bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Niraparib
Intervention description: Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
Intervention MeSH terms: Niraparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; CRPC; Metastatic castrate-resistant prostate cancer; Prostate neoplasm; Galahad; Niraparib; DNA anomalies; DNA defect; PARP inhibitor; PARPi

Summary:

      The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of
      niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and
      deoxyribonucleic acid (DNA) repair anomalies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed prostate cancer (mixed histology is acceptable, with the
             exception of the small cell pure phenotype, which is excluded)

          -  Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer
             with evidence of disease progression on or after treatment, or discontinued from a
             taxane-based chemotherapy due to an adverse event

          -  Received a second-generation or later androgen receptor (AR)-targeted therapy (for
             example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the
             treatment of metastatic prostate cancer with evidence of disease progression or
             non-metastatic castration-resistant prostate cancer with evidence of subsequent
             metastasis

          -  Biomarker-positive by at least one of the following criteria: (a) Biallelic
             deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or
             tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test
             (somatic local results must be confirmed as positive by the sponsor-validated assay
             before dosing)

          -  Progression of metastatic prostate cancer in the setting of castrate levels of
             testosterone or history of bilateral orchiectomy at study entry

        Exclusion Criteria:

          -  Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP)
             inhibitor

          -  Prior platinum-based chemotherapy for the treatment of prostate cancer

          -  Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid
             leukemia (AML)

          -  Symptomatic or impending cord compression

          -  Symptomatic brain metastases
ELITE: Early Versus Late Intervention Trial With Estradiol
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: 17B-estradiol; Placebo
Intervention description: Oral 17B-estradiol 1 mg daily; Matching oral 17B-estradiol placebo daily
Intervention MeSH terms: Hormones; Estradiol; Estrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 643.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: atherosclerosis; CAD; cardiac computed tomography; cardiovascular disease; carotid artery intima-media thickness; cognitive function; computed tomography; coronary artery calcium; coronary artery disease; coronary artery lesions; CVD; estrogen; estrogen therapy; hormone therapy; postmenopausal; subclinical vascular disease; timing hypothesis; ultrasonography; menopausal hormone replacement therapy; menopause; prevention; intervention

Summary:

      The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the
      progression of early (subclinical) atherosclerosis and cognitive decline in healthy
      postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a serum estradiol level 25 pg/ml or less

          -  No period for 6 months or more

          -  Postmenopausal less than 6 years, OR 10 years or longer

        Exclusion Criteria:

          -  Clinical signs, symptoms, or personal history of cardiovascular disease

          -  Women who have had a hysterectomy only and no oophorectomy (since time from menopause
             cannot be determined)

          -  Diabetes mellitus or fasting serum glucose 140 mg/dL or greater

          -  Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)

          -  Thyroid disease (untreated)

          -  Serum creatinine greater than 2.0 mg/dL

          -  Plasma triglyceride levels greater than 500 mg/dL

          -  Life threatening disease with prognosis less than 5 years

          -  Cirrhosis or liver disease

          -  History of deep vein thrombosis or pulmonary embolism

          -  History of breast cancer

          -  Current hormone replacement therapy (HRT)
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: foretinib (formerly GSK1363089 or XL880)
Intervention description: treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: c-Met; Papillary Renal Cell Carcinoma(PRC); Sporadic papillary renal cell carcinoma,; Clear cell renal carcinoma; Hereditary papillary renal cell carcinoma,

Summary:

      This clinical study is being conducted at multiple sites to determine the best confirmed
      response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell
      carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic
      forms; subjects with either classification will be accepted into this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of PRC with metastatic disease or bilateral
             multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance
             status of </= 2.

          -  Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

        Exclusion Criteria:

          -  Radiation to >/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior
             anti-cancer therapy, received prior treatment with a c-met inhibitor, brain
             metastases,

          -  Any uncontrolled intercurrent illness,

          -  Pregnant or breastfeeding,

          -  HIV positive
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Omega 3 pentaenoic acid; icosapent ethyl
Intervention description: Encapsulated omega-3 pentaenoic acid; Encapsulated omega-3 acid ethyl esters
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ≥18 y of age

          -  Judged to be in generally good health

          -  Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening

          -  Body mass index of ≥20.0 kg/m2

          -  No clinically significant findings in a 12-lead ECG or physical examination

          -  Willing and able to undergo the scheduled study procedures

          -  Understands study procedures and signs forms documenting informed consent to
             participate in the study

        Exclusion Criteria:

          -  Laboratory test result of clinical significance

          -  Uncontrolled hypertension

          -  Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic,
             pulmonary, pancreatic, neurologic, or biliary disorder

          -  History of human immunodeficiency virus, hepatitis B or hepatitis C infection

          -  Used any medication intended to alter the lipid profile within 4 weeks of the first
             qualification visit

          -  Active systemic infection

          -  A condition the Investigator believes would interfere subject ability to provide
             informed consent and/or comply with the study protocol
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Intervention: ClariVein RES; Sodium Tetradecyl Sulfate 1% Injection; Sodium Tetradecyl Sulfate 3% Injection
Intervention description: ClariVein system; Sodium Tetradecyl Sulfate STS 1% Injection; Sodium Tetradecyl Sulfate 3% Injection
Intervention MeSH terms: Sodium Tetradecyl Sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      VICARES is a prospective randomized, controlled, multi-center, double blind study treating
      venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium
      Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient with incompetent saphenous vein

          2. Saphenous vein reflux > 500ms (0.5s), as measured by duplex ultrasound

          3. One or more of patient reported symptoms related to the target vein: i.e., heaviness,
             achiness, swelling, throbbing or itching.

          4. Candidate for endovenous procedure

        Exclusion Criteria:

          1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD)
             that would preclude the wearing of compression stockings

          2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an
             Ankle-Brachial Index (ABI) <0.6

          3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments
             (e.g., femoral and popliteal) in the ipsilateral extremity

          4. Previous surgical or endovenous procedure in the treatment section of the target vein

          5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in
             the treatment section

          6. Pregnant or breastfeeding

          7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)

          8. Known high risk of thrombosis

          9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of
             acute superficial vein thrombus, known hypercoagulable condition, post thrombotic
             syndrome

         10. Known history of anaphylaxis or presence of multiple severe allergies
A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
Condition: Synovial Sarcoma
MeSH terms: Sarcoma; Sarcoma, Synovial
Intervention: ipilimumab
Intervention MeSH terms: Antineoplastic Agents, Immunological; Ipilimumab; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: synovial sarcoma; immunotherapy; cancer-testis antigen; cancer-germ cell antigen; soft tissue sarcoma; SYT-SSX chromosomal translocation

Summary:

      The purpose of this study is to determine whether immune therapy with anti-CTLA-4 antibody is
      effective in people with advanced synovial sarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented synovial sarcoma.

          -  Patients with metastatic disease or locally recurrent disease who have failed or
             refused standard treatment. The disease must be measurable by RECIST.

          -  Expected survival of at least 6 months.

          -  Weight at least 35 kg.

          -  ECOG performance scale 0-2.

          -  At least 3 weeks since major surgery, and at least 3 weeks since completing radiation
             therapy or chemotherapy (6 weeks for patients receiving mitomycin C).

          -  Resolution of toxicity from previous treatment to NCI-CTC grade 1 or less before
             treatment.

          -  Adequate bone marrow, renal and hepatic function.

          -  Able and willing to give valid written informed consent.

        Exclusion Criteria:

          -  Clinically significant heart disease (NYHA Class III or IV).

          -  Other serious illnesses, e.g. serious infections requiring antibiotics or bleeding
             disorders.

          -  History of autoimmune disease.

          -  Serious intercurrent illness, requiring hospitalization.

          -  Patients with a second cancer diagnosis in the last five years, except for basal cell
             carcinoma, completely resected, or cervical carcinoma in situ (CIN), completely
             resected.

          -  Known HIV positivity.

          -  Metastatic disease to the central nervous system for which other therapeutic options,
             including radiotherapy, may be available.

          -  Chronic use of immunosuppressive drugs such as systemic corticosteroids.

          -  Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          -  Lack of availability for immunological and clinical follow-up assessments.

          -  Participation in any other clinical trial involving another investigational agent
             within 3 weeks prior to enrollment.

          -  Pregnancy or breast feeding.

          -  Refusal or inability to use effective means of contraception (all men, and women with
             childbearing potential).
Investigation of Contralateral Arytenoid Sparing IMRT for T1a & T2a Larynx Cancer & Analysis of Post-treatment Laryngeal Function
Condition: Laryngeal Neoplasms
MeSH terms: Laryngeal Neoplasms
Intervention: IMRT Radiation
Intervention description: Radiation to Larynx
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T1a Larynx Cancer; T2a Larynx Cancer

Summary:

      The aim of this study is to define a new treatment technique for T1a larynx cancer that
      maintains excellent local control with less extensive radiation fields. It is thought that
      this will lead to patients having fewer changes to their voice and a higher quality of life
      after treatment when compared to the current standard treatment.
    

Eligibility criteria:

        -  Inclusion Criteria:

               -  Patients with T1a or T2a squamous cell carcinoma of the glottic larynx (tumor
                  limited to one vocal cord with normal cord mobility).

               -  Patients must be able to read and write English to comply with the questionnaire
                  portions of the protocol.

               -  ECOG performance status of 0 or 1.

          -  Exclusion Criteria:

               -  Patients with verrucous or adenocarcinoma

               -  Patients with T1 tumors on both cords (T1b)

               -  Patients with T2b-T4 true larynx tumors

               -  Patients with primary supraglottic tumors that involve the true larynx

               -  Patients with a prior or concurrent malignancy (other than nonmelanoma skin
                  cancer or carcinoma in-situ of the cervix) are ineligible unless the previous
                  cancer was treated 5 years or more prior to the current tumor and the patient has
                  remained continually disease free

               -  Patients who have received prior radiation to the head and neck

               -  Pregnant or breastfeeding women
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Condition: Diabetic Macular Edema; Retina Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: GB-102
Intervention description: Intravitreal injection of GB-102
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-arm design
Masking: None (Open Label)
Masking description: Open-label study design
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Macular Edema

Summary:

      Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety,
      tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels
      of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥ 21 years of age

          -  Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein
             occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent
             (aflibercept, bevacizumab, or ranibizumab)

          -  Demonstrated response to prior anti-VEGF treatment since diagnosis

          -  BCVA of 31 letters or better

        Exclusion Criteria:

          -  History, within 6 months prior to screening, of any of the following: myocardial
             infarction, any cardiac event requiring hospitalization, treatment for acute
             congestive heart failure, transient ischemic attack, or stroke

          -  Uncontrolled hypertension, diabetes mellitus or IOP

          -  Chronic renal disease
Does Guanfacine Attenuate Stress-Induced Drinking?
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: Guanfacine 3mg/day; Guanfacine 1.5mg/day; Placebo
Intervention description: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.; 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcohol; Drinkers; Guanfacine

Summary:

      Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize
      that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed)
      during the 2-hour self-administration period across two laboratory sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-65

          -  Able to read and write English

          -  Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
             current (past 6 months) alcohol abuse or alcohol dependence

        Exclusion Criteria:

          -  Participants with any significant current medical conditions, seizures, delirium or
             hallucinations, or other unstable medical conditions including HIV

          -  Current DSM-IV abuse or dependence on substances, other than alcohol abuse, alcohol
             dependence, or nicotine dependence

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal or evidence of current (past 6-month) mental illness

          -  Meet DSM-IV criteria for current (past-6 month) attention deficit hyperactivity
             disorder (ADHD)

          -  Specific exclusions for administration of guanfacine not already specified include:
             EKG evidence at baseline screening of any clinically significant conduction
             abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker;
             history of fainting, syncopal attacks, heart failure or myocardial infarction, or
             impaired liver as indicated by aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) > 3x normal or renal function (estimated creatinine clearance
             <60 cc/min); treatment with any antihypertensive drug or any alpha-adrenergic blocker;
             use of any central nervous system (CNS) depressant (e.g., phenothiazines,
             barbiturates, benzodiazepines)

          -  Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

          -  Individuals who are seeking treatment for drinking
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel
Intervention description: Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of continued administration
      of paclitaxel given weekly in subjects considered to need to continue treatment after
      completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with
      Advanced Breast Cancer (Protocol No. CA139-371)"
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were confirmed to have a response after receiving at least two courses of
             weekly paclitaxel therapy and considered to need to continue the therapy by the
             investigator/subinvestigator among the patients with advanced or recurrent breast
             cancer who had met the selection criteria and participated in the preceding phase II
             clinical study