bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Apo805K1
Intervention description: Sequential parallel dose escalation.
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
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mild to Moderate Chronic Plaque Psoriasis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with
      moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6
             months (before Baseline assessment) with current body surface area (BSA) involvement
             ≥10% and Psoriasis Area Severity Index (PASI) ≥10.

          -  Male and female subjects 18 to 65 years of age, inclusive.

          -  At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).

          -  Signed and witnessed written informed consent form obtained prior to the first study
             intervention, as well as the ability to adhere to study restrictions, appointments and
             evaluation schedule.

        Main Exclusion Criteria:

          -  Treatment of psoriasis with biologic agents within 90 days prior to Baseline
             assessment and during the study.

          -  Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic
             agents within 30 days prior to Baseline assessment and during the study.

          -  Phototherapy within 30 days prior to Baseline assessment and during the study.

          -  Psoriasis topical therapy within 14 days prior to Baseline assessment and during the
             study (exception: non-medicated emollients and tar shampoo will be allowed).

          -  History of liver disease or abnormal liver enzymes

          -  Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched
             controls.

          -  Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.

          -  Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere
             with psoriasis assessments.

          -  History of chronic infection or malignancy
A Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551; Vehicle
Intervention description: Applied twice daily for two weeks; Applied twice daily for two weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; plaque psoriasis; 122-0551; steroid

Summary:

      Corticosteroids are one of the mainstays of treatment for subjects with
      corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to
      determine and compare the efficacy and safety of a formulation of 122-0551 versus the
      corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for
      14 consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis

          -  Subject has an ODS score for the Treatment Area of 3 or 4 at study start

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid
             therapy within 30 days prior to study start

          -  Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous
             products within 90 days prior to study start

          -  Subject has used any systemic biologic therapy for the treatment of psoriasis within 5
             half-lives of the biologic prior to study start

          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to study start

          -  Subject has used topical body (excluding the scalp) psoriasis therapy including coal
             tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days
             prior to study start

          -  Subject has used emollients/moisturizers on areas to be treated within four hours
             prior to clinical evaluation at study start

          -  Subject is currently using lithium or Plaquenil (hydroxychloroquine)

          -  Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE
             (e.g., lisinopril) inhibitor at a dose that has not been stabilized

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study

          -  Subject is currently enrolled in an investigational drug or device study

          -  Subject has used an investigational drug or investigational device treatment within 30
             days prior to study start

          -  Subject has been previously enrolled in this study and treated with a test article
Enzastaurin for Patients With Metastatic Colorectal Cancer
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Intervention: Enzastaurin HCl
Intervention description: 1200 milligrams (mg) loading dose orally, then 500 mg, orally, daily, up to six 28-day cycles.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and
      have not received prior chemotherapy for advanced colorectal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with colorectal cancer that is advanced or metastatic (has spread to other
             parts of the body); able to visit the doctor's office every 28 days for at least 6
             months; able to swallow tablets

        Exclusion Criteria:

          -  women cannot be pregnant or breastfeeding; no history of significant heart disease or
             any other significant medical problems as determined by the participant's physician
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo for BMS-986165
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated
      with BMS-986165
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male and female, ages 18 to 70 years

          -  Diagnosis of plaque psoriasis for 6 months

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test, must not be pregnant, lactating, breastfeeding or planning pregnancy

          -  Males who are sexually active with WOCBP must agree to follow instructions for
             method(s) of contraception for the duration of treatment plus 5 half-lives of the
             study drug plus 90 days.

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Blood transfusion within 4 weeks of study drug administration

          -  Inability to tolerate oral medication

          -  Positive hepatitis-B (HBV) surface antigen

          -  Positive hepatitis-C (HCV) antibody

          -  Any history or risk for tuberculosis (TB)

          -  Any major illness/condition or evidence of an unstable clinical condition

          -  Chest X-ray findings suspicious of infection at screening

          -  has received ustekinumab, secukinumab or ixekizumab within 6 months of first
             administration of study medication

          -  Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first
             administration of study medication

          -  Has received Rituximab within 6 months of first administration of study medication

          -  Topical medications/treatments for psoriasis within 2 weeks of the first
             administration of any study medication

          -  Any systemic medications/treatments for psoriasis within 4 weeks of the first
             administration of any study medication

        Other protocol defined inclusion/exclusion criteria could apply
Study of Lactulose in Children With Chronic Liver Disease
Condition: Minimal Hepatic Encephalopathy
MeSH terms: Liver Diseases; Hepatic Encephalopathy; Brain Diseases
Intervention: Lactulose; placebo
Intervention description: 1.5cc/kg/day po for three months; 1.5 ml sugar water/kg day for three months
Intervention MeSH terms: Lactulose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: encephalopathy; pediatric liver disease; pediatric cirrhosis; serum ammonia levels

Summary:

      Pediatric patients with chronic liver disease may have Minimal Hepatic
      Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological
      function.By utilizing cognitive and developmental testing we will determine if patients have
      MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a
      washout period with no treatment. At this time patients are re-tested and then begin another
      three month period switching to the opposite treatment of first 3 months.Final
      cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt.
             with cirrhosis as evidenced by imaging/biopsy

        Exclusion Criteria:

          -  patients with neurological,psychiatric or unstable medical conditions which may
             contribute to impaired cognitive function.

          -  patients with known hearing or vision difficulties.

          -  those patients who do not speak English will be excluded.
A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Intervention: PD 0360324; Normal Saline for injection
Intervention description: 100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;; normal saline Q2W via intravenous infusion for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase 2; Randomized; Double Blind; Placebo Controlled; Parallel; 20 Week Safety; Tolerability; and Efficacy Study

Summary:

      The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in
      subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care
      therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for
             at least 1 year;

          -  Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal
             values at screening;

          -  age 21-75 years of age;

          -  treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10
             and 30 mg of prednisone) for at least 3 months prior to Screening; (other
             anti-inflammatory drugs may be permitted as defined by the study protocol)

        Exclusion Criteria:

          -  History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring
             maintenance treatment, chronic obstructive pulmonary disease (COPD));

          -  Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB,
             HIV);

          -  treatment with other biologic anti-inflammatory/immuno-modulatory drugs;

          -  active smokers;

          -  class 3 or 4 congestive heart failure;

          -  cancer, or history of cancer within past 5 years;

          -  history of ischemic heart disease, heart attack, stroke, any heart muscle disease;

          -  liver disease;

          -  history of alcohol or drug abuse
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: LCZ696; Valsartan; AHU377; Placebo
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1334.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypertension, valsartan, LCZ696

Summary:

      This study was a dose-ranging efficiacy study in patients with essential hypertension to
      assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and
      placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females from 18 up to and including 75 years

          -  Patients with mild-to-moderate uncomplicated essential hypertension, untreated or
             currently taking antihypertensive therapy (monotherapy or combination therapy of 2
             drugs; therapy with a fixed dose combination of two active substances represents 2
             drugs)

          -  Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit
             (Visit 3) and the 2 preceding visits (Visits 1 and 2).

          -  Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a
             msDBP> 95 mmHg at baseline (Visit 3);

        Exclusion Criteria:

          -  Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)

          -  History of angioedema, drug-related or otherwise, as reported by the patient

          -  Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)

          -  History or evidence of a secondary form of hypertension, such as renal parenchymal
             hypertension, renovascular hypertension, coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or
             bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.

          -  History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic
             heart disease, surgical or percutaneous arterial intervention of any kind (coronary,
             carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid
             artery stenosis, aortic aneurysm or peripheral arterial disease
Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: arsenic trioxide; idarubicin; tretinoin
Intervention MeSH terms: Idarubicin; Arsenic Trioxide; Tretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult acute promyelocytic leukemia (M3); adult acute myeloid leukemia with t(15;17)(q22;q12); untreated adult acute myeloid leukemia

Summary:

      RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and
      spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work
      in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without
      idarubicin may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic
      trioxide with or without idarubicin works in treating patients with acute promyelocytic
      leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the
             following:

               -  Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ
                  hybridization (FISH)

               -  Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction
                  (RT-PCR) assay

          -  Patients with CNS involvement by APL are eligible

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 60-100%

          -  Creatinine ≤ 2.0 mg/dL or creatinine clearance > 60 mL/min

          -  Bilirubin < 2.0 mg/dL (unless attributed to Gilbert disease)

          -  Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 ULN

          -  LVEF ≥ 50% on echocardiogram or MUGA scan

          -  QTc ≤ 500 msec on baseline ECG

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 4 months after the
             completion of study treatment

          -  No active serious infections not controlled by antibiotics

          -  No other concurrent active malignancy requiring immediate therapy

          -  No clinically significant cardiac disease (New York Heart Association class III or IV
             heart disease), including chronic arrhythmias

          -  No pulmonary disease

          -  No other serious or life-threatening condition deemed unacceptable by the principal
             investigator

        PRIOR CONCURRENT THERAPY:

          -  No prior treatment for APL
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Condition: Leukemia; Fungal Infection
MeSH terms: Mycoses; Leukemia
Intervention: Posaconazole
Intervention description: 200 mg (liquid) by mouth 3 times per day.
Intervention MeSH terms: Posaconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Blood; Cancer of Bone Marrow; Acute Leukemia; AML; Fungal infection; Prophylaxis; Posaconazole; SCH 56592; Noxafil; Chemotherapy

Summary:

      The goal of this clinical research study is to learn the amount of posaconazole that is in
      the body at different time points when given to patients with leukemia. The safety of this
      drug will also be studied.

      Objectives:

      Primary:

      To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute
      myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing
      induction chemotherapy or relapsed or refractory patients who will receive salvage
      chemotherapy.

      Secondary:

      To evaluate the safety of posaconazole given as prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients newly diagnosed with AML or high-risk MDS undergoing induction chemotherapy
             or refractory or relapsed patients with AML or high-risk MDS who will receive first or
             second salvage chemotherapy. (Salvage patients are defined as patients that achieved
             remission and relapsed or patients who were refractory to initial frontline
             chemotherapy)

          2. Age > 18 years and able to take oral intake.

          3. Patients must sign an informed consent.

          4. Patients agree to medically approved forms of contraception

          5. Patients on prior antifungal prophylaxis with voriconazole, itraconazole or
             fluconazole are eligible if they completed 3 days wash-out period if on voriconazole,
             or 14 days wash-out period if on itraconazole or 7 days wash-out period if on
             fluconazole

        Exclusion Criteria:

          1. Patients with history of anaphylaxis attributed to azole compounds

          2. Patients with clinical or other evidence that indicates that they have proven or
             probable invasive fungal infection prior to enrollment (EORTC criteria)

          3. Patients with baseline total bilirubin levels > 3 times the upper normal limits (i.e.
             > 3.0 mg/dl); or baseline SGPT > 5 times upper limit normal.

          4. Patients receiving any medication that is contraindicated with the use of posaconazole

          5. Patients with baseline creatinine levels NCI grade 3 or above (> 3.0 - 6.0 X ULN)

          6. Patients with baseline QTc prolongation NCI grade 1 or above (QTc > 0.45 - 0.47
             seconds).