bioihbjkbjnl/mcl2 huggingface dataset:
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma
Intervention: Tislelizumab
Intervention description: Administered intravenously
Intervention MeSH terms: Tislelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced liver cancer; RATIONALE-208

Summary:

      This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1
      monoclonal antibody BGB-A317 in participants with previously treated hepatocellular
      unresectable carcinoma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically confirmed HCC

          2. Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not
             amenable to locoregional therapy or relapsed after locoregional therapy, and not
             amenable to a curative treatment approach

          3. Has received at least 1 line of systemic therapy for unresectable HCC

          4. Has at least 1 measurable lesion as defined per RECIST v1.1

          5. Child-Pugh score A

          6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

          7. Adequate organ function

        Key Exclusion Criteria:

          1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
             histology

          2. Prior therapies targeting PD-1 or PD-L1

          3. Has known brain or leptomeningeal metastasis

          4. Tumor thrombus involving main trunk of portal vein or inferior vena cava

          5. Loco-regional therapy to the liver within 4 weeks before enrollment

          6. Medical history of interstitial lung disease, non-infectious pneumonitis or
             uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis,
             or acute lung diseases

          7. Has received:

               1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug
                  administration: any chemotherapy, immunotherapy (eg, interleukin, interferon,
                  thymoxin) or any investigational therapies

               2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or
                  any Chinese herbal medicine or Chinese patent medicines used to control cancer

          8. Active autoimmune diseases or history of autoimmune diseases that may relapse

          9. Participant with any condition requiring systemic treatment with either
             corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive
             medication within 14 days before study drug administration

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Infant TB Infection Prevention Study
Condition: Tuberculosis
MeSH terms: Infections; Tuberculosis
Intervention: Isoniazid
Intervention description: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.
Intervention MeSH terms: Isoniazid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: M. tuberculosis infection; isoniazid; HIV-exposed infants

Summary:

      Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium
      tuberculosis infection in HIV-exposed uninfected (HEU) infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV exposed infants

          -  Aged 6 weeks within (+ 4 weeks)

          -  Born to HIV-infected mothers

          -  Not premature and over 2.5 kg

        Exclusion Criteria:

          -  Infants with known exposure to active TB in household

          -  Premature and < 2.5 kg
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Condition: Leukemia; Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Rituximab; Cyclophosphamide (CTX); Doxorubicin; Vincristine; Dexamethasone; Methotrexate (MTX); Cytarabine; G-CSF; Mesna; Pegylated asparaginase; Pegfilgrastim; Solumedrol
Intervention description: 375 mg/m2 by vein; 300 mg/m2 by vein; 50 mg/m2 by vein; 2 mg by vein; 40 mg by vein or by mouth (P.O.); 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7
200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8; 100 mg intrathecal for Courses 1,3,5,7
3 gm/m2 by vein for Courses 2,4,6,8; 10 ug/kg subcutaneous injection; 600 mg/m2 a day by vein; 2000 International units/m2 by vein; 6 mg (flat dose) within 72 hrs after completion of chemotherapy; 40 mg by vein for Courses 2,4,6,8
Intervention MeSH terms: Cytarabine; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Pegaspargase; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 220.0
Sex: All
Healthy volunteers: No
Keywords: Lymphoma; HYPER-CVAD; Leukemia; Acute Lymphoblastic Leukemia; ALL; Remission Duration; Chemotherapy; Asparaginase; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Leukine; Methotrexate; Rituximab; Vincristine

Summary:

      The goal of this clinical research study is to learn if intensive chemotherapy (with
      monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed
      by monthly maintenance chemotherapy for 2 ½ years can improve or cure acute lymphoblastic
      leukemia (ALL) or lymphoblastic lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or
             lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of
             induction chemotherapy.

          2. Failure to one induction course of chemotherapy are eligible, but these patients will
             be analyzed separately.

          3. All ages are eligible.

          4. Zubrod performance less than or equal to 3

          5. Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and
             renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).

          6. Adequate cardiac function as assessed by history and physical examination.

          7. No active co-existing malignancy with life expectancy less than 12 months due to that
             malignancy.

        Exclusion Criteria:

        1) N/A
IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients
Condition: Purpura, Thrombotic Thrombocytopenic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: IdeS (0.25 mg/kg); IdeS (0.50 mg/kg)
Intervention description: Single i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of efficacy and safety in the first 3 patients the dose may be increased in the following 3 patients to 0.5 mg/kg.; Single i.v. infusion of IdeS (0.50 mg/kg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asymptomatic antibody-mediated TTP

Summary:

      The main purpose of this study is to evaluate safety and tolerability in patients diagnosed
      with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single
      intravenous dose of IdeS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or above

          -  Diagnosed with acquired TTP with ADAMTS13 levels of ≤ 10 % in clinical remission and
             with measurable or previously confirmed ADAMTS13 antibodies

        Exclusion Criteria:

          -  Prior malignancy within 5 years

          -  Test positive for serum hepatitis B surface antigen, hepatitis C antibody and human
             immunodeficiency virus (HIV)

          -  Ongoing infectious disease including P-CRP >10

          -  Test positive for IgE antibodies against IdeS

          -  Secondary cause of TTP

          -  Rituximab treatment or other antibody-based therapy within 7 days prior to IdeS dosing

          -  Treatment with investigational medicinal product within the last 12 weeks proceeding
             screening

          -  Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure
             > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen
             dependent COPD

          -  History of any other clinically significant disease or disorder which may either put
             the patient at increased risk because of participation in the study, or influence the
             results or the patient's ability to participate in the study

          -  Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or
             history of hypersensitivity to drugs with a similar chemical structure or class to
             IdeS (e. g. streptokinase and/or staphylokinase)

          -  Substance abuse or other concurrent medical condition that could confound study
             interpretation or affect the patient's ability to tolerate or complete the study

          -  Breast feeding women or women with a positive pregnancy test

          -  Previously received IdeS treatment
DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
Condition: Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hyperkinesis; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries
Intervention: IV Propranolol and Per Tube Clonidine; Placebo
Intervention description: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days; Placebo IV q6h and Per Tube q12, both for 7 days
Intervention MeSH terms: Propranolol; Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 16 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Sympathetic Hyperactivity; Traumatic Brain Injury; Agitation; Severe TBI; TBI; Catecholamines; Heart rate variability; Adrenergic alpha-Agonists; Adrenergic beta-Antagonists; Cognitive Impairment

Summary:

      The investigators intend to determine the effect of adrenergic blockade on 1) short-term
      physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe
      Traumatic Brain Injury (TBI).

      The primary hypothesis is that adrenergic blockade after severe TBI will be associated with
      increased ventilator-free days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 16 years to 64 years

          -  Glasgow Coma Scale score less than or equal to 8 (Severe TBI) with injury on CT

          -  Screen within 24 hours of injury

        Exclusion Criteria:

          -  Pre-existing heart disease (i.e. coronary heart disease)

          -  Pre-existing cardiac dysrhythmia

          -  Allergy to study drugs

          -  Penetrating brain injury

          -  Pre-existing brain dysfunction (i.e. prior severe TBI, debilitating stroke)

          -  Impending brain herniation (i.e. loss of bilateral corneal reflexes)

          -  Craniectomy or craniotomy

          -  Spinal cord injury

          -  Myocardial injury

          -  Severe liver disease

          -  Current use of beta-blockers and/or alpha-2-agonist

          -  Withdrawal of care expected in 24 hours

          -  Prisoners

          -  Pregnant women

          -  Unable to follow-up through final visit
Enhancing Medication-based Analgesia in Humans- STUDY 2
Condition: Pain; Cannabis; Opioid Use
Intervention: Within-subject test of blinded study medications
Intervention description: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Within-subject study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clinical Trial; Analgesia; Phase II; Abuse potential

Summary:

      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD;
      Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when
      compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of
      studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-75

          -  Urine sample tests negative for common illicit substances of abuse, including cannabis

          -  Medically cleared to take study medications

          -  Are not pregnant or breast feeding

          -  Willing to comply with the study protocol.

        Exclusion Criteria:

          -  Meet DSM-5 criteria for alcohol/substance use disorder

          -  Taking opioids for pain

          -  Previous adverse reaction to a cannabinoid product

          -  Prescribed and taking stimulants or benzodiazepines

          -  Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain

          -  Self-report any illicit drug or cannabinoid use in the past 7 days

          -  Presence of any clinically significant medical/psychiatric illness judged by the
             investigators to put subject at elevated risk for experiencing an adverse event

          -  History of seizure disorder

          -  Have a known allergy to the study medications or sesame seed oil

          -  ALT or AST levels >3x ULN and/or Bilirubin levels >2x ULN during Screening

          -  Current (past 60-day) suicidal thoughts or past year history of suicidal behavior

          -  Taking medications contraindicated with hydromorphone or cannabidiol

          -  Have a history of clinically significant cardiac arrhythmias or vasopastic disease

          -  Have an abnormal and clinically-significant ECG
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Lasmiditan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 846.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of lasmiditan in the acute treatment of a
      migraine attack in Japanese adult participants with or without aura.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with migraine with or without aura fulfilling the International
             Classification of Headache Disorders (ICHD)-2.

          -  History of disabling migraine for at least 1 year.

          -  Migraine Disability Assessment Test (MIDAS) score ≥11.

          -  Migraine onset before the age of 50 years.

          -  History of 3-8 migraine attacks per month and <15 headache days per month during the
             past 3 months.

        Exclusion Criteria:

          -  Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.

          -  History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing
             the patient at increased risk of seizures.

          -  History of recurrent dizziness and/or vertigo including benign paroxysmal positional
             vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.

          -  History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or
             neuropathy).

          -  History of orthostatic hypotension with syncope.
Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
Condition: Vulvar High Grade Squamous Intraepithelial Lesion (HSIL); Vulvar Dysplasia; Vulvar Intraepithelial Neoplasia (VIN); VIN2; VIN3; Pre-cancerous Lesions of the Vulva; Human Papillomavirus (HPV)
MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell; Carcinoma in Situ
Intervention: VGX-3100; Imiquimod 5% Cream; CELLECTRA™ 2000
Intervention description: One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.; Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.; IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HPV-16; HPV-18

Summary:

      The purpose of this study is to test the safety and efficacy of an investigational
      immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar
      high-grade squamous intraepithelial lesion (HSIL) [vulval intraepithelial neoplasia 2 or 3
      (VIN 2 or VIN 3)] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is
      being assessed as an alternative to surgery with the potential to clear the underlying HPV
      infection. For more information visit our study website at: www.VINresearchstudy.com
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18 and above;

          -  Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3)
             caused by infection with HPV types 16 and/or 18 confirmed at screening visit;

        Exclusion Criteria:

          -  Biopsy-proven differentiated VIN;

          -  Any previous treatment for vulvar HSIL within 4 weeks prior to screening;

          -  Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;

          -  Pregnant, breastfeeding or considering becoming pregnant within 6 months following the
             last dose of investigational product;

          -  Immunosuppression as a result of underlying illness or treatment;

          -  Significant acute or chronic medical illness.
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
Condition: Pyoderma Gangrenosum
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Intervention: vilobelimab
Intervention description: IV infusions of vilobelimab diluted in sodium chloride.
Intervention MeSH terms: Vilobelimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: IV infusions of vilobelimab diluted in sodium chloride
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is
      safe and effective in the treatment of pyoderma gangrenosum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator

        In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:

        History of

          -  Pathergy (ulcer occurring at the sites of trauma)

          -  Personal history of inflammatory bowel disease or inflammatory arthritis

          -  History of papule, pustule or vesicle that rapidly ulcerated

        Clinical examination (or photographic evidence) of

          -  Peripheral erythema, undermining border, and tenderness at site of ulceration

          -  Multiple ulcerations (at least 1 occurring on the lower leg)

          -  Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers

        Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening

        Exclusion Criteria:

          -  Pyoderma gangrenosum target ulcer for more than 3 years before screening

          -  Surgical wound debridement within the previous 2 weeks before screening

          -  Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents
             within 30 days before screening

          -  Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg),
             intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the
             exception of antibiotics for wound superinfection) used within a time of 5 half-lives
             of the drug before screening