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
Dose Ranging Study of the Safety and Efficacy of R115966 in Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Talarozole
Intervention description: Oral Capsule Once Daily
Intervention MeSH terms: R 115866
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or
      placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and
      efficacy of R115866 will be evaluated during the treatment period and the 8-week post
      treatment follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plaque Psoriasis with PASI greater than or equal to 10

          -  Male or a female who was NOT of childbearing potential (i.e., post- menopausal for
             greater than 12 months or had a complete hysterectomy);

        Exclusion Criteria:

          -  Spontaneously improving or rapidly deteriorating plaque psoriasis

          -  Guttate, pustular, erythrodermic, or other non-plaque form of psoriasis

          -  Subject was under treatment for a heart disorder or had a history of cardiovascular
             disease (excluding effectively controlled hypertension)

          -  Any acute psychiatric condition, including an increased risk for suicide attempt,
             based on medical and psychiatric history

          -  Previous use of a psoriasis vaccine or had participated in an investigational study of
             a psoriasis vaccine

          -  Previous use of systemic immunomodulatory therapy known to affect psoriasis and to
             typically decrease immune cell populations

          -  Previous use of any systemic immunomodulatory therapy known to affect psoriasis and
             NOT typically to decrease immune cell populations

          -  Previous use of any photo-therapy (including laser), photo-chemotherapy, or systemic
             psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or
             cyclosporine) within the previous four weeks

          -  Pregnant or a nursing mother

          -  Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic
             pancreatitis, osteoporosis, cancer (except non-melanoma skin cancer), a positive test
             for human immunodeficiency virus (HIV), a history indicating adrenal cortex
             dysfunction
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Condition: Relapse/Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: LBH589 (panobinostat); bortezomib; dexamethasone
Intervention description: Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days); Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) & treatment phase 2 (42 days).; Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days & treatment phase 2 (42 days)
Intervention MeSH terms: Dexamethasone; Bortezomib; Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LBH589; panobinostat; bortezomib; dexamethasone; Phase II; bortezomib and dexamethasone; Japanese patients; relapsed/refractory multiple myeloma; Panobinostat (PAN)

Summary:

      The purpose of this study was to evaluate the efficacy and safety of panobinostat in
      combination with bortezomib and dexamethasone in Japanese patients with relapsed/refractory
      multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a previous diagnosis of multiple myeloma

          -  Patient required retreatment for multiple myeloma

          -  Patient had measurable M component in serum or urine at study screening

        Exclusion Criteria:

          -  Primary refractory disease (patients that never reached at least an minor response for
             over 60 days under any prior therapy)

          -  Patient who had been treated by bortezomib before, and did not reach at least a minor
             response under this therapy, or progressed under it or within 60 days of last dose

          -  Patient received prior treatment with DAC inhibitors including panobinostat

          -  Patient had impaired cardiac function, or a prolonged QTc interval at screening ECG
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Risankizumab; Placebo for risankizumab
Intervention description: Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Placebo for risankizumab is administered as a SC injection in PFS
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hidradenitis Suppurativa; Risankizumab; Placebo

Summary:

      The primary objective of this study is to assess the safety and efficacy of risankizumab 180
      mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe
      hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before
      the Baseline visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant with moderate to severe HS for at least 1 year prior to baseline visit.

          -  HS lesions present in at least two distinct anatomical areas.

          -  Draining fistula count of ≤ 20 at Baseline visit.

          -  Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.

          -  Participants are required to use a daily antiseptic wash on their HS lesions.

          -  Participant must have a history of inadequate response or intolerance to an adequate
             trial of oral antibiotics for treatment of HS.

        Exclusion Criteria:

          -  Participant has a history of active skin disease other than HS that could interfere
             with the assessment of HS.

          -  Participant has active tuberculosis (TB) or concurrent treatment for latent TB or
             evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human
             immunodeficiency virus (HIV) infection.

          -  Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3
             months or 5 half-lives, whichever is longer, prior to baseline.

          -  Participant has received prescription topical therapies (including topical
             antibiotics) within 14 days prior to the Baseline visit.

          -  Participant has received systemic non-biologic therapies that can also be used to
             treat HS within 4 weeks prior to the Baseline visit.

          -  Participant has received any systemic (including oral) antibiotic treatment within 4
             weeks prior to the Baseline visit.
Cannabinoids for Taxane Induced Peripheral Neuropathy
Condition: Chemotherapy-induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: Cannabinoids
Intervention description: Cannabinoids with THC and CBD versus placebo cannabinoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: Female
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing
      breast cancer treatment. Some patients may need to shorten their course of treatment, and do
      not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the
      cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The
      goal of this study is to investigate the cannabinoids THC and CBD for TIPN.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1) Participants with breast cancer, experiencing TIPN due to paclitaxel or docetaxel.

          -  2) Participants must have an ECOG score of 2 or better. Participants must have a score
             of 2 or 3 score for sensory neuropathy, as assessed by the Common Toxicity Criteria
             Adverse Events (CTCAE).

          -  3) Able to give informed consent and comply with all study procedures.

        Exclusion Criteria:

          -  1) Diagnosis of a major medical, neurological, or psychiatric disorder that would
             preclude study participation.

          -  2) Women who are not practicing an effective form of birth control (condoms,
             diaphragm, birth control pill, IUD) or currently pregnant.

          -  3) Subjects taking warfarin.

          -  4) Subjects with orthostatic hypotension, hypertension, cardiovascular disease, or
             neurodegenerative disorders.
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
Condition: Agitation; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation
Intervention: AVP-923-20; Placebo; AVP-923-30
Intervention description: AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine; Placebo capsule; AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: AVP-923-20; AVP-923-30; AVP-923; Dextromethorphan; Quinidine; Neuropsychiatric Inventory; Aggression; Efficacy; Safety

Summary:

      The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923
      compared to placebo, for the treatment of symptoms of agitation in participants with
      Alzheimer's Disease (AD).
    

Eligibility criteria:

        Key Inclusion Criteria:

        Diagnosis of probable Alzheimer's disease (AD).

        The participant has clinically significant symptoms of agitation secondary to AD, that
        interfere with daily routine and for which a prescription medication is deemed indicated,
        in the opinion of the investigator.

        Either out-patients or residents of an assisted-living facility or a skilled nursing home.

        CGI-S score is ≥ 4 (moderately ill) at screening and baseline.

        Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive).

        Caregiver who is able and willing to comply with all required study procedures, ensuring
        that the participant attends all study visits and takes the study medication as instructed.
        In order to qualify as a caregiver for this study, the individual should spend time with
        the participant for a minimum of 4 hours on 4 separate days per week.

        Key Exclusion Criteria:

        Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia,
        Parkinson's disease, substance-induced dementia).

        Participant with co-existent clinically significant or unstable systemic diseases that
        could confound the interpretation of the safety results of the study (e.g. malignancy,
        poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or
        hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac
        conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

        Participant with myasthenia gravis.
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: MIV-711; Placebo
Intervention description: MIV-711 administered orally once daily; Placebo manufactured to mimic MIV-711 capsule.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,
      Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with
      knee osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current average knee pain, defined as pain in either knee, within 1 week before visit
             1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric
             Rating Scale).

          -  Inclusive of 40-80 years old.

          -  Diagnosis of primary knee osteoarthritis

        Exclusion Criteria:

          -  The presence of any inflammatory arthritis

          -  Any generalized pain condition that may interfere with the evaluation of the target
             knee pain (e.g., fibromyalgia) as judged by the investigator.

          -  Any clinically severe or significant uncontrolled concurrent illness, which, in the
             opinion of the Investigator, would impair ability to give informed consent or take
             part in or complete this clinical study.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closely related compounds, or any of the stated ingredients.
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 819.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Depression

Summary:

      An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to
      antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an
      inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo
      + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study
      consisted of approximately 2 weeks of screening and washout followed by 8 weeks of
      double-blind treatment followed by a 1 week safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 18 to 65 years of age, inclusive.

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive
             disorder (MDD).

          -  Current major depressive episode of at least 8 weeks and not exceeding 24 months in
             duration.

          -  Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

        Exclusion Criteria:

          -  Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,

          -  Women who are pregnant, or planning to become pregnant or breastfeed during the study
             or not practicing reliable contraception that will continue through out the study.

          -  History of meeting DSM-IV-TR criteria for:

               1. Depressive episode with psychotic or catatonic features.

               2. Manic, hypomanic or mixed episode, including bipolar disorder and substance
                  induced manic, hypomanic or mixed episode.

               3. Schizophrenia, schizoaffective, or other psychotic disorder.

               4. Obsessive-compulsive disorder.

               5. Bulimia or anorexia nervosa.

               6. Dementia, amnesic, or other cognitive disorder.

               7. Mental retardation.

          -  Participants considered a suicide risk.
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.