 200mg/tenofovir 300mg
Intervention description: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl <30 mL/min, Truvada will be discontinued.
Intervention MeSH terms: Tenofovir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, acceptability and feasibility of
      delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of
      combination HIV prevention services for high-risk MSM and transgender women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Able to understand and provide consent in English or Spanish

          -  Self identified MSM, MSM/W, or Transfemale

          -  At least one male sex partner for anal intercourse in the prior 12 months

          -  HIV negative by enzyme immunoassay (EIA) and viral load (VL)

          -  CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)

          -  No signs or symptoms suggestive of primary HIV infection (PHI).

        Exclusion Criteria:

          -  Participants <18 years of age

          -  Unable to understand and provide consent in English or Spanish

          -  Known or found on testing to be HIV positive

          -  Any condition, which in the opinion of the intake provider, will seriously compromise
             the participant's ability to comply with the protocol, including adherence to PEP or
             PrEP medication dosing

          -  Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within
             60 days of study entry

          -  Previous participation in an HIV vaccine trial. Participants that were documented to
             have received only placebo are not excluded.

          -  Signs or symptoms suspicious for PHI.
Effect of Neuromuscular Blockade and Reversal on Breathing
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Intervention: Sugammadex; Neostigmine; Placebo
Intervention description: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.; Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.; Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In this study the investigators will assess (i) the effect of partial neuromuscular blockade
      (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to
      isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by
      sugammadex, neostigmine or placebo in healthy volunteers.

      Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced
      by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from
      TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male gender

          -  age 18 years and older

          -  body mass index < 30 kg/m2.

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function;

          -  allergies to muscle relaxants, anesthetics or narcotics;

          -  a (family) history of malignant hyperthermia or any other muscle disease;

          -  any medical, neurological or psychiatric illness (including a history of anxiety).
Flu Vaccine Study in Neuromuscular Patients 2011
Condition: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Congenital Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Atrophy; Muscular Atrophy, Spinal
Intervention: 2011-2012 seasonal flu vaccine Subcutaneous; 2011-2012 seasonal flu vaccine Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Participant, care provider, and investigator are not masked. The outcomes assessor (personnel determining the HI titers) is masked.
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: DMD; SMA; CMD; flu vaccine

Summary:

      The purpose of the study is to compare the immune response of two different injection methods
      (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among
      patients with neuromuscular conditions who have significant muscle degeneration. This
      research study hypothesizes that the subcutaneous route of vaccine administration, as
      compared to the intramuscular route, may confer at least comparable, or possibly better,
      immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive
      Care Center will be recruited to participate in this study lasting approximately one to two
      months with two clinic visits and one follow-up telephone call. Immunogenicity will be
      assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and
      post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-ambulatory;

          -  Quadriceps muscle strength of MRC (Medical Research Council Scale) grade 3 or below

          -  Any subject who is between 3 to 8 years of age must have received at least two doses
             of influenza vaccine last season or at least one dose tow or more years ago.

        Exclusion Criteria:

          -  Subject must not have a history of severe reactions following previous immunization
             with influenza vaccine.

          -  Subject must not have previously received a 2011-2012 influenza vaccine.

          -  Subject must not have a history of Guillain-Barre syndrome.

          -  Subject must not have received a live viral vaccine (i.e., MMR, varicella) within 28
             days prior to receipt of the study vaccine.

          -  Subject must not have any condition that the investigator believes would render
             vaccination unsafe or interfere with successful completion of the study.
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Condition: Cerebral Infarction
MeSH terms: Ischemic Stroke; Cerebral Infarction; Infarction
Intervention: Edaravone; Sodium Ozagrel
Intervention description: Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.; Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
Intervention MeSH terms: Ozagrel; Edaravone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study
      on acute ischemic stroke. The primary endpoints were the rate of patients with modified
      Rankin Scale score of 0-1 at 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients can be receive drug treatment within 24 hours after stroke onset

          2. Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name
             and date of birth) according to the Japan Coma Scale

          3. Patients with motor dysfunction of upper and/or lower extremities

          4. Patients aged 20 years or older when giving informed consent

        Exclusion Criteria:

          1. Serum creatinine of >1.5 mg/dL

          2. Embolic infarction

          3. Intracranial haemorrhage

          4. Large infarction with severe consciousness

          5. Transient ischemic attack (TIA)

          6. A modified Rankin Scale score of ≥2 before stroke onset

          7. Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen
             activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol,
             edaravone and sodium ozagrel) after stroke onset

          8. Patients were receive surgical treatment or intravascular treatment

          9. With severe complications (cirrhosis, heart failure, etc.)

         10. Treating malignant tumor

         11. Pregnant or possibly pregnant women, nursing mothers

         12. History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity

         13. Less than 3 months since any other clinical trial or postmarketing study
Simplified Insulin Regimen for the Elderly
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Insulin Glargine; Insulin Aspart; Insulin Lispro
Intervention description: 0.40 units/kg body weight; 0.20 units/kg body weight; 0.20 units/kg body weight; 0.20 units/kg body weight
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes; Elderly; Insulin treatment; Quality of life

Summary:

      Basal-bolus insulin therapy, which includes one injection of long acting insulin and three
      injections of short acting insulin is the most commonly used insulin treatment. However, many
      older patients find the basal-bolus insulin regimen hard to manage because it involves 4
      injections and 4 blood glucose tests each day. It is possible that a simplified treatment
      that involves one injection of long acting insulin daily and two blood glucose tests daily
      might be equally effective. This simplified regimen, if effective, would be easier to use and
      might result in less errors. Therefore, the investigators want to conduct this study to
      compare using a single daily injection of basal insulin with the usual basal-bolus insulin
      regimen in elderly patients (age >65 years) with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

        -Age >65 years

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Enrollment in another research study

          -  History of hypoglycemia unawareness

          -  Pregnant women

          -  Prisoners
Ictal and Interictal Inflammatory Markers in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Treximet; Placebo
Intervention description: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.; One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: migraine, headache, sumatriptan, naproxen sodium

Summary:

      The purpose of this study is to evaluate blood levels of several proteins that may be altered
      in the inflammation associated with migraine headaches. These blood levels will be evaluated
      in individuals during an acute migraine attack and compared to their levels when pain free.
      The investigators study hypothesis is that the pro inflammatory proteins in the blood will be
      greater than the levels of these proteins when evaluated during a pain free period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years of age, migraine

        Exclusion Criteria:

          -  Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular
             disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal,
             cardiovascular or gastrointestinal diseases
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Condition: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Aminophylline; Placebo
Intervention description: 75 mg of intravenous aminophylline; Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Intervention MeSH terms: Aminophylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; chronic kidney disease; renal failure; lexiscan; aminophylline; SPECT; Myocardial Perfusion Imaging; pharmacologic stress test; Patients with stage IV or V chronic kidney disease being assessed with nuclear stress testing of the heart using the stress agent regadenoson (Lexiscan ®)

Summary:

      The routine administration of 75 mg of intravenous aminophylline in patients with severe
      chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can
      reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients referred to undergo a clinically-indicated regadenoson-stress
             myocardial perfusion imaging at Rush University Medical Center

          -  Stage IV or V chronic kidney disease (GFR < 30, hemodialysis, and/or peritoneal
             dialysis).

        Exclusion Criteria:

          -  Patient refusal to participate

          -  Known allergic reaction to aminophylline.

          -  Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea,
             abdominal discomfort, nausea or vomiting.

          -  Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and
             acute coronary symptoms.

          -  Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12
             months or any seizure in the past week.

          -  Pregnant or breast-feeding women.

          -  Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).