bioihbjkbjnl/mcl2 huggingface dataset:
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Beraprost Sodium Modified Release
Intervention MeSH terms: Epoprostenol; Beraprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and
      have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release
      (BPS-MR) tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who remained on study drug and completed all assessments during the Treatment
             Phase of Study BPS MR PAH 203 are eligible for this study.

          -  Women of child-bearing potential (defined as less than 1 year post-menopausal or not
             surgically sterile) must be using an acceptable method of birth control or practicing
             abstinence. If sexually active, female patients must use a double barrier method of
             birth control, such as a condom and spermicidal.

        Exclusion Criteria:

          -  Patients who discontinued study drug during the previous study (BPS MR PAH 203) for
             any reason (e.g. treatment related adverse events) are not eligible for entry into
             this study.

          -  Patients who are pregnant or lactating are excluded from participation in the
             open-label extension.
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
Condition: Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Buparlisib
Intervention description: 100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diffuse large B-cell lymphoma, Mantle cell lymphoma, Follicular lymphoma, PI3K inhibitor, Non-Hodgkin lymphoma, NHL

Summary:

      This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in
      patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell
      lymphoma (MCL) or follicular lymphoma (FL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular
             lymphoma, or diffuse large B cell lymphoma.

          2. Patient had relapsed or refractory disease and received at least one prior therapy.

          3. Patient with diffuse large B cell lymphoma had received or was ineligible for
             autologous or allogeneic stem cell transplant.

          4. Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria
             (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the
             long axis at baseline, then the patient must have had at least one measurable
             extra-nodal lesion.

          5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          6. Patient had adequate bone marrow and organ function.

        Exclusion Criteria:

          1. Patient had received previous treatment with PI3K inhibitors

          2. Patient had evidence of graft versus host disease (GVHD).

          3. Patient had active or history of central nervous system (CNS) disease.

          4. Patient had a concurrent malignancy or had a malignancy within 3 years of study
             enrollment (with the exception of adequately treated basal or squamous cell carcinoma
             or non-melanomatous skin cancer).

          5. Patient had a score ≥ 12 on the PHQ-9 questionnaire.

          6. Patient had a GAD-7 mood scale score ≥ 15.

          7. Pregnant or nursing women

          8. Patient who did not use highly effective contraception methods to avoid becoming
             pregnant or conceiving offspring.
Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
Condition: COVID-19
Intervention: Ivermectin; Placebo
Intervention description: ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days; Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
Intervention MeSH terms: Ivermectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ivermectin

Summary:

      This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients
      with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus
      disease (COVID-19).

      The primary efficacy endpoint is the proportion of participants with a disease control status
      defined as no progression of severe disease Hypothesis (H0): There is no difference between
      group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the
      primary endpoint on day 14.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus
             infection defined by RT-PCR.

          -  Asymptomatic, or with mild symptoms who are taking outpatient treatment of the
             disease.

          -  Signed Informed Consent.

        Exclusion Criteria:

          1. Patients with severe disease COVID-19.

          2. Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.

          3. Recurrent urinary tract infections.

          4. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its
             normal limits.

          5. Pregnant or lactating patients

          6. Patients receiving antihypertensive medication verapamil, the immunosuppressant
             cyclosporin A and / or the antipsychotic trifluoperazine.

          7. Patients with a known allergy or hypersensitivity to dewormers.

          8. Patients who are using an antioxidant supplement.

          9. Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or
             any parasitic disease in the last twelve months.
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: CDZ173; Placebo
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: 75 Years
Healthy volunteers: No

Summary:

      This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary
      therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary Sjögren's syndrome (pSS)

          -  ESSDAI score ≥ 6 at screening visit

        Exclusion Criteria:

          -  Secondary Sjögren's syndrome

        Other protocol-defined inclusion/exclusion criteria may apply.
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer
Condition: Adult Liver Carcinoma; Liver Cirrhosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis
Intervention: 18F-Fluoromisonidazole; Arterial Embolization; Computed Tomography; Positron Emission Tomography
Intervention description: Undergo [18F] FMISO PET/CT; Undergo transcatheter arterial embolization; Undergo [18F] FMISO PET/CT; Undergo [18F] FMISO PET/CT
Intervention MeSH terms: Misonidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission
      tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in
      imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks
      blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor.
      [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that
      have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET
      scan and this may help researchers learn whether changes occur in the tumors after treatment,
      which can help decide how well the treatment worked earlier than is currently possible
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Histopathologic or imaging and clinical features of tumor(s) diagnostic for
             hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features
             diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and
             Data System (LIRADS) 4 or greater

          -  Total bilirubin < 3.0

          -  Child Pugh A or B

          -  Tumor amenable to transcatheter arterial embolization

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Uncontrolled large ascites

          -  Main or segmental portal vein thrombosis

          -  Locoregional treatment of hepatocellular carcinoma within the prior 3 months or
             chemotherapy within the previous 3 months

          -  Inability or contraindication to undergo transcatheter arterial embolization

          -  Inability to lay flat for at least 2 consecutive hours

          -  Severe acute illness

          -  Uncontrolled chronic illness such as hypertension, diabetes, or heart failure

          -  Contraindication to CT or MRI contrast

          -  Pregnancy
A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
Condition: Cutaneous T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Placebo; CD11301 0.03%; CD11301 0.06%
Intervention description: Non active ingredients of CD11301; Topical Gel; Topical Gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T-Cell; Lymphoma; Cutaneous; CTCL

Summary:

      To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel
      vs. placebo for early stage CTCL (IA, IB, or IIA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months

          -  Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3
             distinct lesions

        Exclusion Criteria:

          -  CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary
             cells or CD8+ or large cell transformation or Progressive CTCL

          -  History of autoimmune disease

          -  Laboratory test values at screening outside of the normal range and judged clinically
             significant by the investigator

          -  Current participation in another clinical trial of a drug or device or past
             participation within 4 weeks before Baseline or participant is in exclusion period
             from a previous clinical trial
Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers
Condition: Covid19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine Sulfate (HCQ)
Intervention description: Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: covid19; workers; prevention

Summary:

      The study proposes to conduct an open-label Phase II trial to evaluate the feasibility,
      safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of
      transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development
      of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider
      participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50
      years track record of safety of HCQ for treatment and prevention of various disease states.
      Early data on use of HCQ for COVID treatment suggests anti-viral activity and
      immunomodulatory properties for reducing inflammation associated with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Volunteers ages 18 to 99 years,

          -  Able to sign own informed consent form,

          -  Considered high-risk healthcare care providers in a hospital setting with active
             exposure to COVID-19 infection.

        High-risk healthcare providers are defined as those actively working during the study
        duration in the Emergency Department and in the Intensive Care Setting, for the purpose of
        this study.

        Exclusion Criteria:

          -  Inability to tolerate an oral medication or known allergy to chloroquine or
             hydroxychloroquine

          -  Pregnancy or breast-feeding

          -  Immunocompromised status, hepatic failure, electrolytic imbalance

          -  Creatinine clearance (CCL) <30 mL/min

          -  Prolonged QT interval (QTc > 450ms for males and QTc > 470 for females)

          -  Confirmed COVID-19 infection on baseline testing

          -  Has another known contraindication to treatment with the study drug, including
             retinopathy.
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Wasting Syndrome; Cachexia
Intervention: Tesamorelin; Placebo
Intervention MeSH terms: Tesamorelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD; Muscle wasting

Summary:

      A significant proportion of COPD subjects experience muscle wasting, which has been
      associated with increased morbidity, impaired physical functioning, and a poor quality of
      life.

      Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular,
      weakness of peripheral muscles has been reported to play an important role in the reduced
      functional capacity and impaired exercise performance.

      The primary objective of this study is to investigate the effect of tesamorelin, in
      conjunction with exercise training, on lean body mass measured by dual energy x-ray
      absorptiometry (DXA) scan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 40-75 years (y) inclusive

          -  Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)

          -  Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening

          -  Able to participate in a supervised exercise training program

          -  Evidence of muscle wasting

        Exclusion Criteria

          -  Participation in a pulmonary rehabilitation program or in any supervised exercise
             program during the 4 months prior to screening

          -  More than 4 exacerbations in the year prior to screening

          -  Life-threatening exacerbation in the year prior to screening

          -  Requirement for long-term oxygen therapy (> 12 hours of oxygen per day)

          -  Critical illness or co-morbid conditions that may interfere with study conduct or
             endpoint measurements

          -  Use of agents known to increase lean body mass within 3 months prior to screening

          -  Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head
             trauma
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Condition: Atrial Fibrillation; Heart Failure
MeSH terms: Heart Failure; Atrial Fibrillation
Intervention: Ranolazine; Placebo
Intervention description: Patients will take ranolazine 1000 mg tablets twice daily; Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; heart failure; ranolazine; cardioversion; persistent AF; paroxysmal AF

Summary:

      The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of
      recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved
      ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female > 18 years of age;

          -  Documentation of heart failure and who are in NYHA class II or III;

          -  Documented history of symptomatic AF < 6 months in duration at the time of
             presentation, currently in AF at the time of the external electrical cardioversion,
             and successfully restored to normal sinus rhythm;

          -  Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation
             with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);

          -  Demonstration of preserved ejection fraction (EF) by echocardiography;

          -  Echocardiographic evidence of impaired diastolic filling.

        Exclusion Criteria:

          -  Known history of permanent or long-standing AF (> 6 months);

          -  Other acutely reversible causes of AF, including but not limited to: hyperthyroidism,
             pericarditis, myocarditis or pulmonary embolism;

          -  Known history of cirrhosis;

          -  NYHA Class IV;

          -  Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within
             three months prior to screening;

          -  Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these
             patients need to be placed on rivaroxaban or dabigatran post-cardioversion;

          -  Clinically significant valvular disease;

          -  Clinically significant pulmonary disease;

          -  Stroke within 3 months prior to screening;

          -  Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;

          -  Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;

          -  Concurrent use of drugs considered strong inhibitors of CYP3A;

          -  Concurrent use of drugs considered as CYP3A inducers;

          -  Prior treatment with ranolazine.
A Phase IIa Study of TAS-205 for Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: TAS-205; Placebo
Intervention description: 2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal; 1 group: Placebo group. Oral administration for 24 weeks, BID after meal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Male
Minimum age: 5 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of
      TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give an informed consent. If applicable, able to give an informed assent.

          -  Phenotypic evidence of DMD.

          -  Male and ≧5 years of age.

          -  Bodyweight ≧7.5 kg and <60 kg.

          -  Able to complete the 6MWD test with a distance of at least 75 m.

          -  Able to take tablets.

          -  If taking oral glucocorticoids no significant change in the total daily or dosing 6
             months before enrollment.

        Exclusion Criteria:

          -  Any serious drug allergy.

          -  A forced vital capacity (FVC) of <50% of predicted value.

          -  Wearing a respirator continuously (except for the use during sleep).

          -  A left ventricular ejection fraction (EF) of <40% or fractional shortening (FS) of
             <25% on echocardiogram.

          -  Clinically significant cardiac failure and respiratory failure.

          -  Ongoing immunosuppressive therapy (other than corticosteroids) .

          -  Surgical history or plan for surgery that may affect muscular strength or motor
             function.

          -  Any injury that may affect muscular strength or motor function.

          -  With any systemic allergic disease or any chronic inflammatory disease.

          -  Previous gene therapy (exon skipping, or stop codon read through therapy), cell-based
             therapy, or any other investigational agents.