bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: GSK189075; placebo
Intervention description: investigational drug; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: type 1 Diabetes mellitus, pharmacokinetics,; pharmacodynamics; Adult male and females,

Summary:

      The purpose of this research study is to look at concentrations of GSK189075 in blood when
      single doses of the drug are taken by mouth in combination with basal insulin. The clinical
      effects of the drug in combination with insulin on the body will also be studied. The results
      will help determine doses of GSK189075 can be studied in the future in the type I diabetes
      mellitus population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male/female, 18 to 55 years old

          -  Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous
             insulin pump

          -  Willing and able to follow all study-related instructions provided by the site staff.

          -  Willing to provide signed informed consent.

        Exclusion Criteria:

          -  Pregnant or a nursing female.

          -  Have a past or current disease such as heart, liver, kidney, blood, brain, or other
             disease.

          -  Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.

          -  Have a history of alcohol abuse or have an eating disorder

          -  Have been in another research study in the last month or have taken certain
             medications in the 1 week before study drug would be taken.
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
Condition: Diabetes Mellitus and Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LIK066; Placebo; Empagliflozin
Intervention description: LIK066 was supplied in different doses as tablets taken orally.; Placebo was supplied as tablets and capsules taken orally.; Empagliflozin was supplied as capsules taken orally.
Intervention MeSH terms: Empagliflozin; Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes mellitus; LIK066; Obesity; Type 2 diabetes mellitus (T2DM); Heart Failure (HF); Hypertension; Renal dysfunction; Adult-onset diabetes; Noninsulin-dependent diabetes mellitus (NIDDM); High blood sugar

Summary:

      This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3
      different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart
      failure
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  BMI ≥ 22kg/m^2

          -  Type 2 diabetes with HbA1c between 6.5% and 10.0%

          -  Documented symptomatic chronic heart failure (NYHA II-IV)

          -  Plasma NT-proBNP > 300pg/ml

          -  eGFR ≥ 45ml/min/1.73m^2 (calculated by MDRD)

        Key Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or
             secondary forms of diabetes

          -  History of ketoacidosis, lactic acidosis, or hyperosmolar coma

          -  Symptomatic genital infection or UTI within 4 weeks of screening

          -  Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary
             intervention within 3 months of randomization

          -  Unstable angina within 3 months of screening

          -  Isolated right HF due to pulmonary disease

          -  Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization

          -  History of lower limb amputation

          -  Diabetic foot ulcer at screening
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: lurbinectedin (PM01183)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and
      safety of PM01183 in previously treated patients with advanced solid tumors
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Voluntary signed informed consent (IC)

          -  Pathologically proven diagnosis of any of the following malignancies:

               -  Small cell lung cancer (SCLC).

               -  Head and neck carcinoma (H&N). Salivary glands tumors are excluded.

               -  Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health
                  Organization classification.

               -  Biliary tract carcinoma.

               -  Endometrial carcinoma.

               -  BRCA 1/2- associated metastatic breast carcinoma

               -  Carcinoma of unknown primary site.

               -  Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant
                  transformation.

               -  Ewing's family of tumors (EFTs)

          -  Prior treatment. Patients must have received:

               -  SCLC, endometrial carcinoma: one prior chemotherapy-containing line.

               -  H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines

               -  GCTs: no limit of prior therapy

               -  EFTs: no more than two prior chemotherapy-containing lines in the
                  metastatic/recurrent setting.

               -  BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than
                  three prior chemotherapy-containing lines.

          -  Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]

          -  Adequate major organ function

          -  At least three weeks since the last chemotherapy

          -  Women of childbearing potential must have pregnancy excluded by appropriate testing
             before study entry

        Exclusion Criteria:

          -  Prior treatment with PM01183 or trabectedin

          -  Prior or concurrent malignant disease unless in complete remission for more than five
             years

          -  Known central nervous system (CNS) involvement

          -  Relevant diseases or clinical situations which may increase the patient's risk

          -  Pregnant or breastfeeding women and fertile patients (men and women) who are not using
             an effective method of contraception
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
Condition: Heart Failure; Cardiac Failure; Reduced Ventricular Ejection Fraction
MeSH terms: Heart Failure
Intervention: HNO Donor; Nitroglycerin (NTG); Placebo
Intervention description: Infusion; Infusion; Infusion
Intervention MeSH terms: Nitroglycerin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic
      parameters in patients with heart failure and low ejection fraction.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)

          -  Stable guideline directed therapy for heart failure including oral diuretics, ACEi,
             ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these
             medications in the past 2 weeks

          -  Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10
             pmol/L)

        Exclusion Criteria:

          -  Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization

          -  Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization

          -  Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial
             Flutter

          -  Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2

          -  Ventricular assist device or prior heart transplant

          -  Prior solid organ transplant

          -  Body weight < 45 kg or ≥ 140 kg

          -  Low quality echocardiographic visualization windows and image acquisition

          -  Permanent paced rhythm (VVI, DDD or BiV pacing)

        Other protocol defined inclusion/exclusion criteria could apply
The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
Condition: Cardiomyopathy; Heart Failure
MeSH terms: Renal Insufficiency; Heart Failure; Cardiomyopathies
Intervention: POMx, pomegranate polyphenol extract; Sugar Pill
Intervention description: 1000 mg orally once daily.; Matching sugar pill
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: The participant will either receive POMx or matching placebo (sugar pill)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Cardiomyopathy; Heart Failure

Summary:

      This blinded, controlled study will examine the impact of pomegranate polyphenol extract
      (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal
      insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at
             least 1 year duration and CRI (GFR <60 cc/hr for at least 3 months) will be eligible
             for enrollment.

          -  Subjects must have New York Heart Association (NYHA) functional class I-III symptoms
             and be on stable doses of HF evidence-based therapies (β-blocker, ACE inhibitor or
             ARBs, aldosterone inhibitor [if appropriate]) for at least 3 months or have a
             documented contraindication or intolerance to such therapy

        Exclusion Criteria:

          -  Subjects admitted to a hospital for acute myocardial infarction (defined as positive
             troponins) or HF exacerbation within the last 6 months will not be eligible for
             enrollment.

          -  Subjects on warfarin or rosuvastatin will also be excluded.

          -  Other exclusion criteria are as follows:

               -  HF that is deemed to be congenital or infiltrative in etiology

               -  the presence of a life-threatening illness with a projected survival ≤6 months;
                  ongoing infection

               -  pregnancy

               -  inability to follow-up

               -  end-stage renal disease requiring dialysis

               -  renal transplant listing

               -  recent (within last 6 months) POMx use or intake >8 ounces daily of pomegranate
                  juice

               -  known hypersensitivity to any fruit in the Punicaceae family

               -  connective tissue or collagen vascular disease
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Ipatasertib; Paclitaxel; Placebo
Intervention description: Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.; Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion QW for 3 cycles.; Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
Intervention MeSH terms: Paclitaxel; Ipatasertib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II
      study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy
      versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa
      triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal or postmenopausal women

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma
             of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in
             largest diameter (cT1-3) by MRI

          -  Adequate hematologic and organ function within 14 days before the first study
             treatment

          -  Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy
             of breast primary tumor

          -  For female participants of childbearing potential, agreement to use highly effective
             form(s) of contraception for the duration of the study and for at least 6 months after
             last dose of study treatment

        Exclusion Criteria:

          -  Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor
             (ER)-positive, or progesterone receptor (PgR)-positive breast cancer

          -  Any prior treatment for the current primary invasive breast cancer

          -  Participants with cT4 or cN3 stage breast tumors

          -  Metastatic (Stage IV) breast cancer

          -  Bilateral invasive breast cancer

          -  Multicentric breast cancer

          -  Any disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding that contraindicates the use of an investigational drug or that may
             affect the interpretation of the results or render the participant at high risk from
             treatment complications
Study of Euthyroid Hypothyroxinemia in Metastatic Breast Carcinoma
Condition: Metastatic Breast Cancer; Thyroid Dysfunction
MeSH terms: Breast Neoplasms
Intervention: Triiodothyronine (T3)
Intervention description: Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Triiodothyronine (T3) - IND Exempt
Masking: None (Open Label)
Masking description: N/A (not applicable)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 105 Years
Healthy volunteers: No

Summary:

      Up to one third of breast cancer patients have hypothyroidism or hyperthyroidism. L-thyroxine
      (T4), or Synthroid, is the most commonly prescribed agent for the management of
      hypothyroidism in the US. However, there are data suggesting that triiodothyronine (T3) may
      have benefits in preventing disease progression over l-thyroxine (T4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18

          -  Male or female with diagnosis of metastatic breast carcinoma and documented history of
             hypothyroidism .

          -  TSH level within normal range at baseline

          -  Life expectancy estimated > 3 months

          -  Ability and willingness to provide informed consent

        Exclusion Criteria:

          -  Life expectancy estimated to be less than 3 months

          -  Is currently pregnant or intends to become pregnant during the duration of the study

          -  Active angina, New York Heart Association (NYHA) advanced [Class III/IV] congestive
             heart failure, or uncontrolled cardiac arrhythmia within 6 months of enrollment

          -  History of thyrotoxicosis

          -  History of adrenal insufficiency

          -  Hypersensitivity to any active or extraneous constituents in Triiodothyronine
             (T3)/liothyronine sodium
Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Tapinarof cream, 1%
Intervention description: Tapinarof cream, 1% applied topically once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm study
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label, multicenter study to evaluate the systemic exposure and safety of
      topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque
             psoriasis and stable disease for at least 6 months prior to the study

          -  BSA involvement ≥ 20%

          -  PGA score of ≥ 3 at screening

          -  Females of child bearing potential and male subjects who are engaging in sexual
             activity that could lead to pregnancy agree to follow the specified contraceptive
             guidance throughout the study

          -  Capable of giving written informed consent

        Exclusion Criteria:

          -  Psoriasis other than plaque variant

          -  Any sign of infection of any of the psoriatic lesions

          -  Evidence of significant hepatic, renal, respiratory, endocrine, hematologic,
             neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory
             abnormality that will affect the health of the subject or interfere with the
             interpretation of the results

          -  Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources
             of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such
             exposures during the study which could potentially impact the subject's psoriasis

          -  Use of any prohibited medication within the indicated period before the first dose of
             study drug

          -  Pregnant females or lactating females

          -  The subject has received an investigational product within 30 days, 5 half-lives, or
             twice the duration of the biological effect of the study drug (whichever is longer)
             prior to first dose of study drug

          -  Current or a history of cancer within 5 years except for fully excised skin basal cell
             carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix

          -  Previous known participation in a clinical study with tapinarof
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
Condition: Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: Polyphenon E
Intervention description: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DCIS

Summary:

      The purpose of this study is to find molecular signs (biomarkers) to better understand the
      role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed
      ductal carcinoma in situ (DCIS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on
             breast MRI of at least 1-cm3 in volume.

          -  Patients may have undergone treatment with prior chemotherapy if this was greater than
             12 months prior to current diagnosis.

          -  Age >18 years.

          -  ECOG performance status <2 (Karnofsky >60%)

          -  Life expectancy of greater than 12 months.

          -  Normal organ and marrow function as defined below:

          -  leukocytes >3,000/mcL

          -  absolute neutrophil count >1,500/mcL

          -  platelets >100,000/mcL

          -  total bilirubin within normal institutional limits

          -  AST(SGOT) & ALT(SGPT)within normal institutional limits

          -  creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60
             mL/min/1.73 m2

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Pregnancy

          -  Patients who have undergone prior excisional biopsy for DCIS.

          -  Patients who are unable to undergo MRI due to claustrophobia or other reason.

          -  Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior
             to entering this study.

          -  Patients receiving any other chemotherapy or investigational agents.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to green tea extracts or sensitivity to green tea.

          -  Uncontrolled concurrent 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.