bioihbjkbjnl/mcl2 huggingface dataset:
Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Intervention: Dexamethasone; placebo
Intervention description: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Months
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Asthma; Pediatric; Emergency Department; Dexamethasone; Steroid

Summary:

      Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the
      pediatric emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of asthma defined as at least two (2) prior episodes of respiratory illness
             characterized by wheezing treated with inhaled beta agonists

        Exclusion Criteria:

          -  pregnancy

          -  severe chronic cardiac, respiratory, neurological or neuromuscular disease

          -  complete resolution of symptoms after one treatment of beta agonists

          -  severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Nalmefene hydrochloride
Intervention MeSH terms: Nalmefene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with
      alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed Study 339-14-001

          -  Patients who have signed the informed consent form for Study 339-14-002

        Exclusion Criteria:

          -  The patient has a clinically significant unstable illness (eg, complication of New
             York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal
             function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73
             m2, hepatic failure, and neoplastic disorder)

          -  The patient has a clinically significant abnormal electrocardiogram (ECG) which is
             inappropriate for the participation in the trial in the opinion of the investigator or
             subinvestigator
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Condition: Acute Respiratory Distress Syndrome; COVID-19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Brexanolone; Placebo
Intervention description: Administered as IV infusion.; Administered as IV infusion.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacy and safety of brexanolone in
      participants on ventilator support for acute respiratory distress syndrome (ARDS) due to
      COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was confirmed positive for the novel coronavirus responsible for
             SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection as determined
             by polymerase chain reaction (PCR) at Screening

          -  Participant had a presumptive diagnosis of ARDS at Screening and partial pressure of
             arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (ratio of partial pressure
             of arterial oxygen to fraction of inspired oxygen [PF ratio]) less than (<) 300 prior
             to randomization

          -  Participant was intubated and receiving mechanical ventilation prior to randomization

          -  Participants must had initiated mechanical ventilation within 48 hours prior to
             screening, or had an immediate clinical plan for such intervention at time of
             screening

          -  Participant was likely to survive, in the opinion of the investigator, for at least 72
             hours from the time of screening

        Exclusion Criteria:

          -  Participant had fulminant hepatic failure at Screening

          -  Participant had end stage renal disease at Screening

          -  Participant had a known allergy to progesterone, allopregnanolone, or any excipients
             in the brexanolone injection

          -  Participant was concurrently participating in another clinical trial for an
             investigational product or device at screening
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: Valbenazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine
      (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for
      the treatment of adults with TD until valbenazine is anticipated to be available commercially
      or they complete 72 weeks of treatment. This study will allow enrollment of up to 150
      medically stable male and female participants with TD who previously participated in and
      completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402
             (Kinect 4) Phase 3 study.

          -  Participants of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently throughout the study and
             until 30 days after the last dose of valbenazine.

          -  If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood
             disorder, or other conditions, be on stable doses.

          -  Be in general good health.

          -  Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

        Exclusion Criteria:

          -  Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          -  Have a known history of substance dependence, substance (drug) or alcohol abuse.

          -  Have a significant risk of suicidal or violent behavior.

          -  Have a known history of neuroleptic malignant syndrome.

          -  Have a known history of long QT syndrome or cardiac arrhythmia.

          -  Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          -  Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than valbenazine) during the study.

          -  Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          -  Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

          -  Are currently pregnant or breastfeeding.
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Lurbinectedin (PM01183); Pegylated liposomal doxorubicin (PLD); Topotecan
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the
      activity and safety of PM01183 versus PLD or topotecan as control arm in patients with
      platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the
      experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18 years

          -  Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary
             peritoneal cancer.

          -  Platinum-resistant disease (PFI: 1-6 months after last platinum-containing
             chemotherapy).

          -  Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
             v.1.1 criteria

          -  No more than three prior systemic chemotherapy regimens

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2

          -  Adequate hematological, renal, metabolic and hepatic function

        Exclusion Criteria:

          -  Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active
             hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major
             illness

          -  Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.

          -  Requirement of permanent or frequent (i.e., once per week) external drainages within
             two weeks prior to randomization
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
Condition: Infection, Human Immunodeficiency Virus I
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: GW873140
Intervention description: 400 mg twice daily
Intervention MeSH terms: Aplaviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1 GW873140 CCR5 antagonist experienced

Summary:

      The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist
      GW873140 or placebo in combination with an optimized background regimen in
      treatment-experienced HIV-infected subjects with R5-tropic virus
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected.

          -  Screening viral load at least 5000copies/mL.

          -  R5-tropic only virus at screening.

          -  Total prior antiretroviral experience of at least 3 months and documented resistance
             to at least one drug in each of the following classes: nucleoside reverse
             transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors
             (NNRTI), and protease inhibitors (PI).

          -  Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks
             before screening.

          -  Able to receive a ritonavir-boosted protease inhibitor during treatment studies.

          -  Women of childbearing potential must use specific forms of contraception.

        Exclusion criteria:

          -  Acute laboratory abnormalities.

          -  History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any
             chronic liver disease. Screening liver function tests will be used to determine
             eligibility.

          -  R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.

          -  Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of
             treatment study.

          -  Pregnancy or breastfeeding women.

          -  Recent participation in an experimental drug trial.

          -  Prior use of a CCR5 or CXCR4 antagonist.

          -  Significant ECG abnormalities or significant history of active pancreatitis,
             hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe
             illness.

          -  Current use of certain medications may exclude participation in this study.

          -  Additional qualifying criteria and laboratory test requirements to be assessed by
             study physician.
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: 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)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 447.0
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
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Condition: Prostate Cancer
MeSH terms: Recurrence
Intervention: Ga-68 labeled PSMA-11 PET
Intervention description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Intervention MeSH terms: Edetic Acid; Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 346.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are imaging patients with prostate cancer using a new PET imaging agent
      (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients
      with biochemical recurrence after prostatectomy and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histopathologically proven prostate adenocarcinoma.

          -  Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after
             definitive therapy with prostatectomy or radiation therapy (external beam or
             brachytherapy).

               -  Post radical prostatectomy (RP) - American Urological Association (AUA)
                  recommendation for biochemical recurrence after radical prostatectomy

                    -  PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.

               -  Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical
                  recurrence after radiation therapy

                    -  Nadir + greater than or equal to 2 ng/mL rise in PSA

          -  Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group
             (ECOG)/World Health Organization (WHO) equivalent).

          -  Age >= 18.

          -  Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria

          -  Unable to lie flat, still or tolerate a PET scan.

          -  Concomitant investigational therapy.

          -  Patient undergoing active treatment for non-prostate malignancy, other than skin basal
             cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
             superficial bladder cancer.

          -  Contraindication to furosemide administration including prior allergy or adverse
             reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed
             if Furosemide is omitted as part of the PET imaging protocol if a second-generation
             scatter correction is available for the used PET device).
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696; Valsartan
Intervention description: LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.; Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4822.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Heart failure; preserved ejection fraction; diastolic heart failure

Summary:

      The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the
      reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF
      with preserved ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or
             within 6 months prior to study entry.

          -  Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at
             least 30 days prior to study entry.

          -  Current symptom(s) of HF (NYHA class II-IV)

          -  Structural heart disease (left atrial enlargement or left ventricular hypertrophy)
             documented by echocardiogram.

          -  Elevated NT-proBNP

        Exclusion Criteria:

          -  Any prior measurement of LVEF < 40%.

          -  Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within
             3 months , or urgent percutaneous coronary intervention within 3 months or and
             elective PCI within 30 days prior to entry.

          -  Any clinical event within the 6 months prior to entry could have reduced the LVEF
             (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF
             ≥45%.

          -  Current acute decompensated HF requiring therapy.

          -  Patients who require treatment with 2 or more of the following: an angiotensin
             converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin
             inhibitor.

          -  Alternative reason for shortness of breath such as: significant pulmonary disease or
             severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.

          -  Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at
             entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110
             mmHg at entry.

        Other protocol-defined inclusion/exclusion criteria may apply.