bioihbjkbjnl/mcl2 huggingface dataset:
Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: lanreotide (Autogel formulation); Pegvisomant
Intervention description: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.; Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
Intervention MeSH terms: Lanreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main aim of this study is to assess the efficacy of the co-administration of lanreotide
      Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant
      (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a
      week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the
      percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the
      end of the co-treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must have had documentation supporting the diagnosis of acromegaly,
             including elevated GH and/or IGF-1 levels

          -  The patient is treated with pegvisomant, because of IGF-1 level remaining above ULN
             when treated with somatostatin analogue, on a daily basis for at least 3 months and
             has normal (age and sex adjusted) IGF-1 level, or IGF-1 level above the upper limit of
             normal (ULN) after treatment with pegvisomant 30 mg per day, OR the patient is treated
             with lanreotide Autogel or octreotide LAR for at least 6 months including 3 months at
             the highest marketed dose and has a serum IGF-1 level above ULN, 28 days after the
             last injection

          -  At the end of the run-in period, The patient has a serum IGF-1 level above 1.2 x ULN,
             or a serum IGF-1 level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L
             (assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel 120 mg OR
             the patient is diabetic and has a serum IGF-1 level above 1.2 ULN, 28 days after the
             3rd injection of lanreotide Autogel 120 mg

        Exclusion Criteria:

          -  The patient has undergone pituitary surgery or radiotherapy within 6 months prior to
             study entry, or it is anticipated that it will be done during the study

          -  The patient has already been treated with a somatostatin analogue associated with a GH
             antagonist

          -  The patient has received dopamine agonist within 6 weeks prior to the study entry

          -  The patient has abnormal hepatic function at study entry (defined as AST, ALT, GGT,
             alkaline phosphatase, prothrombin time or total bilirubin above 2 ULN)

          -  The patient is at risk of pregnancy or is lactating
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of LY2439821 compared to placebo in
      participants with moderate to severe, chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic
             psoriasis vulgaris for at least 6 months prior to randomization

          -  At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization

          -  Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and
             Severity Index (PASI) score of at least 12 at screening and at randomization

          -  Candidate for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control during the study

          -  Women must agree to use birth control or remain abstinent during the study and for at
             least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  Pustular, erythrodermic, and/or guttate forms of psoriasis

          -  History of drug-induced psoriasis

          -  Clinically significant flare of psoriasis during the 12 weeks prior to randomization

          -  Concurrent or recent use of any biologic agent

          -  Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light
             therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis
             treatment within the previous 2 weeks prior to randomization

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to randomization and during the study

          -  Have participated in any study with interleukin (IL)-17 antagonists, including
             LY2439821

          -  Serious disorder or illness other than plaque psoriasis

          -  Serious infection within the last 3 months

          -  Breastfeeding or nursing (lactating) women.
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: SPIL1033; Placebo
Intervention description: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.; 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: SPIL1033; type 2 diabetes mellitus

Summary:

      SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in
      reducing blood glucose levels. The purpose of study is to establish safety and efficacy of
      SPIL1033
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 20 years of age and older.

          -  Established clinical diagnosis of type 2 diabetes mellitus treated with diet and
             exercise or anti-diabetic agents as monotherapy or combination therapy.

          -  Weight stable: their weight should not have varied more than 10% of screening visit
             weight, within 6 months prior to screening visit.

          -  Women of child bearing potential practicing an acceptable method of birth control as
             judged by the investigator(s); with a negative urine pregnancy test.

          -  Willing to participate and give written informed consent.

        Exclusion Criteria:

          -  Previous exposure to exenatide (anti-exenatide antibodies at screening) or a
             glucagon-like peptide (GLP-1) analogue.

          -  Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine,
             rimonabant, or similar over-the-counter medications) within 3 months of screening.

          -  Received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of trial entry.

          -  Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.
Condition: Early-Stage Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine trans-dermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
During the first year:
The maximum Rotigotine dose allowed is 6 mg/24 hours.
After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 31 Years
Healthy volunteers: No
Keywords: Rotigotine

Summary:

      The objective of this open-label extension is to assess the safety and tolerability of
      long-term treatment of the rotigotine patch in subjects with early-stage idiopathic
      Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed six months of maintenance treatment in the SP512
             double-blind trial

        Exclusion Criteria:

          -  Subjects who had an ongoing serious adverse event from SP512 double-blind trial that
             was assessed as related to study medication
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Febuxostat; Allopurinol
Intervention description: Febuxostat 80 mg, tablets, orally, once daily.; Febuxostat 120 mg, tablets, orally, once daily.; Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1086.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: uric acid; xanthine oxidase; hyperuricemia; tophi; Drug Therapy

Summary:

      The purpose of this study is to determine the long-term safety of febuxostat, once daily
      (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving
             febuxostat).

          -  Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering
             therapy (other than allopurinol or febuxostat).

          -  Has participated in a clinical study in which febuxostat was administered.

          -  Is completing Phase 3 Studies C02-009 or C02-010.

          -  Must not have experienced any serious study drug-related adverse events in the
             previous study.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study

        Exclusion Criteria:

          -  Has had any other significant medical condition as defined by the investigator that
             would interfere with the treatment, safety, or compliance with the protocol.

          -  Is intolerant of allopurinol.
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
Condition: Severe Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Factor IX (rFIXFc); rFIX
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc;
      to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of
      prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding
      episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and
      participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study
      were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX
      (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week);
      to evaluate participants' response to treatment; to evaluate rFIXFc consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and 12 years of age and older and weigh at least 40 kg

          -  Diagnosed with hemophilia B (baseline Factor IX level less than or equal to 2%)

          -  History of at least 100 exposure days to any Factor IX product

          -  Platelet count ≥100,000 cells/μL

        Exclusion Criteria:

          -  History of Factor IX inhibitors

          -  Kidney or liver dysfunction

          -  Diagnosed with another coagulation defect other than hemophilia B

          -  Prior history of anaphylaxis associated with any Factor IX or intravenous (IV)
             immunoglobulin administration
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
Condition: Healthy Stem Cell Donor; No Evidence of Disease
Intervention: Bone Marrow Donation; Filgrastim; Laboratory Biomarker Analysis
Intervention description: Undergo bone marrow harvest; Given subcutaneously; Optional correlative studies
Intervention MeSH terms: Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized clinical trial is studying the side effects of collection of bone marrow from
      donors treated with or without filgrastim. Giving colony-stimulating factors, such as
      filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so
      they can be collected and stored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Appropriately human leukocyte antigen (HLA)-matched (HLA, A, B, DRB1 identical or
             antigen mismatched [i.e., 5/6 or 6/6 antigens matched]) sibling of the bone marrow
             recipient enrolled on COG-ASCT0631

          -  Adequate size relative to the recipient (i.e., harvesting the maximum of 20 cc/kg from
             the donor would result in a bone marrow graft that will provide an adequate cell and
             volume dose to the recipient, in the opinion of the treating physician)

          -  Enrolled on the COG Umbrella Long-Term Follow-Up Study COG-ALTE05N1

          -  Not pregnant or nursing

          -  No human immunodeficiency virus (HIV) positivity

          -  No sickle cell trait or sickle cell anemia/disease

          -  Not at an increased risk from bone marrow donation after filgrastim administration due
             to a pre-existing medical condition, as determined by an independent physician
             separate from the research team

          -  None of the following:

               -  Active infection, especially pulmonary

               -  Splenomegaly or a history of splenic injury

               -  Active or recent pulmonary disease (i.e., pneumonia within the past 4 weeks)

               -  A condition that would make the donor unsuitable to donate, as determined by an
                  independent physician separate from the research team

          -  No autoimmune disease
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Condition: Acute Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Quetiapine fumarate XR; Lithium carbonate
Intervention description: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.; Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Intervention MeSH terms: Quetiapine Fumarate; Lithium Carbonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute bipolar depression; Lithium carbonate; quetiapine fumarate; MADRS

Summary:

      The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with
      quetiapine fumarate in combination with lithium in the treatment of a major depressive
      episode in patients with bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar
             disorder II with the most recent episode depressed

          -  The total score of the scale that's used for the evaluation of depression (HAM-D)
             should be ≥20

          -  The total score of the scale that' used for the evaluation of mania (YMRS) should be
             ≤12

        Exclusion Criteria:

          -  Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6
             months of enrollment. Patients who pose a current serious suicidal or homicidal risk

          -  Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days
             before randomisation

          -  Patients who are unable to discontinue all psychoactive medications, including
             antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to
             randomisation and consistent with the pharmacokinetics of the drug
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: WC3011 Estradiol Vaginal Cream
Intervention description: WC3011 estradiol vaginal cream, 3 times a week for 40 weeks.
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Postmenopausal Women; Vaginal Dryness; Postmenopausal Vulvovaginal Atrophy

Summary:

      This is an open-label extension study evaluating the long-term safety and efficacy of WC3011
      in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Study PR-04409.3 (NCT01400776)

        Exclusion Criteria:

        Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy
        other than WC3011:

          -  Hypersensitivity to estrogen and/or progestin therapy

          -  Known or suspected premalignant or malignant disease (except successfully treated skin
             cancers)

          -  Manifestation of or treatment for significant cardiovascular disease, stroke or
             ischemic attack

          -  Insulin-dependent diabetes mellitus

          -  Smoking ≥ 15 cigarettes daily

          -  Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95
             mmHg
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
Condition: Bleeding
Intervention: Andexanet; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Andexanet alpha; Anticoagulation; Antidote; Apixaban; Anti-fXa inhibitor; PRT4445; Eliquis; Reversal agent

Summary:

      The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the
      anticoagulation effect of Apixaban.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reasonably healthy men and women aged 50 to 75

        Exclusion Criteria:

          -  History of abnormal bleeding, active bleeding or risk factors for bleeding

          -  History of thrombosis or risk factors for thrombosis

          -  History of adult asthma or use of inhaled medications
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Febuxostat; Allopurinol
Intervention description: Febuxostat 80 mg, orally, once daily for up to 52 weeks.; Febuxostat 120 mg, orally, once daily for up to 52 weeks.; Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 760.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: uric Acid; xanthine oxidase; tophi; Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily
      (QD), versus allopurinol in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meeting the preliminary criteria of the American Rheumatism Association for the
             classification of the acute arthritis of primary gout.

          -  Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

        Exclusion Criteria:

          -  Serum creatinine >1.5 mg/dL

          -  Calculated creatinine clearance of <50 milliliters per minutes (mL/min)

          -  Pregnancy or lactation;

          -  Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine,
             thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;

          -  Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);

          -  A history of xanthinuria, active liver disease, or hepatic dysfunction;

          -  A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.