bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: Placebo; Iltamiocel
Intervention description: Placebo control is the vehicle solution used for the study product.; AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Incontinence, Stress; Tissue Therapy (Cell Therapy); Transplantation, Autologous

Summary:

      This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will
      evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells
      (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of
      stress urinary incontinence (SUI) in adult female patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patient has primary symptoms of SUI, as confirmed by patient medical history
             and clinical symptoms, including a focused incontinence evaluation.

        Exclusion Criteria:

          -  Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of
             etiology from a patient medical history, including a focused incontinence history.

          -  Patient has symptoms of mixed urinary incontinence where urge incontinence is the
             predominant factor.

          -  Patient has had stress urinary incontinence symptoms less than 6 months prior to
             signing the informed consent.

          -  Patient has not previously attempted conservative treatment prior to signing the
             informed consent. (Examples of conservative treatment include behavior modifications,
             bladder exercises, biofeedback, etc.)

          -  Patient has more than 2 episode of awakening to void during normal sleeping hours.

          -  Patient cannot be maintained on a stable dose and/or frequency of medication
             (including diuretics) known to affect lower urinary tract function, including but not
             limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers,
             for at least 2 weeks prior to screening or is likely to change during the course of
             the study.

          -  Patient is pregnant, lactating, or plans to become pregnant during the course of the
             study.

          -  Patient refuses to provide written informed consent.

          -  Patient is not at least 18 years of age.

          -  Patient is not available for the follow-up evaluations as required by the protocol.
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: High Dose ALKS 5461; Low Dose ALKS 5461; Placebo
Intervention description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression; Alkermes; ALKS 5461; Samidorphan

Summary:

      This study will evaluate the efficacy and safety of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive

          -  Agree to use an acceptable method of contraception for the duration of the study

          -  Have a Major Depressive Disorder (MDD) primary diagnosis

          -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
             current Major Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years or received
             more than one course of electroconvulsive treatment during lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a positive test for drugs of abuse

          -  Are pregnant, planning to become pregnant, or breastfeeding

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within 60 days

          -  Additional criteria may apply
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GP2015
Intervention description: Enbrel comparator
Intervention MeSH terms: GP2015
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biosimilars; Rheumatoid Arthritis; Etanercept

Summary:

      Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate
      to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic
      drugs (DMARD) including methotrexate (MTX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR
             20110 criteria >/= 6 months at the time of baseline visit

          -  Patient must have active disease defined as DAS28-CRP>/=3.2

          -  Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR)
             >/=28mm/h

          -  Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after
             proper dose escalation according to local standards

        Exclusion Criteria:

          -  Previous exposure to etanercept in the past

          -  Patients with functional status class IV according to the ACR 1991 revised criteria

          -  History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by
             imaging and/or by the QuantiFERON-TB Gold test at screening
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Saxagliptin; Dapagliflozin; Glimepiride; Placebo
Intervention MeSH terms: Dapagliflozin; Glimepiride; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 444.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin,
      in addition to metformin, results in better glycemic control, as measured by HbA1c, over a
      treatment period of 52 weeks, compared to the addition of glimepiride to metformin in
      subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin
      Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in
      co-administration with dapagliflozin, added to current background therapy with metformin
      compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week
      52.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects must be willing and able to give signed and dated written informed consent

          -  Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control

          -  Subjects should have been taking the same daily dose of metformin ≥ 1500 mg

          -  Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)

          -  Males and females, aged ≥18 years old at time of screening visit

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test

          -  WOCBP and males must agree to follow instructions for method(s) of contraception for
             the duration of treatment with study drug

        Exclusion Criteria:

          -  Clinical diagnosis of type I diabetes

          -  History of diabetic ketoacidosis

          -  Cardiovascular/vascular diseases within 3 months of the enrollment

          -  Renal disease

          -  Hepatic diseases

          -  History of, or currently, acute or chronic pancreatitis

          -  Hematological and oncological disease/conditions

          -  Patients who have contraindications to therapy being studied

          -  Patients on weight loss program(s)

          -  Replacement or chronic systemic corticosteroid therapy
ESP Block VS TAP in Laparoscopic Hysterectomy
Condition: Hysterectomy
Intervention: Liposomal bupivacaine; bupivacaine, 0.125%
Intervention description: 20ml; 60ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ESP Block Group
TAP Block Group
Masking: Double (Participant, Outcomes Assessor)
Masking description: Both the patients and the research staff doing assessments will be blinded to the randomization
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the difference between two different pain control
      methods in patients who will be having a hysterectomy surgery. By collecting this data, we
      aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid
      side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital

          -  ASA class 1, 2, 3 or 4

          -  Age 18 or older, female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion Criteria:

          -  History of substance abuse in the past 6 months.

          -  Patients on more than 30 mg morphine equivalents of opioids.

          -  Any physical, mental or medical conditions which in the opinion of the investigators,
             may confound quantifying postoperative pain resulting from surgery.

          -  Known allergy or other contraindications to the study medications (Acetaminophen,
             Gabapentin, Bupivacaine).

          -  Postoperative intubation.

          -  Any BMI greater than 40.0.
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Intervention: cyclosporine; vehicle of OTX-101
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 745.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: KCS; dry eye; cyclosporine

Summary:

      This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of
      OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis
      sicca to be conducted at approximately 50 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of dry eye syndrome (KCS) for a period of at least 6 months

          -  Clinical diagnosis of bilateral KCS

          -  Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible
             score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the
             Screening and Baseline Visits.

          -  Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits

          -  Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

        Exclusion Criteria:

          -  Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the
             Screening Visit.

          -  Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion
             0.05% (Restasis).

          -  Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.

          -  Clinical diagnosis or any history of seasonal and/or perennial allergic
             conjunctivitis.

          -  Use of systemic or topical medications within 7 days prior to the Screening Visit or
             during the study period that are known to cause dry eye.

          -  Use of any topical ophthalmic medications, prescription (including anti-glaucoma
             medications) or over the counter (including artificial tears), other than the assigned
             study medication during the study period.

          -  Current active eye disease other than dry wyw syndrome (i.e., any disease for which
             topical or systemic ophthalmic medication is necessary).

          -  History of herpes keratitis.

          -  Corneal transplant

          -  Corneal refractive surgery within 6 months prior to the Screening Visit or
             postoperative refractive surgery symptoms of dryness that have not resolved.

          -  Cataract surgery within 3 months prior to the Screening Visit.
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Condition: Macular Edema, Cystoid; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Standard Care; intravitreal triamcinolone injection; intravitreal triamcinolone injection
Intervention description: CRVO: observation; BRVO: standard care; 1 mg dose; 4 mg
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 682.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: macular edema; central retinal vein occlusion (CRVO); branch retinal vein occlusion (BRVO)

Summary:

      The SCORE Study will compare the effectiveness and safety of standard care to intravitreal
      injection(s) of triamcinolone for treating macular edema (swelling of the central part of the
      retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein
      occlusion (BRVO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with macular edema (swelling of the central part of the retina)
             associated with central retinal vein occlusion (CRVO) and branch retinal vein
             occlusion (BRVO).

          -  Individuals, 18 years of age or older, willing to provide consent may be eligible for
             the SCORE Study.

        Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for
        listing.
Hydrocortisone for Term Hypotension
Condition: Infant, Newborn, Diseases; Cardiovascular Insufficiency
MeSH terms: Infant, Newborn, Diseases
Intervention: Hydrocortisone; Placebo
Intervention description: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose; 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
Intervention MeSH terms: Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 34 Weeks
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Summary:

      This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on
      short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in
      critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as
      defined by a need for inotrope therapy in the first 72 hours of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age greater than or equal to 34 weeks at birth

          -  Admitted to the center NICU by 48 hours of age

          -  Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours
             postnatal age

        Exclusion Criteria:

          -  Receiving ECMO

          -  Intubated for the sole purpose of anticipated surgery or airway anomalies

          -  Treatment will be limited based on poor prognosis

          -  Receiving dexamethasone or hydrocortisone

          -  Receiving ibuprofen or indomethacin

          -  Congenital heart disease

          -  Hypotension thought to result from specific, immediately remediable factors including
             placental hemorrhage, acute hemorrhage or tension pneumothorax

          -  Pituitary hypoplasia or congenital adrenal hyperplasia

          -  Any chromosomal disorder

          -  Hypertension in the absence of inotrope therapy as defined by mean arterial blood
             pressure > 95th percentile

          -  Initiation of whole body cooling for moderate or severe neonatal encephalopathy

          -  Brain disorders or any other known structural abnormality

          -  Major anomalies
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome
Condition: Familial Chylomicronemia Syndrome
MeSH terms: Hyperlipoproteinemia Type I; Syndrome
Intervention: Volanesorsen; 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: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52
      weeks in participants with Familial Chylomicronemia Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chylomicronemia

          -  A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)

          -  Fasting triglycerides (TG) ≥ 750 mg/dL (8.4 mmol/L) at Screening

        Exclusion Criteria:

          -  Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%

          -  Other types of severe hypertriglyceridemia

          -  Active pancreatitis within 4 weeks of screening

          -  Acute Coronary Syndrome within 6 months of screening

          -  Major surgery within 3 months of screening

          -  Treatment with Glybera therapy within 2 years of screening

          -  Previous treatment with IONIS-APOCIIIRx

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study