bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: MK-6213; Atorvastatin calcium; Placebo for MK-6312 160 mg; Placebo for Atorvastatin 20 mg
Intervention description: MK-6213 160 mg for 4 weeks.; atorvastatin calcium 20mg for 4 weeks.
Intervention MeSH terms: Atorvastatin; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to
      MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 75 years of age at the time of the study with high cholesterol

          -  Can have diabetes mellitus but is not currently on lipid lowering therapy

          -  Have a stable weight for >6 weeks

        Exclusion Criteria:

          -  Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system),
             respiratory (lung), hepatic (liver) or metabolic disease

          -  history of mental instability or drug/alcohol abuse within the past 5 years

          -  Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer
             within the past 5 years or participation in an investigational trial within the last
             30 days
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Condition: Cancer
MeSH terms: Neoplasm Metastasis
Intervention: Bone scan; 99mTc-methyl diphosphonate; Positron Emission Tomography (PET) scan; 18F-Fludeoxyglucose (18F-FDG); Computed Tomography (CT) scan; 18F-Sodium Fluoride (18F-NaF); Whole Body Magnetic Resonance Imaging (WB-MRI) scan; Gadopentetate dimeglumine; Gadofosveset; Gadobutrol
Intervention description: Scan to diagnose a number of bone conditions including cancer or metastasis; Radiolabel for bone scan procedures; Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F; Radiolabel for positron emission tomography scan procedures; Scan to detect & analyze X-rays; Radiolabel for CT and PET scans, & as a contrast agent for MRI scans.; Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields & radio waves to generate images of the organs in the body.; A gadolinium-based contrast agent for MRI; A gadolinium-based contrast agent for MRI; A gadolinium-based contrast agent for MRI
Intervention MeSH terms: Diphosphonates; Methylene diphosphonate; Listerine; Deoxyglucose; Fluorides; Sodium Fluoride; Fluorodeoxyglucose F18; Technetium Tc 99m Medronate
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F)
      fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance
      imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or
      stage II-IV prostate cancer.
    

Eligibility criteria:

        All patients were enrolled after receiving a regular medical care bone scan using the
        radiolabel 99mTc-methyl diphosphonate (t99-MDP).

        INCLUSION CRITERIA

          -  ≥ 18 years old at the time of the drug administration

          -  ≥ Stage 3 breast cancer OR ≥ stage 2 prostate cancer OR prostate-specific antigen
             (PSA) > 10 micrograms/L OR recurrent breast or prostate cancer

          -  Capable of complying with study procedures

          -  Able to remain still for duration of imaging procedure (about one hour)

          -  Written informed consent

        EXCLUSION CRITERIA

          -  Pregnant or nursing

          -  Metallic implants that contraindicate MRI

          -  Renal function impairment that contraindicates MRI
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Olaparib
Intervention description: Participants will receive capsules of olaparib orally as stated in arm description.
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced breast cancer; Poly(ADP ribose) polymerases; AZD2281,KU-0059436 (olaparib); BRCA1 protein; BRCA2 protein

Summary:

      The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well
      tolerated in treating participants with measurable breast cancer gene (BRCA)1- or
      BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced breast cancer with positive BRCA1 or BRCA2 status

          -  Failed at least one prior chemotherapy

          -  In investigators opinion, no curative standard therapy exists

          -  Measurable disease

        Exclusion Criteria:

          -  Brain metastases

          -  Less than 28 days since last treatment used to treat the disease

          -  Considered a poor medical risk due to a serious uncontrolled disorder
Hypofractionated Radiation Therapy in Treating Participants With Breast Cancer Before Surgery
Condition: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8
MeSH terms: Breast Neoplasms
Intervention: Hypofractionated Radiation Therapy
Intervention description: Undergo hypofractionated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well hypofractionated radiation therapy works in treating
      participants with breast cancer before surgery. Hypofractionated radiation therapy delivers
      higher doses of radiation therapy over a shorter period of time and may kill more tumor cells
      and have fewer side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of breast cancer

          -  Clinical stage T0-T2 N0 M0

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

          -  Able to and provides Institutional Review Board (IRB) approved study specific written
             informed consent

          -  Study entry must be within 120 days of last biopsy (breast)

          -  Able to complete all mandatory tests

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Planned breast surgery and indications for whole breast radiotherapy

        Exclusion Criteria:

          -  Medical contraindication to receipt of radiotherapy

          -  Severe active co-morbid systemic illnesses or other severe concurrent disease which,
             in the judgment of the investigator, would make the patient inappropriate for entry
             into this study or interfere significantly with the proper assessment of safety and
             toxicity of the prescribed regimens

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements or providing informed consent

          -  Active systemic lupus or scleroderma

          -  Pregnancy

          -  Women of childbearing potential who are unwilling to employ adequate contraception

          -  Prior receipt of ipsilateral breast or chest wall radiation

          -  Recurrent breast cancer

          -  Indications for comprehensive regional nodal irradiation

          -  No neo-adjuvant therapy
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Condition: Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Intervention: Exenatide SR
Intervention description: Exenatide SR 2 mg subcutaneous (SQ) weekly
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Transplant

Summary:

      Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is
      well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's
      effective in preventing diabetes.
    

Eligibility criteria:

        Inclusion criteria:

          -  Recipients of solitary kidney transplants (i.e. not combined liver-kidney,
             pancreas-kidney etc.)

          -  At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl;
             or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%)

        Exclusion criteria:

          -  Diabetes pre-transplantation

          -  Diabetes at 4 months

          -  <18 years of age

          -  eGFR <30 ml/min (estimated by MDRD equation from serum creatinine)

          -  Active acute cellular rejection including borderline (If treated and resolved, these
             patients can be included)

          -  BK nephropathy active

          -  History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver
             cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary
             thyroid cancer

          -  Pregnant or breastfeeding women. Female Subject must be either:

               -  Of non-child bearing potential: Post-menopausal (defined as at least 1 year
                  without any menses) prior to screening , or documented surgically sterile or
                  status post-hysterectomy

               -  Or if childbearing potential, agree not to try and become pregnant during the
                  study for at least 90 days after the final study drug administration. And have a
                  negative serum or urine pregnancy test. And if heterosexually active, agree to
                  consistently use two forms of highly effective birth control.

          -  Hypersensitivity to Exenatide
Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: EC-17
Intervention description: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer

Summary:

      Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete
      surgical resection, also known as a R0 resection. At present, the ability to perform a
      complete resection with negative margins is limited by the surgeon's ability to palpate and
      visualize the tumor and its margins. Therefore, in order to reduce operative morbidity and
      costs while maintaining or improving surgical and oncologic outcomes, the investigators must
      develop technologies that improve visualization of the primary tumor and occult metastases,
      real time, during surgery. Recent research has demonstrated that the use of fluorescent
      probes that recognize cancer specific antigens can be used for this purpose when visualized
      using a prototype near-infrared multispectral imaging system.

      This investigation will determine if folate-FITC, a fluorescent probe that recognizes the
      folate receptor (present in > 90% of ovarian cancers) can facilitate surgical resection and
      detect tumor nodules not visible to the naked eye.
    

Eligibility criteria:

        Inclusion Criteria:

        Women who are:

          -  Diagnosed with or at high clinical suspicion of primary ovarian cancer by either
             radiologic imaging or physical examination or biopsy or serum tumor markers

          -  Scheduled to undergo surgical cytoreduction via laparotomy

          -  At least 18 years of age

          -  Capable and willing to provide informed consent

        Exclusion Criteria:

        Women with:

          -  Known sarcomatous histologies

          -  Recurrent ovarian cancer

          -  Planned surgical approach via laparoscopy or robotic surgery

          -  A history of anaphylactic reactions to Folate-FITC or insects

          -  Inability or unwillingness to provide informed consent
Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
Condition: Cardiac Iron Overload
MeSH terms: Iron Overload
Intervention: Deferasirox and Deferoxamine
Intervention MeSH terms: Deferasirox; Deferoxamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Cardiac iron overload,; deferasirox,; deferoxamine

Summary:

      This study will evaluate the efficacy and safety of deferasirox in combination with
      deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to
      chronic blood transfusions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with β-thalassemia major or Diamond-Blackfan anemia (DBA) or congenital
             sideroblastic anemia on chronic transfusion therapy

          -  Myocardial T2* value that is ≥ 5 and < 10 ms

          -  Left ventricular ejection fraction (LVEF) ≥ 56% as determined by Magnetic resonance
             imaging (MRI)

          -  Liver Iron Concentration (LIC) ≥ 7 mg Fe /g dw as determined by R2 MRI.

          -  Lifetime history of at least 50 units of red blood cell transfusions, and must be
             receiving at least ≥ 8 units/yr of red blood cell transfusions

          -  Serum ferritin ≥ 1000 ng/mL

        Exclusion Criteria:

          -  Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or
             exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)

          -  Patients unable to undergo study assessments including MRI

          -  Patients with serum creatinine greater than Upper limit of normal ULN)range or with
             significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥1.0
             mg/mg in a non-first void urine sample at baseline.

        Other protocol-defined inclusion/exclusion criteria may apply
Feasibility Study of Metformin Therapy in ADPKD
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Metformin; Placebo
Intervention description: Monitoring of safety and tolerability; Monitoring of safety and tolerability
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Metformin; total kidney volume; glomerular filtration rate

Summary:

      This study is being done to determine if treatment with metformin, a drug widely used for the
      treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal
      Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly
      decreased kidney function. The study will also evaluate the effects of metformin on kidney
      growth and kidney function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Autosomal Dominant Polycystic Kidney Disease and

          -  An estimated glomerular filtration (GFR) rate of 50-80 ml/min/1.73 m2;

          -  Subject is able to sign an Informed Consent

        Exclusion Criteria:

          -  Diabetes mellitus,

          -  Active infection,

          -  Congestive heart failure,

          -  Liver disease,

          -  Alcohol or substance dependence,

          -  Cigarette smoking within the last 12 months;

          -  Females who are pregnant or breast feeding, or

          -  Are unwilling to use contraception;

          -  Are unable to undergo magnetic resonance imaging, or

          -  Have a contraindication to the use of metformin
Pharmacological Treatment of Rett Syndrome With Statins
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Intervention: Lovastatin
Intervention description: dose escallating
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 3 Years
Healthy volunteers: No
Keywords: Treatment trial; Lovastatin

Summary:

      This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females patients,

          -  Genetically confirmed RTT,

          -  Ambulatory.

        Exclusion Criteria:

          -  Presence of co morbid non-Rett related disease,

          -  History of adverse reaction/hypersensitivity to statins,

          -  Levels of aspartate-amino trans-ferase (AST), alanine-amino transferase (ALT) or
             creatine kinase (CK) triple the normal values,

          -  Active liver disease,

          -  Concomitant use of strong CYP3A4 inhibitors,

          -  Condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis
             surgery within 6 months),

          -  Oral contraceptives use.
The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: ALN-TTR02 (patisiran) administered by intravenous (IV) infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic

Summary:

      The purpose of this study is to evaluate the safety and tolerability of long-term dosing with
      ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.

          -  Adequate Karnofsky performance status, liver function, and renal function.

        Exclusion Criteria:

          -  Pregnant or nursing.

          -  Has had a liver transplant.

          -  Has a New York Heart Association heart failure classification >2.

          -  Has unstable angina.

          -  Has uncontrolled clinically significant cardiac arrhythmia.
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Condition: Antibody Mediated Rejection
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibody Mediated Rejection; AMR; Acute Humoral Rejection; AHR; Living Donor; Kidney Transplant

Summary:

      The purpose of this trial was to determine the safety and efficacy of eculizumab in the
      prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor
      kidney transplant requiring desensitization therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥18 years old

          2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney
             transplant from a living donor to whom they are sensitized and require desensitization
             prior to transplantation

        Exclusion Criteria:

          1. ABO incompatible with living donor

          2. Any medical condition that, in the opinion of the Investigator, might interfere with
             the patient's participation in the study, poses an added risk for the patient, or
             confounds the assessment of the patient