bioihbjkbjnl/mcl2 huggingface dataset:
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin; doxorubicin; bleomycin; vinblastine; dacarbazine
Intervention description: Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.; Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.; Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.; Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle; Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Intervention MeSH terms: Doxorubicin; Bleomycin; Dacarbazine; Brentuximab Vedotin; Vinblastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hodgkin Lymphoma; Hodgkins Lymphoma; Antibody, Monoclonal; Antibody-Drug Conjugate; Antigens, CD-30; Immunotherapy; Lymphoma; Lymphoma, Classical; ECHELON-1

Summary:

      This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of
      comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin
      (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated
      A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and
      dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.

          2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current
             World Health Organization (WHO) classification.

          3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             (<=) 2.

          4. Bidimensional measurable disease as documented by radiographic technique per the
             International Working Group Revised Criteria for Response Assessment for Malignant
             Lymphoma.

        Exclusion Criteria:

          1. Nodular lymphocyte predominant Hodgkin lymphoma.

          2. Cerebral/meningeal disease, including signs and symptoms of progressive
             multifocalleukoencephalopathy (PML).

          3. Sensory or motor peripheral neuropathy.

          4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy
             within 12 weeks of first study drug dose.

          5. Known human immunodeficiency virus (HIV) positive.

          6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
             infection.

        Please note that there are additional exclusion criteria. The study center will determine
        if you meet all of the criteria.
Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: Placebo
Intervention description: Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.; sitagliptin matching placebo for up to a 24-wk treatment period.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients
      with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes
             not controlled with diet and exercise

          -  Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol
             wash-out from oral anti-hyperglycemic agents by the qualifying visit

        Exclusion Criteria:

          -  Patients with type 1 diabetes

          -  History of ketoacidosis or requires insulin use

          -  Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600
             mg/dL, creatinine clearance < 35 mL/min

          -  Fasting plasma glucose consistently > 260 mg/dL

          -  Poorly controlled hypertension
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This was an open label single-arm study; therefore treatment blinding was not necessary.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis; Secukinumab; Simplified Psoriasis Index; CAIN457A; AIN457AFR01; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Summary:

      Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported
      Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,
      tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus
      extension) in patients with moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA
             (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at
             least 6 months

          -  patient candidates for systemic therapy.

          -  informed consent.

        Exclusion Criteria:

          -  previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.

          -  recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for
             methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF
             (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
Condition: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias
Intervention: ABT-335; Rosuvastatin Calcium; Placebo
Intervention description: 135 mg, daily, 12 weeks; Daily, 12 weeks, see Arm Description for dosage information; Daily, 12 weeks, see Arm Description for information regarding placebo type
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1445.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Summary:

      The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)
      + rosuvastatin calcium combination therapy with ABT-335 and rosuvastatin calcium monotherapy
      in subjects with multiple abnormal lipid levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mixed dyslipidemia

        Exclusion Criteria:

          -  Subjects with unstable medical conditions or medical conditions considered
             inappropriate in a clinical trial.

          -  Patients who are taking certain medications or unstable dose of specific medications.

          -  Women who are pregnant or plan on becoming pregnant or women who are lactating.
A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Condition: Acute Moderate-to-severe Pain
MeSH terms: Pain, Postoperative
Intervention: sufentanil sublingual tablet 30 mcg
Intervention description: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Intervention MeSH terms: Sufentanil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label study in patients 40 years and older who are undergoing a
      surgical procedure.

      Patients may receive one dose of ST 30 mcg as needed for pain management, but no more
      frequently than every 60 minutes, for up to 12 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients who are 40 years of age or older.

          2. Patients who have undergone a surgical procedure with general anesthesia or spinal
             anesthesia that does not include intrathecal opioids during the operation.

          3. Patients classified as American Society of Anesthesiologists (ASA) class IIII
             (Appendix I).

        Exclusion Criteria:

          1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
             surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
             hydrocodone per tablet).

          2. Patients with a positive drug of abuse screen unless the positive test result is
             consistent with a prescribed medication.

          3. Patients with a history of opioid dependence within 2 years before the start of the
             study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified
             in Appendix II.

          4. Patients who have used any illicit drugs of abuse within five years before the start
             of the study.

          5. Patients who have abused any prescription medication or alcohol within one year before
             the start of the study.

          6. Patients with an allergy or hypersensitivity to opioids.

          7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
             MAOIs within 14 days of the first dose of study drug.

          8. Patients with current sleep apnea that has been documented by a sleep laboratory study
             or are on home continuous positive airway pressure (CPAP).
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DSXS; Placebo
Intervention description: Active treatment; Placebo treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to
      Severe Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

        - male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of
        moderate to severe atopic dermatitis (AD)

        Exclusion Criteria:

        - Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic
        dermatitis.
Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 µg, once daily, oral administration in the morning; once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 933.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Roflumilast; Salmeterol; COPD; Chronic obstructive pulmonary disease

Summary:

      The aim of the study is to compare the efficacy of roflumilast on pulmonary function and
      symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during
      concomitant administration of salmeterol. The study duration will last up to 28 weeks. The
      study will provide further data on safety and tolerability of roflumilast.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  History of COPD for at least 12 months prior to baseline visit

          -  FEV1/FVC ratio (post-bronchodilator) ≤ 70%

          -  FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

        Main Exclusion Criteria:

          -  COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or
             antibiotics not stopped at least 4 weeks prior to baseline visit
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention description: Administered as an IV infusion.; Film-coated tablets administered orally.; Administered orally.; Administered as an IV infusion.
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded, active-controlled study
Enrollment: 549.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-55 age

          -  Diagnosis of RMS (McDonald criteria 2010)

          -  Active disease

          -  Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening

        Exclusion Criteria:

          -  Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed
             treatment

          -  Treatment with the following therapies at any time prior to randomization:
             alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation

          -  Diagnosed with Primary Progressive MS (PPMS)

          -  Pregnant or nursing
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
Condition: Non-Small-Cell Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Docetaxel; Ganetespib
Intervention description: Docetaxel, 75 mg/m^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent.; Ganetespib, 150 mg/m^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 696.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether combining ganetespib (STA-9090) with
      docetaxel is more effective than docetaxel alone in the treatment of patients with advanced
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)

          -  Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1

          -  Prior therapy defined as 1 prior systemic therapy for advanced disease

          -  Documented disease progression during or following most first line therapy for
             advanced disease

          -  Adequate hematologic, hepatic, renal function

        Exclusion Criteria:

          -  Epidermal growth factor receptor (EGFR) mutations

          -  Anaplastic lymphoma kinase (ALK) translocations

          -  Predominantly squamous, adenosquamous or unclear histologic type

          -  Active or untreated central nervous system (CNS) metastases

          -  Active malignancies other than NSCLC within the last 5 years with the exception of
             adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
             squamous cell carcinoma of the skin

          -  Serious cardiac illness or medical conditions

          -  Pregnant or lactating women

          -  Uncontrolled intercurrent illness
Hydrocortisone for Term Hypotension
Condition: Infant, Newborn, Diseases; Cardiovascular Insufficiency
MeSH terms: Infant, Newborn, Diseases
Intervention: Hydrocortisone; Placebo
Intervention description: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose; 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
Intervention MeSH terms: Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 34 Weeks
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Summary:

      This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on
      short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in
      critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as
      defined by a need for inotrope therapy in the first 72 hours of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age greater than or equal to 34 weeks at birth

          -  Admitted to the center NICU by 48 hours of age

          -  Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours
             postnatal age

        Exclusion Criteria:

          -  Receiving ECMO

          -  Intubated for the sole purpose of anticipated surgery or airway anomalies

          -  Treatment will be limited based on poor prognosis

          -  Receiving dexamethasone or hydrocortisone

          -  Receiving ibuprofen or indomethacin

          -  Congenital heart disease

          -  Hypotension thought to result from specific, immediately remediable factors including
             placental hemorrhage, acute hemorrhage or tension pneumothorax

          -  Pituitary hypoplasia or congenital adrenal hyperplasia

          -  Any chromosomal disorder

          -  Hypertension in the absence of inotrope therapy as defined by mean arterial blood
             pressure > 95th percentile

          -  Initiation of whole body cooling for moderate or severe neonatal encephalopathy

          -  Brain disorders or any other known structural abnormality

          -  Major anomalies
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Tiotropium
Intervention description: Subjects receiving TD-4208 are blinded to one of two doses of 4208.; There is not a placebo, there is an active comparator (Tiotropium) arm.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1060.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the safety and tolerability of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to tiotropium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study