bioihbjkbjnl/mcl2 huggingface dataset:
An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD
Condition: Age Related Macular Degeneration (AMD); Macular Degeneration; Choroidal Neovascularization (CNV)
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Pegaptanib Sodium 0.3 mg
Intervention description: Pegaptanib Sodium dosed every 6 weeks in affected eye.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: neovascular age related macular degeneration; choroidal neovascularization

Summary:

      The purpose of this study is to determine the benefits of treating subjects with neovascular
      age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization
      (CNV) as compared to those with established CNV. Additionally, the study would like to
      determine the efficacy of Macugen in preserving visual function in those subjects having CNV
      secondary to neovascular AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of neovascular AMD in at least one eye. In subjects with bilateral
             neovascular AMD, only one eye would be eligible for enrollment

          -  Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS
             letters in the study eye

        Exclusion Criteria:

          -  Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin,
             thermal laser photocoagulation, external beam radiation or transpupillary
             thermotherapy to the study eye

          -  Subjects having subfoveal fibrosis/ scar or atrophy representing > 25% of the total
             lesion size
Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks
Condition: Hip Arthroplasty; Hip Pain
Intervention: 0.1% Ropivacaine; 0.4% Ropivacaine
Intervention description: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h); Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postoperative pain; perineural catheter; continuous peripheral nerve block; posterior lumbar plexus; hip surgery; psoas compartment; postoperative analgesia

Summary:

      This is a research study to determine if the concentration of local anesthetic through a
      catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle
      strength and sense of touch experienced after surgery. This study is looking at the varying
      concentrations of local anesthetic placed through the catheter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary, unilateral hip arthroplasty

          -  age greater than or equal to 18 years

          -  postoperative analgesic plan includes perineural local anesthetic infusion

        Exclusion Criteria:

          -  morbid obesity as defined by a body mass index greater than 40

          -  chronic high dose opioid use

          -  history of opioid abuse

          -  neuro-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle

          -  vulnerable populations i.e., children, pregnant women, or prisoners
Sitagliptin and Glucagon Counterregulation
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin 100 mg daily; Placebo one tablet daily
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 65 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at
      moderate hypoglycemia in metformin-treated subjects with T2DM
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written consent has been given.

          2. Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the
             preceding 3 months)

          3. Age >65 years.

          4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.

          5. Ability to complete the study

        Exclusion Criteria:

          1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.

          2. Type 2 diabetes, positive GAD antibodies

          3. eGFR <60 ml/min

          4. Acute infections which may affect blood glucose control within 4 weeks prior to visit
             1

          5. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.

          6. Liver disease such as cirrhosis or chronic active hepatitis

          7. History of coronary heart disease or heart failure class III or IV

          8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at
             least one unit of blood within the past 2 weeks or a blood transfusion within the past
             8 weeks.

          9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment
             (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.

         10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable
             for the study
A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; QVA149 Placebo
Intervention description: Delivered once daily via single-dose dry powder inhaler; Placebo delivered once daily via single-dose dry powder inhaler
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; QVA149; nocturnal oxygen levels; combination bronchodilator

Summary:

      The purpose of this study was to determine whether a fixed dose combination of indacaterol
      and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic
      Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a
             post-bronchodilator FEV1/FVC <0.70

          -  Patients with a post-bronchodilator FEV1 ≥30% and <60% of the predicted normal value

          -  Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2

          -  Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes
             a day for 10 years, or 10 cigarettes a day for 20 years)

        Exclusion Criteria:

          -  An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or
             glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to
             screening or during the run-in period

          -  Diagnosed asthma

          -  Patients receiving regular long term oxygen therapy (LTOT)

          -  Ongoing / planned rehabilitation during the study period

          -  Three or more awakenings during the night leading to toilet visit or other reasons for
             exiting the bed during the last week prior to the screening visit due to non-COPD
             reasons

        Other protocol-defined inclusion/exclusion criteria may apply.
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Condition: Type-2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LAF237 (vildagliptin); Metformin
Intervention description: Vildagliptin 50mg capsule; Metformin maximum tolerance dose
Intervention MeSH terms: Metformin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: type-2 diabetes mellitus, inadequately controlled Metformin

Summary:

      The purpose of this study was to observe change of HbA1c over time from baseline to month 12.
      The ultimate goal of this study was to provide a local reference value to the physicians &
      patients in the future when they consider initiating Vildagliptin and taking balance between
      efficacy, compliance, risk factors, convenience and medication cost.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female in age ≥18 at Visit 1

          2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin
             for more than 3 months

          3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%

          4. With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient
             reached his/her maximum tolerated dose of Metformin

        Key Exclusion Criteria:

          1. Patients with hepatic impairment, including patients with a pre-treatment alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of
             normal at Visit 1

          2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on
             haemodialysis at the time of enrolment

          3. Patients with hereditary problems of galactose intolerance, the Lapp lactose
             deficiency or glucose-galactose malabsorption

          4. Pregnant women or breastfeeding women at the time of enrolment

          5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past
             for T2DM treatment
Tetra-NIRS Clinical Study
Condition: Lower Urinary Tract Symptoms; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms
Intervention: Urodynamics + TETRA - NIRS
Intervention description: Urodynamics will be performed as per standard of care for patients enrolled, whereby one catheter is inserted into the bladder and one in the rectum to analyze bladder filling, storage and voiding conditions via pressures measured and urine flow rates detected by a uroflowmeter. Tetra-NIRS will be concurrently performed where Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome. A patch is applied externally to measure these changes in the detrusor muscle of the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified a correlation between the changes in haemoglobin and cytochrome and the pressure values obtained during urodynamics procedures.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LUTS; OAB

Summary:

      The purpose of this evaluation is to validate the previous clinical study results using a
      Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS)
      testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS
      equipment.

      The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to
      enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic
      procedure).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The selection of subjects enrolled for testing must meet the following criteria:

               -  Subjects must be 18 years of age or older.

               -  Subjects are patients of one of the institutions and are currently scheduled for
                  UDS

               -  Male subjects must have LUTS

               -  Female subjects must have OAB

               -  Subjects must give their informed consent prior to enrolment.

        Exclusion Criteria:

          -  The patient has an existing health condition which the investigators feel will not
             allow for safe or accurate measurements with the Tetra-NIRS device.
Assessment of Gait After Dysport Treatment
Condition: Equinovarus; Acquired
MeSH terms: Clubfoot
Intervention: Dysport
Intervention description: Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.
Intervention MeSH terms: abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This pilot study will aim to understand the potential benefit of the assessment of walking
      using video slow motion for muscle selection and the development of an image catalogue guide
      of the potential results of injection of abobotulinumtoxinA by comparing foot postures before
      and after injection. The objective is to evaluate the use of video assessment to improve
      muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary
      outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of
      walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale
      (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with
      equinovarus foot deformity who are able to ambulate will be included in the study. Dysport
      1000 to 1500 units will be used to be distributed on the basis of clinical indication to
      ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors.
      The duration of subjects' participation is 4-6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed and dated informed consent form

          -  Willing to comply with all study procedures and be available for the duration of the
             study

          -  Male or female, aged ≥ 18

          -  Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or
             non-naïve)

          -  Modified Ashworth Scale between 1 to 3

          -  Women of reproductive potential must use effective contraception for the duration of
             the study

        Exclusion Criteria:

          -  Inability to walk without leg brace

          -  Previous surgical intervention to affected/ankle/foot

          -  Uncontrolled seizures

          -  Pregnancy or lactation

          -  Known allergic reactions to Dysport

          -  Treatment with another investigational drug or other intervention in the past 4 months

          -  Modified Ashworth Scale 4

          -  Anything that would place the individual at increased risk or preclude the
             individual's full compliance with or completion of the study

          -  Lower motor neuron disorder

          -  < Four months post botulinum toxin or serial casting
The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
Condition: Atherosclerosis; Coronary Artery Disease
MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis
Intervention: Atorvastatin 20mg; Atorvastatin 20 mg + Pioglitazone 30 mg
Intervention description: 20 mg QD for 3 months; atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
Intervention MeSH terms: Pioglitazone; Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atherosclerosis; Pioglitazone; Atorvastatin; PET CT

Summary:

      This study is a prospective randomized clinical trial and to compare the antiinflammatory
      effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy
      in carotid arteries of stable and unstable angina patients by PET/CT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject who has undergone percutaneous coronary intervention due to coronary
             artery disease ( stable angina or unstable angina)

          -  The subject described above who has atherosclerotic plaque in his/her carotid artery
             by carotid ultrasonography

          -  The subject who or a legal representative agrees to the clinical trial and gives
             written permission to the IRB-approved form.

        Exclusion Criteria:

          -  The subjets who have taken statins or thiazolidinedione with 4 weeks

          -  Marked elevated liver enzyme ( more than 2.5 fold compared to reference range)

          -  Renal insufficiency patients ( serum creatinine more than 2 mg/dl)

          -  Congestive heart failure ( NYHA class 2-4)

          -  Acue myocardial infarction

          -  Unstable angina with ST segment deviation

          -  Pregnancy

          -  The subjects enrolled in another studies
A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Placebo; Fesoterodine fumarate
Intervention description: placebo administered orally in the morning or evening.; Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 794.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Overactive bladder syndrome; fesoterodine; elderly; flexible dose regimen; urgency; frequency; urge urinary incontinence; anticholinergic; antimuscarinic

Summary:

      The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at
      unwanted times and has been shown to help patients with overactive bladder syndrome pass
      urine less frequently than before treatment. It is postulated that this drug will also prove
      effective in elderly patients (aged > 65 years) and that the ability to change dose between 4
      and 8mg will allow each patient to have an optimised treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥65 years old.

          -  Overactive bladder symptoms for at least 3 months prior to study start.

          -  Eight or more micturitions per 24 hours as confirmed by diary records

        Exclusion Criteria:

          -  Predominant Stress Urinary Incontinence

          -  Active or recurrent bladder infections

          -  Other bladder and genital conditions that could be the predominant cause of symptoms
             or interfere with treatment assessment and success.
Primovist / Eovist in Renally Impaired Patients
Condition: Contrast Media
Intervention: Gadoxetic acid disodium (Primovist, BAY86-4873)
Intervention description: Primovist/Eovist in approved indications at approved dosages
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nephrogenic Systemic Fibrosis (NSF); Primovist / Eovist

Summary:

      Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging
      (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to
      participate.

      The administration of contrast agents that contain gadolinium such as Primovist/Eovist might
      increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis
      (NSF) in patients with renal impairment. This study is to assess the potential risk to
      develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

      Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan
      which was prescribed by the referring doctor. After the MRI scan the patient will be included
      in a two year follow-up period to assess if signs or symptoms suggestive of NSF have
      appeared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of
             the liver with Primovist/Eovist based on careful risk/benefit evaluation at the
             recommended dose in one of the approved indications

          -  Patient must fulfill criteria for moderate (Estimated glomerular filtration rate
             [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal
             impairment.

        Exclusion Criteria:

          -  Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for
             any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to
             administration of Primovist/Eovist

          -  History of existing NSF