bioihbjkbjnl/mcl2 huggingface dataset:
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
Condition: Cytomegalovirus (CMV)
MeSH terms: Cytomegalovirus Infections
Intervention: Maribavir
Intervention description: Tablet for oral administration
Intervention MeSH terms: Maribavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: transplant; treatment; resistant; CMV; refractory; cytomegalovirus

Summary:

      This study will assess safety, antiviral activity, and pharmacokinetics of different doses of
      maribavir administered orally for up to 24 weeks for treatment of CMV infections that are
      resistant or refractory to treatment with ganciclovir/valganciclovir or foscarnet in
      recipients of stem cell or solid organ transplants.
    

Eligibility criteria:

        Inclusion Criteria

          1. Be ≥12 years of age.

          2. Weigh ≥ 40 kg.

          3. Be a recipient of stem cell or solid organ transplantation.

          4. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 DNA
             copies/mL.

          5. Have a current CMV infection that is resistant (known CMV genetic mutations) or
             refractory (clinical failure to respond) to treatment with ganciclovir/valganciclovir
             and/or foscarnet.

          6. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy
             test prior to randomization.

          7. Be able to swallow tablets.

          8. If adult, provide written informed consent. If child (age <18 years), have a
             parent/legal guardian who is willing and able to provide written informed consent
             (with assent from the child when appropriate).

          9. Be assessed by the investigator to determine whether prophylaxis for non-CMV
             herpesvirus infections (e.g., herpes simplex virus [HSV type 1 and type 2] and
             varicella zoster virus [VZV]) is appropriate according to institutional guidelines or
             standard practices, keeping in mind that maribavir is not active in vitro against
             these viruses.

        Exclusion Criteria

          1. Be receiving any other anti-CMV agent(s).

          2. Have a current CMV infection that is considered resistant or refractory due to
             inadequate adherence to prior oral anti-CMV treatment.

          3. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24
             hours prior to the time of enrollment.

          4. Have severe hepatic impairment.

          5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of
             enrollment.

          6. Have expected survival less than 6 weeks.

          7. Be pregnant or breastfeeding.

          8. Other clinically significant medical or surgical condition.
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Condition: Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: PF-06650833; PF-06700841; PF-06826647; Placebo
Intervention description: 400 mg QD; 45 mg QD; 400 mg QD; placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment period is a parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in
      participants with moderate to severe HS. The study will have a maximum duration of
      approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing
      Period and a 4 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female participants, between 18-75, with a diagnosis of moderate to severe
             Hidradenitis Suppurativa

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Condition: Macular Edema; Diabetes Mellitus
MeSH terms: Macular Edema; Diabetes Mellitus
Intervention: Dexamethasone intravitreal implant; Steroid plus NSAID eye drop combination therapy
Intervention MeSH terms: Dexamethasone; Prednisolone acetate; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There is a need to find an effective therapy for diabetic patients who develop macular edema
      after cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has diagnosis of Diabetes Mellitus, Type I or II.

          -  Patient has experienced the development of macular edema following cataract surgery in
             at least one eye.

          -  Patient has had cataract surgery within 90 days prior to the screening visit.

        Exclusion Criteria:

          -  Patient has other significant ocular disease in study eye, including glaucoma.

          -  Patient has any active infection in the study eye.

          -  Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure,
             uncontrolled diabetes mellitus).

          -  Patient has experienced a significant increase in intraocular pressure following a
             prior treatment with topical or intravitreal steroidal medication.

          -  Patient has received the OZURDEX® implant before in the study eye.
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: IW-3718; Matching Placebo; PPI
Intervention description: All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, efficacy, and dose-response
      relationship of IW-3718 administered orally to participants who have GERD and continue to
      experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump
      inhibitors (PPIs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is an ambulatory, community-dwelling male or nonpregnant female and is at
             least 18 years old at the Screening Visit. Lactating females must agree not to
             breastfeed.

          -  Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
             regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit
             while taking standard QD PPI therapy.

        Exclusion Criteria:

          -  Patient may not meet any of the excluded conditions specified in the protocol

          -  Patient has any alarm symptoms including but not limited to GI bleeding, anemia,
             vomiting, dysphagia, or unexpected weight loss any time during the Screening or
             Pretreatment Periods

          -  Patient has a history of clinically significant hypersensitivity or allergies to any
             of the excipients contained in the study medication (active or placebo).

        NOTE: Additional inclusion/exclusion criteria may apply.
Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Atorvastatin; Placebo
Intervention description: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months; One out of three subjects will receive a placebo.
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Type I Diabetes (T1DM); Atorvastatin (Lipitor); Insulin; Pancreas; Beta Cells

Summary:

      The goal of this application is to evaluate the safety and efficacy of atorvastatin as a
      potential treatment to preserve beta cell function in children and young adults with newly
      diagnosed type 1 diabetes (T1DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals 10-19 years of age (Tanner Stage II or greater),

          -  The presence of one or more serum antibodies to islet cell proteins (anti- glutamic
             acid decarboxylase [GAD], islet antigen 2 or insulin autoantibodies) as assessed in
             standard practice,

          -  Diagnosis of T1DM within the 8 weeks prior to study entry

          -  Peak stimulated C-peptide level >0.2pmol/mL following mixed meal tolerance test (MMTT)
             performed at least 3 weeks after diagnosis,

          -  Females of reproductive potential must not plan on conceiving a child during the
             treatment program, and agree to use a medically accepted form of contraception

        Exclusion Criteria:

          -  Subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic
             acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or
             protease inhibitors,

          -  Pregnancy or breast-feeding,

          -  Clinical AIDS, AIDS related syndrome (ARS) or known positive HIV serology,

          -  Subjects treated with immunosuppressive therapy in the past 12 months,

          -  Subjects receiving glucocorticoid therapy or therapy other than insulin that is likely
             to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or
             amylin),

          -  Subjects with other autoimmune diseases, except autoimmune thyroid disease,

          -  Subjects with any illness that might complicate diabetes management or preclude
             treatment with atorvastatin,

          -  Transplant recipients,

          -  Evidence of liver dysfunction or myopathy
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: 10% VDA-1102; 20% VDA-1102
Intervention description: 200 mg twice-daily for 12 weeks; 200 mg once-daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: 3-part, open-label, multi-center study
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratosis; efficacy; safety; VDA-1102

Summary:

      This is a Phase 2 clinical study in patients with actinic keratosis involving daily
      application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84
      days). This study has no placebo and the subjects enrolled in the study will know exactly
      what they are receiving. The objectives of the study are to evaluate the safety and benefit
      of these two strengths.
    

Eligibility criteria:

        Inclusion Criteria:

          -  4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

        Exclusion Criteria:

          -  Subject has no clinically significant findings at Baseline

          -  Subject is unable to demonstrate adequate precision applying the study drug to the
             Treatment Field at Baseline

          -  Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric,
             social problem

          -  Subject has at any time been given a diagnosis or treatment associated with
             immunosuppression

          -  Subject has received VDA-1102 in the past
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Condition: B-cell Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual
Intervention: Blinatumomab
Intervention description: Continuous intravenous infusion
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blinatumomab; MRD; B-ALL; Minimal residual disease; adult ALL; Leukemia; ALL; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment

Summary:

      The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab
      (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal
      residual disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with B-precursor ALL in complete hematological remission after at least 3
             intense chemotherapy blocks

          -  Presence of minimal residual disease at a level of ≥ 10^-3

          -  Availability of bone marrow specimen from primary diagnosis for clone-specific MRD
             assessment

          -  Negative human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test
             and hepatitis C virus (anti-HCV) test

          -  Negative pregnancy test in women of childbearing potential

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Presence of circulating blasts or current extra-medullary involvement by ALL

          -  History of relevant central nervous system (CNS) pathology or current CNS pathology

          -  Prior allogeneic hematopoietic stem cell transplant (HSCT)

          -  Eligibility for treatment with tyrosine-kinase inhibitors (TKI)

          -  Systemic cancer chemotherapy within 2 weeks prior to study treatment

          -  Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to
             study treatment

          -  Previous treatment with blinatumomab
Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Condition: Kidney Neoplasms; Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: AG-013736 (axitinib)
Intervention description: AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the activity and response rate of AG-013736 in patients with advanced and
      refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  RCC with metastases and nephrectomy

          -  failure of prior sorafenib-based therapy

          -  at least 1 target lesion that has not been irradiated

          -  adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.

        Exclusion Criteria:

          -  Gastrointestinal abnormalities

          -  current use or inability to avoid chronic antacid therapy

          -  current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2
             inducers

          -  active seizure disorder or evidence of brain metastases.
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: VX-150; Placebo
Intervention description: Capsules for oral administration.; Capsules for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the dose-response relationship and safety of VX-150 in treating
      acute pain following bunionectomy.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Before surgery:

          -  Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)

          -  Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair,
             without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic
             block) not to include base wedge procedure

        After surgery:

          -  Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale
             (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within
             9 hours after removal of the popliteal sciatic block on Day 1

          -  Subject is lucid and able to follow commands

          -  All analgesic guidelines were followed during and after the bunionectomy

        Key Exclusion Criteria:

        Before surgery:

          -  History in the past 10 years of malignancy, except for squamous cell skin cancer,
             basal cell skin cancer, and Stage 0 cervical carcinoma in situ

          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

          -  History of abnormal laboratory results >=2.5*upper limit of normal (ULN)

          -  History of peripheral neuropathy

          -  A known or clinically suspected infection with human immunodeficiency virus or
             hepatitis B or C viruses

          -  Prior medical history of bunionectomy or other foot surgery on the index foot

          -  History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

        After surgery:

          -  Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

        Other protocol defined inclusion/exclusion criteria may apply
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Intervention: AIJP (Arnebia Indigo Jade Pearl); Placebo
Intervention description: Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.; Placebo twice daily for 48 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HSIL; HGAIN; AIN; neoplasia; dysplasia; TCM; Traditional Chinese Medicine

Summary:

      The purpose of this study is to find out if a Chinese herbal cream is effective in treating
      HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal
      intraepithelial neoplasia).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anal HSIL confirmed by biopsy no more than 30 days prior to entry

          -  Anal HSIL deemed not amenable to therapy or participant declines routine ablative
             therapy

          -  HIV positive

          -  Stable HIV treatment regimen for at least 8 weeks prior to entry

          -  At least 18 years of age

          -  Women of childbearing potential must use contraception

          -  Platelet count above 70,000/mm3 within 30 days prior to entry

          -  ANC greater or equal to 1000/mm3 within 30 days prior to entry

          -  Creatinine less then or equal to 1.5 times ULN within 30 days prior to entry

          -  AST and ALT less than or equal to 3 times ULN within 30 days prior to entry

        Exclusion Criteria:

          -  Prior history of invasive anal, cervical, vaginal, or vulvar cancer

          -  Pregnancy or lactation and breast-feeding

          -  Must not participate in a conception process including sperm donation

          -  Medical or psychiatric illness that precludes ability to give informed consent or is
             likely to interfere with ability to comply with protocol

          -  Known allergy to any topical cream components

          -  Patients with lesions clinically suspicious per HRA examiner for early progression
             (less than one year) to anal cancer
Treatment Interruption of Natalizumab
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Intervention: natalizumab; interferon beta 1-a; methylprednisolone; IV placebo; glatiramer acetate
Intervention description: 300 mg intravenous every 4 weeks; 30 ug intramuscular once per week; 1000 mg intravenous every 4 weeks; placebo intravenous every 4 weeks; 20 mg subcutaneous once daily
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methylprednisolone; Glatiramer Acetate; Natalizumab; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: MS

Summary:

      This is a randomized, rater blinded trial in patients who interrupt treatment with
      natalizumab with or without being treated with other immunomodulatory drugs, or continue
      treatment with natalizumab.

      The main purpose of this study is to find out the following, when participants stop taking
      natalizumab for 24 weeks:

        -  when MS symptoms return, and

        -  if other drugs for MS may help control MS symptoms during the natalizumab-interruption
           period.

      This study will also explore how quickly the effects of natalizumab return after resuming
      natalizumab dosing.
    

Eligibility criteria:

        Major criteria include:

          -  A diagnosis of a relapsing form of MS

          -  Treatment with natalizumab according to locally approved prescribing information

          -  Other protocol defined inclusion/exclusion criteria may apply