bioihbjkbjnl/mcl2 huggingface dataset:
Titrating-Dose of Lonafarnib in Combination With Ritonavir
Condition: Chronic Delta Hepatitis
MeSH terms: Hepatitis D; Hepatitis D, Chronic; Hepatitis
Intervention: lonafarnib; Ritonavir
Intervention description: antiviral farnesyltransferase inhibitor; Cytochromes P450 3A4 inhibitor used to boost lonafarnib
Intervention MeSH terms: Ritonavir; Lonafarnib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically
      infected with hepatitis delta virus (HDV)
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female, 18 to 65 years of age, inclusive

          2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6
             months duration and detectable HDV ribonucleic acid (RNA) by quantitative polymerase
             chain reaction (qPCR) at study entry

          3. Liver biopsy demonstrating evidence of chronic hepatitis

          4. Willingness to practice appropriate contraception

        Key Exclusion Criteria:

          1. Previous use of lonafarnib

          2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)

          3. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have
             Gilbert's disease

          4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices,
             ascites, or hepatic encephalopathy

          5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN)

          6. Evidence of another form of viral hepatitis (not including hepatitis B virus or HCV)
             or another form of liver disease

          7. Evidence of hepatocellular carcinoma

          8. Use of alfa interferon, either interferon alfa-2a or interferon alfa-2b, or
             peginterferon alfa-2a within 2 months before the start of screening

          9. Concomitant use of any of the following:

               1. Medications or foods that are known moderate or strong inducers or inhibitors of
                  CYP3A4 or CYP2C19

               2. Drugs known to prolong the PR interval or QT interval of the electrocardiogram

               3. Receipt of systemic immunosuppressive therapy within the 3 months before start of
                  screening

               4. Statins, due to inhibition of mevalonate synthesis, which reduces protein
                  prenylation

               5. Medications contraindicated in the prescribing information for ritonavir
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: ADI-PEG-20; Pharmacology Studies
Intervention description: There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.; tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent melanoma; stage IV melanoma

Summary:

      RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an
      amino acid needed for cell growth.

      PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in
      treating patients with metastatic melanoma that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed metastatic melanoma, meeting any of the following criteria:

               -  Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy

               -  No longer responding to standard therapy OR have refused standard therapy

          -  Unresectable disease

          -  Measurable or evaluable disease

          -  No clinical ascites

          -  No symptomatic pleural effusion

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 12 weeks

          -  Karnofsky performance status 70-100%

          -  Bilirubin ≤ 3.0 mg/dL

          -  Albumin ≥ 3.0 g/dL

          -  Alkaline phosphatase < 5 times upper limit of normal (ULN)

          -  Serum glucose > 60 mg/dL

          -  Amylase < 1.5 times ULN

          -  Absolute neutrophil count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  No New York Heart Association class III-IV heart failure

          -  No serious infection requiring treatment with antibiotics

          -  No known allergy to E. coli drug products (e.g., sargramostim [GM-CSF])

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 forms of effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 4 weeks since prior anticancer therapy

          -  At least 4 weeks since prior surgery and recovered

          -  No concurrent participation in another investigational drug study
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Condition: Endometrial Neoplasms
MeSH terms: Endometrial Neoplasms
Intervention: PF-05212384; PF-05212384; PF-05212384
Intervention description: 154mg IV weekly; 154mg IV weekly; 154mg IV weekly
Intervention MeSH terms: Gedatolisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uterine neoplasms; endometrial; uterine; cancer; PI3K; mTOR; PI3K/mTOR; recurrent; metastatic

Summary:

      This study will investigate the individual safety and efficacy of two dual PI3K/mTOR
      inhibitors in patients with recurrent endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent endometrial carcinoma

          -  Disease progression following one or two lines of prior treatment with platinum
             containing chemotherapy

          -  Tumor tissue available at time of screening for PI3K analysis

          -  Adequate performance status

          -  Adequate glucose control, bone marrow, kidney, liver, and heart function

        Exclusion Criteria:

          -  More than 2 prior cytotoxic chemo regimens for endometrial carcinoma

          -  Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor

          -  Active brain metastases
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2%; Vehicle; Crisaborole ointment 2%; Vehicle
Intervention description: BID regimen; BID regimen; QD regimen; QD regimen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled,
      intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole
      ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older,
      cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ages; Cohort 1: 12 years and older at the time of consent.
             Cohort 2: 2 years to under 12 years old at the time of consent.

          -  Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria
             and has at least 6 months history prior to screening and has been clinically stable
             for more than 1 month

          -  Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals
             and groin area

          -  Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3)
             on Day 1.

        Exclusion Criteria:

          -  Has other acute or chronic medical or psychiatric condition including recent (within
             the past year) or active suicidal ideation or behavior or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Condition: Chronic Kidney Disease; Type 2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: AZD1722; Placebo
Intervention description: Placebo for AZD1722
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: albuminuria

Summary:

      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 80 years, inclusive.

          -  Body mass index between 18 and 45 kg/m2, inclusive.

          -  Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3
             months prior to randomization

          -  Stage 3 CKD

          -  MSSBP ≥130 mmHg

          -  Urinary albumin: mean UACR ≥ 200 mg/g

        Exclusion Criteria:

          -  Urinary albumin: UACR > 3500 mg/g

          -  History of a renal transplant

          -  MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in
             periods

          -  History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: ISV-303; Bromday™
Intervention description: 0.075% bromfenac in DuraSite dosed QD; 0.09% bromfenac dosed QD
Intervention MeSH terms: Bromfenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bromfenac concentrations; ISV-303; Bromday

Summary:

      The purpose of this study is to evaluate the aqueous humor concentration of bromfenac sodium
      in subjects administered multiple topical ocular doses of ISV-303 or Bromday™ QD prior to
      routine cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age 18 or older scheduled for unilateral cataract surgery
             (phacoemulsification or extracapsular extraction) with posterior chamber intraocular
             lens implantation

          -  If a female is of childbearing potential, the subject must agree to and submit a urine
             sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the
             study, and the subject must use effective contraception for the duration of the study.
             Post menopausal is defined as having no menses for at least 12 consecutive months.

          -  Signature of the subject on the Informed Consent Form

          -  Willing and able to follow all instructions and attend all study visits

          -  Able to self-administer study drug (or have a caregiver available to instill all doses
             of study drug)

        Exclusion Criteria:

          -  Use of any drug containing bromfenac within 2 weeks prior to surgery

          -  Contact lens wear during the dosing period

          -  Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the
             investigational medicinal product (IMP) or any of the procedural medications

          -  Any serious complications with or macroscopic damage to the corneal epithelium

          -  Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
             positive urine pregnancy test

          -  Currently suffer from alcohol and/or drug abuse

          -  Prior participation in this study protocol

          -  Prior (within 30 days of beginning study treatment) or anticipated concurrent use of
             an investigational drug or device

          -  A condition or a situation, which in the investigator's opinion may put the subject at
             increased risk, confound study data, or interfere significantly with the subject's
             study participation
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome; Cognitive Dysfunction
Intervention: Donepezil hydrochloride (Aricept)
Intervention description: Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in
      children with Down syndrome who have finished the preceding 10-week, double-blind study of
      donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic
      visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Down syndrome (established during study E2020-A001-220).

          -  Completion of study E2020-A001-219 (NCT00570128 [also known as A2501059]) with no
             ongoing seroius adverse events and no severe drug reactions.

        Exclusion Criteria:

          -  Weight less than 20 kg.

          -  Clinically significant conditions affecting absorption, distribution or metabolism of
             the study medication.

          -  No reliable parent or caregiver, or unwillingness or inability of parent or caregiver
             to fulfill the requirements of the study.

          -  Females of childbearing potential who are not practicing an effective means of birth
             control.
Lorcaserin in the Treatment of Cocaine Use Disorder
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Lorcaserin; Placebo Oral Capsule
Intervention description: Lorcaserin Capsule; sugar pill to mimic lorcaserin 10mg capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine Use Disorder

Summary:

      The objective of this study is to evaluate the efficacy and safety of lorcaserin in the
      treatment of cocaine use disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured
             Clinical Interview for DSM-5

          -  Is seeking treatment for cocaine use disorder

          -  Is able to understand and provide written informed consent

          -  Has used cocaine on at least 1 day in the last 30 days prior to screening

          -  Has completed all psychological assessments and procedures during the screening period

          -  If female, not pregnant, lactating, unable to conceive OR must agree to use an
             acceptable method of birth control

          -  Has a total body weight greater than 110 pounds and body mass index greater than 20

        Exclusion Criteria:

          -  Contact site for more information
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Condition: Smoking Cessation
Intervention: Bupropion SR; Placebo
Intervention description: 150mg, taken orally, taken daily for the 1st 3 days
300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment; -Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking cessation during pregnancy; bupropion

Summary:

      This study is designed to gather preliminary effectiveness and safety data on the use of
      bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This
      study will provide critical preliminary data in preparation for a larger, Phase III clinical
      trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women ≥ 18 years of age

          -  Gestational age between 14 and 26 weeks confirmed by ultrasound

          -  Currently smoking ≥ 5 cigarettes per day

        Exclusion Criteria:

          -  Abnormal liver function tests

          -  History of or current seizure disorder or closed head injury with loss of
             consciousness

          -  Known hypersensitivity to bupropion

          -  Any psychiatric disorder requiring psychotropic medication

          -  Current anorexia or bulimia

          -  Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks

          -  Major Depressive Disorder or current suicidal risk

          -  Use of any illicit substances since receiving knowledge of pregnancy

          -  Regular use of alcohol (>1 drink/week on average)

          -  Unstable medical problems, such as liver or renal disease, uncontrollable
             hypertension, and lupus

          -  Twins or other multiple gestation

          -  Fetal abnormality on the 14 week ultrasound

          -  Plans to deliver at a hospital other than Memorial Hermann

          -  Inability to communicate with research staff or make study visits due to lack of phone
             or transportation access

          -  Participation in another clinical study which may affect study outcomes

          -  Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline
             (Chantix)
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Intervention: Daclatasvir; Daclatasvir; Placebo; peg-interferon alfa-2a; ribavirin
Intervention description: Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response; Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response; Tablets, oral, 0 mg, once daily, 24 weeks; Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response; Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated
      interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
      virologic response rates at least 35% greater than those with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4

          -  HCV RNA viral load of ≥100,000 IU/mL

          -  No previous exposure to interferon, pegIFNα, or RBV

          -  Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior
             to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection
             are eligible, but will be capped at 10% of the randomized study population (biopsy can
             be from any time period prior to randomization)

          -  Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12
             months prior to randomization that do not demonstrate evidence of hepatocellular
             carcinoma

          -  Body mass index of 18 to 35 kg/m^2

        Exclusion Criteria:

          -  Positive for hepatitis B or HIV-1/HIV-2 antibody at screening

          -  Evidence of a medical condition associated with chronic liver disease other than HCV

          -  Evidence of decompensated cirrhosis based on radiologic criteria or biopsy