bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: LDV/SOF; RBV; SOF/VEL; VOX
Intervention description: 90/400 mg FDC tablet administered orally once daily; 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); 400/100 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily with food
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of combination
      therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection

          -  Cirrhosis determination (liver biopsy may be required)

          -  Screening laboratory values within specified limits

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

          -  Specific genotype, prior medical history, or concurrent disease as required by the
             specific study group

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Pregnant or nursing female, or male with pregnant female partner

          -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

          -  Use of any prohibited concomitant medications

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Pasireotide
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acromegaly; Pasireotide; GH; IGF-1

Summary:

      Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth
      hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the
      long-term safety and efficacy of pasireotide in participants with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed all four treatment regimens in the core study
             CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and
             insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide
             administration at any of the three doses.

          -  Participants who did not experience any unacceptable adverse events or tolerability
             issues during the core study CSOM230B2201.

        Exclusion Criteria:

          -  Participants who experienced or developed compression of the optic chiasm causing any
             visual field defect during the core study CSOM230B2201.

          -  Participants who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression during the core study CSOM230B2201.

          -  Participants who experienced or developed congestive heart failure, unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation or acute myocardial
             infraction during the core study CSOM230B2201.

        Other protocol-defined inclusion/exclusion criteria may apply.
Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine
Condition: Migraine in Children
MeSH terms: Migraine Disorders
Intervention: Valproic Acid (VPA); Dihydroergotamine (DHE)
Intervention description: IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours; 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
Intervention MeSH terms: Dihydroergotamine; Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Valproic acid; Dihydroergotamine; Pediatric

Summary:

      The objective of this study is to compare clinical efficacy and tolerability of valproic acid
      (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  acute migraine as per ICHD-II criteria

          -  pediatric (age 10-18)

        Exclusion Criteria:

        For Valproic Acid (VPA)

          -  Pregnancy

          -  Liver disease (Acute or Chronic)

          -  Urea Cycle Disorder

          -  Mitochondrial Disease

        For Dihydroergotamine (DHE)

          -  Pregnancy

          -  Peripheral vascular disease, coronary heart disease

          -  History of cerebrovascular event

          -  Severe or poorly controlled hypertension

          -  Impaired liver or renal function

          -  Triptan given in last 24 hours

          -  Hemiplegic migraine
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla
Condition: Ductal Adenocarcinoma of Pancreas; Adenocarcinoma of Ampulla
MeSH terms: Adenocarcinoma
Intervention: Gemcitabine and nanoparticle albumin bound paclitaxel; 5-fluorouracil and irinotecan; Preoperative chemoradiation; Definitive resection
Intervention description: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles; FOLFIRI.3 given every 14 days x 4 cycles; Pre-operative chemoradiation to 40 Gy in 20 fractions; Definitive surgical resection of primary tumor
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease
      will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then
      surgical resection for those with resectable or borderline resectable disease. The primary
      endpoint is disease-free survival at 1 yr from initiation of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or
             ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional
             imaging.

          -  Fitness for chemotherapy in judgement of treating physician

          -  Bilirubin < 4 (any means of biliary drainage acceptable)

        Exclusion Criteria:

          -  Medical or mental illness precluding provision of informed consent

          -  Pregnancy

          -  Active infection for which neutropenia would pose high risk of mortality
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Sotrovimab (Gen1); Sotrovimab (Gen2); Sotrovimab (Gen2)
Intervention description: Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection; Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion
Intervention MeSH terms: Sotrovimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Part A is double-blinded. Parts B and C are open label.
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; coronavirus; coronavirus disease 2019; COVID-19

Summary:

      This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will
      receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2
      (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Part A, participants must be aged 18 years or older at the time of obtaining
             informed consent

          -  For Parts B and C, participants must be aged between 18 years and 69 years old at the
             time of obtaining informed consent

          -  Participants who have a positive SARS-CoV-2 test result ≤7 days prior to enrollment
             and oxygen saturation ≥94% on room air and have COVID-19 symptoms and ≤7 days from
             onset of symptoms

        Exclusion Criteria:

          -  Currently hospitalized or judged by the investigator as likely to require
             hospitalization in the next 24 hours

          -  Symptoms consistent with severe COVID-19

          -  Participants who, in the judgement of the investigator are likely to die in the next 7
             days.

          -  Severely immunocompromised participants

          -  For Parts A and B, prior receipt of a SARS-CoV-2 vaccine at any time prior to
             enrollment (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be
             allowed for 90 days after dosing)

          -  For Parts B and C, conditions that would prohibit receipt of IM injections in the
             investigator's opinion

          -  For Parts A, B and C, receipt of any vaccine within 48 hours prior to enrollment
             (vaccination with an authorized or approved SARS-CoV-2 vaccine will not be allowed for
             90 days after dosing)
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Dociparstat sodium; Idarubicin; Cytarabine
Intervention description: Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy.; Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy.; Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5.
Intervention MeSH terms: Cytarabine; Idarubicin; Heparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to
      determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different
      does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation
      therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid
      leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects had to meet all the following criteria to be eligible for enrollment in this
        study:

          1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia
             (AML).

          2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

        Exclusion Criteria:

        Subjects who met any of the following criteria were not eligible for enrollment in this
        study:

          1. Had acute promyelocytic leukemia

          2. Had prior chemotherapy for AML.

          3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of
             myelodysplastic syndrome.

          4. Had central nervous system (CNS) leukemia.
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Condition: Preterm Delivery; Inadequate Milk Production
MeSH terms: Premature Birth
Intervention: Merotocin; Placebo
Intervention description: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).; Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: Inadequate Milk Production

Summary:

      Induction and support of lactation in women with preterm delivery and inadequate milk
      production.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Delivered at the hospital system associated with the trial center

          -  Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days

          -  Willing to express milk at least 5 times every 24 hours during the observation period
             and 6 to 8 times every 24 hours during the treatment and post-treatment follow up

          -  Produced < 200 mL milk in 24 hours prior to randomization

          -  Delivered 96 to 192 (+4) hours prior to randomization

        Exclusion Criteria:

          -  Pre-pregnancy body mass index (BMI) > 50 kg/m^2

          -  Mastitis

          -  History of breast trauma, breast surgery, nipple piercing

          -  Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary
             surgery/radiation therapy

          -  Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note:
             gestational diabetes is allowed (also when requiring the use of insulin for treatment)

          -  Unstable thyroid disease

          -  Moderate or severe renal or hepatic impairment

          -  Mental illness

          -  Significant nasal congestion or mucous production

          -  Use of anti-psychotic drugs within past 12 months
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Condition: Malignant Neoplasm; Oral Pain; Stomatitis
MeSH terms: Neoplasms; Mucositis; Stomatitis
Intervention: Best Practice; Methylene Blue; Methylene Blue; Methylene Blue
Intervention description: Given standard of care therapy; Given lower dose PO; Given medium dose PO; Given higher dose PO
Intervention MeSH terms: Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well methylene blue works in treating patients with cancer
      and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral
      mucositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the
             combination

          -  Patients with a current diagnosis of oral mucositis

          -  Patients with pain and oral dysfunction associated with oral mucositis despite
             conventional therapy

          -  Voluntary written consent

          -  Patient must agree to use of contraception or abstinence from sex during the treatment
             period and for 30 days after patient's last dose

        Exclusion Criteria:

          -  Patients with known allergy to MB

          -  Patients taking medications with known significant drug interactions

          -  Pregnant or lactating patients

          -  Patients who are cognitively impaired and unable to consent for the study

          -  Patients with risk of broncho-aspiration based on documented swallowing test by a
             speech pathologist (if available)

          -  Patients with known history of G6PD deficiency

          -  Patients undergoing any other experimental intervention for oral mucositis

          -  Patients who have no pain or impairment in oral function, patients who are not
             symptomatic

          -  Patients with head and neck cancer

          -  Patients on serotonergic drugs
Clinical Evaluation of Flortaucipir F 18
Condition: Alzheimer's Disease; Traumatic Brain Injury; Depression
MeSH terms: Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 MBq (10 mCi), up to two doses; positron emission tomography (PET) scan of the brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to expand the database of flortaucipir F 18 safety and tau binding as
      measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data
      collection and analysis to facilitate companion studies including, but not limited to,
      longitudinal studies of aging, depression, and traumatic brain injury.
    

Eligibility criteria:

        Subjects should meet inclusion and exclusion criteria for the companion protocol in
        addition to the criteria below.

        Inclusion Criteria:

          -  Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of
             the companion study

        Exclusion Criteria:

          -  Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
             endocrine disturbances

          -  Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if
             male or QTc > 470 msec if female

          -  Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking
             drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the
             setting of intraventricular conduction block may be enrolled with sponsor approval

          -  Have a history of drug or alcohol dependence within the last year, or prior prolonged
             history of dependence unless approved by the sponsor

          -  Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity or not using reliable methods of contraception

          -  Have a history of relevant severe drug allergy or hypersensitivity

          -  Are patients who have received an investigational medication within 30 days prior to
             the planned imaging session for this study

          -  Are patients with current clinically significant unstable medical comorbidities

          -  Are patients who have received a radiopharmaceutical for imaging or therapy within the
             past 24 hours prior to the imaging session for this study
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
Condition: Pneumonia, Ventilator-associated; Pneumonia, Staphylococcal
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia, Staphylococcal
Intervention: ASN100; Placebo
Intervention description: monoclonal antibody combination of ASN-1 and ASN-2; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia; S. aureus; Mechanically ventilated

Summary:

      The purpose of this study is the prevention of Staphylococcus aureus pneumonia in
      mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a
      human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.
      Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including
      ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a
      significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is
      an investigational monoclonal antibody product that targets the toxins produced by S. aureus
      to protect subjects from developing S. aureus pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e.,
        orotracheal or nasotracheal) and, in the Investigator's opinion, will require ongoing
        ventilator support for at least 48 hours;

        Exclusion Criteria:

          -  Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive
             for a diagnosis of pneumonia

          -  Subject has a known and documented ETA culture showing heavy colonization with a
             -Gram-negative organism at enrollment or at any time during the Screening period;

          -  Significant Neutropenia

          -  Severe non-pulmonary source of infection.

          -  Subjects with a known history or current (suspected) diagnosis of cytokine release
             syndrome associated with the administration of peptides, proteins, and/or antibodies.