bioihbjkbjnl/mcl2 huggingface dataset:
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: placebo (unspecified)
Intervention description: Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration; Pbo for a study approximately 120 minutes in duration
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 276.0
Sex: All
Minimum age: 6 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      This study will attempt to find out if the addition of an intravenous form of a drug that is
      already used for treating asthma in children will help resolve asthma attacks faster than
      using the current standard care alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 6-14 years of age seeking treatment in emergency departments with acute
             asthma attacks

        Exclusion Criteria:

          -  Other respiratory conditions (including congenital lung abnormalities) or other acute
             illnesses that would complicate current treatment and response for asthma
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Rosiglitazone (BRL49653C)
Intervention description: study drug
Intervention MeSH terms: Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: rosiglitazone; Avandia; type 2 diabetes mellitus; diabetes

Summary:

      This study was designed to compare the efficacy and safety of BRL49653C versus placebo with
      concomitant use of sulfonyl urea (SU).
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with type 2 diabetes mellitus managed by SU will be candidate for this study.
             These candidates will be checked up on their clinical laboratory data, and must have
             adequate blood, liver and kidney function.

        Exclusion criteria:

          -  Patient with serious cardiovascular disease or serious hepatic disease will not be
             eligible.
A Trial of AXS-05 in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: AXS-05; Placebo
Intervention description: Oral AXS-05 tablets, taken daily for 6 weeks.; Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depressive Disorder; Depressive Disorder, Major; Bupropion; Dextromethorphan; MDD; Dopamine Reuptake Inhibitor; AXS-05; NMDA Receptor Antagonist; Central Nervous System; CNS; Sigma-1 Receptor Agonist; Nicotinic Acetylcholine Receptor Antagonist; Norepinephrine Reuptake Inhibitor; Glutamate Modulator; Axsome Therapeutics; GEMINI; Serotonin Reuptake Inhibitor

Summary:

      A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in
      patients with major depressive disorder (MDD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Age 18 - 65

          -  Currently meets DSM-5 criteria for MDD

          -  Body Mass Index between 18 and 40 kg/m^2, inclusive

        Key Exclusion Criteria:

          -  Suicide risk

          -  History of treatment resistance in current depressive episode

          -  History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic
             stimulation or any experimental central nervous system treatment during the current
             episode or in the past 6 months

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Clinical Evaluation of BW430C in Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: lamictal
Intervention description: anti-epileptic drug
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: epilepsy; Incidence of rash; safety evaluation for initial dose; patients with Valproic acid

Summary:

      To evaluate safety information of BW430C when administered using the lower starting doses and
      slower dose escalations as recommended Global Data Sheet
    

Eligibility criteria:

        Inclusion criteria:

          -  Epilepsy with partial seizures

          -  Tonic clonic seizures

          -  Generalized seizures of Lennox-Gastaut

          -  Subjects whose seizures are easily recognizable at least one seizure per month and
             counts for 8 consecutive weeks prior to the start of the study drug.

          -  Concurrent AEDs: Subjects taking concurrent VPA.

        Exclusion criteria:

          -  Previous participation in a study of Lamictal

          -  Known hypersensitivity to any drugs

          -  Pregnant women

          -  nursing mothers

          -  women who may be pregnant

          -  women contemplating pregnancy during the study period
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: CB-5945; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1407.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Constipation; Chronic; Pain

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for
      the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for
      chronic non-cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily
             dose (METDD) for chronic non-cancer pain

          -  Has constipation that is caused by the chronic use of opioids

          -  Is willing to use only the study-provided laxative(s) and to discontinue use of all
             other laxatives, enemas, stool softeners, and other medications to treat constipation
             (for example, lubiprostone) during the study period (from Screening until the last
             study assessment).

          -  Is able and willing to refrain from facilitating defecation via manual maneuvers (for
             example, digital evacuation or support of the pelvic floor) during the study period
             (from Screening to the last study assessment)

        Exclusion Criteria:

          -  Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for
             example, obstruction) or contribute to bowel dysfunction

          -  Has evidence of intestinal obstruction

          -  Has a history of rectal bleeding not due to hemorrhoids or fissures

          -  Has an active malignancy of any type (participants with a history of successfully
             treated malignancy >5 years before the scheduled administration of study medication
             and participants with treated basal or squamous cell cancer may be enrolled)

          -  Is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example,
             loperamide), prokinetics (for example, metoclopramide), or locally acting chloride
             channel activators (for example, lubiprostone)

          -  Is taking non-opioid medications known to cause constipation (for example, iron
             sulfate therapy or tricyclic antidepressants)
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Ravulizumab; Placebo
Intervention description: Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.; Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for
      the treatment of participants with generalized myasthenia gravis (gMG).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the
             Screening Visit as confirmed by specific criteria.

          2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at
             screening.

          3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).

          4. Vaccinated against meningococcal infections within 3 years prior to, or at the time
             of, initiating study drug to reduce the risk of meningococcal infection (N
             meningitidis).

        Exclusion Criteria:

        Medical Conditions

          1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy
             unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years
             before screening.

          2. History of thymectomy within the 12 months prior to screening.

          3. History of N meningitidis infection.

          4. Use of the following within the time period specified below:

               -  IV immunoglobulin within 4 weeks of randomization

               -  Use of plasma exchange within 4 weeks of randomization

               -  Use of rituximab within 6 months of screening

          5. Participants who have received previous treatment with complement inhibitors (for
             example, eculizumab).
Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren; Amlodipine; Hydrochlorothiazide (HCTZ); Placebo; Placebo
Intervention description: 150 and 300 mg tablets; 5 and 10 mg capsules; 12.5 and 25 mg capsules; tablet; capsules
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aliskiren; antihypertensive; hypertension; renin inhibitor; moderate-severe hypertension

Summary:

      This study evaluated the efficacy (blood pressure lowering effect) and safety of
      aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  18 years of age or older

          -  msDBP and msSBP requirements:

               -  3A:

                    -  Diagnosis of moderate to severe hypertension (msSBP ≥ 160 mmHg and < 200
                       mmHg, and/or msDBP ≥ 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6
                       (Qualifying BP visit)

                    -  In addition, at the visit immediately prior to the above qualifying visit,
                       patients were also to have msSBP ≥ 145 mmHg and < 200 mmHg and msDBP ≥ 95
                       mmHg and < 120 mmHg) at Visits 3, 5 or 5.

                    -  Patients had to meet the above two sets of requirements at subsequent
                       adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and
                       6.

               -  OR

               -  3B:

                    -  msSBP ≥ 180 mmHg and < 200 mmHg with msDBP ≥ 95 mmHg and < 120 mmHg, or
                       msDBP ≥ 110 mmHg and < 120 mmHg with msSBP ≥ 150 mmHg and < 200 mmHg after
                       at least one week of treatment with placebo (Visit 3 and on).

        Exclusion Criteria:

          -  Continued use of anti-hypertensive medicines or use of 4 or more hypertensive
             medicines at study start

          -  Patients with an msSBP ≥ 200 mmHg or msDBP ≥ 120 mmHg at any time during the placebo
             run-in period were to be discontinued from the study.

          -  Extremely elevated (defined) blood pressure at any point during the study

          -  Pregnant or lactating women

          -  Pre-menopausal women not taking accepted form of birth control

          -  History or evidence of secondary form of hypertension

          -  History of cardiovascular conditions

        Other protocol-defined inclusion/exclusion criteria applied to the study.
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Glargine
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to evaluate glycemic control in participants with type 2 diabetes
      who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine.
      Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system)
      during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1
             year prior to screening.

          -  Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least
             90 days prior to screening including:

               -  Basal insulin glargine U-100, in combination with bolus insulin analog (insulin
                  lispro, insulin aspart, or insulin glulisine) with meals.

               -  Participant must have been treated with the same type of allowed bolus insulin
                  analog for at least 30 days prior to screening.

          -  Participants may be treated with up to 3 of the following oral antihyperglycemic
             medications (OAMs) for T2D in accordance with local regulations:

               1. Metformin

               2. Dipeptidyl peptidase-4 (DPP-4) inhibitor

               3. sodium glucose cotransporter 2 (SGLT2) inhibitor

               4. oral glucagon-like peptide 1 (GLP-1) agonist

          -  Doses of OAMs are required to have been stable for at least 90 days prior to
             screening.

          -  Participants may be treated with injectable GLP-1 receptor agonist for T2D in
             accordance with local regulations. The GLP-1 receptor agonist dose is required to have
             been stable for at least 90 days prior to screening.

          -  Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.

        Exclusion Criteria:

          -  Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune
             diabetes in adults.

          -  Have had any episode of severe hypoglycemia (defined as requiring assistance due to
             neurologically disabling hypoglycemia) within 6 months prior to screening.

          -  Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis
             within 6 months prior to screening.

          -  Have hypoglycemia unawareness as judged by the investigator.
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Condition: Asthma
MeSH terms: Asthma
Intervention: Ciclesonide; Ciclesonide; Placebo
Intervention description: Ciclesonide MDI 40 µg BID over twelve weeks; Ciclesonide MDI 80 µg BID over twelve weeks; Placebo MDI over twelve weeks
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 528.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Bronchial Asthma

Summary:

      Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg
      twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

      Secondary objective: To assess the safety and tolerability of ciclesonide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of persistent bronchial asthma for at least 3 months prior to screening;

          -  For patients with persistent bronchial asthma and being treated with a controller
             therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;

          -  For patients with persistent bronchial asthma and not being treated with controller
             therapy: Patients may have documented use of a reliever therapy such as
             albuterol/salbutamol or may be untreated;

          -  Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic
             spirometry after a 6 hour withhold of albuterol/salbutamol;

          -  Only patients aged between 6 to <12 years must have a forced expiratory volume in one
             second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of
             albuterol/salbutamol

        Exclusion Criteria:

          -  Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for
             4 or more nights out of the last 7 days of the screening period;

          -  Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days
             within the last 7

          -  Upper or lower respiratory tract infection within 4 weeks prior to screening and
             during screening period;

          -  History of life-threatening asthma, including a history of significant hypercarbia
             (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an
             exacerbation of asthma;

          -  More than 3 in-patient hospitalization or emergency care visits due to asthma
             exacerbations in the year prior to screening;

          -  Use of injectable or oral corticosteroids within one month prior to screening, or more
             than 3 bursts) within 6 months prior to screening;
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Aripiprazole; Placebo
Intervention description: Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks; Tablets, Oral, once daily, 8 weeks
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Serious behavioral problems in children and adolescents with AD; Behavioral Problems

Summary:

      This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly
      dosed with a placebo, in reducing serious behavioral problems in children and adolescents
      with a diagnosis of autistic disorder (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition
             (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems.
             Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)

          -  CGI score > = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation
             subscale score > = 18 at screening and baseline (randomization)

          -  Mental age of at least 18 months

          -  Male or female 6 to 17 years of age, inclusive, at the time of randomization

        Exclusion Criteria:

          -  Patients considered treatment resistant to neuroleptic medication based on lack of
             therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks
             each.

          -  Patients previously treated and not responding to aripiprazole treatment

          -  The patient is currently diagnosed with another disorder on the autism spectrum,
             including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or
             Childhood Disintegrative Disorder

          -  Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major
             depression

          -  A seizure in the past year

          -  History of severe head trauma or stroke

          -  Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral
             modification) must have started at least 2 months prior to the initial screening visit
             and must remain in a consistent treatment program for the duration of the study.