bioihbjkbjnl/mcl2 huggingface dataset:
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Cardiotoxicity
Intervention: Carvedilol; placebo
Intervention MeSH terms: Carvedilol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carvedilol; Anthracycline; HER2; 14-099

Summary:

      The purpose of this study is to find out the effects, good and/or bad, of a beta blocker
      (carvedilol) on heart function during treatment with anti-HER2 medication(s) including
      trastuzumab (Herceptin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Age ≥ 18 years

          -  Non-metastatic histologically confirmed primary invasive breast carcinoma

          -  Pathologically confirmed HER2-positive breast cancer

          -  Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at MSKCC

          -  Able and willing to provide informed consent

          -  Willing and able to comply with the requirements of the protocol

          -  Able to swallow capsules

        For Aim 2, all patients must meet the following criteria:

          -  Meet all inclusion criteria above

               -  LVEF > 50%

          -  Abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline)
             prior to initiation of planned anti-HER2 therapy

          -  Heart rate ≥ 50 beats per minute

          -  Sitting systolic blood pressure > 90 mmHg

        Exclusion Criteria:

          -  Patients are to be excluded from randomization for Aim 2 of this study if they meet
             any of the following criteria:

          -  Current treatment with ACE-inhibitors or beta blockers

          -  Allergies or inability to tolerate beta blockers previously due to bradycardia,
             hypotension, or AV block.

          -  Known history of NCI CTCAE (Version 4.0) Grade ≥ 2 symptomatic CHF, myocardial
             infarction within 12 months prior to randomization, significant symptoms (Grade ≥ 3)
             relating to left ventricular dysfunction, significant (moderate or severe) valvular
             disease, or significant cardiac arrhythmia (Grade ≥ 3)

          -  Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks
             of starting treatment

          -  Enrollment in a therapeutic intervention trial in the Breast Medicine service
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Condition: Primary Mitochondrial Disease
MeSH terms: Mitochondrial Myopathies; Mitochondrial Diseases
Intervention: elamipretide
Intervention description: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Primary Mitochondrial Disease; Stealth; elamipretide

Summary:

      This is a Phase 2 Open-Label extension study to evaluate the long term safety and
      tolerability of daily elamipretide injections in patients with genetically confirmed Primary
      Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Investigator determines the subject can, and subject agrees to, adhere to the trial
             requirements for the length of the trial including self-administration (by subject or
             trained caregiver) of the study drug

          -  Subject completed the End-of-Study Visit in SPIMM-202

        Exclusion Criteria:

          -  Subject has any prior or current medical condition that, in the judgment of the
             Investigator, would prevent the subject from safely participating in and/or completing
             all trial requirements

          -  Subject has received any investigational compound (excluding elamipretide) and/or has
             participated in another interventional clinical trial within 30 days prior to the
             SPIMM-203 Baseline Visit (excluding SPIMM-202) or is concurrently enrolled in any
             non-interventional research of any type judged to be scientifically or medically
             incompatible with the trial as deemed by the Investigator in consultation with the
             Sponsor

          -  Subject experienced an adverse reaction attributed to study drug resulting in
             permanent discontinuation of study drug in the SPIMM-202 trial.

          -  Female subjects who are pregnant, planning to become pregnant, or lactating

          -  Subject has undergone an in-patient hospitalization within the 1 month prior to the
             SPIMM-203 Baseline Visit
Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Condition: Type 1 Hyperlipoproteinemia
MeSH terms: Hyperlipoproteinemias; Hyperlipidemias
Intervention: SLx-4090 placebo; Orlistat Placebo; Orlistat; Slx-4090
Intervention description: Given for 4 weeks; Given for 4 weeks; Given for 4 weeks; Given for 4 weeks
Intervention MeSH terms: Orlistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This trial is adaptive design/flexible design. The participants were randomized from the start of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: hypertriglyceridemia

Summary:

      Funding Source - FDA OOPD

      This study is being done to find out whether an investigational (not approved by FDA ) drug
      called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in
      combination can treat the high blood fat (elevated triglycerides)levels found in the
      condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,
      the current standard medical care.

      It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in
      lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The
      researchers are interested in learning whether any one of these drugs when given alone or in
      combination is more effective and safe in treating T1HLP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type I hyperlipoproteinemia.

          -  Fasting serum triglyceride levels of greater than 1000 mg/dL.

          -  Age > 12 years

        Exclusion Criteria:

          -  Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism,
             alcoholism and drug therapy such as estrogens and estrogen analogues, steroids,
             HIV-protease inhibitors, retinoic acid derivatives and interferons.

          -  Pregnant or lactating women

          -  Significant liver disease (elevated transaminases > 2 times upper limit of normal)

          -  Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks for men or 168 g
             per week for men)

          -  Drug use (cocaine, marijuana, LSD, etc.)

          -  Major surgery in the past three months

          -  Congestive heart failure

          -  Serum creatinine greater than 2.5 mg/dL

          -  Cancer within the past five years

          -  Gastrointestinal surgery in the past

          -  Current therapy with anti-coagulants, digoxin and anti-arrhythmics

          -  Chronic malabsorption syndromes

          -  Cholestasis

          -  Acute illnesses such as acute pancreatitis in the last 8 weeks
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
Condition: Acute Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: APD418; APD418; Placebo
Intervention description: Participants will receive a single dose of APD418 as an intravenous (IV) infusion.; Participants will receive a single dose of APD418 as an IV infusion.; Participants will receive a single dose of APD418 matching placebo as an IV infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Heart failure with reduced ejection fraction; HFrEF; APD418; Acute Heart Failure (AHF)

Summary:

      The purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac
      function of intravenous APD418 in adult participants with heart failure with reduced ejection
      fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left
             ventricular ejection fraction (LVEF) less than or equal to (≤) 35% at Screening,
             including documented history of HFrEF (LVEF ≤ 35%) for at least 4 months prior to
             Screening

          -  New York Heart Association Class II-IV

          -  Cardiac index ≤ 2.5 liters per minute per square meter (L/min/m^2) and pulmonary
             capillary wedge pressure ≥ 15 millimeters of mercury (mm Hg) at Day 1

          -  Body mass index 18.0 to 37.0 kilograms per square meter (kg/m^2), inclusive, and body
             weight < 150 kg at Screening and Day 1

        Exclusion Criteria:

          -  Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to
             progress to becoming hemodynamically unstable during the course of the study

          -  Treated with carvedilol or at a dose higher than a total of 25 milligrams per day any
             time within 72 hours of Day 1 through the end of the in-clinic observation Post-dose
             Period.

          -  Receiving any mechanical (respiratory or circulatory) or renal support therapy at
             Screening or Day 1

          -  Systolic Blood Pressure ≤ 90 millimeter of mercury (mm Hg) or ≥ 160 mm Hg, or Heart
             Rate < 50 beats per minute (bpm) or > 110 bpm, at Screening or Day 1

          -  Recently treated with inotropic, intravenous (IV) vasoactive or IV diuretic therapy,
             or expected to require such therapy with these drugs any time from Day 1 through the
             end of study conduct.
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Minocycline
Intervention description: BPX-01 1 or 2% topical gel will be applied to face once daily
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      This is a multi center open label study intended to provide photo documentation and time to
      response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to
      severe non-nodular inflammatory acne vulgarism.
    

Eligibility criteria:

        Inclusion Criteria:

        - moderate to severe inflammatory non-nodular acne vulgaris

        Exclusion Criteria:

          -  female subject who is breastfeeding, pregnant or planning a pregnancy during the study

          -  have other skin condition or disease that would interfere with the study

          -  have had any prior treatment with minocycline

          -  have a known or suspected allergy to tetracycline class products

          -  have used OTC medications for the treatment of facial acne within the last 14 days

          -  have used any prescription topical or oral medications for the treatment of facial
             acne in the last 28 days

          -  have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last
             8 weeks
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MEDI3506; Placebo
Intervention description: multiple doses; multiple doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Investigation product only will be prepared and administered by unmasked personnel. All subjects will receive the same number of injections at each dose.
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MEDI3506; Safety; Efficacy; Atopic Dermatitis; Eczema

Summary:

      This is a research study to determine the efficacy and safety of investigational drug
      MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 65 years inclusive at the time of consent.

          -  Body mass index between 19.0 and 40.0 kg/m2 inclusive.

          -  Documented history of chronic AD, for at least 1 year prior to screening Visit 1.

          -  Meets at minimum 1 of the criteria, as follows:

               -  History of inadequate response to topical medications for AD

               -  Subject intolerance to treatment with topical medications for AD, or

               -  Topical medications are otherwise medically inadvisable

          -  AD that affects ≥ 10% of the body surface area (BSA).

          -  An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).

          -  An IGA score of ≥ 3.

        Exclusion Criteria:

          -  Any active medical or psychiatric condition, or other reason, that would interfere
             with evaluation of the investigational product or interpretation of subject safety or
             study results.

          -  Any other clinically relevant abnormal findings from physical examination (including
             vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.

          -  Active dermatologic conditions that might confound the diagnosis of AD or would
             interfere with the assessment of the skin.

          -  Known active allergic or irritant contact dermatitis.
Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Continue to Benefit From the Treatment as Judged by the Investigator
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Intervention: Panobinostat
Intervention description: Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Healthy volunteers: No
Keywords: Hematologic Neoplasms, LBH589,; Panobinostat,

Summary:

      The study allowed continued use of single agent panobinostat in patients who were on single
      agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and
      were benefiting from the treatment as judged by the investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient had been enrolled in a Novartis-sponsored, Oncology OGD&GMA study receiving
             s.a. oral panobinostat and had fulfilled all their requirements in the parent study

          -  patient had been benefiting from the treatment with s.a. oral panobinostat as
             determined by the guidelines of the parent protocol and according to the
             Investigator's clinical judgment

          -  patient had demonstated compliance

          -  patient had given written informed consent.

        Exclusion Criteria:

          -  patient had been permanently discontinued from s.a. oral panobinostat study treatment
             in the parent study due to unacceptable toxicity, withdrawal of consent,
             non-compliance to study procedures or any other reason (including progression of
             disease).

          -  patient had participated in a Novartis sponsored combincation trial where panobinostat
             was dispensed in combination with another study medication and was still receiving
             combination therapy

          -  patient was pregnant or nursing at the time of entry

          -  women of child-bearing potential and male patients with sexual partners of
             child-bearing potential who were unwilling to use highly effective methods of
             contraception during dosing and for a specified duration after stopping study
             treatment
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Fludeoxyglucose PET CT; Sodium Acetate C11 PET CT; Fludeoxyglucose PET MRI; Sodium Acetate C11 PET MRI
Intervention description: Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).; Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).; Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).; Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: positron emission tomography (PET); computerized tomography (CT); Magnetic resonance imaging (MRI); Fludeoxyglucose (F-18 FDG); C-11 acetate

Summary:

      Investigators are doing this study to determine which of four imaging techniques:
      Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18
      FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is
      the best test for finding sites of active myeloma disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being staged for multiple myeloma as follows: new diagnosis, high risk
             smoldering multiple myeloma, relapsed as defined by investigator

          -  Patients who have undergone standard of care workup

          -  300 pounds or less

          -  Can provide informed consent

          -  Scheduled for a clinically indicated F-18 FDG PET scan

          -  English speaking

        Exclusion Criteria:

          -  Pregnant, breast feeding

          -  Concurrent active non-multiple myeloma malignancy

          -  Contraindication to PET MRI

          -  Previous Type I or Type II Diabetes mellitus or a fasting blood glucose >150 mg/dl
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: IMO-2055
Intervention description: immunostimulatory oligonucleotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal; cell; renal carcinoma; metastatic; recurrent; treatment naive

Summary:

      -  Multi-Center

        -  Randomized

        -  Open-Label Study of single agent IMO-2055

        -  Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage IV clear cell renal carcinoma with metastatic or
             locally recurrent disease that is not surgically resectable.

          -  At least one measurable lesion

          -  Adequate organ function

          -  Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.

          -  If female and of childbearing potential, a negative serum pregnancy test performed and
             documented no more than 14 days before the first dose of study drug.

        Exclusion Criteria:

          -  Known untreated central nervous system (CNS) metastasis

          -  Pre-existing autoimmune or antibody-mediated diseases

          -  Other significant medical disease.