bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
Condition: Healthy Volunteers
Intervention: PRT064445/Apixaban; Placebo/Apixaban; Placebo
Intervention MeSH terms: Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women between the ages of 18 and 45 years old

        Exclusion Criteria:

          -  History (including family history) or symptoms of, or risk factors for bleeding

          -  History (including family history) of or risk factors for a hypercoagulable or
             thrombotic condition

          -  Absolute/relative contraindication to anticoagulation or treatment with specific
             anticoagulants

          -  History of major surgery, severe trauma or bone fracture within 3 months prior to
             dosing; or planned surgery within 1 month after dosing.
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Bimekizumab
Intervention description: Bimekizumab at a prespecified dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; Psoriatic Arthritis; PsA

Summary:

      This is a study to assess the long-term safety and tolerability of bimekizumab in subjects
      with psoriatic arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  In the opinion of the Investigator, the subject is expected to benefit from
             participation in an Open Label Extension (OLE) study

          -  Subject completed PA0008 without meeting any withdrawal criteria

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active

        Exclusion Criteria:

          -  Female subjects who plan to become pregnant during the study or within 20 weeks
             following the last dose of IMP. Male subjects who are planning a partner pregnancy
             during the study or within 20 weeks following the last dose

          -  Subjects with any current sign or symptom that may indicate a medically significant
             active infection (except for the common cold) or has had an infection requiring
             systemic antibiotics within 2 weeks of study entry

          -  Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing
             Serious Adverse Event, or a history of serious infections (including hospitalizations)
             in the lead-in study, the Medical Monitor must be consulted prior to the subject's
             entry into PA0009
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
Condition: Heparin-induced Thrombocytopenia Type II
MeSH terms: Thrombocytopenia
Intervention: argatroban
Intervention MeSH terms: Argatroban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Argatroban; heparin induced thrombocytopenia (HIT); direct thrombin inhibitor (DTI)

Summary:

      The purpose of this study is to collect data on the clinical management of Argatroban in
      patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or
      without ongoing thrombosis who require parenteral antithrombotic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged >= 18 years

          -  Females of child bearing potential must have a negative urine pregnancy test prior to
             entry into the study

          -  Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or
             without ongoing thrombosis who require parenteral anticoagulation

          -  Signed written informed consent by the subject, or if the subject is unable to do so,
             consent will be sought from their family member, or a trusted person nominated by the
             subject or the legal representative

        Exclusion Criteria:

          -  Uncontrolled bleeding

          -  Severe hepatic impairment (Child-Pugh Class C)

          -  Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)

          -  Pregnancy (exclusion by routine urine test)

          -  Lactating woman
Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Condition: Immune Mediated Necrotizing Myopathy
MeSH terms: Muscular Diseases
Intervention: zilucoplan; Placebo
Intervention description: Daily subcutaneous (SC) inection; Daily subcutaneous (SC) inection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients
      with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio
      to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of IMNM (Immune-Mediated Necrotizing Myopathy)

          -  Positive serology for anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMGCR) or
             anti-signal recognition particle (SRP) autoantibodies

          -  Clinical evidence of weakness (≤ grade 4 out of 5) on manual muscle testing in at
             least one proximal limb muscle group

          -  Creatine kinase (CK) of >1000 U/L at Screening

          -  No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated
             to occur during the first 8-weeks on study

          -  No changes in immunosuppressive therapy, including dose, for at least 30 days prior to
             Baseline or anticipated to occur during the first 8-weeks on study

        Exclusion Criteria:

          -  History of meningococcal disease

          -  Current or recent systemic infection within 2 weeks prior to Screening or infection
             requiring intravenous (IV) antibiotics within 4 weeks prior to Screening

          -  Recent initiation of intravenous immunoglobulin (IVIG) (i.e., first cycle administered
             less than 90 days prior to Baseline)

          -  Rituximab use within 90 days prior to Baseline or anticipated to occur during study

          -  Statin use within 30 days prior to Baseline or anticipated to occur during study

          -  Plasma exchange within 4 weeks prior to Baseline or expected to occur during the
             8-week Treatment Period
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: CTP-543; CTP-543 Matching Placebo
Intervention description: Administered as 12 mg tablets.; Administered as tablets to aid treatment masking.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and tolerability of once-daily versus twice-daily
      dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical presentation compatible with alopecia areata with a current episode lasting
             at least 6 months and not exceeding 10 years at the time of Screening. Total disease
             duration greater than 10 years is permitted.

          -  At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score
             ≥50, at Screening and Baseline.

        Exclusion Criteria:

          -  Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical
             treatment to the scalp, significant trauma to the scalp, or untreated actinic
             keratosis on the scalp.

          -  Treatment with systemic immunosuppressive medications within 3 months of screening or
             during the study, or biologics within 6 months of screening or during the study.

          -  Clinical lab results outside the normal range.
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: vitamin D3; Placebo daily for one year
Intervention description: 4,000 IU daily for one year; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: Male
Minimum age: 19 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: prostate cancer; vitamin D

Summary:

      Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated
      phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising
      the possibility that vitamin D deficiency over time promotes the progression of subclinical
      prostate cancer to clinical disease. The investigators propose to conduct a clinical study
      aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans
      diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease
      monitored through active surveillance. The successful completion of this proposed clinical
      study will allow us to determine whether correcting vitamin D deficiency in Veterans
      diagnosed with early-stage prostate cancer will prevent progression of their disease and
      improve their prognosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically
             documented adenocarcinoma of the prostate)

          -  A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or
             less in either architectural pattern)

          -  For the purpose of eligibility, these additional criteria will be verified: *serum
             creatinine 2.0 mg/dL

               -  serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dL

               -  serum calcium > 8.5 and < 10.5 mg/dL

        Exclusion Criteria:

          -  Subjects with any concurrent malignancy, except non-melanoma skin cancer

          -  Subjects with a history of sarcoidosis

          -  Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation

          -  Subjects with a history of hypercalcemia

          -  Subjects who use lithium as a medication
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
Condition: Kidney Transplantation
Intervention: Tacrolimus; CP-690,550; CP-690,550
Intervention description: Standard of care; CP-690,550 5 mg BID; CP-690,550 10 mg BID
Intervention MeSH terms: Tacrolimus; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: immunosuppression; JAK3 inhibitor; kidney transplant; tofacitinib; Xeljanz; CP-690; 550; tacromilus; mycophenolate mofetil

Summary:

      A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune
      system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study
      A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months
      posttransplant. Patients who completed study A3921009 were offered the opportunity to
      participate in study A3921021 which will extend the evaluation of safety and efficacy of
      CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control
      arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects
      will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be
      discontinued.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with
             trial medications (CP-690,550 or tacrolimus)

          -  Recipient of a first-time kidney transplant

        Exclusion Criteria:

          -  Subject with any untreated condition that may affect drug absorption (eg, gastrectomy
             or clinically significant diabetic gastroenteropathy).

          -  Subjects who are on the waiting list for a second kidney transplant or any non-renal
             organ transplants.
Ramelteon in the Prevention of Post-operative Delirium
Condition: Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders
MeSH terms: Delirium; Emergence Delirium; Delayed Emergence from Anesthesia; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders
Intervention: Ramelteon; Microcrystalline Cellulose; Riboflavin 100 mg
Intervention description: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered; Placebo Comparator; Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)
Intervention MeSH terms: Riboflavin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Post-operative Delirium

Summary:

      This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness
      and safety of peri-operative administration of ramelteon, a melatonin agonist in the
      prevention of postoperative delirium.
    

Eligibility criteria:

        -  Planned orthopedic surgery under general or regional anesthesia and post-operative
             inpatient stay

          -  65 years of age or older

          -  Mini-mental Status Exam (MMSE) score of 15 or greater prior to surgery;

          -  Ability to understand, speak, read and write English.

        Exclusion Criteria:

          -  Delirium diagnosis on the Confusion Assessment Method instrument at baseline

          -  Is unable to give informed consent due to cognitive impairment and a suitable legally
             authorized representative (LAR) cannot be identified

          -  Declines participation

          -  Current medications that include:

               1. ramelteon

               2. melatonin

               3. fluvoxamine

               4. rifampin

               5. ketoconazole

               6. fluconazole

          -  History of ramelteon or riboflavin intolerance

          -  Heavy daily alcohol intake by medical record or history

          -  Current moderate to severe liver failure (as defined by Charlson criteria

          -  Evidence of Systemic Inflammatory Response Syndrome (SIRS) as measured by > 2
             criteria8)

          -  Presence of a condition that in the opinion of the PI compromises patient safety or
             data quality if enrolled in the study.
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Intervention: DSXS
Intervention description: Active treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      this study is to evaluate the potential of DSXS to suppress HPA axis function in patients
      with moderate to severe atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a definite clinical diagnosis of stable atopic dermatitis

        Exclusion Criteria:

          -  Patient is under the age of 2
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
Condition: Locally Recurrent; Metastatic Breast Cancer ( HER2 Negative)
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Eribulin mesylate
Intervention description: Eribulin mesylate 1.4 mg/m2 will be administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of single-agent eribulin
      mesylate for first-line treatment of subjects with locally recurrent or metastatic breast
      cancer.
    

Eligibility criteria:

        Key Inclusion Criteria

        Females age 18 years or older at the time of informed consent

        Have histologically or cytologically proven adenocarcinoma of the breast

        Subjects with locally recurrent or metastatic disease with at least one measurable lesion
        according to Response Evaluation Criteria in Solid Tumors

        (RECIST) criteria v 1.1

        Human epidermal growth factor receptor (HER2)-negative disease as determined by
        fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.

        Life expectancy of greater than 24 weeks

        Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2

        At least 12 months since prior neoadjuvant or adjuvant chemotherapy

        At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from
        the effects of these interventions

        Adequate renal function

        Adequate bone marrow function

        Adequate liver function

        Key Exclusion Criteria

        Subjects who meet any of the following criteria will be excluded from participation in this
        study:

        Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or
        metastatic breast cancer

        Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or
        nonmelanoma skin cancer

        Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than
        120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2
        epirubicin

        Inflammatory breast cancer

        Clinically significant cardiovascular impairment

        Subjects with known CNS disease are not eligible, except for those with treated brain
        metastasis.

        Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use
        of oxygen

        Currently pregnant or breast-feeding.

        Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover
        to Grade 2 before enrollment.