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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 - AMEERA-5 (w/Palbociclib, 1st Line); BRIEF: Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms. ; DRUG USED: SAR439859; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Selective Estrogen Receptor Degrader (SERD); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria : - Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment. - Confirmed diagnosis of ER+/HER2- breast cancer. - No prior systemic treatment for loco-regional recurrent or metastatic disease. - Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease. - Eastern Cooperative Oncology Group (ECOG) performance status 0-2. - Participants should be willing to provide tumor tissue. - Capable of giving informed consent. Exclusion criteria: - Known active brain metastases. - Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD). - Inadequate organ and marrow function. - Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy. - Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods. - Male participants who disagree to follow contraception. - Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term. - Participants with significant concomitant illness. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Progression-free Survival (PFS); 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 - EMPEROR-Reduced; BRIEF: The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening - Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) - If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF - If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF - If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF - EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF - Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1 - Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines - Signed and dated written ICF (Informed Consent Form) - Further inclusion criteria apply Exclusion criteria: - Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1 - Heart transplant recipient, or listed for heart transplant - Acute decompensated HF - Systolic blood pressure (SBP) >= 180 mmHg at Visit 2. - Symptomatic hypotension and/or a SBP < 100 mmHg - Indication of liver disease - Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis - History of ketoacidosis - Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor - Currently enrolled in another investigational device or drug study - Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Further exclusion criteria apply ; PRIMARY OUTCOME: Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF); SECONDARY OUTCOME 1: Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)[/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 - 1237.15 (12 wks); BRIEF: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD. ; DRUG USED: Stiolto Respimat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with, at visit 1: a post-bronchodilator 30% <= FEV1 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1 3. Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years Patients who have never smoked cigarettes must be excluded. 5. Patients must be able to perform technically acceptable pulmonary function tests (spirometry), must be able to complete multiple symptom-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol. 6. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI). Exclusion criteria: 1. Patients with a significant disease other than COPD 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN will be excluded regardless of clinical condition 3. Patients with a history of asthma 4. A diagnosis of thyrotoxicosis 5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) 6. A history of myocardial infarction within 1 year of screening visit (Visit 1) 7. Unstable or life-threatening cardiac arrhythmia 8. Hospitalized for heart failure within the past year 9. Known active tuberculosis 10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure 12. A history of cystic fibrosis 13. Clinically evident bronchiectasis 14. A history of significant alcohol or drug abuse 15. Any contraindications for exercise testing 16. Patients who have undergone thoracotomy with pulmonary resection 17. Patients being treated with any oral ß-adrenergics 18. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day 19. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits 20. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program 21. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea or morbid obesity 22. Patients with an endurance time >=25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry 23. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1) 24. Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC, EDTA or any other component of the RESPIMAT inhalation solution delivery system 25. Pregnant or nursing women 26. Women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years 27. Patients who have previously been randomized in this study or are currently participating in another study 28. Patients who are unable to comply with pulmonary medication restrictions prior to randomization At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests: 29. Patients who complete level 12 at the incremental shuttle walk test at visit 1a. 30. Patients with an endurance time >=15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test. ; PRIMARY OUTCOME: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks; SECONDARY OUTCOME 1: Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 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 - CONTACT-01; BRIEF: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially. ; DRUG USED: Cabometyx / Cometriq; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Angiopoietin Receptors (TIE-1 and TIE-2), FMS-like tyrosine kinase 3 (FLT-3) , Hepatocyte growth factor receptor (c-Met, HGFR), KIT/c-KIT, RET, VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Histologically or cytologically confirmed metastatic NSCLC - Documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC - Measurable disease per RECIST v1.1 outside CNS as assessed by investigator - Known PD-L1 status or availability of tumor tissue for central PD-L1 testing - ECOG Performance Status score of 0 or 1 - Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator - Adequate hematologic and end-organ function - Negative HIV test at screening - Negative hepatitis B surface antigen (HBsAg) test at screening - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm. Exclusion Criteria: - Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI) - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene - Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly) - Severe hepatic impairment - Uncontrolled or symptomatic hypercalcemia - Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast - Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment - Significant vascular disease within 6 months of initiation of study treatment - Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina - Active tuberculosis - Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion on the investigator, could impact patient safety - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment - Current treatment with anti-viral therapy for HBV - Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study - Pregnant or lactating females, or intention of becoming pregnant during the treatment with atezolizumab in combination with cabozantinib in the experimental arm or during the treatment with docetaxel in the control arm, or within 5 months after the final dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever is later. - Ongoing Grade >= 2 sensory or motor neuropathy - Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions: Patients with a history of autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are eligible for the study. Patients with controlled Type 1 diabetes mellitus are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Rash must cover < 10% of body surface area. - Pharmacologically uncompensated, symptomatic hypothyroidism - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan - Prior allogeneic stem cell or solid organ transplantation - Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab - Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after Medical Monitor confirmation has been obtained. Patients who received mineralocorticoids, inhaled or low-dose systemic corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation - Known allergy or hypersensitivity to any component of the cabozantinib formulation - History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80 - Concomitant anticoagulation with coumarin agents, direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors - History of risk factors for torsades de pointes - Corrected QT interval corrected through use of Fridericias formula (QTcF) > 480 ms per ECG within 14 days before initiation of study treatment - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal antihypertensive treatment - Tumors invading the GI-tract, active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric outlet obstruction, or inflammatory bowel disease - Abdominal fistula, bowel obstruction, GI perforation, or intra-abdominal abscess within 6 months before initiation of study treatment - Known cavitating pulmonary lesion(s) or known endobronchial disease manifestation - Lesions invading major pulmonary blood vessels - Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL) of red blood, coagulopathy, or other history of significant bleeding within 3 months before initiation of study treatment - Serious non-healing wound/ulcer/bone fracture - Malabsorption syndrome - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption are also excluded. - Requirement for hemodialysis or peritoneal dialysis - Inability to swallow tablets ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-Free Survival (PFS) as Determined 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 - KAITLIN (w/Perjeta, HER2+); BRIEF: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1 - Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable - HER2-positive breast cancer - Known hormone receptor status of the primary tumor - Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy - Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either: Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory - Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive - No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization - Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans - Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required - Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment Exclusion Criteria: - History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma - History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin - Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer - For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable) - Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy - History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study - Participants with contraindication to RT while adjuvant RT is clinically indicated - Concurrent anti-cancer treatment in another investigational trial - Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV - Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines - Inadequate hematologic, renal or liver function - Pregnant or lactating women - Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol - Chronic immunosuppressive therapies, including systemic corticosteroids ; PRIMARY OUTCOME: Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation; SECONDARY OUTCOME 1: IDFS Plus Second Primary Non-Breast Cancer[/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 - Adjunctive (OLE); BRIEF: To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia ; DRUG USED: Nuplazid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Schizophrenia; TARGET: Serotonin 5-HT2A receptor; THERAPY: Monotherapy; LEAD SPONSOR: ACADIA Pharmaceuticals Inc.; CRITERIA: Inclusion Criteria: 1. Patient is able to understand and provide signed informed consent 2. Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale 3. Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigators opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic 4. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception 5. The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below: - Aripiprazole - Aripiprazole long-acting injectables: - Abilify Maintena® - Aristada® - Asenapine - Risperidone - Risperidone long-acting injection - Olanzapine - Paliperidone extended release (ER) (≤9 mg) - Paliperidone palmitate - Invega Sustenna® (≤156 mg) - Invega Trinza® (≤546 mg) - Trevicta® (≤350 mg) - Xeplion® (≤100 mg) - Lurasidone - Cariprazine - Brexpiprazole - Asenapine Exclusion Criteria: 1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064) 2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse 1. Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subjects participation 2. Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study 3. Is taking a medication or drug or other substance that is prohibited according to this protocol 4. Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval 5. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patients ability to participate in the study. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria). ; PRIMARY OUTCOME: Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability]); 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 - PIONEER PLUS; BRIEF: This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®. ; DRUG USED: Rybelsus; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. - HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive). - BMI equal to or above 25 kg/m^2 - Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens: - No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a *: - Metformin (equal to or above1500 mg or maximum tolerated or effective dose). - Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose). - Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose). - Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label). - Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out). Exclusion Criteria: - Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed. - Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. ; PRIMARY OUTCOME: Change in glycated haemoglobin (HbA1c); SECONDARY OUTCOME 1: Change 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 - Add-on to Metformin; BRIEF: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise. ; DRUG USED: Ranexa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Late Sodium Current; THERAPY: Combination; LEAD SPONSOR: Gilead Sciences; CRITERIA: Inclusion Criteria: - Documented history of T2DM - Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening - Body mass index (BMI) 25 to 45 kg/m^2, inclusive, at Screening - HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose - C-peptide ≥ 0.8 ng/mL at Screening - Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period Exclusion Criteria: - Type 1 diabetes mellitus - History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma - History of severe hypoglycemia - Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening - History of congestive heart failure - Corrected QT interval (QTc) > 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone) - Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening - Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL - Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization - Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days) - Treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization - Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization - Treatment with simvastatin or lovastatin at a dose > 20 mg or > 40 mg daily, respectively, within 14 days prior to randomization ; PRIMARY OUTCOME: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24; SECONDARY OUTCOME 1: Change From Baseline in Fasting Serum Glucose at Week 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 - ARTIOS; BRIEF: Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease. ; DRUG USED: Kesimpta; DRUG CLASS: Biologic; INDICATION: Multiple Sclerosis (MS); TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Diagnosis of MS according to the 2017 Revised McDonald criteria - Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) - Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive) - MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT - Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration - Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions) - Neurologically stable within one month prior to first study drug administration Exclusion Criteria: - Subjects with primary progressive MS or SPMS without disease activity - Subjects meeting criteria for neuromyelitis optica - Disease duration of more than 10 years since diagnosis - Pregnant or nursing (lactating) women - Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication - Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome - Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS) - Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML - Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice - Subjects with active hepatitis B and C disease, assessed locally - Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration - Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.) - Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator ; PRIMARY OUTCOME: Annual Relapse Rate (ARR); SECONDARY OUTCOME 1: Safety evaluation[/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 - KEYNOTE 716; BRIEF: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Melanoma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion: - Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines - Has not been previously treated for melanoma beyond complete surgical resection - Has ≤12 weeks between final surgical resection and randomization - Has no evidence of metastatic disease on imaging as determined by investigator - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old - Has recovered adequately from toxicity and/or complications from surgery prior to study start - Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP) Exclusion: - Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment - WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required - Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) - Has received prior systemic anti-cancer therapy for melanoma including investigational agents - Has received a live vaccine within 30 days prior to the first dose of study treatment - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment - Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab - Has an active autoimmune disease that has required systemic treatment in the past 2 years - Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis - Has an active infection requiring systemic therapy - Has a known history of human immunodeficiency virus (HIV) infection - Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid [RNA] [qualitative] is detected) infection - Has a history of active tuberculosis (Bacillus tuberculosis) - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator - Has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study - Has had an allogeneic tissue/solid organ transplant ; PRIMARY OUTCOME: Recurrence-free Survival (RFS); SECONDARY OUTCOME 1: Distant Metastasis-free Survival (DMFS)[/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 - OSTRO; BRIEF: The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing. ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Nasal Polyposis; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol. 2. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines. 3. Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis. 4. Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF. 5. Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: - A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab; - Ongoing symptoms for at least 12 weeks prior to V1; - Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe). 6. SNOT-22 total score ≥ 30 at enrolment. Patient must meet the following criteria (points 7-10) at the randomization visit: 7. At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0). 8. At randomization, a bi-weekly mean NBS ≥ 1.5. 9. SNOT-22 total score ≥ 30 at randomization. 10. At least 70% compliance with INCS during the run-in period based on daily diary. 11. Patients with a minimum weight of 40kg. 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential. 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP). 15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements Exclusion Criteria: 1. Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1. 2. Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: - Unilateral antrochoanal polyps; - Nasal septal deviation that occludes at least one nostril; - Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening; - Current rhinitis medicamentosa; - Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS); - Nasal cavity tumors. 3. Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegeners granulomatosis), Youngs syndrome, etc. 4. Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: - Affect the safety of the patient throughout the study; - Influence the findings of the studies or their interpretations; - Impede the patients ability to complete the entire duration of study. 5. Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1. 6. History of anaphylaxis to any biologic therapy or vaccine. 7. Known history of allergy or reaction to any component of the Investigational Product (IP) formulation. 8. History of Guillain-Barré syndrome. 9. A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy. 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1. NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible. 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments. 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll). 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test. 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1. 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo. 17. Previous receipt of benralizumab. 18. Receipt of immunoglobulin or blood products within 30 days prior to V1. 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization. 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization. 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period. NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1. 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for ≥30 days prior to V1. 23. Concurrent enrolment in another clinical drug interventional trial. 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 3 times the upper limit of normal (ULN) confirmed during screening period. 25. Previous randomization in the present study. 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization. 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period. 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating. ; PRIMARY OUTCOME: Change From Baseline in Total NPS at Week 40; SECONDARY OUTCOME 1: Change From Baseline in SNOT-22 at Week 40[/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 - QRK309; BRIEF: This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo. ; DRUG USED: QPI-1002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Renal Disease / Renal Failure; TARGET: p53; THERAPY: Monotherapy; LEAD SPONSOR: Quark Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Male or female, age ≥ 18 years old - At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors: - Reduced renal function - Diabetes with ongoing insulin treatment - Albuminuria - Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest Key Exclusion Criteria: - Emergent surgeries, including aortic dissection, and major congenital heart defects - Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects <45 years old is allowed.) - Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated ; PRIMARY OUTCOME: Proportion of subjects through day 90 who develop major adverse kidney events; SECONDARY OUTCOME 1: Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery[/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 - MC-105; BRIEF: The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo. ; DRUG USED: CureXcell; DRUG CLASS: Biologic; INDICATION: Chronic Venous Ulcers; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Macrocure Ltd.; CRITERIA: Inclusion Criteria: - Ankle Brachial Pressure Index (ABI) ≥ 0.80 - Venous insufficiency confirmed by duplex Doppler ultrasound - Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit Exclusion Criteria: - Target Ulcer has decreased >30% in size from Screening to Baseline - Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit. - Patients who are unable to tolerate multi-layer compression therapy. - Ulcer, which in the opinion of the Investigator is suspicious for cancer. - Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. - History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit. - Patients with clinically significant claudication - Current sepsis - Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV ; PRIMARY OUTCOME: Time to complete closure of Target Ulcer; SECONDARY OUTCOME 1: Proportion of complete closure of Target Ulcer[/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 - US03; BRIEF: This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis ; DRUG USED: Pefcalcitol; DRUG CLASS: New Molecular Entity (NME); INDICATION: Psoriasis; TARGET: Phosphodiesterase; THERAPY: Monotherapy; LEAD SPONSOR: Maruho North America Inc.; CRITERIA: Inclusion Criteria: - Who are able and willing to give signed informed consent - Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator. - Who have up to 20% of body surface area (BSA) afflicted with plaques - Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study. Exclusion Criteria: - Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity. - Who are pregnant or lactating. - Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease. - Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests. - Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study - Whose serum calcium levels exceed the upper limit of reference range - Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization. - Who have been treated with systemic therapy within 30days of randomization. - Who have treated with biologics within 5 half-lives of the biologics before the day of randomization - Who have been treated with topical therapy within 14days before the day of randomization. ; PRIMARY OUTCOME: Investigator Global Assessment; 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 - Previously Untreated Patients (PUPs); BRIEF: This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study. ; DRUG USED: Adynovate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Baxalta now part of Shire; CRITERIA: Inclusion Criteria 1. Participant is <6 years old at the time of screening. 2. Participant is previously untreated with <3 exposure days (EDs) to ADVATE, BAX 855 or plasma transfusion at any time prior to screening. 3. Participant has severe hemophilia A (Factor VIII (FVIII) <1%) as determined by the central laboratory, or a historical FVIII level <1% as determined at any local laboratory, optionally supported by an additional FVIII gene mutation consistent with severe hemophilia A. 4. Participant is immune competent with a cluster of differentiation 4 (CD4+) count > 200 cells per cubic millimeter (mm^3), as confirmed by the central laboratory at screening. 5. Parent or legally authorized representative is willing and able to comply with the requirements of the protocol. Additional inclusion criteria for Part B (immune tolerance induction [ITI]). 1. Parent or legal representative has/have voluntarily provided signed informed consent for ITI portion. 2. Participant has a confirmed positive high titer inhibitor (> 5.00 Bethesda unit (BU)) or has a positive confirmed low titer inhibitor (greater than or equal to [>=] 0.6 BU) as determined by the central laboratory based on a second repeat blood sample with 1. poorly controlled bleeding despite increased BAX 855 doses, or 2. requires bypassing agents to treat bleeding. Exclusion Criteria 1. Participant has detectable FVIII inhibitory antibodies (>=0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening. 2. Participant has a history of FVIII inhibitory antibodies (>=0.6 BU using the Nijmegen modification of the Bethesda assay or the Bethesda assay) at any time prior to screening. 3. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrands disease). 4. Participant has been previously treated with any type of FVIII concentrate other than ADVATE or BAX 855, or was administered ADVATE, BAX 855 or plasma transfusion for >=3 EDs at any time prior to screening. 5. Participant receives > two EDs of ADVATE in total during the periods prior to enrollment and during the screening period, until the baseline infusion. 6. The participants weight is anticipated to be <5 kilogram (kg) at the baseline visit. 7. Participants platelet count is <100,000 per milliliter (mL). 8. Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene glycol (PEG) or Tween 80. 9. Participant has severe chronic hepatic dysfunction (eg, >5 times upper limit of normal alanine aminotransferase [ALT], aspartate aminotransferase [AST], or a documented international normalized ratio [INR] >1.5) in his medical history or at the time of screening. 10. Participant has severe renal impairment (serum creatinine >1.5 times the upper limit of normal). 11. Participant has current or recent (<30 days) use of other PEGylated drugs prior to study participation or is scheduled to use such drugs during study participation. 12. Participant is scheduled to receive during the course of the study a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day or α-interferon) other than anti-retroviral chemotherapy. 13. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study. 14. Parent or legally authorized representative has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance. 15. Parent, legally authorized representative or participant are a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study. Additional exclusion criteria for Part B (ITI) 1. Spontaneous disappearance of the inhibitor prior to ITI. 2. FVIII inhibitor titer >=0.6 BU is not confirmed by a second new blood sample and determined at the central laboratory. 3. Inability or unwillingness to comply with the protocol. ; PRIMARY OUTCOME: Number of Participants With FVIII Inhibitor Development; SECONDARY OUTCOME 1: Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies[/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 - MP4001; BRIEF: The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone) ; DRUG USED: Dymista; DRUG CLASS: New Molecular Entity (NME); INDICATION: Allergic Rhinitis; TARGET: Glucocorticoid Receptor (GR), Histamine H1 Receptor (HRH1); THERAPY: Monotherapy; LEAD SPONSOR: Meda Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female subjects 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis - Must be in generally good health - Must meet minimum symptom requirements, as specified in the protocol. - Must be willing and able to provide informed consent and to participate in all study procedures - Positive skin test to a prevalent Texas Mountain Cedar allergen Exclusion Criteria: - On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study. - Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities. - Nasal surgery or sinus surgery within the previous year. - Chronic sinusitis - more than 3 episodes per year - Planned travel outside of the study area during the study period - The use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study - Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate - Women who are pregnant or nursing - Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception* see section 6.1.1 - Respiratory Tract Infections within 14 days prior to Day screening - Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening - Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment - Significant pulmonary disease including COPD - Clinically significant arrhythmia or symptomatic cardiac conditions - A known history of alcohol or drug abuse within the last 2 years - Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsors medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subjects ability to complete this trial; or their safety in this trial. - Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures ; PRIMARY OUTCOME: Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS); SECONDARY OUTCOME 1: Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)[/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 - CL-001; BRIEF: MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the number of times subjects experience bowel movements. ; DRUG USED: MP-101; DRUG CLASS: Non-NME; INDICATION: Short Bowel Syndrome (SBS); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Marathon Pharmaceuticals, LLC; CRITERIA: Inclusion Criteria: 1. Be male or female adults, 18 years of age or older at the time of consent 2. Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies, based on the 7 days prior to Day 1 of the study a. Subjects must be >3months post intestinal resection 3. Have a history of persistent loose stools for more than 4 weeks 4. Be on a combination of Opium Tincture and an anti-diarrheal (loperamide or diphenoxylate) or an anti-diarrheal agent alone 5. If currently taking Opium Tincture, be willing to stop the continued use of Opium Tincture at screening visit until the start of study treatment and willing to stop the use of any other anti-diarrheal for the duration of the study 6. Be able to maintain their current diet for the duration of the study 7. Be on stable nutritional support (parenteral or oral) 8. Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy) 9. Females of childbearing potential must agree to use 1 of the following acceptable birth control methods: 1. Surgically sterile (hysterectomy or bilateral oophorectomy) 2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation) 3. Intrauterine device (IUD) in place for at least 3 months 4. Abstinence (not having sexual intercourse) 5. Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion 6. Stable hormonal contraceptive for at least 3 months prior to study and through study completion 7. Vasectomized partner 10. Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening 11. Be able to understand and provide signed informed consent Exclusion Criteria: 1. Unable or unwilling to stop the use of Opium Tincture or any anti-diarrheal medication at the screening visit. 2. Have any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant, is not currently controlled by medication, and is stable as deemed by the Investigator 3. Have clinically significant electrocardiogram (ECG) abnormalities as determined by the PI or vital sign abnormalities (systolic blood pressure < 90 mmHg, diastolic blood pressure < 60 mmHg, or heart rate >100 bpm) at screening 4. Have clinically significant elevation of liver enzymes (> 3 times the upper limit of normal) or clinically relevant renal disease, (creatinine >1.5) or any other clinically significant abnormal laboratory test results found during medical screening as determined by the Principal Investigator 5. Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to safely participate and reliably complete the study 6. Have a history of alcohol or substance abuse within the past 2 years. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz. beer, 5.0 oz. wine, or 1.5 oz. distilled spirits) 7. Have a known allergy or intolerance to Opium Tincture or any of the excipients in the formulation (alcohol, opium, or morphine) 8. Is currently taking an opioid derivative (other than Opium Tincture) or any other medication which, in the opinion of the investigator, could interfere with the interpretation of the study results 9. Are currently taking antibiotics for bacterial overgrowth 10. Have participated in another interventional clinical trial within 30 days prior to screening with the exception of observational cohort studies or non-interventional studies. 11. Have known or suspected pregnancy, planned pregnancy, or lactation 12. Have a planned surgery over the course of the study 13. Have a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk ; PRIMARY OUTCOME: Percentage of responders between Treatments A and B for the Intent-To-Treat (ITT) population; SECONDARY OUTCOME 1: Percentage of responders between Treatments A and B for the Modified-Intent-To-Treat (mITT) population[/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 - Protocol 303; BRIEF: A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers ; DRUG USED: OTI-15-01; DRUG CLASS: Biologic; INDICATION: Diabetic Foot and Other Ulcers; TARGET: Stem Cells/Other Cell Therapies, Tissue Scaffolding; THERAPY: Monotherapy; LEAD SPONSOR: Osiris Therapeutics; CRITERIA: Inclusion Criteria: 1. Between 18 years and 80 years of age inclusive, as of the date of screening 2. Confirmed diagnosis of Type I or Type II Diabetes 3. An Index Ulcer defined as chronic (presence of wound for > 4 weeks), but not present for more than 52 weeks at the Screening Visit 4. Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot 5. The Index Ulcer is between 1 cm2 and 15 cm2, inclusive, at the Screening Visit 6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule 7. Wound is free of necrotic debris 8. Patient has adequate circulation to the foot as documented by either: - Ankle Brachial Index (ABI) > 0.70 and < 1.30, or - In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50, or - In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing). Exclusion Criteria: 1. Index Ulcer is of non-diabetic pathophysiology 2. Gangrene is present on any part of the affected foot 3. Index Ulcer is over an active Charcot deformity 4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit 5. Patient is currently receiving dialysis or planning to go on dialysis 6. Patient has had 2 or more previous disease-related amputations of the lower extremities 7. Patient has a glycated hemoglobin A1c (HbA1c) level of >10% 8. Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening 9. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening 10. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening 11. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration 12. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS) 13. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site 14. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening 15. Patient has active malignancy other than non-melanoma skin cancer 16. Patients Index Ulcer has decreased by ≥20% during 1-week screening period 17. Patients random blood sugar is >350 mg/dl at screening 18. Patient has untreated alcohol or substance abuse at the time of screening 19. Pregnant women and women who are breastfeeding 20. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening 21. Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies 22. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study 23. Patients who have already been randomized in Protocol 303 at any center may not be considered for screening or for re-entry into the trial at any center, even after the end of their follow-up period 24. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol. ; PRIMARY OUTCOME: Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, by the End of Single-Blind Treatment Visit with follow-up confirmation of continued closure at 2 consecutive study visits 2 weeks apart; SECONDARY OUTCOME 1: Complete index wound closure by the End of Single-Blind Treatment Visit as defined by 100% re-epithelialization, 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 - SEQUOIA (w/FOLFOX); BRIEF: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. ; DRUG USED: Pegilodecakin; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: IL-10 (Interleukin-10) and IL-10 Receptor (IL-10R); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: 1. The presence of metastatic pancreatic adenocarcinoma 2. Measurable disease per RECIST v.1.1 3. Participant must have documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan 4. Eastern Cooperative Oncology Group Performance Status of 0 - 1 5. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline 6. Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease. 7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study 8. No peripheral neuropathy 9. No known history of dihydropyrimidine dehydrogenase deficiency Exclusion Criteria: 1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma 2. Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours. 3. Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen 4. Participants who were intolerant of a gemcitabine containing regimen. 5. History of positivity for human immunodeficiency virus 6. Chronic active or active viral hepatitis A, B, or C infection 7. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage) 8. Pregnant or lactating women 9. Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders 10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks 11. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy),within 28 days prior to randomization or anticipated surgery during the study period 12. Prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1 ; 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 - EMPOwER (vs. Placebo); BRIEF: This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine ; DRUG USED: Aimovig; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key inclusion criteria: 1. Documented history of migraine in the 12 months prior to screening 2. 4-14 days per month of migraine symptoms 3. >=80% diary compliance during the Baseline period Key exclusion criteria: 1. >50 years old at migraine onset 2. Pregnant or nursing 3. History of cluster or hemiplegic headache 4. Evidence of seizure or major psychiatric disorder 5. Score of 19 or higher on the BDI 6. Active chronic pain syndrome 7. Cardiac or hepatic disease ; PRIMARY OUTCOME: Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP); SECONDARY OUTCOME 1: Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 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 II/III - BROADEN Study (Partial Lipodystrophy); BRIEF: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing. ; DRUG USED: Waylivra; DRUG CLASS: New Molecular Entity (NME); INDICATION: Familial Partial Lipodystrophy (FPL); TARGET: Apolipoprotein C-III (apoCIII, apo-CIII, apo-C3); THERAPY: Monotherapy; LEAD SPONSOR: Akcea Therapeutics; CRITERIA: Inclusion Criteria: - Must give written informed consent to participate in the study (signed and dated) and any authorizations required by law. - Clinical diagnosis of familial partial lipodystrophy (FPL) plus diagnosis of type 2 diabetes mellitus, hypertriglyceridemia, and fatty liver. - Diagnosis of FPL is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (less than or equal to [≤] 10 millimeters [mm]) and women (≤ 22 mm), and at least 1 of the following: 1. Genetic diagnosis of FPL OR 2. Family history of FPL or of similar abnormal fat distribution plus 1 Minor Criteria OR 3. In the absence of FPL-associated genetic variant or family history, 2 Minor Criteria and body mass index (BMI) less than (<) 35 kilogram per meter square (kg/m^2). - Diabetes not well controlled on antidiabetic therapy with glycated hemoglobin (Hb) HbA1c more than or equal to (≥) 7 percentage (%) to ≤ 12% at Screening. - Hypertriglyceridemia with fasting triglycerides (TG) levels greater than or equal to (≥) 500 milligrams per deciliter (mg/dL) (≥ 5.7 millimoles per liter [mmol/L]) at Screening and Qualification visit, or Fasting TG levels ≥ 200 (≥ 2.26 mmol/L) at both Screening and Qualification Visits for participants who meet the genetic or family history criteria. - Presence of hepatosteatosis (fatty liver), as evidenced by a screening magnetic resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%. Exclusion Criteria: - A diagnosis of generalized lipodystrophy. - A diagnosis of acquired partial lipodystrophy. - Acute pancreatitis within 4 weeks of Screening. - History within 6 months of Screening of acute or unstable cardiac condition. - Low-density lipoprotein cholesterol (LDL-C) more than (>) 130 mg/dL on maximal tolerated statin therapy. - Platelet count < lower limit of normal (LLN). - Treatment with metreleptin within the last 3 months prior to Screening. ; PRIMARY OUTCOME: Randomized Treatment Period: Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG); SECONDARY OUTCOME 1: Randomized Treatment Period: Percent Change From Baseline in Hepatic Steatosis as Assessed by Hepatic Fat Fraction Using Magnetic Resonance Imaging (MRI)[/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 - 1220.8 (Treatment-naive/Experienced); BRIEF: The objectives of this study are: 1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335 (high dose given for 12 weeks or low dose given for 24 weeks both in combination with Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients. 2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV treatment. ; DRUG USED: Faldaprevir; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detectable hepatitis C virus (HCV) ribonucleic acid ( RNA) at screening in addition to: 1. Positive anti-HCV antibodies or detectable HCV RNA at least 6 months prior to screening or, 2. Liver biopsy consistent with chronic HCV infection 2. HCV genotype 1 infection confirmed by genotypic testing at screening 3. Therapy-naïve to interferon, pegylated interferon, and ribavirin (cohort 1). Or Confirmed prior relapse with an approved dose of PegIFN/RBV(Cohort 2) defined as undetectable HCV RNA (based on an assay considered sensitive at the time of treatment) at the end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow up 4. HCV RNA =1,000 IU/mL at screening 5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation 6. Age 18 to 70 years 7. Female patients: 1. with documented hysterectomy, 2. who have had both ovaries removed, 3. with documented tubal ligation, 4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or 5. of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin 6. Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, and intra uterine device. Male patients: 1. who are documented to be sterile, or 2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor) 8. Signed informed consent form prior to trial participation Exclusion criteria: 1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Incidental steatosis diagnosed by biopsy is not an exclusion criterion 3. HIV co-infection 4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface Antigen (HBs-Ag) 5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months 7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study 8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study 9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomisation.Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened 10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to randomisation and throughout the treatment phase 11. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors 12. Known hypersensitivity to any ingredient of the study drugs 13. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI)) within last 6 months prior to randomisation (Visit 2) Other exclusion criteria related to pegylated interferon-a and/or ribavirin restrictions are not listed here. ; PRIMARY OUTCOME: Sustained Virological Response 12 weeks post-treatment (SVR12): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid ( RNA) <25 IU/mL undetected at 12 weeks after the originally planned treatment duration.; SECONDARY OUTCOME 1: Virological response after 24 weeks of treatment discontinuation (SVR24): Plasma HCV RNA level <25 IU/mL, undetected; 24 weeks after the originally planned treatment duration[/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 - 1245.28 - vs. Glimepiride; BRIEF: This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control. ; DRUG USED: Jardiance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Diagnosis typ 2 diabetes mellitus - Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation - HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1 - 18 years or more - BMI equal or less than 45Kg/m2 Exclusion criteria: - Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in - Any other antidiabetic drug within 12 weeks prior to randomisation except metformin - Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent - Indication of liver disease - Moderate to severe renal impairment - Bariatric surgery within past 2 years - Medical history of cancer or treatment for cancer within last 5 years - Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell - Contraindications hypersensitivity to concomitant drugs - Treatment with anti-obesity drugs ; PRIMARY OUTCOME: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.; SECONDARY OUTCOME 1: The Change in Body Weight From Baseline After 104 Weeks of Treatment.[/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 - SEC-WH-301; BRIEF: This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis. ; DRUG USED: Solosec; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Microbial DNA, Reactive Oxygen Species/Free Radicals; THERAPY: Monotherapy; LEAD SPONSOR: Lupin Research Inc; CRITERIA: Inclusion Criteria: - adult female or post-menarche adolescent girl ≥12 years of age in general good health - Have a diagnosis of trichomoniasis at the screening visit as determined by one of the following: - positive T. vaginalis NAAT test within 30 days of screening for which treatment has not been initiated. - positive OSOM® rapid test. - positive wet mount assessment. - Agree to abstain from vaginal intercourse until the final study visit - Agree not to have any vaginal penetration or use of any vaginal products for the duration of the study Exclusion Criteria: - Are pregnant, lactating, or planning to become pregnant during the study. - Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak - Are suspected clinically of having an acute urinary tract infection. - Have active genital lesions, including primary syphilitic chancres and herpes simplex virus lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator (patients with genital warts may be enrolled). - Have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the Baseline Visit (Day 1). ; PRIMARY OUTCOME: Microbiological Cure at the TOC Visit; 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 - CHAMPION-ALS; BRIEF: The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS. ; DRUG USED: Ultomiris; DRUG CLASS: Biologic; INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Complement component 5 (C5), Complement Pathway; THERAPY: Monotherapy; LEAD SPONSOR: Alexion Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS). 2. ALS onset ≤ 36 months from Screening. 3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment. 4. Upright slow vital capacity ≥ 65% predicted at Screening. 5. If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles). 6. Body weight ≥ 40 kilograms at Screening. 7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Key Exclusion Criteria: 1. History of Neisseria meningitidis infection. 2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer). 3. Dependence on invasive or non-invasive mechanical ventilation. 4. Previously or currently treated with a complement inhibitor. 5. Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater. ; PRIMARY OUTCOME: Change From Baseline In Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score; SECONDARY OUTCOME 1: Time To Ventilator Assistance-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 - vs. Palliative Chemotherapy; BRIEF: The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy. ; DRUG USED: CV-301; DRUG CLASS: Biologic; INDICATION: Pancreatic Cancer; TARGET: Carcinoembryonic antigen (CEA), Immune System, Mucin 1 (MUC-1); THERAPY: Monotherapy; LEAD SPONSOR: Therion Biologics Corporation; CRITERIA: Inclusion Criteria: - Patients > 18 years of age who have been vaccinated against smallpox; - Histologically confirmed diagnosis of adenocarcinoma of the pancreas; - Patient has metastatic (Stage IV) disease; - ECOG performance status 0-1; - Failed a gemcitabine-containing chemotherapeutic regimen within 3 months of study entry. Exclusion Criteria: - Prior or concurrent immunotherapy for cancer; - Radiation therapy within 28 days prior to registration; - Systemic corticosteroid therapy (except inhaled or topical steroids) within 28 days of registration; - Significant cardiovascular abnormalities or diseases; - Known positive for HIV, hepatitis B and/or C; - Evidence of immunodeficiency or immune suppression. ; PRIMARY OUTCOME: ; 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 - HER2CLIMB-02 (w/T-DM1); BRIEF: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. ; DRUG USED: Tukysa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: HER2/neu or ErbB-2; THERAPY: Monotherapy; LEAD SPONSOR: Seagen Inc.; CRITERIA: - Inclusion Criteria: - Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory - History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination - Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy - Measurable or non-measurable disease assessable by RECIST v1.1 - ECOG performance status score of 0 or 1 - CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following: (a) No evidence of brain metastases (b) Untreated brain metastases not needing immediate local therapy (c) Previously treated brain metastases 1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy 2. Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met: (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days. (ii) Other sites of evaluable disease are present 3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions - Exclusion Criteria: - Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). - CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following: 1. Any untreated brain lesions >2 cm in size 2. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent). 3. Any brain lesion thought to require immediate local therapy 4. Known or concurrent leptomeningeal disease as documented by the investigator 5. Poorly controlled generalized or complex partial seizures ; PRIMARY OUTCOME: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment; SECONDARY OUTCOME 1: 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 - 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 III - ILLUMINATE-A; BRIEF: The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1). ; DRUG USED: Oxlumo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyperoxaluria; TARGET: Glycolate Oxidase (GO); THERAPY: Monotherapy; LEAD SPONSOR: Alnylam Pharmaceuticals; CRITERIA: Inclusion Criteria: - Willing to provide written informed consent or assent and to comply with study requirements - Confirmation of PH1 disease - Meet the 24 hour urine oxalate excretion requirements - If taking Vitamin B6 (pyridoxine), must have been on stable regimen for at least 90 days Exclusion Criteria: - Clinically significant health concerns (with the exception of PH1) or clinical evidence of extrarenal systemic oxalosis - Clinically significant abnormal laboratory results - Known active or evidence of HIV or hepatitis B or C infection - An estimated GFR of < 30 mL/min/1.73m^2 at screening - Received an investigational agent within 30 days or 5 half-lives before the first dose of study drug or are in follow-up of another clinical study - History of kidney or liver transplant - Known history of multiple drug allergies or allergic reaction to an oligonucleotide or GalNAc - History of intolerance to subcutaneous injection - Women who are pregnant, planning a pregnancy, or breast-feeding or those of child bearing potential and not willing to use contraception - History of alcohol abuse within the last 12 months, or unable or unwilling to limit alcohol consumption throughout the study ; PRIMARY OUTCOME: Percent Change in 24-hour Urinary Oxalate Excretion Corrected for Body Surface Area (BSA) From Baseline to Month 6; SECONDARY OUTCOME 1: Absolute Change in 24-hour Urinary Oxalate Corrected for BSA From Baseline to Month 6[/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 - CARMEN-LC03; BRIEF: Primary Objectives: - Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS]) - Study success is defined either on PFS or OS - The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) - The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: - To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel - To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel - To evaluate the safety of tusamitamab ravtansine compared to docetaxel - To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel ; DRUG USED: SAR408701; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Antibody-drug Conjugate (ADC), CEACAM5 (CD66e); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - At least 18 years of age or above (or countrys legal age of maturity if above 18 years) and signed the informed consent. - Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor. - Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of greater than or equal to 2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50% of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC). - At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1. - A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention. - A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention. Exclusion Criteria: - Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention. - Significant concomitant illnesses, including all severe medical conditions that would impair the patients participation in the study or interpretation of the results. - History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment. - Non-resolution of any prior treatment related toxicity to less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy - History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis - Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted. - Concurrent treatment with any other anticancer therapy. - Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5. - Contraindication to use of corticosteroid premedication. - Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research. - Poor bone marrow, liver or kidney functions - Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial. ; PRIMARY OUTCOME: Progression free survival (PFS); SECONDARY OUTCOME 1: Objective response rate (ORR)[/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 - FREEDOM-HF (Real World Observation Study); BRIEF: The study is to evaluate the safe admission avoidance and the overall economic impact associated with management of worsening HF using the drug-device combination product, the Furoscix Infusor, outside the hospital setting in patients initially presenting to the emergency department. The study drug, Furoscix (furosemide injection 8 mg/ml), is a furosemide solution buffered to a neutral pH containing 80 mg/10 mL for subcutaneous administration over 5 hours via the Furoscix Infusor. The study objectives are: 1. To evaluate differences in healthcare resource utilization and direct medical costs for patients treated with the Furoscix Infusor outside the hospital versus patients receiving intravenous furosemide for ≤ 72 hours in the hospital setting for 30 days post-discharge from the emergency department. 2. To evaluate the safety of Furoscix administered outside the hospital. 3. To evaluate and describe quality of life and patient satisfaction for patients who receive the Furoscix Infusor outside the hospital setting. ; DRUG USED: Furoscix; DRUG CLASS: Non-NME; INDICATION: Chronic Heart Failure - Reduced Ejection Fraction (Chronic HFrEF); TARGET: Na-K-Cl cotransporter (NKCC2); THERAPY: Monotherapy; LEAD SPONSOR: scPharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Age 18-80 years 2. NYHA Class II-III HF presenting to the emergency department for worsening HF at baseline 3. On background therapy includes those receiving 40-160 mg of oral furosemide equivalents daily (20-80 mg Torsemide or 1-4 mg Bumetanide). 4. Signs of extracellular volume expansion, defined as one or more of the following: 1. jugular venous distention 2. pitting edema (≥1+), 3. abdominal distension 4. pulmonary congestion on chest x-ray 5. pulmonary rales 5. After initial emergency department evaluation and treatment (i.e., at the time of the care transition decision*), candidates for parenteral diuresis outside of the hospital, defined as all the following: 1. Oxygen saturation ≥ 90% on exertion 2. Respiratory Rate < 24 breaths per minute 3. Resting Heart Rate < 100 beats per minute 4. Systolic Blood Pressure > 100 mmHg 6. Adequate environment for at-home administration of Furoscix Exclusion Criteria: 1. Presence of a complicating condition, other than HF that requires immediate hospitalization or anticipated hospitalization in the next 30 days 2. Evidence of acute renal failure as determined at the discretion of the investigator 3. Known allergy to the active and inactive ingredients of the study medication or device adhesive 4. Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc. 5. Currently participating in another interventional research study 6. Women who are pregnant or who could become pregnant and are not willing to use an adequate form of contraception 7. Estimated Creatinine Clearance < 30 mL per minute by Cockcroft-Gault equation CrCl (mL/min) = {(140 - age) x Lean Body Weight (kg)/Serum Creatinine (mg/dL) x 72} (x 0.85 if female) 8. If baseline creatinine value is available: an increase of ≥ 0.5 mg/dL in creatinine from baseline 9. HF requiring immediate hospitalization ; PRIMARY OUTCOME: Healthcare Utilization Costs; SECONDARY OUTCOME 1: Heart-Failure Related Hospital Admissions[/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. Sorafenib; BRIEF: This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study. ; DRUG USED: Tislelizumab; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: BeiGene; CRITERIA: Key Inclusion Criteria: 1. Histologically confirmed diagnosis of HCC 2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach 3. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only]) 4. Measurable disease 5. Child-Pugh score A 6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1 7. Adequate organ function Key Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology 2. Tumor thrombus involving main trunk of portal vein or inferior vena cava 3. Loco-regional therapy to the liver within 28 days before randomization 4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization 5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment 6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse 7. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization 8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy 9. QT interval corrected for heart rate (QTc) (corrected by Fridericias method) > 450 msec at Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/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 - HARMONY II (Add on to Modafinil); BRIEF: The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy ; DRUG USED: Wakix; DRUG CLASS: New Molecular Entity (NME); INDICATION: Narcolepsy; TARGET: Histamine H3 Receptor (HRH3); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Bioprojet; CRITERIA: Inclusion Criteria: - De novo patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy - patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months - partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period Exclusion Criteria: - Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances - Current or recent history of a substance abuse or dependence disorder including alcohol abuse - Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigators opinion would preclude the patients participation ; PRIMARY OUTCOME: Cataplexy attacks reported on sleep diary; SECONDARY OUTCOME 1: Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,[/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 - CheckMate 498 (vs. Temozolomide); BRIEF: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - Males and Females, age ≥ 18 years old - Newly-diagnosed brain cancer or tumor called glioblastoma or GBM - Tumor test result shows MGMT unmethylated type - Karnofsky performance status of ≥ 70 (able to care for self) Exclusion Criteria: - Prior treatment for GBM (other than surgical resection) - Any known tumor outside of the brain - Recurrent or secondary GBM - Active known or suspected autoimmune disease - Biopsy with less than 20% of tumor removed Other protocol-defined inclusion/exclusion criteria apply ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Kaplan-Meier Plot of 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 - PGTC Seizures; BRIEF: This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures. Eligible Subjects, adults and adolescents, will continue to take their usual AEDs and receive either cenobamate or placebo. Subjects will have a 50% chance or receiving cenobamate or placebo (sugar pill). Subjects will initially receive 12.5 mg of cenobamate or placebo (study drug) and increase the dose every two weeks until they reach a target dose of 200 mg. Subjects will take study drug at approximately the same time in the morning (once a day) with or without food. If tolerability issues arise, dosing can be changed to evening. Also, once a subject reaches 200 mg, the dose can be decreased one time to 150 mg, if necessary. The treatment period is 22 weeks and there is a 3 week follow up period, which includes a one week decrease in study drug to 100 mg prior to stopping. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight. Subjects who complete may be eligible for an extension study and will not have to complete the follow up period. Subjects will track their seizure types and frequency in a diary throughout the study. ; DRUG USED: Xcopri; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: GABA, Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: SK Life Science, Inc.; CRITERIA: Inclusion Criteria: 1. Subject is male or female and aged ≥12 years. 2. Written informed consent signed by the subject or legal guardian, or legally authorized representative (LAR), prior to entering the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. Age- appropriate assent will be obtained for adolescents. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the Informed Consent Form (ICF) in accordance with ICH guidelines. 3. Female subjects of childbearing potential are willing to use an acceptable form of birth control 4. Subject has a clinical diagnosis of PGTC seizures (with or without other subtypes of generalized seizures) in the setting of idiopathic generalized epilepsy. 5. Subject experiences at least 5 PGTC seizures in 12 weeks during the Pre-Randomization Period. 6. Subject has had a routine electroencephalogram (EEG) within 5 years prior to Visit1 (Screening/Baseline) or during the Pre-Randomization Period with electroencephalographic features consistent with idiopathic generalized epilepsy; other concomitant anomalies must be explained by adequate past medical history. 7. Subject has undergone computed tomography (CT) or magnetic resonance imaging (MRI) within 10 years prior to Visit 1 (Screening/Baseline) or during the Pre-Randomization Period that ruled out a progressive cause of epilepsy. 8. Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens for a minimum of 30 days prior to Visit 1 (Screening/Baseline). 1. Benzodiazepines (except diazepam, see Exclusion Criterion No.7) taken at least once per week during the 30 days prior to Visit 1 (Screening/Baseline) for epilepsy, anxiety, or sleep disorder will be counted as 1 AED and the dosage must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed. (See Exclusion Criterion No. 10 for intermittent benzodiazepine rescue parameters.) 2. Subjects receiving felbamate as a concomitant AED must meet the following criteria: i. Have a 2-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening/Baseline). ii. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate. 9. Subject with an implanted vagal nerve or deep brain stimulator will be allowed if the stimulator was implanted at least 5 months prior to Visit 1 (Screening/Baseline) and the stimulator parameters are not changed for 30 days prior to Visit 1 and for the duration of the study. 10. Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 (Screening/Baseline) and will remain stable for the duration of the study. Exclusion Criteria: 1. Female subjects who are pregnant (or planning to become pregnant during the study), lactating, or breast-feeding. 2. Subject has a history o f status epilepticus that required hospitalization within 12 months prior to Visit 1 (Screening/Baseline). 3. Subject has PGTC seizure clusters where individual seizures cannot be counted or classified. 4. Subject has a history of non-epileptic psychogenic seizures. 5. Subject has a concomitant diagnosis of Partial Onset Seizures (POS). 6. Subject has a clinical diagnosis of Lennox-Gastaut syndrome. 7. Subject is currently taking (within the 30 days prior to Visit 1 [Screening/Baseline]) any of the following medications: diazepam (for any reason other than as intermittent benzodiazepine rescue medication), phenytoin, mephenytoin, fosphenytoin, phenobarbital, primidone, ethotoin, clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, or efavirenz. 8. Subject has participated in previous cenobamate clinical studies. 9. Subject has a history of vigabatrin use within 5months prior to Visit 1 (Screening/Baseline), or the subject plans to begin treatment with vigabatrin during the study. a) A subject with a history of vigabatrin use that ended more than 5 months prior to Visit1 may be enrolled after documented evidence of no vigabatrin-associated clinically significant abnormality in an automated visual perimetry test. 10. Subject has a history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) 4 or more times within the 30 days prior to Visit 1 (Screening/Baseline). 11. Subject has received an investigational drug or device within 30 days prior to Visit 1 (Screening/Baseline). 12. Subject has a history of drug or alcohol dependency or abuse within 2 years prior to Visit 1 (Screening/Baseline). 13. Subject tests positive, via urine drug screen at Visit 1 (Screening/Baseline), for illicit drugs not legalized in your region/state, or for a drug that has not been prescribed (e.g., certain opiates). 14. Subject has a history of any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization. 15. History of AED-associated rash that involved conjunctiva or mucosae. 16. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication. 17. Subject has evidence of clinically significant abnormalities or disease (e.g., psychiatric, cardiac, respiratory, gastrointestinal, hepatic [aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal (ULN), or total or direct bilirubin not more than ULN], or renal disease) that, in the opinion of the Principal Investigator, could affect the subjects safety or conduct of the study. 18. Presence of congenital short QT syndrome or relevant replicated change in QT/QTc interval less than 340 msec on ECG. 19. Subject has any significant active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results. 20. Subject has a creatinine clearance less than 50 mL/min, as calculated by Cockcroft-Gault equation. 21. Subject has an absolute neutrophil count less than 1500/µL. 22. Subject has platelet count lower than 80,000/µL in subjects treated with valproate. 23. Subject has a history of positive antibody/antigen test for hepatitis A, hepatitis B, hepatitis C, or HIV. 24. Subject has any suicidal ideation (with intent with or without a plan) at Visit 1 (Screening/Baseline) or Visit 4 (Randomization) (i.e., answering YES to Question 4 and/or Question 5 on the Suicidal Ideation section of the C-SSRS). 25. Subject has more than 1 lifetime suicide attempt. 26. Subject is a staff member or immediate family member of study staff. 27. Previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension. Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor. ; PRIMARY OUTCOME: Seizure Diary; 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 - AHEAD 3-45 ; BRIEF: The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). ; DRUG USED: Lecanemab; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, cerebrospinal fluid (CSF), or plasma testing • Those 55 to 64 must have 1 of the following additional risk factors, given the relatively low rates of amyloid positivity less than (<) 65 years, before screening: - First degree relative diagnosed with dementia onset before age 75, or - Known to possess at least 1 apolipoprotein E4 variant (APOE4) allele, or - Known before screening to have elevated brain amyloid according to previous PET or CSF testing 2. Global Clinical Dementia Rating (CDR) score of 0 at screening 3. Mini Mental State Examination score greater than or equal to (>=) 27 (with educational adjustments) at screening. 4. Wechsler Memory Scale-Revised Logical Memory subscale II (WMS-R LM II) score at screening of >=6 5. A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately greater than (>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids on screening scan 6. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participants daily function 7. Provide written (or electronic, if allowed per country-specific regulations) informed consent 8. Willing and able to comply with all aspects of the protocol Exclusion criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Females who are breastfeeding or pregnant at screening or baseline 2. Females of childbearing potential who: • Within 28 days before study entry, did not use a highly effective method of contraception For sites outside of Europe, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception 3. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of screening 4. Current or history within the past 2 years of psychiatric diagnosis or symptoms that, in the opinion of the investigator, could interfere with study procedures 5. Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening 6. Hypersensitivity to any monoclonal antibody treatment 7. Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study 8. Bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5) at screening 9. Results of laboratory tests conducted during screening that are outside the following limits: - Thyroid stimulating hormone (TSH) above normal range - Abnormally low (below lower limit of normal [LLN]) serum vitamin B12 levels for the testing laboratory (if participant is taking vitamin B12 injections, level should be at or above the LLN for the testing laboratory). A low vitamin B12 is exclusionary, unless the required follow-up labs (homocysteine and methylmalonic acid [MMA]) indicate that it is not physiologically significant 10. Known to be human immunodeficiency virus (HIV) positive 11. Any other clinically significant abnormalities that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety 12. Malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants with treatment cycles completed at least 6 months before screening). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before screening need not be excluded 13. Answer yes to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before screening, at screening, or at baseline, or has been hospitalized or treated for suicidal behavior in the past 5 years before screening 14. Known or suspected history of drug or alcohol abuse or dependence within 2 years before screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse 15. Taking prohibited medications 16. Participation in a clinical study involving: - Any anti-amyloid immunotherapy (example, therapeutic monoclonal antibody or active anti-amyloid vaccine) at any time, unless it can be documented that the participant was randomized to placebo or never received study drug - Any immunoglobulin therapy, or vaccine within 6 months before Screening, unless it can be documented that the participant was randomized to placebo or never received study drug - Lecanemab - Any new chemical entities or investigational drug for AD within 6 months before screening unless it can be documented that the participant received only placebo - Any other investigational medication or device study in the 8 weeks or 5 half-lives (whichever is longer) of the medication before randomization unless it can be documented that the participant was in a placebo treatment arm 17. Planned surgery during the pre-randomization phase or within 3 months of randomization, which requires general anesthesia ; PRIMARY OUTCOME: A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216; SECONDARY OUTCOME 1: A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216[/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 - Cardiogenic Shock (TRIUMPH); BRIEF: Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from making a bodily substance called nitric oxide. The body may produce excess nitric oxide following severe heart damage leading to shock. During a heart attack, and especially after a blocked artery causing the heart attack is reopened, a large amount of nitric oxide is released into the heart muscle and into the blood. Normally small amounts of nitric oxide are good for the heart and blood vessels. However, when released in large amounts, such as during a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering the hearts ability to pump blood to the body. It may cause blood pressure to be lowered and reduce the amount of blood flow to the bodys vital organs. This may interfere with the bodys organs being able to do their work. If Tilarginine Acetate Injection can stop extra nitric oxide from being made, the performance of the heart and blood flow to the organs may get better, which may result in the improvement of symptoms. The purpose of this study (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection compared to placebo (an inactive fluid that has no effect on the body but looks exactly like the medication being studied). The study will help determine whether Tilarginine Acetate Injection, by temporarily lowering the amount of nitric oxide released into the vital organs can improve blood pressure and the blood flow to the bodys organs. ; DRUG USED: Tilarginine acetate; DRUG CLASS: New Molecular Entity (NME); INDICATION: Acute Coronary Syndrome (ACS); TARGET: Nitric Oxide Synthase; THERAPY: Monotherapy; LEAD SPONSOR: Arginox Pharmaceuticals; CRITERIA: Inclusion Criteria: - Confirmed myocardial infarction (heart attack) - Confirmed persistent cardiogenic shock - Confirmed patency of the infarct related artery (heart attack artery has been opened through the use of a blood clot dissolving drug or a balloon or angioplasty heart procedure) - Less than 24 hour duration of cardiogenic shock (the time since the heart attack occurred and the artery was opened must be less than 24 hours) Exclusion Criteria: - Infection - Other cause of shock (not heart attack) - Shock due to heart valve disease - Severe heart valve disease - Right sided heart failure - Shock due to arrhythmia (irregular heart rhythm) - Severe kidney disease - Aortic dissection (tear in aorta) - Adult respiratory distress syndrome (ARDS) (severe lung inflammation) - Severe brain damage - Severe irreversible multi-system failure (failure of multiple body organs) - Major chest or abdominal surgical procedure within 30 days except if prior CABG and reocclusion occurs - Primary pulmonary hypertension (high blood pressure in the arteries of the lungs) - Age younger than 18 years - Requirement for emergency coronary artery bypass grafting (CABG) or infarct-related artery occlusion (heart attack artery completely blocked) - Ongoing or recent participation in another clinical trial of an investigational drug - Prior enrollment in this study or rapid resolution of cardiogenic shock before treatment (shock gets better before study starts) - Positive pregnancy test in women who are of childbearing potential ; PRIMARY OUTCOME: All cause mortality at 30 days post randomization; SECONDARY OUTCOME 1: Number of patients demonstrating resolution of cardiogenic shock compared to placebo[/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 - 1966; BRIEF: The control of glucose homeostasis in subjects with type 1 diabetes is fragile since exogenous insulin cannot compensate for changing requirements and is not precise either in terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near total absence of insulin secretion, the physiological post prandial inhibition of glucagon secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a need for therapies beyond insulin that can further improve glycemic control and reduce fluctuations in glucose in these subjects. The investigators have recently shown that Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours, when added to insulin in subjects with well controlled type 1 diabetes reduces mean and standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide concentrations did not alter following Liraglutide, it is likely that the suppression of glucagon may have contributed to this effect. The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the dose of insulin required prior to and following 52 weeks of treatment with 1.8 mg of liraglutide daily. Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying. Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after treatment with 1.8 mg of daily subcutaneous liraglutide. ; DRUG USED: Victoza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: University at Buffalo; CRITERIA: Inclusion Criteria: 1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2. Regularly measuring blood sugars four times daily. 3. HbA1c of less than 8.5%. 4. Well versed with carbohydrate counting. 5. Age 18-75 years. 6. BMI 20-40 kg/m2 Exclusion Criteria: 1. Type 1 diabetes for less than 6 months; 2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3. Hepatic disease (transaminase > 3 times normal) or cirrhosis; 4. Renal impairment (serum eGFR < 30ml/min/1.73m2); 5. HIV or Hepatitis B or C positive status; 6. Participation in any other concurrent clinical trial; 7. Any other life-threatening, non-cardiac disease; 8. Use of an investigational agent or therapeutic regimen within 30 days of study. 9. history of pancreatitis 10. pregnancy 11. inability to give informed consent 12. history of gastroparesis 13. history of medullary thyroid carcinoma or MEN 2 syndrome. ; PRIMARY OUTCOME: HbA1c; SECONDARY OUTCOME 1: Mean weekly glucose 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 - C21005 (Chemo-Experienced); BRIEF: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy ; DRUG USED: Orteronel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Cytochrome P450c17; THERAPY: Combination; LEAD SPONSOR: Millennium Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: Each participant must meet all of the following inclusion criteria: - Voluntary written consent - Male 18 years or older - Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - Radiograph-documented metastatic disease - Progressive disease - Prior surgical castration or concurrent use of an agent for medical castration - Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse - Screening laboratory values as specified in protocol - Stable medical condition - Life expectancy of 6 months or more - Participants who have had up to 2 prior chemotherapy treatments are eligible to participate Exclusion Criteria: Participants meeting any of the following exclusion criteria are not to be enrolled in the study: - Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue - Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone - Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug - Radioisotope therapy or external beam radiation therapy within 4 weeks of first dose of study drug - Documented central nervous system metastases - Treatment with any investigational compound within 30 days prior to first dose of study drug (Participants who are in long-term follow-up following active treatment in other trials are eligible) - Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected - Uncontrolled cardiovascular condition as specified in study protocol - Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C - Unwilling or unable to comply with protocol - Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel - Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy - Prostate cancer confined to just the prostrate bed or immediate adjacent tissue ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Radiographic Progression-free Survival (rPFS)[/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 - WHO study; BRIEF: This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin. ; DRUG USED: Moxidectin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anti-Parasitic and Anti-Protozoal; TARGET: Glutamate-gated chloride ion channels (invertebrates); THERAPY: Monotherapy; LEAD SPONSOR: Medicines Development for Global Health; CRITERIA: Inclusion Criteria: - Male and female subjects with Onchocerca volvulus infection Exclusion Criteria: - Pregnant or breast feeding women; coincidental loiasis ; PRIMARY OUTCOME: skin microfilaria density (mf/mg); SECONDARY OUTCOME 1: skin microfilaria density (mf/mg)[/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 - Onset 7; BRIEF: This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes. ; DRUG USED: FIAsp; DRUG CLASS: Non-NME; INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening ; PRIMARY OUTCOME: Change in the Percentage of HbA1c; SECONDARY OUTCOME 1: Change in 8-point SMPG Profile: Mean PPG Over All Three Meals[/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 - Dementia (JP); BRIEF: To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory [CMAI] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimers type dementia ; DRUG USED: Abilify (Oral and IM); DRUG CLASS: New Molecular Entity (NME); INDICATION: Alzheimers Disease (AD); 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: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible). - Patients who satisfy both of the following diagnostic criteria: - Diagnosis of major neurocognitive disorder due to Alzheimers disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5) - Diagnosis of probable Alzheimers disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) - Hospitalized patients or care facility patients - Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22 Exclusion Criteria: - Patients with complications of dementia or memory impairment other than Alzheimers type dementia - Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher - Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances - Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke - Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV - Patients who require drug therapy for arrhythmia or ischemic heart disease - Body weight of less than 30 kg - Patients with a high risk of suicide - Patients with a complication or history of seizure disorder - Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis - Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent) ; PRIMARY OUTCOME: CMAI; SECONDARY OUTCOME 1: Clinical Global Impression of Severity （CGI-S）[/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 - ASTEROID 5; BRIEF: The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids. ; DRUG USED: Vilaprisan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine Fibroids; TARGET: Progesterone Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Women, 18 years or older at the time of Visit 1 - Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm - Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period - Use of an acceptable non-hormonal method of contraception - An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology Exclusion Criteria: - Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) - Hypersensitivity to any ingredient of the study drugs - Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) - Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug including - Abuse of alcohol, drugs, or medicines (eg: laxatives) - Undiagnosed abnormal genital bleeding - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results ; PRIMARY OUTCOME: Amenorrhea (yes/no); SECONDARY OUTCOME 1: Total volume of menstrual blood loss[/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/Glucocorticoid Treatment; BRIEF: To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults. ; DRUG USED: Orencia; DRUG CLASS: Biologic; INDICATION: Giant Cell Arteritis; TARGET: Cluster of Differentiation 80 (CD80), Cluster of Differentiation 86 (CD86); THERAPY: Combination; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - New headache (new onset or new type of localized pain in the head) - Elevated ESR (≥ 50 mm/h by the Westergren method) or CRP ≥ 1 mg/dL - Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries) - Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells - Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance Angiography), ultrasound (eg, halo sign on color duplex sonography), or CT scan - Patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to enrollment into the study Exclusion Criteria: - Rheumatic disease other than GCA such as Takayasus Arteritis, granulomatosis with polyangiitis (Wegeners), rheumatoid arthritis, systemic lupus erythematosus - Patients with unilateral blindness (partial or complete) or who have unstable or recurrent visual symptoms attributable to GCA within 4 weeks of randomization - Patients with a history of dissection of aorta - Patients with a history of myocardial infarction, stroke or transient ischemic attack attributable to GCA within the 3 months of screening - Patients who have been treated with intravenous (pulse) doses of glucocorticoids defined as methylprednisolone > 1000 mg/day if given within 6 weeks of randomization - Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA - Patients at risk of tuberculosis Other protocol defined inclusion/exclusion criteria could apply ; PRIMARY OUTCOME: Patients in sustained remission; SECONDARY OUTCOME 1: Physicians Global Assessment of Disease Activity according to visual analog scale (VAS)[/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 - ARVI; BRIEF: A multicenter double-blind, randomized, placebo-controlled, parallel-group comparative Phase II / III clinical study to assess safety, tolerability, efficacy and optimal dose ranging of XC8 vs. placebo in patients with uncomplicated influenza or other ARVI during a 5-day treatment. The primary objective of the study was to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Severity Rating Scale for ARVI, and to determine the optimal dose of XC8 in the treatment of influenza and other ARVI. ; DRUG USED: XC-8; DRUG CLASS: New Molecular Entity (NME); INDICATION: Influenza (excluding vaccines); TARGET: Histamine Receptors (unspecified) ; THERAPY: Monotherapy; LEAD SPONSOR: PHARMENTERPRISES LLC; CRITERIA: Inclusion Criteria: 1. Men and women aged 18 to 45 years (inclusively). 2. Clinically diagnosed influenza or other acute or moderate ARVI based on the patients body temperature ≥37.5ºС, nasal congestion or profuse rhinorrhea and at least 1 of the following symptoms of intoxication: headache, general malaise, myalgia, pain in the eyeballs. 3. Uncomplicated course of ARVI or influenza. 4. The onset of symptoms no more than 36h prior to the inclusion into the study. 5. Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period. 6. Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol. 7. Signed Informant Consent Form. Exclusion Criteria: The patient will be deemed ineligible for the study meeting any of the following criteria: 1. Complicated course of influenza or ARVI (including the presence / development of bacterial infection). 2. Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action. 3. Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis). 4. Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs). 5. Infectious diseases during the last week before including into the study. 6. History of bronchial asthma. 7. History of increased convulsive activity. 8. Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patients prognosis, and make him/her ineligible for the clinical study). 9. History of oncological diseases, HIV, tuberculosis. 10. Hypersensitivity to excipients of the XC8. 11. Diabetes mellitus, lactose intolerance, lactase deficiency. 12. Drug or alcohol abuse. 13. Participation in any other clinical trial in the last 90 days. 14. Pregnancy or lactation. 15. Military or prison populations. 16. Impossibility or inability to comply with the study procedures. 17. A member of the investigators family or other person interested in the results of the study 18. Abnormal laboratory results, which, according to the study doctor, interfere with the patients inclusion in the study. 19. History of renal insufficiency. 20. Only for patients participating in Phase III study: Patient involvement in the first part of the study (Phase II) of FLU-XC8-01. - ; PRIMARY OUTCOME: Time to sustained improvement in clinical symptoms; SECONDARY OUTCOME 1: Body temperature below 37°C without further elevation[/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 - Co-Administration (US); BRIEF: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA. ; DRUG USED: Rotarix; DRUG CLASS: Vaccine; INDICATION: Rotavirus Vaccines; TARGET: Immune System, Rotavirus; THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Healthy infants 6 -12 weeks old at Dose 1 with written informed consent. Exclusion Criteria: - Allergic reaction to vaccine components; - clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; - immunocompromised. ; PRIMARY OUTCOME: Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.; SECONDARY OUTCOME 1: Assess immunogenicity and safety of HRV vaccine.[/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 - ADRIATIC; BRIEF: This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion criteria: 1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III). 2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules. 3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP. 4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment. Exclusion criteria: 1. Extensive-stage SCLC 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. 4. Active infection including tuberculosis, HIV, hepatitis B and C 5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy) ; PRIMARY OUTCOME: Progression-free survival (PFS); 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 - REFINE-1; BRIEF: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin). ; DRUG USED: Kybella; DRUG CLASS: New Molecular Entity (NME); INDICATION: Fat Removal; TARGET: Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Kythera Biopharmaceuticals; CRITERIA: Inclusion Criteria: 1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1 (within 28 days before randomization). 2. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1 (within 28 days before randomization). 3. Males and nonpregnant, nonlactating females 18 to 65 years of age, inclusive, on the day of randomization (Visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before Visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study. Females of childbearing potential who are not sexually active need not practice contraception. 4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. 5. Expected to understand and agree to comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subjects participation. 6. Agreement to forego any treatment or behavior (e.g., unshaven facial hair) during the subjects participation in the study that may affect the assessments of the submental area. 7. Medically able to undergo the administration of study material determined by clinical and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality. 8. Signed informed consent obtained before any study-specific procedure is performed. Exclusion Criteria: 1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents). 2. History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment. 3. A Submental Skin Laxity Grade (SMSLG) of 4 or other anatomical feature (e.g., predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands), as assessed within 28 days before randomization, for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome. 4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat. 5. Body mass index of > 40.0 as determined on Visit 1. 6. History or current symptoms of dysphagia. 7. A result on coagulation tests (PT, PTT) obtained within 28 days before randomization that indicates the presence of any clinically significant bleeding disorder. 8. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subjects ability to undergo study procedures or give informed consent. 9. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization. 10. Treatment with botulinum toxin injections in the neck or chin area within 6 months before randomization. 11. History of sensitivity to any components of the study material 12. History of sensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine). 13. Previous randomization in this study or previous participation in a Kythera-sponsored ATX 101 trial. 14. Treatment with an investigational device or agent within 30 days before randomization. 15. For centers selected to conduct magnetic resonance imaging (MRI) evaluations, any subject with the presence of any condition that would render a subject unsuitable for MRI evaluation (e.g., claustrophobia), or metals in the body that would interfere with MRI acquisition (e.g., nonremovable metal appliances in the mouth such as silver or gold caps, pacemakers, metal joints). ; PRIMARY OUTCOME: Percentage of Participants Who Achieved a Composite 1-grade Response; SECONDARY OUTCOME 1: Percentage of Participants With a Magnetic Resonance Imaging (MRI) 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 - SHIELD II; BRIEF: Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection. ; DRUG USED: D-PLEX; DRUG CLASS: Non-NME; INDICATION: Intra-Abdominal Infections (Antibacterial); TARGET: Bacterial ribosome, Protein synthesis; THERAPY: Combination; LEAD SPONSOR: PolyPid Ltd.; CRITERIA: Inclusion Criteria: 1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is >20cm (target incision). 2. Subjects are preoperative hemodynamically stable. (BP≤180/110 and >90/60 mmHg, and HR≤120 and >60 bpm, and temperature ≤37.50C and >35.50C). 3. Male or non-pregnant female. 4. Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure. 5. Subjects age 18 years old and above at screening. 6. Subjects who sign the written Informed Consent Form. 7. Subjects who are willing and able to participate and meet all study requirements. 8. Survival expectancy of at least 60 days post randomization. Exclusion criteria: 1. Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, etc.) 2. Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization. 3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis. 4. Subjects undergoing concomitant major procedures in addition to the colorectal resection. Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor . 5. Subjects who received any anti-cancer treatment within the last 4 weeks of surgery. 6. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, prior to the planned abdominal surgery. 7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization. 8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEXs excipients. 9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process). 10. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions. 11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5). 12. Subjects with severe hepatic impairment. 13. Subjects with chronic urticaria. 14. Subjects diagnosed with CVA within the past 6 months prior to randomization. 15. Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years. 16. Any subject with an active malignancy or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years. Excluding: Subjects with potentially resectable non-metastatic colorectal cancer, that is the reason for the index surgery. Subjects who have had carcinoma in situ (or other cancer in situ = Stage 0), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin. Subjects with any additional non-violent cancer that does not require treatment 4 weeks prior to the surgery, and throughout the entire study duration. 17. Subjects with other concurrent severe and/or uncontrolled medical condition. 18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study. 19. Chronic alcoholic or drug abuse subjects. 20. Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period. 21. Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study. 22. Subjects participating in any other interventional study. 23. Subjects who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition). ; PRIMARY OUTCOME: To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control.; SECONDARY OUTCOME 1: Assessment of Infection rate in patient undergoing abdominal colon surgery[/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 - ISTART; BRIEF: The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety. ; DRUG USED: Zubsolv; DRUG CLASS: Non-NME; INDICATION: Substance Use Disorder; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Orexo AB; CRITERIA: Inclusion Criteria: 1. Male/female 18-65 years old 2. Able to read, comprehend & sign the informed consent form 3. Meet opioid dependence criteria in DSM-IV-TR the past 12 months 4. Have a buprenorphine-negative UDS &/or urine dipstick 5. Prepared to abstain from opioids other than the study drug & from other addictive drugs 6. Negative urine pregnancy test 7. Females of childbearing potential who use a reliable method of contraception. Females of non-childbearing potential; surgically sterile or post-menopausal as defined by being at least 50 years of age & having an absence of menses for at least 2 years 8. Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain 9. Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor 10. At least mild withdrawal symptoms (COWS ≥9) Exclusion Criteria: 1. Pregnant, lactating or planning to be pregnant during study 2. Unwilling/unable to comply with the requirements of the protocol (e.g., pending incarceration) are in a situation/condition that may interfere with participation in the study 3. Prescribed treatment with generic buprenorphine monotherapy within 90 days prior start of treatment 4. Daily dose of methadone over 30 mg during the past week or who received the last dose of methadone less than 30 hours prior to treatment 5. Participating in other clinical studies in which medications is delivered or who have used an investigational drug/device within the last 30 days 6. Allergy, sensitivity or intolerance to BUP, NAL or any related drug; history of drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject/study 7. Staff, affiliated with, or family member of the staff directly involved with this study 8. Serious untreated Axis I DSM-IV-TR psychiatric comorbidity (actively suicidal or homicidal, have untreated schizophrenia) 9. Tongue/oral deformities that may affect the absorption of the drug products 10. Current/history of clinically significant medical disorder or condition which would jeopardize the safety or impact the validity of the results. Unclear cases should be discussed with & approved by the medical monitor 11. HIV-seropositive with a CD4+ count <200, active AIDS defining infection in the last 120 days 12. Have Class III/IV congestive heart failure, symptomatic myocardial ischemia or history of long QT syndrome (or an immediate family member with this condition) 13. Currently taking Class 1A antiarrhythmic medications (e.g., quinidine, procainamide, & disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, & dofetilide) 14. Have uncontrolled hypertension, pulse oximetry ≤92%or clinically significant abnormality on 12-lead ECG, including a corrected QT (QTc) interval >450 ms 15. Severe liver disease ; PRIMARY OUTCOME: Primary Endpoints of Retention in Treatment at Days 3 and 15; SECONDARY OUTCOME 1: Clinical Opiate Withdrawal Scale (COWS) Scores: Induction[/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 - KEYNOTE-040; BRIEF: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigators choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. ; DRUG USED: Keytruda; 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: Monotherapy; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Has histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies - Failure of prior platinum therapy - Radiographically-measurable disease based on RECIST 1.1 - Tumor tissue available for PD-L1 biomarker analysis - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ function - Female participants of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care - Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care Exclusion Criteria - Disease is suitable for local therapy administered with curative intent - Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to randomization - Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease - Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy - Not recovered from adverse events due to therapy more than 4 weeks earlier - Prior anti-cancer monoclonal antibody (mAb) therapy within 4 weeks prior to study Day 1, or not recovered from adverse events due to agents administered more than 4 weeks earlier - Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 - Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast cancers - Active autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, corticosteroids, or immunosuppressive agents - Active central nervous system (CNS) metastases and/or carcinomatous meningitis - Active, non-infectious pneumonitis - Active infection requiring systemic therapy - Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial therapy according to local standard of care - Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy or previously participated in a Merck pembrolizumab (MK-3475) trial - Human immunodeficiency virus (HIV) - Hepatitis B or C - Live vaccine within 30 days of planned start of study therapy ; PRIMARY OUTCOME: Initial Overall Survival (OS) for All Participants; SECONDARY OUTCOME 1: OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)[/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 - MARIPOSA; BRIEF: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). ; DRUG USED: Lazertinib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor), T790M EGFR; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation - The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care - Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis) - Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level - Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy Exclusion Criteria: - Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease) - Participant has an active or past medical history of leptomeningeal disease - Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent - Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis - Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib - Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study ; PRIMARY OUTCOME: Progression-Free Survival (PFS) According to RECIST v1.1 by Blinded Independent Central Review (BICR); 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 - Egypt; BRIEF: The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, Non-structural 5A protein (NS5A); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Willing and able to provide written informed consent - Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy - HCV genotype 4 at screening - HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only) - Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI) - Body mass index (BMI) ≥ 18 kg/m^2 - Screening laboratory values within defined thresholds - Use of effective protocol-approved contraception methods Key Exclusion Criteria: - History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) - Pregnant or nursing females or male with pregnant female partner - Clinically-relevant drug or alcohol abuse within 12 months of screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 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 II/III - MOTIVATE-1; BRIEF: Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48. ; DRUG USED: Selzentry; DRUG CLASS: New Molecular Entity (NME); INDICATION: HIV / AIDS; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Combination; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities) - HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL - Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks - Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide - Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure - A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP) - Effective barrier contraception for WOCBP and males Exclusion Criteria: - Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir) - Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days - Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy - Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days - Active alcohol or substance abuse sufficient, in the Investigators judgement, to prevent adherence to study medication and/or follow up - Lactating women, or planned pregnancy during the trial period - Significant renal insufficiency - Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period - Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization - Significantly elevated liver enzymes or cirrhosis - Significant neutropenia, anemia or thrombocytopenia - Malabsorption or an inability to tolerate oral medications - Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease - Certain medications - Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial - X4- or dual/mixed-tropic virus or repeated assay failure - Any other clinical condition that, in the Investigators judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy ; PRIMARY OUTCOME: Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline; SECONDARY OUTCOME 1: Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL[/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 - Korean; BRIEF: The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis. ; DRUG USED: Prolia (Osteoporosis); DRUG CLASS: Biologic; INDICATION: Osteoporosis / Osteopenia; TARGET: RANK Ligand (RANKL); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Ambulatory Korean postmenopausal women with osteoporosis - greater than 5 years postmenopausal - aged 60 to 90 years old - absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded. Exclusion Criteria: - previous or current metabolic bone disease, Pagets or Cushings disease, or hyperprolactinemia - current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria - rheumatoid arthritis - cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal - medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates - medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists - malignancy within 5 years except certain resected types - malabsorption syndrome or gastrointestinal disorders associated with malabsorption - abnormal calcium level - vitamin D deficiency - any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results - severe renal impairment or on dialysis - impaired immune system or subject is taking immunosuppressants - oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery - any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures - any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results - known to have tested positive for HIV - less than two lumbar vertebrae evaluable for DXA measurements - height, weight, or girth that may preclude accurate DXA measurements - drug or alcohol abuse within 12 months that interferes with understanding or completing the study - known sensitivity to mammalian cell-derived drug products - use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s) ; PRIMARY OUTCOME: Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6; SECONDARY OUTCOME 1: Mean Percent Change From Baseline in Lumbar Spine BMD at Month 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 - RESET-HA; BRIEF: This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201. ; DRUG USED: TRM-201; DRUG CLASS: Non-NME; INDICATION: Cartilage and Joint Repair; TARGET: Cyclooxygenase 2 (COX2) / Prostaglandin-Endoperoxide Synthase 2 (PTGS2); THERAPY: Monotherapy; LEAD SPONSOR: Tremeau Pharmceuticals, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of hemophilia A or B - Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial - Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening - Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening. - Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain - Primary source of pain is due to Hemophilic Arthropathy Exclusion Criteria: - Taking opioids for greater than 4 days per week prior to screening - Has a history of advanced renal disease or severe liver disease (within the last 6 months) - Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA) - Uncontrolled or poorly controlled hypertension - History of major cardiac or cerebrovascular disease - History of an upper GI perforation, obstruction, or major GI bleed or current evidence of GI bleeding - Has active hepatitis C or hepatitis B infection or uncontrolled HIV. Note: Patients who are HIV positive are allowed to participate if considered to be controlled. - Has a positive drug screen for all prohibited drugs of potential abuse at screening - Has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening ; PRIMARY OUTCOME: The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine.; 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 - A2328 27.5/12.5mcg; BRIEF: Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation. ; DRUG USED: Utibron Neohaler; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: Beta Adrenergic Receptors, Muscarinic acetylcholine receptor; THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases. Other protocol-defined inclusion/exclusion criteria may apply. ; PRIMARY OUTCOME: Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment; SECONDARY OUTCOME 1: Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks 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 III - AURA3; BRIEF: A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene ; DRUG USED: Tagrisso; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Subjects with histologically or cytologically documented NSCLC. - Locally advanced or metastatic NSCLC - Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment - Eligible to receive treatment with the selected doublet-chemotherapy - Central confirmation of T790M+ mutation status - World Health Organization (WHO) performance status 0-1 - At least one lesion, not previously irradiated. Exclusion Criteria: - • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment - Treatment with more than one prior line of treatment for advanced NSCLC - Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment - Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment - Previous treatment with Osimertinib, or a 3rd generation EGFR TKI For subjects who cross-over to Osimertinib: - Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review. - At least 14 days since last dose of platinum-based doublet chemotherapy ; PRIMARY OUTCOME: Progression Free Survival (PFS) by Investigator Assessment; SECONDARY OUTCOME 1: Objective Response Rate (ORR) by Investigator Assessment[/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 - NEO3-06; BRIEF: The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. ; DRUG USED: Lymphoseek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Head and Neck Cancer - Imaging; TARGET: Macrophages, Mannose, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Navidea Biopharmaceuticals; CRITERIA: Inclusion Criteria: Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study: 1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study. 2. The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0. 3. Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation. 4. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy. 5. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan. 6. Patients with prior malignancy are allowed provided the patient meets the following criteria: Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; AND No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence. 7. The patient is at least 18 years of age at the time of consent. 8. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2. 9. If the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of Lymphoseek, OR has documentation of surgical sterilization, OR has documented evidence of postmenopausal status for at least 1 year. Exclusion Criteria: Patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study: 1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx. 2. The patient is pregnant or lactating. 3. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes. 4. Patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck. 5. Patients who have had other nuclear imaging studies conducted within 15 days or consenting. 6. The patient is actively receiving systemic cytotoxic chemotherapy. 7. Patient is currently participating in another investigational drug study or participated within 30 days prior to consenting. 8. Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy. ; PRIMARY OUTCOME: False Negative Rate (FNR); SECONDARY OUTCOME 1: Negative Predictive Value (NPV)[/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 - ASSERT-EXT; BRIEF: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) ; DRUG USED: Bylvay; DRUG CLASS: New Molecular Entity (NME); INDICATION: Alagille Syndrome; TARGET: Ileal Bile Acid Transporter (IBAT)/Apical Sodium-dependent Bile Acid Transporter (ASBT); THERAPY: Monotherapy; LEAD SPONSOR: Albireo; CRITERIA: Inclusion Criteria: 1. Completion of the 24-week Treatment Period of Study A4250-012 2. Signed informed consent and assent as appropriate. Patients who turn 18 years of age (or legal age per country) during the study will be required to re-consent to remain on the study 3. Caregivers (and age-appropriate patients) must be willing and able to use an electronic diary (eDiary) device as required by the study 4. Sexually active males and females must agree to use a reliable contraceptive method with ≤1% failure rate (such as hormonal contraception, intra-uterine device, or complete abstinence) from signed informed consent through 90 days after last dose of study drug. Exclusion Criteria: 1. Decompensated liver disease, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy 2. Patients who were not compliant with study drug treatment or procedures in Study A4250-012 3. Any other conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study 4. Known hypersensitivity to any components of odevixibat ; PRIMARY OUTCOME: Change in pruritus; SECONDARY OUTCOME 1: Change in serum bile acids[/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 - ORACLE MS (Early MS); BRIEF: A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS. ; DRUG USED: Mavenclad; DRUG CLASS: Non-NME; INDICATION: Multiple Sclerosis (MS); TARGET: Ribonucleotide Reductase (RNR); THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Male or female between 18 and 55 years old, inclusive - Weighed between 40 to 120 kilogram (kg), inclusive - Participant has experienced a single, first clinical event suggestive of MS within 75 days prior to the Screening visit, (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic - Participant has at least two clinically silent lesions on the T2-weighted MRI scan, at screening, with a size of at least 3 millimeter (mm), at least one of which is ovoid or periventricular or infratentorial on screening MRI - Participant has EDSS 0 - 5.0 at Screening - Participant has no medical history or evidence of latent tuberculosis infection (LTBI) or active tubercular disease, as evidenced by the Mantoux tuberculosis (TB) skin test or a comparable sensitive test according to local regulations/guidelines (if the Mantoux test is not available), and/or a chest X-ray - Participant has normal hematological parameters at Screening, as defined by the central laboratory that performed all the assessments - If female, she must: - be neither pregnant nor breast-feeding, nor attempting to conceive and - use a highly effective method of contraception throughout the entire duration of the study and for 90 days following completion of the last dose of study medication. A highly effective method of contraception is defined as those which result in a low failure rate (that is less than 1 percent per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner, or - be post-menopausal or surgically sterilized (Note: for Danish sites only, participants should use a hormonal contraceptive or intrauterine device for the duration of the trial) - Male participants must be willing to use contraception to avoid impregnating partners throughout the study, and for 90 days following the last dose of study medication - Be willing and able to comply with study procedures for the duration of the study - Participant has to provide written informed consent voluntarily, including, for United states of America (USA), participant authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care - Participant has refused any treatment already available for clinically isolated syndrome (CIS) such as interferons or glatiramer acetate, at the time of entry into the Initial Treatment Period of this study Exclusion Criteria: - Participant has a diagnosis of MS (per McDonald criteria, 2005) - Participant has any other disease that could better explain the participants signs and symptoms - Participant has complete transverse myelitis or bilateral optic neuritis - Participant using or has used any other approved MS disease modifying drug (DMD) - Participant has used any investigational drug or undergone an experimental procedure within 12 weeks prior to Study day 1 - Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to screening MRI. The MRI had to be performed 30 days after the oral or systemic corticosteroids or ACTH treatment. In case this interfered with MRI timing the screening period could be extended accordingly. - Participant has abnormal total bilirubin, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit of normal - Participant suffered from current autoimmune disease other than MS - Participant suffered from psychiatric illness (including history of, or concurrent, severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the participant or could affect compliance with the study protocol - Participant suffered from major medical illness such as cardiac (for example angina, congestive heart failure or arrhythmia), endocrinologic, hepatic, immunologic, metabolic, renal, pulmonary, gastrointestinal, dermatologic, or other major disease that would preclude the administration of oral cladribine - Participant has a history of seizures not adequately controlled by medications - Participant has a known allergy to cladribine, interferon-beta, the excipient(s) of the study medications, or to gadolinium- diethylenetriamine penta-acetic acid (DTPA) - Participant has any renal condition that would preclude the administration of gadolinium (for example acute or chronic severe renal insufficiency (glomerular filtration rate [GFR] less than 30 milliliter per minute per 1.73 square meter [mL/min/1.73 m^2]) - Participant has a history of chronic or clinically significant hematological abnormalities - Participant has a history of active or chronic infectious disease or any disease that compromises immune function (for example human immunodeficiency virus positive [HIV+], human T-lymphotrophic virus [HTLV-1], Lyme disease, latent tuberculosis infection [LTBI] or TB, insulin-dependent diabetes). - Participant has previously been screened in this study (signed an informed consent) and then withdrawn - Participant has received any immunomodulatory or immunosuppressive therapy) at any time prior to Study Day 1, including, but not limited to, the following products: any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (for example natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4 [CD4]), intravenous immunoglobulin G (IVIG), cytokines or anti-cytokine therapy - Participant has received experimental MS treatment - Participant has a history of alcohol or drug abuse - Participant has intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen - Participant has inability to administer subcutaneous injections either by self or by caregiver - Participant has prior or current malignancy (with the exception of in situ basal or squamous cell skin cancer surgically removed without recurrence for at least five years) - Participant has a positive stool hemoccult test at Screening ; PRIMARY OUTCOME: ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS; SECONDARY OUTCOME 1: ITP: Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS[/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. Erlotinib or Gefitinib; BRIEF: This is a phase III, open label, randomized controlled multi-center global study designed to evaluate the safety and efficacy of single agent nazartinib (EGF816) compared with investigators choice (erlotinib or gefitinib) in patients with locally advanced or metastatic NSCLC who are treatment naïve and whose tumors harbor EGFR activating mutations (L858R or ex19del). ; DRUG USED: EGF816; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Written informed consent obtained prior to any screening procedures. - Histologically documented locally advanced or metastatic, stage IIIB/ IIIC or stage IV NSCLC with documented EGFR activating mutation (L858R or ex19del) - Provision of a tumor tissue sample to allow for retrospective analysis of EGFR mutation status - No prior treatment with any systemic antineoplastic therapy in the advanced setting - Recovered from all toxicities related to prior treatment - Presence of at least one measurable lesion according to RECIST 1.1 - Eastern Cooperative Oncology Group (ECOG) performance ≤1 - Meet the following laboratory values at the screening visit: - Absolute Neutrophil Count ≥1.5 x 109/L - Platelets ≥75 x 109/L - Hemoglobin (Hgb) ≥9 g/dL - Creatinine Clearance ≥ 45 mL/min using Cockcroft-Gault formula - Total bilirubin ≤1.5 x ULN - Aspartate transaminase (AST) ≤ 3.0 x ULN, except for patients with liver metastasis, who may only be included if AST ≤5.0 x ULN - Alanine transaminase (ALT) ≤ 3.0 x ULN, except for patients with liver metastasis, who may only be included if ALT ≤5.0 x ULN Exclusion Criteria: - Prior treatment with EGFR-TKI. - Known T790M positive mutation. Any other known EGFR activating mutations other than L858R or ex19del. Patients whose tumors harbor other EGFR mutations concurrent with L858R or ex19del EGFR mutations are eligible. - Symptomatic brain metastases - History of interstitial lung disease or interstitial pneumonitis - Any medical condition that would, in the investigators judgment, the patients in the study due to safety concerns, compliance with clinical study procedures or interpretation of study results - Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.. - Presence of clinically significant ophthalmologic abnormalities - Bullous and exfoliative skin disorders of any grade - Presence or history of microangiopathic hemolytic anemia with thrombocytopenia. - Known history of testing positive for human immunodeficiency virus (HIV) infection - Cardiac or cardiac repolarization abnormality - Major surgery: ≤4 weeks to starting study treatment or who have not recovered from side effects of such procedure. - Unable or unwilling to swallow tablets or capsules - Female patients who are either pregnant or nursing - Women of child bearing potential who refuse or are not able to use a highly effective method of contraception as defined in the study protocol. - Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of study treatment. Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Progression Free Survival (PFS) by Blinded independent review committee (BIRC); SECONDARY OUTCOME 1: 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 - DR-103-301 (Efficacy; Teva); BRIEF: This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary. ; DRUG USED: Quartette; DRUG CLASS: Non-NME; INDICATION: Contraception; TARGET: Estrogen Receptor Alpha (ER1 or ER alpha), Estrogen Receptor Beta (ER2 or ER beta), Progesterone Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Teva Womens Health; CRITERIA: Inclusion Criteria: - Sexually active at risk for pregnancy - Agreement to use study OC therapy as their only method of birth control during the study - history of regular spontaneous menstrual cycles or withdrawal bleeding episodes - Others as dictated by FDA-approved protocol Exclusion Criteria: - Any contraindication to the use of oral contraceptives - Pregnancy or plans to become pregnant in the next 14 months - Smoker and age ≥ 35 years - Others as dictated by FDA-approved protocol ; PRIMARY OUTCOME: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight; SECONDARY OUTCOME 1: All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant 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 - JADE Compare; BRIEF: B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy 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. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment. ; DRUG USED: Cibinqo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Atopic Dermatitis (Eczema); TARGET: JAK/STAT ; THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female subjects aged 18 years or older at the time of informed consent - 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) - Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease. - Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study - Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: 1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization; 2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product. - Female subjects of non-childbearing potential must meet at least 1 of the following criteria: - Have undergone a documented hysterectomy and/or bilateral oophorectomy; - Have medically confirmed ovarian failure; or - Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. -If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study Exclusion Criteria: - Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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 subject inappropriate for entry into this study - 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 - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study - Other active nonAD inflammatory skin diseases or conditions affecting skin - Prior treatment with JAK inhibitors - Previous treatment with dupilumab - Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study ; PRIMARY OUTCOME: Percentage of Participants Achieving Investigators Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12; SECONDARY OUTCOME 1: Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16[/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 - RIM-TD; BRIEF: The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809. ; DRUG USED: Austedo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Tardive Dyskinesia; TARGET: Vesicular monamine transporters (VMATs); THERAPY: Monotherapy; LEAD SPONSOR: Auspex Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - History of using a dopamine receptor antagonist for at least 3 months - Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening - Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia - Participants with underlying psychiatric diagnosis are stable and have no change in psychoactive medications - Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months - History of being compliant with prescribed medications - Able to swallow study drug whole - Be in good general health and is expected to attend all study visits and complete study assessments - Female participants must not be pregnant and agree to an acceptable method of contraception Exclusion Criteria: - Currently receiving medication for the treatment of tardive dyskinesia - Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias - Have a serious untreated or undertreated psychiatric illness - Have recent history or presence of violent behavior - Have unstable or serious medical illness - Have evidence of hepatic impairment - Have evidence of renal impairment - Have known allergy to any component of SD-809 or tetrabenazine - Has participated in an investigational drug or device trial (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug within 30 days - Have acknowledged use of illicit drugs - Have a history of alcohol or substance abuse in the previous 12 months ; PRIMARY OUTCOME: Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal; SECONDARY OUTCOME 1: Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating[/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 - AFFINE; BRIEF: C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004. ; DRUG USED: Girocotocogene Fitelparvovec; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Main inclusion Criteria - Males who have been followed on routine Factor VIII prophylaxis therapy during the lead-in study (C0371004) and have > = 150 documented exposure days to a Factor VIII protein product - Moderately severe to severe hemophilia A (Factor VIII activity < =1%) - Suspension of FVIII prophylaxis therapy post study drug infusion Main exclusion Criteria - Anti-AAV6 neutralizing antibodies - History of inhibitor to Factor VIII - Laboratory values at screening visit that are abnormal or outside acceptable study limits - Significant and/or unstable liver disease, biliary disease, significant liver fibrosis - Conditions associated with increased thromboembolic risk such as inherited or acquired thrombophilia, or a history of thrombotic events - Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit - Active hepatitis B or C - Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of Differentiation 4 positive (CD4+) cell count ≤200 mm3 and/or viral load >20 copies/mL ; PRIMARY OUTCOME: Total annualized bleeding rate (ABR); SECONDARY OUTCOME 1: FVIII activity levels[/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 - SCC/ Other Skin Neoplasia; BRIEF: One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months. ; DRUG USED: LEO 43204; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Mitochondria, Protein Kinase C (PKC); THERAPY: Monotherapy; LEAD SPONSOR: LEO Pharma; CRITERIA: Inclusion Criteria: - Signed and dated informed consent has been obtained. - The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at the end of follow-up visit (month 14) of that trial. Exclusion Criteria: - The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area . - The subject is enrolled in any other interventional clinical trial. For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial: - The subject has been treated with ingenol mebutate or ingenol disoxate in the selected treatment area after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial. - The subject has been enrolled in any other interventional clinical trial after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial. ; PRIMARY OUTCOME: Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area; SECONDARY OUTCOME 1: Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area[/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 - MM-015; BRIEF: The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Multiple Myeloma (MM); TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Combination; LEAD SPONSOR: Celgene Corporation; CRITERIA: Inclusion Criteria 1. Must understand and voluntarily sign an informed consent form 2. Age greater than or equal to 65 years at the time of signing the informed consent 3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below: MM diagnostic criteria (all of next 3 required) 1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma 2. Monoclonal protein present in the serum and/or urine 3. Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2mg/dl) [A] Anemia (hemoglobin <10g/dl or 2g < normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease as defined by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level greater than or equal to 1.0g/dL or urine M-protein level greater than or equal to 200mg/24hours 4. Karnofsky performance status greater than or equal to 60%. 5. Able to adhere to the study visit schedule and other protocol requirements. 6. Women of Childbearing potential (WCBP) must: a. Have a negative medically supervised pregnancy test prior to the start of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices and continues sexual abstinence. b Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. 7. Males Subjects must: 1. Agree to use a condom during sexual contact with a WCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after the cessation of study therapy. 2. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 8. All subjects must 1. Have an understanding that the study drug could have potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. 4. All patients must be counseled about pregnancy precautions and risks of fetal exposure. Female Subjects: Females of childbearing potential (FCBP) with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study. In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood. Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation. Females must agree to abstain from breastfeeding during study participation and for at least 28 days after the discontinuation from the study. Male Subjects: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen. If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a study subject during study participation, study drug must be immediately discontinued. Exclusion Criteria 1. Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomization]). 2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study. 3. Pregnant or lactating females. 4. Radiotherapy within 14 days (2 weeks) of randomization. 5. Plasmapheresis within 28 days (4 weeks) of randomization. 6. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,500 cells/mL (1.5*10^9/L) Platelet count < 75,000 cells/uL (75*10^9/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/uL for subjects in whom >= 50% of bone marrow nucleated cells are plasma cells Haemoglobin < 8.0 g/dL (80 g/L) Serum creatinine > 2.5 mg/dL (221 µmol/L) Serum aspartate aminotransferase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 3.0 times upper limit of normal (ULN) 7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for greater than or equal to 3 years. Exceptions include the following: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b) 8. Neuropathy of >= grade 2 severity. 9. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis, type A, B or C. ; PRIMARY OUTCOME: Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC); SECONDARY OUTCOME 1: Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)[/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 - SPLASH; BRIEF: The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT). ; DRUG USED: PNT2002; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Androgen receptors, Folate Receptor (FOLR1), Prostate-specific Membrane Antigen (PSMA), Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: POINT Biopharma; CRITERIA: Inclusion Criteria: 1. Male aged 18 years or older. 2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3. Ineligible or averse to chemotherapeutic treatment options. 4. Patients must have progressive mCRPC at the time of consent based on at least 1 of the following criteria: 1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart. 2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion. 3. Progression of bone disease defined as the appearance of two or more new lesions by bone scan. 5. Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting. 6. PSMA-PET scan (i.e., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by the sponsors central reader. 7. Castrate circulating testosterone levels (<1.7 nmol/L or <50 ng/dL). 8. Adequate organ function, independent of transfusion: a. Bone marrow reserve: i. White blood cell (WBC) count ≥2.5 × 10^9/L OR absolute neutrophil count (ANC) ≥1.5 × 10^9/L. ii. Platelets ≥100 × 10^9/L. iii. Hemoglobin ≥8 mmol/L. b. Liver function: i. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). For patients with known Gilberts syndrome, ≤3 × ULN is permitted. ii. ALT or AST ≤3.0× ULN. c. Renal function: i. Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula (for patients in France, serum/plasma creatinine ≤1.5 × ULN or CrCl ≥60 mL/min based on Cockcroft-Gault formula). d. Albumin ≥30 g/L. 9. Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are included in this trial. 10. For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence]. 11. Willing to initiate ARAT therapy (either enzalutamide or abiraterone), pre-specified by investigator, if randomized to Treatment Arm B. 12. ECOG performance status 0 to 1. 13. Willing and able to comply with all study requirements and treatments (including 177Lu PNT2002) as well as the timing and nature of required assessments. 14. Signed informed consent. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. If noted in pathology report, prostate cancer with known significant (>10% present in cells) sarcomatoid or spindle cell or neuroendocrine components. Any small cell component in the cancer should result in exclusion. 2. Prior treatment for prostate cancer ≤28 days prior to randomization, with the exclusion of first-line local external beam, ARAT, luteinizing hormone-releasing hormone (LHRH) therapy, or non-radioactive bone-targeted agents. 3. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the last dose was administered >1 year prior to consent. 4. Prior treatment with systemic radionuclides (e.g. radium-223, rhenium-186, strontium 89). 5. Prior immuno-therapy, except for sipuleucel-T. 6. Prior PSMA-targeted radioligand therapy, e.g., Lu-177-PSMA-617, I 131-1095. 7. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer. 8. Patients who progressed on 2 or more lines of ARATs. 9. Patients receiving bone-targeted therapy (e.g. denosumab, zoledronic acid) not on stable doses for at least 4 weeks prior to randomization. 10. Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization. 11. Major surgery ≤30 days prior to randomization. 12. Estimated life expectancy <6 months as assessed by the principal investigator. 13. Presence of liver metastases >1 cm on abdominal imaging. 14. A superscan on bone scan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity. 15. Dose escalation or initiation of opioids for cancer-related pain ≤30 days prior to consent up to and including randomization. 16. Known presence of central nervous system metastases. 17. Contraindications to the use of planned ARAT therapy, [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 therapy, including but not limited to the following: - Hypersensitivity to [Ga-68]-PSMA-11, [F-18]-DCFPyL or [Lu-177]-PNT2002 excipients (Diethylenetriaminepentaacetic acid (DTPA), Sodium ascorbate, Lascorbic acid, Sodium gentisate, HCl, Sodium hydroxide). - Recent myocardial infarction or arterial thrombotic events (in the past 6 months) or unstable angina (in the past 3 months), bradycardia or left ventricular ejection fraction measurement of < 50%. - History of seizures in patients planned to receive enzalutamide. 18. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer. 19. Concurrent illness that may jeopardize the patients ability to undergo study procedures. 20. Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule. Patients that travel need to be capable of repeated visits even if they are on the control arm. 21. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 22. Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure (see 12.1 Appendix 1), unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. ; PRIMARY OUTCOME: Radiographic Progression Free Survival (rPFS); SECONDARY OUTCOME 1: Objective Response Rate (ORR)[/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 - FGCL-4592-808 (China); BRIEF: This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks. ; DRUG USED: Roxadustat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Independent; TARGET: Hypoxia-Inducible Factor-Prolyl Hydroxylase (HIF-PH); THERAPY: Monotherapy; LEAD SPONSOR: FibroGen; CRITERIA: Inclusion Criteria: 1. Ages 18 to 75 years 2. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. 3. Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4, or 5, not receiving dialysis; with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation. 4. No use of an erythropoiesis-stimulating agent (ESA) for at least 5 weeks before randomization. 5. Mean of the two most recent Hb values during the Screening Period obtained at least 6 days apart must be ≥7.0 g/dL and <10 g/dL. 6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit (based on central laboratory results). 7. Body weight: 40 to 100 kg inclusive. 8. Subjects agreeing not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period without approval of the FibroGen China Medical Monitor. Exclusion Criteria: 1. Any clinically significant infection or evidence of an active underlying infection. 2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab). 3. Chronic liver disease. 4. New York Heart Association Class III or IV congestive heart failure. 5. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1. 6. Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization). 7. Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound. 8. History of malignancy except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site. 9. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease). 10. Clinically significant gastrointestinal bleeding. 11. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition. 12. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric. 13. Anticipated elective surgery that could lead to significant blood loss during the study period. 14. Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 days. 15. Serum albumin <2.5 g/dL. 16. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1. 17. Life expectancy of <12 months. 18. Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion. 19. IV iron supplement during the Screening Period and /or unwilling to withhold IV iron. 20. Immune suppressive or systematic steroid treatment within 12 weeks prior to Day 1. 21. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day. 22. Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). 23. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study. 24. Women who are pregnant or breastfeeding. 25. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception. 26. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this study, may confound efficacy or safety assessment, or may interfere with study participation. ; PRIMARY OUTCOME: Change in Hb from baseline to the average level; SECONDARY OUTCOME 1: The proportion of subjects who achieve a confirmed Hb 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 - ATALANTE (w/Bevacizumab); BRIEF: This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months). ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Ovarian Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: ARCAGY/ GINECO GROUP; CRITERIA: Inclusion Criteria: 1. Female Patients must be ≥18 years of age. 2. Signed informed consent and ability to comply with treatment and follow-up. 3. Patients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma 4. Patients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample. - Cell pellet from pleural effusion, or ascites or lavage are not acceptable. - For core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor. 5. Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization: 1. criterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms 2. the interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry. 6. Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum. 7. Availability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy 8. Patients must have normal organ and bone marrow function : 1. Haemoglobin ≥ 10.0 g/dL. 2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. 3. Platelet count ≥ 100 x 109/L. 4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). 5. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN. 6. Serum creatinine ≤ 1.5 x institutional ULN, 7. Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or APTT is within therapeutic limits (according to site medical standard) and if the patient is on a stable dose of anticoagulants for at least two weeks at the time of randomization. 8. Urine dipstick for proteinuria < 2+. If urine dipstick is ≥2+, 24-hours urine must demonstrate ≤1 g of protein in 24 hours. 9. Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg). 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category Exclusion Criteria: 1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors). 2. Ovarian tumors of low malignant potential (e.g. borderline tumors) 3. Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1. stage < II, 2. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1or 2 endometrioid adenocarcinoma. 3. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible. 4. Other malignancy within the last 5 years except cervix or breast in situ carcinoma, breast cancer ≥ 3 years free of disease and treatment, type I stage I endometrial cancer). 5. Patients receiving radiotherapy within 6 weeks prior to study treatment. 6. Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1 7. Previous allogeneic bone marrow transplant or previous solid organ transplantation. 8. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted). 9. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4. 10. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial 1. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed. 2. Prophylactic anti-emetic corticosteroids will be avoided if possible in patients treated with pegylated liposomal doxorubicin-carboplatin or gemcitabine-carboplatin regimen. The use of corticosteroids is allowed as premedication for paclitaxel-based regimen and/or premedication in case of carboplatin hypersensitivity. 12. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegeners granulomatosis, Sjögrens syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Are eligible patients with: 1. a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone 2. controlled Type 1 diabetes mellitus on a stable insulin regimen 13. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted 14. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 15. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 16. Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza 17. Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day. 18. Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy. 19. Inadequately controlled HTN (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) 20. Clinically significant (e.g. active) cardiovascular disease, including: 1. Myocardial infarction or unstable angina within ≤ 6 months of randomization, 2. New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF), 3. Poorly controlled cardiac arrhythmia despite medication (patients with rate controlled atrial fibrillation are eligible), 4. Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision) 21. Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. 22. Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal (only applicable for patients intended to be treated with pegylated liposomal doxorubicin). 23. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization. 24. History or evidence of hemorrhagic disorders within 6 months prior to randomization. 25. Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation). 26. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression. 27. History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures). 28. Significant traumatic injury during 4 weeks prior to randomization. 29. Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations. 30. History of VEGF therapy related abdominal fistula or gastrointestinal perforation. 31. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease. 32. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure. 33. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications. 34. Women of childbearing potential (<2 years after last menstruation and not surgically sterile) not willing to use highly-effective means of contraception (Appendix 1) during the study and for 6 months after the last dose of study medication 35. Pregnant or lactating women. 36. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 37. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation. 38. Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, carboplatin, gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contraindicates the subjects participation ; PRIMARY OUTCOME: Efficacy: Progression free survival, where the date of progression is based on investigator assessment using the RECIST version 1.1; SECONDARY OUTCOME 1: Efficacy: 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 - REVISE (0091); BRIEF: This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo. ; DRUG USED: Juvista; DRUG CLASS: Biologic; INDICATION: Wound Healing; TARGET: Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Renovo; CRITERIA: Inclusion Criteria: - Patients aged 18-85 years who have provided written informed consent. - BMI between 15 and 35 kg/m2 - Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. - If females of child bearing potential, patients must be using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. - The scar area to be revised is disfiguring. To be considered disfiguring for this trial scars must have at least one of the following characteristics. - Scar area 13 or more cm in length. - Scar area at least 0.6 cm wide at widest part. - Surface contour of scar area elevated or depressed on palpation. - Scar area adherent to underlying tissue. - Skin hypo-or hyper-pigmented in an area exceeding 39cm2. - Skin texture abnormal (irregular, atrophic, shiny, scaly, etc.) in an area exceeding 39cm2. - The scar to be revised is at least 12 months old. - The investigator considers that the appearance of the scar area to be revised can be improved with surgery alone. - The scar area is linear and suitable for revision by excision and direct closure. - The scar area to be revised is symmetrical in appearance around the mid-line. - The scar area to be revised is between 7 and 20cm in length. - The scar area to be revised runs along a flat surface which is in the same focal plane and suitable for accurate medical photography. - The scar is approved for entry into the trial by the Independent Expert Screening Panel. Exclusion Criteria - Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing. - Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula : - CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) {x 0.85 for females} - Patients with a skin disorder that is chronic or currently active. - Patients who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits. - Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. - Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. - Patients undergoing investigations or changes in management for an existing medical condition (excluding the scar for revision). - Patients who are or who become pregnant up to and including Day 0 or who are lactating. - In the opinion of the Investigator, a patient who is not likely to complete the trial. - Patients who on direct questioning and physical examination have history or evidence of keloid scarring. - Patients with scar areas for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar or difficulty in taking photographs. - Patients with additional scars less than 3cm away from the area to be revised. - Patients with scars that require revision using Z-plasty, W-plasty or any other such techniques. - Patients who are involved in ongoing litigation in connection with the scar to be revised. - Patients who have had surgery in the area to be excised within one year of Day 0. ; PRIMARY OUTCOME: Global Scar Comparison Scale as assessed by an Independent Clinical Scar Assessment Panel using photographs of the treated scars.; SECONDARY OUTCOME 1: Global Scar Comparison Scale assessed by the patient looking at their own scars.[/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 - SWORD-1; BRIEF: The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants. ; DRUG USED: Juluca; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: HIV Integrase, Reverse Transcriptase; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: ViiV Healthcare; CRITERIA: Inclusion Criteria: - Participants must be able to understand and comply with protocol requirements, instructions, and restrictions. - Participants must be likely to complete the study as planned. - Participants must be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.). - HIV-1 infected men or women of >=18 years of age. - Must be on uninterrupted current regimen (either the initial or second combination antiretroviral therapy [cART] regimen) for at least 6 months prior to screening; Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification. Acceptable stable cART regimens prior to screening include 2 NRTIs plus INI (either the initial or second cART regimen), or an NNRTI (either the initial or second cART regimen), or a Boosted PI (or atazanavir unboosted) (either the initial or second PI-based cART regimen). - Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening; - Plasma HIV-1 RNA <50 c/mL at Screening; - A female may be eligible to enter and participate in the study if she is of : Non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, Child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications and completion of the Follow-up visit; Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion); Male partner sterilization with documentation of azoospermia prior to the female participants entry into the study and this male is the sole partner for that participant; The documentation on male sterility can come from the site personnels review of participants medical records, medical examination, and/or semen analysis, or medical history interview provided by her or her partner; Approved hormonal contraception for participants randomly assigned to DTG + RPV arm (and for participants randomly assigned to CAR following switch to DTG + RPV at Week 52) or approved hormonal contraception plus a barrier method for participants assigned to CAR through Week 52; Approved hormonal contraception includes: Combined estrogen and progestogen oral contraceptive, Contraceptive subdermal implant, Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label during treatment with study drug and for at least 2 weeks after discontinuation of study drug and completion of the Follow-Up Visit. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Note: these contraceptive requirements do not apply to females of reproductive potential with same sex partners only, when this is their preferred and usual lifestyle. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner. - Participants who are willing and able to understand requirements of study participation and provide signed and dated written informed consent prior to screening. - For participants enrolled in France: participants will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: Exclusionary Criteria prior to screening or Day 1: - Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL. - Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL. - Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA measurements >=50 c/mL. - Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns. - Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen). Exclusionary medical conditions: - Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study. - Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions include cutaneous Kaposis sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells per cubic millimeter (cells/mm^3). - Participants with severe hepatic impairment (Class C) as determined by Child-Pugh Classification. - Unstable liver disease (as defined by the presence of any of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). - Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg are excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb are excluded. Note: Participant positive for anti-HBc (negative HBsAg status) and positive for HBsAb are immune to HBV and are not excluded. - Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period. - History or presence of allergy to the study drugs or their components or drugs of their class; - Ongoing malignancy other than cutaneous Kaposis sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization; - Participants who in the investigators judgment pose a significant suicidality risk. Participants history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk; - Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participants ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants; - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication; Exclusionary Treatments prior to Screening or Day 1: - Use of medications which are associated with Torsades de Pointes. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses. - Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. - Participants who are currently participating or are anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization (NOTE: Participants who are already enrolled into another interventional study at time of screening may be eligible after consultation with the GlaxoSmithKline study team prior to randomization. Considerations include participants ability to attend all visits on schedule, and possible drug and study procedure compatibility). - A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART. - Current or prior history of etravirine (ETR) use. - Current use of tipranavir/ritonavir or fosamprenavir/ritonavir. - Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease DTG or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose. Exclusionary Laboratory Values or Clinical Assessments at Screening: - Evidence of viral resistance based on the presence of any resistance associated major PI, INI, NRTI, or NNRTI mutation and integrase (IN) resistance associated substitution R263K in any available prior resistance genotype assay results. Note: Prior genotypic resistance testing is not required but if available it must be provided to GlaxoSmithKline, after screening and before randomization, to provide direct evidence of no pre-existing exclusionary resistance mutations. You must wait for the study virologists to confirm the lack of exclusionary resistance mutations, which will be provided before the screening window closes. - Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result. - Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participants participation in the study of an investigational compound. - Alanine aminotransferase (ALT) >=5 × upper limit of normal (ULN), or ALT >=3 × ULN and bilirubin >=1.5 × ULN (with >35% direct bilirubin). - Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to Bazetts formula (QTcB). ; PRIMARY OUTCOME: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm; SECONDARY OUTCOME 1: Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48[/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 - AUGMENT - w/Rituximab (R/R Indolent); BRIEF: This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year. ; DRUG USED: Revlimid; DRUG CLASS: New Molecular Entity (NME); INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Angiogenesis, E3 ubiquitin ligase, Immune System; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Celgene; CRITERIA: Inclusion Criteria: - Age ≥18 years at the time of signing the informed consent document. - Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. - Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry). - Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab. - Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory. - Investigator considers rituximab monotherapy appropriate. - Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI). - Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator. - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. - Adequate bone marrow function. - Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements. Exclusion Criteria: - Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma. - Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to < 20 mg/day prednisone or prednisolone. - Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months. - Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and human immunodeficiency virus (HIV). - Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization). - Life expectancy < 6 months. - Known sensitivity or allergy to murine products. - Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years. - Prior use of lenalidomide. - Known allergy to thalidomide. - Neuropathy > Grade 1. - Presence or history of central nervous system involvement by lymphoma. - Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it. - Uncontrolled intercurrent illness. - Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document. - Pregnant or lactating females. - Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study. ; PRIMARY OUTCOME: Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC); SECONDARY OUTCOME 1: Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC[/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 - APPEAR-C3G; BRIEF: The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy. ; DRUG USED: Iptacopan; DRUG CLASS: New Molecular Entity (NME); INDICATION: C3 Glomerulopathy (C3G), including Dense Deposit Disease (DDD) and C3 Glomerulonephritis (C3GN); TARGET: Factor D (alternate complement pathway); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Male and female participants age ≥ 12 and ≤ 60 years at screening. - Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents. - Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization. - Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening. - UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15. - Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15. - Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment. - If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. Exclusion Criteria: - Participants who have received any cell or organ transplantation, including a kidney transplantation. - Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli. - Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50% - Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. - Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration - The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration. - A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae. - The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit. - The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration. - Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator. ; PRIMARY OUTCOME: Adult cohort: Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection); SECONDARY OUTCOME 1: Change from baseline in eGFR.[/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 1; BRIEF: Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: - Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator. - Subject is 18 to 75 years of age, inclusive. - Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]). - Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304): - Elevated, expansive mood - Inflated self-esteem or grandiosity - More talkative than usual or pressure to keep talking - Flight of ideas or subjective experience that thoughts are racing - Increase in energy or goal-directed activity (either socially, at work or school, or sexually) - Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments) - Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Exclusion Criteria: - Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening. - Subject answers yes to Suicidal Ideation Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit. - Subject has attempted suicide within the past 3 months. - Subject has a lifetime history of any bipolar I manic or mixed manic episode. - Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator. ; PRIMARY OUTCOME: Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores; SECONDARY OUTCOME 1: Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score[/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 - GT-1 (China, Korea and Taiwan); BRIEF: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. ; DRUG USED: Harvoni; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Polymerase - Nucleoside Binding Site, 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 - HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse. - Genotype 1 HCV at screening - HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy Key Exclusion Criteria: - Pregnant or nursing female - Chronic liver disease of a non-HCV etiology - Current or prior history of any clinically-significant illness (other than 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 12 Weeks After Discontinuation of Therapy (SVR12); SECONDARY OUTCOME 1: Percentage of Participants With Sustained Virologic Response 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 - Episodic Cluster Headache (ECH); BRIEF: This is a 13-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and safety of 2 dose regimens of TEV-48125 (Fremanezumab) versus placebo in adult participants for the prevention of ECH. ; DRUG USED: Ajovy; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant has a history of ECH according to the International Classification of Headache Disorders - 3 beta criteria (Headache Classification Committee of the International Headache Society [IHS] 2013) for ≥12 months prior to screening. - The participant has a total body weight of ≥45 kg (99 lbs.) - The participant is in good health in the opinion of the investigator - Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study. - Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [for example, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control for the duration of the study. - If a participant is receiving Botox, it should be in a stable dose regimen, considered as having ≥2 cycles of Botox prior to screening. The participant should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated. - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - The participant has used systemic steroids for any medical reason (including treatment of the current CH cycle within ≤7 days prior to screening The participant has used an intervention/device (for example, scheduled nerve blocks) for headache during the 4 weeks prior to screening. - The participant has clinically significant hematological, renal, endocrine, immunologic, pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the discretion of the investigator. - The participant has evidence or medical history of clinically significant psychiatric issues determined at the discretion of the investigator. - The participant has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma. - The participant is pregnant or lactating. - The participant has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies. - The participant has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is known that the participant received placebo during the study. - The participant has a history of prior exposure to a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If participant has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the participant received placebo in order to be eligible for this study. - The participant is an employee of the sponsor/participating study center who is directly involved in the study or is the relative of such an employee. - The participant has an active implant for neurostimulation used in the treatment of CH. - The participant is a member of a vulnerable population (for example, people kept in detention). - The participant has a history of alcohol abuse prior to screening and/or drug abuse that in the investigators opinion could interfere with the study evaluations or the participants safety . - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Mean Change From Baseline in the Weekly Average Number of Cluster Headache (CH) Attacks During the 4-Week Period After Administration of the First Dose of the IMP; SECONDARY OUTCOME 1: Percentage of Participants With a ≥50% Reduction From Baseline in the Weekly Average Number of CH Attacks During the 4-Week Period After the First Dose of the IMP[/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 - M13-606 (China); BRIEF: A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: AbbVie (prior sponsor, Abbott); CRITERIA: Inclusion Criteria: - Clinical diagnosis of psoriasis for at least 6 months. - Must have stable plaque psoriasis for at least 2 months before screening and baseline visits. - Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit. - Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit. - Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit. Exclusion Criteria: - Diagnosis of other active skin diseases or skin infections. - Participant has known hypersensitivity to adalimumab or it excipients. - Participant has chronic recurring infections or active tuberculosis. - Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease. - Participant is known to have immune deficiency or is immunocompromised. ; PRIMARY OUTCOME: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12; SECONDARY OUTCOME 1: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A][/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 - FORWARD-4 ; BRIEF: This study will evaluate the efficacy and safety of ALKS 5461. ; DRUG USED: ALKS 5461; DRUG CLASS: New Molecular Entity (NME); INDICATION: Major Depressive Disorder (MDD); TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Alkermes, Inc.; CRITERIA: Inclusion Criteria: - Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive - Agree to use an acceptable method of contraception for the duration of the study - Have a Major Depressive Disorder (MDD) primary diagnosis - Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE) - Additional criteria may apply Exclusion Criteria: - Have a current primary Axis-I disorder other than MDD - Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days - Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime - Have attempted suicide within the past 2 years - Have a positive test for drugs of abuse - Are pregnant, planning to become pregnant, or breastfeeding - Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone) - Have had a significant blood loss or blood donation within 60 days - Additional criteria may apply ; PRIMARY OUTCOME: Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score; SECONDARY OUTCOME 1: Proportion of Patients Who Exhibited Treatment Response (MADRS-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 - MSI-78-303 (vs. Ofloxacin); BRIEF: 224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic. ; DRUG USED: Locilex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Foot and Other Ulcers; TARGET: Bacteria-miscellaneous, Cell Membrane; THERAPY: Monotherapy; LEAD SPONSOR: Abeona Therapeutics, Inc; CRITERIA: Inclusion Criteria: - Non-hospitalized ambulatory patients with diabetes mellitus - Men or Women greater than 18 years old - Patients must be considered reliable, willing and able to give consent - Female patients must be postmenopausal for a least 6 months or surgically sterilized - Localized infection of the ulcer that would ordinarily be treated on an outpatient basis - Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected - Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis - Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot - Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry Exclusion Criteria: - Patients requiring concurrent local or systemic antimicrobials during the study period for other infections - Patients who are currently treated or awaiting dialysis - Patients who are unable to care for their ulcers - Patients with known alcohol or substance abuse within 6 months or study entry - Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin - Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents - Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease. - Previous enrollment in this study or previous treatment with MSI-78 Topical Cream - Patients with gangrene or severely impaired arterial supply to any portion of the affected foot - Other conditions considered by the investigator to be sound reason for disqualification - Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream - Women who are breast feeding, pregnant or attempting to become pregnant ; PRIMARY OUTCOME: Reduction in clinical signs and symptoms of the infection; SECONDARY OUTCOME 1: microbiological response to therapy,[/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 - CS31; BRIEF: This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume. The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection. ; DRUG USED: Firmagon; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Ferring Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Patient has given written informed consent 2. Patient is 18 years or older 3. Patient has histologically confirmed prostate cancer 4. Patient has a serum prostate-specific antigen (PSA) level at screening >2 ng/mL 5. The prostate size is >30 cubic centimetres (cc), measured by TRUS 6. Patient has had a bone-scan within 12 weeks before inclusion 7. Patient must be able to undergo transrectal examinations 8. Patient has an estimated life expectancy of at least 12 months Exclusion Criteria: 1. Any previous treatments for prostate cancer 2. Previous trans-urethral resection of the prostate (TURP) 3. Is not considered a candidate for medical castration 4. Use of urethral catheter 5. Is currently treated with a 5-alpha reductase inhibitor 6. Is currently treated with an alpha-adrenoceptor antagonist 7. Treatment with botulinum toxin A (Botox) 8. Require radiotherapy during the trial 9. History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema 10. Hypersensitivity towards any component of the investigational products or excipients 11. Previous history or presence of another malignancy 12. A clinically significant disorder 13. A corrected QT interval over 450 msec 14. Mental incapacity or language barrier precluding adequate understanding or co-operation 15. Receipt of an investigational drug within the last 28 days proceeding screening 16. Previous participation in any degarelix trial ; PRIMARY OUTCOME: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set); SECONDARY OUTCOME 1: Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8[/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 - CQGE031C2302E1; BRIEF: The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878). ; DRUG USED: QGE031; DRUG CLASS: Biologic; INDICATION: Urticaria; TARGET: Immunoglobulin E (IgE); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Key Inclusion Criteria: - Written informed consent - Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878) - Male and female, adult and adolescent subjects ≥12 years of age - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule Key Exclusion Criteria: - Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment - Use of omalizumab within 16 weeks of Screening - History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes - New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356) or CQGE031C2202 (NCT03437278). - Diseases with possible symptoms of urticaria or angioedema - Subjects with evidence of helminthic parasitic infection - Documented history of anaphylaxis - Pregnant or nursing (lactating) women ; PRIMARY OUTCOME: Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12; SECONDARY OUTCOME 1: Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 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 IIIb - G-PLUS (Palmoplantar-non-Pustular Psoriasis); BRIEF: The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis. ; DRUG USED: Tremfya; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: Janssen-Cilag Ltd.; CRITERIA: Inclusion Criteria: - Should have all the following: A confirmed diagnosis of moderate-to-severe palmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least one plaque at a body site other than the palms and soles for at least 6 months, to confirm a diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) score greater than or equal to (>=) 3 and less than (<) 10 at screening and at baseline; Palmoplantar Investigator Global Assessment (ppIGA) score >=3 at screening and at baseline - Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included - A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 - Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention - Agree to avoid prolonged sun exposure and agree not to use tanning booths or other ultraviolet (UV) light sources from the first administration of study intervention through 12 weeks after the final dose of study intervention (Week 56) Exclusion Criteria: - Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis (e.g, erythrodermic, guttate), or hyperkeratotic eczema - Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Has received prior systemic treatment with biological agents or Janus Kinase (JAK) inhibitors - Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents - Is infected with human immunodeficiency virus (HIV, positive serology for HIV antibody) ; PRIMARY OUTCOME: Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16; SECONDARY OUTCOME 1: Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48[/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 - ADVANCE CAPACITY; BRIEF: Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment ; DRUG USED: Ralinepag; DRUG CLASS: New Molecular Entity (NME); INDICATION: Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension (PH); TARGET: Prostacyclin Receptors; THERAPY: Monotherapy; LEAD SPONSOR: United Therapeutics; CRITERIA: Inclusion Criteria: 1. Signed informed consent form. 2. At least 18 years of age. 3. Primary diagnosis of PAH. 4. Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH. 5. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms 6. Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 90 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both. 7. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening. 8. Has a peak VO2 of ≥9 to <18 mL/min/kg during the Screening CPET, as assessed by the CPET core laboratory. 9. If the subject is taking concomitant medications that may affect the clinical manifestations of PAH, the subject must be on a stable dose for at least 30 days prior to randomization. The exception is that the dose of diuretics must be stable for at least the 10 days prior to randomization. 10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the Week 28 Visit/28-day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the final dose of study drug. Eligible male subjects must agree not to participate in sperm donation for 90 days after the final dose of study drug. Women who are surgically sterile or postmenopausal are not considered to be of childbearing potential. If of childbearing potential, female partners of male study participants should agree to utilize medically acceptable methods of contraception for the duration of study participation. Exclusion Criteria: 1. For subjects with known human immunodeficiency virus-associated PAH, a cluster of differentiation 4 T-cell count <200/mm3 at Screening. 2. Has 3 or more left ventricular disease/dysfunction risk factors. 3. Symptomatic coronary artery disease and/or myocardial infarction within past 6 months. 4. Current symptomatic aortic or mitral valve disease. 5. Has evidence of more than mild lung disease on pulmonary function tests performed within 1 year prior to, or during, Screening. 6. Has evidence of thromboembolic disease as determined by ventilation-perfusion lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. 7. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator. 8. Requires use of supplemental oxygen during CPET. 9. Respiratory exchange ratio <1.0 at Screening CPET as determined by the CPET core laboratory. 10. Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis). 11. Male subjects with a QTcF >450 msec and female subjects with a QTcF >470 msec on electrocardiogram (ECG) recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval >110 msec, will be excluded if QTcF is >500 msec for both males and females. 12. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis, or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). 13. Confirmed active infection with hepatitis B virus or hepatitis C virus. 14. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal or total bilirubin ≥2 times the upper limit of normal at Screening. 15. Chronic renal insufficiency as defined by an estimated glomerular filtration rate using the Modification of Diet in Renal Disease Study equation of <30 mL/min/1.73 m2 or requiring dialysis at Screening. 16. Hemoglobin concentration <9 g/dL at Screening. 17. Subjects treated with an intravenous, subcutaneous, inhaled, or oral prostacyclin pathway agent (eg, epoprostenol, treprostinil, iloprost, beraprost, or selexipag) for PAH within 90 days of randomization (use in vasoreactive testing is permitted). Subject is not eligible if previous prostacyclin therapy was stopped for a safety or tolerability issue related to systemic prostacyclin adverse effects. 18. Subject has pulmonary veno-occlusive disease. 19. Malignancy diagnosed and/or treated within 3 years of Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. 20. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. Subjects will not be excluded due to a positive drug screen caused by prescribed medications. 21. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation. 22. Prior participation in any study of ralinepag or another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, if the subject can fulfill all other entry criteria and comply with all study procedures. 23. Any reason that, in the opinion of the Investigator, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis (eg, right-to-left shunt detected during CPET) or impair study participation or cooperation. 24. Known hypersensitivity to ralinepag or any of the excipients. 25. Life expectancy <12 months based on the Investigators opinion. 26. Women who are pregnant, lactating, or breast-feeding. ; PRIMARY OUTCOME: Change from Baseline in peak VO2 assessed by CPET; SECONDARY OUTCOME 1: Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)[/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 - PREVAIL 3 (Study 292; Depression); BRIEF: Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression. ; DRUG USED: Latuda; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Dopamine 2 (D2) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT7 receptor; THERAPY: Combination; LEAD SPONSOR: Sumitomo Pharma America, Inc.; CRITERIA: Inclusion Criteria: 1. Provide written informed consent and is 18 to 75 years of age inclusive. 2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. 3. Has a lifetime history of at least one bipolar manic or mixed manic episode. 4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex. 5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study. 6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after 7. Good physical health on the basis of medical history, physical examination, and laboratory screening. Exclusion Criteria: 1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. 2. Any chronic organic disease of the CNS (other than Bipolar I Disorder). 3. Hospitalization for a manic or mixed episode within the past two months. 4. Used investigational compound within past 6 months. 5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months. ; PRIMARY OUTCOME: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6); SECONDARY OUTCOME 1: Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)[/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 - PAVES (w/Bevacizumab/chemo); BRIEF: This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up. ; DRUG USED: Neulasta; DRUG CLASS: Biologic; INDICATION: Neutropenia / Leukopenia; TARGET: Granulocyte-colony Stimulating Factor (G-CSFR)/CD114; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: Disease-related: - Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum - Locally-advanced or metastatic disease by radiographic evaluation - Measurable disease - Has not previously received chemotherapy for locally-advanced or metastatic colorectal cancer. Patient may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent/metastatic disease was documented. - Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Demographic: - Age of 18 years or over Laboratory: Adequate organ and marrow function as defined below: - Absolute neutrophil count at least 1.5 x 10^9/L - Platelet count at least 100 x 10^9/L - Bilirubin ≤ 1.5 times upper limit of normal - Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal or Aspartate aminotransferase and alanine aminotransferase ≤ 5.0 x upper limit of normal if attributable to liver metastasis - An in-range international normalized ratio (INR) (in-range is usually defined as between 2 and 3) for patients on a stable dose of oral anticoagulant or stable dose of low molecular weight heparin - Has no active bleeding or pathological condition that carries high risk of bleeding (eg, tumor involving major vessels or known varices). If a suspicion of bleeding diathesis exists, a bleeding time should be performed - Creatinine ≤ 1.5 times upper limit of normal General: - Written informed consent obtained - Afebrile on day 1 of cycle 1 - Must be able and willing to comply with study and/or follow-up procedures Exclusion Criteria: Disease-Related: - Known brain metastases - History of another primary malignancy less than/equal to 5 years prior to randomization, with the exception of non-melanoma skin cancer, carcinoma in situ of uterine cervix, and prostatic intraepithelial neoplasia without evidence of prostate cancer - Prior major surgical procedure less than 28 days prior to day 1 of cycle 1 chemotherapy dosing; anticipated need for major surgical procedure during the 4 cycle treatment period of the study - Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1 chemotherapy dosing - Serious nonhealing wound, ulcer, or bone fracture, or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of cycle 1 - Uncontrolled high blood pressure, history of labile hypertension, uncontrolled congestive heart failure, unstable angina within the past 3 months, myocardial infarction or history of stroke within the past 12 months, unstable symptomatic arrhythmia requiring medication, or clinically significant peripheral vascular disease - History of clinically significant bleeding within 6 months prior to randomization - History of arterial or venous thromboembolism within 6 months prior to randomization - History of other disease including uncontrolled diabetes, serious active or uncontrolled infection, metabolic dysfunction; physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the prescribed therapy or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications Laboratory: - Proteinuria > 1+, or total quantitative protein > 500 mg protein/day as determined by 24-hr urine collection Medications: - Prior radiotherapy unless treatment was limited to the target lesion and only 1 measurable lesion was treated. Progression of the irradiated lesion must be demonstrated. Patients may not have received prior radiotherapy to greater than 25% of bone marrow. Radiation must have concluded ≥ 4 weeks prior to enrollment. Prior radio-sensitizing chemoradiation will be allowed as long as it was concluded ≥ 4 weeks prior to enrollment. - Radiotherapy to non-target lesions for pain control will be allowed - Prior bevacizumab use or other agents targeting VEGF - Concurrent use of other biological agents - Use of systemic anti-infectives for active infection, during the 3 calendar days before starting study chemotherapy and bevacizumab or planned during the study treatment period General: - Current, recent (within 4 weeks of the first infusion of this study), or planned participation (during the study treatment period) in an experimental therapeutics study other than this protocol - Female participants who are pregnant or lactating or men and women of reproductive potential not willing to employ an effective method of birth control during treatment and for 20 weeks for women, and 30 weeks for men after discontinuing study treatment - History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-fluorouracil (5-FU), oxaliplatin, or leucovorin, including known sensitivity to E. Coli derived products (eg, Filgrastim, HUMULIN insulin, L-asparaginase) - Known dihydropyrimidine dehydrogenase deficiency ; PRIMARY OUTCOME: Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy; SECONDARY OUTCOME 1: Overall 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 - w/Chemotherapy +/- Bevacizumab (China); BRIEF: This is A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate AK104 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer ; DRUG USED: AK104; DRUG CLASS: Biologic; INDICATION: Cervical Cancer; TARGET: Cytotoxic T-Lymphocyte Antigen 4 (CTLA4), Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Akeso; CRITERIA: Inclusion Criteria: 1. signs the written informed consent form. 2. Women aged ≥ 18 and ≤ 75 years. 3. ECOG of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed cervical cancer, not amenable to curative surgery or concurrent chemoradiotherapy. 1. The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma; 2. No prior systemic therapy for persistent, recurrent or metastatic ([FIGO] Stage IVB) disease. 6. At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy. 7. All subjects must provide archival tumor tissue samples within 2 years prior to randomization,or fresh tumor tissue samples obtained by biopsy. 8. Subjects must have adequate organ function as assessed in the laboratory tests. 9. Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. If a female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 120 days after the last dose of study drug. Exclusion Criteria: 1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, clear cell carcinoma, sarcoma, etc. 2. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator. 3. Presence of nervous system (CNS) metastases or carcinomatous meningitis; 4. Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. Patients with other active malignancies within 3 years prior to randomization. 6. Patients who have received other prior chemotherapeutic agents. 7. Any prior treatments targeting the mechanism of tumor immunity, such as anti-angiogenic therapy (e.g., bevacizumab), immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc). 8. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study. 9. Active or potentially recurrent autoimmune disease. 10. Subjects who require systemic treatment with glucocorticoid (> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization; 11. Use of live vaccines within 4 weeks prior to randomization. 12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies. 13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 14. Known history of interstitial lung disease or non-infectious pneumonitis; unless induced by radiation therapies. 15. Serious infections requiring hospitalization. 16. Presence of active infection requiring systemic therapy. 17. Subjects with active hepatitis B and active viral hepatitis C. 18. Active or documented inflammatory bowel diseases, active diverticulitis. 19. Subjects with known history of severe hypersensitivity reactions to other monoclonal antibodies. 20. Known any contraindication to cisplatin/carboplatin, paclitaxel or allergy to any of their ingredients. 21. Pregnant or lactating women. 22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug. ; PRIMARY OUTCOME: progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST v1.1; SECONDARY OUTCOME 1: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR[/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 - CADHUM; BRIEF: This is a study that invites adults with Crohns disease and have been responding well to Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance medications in Crohns disease, particularly when in remission. Patients want to know that they truly need to take a medication, yet they dont want to have flares. The purpose of this study is to see that if we monitor the patient, along with looking at changes in their stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add as-needed dosing only, and keep them in remission. ; DRUG USED: Humira; DRUG CLASS: Biologic; INDICATION: Crohns Disease; TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Peter Higgins; CRITERIA: Inclusion Criteria: 1. Men or women 18 years of age or older at the time of informed consent. 2. Crohns disease confirmed by endoscopy with biopsies. 3. On maintenance Adalimumab at a dose of 40 mg SC q 2 weeks without concomitant immunosuppressive therapy. 4. Must be in clinical remission (CDAI <150) at the baseline/randomization (Week 0) visit and biologic remission (both CRP <0.8 and FCP <167)at Week 0. 5. Prior medication for Crohns disease may include one of the following and must have been stopped with wash out periods: Methotrexate, Azathioprine, 6-Mercaptopurine, Tacrolimus, Steroids. 6. Negative for TB, Hepatitis B-negative, and negative stool for Clostridium difficile. Exclusion Criteria 1. Unable to consent for themselves. 2. Are prisoners, students or employees of the investigators, or mentally incapacitated. 3. Are unwilling to complete this 48 week study, provide stool samples throughout, or unwilling to undergo multiple venipunctures. 4. Have a current infection with Clostridium difficile, clinically-significant intestinal stricture, history of allergy, or adverse reaction, to Adalimumab, history of sensitivity to latex. 5. Are currently using steroids or systemic immunomodulators (MTX, AZA, 6-MP, or Tacrolimus), or have used another biologic medication in the past 12 weeks other than Adalimumab, or have current or past use of Kineret® (Anakinra) or Tysabri® (natalizumab). 6. Have received any live bacterial or viral vaccinations ≤ 12 weeks prior to Week 0 and must not receive 12 months after study as well as BCG vaccination 7. Are known to have congestive heart failure. 8. Have a history of, or ongoing chronic or recurrent infectious disease, including but not limited to chronic renal, chest infection (i.e. bronchiectasis) or urinary tract infection (i.e. recurrent pyelonephritis) or open, draining, or infected skin wounds or ulcers. 9. Have evidence of current clinically active and important infection. 10. Have or ever had a non-tuberculous mycobacterium infection or serious opportunistic infection (i.e. cytomegalovirus, Pneumocystis carinii, aspergillosis). 11. Are known to be infected with HIV, Hepatitis B, or Hepatitis C. 12. Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. 13. Have a known history of lymphoproliferative disease including lymphoma. Have a history of certain malignancies within five years of screening. ; PRIMARY OUTCOME: Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms; SECONDARY OUTCOME 1: Percent Time in Remission MAINT vs. PRNLOAD[/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 - LITHE (MTX-IR); BRIEF: This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5). ; DRUG USED: Actemra (Intravenous) ; DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: IL-6 Receptor (IL-6R); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - adult patients at least 18 years of age with moderate to severe active RA for at least 6 months; - inadequate response to a stable dose of MTX; - patients of reproductive potential must be using reliable methods of contraception. Exclusion Criteria: - major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; - prior treatment failure with an anti-tumor necrosis factor agent; - women who are pregnant or breast-feeding. ; PRIMARY OUTCOME: Percentage of Participants With American College of Rheumatology-ACR20 Response; SECONDARY OUTCOME 1: Percentage of Participants With ACR50 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 IIIb - EMBARK (Re-Dosing OLE); BRIEF: The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants). ; DRUG USED: Aduhelm; DRUG CLASS: Biologic; INDICATION: Alzheimers Disease (AD); TARGET: Amyloid Beta/Amyloid Plaques; THERAPY: Monotherapy; LEAD SPONSOR: Biogen; CRITERIA: Key Inclusion Criteria: Core Treatment Period: - Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies). - Has one care partner who, in the Investigators opinion, has adequate contact with the participant as to be able to provide accurate information about the participants cognitive and functional abilities. LTE Treatment Period: - Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator. - Has one informant/care partner who, in the Investigators opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participants cognitive and functional abilities. Key Exclusion Criteria: Core Treatment Period: - Any medical or neurological condition (other than Alzheimers Disease) that might be a contributing cause of the participants cognitive impairment. - Stroke or any unexplained loss of consciousness within 1 year prior to Screening. - Clinically significant unstable psychiatric illness in past 6 months. - History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening. - A seizure event that occurred after the last visit of the feeder study and before Screening for this study. - Evidence of impaired liver function as shown by an abnormal liver function profile at Screening. - History of or known seropositivity for HIV. - Clinically significant systemic illness or serious infection within 30 days prior to or during Screening. - Contraindications to having a brain magnetic resonance imaging (MRI). LTE Treatment Period: - Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participants enrollment in and completion of the study. Note- Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); 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 - 004; BRIEF: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). ; DRUG USED: Gattex; DRUG CLASS: New Molecular Entity (NME); INDICATION: Short Bowel Syndrome (SBS); TARGET: GLP-2 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Inclusion Criteria: - Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF) - SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding - Body weight must be less than 90 kg - At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing - Body mass index (BMI) 18 to 27 kg/m2 - Adequate hepatic and renal function Exclusion Criteria: - History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state - History of alcohol or drug abuse (within previous year) - Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study - Clinically significant laboratory abnormalities at the time of randomization - Previous use of teduglutide (ALX-0600) - Prior use of native GLP-2 within 3 months of screening visit - Hospital admission within 1 month prior to screening visit - Pregnant or lactating women - Any condition or circumstance, which in the investigators opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results. - Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases ; PRIMARY OUTCOME: A Graded Response Score in Parenteral Nutrition (PN) Reduction; SECONDARY OUTCOME 1: Number of Subjects Achieving Binary Response at Week 20, Maintained 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 - REACH; BRIEF: This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. ; DRUG USED: Cyramza; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 - Child-Pugh score of <7 (Child-Pugh Class A only) - Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy - Diagnosis of HCC (excluding fibrolamellar carcinoma) in the absence of histologic or cytologic confirmation - There are either clinical, laboratory, or radiographic findings consistent with a diagnosis of liver cirrhosis - Has a liver mass measuring at least 2 centimeters (cm) with characteristic vascularization seen on either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI) with gadolinium - At least 1 measurable or evaluable lesion that is viable [that is (i.e.), is vascularized], and has not been previously treated with locoregional therapy. A lesion that has been previously treated will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy - Previously treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization. Participants may have experienced: - Radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy, or - Discontinuation of sorafenib due to an adverse drug reaction, despite dose reduction by 1 level and BSC - The participant has received sorafenib as the only systemic therapeutic intervention. Any hepatic locoregional therapy that has been administered prior to sorafenib is allowed, but not following sorafenib. Radiation to metastatic sites [for example (e.g.), bone] following sorafenib therapy is permitted. - Resolution of clinically significant toxicity of any anti-cancer therapy to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events volume 4.0 (NCI-CTCAE v. 4.0). Adequate Organ Function defined as: - Total bilirubin <3.0 milligrams/deciliter (mg/dL) [51.3 micromole/liter (µmol/L)], aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × upper limit of normal (ULN) - Serum creatinine ≤1.2 × ULN or calculated creatinine clearance >50 milliliters/minute (mL/min) - Absolute neutrophil count (ANC) ≥1.0 × 10^3/microliter (μL) (1.0 × 10^9/liter (L)]), hemoglobin ≥9 grams/deciliter (g/dL) [5.58 millimoles/liter (mmol/L)], and platelets ≥75 × 10^3/µL (75 × 10^9/L) - International Normalized Ratio (INR) ≤1.5 and partial thromboplastin time (PTT) ≤5 seconds above ULN. Participants receiving prophylactic low-dose anticoagulant therapy are eligible provided that INR ≤1.5 and PTT ≤5 seconds above the ULN - The participants urinary protein is ≤1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates ≥2+ proteinuria, then a 24-hour urine must be collected and must demonstrate <1000 milligrams (mg) of protein in 24 hours to allow participation in the study Exclusion criteria: - Major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization - Hepatic locoregional therapy within 28 days prior to randomization - Radiation to any nonhepatic (e.g., bone) site within 14 days prior to randomization - Sorafenib within 14 days prior to randomization - Received any investigational therapy or non-approved drug within 28 days prior to randomization - Received any previous systemic therapy with vascular endothelial growth factor (VEGF) inhibitors or vascular endothelial growth factor receptor (VEGFR) inhibitors (including investigational agents) other than sorafenib for treatment of HCC - Fibrolamellar carcinoma - Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony-stimulating factors (G-CSF) within 14 days prior to randomization - Therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR ≤1.5 and PTT ≤5 seconds above the ULN) are met - Receiving ongoing therapy with nonsteroidal anti-inflammatory agents (NSAIDs, e.g., indomethacin, ibuprofen, naproxen, nimesulide, celecoxib, etoricoxib, or similar agents) or other antiplatelet agents (e.g., clopidogrel, ticlopidine, prasugrel, dipyridamole, picotamide, indobufen, anagrelide, triflusal). Aspirin (ASA) at doses up to 100 milligrams/day (mg/day) is permitted - Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia - Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization - Uncontrolled arterial hypertension systolic ≥150 / diastolic ≥90 millimeters of mercury (mm Hg) despite standard medical management - Grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to randomization requiring transfusion, endoscopic or operative intervention (participants with any bleeding episode considered life-threatening during the 3 months prior to randomization are excluded, regardless of transfusion or intervention status) - Esophageal or gastric varices that require immediate intervention (e.g., banding, sclerotherapy) or represent a high bleeding risk. Participants with evidence of portal hypertension (including splenomegaly) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to randomization. Participants with evidence of portal hypertension are eligible for study participation if endoscopic evaluation does not indicate esophageal or gastric varices that require immediate intervention or represent a high bleeding risk; however, these eligible participants must receive supportive therapy (e.g., beta blocker therapy) according to institutional standards and clinical guidelines during study participation - Central nervous system (CNS) metastases or carcinomatous meningitis - History of or current hepatic encephalopathy or current clinically meaningful ascites ; PRIMARY OUTCOME: Overall Survival (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 III - TACT; BRIEF: TACT is a real world randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications. ; DRUG USED: Tecarfarin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Anticoagulation; TARGET: Vitamin K Epoxide Reductase (VKOR); THERAPY: Monotherapy; LEAD SPONSOR: Espero Biopharma; CRITERIA: General Screening Inclusion Criteria 1. Is male or female and at least 18 years of age. 2. Is able and willing to sign an IRB-approved written informed consent. 3. Is able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits. 4. Is taking a CYP2C9-interacting medication (inhibitor, substrate, or inducer; see list in Appendix A) at the time of randomization and is expected to receive this medication chronically for the duration of the trial. 5. Has either 1. Chronic kidney disease stage 3 or 4 (eGFR ≥ 15 to <60 mL/min/1.73 m2 at Screening based on central laboratory) and/or 2. A CYP2C9 genotype variant allele 6. (Only for warfarin experienced patients) Patient is considered poorly controlled on warfarin therapy as judged by the investigator, e.g. has at least 2 INR values out of target range within previous 12 months Anticoagulation-Related Inclusion Criteria 7. Requires chronic anticoagulation therapy. 8. Is willing to receive chronic anticoagulation investigational therapy for the duration of the study or, for warfarin-naïve DVT subjects, treating physician prescribed at least a 6-month treatment period with an oral anticoagulation agent. 9. Has one or more of the following indications for chronic oral anticoagulation: 1. Atrial fibrillation/flutter (paroxysmal, persistent or permanent), not due to a reversible cause, documented by electrocardiography (ECG) 2. Aortic and/or mitral prosthetic HV 3. History of venous thromboembolic disease 4. History of myocardial infarction or cardiomyopathy 5. Any another indication for which warfarin is approved or recommended, with Sponsor approval 10. Conforms to the following restrictions regarding vitamin-K containing dietary supplements: 1. If taking at Baseline (Visit 2), is willing to continue with consistent doses throughout the study 2. If not taking at Baseline (Visit 2), is willing to abstain from such supplements throughout the study General Exclusion Criteria 1. Is pregnant, nursing, or a woman of childbearing potential who cannot assure that they will not become pregnant for the duration of the study. 2. Has been treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, at time of screening. Safety-Related Exclusion Criteria 3. Has a life expectancy <1 year 4. Is age >85 years 5. Has severe end-organ disease, such as: 1. Estimated GFR (eGFR) < 15 mL/min/1.73 m2 at Screening per the central laboratory 2. Is on dialysis 3. Is expected to be on dialysis or receive kidney transplant within 6 months of screening 4. Advanced pulmonary disease requiring home oxygen 5. NYHA class IV heart failure 6. Severe psychiatric disorder such as advanced dementia 6. Has a history of ischemic stroke without residual neurologic deficit within the last 3 months, prior major ischemic stroke with residual neurologic deficit, or any history of intracranial bleeding 7. Is an ongoing alcohol or substance abuser 8. Has anemia (screening hemoglobin <9 g/dL) For subjects who have received a MHV within 4 weeks of Screening, who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed. For subjects with severe CKD (eGFR ≥ 15 to <30 mL/min/1.73 m2), who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed. 9. Has thrombocytopenia (screening platelet count <90,000 x 103/microL) 10. Has a history of or presence of any illness or condition, which, in the judgment of the Investigator, may compromise the safety of the subject during Study Drug administration. Anticoagulation-related Exclusion Criteria 11. Has active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral arterio-venous malformations, cerebral or aortic aneurysms, pericarditis or endocarditis 12. Except for MHV replacement surgery and related or concurrent procedures, has recently (<14 days from Screening) undergone non-thromboembolic surgery or other invasive procedures such as lumbar puncture. 13. Has blood dyscrasias or inherited disorders of hemostasis. 14. Has a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum. 15. Has active gross hematuria or gastrointestinal bleeding 16. Has a history of gross hematuria or gastrointestinal bleeding within the past 6 months prior to Screening. (Note: Investigators may enroll patients with such bleeding episodes if they are resolved at least 4 weeks prior to screening and if the benefits of anticoagulation outweigh the risks using accepted risk stratification methods such as HASBLED.) 17. Has received concomitant therapy with other anticoagulant or antiplatelet agents, such as clopidogrel, prasugrel, ticlopidine, dipyridamole, heparin or low molecular weight heparin (LMWH), or nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued prior to initiating tecarfarin/warfarin dosing, unless use of such drugs is necessary as part of bridging/transitioning during the first several days of Study Drug administration. Daily use of 81 - 100 mg aspirin and intermittent or chronic use of the selective COX-2 inhibitors celecoxib and valdecoxib is allowed. 18. Has congenital or acquired coagulant inhibitors present which would interfere with the use of the INR, eg: 1. Antiphospholipid antibody syndrome or positive lupus anticoagulant 2. Abnormally prolonged prothrombin time, in the absence of therapeutic anticoagulation, due to an endogenous inhibitor ; PRIMARY OUTCOME: Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population; SECONDARY OUTCOME 1: Percentage TTR for tecarfarin vs. warfarin in the sub-population of patients who are taking a CYP2C9-interacting medication and have a CYP2C9 genotype variant allele[/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 - 3583 - BEGIN: BB T1 LONG; BRIEF: This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644. ; DRUG USED: Tresiba; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type I; TARGET: Insulin Receptor; THERAPY: Combination; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Type 1 diabetes mellitus for at least 12 months - Current treatment with any basal bolus insulin for at least 12 months - HbA1c below or equal to 10.0% - BMI (Body Mass Index) below or equal to 35.0 kg/m^2 - For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228) Exclusion Criteria: - Use of any other antidiabetic drug than insulin within the last 3 months - Cardiovascular disease within the last 6 months - Uncontrolled treated/untreated severe hypertension - Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months - Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements - Cancer and medical history of cancer ; PRIMARY OUTCOME: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment; SECONDARY OUTCOME 1: Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes[/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 - MAKO (w/Lucentis); BRIEF: A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint ; DRUG USED: Squalamine Eye Drops; DRUG CLASS: New Molecular Entity (NME); INDICATION: Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology); TARGET: Calmodulin (CaM), Na+/H+ (Sodium/Hydrogen) ion transporter pump; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Ohr Pharmaceutical Inc.; CRITERIA: Inclusion Criteria: - Age ≥ 50 years - A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA) - Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm - Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study [ETDRS] chart) Exclusion Criteria: - Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea - Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes - Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye - Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease) - Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement - Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye ; PRIMARY OUTCOME: Functional change in visual acuity; SECONDARY OUTCOME 1: Functional changes in 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 - ONTRAC; BRIEF: The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study, patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be assigned by chance either to the group that will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group) or, to the group that will be treated with Gemcitabine only (about 50 patients will be in this group). How long patients survive in the 2 groups will be compared. If it looks like there is no difference between the groups, the study will stop. If it looks like patients in the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study will continue into a second part where more patients will be treated in order to confirm and better understand the findings of the first part of the study. ; DRUG USED: Estybon (Intravenous); DRUG CLASS: New Molecular Entity (NME); INDICATION: Pancreatic Cancer; TARGET: PI3K/AKT pathway, Polo-like kinase 1 (Plk1); THERAPY: Combination; LEAD SPONSOR: Onconova Therapeutics, Inc.; CRITERIA: Inclusion Criteria: - Patients at least 18 years old presenting with histopathologically or cytologically confirmed metastatic adenocarcinoma of the pancreas; metastatic disease is defined as disease which has spread beyond the peri-pancreatic lymph nodes. - Patients must have received no prior chemotherapy for pancreatic cancer, including adjuvant chemotherapy. - Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral computed tomography (CT) scan; measurable lymph nodes must be ≥15 mm in the short axis. - ECOG Performance Status of 0, 1, or 2. - Patients must have adequate renal function and serum creatinine ≤2.0 mg/dL. - Patients must have adequate liver function as defined by total bilirubin ≤2.0 mg/dL and transaminase levels no higher than 3.0 times the institutions upper limit of normal (ULN). Patients with hepatic metastases may have transaminase levels of up to 5.0 times the ULN. - All patients must have a serum albumin ≥3.0 g/dL. - Patients must have adequate bone marrow (BM) function as defined by a granulocyte count ≥1,500/mm3, a platelet count ≥100,000/mm3, and hemoglobin >9 g/dL. - Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] breast disease). - Adequate contraceptive regimen (including prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study for female patients of reproductive potential or female partners of male patients. - Female patient with reproductive potential must have a negative urine beta human chorionic gonadotropin (bHCG) pregnancy test at Screening. - Willing to adhere to the prohibitions and restrictions specified in this protocol. - Patient must have signed an informed consent document. Exclusion Criteria: - Patients with unresectable locally advanced disease without evidence of disease elsewhere. - Life expectancy of less than 12 weeks. - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or seizure disorder. - Active infection not adequately responding to appropriate therapy. - Symptomatic or clinically evident ascites. - Serum sodium less than 130 mEq/L or conditions that may predispose patients to hyponatremia. - Female patients who are pregnant or lactating. - Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol. - Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start. - Evidence of brain metastases. - Any concurrent administration and/or prior administration within 4 weeks of the first dose of study drug, of radiotherapy, or immunotherapy. - Psychiatric illness/social situations that would limit the patients ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures (e.g., drug addition, chronic non-compliance, etc.). ; PRIMARY OUTCOME: 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 - 911502 ; BRIEF: The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA) ; DRUG USED: Biosimilar Adalimumab (Momenta); DRUG CLASS: Biosimilar; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Momenta Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: 1. Participants ≥18 years old at the time of Screening 2. 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 related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations. 3. RA diagnosed for at least 6 months before Screening 4. Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria 5. Active disease at Screening and Baseline 6. Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor 7. Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s) 8. Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose. 9. Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception. Exclusion Criteria: 1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy. 2. Prior use of rituximab 3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening 4. Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted. 5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline 6. Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening 7. Current use of more than 1 nonsteroidal anti-inflammatory drug. 8. Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline 9. Prior or current use of other self-injected drugs, eg, insulin 10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline 11. Meets Class IV Steinbrocker criteria for disability/activities of daily living 12. Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor. 13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogrens syndrome is permitted. 14. Joint surgery within the last 8 weeks prior to Screening 15. Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk 16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder 17. History or presence of Class III or IV New York Heart Association congestive heart failure 18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma 19. Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas 20. Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis) 21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus 22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB. 23. Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study 24. Participant is a family member or employee of the Investigator or Baxalta or its partners ; PRIMARY OUTCOME: Usability of the Auto-injector (AI) at Week 4; SECONDARY OUTCOME 1: Number of Participants With Successful Injections as Assessed by the Observer at Week 4[/INST]No</s>