bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Condition: Renal Transplantation
Intervention: Enteric-coated mycophenolate sodium (EC-MPS); Prednisone
Intervention description: An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.; Oral tablets
Intervention MeSH terms: Mycophenolic Acid; Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Steroids avoidance,; enteric-coated mycophenolate sodium (EC-MPS),; de novo renal transplantation

Summary:

      This study will investigate the efficacy and safety of a steroid avoidance regimen in
      comparison with steroid treatment in combination with an initially higher dose of
      enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal
      transplant recipients. Patients will be randomly allocated to receive either EC-MPS or
      steroids in combination with EC-MPS. Patients of both treatment groups will receive
      monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary donor kidney transplant

          -  Panel reactive antibody (PRA) ≤ 20%

        Exclusion Criteria:

          -  Multi-organ transplantation including dual kidneys or previous transplant with any
             other organ different from kidney

          -  Non-heart beating donor or kidney from a non-compatible donor

        Other protocol-defined inclusion/exclusion criteria may apply.
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Condition: Melanoma
MeSH terms: Melanoma
Intervention: pembrolizumab + epacadostat; pembrolizumab + placebo
Intervention description: Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
Epacadostat will be administered orally daily starting at Day 1 (Week 1); Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
Placebo will be administered orally daily starting at Day 1 (Week 1)
Intervention MeSH terms: Pembrolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Metastatic Melanoma

Summary:

      The purpose of the study is to assess the efficacy, safety, and tolerability when combining
      pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic
      melanoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed melanoma

          -  Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not
             amenable to local therapy

          -  A minimum of 1 measurable lesion by CT or MRI

          -  Provide a baseline tumor biopsy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

        Exclusion Criteria:

          -  Has received prior systemic treatment for unresectable or metastatic melanoma (except
             BRAF directed therapy)

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
             IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint
             pathways other than anti-CTLA-4 which is permitted in the adjuvant setting

          -  Has received prior adjuvant therapy, monoclonal antibody or an investigational agent
             or device within 4 weeks or 5 half-lives (whichever is longer)

          -  Has an active infection requiring systemic therapy

          -  Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

          -  Has known history of or is positive for Hepatitis B or Hepatitis C

          -  Is pregnant or breastfeeding or expecting to conceive or father children within the
             projected duration of the study, starting with the screening visit through 120 days
             after the last dose of study treatment
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Buprenorphine Sublingual Spray; Placebo
Intervention description: Buprenorphine sublingual spray delivered via single 100 μL spray; Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bunionectomy

Summary:

      This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group,
      placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of
      Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants
      with moderate to severe postoperative pain after bunionectomy. The study will comprise 4
      periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up
      Period.

      Participants will be admitted to the study site on the morning of the scheduled surgery, will
      remain at the study site until postoperative Day 3 (a total of 3 nights at the study site),
      and will return for the Follow-up Visit 5 to 9 days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Is able to speak and understand the language in which the study is being conducted, is
             able to understand the procedures and study requirements and has voluntarily signed
             and dated an informed consent form approved by the Institutional Review Board before
             the conduct of any study procedure

          -  Is willing and able to comply with study requirements (including diet, alcohol, and
             smoking restrictions), complete the pain evaluations, remain at the study site for
             three days, and return for follow up between 7 and 9 days after surgery.

        Exclusion Criteria:

          -  History or current use of over-the-counter medications, dietary supplements, or drugs
             (including nicotine and alcohol) outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding)

               3. the analysis of results
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Silodosin; Placebo
Intervention description: 8 mg daily for 12 weeks; One capsule daily for 12 weeks
Intervention MeSH terms: Silodosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 462.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign prostatic hyperplasia, alpha blocker

Summary:

      A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is
      safe and effective. The study lasts approximately 20 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males in good general health and at least 50 years of age, with symptoms of moderate
             to severe BPH.

        Exclusion Criteria:

          -  Medical conditions that would confound the efficacy evaluation.

          -  Medical conditions in which it would be unsafe to use an alpha-blocker.

          -  The use of concomitant drugs that would confound the efficacy evaluation.

          -  The use of concomitant drugs that would be unsafe with this alpha-blocker.
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Condition: Herpes Simplex
MeSH terms: Herpes Simplex; Neutropenia
Intervention: acyclovir sodium
Intervention description: Given IV
Intervention MeSH terms: Acyclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: chemotherapeutic agent toxicity; renal toxicity; infection; neutropenia

Summary:

      RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in
      patients with neutropenia.

      PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is
      comparing two doses of acyclovir in preventing herpes simplex virus infection in patients
      with neutropenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years of age or older.

          -  Receiving treatment in inpatient oncology services at Wake Forest University Baptist
             Medical Center

          -  Receiving chemotherapy or have received chemotherapy within the past 2 weeks

          -  Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay

          -  Creatinine clearance ≥ 50 mL/min

          -  Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon
             clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Hypersensitivity to acyclovir sodium

          -  High tumor burden (i.e., WBC > 50,000/mm^3 at admission)

          -  Neutropenic, defined as one of the following:

          -  ANC < 500/mm^3

          -  ANC < 1,000/mm^3 with a predicted decrease to 500/mm^3

          -  Active HSV infection, as evidenced by any of the following:

          -  Positive HSV cultures

          -  Oral lesions

          -  Receiving 5 mg/kg acyclovir sodium every 8 hours
Vitamin D in Vulnerable Adults (VIVA-VA)
Condition: Frail Elderly; Vitamin d Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: vitamin D; placebo
Intervention description: cholecalciferol; placebo tablet
Intervention MeSH terms: Vitamin D
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: Male
Minimum age: 65 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: aged; vitamin d deficiency

Summary:

      Vitamin D insufficiency is a problem of growing concern, given its prevalence in older
      persons and the association of low vitamin D with multiple major health problems, including
      mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain
      cancers. Sedentary persons are particularly vulnerable for these health problems and
      generally not adherent to prescribed physical activity. This study will investigate if
      treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male veterans

          -  65 to 95 years of age

          -  independent

          -  sedentary

          -  vitamin D insufficiency

        Exclusion Criteria:

          -  hypercalcemia

          -  renal failure

          -  living in a nursing home
Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
Condition: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Intervention: Denosumab; Placebo for risendronate; Risendronate; Placebo for denosumab
Intervention description: Administered by subcutaneous injection once every 6 months; Administered orally once a day; Administered orally once a day; Administered by subcutaneous injection once every 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 795.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density

Summary:

      This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with
      glucocorticoid-induced osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men
        and women who are less than 50 years of age must have had a fracture as an adult to be
        eligible. Men and women who are 50 years of age or older who have been taking
        glucocorticoids must meet protocol-specific BMD criteria.

        Exclusion Criteria:

        Use of agents affecting bone metabolism, use of more than one biologic agent for
        inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level
        (one can enter the trial after vitamin D levels are corrected), abnormalities of blood
        calcium, an underactive or overactive thyroid condition that is not treated and stable,
        Addison's disease, any abnormality of the parathyroid glands (the glands that control blood
        calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other
        criteria may apply.
Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: SkQ1 Vehicle Solution; SkQ1 Ophthalmic Solution
Intervention description: SkQ1 Ophthalmic Solution Vehicle; SkQ1 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 610.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Summary:

      The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and
      effective compared to Vehicle for the treatment of the signs and symptoms of dry eye
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms;

          -  Ocular Discomfort;

          -  Schirmer's Test score;

          -  Have corneal fluorescein staining ;

          -  Have lissamine green conjunctival Staining;

          -  Have a conjunctival redness;

        Exclusion Criteria:

          -  Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;

          -  Have any clinically significant slit lamp findings at Visit 1;

          -  Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
             1;

          -  Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
             over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the study drug or its components;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days of Visit 1;
Trial of Adjuvant Chemotherapy for Gastric Cancer
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Intervention: cisplatin, mitomycin-C, doxifluridine
Intervention description: Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)
Intervention MeSH terms: Mitomycins; Mitomycin; Doxifluridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 528.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: stomach cancer; adjuvant chemotherapy; mitomycin; cisplatin; doxifluridine

Summary:

      This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with
      early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine
      compared to mitomycin plus doxifluridine in resected advanced gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven gastric adenocarcinoma

          -  Grossly serosa invasion of primary tumor is suspicious

          -  Curative resection was done

          -  Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node
             metastasis)

          -  Age: 18-69 years old

          -  Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥
             100,000/ul, hemoglobin ≥ 10 g/dl)

          -  Adequate renal function (serum creatinine≤ 1.5)

          -  Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase
             (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)

          -  Written informed consent was signed by the patient

        Exclusion Criteria:

          -  Previous chemotherapy or radiotherapy

          -  Active ongoing infection which antibiotic treatment is needed

          -  Pregnant or lactating women

          -  Psychosis or convulsion disorder

          -  Ascites in preoperative abdomen computed tomography (CT)

          -  Systemic disease which interfere the administration of chemotherapy

          -  Postoperative pathologic stage IA, IB

          -  Postoperative pathology indicates that resection margin is involved

          -  Previous history of other malignancy except cured non-malignant skin cancer and
             uterine cervical cancer in situ
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Condition: Chronic Gout Refractory to Conventional Therapy
MeSH terms: Gout
Intervention: pegloticase 8 mg i.v.
Intervention description: pegloticase 8 mg i.v. every 2 weeks for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; Gouty Arthritis; Anti-Gout preparations

Summary:

      The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24
      week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase
      i.v. was at least one year before study entry.

      This study is limited to four study centers in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous treatment in studies of pegloticase i.v.

          -  Last exposure to pegloticase i.v. greater than one year prior to study entry

          -  Symptomatic gout

          -  Documented hyperuricemic (SUA ≥ 7 mg/dL)

        Exclusion Criteria:

          -  Prior exposure to Elitek® (rasburicase)

          -  Unstable angina

          -  Uncontrolled arrhythmia or hypertension

          -  Non-compensated congestive heart failure

          -  End stage renal disease requiring dialysis

          -  Concomitant use of SUA lowering agents and use of other investigational drugs