bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Intervention: Lanabecestat
Intervention description: Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Dementia; Brain Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Delirium, Dementia, Amnestic, Cognitive Disorders; Tauopathies; Memory; Amyloid

Summary:

      This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The
      purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in
      participants with early Alzheimer's disease dementia at the time of entry into study
      I8D-MC-AZES.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility
             criteria for delayed-start I8D-MC-AZFD.

        Exclusion Criteria:

          -  Participants who participate in AMARANTH (NCT02245737) who develop new conditions
             precluding them from enrolling into I8D-MC-AZFD.
Ezetimibe in Patients Hypo-responsive to Statins
Condition: High Cholesterol; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hypercholesterolemia
Intervention: Ezetimibe; Atorvastatin
Intervention description: 10 mg; Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy.
Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients
Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit.
Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test
Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation.
Visit 6: Final cholesterol panel and conclusion of study period
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Response to statin therapy for elevated low density lipoprotein is variable and may be
      influenced by cholesterol absorption. This study will evaluate whether combination therapy
      with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less
      than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin
      20 mg daily).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will need to have an LDL-C level of 130 mg/dl or greater without treatment.

          -  They must have demonstrated an initial LDL-C reduction of less than 25% on 10 mg of
             atorvastatin or 20 mg of simvastatin.

          -  Eligible patients will be those deemed by their physicians to be eligible for lipid
             lowering therapy with a statin and to have stable CAD, CAD equivalent per NCEP
             guidelines, or Framingham risk of 10-20%.

        Exclusion Criteria:

          -  Recent (<3 months) diagnosis of Acute Coronary Syndromes due to ethical considerations
             [10].

          -  Pregnant patients, those planning to become pregnant, or those who are breast feeding,
             those with liver disease, history allergic reaction to any agent used in the trial,
             history of myositis, myopathy, pancreatitis, hypertriglyceridemia (TG > 400 mg/dL),
             history of significant alcohol or drug abuse, history of organ transplantation, or
             patient refusal.
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Condition: Autosomal Dominant Polycystic Kidney Disease （ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: tolvaptan
Intervention description: Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 23 Years
Maximum age: 53 Years
Healthy volunteers: No

Summary:

      ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of
      tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has
             been completed.

          -  Patients who completed 3-year repeated administration and who completed the second
             follow-up visit or patients whose treatment with the trial drug was interupted due to
             pregnancy and who completed out the second follow-up visit in Trial 156-04-251.

          -  Patients in whom any adverse events occurring in Trial 156-04-251 were resolved
             orstabilized and require no further follow-up.

        Exclusion Criteria:

          -  Patients with eGFR of less than 15 mL/min/1.73 m2

          -  Pregnant, breast-feeding, or possibly pregnant women or women who are planning to
             become pregnant

          -  Patients who received any investigational drug other than Tolvaptan within 30 days
             prior to commencement of administration of tolvaptan

          -  Any patients who, in the opinion of the principle investigator or subinvestigators,
             should not participate in the study
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate; Placebo
Intervention description: BG00012 capsules; Capsules taken to maintain the blind in the 240 mg BID treatment group.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1736.0
Sex: All
Minimum age: 19 Years
Maximum age: 58 Years
Healthy volunteers: No
Keywords: relapsing; multiple sclerosis; remitting; oral

Summary:

      The primary objective of this study is to evaluate the long-term safety profile of BG00012
      (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term
      efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further
      the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic
      resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301
      (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on
      health economics assessments and the visual function test.
    

Eligibility criteria:

        Key Inclusion Criteria:

        -Subjects who participated in and completed as per protocol previous BG00012 clinical
        studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).

        Key Exclusion Criteria:

          -  Any significant change in medical history from 109MS301 or 109MS302 that would have
             excluded subject's participation from their previous study.

          -  Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE
             or due to reasons other than protocol-defined relapse/disability progression.

          -  Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability
             progression or relapses and did not follow the modified visit schedule up to Week 96.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial
Condition: Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic
Intervention: Whole blood
Intervention description: Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

Summary:

      Despite advances in trauma resuscitation, a paucity of therapeutic interventions are
      available early enough to reduce the downstream morbidity and mortality attributable to
      hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of
      hemorrhage, the ideal resuscitation intervention would entail use of a blood product
      containing all essential hemostatic components, closest to time of injury, where prevention
      or reversal of the devastating downstream consequences of shock and coagulopathy can occur.
      This proposal will characterized the efficacy of whole blood resuscitation initiated in the
      prehospital setting to patients in hemorrhagic shock which represents this ideal intervention
      post-injury. These results will have great potential to dramatically change the way trauma
      resuscitation occurs today.
    

Eligibility criteria:

        Inclusion Criteria:

        Injured patients being transport via an air medical service with hypotension (SBP =/<
        90mmHg with tachycardia >108 OR SBP=/<70 without the tachycardia requirement)

        Exclusion Criteria:

        Age < 18 or > 89 years

        Isolated fall from standing injury mechanism

        Brain matter exposed or penetrating brain injury (GSW)

        CPR > 5 mins with out ROSC

        Isolated burns without evidence of traumatic injury

        Isolated Drowning or Hanging

        No Intravenous or Intraosseous access

        Known prisoner or known pregnancy

        Referral Hospital Admission

        Wearing No PPOWER bracelet

        Objection to study voiced by subject or family at scene
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19
Intervention: Efprezimod alfa; Placebo
Intervention description: Efprezimod alfa is given on Day 1.; Placebo is given on Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult
      participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen
      support.

      The primary hypothesis of the study is clinical improvement in the experimental group versus
      the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute
             respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection

          -  Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases
             (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical
             ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive
             ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a
             peripheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate
             >/= 24 breaths/min). Intubation should be within 7 days

        Exclusion Criteria:

          -  Participants who are pregnant, breastfeeding, or have a positive pregnancy test result
             before enrollment

          -  Participants previously enrolled in the efprezimod alfa study

          -  Intubation for invasive mechanical ventilation is over 7 days

          -  Documented acute renal or hepatic failure

          -  The investigator believes that participating in the trial is not in the best interests
             of the participant, or the investigator considers unsuitable for enrollment (such as
             unpredictable risks or subject compliance issues)
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Lanreotide Autogel®; Lanreotide Acetate
Intervention description: Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).; Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).
Intervention MeSH terms: Lanreotide; Somatostatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg
      with lanreotide 40mg PR in subjects with active acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a
             central laboratory) as outlined below:

               -  A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the
                  screening period (applicable to both treatment naïve subjects and subjects who
                  have stopped treatment and undergone a washout period prior to Visit 1(Week -4).

               -  Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples
                  taken at 0, 30, 60, 90 and 120 minutes) during the screening period.

          -  The subject has undergone surgical removal of an adenoma for acromegaly at least 3
             months prior to Screening, or is likely to require pituitary surgery in the future but
             not before completing at least 32 weeks of study treatment plus an additional follow
             up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for
             whom pituitary surgery is not an option (due to contraindications, refusal etc.) and
             is therefore never likely to undergo pituitary surgery.

        Exclusion Criteria:

          -  The subject has been treated with radiotherapy within 10 years prior to Screening.

          -  The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant,
             cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate
             release (IR) or bromocriptin within 2 weeks of Screening.

          -  The subject has a history of or currently presents with clinically significant
             ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute
             Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

          -  The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8.5%).
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis Patients With Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21
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: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to investigate the safety and efficacy for 52-week dosing in
      hemodialysis patients with hyperphosphatemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Dialysis patients with hyperphosphatemia

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: 64Cu-DOTATATE
Intervention description: Detection of somatostatin positive lesions in NET
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE
      peptide, labelled with the 64Cu tracer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed or suspicion of NET based on histology/ biopsy report.

          -  Confirmed or suspicion of NET based on conventional imaging scans of affected area
             such as MRI and/or contrast enhanced CT and/or an FDG PET

          -  CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to
             study date.

        Exclusion Criteria:

          -  Pregnant, planning to be pregnant within the next two weeks

          -  Inability to provide written consent.

          -  Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and
             Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging.
             If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28
             days is required before the injection of the study drug.
Vortioxetine to Prevent Return of Symptoms in Children With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Vortioxetine; Placebo
Intervention description: Tablets; Tablets
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills)
      in preventing depression in children who improved when treated with vortioxetine.
    

Eligibility criteria:

        Inclusion Criteria:

        De novo participants

          -  The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid
             anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and
             Obsessive Compulsive Disorder (OCD)).

          -  The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.

          -  The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at
             the Screening and Baseline Visit

        Exclusion Criteria:

          -  The participant receives ongoing current psychotherapy that is planned to be
             intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT)
             are not allowed.

          -  The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of
             Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or
             Schizophrenia or Schizoaffective Disorder.

          -  The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and
             is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum
             of 4 weeks prior to the study treatment.

          -  The participant has attempted suicide or is at significant risk of suicide

        Other inclusion and exclusion criteria may apply.
Actinic Keratoses Treatment With Metvix® in Combination With Light
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Metvix®; Photodynamic Therapy Blue light; Photodynamic Therapy Daylight
Intervention description: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug; Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to compare efficacy and safety of Metvix® natural
      daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in
      subjects with mild actinic keratoses (intra-individual comparison)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female above 18 years;

          -  Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the
             scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

        Exclusion Criteria:

          -  Subject with clinical diagnosis of at least one severe AK on TAs

          -  Subject with clinical diagnosis of other skin disease (including non-melanoma skin
             cancer) on the TAs;

          -  Subject with pigmented AK on the TAs