bioihbjkbjnl/mcl2 huggingface dataset:
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Condition: Diabetic Macular Edema; Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Intervention: dexamethasone intravitreal implant; intravitreal bevacizumab
Intervention description: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5); Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Intervention MeSH terms: Dexamethasone; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema; DME; PDR; NPDR; Ozurdex; Dexamethasone; Avastin; Bevacizumab

Summary:

      The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone
      implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant
      diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of NPDR or PDR as confirmed by fluorescein angiography

          -  Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4
             weeks

          -  < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit
             and following treatment with >= 2 intravitreal anti-VEGF injections

          -  Age 18 years or older

          -  ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25
             to 20/800)

          -  Ability to provide written informed consent

          -  Capable of complying with study protocol.

        Exclusion Criteria:

          -  Intraocular injection of steroid medication within prior 3 months

          -  Evidence of significant geographic atrophy on fluorescein angiography in the opinion
             of the treating physician

          -  Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual
             acuity in the opinion of the treating physician

          -  Prior vitrectomy surgery

          -  Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
             extensive dermal) within 1 month prior to day 1.

          -  Known history of IOP elevation in response to steroid treatment in either eye that
             resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid
             injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to
             keep IOP below 21 mm Hg.

          -  Patients who are pregnant.

          -  Unwilling or unable to follow or comply with all study related procedures
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: TDF; Vesatolimod; Placebo
Intervention description: 300 mg tablets administered orally once daily; Tablets administered orally once a week (every 7 days) for 12 doses; Placebo administered orally once a week (every 7 days) for 12 doses
Intervention MeSH terms: Vesatolimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HBV; Hepatitis; Liver Disease

Summary:

      The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
      of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are
      currently not being treated.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adult males or females between the ages of 18-65

          -  Chronic hepatitis B virus (HBV) infection

          -  HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening

        Key Exclusion Criteria:

          -  Extensive bridging fibrosis or cirrhosis

          -  Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators
             or biologics within 3 months of screening

          -  Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or
             hepatitis D virus (HDV)

          -  Chronic liver disease other than HBV

          -  Lactating or pregnant females or those that wish to become pregnant during the course
             of the study

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
2 Regimens of Lactulose for Colonoscopy Preparation in Adults
Condition: Colonoscopy Preparation
Intervention: Full dose preparation; Split dose preparation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bowel Evacuation; Colonoscopy Preparation

Summary:

      The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a
      preparation for colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients requiring bowel evacuation for colonoscopy.

        Exclusion Criteria:

          -  Patients with galactosemia (galactose-sensitive diet).

          -  Patients known to be hypersensitive to any of the components of lactulose for oral
             solution.

          -  Patients with an abnormality on screening blood work or vital sign assessments that,
             in the Investigator's judgment, may pose a significant risk including those pertaining
             to dehydration or electrolyte shifts.

          -  Patients with a history of impaired renal function.

          -  Patients with current or recent history of hypotension, as defined by the
             Investigator.

          -  Patients with a history of long Q-T syndrome.

          -  Patients with a history of a failed bowel preparation.

          -  Patients with severe constipation, defined as those patients taking daily prescription
             or over-the-counter laxatives.

          -  Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic
             colitis, toxic megacolon, ileus or previous colonic surgery.

          -  Patients on lactulose therapy or receiving any treatment for chronic constipation.

          -  Be pregnant or nursing.

          -  Patients with known large polyps or flat polyps (i.e. polyps requiring electrocautery
             or argon plasma coagulation).

          -  Patients less than 18 years of age.

          -  Inability to understand the requirements of the study or be unwilling to provide
             written informed consent (as evidenced by signature on an informed consent document
             approved by an Institutional Review Board [IRB]) and agree to abide by the study
             restrictions.

          -  Be otherwise unsuitable for the study, in the opinion of the Investigator.
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine/naloxone Film Strip; Buprenorphine/naloxone Film Strip
Intervention description: Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route; Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Opioid dependence

Summary:

      This study will evaluate the safety and tolerability on the oral mucosa of
      buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12
      weeks in opioid dependent individuals who are already on a stable regimen of
      buprenorphine/naloxone.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must:

          -  Be 18-to-65 years of age, inclusive.

          -  Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR
             criteria.

          -  Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of
             Suboxone for at least 30 days.

          -  If female, have a negative pregnancy test during screening and agree to use an
             acceptable method of birth control which may include:

        Exclusion Criteria:

        Subjects must not:

          -  Have participated in an experimental drug or device study within the last 30 days.

          -  If female, be breast feeding or lactating.

          -  Have any medical condition that in the opinion of the physician investigator would
             preclude the subject from completing the study.

          -  Have a clinically significant abnormal finding (in the opinion of the Investigator) on
             oral cavity exam (e.g., active mouth ulcers).

          -  Have any piercing of the tongue or mouth within 30 days prior to the first dose of
             study medication.
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab; Placebo
Intervention description: Patients will receive subcutaneous injections of ustekinumab (45 or 90 mg).; Patients in the placebo group will receive placebo medication.
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; CNTO 1275; Ustekinumab; Stelara; Interleukin-12; IL-12; Interleukin-23; IL-23

Summary:

      The purpose of this study is to evaluate the efficacy and safety of initial single and
      multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to
      severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque-type psoriasis at least 6 months

          -  Plaque-type psoriasis covering at least 10% of total body surface areas

          -  Psoriasis area-and-severity index score of 12 or greater

          -  Considered by treating dermatologist to be a candidate for phototherapy or systemic
             treatment of psoriasis

          -  Women of childbearing potential and all men must agree to use adequate birth control
             measures

          -  Have no history of latent or active tuberculosis

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis or drug-induced psoriasis

          -  Women who are pregnant or nursing, or men and women planning pregnancy while enrolled
             in the study

          -  Patients who have a history of chronic or recurrent infectious disease or who have or
             have had a serious infection requiring hospitalization or intravenous antibiotics
             within the previous 2 months

          -  Patients who have or ever have had a nontuberculous mycobacterial infection or
             opportunistic infection

          -  Patients known to be infected with human immunodeficiency virus, hepatitis B, or
             hepatitis C

          -  Patients who have current signs or symptoms of severe, progressive, or uncontrolled
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
             neurologic, cerebral, or psychiatric disease

          -  Have any known malignancy or have a history of malignancy within the previous 5 years
             (with the exception of basal cell carcinoma of the skin that has been treated with no
             evidence of recurrence)
Low Vision Intervention Trial II (LOVIT II)
Condition: Central Vision Loss From Macular Diseases
MeSH terms: Vision, Low
Intervention: Interdisciplinary Low Vision Service; Basic Low Vision Service
Intervention description: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.; Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vision, low

Summary:

      This study will determine if the interdisciplinary team low vision rehabilitation program is
      more effective than basic low vision care provided by an optometrist working alone in
      improving visual reading ability in veterans with macular diseases and best corrected visual
      acuity of 20/50 to 20/200.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary eye diagnosis (better seeing Eye) macular disease

          -  Best-corrected visual acuity (better seeing eye) 20/50-20/200

        Exclusion Criteria:

          -  Does not have a telephone

          -  Does not speak English

          -  Has received interdisciplinary low vision services

          -  English literacy less that 5th grade reading level

          -  Failed TICS

          -  Unable or unwilling to attend required clinic visits

          -  Severe hearing impairment preventing administration of telephone questionnaires

          -  Planned cataract extraction in next 4 months

          -  Visual fields contracted to diameter of 20 degrees in better-seeing eye

          -  Vitreous hemorrhage or serous hemorrhagic detachment of macula

          -  CNVM treated with fewer than 3 anti-VEGF injections

          -  Diabetic macular edema (DME) treated with focal/grid laser within the last two months

          -  DME treated with intravitreal injections of anti-VEGF or intravitreal triamcinolone
             acetonide (IVTA) within the last two months

          -  Cystoid macular edema (CME) treated with topical (non-steroidal anti-inflammatory
             drugs) NSAIDS, topical steroids or IVTA within the last three months
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
Condition: Advanced Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: BKM120
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced endometrial cancer; PI3K pathway; second-line treatment

Summary:

      This is a prospective multi-center, open-label, single arm, Phase II study to investigate the
      safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease
      progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120
      orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a
      fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase
      (PI3K) pathway activation status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

          -  histologically confirmed diagnosis of advanced endometrial carcinoma with available
             tissue specimen for identification of PI3K pathway activation (archival tissue or a
             fixed fresh biopsy)

          -  one prior line of antineoplastic treatment with a cytotoxic agent

          -  objective progression of disease after prior treatment and at least one measurable
             lesion as per RECIST criteria

          -  adequate bone marrow and organ function

        Exclusion Criteria:

          -  previous treatment with PI3K and/or mTOR inhibitors

          -  symptomatic CNS metastases

          -  concurrent malignancy or malignancy within 3 years of study enrollment

          -  Active mood disorder as judged by investigator or medically documented history of mood
             disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive
             disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety

          -  pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study

          -  poorly controlled diabetes mellitus (HbA1c > 8 %)

          -  history of cardiac dysfunction or active cardiac disease as specified in the protocol

          -  impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of BKM120

        Other protocol-defined inclusion/exclusion criteria may apply
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; Peg-IFN-alfa-2a + Ribavirin (Standard Treatment); Placebo
Intervention description: Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.; Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.; Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
Intervention MeSH terms: Ribavirin; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Genotype 2; Genotype 3; Telaprevir

Summary:

      The purpose of this study is to assess the effect of telaprevir on early hepatitis
      (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who
      are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with
             amount of virus in the blood greater than 10,000 international units per milliliter
             (IU/ml)

          -  Participants who were never treated for hepatitis C virus infection

          -  Participants without any significant lab abnormalities

          -  Participants who agree to the use of two effective methods of contraception

          -  Participant who were judged to be in good health

        Exclusion Criteria:

          -  Participants who had contraindications for starting anti-HCV therapy

          -  Participants who had history or evidence of liver cirrhosis (serious liver disorder in
             which connective tissue replaces normal liver tissue, and liver failure often occurs)
             or decompensated liver disease or hepatocellular carcinoma (type of cancer)

          -  Participant infected with human immunodeficiency virus (a life-threatening infection
             that you can get from an infected person's blood or from having sex with an infected
             person) or hepatitis B virus

          -  Females who are pregnant (carrying an unborn baby), planning to be pregnant or
             breastfeeding

          -  Participants who have hypersensitivity to tartrazine
Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Iodofiltic acid I 123
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 510.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is an open-label phase 2 study recruiting low, moderate, and high likelihood ACS
      patients from approximately 60 centers. Patients will be imaged with iodofiltic acid I 123
      for the detection of myocardial ischemia. Readers independent of the clinical study centers
      will review results of imaging studies in a blinded fashion at an imaging core lab. The
      resulting independent reading of the images will be compared against the truth standard for
      ACS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and are willing to comply with protocol requirements

          -  Are 40 years of age or older.

          -  Are being evaluated for possible ACS.

          -  If female, then not of childbearing potential as documented by history or has a
             negative serum or urine pregnancy test within 4 hours prior to receiving the test drug
             and agrees to use an acceptable form of birth control.

        Exclusion Criteria:

          -  <40 years of age.

          -  Females who are pregnant or lactating.

          -  History of left ventricular ejection fraction (LVEF)=40%.

          -  History of MI.

          -  Acute ST segment elevation on ECG.

          -  Left bundle branch block on ECG.

          -  Known history of significant allergy to x-ray contrast media or iodine/iodides.

          -  Currently or formerly on medication that targets fatty acid uptake or metabolism, eg
             ranolazine, (Ranexa).

          -  Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days
             prior to study enrollment.

          -  Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.

          -  Serum creatinine level >2.0 mg per dL.

          -  Received investigational compound and/or medical device within 30 days of admission
             into this study.

          -  Q-wave abnormalities consistent with previous MI