bioihbjkbjnl/mcl2 huggingface dataset:
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant
Condition: Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Leukemia; Lymphoma; Multiple Myeloma; MDS; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Multiple Myeloma; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases
Intervention: Ganciclovir
Intervention description: Following the first CMV-positive blood culture on day 21 or later, or the first two consecutive CMV-positive PCR tests on day 21 or later, 5mg/kg/bid x 7 days of Ganciclovir is given intravenously, followed by oral Ganciclovir 1000 mg tid 7 days per week x 5 weeks
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Antiviral drugs, such as ganciclovir, act against viruses. Giving ganciclovir by
      infusion and then by mouth may be effective treatment for cytomegalovirus that has become
      active after donor bone marrow transplant.

      PURPOSE: This phase II trial is studying how well giving ganciclovir by infusion and by mouth
      works in treating patients with cytomegalovirus after donor bone marrow transplant.
    

Eligibility criteria:

        Inclusion Criteria:

        DISEASE CHARACTERISTICS:

          -  Undergoing allogeneic transplantation, including unrelated donor bone marrow
             transplantation (BMT) and/or allogeneic donor leukocyte infusion, for any indication

          -  Patients or their donors must have had a positive pre-BMT cytomegalovirus (CMV)
             antibody titer as measured by enzyme-linked immunosorbent assay (ELISA)

        PATIENT CHARACTERISTICS:

          -  Able to comply with study requirements

        Exclusion criteria:

          -  Signs or symptoms of documented CMV infection, including any positive CMV culture from
             any site and/or any suspected or documented CMV-associated clinical syndrome, at the
             time of study entry

          -  History of symptomatic CMV-associated clinical syndrome

        PRIOR CONCURRENT THERAPY:

          -  Receiving concurrent investigational antiviral agents

        PATIENT CHARACTERISTICS:

          -  History of hypersensitivity to ganciclovir or acyclovir
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
Condition: Resistant Hypertension
MeSH terms: Hypertension
Intervention: Placebo; TBC3711; TBC3711; TBC3711; TBC3711
Intervention description: placebo tablet once daily for 12 weeks; 10 mg tablets once daily for 10 weeks; 50 mg tablet once daily for 10 weeks; 100 mg tablet once daily for 10 weeks; 200 mg tablet once daily for 10 weeks
Intervention MeSH terms: N-(2-acetyl-4,6-dimethylphenyl)-3-(3,4-dimethylisoxazol-5-ylsulfamoyl)thiophene-2-carboxamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study was to determine the safe and effective dose of TBC3711 in patients with
      uncontrolled high blood pressure while already taking blood pressure medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of resistant hypertension.

          -  A stable anti-hypertensive drug regimen for at least 30 days.

        Exclusion Criteria:

          -  Sustained blood pressure greater than or equal to 180/120 mmHg.

          -  Required use of thigh cuff for blood pressure readings.

          -  Uncontrolled diabetes mellitus.
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: NOV03; Placebo
Intervention description: Perfluorohexyloctane; Saline solution (0.9% sodium chloride solution)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane
      (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye
      Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of Drye Eye Disease (DED) in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning pregnancy

          -  Unwillingness to submit a blood pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/peri-ocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that are expected to be active during the
             study

          -  Ongoing ocular or systemic infection

          -  Wear contact lenses within 1 month prior to screening or anticipated use of contact
             lenses during the study

          -  Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or saline components

          -  Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears
             or topical anti-glaucoma medication within 2 months prior to screening
Chloroprocaine Spinal for Outpatient Knee Surgery
Condition: Knee Arthroscopy
Intervention: Chloroprocaine; Mepivacaine; General Anesthetics
Intervention description: A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed; A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed; General anesthetics will be administered intravenously
Intervention MeSH terms: Anesthetics; Mepivacaine; Chloroprocaine; Anesthetics, General
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of
      spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating
      a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize
      that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while
      avoiding the side effects of a general anesthetic, thus promoting earlier discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for a knee arthroscopy that is anticipated to be less than one hour

          -  Age 18 to 80 years

          -  Ability to follow study protocol

          -  English speaking

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Allergy or intolerance to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (taking opioids for longer than 3 months)

          -  Patients unable to undergo a spinal anesthetic or Laryngeal Mask Airway (LMA)/GA or
             patient refusal to spinal anesthesia or LMA/GA
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Condition: Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Intervention: BYM338 active drug; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Wasting syndrome; emaciation; lung cancer; adenocarcinoma; pancreatic cancer

Summary:

      A safety & efficacy clinical study of the investigational medicinal product BYM338 for the
      treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
    

Eligibility criteria:

        Key Inclusion criteria:

          1. Patients must sign an informed consent before assessment

          2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV
             non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV
             adenocarcinoma of the pancreas.

          3. Patients with stage IV NSCLC will be receiving or completed or discontinued standard
             chemotherapy or be chemotherapy-naive by choice.

          4. Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard
             chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in
             chemotherapy is not expected.

          5. Greater than or equal to 5% unintentional weight loss over the previous 3-6 months,
             not explained by simple starvation. Simple starvation is considered to be excluded
             when weight loss is not ameliorated by standard nutritional counseling and oral
             supplementation over a 2 week period.

          6. Body mass index (BMI) ≤ 30 kg/m2.

          7. Life expectancy of at least 4 months.

          8. Able to communicate well and comply with the requirements of the study, including by
             phone and written logs.

        Key Exclusion criteria:

          1. Patients who have received investigational anti-neoplastic therapy within 3 weeks of
             screening

          2. Evidence of inadequate organ or brain function, as defined by lab tests and imaging

          3. Patients with severe and/or uncontrolled medical conditions that could interfere with
             the study (e.g. heart conditions, high blood pressure, diabetes, infection)
             uncontrolled pain or any other non-stable illness

          4. Pregnant or lactating women.

          5. Women capable of becoming pregnant must use highly effective contraception during the
             study and for 8 weeks after stopping treatment. All female patients must have negative
             pregnancy test results throughout the study

          6. Patients unwilling or unable to follow instructions.

        Other protocol-defined inclusion/exclusion criteria may apply.
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: UB-311; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety, tolerability and potential efficacy, patients who
      previously participated in V203-AD study (NCT02551809) will be eligible to participate in the
      extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period
      followed by a 12-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in V203-AD trial without major safety concerns;

          -  Stable doses of permitted medications for 3 months before screening;

          -  With a caregiver;

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Clinically significant neurological disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Severe systemic disease

          -  Serious adverse reactions to any vaccine

          -  Other exclusion criteria apply
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
Condition: HCV Infection
MeSH terms: Infections; Hepatitis C; Renal Insufficiency
Intervention: SOF; RBV; LDV/SOF
Intervention description: Tablet(s) administered orally once daily; 200 mg tablet administered orally once daily; 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir
      (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and
      to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in
      participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic
      renal insufficiency (impaired kidney function).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection

          -  Cohort 3: chronic genotype 1 or 4 HCV infection

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Screening labs within defined thresholds

          -  Cirrhosis determination at screening

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing or males who have a pregnant partner

          -  Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or
             for individuals with cirrhosis, prior treatment failure with IFN-based therapy not
             resulting from treatment intolerance (Cohort 3)

          -  Current of prior history of hepatic decompensation

          -  Infection with hepatitis B virus (HBV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with individual's treatment and/or adherence
             to the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: C11 PiB; F18 Flutametamol
Intervention description: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB; One time intravenous administration of 3-7 mCi F18 Flutametamol.
Intervention MeSH terms: Corticosterone; Flutemetamol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The intent of this research protocol is to test the equivalency of two amyloid imaging drugs
      (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there
      will be no significant difference in the distribution of the agents to areas of amyloid
      deposition in the brain or to other normal brain structures. Recent data have shown
      similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild
      cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has
      been published. It is important to understand differences in the images and biodistribution
      from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain
      structures such as white matter appear to differ slightly and could affect image performance.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females 30 years of age or older.

          2. Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who
             have a study partner who is the participant's power of attorney (POA) or legally
             authorized representative (LAR), cognitive normal elderly (30) age >60 and cognitive
             normal young subjects (30) ages 30-60.

          3. Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of
             0.5 or greater.

        Exclusion Criteria:

          1. Subjects unable to lie down without moving for 30 minutes.

          2. Women who are pregnant or who cannot stop breast feeding for 24 hours.

          3. Standard safety exclusionary criteria for MRI such as metallic foreign bodies,
             pacemaker, etc,.

          4. Subjects who are too claustrophobic to perform the tests.

          5. Subject who have had previous brain irradiation, stroke or brain tumor(s)
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of investigational doses of
      dulaglutide in participants with type 2 diabetes on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
             Organization (WHO) classification

          -  Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory

          -  Have been treated with stable doses of metformin for at least 3 months

          -  Have a body mass index (BMI) ≥25 kilograms per square meter

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D)

          -  Have used any glucose-lowering medication other than metformin 3 months prior to study
             entry or during screening/lead-in period or have used any glucagon-like peptide-1
             receptor agonists (GLP-1 RAs) at any time in the past

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke)

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial

          -  Have had chronic or acute pancreatitis any time prior to study entry

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry
Ofatumumab as Front-Line Therapy in Treating Elderly Participants With Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ofatumumab
Intervention description: Given IV
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 66 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well ofatumumab works as front-line therapy in treating
      elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as
      ofatumumab, may interfere with the ability of cancer cells to grow and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic lymphocytic leukemia requiring treatment at the time of signing
             informed consent.

          -  Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status of 2-3 and a Cumulative Illness Rating Scale (CIRS) or Charlson co-morbidity
             score of 2 or higher.

          -  Creatinine < 2mg/dL.

          -  Estimated glomerular filtration rate (eGFR) more than 30cc/minute.

          -  Bilirubin < 2mg/dL.

          -  Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may
             be eligible after discussion with the study chairman.

          -  Patients with Gilbert's syndrome are eligible.

        Exclusion Criteria:

          -  Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the
             blood).

          -  Known positivity for human immunodeficiency virus (HIV).

          -  Hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg).
             In addition, if negative for HGsAg but hepatitis B core antibody (HBcAb) positive
             (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed
             and if positive the subject will be excluded.

          -  Prior treatment for chronic lymphocytic leukemia.

          -  Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal
             antibodies. Localized radiotherapy to an area not compromising bone marrow function
             does not apply. Patients with malignancies with indolent behavior such as prostate
             cancer treated with radiation or surgery can be enrolled in the study as long as they
             have a reasonable expectation to have been cured with the treatment modality received.

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             places the subject at unacceptable risk if he/she were to participate in the study.

          -  Any known hypersensitivity to ofatumumab or its components.