bioihbjkbjnl/mcl2 huggingface dataset:
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; RBV; GS-9669
Intervention description: Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg); GS-9669 tablet(s) administered orally once daily
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1; HCV; Sustained Virologic Response; Direct-Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Open Label; Sofosbuvir; Treatment-Naive; Protease Inhibitors; PI; Treatment experienced; Cirrhotic

Summary:

      This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose
      combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or
      treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
      A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment,
      approximately 60 having had prior treatment with a regimen containing pegylated interferon
      (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus
      treatment-experienced and by HCV genotype (1a versus 1b).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18, with chronic genotype 1 HCV infection

          -  Documented HCV treatment-naïve or treatment-experienced subjects who failed previous
             PEG+RBV regimen

          -  HCV RNA > 10,000 IU/mL at Screening

          -  Presence of compensated cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol
A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Siltuximab; Placebo; Best supportive care (BSC)
Intervention description: 15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks; Administered as a 1-hour intravenous infusion every 4 weeks; Best supportive care according to local standards and guidelines
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; MDS; Blood and lymphatic diseases; Siltuximab; Anemic

Summary:

      The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a
      reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic
      Syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of myelodysplastic syndrome (MDS), according to World Heath
             Organization or the French-American-British Cooperative Group pathologic
             classification, with an International Prognostic Scoring System score 0, 0.5, or 1.0,
             indicating Low- or INT-1-risk disease.

          -  Documented RBC transfusion of at least 2 units of RBC for the treatment of the anemia
             of MDS in the 8 weeks preceding the start of the Screening Period.

          -  Adequate iron stores, demonstrated by either the presence of stainable iron in the
             bone marrow or a serum ferritin of > 100 ng/mL.

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

          -  Symptomatic anemia (defined by a score > 0 on the Non-Chemotherapy Anemia Symptom
             Scale [NCA-SS]).

        Exclusion Criteria:

          -  Had treatment with drugs or other agents targeting IL-6 or its receptor within 4 weeks
             of randomization.

          -  Any condition that, in the opinion of the investigator, would make participation not
             in the best interest (eg, compromise the well-being) of the patient or that could
             prevent, limit, or confound the protocol-specified assessments.

          -  Patients with Chronic Myelomonocytic Leukemia (CMML).

          -  Causes other than MDS contributing to anemia, such as Vitamin B12 or folate
             deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic renal failure.
An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
Condition: Autism; Asperger's Disorder; Pervasive Developmental Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Asperger Syndrome
Intervention: Aripiprazole
Intervention description: open-label, flexible-dosing
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: behavioral problems; aggression; autism; aripiprazole

Summary:

      The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole
      monotherapy in the treatment of children and adolescents suffering from Autism Spectrum
      Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in
      reducing ASD-associated symptoms of anxiety and aggression, resulting in significant
      improvements in global outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females ages 6-17

          -  A diagnosis of Autism, Asperger's Disorder, or Pervasive Developmental Disorder - not
             otherwise specified (PDD NOS)

          -  Medically healthy

          -  Ability to give assent

          -  Significant tantrums, aggression, self-injurious behavior and/or agitation by
             achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability
             subscale and a score of moderate or higher on the Clinical Global Impressions-Severity
             Scale.

        Exclusion Criteria:

          -  Co-morbid serious mental illness.

          -  Intelligence Quotient (IQ) <50, based on verified records of cognitive testing
             performed within 2 years of enrollment. In event that suitable records of prior
             testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of
             Intelligence (WASI, 1999 Harcourt Assessment, Inc.).

          -  Significant active medical and/or neurological illness.

          -  Subjects that require other psychotropic medications such as antidepressants, mood
             stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic
             medications in order to maintain clinical stability.

          -  Active substance abuse/dependence based upon history and urine toxicology screen.

          -  Inability to have blood drawn at baseline and termination visits.

          -  Known allergy or hypersensitivity to aripiprazole or its ingredients.

          -  Patients clinically stable on current medications.
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab; Trastuzumab
Intervention description: Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.; 2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.
Intervention MeSH terms: Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with
      Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on
      trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the
      efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and
      clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840
      milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab
      will be administered at the same schedule the participant was following before entry into the
      study. An additional cohort of participants at certain centers will receive pertuzumab
      monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks.
      These participants may have trastuzumab added to the regimen in the event of progression
      during single-agent pertuzumab treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females greater than or equal to (≥) 18 years of age, with histologically-confirmed
             HER2-positive breast cancer

          -  Metastatic breast cancer, with progression on trastuzumab-based therapy as last
             treatment for metastatic disease

          -  Less than or equal to (≤) 3 chemotherapy regimens prior to study entry

          -  Last trastuzumab dose ≤9 weeks before study entry for participants receiving
             pertuzumab + trastuzumab, and ≥4 weeks for participants receiving pertuzumab
             monotherapy

          -  Left ventricular ejection fraction ≥55% at study entry

        Exclusion Criteria:

          -  Previous treatment with an anti-cancer vaccine or any targeted therapy other than
             trastuzumab

          -  Brain metastases

          -  History of any cardiac adverse event related to trastuzumab therapy

          -  Any other malignancy in the last 5 years, except for basal cell cancer or cancer in
             situ of the cervix
MP1032 Treatment in Patients With Moderate to Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: MP1032; Placebo
Intervention description: Hard gelatin capsules for oral administration.; Placebo capsules matched to MP1032 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; MP1032

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of
      care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to
      severe coronavirus disease 2019 (COVID-19).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant is admitted to hospital and has a positive severe acute respiratory
             syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse
             transcription-polymerase chain reaction (RT-PCR) assay or equivalent test

          -  Participant has the presence of any symptom(s) suggestive of moderate or severe
             systemic illness with COVID-19

        Key Exclusion Criteria:

          -  Participant, in opinion of the investigator, is not likely to survive >=48 hours
             beyond Day 1

          -  Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical
             COVID-19 on Day 1

          -  Participant has a documented medical history of infection with hepatitis A, B, C, or
             with human immunodeficiency virus (with a detectable viral load and CD4 count <500
             cells per micro liter), or a documented active infection with tuberculosis.

          -  The Participant has clinically significant electrocardiogram (ECG) abnormalities at
             screening

        Other protocol defined inclusion/exclusion criteria may apply
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Condition: Heart Failure; Elevated Serum Uric Acid
MeSH terms: Heart Failure
Intervention: allopurinol; sugar pill
Intervention description: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.; Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Intervention MeSH terms: Allopurinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether allopurinol is effective in relieving
      symptoms of patients with heart failure and high blood uric acid levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.

          -  Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms
             for 3 months despite standard treatment.

          -  Serum uric acid level ≥ 9.5 mg/dl.

          -  At least one of the following additional markers of increased risk: Hospitalization,
             ER visit or urgent clinic visit for heart failure requiring IV diuretics within the
             previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic
             peptide level > 250 pg/ml

        Exclusion Criteria:

          -  Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven
             myocarditis, severe stenotic valvular disease, or complex congenital heart disease.

          -  Acute coronary syndrome, PCI or CABG within 3 months.

          -  Current ventricular assist device or ventricular assist device or heart transplant
             likely within the next 6 months.

          -  Uncontrolled hypertension (i.e., SBP > 170 mm Hg or DBP > 110 mm Hg)

          -  Serum creatinine > 3 mg/dL or estimated GFR < 20 ml/min.

          -  Evidence of active hepatitis with ALT and AST greater than 3x normal.

          -  Any condition other than HF which could limit the ability to perform a 6-minute walk
             test

          -  Any diseases other than HF which are likely to alter the patient's global perception
             of status or quality of life over a period of 6 months.

          -  Receiving treatment with allopurinol currently or within 30 days, or having
             symptomatic hyperuricemia which requires treatment with allopurinol.
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Condition: Hypertension, Pulmonary; Ventricular Dysfunction, Left
MeSH terms: Hypertension, Pulmonary; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Riociguat (Adempas, BAY63-2521); Riociguat (Adempas, BAY63-2521); Riociguat (Adempas, BAY63-2521); Placebo
Intervention description: up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg); up to 1 mg three times a day (increasing from 0.5 to 1 mg); fixed 0.5 mg three times a day; Placebo three times a day
Intervention MeSH terms: Riociguat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pulmonary Hypertension; Left ventricular dysfunction

Summary:

      The aim of this study is to assess whether increasing oral doses of Riociguat are safe and
      improve the well-being, symptoms and outcome in patients with pulmonary hypertension
      associated with left ventricular systolic dysfunction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with symptomatic pulmonary hypertension due to left
             ventricular systolic dysfunction despite optimized heart failure therapy

        Exclusion Criteria:

          -  Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Condition: Sleep; Burns
Intervention: zolipidem; ramelteon
Intervention description: zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization; ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      To examine sleep changes following therapeutic drug interventions designed to promote sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Burn injury > 20% total body surface area

          -  Between 3 and 18 years of age

          -  < 7 days from acute injury

          -  Written informed consent and HIPPA release signed

        Exclusion Criteria:

          -  Suspected anoxic brain injury or head injury

          -  Hepatic or endocrine disease

          -  History of alcoholism or substance abuse

          -  Pre-existing neurological or primary psychiatric disorder

          -  Medical history of pre-existing sleep disorder or lactose deficiency

          -  Questionable survival (<72 hrs) as decided by PI

          -  Receipt of drugs with known effects on sleep within 24 hrs of study entry

          -  No informed consent/HIPPA release
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
Condition: AL Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: NEOD001; Placebo
Intervention description: NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates; Saline Bag
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: amyloidosis; ntprobnp; NEOD001; Prothena; PRONTO; amyloid; plasma cell dyscrasia; immunotherapy

Summary:

      This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled,
      two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered
      intravenously in adults with AL amyloidosis who had a hematologic response to previous
      treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT])
      and have persistent cardiac dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years

          2. Confirmed diagnosis of systemic AL amyloidosis

          3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic
             response

          4. Cardiac involvement

          5. NT-proBNP ≥650

        Exclusion Criteria:

          1. Non-AL amyloidosis

          2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma

          3. NT-proBNP >5000

          4. Received Plasma cell directed chemotherapy within 6 months

          5. Received autologous stem cell transplant (ASCT) within 12 months