bioihbjkbjnl/mcl2 huggingface dataset:
Primary Tube Versus Trabeculectomy Study
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Tube shunt surgery; Trabeculectomy; Mitomycin C
Intervention description: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.; The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.; A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Tube shunt surgery; Trabeculectomy

Summary:

      The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the
      long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with
      mitomycin C in eyes that have not had previous ocular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-85 years

          -  Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular
             Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg

          -  No previous incisional ocular surgery

        Exclusion Criteria:

          -  Unwilling or unable to give consent, unwilling to accept randomization, or unable to
             return for scheduled protocol visits

          -  Pregnant or nursing women

          -  No light perception vision

          -  Active iris neovascularization or active proliferative retinopathy

          -  Iridocorneal endothelial syndrome

          -  Epithelial or fibrous ingrowth

          -  Chronic or recurrent uveitis

          -  Steroid-induced glaucoma

          -  Severe posterior blepharitis

          -  Unwilling to discontinue contact lens use after surgery

          -  Previous cyclodestructive procedure

          -  Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a
             superior trabeculectomy

          -  Functionally significant cataract

          -  Need for glaucoma surgery combined with other ocular procedures or anticipated need
             for additional ocular surgery
Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol
Condition: Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension
Intervention: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Intervention MeSH terms: Timolol; Travoprost
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; IOP

Summary:

      The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering
      efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with
      open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary
             glaucoma;

          -  Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least
             one eye (designated as the study eye);

          -  On a stable medication regimen for IOP reduction one week prior to the screening
             visit;

          -  Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;

          -  Sign informed consent;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known medical history of allergy, hypersensitivity or low tolerance to any of the
             components of DuoTrav®;

          -  Any abnormality that would preclude the reliable performance of applanation tonometry
             in either eye;

          -  Infection in either eye;

          -  Conventional or laser intraocular surgery in either eye 3 months prior to screening
             visit;

          -  Risk for visual field or visual acuity worsening, in the opinion of the investigator;

          -  Women of childbearing potential;

          -  Pregnant or lactating women;

          -  Any condition that, in the opinion of the principal investigator, could interfere with
             participation in the study, or that could present a risk to the participant.

          -  Participation in another clinical study within 30 days before the screening visit;

          -  Other protocol-defined exclusion criteria may apply.
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
Condition: Patient Comfort and Safety
Intervention: Iodixanol; Iopamidol
Intervention description: Iodixanol 320 mg I/mL as a single iv. administration.; Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Safety

Summary:

      The purpose of this study is to evaluate and compare overall patient comfort profile between
      the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast
      media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed
      Tomographic (CECT) imaging of the abdomen/pelvis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is over 18 years old.

          -  Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their
             routine clinical care.

        Exclusion Criteria:

          -  The subject has known allergies to iodine or any prior history of adverse reaction to
             iodinated CM.

          -  The subject received another administration of CM within 24 hours prior to baseline or
             is scheduled to receive one within the 24 hour follow-up period.

          -  The subject is pregnant.

          -  The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to
             discontinue at the time of the study procedure.

          -  The subject manifests thyrotoxicosis or is on dialysis.
Organic Cation Transporter 1 (OCT1), on Response to Metformin in Healthy Subjects
Condition: Other Conditions That May Be A Focus of Clinical Attention
Intervention: Metformin
Intervention description: 2 doses of Metformin Day 1 1000mg, Day 2 850 mg
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy controls

Summary:

      Specific Objectives:

        -  To determine if individuals who carry a decreased or non-functional variant of OCT1
           exhibit differences in the pharmacokinetics of metformin in comparison to individuals
           who carry the common allele.

        -  To determine if individuals who carry the decreased or non-functional variants exhibit
           differences in the response to metformin in comparison to individuals who carry the
           common allele.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in the Study Of Pharmacogenetics In Ethnically Diverse
             Populations (SOPHIE) study.

          -  Between the ages of 18 and 40.

          -  Possess a specific OCT1 genotype.

        Exclusion Criteria:

          -  Taking any medications other than vitamins

          -  Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to
             higher than double the respective normal value, or elevated creatinine concentrations
             (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)

          -  Pregnant at time of study.
Reducing Intracranial atheroSclErosis With Repatha
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Intracranial Arteriosclerosis; Atherosclerosis
Intervention: Repatha
Intervention description: 140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Intracranial Atherosclerosis

Summary:

      The purpose of this study will be to understand the underlying mechanism by which PCSK9
      inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its
      FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled
      almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The
      investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing
      atherosclerotic plaque, which would be particularly beneficial for patients with intracranial
      atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age

          -  History of ischemic stroke, defined as an episode of neurological dysfunction caused
             by focal cerebral, spinal, or retinal infarction (American Heart Association
             definition).

          -  Large vessel atherosclerosis of an intracranial artery in the circle of Willis with
             50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter
             normal]) x 100%) on MRA, CTA or DSA

             ------ Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA,
             ACA (A1)

          -  Current statin use or contraindication to statin

          -  Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) > 30 mg/ dL

        Exclusion Criteria:

        Gadolinium or PCSK9 inhibitor allergy

          -  Acute or chronic kidney disease with eGFR<30 ml/min/1.73m2

          -  Pacemaker or other MRI contraindications per American College of Radiology guidelines

          -  Inability to return for 78 week follow-up clinic visit and vwMRI
The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Intervention: Exenatide; Metformin
Intervention description: exenatide 10 mcg twice daily; metformin 500 twice daily
Intervention MeSH terms: Metformin; Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of exenatide versus metformin on vascular
      health with chronic (3-month) therapy and during a 2-hour period following a meal in patients
      with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater
      degree compared to metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to 18 years old

          -  Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose
             >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated
             glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%

          -  Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)

          -  Stable cardiovascular medication regimen (or other medications known to affect
             endothelial function) at least 1 month prior to enrollment and throughout the study

        Exclusion Criteria:

          -  Type 2 diabetes

          -  Current use of glycemic control medications within one month of randomization

          -  Fasting glucose >126 mg/dL

          -  Current use of weight loss medication

          -  Previous weight loss surgery

          -  History of severe gastrointestinal disease

          -  Standard clinical contraindications to exenatide or metformin therapy

          -  Unstable angina

          -  Heart failure

          -  Stroke or coronary artery bypass graft within 3 months of screening

          -  Women who are currently pregnant or planning to become pregnant

          -  Breastfeeding women

          -  Clinically significant liver disease

          -  Creatinine > 1.5 mg/dL

          -  Hepatic function greater than 3 times upper limit of normal

          -  Patients who are mentally incompetent and cannot sign a Patient Informed Consent
A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: quetiapine fumarate; risperidone
Intervention description: flexible dose oral; flexible dose oral
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1098.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective Disorder

Summary:

      This Phase IV, randomized, parallel-group study is designed to evaluate the cataractogenic
      potential of quetiapine fumarate (SEROQUEL) compared with that of a putative
      non-cataractogenic antipsychotic medication risperidone (RISPERDAL). This study is being
      conducted to fulfill the SEROQUEL Phase IV commitment regarding evaluation of cataractogenic
      potential.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18 to 65

          -  Both Eyes present with lenses intact (no previous cataract extractions)

          -  Stable place of residency

        Exclusion Criteria:

          -  History of corneal surgery

          -  Legal blindness (defined as best corrected visual acuity of 20/200 or worse in one or
             both eyes

          -  Previous participation in this study
OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
Condition: Colorectal Cancer
MeSH terms: Neoplasm Metastasis; Colonic Neoplasms
Intervention: bevacizumab [Avastin]; Oxaliplatin; Xeloda
Intervention description: 7.5mg iv on day 1 of each 3 week cycle; 130mg/m2 iv on day 1 of each 3 week cycle; 1000mg/m2 po bid on days 1-14 of each 3 week cycle
Intervention MeSH terms: Bevacizumab; Oxaliplatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of a first-line regimen of
      Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or
      rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on
      day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14,
      for a maximum of 6 months. Patients with stable disease or complete or partial response may
      continue on Avastin therapy. The anticipated time on study treatment is until disease
      progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  locally advanced or metastatic colorectal cancer;

          -  no previous treatment with chemotherapy for metastatic disease;

          -  at least one measurable lesion.

        Exclusion Criteria:

          -  radiotherapy to any site within 4 weeks before study;

          -  untreated brain metastases or primary brain tumors;

          -  clinically significant cardiovascular disease;

          -  chronic daily treatment with high dose aspirin (>325 mg/day);

          -  other co-existing malignancies or malignancies diagnosed within last 5 years.
Early Mobilization Following Mini-Open Rotator Cuff Repair
Condition: Full Thickness Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Intervention: Sling; No sling
Intervention description: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.; Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: rotator cuff tear; arthroscopically assisted; health related quality of life(HRQL); functional outcome

Summary:

      The primary objective of this study is to determine if early active range of motion after
      mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6
      weeks and 3 months after surgery. The secondary objective of this study is to determine if
      early mobilization improves disease-specific quality of life and promotes earlier return to
      work/function.

      Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of
      range of motion, improved disease specific quality of life and earlier return to
      work/function if allowed to begin early active range of motion compared to subjects who are
      immobilized in a sling for 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical:

          -  males and females over 18 years of age

          -  failed non-operative management defined as persistent pain and/or disability following
             3 months of conservative medical treatment including analgesic/anti-inflammatory
             medications, intra-articular corticosteroids, activity modification and physical
             therapy.

        Radiological:

          -  confirmed full-thickness rotator cuff tear on arthrogram or MRI

        Surgical:

          -  full-thickness tear of the rotator cuff confirmed through arthroscopy

          -  rotator cuff repairable using mini-open approach

        Exclusion Criteria:

          -  previous shoulder surgery

          -  previous fracture of scapula or humerus

          -  history of charcot joint or inflammatory arthropathy

          -  cervical radiculopathy

          -  active joint or systemic infection

          -  neurological disorder

          -  significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature

          -  major medical illness (life expectancy less than 2 years or unacceptably high
             operative risk)

          -  unable to speak or read English

          -  immunosuppressive therapy or chronic steroids (eg. prednisone)

          -  patient unwilling to be followed for 2 years

          -  psychiatric illness that precludes informed consent
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]
Intervention description: 90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a long-term post-treatment follow-up to study WV19432, which evaluated the
      efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B
      (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to
      enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent for Study WV19432

          -  Patients who have completed treatment and follow-up on study WV19432

        Exclusion Criteria:

          -  As for Study WV19432
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic
Intervention: hepatitis, alcohol, probiotics; alcohol, hepatitis, Placebo
Intervention description: 7 days of probiotics (1500 mg/day); Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
Intervention MeSH terms: Ethanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hepatitis, alcohol

Summary:

      Background/Aims:

      The investigators explored the therapeutic effects of probiotics in patients with AH.

      Methods:

      Between September 2010 and April 2012, the investigators conducted a 7-day,
      double-controlled, randomized, prospective clinical trial comparing the efficacy of
      probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an
      aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 and elevated AST (ALT)
      level with an alcohol consumption history within 48 hours. Patients were randomized to
      receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified
      Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and
      again after therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alcoholic Hepatitis

        Exclusion Criteria:

          -  Cancer

          -  Viral Hepatitis, other Hepatitis