bioihbjkbjnl/mcl2 huggingface dataset:
American Ginseng Treatment for Multiple Sclerosis Related Fatigue
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Intervention: American ginseng extract HT-1001; placebo
Intervention description: Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period.; Placebo capsules were identical to the study drug and were dose escalated to match the study drug. Subjects were maintained on placebo capsules for the remainder of the 6 week treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; fatigue; ginseng

Summary:

      This research project will determine the safety and tolerability of ginseng in subjects with
      MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment
      of MS fatigue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MS as diagnosed by the McDonald criteria

          -  Complaint of fatigue that has been persistent for at least 2 months

          -  FSS score of 4 or greater;

          -  Age 18-70.

        Exclusion Criteria:

          -  Use of ginseng or stimulants in the prior 6 weeks

          -  Acute treatment with glucocorticoids in the prior 6 weeks

          -  BDI >31

          -  Significant MS exacerbation in prior 30 days

          -  Diabetes

          -  Uncontrolled hypertension

          -  Other serious medical disease, pregnancy or breastfeeding

          -  Breast disease

          -  Abnormal bleeding or clotting disorder

          -  Current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline,
             isocarboxazid, or phenelzine

          -  Current use of lasix for poorly controlled hypertension or congestive heart failure

          -  Current drug or alcohol abuse; inability to complete the self report forms
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353; Placebo
Intervention description: oral liquid formulation; oral liquid formulation to match BCX7353
Intervention MeSH terms: Berotralstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HAE; hereditary angioedema; kallikrein inhibitor; plasma kallikrein

Summary:

      This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor,
      BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary
      angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks)
      or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be
      assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a
      further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if
      efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of
      BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject
      diary entries completed at pre-defined times post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written, informed consent.

          2. A clinical diagnosis of hereditary angioedema Type 1 or Type 2 as documented at any
             time in the medical records or at the screening visit.

          3. Access to and ability to use standard of care acute attack treatment for attacks of
             HAE.

          4. Sexually active women of child-bearing potential and sexually active men must utilize
             effective contraception.

        Exclusion Criteria:

          1. Women who are pregnant or breast-feeding.

          2. Any clinical condition or medical history that would interfere with the subject's
             safety or ability to participate in the study.

          3. Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks.

          4. History of or current alcohol or drug abuse.

          5. Infection with hepatitis B, hepatitis C or HIV.

          6. Participation in any other investigational drug study currently or within the last 30
             days.

          7. Positive drugs of abuse screen (unless as used as medical treatment, e.g., with a
             prescription).

          8. An immediate family relationship to either Sponsor employees, the Investigator or
             employees of the study site.
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Condition: Macular Edema
MeSH terms: Cataract; Macular Edema; Retinal Diseases; Diabetic Retinopathy
Intervention: Nepafenac ophthalmic suspension, 0.1% (NEVANAC); Nepafenac ophthalmic suspension vehicle; Prednisolone acetate ophthalmic suspension (OMNIPRED)
Intervention description: 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.; 1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery; One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 263.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetic retinopathy; cystoid macular edema;

Summary:

      The purpose of this study is to determine whether nepafenac is safe and effective for
      reducing the incidence of macular edema following cataract surgery in diabetic retinopathy
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and
             planned cataract extraction by phacoemulsification.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Central subfiled macular thickness greater than or equal to 250 microns

          -  CME in either eye.

          -  Other protocol-defined exclusion criteria may apply.
Ranolazine Cardioprotection in PCI
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Intervention: Ranolazine; Placebo
Intervention description: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI; Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome; ACS; Percutaneous Coronary Intervention; PCI; Ranolazine; Coronary Angiogram; Cardioprotectant

Summary:

      The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker
      release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Patients undergoing Coronary Angiography with possible PCI

          -  Able and willing to give consent

          -  Able to read and write English

        Exclusion Criteria:

          -  Current EKG or Biomarker of Acute Myocardial Infarction (MI) or Acute Coronary
             Syndromes (ACS)

          -  History of Allergy to Ranolazine

          -  Pregnant or Nursing

          -  Currently taking Ranolazine
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: NCX 4251; Placebo
Intervention description: NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily; Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double-masked
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial
      evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal)
      Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  documented history of blepharitis and meet qualifying criteria for an acute
             exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits

          -  have a qualifying best-corrected visual acuity

        Exclusion Criteria:

          -  abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid
             surgery

          -  IOP > 21 mmHg at Screening or Baseline/Day 1 Visits

          -  use of steroids in the past 30 days or retinoids in the past 12 months

          -  uncontrolled systemic disease
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Condition: Obstetric Labour, Premature
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: GSK221149A; Placebo
Intervention description: 6mg/h and 12 mg/h; Matched Placebo to Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Premature Labor; Pre Term Labor; intravenous; fetal fibronectin

Summary:

      Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity
      and mortality and is frequently associated with long-term disability. Oxytocin is a hormone
      produced by the body during labor. GSK221149A is an experimental drug that will be used to
      block the effects of oxytocin, and therefore pause or prevent contractions. In this study,
      patients with preterm labor will be given an intravenous infusion of GSK221149A over
      approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study,
      patients with preterm labor will be give an intravenous infusion of GSK221149A over
      approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes

          -  18-45 inclusive

          -  Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour,
             each of which at least 30 sec in duration, with cervical dilatation of less than or
             equal to 4 cm, (measured by tocodynamometry).

        Exclusion criteria:

          -  Any clinically relevant abnormality identified on the screening examination or any
             other medical condition or circumstance making the patient (mother and/or fetus)
             unsuitable for participation in the study

          -  Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may
             affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes
             mellitus, bleeding/clotting diathesis)
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);
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Condition: Pulmonary Cancer
MeSH terms: Adenocarcinoma; Lung Neoplasms
Intervention: Gefitinib
Intervention description: 250mg tablet oral tablet once daily
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation; Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation; Recurrent pulmonary adenocarcinoma with EGFR mutation

Summary:

      The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of
      Gefitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients require histological biopsy and paraffin block more than 5mg from the
             original tumour or metastatic site to perform EGFR mutational analysis

          -  WHO Performance Status 0-2

          -  No prior chemotherapy, biological or immunological therapy/surgery

        Exclusion Criteria:

          -  Any evidence of clinically active interstitial lung disease

          -  Newly diagnosed CNS metastases that have not yet been definitively treated with
             surgery /radiation

          -  Patients with previously diagnosed and treated CNS metastases or spinal cord
             compression
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Condition: Breast Cancer; Precancerous Condition
MeSH terms: Carcinoma in Situ; Precancerous Conditions
Intervention: broccoli sprout extract; placebo
Intervention description: Given orally; Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: Female
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: mammography; biopsy; ductal breast carcinoma in situ; atypical ductal breast hyperplasia

Summary:

      RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal
      cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal
      hyperplasia.

      PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in
      treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical
      ductal hyperplasia.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Diagnostic mammogram

          -  English speaking

        EXCLUSION CRITERIA:

          -  Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test)

          -  No biopsy referral after diagnostic mammogram

          -  Patient reported breast feeding

          -  Significant active medical illness which in the opinion of the investigator would
             preclude protocol treatment

          -  History of or active liver disease or baseline total bilirubin greater than
             institutional upper limit of normal

          -  Patient reported allergy or sensitivity to cruciferous vegetables

          -  Use of oral antibiotics within three months prior to randomization

          -  Oral steroid therapy at enrollment

          -  Current therapy with valproate acid or SAHA

          -  Current use of nutrient supplements or herbal remedies containing sulforaphane and
             unwillingness or inability to quit 72 hours prior to randomization and for the
             duration of the trial

          -  Radiation for currently-diagnosed disease prior to or during study supplementation

          -  Chemotherapy for currently-diagnosed disease prior to or during study supplementation
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
Condition: Cholesterol Ester Storage Disease (CESD); Lysosomal Acid Lipase Deficiency; LAL-Deficiency
MeSH terms: Wolman Disease; Cholesterol Ester Storage Disease
Intervention: sebelipase alfa
Intervention description: Sebelipase alfa is a recombinant human lysosomal acid lipase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enzyme replacement therapy (ERT); Lysosomal storage disease; Late onset lysosomal acid lipase (LAL) deficiency; Acid cholesteryl ester hydrolase deficiency, type 2; Acid lipase disease; Cholesterol ester hydrolase deficiency; LAL deficiency; LIPA enzyme deficiency

Summary:

      This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the
      study was to evaluate the long-term safety and tolerability of sebelipase alfa in
      participants with liver dysfunction due to lysosomal acid lipase (LAL) deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with
             no life-threatening or unmanageable study drug toxicity.

        Exclusion Criteria:

          -  Clinically significant concurrent disease, serious inter-current illness, concomitant
             medications or other extenuating circumstances

          -  Clinically significant abnormal values on laboratory screening tests, other than LFTs
             or lipid panel tests
Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
Condition: Follicular Lymphoma; B-cell Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Ibrutinib; rituximab
Intervention description: All subjects will receive 560 mg of Ibrutinib orally.; All subjects will receive rituximab 375 mg/m2 intravenously
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacyclics (PCYC); PCYC; Lymphoma; Follicular Lymphoma; FL; Rituximab; Ibrutinib; Rituxan; Non-Hodgkin's Lymphoma (NHL); NHL; B-cell Lymphoma

Summary:

      This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib
      combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
    

Eligibility criteria:

        Key Inclusion criteria:

          1. Histologically documented FL (Grade 1, 2 and 3A)

          2. Not previously treated with prior anti-cancer therapy for FL

          3. Stage II, III or IV disease

          4. At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan

          5. Men and women ≥ 18 years of age

          6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

        Key Exclusion criteria:

          1. Medically apparent central nervous system lymphoma or leptomeningeal disease

          2. FL with evidence of large cell transformation

          3. Any prior history of other hematologic malignancy besides FL or myelodysplasia

          4. History of other malignancies, except

               1. Malignancy treated with curative intent and with no known active disease present
                  for ≥5 years before the first dose of study drug and felt to be at low risk for
                  recurrence by treating physician.

               2. Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of
                  disease.

               3. Adequately treated carcinoma in situ without evidence of disease.

          5. Currently active, clinically significant cardiovascular disease or myocardial
             infarction within 6 months of screening

          6. Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine
             proteins or to any component of rituximab (Rituxan®)

          7. Requires anti-coagulation with warfarin or a vitamin K antagonist.

          8. Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.

          9. Known bleeding diathesis or hemophilia