bioihbjkbjnl/mcl2 huggingface dataset:
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Dapagliflozin; Placebo for dapagliflozin
Intervention description: Tablets; Tablets
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 833.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dapagliflozin; Efficacy; Safety; Add on to insulin; Oral Antidiabetic; Type 1 diabetes

Summary:

      The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
      effective therapy to improve glycemic control in patients with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 Diabetes mellitus (T1DM)

          -  Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

          -  Insulin use for at least 12 months per patient reported or medical records

          -  Method of insulin administration (MDI or CSII) must have been unchanged for at least 3
             months prior to screening

          -  Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior
             to screening

          -  If on MDI insulin administration, subject must be on ≥ 3x injections per day

          -  Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%

          -  Body mass index (BMI) ≥ 18.5 kg/m2

        Exclusion Criteria:

          -  History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young
             (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased
             beta cell capacity

          -  Taking metformin and/or thiazolidinediones within 2 months prior to screening

          -  Taking any antidiabetic medication (other than insulin), within 1 month prior to
             screening

             - Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly
             administration and within 1 month prior to screening for once or twice daily
             administration

          -  History of diabetes ketoacidosis requiring medical intervention within 1 month prior
             to screening

          -  History of hospital admission for glycemic control (either hyperglycemia or
             hypoglycemia) within 1 month prior to screening

          -  Frequent episodes of severe hypoglycemia (more than one episode requiring medical
             assistance, emergency care), and/or glucagon therapy administered by a third-party
             individual within 1 month prior to screening

          -  History of Addison's disease
Lasix for the Prevention of De Novo Postpartum Hypertension
Condition: Postpartum Pregnancy-Induced Hypertension; Postpartum Preeclampsia; Hypertension, Pregnancy-Induced; Hypertension
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Intervention: Furosemide; Placebo
Intervention description: Furosemide 20 mg pill taken daily for 5 days; Identical-appearing placebo pill taken daily for 5 days
Intervention MeSH terms: Furosemide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized controlled clinical trial of 82 women with one or more high-risk factors for de novo postpartum hypertension, randomized to one of two arms: 20 mg PO Lasix (furosemide) daily for 5 days or identical-appearing daily placebo for 5 days.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Consenting women will be assigned to Lasix (furosemide) or placebo in a 1:1 ratio according to a randomization scheme achieved using a computer generated algorithm. Neither the participant nor the clinical care team will be aware of the allocation arm.
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: De novo postpartum hypertension; New-onset postpartum hypertension; Lasix; Furosemide

Summary:

      Primary objective: To evaluate whether oral furosemide can help prevent de novo postpartum
      hypertension (new-onset high blood pressure after delivery) by reducing blood pressure after
      delivery in high-risk women.

      Secondary objectives: To evaluate whether oral furosemide administered to high-risk women
      after delivery can reduce the frequency of postpartum hypertensive episodes, the need for
      antihypertensive therapy, the risk of postpartum preeclampsia, and the incidence of severe
      maternal morbidity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women

          -  No antenatal diagnosis of hypertensive disorder of pregnancy at the time of admission
             for delivery, defined as existing chronic hypertension diagnosis or documented blood
             pressure of ≥140 systolic OR ≥90 diastolic on at least 2 occasions at least 4 hours
             apart prior to delivery admission who do not go on to get magnesium for seizure
             prophylaxis by the time of delivery

          -  At least 18 years of age

          -  English or Spanish speakers

          -  One or more high risk factors for development of de novo postpartum hypertension

        Exclusion Criteria:

          -  Non-English or Spanish speakers

          -  Women with a contraindication to diuretic therapy

          -  Women who have used diuretics in the two weeks prior to delivery
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Intervention: OTX-101 0.09%
Intervention description: 0.09% cyclosporine nanomicellar solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety extension enrolling subjects participating in Study OTX-101-2016-001
      (NCT02688556)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of Study OTX-101-2016-001

        Exclusion Criteria:

        -
A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: Turoctocog alfa pegol; Turoctocog alfa pegol; Turoctocog alfa pegol
Intervention description: Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.; Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.; Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Male
Healthy volunteers: No

Summary:

      This study will look at how a known study medicine N8-GP works in previously N8-GP treated
      people with haemophilia A. The aim is to look at how N8-GP works during regular use.
      Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A
      for several years. Participants will get an injection of N8-GP into a blood vessel, one, two
      or three times weekly. Participants will get more doses if they bleed or if they will need a
      surgery. The study will last for about 2 years. Participants will have at least 9 visits with
      the study doctor. If participants agree to be in this study, they will get their first
      injection (in this study) at the first visit. Participants will also get an injection at
      visit 3, 5 and 7. Participants will be trained to give all other injections themselves.
      Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood
      thinners) during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients of all ages with the diagnosis of severe congenital haemophilia A
             (coagulation Factor VIII [FVIII] activity less than 1%) based on medical records

          -  On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at
             the time of transfer

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product including allergy to hamster
             protein or related products

          -  Any disorder, except for conditions associated with haemophilia, which in the
             investigator's opinion might jeopardise patient's safety or compliance with the
             protocol - Current participation in any clinical trial (except NN7088-3859
             (pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved
             investigational medicinal product
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1117.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug known as
      galcanezumab in participants with chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

        Main Study:

          -  Have a diagnosis of chronic migraine as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines
             (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to
             screening, and migraine onset prior to age 50.

        Israel addendum:

          -  Participants must have completed all phases of main study, including the 4-month
             post-treatment follow-up phase, during which no investigational product was
             administered.

          -  Participants also must be considered by the investigator to have benefited from
             galcanezumab treatment and must have exhausted alternative therapies for the
             prevention of migraine.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another calcitonin gene-related
             peptide (CGRP) antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: BI 695502; Avastin
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate the safety and tolerability of BI 695502 in
      combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy
      (when applicable). As well as to evaluate the following efficacy parameters: Progression-free
      survival (PFS), objective response rate (proportion of patients with complete response [CR]
      plus partial response [PR]), overall survival (OS), duration of response (DOR), time to
      progression (TTP).
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females aged >=18 years (for Japan only: Age >=20 years at time of signing
             Informed Consent Form) with histologically confirmed metastatic colorectal cancer
             (mCRC).

          -  Metastatic disease not amenable to surgical curative treatment and eligible to receive
             therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.

          -  At least one measurable lesion according to Response Evaluation Criteria in Solid
             Tumors (RECIST) 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

          -  Adequate hepatic, renal and bone marrow function.

          -  Further inclusion criteria apply.

        Exclusion criteria:

          -  Prior systemic therapy for metastatic disease

          -  Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular
             endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin®
             biosimilar

          -  Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for
             basal cell cancer of the skin or pre-invasive cancer of the cervix

          -  Spinal cord compression or brain metastases unless asymptomatic, stable and not
             requiring steroids for at least 6 weeks prior to start of study treatment

          -  Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from
             previous anticancer therapy (including radiotherapy)

          -  History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
             bleeding

          -  A thrombotic or hemorrhagic event <=6 months prior to screening (includes hemoptysis,
             Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage,
             epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks,
             myocardial infarction, angina, and coronary artery disease)

          -  Further exclusion criteria apply
Long Term Safety Study of Plecanatide
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Plecanatide
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2272.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Multi-center, open-label, long-term safety study
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with documented diagnosis of IBS-C who:

          -  Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the
             previous study's requirements, and did not experience any Serious Adverse Event (SAE)
             deemed related to study drug during the course of the previous study, OR

          -  Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an
             exclusion in the core study) or due to an administrative reason and is allowed to
             enter this study by notification from Sponsor or delegate.

        Key Exclusion Criteria:

          -  Patient is unwilling or unable to: participate in the study for the required duration,
             understand and sign the informed consent form (ICF) and undergo all protocol related
             tests and procedures throughout the study.

          -  Female patient of childbearing potential with a positive urine pregnancy test on Day
             1.

          -  Male and female patients of childbearing potential who do not agree to continue to use
             the method of birth control used in the core double-blind plecanatide study for the
             duration of this clinical trial.

          -  Patient has experienced a significant negative change in health status during the
             course of participation in the core double-blind plecanatide study or after completion
             of the study.

          -  In the opinion of the Investigator or Medical Monitor, it is not in the patient's best
             interest to participate in the study. The reason(s) for the patient's exclusion must
             be specified.
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ALKS 8700
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1057.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MS; Relapsing Remitting Multiple Sclerosis; RRMS; dimethyl fumarate; DMF

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary
      objective of this study is to evaluate treatment effect over time in adult participants with
      RRMS treated with ALKS 8700.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has a confirmed diagnosis of RRMS

          -  Neurologically stable with no evidence of relapse within 30 days prior to Visit 2

        Exclusion Criteria:

          -  Subject is pregnant or breastfeeding or plans to become pregnant or begin
             breastfeeding at any point during the study and for 30 days after any study drug
             administration

          -  Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS

          -  History of clinically significant cardiovascular, pulmonary, gastrointestinal,
             dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that
             would preclude participation in a clinical trial

          -  History of a myocardial infarction, including a silent myocardial infarction
             identified on ECG, or unstable angina

        NOTE: Other protocol defined Includison/Exclusion criteria may apply.
Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Condition: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Wet Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Brolucizumab ophthalmic solution; Aflibercept ophthalmic solution
Intervention description: Ophthalmic solution for IVT injection; Ophthalmic solution for IVT injection
Intervention MeSH terms: Aflibercept; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1775.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; CNV; IVT

Summary:

      The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for
      intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic
      solution for IVT injection (2 mg) in subjects with untreated active choroidal
      neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study
      eye.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written informed consent

          -  Active choroidal neovascularization (CNV) lesions secondary to age-related macular
             degeneration (AMD) that affected the central subfield in the study eye at Screening;

          -  Total area of CNV comprising >50% of the total lesion area in the study eye at
             Screening;

          -  Intraretinal and/or subretinal fluid affecting the central subfield of the study eye
             at Screening;

          -  Best Corrected Visual Acuity (BCVA) between 78 and 23 letters, inclusive, in the study
             eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS)
             testing.

        Key Exclusion Criteria:

          -  Any active intraocular or periocular infection or active intraocular inflammation in
             either eye at Baseline;

          -  Central subfield of the study eye affected by fibrosis or geographic atrophy or total
             area of fibrosis >50% of the total lesion in the study eye at Screening;

          -  Subretinal blood affecting the foveal center point and/or >50% of the lesion of the
             study eye at Screening;

          -  Any approved or investigational treatment for neovascular age-related macular
             degeneration (nAMD) in the study eye at any time;

          -  Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or
             current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within
             4 weeks prior to Baseline;

          -  Pregnant or nursing women; women of child-bearing potential;

          -  Stroke or myocardial infarction in the 90-day period prior to Baseline.
An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-2)
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: CSF-1; Vehicle
Intervention description: One drop bilaterally twice daily for approximately 2 weeks.; One drop bilaterally twice daily for approximately 2 weeks.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 45 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study
      evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have presbyopia.

        Exclusion Criteria:

        Subjects must not:

          -  Have any contraindications to the study medications or diagnoses that would confound
             the study.