bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Updated DEX PS DDS Applicator; Approved DEX PS DDS Applicator; Dexamethasone
Intervention description: Intravitreal Administration; Intravitreal administration; Dexamethasone 0.7 mg in a solid polymer drug delivery system
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular Edema; Dexamethasone; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion; Diabetic Macular Edema; Noninfectious Uveitis; Ozurdex; Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS)

Summary:

      The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to
      deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator.
      This purpose of this study is to show that the updated DEX PS DDS Applicator works in adult
      participants with macular edema due to retinal diseases.

      The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed
      into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug
      delivered using different applicators. Around 54 adult participants with macular edema will
      be enrolled in the study in approximately 7-10 sites in the United States.

      Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS
      implant using either the currently-approved DEX PS DDS Applicator or the the updated
      Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS
      implant received on day 1 and follow-up through day 7.

      The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with
      the safety and efficacy of the DEX PS DDS implant well characterized and the same as the
      currently marketed product. Participants will attend regular visits during the study at a
      hospital or clinic. The applicator function will be checked by medical assessment, checking
      for side effects, procedural complications and/or product complaints, and evaluating the
      administration procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Participants with macular edema due to retinal vein occlusion (branch retinal vein
        occlusion or central retinal vein occlusion) or diabetic macular edema.

        Exclusion Criteria:

        - Participants with ocular conditions in the study eye for which Dexamethasone Posterior
        Segment Drug Delivery System Implant is contraindicated.
A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
Condition: Parental/Caregiver Anxiety; Child's Anxiety
MeSH terms: Anxiety Disorders
Intervention: zolpidem; Midazolam
Intervention description: Zolpidem will be given one time at 0.25 mg/kg pre-operatively
Intervention MeSH terms: Midazolam; Zolpidem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: No
Keywords: Pre-medication; Pre-operative anxiety

Summary:

      The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam
      and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time
      of separation, and ease of mask acceptance at induction in children. Subjects will be
      randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to
      surgery. No placebo will be administered in this study. Subjects will be male and female
      children between 2 and 9 years of age. In total, subject participation will last
      approximately the duration of their preoperative, perioperative, and immediate postoperative
      period. A member of the research team will recruit subjects preoperatively in the operating
      room holding area prior to surgery. Consent will take place at the time of recruitment in the
      preoperative holding area following a detailed explanation of the study and medications
      involved in the study. Participants will be of ASA (American Society of Anesthesiologists)
      class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to
      remain inpatient for at least 23 hours postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients ages 2-9 years

          -  ASA class I-II

          -  inpatient surgeries of at least 2 hours duration

          -  requiring postoperative admission of at least 23 hours Exclusion Criteria:

        Exclusion Criteria:

          -  contraindication to preoperative sedation, known allergy or sensitivity to the study
             medications,

          -  those who lack legal representative consent

          -  Patients with weights lying below the 5th percentile or above the 95th percentile
             according to the current published CDC growth chart will also be excluded regardless
             of existing specific contraindication.
A Study In Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: GSK523338
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes Type II

Summary:

      This study evaluates the effect of medicines for type 2 diabetes and lipids control. This
      study will require about 6 office visits for lab tests and examinations. All study related
      medicines and medical examinations will be provided at no cost to the subjects.
    

Eligibility criteria:

        Inclusion criteria:

          -  A clinical diagnosis type 2 diabetes mellitus.

          -  Women must not be pregnant or breastfeeding during the study and 30 days after the
             study.

          -  Must sign an informed consent form at the study clinic.

        Exclusion criteria:

          -  Severe chronic diseases that would prevent from participating and completing the study
             by investigator's judgement.

          -  Use of an investigational drug within 30 days or 5 half lives before first dose of
             study medication.

          -  Insulin use for > 1 week in past 3 months.
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Placebo; SAGE-547 90 μg/kg/h
Intervention description: Intravenous infusion of matching placebo for SAGE-547.; Intravenous infusion of SAGE-547
Intervention MeSH terms: Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Moderate Postpartum Depression; SAGE-547

Summary:

      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate
      postpartum depression (PPD) compared to placebo injection as assessed by the change from
      baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at screening; or if still lactating or
             actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to
             their infant(s).

          -  Participant had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).

          -  Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to
             dosing).

          -  Participant was ≤ six months postpartum.

          -  Participant was amenable to intravenous therapy.

        Key Exclusion Criteria:

          -  Active psychosis.

          -  Attempted suicide associated with index case of postpartum depression.

          -  Medical history of bipolar disorder.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 20mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed as a prospective, multi-centre, parallel group, double-blind
      randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of
      MP-513 (Teneligliptin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form has been obtained from the subject, in
             accordance with International Conference on Harmonisation guidelines on Good Clinical
             Practice (ICH GCP), before any screening or study related procedures take place.

          -  The subject is aged ≥18 years at signature of the informed consent form.

          -  Hospitalization status: outpatient.

          -  The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3
             months at the screening visit (Day -28).

          -  The subject is undergoing diet and exercise therapy, and diet and exercise regimen has
             not been changed for at least 8 consecutive weeks at the screening visit (Day -28).
             Subjects who cannot do exercise due to complication are not limited to this criteria.

          -  The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and < 10.0% at the
             screening visit (Day -28) and on Day -14.

        Exclusion Criteria:

          -  The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.

          -  The subject has received insulin within 1 year prior to the screening visit (Day -28),
             with the exception of insulin therapy during hospitalization or insulin therapy for
             medical conditions not requiring hospitalization (< 2 weeks' duration).

          -  The subject has received an anti-diabetic drug within 8 weeks prior to the screening
             visit (Day -28).
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo Ezetimibe
Intervention description: Administered by subcutaneous injection; Tablet for oral administration; Administered by subcutaneous injection; Tablet for oral administration
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Japanese; High cholesterol; Treatment of high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia; Statin intolerant

Summary:

      The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous
      (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density
      lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an
      effective dose of a statin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 20 to ≤ 80 years of age

          -  Japanese by self-identification

          -  Not on a statin or on a low dose statin with stable dose for at least 4 weeks.

          -  Subject not at LDL-C goal

          -  History of statin intolerance to at least 2 statins

          -  Lipid lowering therapy has been stable prior to screening for at least 4 weeks

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure

          -  Uncontrolled cardiac arrhythmia

          -  Uncontrolled hypertension

          -  Type 1 diabetes

          -  Poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: S5G4T-1; S5G4T-2
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: papulopustular rosacea

Summary:

      To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily
      for 12 weeks in participants with papulopustular rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 18 years of age and older.

          3. Participants must have clinical diagnosis of moderate to severe rosacea.

          4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules
             and/or pustules) including those present on the nose.

          5. Have 2 nodules or less.

        Exclusion Criteria:

          1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of
             their study participation or were found to have positive pregnancy test at Baseline or
             screening visits.

          2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).

          3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or
             keratitis) of sufficient severity to require topical or systemic antibiotics.
A Safety Study of 3 Different Bowel Cleansing Preparations
Condition: Colonoscopy; Bowel Preparation; Endoscopy
Intervention: PEG-3350 based bowel preparation; BLI800 approved preparation regimen; BLI800 investigational preparation regimen
Intervention description: solution for oral administration prior to colonoscopy; solution for oral administration prior to colonoscopy; solution for oral administration prior to colonoscopy
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colonoscopy; bowel preparation; endoscopy

Summary:

      The objective of this study is to compare the safety, tolerance and efficacy of BLI800
      (approved and investigational regimens) to an approved control preparation as bowel
      preparations prior to colonoscopy in adult patients, particularly including the elderly and
      those with renal and/or hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication.

          -  At least 18 years of age

          -  If female, and of child-bearing potential, is using an acceptable form of birth
             control

          -  Negative urine pregnancy test at screening, if applicable

          -  In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study

        Exclusion Criteria:

          -  Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

          -  Subjects who had previous significant gastrointestinal surgeries.

          -  Subjects who have uncontrolled clinically significant pre-existing electrolyte
             disturbances.

          -  Subjects with severe liver or renal insufficiency.

          -  Subjects with a history of congestive heart failure or other clinically significant
             cardiac abnormality.

          -  Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          -  Subjects undergoing colonoscopy for foreign body removal and decompression.

          -  Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          -  Subjects of childbearing potential who refuse a pregnancy test.

          -  Subjects allergic to any preparation components

          -  Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

          -  Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Condition: Bipolar I Disorder; Acute Mania
MeSH terms: Mania
Intervention: Brexpiprazole
Intervention description: Brexpiprazole tablets
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Intervention model description: Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).
Masking: None (Open Label)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar; Mania; Brexpiprazole

Summary:

      This study evaluated the safety and evaluate the safety and tolerability of open-label
      brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult
      subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
    

Eligibility criteria:

        Inclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)

          -  Participants remaining in hospital at the Day 21 visit of trial 331-201-00080 or
             331-201-00081 were permitted to enroll in the 331-201-00083 trial at the week 3 visit
             of the double-blind trial if they were planned to be discharged from the hospital
             before the week 1 visit of trial 331-201-0083. Participants not discharged by the week
             1 visit of trial 331-201-0083 were withdrawn.

          -  Participants who, in the opinion of the investigator, could potentially benefit from
             administration of oral brexpiprazole for the treatment of bipolar I disorder and who
             completed 3 weeks of post-randomization treatment in Trial 331-201-00080 & Trial
             331-201-00081.

        Exclusion Criteria (rollover participants from 331-201-00080 & 331-201-00081 trials)

          -  Participants with a major protocol violation during the course of their participation
             in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied
Condition: Glaucoma, Neovascular
MeSH terms: Glaucoma; Glaucoma, Neovascular
Intervention: Aflibercept (EYLEA, BAY86-5321); Topical IOP-lowering drugs
Intervention description: 2 mg (0.05 mL), Intravitreal injection (IVT), single dose.; A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The researchers in this trial want to learn how the drug aflibercept works in in Japanese
      patients with increased eye pressure that is caused by new blood vessels growing in the eye
      (neovascular glaucoma or NVG). They also want to find out how patient tolerate the
      application of the drug that is injected in the vitreous humor of the eye and if this will
      cause any medical problems during the trial (vitreous humor, also called vitreous body is the
      clear gel that fills the space between the lens and the retina of the eyeball).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese men and women aged 20 years or older

          -  Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the
             anterior segment (both iris and anterior chamber angle)

          -  Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to
             anterior segment (both iris and anterior chamber angle) neovascularization

        Exclusion Criteria:

          -  Patients with angle-closure due to conditions other than NVG or complete angle-closure
             due to NVG

          -  Patients with a known or suspected ocular or peri-ocular infection

          -  Patients with severe intraocular inflammation in the study eye

          -  Women who are pregnant, suspected of being pregnant or lactating

          -  Patients with known allergy to aflibercept