bioihbjkbjnl/mcl2 huggingface dataset:
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: HX575 epoetin alfa (Sandoz)
Intervention description: Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epoetin alfa, ESA, HX575, CKD

Summary:

      The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa
      administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney
      disease (CKD)
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Adult male and female patients w or w/o dialysis treatment

          -  Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA
             naïve.

          -  Adequate iron substitution

        Main Exclusion Criteria:

          -  History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies

          -  Contraindications for ESA therapy

          -  Serum albumin < 3.0 g/dL

          -  Immunocompromized patients (immunosuppressive treatment, chemotherapy)

          -  Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency
             virus (HIV) infection

          -  Systemic lupus erythematosus

          -  Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial
             infarction within 6 months

          -  History of malignancy of any organ system within the last 5 years

          -  History of use of any non-EU approved ESA
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Vehicle; Pilocarpine HCl Ophthalmic Solution
Intervention description: Vehicle, one drop in each eye, once daily, for up to 30 days.; Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Intervention MeSH terms: Ophthalmic Solutions; Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride
      (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days
      in participants with presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subjective complaints of poor near vision that impact activities of daily living

        Exclusion Criteria:

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery,
             radial keratotomy, or any intraocular surgery

          -  Use of any topical ophthalmic medications, including artificial tears other than the
             study medications during the study

          -  Use of temporary or permanent punctal plugs or history of punctal cautery in one or
             both eyes

          -  Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial
             dystrophy, guttata, or edema) in either eye that are likely to interfere with visual
             acuity

          -  Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination),
             history of angle-closure glaucoma, or previous iridotomy

          -  Diagnosis of any type of glaucoma or ocular hypertension
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Topical Herbal Solution; Topical Minoxidil 5%
Intervention description: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.; Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
Intervention MeSH terms: Minoxidil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Androgenic Alopecia; Hair Diseases; Skin Diseases; Baldness; Alopecia; Hair Loss

Summary:

      The purpose of this study is evaluating the efficacy and safety of a topical herbal solution
      in males for the treatment of Androgenetic alopecia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18 to 50 years old

          -  Written consent

          -  Normal general health status

          -  Men who have a presentation of androgenetic alopecia (Norwood II - V).

        Exclusion Criteria:

          -  Use of any topical product in the target region interfering with the study product in
             the last three months

          -  Within the past 6 months receiving of chemotherapy/cytotoxic agents

          -  Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia

          -  Uncontrolled hypertension

          -  Any dermatological disorders in the scalp, such as fungal or bacterial infections,
             eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer

          -  Hormonal diseases such as thyroid disorders, diabetes and, ...

          -  Smokers

          -  Liver and kidney disease

          -  History of hair transplants

          -  History of surgical correction of hair loss on the scalp

          -  Subject having dyed, bleached hair or, with a permanent wave prior to study start.

          -  No written consent
Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
Condition: Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: C-11 choline PET tracer; Gadobutrol; PET/MR scanner
Intervention description: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.; Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.; C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Intervention MeSH terms: Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: high risk; prostate cancer; C11-choline; PET/MR; mpMRI

Summary:

      The purpose of this study is to find out if a PET/MR scan in combination with standard MRI
      and CT scans can improve the early detection and treatment of patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Untreated patients with high-risk and very high-risk prostate cancer, who require
        clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and
        management of prostate cancer.

        Exclusion Criteria:

          1. Patients who already received primary treatment or neo-adjuvant therapy.

          2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone
             scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone
             scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality.
             Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in
             this study.

          3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm,
             involuntary movement [e.g., tremor, dystonia]).

          4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility
             artifact and degrade image quality of mpMRI.

          5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device
             which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.

          6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal
             failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth
             factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oxymorphone IR
Intervention description: Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid tolerant; Pediatric; Pain; Non malignant; Malignant

Summary:

      When post-operative parenteral analgesia is discontinued, oral dosing with study medication
      may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
      (pain intensity score greater than or equal to 40).

      This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
      promotes opioids and no longer markets Opana® ER.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > 12 to 17 years of age, inclusive

          -  Weigh at least 50 kg

          -  Postoperative oral opioid analgesia required for at least 24 hours or 48 hours
             following postoperataive parenteral analgesia

          -  Are expected to be hospitalized for the duration of the study

        Exclusion Criteria:

          -  Known allergy to, or a significant reaction to, oxymorphone or another opioid

          -  Life expectancy of < 4 weeks

          -  Positive pregnancy test at screening
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone; Placebo; Fluoxetine
Intervention MeSH terms: Fluoxetine; Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 473.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      compared with placebo in pediatric outpatients (7-17 years of age) with major depressive
      disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients between 7-17 years of age

          -  Primary diagnosis of Major Depressive Disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder
             other than major depressive disorder (MDD) that is the primary focus of treatment.

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: Tenapanor; Placebo; Sevelamer Carbonate
Intervention description: Active Drug; Inactive Drug; Active control
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1559.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized
      withdrawal period followed by an open label long term safety extension will evaluate the
      safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD)
      on hemodialysis and peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be non-pregnant, non-lactating, and either be post-menopausal for at
             least 12 months, have documentation of irreversible surgical sterilization, or confirm
             the use of one of the acceptable contraceptive methods

          -  Males must agree to avoid fathering a child and agree to use an appropriate method of
             contraception

          -  Chronic maintenance hemodialysis 3x a week for at least 3 months

          -  Chronic maintenance peritoneal dialysis for a minimum of 6 months

          -  Kt/V ≥ 1.2 at most recent measurement prior to screening

          -  Prescribed and taking at least 3 doses of phosphate binder per day

          -  Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening

          -  Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening

          -  For enrollment in the study after at least 2 weeks of wash-out, subjects must have
             serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have
             had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks
             wash-out of phosphate binders

        Exclusion Criteria:

          -  Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on
             phosphate-binders at any time point during clinical routine monitoring for the 3
             preceding months before screening visit

          -  Serum/plasma parathyroid hormone >1200 pg/mL

          -  Clinical signs of hypovolemia at enrollment

          -  History of IBD or IBS-D

          -  Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD
             or plans to relocate to another center during the study period

          -  Positive serology with evidence of significant hepatic impairment or WBC elevation
             according to the Investigator

          -  Life expectancy <6 months

          -  Previous exposure to tenapanor
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Condition: Anaplastic Large-Cell Lymphoma; Non-Hodgkin Lymphoma; T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic
Intervention: brentuximab vedotin; doxorubicin; prednisone; vincristine; cyclophosphamide
Intervention description: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles; 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles; 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles; 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles; 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Drug Therapy; Hematologic Diseases; Lymphoma; Monomethyl auristatin E; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic

Summary:

      This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the
      efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care
      CHOP in patients with CD30-positive mature T-cell lymphomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed, CD30-positive mature T-cell lymphomas

          -  Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm
             by CT

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

        Exclusion Criteria:

          -  History of another primary invasive malignancy that has not been in remission for at
             least 3 years

          -  Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative
             disorders and lymphomas or mycosis fungoides

          -  History of progressive multifocal leukoencephalopathy (PML)

          -  Cerebral/meningeal disease related to the underlying malignancy
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1; HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Sofosbuvir; ledipasvir; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Virus Diseases; Antiviral Agents; HCV/HIV co-infection

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants who failed treatment in Study GS-US-334-0119 who meet relevant
             inclusion/exclusion criteria are eligible for retreatment in this study

          -  Chronic genotype 1 HCV infection

          -  HCV treatment-naive

          -  HCV RNA > 10,000 IU/mL at screening

          -  Absence of cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Infection with hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment, or compliance with the protocol

          -  For HIV-1/HCV co-infected individuals:

               -  Opportunistic infection within 6 months prior to screening

               -  Active, serious infection (other than HIV-1 or HCV) requiring parental
                  antibiotics, antivirals or antifungals within 30 days prior to baseline

               -  Treatment with an antiretroviral (ARV) regimen other than one of those listed in
                  the study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1997.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series
      in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at >36 weeks of gestation and 2 months of age at the time
             of consent.

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Major known congenital malformation or serious chronic disorder

          -  Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results

          -  Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B
             vaccine dose administered at >30 days old, or previous receipt of any licensed or
             investigational pneumococcal vaccine, or planned receipt through study participation