bioihbjkbjnl/mcl2 huggingface dataset:
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Grazoprevir; Placebo to Grazoprevir; Peginterferon alfa-2b (Peg-IFN); Ribavirin (RBV)
Intervention description: Grazoprevir 100 mg tablets once daily for 12 weeks.; Placebo to Grazoprevir once daily for 12 weeks; Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks; Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Grazoprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir
      (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin
      (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3)
      hepatitis C virus (HCV) infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≥ 88 lbs and ≤ 275 lbs

          -  Documented chronic Hepatitis C (CHC) GT2 or GT3 infection

          -  No known cirrhosis

          -  Agrees to use two acceptable methods of birth control during study and through 6
             months after last dose of study drug

          -  Chest X-ray within the last 6 months

          -  Eye exam within the last 6 months

        Exclusion Criteria:

          -  Known to be human immunodeficiency virus (HIV) positive or co-infected with active
             hepatitis B virus (positive for Hepatitis B surface antigen)

          -  Prior approved or investigational treatment for hepatitis C

          -  Evidence of hepatocellular carcinoma

          -  Diabetic and/or high blood pressure with clinically significant eye exam findings

          -  Pre-existing psychiatric condition

          -  Clinical diagnosis of abuse of certain substances within specified timeframes

          -  Known medical condition that could interfere with participation

          -  Active or suspected cancer within the last 5 years

          -  Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs

          -  Male who is planning to impregnate partner or donate sperm

          -  Male with a pregnant female partner

          -  Chronic hepatitis not caused by HCV
Brain Stimulation and Aphasia Treatment
Condition: Aphasia
MeSH terms: Aphasia
Intervention: Activa Dose II Real tDCS; Activa Dose II Sham tDCS
Intervention description: 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions); 20 minutes of sham stimulation per treatment day (15 total sessions)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Aphasia; Brain; Stimulation; Communication; Stoke; Post; Phase II Clinical Trial; Treatment; tDCS; Fridriksson

Summary:

      The purpose of this study is to assess the changes in language processing of patients with
      chronic, post-stroke aphasia following the application of brain stimulation. The brain
      stimulation the investigators administer is called transcranial direct current stimulation
      (tDCS). It involves passing a weak electrical current through the brain between two
      electrodes in the form of damp sponges. One sponge will be placed over a specified area on
      the damaged left hemisphere, while the other sponge will be placed on the right scalp.
      Computer-controlled speech-language treatment will be administered during the application of
      tDCS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be willing and able to give informed consent.

          2. Patients must be willing and able to comply with study requirements.

          3. Patients must be between 25- and 80-years of age.

          4. Patients must be native English speakers.

          5. Patients must be pre-morbidly right-handed.

          6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.

          7. Patients must be greater than 6-months post-stroke.

          8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia
             Battery-Revised.

          9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).

         10. Patients must achieve at least 65% accuracy on naming task during screening -

        Exclusion Criteria:

          1. History of brain surgery

          2. Seizures during the previous 12 months

          3. Sensitive scalp (per patient report)

          4. Able to overtly name more than an average of 140 out of 175 items during the
             pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.

          5. Unable to overtly name at least an average of 5 out of 80 items during the
             pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or
             3.
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture
Intervention: Contrast Ultrasound
Intervention description: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal is to non-invasively study the metabolic processes within the aortic wall that are
      thought to explain progression to clinical manifestations of an aortic aneurysm.

      Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast
      ultrasound, coupled with serum biomarker measurements will allow the identification of the
      vulnerable aortic wall and patients who are at risk of AAA growth or rupture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.

          -  21 years of age or older

          -  ability to give informed consent.

        Exclusion Criteria:

          -  Inability to provide an informed consent

          -  Known allergy to Definity

          -  Unstable cardiopulmonary conditions

          -  pregnancy
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: AGN-199201 ophthalmic solution; AGN-190584 ophthalmic solution; AGN-199201 Vehicle; AGN-190584 Vehicle
Intervention description: 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; 1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.; Vehicle to AGN-199201; Vehicle to AGN-190584
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201
      and AGN-190584 in participants with presbyopia (inability to focus on items close-up).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal vision at distance, either natural or post corneal laser refractive surgery,
             with presbyopia in each eye and complaints of poor near vision that impacts activities
             of daily living

        Exclusion Criteria:

          -  Use of any topical ophthalmic medications, including artificial tears other than the
             study medications during the study

          -  Corneal abnormalities in either eye that interfere with visual acuity

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or
             any intraocular surgery

          -  Diagnosis of glaucoma or ocular hypertension.
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib
Intervention description: Administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to examine the side effects that participants with
      metastatic breast cancer experience when taking abemaciclib with or without food.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

          -  Have all of the following:

               -  Recurrent, locally advanced, unresectable or mBC with disease progression
                  following anti-estrogen therapy.

               -  Prior treatment with chemotherapy for locally advanced or metastatic disease.

               -  No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.

          -  Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.

          -  Have discontinued all previous treatments for cancer and recovered from the acute
             effects of therapy.

          -  Have adequate organ function.

          -  Women of child-bearing potential must have a negative pregnancy test.

          -  Are able to swallow tablets/capsules.

        Exclusion Criteria:

          -  Are currently receiving treatment in a clinical study involving an investigational
             product.

          -  Have a serious concomitant systemic disorder.

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis.

          -  Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic
             activated/reactivated hepatitis A, B, or C.

          -  Have a personal history of syncope of either unexplained or cardiovascular etiology,
             ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.

          -  Have a history of any other cancer.

          -  Had major surgery within 14 days prior to randomization.

          -  Are breastfeeding.

          -  Have received treatment with a drug that has not received regulatory approval for any
             indication within 14 or 21 days of the initial dose of study drug for a
             nonmyelosuppressive or myelosuppressive agent, respectively.
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
Condition: Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Dasatinib; Imatinib Mesylate; Nilotinib
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in
      treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in
      which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature
      blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth
      of cancer cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML)
             (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days
             prior to enrollment)

          -  Clinically significant gastrointestinal disease, digestive dysfunction, or surgery
             that would compromise absorption of oral administration of medications

          -  Able to give written informed consent and comply with all study visits and procedures

        Exclusion Criteria:

          -  Chronic myeloid leukemia (CML) in AP or BP

          -  Unable to receive TKI for insurance reasons (uninsurable)

          -  Refuse or unable to perform telephone or video conferences with research coordinator

          -  Subjects who are pregnant, breast feeding or sexually active and unwilling to use
             effective birth control while on treatment with TKI

          -  Any medical or psychological condition that, in the opinion of the investigator, might
             interfere with the subject's participation in the trial, poses any additional risk for
             the subject, or confounds the assessment of the subject
Irinotecan Study For Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: Irinotecan
Intervention description: An Open Labeled, Single-Arm, Multicentre Phase II Study To Evaluate The Efficacy And Safety Of Weekly Irinotecan (60mg/sqm, D1, 8, 15) Plus Cisplatin (60mg/sqm, D1) As First-Line Chemotherapy For Advanced Or Recurrent Squamous Cell Carcinoma Of The Uterine Cervix
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Weekly Irinotecan(60mg/sqm, D1, 8, 15) in combination with Cisplatin (60mg/sqm, D1), Squamous Cell Carcinoma Of The Uterine Cervix

Summary:

      The purpose of the study is to evaluate the efficacy and safety of Irinotecan plus cisplatin
      as first-line chemotherapy for advanced or recurrent cervical cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented, advanced or recurrent squamous cell carcinoma of uterine
             cervix. Patients may have received concurrent (with radiotherapy) or (neo)adjuvant
             (before or after local treatment) chemotherapy for primary tumor providing that at
             least 6 months have passed from the completion of previous therapy and the diagnosis
             of recurrent disease was documented

          -  Having measurable lesion(s), without previous radiation therapy.

        Exclusion Criteria:

          -  Patients had ever received primary chemotherapy for cervical cancer other than
             mentioned previously (in the inclusion criteria).

          -  Patients ever received cisplatin with total dose > 300 mg/m2 and received radiotherapy
             or local treatment delivered to the target lesion.
Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Cannabidiol 600mg
Intervention description: All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this week-long study is to determine the impact of cannabidiol on cue-induced
      cravings among individuals with opioid use disorder who are stable on sublingual
      buprenorphine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opioid use
             disorder, severe

          -  Currently in treatment with methadone or buprenorphine

        Exclusion Criteria:

          -  Requiring level of care higher than outpatient treatment for alcohol,
             sedative/hypnotics, or stimulants

          -  Any current mood episode requiring level of care higher than outpatient treatment

          -  History of psychotic disorder or bipolar disorder

          -  Currently pregnant

          -  Hepatic liver enzymes greater than 3x upper normal limit

          -  Hypersensitivity to cannabinoids or sesame oil (cannabidiol solution comes in sesame
             oil emulsion)

          -  Currently taking any medications with known significant pharmacokinetic interactions
             with CBD
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Condition: Age-Related Memory Disorders
MeSH terms: Memory Disorders
Intervention: LX6171 High Dose; LX6171 Low Dose; Placebo
Intervention description: A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.; A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.; Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine the safety, tolerability, and effectiveness of 2
      dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment
      (AAMI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 60-80 years old.

          -  Complaints of memory loss in everyday life

          -  Non-smokers or very light smokers (no more than 10 cigarettes/day)

          -  Negative urine screen for drugs of abuse

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  History or evidence of any disease, disorder or injury that could cause cognitive
             deterioration.

          -  Need for medications other than hormone replacement therapy, daily vitamins, or
             over-the-counter pain killers

          -  Clinically significant abnormality on electrocardiogram

          -  History of alcoholism or drug dependence

          -  Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine,
             or Docosahexaenoic acid (DHA)
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: VESANOID; Ipilimumab
Intervention description: All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).; Ipilimumab is current standard of care treatment for melanoma.
Intervention MeSH terms: Ipilimumab; Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Melanoma; Malignant Melanoma

Summary:

      The purpose of this study is to assess the safety and efficacy of combined treatment with
      Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18 year.

          -  Patients diagnosed with advanced melanoma.

          -  Patients that are considered candidates for ipilimumab therapy.

          -  Patients able to understand and willing to sign a written informed consent documents.

          -  Patients willing to have regular blood draws, one before treatment and four during or
             after treatment.

        Exclusion Criteria:

          -  Patients under the age of 18.

          -  Patients with Stage I or II, melanoma who are not candidates for Ipilimumab.

          -  Patients that have received systemic treatments within four weeks prior to the
             beginning of treatment.

          -  Women that are pregnant or nursing.

          -  Patients taking immunosuppressive medications.

          -  Patients with active autoimmune disease.

          -  Patients with known sensitivity to retinoic acid derivatives.

          -  Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
             bilirubin > 2.5 × ULN.