bioihbjkbjnl/mcl2 huggingface dataset:
Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: REGN2176-3; Intravitreal Aflibercept Injection (IAI)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 505.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to explore the effect of REGN2176-3 on the Early
      Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in
      participants with neovascular age-related macular degeneration (AMD), compared to
      intravitreal aflibercept injection (IAI) monotherapy.

      The secondary objectives of the study were the following:

        -  To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in
           participants with nAMD compared to IAI monotherapy (at week 12)

        -  To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered
           the same or additional benefit compared to continuous treatment with REGN2176-3. Also to
           determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared
           to continuous treatment with IAI.

        -  To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥50 years of age

          2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as
             determined by the reading center, including juxtafoveal lesions that affect the fovea

          3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the
             screening visit

          4. Provide signed informed consent

        Key Exclusion Criteria:

          1. Any prior treatment with anti-VEGF treatment in the study eye

          2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors

          3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea

          4. Presence of retinal pigment epithelial tears or rips involving the macula in the study
             eye

          5. Prior vitrectomy in the study eye

          6. Any history of macular hole of stage 2 and above in the study eye

          7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye,
             except lid surgery

          8. History of corneal transplant in the study eye

          9. Evidence of diabetic retinopathy or diabetic macular edema in either eye

         10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or
             baseline visit
Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)
Condition: Glucose Homeostasis
Intervention: Placebo; Januvia
Intervention description: 1 tablet 100 mg once a day; 1 tablet 100 mg once a day
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers; GLP-1; Januvia; Sitagliptin

Summary:

      This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a
      naturally occurring hormone) on insulin release and to examine whether there is extra insulin
      release when GLP-1 is not allowed to be rapidly inactivated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hct level of at least 34% for women and 36% for men

          -  Women of non-bearing potential and women of childbearing potential using adequate
             contraception

          -  Serum creatine level of less than 1.7 mg/dl

          -  Four groups:

               -  Age 21-45 (BMI between 18.50-24.99) & (BMI between 30-35)

               -  Age greater than 65 years (BMI between 18.50-24.99) & (BMI between 30-35)

        Exclusion Criteria:

          -  Pregnant and/or lactating females

          -  Women of childbearing potential not willing to use adequate contraception

          -  Hct below inclusion criteria

          -  Serum creatine level greater than 1.8 mg/dl

          -  Age less than 21 and age between 46-64

          -  Diabetes mellitus

          -  BMI less than 18 and BMI greater than 35
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Intervention: Pemigatinib
Intervention description: Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cholangiocarcinoma; fibroblast growth factor (FGF); fibroblast growth factor receptor (FGFR); FGF/FGFR alterations

Summary:

      The purpose of this study is evaluate the efficacy of pemigatinib in subjects with
      advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation
      who have failed at least 1 previous treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed cholangiocarcinoma.

          -  Radiographically measurable or evaluable disease per RECIST v1.1.

          -  Tumor assessment for FGF/FGFR gene alteration status.

          -  Documented disease progression after at least 1 line of prior systemic therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

          -  Life expectancy ≥ 12 weeks.

        Exclusion Criteria:

          -  Prior receipt of a selective FGFR inhibitor.

          -  History of and/or current evidence of ectopic mineralization/calcification, including
             but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
             calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.

          -  Current evidence of clinically significant corneal or retinal disorder confirmed by
             ophthalmologic examination.

          -  Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives,
             whichever is shorter, before the first dose of study drug. Topical ketoconazole will
             be allowed.
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Bevacizumab; Paclitaxel; Carboplatin
Intervention description: Bevacizumab was supplied as a sterile solution for infusion.; Paclitaxel was supplied locally in commercial batches.; Carboplatin was supplied locally in commercial batches.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study evaluated the efficacy and safety of first-line chemotherapy with
      carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with
      epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8
      3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each
      cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an
      area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy,
      bevacizumab could be continued to be given as a monotherapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Female patients, ≥ 18 years of age.

          -  Epithelial ovarian, fallopian tube, or primary peritoneal cancer.

          -  Initial surgery, but no chemotherapy or radiotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

        Exclusion Criteria

          -  Non-epithelial tumors.

          -  Ovarian tumors with low malignant potential.

          -  Previous systemic anti-cancer therapy for ovarian cancer.

          -  History or evidence of synchronous primary endometrial cancer.

          -  Current or recent daily treatment with aspirin (> 325mg/day) or with full dose
             anticoagulant or thrombolytic agents for therapeutic purposes.
Cavitation Ultrasound in Treatment of Patients With PCOS
Condition: PCOS
Intervention: Cavitation US; Metformin; Cavitation US + Metformin
Intervention description: The areas with localized fat are treated 2 times per week for 3 months using Aesthetic cavitation via ultrasonic cavitation machine (Cavi SMART, South Korea, supplied with one piece cavitation probe of 40 KHz, 3-6 watt(W)/cm^2 adjustable, 60W with 20cm^2 active surface).; Metformin hydrochloride (Glucophage 500 mg/tablet, Bristol-Myers Squibb, New York, USA). Medication is initiated in a step-up fashion every 5 days, from one tablet per day to three. This dose is maintained as tolerated throughout the 3 months of the study.; Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin
      or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding
      clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid
      profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese infertile polycystic ovarian syndrome (PCOS) women

        Exclusion Criteria:

          -  Women 40 years or older

          -  Women using fertility treatments, oral contraceptives or other confounding medications
             during the last 3 months

          -  Smokers or with history of general diseases like cardiovascular, liver, kidney or
             respiratory disease, diabetes, uncontrolled hypertension, or malignancy
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
Condition: Diabetes Mellitus
MeSH terms: Proteinuria; Diabetes Mellitus
Intervention: Rosuvastatin; Rosuvastatin; Atorvastatin
Intervention description: 10 mg oral dose administered once daily for 52 weeks; 20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks; 40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperlipidemia; Proteinuria; Diabetes Mellitus

Summary:

      The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor)
      atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes
      with moderate proteinuria and hypercholesterolaemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  hyperlipidemia

          -  urinary protein

          -  diabetes

        Exclusion Criteria:

          -  previous rosuvastatin treatment < 6 months prior to Visit 1

          -  statin intolerance

          -  severe hypertension
Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: bcr-abl peptide vaccine; reverse transcriptase-polymerase chain reaction
Intervention description: Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.; A "baseline" reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a "baseline" circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia

Summary:

      RATIONALE: Vaccines made from a peptide may help the body build an effective immune response
      to kill cancer cells.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
      with chronic phase chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase
             chronic myelogenous leukemia (CML)

               -  In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart

               -  Minimal residual disease

          -  Detectable BCR-ABL transcript levels obtained < 6 months apart AND ≤ 0.5-log lower
             than the lowest value obtained within the past 6 months

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 80-100%

          -  Bilirubin < 2 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN

          -  ALT and AST < 2.5 times ULN

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  No major surgery within the past 4 weeks

          -  No prior chemotherapy

          -  No prior immunosuppressive therapy

          -  No prior corticosteroids

          -  No prior stem cell transplantation

          -  No radiotherapy within the past 4 weeks

          -  No other concurrent investigational agents
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]; Radiation therapy; Mesorectal excision; bevacizumab [Avastin]; 5-fluorouracil; leucovorin
Intervention description: 5 mg/kg intravenously every 2 weeks, 4 cycles; 825 mg/m2 twice daily orally, 38 days; Total dose of 45 Gy over 38 days; 6-8 weeks after completion of neoadjuvant treatment; Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months; Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months; Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months
Intervention MeSH terms: Leucovorin; Bevacizumab; Capecitabine; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus
      Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic
      region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer.
      Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2
      weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy.
      After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of
      the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >=18 years of age

          -  Patients with confirmed rectal cancer who are subject to surgery and would benefit
             from pre-operative combined chemo-radiotherapy

          -  Measurable and/or evaluable lesions according to RECIST criteria

          -  EOCG performance status 0-1

        Exclusion Criteria:

          -  Prior radiotherapy or chemotherapy for rectal cancer

          -  Untreated brain metastases or spinal cord compression or primary brain tumors

          -  Chronic daily treatment with high-dose aspirin (>325 mg/day) or other medications
             known to predispose to gastrointestinal ulceration

          -  Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the
             exception of basal and squamous cell cancer, or cervical cancer in situ.
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Condition: Primary Open-angle Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-117 Ophthalmic Solution QD; DE-117 Ophthalmic Solution BID
Intervention description: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye; DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed
      with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their
      current topical IOP lowering medication(s), if any. After completing the required washout
      period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility
      criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up
      to 6 weeks.

      Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

        -  DE-117 ophthalmic solution 0.002% QD (Once Daily)

        -  DE-117 ophthalmic solution 0.002% BID (Twice Daily)

      This study will consist of a screening period of up to 35 days including a washout period of
      up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

        Provide signed written informed consent

          -  Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with
             OHT.

          -  Qualifying corrected visual acuity in each eye

          -  Qualifying central corneal thickness in each eye

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes

          -  Qualifying Anterior chamber angle

        Exclusion Criteria:

          -  History of ocular surgery specifically intended to lower IOP

          -  Subjects who cannot safely discontinue use of ocular hypotensive medications during
             the wait/washout period

          -  Advanced glaucoma in either eye

          -  Any corneal abnormality or other condition interfering with or preventing reliable
             Goldmann applanation tonometry

          -  Any ocular surgery or ocular laser treatment within 180 days prior to Screening and
             throughout the study in either eye

          -  Females who are pregnant, nursing, or planning a pregnancy
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate
Intervention description: Telotristat etiprate capsules orally three times daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and tolerability of orally administered
      telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, aged 18 and older

          -  Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with
             disease extent confirmed by computed tomography (CT), magnetic resonance imaging
             (MRI), or radionuclide imaging

          -  Symptomatic carcinoid syndrome (≥4 bowel movements per day)

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  ≥ 12 high-volume, watery bowel movements per day

          -  Sponsor-unacceptable clinical laboratory values for hematology and liver function
             tests at screening

          -  Karnofsky status ≤70% - unable to care for self

          -  Surgery within 60 days prior to screening

          -  A history of short bowel syndrome

          -  Life expectancy < 12 months

          -  History of substance or alcohol abuse within 2 years prior to screening

          -  Administration of any investigational drug within 30 days of screening or any
             therapeutic protein or antibody within 90 days of screening