bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: AL-335; Odalasvir; Simeprevir
Intervention description: AL-335 800 mg (2*400) tablet will be administered once daily.; Odalasvir 25 mg tablet will be administered once daily.; Simeprevir 75 mg capsule will be administered once daily.
Intervention MeSH terms: Simeprevir; Odalasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; AL-335; Odalasvir; Simeprevir; ODV; SMV; ACH-3102; ACH-0143102; TMC435

Summary:

      The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12),
      safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335,
      odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected
      subjects without cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection

          -  Documented as treatment naive or experienced with a prior regimen consisting of
             Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response

          -  Absence of cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Must use specific contraceptive methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

          -  Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination
             with pegylated interferon (PegIFN) or IFN-free

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically significant illness or any other medical disorder including
             cardiovascular conditions that may interfere with individual's treatment, assessment
             or compliance with the protocol

          -  Pregnant or a nursing female
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: lenalidomide
Intervention description: 25mg oral capsules continuous days 1-21 each of a 28 day cycle
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; CC-5013; Revlimid; Lenalidomide

Summary:

      To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle
      cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven mantle cell lymphoma

          -  Patients must have documents relapsed, refractory or PD after treatment with
             bortezomib

          -  Must have measureable disease on cross sectional imaging by CT

          -  Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2

          -  Willing to follow pregnancy precautions

        Exclusion Criteria:

          -  Any of the following laboratory abnormalities

               -  Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)

               -  Platelet count < 60,000/mm3 (60 x 109/L)

               -  Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or
                  alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper
                  limit of normal (ULN), except in patients with documented liver involvement by
                  lymphoma.

               -  Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and
                  documented liver involvement by lymphoma.

               -  Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min

               -  Patients who are candidates for high dose chemotherapy/allogeneic stem cell
                  transplant are not eligible

               -  History of active central nervous system (CNS) lymphoma within the previous 3
                  months

               -  Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis

               -  Prior history of malignancies, other than MCL, unless the patient has been free
                  of the disease for ≥ 3 years

               -  Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114 Lot 1; V114 Lot 2; Prevnar 13™
Intervention description: Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1051.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety, tolerability, and immunogenicity of two
      different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
      primary hypothesis of the study is that the proportion of participants receiving V114 who
      have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
      6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
      recipients of Prevnar 13™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infant approximately 2 months of age (42 days to 90 days), inclusive

          -  In good health

        Exclusion Criteria:

          -  Prior administration of any pneumococcal vaccine

          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any
             diphtheria toxoid-containing vaccine

          -  Known or suspected impairment of immunological function

          -  History of congenital or acquired immunodeficiency (eg, splenomegaly)

          -  Mother has documented human immunodeficiency virus (HIV) infection

          -  Mother has documented hepatitis B surface antigen-positive test result

          -  Known or history of functional or anatomic asplenia

          -  History of failure to thrive

          -  History of a coagulation disorder

          -  History of autoimmune disease

          -  Known neurologic or cognitive behavioral disorder

          -  Expects to require systemic corticosteroids within 30 days after each vaccination
             during the trial

          -  Prior administration of a blood transfusion or blood products, including
             immunoglobulin

          -  Participated in another clinical trial of an investigational product

          -  History of invasive pneumococcal disease or known history of other culture-positive
             pneumococcal disease
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Glucose Intolerance
Intervention: Azeliragon; Placebo
Intervention description: Azeliragon 5 mg capsule administered orally, once daily; Matching placebo capsule administered orally, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Receptor for Advanced Glycation Endproducts (RAGE); ADAS-cog; CDR-sb

Summary:

      This is a study to evaluate the efficacy and safety of azeliragon in patients with mild
      Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon
      or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21
      months (in Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression
             of disease

          -  Mini Mental State Examination (MMSE) score of 21-26, inclusive

          -  Clinical Dementia Rating global score of 0.5 or 1

          -  Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more

          -  Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD

          -  Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least
             2 months prior to screening

          -  Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive

          -  Caregiver willing to participate and be able to attend clinic visits with patient

          -  Ability to ingest oral medications

        Exclusion Criteria:

          -  Significant neurological or psychiatric disease other than Alzheimer's disease

          -  Previous clinical trial participation within 90 days of screening

          -  Previous exposure to putative disease modifying therapy for Alzheimer's disease within
             1 year of screening

          -  History of cancer within the last 5 years except adequately treated cervical carcinoma
             in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate
             cancer not requiring current treatment

          -  Women of childbearing potential

          -  Uncontrolled blood pressure and/or blood pressure above 140/90

          -  Participants receiving medications that may negatively impact cognitive function

          -  History of diabetic ketoacidosis within the past year

          -  History of chronic pancreatitis

          -  Stage 4 kidney disease

          -  Use of insulin therapy
CAndesartan vs LIsinopril Effects on the BRain
Condition: Hypertension; Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: Candesartan; Lisinopril
Intervention description: blinded; Blinded
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Lisinopril
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Cerebrovascular function

Summary:

      The aim of this study is to conduct a 1-year double blind randomized control trial comparing
      candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive
      impairment in their effects on executive function, neuroimaging markers, and vascular
      indicators.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age: 55 years or older;

          2. Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications.

          3. Executive MCI will be defined using these criteria:

               1. The Montreal Cognitive Assessment (MoCA) score less than or equal to 26

               2. Executive dysfunction: A performance at the 10th percentile or below on at least
                  one of four screening tests for executive function: Trail Making Test, Part B
                  (TMT-B), modified Stroop interference, Digit Span and Digit Sequencing, and
                  Letter fluency.

               3. Minimal Functional limitation as reflected by the Functional Assessment
                  Questionnaire (FAQ)≤7

        Exclusion Criteria:

          1. Intolerance to study drugs;

          2. SBP >200 or DBP >110 mm Hg;

          3. Renal disease or hyperkalemia

          4. Active medical or psychiatric problems

          5. Uncontrolled congestive heart failure;

          6. History of stroke in the past 3 years;

          7. Inability to perform the study procedures

          8. Women of childbearing potential

          9. diagnosis of dementia

         10. In those who lack decision capacity, a study surrogate who can sign on their behalf
             will be required. Since we are enrolling only those with MCI, we anticipate that most
             participants will have decision capacity

         11. Current use of Lithium, as most antihypertensive classes may lead to increased lithium
             toxic levels.
Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
MeSH terms: Mycoses; Invasive Fungal Infections; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Voriconazole; Liposomal amphotericin B; Liposomal amphotericin B
Intervention description: 400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily; 3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes; 9 mg/kg intravenously once per week over 2 hours +/- 15 minutes
Intervention MeSH terms: Voriconazole; Amphotericin B; Liposomal amphotericin B
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Voriconazole; Vfend; Liposomal amphotericin B; Ambisome; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; AML; MDS

Summary:

      The goal of this clinical research study is to compare the effectiveness of liposomal
      amphotericin B given three times per week , versus liposomal amphotericin B given once per
      week, versus oral voriconazole in the prevention of fungal infections in patients with acute
      myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The
      safety of these treatments will also be studied and compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage
             chemotherapy.

          -  Age >/=18 years.

          -  Patients must sign an informed consent.

        Exclusion Criteria:

          -  Patients with history of anaphylaxis attributed to azole or amphotericin B compounds.

          -  Patients with clinical or other evidence that indicates that they have proven or
             probable invasive fungal infection prior to enrollment.

          -  Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0
             mg/dl); or serum glutamic pyruvic transaminase (SGPT)> 5 times upper limit normal.

          -  Patients with serum creatinine > 2.0 mg/dl.

          -  Patients receiving any medication that is contraindicated with the use of
             voriconazole.

          -  Patients who have participated in this study during induction chemotherapy.
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Galantamine; Computer Assisted Cognitive Behavioral Therapy (CBT)
Intervention description: Daily 8 mg galantamine capsule; CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.
Intervention MeSH terms: Galantamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cocaine; Methadone; CBT

Summary:

      We are testing to see if Galantamine, a learning enhancing medication, will help methadone
      maintained cocaine abusers with their learning and memory specific to CBT using an innovative
      CBT computer program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between ages of 18 and 50

          -  Enrolled in RNP methadone program and stable on methadone for at least 3 weeks

          -  Current cocaine abuse or dependence according to DSM-IV criteria

          -  No current medical problems and normal ECG

          -  If female, not currently pregnant or breast feeding and using reliable birth control

          -  Fluent in English and have at least a 6th grade reading level

          -  Can commit to 12 weeks of treatment and are willing to be randomized

        Exclusion Criteria:

          -  Current major psychiatric illness including mood, psychotic or anxiety disorder

          -  History of major medical illnesses including asthma, chronic obstructive lung disease,
             gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances

          -  Use of medications including beta blockers and NASAIDs

          -  Known allergy to Galantamine
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD); Laymen Terminology Chronic Bronchitis and Emphysema
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Intervention: Placebo; AZD5069 50mg; AZD5069 80mg
Intervention description: Oral dose bid; Oral dose bid; Oral dose bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease

Summary:

      The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients
      with Chronic Obstructive Pulmonary Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of COPD with symptoms for more than one year before screening

          -  Body mass index of 18-30 kg/m2 and weight of 50-100kg

          -  Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year =
             tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at
             screening

          -  FEV1 of 30% or above and less than 80% of the predicted normal value
             post-bronchodilator at screening

          -  FEV1/FVC less than 70% post-bronchodilator at screening

        Exclusion Criteria:

          -  Any clinically significant disease or disorder

          -  Exacerbation of COPD which was not resolved within 30 days of first dosing

          -  Patients who have received live or live-attenuated vaccine in the 2 weeks prior to
             first dosing

          -  Asthma and any current respiratory tract disorder other than COPD which is considered
             to be clinically significant

          -  Disease history suggesting reduced or abnormal immune function other than that related
             to COPD
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Rapamycin; Mycophenolate Mofetil; Tacrolimus; Steroids
Intervention description: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.; MMF 1 gm BID beginning 1st day postoperative day; Part of standard maintenance.; Part of standard maintenance
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rapamycin; Mycophenolate Mofetil (MMF); Kidney-Pancreas Transplant

Summary:

      This study was designed to determine which maintenance immunosuppressive agent, rapamycin or
      mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal
      failure, who presented for a kidney-pancreas transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with Type 1 diabetes and end stage renal disease.

          -  Women of childbearing potential must have had a negative pregnancy test (serum or
             urine).

          -  Patient agrees to participate in the study and sign an informed consent.

          -  Patient has no known contraindication to the administration of rapamycin or
             mycophenolate mofetil.

          -  Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

        Exclusion Criteria:

          -  Patient has history of a malignancy within two years, with the exception of adequately
             treated localized squamous or basal cell carcinoma of the skin without evidence of
             recurrence.

          -  Patient is currently abusing drugs or alcohol.

          -  Patient is known or suspected to have an active infection or be seropositive for
             hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus
             (HIV).