bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: 40/0mg taken first; 80/0mg taken first; 40/240mg taken first; 80/480mg taken first; 0/0mg taken first
Intervention description: 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses; Placebo All arms taken with a 48 hour washout between doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Matching white tablets
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Summary:

      The primary objective of this study is to compare the relative abuse potential of two
      different doses of orally administered Acurox Tablets to orally administered
      immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female between 18 and 55 years old.

          -  Subject is in generally good health, including no history of pulmonary disease, and
             has a body mass index (BMI) within 18-33 kg/m2.

          -  Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12
             months, and at least 1 within the past 12 weeks) who is NOT physically dependent on
             opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text
             Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will
             provide written informed consent.

          -  Subject has a minimum of a 6th grade reading level as determined by the Investigator
             or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

        Exclusion Criteria:

          -  History or current diagnosis of substance dependence (except nicotine and caffeine)
             and/or alcohol abuse according to the criteria of DSM-IV-TR.

          -  History or current diagnosis of neurological, hepatic, renal, endocrine,
             cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.

          -  Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any
             component of Acurox Tablets.
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
Condition: Heart Transplantation; Liver Transplantation; Kidney Transplantation
Intervention: Tacrolimus
Intervention description: Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Transplant; Pediatrics; Tacrolimus; Prograf

Summary:

      Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid
      organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus
      through genetics will help in early attainment and maintenance of the correct dosage level in
      the early post-transplant period. This pilot dose-finding trial will help to determine a
      dosing strategy guided by genotypes and age for solid organ transplant recipients that will
      be further validated through a multi-centre trial as an immediate next step. The study
      hypothesizes that dosage levels determined through age and genotype will be attained faster
      and more accurately than the standard dosing procedures in the 14-days after the transplant.
      Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster
      recovery (tested through the kidneys' ability to clear creatine from the blood) and result in
      lower frequencies of adverse effects and rejection of the transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 18 years old

          -  Assessed and/or listed for heart, kidney, liver transplantation

          -  Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant

          -  Informed consent of legal guardian

        Exclusion Criteria:

          -  Contra-indications to oral or enteral tacrolimus

          -  Co-morbidities that preclude standard dosing e.g. significant renal or hepatic
             insufficiency

          -  Participation in other investigational drug trials within 30 days of study initiation
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Ipilimumab
Intervention description: Specific dose on specific days; Specific dose on specific days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the effectiveness of re-induction with Nivolumab
      combined with ipilimumab.
    

Eligibility criteria:

        Inclusion Criteria:

        -Participants and Target Disease Characteristics- -

          -  Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after
             induction with ipilimumab and nivolumab

          -  Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be
             submitted for embedded tissue block or tumor tissue.

        Age and Reproduction Sexually active males with WOCBP must agree to instructions for
        contraception and fetal protection.

        WOCBP need to use contraception throughout the study and for 5 months post treatment.

        Exclusion Criteria autoimmune disease statement

          -  Active central nervous system metastases

          -  Participants with an active autoimmune disease, diabetes mellitus, skin disorders,
             hyperthyroidism requiring hormone treatments are permitted to enroll.

          -  Any major surgery 28 days before 1st treatment Concomitant Therapy

          -  participants that have received a live vaccine within 30 days of treatment.

          -  use of investigational agent or device with in 28 days before first dosage study
             treatment.

        Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and
        Reproduction
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
Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis; Skin Diseases
MeSH terms: Psoriasis; Skin Diseases
Intervention: JTE-051; Placebo
Intervention description: Active drug tablets containing JTE-051; Placebo tablets identical in appearance to the active drug tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JTE-051; Psoriasis

Summary:

      Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051
      administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1

          -  Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;

          -  Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;

          -  Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;

          -  Body Mass Index (BMI) ≤40 at Visit 1.

        Exclusion Criteria:

          -  Medical history of treatment failure to any systemic agents for plaque psoriasis;

          -  Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
             medication-induced psoriasis or other skin conditions at (e.g., clinically-significant
             eczema or severe acne) that could interfere with study evaluations at Visit 1;

          -  Presence or history of any itch due to underlying conditions other than plaque
             psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus,
             significant other systemic diseases with itch) within 12 months prior to Visit 1;

          -  History of a clinically-significant infection (e.g., that required oral antimicrobial
             therapy) within 8 weeks prior to Visit 2;

          -  History of infections requiring hospitalization or parenteral antibiotic, antiviral,
             antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of
             recurrent infections or conditions predisposing to chronic infections (e.g.,
             bronchiectasis, chronic osteomyelitis);
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Condition: Refractory Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Zanubrutinib
Intervention description: Administered as specified in the treatment arm.
Intervention MeSH terms: Zanubrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to evaluate the efficacy of zanubrutinib in
      participants with centrally confirmed relapsed or refractory MCL.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Diagnostic report had to include evidence for morphological and cyclin D1 or t (11;
             14).

          2. Eastern Cooperative Oncology Group performance status of 0-2.

          3. Measurable disease by computed tomography/magnetic resonance imaging.

          4. Received prior regimens for MCL.

          5. Documented failure to achieve any response, (stable disease or progressive disease
             during treatment) or documented progressive disease after response to the most recent
             treatment regimen.

          6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal
             (ULN).

          7. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).

          8. Life expectancy of > 4 months.

        Key Exclusion Criteria:

          1. Current or history of central nervous system lymphoma.

          2. Prior exposure to a BTK inhibitor before enrollment.

          3. Prior corticosteroids with anti-neoplastic intent within 7 days.

          4. Major surgery within 4 weeks of screening.

          5. Toxicity must have recovered from prior chemotherapy.

          6. History of other active malignancies within 2 years of study entry.

          7. Currently clinically significant active cardiovascular disease.

          8. QT interval corrected with Fridericia's formula > 450 microseconds or other
             significant electrocardiogram abnormalities.

          9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial
             therapy.

         10. Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C
             infection (detected positive by polymerase chain reaction).

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Condition: Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Hypersensitivity
Intervention: Oral rucaparib
Intervention description: 600 mg BID
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; fallopian tube cancer; primary peritoneal cancer; peritoneal cancer; platinum sensitive; relapsed disease; PARP Inhibitor; rucaparib; homologous recombination; homologous recombination deficiency; genomic scarring; loss of heterozygosity; CO-338; PF 01367338; AG 14699; platinum sensitive ovarian cancer; platinum sensitive fallopian tube cancer; platinum sensitive primary peritoneal cancer; platinum sensitive peritoneal cancer; gynecological cancer; Clovis; Clovis Oncology; ARIEL2; ARIEL 2; ARIEL3; ARIEL 3

Summary:

      The purpose of this study is to determine which patients with ovarian, fallopian tube, and
      primary peritoneal cancer will best respond to treatment with rucaparib.
    

Eligibility criteria:

        The following eligibility criteria pertain to patients enrolling into PART 2 of the study:

        Inclusion:

          -  Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3
             endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer

          -  Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and
             maintenance therapies administered as single agent treatment will not count as a
             chemotherapy regimen

          -  Relapsed/progressive disease as confirmed by CT scan

          -  Have biopsiable and measurable disease. Note: biopsy is optional for patients known to
             harbor a deleterious gBRCA mutation

          -  Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue
             available for planned analyses

        Exclusion:

          -  History of prior cancers except for those that have been curatively treated, with no
             evidence of cancer currently (provided all chemotherapy was completed >6 months prior
             and/or bone marrow transplant >2 years prior to first dose of rucaparib).

          -  Prior treatment with any PARP inhibitor

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that
             would, in the opinion of the Investigator, interfere with absorption of rucaparib

          -  Hospitalization for bowel obstruction within 3 months prior to enrollment
Palliative Management of Inoperable Malignant Bowel Obstruction
Condition: Malignant Bowel Obstruction
MeSH terms: Intestinal Obstruction
Intervention: Dexamethasone; Metoclopramide; Octreotide
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Dexamethasone; Octreotide; Metoclopramide
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
Healthy volunteers: No
Keywords: bowel obstruction

Summary:

      To identify the role of palliative medical management of inoperable malignant bowel
      obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years of age.

          -  Diagnosis of partial bowel obstruction secondary to active or prior malignancy
             (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or
             adhesions inthe setting of active malignancy.

          -  Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel
             obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital
             admission.

          -  Patient must have an inoperable MBO

          -  Participant must understand the investigational nature of this study and sign an
             Independent Ethics Committee/Institutional Review Board approved writteninformed
             consent form prior to receiving any study related procedure.

        Exclusion Criteria:

          -  Evidence of complete bowel obstruction by imaging.

          -  Bacteremia/septicemia with a documented positive blood culture: If a blood culture
             comes back positive after study enrollment, patient will be excluded.

          -  Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to
             study enrollment.

          -  Patients undergoing bowel surgery or stent placement for bowel obstruction.

          -  Those patients with MBO in setting of incarcerated hernia.

          -  Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470
             msec in females on baseline EKG within 2 weeks of enrollment.

          -  Lack of decision making capacity/delirium.

          -  Pregnant or nursing female participants.

          -  Actively suicidal patients.

          -  Acute cholecystitis
Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Nidufexor; Placebo; Standard of Care (SoC)
Intervention description: 50 mg (two 25 mg) LMB763 capsules for oral administration; Placebo capsules for oral administration; Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore
      has the potential to improve the management of diabetic kidney disease when added to the
      standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin
      receptor blocker (ARB)).

      This non-confirmatory Phase 2 study was designed to determine the safety, tolerability,
      efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB
      at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes
      and nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female patients, 18-75 years

          -  Written informed consent

          -  Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to
             screening

          -  Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at
             screening while receiving a dose of angiotensin converting enzyme inhibitor or
             angiotensin receptor blocker that is the standard of care as judged by the study
             doctor.

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus

          -  Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at
             screening

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using basic methods of contraception
             during dosing of study treatment

          -  Uncontrolled diabetes mellitus at screening

          -  History or current diagnosis of ECG abnormalities prior to first study dose

          -  History of kidney disease other than diabetic nephropathy at screening

          -  Uncontrolled hypertension at screening

          -  Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2
             inhibitors.