bioihbjkbjnl/mcl2 huggingface dataset:
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Condition: Breast Cancer; Breast Tumors
MeSH terms: Breast Neoplasms; Cardiotoxicity
Intervention: Metformin; Doxorubicin
Intervention description: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.; Standard of care treatment with doxorubicin
Intervention MeSH terms: Metformin; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: breast; cancer; doxorubicin; metformin; cardiotoxicity; ejection fraction; LVEF

Summary:

      The goal of this study is to determine if co-administration of metformin and doxorubicin in
      breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of
      patients who develop a significant change in left ventricle ejection fraction (LVEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin

          -  Complete metabolic panel demonstrating adequate organ functions as defined by the
             following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal
             (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less
             than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than
             ULN

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Age greater than or equal to 21 years

        Exclusion Criteria:

          -  Known diabetes

          -  History of cardiac arrhythmias or symptomatic cardiac disease

          -  Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling
             cardiac medications

          -  Currently taking metformin and/or sulfonylureas

          -  Known hypersensitivity or intolerance to metformin

          -  Baseline ejection fraction of less than 50% measured by echocardiogram

          -  Known hypersensitivity to contrast used during echocardiogram

          -  Risk factors associated with increased risk of metformin-associated lactic acidosis
             (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more
             alcoholic beverages per day)

          -  Pregnant or breast feeding
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: TAK-831; TAK-831 Placebo
Intervention description: TAK-831 tablets; TAK-831 placebo matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper
      extremity (arm and hands) motor function and manual dexterity. This study will also evaluate
      the efficacy of TAK-831 versus placebo on activities of daily living (ADL) and other
      secondary assessments.
    

Eligibility criteria:

        Key Inclusion Criteria:

        1. Has a genetically-confirmed diagnosis (homozygous for guanine-adenine-adenine [GAA]
        repeat expansions in the frataxin gene [FXN] in the affected range of Friedreich ataxia
        [FRDA] or a compound heterozygous expansion with a point mutation or deletion), with an
        established disease stage of 2 to 5, inclusive, as determined by the Functional Staging for
        Ataxia, at Screening.

        Key Exclusion Criteria:

          1. Received a diagnosis of ataxic syndromes other than FRDA.

          2. Has a history of cancer, except basal cell carcinoma or in situ cervical cancer that
             has been in remission for greater than or equal to (>=5) years prior to first dose of
             study drug.

          3. Known to be currently infected or has been infected with human immunodeficiency virus
             (HIV), hepatitis B virus, or hepatitis C virus.

          4. Has a known hypersensitivity to any component of the formulation of TAK-831.

          5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse.

          6. Has taken any excluded medication, or has had insufficient washout of medications or
             is unable or unwilling to discontinue medications as required by the protocol.

          7. If male, the participant intends to donate sperm during the course of this study or
             for 95 days after the last dose of study drug.

          8. If female, the participant is of childbearing potential and lactating, pregnant
             (positive prerandomization serum pregnancy test), or plans to become pregnant before
             participating in the study, during the study, or within 35 days after last dose of the
             study drug, or intending to donate ova during such time period.

          9. Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic
             ileus or other conditions that may interfere with absorption of study medication.
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Placebo; BIBF 1120; BIBF 1120; BIBF 1120
Intervention description: Placebo BID for cohort 1,2,3; 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively; 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively; 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
Intervention MeSH terms: Nintedanib
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis
      (IPF), with and without pirfenidone background treatment.

      To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone
      background treatment.

      To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with
      BIBF 1120 treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic
             Society (ATS) /European Respiratory Society (ERS) guideline

          2. Forced vital capacity (FVC) 50-90%

          3. Diffusing capacity for carbon monoxide (DLCO) 30-79%

          4. For patients on pirfenidone, have been on a steady dose for at least 3 months

        Exclusion criteria:

          1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit
             of normal range (ULN) at screening.

          2. Bilirubin > 1.5 x ULN at screening.

          3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.

          4. Continuous oxygen supplementation.

          5. Active infection at screening or randomisation.

          6. Being treated with any of the following concomitant medications.

               -  Oral corticosteroid medication at unstable dose

               -  ketoconazole or atazanavir

          7. Patients who are expected to go on to lung transplantation, have rapidly deteriorating
             disease, or have a life expectancy less than 3 months from screening
Pilot Efficacy and Safety Study of AQX-1125 in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AQX-1125; Placebo
Intervention description: Synthetic SHIP1 activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic dermatitis; Eczema; AD; AQX-1125; SHIP1

Summary:

      The primary objective of this study is to evaluate the effect of 12 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo on change from baseline in Total
      Lesion Symptom Score in subjects with mild to moderate atopic dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged from 18 to 65 years old

          2. Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin
             and Rajka criteria

          3. At least a 6 months history of atopic dermatitis.

          4. Body Surface Area (BSA) covered with atopic dermatitis of 1% or more

          5. Mild or moderate atopic dermatitis (IGA score of 2 or 3).

          6. TLSS of 5 or more at Day 0.

          7. Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day
             0 and should continue using that same emollient, at the same frequency, throughout the
             study.

        Exclusion Criteria:

          1. Female subject who is pregnant or breast-feeding

          2. Unstable or clinically infected atopic dermatitis
Interleukin-2 in Metastatic Melanoma
Condition: Melanoma Metastatic
MeSH terms: Melanoma
Intervention: Interleukin-2
Intervention description: Interleukin-2
Intervention MeSH terms: Interleukin-2
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
Healthy volunteers: No
Keywords: Metastatic Melanoma

Summary:

      To determine whether Interleukin-2 at the dose and schedule will help to increase tumor
      shrinkage
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have
             received prior systemic therapy or may be previously untreated.

          2. Patients must have bi-dimensional measurable disease on physical exam or radiologic
             studies.

          3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.

          4. White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl;
             bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.

          5. Patients must undergo a low-level cardiac stress test as a screen for possible
             atherosclerotic heart disease. Patients with a positive stress test would be excluded
             from this trial.

          6. Patients with elevated temperatures > 100.5 F must have sources of occult infection
             excluded.

          7. Patients must be felt to have recovered from effects of prior therapy, such as > 2
             weeks after prior chemotherapy.

          8. Patient consent must be obtained prior to entrance onto study.

          9. Women of childbearing potential must have a negative pregnancy test and must take
             adequate precautions to prevent pregnancy during treatment

        Exclusion Criteria:

          1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as
             cyclosporin or methotrexate.

          2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by
             immune-based therapy.

          3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.

          4. Lactation or pregnancy.

          5. Evidence of significant cardiovascular disease including history of recent (< 6 months
             prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias
             (not due to electrolyte disorder or drug toxicity, for example) beyond occasional
             PVC's, angina, positive low-level stress test, or cerebrovascular accident.

          6. Current brain metastasis.
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin lispro; Insulin aspart; Recombinant human hyaluronidase PH20; Insulin glulisine; Insulin glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro; Insulin glulisine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 diabetes

Summary:

      The purpose of the study was to compare Humalog (insulin lispro)-recombinant human
      hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the
      treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥18 years

          -  Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin
             (at least 2 meals per day) for ≥2 months

          -  Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)

          -  Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive

          -  Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)

          -  Willingness to use insulin glargine twice a day as basal insulin for the duration of
             the study

          -  Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose
             monitoring (CGM) during the study

        Exclusion Criteria:

          -  Known or suspected allergy to any component of any of the study drugs

          -  Exclusive use of pre-mixed insulins

          -  Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening

          -  Use of sulfonylureas within two months of screening

          -  Use of drugs (such as corticosteroids or antimetabolites) that could interfere with
             the interpretation of study results or are known to cause clinically relevant
             interference with insulin action, glucose utilization, or recovery from hypoglycemia,
             during the study or within 30 days of screening

          -  Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or
             hypoglycemic unawareness, as judged by the investigator
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.
This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: agalsidase alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Replagal

Summary:

      This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient must be diagnosed with Fabry disease using the following criteria: The
             patient is a hemizygous male with Fabry disease as confirmed by a deficiency of
             α-galactosidase A activity measured in serum, leukocytes, or fibroblasts or has a
             confirmed mutation of the α-galactosidase A gene.

          2. Patient is male and between 18 and 65 years of age, inclusive.

          3. Patient must be willing to remain in the clinic as required by the study and comply
             with the procedures and evaluations of the study.

          4. At the time of confirmation of study eligibility visit, patients must have received at
             least 26 weeks of treatment with RB Replagal at a dose of 0.2 mg/kg administered IV
             EOW.

          5. Patient provides informed consent.

        Patients who are naive to ERT:

        1. Treatment naive patients must have a pretreatment plasma Gb3 level above the normal
        range (if value is available).

        Exclusion Criteria:

          1. Patient is unable to be venipunctured and/or tolerate venous access.

          2. Patient has tested positive for anti-agalsidase alfa antibodies either at screening or
             confirmation of eligibility visit.

          3. Patient had pre-ERT plasma Gb3 levels within the normal range (if value is available).

          4. Patient is participating in any other Shire HGT investigational study.

          5. Patient is currently on dialysis, is expected to begin dialysis during the study, has
             received a kidney transplant, or is on the renal transplant waiting list.

          6. Patient is unable to comply with the protocol (eg, clinical relevant medical condition
             making implementation of the protocol difficult, unstable social situation, or
             otherwise unlikely to complete the study) or is, in the opinion of the Investigator,
             otherwise unsuited for the study.

          7. The patient is enrolled in another clinical study that involves clinical
             investigations or use of any investigational product (drug or device), except for the
             Canadian Fabry Disease Initiative, within 6 months prior to receiving the first dose
             of AF Replagal in this study or at any time during the study.

          8. The patient has previously received AF Replagal prior to study entry.
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
Condition: Acute Myelogenous Leukemia; Chemotherapy-induced Nausea and Vomiting
MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute; Nausea; Vomiting
Intervention: Ondansetron; Palonosetron
Intervention description: 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.; Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy.
Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy.
Intervention MeSH terms: Ondansetron; Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nausea; Vomiting; CINV; Leukemia; High-risk Myelodysplastic syndrome; AML; Hematologic malignancies; Hematologic Disorder; Continuous multi-day chemotherapy; High-dose cytarabine; Palonosetron; Aloxi; Ondansetron; Zofran

Summary:

      The goal of this clinical research study is to compare the effectiveness of 3 drug schedules
      in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous
      leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic
             syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing
             regimens.

          2. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

        Exclusion Criteria:

          1. Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3
             nausea (no significant intake requiring intravenous fluids)</= 24 hours before
             chemotherapy.

          2. Patients with ongoing emesis due to any organic etiology.

          3. Patients with known hypersensitivity to the study drug or to other selective 5-HT3
             receptor antagonists.