bioihbjkbjnl/mcl2 huggingface dataset:
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Condition: Hyperphosphatemia; Kidney Failure
MeSH terms: Renal Insufficiency; Hyperphosphatemia
Intervention: ferric citrate, ca acetate, sevelamer carbonate, placebo
Intervention description: All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ESRD; end-stage renal disease; dialysis; hemodialysis; peritoneal dialysis; hemodialysis (HD); peritoneal dialysis (PD); chronic renal insufficiency; phosphate binder; kidney failure; renal failure

Summary:

      This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD
      dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or non-pregnant, non-breast-feeding females

          2. Age ≥18 years

          3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous
             three months prior to Screening

          4. Serum phosphorus ≥6.0 mg/dL for study entry

          5. Taking less than 3-18 pills/day of current phosphate binder

          6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric
             citrate

          7. Willing and able to give informed consent

          8. Life expectancy >1 year

        Exclusion Criteria:

          1. Parathyroidectomy within six months prior to Screening

          2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease

          3. History of multiple drug allergies or intolerances

          4. History of malignancy in the last five years (treated cervical or non-melanomatous
             skin cancer may be permitted if approved by CCC)

          5. Previous intolerance to oral ferric citrate

          6. Intolerance to oral iron-containing products

          7. Psychiatric disorder that interferes with the patient's ability to comply with the
             study protocol

          8. Inability to tolerate oral drug intake

          9. Intolerance to calcium acetate and sevelamer carbonate

         10. Any other medical condition that renders the patient unable to or unlikely to complete
             the trial or that would interfere with optimal participation in the trial or produce
             significant risk to the patient

         11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)

         12. Inability to cooperate with study personnel or history of noncompliance

         13. Unsuitable for this trial per Investigator's clinical judgment.
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: adalimumab; Calcipotriol/Betamethasone Ointment; placebo (vehicle ointment)
Intervention description: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15; Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16; Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
Intervention MeSH terms: Adalimumab; Betamethasone; Calcipotriene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Moderate Psoriasis; Severe Psoriasis; Chronic Plaque Psoriasis; Severe Chronic Plaque Psoriasis

Summary:

      The objective of this study is to assess the efficacy and safety of adalimumab in combination
      with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination
      with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is >= 18 years of age

          -  Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months,
             and has moderate to severe plaque psoriasis

          -  Subject must have been treated and failed to respond to, or has a contraindication to,
             or is intolerant to at least two different systemic therapies, one of which must be
             cyclosporine, or methotrexate or oral PUVA

          -  Subject is judged to be in generally good health as determined by the principal
             investigator

        Exclusion Criteria:

          -  Subject has previous exposure to adalimumab

          -  Subject cannot discontinue systemic therapies and/or topical therapies for the
             treatment of psoriasis and cannot avoid UVB or PUVA phototherapy

          -  Subject is taking or requires oral or injectible corticosteroids

          -  Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced
             or medication-exacerbated psoriasis or new onset guttate psoriasis

          -  Subject considered by the investigator, for any reason, to be an unsuitable candidate

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant

          -  Subject has a calcium metabolism disorder
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Condition: Urinary Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive
Intervention: Fesoterodine PR 4 mg; Fesoterodine PR 8 mg; Fesoterodine BIC 2 mg; Fesoterodine BIC 4 mg
Intervention description: Fesoterodine 4 mg tablet once daily for 28 or 40 weeks; Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks; Fesoterodine BIC 2 mg tablet once daily for 28 weeks; Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: neurogenic detrusor overactivity; fesoterodine; Japan

Summary:

      The purpose of this study is to investigate the safety and tolerability of fesoterodine
      following once daily long-term treatment in Japanese pediatric neurogenic detrusor
      overactivity (NDO) subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        •Subjects who completed 24 week treatment and all visit procedures in the precedent Study
        A0221047

        Exclusion Criteria:

          -  Subjects who had major protocol violation (as determined by the Sponsor) in Study
             A0221047

          -  Concomitant medications which may increase the risk to subjects or confound study
             results

          -  Other medical conditions which may increase the risk to subjects or confound study
             results
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Condition: Chronic Hepatitis C(CHC)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: MP-424; RBV(24 weeks); IFN beta(24 weeks); RBV(48 weeks); IFN beta(48 weeks)
Intervention description: MP-424: 750mg every 8 hours (q8h) for 12 weeks; RBV: 600 - 1000mg/day based on body weight for 24 weeks; IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks; RBV: 600 - 1000mg/day based on body weight for 48 weeks; IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks
Intervention MeSH terms: Interferon-beta
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Feron

Summary:

      This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients
      with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1 or 2, chronic hepatitis C, with depression(including the past)

          -  Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based
             treatment

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent serious depression, schizophrenia, or suicide attempt in the
             past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Condition: Autoimmune Disease
MeSH terms: Autoimmune Diseases
Intervention: Enteric-coated Mycophenolate Sodium
Intervention description: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Autoimmune disease, mycophenolate, GI problems

Summary:

      Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in
      gastrointestinal (GI) complications in some patients. This study will 1) determine the
      proportion of patients with autoimmune diseases who are experiencing any GI complaints under
      MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated
      mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life
      outcomes.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with autoimmune diseases;

          2. receiving immunosuppressive therapy that includes MMF at time of study enrollment;

          3. receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1
             month prior to enrollment. Patients can only be enrolled into the study if it is
             expected that treatment will continue at the same dose until study end (6-8 weeks
             after enrollment).

        Exclusion criteria:

          1. If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid
             (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);

          2. Women of child-bearing potential who are planning to become pregnant or are pregnant
             and/or lactating or who are unwilling to use effective means of contraception;

          3. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the
             opinion of the site investigator, would interfere with study requirements;

          4. Current acute medical intervention or hospitalization;

          5. Presence of a medical condition not related to a GI event at time of visit, which
             requires immediate medical intervention.

        Other protocol-defined inclusion/exclusion criteria may apply
Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; docetaxel
Intervention description: 500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment; 75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment
Intervention MeSH terms: Docetaxel; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel
      administered on a 3-weekly schedule in the treatment of patients with locally advanced or
      metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to
             curative surgery or radiotherapy

          -  At least one prior chemotherapy for palliative therapy

          -  Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status
             assessment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

        Exclusion Criteria:

          -  Concurrent administration of any other tumor therapy

          -  Pregnant or breast feeding

          -  Serious concomitant disorders

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: IKH-01; Placebo
Intervention description: ethinyl estradiol 0.035mg and norethisterone 1mg; Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 115.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether combination oral contraceptive pill of
      norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary dysmenorrhea

        Exclusion Criteria:

          -  severe hepatopathy

          -  pregnant woman
Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: Sodium Hyaluronate Ophthalmic Solution, 0.18%; Vehicle
Intervention description: Inactive ingredients used as run-in and placebo comparator
Intervention MeSH terms: Ophthalmic Solutions; Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1936.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry eyes; Ocular discomfort

Summary:

      The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in
      treating the signs and symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of dry eyes for at least 3 months.

          -  Ocular discomfort due to dry eyes.

          -  Presence of corneal and conjunctival staining.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women who are pregnant or lactating.

          -  Contact lens wear within 1 week before Screening and during the study.

          -  Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4
             months prior to Screening.

          -  Punctal plugs or punctal occlusion initiated within 3 months of screening

          -  Other protocol-defined exclusion criteria may apply.
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Intervention: Ulipristal acetate (UPA); Placebo
Intervention description: Ulipristal acetate (UPA) tablet.; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 432.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women, 18-50 years, inclusive.

          -  Cyclic abnormal uterine bleeding (heavy or prolonged).

          -  Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
             the first 8 days of menses.

          -  Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

          -  Endometrial biopsy without evidence of malignancy or atypical or non-atypical
             hyperplasia.

        Exclusion Criteria:

          -  History of uterine surgery that would interfere with the study endpoints.

          -  Known coagulation disorder including bleeding disorder or clotting disorder.

          -  History of, or current uterine, cervix, ovarian, or breast cancer.

          -  Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
             or total bilirubin two times or greater than the upper limit of normal range.
Behavioral Treatment of Overactive Bladder in Men
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Behavioral training; Oxybutynin chloride, extended-release
Intervention description: Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.; Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.
Intervention MeSH terms: Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Overactive bladder; Behavioral treatment; Drug therapy; Lower urinary tract symptoms; Urinary incontinence; Clinical trial

Summary:

      The primary purpose of this project is to evaluate the effectiveness of behavioral treatment
      compared to standard drug therapy for symptoms of OAB in male veterans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Community-dwelling

          -  Veteran

          -  Self-reported urgency

          -  Self-reported frequent urination

          -  Mean of > 8 voids per 24-hour day on bladder diary

          -  Able to come to clinic

        Exclusion Criteria:

          -  Urologic surgery in the past 6 months

          -  Nonambulatory (unless has independent transfer skills)

          -  Flow rate < 5mL at baseline and < 10mL/sec after run-in (on simple uroflowmetry)

          -  Post-void residual urine volume > 250mL at baseline and > 150mL after run-in (on
             bladder ultrasound)

          -  Continual leakage

          -  Urinary tract infection (growth of > 100,000 colonies per ml of a urinary pathogen on
             urine culture). May be reconsidered after treatment and negative culture.

          -  Fecal impaction

          -  Poorly controlled diabetes (glycosylated hemoglobin >9 within last 3 months)

          -  Hematuria on microscopic examination in the absence of infection

          -  Any unstable medical condition (particularly: decompensated congestive heart failure,
             malignant arrhythmias, unstable angina)

             -- Impaired mental status (< 24 on Folstein's Mini-Mental State Exam)

          -  Narrow angle glaucoma

          -  Gastric retention (by medical history)

          -  Hypersensitivity to tamsulosin or oxybutynin

          -  Current use of anticholinergic agents for detrusor instability. May be reconsidered
             after 2-week wash-out.

          -  If on diuretic, dose has not been stable for at least three months

          -  Sleep apnea, unless surgically corrected
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Intervention: BI 1356; placebo
Intervention description: BI 1356 dosed once daily; placebo matching BI 1356 taken once daily
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      to determine safety, efficacy and tolerability of BI 1356 versus placebo
    

Eligibility criteria:

        Inclusion criteria:

          -  Male and female patients with type 2 diabetes and with glomerular filtration rate
             (GFR) <30 ml/min, who are not on chronic dialysis.

          -  Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)

          -  Age 18 or over and not older than 80 years

        Exclusion criteria:

          -  Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea
             within 3 months prior to informed consent

          -  Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior
             to informed consent

          -  Unstable or acute congestive heart failure