bioihbjkbjnl/mcl2 huggingface dataset:
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Maraviroc
Intervention description: Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
Intervention MeSH terms: Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics

Summary:

      The primary purpose of this study is to determine the pharmacokinetic properties (what the
      body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1
      infected children and adolescents. This study will also determine whether maraviroc is safe
      to use in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with
             at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL

        Exclusion Criteria:

          -  X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay

          -  Concomitant therapy with other investigational agents (other than experimental ARV
             agents available through pre-approval access programs)

          -  Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days
             prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and
             creatinine, lipase;

          -  Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen
             includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus.

          -  Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Liposomal Bupivacaine; 0.25% Bupivacaine with epinephrine; Saline
Intervention description: 266mg liposomal bupivacaine; 0.25% bupivacaine with epinephrine; Normal saline
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Exparel; total hip replacement; bupivacaine

Summary:

      The purpose of this study is to compare two medications currently injected intra-operatively
      to help decrease pain after surgery in patients undergoing a primary total hip replacement
      (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus
      bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to
      see if one medication works better than the other in managing post-operative pain after THR.
      The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate
      better pain management in THR patients post-operatively. Both medications are FDA-approved
      for post-operative analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo primary unilateral total hip replacement

          -  Patients diagnosed with hip osteoarthritis

          -  Patients failed to improve with conservative measures

          -  Patients willing and able to sign informed consent

        Exclusion Criteria:

          -  Revision total hip replacement

          -  Bilateral total hip replacement

          -  Birmingham hip resurfacing

          -  Patients with hepatic/kidney disease

          -  Patients with a known allergy to bupivacaine or other local anesthetics
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Paclitaxel
Intervention description: Solution, I.V., 100 mg/m2, Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of continued administration
      of paclitaxel given weekly in subjects considered to need to continue treatment after
      completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with
      Advanced Breast Cancer (Protocol No. CA139-371)"
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were confirmed to have a response after receiving at least two courses of
             weekly paclitaxel therapy and considered to need to continue the therapy by the
             investigator/subinvestigator among the patients with advanced or recurrent breast
             cancer who had met the selection criteria and participated in the preceding phase II
             clinical study
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
Condition: GVHD, Chronic
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: BN101
Intervention description: BN101 is an orally ROCK2 selective inhibitor
Intervention MeSH terms: Belumosudil
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
Healthy volunteers: No

Summary:

      This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101
      in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of
      systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects at least 18 years of age who have had allogenic hematopoietic
             cell transplant (HCT).

          -  Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD

          -  Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to
             screening;

          -  Have persistent cGVHD manifestations and systemic therapy is indicated

        Exclusion Criteria:

          -  Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at
             least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin
             inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis
             (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).

          -  Histological relapse of the underlying cancer or post-transplant lymphoproliferative
             disease at the time of screening.

          -  Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a
             washout of at least 28 days prior to treatment.
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Roux-en-Y Gastric Bypass (RYGB); Caloric Restriction; Exendin-9,39; Normal Saline
Intervention description: Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.; Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.; A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.; subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bariatric Surgery; Weight loss

Summary:

      What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2
      diabetes outside of weight loss alone?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20-65 years of age.

          -  Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.

          -  Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested
             in surgery but are interested in supervised caloric restriction.

        Exclusion Criteria:

          -  Previous treatment with thiazolidinediones.

          -  Chronic antibiotic therapy.

          -  Active microvascular or macrovascular complications of diabetes.
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)
Condition: Mycoses
MeSH terms: Mycoses
Intervention: Posaconazole
Intervention description: Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
Intervention MeSH terms: Posaconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Triazoles

Summary:

      The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early
      treatment of fungal infections in participants who are refractory to, intolerant to, or
      medically precluded from first-line monotherapy or first-line combination antifungal therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proven or probable invasive fungal infection (IFI) including breakthrough infection
             while on antifungal treatment for at least 7 days.

          -  Refractory or intolerant to prior antifungal therapy, or medically unable to receive
             standard antifungal therapy.

          -  Age ≥13 years old.

          -  Expected to survive >1 month.

          -  Negative pregnancy test (serum or urine) at baseline for women of childbearing
             potential.

        Exclusion Criteria:

          -  Serum bilirubin >10 times upper limit of normal (ULN).

          -  Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times
             ULN.

          -  Documented allergy to azoles.

          -  Unable to take oral suspension medications or enteral feeding.

          -  Pregnant or breastfeeding.

          -  Participants who have received an investigational drug are allowed to be enrolled if
             the investigational drug was given 30 days prior to study registration, unless
             approved by the Sponsor.

          -  Requires surgery.
Open Label Study of Long Term Evaluation Against LDL-C Trial
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Standard of care
Intervention description: Administered by subcutaneous injection; Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Intervention MeSH terms: Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1324.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: High cholesterol; Raised cholesterol; Cholesterol; Elevated Cholesterol

Summary:

      The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be
      safe and well tolerated in adults with hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154
             (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764),
             and 20110231 (NCT01652703)

        Exclusion Criteria:

          -  Experienced a treatment-related serious adverse event that led to investigational
             product (IP) discontinuation in the parent study

          -  Have an unstable medical condition, in the judgment of the investigator

          -  Known sensitivity to any of the products to be administered during dosing

          -  Currently enrolled in another investigational device or drug study (excluding
             evolocumab (AMG 145) parent study), or less than 30 days since ending another
             investigational device or drug study(s),or receiving other investigational agent(s)
Alzheimer's Disease Acitretin Medication
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Acitretin; Placebo
Intervention description: 30mg per day from Day 1 to Day 28; Placebo
Intervention MeSH terms: Acitretin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease

Summary:

      The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase
      cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild
      to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of
      the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD.
      Second, the safety and tolerability of acitretin in AD patients should be proven.
    

Eligibility criteria:

        Inclusion Criteria:

          -  mild to moderate AD (NINCDS-ADRDA criteria)

          -  Mini-Mental State Examination (MMSE): 27-14 points

          -  Geriatric Depression Scale ≤ 14

        Exclusion Criteria:

          -  hereditary cognitive impairment

          -  known history of brain injuries

          -  Insufficient German language skills

          -  actual treatment with other potential disease modifying drugs of AD

          -  multimorbidity or significant organ (esp. liver or renal) dysfunction

          -  evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)

          -  contraindication to acitretin such as osteoporosis, hypoalbuminaemia
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Condition: Prevention of Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM Vaccine; MenACWY-PS Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 910.0
Sex: All
Minimum age: 12 Months
Maximum age: 10 Years

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly
      Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10
      years
    

Eligibility criteria:

        Inclusion Criteria:

          -  Group 1: Healthy children 2-10 years of age;

          -  Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate
             immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus
             influenzae type b, and pneumococcus.

        Exclusion Criteria:

          -  Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or
             previous immunization with a meningococcal vaccine or vaccine containing meningococcal
             antigen(s); Any serious acute, chronic or progressive disease.

          -  Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or
             previous immunization with a meningococcal vaccine or vaccine containing meningococcal
             antigen(s); Any serious acute, chronic or progressive disease.
Efficacy and Safety Study of Selinexor in Relapsed or Refractory Peripheral T-cell Lymphoma or Cutaneous T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma (PTCL); Cutaneous T-cell Lymphoma (CTCL)
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Selinexor
Intervention description: 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0).
20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.<3.0).
Number of Cycles: up to 12 but there is no maximal duration for treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTCL; CTCL; Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; Karyopharm; KPT-330; Selinexor

Summary:

      This is a single-arm, multi-center, open-label phase 2 study of the SINE™ compound selinexor
      given orally to patients with relapsed or refractory PTCL or CTCL.

      Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility
      criteria and have none of the exclusion criteria will be enrolled to receive selinexor until
      either disease progression or intolerance has occurred.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG performance status of ≤2.

          -  Relapsed or refractory disease to at least one prior systemic regimen.

          -  Measurable disease: according to International Working Group (IWG) guidelines for all
             patients with PTCL and according to CTCL Response in Skin consensus criteria for all
             patients with CTCL.

          -  Objective, documented evidence of disease progression on study entry.

        Exclusion Criteria:

          -  Known active central nervous system (CNS) lymphoma.

          -  Active graft-versus-host disease after allogeneic stem cell transplantation. At least
             4 months must have elapsed since completion of allogeneic stem cell transplantation.

          -  Unable to swallow tablets or malabsorption syndrome, disease significantly affecting
             gastrointestinal function.
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth; Birth Weight
Intervention: Omegaven; Standard lipids (primarily omega-6 fatty acids)
Intervention description: Infants will receive nutritional supplementation with omega-3 fatty acids (omegaven).; Infants will receive nutritional supplementation with standard intralipid, composed primarily of omega-6 fatty acids.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 48.0
Sex: All
Maximum age: 7 Days
Healthy volunteers: No
Keywords: ROP; Premature infant

Summary:

      Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely.
      These infants do not have enough essential fatty acids to structurally support the retina,
      the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3
      (n-3) fatty acids to these infants soon after birth made them less likely to need invasive
      treatments for eye disease. This research trial will give young infants born prematurely n-3
      fish oil treatment and look at how this changes factors in the blood that promote disease.
      Detailed blood studies comparing infants with and without ROP will be performed and the
      infants will be followed over time to assess their eye development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants born less than or equal to 30 weeks gestation or less than 1500 g at birth

        Exclusion Criteria:

          -  Patients with liver disease as tested by liver function tests (LFTs)

          -  ≤ 500 grams birthweight