bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Pharmacokinetics and Safety of Testosterone
Condition: Testicular Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone gel (FE 99903)
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label study of a single and repeated application of three dose levels of
      topical testosterone in hypogonadal males with morning serum testosterone concentrations <
      297 ng/dL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-65

          -  History of hypogonadism

          -  In good health based on medical history, physical examination and clinical laboratory
             tests

          -  Screening morning serum testosterone ≤ 297 ng/dL

          -  One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or
             reduced sexual functioning of non-vasculogenic or neurogenic nature)

          -  Body mass index (BMI) between 18 and 31

        Exclusion Criteria:

          -  Prostate cancer

          -  Palpable prostatic mass(es)

          -  Generalized skin irritation or significant skin disease

          -  Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
             (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride,
             ketoconazole)

          -  Clinically significant anemia or renal dysfunction

          -  Hyperparathyroidism or uncontrolled diabetes

          -  Serum PSA Levels; ≥ 4ng/mL

          -  History of cardiovascular disease

          -  Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human
             growth hormone (hGH), (within previous 12 months)

          -  Use of testosterone products (within eight months for parenteral products, or six
             weeks for other preparations)
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Intervention: perampanel
Intervention description: Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Seizure; epilepsy

Summary:

      The purpose of this trial is to investigate the safety and tolerability of perampanel in
      long- term treatment in the patients with refractory partial epilepsy (uncontrolled with
      other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients who consent to the study entry on their free will before starting any
             trial-related activities.

          2. Patients who participated in Study 231 and completed the required evaluation period
             (10 weeks).

          3. Patients who are certainly and voluntarily able to participate in this study and
             record their seizures by themselves or have family members or caregivers (or nurses,
             if hospitalized) record the seizures. Patients who wish to continue perampanel
             treatment and necessitate receiving the long- term administration judged by the
             investigator or sub-investigator.

        Exclusion criteria:

          1. Pregnant or lactating women, women of child-bearing potential, women willing to become
             pregnant.

          2. Patients who are ineligible judged by the investigator or sub investigator in light of
             medical history or complication at enrollment in treatment period.

          3. Patients who operate heavy equipment or drive should not be recruited into the study.

          4. Patients who are ineligible for study entry judged by the investigator or
             sub-investigator.
Trental & Vitamin E for Radiation-Induced Fibrosis
Condition: Fibrosis
MeSH terms: Fibrosis
Intervention: Pentoxifylline; Vitamin E
Intervention description: Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.; Vitamin E (Over-the-counter) 400 I.U. once daily
Intervention MeSH terms: Vitamin E; Pentoxifylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Breast Neoplasms; Radiotherapy

Summary:

      This study seeks to determine if a combination of Trental and Vitamin E prevents the
      development of radiation fibrosis in women treated with radiation for the definitive
      management of their breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically documented cancer of the breast or DCIS or head and neck
             referred for definitive radiation with curative intent.

          -  No evidence of metastatic disease.

          -  Minimum life expectancy of at least 12 months.

          -  Aged greater than 20 years.

          -  If female, pregnancy excluded.

          -  No documented history of collagen vascular disease.

        Exclusion Criteria:

          -  Cognitively impaired patients

          -  Prisoners

          -  No histology available

          -  Documented metastatic disease

          -  Allergy to Trental

          -  Life expectance of less than 12 months.

          -  Aged less than 20 years

          -  Collagen vascular disease present

          -  Pregnant

          -  History of liver disease

          -  Use of anticoagulants
Mild Encephalopathy in the Newborn Treated With Darbepoetin
Condition: Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy Mild
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain
Intervention: Darbepoetin Alfa; Normal Saline
Intervention description: Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age; Single dose of normal saline, IV, given at less than 24 hours of age
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 1 Hour
Maximum age: 24 Hours
Healthy volunteers: No
Keywords: darbepoetin; Brain Diseases

Summary:

      This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial.
      Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on
      the modified Sarnat neurologic examination at less than six hours of age. Participants will
      be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth.
      Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be
      performed at 24 months of age. Pharmacokinetics will be assessed on those infants that
      received Darbe.
    

Eligibility criteria:

        Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational
        age > 34 weeks by best obstetric estimate, are <24 hours old and have evidence of mild
        encephalopathy as defined by Shankaran et al based on a modified Sarnat examination
        performed at <6 hours of age.

          1. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart
             rate abnormality, or meconium staining)

          2. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for
             TH.

          3. Infant has an IV for clinical treatment

        Exclusion Criteria:

          1. Moderate/Severe encephalopathy on modified Sarnat examination at < 6 hours of age

          2. Major congenital and/or chromosomal abnormalities

          3. Prenatal diagnosis of brain abnormality or hydrocephalus

          4. Severe growth restriction (< 3%)

          5. Central venous hematocrit >65%, platelet count >600,000/dL, and/or neutropenia
             (ANC<500 μL)

          6. ECMO

          7. Infant judged critically ill and unlikely to benefit from neonatal intensive care by
             the attending neonatologist
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
Condition: LMNA-Related Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: ARRY-371797, p38 inhibitor, oral
Intervention description: multiple dose, single schedule
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: laminopathy; ARRY-797

Summary:

      This is a rollover study designed to investigate the safety and effectiveness of
      investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a
      study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and
      may, in the Investigator's opinion, derive benefit from continued treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to
             LMNA mutations in a clinical study sponsored by Array BioPharma.

          -  May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.

          -  Additional criteria exist.

        Key Exclusion Criteria:

          -  Discontinued treatment in the parent study for any reason other than study completion
             or Sponsor termination of the study.

          -  Additional criteria exist.
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AZD1656; Placebo; Glipizide
Intervention description: Different doses of AZD1656 administered to 5 groups of patients; AZD1656 placebo and glipizide placebo administered to 1 group of patients; Glipizide administered to 1 group of patients
Intervention MeSH terms: Glipizide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type II Diabetes Mellitus; metformin; glipizide

Summary:

      The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on
      Treatment to Metformin in TD2M Patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  female of non-childbearing potential

          -  Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10
             weeks prior to enrolment.

          -  Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort
             1.Patients with HbA1c between >10 % and <12 % can enter the open-label arm with
             AZD1656 (cohort 2)

        Exclusion Criteria:

          -  Significant cardiovascular event within the last 6 months prior to enrolment or heart
             failure New York Heart Association (NYHA) class III-IV.

          -  Impaired renal function in terms of GFR<60 ml/min, based on Modification of Diet in
             Renal Disease Study Group (MDRD) calculation.

          -  Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use
             of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14
             days before randomisation.
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Condition: Nonvalvular Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AZD0837; Vitamin-K antagonist at INR 2-3; AZD0837
Intervention description: ER tablet, PO, once daily for a period of 3-9 months.; Tablet, PO for a period of 3-9 months.; ER tablet, PO, twice daily for a period of 3-9 months
Intervention MeSH terms: Vitamin K; Warfarin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1084.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anticoagulant Treatment; Risk Factors For Stroke

Summary:

      The main purpose of this study is to provide dose-guiding information by assessing the safety
      and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of
      AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for
      an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial
      fibrillation (AF) with one or more additional risk factors for stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at
             least one week.

          -  Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)

          -  Previous systemic embolism.

          -  Symptomatic congestive heart failure (CHF)

          -  Impaired left ventricular systolic function

          -  Diabetes mellitus

          -  Hypertension requiring anti-hypertensive treatment.

        Exclusion Criteria:

          -  AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism

          -  Known contraindication to VKA treatment

          -  Presence of a valvular heart disease, mechanical heart valves, active endocarditis,
             left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF
             requiring chronic anticoagulation treatment

          -  Conditions associated with increased risk of major bleeding for example: history of
             intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical
             procedure or trauma two weeks prior to randomization
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: MIV-711
Intervention description: MIV-711 administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Maximum age: 81 Years
Healthy volunteers: No

Summary:

      This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety
      and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

        - Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by

          -  Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary
             endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by

          -  Receiving placebo and had a clinically significant worsening on the primary endpoint
             as defined by a NRS increase of ≥2

        Exclusion Criteria:

          -  The presence of any inflammatory arthritis

          -  Any generalized pain condition that may interfere with the evaluation of the target
             knee pain (e.g., fibromyalgia) as judged by the investigator.

          -  Any clinically severe or significant uncontrolled concurrent illness, which, in the
             opinion of the Investigator, would impair ability to give informed consent or take
             part in or complete this clinical study.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closely related compounds, or any of the stated ingredients.
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Degarelix
Intervention description: Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.; Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The study will have two treatment groups, evaluating two Degarelix doses. First dose is the
      initial dose followed by a maintenance dose given every three months. The initial dose given
      to suppress the testosterone level and the three month maintenance dose to maintain the
      suppressed testosterone level over one year of treatment.
    

Eligibility criteria:

        Inclusion / Exclusion Criteria:

          -  Patients, aged 18 years or older, with histologically proven prostate cancer of all
             stages in whom endocrine treatment is indicated.

          -  Screening testosterone level above the lower limit of normal range, globally defined
             as >2.2 ng/mL.

          -  Eastern Cooperative Oncology Group (ECOG) score of ≤2.

          -  Screening prostate-specific antigen (PSA) level ≥ ng/mL.
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir & Lopinavir/ritonavir; Raltegravir and emtricitabine/tenofovir
Intervention description: Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor; Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; antiretroviral therapy naive; Integrase inhibitor; HIV/AIDS; treatment naïve

Summary:

      A prospective, randomized, open-label pilot study to assess virologic suppression and
      immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the
      protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and
      two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.

      Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and
      subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with
      Raltegravir based regimens and their relationship with functional CD8 T cells and if
      Raltegravir containing therapies leads to decreases in markers of gut microbial translocation
      and of cellular and soluble markers of immune activation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV Infection

          -  Genotypic resistance without major resistance mutations within 30 days

          -  Antiretroviral drug-naïve

          -  Screening HIV-1 RNA ≥5000

          -  Women of reproductive potential

          -  Negative pregnancy test within 48 hours

        Exclusion Criteria:

          -  Acute or recent HIV-1 infection

          -  Currently breast feeding

          -  Use of immunomodulators

          -  Evidence of major resistance mutations

          -  HBsAg positive

          -  Acute hepatitis of any etiology or clinically significant liver disease

          -  Current imprisonment or involuntary incarceration
Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
Condition: Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Decitabine; Azacitidine
Intervention description: 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.; 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Myelodysplastic syndromes; MDS; Low and Intermediate-1 Risk Disease; Decitabine; DAC; Dacogen; Azacitidine; AZA; 5-azacytidine; 5-aza; Vidaza; 5-AZC; AZA-CR; Ladakamycin; NSC-102816

Summary:

      The goal of this clinical research study is to compare how two different drugs, decitabine
      and azacitidine, when given on a shorter than standard dosing schedule can help to control
      MDS. The safety of the drugs will also be studied.

      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
      cancer cells to die.

      Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the
      function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting
      genes may be able to work better. This could cause the cancer cells to die.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sign an Institutional Review Board (IRB)-approved informed consent document.

          2. Age >/= than18 years

          3. de novo or secondary International Prostate Symptom Score (IPSS) low- or
             intermediate-1 - risk MDS, including CMML

          4. Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.

          5. Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total
             bilirubin </= 2 x ULN, Alanine transaminase (ALT) (SGPT) </= 2 x ULN

          6. Women of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days and will also need to use contraceptives. Men must agree not to father a
             child and agree to use a condom if his partner is of child bearing potential.

        Exclusion Criteria:

          1. Breast feeding females

          2. Prior therapy with decitabine or azacitidine