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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Glimepiride (Japan); BRIEF: The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients. ; DRUG USED: Fasiglifam; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GPR40 (FFAR1, free fatty acid receptor 1); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: - The participant is an outpatient. - The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: - The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. - The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator. ; PRIMARY OUTCOME: Blood glucose; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EMBODY 4 (Extension); BRIEF: The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) ; DRUG USED: Epratuzumab - SLE; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment - Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment - Women of childbearing potential must agree to use an acceptable method of birth control Exclusion Criteria: - Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease - Subjects with active, severe SLE disease activity which involves the renal system - Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections - Substance abuse or dependence - History of malignant cancer - Subjects with any other condition which, in the investigators judgment, would make the subject unsuitable for inclusion ; PRIMARY OUTCOME: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks); SECONDARY OUTCOME 1: Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Early Myelofibrosis; BRIEF: Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population. ; DRUG USED: Jakafi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelofibrosis (MF); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective of JAK2 mutational status - Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2) - Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion - Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3 Exclusion Criteria: - Patients with prior treatment with ruxolitinib or other JAK inhibitors. ; PRIMARY OUTCOME: Progression Free Survival (PFS-1); SECONDARY OUTCOME 1: Time to Primary Progression (TTP)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INHALE 1; BRIEF: To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU). ; DRUG USED: Amikacin Inhale; DRUG CLASS: Non-NME; INDICATION: Hospital Acquired (Nosocomial) Pneumonia (HAP) (Antibacterial); TARGET: Bacterial ribosome, Cell wall synthesis, Protein synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Males and non-pregnant, non-lactating females, 18 years of age or older - Intubated and mechanically-ventilated - Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph - Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen - Impaired oxygenation - Clinical Pulmonary Infection Score (CPIS) of at least 6 - Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms Exclusion Criteria: - History of hypersensitivity to amikacin or other aminoglycosides - Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization - Known or suspected bacteremia secondary to Staphylococcus aureus - A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test - Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment] - Has been on mechanical ventilation for > 28 days - Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment - The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy - Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10 - Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO) ; PRIMARY OUTCOME: Number of Participants Surviving Through LFU Visit; SECONDARY OUTCOME 1: Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TANGO; BRIEF: The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy. ; DRUG USED: CER-001; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Reverse Cholesterol Transport (RCT); THERAPY: Combination; LEAD SPONSOR: Cerenis Therapeutics, SA; CRITERIA: Main Inclusion Criteria: - Male and female patients, aged 18 and above. - ApoA-I < 70 mg/dL - Symptomatic or asymptomatic cardiovascular disease - Diagnosis of genetically confirmed HDL-c deficiency due to defects in genes coding for ABCA1 and/or ApoA-1 - Stable doses of lipid lowering therapies for at least 6 weeks prior to baseline procedures Main Exclusion Criteria: - Females of childbearing potential - Patients with LCAT mutations - Patients who experienced recent cardiovascular or cerebrovascular events - Hypertriglyceridemia (>500 mg/dL) - Severe anemia (Hgb < 10 g/dL) - Uncontrolled diabetes (HbA1c >10%) - Congestive heart failure (NYHA class II or higher) - Contraindication for MRI scanning (e.g., implanted metal objects, claustrophobia) ; PRIMARY OUTCOME: Change in mmean vessel wall area (MVWA) of the carotid artery; SECONDARY OUTCOME 1: Change in mean vessel wall area (MVWA) of the carotid artery[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAP-MD-32 (Monotherapy); BRIEF: The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD). ; DRUG USED: Rapastinel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: NMDA Receptor - Glycine Site; THERAPY: Monotherapy; LEAD SPONSOR: Naurex, Inc, an affiliate of Allergan plc; CRITERIA: Inclusion Criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 - Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode - If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test Exclusion Criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1 - Lifetime history of meeting DSM-5 criteria for: - Schizophrenia spectrum or other psychotic disorder - Bipolar or related disorder - Major neurocognitive disorder - Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participants ability to consent, follow study directions, or otherwise safely participate in the study - Dissociative disorder - Posttraumatic stress disorder - MDD with psychotic features - Significant suicide risk, as judged by the Investigator ; PRIMARY OUTCOME: Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6); SECONDARY OUTCOME 1: Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - w/Cryoablation (Thailand); BRIEF: This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body) cancer vaccine step which combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body. ; DRUG USED: AlloStim; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Immune System, Stem Cells/Other Cell Therapies; THERAPY: Combination; LEAD SPONSOR: Immunovative Therapies, Ltd.; CRITERIA: Inclusion Criteria: 1. Adult males and female subjects aged 18 years or older at screening visit 2. Pathological diagnosis of colorectal adenocarcinoma 3. Metastatic disease with at least one lesion in liver - Primary can be intact or resected - Metastatic lesion(s) in liver non-resectable - Extrahepatic disease acceptable 4. KRAS/BRAF mutant disease or KRAS wild type w/previous anti-EGFR treatment 5. At least one liver lesion able to be visualized by ultrasound and determined to be safely assessable for percutaneous cryoablation 6. Previous treatment failure of at 2 previous lines of active systemic chemotherapy for metastatic disease: - Previous chemotherapy must have included one line with oxaliplatin (e.g. FOLFOX) and a previous second line with irinotecan (e.g. FOLFIRI) with or without bevacizumab - If KRAS wild type, at least one anti-EGFR therapy in first or second line - Treatment failure can be due to disease progression or toxicity - Disease progression on 2nd line therapy must be documented radiologically and have occurred during or within 30 days following the last administration of 2nd line chemotherapy 7. ECOG performance score: 0-1 8. Adequate hematological function: Absolute granulocyte count ≥ 1,200/mm3, Platelet count ≥ 100,000/mm3, PT/INR ≤ 1.5 or correctable to <1.5 at time of interventional procedures, Hemoglobin ≥ 9 g/dL (may be corrected by transfusion) 9. Adequate Organ Function: Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤ 1.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN, AST or SGOT ≤ 2.5 times ULN, ALT or SGPT≤2.5 times ULN 10. EKG without clinically relevant abnormalities 11. Female subjects: Not pregnant or lactating 12. Subjects with child bearing potential must agree to use adequate contraception 13. Study specific informed consent in the native language of the subject Exclusion Criteria: 1. Peritoneal carcinomatosis 2. Moderate or severe ascites requiring medical intervention 3. Prior hepatectomy, ablation or chemoembolization of liver lesion 4. Prior pelvic radiotherapy 5. Clinical or radiological evidence of brain metastasis/leptomeningeal involvement 6. Symptomatic asthma or COPD or any lung condition requiring treatment with steroids 7. Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment or oxygen saturation <92% on room air 8. Bevacizumab (Avastin®) treatment within 6 weeks of scheduled cryoablation 9. No Regorafenib prior to or during the Study Period 10. Anticoagulant medication for concomitant medical condition (unless can be safely discontinued for invasive cryoablation, biopsy and intratumoral injection procedures) 11. Prior allogeneic bone marrow/stem cell or solid organ transplant 12. Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to>5 mg/day of prednisone) within 30 days of the 1st day of study treatment o Topical corticosteroids are permitted 13. Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis). Well controlled Type I diabetes allowed. 14. Prior experimental therapy 15. History of blood transfusion reactions 16. Known allergy to bovine products 17. Progressive viral or bacterial infection o All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study 18. Cardiac disease of symptomatic nature 19. History of HIV positivity or AIDS 20. Concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless such medications can be discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) prior to cryoablation procedure 21. History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs 22. Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Safety[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ADJUNCT ONE; BRIEF: This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: GLP-1 Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - - Informed consent obtained - - Type 1 diabetes mellitus for 12 months or longer - - Basal bolus or CSII (Continuous Subcutaneous Insulin Infusion, insulin pump) treatment for 6 months or longer - - Stable insulin treatment for the last 3 months prior to Screening, as judged and documented by the investigator - - HbA1c 7.0-10% (Diabetes Control and Complications Trial (DCCT)), both inclusive, (corresponding to 53-86 mmol/mol (International Federation of Clinical Chemistry (IFCC)) - - Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, complete trial related questionnaires, diaries, self-monitoring of plasma glucose, self titration of insulin and attend all scheduled visits Exclusion Criteria: - - Prior use of glucagon-like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase IV (DPP-4) inhibitors - - Use of any medication, which in the investigators opinion could interfere with the glycaemic control or affect the subjects safety.Premix insulin is not allowed - - Known proliferative retinopathy or maculopathy requiring acute treatment - - Severe neuropathy, in particular autonomic neuropathy, i.e. gastroparesis, as judged by the investigator - - Uncontrolled/ untreated blood pressure at screening above 160 mmHg for systolic or above 100 mmHg for diastolic - - History of acute or chronic pancreatitis - - Screening calcitonin value equal to or above 50 ng/L - - Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2) - - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A3921044 - ORAL Scan; BRIEF: This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate. ; DRUG USED: Xeljanz/Xeljanz XR; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate Exclusion Criteria: - Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities. ; PRIMARY OUTCOME: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6; SECONDARY OUTCOME 1: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MK-0431D-266; BRIEF: The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone. ; DRUG USED: Juvisync; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), HMG CoA Reductase (HMGR); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - has T2DM - (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug - is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks - is not on a lipid-lowering agent for at least 6 weeks prior to entering the study Exclusion Criteria: - has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or possibly has T1DM - has been on a thiazolidinedione (TZD) within the previous 16 weeks - has been treated with a statin or other lipid-lowering agent (including over-the-counter [OTC] supplements) within the previous 6 weeks - currently participating in or has participated in another clinical study within the past 12 weeks - intends to consume >1.2 liters of grapefruit juice daily during the study - is on or likely to require treatment for at least 2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted) - intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride - is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery in the previous 12 months - has undergone a surgical procedure in the past 4 weeks or planned major surgery during the study - has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy - has a history of myopathy or rhabdomyolysis with any statin - has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled high blood pressure - has a history of active liver disease - has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV), hematological disorder, or uncontrolled endocrine or metabolic disease - is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks - has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer) - is pregnant or breast feeding, or is expecting to conceive or donate eggs during the course of the study, including 14 days after the last dose of study drug - is a user of recreational or illicit drugs or has had a recent history of drug abuse - consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin); SECONDARY OUTCOME 1: Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CONSTANT; BRIEF: A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults ; DRUG USED: Sci-B-Vac; DRUG CLASS: Vaccine; INDICATION: Hepatitis B Prevention (Vaccines, Antiviral); TARGET: Hepatitis B/HBV, Immune System; THERAPY: Monotherapy; LEAD SPONSOR: VBI Vaccines Inc.; CRITERIA: Inclusion Criteria: - Any gender - Age 18-45 years - Healthy, as determined by a physical examination and values of laboratory tests - If female, either is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), is of childbearing potential and must agree to use an adequate birth control method - Able and willing to give informed consent Exclusion Criteria: - Previous vaccination with any Hep B vaccine (HBV) (licensed or experimental) - Treatment by immunosuppressant within 30 days of enrollment - History of immunological function impairment - Pregnancy or breastfeeding - Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment - Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrolment - Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period - Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment - Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period - Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. - Any skin abnormality or tattoo that would limit post-vaccination injection site assessment - History of allergic reactions or anaphylactic reaction to any vaccine component - Unwilling, or unable in the opinion of the investigator, to comply with study requirements - Immediate family members of study center staff - Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers - Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured - Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening - Renal impairment with Glomerular Filtration Rate (GFR) <90 mL/min/ 1.73 m2 at screening - BMI ≥ 35 - Uncontrolled hypertension - Diagnosis of Type 1 or Type 2 diabetes or HbA1C ≥ 6.5% at screening - Any laboratory test abnormality that would be considered of Grade 1 severity or above as per FDA guidelines for grading clinical laboratory abnormalities and is considered as clinically significant by the investigator. ; PRIMARY OUTCOME: Geometric Mean Concentration (GMC) of Anti-HBs at Day 196 for Lot-to-Lot Consistency (Per Protocol Set 1); SECONDARY OUTCOME 1: Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 318 - Long-Term Safety Extension (Europe); BRIEF: For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503). ; DRUG USED: Intuniv Extended Release; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Alpha 2 Adrenergic Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: 1. Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is satisfied with their current ADHD medication. 2. Subject satisfied all entry criteria for the antecedent study (SPD503 315 or SPD503-316). 3. Subject who is a female of child-bearing potential (FOCP), defined as >9 years of age or <9 years of age and is post-menarchal, must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol. 4. Subjects parent or legally authorised representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures. 5. Subject and parent/LAR are willing, able, and likely to fully comply with all the testing and requirements defined in this protocol, including oversight of dosing. Specifically, the parent/LAR must be available upon awakening, to dispense the dose of investigational product for the duration of the study. 6. Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, sex, and height. 7. Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator. 8. Subject is able to swallow intact tablets. Exclusion Criteria: 1. Subject has any current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis (except oppositional defiant disorder), including any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder that, in the opinion of the Investigator, contraindicate treatment with SPD503 or confound efficacy or safety assessments. The Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL) rating from the antecedent study should be reviewed to confirm diagnosis, if necessary. 2. Subject who early terminated from Study SPD503-315 or Study SPD503-316 for protocol non-adherence, subject non-compliance, an AE, SAE, or withdrawal by subject. 3. Subject experienced any clinically significant AE in their prior SPD503 study (SPD503-315 or SPD503 316) that, in the opinion of the Investigator, would preclude exposure to SPD503. 4. Clinically important abnormality on urine drug and/or alcohol screen at the Screening Visit (Visit 1). 5. Subject has taken any investigational product as follows: last dose of investigational product in Study SPD503-315 within 7 days prior to the Baseline Visit (Visit 2); investigational product in Study SPD503 316 within 30 days prior to the Baseline Visit (Visit 2); any other investigational product within 30 days prior to the Baseline Visit (Visit 2) or any other ADHD medication within 30 days prior to Baseline Visit (Visit 2). 6. Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age sex-specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile. 7. Children aged 6 12 years with a body weight of less than 25.0kg or adolescents aged 13 years and older with a body weight of less than 34.0kg at the Screening Visit (Visit 1). 8. Subject has any condition or illness including clinically significant abnormal laboratory values at the Screening Visit (Visit 1) which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study. 9. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. 10. Subject has clinically significant ECG findings, as judged by the Investigator with consideration of the central ECG laboratorys interpretation, at the Baseline Visit (Visit 2). 11. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride, or any components found in SPD503. 12. Subject has a history of alcohol or other substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text RevisionÒ (DSM-IV-TRÒ; with the exception of nicotine) within the last 6 months. 13. Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or the presence of a serious tic disorder including Tourettes syndrome. 14. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically significant heart block), exercise related cardiac events including syncope and pre syncope, or clinically significant bradycardia. 15. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension. 16. Current use of any prohibited medication or other medications, including herbal supplements, that affect BP or heart rate or that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (ie, antihistamines) in violation of the protocol specified washout criteria at the Baseline Visit (Visit 2). 17. Subject has a medical condition, other than ADHD, that requires treatment with medications that have CNS effects and/or affect performance. 18. Subject is female and is pregnant or currently lactating. 19. Subject failed screening or was previously enrolled in this study. ; PRIMARY OUTCOME: Change From Baseline in Mean Systolic Blood Pressure at Final Assessment; SECONDARY OUTCOME 1: Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - Study 094 (REALISTIC); BRIEF: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis. ; DRUG USED: Cimzia; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Adult patient with established moderate to severe rheumatoid arthritis Exclusion Criteria: - All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment - Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials ; PRIMARY OUTCOME: American College of Rheumatology 20% (ACR20) Response at Week 12; SECONDARY OUTCOME 1: American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SOLACE (Noninfectious Anterior Uveitis); BRIEF: A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis. ; DRUG USED: Reproxalap; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uveitis (Ophthalmology); TARGET: Aldehydes; THERAPY: Monotherapy; LEAD SPONSOR: Aldeyra Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Male or female subjects aged ≥ 18 years and ≤ 85 years. - Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks. - Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing. Exclusion Criteria: - Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator. - Active intermediate or posterior uveitis in the study eye(s). - Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening. - Have participated in another investigational device or drug study within 30 days prior to screening. - Participation in a prior ADX-102 study. ; PRIMARY OUTCOME: Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale.; SECONDARY OUTCOME 1: Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - GS-US-366-1160; BRIEF: The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants. ; DRUG USED: Odefsey; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: DNA polymerase, Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening visit - Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or blip) and prior to screening is acceptable - Have no documented resistance to any of the study agents at any time in the past - HIV-1 RNA < 50 copies/mL at the screening visit - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL) - Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN) - Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) - Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula Key Exclusion Criteria: - Hepatitis B surface antigen (HBsAg) positive - Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll) - Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) - Females who are breastfeeding - Positive serum pregnancy test - Current alcohol or substance use judged by the Investigator to potentially interfere with the individuals study compliance - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposis sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1 - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial - Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals with any known allergies to the excipients of FTC/RPV/TAF Note: Other protocol defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 0119 (w/Ofatumumab); BRIEF: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL). ; DRUG USED: Zydelig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: p110 delta/PIK3CD, PI3K/AKT pathway; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Adults with previously treated recurrent CLL who have measurable lymphadenopathy - Require therapy for CLL - Have experienced CLL progression < 24 months since the completion of the last prior therapy - Have disease that is not refractory to ofatumumab Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Progression-Free Survival; SECONDARY OUTCOME 1: Overall Response Rate[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN; BRIEF: The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subjects treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description. ; DRUG USED: GED 0301; DRUG CLASS: New Molecular Entity (NME); INDICATION: Crohns Disease; TARGET: Smad; THERAPY: Monotherapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria for Adult Subjects: Subjects must satisfy the following criteria to be screened and enrolled in the study: - Male or female ≥ 18 years of age. - Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study. - Subject must use protocol approved contraception. Inclusion Criteria for Adolescent Subjects: Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study - Male or female 12 to 17 years of age. - Subject must have participated in the GED 0301 CD 003 study. - Subject is able to swallow the IP tablets. - Subject must use protocol approved contraception. Exclusion Criteria for Adult and Adolescent Subjects: The presence of any of the following will exclude a subject from screening and enrollment: - Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study. - Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists. - Subject is pregnant or breastfeeding. - Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product. ; PRIMARY OUTCOME: Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COMMANDER-HF (HF/CAD); BRIEF: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Coagulation Factor X; THERAPY: Combination; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Must have symptomatic heart failure for at least 3 months prior to Screening - Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition - Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization - Must have evidence of significant coronary artery disease - Must be medically stable in terms of their heart failure clinical status at the time of randomization - Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization Exclusion Criteria: - Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization - Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event - Prior stroke within 90 days of randomization - Has been hospitalized for longer than 21 days during the index event - Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously ; PRIMARY OUTCOME: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke; SECONDARY OUTCOME 1: Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GE-067-015 (Healthy Young Adults); BRIEF: Amyloid is an abnormal chemical found in the brain of patients with Alzheimers Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects. ; DRUG USED: Vizamyl; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease - Imaging; TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: GE Healthcare; CRITERIA: Inclusion Criteria: - The subject age is 18 to 40 years. - The subject has no evidence of thinking or memory problems by medical history. - The subject has a normal MRI scan. - The subjects general health is adequate to comply with study procedures. - The subject is willing and able to participate in all study procedures. Exclusion Criteria: - The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT). - The subject has a contraindication for (cannot undergo) MRI. - The subject has a history of head injury with loss of consciousness. - The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology. - The subject has a family history of Alzheimers Disease (AD); more than 1 first-degree relative. ; PRIMARY OUTCOME: Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid; SECONDARY OUTCOME 1: Measurement of Amyloid Content in Different Parts of the Brain[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - FUTURE 1 Extension; BRIEF: This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time. ; DRUG USED: Cosentyx; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-17 (Interleukin 17); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion criteria - Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed - Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period - Subjects must be deemed by the investigator to benefit from continued secukinumab therapy Exclusion criteria - Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab - Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms - Pregnant or nursing (lactating) women - Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU) Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20; SECONDARY OUTCOME 1: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - +/- Immunosuppressants (Canada); BRIEF: LPLD is a rare autosomal recessive disorder, characterized by the presence of marked chylomicronemia and hence hypertriglyceridemia. Clinically the most severe manifestation of chylomicronemia, is acute pancreatitis, which can be lethal. There is no effective therapy available to modulate the course of the illness and prevent complications for these patients. The current clinical management consists of severe reduction of dietary fat that is hard if not almost impossible to comply with. LPLD subjects continue to experience pancreatitis attacks, and are admitted to intensive care units on several occasions. Alipogene tiparvovec corrects or restores lipoprotein lipase (LPL) function long term, and hence reverses some symptoms, halts the disease progression and prevents further complications. Alipogene tiparvovec gene therapy ensures that a catabolically beneficial variant of the human LPL gene, LPL[S447X] is expressed and active in the relevant tissues in humans. Delivery of the gene is realized via intramuscular injection of an adeno-associated viral vector, pseudotyped with AAV1 capsids. ; DRUG USED: Glybera; DRUG CLASS: Biologic; INDICATION: Familial Chylomicronemia Syndrome (FCS)/Lipoprotein Lipase Deficiency (LPLD); TARGET: Lipoprotein lipase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Amsterdam Molecular Therapeutics; CRITERIA: Inclusion Criteria: - Eligible Population Study participants must have participated in the preceding observation study (Prep-02: Appendix III) and be diagnosed with lipoprotein lipase deficiency, meeting the following criteria: (I) Their lipoprotein lipase activity levels in post-heparin plasma should be ≤20 % of normal; (II) Confirmed homozygocity or compound heterozygocity for mutations in the LPL gene; (III) Post-heparin plasma LPL mass should be >5% of normal; (IV) Median fasting plasma TG concentrations >10.00mmol/L, as determined on the basis of 5 consecutive time points in the preceding observation study with a history of pancreatitis. - General Health The participant must be in good general physical health with, in the opinion of the investigator, no other clinically significant and relevant abnormalities of medical history, and no abnormalities at the physical examination and routine laboratory evaluation performed prior to the trial. - Age Age ≥18 years old. - Sex Male or female. Females must be of non-child bearing potential or with a negative pregnancy test and not breast feeding. Female subjects must use appropriate contraception (if relevant) and their spouse must use barrier contraception for the duration of the study (12 weeks). Males must practice barrier birth control and their spouse should use appropriate contraception until three consecutive semen samples, taken at least 75 days after administration, are negative for AMT-011 vector DNA. - Compliance The participant is willing to fully comply with all study procedures and requirements of the trial such as restrictions to a low-fat diet (see section 8.1). - Consent The participant has the mental ability to give voluntary written informed consent to participate in the study. Exclusion Criteria: - Disease - Apolipoprotein CII deficiency. - Inflammatory muscle disease (e.g. myositis, myopathies or rhabdomolysis). - Any current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures (e.g. malignant neoplasia). - Active infectious disease of any nature, including clinically active viral infections. - Laboratory Parameters The following blood screening tests will result in exclusion from participation: - Platelet count < 100 x 109 /L. - Hemoglobin < 7.0 mmol/L. - Liver function disturbances (bilirubin >2.50 x normal, transaminases >3 x ULN). - CPK > 3 x ULN. - Creatinine > 3 x ULN. ; PRIMARY OUTCOME: Reduction of fasting triglyceride (TG) concentrations; SECONDARY OUTCOME 1: Reduction of TG concentrations[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NEUTRINO (w/PegIFN + RBV, Any Genotype); BRIEF: This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12). ; DRUG USED: Sovaldi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Infection with HCV genotype 1, 4, 5, or 6 - Cirrhosis determination - Subject met the following classifications: - Treatment-naive - Screening laboratory values within defined thresholds - Not treated with any investigational drug or device within 30 days of screening - Use of highly effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: - Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase - Pregnant or nursing female, or male with pregnant female partner - Current or prior history of clinical hepatic decompensation - History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol - Excessive alcohol ingestion or significant drug abuse ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response (SVR)12; SECONDARY OUTCOME 1: Percentage of Participants Achieving SVR4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Post-Melphalan w/ASCT - Nordic; BRIEF: Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. However, the disease will eventually relapse and new treatment is demanded. Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a different biological effect and response even in patients refractory to conventional chemotherapy. The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy. ; DRUG USED: Velcade; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Proteasome; THERAPY: Combination; LEAD SPONSOR: Nordic Myeloma Study Group; CRITERIA: Inclusion Criteria: - Symptomatic myeloma diagnosis according to criteria in attachment 3 - ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy - Signed informed consent given prior to any study related activities have been performed Exclusion Criteria: - Prior exposure to bortezomib - Allogeneic transplantation scheduled as a part of the primary treatment - Neuropathy > Grade 2 (neurological symptoms interfering with ADL) - Non-secreting myeloma - Other concurrent disease making bortezomib treatment unsuitable - Positive pregnancy test (only applicable for women with childbearing potential) - Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used - Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis - History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg) - Serious medical or psychiatric illness likely to interfere with participation in this clinical study - Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study ; PRIMARY OUTCOME: Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation; SECONDARY OUTCOME 1: Overall survival from ASCT[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - STEP 6 ; BRIEF: This study will look at the change in participants body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking dummy medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as dummy medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obesity; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age more than or equal to 18 years at the time of signing informed consent - BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D) - History of at least one self-reported unsuccessful dietary effort to lose body weight - For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) Exclusion Criteria: - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records - For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening - For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation ; PRIMARY OUTCOME: Change in Body Weight (%); SECONDARY OUTCOME 1: Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - JADE Mono-2; BRIEF: B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment. ; DRUG USED: Cibinqo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT ; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - 12 years of age or older with a minimum body weight of 40 kg - Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4) - Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control Exclusion Criteria: - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study - Prior treatment with JAK inhibitors - Other active nonAD inflammatory skin diseases or conditions affecting skin - Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator - Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception ; PRIMARY OUTCOME: Percentage of Participants Achieving Investigators Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Paclitaxel; BRIEF: The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week. ; DRUG USED: IG-004; DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Achieve Life Sciences; CRITERIA: Inclusion Criteria: - Patients with histologic diagnosis of breast carcinoma - Stage IV (M1) disease - Adult (18 years of age or older) patients Exclusion Criteria: - Patients treated with a taxane within the past year - Patients whose tumor tissue is known to show over expression of HER2/neu ; PRIMARY OUTCOME: Objective response rates; SECONDARY OUTCOME 1: Median overall survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - D1693C00005 - Background Metformin/SU; BRIEF: This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Type 2 diabetes mellitus - Men or women age ≥ 18 years old - Stable dose combination of metformin and sulfonylurea - HbA1c ≥7.7% and ≤11.0% Exclusion Criteria: - Type 1 diabetes mellitus or diabetes insipidus - Recent cardiovascular events - Kidney or urological disorders - Hepatic disorders ; PRIMARY OUTCOME: Adjusted Mean Change From Baseline in HbA1c Levels; SECONDARY OUTCOME 1: Adjusted Mean Change From Baseline in FPG[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - EDITION JP II (Japan); BRIEF: Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 2 diabetes mellitus. Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile. To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia ; DRUG USED: Toujeo; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit; Exclusion criteria: - Age < 18 years at screening visit; - BMI(body mass index) ≥ 35 kg/m2 at screening visit; - HbA1c < 7.0% or > 10% (national glycohemoglobin standardization program [NGSP] value) at screening visit; - Diabetes other than type 2 diabetes mellitus; - Patients on self-monitoring of blood glucose less than 6 months before screening visit; - Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit; - Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit; - Use of insulin pump in the last 6 months before screening visit; - Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit; - Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit; - Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial. ; PRIMARY OUTCOME: Change from baseline in HbA1c; SECONDARY OUTCOME 1: Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - PEARL (HR+/HER-; Spanish Breast Cancer Research Group); BRIEF: This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125 mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3 weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous nonsteroidal aromatase inhibitors (NSAI) (letrozole or anastrozole) in cohort 1 or previous aromatase inhibitors (AI) (letrozole, anastrozole or exemestane) in cohort 2 defined as: recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or progression while on or within 1 month after the end of treatment with NSAI/AI for MBC. Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as first line for MBC. Patients must have measurable disease according to RECIST 1.1 or bone lesions, lytic or mixed, in the absence of measurable disease. ; DRUG USED: Ibrance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Spanish Breast Cancer Research Group; CRITERIA: Inclusion Criteria: 1. The patient has signed the informed consent document. 2. a) Patients in cohort 1: Females with histologically confirmed MBC whose disease is resistant to previous non-steroidal aromatase inhibitors (letrozole or anastrozole) b) Patients in cohort 2: Females with histologically confirmed MBC whose disease was resistant to previous aromatase inhibitors (exemestane, letrozole or anastrozole). Resistance is defined as: Recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or Progression while on or within 1 month after the end of treatment with NSAI/AI for advanced disease. 3. Previous chemotherapy is permitted either in the (neo) adjuvant setting and/or first line therapy for MBC (chemotherapy administered as second adjuvant therapy for locoregional recurrence should be considered as first line chemotherapy for MBC). 4. It is not mandatory to have exemestane, letrozole or anastrozole as the most recent treatment before randomization but recurrence or progression of breast cancer while receiving (or immediately after the enf of) the most recent systemic therapy has to be documented before randomization. 5. Hormonal receptor positive (HR+) breast cancer based on local laboratory determination. HR+ defined as major or equal to 1 percent positive cells by Immunohistochemistry (IHC) for ER and/or Progesterone Receptor (PgR). 6. Documented HER2 negative breast cancer based on local laboratory determination on most recent tumor biopsy. HER2 negative tumor is determined as IHC score 0 or 1+ or negative by ISH (FISH/Chromogenic In Situ Hybridization (CISH)/SISH) defined as a HER2/CEP17 ratio minor to 2 or for single probe assessment a HER2 copy number minor to 4. 7. Measurable disease or at least one bone lesion, lytic or mixed (lytic+blastic), which has not been previously irradiated and is assessable by CT/MRI in the absence of measurable disease according to RECIST 1.1 criteria. 8. Patient is at least 18 years of age. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status minor or equal to 1. 10. Life expectancy major or equal to 12 weeks. 11. Adequate organ and bone marrow function. 12. Postmenopausal women defined as women with: Prior bilateral surgical oophorectomy, or Age > 60 years, or Age < 60 years and medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause or follicle-stimulating hormone (FSH) and estradiol blood levels in their respective postmenopausal ranges 13. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade minor or equal to 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator´s discretion). 14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: 1. Have received more than 1 prior chemotherapy regimen for MBC. (NOTE: Chemotherapy administered as second adjuvant therapy for locoregional recurrence should be considered one prior chemotherapy for MBC).Other previous anticancer endocrine treatments for advanced disease are allowed. 2. Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis and over 50% liver involvement). 3. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy,) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization. 4. Prior treatment with any CDK4/6, mTOR or PI3K inhibitor (any agent whose mechanism of action is to inhibit the PI3 kinase-mTOR pathway) or capecitabine. 5. a) Patients included in cohort 1: Prior treatment with exemestane in the metastatic setting. If the patient has received exemestane in the adjuvant setting and developed MBC, she will be eligible for the study provided: - She has received letrozole/anastrozole as first-line MBC and progressed. - At least 1 year has elapsed since the end of adjuvant exemestane treatment. b) Patients included in Cohort 2: Prior treatment with fulvestrant in the metastatic setting. If the patient has received fulvestrant in the adjuvant setting and developed MBC, she will be eligible for the study provided: - She has received letrozole/anastrozole as first-line MBC and progressed. - At least 1 year has elapsed since the end of adjuvant fulvestrant treatment. 6. Patients treated within the last 7 days prior to randomization with: - Food or drugs that are known to be CYP3A4 inhibitors - Drugs that are known to be CYP3A4 inducers - Drugs that are known to prolong the QT interval 7. Patients who received before randomization: - Any investigational agent within 4 weeks - Chemotherapy within a period of time that is minor than the cycle length used for that treatment (e.g. less 3 weeks for fluorouracil, doxorubicine, epirubicin or less than 1 week for weekly chemotherapy) - Previous endocrine therapy is permitted without any window - Radiotherapy within 2 weeks (all acute toxic effects must be resolved to NCI CTCAE version 4.0 grade minor 1, except toxicities not considered a safety risk for the patient at investigator´s discretion) but patients who received prior radiotherapy to less than 25 per cent of bone marrow are not eligible independent of when it was received - Major surgery or other anti-cancer therapy not previously specified within 4 weeks, (all acute toxic effects must be resolved to NCI CTCAE version 4.0 grade minor 1, except toxicities not considered a safety risk for the patient at investigator´s discretion) 8. Diagnosis of any other malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 9. QTc major 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP). 10. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia). 11. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 Grade major or equal to 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. 12. Difficulties to swallow tablets, malabsorption syndrome disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or active inflammatory bowel disease or chronic diarrhea. 13. Known hypersensitivity to exemestane, palbociclib, capecitabine, fulvestrant or any of their excipients. 14. Any of the following contraindications for chemotherapy with capecitabine: - Known deficiency or family history of deficiency of dihydropyrimidine dehydrogenase. - Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine. 15. Only for patients in Cohort 2 any of the following contraindications for treatment with fulvestrant: - Bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) provided that the International Normalised Ratio (INR) is less than 1.6. 16. Known human immunodeficiency virus infection. 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 18. Recent or active suicidal ideation or behavior ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Objective Response (OR)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - C-EDGE TN (GT1, 4, 5, 6); BRIEF: This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%. ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria: - Documented chronic HCV GT1, GT4, or GT6 with no evidence of non-typeable or mixed genotype infection (positive for anti-HCV antibody, HCV RNA, or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results) - Cirrhosis defined by: liver biopsy showing cirrhosis METAVIR F4; or Fibroscan showing cirrhosis with a result of >12.5 kiloPascals (kPa); or FibroSure® (Fibrotest®) score of >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of >2 - Absence of cirrhosis defined by: liver biopsy showing absence of cirrhosis, or Fibroscan with a result of ≤12.5 kPa, or Fibrosure® (Fibrotest®) score of <= 0.48 and APRI of <=1 - HCV treatment status of treatment naïve (naïve to all anti-HCV treatment) and can also be ineligible to take pegylated interferon - Female participant not of reproductive potential, or female of reproductive potential and agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug (using abstinence or acceptable methods of contraception) Exclusion criteria: - Evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. For cirrhotics, participants who are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >6 - Co-infection with hepatitis B virus or human immunodeficiency virus (HIV) - History of malignancy <=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy - Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC - Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study - Clinically-relevant drug or alcohol abuse within 12 months of screening - Pregnant, breast-feeding, or expecting to conceive or donate eggs from Day 1 throughout treatment and 14 days after the last dose of study medication or longer if dictated by local regulations - Organ transplant (including hematopoietic stem cell transplants) other than cornea and hair - Poor venous access - History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorder (e.g., celiac sprue disease) - Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial - Evidence of history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis ; PRIMARY OUTCOME: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12); SECONDARY OUTCOME 1: Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Insulin Glargine; BRIEF: This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks. ; DRUG USED: Qtern; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4), SGLT; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - At least 18 years of age at screening - HbA1c ≥ 8% and ≤ 12% at screening - Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L) - Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks - estimated glomerular filtration rate (eGFR) &lt; 60 ml/ml/1.73m2 - Body Mass Index ≤ 45.0 kg/m2 Exclusion Criteria: - Clinical diagnosis of Type 1 diabetes - History of ketoacidosis - Renal, hepatic or pancreatic disease - Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min - Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min ; PRIMARY OUTCOME: Mean Change From Baseline in HbA1c at Week 24; SECONDARY OUTCOME 1: Mean Change From Baseline in Total Body Weight at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Polymyalgia Rheumatica; BRIEF: Sirukumab is a human anti-IL-6 monoclonal antibody that selectively binds to the cytokine with high affinity that may have therapeutic benefit in the treatment of polymyalgia rheumatica (PMR) by interrupting multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active PMR. The study will be conducted in 2 parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 52-week extension phase with no study drug administration and a 16-week follow-up phase if applicable. Approximately 150 subjects with a diagnosis of PMR and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study who are in clinical remission will be eligible to enter Part B, the 52-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable for those who have withdrawn prematurely from the study or who have completed Part A but are not eligible for Part B. ; DRUG USED: Sirukumab; DRUG CLASS: Biologic; INDICATION: Inflammatory Disorders; TARGET: IL-6 (Interleukin-6); THERAPY: Combination; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Age >=50 years - Diagnosis of PMR based on the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2012 provisional PMR classification criteria, that is, at the time of PMR diagnosis, subjects should be aged 50 years or older, presenting with new-onset (<12 weeks of diagnosis) bilateral shoulder pain and abnormal acute-phase response, and are required to score 4 or more on the following criteria for the diagnosis of PMR: Morning stiffness duration >45 minutes (2 points) or Hip pain or limited range of motion (1 point) or Absence of rheumatic factor (RF) or anti-citrullinated protein antibody (ACPA) (2 points) or Absence of other joint involvement (1 point). - Active PMR within 6 weeks of randomization where active disease is defined by an ESR >=30 millimeter (mm)/hour (hr) or CRP >=1 mg/dL within 6 weeks of randomization AND the presence of at least one of the following at screening (within 6 weeks of randomization): Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness or Other features judged by the clinician investigator to be consistent with PMR or PMR flares (e.g. fever of unknown origin). - Receiving oral prednisone 0-25 mg once daily (or equivalent) for PMR treatment at screening. Dosage of oral prednisone or equivalent, during the screening period can remain constant or be adjusted within the range of 0-25 mg prednisone equivalent based on investigators discretion. - Willing and able to receive treatment with oral prednisone 20 mg once daily at randomization and undergo a pre-defined blinded prednisone taper. - No evidence of active or latent infection with Mycobacterium tuberculosis (TB) - Be able to read, understand, and complete study questionnaires. - Male and female subjects, where male subjects with female partners of child bearing potential must comply with the contraception requirements and not to donate sperm from the time of first dose of study medication until 4 months after the last dose of study medication. A female subject of child bearing potential must comply with contraception requirements. Exclusion Criteria: - Features consistent with atypical PMR according to the investigators clinical judgment. Investigators are encouraged to discuss with the medical monitor when there are questions regarding excluding subjects with atypical PMR. Atypical features or features that increase the likelihood of a non-PMR diagnosis may include some or all of the following: Age <60 years; Chronic onset (>2 months) at time of diagnosis; Lack of shoulder involvement; lack of inflammatory stiffness; prominent systemic features, weight loss, night pain, neurological signs; features of other rheumatic disease; Normal or extremely high acute-phase response; AND treatment dilemmas such as incomplete, poorly sustained or non-response to GCs, inability to reduce GCs, contraindications to GC therapy, the need for prolonged GC therapy (>2 years). - History or current diagnosis of Giant Cell Arteritis (GCA), or Large Vessel Vasculitis (LVV). If GCA/LVV is suspected, this should be ruled out by ultrasound or other imaging techniques (example. fluorodeoxy-glucose positron emission tomography) prior to entering the study. - Maintained on GCs for 2 years or more prior to Screening. - Other inflammatory rheumatic diseases with the exception of gout controlled on stable suppressive therapy and without flares for at least 2 years prior to screening and expected to remain on this therapy for the duration of the study. - Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments. - Organ transplantation recipients (except corneas within 3 months prior to randomization visit). - Requires continued or repeated use of systemic GCs for conditions other than PMR. - Evidence of serious concomitant disease, which in the opinion of the investigator makes the subject unsuitable for participation in the study for either safety or efficacy. - Major ischemic event within 12 weeks of screening. - At screening, marked prolongation of corrected QT interval (QTc) > 450 millisecond (msec) [QTc by Bazetts formula (QTcB) or QTc by Fridericias formula (QTcF)] or QTc > 480 msec in subjects with Bundle Branch Block. History of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastro intestinal (GI) tract condition that might predispose to bowel perforation. - History of known demyelinating diseases such as multiple sclerosis or optic neuritis. - Active infections, or history of recurrent infections or required management of acute or chronic infections, as follows: currently on any suppressive therapy for a chronic infection and History or suspicion of chronic infection (e.g. joint infection) OR Hospitalization for treatment of infection within 60 days of the randomization visit OR Use of parenteral (intravenous [IV] or intramuscular [IM]) antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) within 60 days of randomization or oral antimicrobials within 30 days of randomization. - Primary or secondary immunodeficiency. - Human immunodeficiency syndrome (HIV) infection, hepatitis C. - Hepatitis B infection - Active malignancy or history of malignancy within previous 5 years. - Any other autoimmune disease. - Uncontrolled thyroid disease. - Uncontrolled psychiatric or emotional disorder. - Current history of suicidal ideation or past history of suicide attempt. - Has received prior treatment with any of the following: Systemic immunosuppressives within 4 weeks of randomization; Systemic GCs for conditions other than PMR within 8 weeks of randomization; Biologic agents targeted at reducing Tumor necrosis factor (TNF) alpha within 4-8 weeks of randomization, depending on the agent; B-cell depleting agents (e.g., rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to the normal range or baseline levels; Any prior use of tocilizumab or other anti-IL-6 agents, Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents, Abatacept and Tofacitinib; Methotrexate use within 2 weeks of randomization; Methylprednisolone > 100 mg/day IV (or equivalent) within 8 weeks of randomization. - Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months of randomization, during the study, or within 4 months after the last administration of study treatment. Have had a Bacille Calmette Guérin (BCG) vaccination within 12 months of screening. - Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before randomization. - History of drug abuse, alcohol abuse within 3 years prior to screening. - History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation - Laboratory abnormalities at screening - A female subject who is pregnant or lactating. ; PRIMARY OUTCOME: Proportion of subjects in sustained; SECONDARY OUTCOME 1: Part A: Cumulative prednisone dose at Week 52[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - E16 (Paediatric; Stages 3b - 5; no dialysis); BRIEF: The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to <18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis. ; DRUG USED: BindRen; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperphosphatemia; TARGET: Bile Acids, Phosphate; THERAPY: Monotherapy; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Children aged 2 years to <18 years with CKD stages 3b to 5, not on dialysis (stage 3b is defined as a glomerular filtration rate below 45 mL/min/1.73 m²). - The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus (P) levels above the age-related upper limit of normal (ULN) (Kidney Disease Outcomes Quality Initiative [KDOQI] Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008). - The subject is on a stable P diet at baseline (as judged by the Investigator). Inclusion criteria for subjects not currently treated with phosphate binders: - The subject, with serum P not controlled despite being on an appropriate P diet, must demonstrate serum P levels >1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the screening period. Such subjects do not require wash-out and should proceed to baseline for the next visit if additional screening visits are not required. Baseline inclusion criteria for subjects treated with phosphate binders: - The subject must enter the wash-out period, during which he/she must demonstrate serum P levels >1.5 SD above the KDOQI 2008 age-related mean value at any time during the wash-out period (after stopping phosphate binders), and; - The subject must demonstrate an increase in serum P levels by at least 10% above the pre wash-out level (after stopping phosphate binders). Note: should a subject fail to meet any of the above criteria, the subject is permitted to be re-screened once after an interval of at least three months. Exclusion Criteria: - The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices) - The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery) - The subject cannot stop treatment (prescription or over the-counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril - The subject is receiving immunosuppressant treatment for any medical condition at the baseline visit or is expected to receive such treatment during the course of the study - The subject is considered as unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism [i.e, serum P and Ca levels] Exclusion criteria for subjects treated with phosphate binders: - The subject was treated with a combination of two or more phosphate binders within one month prior to screening ; PRIMARY OUTCOME: Percentage of subjects who, due to hyperphosphataemia, require rescue treatment and/or discontinuation of therapy with colestilan.; SECONDARY OUTCOME 1: Incidence of TEAEs of hypercalcaemia and hypocalcaemia[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NP101-007; BRIEF: This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation. Key secondary objectives included: 1. The proportion of subjects who were nausea free at two hours after patch activation. 2. The proportion of subjects who were photophobia free at two hours after patch activation. 3. The proportion of subjects who were phonophobia free at two hours after patch activation. ; DRUG USED: Zecuity; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: NuPathe Inc.; CRITERIA: Inclusion Criteria: - Subject is an adult male or female, age range 18 years to 65 years. - Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICDH-II and the diagnosis was made before the age of 50. - Subject typically experiences moderate to severe headaches during a migraine attack. - Subject has at least a one year history of migraine. - Subject will be judged to be in good health, based on results of a medical history, physical examination, vital signs, ECG and laboratory profile. - Female subject of childbearing potential must have a negative pregnancy test at screening and prior to randomization. - Subject must have a negative drug screen. - Subject must be capable of reading and understanding either English or Spanish subject information materials. Be able to successfully apply a practice patch, carry-out all subject procedures, and be able to voluntarily sign and date an IRB approved IC agreement. - Subject has an acceptable patch application site (upper arm) that is relatively hair free and has no scars, tattoos, scratches, or bruises. Exclusion Criteria: - Subject has or plans to start, stop, or change treatment or dose with prophylactic anti-migraine treatment within 3 months prior to the subjects study randomization date and through the final visit. - Subject has or plans to start, stop, or change treatment or dose of any of the following within 3 months prior to the subjects study randomization date through final visit: anxiolytics, lithium and other mood stabilizers, hypnotics or antipsychotics. - Subject had less than one migraine per month or more than six migraines per month, or more than 15 headache days per month for any of the three months prior to randomization. - Subject has suspected or confirmed cardiovascular disease that contraindicates study participation. - Subject has a history of epilepsy or conditions associated with a lowered seizure threshold. - Subject has Raynauds disease. - Subject has a history of basilar or hemiplegic migraines. - Subject has a current diagnosis of a major depressive disorder per the DSM IV R. - Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence. - Subject is unwilling to discontinue use of serotonin agonists (triptans), except for the study patch, through the Final Visit. - Subject has taken SSRIs, SNRIs, TCAs, MAOIs or preparations containing St. Johns Wort within 1 month prior to screening and/or is planning to start any of these medications during the study. - Subject is unwilling to discontinue use of a PD-5 inhibitors through the Final Visit. - Subject has taken ergot medications within 7 days prior to Randomization and/or is unwilling to discontinue use through the Final Visit. - Subject has a history of a significant allergy or hypersensitivity to any component of the study patch. - Subject has any generalized skin irritation or disease including eczema, psoriasis, melanoma, or contact dermatitis. - Subject has clinically significant abnormal laboratory parameters, vital signs or ECG parameters. - Subject is known to be hepatitis B, hepatitis C or HIV positive. - Subject has hepatic dysfunction based on laboratory results or if in the opinion of the Investigator the subjects history, physical examination or other laboratory tests suggest hepatic dysfunction. - Female subject who is pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception during the study and for a period of 30 days following dosing. - Subject has known history of failure to respond to sumatriptan. - Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study. - Subject has been previously enrolled in NP101-007 - Subject is electrically sensitive or who have electrically sensitive support systems (e.g., pacemaker). ; PRIMARY OUTCOME: Pain Free at Two Hours; SECONDARY OUTCOME 1: Photophobia Free at Two Hours[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - Ventilated ICU (EU); BRIEF: This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years. ; DRUG USED: VLA43; DRUG CLASS: Vaccine; INDICATION: Pseudomonas-Specific Agents (Antibacterial); TARGET: Immune System, Pseudomonas aeruginosa; THERAPY: Monotherapy; LEAD SPONSOR: Valneva Austria GmbH; CRITERIA: Inclusion Criteria: - male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0 - written informed consent or waiver according to the national regulations - no childbearing potential or negative pregnancy test Exclusion Criteria: - Sequential Organ Failure Assessment (SOFA) < 4 on Day 0 - Patients <6 months post organ transplantation - readmission to ICU during the current total hospital stay on Day 0 - patients admitted to ICU within 2 days after surgery - patients admitted to ICU due to trauma - elective surgery until Day 28 after first vaccination ; PRIMARY OUTCOME: number of deaths until Day 28; SECONDARY OUTCOME 1: number of deaths in comparison on Day 14, 56 and 90[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - V72_28E1; BRIEF: The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72_28 study. ; DRUG USED: Bexsero; DRUG CLASS: Vaccine; INDICATION: Meningococcal Vaccines and Other Meningococcus-Specific Agents (Antibacterial); TARGET: Immune System, Neisseria meningitidis - Group B; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Vaccines; CRITERIA: Inclusion Criteria: For naïve subjects newly enrolled: 1. Healthy infants and children according to the following age groups: 1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age), 2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age). 3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age). 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. For Subjects who participated in the V72_28 study (Follow-on Subjects): 1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 3. in good health as determined by medical history, physical examination, clinical judgment of the investigator 4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1 Exclusion Criteria: For naïve subjects newly enrolled: 1. History of any serogroup B meningococcal vaccine administration; 2. Previous known or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization; 4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine; 5. Pregnancy or nursing (breastfeeding) mothers; 6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): - Receipt of any chronic immunosuppressive therapy - Receipt of any chronic immunostimulants - Immune deficiency disorder, or known HIV infection 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable). 9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 10. Subjects parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 11. Intent to participate in another clinical study during this study. 12. Family members and household members of study staff; 13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study. 14. Any significant chronic infection. 15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). For Subjects who participated in the V72_28 study (Follow-on Subjects): Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1. ; PRIMARY OUTCOME: Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains; SECONDARY OUTCOME 1: Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MISSION - 3rd/4th Line; BRIEF: The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone. ; DRUG USED: Nexavar; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: FMS-like tyrosine kinase 3 (FLT-3) , KIT/c-KIT, Platelet-derived growth factor receptor (PDGFR), Raf kinase, RET, Tyrosine Kinases, VEGF Receptor (VEGFR); THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Ability to understand and willingness to sign a written Informed Consent - Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically - Patients must have measurable or non-measurable disease - At least two but not more than three prior standard treatment regimens for NSCLC - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent - Life expectancy of at least 12 weeks - Ability to swallow oral medication - Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug: - Haemoglobin > 9.0 g/dl - Absolute neutrophil count (ANC) >1,500/mm3 - Platelet count >/= 100,000/µl - Total bilirubin </=1.5 x the upper limit of normal - Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) - Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) - Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal - Serum creatinine < 1.5 x upper limit of normal - Calculated creatinine clearance of >/= 50 mL/min Exclusion Criteria: - NSCLC patients with predominantly squamous cell carcinoma histology Excluded medical conditions: - History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0) - Uncontrolled hypertension despite two anti-hypertensive medications - History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C - History of organ allograft - Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0) - Patients with seizure disorder requiring medication - Patients with evidence or history of bleeding diathesis or coagulopathy - Patients undergoing renal dialysis - Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the first dose of the study drug - Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to the first dose of the study drug - Thrombotic or embolic venous or arterial events such as cerebrovascular accident - Pregnant or breast-feeding women. - Any condition which could affect the absorption or pharmacokinetics of the study drug - Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted. ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Progression-free Survival[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - X052173; BRIEF: The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG). ; DRUG USED: Gevokizumab; DRUG CLASS: Biologic; INDICATION: Neutrophilic Dermatoses; TARGET: IL-1 (Interleukin-1); THERAPY: Monotherapy; LEAD SPONSOR: XOMA (US) LLC; CRITERIA: Inclusion Criteria: - A clinical diagnosis of classic pyoderma gangrenosum - An active pyoderma gangrenosum ulcer - Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: - Clinical evidence of acutely infected pyoderma gangrenosum - History of allergic or anaphylactic reactions to monoclonal antibodies - History of recurrent or chronic systemic infections - Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment; SECONDARY OUTCOME 1: The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RESOLVE; BRIEF: This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma. ; DRUG USED: Imbruvica; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: Brutons Tyrosine Kinase (BTK), Interleukin-2-inducible T-cell kinase (ITK); THERAPY: Combination; LEAD SPONSOR: Pharmacyclics LLC.; CRITERIA: Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma. 2. Stage IV disease diagnosed within 6 weeks of randomization 3. Adequate hematologic function: - Absolute neutrophil count (ANC) ≥1.5 x 109/L - Platelet count ≥100 x 109/L - Hemoglobin ≥9 g/dL 4. Adequate hepatic and renal function defined as: - AST and/or ALT ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases - Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present - Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilberts syndrome or of non-hepatic origin, such as hemolysis) - Estimated Creatinine Clearance ≥30 mL/min 5. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN 6. KPS ≥70. 7. Eastern Cooperative Oncology Group (ECOG) 0-1 Exclusion Criteria: 1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma. 2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma 3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement). 4. Major surgery within 4 weeks of first dose of study drug. 5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor. ; PRIMARY OUTCOME: Progression Free Survival (PFS); SECONDARY OUTCOME 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - JAVELIN HEAD AND NECK 100; BRIEF: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer. ; DRUG USED: Bavencio; DRUG CLASS: Biologic; INDICATION: Head and Neck Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: INCLUSION CRITERIA - Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx - HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3 - No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent. - Available tumor samples for submission or willing to undergo further tumor biopsies: - Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan). - ECOG Performance Status 0 or 1 - Adequate bone marrow function - Adequate renal function - Adequate liver function - Pregnancy test (for patients of childbearing potential) negative at screening EXCLUSION CRITERIA - Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways. - Major surgery 4 weeks prior to randomization. - Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer. - Active autoimmune disease - Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. - Active infection requiring systemic therapy. - Use of immunosuppressive medication at time of randomization - Prior organ transplantation including allogenic stem-cell transplantation. - Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. - Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection - Vaccination within 4 weeks prior to randomization. - Current use of or anticipated need for treatment with other anti-cancer drugs. - Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later). ; PRIMARY OUTCOME: Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator; SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SHP465-309; BRIEF: The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years. ; DRUG USED: Mydayis; DRUG CLASS: Non-NME; INDICATION: Attention Deficit Hyperactivity Disorder (ADHD); TARGET: Dopamine, Norepinephrine (Noradrenaline); THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Participant is male or female aged 6-12 years inclusive at the time of consent. - Participants parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (as applicable) by the participant. - Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (any subtype). - Participant who is a female and of child-bearing potential must not be pregnant and agree to comply with any applicable contraceptive requirements. - Participant has an ADHD-RS-5 Child, Home Version Total Score of greater than or equal to (>=) 28 and Clinical Global Impression - Severity of Illness (CGI-S) score >=4 at baseline (Visit 2). Participant is currently not on ADHD therapy, or is not completely satisfied with their current ADHD therapy. Exclusion Criteria: - Participant is required or anticipated to take medications that have central nervous system effects or affect performance. Stable use of bronchodilator inhalers is not exclusionary. - Participant has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the participant. - Participant has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product. - Participant has failed to fully respond, based on investigator judgment, to an adequate course of amphetamine therapy. - Participant has a known family history of sudden cardiac death or ventricular arrhythmia. - Participant has a blood pressure measurement >=95th percentile for age, sex, and height at screening (Visit 1) and/or baseline (Visit 2). - Participant has a height less than or equal to (<=) 5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2). - Participant has a weight <=5th percentile for age and sex at screening (Visit 1) or baseline (Visit 2). - Participant has a known history of symptomatic cardiovascular disease, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac conditions placing them at increased vulnerability to the sympathomimetic effects of a stimulant drug. - Participant has a history of seizures (other than infantile febrile seizures). - Participant is taking any medication that is excluded per the protocol. - Participant had any clinically significant ECG or clinical laboratory abnormalities at the screening (Visit 1) or baseline visit (Visit 2). - Participant has current abnormal thyroid function, defined as abnormal thyroid-stimulating hormone and thyroxine at the screening or baseline visit. Treatment with a stable dose of thyroid medication for at least 3 months is permitted. - Participant has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder. - Participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of or currently demonstrating suicidal ideation. ; PRIMARY OUTCOME: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4; SECONDARY OUTCOME 1: Clinical Global Impression of Improvement (CGI-I) at Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - BOND; BRIEF: The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs. ; DRUG USED: CG0070; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Granulocyte Macrophage Colony-Stimulating Factor Receptor (GM-CSFR)/CD116, Immune System, Oncolytic Virus Therapy; THERAPY: Monotherapy; LEAD SPONSOR: CG Oncology, Inc.; CRITERIA: Inclusion Criteria: 1. Patients must be considered high risk, with pathologically confirmed high grade disease (HG) WHO 2004 2. Patients must have pathologically-proven unresectable, primary, secondary or concurrent carcinoma in situ disease, defined by having either Ta and/or T1 with CIS, or CIS 3. Patients must have no evidence of muscle invasive disease 4. Patient need to sign a specific informed consent acknowledging that a delay of cystectomy may lead to an increase chance of progression and/or metastasis with serious or sometimes fatal consequences. 5. Patients must have received at least two or more prior courses of intravesical therapy. BCG must have been one of the prior therapies administered. Patients can have either failed BCG induction therapy within a six month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG can consist of three weekly treatments 6. 18 years of age or older 7. Residual disease at accrual 8. Pathologically diagnosed transitional cell (urothelial) bladder cancer (further details in 10.) patients where radical cystectomy with curative intent is indicated for superficial bladder cancer that is resistant to treatment. 9. Patients must be able to enter into the study within five weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET procedures. 10. Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible. 11. No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years. 12. Eastern Cooperative Oncology Group (ECOG) performance status <2. 13. Not pregnant or lactating 14. Patients with child bearing potential must agree to use adequate contraception 15. Agree to study specific informed consent and HIPAA authorization for release of personal health information 16. Adequate baseline CBC, renal and hepatic function. Renal parameters as detailed above. Absolute lymphocyte count ≥ 1,000/μL before all doses of CG0070 17. Patient to provide a tumor specimen for determination of RB pathway status Exclusion Criteria: 1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable 2. No bladder cancer residual disease, such as patients that are rendered disease free by TURBT 3. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs. 4. Known infection with HIV, HBV or HCV. 5. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study 6. Any underlying medical condition that, in the Investigators opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or surgical resection. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study 7. Systemic treatment on any investigational clinical trial within 28 days prior to registration. 8. Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans. 9. Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry. 10. History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) 11. History of partial cystectomy in the setting of bladder cancer primary tumor. 12. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs. 13. History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 3 years at the time of registration. 14. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis) 15. Progressive viral or bacterial infection 16. All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study 17. Any underlying medical condition that, in the Investigators opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection. 18. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel ; PRIMARY OUTCOME: Complete Response Proportion (CR); SECONDARY OUTCOME 1: Progression rate to muscle invasive disease[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Children; BRIEF: Study objectives are to obtain safety, pharmacokinetic, and pharmacodynamic data on the effect of mifepristone on glucose metabolism, body weight and the growth-hormone-IGF in children with refractory Cushings disease. ; DRUG USED: Korlym; DRUG CLASS: Non-NME; INDICATION: Cushings Syndrome; TARGET: Androgen receptors, Glucocorticoid Receptor (GR), Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Corcept Therapeutics; CRITERIA: Inclusion Criteria: - Males and females 6-17 years at informed consent - Active Cushings disease as demonstrated by the following: - 24 hour Urinary Free Cortisol greater than the upper limit of normal for age on two urine collections during screening and - midnight serum cortisol >4.4 mcg/dL (mean of two determinations on a single day at 2330 and 2400 during screening) - Previous trans-sphenoidal surgery (TSS) for ACTH secreting pituitary tumor at least 3 months prior to screening - Increased body weight defined by BMI Z-score of 1.5 or above - Able to provide consent/assent - Able to swallow study drug tablets (not crushed or split) - Willing to use non-hormonal method of contraception in patients of reproductive potential - Primary health care provider in home location Exclusion Criteria: - Hypercortisolism not due to Cushings disease. - Type 1 diabetes mellitus - HbA1c ≥9.5% at Screening - Body weight <25 kg - Use of certain medications that are CYP3A substrates with narrow therapeutic ranges, such as simvastatin, lovastatin, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus during the 4 weeks prior to starting study drug. Use of these medications is also prohibited until 2 weeks after end of dosing. - Use of certain medications that are strong CYP3A inhibitors such as itraconazole, nefazodone, ritonavir, nelfinavir, indinavir, atazanavir, amprenavir, fosamprenavir, boceprevir, clarithromycin, conivaptan, lopinavir, mibefradil, posaconazole, saquinavir, telaprevir, telithromycin, and voriconazole during the 2 weeks prior to starting study drug. Use of these medications is also prohibited until 2 weeks after end of dosing. Grapefruit and grapefruit juice, as well as grapefruit-related fruits and their juice (e.g. Seville oranges, pomelos), are prohibited during this time frame. - Use of certain medications that are strong inducers of CYP3A such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. Johns wort during the 2 weeks prior to starting study drug. Use of these medications is also prohibited until 2 weeks after end of dosing. - Use of medications used to treat hypercortisolism from the duration indicated below prior to Day 1. Use of the medications is also prohibited until after the end of study 4 week follow up visit. - steroidogenesis inhibitors such as ketoconazole, metyrapone: 4 weeks - cabergoline, bromocriptine, somatostatin analogs such as octreotide, lanreotide, pasireotide long acting formulations: 8 weeks (immediate release formulations: 2 weeks) - mitotane: 8 weeks - Use of systemic glucocorticoid medications beginning 1 month prior to screening or anticipated use of these medications except for the treatment of adrenal insufficiency. Use of glucocorticoid medications is prohibited during the study until after the end of study 4 week study visit. - Inflammatory, rheumatological, proliferative or other disorder(s) that would be anticipated to worsen with glucocorticoid blockade (e.g. inflammatory bowel disease, rheumatoid arthritis, psoriasis, etc.). - Uncontrolled hypo- or hyperthyroidism. - Uncorrected hypokalemia (<3.5 mEq/L). The screening period may be used to correct hypokalemia prior to starting study drug. Use of potassium and/or mineralocorticoid antagonists is permitted during the study. - QTc ≥450 msec on Screening electrocardiogram - Unexplained vaginal bleeding in females and/or any history of endometrial pathology. - Positive pregnancy test in females. ; PRIMARY OUTCOME: Adverse events; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACN04; BRIEF: The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris ; DRUG USED: Olumacostat Glasaretil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acne; TARGET: Acetyl-CoA carboxylase (ACAC, ACC); THERAPY: Monotherapy; LEAD SPONSOR: Dermira, Inc.; CRITERIA: Inclusion Criteria: - Signed informed consent and, for subjects under legal adult age, signed assent - Age ≥ 9 years - Clinical diagnosis of facial acne vulgaris defined as: - At least 20 inflammatory lesions, and - At least 20 non-inflammatory lesions, and - Investigator Global Assessment of 3 or greater Exclusion Criteria: - Active cystic acne or acne conglobata, acne fulminans, and secondary acne - Two or more active nodulocystic lesions on the face - Clinically significant abnormal laboratory or ECG result - Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit - Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline - Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline - Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills). - Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline. - Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline - Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks ; PRIMARY OUTCOME: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SWOG-S0421; BRIEF: RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy. ; DRUG USED: Atrasentan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Endothelin Receptor Type A (EDNRA); THERAPY: Combination; LEAD SPONSOR: SWOG Cancer Research Network; CRITERIA: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Stage IV disease (any T, any N, M1b) - Evidence of bone metastases by bone scan or MRI - Measurable or nonmeasurable disease - Soft tissue disease that has been irradiated within the past 2 months is not assessable as measurable disease - Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria: - Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart - PSA ≥ 5 ng/mL NOTE: *If the third confirmatory PSA level is < the second level, the patient is considered eligible provided a fourth PSA level is > the second level - Progression of measurable disease - Progression of nonmeasurable disease by bone scan - Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration - Patients who have undergone medical castration must continue LHRH agonist or antagonist therapy during study treatment - Must have completed 12 courses of blinding protocol treatment (atrasentan/placebo) AND stopped docetaxel for any reason (including completion of 12 courses) other than progressive disease - No symptomatic pleural effusion - No third space fluid accumulation (e.g., ascites) - No prior or concurrent brain metastases - Patients with clinical evidence of brain metastases must have a negative brain CT scan or MRI within the past 8 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-3* NOTE: For a performance status of 3, the cause must be due to pain secondary to bone metastases Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Fertile patients must use effective contraception - Able to take oral medication without crushing, dissolving, or chewing tablets - No major infection - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission - No symptomatic sensory neuropathy ≥ grade 2 - No history of hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No other significant, active medical illness that would preclude study treatment or survival PRIOR CONCURRENT THERAPY: Biologic therapy - No more than 1 prior systemic vaccine or biologic therapy - At least 4 weeks since prior vaccine or biologic therapy and recovered - No concurrent biological response modifiers - No concurrent prophylactic colony-stimulating factors Chemotherapy - More than 2 years since prior adjuvant therapy with a single non-taxane-containing cytotoxic regimen - No prior cytotoxic chemotherapy for metastatic prostate cancer - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 6 weeks since prior bicalutamide or nilutamide AND has subsequent disease progression - At least 4 weeks since prior flutamide or ketoconazole AND has subsequent disease progression - Prior or concurrent megestrol for treatment of hot flashes allowed - No other concurrent corticosteroid or hormonal therapy unless continuing luteinizing hormone-releasing hormone treatment and/or bisphosphonate therapy Radiotherapy - See Disease Characteristics - Prior samarium allowed - At least 3 weeks since prior radiotherapy and recovered - No prior radiotherapy to ≥ 30% of the bone marrow - No prior strontium - No concurrent radiotherapy Surgery - See Disease Characteristics - At least 3 weeks since prior surgery and recovered Other - More than 4 weeks since prior investigational drugs - Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression - No initiation of bisphosphonates during the first 12 weeks of study treatment - No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. Johns wort]) - Concurrent daily vitamins and calcium supplements allowed - At least 14 days since prior and no concurrent administration of any of the following: - Antibiotics (e.g., clarithromycin, erythromycin, troleandomycin, rifampin, rifabutin, and rifapentine) - Antifungals (e.g., itraconazole, ketoconazole, fluconazole [doses > 200 mg/day], and voriconazole) - Antidepressants (e.g., nefazodone and fluvoxamine) - Calcium channel blockers (e.g., verapamil, diltiazem) - Miscellaneous (e.g., amiodarone [no use within 6 months prior to study entry], grapefruit juice, bitter orange, or modafinil) - Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, and oxcarbazepine) - Antibiotics (e.g., rifampin, rifabutin, and rifapentine) ; PRIMARY OUTCOME: Compare Survival Between a Control or Standard Therapy Arm of Docetaxel + Placebo + Prednisone With Docetaxel + Atrasentan + Prednisone in Patients With Hormone Refractory Prostate Cancer.; SECONDARY OUTCOME 1: Compare Pain Progression Between the Two Study Arms.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AMAGINE-3 (vs. Ustekinumab); BRIEF: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab. ; DRUG USED: Siliq; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-17 Receptor (IL-17R); THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Subject has had stable moderate to severe plaque psoriasis for at least 6 months - Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline Exclusion Criteria: - Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations - Subject has known history of Crohns disease - Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol - Subject has not stopped using certain psoriasis therapies as defined in the study protocol - Subject has previously used ustekinumab or any anti-IL-17 biologic therapy - Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study - Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile ; PRIMARY OUTCOME: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1001; BRIEF: This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up. ; DRUG USED: MSRD-100; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Merz North America, Inc.; CRITERIA: Key Inclusion Criteria: 1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit. 2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis. 3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline. 4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants). 5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected. Key Exclusion Criteria: 1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. 2. Concurrent conditions and history of other diseases. 3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study. 4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease. ; PRIMARY OUTCOME: Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group; SECONDARY OUTCOME 1: Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Ivacaftor (Pediatric); BRIEF: This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation. ; DRUG USED: Symdeko; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cystic Fibrosis (CF); TARGET: CF transmembrane conductance regulator (CFTR); THERAPY: Combination; LEAD SPONSOR: Vertex Pharmaceuticals Incorporated; CRITERIA: Inclusion Criteria: - Subjects who weigh ≥15 kg without shoes at the Screening Visit. - All genotypes as specified by the study protocol are eligible in Part A. - The following genotypes are eligible in Part B: - homozygous for the F508del CFTR mutation - heterozygous for the F508del CFTR mutation and with a second allele with a CFTR mutation predicted to have residual function. - heterozygous for the F508del CFTR mutation and with a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive - Subjects with a confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L or chronic sinopulmonary and/or gastrointestinal disease consistent with a diagnosis of CF. Subjects who are homozygous for the F508del-CFTR mutation must have a sweat chloride value ≥60 mmol/L. - Subjects with ppFEV1 of ≥40 percentage points at the Screening Visit - Subjects with stable CF disease as deemed by the investigator at the Screening Visit. - Subjects who are willing to remain on their stable CF medication regimen through Day 14 (Part A) or through Week 24 (Part B) or, if applicable, through the Safety Follow up Visit. - Subjects who are able to swallow tablets. - Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Day 1 Visit before receiving the first dose of study drug. - Subjects of childbearing potential who are sexually active must meet the contraception requirements Exclusion Criteria: - History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. - Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject. - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1 - Colonization with organisms associated with a more rapid decline in pulmonary status. - A standard 12 lead ECG demonstrating QTc >450 msec at the Screening Visit. - History of solid organ or hematological transplantation at the Screening Visit. - Ongoing or prior participation in an investigational drug study or use of commercially available CFTR modulator (except physician-prescribed Kalydeco for approved indications) within 30 days of screening. - Use of restricted medication or food within a specified duration before the Screening Visit or first dose of study drug and/or unwillingness to maintain the restrictions. - History or evidence of cataract, lens opacity, Y-suture, or lamellar rings determined to be clinically significant by the ophthalmologist during the ophthalmologic examination at the Screening Visit. - Pregnant and nursing females. ; PRIMARY OUTCOME: Part A: Maximum Observed Concentration (Cmax) of TEZ and IVA; SECONDARY OUTCOME 1: Part A: Cmax of TEZ Metabolites (M1-TEZ, M2-TEZ) and IVA Metabolites (M1-IVA, M6-IVA)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - OPTIMOX 3; BRIEF: PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Colorectal Cancer (CRC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: GERCOR - Multidisciplinary Oncology Cooperative Group; CRITERIA: MAIN ELIGIBILITY CRITERIA - Histologically proven metastatic adenocarcinoma of colon or rectum - Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection) - Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan - No previous therapy for metastatic disease - No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated - No exclusive bone metastasis - ECOG performance status 0-2 - WBC ≥ 1,500/mm^3 - Platelets ≥ 100,000/mm^3 - Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) - Proteinuria < 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection - Bilirubin < 1.5 times ULN - Alkaline phosphatase < 3 times ULN - No peripheral sensory neuropathy - Negative pregnancy test - Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization) - No peripheral neuropathy ≥ grade 1 - No clinically significant (i.e. active) cardiovascular disease - No evidence of bleeding diathesis or coagulopathy - No serious, non-healing wound, ulcer, or bone fracture - No significant ophthalmologic abnormality - More than 28 days since prior major surgical procedure or open biopsy ; PRIMARY OUTCOME: Progression-free survival during maintenance therapy; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOZ-CL06; BRIEF: Phase 3, international, multicenter, open-label 12 month safety study. ; DRUG USED: Tozadenant; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Adenosine A2a Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Biotie Therapies Inc.; CRITERIA: Inclusion Criteria: - Patient understands study requirements and has given his/her written informed consent on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved consent form. - Parkinsons disease diagnosis consistent with UK Parkinsons Disease Society Brain Bank Diagnostic criteria - Minimum of 3 years since diagnosis. - Meet Hoehn and Yahr PD stage - Good response to levodopa - Stable regimen of anti-PD medications - Patients must have been taking a levodopa-containing anti-PD medication continuously for at least the previous 12 months - Patient has documented a minimum amount of Off time. - If of childbearing potential (male and female) must use an acceptable method of contraception Exclusion Criteria: - Previous tozadenant study participation - Current or recent participation in another study. - Secondary or atypical parkinsonism - Neurosurgical intervention for PD (except DBS if electrode placement has been performed over 12 months prior to screening) - Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa® - Treatment with excluded medications - Untreated or uncontrolled hyperthyroidism or hypothyroidism - Clinically significant out-of-range laboratory - MMSE out of range - Current episode of major depression (stable treatment for depression is permitted). - Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) - Women lactating or pregnant - Hypersensitivity to any components of tozadenant or excipients - Abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study - History of hepatitis or cholangitis ; PRIMARY OUTCOME: To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.; SECONDARY OUTCOME 1: To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Gatifloxacin ; BRIEF: The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1). ; DRUG USED: Besivance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ophthalmia Neonatorum (Neonatal Conjunctivitis) (Ophthalmology); TARGET: DNA synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Bausch & Lomb Incorporated; CRITERIA: Inclusion Criteria: - Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye. Exclusion Criteria: - Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye. - Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible. - Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible. - Subjects with systemic disease/disorder specified in the protocol as ineligible. - Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components. - Subjects who have a condition or are in a situation which in the investigators opinion may impact their safety or would negatively affect the conduct or outcome of the study. ; PRIMARY OUTCOME: Clinical Resolution; SECONDARY OUTCOME 1: Clinical Resolution[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Fluarix or GSK2604409A - Children Safety/Efficacy; BRIEF: This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals investigational vaccine GSK2321138A in children aged 6 to 35 months. ; DRUG USED: Fluarix Quadrivalent; DRUG CLASS: Vaccine; INDICATION: Seasonal Influenza Vaccines; TARGET: Immune System, Influenza Virus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. - For non US countries: - - Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination. For US : - Children, male or female, aged between 3 and 17 years at the time of the first study vaccination - Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable. - Subjects in stable health as determined by investigators clinical examination and assessment of subjects medical history. - Written informed assent obtained from the subject if/as required by local regulations. - Female subjects of non-childbearing potential may be enrolled in the study. - Female subjects of childbearing potential may be enrolled in the study, if the subject: - - has practiced adequate contraception for 30 days prior to vaccination, - - and has a negative urine pregnancy test on the day of vaccination, - - and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series Exclusion Criteria: - Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted. - Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. - Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. - Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. - Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. - Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. - History of seizures or progressive neurological disease. - History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. - Concurrently participating in another clinical study, at any time during the study period in which the subject has been or will be exposed to an investigational or a non-investigational product . - History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines - Acute disease and/or fever at the time of enrolment - Ongoing aspirin therapy - Pregnant or lactating female - Female planning to become pregnant or planning to discontinue contraceptive precautions. - Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study - Child in Care. ; PRIMARY OUTCOME: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.; SECONDARY OUTCOME 1: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - INSPIRE (Nonsquamous); BRIEF: The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone. ; DRUG USED: Portrazza; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer - Has Stage IV disease at the time of study entry - Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (participants with only truly nonmeasurable disease are not eligible) - Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia) - Has an Eastern Cooperative Oncology Group performance status score of 0-2 - Has adequate hepatic function - Has adequate renal function - Has adequate hematologic function - If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method). If male, the participants surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period - Female participants of childbearing potential must have a negative serum Exclusion Criteria: - Has squamous non small cell lung cancer - Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the Epidermal Growth Factor Hormone (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor - Received previous chemotherapy for advanced NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization) - Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization - Undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) - Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible - Has superior vena cava syndrome contraindicating hydration - Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure - Has experienced myocardial infarction within 6 months prior to randomization - Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus - Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder, potentially precluding protocol compliance - Has Grade ≥ 2 peripheral neuropathy - Has significant third space fluid retention, requiring repeated drainage - Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the participants ability to complete the study or sign an informed consent document The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of IMC-11F8, or any other contraindication to one of the administered treatments - Is pregnant or breastfeeding - Has a known history of drug abuse - Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years ; PRIMARY OUTCOME: Overall Survival Time (OS); SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase II/III - TESLA (hoFH); BRIEF: A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH). ; DRUG USED: Repatha; DRUG CLASS: Biologic; INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Males and females ≥ 12 to ≤ 80 years of age - Diagnosis of homozygous familial hypercholesterolemia - Stable lipid-lowering therapies for at least 4 weeks - LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L) - Triglyceride ≤ 400 mg/dL (4.5 mmol/L) - Bodyweight of ≥ 40 kg at screening. Exclusion Criteria: - LDL or plasma apheresis within 8 weeks prior to randomization - New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30% - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization - Planned cardiac surgery or revascularization - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension ; PRIMARY OUTCOME: Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12; SECONDARY OUTCOME 1: Part A: Change From Baseline in LDL-C at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - POWER2; BRIEF: The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle. ; DRUG USED: Enobosarm; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cachexia / Weight Loss; TARGET: Androgen receptors; THERAPY: Monotherapy; LEAD SPONSOR: GTx; CRITERIA: Inclusion Criteria: - give voluntary, signed informed consent in accordance with institutional policies - be non-obese as defined as body mass index (BMI)< or = 32 and weight < 300 pounds (< 136 kg) - have been diagnosed with Stage III or IV NSCLC - be prior to first line chemotherapy - planned first line chemotherapy regimen is platinum plus gemcitabine only or platinum plus vinorelbine only or platinum plus pemetrexed only - if surgery is part of the cancer treatment, screening for this study should be conducted at least 4 weeks (28 days) after surgery - life expectancy of > 6 months - ECOG score < or = 1 - serum creatinine < or = 2.0 mg/dL - MALES - age > or = 30 years - - FEMALES - age >or=30 years and clinically confirmed as postmenopausal.Subjects must have undergone the onset of spontaneous or surgical menopause prior to the start of this study. Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for >or=6 months but <12 months they must have a serum FSH concentration of >or=50 mIU/mL and an estradiol concentration of <or=25 pg/mL. Surgical menopause is defined as bilateral oophorectomy. - MALES - subjects must agree to use a double barrier method of contraception during the study and for 3 months after study completion. This may include the following: condom + spermicide or condom + oral hormonal contraception - MALES - have a serum PSA of < or = 4.0 ng/mL or a negative prostate biopsy (no prostate cancer) within 6 months of evaluation Exclusion Criteria: - Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol - Have ALT/SGOT or AST/SGPT above 1.5 times the upper limit of normal (ULN) without evidence of liver metastases and above 5 times the ULN in subjects with evidence of liver metastases - have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline - have biologic agents or kinase inhibitors as part of their first line chemotherapy regimen including, but not limited to bevacizumab (Avastin), gefitinib (Nexavar) and erlotinib (Tarceva) - cardiovascular: uncontrolled hypertension, congestive heart failure or angina - Pulmonary: Stage 4 chronic obstructive pulmonary disease (COPD) - positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject was diagnosed > 10 years prior to enrollment and no evidence of active liver disease - currently taking testosterone, oxandrolone (Oxandrin), testosterone-like agents (such as dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds including herbals), or antiandrogens; previous therapy with testosterone and testosterone-like agents is acceptable with a 30 day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the medical monitor for this study to determine appropriate washout period) - currently taking megestrol acetate (Megace), dronabinol (Marinol), medical marijuana (medical cannabis) or any prescription medication intended to increase appetite or treat unintentional weight loss - have a baseline stair climb time >or=30 seconds (mean of two stair climbs) - have active cancer, other than NSCLC or non-melanoma carcinoma of the skin, within the previous two years. ; PRIMARY OUTCOME: Physical Function; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III; BRIEF: The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan). ; DRUG USED: Ultresa; DRUG CLASS: Biologic; INDICATION: Exocrine Pancreatic Insufficiency; TARGET: Protein, fat, and/or carbohydrate absorption; THERAPY: Monotherapy; LEAD SPONSOR: Forest Laboratories; CRITERIA: Inclusion Criteria: - Participants or their legally authorized representative must understand the nature of the study and sign an informed consent or assent form along with a parental form - Participants must have a confirmed diagnosis of CF based on 1 or more clinical features consistent with the CF phenotype, and one of the following: - A genotype with 2 identifiable mutations consistent with CF - A sweat chloride test greater than 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis - Participants must have PI as demonstrated by a fecal elastase-1 (FE-1) concentration less than 100 microgram per gram (mcg/g) of stools (ScheBo test) and must require pancreatic enzyme supplementation - Participants must be clinically stable as evidenced by medical and medication history, baseline physical examination including vital signs and laboratory analyses - Participants must be 7 years and older - Participants must have an adequate nutritional status based on the following body mass index (BMI): - Participants 7 to 20 years old must have a BMI greater than or equal to fifth percentile - Female participants greater than 20 years old must have a BMI greater than or equal to 16 - Male participants greater 20 years old must have a BMI greater than or equal to 16.5 - Participants must be on an optimal clinical dose of pancreatic enzymes (Ultrase® MT18 or MT20 or other pancreatic enzymes preparations including Ultrase® MT12) prior to entry in the study, and must tolerate this medication in the opinion of the investigator - Participants must be able to swallow capsules and must be able to eat a high fat diet calculated as 2 gram (± 15%) fat per kilogram body weight per day - Participants must be, in the opinion of the investigator, able and willing to complete this study - Female participants must be premenarcheal, surgically sterile or postmenopausal for at least 12 consecutive months. Otherwise, the women of childbearing potential (WOCBP) must not be pregnant and must have practiced an acceptable method of contraception for at least one month prior to the study entry Exclusion Criteria: - Participants with a known contraindication, sensitivity or hypersensitivity to Ultrase or any porcine protein - Participants with a known allergy to the food drug and cosmetic (FD&C) Blue No. 2 dye indicator (stool marker) - Participants not willing to stop the prohibited medications or products at study entry and throughout the study - Participants who are using narcotics - Participants who are using bowel stimulants and/or laxatives on a regular basis - Participants with acute pancreatitis or acute exacerbation of chronic pancreatic disease - Participants with an acute pulmonary infection - Participants with a history of bowel resection - Participants suffering from any dysmotility disorders - Participants with chronic or severe abdominal pain - Participants receiving enteral tube feeding and not willing to stop during the course of the study - Participants known to have a significant medical disease that would compromise their welfare or confound the study results - Participants with a history of or a current diagnosis of clinically significant portal hypertension - Participants who have a condition known to increase fecal fat loss including celiacs disease, biliary cancer, biliary stricture, cholelithiasis, Crohns disease, pancreas cancer, radiation enteritis, tropical sprue, Whipples disease, lactose intolerance, pseudomembranous colitis - Participants with a current diagnosis or a history of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months; or, participants who had 2 or more episodes of DIOS in the past year - Participants with poorly controlled diabetes to the investigators opinion - Female participants who are pregnant or lactating - Participants who received an investigational drug within 30 days prior to entry into the study ; PRIMARY OUTCOME: Percent Coefficient of Fat Absorption (CFA); SECONDARY OUTCOME 1: Percent Coefficient of Nitrogen Absorption (CNA)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - vs. Vancocin; BRIEF: The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD). ; DRUG USED: Xifaxan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Clostridium difficile-Associated Diarrhea/Infection (CDAD/CDI); TARGET: Gram-Negative Bacteria, RNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Bausch Health Americas, Inc.; CRITERIA: Inclusion Criteria: - Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort. - Subject has a positive Clostridium difficile stool toxin assay at screening Exclusion Criteria: - Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months. - Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) - Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization. ; PRIMARY OUTCOME: Proportion of Participants Achieving Clinical Success, Where Clinical Success is Defined as Resolution or Improvement of Baseline Signs and Symptoms i.e., Abdominal Pain, Fever, Diarrhea.; SECONDARY OUTCOME 1: Proportion of Participants Recurrence-free of Clostridium Difficile-associated Diarrhea (CDAD), After Achieving Clinical Success[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RELAX-ASIA; BRIEF: The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients. ; DRUG USED: Reasanz; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Decompensated Heart Failure - Reduced Ejection Fraction (Acute HFrEF); TARGET: Relaxin Family Peptide Receptors 1-4 (RXFP1-4); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female ≥ 18 years of age, with body weight ≤160 kg - Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening: - Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization - Pulmonary congestion on chest radiograph - Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL - Systolic BP ≥125 mmHg at the start and at the end of screening - Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic - Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode - Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines). Exclusion Criteria: - Dyspnea primarily due to non-cardiac causes - Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period). - Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment *Patients with systolic blood pressure >180 mmHg at the end of screening - AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute - Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period). *Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year ; PRIMARY OUTCOME: Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.; SECONDARY OUTCOME 1: Time to WHF[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ENABLE 2 (Hep C); BRIEF: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). ; DRUG USED: Promacta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thrombocytopenia; TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned Exclusion criteria: Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin Subjects with a history of any one of the following: Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional: - Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago - Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag. Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit ; PRIMARY OUTCOME: Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase; SECONDARY OUTCOME 1: Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - reSURFACE 1; BRIEF: This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis. ; DRUG USED: Ilumya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Sun Pharmaceutical Industries Limited; CRITERIA: Inclusion Criteria: - Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to study enrollment - A candidate for phototherapy or systemic therapy - For the extension study: must have completed Part 3 of the base study - For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study - For the extension study: must have received active tildrakizumab (MK-3222) treatment within 12 weeks prior to the end of Part 3 of the base study - Premenopausal female participants must agree to abstain from heterosexual activity or use a medically accepted method of contraception or use appropriate effective contraception as per local regulations or guidelines - If enrolled at a Japanese site, participants with psoriatic arthritis using non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4 weeks prior to the first dose of study drug and must not be expected to require an increase in dose over the course of the study Exclusion Criteria: - Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis - Current or history of severe psoriatic arthritis and is well-controlled on current treatment - Women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding - Expected to require topical treatment, phototherapy, or systemic treatment during the trial - Presence of any infection - History of recurrent infection requiring treatment with systemic antibiotics within 2 weeks of screening - Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors including P40, p19, and IL-17 antagonists - Evidence of active or untreated latent tuberculosis (TB) - Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) - At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) - At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA - For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding - For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities - For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study - At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the screening visit. ; PRIMARY OUTCOME: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study); SECONDARY OUTCOME 1: Percentage of Participants With PASI-90 Response At Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CLEAR Harmony OLE; BRIEF: The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy. ; DRUG USED: Nexletol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Dyslipidemia / Hypercholesterolemia; TARGET: ATP citrate lyase (ACL); THERAPY: Monotherapy; LEAD SPONSOR: Esperion Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Successfully completed CLEAR Harmony (1002-040) parent study Exclusion Criteria: - Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study. - Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy. ; PRIMARY OUTCOME: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); SECONDARY OUTCOME 1: Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GOYA (BO21005); BRIEF: This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks. ; DRUG USED: Gazyva; DRUG CLASS: Biologic; INDICATION: Diffuse Large B-Cell Lymphoma (DLBCL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Previously untreated CD20-positive DLBCL - At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in its largest dimension on the computed tomography [CT] scan) - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Adequate hematological function - Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (>/=) 7.5 cm) - Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram Exclusion Criteria: - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab - Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines - Participants with transformed lymphoma and participants with follicular lymphoma IIIB - Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation - Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody - Prior use of any monoclonal antibody within 3 months of the start of Cycle 1 - Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control - Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL ; PRIMARY OUTCOME: Median Time to Progression-Free Survival (PFS), Investigator-Assessed; SECONDARY OUTCOME 1: Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - A304 (Long-Term Safety); BRIEF: The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia. ; DRUG USED: Lybalvi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 4 (D4) Receptor, Histamine H1 Receptor (HRH1), Opioid receptors, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Alkermes, Inc.; CRITERIA: Inclusion Criteria: - Agrees to use an acceptable method of contraception for the duration of the study - Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days - Additional criteria may apply Exclusion Criteria: - Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine - Subject has a positive test for drugs of abuse at study entry - Subject is pregnant, planning to become pregnant, or breastfeeding during the study - Additional criteria may apply ; PRIMARY OUTCOME: Number of Subjects With Adverse Events; SECONDARY OUTCOME 1: [/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TURANDOT (CECOG; HER2-); BRIEF: First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Central European Cooperative Oncology Group; CRITERIA: Inclusion Criteria 1. Written informed consent obtained prior to any study-specific procedure. 2. Age ≥18 years. 3. Able to comply with the protocol. 4. Histologically or cytologically confirmed, HER2-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiotherapy or resection with curative intent. 5. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2. 6. Life expectancy more than 12 weeks. 7. Prior (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was more than 6 months prior to randomization. However, if (neo)adjuvant chemotherapy was: - Taxane-based, patients are eligible only if they received their last taxane more than 12 months prior to randomization. - Anthracycline-based, the maximum cumulative dose of prior anthracycline therapy must not exceed 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin. 8. Prior adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that last fraction of radiotherapy occurred at least 6 months prior to randomization. Radiotherapy administered solely for the relief of metastatic bone pain is allowed prior to study entry, providing that: - no more than 30% of marrow-bearing bone was irradiated - the last fraction of radiotherapy was administered ≥ 3 weeks prior to randomization. 9. Adequate left ventricular ejection function (LVEF) at baseline, defined as LVEF ≥ 50% by either echocardiogram or multigated acquisition scan (MUGA). 10. Adequate hematological function - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Hemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level). 11. Adequate liver function - Total bilirubin ≤ 1.25 x upper normal limit (ULN) - Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 x ULN in patients without liver metastases; < 5.0 x ULN in patients with liver metastases. 12. Adequate renal function - Serum creatinine ≤ 1.25 x ULN or calculated creatinine clearance ≥ 50 mL/min. - Urine dipstick for proteinuria < +2. Patients discovered to have ≥ +2 proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours 13. The use of full-dose oral or parenteral anticoagulants is permitted as long as the patient has been on a stable level of anticoagulation for at least two weeks at the time of randomization - Patients on heparin treatment should have a baseline activated partial thromboplastin time (aPTT) between 1.5 - 2.5 times ULN or patients value before starting heparin treatment - Patients on low molecular weight heparins (LMWH) should receive daily dose of 1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent anticoagulant, according to package insert - Patients on coumarin derivatives should have an international normalized ratio (INR) between 2.0 and 3.0 assessed at baseline in two consecutive measurements 1-4 days apart - Patients not receiving anticoagulant medication must have an INR ≤ 1.5 and aPTT ≤ 1.5 times ULN within 7 days prior to randomization Exclusion Criteria 1. Previous chemotherapy for metastatic or locally recurrent breast cancer. 2. Concomitant hormonal therapy for locally recurrent or metastatic disease. Note: previous hormonal therapy is allowed for adjuvant, locally recurrent or metastatic breast cancer, but must have been discontinued at least 3 weeks prior to randomization. 3. Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain and with the precautions mentioned above). 4. Other primary tumors within the last 5 years, except for adequately controlled limited basal cell carcinoma of the skin, or carcinoma in situ of the cervix. 5. Pre-existing peripheral neuropathy NCI CTCAE grade > 2 at randomization. 6. Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases (even if previously treated). If suspected, the patient should be scanned by CT or magnetic resonance imaging (MRI) within 28 days prior to randomization to rule out spinal / CNS metastases. 7. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). 8. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment. 9. Minor surgical procedures, including insertion of an indwelling catheter, within 24 hours prior to randomization. 10. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day). 11. Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids). 12. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. 13. Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg). 14. Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication. 15. Non-healing wound, active peptic ulcer or bone fracture. 16. History of abdominal fistula, or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of randomization. 17. Active infection requiring i.v. antibiotics at randomization. 18. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. 19. Women of childbearing potential (< 2 years after the last menstruation) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of study drug. 20. Men who do not agree to use effective contraception during the study and for a period of 6 months following the last administration of study drug. 21. Current or recent (within 28 days of randomization) treatment with another investigational drug or participation in another investigational study 22. Clinically significant malabsorption syndrome or inability to take oral medication. 23. Psychiatric disability judged by the Investigator to be interfering with compliance for oral drug intake. 24. Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine. 25. Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications. 26. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency or prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) 27. Known hypersensitivity to any of the study drugs (including 5-FU) or excipients. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. History of hypersensitivity reactions with drugs formulated in Cremophor® EL (polyoxyethylated castor oil), or previous therapy with bevacizumab. ; PRIMARY OUTCOME: Overall Survival (PP Population); SECONDARY OUTCOME 1: Observation Time (ITT Population)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MIVI-TRUST 007 (EU/US); BRIEF: This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks. ; DRUG USED: Jetrea; DRUG CLASS: Biologic; INDICATION: Vitreomacular Adhesion (Ophthalmology); TARGET: Fibrin (Coagulation Factor Ia) ; THERAPY: Monotherapy; LEAD SPONSOR: ThromboGenics; CRITERIA: Inclusion Criteria: - Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint) Exclusion Criteria: - Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye - Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye - Subjects with macular hole diameter > 400 µm in the study eye - Aphakia in the study eye - High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion). ; PRIMARY OUTCOME: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28; SECONDARY OUTCOME 1: Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - NATRUL-3; BRIEF: A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo. ; DRUG USED: HMPL-004; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ulcerative Colitis (UC); TARGET: IL-1 (Interleukin-1), IL-6 (Interleukin-6), NF-Kappa B (nuclear factor kappa-light-chain-enhancer of activated B cells) , Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Hutchison Medipharma Limited; CRITERIA: Inclusion Criteria: - Patients must be currently receiving mesalamine ≥ 2.4 g/day (or the equivalent) for at least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior to entering the screening phase of the study to ensure a stable dose is established at least 2 weeks prior to the endoscopic procedures. - Have active mild to moderate ulcerative colitis defined by a modified Mayo Score 4-10, and with endoscopy score activity of 2-3 points confirmed by centrally read colonoscopy (within 2 weeks prior to randomization. - Minimum modified Mayo endoscopy score of >2 at the time of study colonoscopy. - Age ≥ 18 years. - Patients have no prior exposure to HMPL-004. - Have adequate renal, hepatic and bone marrow function (see exclusion criteria). - All fertile male and female subjects must agree to use one of the following types of contraception: abstinence, intrauterine device, implantable progesterone device, and progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one and continues for the duration of the trial, contraceptive patch, or condom with spermicide. - Show evidence of a personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial Exclusion Criteria: 1. Subjects with intolerance or adverse reactions to mesalamine (or equivalent medications). 2. Diagnosed with Crohns Disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope, which would be suspicious for Crohns disease, or with a diagnosis of indeterminate colitis. Subjects with Primary Sclerosing Cholangitis (PSC) are excluded.. 3. Severe disease with an ulcerative colitis modified Mayo Clinic score above 10 points at baseline. 4. Positive stool test for pathogens for sample taken within the previous 2 weeks prior to study entry. 5. Active Clostridium difficile (C. diff) infection. 6. Use of Inflammatory Bowel Disease related herbal supplements including but not limited to supplements containing andrographis and probiotics two weeks prior to study entry or during the study. 7. Toxic megacolon or toxic colitis. 8. Probable requirement for intestinal surgery within 12 weeks after the start of study medication. 9. Receiving oral or rectal steroids within 1 month prior to study entry. 10. Receiving rectal mesalamine within one week prior to study entry. 11. Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy at the time of screening or within the preceding 6 weeks. 12. Receiving anti-tumor necrosis factor-α agents such as infliximab, adalimumab, golimumab, or certolizumab pegol at the time of screening or within the preceding 8 weeks. 13. Receiving other investigational drugs or biologics within 1 month or five half lives. 14. Receiving antibiotics within 2 weeks of study entry. 15. Hemoglobin concentration < 9 g/dl. 16. White blood cell count (WBC) below 3,000/cmm, or platelets below 100,000/cmm. 17. Serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphatase >2.5 upper limit of normal. 18. Serum creatinine >1.5 times upper limit of normal. 19. Significant concurrent medical diseases including: active peptic ulcer disease; uncompensated congestive heart disease; myocardial infarction within the last 12 months; unstable angina pectoris; uncontrolled hypertension; pulmonary disease requiring oxygen therapy. 20. Chronic Hepatitis B or any history of Hepatitis C. 21. Previous colonic surgery except for simple polypectomy or appendectomy. . 22. History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, and in situ cervical cancer. 23. Patients with a history of or concurrent colonic dysplasia associated with UC, except those with completely excised sporadic colorectal polyps. 24. Women who are pregnant or breast feeding. 25. Patients known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder. 26. Patients with a history of tuberculosis or exposure to tuberculosis, or a history of a chest X-ray suspicious for tuberculosis, unless confirmed to be purified protein derivative (PPD) skin test negative or latent tuberculosis that has been previously treated. 27. History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure. 28. Known allergy to plants of the Acanthaceae family. 29. Unwillingness to participate in the study. 30. Any underlying medical condition that in the Investigators opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events. ; PRIMARY OUTCOME: Percentage of Subjects With a Clinical Remission at Week 8; SECONDARY OUTCOME 1: The Proportion of Subjects With Clinical Response at Week 8[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 4060 (Japan); BRIEF: This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes. ; DRUG USED: Ryzodeg 70/30; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone. - Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit) - HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or below 35 kg/m^2 Exclusion Criteria: - Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subjects safety or compliance with the protocol - Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit) - Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation ; PRIMARY OUTCOME: Change From Baseline in HbA1c (%) Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Fasting Plasma Glucose (FPG)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - COSMOS; BRIEF: The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Psoriatic Arthritis (PA); TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Pharmaceutica N.V., Belgium; CRITERIA: Inclusion Criteria: - Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening - Have active PsA as defined by at least 3 swollen joints and at least 3 tender joints at screening and at baseline - Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis - Have an inadequate response to anti-TNF alpha therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNF alpha agents and either of the following: a) Lack of benefit of an anti-TNF alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilars) and/or at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilars). Documented lack of benefit may include inadequate improvement in joint counts, skin response, physical function, or disease activity, b) Intolerance to an anti-TNF alpha therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars, if available) - Be willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications and acupuncture within 2 weeks before the first study intervention administration and through Week 48 Exclusion Criteria: - Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease - Has ever received more than 2 different anti-TNF alpha agents - Has previously received any biologic treatment (other than anti-TNF Alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment - Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX 509), or any other a Janus kinase (JAK) inhibitor - Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention ; PRIMARY OUTCOME: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24; SECONDARY OUTCOME 1: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - GS-US-342-3921 (Japan); BRIEF: The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen. ; DRUG USED: Epclusa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Genotype 1 or 2 HCV infection - Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy - Previously treated with a DAA-containing regimen of at least 4 week duration Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIb - RUBY-I (Ombitasvir/ABT-450/Ritonavir/Dasabuvir +/- RBV; GT1 Naive); BRIEF: This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis or peritoneal dialysis. ; DRUG USED: Exviera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening. 2. Screening laboratory result indicating HCV genotype 1 infection. 3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment). 4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab). 3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment; SECONDARY OUTCOME 1: Percentage of Participants With On-treatment Virologic Failure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Abdominoplasty Surgery (Soft Tissue); BRIEF: The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery. ; DRUG USED: Anjeso; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3); THERAPY: Monotherapy; LEAD SPONSOR: Baudax Bio; CRITERIA: Inclusion Criteria: - Voluntarily provide written informed consent. - Male or female between 18 and 75 years of age, inclusive. - Be scheduled to undergo elective abdominoplasty surgery without collateral procedures. - Be American Society of Anesthesiology (ASA) physical class 1 or 2. - Female subject are eligible only if all the following apply: - Not pregnant; - Not lactating; - Not planning to become pregnant during the study; - Commit to the use of an acceptable form of birth control for the duration of the study. - Have a body mass index ≤35 kg/m2 - Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program. Exclusion Criteria: - Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study. - Have a clinically significant abnormal clinical laboratory test value. - Have history of or positive test results for HIV, or hepatitis B or C. - Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study. - Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months - Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants. - Have active or recent (within 6 months) gastrointestinal ulceration or bleeding. - Have a known bleeding disorder or be taking agents affecting coagulation. - Have another painful physical condition that may confound the assessments of post operative pain. - Have evidence of a clinically significant 12 lead ECG abnormality. - Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse. - Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse. - Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery. - Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigators opinion may exert significant analgesic properties or act synergistically with N1539. - Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing with study medication. - Have utilized corticosteroids, either systemically or by intra-articular injection, within 6 weeks prior to the surgical procedure. - Have received any investigational product within 30 days before dosing with study medication. - Be receiving warfarin, lithium, or a combination of furosemide with either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker - Be currently receiving treatment with oral meloxicam (Mobic®) within 7 days prior to surgery - Have previously received N1539 in clinical trials, or had major surgery in the last 3 months that would interfere with study outcomes or increase the risk of study participation. ; PRIMARY OUTCOME: Summed Pain Intensity Difference Over the First 24 Hours (SPID24); SECONDARY OUTCOME 1: Summed Pain Intensity Difference (SPID) at Other Intervals[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 12-02 (Chronic Non-Cancer Pain); BRIEF: The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain. ; DRUG USED: Bevenopran; DRUG CLASS: New Molecular Entity (NME); INDICATION: Opioid Induced Constipation (OIC); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); CRITERIA: Key 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 (e.g., lubiprostone) from Screening until the last study assessment Key Exclusion Criteria: - Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example [e.g.], obstruction) or contribute to bowel dysfunction - Has evidence of intestinal obstruction - Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening - 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 (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone) - Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants) ; PRIMARY OUTCOME: Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks; SECONDARY OUTCOME 1: Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - POLARIS-2; BRIEF: The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection. ; DRUG USED: Vosevi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase (NS5B) - Allosteric binding sites (Non-nucleosides), HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL at screening - Chronic HCV infection (≥ 6 months) - HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen - Use of protocol specified methods of contraception Key Exclusion Criteria: - Current or prior history of clinically significant illness that may interfere with participation in the study - Screening ECG with clinically significant abnormalities - Laboratory parameters outside the acceptable range at screening - Pregnant or nursing female - Chronic liver disease not caused by HCV - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - RAISE; BRIEF: The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity. ; DRUG USED: RemuneX; DRUG CLASS: Vaccine; INDICATION: HIV / AIDS; TARGET: Human Immunodeficiency Virus (HIV) , Immune System; THERAPY: Combination; LEAD SPONSOR: Immune Response BioPharma, Inc.; CRITERIA: Inclusion Criteria: - Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV. - Are at least 16 years old (consent of parent or guardian required if under 18 years). Exclusion Criteria: - Healthy Subjects - Currently abuse alcohol or drugs. ; PRIMARY OUTCOME: The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52; SECONDARY OUTCOME 1: The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 205.418 - MezzoTinA-asthma 1; BRIEF: The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events. ; DRUG USED: Spiriva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1). 2. Male or female patients aged at least 18 years but not more than 75 years. 3. All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5. 4. The initial diagnosis of asthma must have been made before the patients age of 40. 5. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL. 6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 4 weeks prior to Visit 1. 7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5. 8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1. 9. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%. 10. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years. 11. Patients must be able to use the Respimat® inhaler and metered dose inhaler correctly. 12. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter. Exclusion criteria: 1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patients ability to participate in the trial. 2. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1. 3. Patients with a recent history (i.e. six months or less) of myocardial infarction. 4. Patients who have been hospitalised for cardiac failure during the past year. 5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 6. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)). 7. Patients with known active tuberculosis. 8. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1. 10. Patients with significant alcohol or drug abuse within the past two years. 11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening). 12. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems. 13. Pregnant or nursing woman. 14. Women of childbearing potential not using a highly effective method of birth control. 15. Patients who have taken an investigational drug within four weeks prior to Visit 1. 16. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed. 17. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period. 18. Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period. 19. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period. 20. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period. 21. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period. 22. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period. 23. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. 24. Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period. 25. Patients who have previously been randomised in this trial or in the respective twin trial (205.419) or are currently participating in another trial. ; PRIMARY OUTCOME: Peak FEV1 Within 3 Hours Post-dose Response; SECONDARY OUTCOME 1: Peak FVC Within 3 Hours Post-dose Response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - LLC 2007 SA; BRIEF: RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL) despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response rate yet published in the treatment of first-line CLL has been obtained by the association of fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response can be improved, as some trials showed that eradication of minimal residual disease (MRD) in CLL is associated with a longer treatment-free and overall survival. Maintenance therapy using rituximab has been recently approved as a means of prolonging remission in patients with indolent non Hodgkins lymphoma. Maintenance therapy with rituximab could be of interest in treatment of MRD in CLL and prolonging remission and survival times. PURPOSE: The overall purpose of the study is to determine the value of immunotherapy maintenance with single agent rituximab in comparison with no further treatment (observation ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who respond to induction immunochemotherapy with FCR. ; DRUG USED: Rituxan; DRUG CLASS: Biologic; INDICATION: Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Combination; LEAD SPONSOR: University Hospital, Tours; CRITERIA: Inclusion criteria - B-CLL - Matutes score 4 or 5 - Binet stages B or C - Age > 65 years old - No previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy, except glucocorticoids < 1 month - Patients written informed consent - Life expectancy > 6 months Exclusion criteria - Binet stage A - ECOG performance status 2 or more - Presence of a 17p deletion by FISH (> 10% positive cores) - Clinically significant auto-immune cytopenia, Coombs-positive hemolytic anemia as judged by the treating physician - Patients with a history of another malignancy in complete remission less than 5 years, except basal cell skin cancer or tumor treated curatively by surgery - Concomitant disease requiring prolonged use of corticosteroids (> 1 month) - Any severe co-morbidities such as NYHA Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, severe uncontrolled myocardiopathy, uncontrolled hypertension, severe chronic obstructive pulmonary disease with hypoxemia, or uncontrolled diabetes mellitus. - CIRS (Cumulative Illness rating Scale) > 6 - Known hypersensitivity to murine proteins or to any of the study drugs or to their components - Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma) or prolymphocytic leukemia - Active bacterial, viral or fungal infection - Seropositivity HIV, hepatitis C or hepatitis B (unless clearly due to vaccination) - Total bilirubin, alkaline phosphatases and aminotransferases > 2 x ULN - Creatinine clearance < 60 ml/min calculated according to the formula of Cockcroft and Gault - Any coexisting medical or psychological condition that would preclude participation to the required study procedures - Patient with mental deficiency preventing proper understanding of the requirements of treatment Inclusion criteria at randomization - Patients having received the full induction phase with 4 FC and 6 rituximab courses (with/without dose adjustments as per protocol) - Complete or partial response according to NCI and iwCLL criteria at the end of induction phase - Recovery from FCR toxicities - Patient willingness to continue on protocol ; PRIMARY OUTCOME: Progression-free survival; SECONDARY OUTCOME 1: Event-free survival[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 842 (BID and TID); BRIEF: The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel ; DRUG USED: Lotemax SM; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Bausch & Lomb Incorporated; CRITERIA: Inclusion Criteria: Visit 1 (Screening Visit) - Be willing and able to comply with all treatment and follow-up/study procedures. - Be a candidate for routine, uncomplicated cataract surgery Visit 3 (Postoperative Day 1) - Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with posterior chamber IOL implantation, not combined with any other surgery) in the study eye. - Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye. Exclusion Criteria: - Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. - Have known hypersensitivity or contraindication to the study drug(s) or their components. ; PRIMARY OUTCOME: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells; SECONDARY OUTCOME 1: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Crimson-1; BRIEF: The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC). ; DRUG USED: Marzeptacog alfa; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Coagulation Factor IX, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Catalyst Biosciences; CRITERIA: Inclusion Criteria: - Diagnosis of congenital hemophilia A or B with inhibitors - Male or Female, age 12 or older - History of frequent bleeding episodes - Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities Exclusion Criteria: - Previous participation in a clinical trial evaluating a modified rFVIIa agent - Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect - Known hypersensitivity to trial or related product - Known positive antibody to FVII or FVIIa detected by central lab at screening - Have a coagulation disorder other than hemophilia A or B - Be immunosuppressed - Significant contraindication to participate ; PRIMARY OUTCOME: Bleeding episode treatment success; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 302 (South Korea); BRIEF: The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4. ; DRUG USED: Fexuprazan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Daewoong Pharmaceutical Co. LTD.; CRITERIA: Inclusion Criteria: 1. Subjects aged between 20 and 75 years 2. Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD 3. Subjects who had experienced major symptom within 3 months 4. Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week 5. Subjects who is able to understand and follow the instructions 6. Subjects who voluntarily signed written informed consent form Exclusion Criteria: 1. Subjects who have Barretts esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy 2. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1 3. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months 4. Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery 5. Subjects with Zollinger-Ellison syndrome 6. Subjects with eosinophilic esophagitis 7. Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease . ; PRIMARY OUTCOME: 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week; SECONDARY OUTCOME 1: Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 011 - Cancer; BRIEF: This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving chemotherapy and to assess the impact of V212 on the development of herpes zoster (HZ) in adults with STM receiving chemotherapy. The primary hypothesis is that vaccination with V212 will reduce the incidence of HZ compared with placebo in adults with STM (lower bound of the 97.5% {one-sided α=0.0125} confidence interval [CI] for the estimated vaccine efficacy in adults with STM be >25%). Participants with hematologic malignancy (HM) were also enrolled and were to be originally included in the primary and secondary objectives and analyses. After an interim analysis demonstrated clear evidence of futility of V212 in the HM population, enrollment of this population was stopped and all HM-related objectives and analyses were made exploratory and are not reported in this record. ; DRUG USED: V212; DRUG CLASS: Vaccine; INDICATION: Chickenpox and Shingles - Vaccines and Treatments; TARGET: Immune System, Varicella Zoster Virus (VSV); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion criteria: - Has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and is either ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen OR is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not - Life expectancy ≥12 months - Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is <30 years old, attended primary or secondary school in a country with endemic VZV infection - Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose - Female participants of childbearing potential must have a negative serum or urine pregnancy test Exclusion criteria: - History of hypersensitivity reaction to any vaccine component - Prior history of Herpes Zoster within 1 year of enrollment - Has received or is expected to receive any varicella or non-study zoster vaccine - Currently receiving or expected to receive long-term antiviral prophylaxis (>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV) - Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months from last vaccination dose - Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4 - Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4 ; PRIMARY OUTCOME: Incidence of Confirmed Herpes-Zoster; SECONDARY OUTCOME 1: Incidence of Moderate to Severe Herpes-Zoster-Associated Pain[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 1222.11; BRIEF: This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo. ; DRUG USED: Striverdi Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - All patients must have a diagnosis of chronic obstructive pulmonary disease - Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 <80% predicted and post-bronchodilator FEV1/FVC <70% Exclusion criteria: - Patients with a significant disease other than COPD - Patients with a history of asthma - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis ; PRIMARY OUTCOME: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks); SECONDARY OUTCOME 1: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ASTRA; BRIEF: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer. ; DRUG USED: Koselugo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Thyroid Cancer; TARGET: Mitogen-activated ERK kinase (MEK, MAPKK, MAP2K); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression Exclusion criteria: Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2 ; PRIMARY OUTCOME: Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set; SECONDARY OUTCOME 1: Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Re-emergence Prevention; BRIEF: The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period. This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks. ; DRUG USED: Edivoxetine; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Outpatients with clinical diagnosis of Major Depressive Disorder (MDD) - Using a reliable method of birth control - Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participants country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country - Have a partial response to SSRI treatment - Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment - Reliable and able to keep all scheduled appointments - Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years Exclusion Criteria: - Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening - Have a current or any previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder - Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine. - Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol - Have any diagnosed medical condition which could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention - Have initiated or discontinued hormone therapy (including birth control or thyroid hormone) within the previous 3 months prior to enrollment - Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery - Have received electroconvulsive therapy (ECT) in the past year - Have a serious or unstable medical condition - Have a history of seizure disorders - Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study - Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others - Are pregnant or breastfeeding - Meet criteria for treatment-resistant depression ; PRIMARY OUTCOME: Percentage of Participants Who Meet Criteria for Re-emergence of Depressive Symptoms Estimated by Kaplan-Meier Product Limit Method (Double-blind Randomized Withdrawal Period); SECONDARY OUTCOME 1: Percentage of Participants With Re-emergence of Depressive Symptoms (Double-blind Randomized Withdrawal Period)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CN138-163; BRIEF: This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder. ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Alpha Adrenergic Receptors, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2C receptor; THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Men and women, 18-65 years old - Experienced a Major Depressive Disorder with the current episode of minimally 8 weeks in duration. - Treatment history of an inadequate response to at least one and no more than three antidepressants. ; PRIMARY OUTCOME: Change in a depression rating scale at endpoint; SECONDARY OUTCOME 1: Change in a disability scale and Clinical Global Impression scale at endpoint[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUPPRESS (CMV Prevention); BRIEF: This randomized, double-blind, placebo-controlled, parallel group, multicenter study compared the effectiveness of oral brincidofovir (BCV) to placebo for the prevention of cytomegalovirus (CMV) infection in stem cell transplant patients who were CMV seropositive but negative for CMV viremia before starting treatment with BCV. ; DRUG USED: Tembexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cytomegalovirus (CMV) Infection (Antiviral); TARGET: DNA polymerase; THERAPY: Monotherapy; LEAD SPONSOR: Chimerix; CRITERIA: Inclusion Criteria Subjects were required to meet all of the following criteria, as applicable, to be eligible to participate in this study: 1. Were allogeneic hematopoietic stem cell transplant (HCT) recipients who had prior evidence of cytomegalovirus (CMV) exposure (CMV-seropositive) before transplantation and were CMV viremia negative at screening and at any other assessments performed prior to the first dose of study drug. 2. Were aged ≥18 years. 3. If male, were willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 24, when engaging in sexual intercourse with a female subject of childbearing potential. 4. If female of childbearing potential, i.e., not postmenopausal or surgically sterile, were willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 24, when engaging in sexual intercourse with a nonsterile male partner. 5. Were able to begin study drug dosing within 28 days following the qualifying HCT. 6. Were able to comfortably ingest and absorb oral medication (in the judgment of the investigator and base don lack of significant gastrointestinal events/medical history). 7. Were willing and able to understand and provide written informed consent. 8. Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 24). Exclusion Criteria Subjects who met any of the following criteria, as applicable, were not eligible to participate in this study: 1. Was pregnant or planned to become pregnant during the anticipated duration of her participation in the study (i.e., through Week 24), or was nursing a child. 2. Had a positive CMV viremia test (at the designated central virology laboratory or a local virology laboratory) at any time between transplant and the first dose of study drug. 3. Weighed ≥120 kg (~265 lbs). 4. Had hypersensitivity (not renal dysfunction or eye disorder) to cidofovir (CDV), brincidofovir (BCV), or its excipients. 5. Had received (or were anticipated to need treatment with) any of the following: - Ganciclovir, valganciclovir, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir, or maribavir) at any time post-transplant; - Any anti-CMV vaccine at any time; - Any other investigation drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix medical monitor or designee); or - Prior treatment with BCV at any time. 6. Were receiving of the following drugs on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the first dose of study drug: - Acyclovir orally at >2000 mg total daily dose (TDD) or intravenously at >15 mg/kg TDD; - Valaciclovir at >3000 mg TDD; or - Leflunomide at any dose. 7. Were receiving digoxin or ketoconazole (other than topical formulations) at the first dose of study drug or were anticipated to need treatment with either digoxin or ketoconazole during the treatment phase (through Week 14). 8. Had possible, probably, or definitive CMV disease diagnosed within 6 months prior to first dose of study drug. 9. Were infected with HIV (based on serology), or had an active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection, as evidence by detectable plasma HCV RNA or HBV DNA, respectively. 10. Had received another allogeneic HCT (i.e., other than the qualifying HCT) within 2 years prior to the first dose of study drug. 11. Had renal insufficiency, as evidence by an estimated glomerular filtration rate (eGFR) <15 mL/min or required renal dialysis. 12. Had hepatic abnormalities as evidence by a screening of alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of normal (ULN), as reported by the central safety laboratory. 13. Had a screening total bilirubin >2 x the ULN and direct bilirubin >1.5 x the ULN, as reported by the central safety laboratory. 14. Had active solid tumor malignancies with the exception of basal cell carcinoma or the underlying condition necessitating HCT (e.g., lymphomas). 15. Had Stage 2 or higher graft versus host disease of the gut or any other GI disease that would have, in the judgment of the investigator, precluded the subject from taking or absorbing oral medication (e.g., clinically active Crohns disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition expected to require abdominal surgery during the course of study participation). 16. Had any other condition, including abnormal laboratory values, that would have, in the judgement of the investigator, put the subject at increased risk by participating in the study or would have interfered with the conduct or planned analyses of the study. ; PRIMARY OUTCOME: Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant; SECONDARY OUTCOME 1: Incidence of Clinically Significant CMV Infection Through Week 14[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - BREVAS (w/Azathioprine); BRIEF: The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegeners granulomatosis or microscopic polyangiitis. The random assignment in this study is 1 to 1 which means that participants have an equal chance of receiving belimumab or placebo. ; DRUG USED: Benlysta; DRUG CLASS: Biologic; INDICATION: Antineutrophil Cytoplasmic Antibodies (ANCA) Associated Vasculitis; TARGET: B-cell activating factor (BAFF); THERAPY: Combination; LEAD SPONSOR: Human Genome Sciences Inc., a GSK Company; CRITERIA: Key Inclusion Criteria: - Clinical diagnosis Wegeners granulomatosis or microscopic polyangiitis by Chapel Hill criteria. - Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide. - Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment. - Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart. - Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission. Key Exclusion Criteria: - Pregnant or nursing. - Receipt of a B cell targeted therapy (other than rituximab) at anytime - Receipt of an investigational biological agent within the past 60 days. - Required management of acute or chronic infections within the past 60 days. - Current drug or alcohol abuse or dependence. - Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. - History of severe allergic reaction to contrast agents or biological medicines. ; PRIMARY OUTCOME: Time to First Relapse; SECONDARY OUTCOME 1: Number of Participants With Major Relapse During the Double-blind Phase of the Study[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - 302; BRIEF: The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-121 Lotion and vehicle in the treatment of subjects with acne vulgaris. ; DRUG USED: Altreno; DRUG CLASS: Non-NME; INDICATION: Acne; TARGET: Retinoic acid receptor (RARs); THERAPY: Monotherapy; LEAD SPONSOR: Valeant Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male or female at least 9 years of age and older - Written and verbal informed consent must be obtained. - Subject must have a score moderate or severe on the Evaluators Global Severity assessment at the screening and baseline visit - Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits - Subjects must be willing to comply with study instructions and return to the clinic for required visits. Exclusion Criteria: - Any dermatological conditions on the face that could interfere with clinical evaluations - Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive - Subjects with a facial beard or mustache that could interfere with the study assessments - Concomitant use of potentially irritating over-the-counter products ; PRIMARY OUTCOME: Absolute change in inflammatory lesion count from baseline to Week 12; SECONDARY OUTCOME 1: Percent change in inflammatory lesion count from baseline to Week 4, 8, and 12[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - SUSTAIN 3 (vs. Exenatide Q1W); BRIEF: This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subjects safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV ; PRIMARY OUTCOME: Change From Baseline in HbA1c (Glycosylated Haemoglobin); SECONDARY OUTCOME 1: Change From Baseline in Body Weight[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MAVIS; BRIEF: The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery. ; DRUG USED: Seviprotimut-L; DRUG CLASS: Vaccine; INDICATION: Melanoma; TARGET: Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Polynoma LLC; CRITERIA: Inclusion Criteria: - Histologically confirmed Stage IIb, IIc, III melanoma - Surgical resection within 90 days of first dosing - Persons with positive sentinel nodes must have a complete lymphadenectomy - ECOG performance status 0 or 1 Exclusion Criteria: - Any prior melanoma treatment other than surgery or regional irradiation - Use of biologic response modifiers within 60 days of first dosing - Subjects with history of other malignancy within past 5 years (with exceptions) ; PRIMARY OUTCOME: Recurrence Free Survival (RFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - w/Carboplatin and Paclitaxel; BRIEF: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC). ; DRUG USED: Veliparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Life expectancy > 12 weeks 2. Subject must have cytologically or histologically confirmed squamous NSCLC. 3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening. 4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible. 5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1). Exclusion Criteria: 1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). 2. Subject has a known hypersensitivity to platinum compounds. 3. Subject has peripheral neuropathy >= grade 2. 4. Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement. 5. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy. ; PRIMARY OUTCOME: Overall Survival (OS) in current smokers; SECONDARY OUTCOME 1: Overall Survival (OS) in all subjects[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - First-Line (315); BRIEF: The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer. ; DRUG USED: Camrelizumab; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Jiangsu HengRui Medicine Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology. 2. No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle. 3. Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene. 4. Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria; 5. Freshly acquired samples or archived specimens within 6 months before randomization must be provided. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Radiologically confirmed central squamous cell carcinoma. 2. Untreated central nervous system metastases (such as brain or meningeal metastases). 3. Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage 4. Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function 5. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed. 6. Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms. 7. Uncontrolled Cardiac Symptoms or Diseases. 8. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg). 9. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization. 10. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy. ; PRIMARY OUTCOME: Progression Free Survival (PFS) assessed by Independent review committee (IRC); SECONDARY OUTCOME 1: PFS assessed by investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ARCADE (Low Risk MDS); BRIEF: The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS. ; DRUG USED: Aranesp; DRUG CLASS: Biologic; INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Erythropoietin Receptor (EPOR); THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Low or intermediate-1 risk MDS patients per International Prognostic Scoring System (IPSS) at the time of randomisation, as determined by complete blood count (CBC) during screening and bone marrow examination and marrow cytogenetic analysis performed within 16 weeks prior to randomisation. Subject cannot have been rendered low or intermediate-1 risk by prior disease modifying therapy. Bone marrow slides must be available for centralized review at any time throughout the study - World Health Organization (WHO) classification of refractory anemia (RA), refractory anemia with ring sideroblasts (RARS), refractory cytopenias with multilineage dysplasia (RCMD), MDS-unclassified (MDSU), MDS with isolated del(5q) (5q- syndrome) or refractory anaemia with excess blasts-1 (RAEB-1) - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 assessed during screening - Haemoglobin level ≤ 10.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomisation (retest during screening is acceptable) - Adequate transferrin saturation (Tsat) (≥ 15%) and serum ferritin (≥ 10 ng/mL) as assessed by the central laboratory during screening (supplementation and retest during screening is acceptable) - Adequate serum folate (≥ 4.5 nmol/L [≥ 2.0 ng/mL]) or RBC folate (≥ 317 nmol/L [≥ 140 ng/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable) - Adequate vitamin B12 (≥ 148 pmol/L [≥ 200 pg/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable) - 18 years of age or older - Subject or subjects legally acceptable representative has provided informed consent - Exclusion Criteria: - Previously diagnosed with intermediate-2 or high risk MDS per IPSS - Therapy-related or secondary MDS - History of acute leukemia - Evidence of bone marrow collagen fibrosis - Inherited anaemia (eg, haemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency), active hemorrhage, red cell aplasia, haemolytic anaemia - History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma - History of thrombosis within 6 months prior to randomisation - Previous bone marrow or stem cell transplantation - Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomisation - Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening - Clinically significant systemic infection or uncontrolled chronic inflammatory disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator at screening - History of seizure disorder (subject with previous history of seizure disorder will be eligible for the study if he/she had no evidence of seizure activity within 5 years of randomisation and is currently free of antiseizure medication) - Previous or ongoing use of erythropoiesis-stimulating agent (ESA) therapy, eg, recombinant human erythropoietin (rHuEpo), darbepoetin alfa - High transfusion demand: receiving a total of ≥ 4 units of RBC transfusion during either of 2 consecutive 8-week periods (ie, days -113 to -57 or days -56 to 0) prior to randomisation - Received any RBC transfusion within 14 days prior to randomisation - Received cytotoxic chemotherapy for any oncologic indication or planning to receive cytotoxic chemotherapy during the double-blind treatment period of the study - Received biologic response modifiers (eg, thalidomide, lenalidomide, arsenic trioxide, azacitidine, decitabine) to treat MDS or planning to receive biologic response modifiers during the double-blind treatment period of the study - Received myeloablative or craniospinal radiation or planning to receive myeloablative or craniospinal radiation during the double-blind treatment period of the study - Received granulocyte colony stimulating factor (G-CSF) therapy within 30 days prior to randomization or planning to receive G-CSF therapy during the double-blind treatment period of the study (temporary use of G-CSF for neutropenia with fever and/or infection is acceptable) - Abnormal renal function (serum creatinine level > 2 times the upper limit of the respective normal range [ULN]) as assessed by the central laboratory at screening - Abnormal liver function (total bilirubin > 2 times, alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times ULN) as assessed by the central laboratory at screening. (Subjects with abnormal bilirubin at screening due to documented Gilberts Disease are eligible if all other criteria are met.) - Serum endogenous erythropoetin (EPO) level > 500 mU/mL as assessed by the central laboratory at screening - Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of acquired Immunodeficiency syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus - Subjects with active ethanol abuse, as judged by the investigator - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) - Female subject is not willing to use highly effective contraception during treatment and for at least 1 month after the end of treatment - Female subject is pregnant or planning to become pregnant within 1 month after the end of treatment - Subject has known sensitivity to any of the products to be administered during dosing - Subject has previously been randomised into this study - Subject will not be available for protocol-required study visits, to the best of the subject and investigators knowledge - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures - Confirmed history of neutralising antibody activity to rHuEpo or darbepoetin alfa ; PRIMARY OUTCOME: Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ROCKET 1; BRIEF: To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5% ; DRUG USED: Rhopressa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Subject Inclusion criteria: 1. 0-2 years of age and 18 years or greater. 2. Diagnosis of open angle glaucoma or ocular hypertension 3. Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits. 4. Corrected visual acuity in each eye equivalent to 20/200. 5. Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) and follow study instructions. Subject exclusion criteria Ophthalmic: 1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable. 2. Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications. 3. Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or beta adrenoceptor antagonists. 4. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye 5. Refractive surgery in either eye. 6. Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening. 7. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye. 8. Ocular medication in either eye of any kind within 30 days of screening. 9. Clinically significant ocular disease in either eye (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe. 10. Central corneal thickness in either eye greater than 600 µm at screening. 11. Any abnormality in either eye preventing reliable applanation tonometry of either eye. Systemic: 12. Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study. 13. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes). 14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 15. Participation in any investigational study within 30 days prior to screening. 16. Changes of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening, or anticipated during the study. 17. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study. ; PRIMARY OUTCOME: Intraocular Pressure (IOP); SECONDARY OUTCOME 1: Extent of Exposure[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CAIRO3 (Maintenance w/Capecitabine); BRIEF: The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown. In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin, capecitabine and bevacizumab (induction treatment, at standard doses). This treatment is continued until progression or severe toxicity. This regimen is compared to the effects a observation without treatment after the induction treatment. In case of disease progression, induction treatment will be reintroduced. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Colorectal Cancer (CRC); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Dutch Colorectal Cancer Group; CRITERIA: Before the start of induction therapy: Inclusion Criteria: - Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained); - Distant metastases (patients with only local recurrence are not eligible); - Unidimensionally measurable disease (> 1 cm on spiral CT scan or > 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation; - In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field. - Ongoing or planned first line treatment with 6 cycles of Xeloda, Eloxatin, and Avastin. Exclusion criteria - Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment - Any prior adjuvant treatment after resection of distant metastases - Previous systemic treatment for advanced disease At randomisation: Inclusion criteria: - WHO performance status 0-1 (Karnofsky PS > 70%); - Disease evaluation with proven SD, PR or CR according to RECIST after 6 cycles of MTD chemotherapy performed in week 3-4 of the 6th cycle induction therapy, and randomisation performed in week 3-5 of the 6th cycle (see time table); - Laboratory values obtained ≤ 2 weeks prior to randomisation: adequate bone marrow function (Hb > 6.0 mmol/L, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L), renal function (serum creatinine ≤ 1.5x ULN and creatinine clearance, Cockroft formula, > 30 ml/min), liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases); - Life expectancy > 12 weeks; - Age >= 18 yrs; - Negative pregnancy test in women with childbearing potential; - Expected adequacy of follow-up; - Institutional Review Board approval; - Written informed consent Exclusion criteria - History or clinical signs/symptoms of CNS metastases; - History of a second malignancy ≤ 5 years with the exception of adequately treated carcinoma of cervix or basal/squamous cell carcinoma of skin; - Previous intolerance of XelodaR, EloxatinR, and/or AvastinR for which any of these drugs have been permanently discontinued; patients with previous dose reductions or delays are eligible; patients with grade 2 neurotoxicity after the 6th cycle are eligible, and retreatment with EloxatinR after PFS1 should depend on the grade of neurotoxicity at that moment; - Known dihydropyrimidine dehydrogenase (DPD) deficiency; - (Planned) radical resection of all metastatic disease; - Uncontrolled hypertension, i.e. consistently > 150/100 mmHg; - Use of more than 3 antihypertensive drugs; - Significant cardiovascular disease < 1 yr before randomisation (symptomatic congestive heart failure, myocardial ischemia or infarction, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular event, pulmonary embolism); - Any of these significant cardiovascular events during previous fluoropyrimidine therapy; - Chronic active infection; - Any other concurrent severe or uncontrolled disease preventing the safe administration of study drugs; - Any impairment of gastrointestinal function or -disease that may significantly impair the absorption of oral drugs (i.e. uncontrolled nausea, vomiting, diarrhoea (defined as >CTC grade 2), malabsorption syndrome, bowel obstruction, or inability to swallow tablets); - Concomitant treatments: concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation; concurrent treatment with any other anti-cancer therapy; full-dose anticoagulation (is allowed if started during induction therapy); - Continuous use of immunosuppressive agents (except the use of corticosteroids as anti-emetic prophylaxis/treatment). ; PRIMARY OUTCOME: Progression-free survival after re-introduction of MTD chemotherapy and bevacizumab (PFS2); SECONDARY OUTCOME 1: Progression-free survival between observation versus maintenance therapy (PFS1)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ACHIEVE 2/3; BRIEF: This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive. ; DRUG USED: Zalbin; DRUG CLASS: Biologic; INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: Interferon Receptor; THERAPY: Combination; LEAD SPONSOR: Human Genome Sciences Inc.; CRITERIA: Key Inclusion Criteria: - Diagnosis of chronic hepatitis C. - Liver biopsy performed within 2 years of Day 0 or during screening. - Infected with hepatitis C virus genotype 2/3. - Interferon alfa treatment naïve (ie, have never been treated with an interferon product). - Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin. - Have compensated liver disease. Key Exclusion Criteria: - Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy. - History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. - Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG). - Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilsons Disease, or alpha 1-antitrypsin deficiency. - A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus). - Active seizure disorder within the last 2 years. - Organ transplant other than cornea and hair transplant. - Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia). - Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix). - Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study. - Received any experimental agent within 28 days prior to Day 0. ; PRIMARY OUTCOME: Sustained virologic response (SVR); SECONDARY OUTCOME 1: Rapid virologic response[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Study 301 (Moderate to Severe GERD); BRIEF: The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD). ; DRUG USED: AcipHex ER; DRUG CLASS: New Molecular Entity (NME); INDICATION: Gastroesophageal Reflux Disease (GERD); TARGET: Proton pump; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: KEY INCLUSION CRITERIA: 1. Male or female, ages 18 to 75 years. 2. History of GERD symptoms for at least 3 months immediately before screening. 3. Heartburn for at least 2 days a week for at least 1 month before screening. 4. Esophageal erosions of Los Angeles (LA) grades C or D based on EGD taken within 14 days prior to enrollment. 5. Subjects who are H. pylori negative based on a screening test. 6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception. 7. Subjects must be able to read, write, and understand the language of the symptom diary. KEY EXCLUSION CRITERIA: 1. Current or a history of esophageal motility disorders. 2. Current or a history of Barretts esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications). 3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer. 4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma. 5. Inflammatory bowel disease. 6. Unstable diabetes mellitus. 7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer. 8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (->;= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day). ; PRIMARY OUTCOME: Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks; SECONDARY OUTCOME 1: Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - TOPAZ; BRIEF: This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone. ; DRUG USED: Xipere; DRUG CLASS: Non-NME; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: Clearside Biomedical, Inc.; CRITERIA: Inclusion Criteria: - Has a clinical diagnosis of RVO in the study eye - Has a CST of ≥ 300 µm in the study eye - Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye - Is naïve to local pharmacologic treatment for RVO in the study eye Exclusion Criteria: - Any active ocular disease or infection in the study eye other than RVO - History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication - Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study - Any evidence of neovascularization in the study eye ; PRIMARY OUTCOME: Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS); SECONDARY OUTCOME 1: Mean Change From Baseline in Best Corrected Visual Acuity[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric; BRIEF: The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients. ; DRUG USED: Ionsys; DRUG CLASS: Non-NME; INDICATION: Postsurgical Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Alza Corporation, DE, USA; CRITERIA: Inclusion Criteria: - The patients must: weigh >= 40 kg - be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery - Be expected by the investigators staff to require injected opioid analgesia for at least 24 hours after surgery - Be judged by the investigators staff to be capable of understanding and cooperating with the requirements of the study. Exclusion Criteria: - Patients who have undergone any surgery on the airway, head or neck - Patients who are expected to require intensive care - Patients who require airway(breathing) support after their surgery - Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil - Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg). ; PRIMARY OUTCOME: Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.; SECONDARY OUTCOME 1: Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - N01395 (Previous Treatment w/Levetiracetam); BRIEF: Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed. ; DRUG USED: Briviact; DRUG CLASS: New Molecular Entity (NME); INDICATION: Seizure Disorders (Epilepsy); TARGET: SV2A synaptic vesicle protein; THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma SA; CRITERIA: Inclusion Criteria: - Subject with well-characterized Epilepsy according to the 1989 International League Against Epilepsy (ILAE) classification - Subject with Epilepsy who the investigator expects will benefit from Levetiracetam (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of LEV - Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day) - Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs) including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED - Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method Exclusion Criteria: - Subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1 - Subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries) - Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline - Subject has history or presence of known psychogenic nonepileptic seizures - Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol - Subject is pregnant or lactating ; PRIMARY OUTCOME: Percentage of Subjects Who Achieved a Clinically Meaningful Reduction of Nonpsychotic Behavioral Side Effects Based on the Investigators Overall Assessment From Study Entry to the End of the Treatment Period; SECONDARY OUTCOME 1: Shift in the Maximum Intensity From Baseline to the End of the Treatment Period for Side Effects Primarily Associated With Discontinuation of Levetiracetam (LEV) as Determined by the Investigator[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Cancer Related Fatigue - MM; BRIEF: The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of cancer-related fatigue in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56-day treatment phase, and a final assessment to occur 28 days after the end of the last treatment. ; DRUG USED: Nuvigil; DRUG CLASS: Non-NME; INDICATION: Excessive Sleepiness Associated with Medical Conditions; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Oncotherapeutics; CRITERIA: Inclusion Criteria: - The patient has been diagnosed with multiple myeloma based on standard criteria - The patient is diagnosed with cancer-related fatigue based on ICD-10 diagnostic criteria - The patient shows signs of severe fatigue as evidenced by a Brief Fatigue Inventory score of at least 4 - The patient is a man or woman aged 18 years or older at the time of informed consent - The patient has given voluntary written informed consent before any study-related procedure is performed which is not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care - Women of child bearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. - Men must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug - The patient must be willing and able to comply with study restrictions - The patient must have an ECOG performance status not greater than 2 - The patient must have a life-expectancy of greater than 3 months - The patient must meet the following laboratory criteria within 14 days of enrollment: - Platelet count greater than 50 x 109/L - Absolute neutrophil count greater than 0.5 x 109/L - Hemoglobin greater than 8 g/dL - AST and ALT not greater than 3.0 x the upper limit of normal (ULN) - Serum bilirubin not greater than 2.0 x ULN - Calculated or measured creatinine clearance of at least 10 mL/minute Exclusion Criteria: - The patient has been concurrently diagnosed with clinically significant depression - The patient is concurrently enrolled in another investigational study that does not apply to the specific treatment of multiple myeloma - The patient is receiving an investigational agent (non-FDA-approved) for any reason within 28 days of starting treatment on this study - The patient has previously received armodafinil - The patient has received modafinil or a psychostimulant within 14 days of enrollment - The patient has received a blood transfusion within 14 days of enrollment - The patient has impaired cardiac function or clinically significant cardiac diseases - The patient has other concurrent severe and/or uncontrolled medical or psychiatric conditions including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol - The patient has known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis B or C is not required - The patient has undergone major surgery within 28 days of enrollment or has not recovered from side effects of such therapy (Kyphoplasty is not considered to be a major surgery; however, the investigator is to discuss enrollment of a patient with a recent history of kyphoplasty with Oncotherapeutics medical monitor) - The patient has a significant history of noncompliance to medical regimens or unwilling or unable to comply with the instructions given to him or her by the study staff - The patient has a history of skin reactions and/or known sensitivity attributable to compounds of similar chemical or biological composition to modafinil, armodafinil, or the inactive ingredients in armodafinil including lactose monohydrate, starch, microcrystalline cellulose, croscarmellose, sodium, magnesium stearate or povidone - The patient is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study - The patient is male whose sexual partner is a woman of childbearing potential not using effective birth control ; PRIMARY OUTCOME: BFI Score; SECONDARY OUTCOME 1: Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score[/INST]No</s>