bioihbjkbjnl/mcl2 huggingface dataset:
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta 1b (Betaseron, BAY86-5046)
Intervention description: 250 mcg administered s.c.(subcutaneous) every other day; 250 mcg administered s.c. every other day (for patients having received 500 mcg before); 500 mcg administered s.c. every other day; 500 mcg administered s.c. every other day (for patients having received 250 mcg before)
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron

Summary:

      The purpose of this study is to determine if a higher dose of study drug is more effective in
      preventing relapses in patients with Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated statement of informed consent

          -  Completion of Protocol 307000A

          -  Negative serum pregnancy test results

          -  Agreement to adequate contraception, for female patients

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  History of alcohol or drug abuse

          -  Inability to administer subcutaneous injections either by self or by caregiver

          -  Medical, psychiatric or other conditions that compromise the patient's ability to give
             informed consent, to understand the patient information, to comply with the study
             protocol, or to complete the study

          -  Any significant change in the patient's medical condition after enrollment in Study
             307000A which would have lead to his/her exclusion from participation that study
Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Nelfinavir
Intervention description: 1250 mg twice daily starting for approximately 6.5 weeks.
Intervention MeSH terms: Nelfinavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; chemotherapy; radiation therapy; nelfinavir; NFV

Summary:

      This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment
      for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0)
             NSCLC in whom neoadjuvant therapy is recommended.

          -  Must have had a mediastinoscopy to determine nodal status and potential resectability

          -  Must have enough tissue from the biopsy for tissue marker determination for
             correlative studies

          -  Negative metastatic work up (FDG PET/CT, brain CT or MRI)

          -  No prior thoracic radiotherapy will be permitted

          -  Age 18 years or greater

          -  ECOG performance status 0-1 (Karnofsky at least 70%)

          -  Normal organ and marrow function

          -  No known HIV infection

          -  Not pregnant

          -  Ability to understand and the willingness to sign an informed consent document

        Exclusion Criteria:

          -  Patients requiring a pneumonectomy

          -  Patients who have had chemotherapy or radiation therapy within 4 weeks prior to
             entering the study, or who have not recovered from adverse events due to agents
             administered earlier.

          -  Prior thoracic radiation

          -  Treatment with any other investigational agents.

          -  Known metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to NFV

          -  Patients receiving drugs contraindicated with NFV will be excluded.

          -  Uncontrolled, intercurrent 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 compliance.

          -  Pregnant or lactating women

          -  HIV-positive patients on combination antiretroviral therapy
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia; Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Azacitidine; Lenalidomide; Best Supportive Care (BSC)
Intervention description: Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7; Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily; The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Intervention MeSH terms: Lenalidomide; Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: AML; elderly; acute myelogenous leukemia; vidaza; azacitidine; elderly AML; revlimid; lenalidomide

Summary:

      The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential
      azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed
      acute myeloid leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder
             or therapy-related AML

          -  Male or female subjects aged ≥ 65

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

          -  White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

        Exclusion Criteria:

          -  Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide

          -  Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted
             therapy agents.

          -  Suspected or proven acute promyelocytic leukemia

          -  Prior bone marrow or stem cell transplantation

          -  Candidate for allogeneic bone marrow or stem cell transplantation

          -  AML antecedent hematologic disorder such as chronic myelogenous leukemia or
             myeloproliferative neoplasms

          -  Presence of malignant disease within the previous 12 months with exceptions
Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks
Condition: HIV Infections; Heart Disease
MeSH terms: Heart Diseases
Intervention: Rosuvastatin 10 mg. daily for 96 weeks; Placebo
Intervention description: Participants will take Rosuvastatin 10 mg. daily for 96 weeks.; participants will take a sugar pill daily for 96 weeks
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Heart Disease; Bone Density

Summary:

      The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in
      decreasing cardiovascular risk and bone loss in the HIV+ population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of HIV Disease

          -  Age > 18 years old

          -  Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and
             cumulative duration of ARV for 12 months

          -  Fasting LDL cholesterol < 130 mg/dl

          -  Fasting triglycerides < 300 mg/dL

          -  hsCRP > 2 mg/L or CD38+DR+/CD8+ > 19%

          -  If on Vit D replacement therapy, stable regimen for > 3 months prior to study entry

        Exclusion Criteria:

          -  Women who are pregnant or breast feeding

          -  Any active or chronic inflammatory condition

          -  Cardiovascular disease

          -  Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids,
             fibrates, ezetimibe or statins

          -  Uncontrolled hypothyroidism or hyperthyroidism

          -  Uncontrolled diabetes

          -  Use of systemic cancer chemotherapy of immunomodulating agents

          -  Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other
             anabolic agents, except for stable replacement testosterone.

          -  Use of biphosphonates or other bone therapies

          -  Any of the following lab findings obtained within 14 days prior to the screening
             evaluation including the following:

               -  AST and/or ALT > 2.5 x ULN

               -  Hemoglobin < 9.0 g/dL

               -  CK > 3 X ULN

               -  Calculated creatinine clearance < 50 mL/min
Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exubera® (inhaled insulin)
Intervention description: Treatment of type 1 and type 2 diabetes with short-acting insulin
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera®
      (inhaled insulin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2
             extension protocols

        Exclusion Criteria:

          -  Smoking

          -  Pregnancy
Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia (HPP)
MeSH terms: Hypophosphatasia
Intervention: Asfotase Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; genetic metabolic disorder; alkaline phosphatase; tissue non-specific alkaline phosphatase; rickets; osteomalacia

Summary:

      This clinical trial studies the long term safety and efficacy of asfotase alfa in children
      with HPP who completed Study ENB-006-09 (NCT00952484).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Compliant and satisfactory completion of Enobia-sponsored clinical trial ENB-006-09

          -  Written informed consent by parent or other legal guardian prior to any study
             procedures being performed

          -  Parent or other legal guardian willing to comply with study requirements

        Exclusion Criteria:

          -  Clinically significant disease that precludes study participation, in the
             Investigator's opinion

          -  Treatment with an investigational drug other than asfotase alfa

          -  Enrollment in any study (other than ENB-006-09) involving an investigational drug,
             device, or treatment for HPP

          -  Prior treatment with bisphosphonates
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Condition: Metastatic Androgen Independent Prostate Cancer
MeSH terms: Disease Progression
Intervention: APC8015F
Intervention description: APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease
      progression on protocol D9902 part B (NCT00065442)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Objective disease progression

          -  Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

        Exclusion Criteria:

          -  Infection requiring IV antibiotics

          -  Treatment with anticancer interventions within 14 days prior to enrollment

          -  Any medical condition which could compromise the study's objectives (discretion from
             sponsor)
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
Condition: Portal Hypertension; Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension
Intervention: Ifetroban; Placebo
Intervention description: thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule; matched placebo delivered as infusion and oral capsule
Intervention MeSH terms: Ifetroban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This placebo-controlled study will assess the safety and efficacy of a 90-day course of
      treatment with ifetroban for portal hypertension in cirrhotic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  liver cirrhosis

          -  baseline hepatic venous pressure gradient (HVPG) >= 8 mmHg and <= 18 mmHg

          -  stable liver function enzymes

        Exclusion Criteria:

          -  portal or splenic vein thrombosis

          -  Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt

          -  variceal bleed in last 2 months

          -  hemodialysis

          -  Child-Pugh Score >= 12

          -  Model for End-stage Liver Disease- Sodium score (MELD-Na) >= 20

          -  Acute kidney injury, Chronic kidney disease and/or Serum Creatinine >= 2.0 mg/dL

          -  current alcohol consumption > 2 drinks per day

          -  Platelet count (PLT) < 60 x 10^3/microliter (uL)

          -  A change in statin therapy in the last 3 months

          -  Current Hepatitis Virus B or C (HBV or HCV) therapy; or planned initiation of therapy
             during the treatment period

          -  Myocardial infarction within 30 days

          -  History of bleeding diathesis or current (within previous 14 days) or planned use of
             anticoagulant or antiplatelet drugs including aspirin
Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency
Condition: Lysosomal Acid Lipase Deficiency
MeSH terms: Wolman Disease
Intervention: Sebelipase Alfa
Intervention description: Sebelipase alfa is a recombinant human lysosomal acid lipase. The investigational medicinal product is an enzyme replacement therapy intended for treatment of participants with LAL-D. Dosing occurred once weekly for up to 3 years.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Maximum age: 8 Months
Healthy volunteers: No
Keywords: LIPA; Wolman Disease; Wolman Phenotype; Acid Lipase Deficiency; Acid Cholesteryl Hydrolase; Acid Lipase Disease Deficiency, type 2; Cholesteryl Ester Storage Disease (CESD); Cholesteryl Ester Hydrolase Deficiency; Early Onset Lysosomal Acid Lipase Deficiency (Wolman Disease); LAL Deficiency; Late Onset Lysosomal Acid Lipase Deficiency (CESD); Wolman Disease (early onset LAL Deficiency); Related Disorders:; Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH); Alcoholic Liver Disease; Cryptogenic Cirrhosis; Niemann-Pick Disease (NPD) Type C; Chanarin Dorfman Syndrome

Summary:

      This was an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly
      progressive lysosomal acid lipase deficiency (LAL-D). Eligible participants received
      once-weekly infusions of sebelipase alfa for up to 3 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant's parent or legal guardian (if applicable) consent to participation in the
             study

          2. Confirmation of documented decreased LAL activity relative to the normal range of the
             lab performing the assay or confirmation of LAL-D diagnosis as determined by a
             Sponsor-approved central laboratory

          3. Substantial clinical concerns, in the opinion of Investigator and Sponsor, of rapid
             disease progression requiring urgent medical intervention including, but not
             restricted to the following:

               -  Marked abdominal distension and hepatomegaly

               -  Failure to thrive

               -  Disturbance of coagulation

               -  Severe anemia

               -  Sibling with rapidly progressive course of LAL-D

        Exclusion Criteria:

          1. Clinically important concurrent disease

          2. Participant was > 8 months of age at the time of first dosing

          3. Participant received an investigational medicinal product other than sebelipase alfa
             within 14 days prior to the first dose of sebelipase alfa in this study

          4. Myeloablative preparation, or other systemic pre-transplant conditioning, for
             hematopoietic stem cell or liver transplantation

          5. Previous hematopoietic stem cell or liver transplant

          6. Known hypersensitivity to eggs
Dose Ranging Study for Indacaterol in Japanese Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol; Placebo; Salmeterol
Intervention description: In the morning, powder filled capsules inhaled using a single dose dry powder inhaler (SDDPI).; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: asthma; QAB149; indacaterol; long acting β2-agonist; bronchodilator

Summary:

      This study was designed to provide data about the safety and efficacy of 3 doses of
      indacaterol (150, 300, and 600 µg) in Japanese asthma patients so that an optimal dose, or
      doses, could be chosen for testing in later studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female Japanese asthmatic patients aged 18 to 75 years old.

        Exclusion Criteria:

          -  Patients who have been hospitalized or had emergency room treatment for an acute
             asthma attack in the 6 months prior to the first day of screening or during the
             screening period.

          -  Patients who have used tobacco products within 6 months prior to the first day of
             screening or have a smoking history of greater than 10 pack years.

          -  Patients with a history of malignancy with the exception of localized basal cell
             carcinoma of the skin.

          -  Pregnant or nursing (lactating) women.

          -  Patients who have had treatment with disallowed medications including investigational
             drug.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Quetiapine in Postpartum Depression
Condition: Postpartum Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: Quetiapine
Intervention description: 150-800 mg, oral, twice a day (bid)
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: Postpartum Depression; Quetiapine; Psychotic Symptoms

Summary:

      The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female
      patients with postpartum depressive disorder with psychotic symptoms
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent.

          -  Female patients with severe postpartum depressive disorders with psychotic symptoms
             and a minimum HAM-D cut off score of 20 points

        Exclusion Criteria:

          -  Woman with pre-existing psychotic disorder

          -  Patients with alcohol or substance abuse or dependence

          -  Patients who pose an imminent risk of suicide or danger to self or others
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DSXS topical
Intervention description: topical treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS in Patients with Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parent/legal guardian has signed informed consent form, which meets all criteria of
             current FDA regulations.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy