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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 - RISE; BRIEF: The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment ; DRUG USED: TV-46000; DRUG CLASS: Non-NME; INDICATION: Schizophrenia; TARGET: Alpha 1 Adrenergic Receptor , Alpha 2 Adrenergic Receptor, Dopamine 2 (D2) Receptor, Histamine H1 Receptor (HRH1), Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - The participant has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of relapse in the last 24 months. - The participant has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on discussions with family members or healthcare professionals. - The participant has a stable place of residence for the previous 3 months before screening, and changes in residence are not anticipated over the course of study participation. - The participant has no significant life events that could affect study outcomes expected throughout the period of study participation. - Women of childbearing potential and sexually-active female adolescents must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception, and agree to continue use of this method beginning 1 month before the first administration of study drugs and for the duration of the study and for 120 days after the last injection of study drug. - The participant, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, or has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male participants with sex partners who are women of childbearing potential must use condoms even if surgically sterile - Additional criteria apply, please contact the investigator for more information Exclusion Criteria: - The participant has a current clinically significant Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. - The participant is currently on clozapine or received electroconvulsive therapy in the last 12 months. - The participant has a history of epilepsy or seizures, neuroleptic malignant syndrome, tardive dyskinesia, or other medical condition that would expose the participant to undue risk. - The participant has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen, and/or hepatitis C. - The participant has current or history of known hypersensitivity to risperidone or any of the excipients of TV-46000 or the oral formulation of risperidone used in the stabilization phase. - The participant has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine. - The participant has previously participated in a Teva-sponsored clinical study with TV-46000. - The participant is a pregnant or lactating female. - The participant has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). - The participant has used an investigational drug within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening. - Additional criteria apply, please contact the investigator for more information ; PRIMARY OUTCOME: Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set; SECONDARY OUTCOME 1: Time to Impending Relapse (Number of Participants With Impending Relapse) for Extended ITT [eITT] Analysis Set[/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. LASW1510 ; BRIEF: The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK). ; DRUG USED: LAS41007; DRUG CLASS: New Molecular Entity (NME); INDICATION: Actinic Keratoses; TARGET: Unknown; THERAPY: Monotherapy; LEAD SPONSOR: Almirall, S.A.; CRITERIA: Inclusion Criteria: - Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp, - The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm, - The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm, - The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2), - Diagnosis of AK histologically confirmed Exclusion Criteria: - Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs and other non-steroidal anti-inflammatory agents, - Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of non-steroidal anti-inflammatory drugs (NSAIDs), - Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs, - Have evidence of clinically significant or unstable medical conditions, - Have currently and within the past 3 months other malignant tumors of the skin in the TAs, - Suffer from paresthesia in the TAs, - Show cornu cutaneum of the skin and/or hypertrophic AK lesions in the TAs, - Are known to be pregnant or lactating (currently or within the past 3 months), - Any clinically relevant abnormal finding during Screening and/or Baseline, - Specific topical treatments in the target area within defined time periods. - Specific physical treatments in the TAs within defined time periods. - Specific systemic treatments within defined time periods. - Patients suffering from AK in locations other than the target areas, receiving any topical AK-therapy throughout the interventional phase of the study until termination of V6, - Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as prn (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use of ASA as anticoagulative therapy will be allowed, - Patients taking methotrexate or sulfonylurea during the interventional phase of the study, - Anticoagulative therapy, e.g. with cumarines or heparines throughout the interventional phase of the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed, - Patients having any significant physical abnormalities in the potential TAs that may cause difficulty with examination or final evaluation, - Have any dermatological disease in the TAs or surrounding area that may be exacerbated by treatment with topical diclofenac or cause difficulty with examination, - Physical or mental inability and/or unwillingness to apply the study preparations correctly and to follow the study restrictions and visits, - Any suspicion of current drug and/or alcohol abuse as assessed by the investigator, - Anticipated non-availability for study visits / procedures, - Exposure to an investigational product within the last 3 months, - Any previous randomization into this trial, - Patient is institutionalized because of legal or regulatory order, - Employee of the study site or of the Sponsors company or the CRO. ; PRIMARY OUTCOME: superiority of LAS41007 compared to vehicle; SECONDARY OUTCOME 1: superiority of LAS41007 compared to vehicle[/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 305 vs. Eltrombopag; BRIEF: Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet response. Open-label Extension Phase: To evaluate the safety and tolerability of long-term therapy with avatrombopag in participants with chronic ITP (cITP). ; DRUG USED: Doptelet; DRUG CLASS: New Molecular Entity (NME); INDICATION: Immune Thrombocytopenic Purpura (ITP); TARGET: Thrombopoietin Receptor (TPO-R, c-Mpl, CD110); THERAPY: Monotherapy; LEAD SPONSOR: Eisai Inc.; CRITERIA: Inclusion Criteria: 1. Men and women greater than or equal to 18 years of age. 2. Participants diagnosed with cITP (greater than or equal to 12 months duration) according to the American Society for Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines, and an average of 2 platelet counts less than 30x10^9/L). The physical exam should not suggest any disease which may cause thrombocytopenia other than ITP. 3. Participants who previously received one or more ITP therapies (including, but not limited to corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab). 4. Participants must have had either initially responded (platelet count greater than 50x10^9/L) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndrome (MDS) or other causes of thrombocytopenia. 5. Prothrombin time/International Normalized Ratio (PT/INR) and activated partial thromboplastin time (aPTT) must have been within 80% to 120% of the normal range with no history of hypercoagulable state. 6. A complete blood count within the reference range (including white blood count [WBC] differential not indicative of a disorder other than ITP), with the following exceptions: a) Hemoglobin: participants with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal (LLN) are eligible for inclusion, if anemia was clearly attributable to ITP (excessive blood loss); b) Absolute neutrophil count (ANC) greater than or equal to 1500/uL (1.5x10^9/L) (elevated WBC/ANC due to corticosteroid treatment is acceptable). Exclusion Criteria: Core Study 1. Participants with known secondary immune thrombocytopenia (e.g., participants with known Helicobacter pylori-induced ITP, infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or with known systemic lupus erythematosus [SLE]). 2. Participants considered unable, or unwilling to comply with the study protocol requirements or give informed consent, as determined by the investigator. 3. Participants with significant medical conditions that may impact the safety of the participant or interpretation of the study results (e.g., acute hepatitis, active chronic hepatitis; lymphoproliferative disease; myeloproliferative disorders, leukemia). 4. History of MDS. 5. History of pernicious anemia or participants with vitamin B12 deficiency who have not had pernicious anemia excluded as a cause. 6. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), and more than two of the following risk factors: estrogen-containing hormone replacement or contraceptive therapies, smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.), or any other family history of arterial or venous thrombosis. 7. Participants with a history of significant cardiovascular disease (e.g., congestive heart failure [CHF] New York Heart Association Grade III/IV), arrhythmia known to increase the risk of thromboembolic events [e.g., atrial fibrillation], participants with a QT interval corrected for heart rate of >450 msec, angina, unstable angina, coronary artery stent placement, angioplasty, or coronary artery bypass grafting). 8. Participants with a history of cirrhosis, portal hypertension, and chronic active hepatitis. 9. Participants with concurrent malignant disease. 10. Use of immunoglobulins (IVIg and anti-D) within 1 week of randomization. 11. Splenectomy or use of rituximab within 12 weeks of randomization. 12. Use of romiplostim or eltrombopag within 4 weeks of randomization. 13. Participants who are currently treated with corticosteroids or azathioprine but have not been receiving a stable dose for at least 4 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization. 14. Participants who are currently treated with MMF, CsA, or danazol but have not been receiving a stable dose for at least 12 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization. 15. Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of randomization. 16. Participants who are currently treated with PPIs or H2 antagonist therapy but have not been receiving a stable dose for at least 6 weeks prior to randomization or have not completed these therapies more than 2 weeks prior to randomization. 17. Fasting gastrin-17 blood levels exceeding ULN (including subjects on PPIs and H2 antagonists) at Screening. 18. Blood creatinine exceeding ULN by more than 20% OR total albumin below the LLN by 10% (revised per Amendment 01). 19. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding 2 times the ULN; total bilirubin exceeding 1.5 times the ULN. 20. Participants with a history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy. 21. Participants with a history of ITP treatment with cytotoxic chemotherapy are still eligible for enrollment. 22. Females who are pregnant (positive beta-human chorionic gonadotropin [B-hCG] test) or breastfeeding. 23. Participants with a known allergy to E5501 or eltrombopag and any of their excipients. 24. Participants with a history of significant aminotransferase elevations while receiving eltrombopag (defined as ALT and/or AST elevation >3 x ULN). 25. Participants who are known nonresponders (defined as platelet counts that never exceed 50 x 10^9/L) to all previous TPO agonist therapy (including previous E5501 therapy) who do not have a bone marrow examination consistent with ITP taken at any point after failure of TPO therapy to rule out MDS or other causes of thrombocytopenia. ; PRIMARY OUTCOME: Change From Baseline in Local Platelet Count for the 6 Month Treatment Period; 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 - PARA_OA_002 (US/Australia); BRIEF: The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee osteoarthritis pain. Study details include: - The study duration will be up to 28 weeks per participant - The treatment duration will be 6 weeks. - The visit frequency will be twice weekly during treatment.. ; DRUG USED: Zilosul; DRUG CLASS: Non-NME; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Cell Membrane, MMP (metalloproteinase); THERAPY: Monotherapy; LEAD SPONSOR: Paradigm Biopharmaceuticals USA (INC); CRITERIA: Inclusion Criteria: - Participant must be >= 18 years of age inclusive, at the time of signing the informed consent. - Clinical diagnosis of OA in the index knee by American College of Rheumatology criteria 1986 criteria. - Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee. - Osteoarthritis pain in the index knee unresponsive (ie, the participant still experiences pain) to conservative therapy for ≥ 6 months preceding Screening, defined as history indicating that: 1. Acetaminophen/paracetamol therapy has not provided sufficient pain relief or participant is unable to take acetaminophen/paracetamol chronically/long term because of contraindication or inability to tolerate; AND 2. At least 1 oral non-steroidal anti-inflammatory drug (NSAID, including cyclooxygenase-2 inhibitors) and/or topical NSAID therapy that has not provided sufficient pain relief or participant is unable to take NSAIDs because of contraindication or inability to tolerate. - Average WOMAC NRS 3.1 Index pain sub-scale score of 4 to 10 in the index knee at Screening AND Day 1 AND a minimum pain score of 4 on either of the individual WOMAC NRS 3.1 Index questions of pain on walking on a flat surface or pain on climbing stairs at Screening AND Day 1. - Average WOMAC NRS 3.1 Index function sub-scale score of 4 to 10 in the index knee at Screening and Day 1. - Body mass index of >=18 to <=35.0 kg/m2 - Female subjects of childbearing potential and Male subjects must agree to comply with protocol specified contraceptive requirements - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. - Current non-pharmacologic treatment regimen for knee OA (excluding knee brace) must be stable for at least 2 weeks before Day 1 and remain stable throughout the study. Participant must be willing to abstain from starting a new or changing their non-pharmacologic treatment regimen for the duration of the study. - Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study. - Agrees to use acetaminophen/paracetamol or topical analgesics (topical NSAIDs are prohibited) as rescue therapy if required. Exclusion Criteria: - Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy. - History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4]). - Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding. - Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy, or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with osteoarthritis. Participants with a present (current) history of sciatica are not eligible for participation. Participants with a history of sciatica who have been asymptomatic for ≥ 3 months and who have no evidence of radiculopathy or sciatic neuropathy on thorough neurologic examination are eligible for participation. - History of other disease that may involve the index joint, including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease-related arthropathy), crystalline disease (eg, gout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Pagets disease, or tumours. - History of osteonecrosis or osteoporotic fracture (ie, a participant with a history of osteoporosis and a minimally traumatic or atraumatic fracture). - History of hypersensitivity to PPS, heparin or heparin-like drugs, or drugs of a similar chemical or pharmacological class. - Predisposition to hypersensitivity due to multiple (2 or more) atopic diseases (such as atopic eczema, asthma, and chronic allergic rhinitis and/or rhinoconjunctivitis) or multiple (2 or more) severe allergies - Allergy or contraindication to Gadolinium contrast agents - Allergy or contraindication to Tetracosactide - Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day 1. Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, Cirrhosis (Child-Pugh stage B or C), uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation. - History of pituitary irradiation or recent (within 1 year) history of transsphenoidal surgery - Any cancer within the previous 5 years, except for basal cell carcinomas. - History of or current hyperkalemia and/or hyponatremia. - History or current autoimmune polyglandular syndromes - Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. - Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin ≤100 mg/day. - Previous treatment with PPS in any form. - Current or recent (within 90 days before Day 1) immunosuppressive or immunomodulatory systemic therapy including all oral, inhaled, intranasal, intra-articular and topical corticosteroids (occasional limited use of over the counter hydrocortisone cream allowed; however, cannot be used within 1 week of any cortisol testing) - Use of opioids within 6 weeks before Day 1. - Use of bisphosphonates within 12 weeks before Day 1. - Use of denosumab and iloprost within 12 weeks before Day 1. - Use of a knee brace on the index knee within 2 weeks before Day 1. - Systemic steroids administered intravenously, intramuscularly, and orally for OA or other indications within 8 weeks before Day 1. - Intra-articular injections to the index knee: steroids within 24 weeks; hyaluronic acid or any other intra-articular injections within 24 weeks before Day 1. - Cannabinoids within 30 days before Day 1. - Use of vitamins and dietary supplements known to alter haemostasis within 2 weeks before Day 1, including ajoene, birch bark, cayenne, Chinese black tree fungus, cumin, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, grapeseed extract, milk thistle, omega 3 fatty acids, onion extract, St. Johns wort, turmeric, vitamins C and E, vitamin K. - Known prior exposure to heparin as determined by history of drug use or history of the following medical conditions or interventions: cardiac bypass surgery or thromboembolic disease - Treatment with dehydroepiandrosterone sulfates within 6 weeks before Day 1. - Chronic use of oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors within12 weeks before Day 1. - Biotin within 6 weeks before Day 1. - Megestrol Acetate within 6 weeks before Day 1 - Any medication that alters sodium and/or potassium levels (see Table Prohibited Therapy) - Participation in another clinical trial or administration of any IP or experimental product within 24 weeks or 5 half-lives (whichever is longer) before Day 1. - Activated partial thromboplastin time [aPTT]) > upper limit of normal (ULN), platelets <150,000/µL, or liver enzyme tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) ≥ 2 × ULN at Screening. - Active or chronic hepatitis B virus, hepatitis C virus, or uncontrolled HIV infection (detectable virus or diagnosis of AIDS); participants with HIV infection must be on chronic suppressive antiviral medication. - Radiographic evidence of any of the following conditions in any Screening radiograph: excessive malalignment of the knee, severe chondrocalcinosis; other arthropathies (eg, rheumatoid arthritis, psoriatic arthritis, gout), systemic metabolic bone disease (eg, Pagets disease, metastatic calcifications), primary or metastatic tumour lesions, stress, or traumatic fracture. - Radiographic evidence of any of the following conditions at Screening: 1. subchondral insufficiency fractures 2. spontaneous osteonecrosis of the knee 3. osteonecrosis 4. pathologic fracture - Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the Investigator (at Screening). - Resting, supine blood pressure (BP) ≥160 mmHg in systolic pressure or ≥100 mmHg in diastolic pressure at Screening. If a participant is found to have uncontrolled and/or untreated significant hypertension at Screening and anti-hypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month before Screening. - Evidence of pigmentary maculopathy identified by a retinal specialist during Screening. - Morning Cortisol ≤ 3 µg/dL. - Plasma renin concentration > ULN; ACTH <10 pg/ml; Morning Cortisol >3 µg/dL and <10 µg/dL and peak cortisol (by ACTH stimulation test) <18 µg/dL. - Largely or wholly incapacitated (eg, bedridden or confined to a wheelchair, permitting little or no self-care). - Major surgery or anticipated surgery during the study. - Currently hospitalized or any planned hospitalizations during the study. - Plan for total knee reconstruction in affected knee(s) during the study. - Knee surgery or trauma to the index knee within 1 year before Day 1. - A history of drug or alcohol abuse and/or dependence within the 12 months before Screening that, in the opinion of the investigator, may affect participant ability to comply with study requirements. - Contraindication to MRI scans. - An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted. ; PRIMARY OUTCOME: Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index.; SECONDARY OUTCOME 1: Key secondary: Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC NRS 3.1 Index[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ECHELON-2; BRIEF: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas. ; DRUG USED: Adcetris; DRUG CLASS: Biologic; INDICATION: Peripheral T-Cell Lymphoma (PTCL) - NHL; TARGET: Antibody-drug Conjugate (ADC), Cluster of Differentiation 30 (CD30) / TNFRSF8, Microtubules (Tubulin); THERAPY: Combination; LEAD SPONSOR: Seagen Inc.; CRITERIA: Inclusion Criteria: - Patients with newly diagnosed, CD30-positive mature T-cell lymphomas - Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: - History of another primary invasive malignancy that has not been in remission for at least 3 years - Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides - History of progressive multifocal leukoencephalopathy (PML) - Cerebral/meningeal disease related to the underlying malignancy ; PRIMARY OUTCOME: Progression-free Survival Per Independent Review Facility (IRF); SECONDARY OUTCOME 1: Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)[/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 IIb/III - JS-OAP3-US01; BRIEF: This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis. ; DRUG USED: JointStem; DRUG CLASS: Biologic; INDICATION: Osteoarthritis and Osteoarthritis Pain; TARGET: Stem Cells/Other Cell Therapies; THERAPY: Monotherapy; LEAD SPONSOR: Nature Cell Co. Ltd.; CRITERIA: Inclusion Criteria: - Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria) - Subject who has ≥ 34 on WOMAC function score at Screening and Baseline - Subject who has knee pain ≥ 70 mm for one knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline - Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria. - Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options - Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study - Subject who is willing and able to give written informed consent for participation in the study Exclusion Criteria: - Subject who has Body Mass Index (BMI) > 35 kg/m2 - Subject judged by the investigator to have a history of clinically significant disease - Subject who has any of following clinically significant disease - Autoimmune diseases - Pagets disease, ochronosis, acromegaly, hemochromatosis, or Wilsons disease - Genetic diseases (hyperkinesia, collagen gene abnormality, etc.) - Inflammatory joint disorders (e.g. rheumatoid inflammation) - Infectious joint disorders (e.g. septic arthritis) - Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis) - Subject who has any history of cancer or currently receiving treatment for a current cancer diagnosis - Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis) - Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening - Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening - Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening - Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 6 months prior to Screening - Subject who has history of stem cell therapy - Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment): - Serum ALT and AST > 2 x upper limit of normal - Serum creatinine out of normal range - PT/INR out of normal range - Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject - Platelets out of normal range - Subject for whom the investigator judges the lipoaspiration can cause any problem - Subject who has history of local anesthetic allergy - Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.) - Subject who is an active drug/alcohol abuser - Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method) - Subject who is enrolled in any other clinical trials within 3 months from Screening - Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline) - Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above ; PRIMARY OUTCOME: Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score; SECONDARY OUTCOME 1: Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function)[/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 - CAPItello290; BRIEF: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC) ; DRUG USED: Capivasertib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: PI3K/AKT pathway; THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: 1. Histologically confirmed TNBC from most recently collected tumour tissue sample 2. Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible) 3. ECOG/WHO PS: 0-1 4. Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease 5. FFPE tumour sample from primary/recurrent cancer Exclusion Criteria: 1. Prior Chemotherapy in the neoadjuvant or adjuvant setting within 6 months from the end of chemotherapy to the date of randomization; taxane chemotherapy in the neoadjuvant or adjuvant setting within 12 months from the end of chemotherapy to the start of randomization 2. Prior systematic therapy for inoperable locally advanced or metastatic disease 3. Prior treatment with any of the treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions: - AKT, PI3K, and/or mTOR inhibitors - Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study) - Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor - Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St Johns wort), or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to the first dose of study treatment. 4. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo) 5. Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5 6. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment 7. Any of the following cardiac criteria at screening: - Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block) - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval - Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2 - Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg - Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiplegated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive). 8. Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening: - Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment - HbA1c ≥8.0% (63.9 mmol/mol) 9. Inadequate bone marrow reserve or organ function at screening 10. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression-Free Survival (PFS)[/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 - GO-FURTHER (MTX Non-responders); BRIEF: The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone. ; DRUG USED: Simponi Aria (IV); DRUG CLASS: Biologic; INDICATION: Rheumatoid Arthritis (RA); TARGET: Tumor Necrosis Factor-alpha (TNF-alpha); THERAPY: Monotherapy; LEAD SPONSOR: Centocor, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening - Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline - C-Reactive Protein greater than or equal to 1.0 mg/dL at screening - No history of latent or active tuberculosis prior to screening Exclusion Criteria: - Other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease - Treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent - Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent - Known allergy to human immunoglobulin proteins or other components of golimumab - Received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept ; PRIMARY OUTCOME: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14; SECONDARY OUTCOME 1: Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14[/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 - IV Push (TMB-302); BRIEF: This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via IV Push or intramuscular injection. An initial Sentinel Group of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration and decreasing administration time until undiluted IV Push over 30 seconds is achieved, while safety and pharmacokinetics are evaluated. If no safety signals are seen, the Core Group of 15 participants will be enrolled. The Core Group will receive 800mg Trogarzo via undiluted IV Push over 30 seconds while safety and pharmacokinetics are monitored. After completion of the IV Push portion of the study, a second group of 20 participants will be enrolled to evaluate the safety and pharmacokinetics of administration of 800mg via intramuscular injection. ; DRUG USED: Trogarzo; DRUG CLASS: Biologic; INDICATION: HIV / AIDS; TARGET: Cluster of Differentiation 4 (CD4); THERAPY: Monotherapy; LEAD SPONSOR: TaiMed Biologics Inc.; CRITERIA: Inclusion Criteria - HIV-infected participants (all groups): 1. Are capable of understanding and have voluntarily signed the informed consent document 2. Currently receiving a stable Trogarzo-containing ARV regimen for a minimum of 3 months, and no change in background ARVs anticipated over the period of study participation; a stable regimen is defined as having no changes in dose or frequency and no interruptions greater than or equal to 2 weeks during the 3 month period 3. Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposis sarcoma or wasting syndrome due to HIV 4. Are able and willing to comply with all protocol requirements and procedures 5. Are 18 years of age or older 6. Have a life expectancy that is >6 months. 7. Have a viral load <1,000 copies/mL at Screening 8. CD4+ T-cell count > 50 cells/mm3 at Screening 9. Prothrombin time (PT) and partial thromboplastin time (PTT) <1.5 times the upper limit of normal (IM Group only) Inclusion Criteria - Healthy Volunteers (all groups): 1. Healthy volunteers born male and female as assessed by medical history and physical examination 2. Aged >18 and <50 years at the time of Screening 3. Ability and willingness to provide written informed consent 4. Willingness to comply with protocol schedule 5. Willingness to undergo HIV-1 testing 6. Non-reactive 4th generation point of care HIV-1 test at Screening 7. Hepatitis B Surface antigen negative 8. Hepatitis C antibody negative, or if reactive, Hepatitis C RNA undetectable in plasma 9. PT and PTT <1.5 times the upper limit of normal (IM Group only) 10. Volunteers born female of reproductive potential who are sexually active with a male sex partner must agree to use one effective method of contraception from the time of signing the consent to completion of the study and agree to pregnancy testing as per the schedule of events. Volunteers born female with reproductive potential are defined as pre-menopausal volunteers born female who have not had a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). Volunteers born female are considered menopausal if they have not had a menses for at least 12 months and have a follicle-stimulating hormone (FSH) of greater than 40 IU/L or if FSH testing is not available, they have had amenorrhea for 24 consecutive months. Exclusion Criteria - HIV-infected participants (all groups): 1. Any active AIDS-defining illness according to the Centers for Disease Control and Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 (Morbidity and Mortality Weekly Report (MMWR) Vol.57/No. RR-10, Appendix A), or history of the same during the 3 months preceding Screening, with the following exceptions: cutaneous Kaposis sarcoma and wasting syndrome due to HIV 2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from Screening, medical history, and/or physical examination that, in the investigators opinion, would preclude the subject from participating in this study 3. Any significant acute illness within 1 week before the initial administration of study drug 4. Any active infection secondary to HIV requiring acute therapy; however, subjects that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study 5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment 6. Any vaccination within 7 days before Day 1 7. Any female subject who either is pregnant, intends to become pregnant, or is currently breastfeeding 8. Any current alcohol or illicit drug use that, in the investigators opinion, will interfere with the subjects ability to comply with the study schedule and protocol evaluations 9. Any radiation therapy during the 28 days before first administration of study medication 10. Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale, except for the following asymptomatic Grade 3 events: - triglyceride elevation - total cholesterol elevation - or Grade 3 or 4 reductions in levels of CD4+ T cells 11. History of coagulopathy that would preclude administration of IM injections (IM Group only) 12. Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site reactions (IM Group only) 13. Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole or other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only). Exclusion Criteria - Healthy Volunteers (all groups): 1. Confirmed HIV-1 infection 2. At high risk of severe COVID-19 disease as defined by one of the following: - History of hypertension, atherosclerotic cardiovascular disease (ASCVD), coronary artery disease, diabetes mellitus - History of asthma or chronic pulmonary disease - History of renal disease and chronic renal insufficiency - BMI over 35 3. Any acute or chronic medical condition that in the opinion of the investigator would preclude participation 4. Chronic autoimmune disease 5. Active IV drug use 6. Excessive use of alcohol or recreational drugs that in the opinion of the investigator would preclude participation 7. Decompensated psychiatric illness 8. Need for chronic immunotherapy including systemic corticosteroids, other MAb therapy, or immunosuppressive drugs 9. Volunteers born female who are pregnant, lactating, or planning on becoming pregnant over the study period 10. Any of the following laboratory parameters: - Hemoglobin <10.0 g/dL - Absolute neutrophil count <1,000/mm3 - Absolute lymphocyte count <500/mm3 - Platelet count <100,000/mm3 - Creatinine >1.25x upper limit of normal (ULN) - Aspartate aminotransferase (AST) >1.5x ULN - Alanine aminotransferase (ALT) >1.5x ULN - Glucose (non-fasting) >160 mg/dL - Proteinuria: 2+ or greater - Hematuria: >10 red blood cells (RBCs) per high-power field 11. Previous receipt of an experimental MAb for HIV-1treatment or prevention in a research study 12. History of severe allergic reactions to drugs, vaccines, or drug infusion 13. Participation in another investigational clinical trial within the past 12 weeks or anticipated during the course of the current study 14. History of coagulopathy that would preclude administration of IM injections (IM Group only) 15. Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site reactions (IM Group only) 16. Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamoleor any other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only). ; PRIMARY OUTCOME: Safety of Trogarzo given as IV Push over 30 seconds in Sentinel Group; SECONDARY OUTCOME 1: Percent of subjects in the Sentinel Group who fail to maintain virologic control[/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 - EVOLVE-2 (Episodic Migraine); BRIEF: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine. ; DRUG USED: Emgality; DRUG CLASS: Biologic; INDICATION: Migraine and Other Headaches; TARGET: Calcitonin Gene-Related Peptide (CGRP) / Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MHD. Exclusion Criteria: - Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. - Current use or prior exposure to galcanezumab or another Calcitonin Gene-Related Peptide (CGRP) antibody. - Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab. - History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta. ; PRIMARY OUTCOME: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days; SECONDARY OUTCOME 1: Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days[/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 - SONAR; BRIEF: The study objective was to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine (DBSC) or the onset of end-stage renal disease (ESRD) in participants with type 2 diabetes and nephropathy who were treated with the maximum tolerated labeled daily dose (MTLDD) of a renin-angiotensin system (RAS) inhibitor. In addition, the study assessed the effects of atrasentan compared with placebo on cardiovascular (CV) morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as the impact on quality of life in participants with type 2 diabetes and nephropathy. ; DRUG USED: Atrasentan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetic Nephropathy; TARGET: Endothelin Receptor Type A (EDNRA); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant, or legal representative, had voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study had been explained and the participant had the opportunity to ask questions. The informed consent must have been signed before any study-specific procedures were performed. - Participant had type 2 diabetes (including participants with latent autoimmune diabetes or insulin-treated participants without a history of diabetic ketoacidosis who also had a negative anti-glutamic acid decarboxylase test AND an elevated post-prandial serum C-peptide level) and had been treated with at least one anti-hyperglycemic medication and an angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB; RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit. - For entry into the Run-In Period the participant must have satisfied the following criteria based on the Screening laboratory values: - Estimated glomerular filtration rate (eGFR) 25 to 75 mL/min/1.73 m^2 [until the eGFR cap on participants (approximately 300) with a baseline of > 60 mL/min/1.73 m^2 was reached] and a urine albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000 mg/g (greater than or equal to 34 mg/mmol and less than 565 mg/mmol); - Serum albumin greater than or equal to 2.5 g/dL (25 g/L); - Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L); - Systolic blood pressure (SBP) greater than or equal to 110 and less than or equal to 180 mmHg; - Serum potassium greater than or equal to 3.5 mEq/L (3.5 mmol/L) and less than or equal to 6.0 mEq/L (6.0 mmol/L); - Participants on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor for greater than or equal to 4 weeks and on a diuretic at the time of screening and who satisfied the above criteria may have proceeded to the last visit in the Run-In Period (R6); - Participants already on a MTLDD of a RAS inhibitor for greater than or equal to 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening were to start with a diuretic and participate in Run-In for at least 2 weeks. - For entry into the Enrichment Period the participant must have satisfied the following criteria based on the last visit of the Run-In Period: - RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose; - Participants that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks. - For entry into the Double-Blind Treatment Period, participants must have satisfied the following criteria based on the last visit of the Enrichment Period: - RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose; - Diuretic at any dose unless medically contraindicated or clinically intolerable in the investigators judgement (i.e., hypotension or hypokalemia); - Participants must not have had a weight change greater than or equal to 3 kg from the beginning of Enrichment to the end of the Enrichment Period and absolute serum BNP greater than or equal to 300 pg/mL (300 ng/L) at the last Enrichment visit; - Participants must not have had an increase in serum creatinine greater than 0.5 mg/dL and greater than 20% increase from the beginning of Enrichment to the end of the Enrichment Period. Exclusion Criteria: A participant was not eligible for entry into the Run-in Period if he/she met any of the following criteria: - Participant had a history of severe peripheral edema or facial edema requiring diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial Screening S1 visit. - Participant had a history of pulmonary hypertension, pulmonary fibrosis or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema). - Participant had a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure. - Participant had known non-diabetic kidney disease (other than kidney stones). - Participant had elevated liver enzymes (serum alanine aminotransaminase [ALT] and/or serum aspartate aminotransaminase [AST]) > 3 × the upper limit of normal (ULN). - Participant had hemoglobin < 9 g/dL (90 g/L). - Participant had a sensitivity to loop diuretics. - Participant had a history of an allergic reaction or significant sensitivity to atrasentan (or its excipients) or similar compounds. - Participant had a history of chronic gastrointestinal disease, which, in the Investigators opinion, may have caused significant GI malabsorption. - Participant had a history of secondary hypertension (i.e., hemodynamically significant renal artery stenosis, primary aldosteronism or pheochromocytoma). - Participant had significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. - Participant had clinically significant cerebrovascular disease (CVD) or coronary artery disease (CAD) within 3 months prior to the Screening S1 visit, defined as one of the following: - Hospitalization for MI or unstable angina; or - New onset angina with positive functional study or coronary angiogram revealing stenosis; or - Coronary revascularization procedure; or - Transient Ischemic Attack or Stroke. - Participant had received any investigational drug including atrasentan within 3 months prior to the Screening S1 visit. - Participant received dialysis treatments or was expected to receive dialysis or renal transplant within 6 months of screening. - Participant was currently receiving rosiglitazone, moxonidine, aldosterone blockers, aliskiren or a combination of ACEi and ARB. - Participant was a premenopausal woman defined as (for study purposes) any female subject with a menses in the past 2 years. For women who were < 50 years old, serum FSH must have been greater than 35 IU/L. Women who were surgically sterile or had a history of hysterectomy may not have necessarily be postmenopausal, and must also have had an FSH > 35 IU/L. - Participant was at high risk for QT/QTc prolongation such as a family history of Long QT Syndrome, defined as QTc prolongation exceeding 450 ms in men, or 460 ms in women. - Participant had type 1 diabetes. - Participant was considered to be clinically unstable regarding general, metabolic or cardiovascular health as determined by the Investigator. ; PRIMARY OUTCOME: Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized); SECONDARY OUTCOME 1: Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)[/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 - Cataract Surgery (C13-04); BRIEF: The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery. ; DRUG USED: Dexycu; DRUG CLASS: Non-NME; INDICATION: Ocular Pain and/or Inflammation (Ophthalmology); TARGET: Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: ICON Bioscience Inc; CRITERIA: Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. 3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye. 4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye. 5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology. 6. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study. 7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel. Key Exclusion Criteria: 1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0. 2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. 3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time. 4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. 5. Patients with an allergy or hypersensitivity to dexamethasone. 6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye). 7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0. 8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening. 9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening. 10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study. ; PRIMARY OUTCOME: Number of Participants With Anterior Chamber Cell Clearing; 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 - NHL; BRIEF: The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkins lymphoma patients for autologous transplantation. ; DRUG USED: Mozobil; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bone Marrow Transplant and Stem Cell Transplant; TARGET: Chemokine (C-X-C motif) Receptor 4 (CXCR4); THERAPY: Combination; LEAD SPONSOR: Genzyme, a Sanofi Company; CRITERIA: Inclusion Criteria (Abbreviated List): - Non-Hodgkins lymphoma in first or second complete or partial remission - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - White Blood Cell count (WBC) > 2.5*10^9/L - Platelet (PLT) > 100*10^9/L Exclusion Criteria (Abbreviated List): - Failed previous stem cell collection - Prior autologous or allogeneic transplant - Brain metastases or bone marrow involvement > 20% - Radiation to pelvis - Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality ; PRIMARY OUTCOME: Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis; SECONDARY OUTCOME 1: Number of Participants With Adverse Events[/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 - DUAL-1; BRIEF: The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period. ; DRUG USED: Opsumit; DRUG CLASS: New Molecular Entity (NME); INDICATION: Scleroderma; TARGET: Endothelin Receptor Type A (EDNRA), Endothelin Receptor Type B (EDNRB); THERAPY: Monotherapy; LEAD SPONSOR: Actelion; CRITERIA: Inclusion Criteria : - Patients ≥ 18 years of age - Women of childbearing potential must use two reliable methods of contraception - Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR) - At least one visible, active ischemic digital ulcers (DU) at baseline - History of at least one additional recent active ischemic DU Exclusion Criteria : - DUs due to condition other than SSc - Symptomatic Pulmonary arterial hypertension (PAH) - Body mass index (BMI) < 18 kg/m^2 - Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 x upper limit of the normal range (ULN) - Hemoglobin < 75% of the lower limit of the normal range - Systolic blood pressure < 95 mmHg or diastolic blood pressure < 50 mmHg - Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition. - Females who are pregnant or breastfeeding or plan to do so during the course of this study. - Substance or alcohol abuse or dependence, or tobacco use at any level. - Treatment with phosphodiesterase type-5 (PDE5) inhibitors. - Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period. - Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period. - Treatment with prostanoids within 3 months. - Treatment with disease modifying agents if present for less than 3 months prior to Screening or whose treatment has not been stable for at least 1 month prior to Screening. - Treatment with oral corticosteroids (> 10 mg/day of prednisone or equivalent). - Treatment with ERAs within 3 months. - Systemic antibiotics to treat infected DU(s) within 4 weeks. ; PRIMARY OUTCOME: Incidence Rate of New Digital Ulcers (DUs) up to Week 16; SECONDARY OUTCOME 1: Percentage of Participants Without a New DU Up To Week 16[/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 - ECLIPSE; BRIEF: The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Diabetic Retinopathy (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Active choroidal neovascularization (CNV) - Active macular edema (ME) - Rubeosis iridis/neovascular glaucoma. - Proliferative diabetic retinopathy requiring vitrectomy. Exclusion Criteria: - wet Age-related macular degeneration - pathologic myopia - pseudoxanthoma elasticum - diabetic macular edema - retinal vein occlusion - < 18 years of age - History of hypersensitivity to ranibizumab - Use of any systemic anti-angiogenic drugs 3 months before inclusion - Women of child-bearing potential and Pregnant or nursing (lactating) women. - Active or suspected ocular infection ; PRIMARY OUTCOME: Number of Participants With Adverse Events as a Measure of Safety and Tolerability; SECONDARY OUTCOME 1: Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)[/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 - REFRESH (Global); BRIEF: This is a double-blind, placebo-controlled and open-label, multicenter efficacy and long-term safety study of firibastat (QGC001) 1000 mg (2×500 mg tablets) administered po, QD, for up to 48 weeks in patients with difficult-to-treat/treatment-resistant HTN. Subjects will continue to take their chronic antihypertensive therapies (at least 2 classes of antihypertensive therapies) at the MTDs during the Run in Period and for the duration of the study. For treatment-resistant subjects, one of the antihypertensive therapies must be a diuretic; for difficult-to-treat subjects, the antihypertensive therapies do not have to include a diuretic. Subjects will complete subject medication diaries during the Run-in Period. If systolic automated office BP (AOBP) is ≥180 mmHg or diastolic BP (DBP) ≥110 mmHg at any visit during the study (and repeated and confirmed within 30 min), the subject will be withdrawn from the study and will receive appropriate treatment. ; DRUG USED: Firibastat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hypertension (Systemic); TARGET: Aminopeptidase A (APA); THERAPY: Monotherapy; LEAD SPONSOR: Quantum Genomics SA; CRITERIA: Inclusion Criteria: - Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions. - Adult men and women (at Screening). - Diagnosis of primary HTN for at least 6 months prior to Screening and: - Currently treated with 2 antihypertensive classes of drug (difficult-to-treat subjects), or currently treated with at least 3 antihypertensive classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence ≥80% during the Run in Period. - Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments. - Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded. - Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam. - Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1) Exclusion Criteria: - Target population: Subjects with uncontrolled primary HTN despite being treated with at least 2 classes of antihypertensive therapies, at the MTDs (difficult-to-treat or treatment-resistant patients). Inclusion criteria: Subjects who meet all of the following criteria will be eligible to participate in the study: 1. Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions. 2. Adult men and women (at Screening). 3. Diagnosis of primary HTN for at least 6 months prior to Screening and: - Currently treated with 2 antihypertensive classes of drug (difficult-to-treat subjects), or currently treated with at least 3 antihypertensive classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence ≥80% during the Run in Period. - Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments. - Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded. 4. Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam. 5. Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1). Exclusion criteria: Subjects who meet any of the following criteria will be excluded from participation in the study: 1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushings disease). 2. Systolic AOBP ≥180 mmHg or DBP ≥110 mmHg at the Screening or Inclusion Visit (Visit 2B, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour. 3. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy. 4. Upper arm circumference that is outside the limits of the study-provided BP cuff associated with either the ABPM and/or AOBP measurement device. 5. History of spontaneous or drug-induced angioedema. 6. History of any drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo). 7. Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²). 8. Subjects with severe symptomatic heart failure (New York Heart Association [NYHA] Class III or Class IV). 9. History of acute coronary syndrome (non-ST elevation myocardial infarction [MI], ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Visit 2A, Day 0. 10. Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures that induce chronic malabsorption, within 2 years of Screening. 11. Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight. 12. Female who is breastfeeding, pregnant, or planning to become pregnant during the study period. 13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years. 14. Shift workers who routinely sleep during the daytime and/or whose work hours include midnight. 15. Subjects with moderate to severe hepatic impairment (Child-Pugh A, B, or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or a total bilirubin ≥1.5×ULN (unless secondary to Gilberts syndrome), or direct bilirubin >ULN in subjects with Gilberts syndrome at Screening. 16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Levey AS, et al. 2009) at Screening. 17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia). 18. Subjects with documented DI. 19. Subjects with Type 1 diabetes mellitus. 20. Subjects with Type 2 diabetes mellitus who: - Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR - Are taking short-acting insulin. Use of a stable dose [≥12 weeks prior to Screening] of the following medications, (or any combination of the following medications) is permitted: glucagon like peptide 1 analog, metformin, sulfonylurea, dipeptidyl peptidase-4 inhibitor, and single basal insulin, sodium glucose co-transporter 2 (SGLT2) inhibitors and pioglitazone. 21. Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra articular or nasal corticosteroids is permitted. 22. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable ≥4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75×lower limit of normal or >1.5×ULN at Screening. 23. History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP intake in the investigators opinion. 24. Participation in another clinical study involving an investigational drug within 30 days prior to Screening or plans to participate in another clinical study within 30 days of discontinuation of IP. 25. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the subjects safety, as per the investigators judgment. 26. Subjects with a life expectancy of less than 1 year per investigators discretion. 27. Legal incapacity or limited legal capacity. 28. Previous participation in any clinical study with firibastat (QGC001). 29. Subjects with any history of documented allergic reactions or allergic diseases, with the exception of documented seasonal allergies (per the investigators decision). ; PRIMARY OUTCOME: The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.; SECONDARY OUTCOME 1: [/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - MELTEMI (Ext.); BRIEF: The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542). ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines. - Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021. - Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP) - For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1. - All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose. Exclusion Criteria: - Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the study or their interpretations - Impede the patients ability to complete the entire duration of study - A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy - Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patients ability to complete the entire duration of the study - Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded). - Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP - Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 - Planned major surgical procedures during the conduct of the study - Previous participation in the present study - Concurrent enrolment in another drug-related interventional clinical trial - AstraZeneca staff involved in the planning and/or conduct of the study - Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals - Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor - Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved ; PRIMARY OUTCOME: Change From Baseline in Basophils, Full Analysis Set; SECONDARY OUTCOME 1: Number of Participants With Asthma Exacerbations During Study Period[/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 - DORI-06; BRIEF: The purpose of this study is to assess the microbiological cure rate of doripenem in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis. ; DRUG USED: Doribax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; CRITERIA: Inclusion Criteria: - Diagnosis of complicated lower urinary tract infection or pyelonephritis Exclusion Criteria: - Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control - History of moderate or severe hypersensitivity reactions to antibiotic medications ; PRIMARY OUTCOME: Microbiological response measured at test of cure visit at early follow-up.; SECONDARY OUTCOME 1: Clinical response (cure) assessed at early follow-up visit. Proportion of patients with sustained microbiological and clinical response measured at late follow-up visit. Safety evaluations conducted throughout the study.[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AVAGAST - w/Xeloda; BRIEF: This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease. ; DRUG USED: Avastin; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Written informed consent obtained prior to any study specific procedures. - Age ≥ 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Life expectancy of at least 3 months. - Able to comply with the protocol. - Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy. - Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours (RECIST). - Patient not receiving anticoagulant medication must have an International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x Upper Limit of Normal (ULN) within 7 days prior to randomisation. Exclusion Criteria: - Previous chemotherapy for locally advanced or metastatic gastric cancer. Patients may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to randomisation. - Previous platinum or anti-angiogenic therapy (ie, anti-vascular endothelial growth factor [VEGF] or VEGF receptor tyrosine kinase inhibitor, etc.). - Patients with locally advanced disease who are candidates for curative therapy (including operation and/or chemotherapy and/or radiotherapy). - Radiotherapy within 28 days of randomisation. - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomisation, or anticipation of the need for major surgery during the course of the study treatment (planned elective surgery). - Minor surgical procedures within 2 days prior to randomisation. - Evidence of central nervous system (CNS) metastasis at baseline. - History or evidence upon physical/neurological examination of CNS disease unrelated to cancer unless adequately treated with standard medical therapy, eg, uncontrolled seizures. - History of another malignancy which could affect compliance with the protocol or interpretation of results. - Inadequate bone marrow function. - Inadequate liver function. - Inadequate renal function. - Uncontrolled hypertension or clinically significant (ie, active) cardiovascular disease. - Active infection requiring intravenous antibiotics at randomisation. - History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. - Serious or non-healing wound, peptic ulcer, or (incompletely healed) bone fracture. - Active gastrointestinal bleeding. - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomisation. - Neuropathy (eg, impairment of hearing and balance) ≥ grade II according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0. - Chronic daily treatment with aspirin or clopidogrel. - Chronic daily treatment with oral corticosteroids; inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed. - Known hypersensitivity to any of the study drugs or excipients or to Chinese hamster ovary cell products or to other recombinant human or humanised antibodies. - Known dihydropyrimidine dehydrogenase (DPD) deficiency. - Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that may affect patient compliance with the study, or place the patient at high risk from treatment complications. - Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). - Pregnant or lactating females. - Women of childbearing potential not using effective nonhormonal (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) means of contraception. - Sexually active men unwilling to practice contraception during the study. - Current or recent (within the 28 days prior to randomisation) treatment with another investigational drug or participation in another investigational study. ; 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 - ACES 255; BRIEF: This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participants self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participants medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ. ; DRUG USED: Aripiprazole/Escitalopram; DRUG CLASS: Non-NME; INDICATION: Major Depressive Disorder (MDD); TARGET: Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin Reuptake; THERAPY: Combination; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: - Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration - Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period - Participants with a Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline Visit for the Prospective Treatment Phase Exclusion Criteria: - Lack of prior treatment with an antidepressant during the current depressive episode - Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode - Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode - Participants with epilepsy or significant history of seizure disorders - Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder - Participants who have received electroconvulsive therapy (ECT) in the last 10 years ; PRIMARY OUTCOME: Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14); SECONDARY OUTCOME 1: Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CAROLINA (CV Safety vs glimepiride); BRIEF: The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride. ; DRUG USED: Tradjenta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: Dipeptidyl peptidase IV (DPP-IV, DPP-4); THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: 1. Type 2 diabetes 2. Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy) 3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor 4. BMI =< 45kg/m² 5. age between >= 40 and =< 85 years 6. signed and dated written International Conference of Harmonisation( ICF) 7. stable anti-diabetic background for at least 8 wks before study start Exclusion criteria: 1. Type 1 diabetes 2. Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent) 3. treatment with any anti-obesity drug less than 3 months before ICF 4. uncontrolled hyperglycemia 5. previous or planned bariatric surgery or intervention 6. current or planned system corticoid treatment 7. change in thyroid hormones treatment 8. acute liver disease or impaired hepatic function 9. pre-planned coronary artery revascularization within 6 months of ICF 10. known hypersensitivity to any of the components 11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information 12. congestive heart failure class III or IV 13. acute or chronic metabolic acidosis 14. hereditary galactose intolerance 15. alcohol or drug abuse 16. participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start 17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control 18. patients considered reliable by the investigator 19. acute coronary syndrome =< 6 wks before ICF 20. stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF ; PRIMARY OUTCOME: The First 3-point Major Adverse Cardiovascular Events (3P-MACE); SECONDARY OUTCOME 1: The First 4-point (4P)- MACE[/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 - TRANXITION; BRIEF: The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy. ; DRUG USED: Viramune XR; DRUG CLASS: Non-NME; INDICATION: HIV / AIDS; TARGET: Reverse Transcriptase; THERAPY: Monotherapy; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: HIV infected subjects treated with a Viramune based regimen. A subject that meets the following inclusion criteria will be eligible for participation in this study: 1. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation. 2. HIV-1 infected males or females of at least 18 years. 3. Treatment with Viramune regimen for at least the preceding 18 weeks. 4. Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®). 5. An HIV viral load < 50 copies/mL in preceding 3 months. 6. An HIV viral load of < 50 copies/mL at screening (Visit 1). 7. Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions: alanine aminotrnasferase (ALT) and asparatate aminotransferase (AST) < 2.5 × upper limit of normal (ULN) Division of Acquired Immunodeficiency Syndrome (DAIDS Grade 1). 8. Willingness to abstain from ingesting medications that are listed as contraindicated in the Summary of Product Characteristics (SPC) or package insert (or PI) or Investigators Brochure during the study. 9. Karnofsky performance score of < 70 Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded from the study: 1. Current treatment with an HIV protease inhibitor 2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study 3. Female patients of child-bearing potential who: 1. Have a positive serum pregnancy test at screening. 2. Are breast feeding. 3. Are planning to become pregnant 4. Are not willing to use a double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.. 4. Laboratory parameters > DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase) 5. Laboratory parameters > DAIDS grade 3 Total triglycerides (total cholesterol no restriction) 6. Hypersensitivity to any ingredients of the test products 7. Active drug abuse or chronic alcoholism. 8. Hepatic cirrhosis stage Child-Pugh B or C 9. History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial 10. Inability to comply with protocol requirements ; PRIMARY OUTCOME: Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population; SECONDARY OUTCOME 1: Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - UNIVERSE; BRIEF: The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment. ; DRUG USED: Xarelto; DRUG CLASS: New Molecular Entity (NME); INDICATION: Venous Thromboembolism (VTE); TARGET: Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Janssen Research & Development, LLC; CRITERIA: Inclusion Criteria: - Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings - Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol - Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements Exclusion Criteria: - Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study - History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption - History of or signs/symptoms suggestive of protein-losing enteropathy - Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding - Platelet count less than (<)50*10^9/Liters (L) at Screening - Estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) - Known clinically significant liver disease ; PRIMARY OUTCOME: Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic); SECONDARY OUTCOME 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)[/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 - P06107; BRIEF: Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized. In this 3-weeks, double-blind, parallel design trial, eligible participants will be randomized to receive one out of three fixed dose levels of asenapine, or placebo. The study primary hypothesis is that at least one asenapine dose is superior to placebo as measured by the change from baseline to Day 21 in Young Mania Rating Scale (Y-MRS) total score. Trial medication and placebo are provided as identical-looking sublingual tablets; concurrent use of psychotropics is prohibited, except use of short-acting benzodiazepines and psychostimulants approved for the treatment of attention deficit hyperactivity disorder (ADHD). Main treatment effect is measured using Y-MRS and safety is evaluated using the recordings of adverse events, routine blood panels, physical examinations (including vital signs), and electrocardiograms. Participants who complete the double blind trial may be offered to continue (open-label) treatment with asenapine for an extended period of time. Follow-up information on safety parameters will be collected in all participants within 30 days following treatment discontinuation. ; DRUG USED: Saphris; DRUG CLASS: New Molecular Entity (NME); INDICATION: Bipolar Disorder; TARGET: Alpha 2 Adrenergic Receptor, Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor, Serotonin 5-HT1 receptor, Serotonin 5-HT2A receptor, Serotonin 5-HT2B receptor; THERAPY: Monotherapy; LEAD SPONSOR: Organon and Co; CRITERIA: Inclusion criteria: - Participants who (or whose parent/legal representative) are able to give written informed consent. - Participants must be 10 years of age or older and 17 years of age or younger at the time of treatment assignment (randomization). - Participants must have a diagnosis of bipolar I disorder, confirmed by structured interview at screening. - Participants must not be pregnant or lactating, and those who are sexually active or become sexually active during the trial, and of child-bearing potential, must be using a medically accepted form of birth control. - Participants will be required to have stopped taking certain psycho-active medications prior to baseline. - Participants must have a caregiver, or other responsible person living with them who agrees to provide support to the participant to ensure study and procedure compliance. Exclusion criteria: - Diagnosis of bipolar II disorder, or other form of bipolar or psychotic disorder. - Known or suspected mental retardation. - Substance abuse, or dependence, within the past 6 months. - There is risk of self-harm or harm to others. - There is a history of tardive dyskinesia or dystonia. - Pregnancy or lactation during the study. - History of seizure disorder. - Participation in any other clinical trial at the same time. - A family member who is part of the study staff or is directly involved with the study. - Other medical conditions determined by the study staff to possibly interfere with the study safety and efficacy evaluations. ; PRIMARY OUTCOME: Change From Baseline in Y-MRS Total Score at Day 21; SECONDARY OUTCOME 1: Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21[/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 - REGAiN-1A; BRIEF: The purpose of this study is to evaluate the efficacy and safety of intramuscular (IM) administration of Engensis on pain in participants with painful diabetic peripheral neuropathy (DPN) in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis. ; DRUG USED: Engensis; DRUG CLASS: Biologic; INDICATION: Diabetic Peripheral Neuropathy (DPN); TARGET: Hepatocyte growth factor receptor (c-Met, HGFR); THERAPY: Monotherapy; LEAD SPONSOR: Helixmith Co., Ltd.; CRITERIA: Inclusion Criteria 1. Male or female participants age ≥ 18 years at time of completion of the informed consent process 2. Type 1 or 2 diabetes mellitus (DM) and on current Standards of Medical Care in Diabetes - 2020 optimal guideline-directed medical therapy in participants (including vaccine recommendations if possible), AND without unstable diabetes or significant medical problems, such as progressive end-organ disease, within 3 months of or during Screening, in the judgment of the Investigator 3. Glycosylated hemoglobin A1c (HbA1c) of ≤ 10.0% using the first assessment collected during Screening 4. Documented diagnosis of bilateral painful DPN in both lower extremities at least 6 months prior to Screening 5. An Average Daily Pain Score ≥ 4 (standard deviation ≥ 0.3 and ≤ 1.5) that is completed during the 7 days prior to randomization (Day 0) 6. The physical examination component of the Michigan Neuropathy Screening Instrument (MNSI) score of ≥ 2.5 7. If on medication for painful DPN (other than gabapentin or pregabalin), must be on a stable dose defined as < 50% change in total dose over 3 months prior to completion of informed consent process 8. Male participants and their female partners must agree to use double-barrier contraception during the study or provide proof of postmenopausal state (minimum 1 year) or surgical sterility 9. Male participants must not donate sperm during the study 10. Female participants must be nonpregnant, nonlactating, and either postmenopausal for at least 1 year, or surgically sterile for at least 3 months, or agree to use double barrier contraception from 28 days prior to randomization and/or their last confirmed menstrual period prior to study randomization (whichever is longer) until the end of the study 11. Capable and willing to comply with the requirements and restrictions of the protocol and informed consent form 12. Able to complete all screening activities within 45 days of signing the informed consent form Exclusion Criteria 1. Other sources of pain that would prevent accurate assessment of DPN pain (e.g., thoracic and/or lumbar root proximal neuropathy, mononeuritis multiplex) 2. Peripheral neuropathy caused by a condition other than diabetes: e.g., anatomic (sciatic nerve compression), systemic (monoclonal gammopathy), metabolic (thyroid disease), and toxic (alcohol use) neuropathies 3. Has taken gabapentin or pregabalin during 30 days before completion of informed consent process or will take at any time during the study 4. Progressive or degenerative neurological disorder, such as amyotrophic lateral sclerosis (ALS), Alzheimers disease, Parkinsons disease, vascular dementia, multiple sclerosis, or other neurological disorders determined by the Investigator to preclude participation 5. Symptomatic peripheral artery disease (PAD) or PAD requiring revascularization and/or that may interfere with the conduct of the study 6. Vasculitis, such as from Buergers or other disease 7. Systolic blood pressure >180 mm Hg on tolerable doses of standard antihypertensive medications at Screening determined by the Investigator to preclude participation 8. Hyperlipidemia or dyslipidemia not being treated with an optimal treatment regimen that follows the Standards of Care for hyperlipidemic/dyslipidemic patients with DM 9. Class 3 or 4 heart failure 10. Symptomatic bradycardia or untreated high degree atrioventricular block 11. Stroke or cerebrovascular accident or myocardial infarction within 3 months before Screening 12. eGFR < 30 mL/min/1.73 m2 13. Progressive renal dysfunction, defined as a decrease in eGFR to chronic kidney disease (CKD) Stage 1, 2, or 3 in the past 6 months before Screening 14. Ophthalmologic conditions pertinent to signs or symptoms of proliferative diabetic retinopathy (PDR) or other ocular conditions that preclude standard ophthalmologic examination 15. Myopathy (e.g., Duchenne or Becker muscular dystrophy, polymyositis) 16. Any prior or planned lower extremity amputation (excluding toe amputations) due to diabetic complications or prior lower leg injury (e.g., scarring, muscle atrophy) in the calf area (gastrocnemius) that would significantly reduce the surface area of the skin or amount of intact skeletal muscle required for the 16 treatment injections of Engensis 17. Active infection requiring antimicrobial agent(s) (chronic infection or severe active infection that may compromise the Participants well-being or participation in the study, in the Investigators judgment) 18. Chronic inflammatory or autoimmune disease (e.g., Crohns disease, rheumatoid arthritis) 19. Immunosuppression due to underlying disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) or to currently receiving immunosuppressive drugs, (e.g., chemotherapy, corticosteroids) or to radiation therapy 20. Participants requiring chronic oral or injectable steroids and unwilling to refrain from taking these drugs for the duration of the study 21. Participants with a family medical history of 2 or more first-degree relatives (parent, sibling, child) diagnosed to have the same type of cancer - breast cancer, cervical cancer, colon cancer, endometrial cancer, lung cancer, or prostate cancer, or with a family medical history of Lynch syndrome (hereditary non-polyposis colorectal cancer) in any first-degree relative; or who show positive results during cancer screening 22. Positive human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) I/II test at Screening 23. Participants who have not been cancer-free for ≥ 5 years with the following exceptions (not excluded): Participants with in-situ basal cell or squamous cell carcinoma 24. Participants with a prior history of stem cell transplant for cancer no matter how long they have been cancer-free 25. Active acute or chronic hepatitis B 26. Active hepatitis C 27. Clinically significant laboratory values or current medical conditions during Screening that, in the judgment of the Investigator, should be exclusionary 28. Hospital Anxiety and Depression Scale (HADS) score of ≥ 15 on either subscale 29. History of drug abuse (the habitual taking of addictive or illegal drugs) in the past 3 months and positive for Drugs of Abuse, with the exception of cannabis, during Screening 30. Participants unwilling to discontinue their use of the following during Screening at least 7 days before starting eDiary entries and not use any of the following during the study: - skeletal muscle relaxants - opioids - transcutaneous electrical nerve stimulation (TENS) - acupuncture - benzodiazepines (other than stable bedtime dose) - injectable or oral steroids 31. Participants not on a stable dose and not willing to remain on a stable dose during the study for the following drugs: - antidepressants - antiepileptics - duloxetine 32. Participants currently using the following medications and unwilling to discontinue topical use on the lower legs and feet and throughout the study: - capsaicin - anesthetic creams (except during Study Injections) - anesthetic patches - ISDN spray 33. Use of an investigational drug or treatment in past 30 days or previous participation in a clinical study with Engensis 34. Body mass index (BMI) ≥ 42 kg/m2 35. Recent treatment for COVID-19 with ongoing sequelae ; PRIMARY OUTCOME: Efficacy of Engensis compared to Placebo on painful DPN in the feet and lower legs comparing the Average Daily Pain Score from the Day 0 Visit to the Day 180 Visit on the Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy; SECONDARY OUTCOME 1: Efficacy of Engensis on the worst pain in painful DPN in the feet and lower legs by comparing the change from baseline (Day 0) in the Worst Pain score from the Brief Pain Inventory for Diabetic Peripheral Neuropathy to Day 180 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 - VIGOR-ALS (ext.); BRIEF: The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031). ; DRUG USED: Tirasemtiv; DRUG CLASS: New Molecular Entity (NME); INDICATION: Amyotrophic Lateral Sclerosis (ALS); TARGET: Troponin; THERAPY: Monotherapy; LEAD SPONSOR: Cytokinetics; CRITERIA: Inclusion Criteria: - Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal consent is given, a Legal Designee of the patient must sign the ICF form - Completed participation on study drug and the Follow-Up Visit in the CY 4031 study - Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree for the duration of their participation in the study to either: - Use a condom during sexual intercourse with female partners who are of childbearing potential AND to have female partners use a highly effective means of contraception OR - Abstain from sexual intercourse during participation in the study - Female patients who are not post-menopausal (≥ 1 year) or sterilized, must: - Not be breastfeeding - Have a negative pregnancy test - Have no intention to become pregnant during participation in the study AND - Practice sexual abstinence, defined as refraining from intercourse during the duration of the study OR if male partners are not vasectomized with a confirmed zero sperm count, require use of a condom AND use of a highly effective contraceptive measure Exclusion Criteria: - Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study - Has taken an investigational study drug (other than tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater - Use of tizanidine and theophylline-containing medications during study participation - Participation or planning to participate in any form of stem cell therapy for the treatment of ALS or another investigational drug ; PRIMARY OUTCOME: Number of Participants With Adverse Events; SECONDARY OUTCOME 1: Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 24 in CY 4033[/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 - 015 - Bacterial Vaginosis; BRIEF: The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30). ; DRUG USED: VivaGel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Urinary Tract and Reproductive Tract Infections (Antibacterial); TARGET: Cell Membrane, Viral Capsid; THERAPY: Monotherapy; LEAD SPONSOR: Starpharma Pty Ltd; CRITERIA: Key eligibility criteria: - Post-menarchal females, aged 12 years or more - Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells - Nugent score of at least 4 - Otherwise healthy, as determined by medical history, physical examination - normal Pap smear at or documented within 24 months of screening ; PRIMARY OUTCOME: Number of Women With Clinical Cure at the End of Treatment Visit (EOT); SECONDARY OUTCOME 1: Number of Women With Nugent Cure at the EOT Visit[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Adult Patients (China); BRIEF: Primary Objective: To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD). Secondary Objectives: - To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD. - To evaluate the effect of dupilumab on improving patient reported outcomes (PROs). - To evaluate dupilumab immunogenicity. ; DRUG USED: Dupixent; DRUG CLASS: Biologic; INDICATION: Atopic Dermatitis (Eczema); TARGET: IL-13 (Interleukin-13), IL-4 Receptor (IL-4R); THERAPY: Monotherapy; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion criteria: - Male or female, 18 years or older. - AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 3 years before the screening visit. - Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits. - Investigators Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits. - Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits. - Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4. - Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks). Exclusion criteria: - Had used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 4 weeks of study treatment: - Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma [IFN-γ], Janus kinase inhibitors, azathioprine, methotrexate); - Phototherapy for AD. - Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit. - Treatment with systemic Traditional Chinese Medicine (TCM) within 4 weeks before the baseline visit or treatment with topical TCM within 1 week before the baseline visit. - Treatment with biologics as follows: - Any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer; - Other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer. - Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit). - Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit. - Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit. - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: participants may be rescreened after infection resolves. - Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per investigator judgment. - Active TB, latent untreated TB or a history of incompletely treated TB or non-tuberculous mycobacterial infection were excluded from the study unless that was well documented by a specialist that the participants had adequately treated and could then start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. TB testing would be performed according to local guidelines if required by regulatory authorities or ethics committees. The above information was not intended to contain all considerations relevant to a participants potential participation in a clinical trial. ; PRIMARY OUTCOME: Number of Participants With Investigators Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16; SECONDARY OUTCOME 1: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 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 III - China (R/R); BRIEF: This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery [CR/CRh*]) induced by blinatumomab in Chinese adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). ; DRUG USED: Blincyto; DRUG CLASS: Biologic; INDICATION: Acute Lymphoblastic Leukemia (ALL); TARGET: Cluster of Differentiation 19 (CD19), Cluster of Differentiation 3 (CD3), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Amgen; CRITERIA: Inclusion Criteria: - Subjects have provided informed consent/assent prior to initiation of any study-specific activities/procedures or subjects legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent. - Subjects with Ph-negative B-precursor ALL, with any of the following: - Primary refractory after induction therapy or who had relapsed within 12 months of first remission or - Relapsed within 12 months of receiving allogeneic hematopoietic stem cell transplantation (alloHSCT) or - Relapsed or refractory after first salvage therapy or beyond - > 5% blasts in bone marrow (by morphology) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 - Age ≥ 18 years at the time of informed consent Exclusion Criteria: Disease Related - Subjects with Ph-positive ALL - Subjects with Burkitt´s Leukemia according to World Health Organization (WHO) classification. - History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, and psychosis - Active ALL in the central nervous system (CNS) (confirmed by cerebrospinal fluid [CSF] analysis) or testes - Isolated extramedullary disease - Current active autoimmune disease or history of autoimmune disease with potential CNS involvement Other Medical Conditions - History of malignancy other than ALL within 5 years prior to start of protocol-specified therapy with the exception of: - Malignancy treated with curative intent and with no known active disease present for 5 years before enrollment and felt to be at low risk for recurrence by the treating physician. - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated cervical carcinoma in situ without evidence of disease. - Adequately treated breast ductal carcinoma in situ without evidence of disease. - Prostatic intraepithelial neoplasia without evidence of prostate cancer. - Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) Medications or Other Treatments - Autologous HSCT within 6 weeks prior to start of blinatumomab treatment - AlloHSCT within 3 months prior to start of blinatumomab treatment - Any active acute Graft-versus-Host Disease (GvHD), grade 2-4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment - Any systemic therapy against active GvHD within 2 weeks prior to start of blinatumomab treatment - Cancer chemotherapy within 2 weeks prior to start of blinatumomab treatment (intrathecal chemotherapy and dexamethasone are allowed until start of blinatumomab treatment). In addition, any subject whose organ toxicity (excluding hematologic) from prior ALL treatment has not resolved to common terminology criteria for adverse events (CTCAE) ≤ grade 1. - Radiotherapy within 2 weeks prior to start of blinatumomab treatment - Immunotherapy (eg, rituximab) within 4 weeks prior to start of blinatumomab treatment - Currently receiving treatment in another investigational device or drug study, or less than 4 weeks prior to start of blinatumomab treatment. - Previous treatment with anti-CD19 therapy General - Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation - Pregnant women and women planning to become pregnant should not participate in this study. Subjects who are breast feeding prior to start of blinatumomab treatment may be enrolled if they stop breast feeding with breast milk produced during blinatumomab treatment and for an additional 48 hours after the last dose of blinatumomab. - Male participants are not required to use birth control during treatment with blinatumomab. However, you should let your female partner know you are in this study. - Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject and investigators knowledge. - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. - Previous treatment with blinatumomab - Abnormal screening laboratory values as defined below: - Aspartate aminotransferase (AST) and/or alanine aminotransferase ALT and/or alkaline phosphatase (ALP) ≥ 5 * upper limit of normal (ULN) - Total bilirubin (TBL) ≥ 1.5 * ULN (unless related to Gilbert´s or Meulengracht disease) - Creatinine ≥ 1.5 ULN or creatinine clearance < 60 ml/min (calculated) - Woman of childbearing potential and is not willing to use 2 effective methods of contraception during treatment and for an additional 48 hours after the last dose of blinatumomab. Birth control is not required for postmenopausal women, or women with uterus/or both ovaries/ or both fallopian tubes removed. ; PRIMARY OUTCOME: Percentage of Participants With a Hematological Response of Complete Remission (CR) or Complete Remission With Partial Hematological Recovery (CRh*) During the First 2 Treatment Cycles With Blinatumomab; SECONDARY OUTCOME 1: Percentage of Participants With a Hematological Response of Complete Remission (CR) During the First 2 Treatment Cycles With Blinatumomab[/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 - CAURAL (w/AZD9291); BRIEF: A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy ; DRUG USED: Imfinzi; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Aged at least 18 years. Japan patients aged at least 20 years. - Locally advanced/metastatic NSCLC, not amenable to curative surgery or radiotherapy - Confirmation from a previous archival sample that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity - Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI. Additional other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. - Patients must have central lab confirmation of tumour T790M status from a biopsy taken after disease progression on the most recent treatment regimen. Only patients with T790M+ will be included in the study - At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerised tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements - World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks - Females of child-bearing potential using contraception; negative pregnancy test Exclusion Criteria: - Treatment with an EGFR-TKI within 5x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of study entry; current treatment with potent inhibitors/inducers of cytochrome P450 3A4 (CYP3A4); previous treatment with AZD9291 (or other agents specifically targeted against EGFR T790M mutation positive NSCLC); Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months of starting 1st EGFR TKI treatment; prior exposure to immune-mediated therapy including, but not limited to, other anti cytotoxic T-lymphocyte-associated antigen 4 (anti CTLA-4), anti- programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 (anti-PD-L1), and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks; major surgery within 4 weeks; - Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 (excluding intranasal, inhaled, topical steroids, or local steroid injections) - Unresolved toxicities from prior therapy - History of active primary immunodeficiency - Unstable brain metastases or spinal cord compression - Severe/uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, bleeding diatheses or infection - Cardiac disease - Ophthalmological conditions - Refractory nausea/vomiting, chronic gastrointestinal diseases or bowel resection - Past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. - History of another primary malignancy - Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment - History of organ transplant that requires use of immunosuppressive medications - Known history of tuberculosis - Receipt of live, attenuated vaccine within 30 days prior to the first dose of MEDI4736 - Inadequate bone marrow reserve or organ function ; PRIMARY OUTCOME: Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab; 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 - Back or Neck Pain; BRIEF: This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain ; DRUG USED: Capsaicin + Diclofenac Gel; DRUG CLASS: Non-NME; INDICATION: Acute Pain; TARGET: Cyclooxygenases (COX-1, COX-2, and COX-3), TRPV1, transient receptor potential vanilloid receptor 1, VR-1; THERAPY: Combination; LEAD SPONSOR: Boehringer Ingelheim; CRITERIA: Inclusion criteria: - Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice and local legislation - Male or female patients >=18 years with current diagnosis of acute back pain or of neck pain for at least 24 hours, but less than 21 days - Acute back pain or acute neck pain resulting in pain on movement (POM) >= 50 mm (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized procedures. - Sensitivity to algometric pressure on the painful trigger point <= 25 N/cm2 - Women of childbearing potential must be ready and able to use highly effective methods of birth control Exclusion criteria: - History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode - Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months - Back or neck pain that is attributable to any specific identifiable cause (e.g. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour) - Trauma or strains of the back or neck muscles within the last 3 months - Prior use within the last 3 days before Visit 1 or concomitant use of any anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting glucocorticoids must have been discontinued 10 days before study entry. Spinal injections should have been discontinued in due time (investigators judgement) before patient enrolment to allow complete wash-out of the active ingredient based on investigators judgment - Non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle), or massage, acupuncture, transcutaneous electrical nerve stimulation) or locally applied pharmacological product to the back or neck area 24 hours prior study entry and during the study period - Known severe hepatocellular insufficiency, severe renal insufficiency or Gilberts syndrome (Morbus Meulengracht) - Any other medical condition that would interfere with efficacy and safety assessments based on investigators judgement or any on-going clinical condition that would jeopardize patients or site personnels safety or study compliance based on investigator judgement. - Known intolerance or hypersensitivity to the active ingredients or any excipient(s). - Patients in whom attacks of asthma, bronchospasm, rhinitis or urticaria were precipitated by the intake of Acetyl salicylic acid (ASS) or other NSAIDs - Irritated skin (based on investigators judgement), skin wounds, eczema or open injuries at application site - Negative experience in the past with heat treatments for muscle complaints - Patient not able to understand and comply with trial requirements based on investigators judgement - Alcohol or drug abuse - Participation in a clinical trial within the previous 30 days or simultaneous participation in another clinical trial - Women who are pregnant, nursing, or who plan to become pregnant while in the trial ; PRIMARY OUTCOME: Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application; SECONDARY OUTCOME 1: POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))[/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 - TK008; BRIEF: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT ; DRUG USED: Zalmoxis; DRUG CLASS: Biologic; INDICATION: Bone Marrow and Stem Cell Transplant - Graft vs. Host Disease (GVHD) Prophylaxis; TARGET: Thymidine Kinase; THERAPY: Monotherapy; LEAD SPONSOR: AGC Biologics S.p.A.; CRITERIA: Inclusion Criteria: - Age ≥ 18 years - Any of the following conditions: 1. AML and ALL in 1st complete remission (CR1) 2. AML and ALL in 2nd or subsequent CR 3. secondary AML in CR 4. AML and ALL in 1st or 2nd relapse or primary refractory - Family donor with patient-donor number of HLA mismatches ≥ 2 (full haploidentical), or family donors sharing one HLA-haplotype with the patient - Stable clinical conditions and life expectancy > 3 months - PS ECOG < 2 - Serum creatinine < 1.5 x ULN - Bilirubin < 1.5 x ULN; transaminases < 3 x ULN - Left ventricular ejection fraction > 45% - QTc interval < 450 ms - DLCO > 50% - Patients, or legal guardians, and donors must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects Exclusion Criteria: - Patients with life-threatening condition or complication other than their basic condition - Contraindication to haploidentical HCT as defined by the Investigator - Patients with active CNS disease - Pregnant or lactation. Exclusion criteria for HSV-Tk infusion: - Infections requiring administration of ganciclovir or valganciclovir at the time of infusion - GvHD requiring systemic immunosuppressive therapy - Ongoing systemic immunosuppressive therapy after haploidentical HCT - Administration of G-CSF after haploidentical HCT HSV-Tk cells can be administered after an adequate patient wash-out period (24 hours) ; PRIMARY OUTCOME: Disease-free Survival (DFS); 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 - P07755; BRIEF: The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele. The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24. ; DRUG USED: Victrelis; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Merck Sharp & Dohme LLC; CRITERIA: Inclusion Criteria: - Is ≥ 40 kg and ≤ 125 kg. - Documented CHC genotype 1 with HCV RNA ≥10,000 International Units (IU)/mL - Has IL-28B CC allele gene - Has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma (non-invasive fibroscan and Fibrotest can also be used for staging of liver disease). Exclusion Criteria: - Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive). - Previously treated with an interferon and ribavirin regimen or HCV direct acting antiviral regimen. - Treatment for hepatitis C with any investigational medication, or prior treatments with herbal remedies with known hepatotoxicity - Receiving any medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on Cytochrome P450 3A4 (CYP3A4/5) for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events - Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial. - Evidence of decompensated liver disease or hepatocellular carcinoma (HCC) - Is diabetic and/or hypertensive with significant retinopathy - Has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction. - Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years - Hemoglobin <12 g/dL for females and <13 g/dL for males - Neutrophils <1,500/mm^3, or <1,200/mm^3 for participants of African descent - Platelets <150,000/mm^3 - Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range. ; PRIMARY OUTCOME: Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24); SECONDARY OUTCOME 1: Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving 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 - MERCURY 3 (EU); BRIEF: The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure ; DRUG USED: Rocklatan; DRUG CLASS: Non-NME; INDICATION: Glaucoma / Ocular Hypertension (Ophthalmology); TARGET: Norepinephrine (Noradrenaline) Reuptake/Transporter, Prostaglandin F receptor (FP)/PGF2 alpha receptor , Rho GTPase/Rho Kinase; THERAPY: Monotherapy; LEAD SPONSOR: Aerie Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Must be 18 years of age or older. 2. Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable). 3. Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators. 4. Medicated intraocular pressure ≥ 17 mmHg in at least one eye and < 28mmHg in both eyes at screening visit. 5. Unmedicated (post-washout) IOP >20mmHg in at least one eye and < 36mmHg in both eyes at 2 qualification visits at 08:00 hour, 2-7 days apart. At the second qualification visit, have IOP >17mmHg in at least one eye and < 36mmHg in both eyes at 10:00 and 16:00 hours. Note: For purposes of determining eligibility of subjects to be enrolled, the non-integral IOP mean number will be used. Any non-integral mean IOP number should not be rounded. If only one eye qualifies at the second qualification visit it MUST be the same eye that qualified on the first visit and this will be the study eye for the duration of the study. 6. Best corrected visual acuity +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200 or better Snellen visual acuity in each eye). 7. Be able and willing to give signed informed consent and follow study instruction. 8. Women must be either of non-childbearing potential, or women with childbearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study. 9. Women of childbearing potential must have a negative urine pregnancy test within 7 days of first dose of study treatment and agree to use highly effective contraception during the study and for 3 months after the last dose of study medication. 10. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use an effective form of contraception from time of randomization and for 3 months following the last dose of study medication. 11. In France, a subject will be eligible for inclusion in this study only if either affiliated to or as a beneficiary of a social security number. Exclusion Criteria: Ophthalmic: 1. Clinically significant ocular disease (e.g., corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage so severe that washout of ocular hypotensive medications for 4 weeks or longer if needed is not judged safe as it would put the subject at risk for further vision loss. 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles i.e. Grade 2 Shaffer (Chan 1981) or less extreme narrow angle with complete or partial closure. Note: Previous laser peripheral iridotomy is NOT acceptable. 3. Intraocular pressure ≥ 36mmHg (unmedicated) in either eye (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication. However, subjects currently taking 2 fixed dose combination products are excluded. 4. Treatment-naïve subjects. 5. Prior treatment with GANFORT® topical eye drops where the subjects IOP did not achieve the target IOP and was considered either a therapeutic failure or to have insufficient response. Subjects currently (immediately prior to screening visit) being treated with GANFORT® are excluded from the study. 6. Known hypersensitivity to any component of the investigational formulations to be used (e.g., benzalkonium chloride) or to fluorescein. 7. Previous glaucoma intraocular surgery, including SLT or ALT in either eye. 8. Refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, corneal cross-linking, keratoplasty). 9. Ocular trauma within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening. 10. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, current evidence or history of herpes simplex or zoster keratitis in either eye at screening. 11. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications which must have been the same medication for 30 days prior to screening (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), as prescribed by the Investigator. 12. Mean central corneal thickness greater than 620μm at screening. 13. Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g., keratoconus). Systemic: 14. Clinically significant abnormalities in laboratory tests at screening. 15. Known hypersensitivity or contraindication to GANFORT® (Appendix 3 Marketed Product Medication Information Section 4.3) and to β-adrenoceptor antagonists (e.g. Chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third-degree heart block or congestive heart failure, cardiac failure, cardiac shock and severe diabetes). 16. Clinically significant systemic disease which might interfere with the study. 17. Participation in any investigational study within 30 days prior to screening. 18. Systemic medication including corticosteroid containing drugs that could have a substantial effect on IOP which HAVE NOT been maintained at a consistent dose and regime within 30 days prior to screening, and are anticipated to change in dose and/or regime during the study. 19. Use of topical steroid containing medications on the face or in or around the eyes will exclude the subject (see Section 5.6 Concomitant Medications). 20. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable and highly effective form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal (1 year without menses with appropriate clinical profile, e.g. age appropriate, > 45 years in the absence of HRT. In questionable cases the subject must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months post-surgical sterilization. 21. Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care. ; PRIMARY OUTCOME: Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry; 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 - 12 weeks (Efficacy & Safety); BRIEF: This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7). ; DRUG USED: Breo Ellipta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Beta Adrenergic Receptors, Glucocorticoid Receptor (GR); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subjects current medication is changed as a result of study participation - Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age - Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly. - Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value. - Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required. - If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers. - Use of ICS/LABA are not permitted with LABA on the day of Visit 1. - Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits Exclusion Criteria: - History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years. - Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, expected to affect the subjects asthma status or the subjects ability to participate in the study. - Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. - A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of concurrent respiratory disease other than asthma - A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study - Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible - Clinical visual evidence of candidiasis at Visit 1 - Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two. - Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy - Administration of medication that would significantly affect the course of asthma, or interact with study drug - Use of immunosuppressive medications during the study. - Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1. - A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a geographical location which seems likely, in the opinion of the Investigator, to impair compliance with any aspect of this study protocol, including visit schedule, and completion of the daily diaries. - Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco). - If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator. - Subject previously randomized to treatment with FF/VI or FF in another Phase III study - Subjects working on night shift a week prior to Visit 1 or during the study period. - Adolescents who are wards of the state or government ; PRIMARY OUTCOME: Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period; SECONDARY OUTCOME 1: Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period[/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 - BouNDless (US); BRIEF: This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period. ; DRUG USED: ND0612; DRUG CLASS: Non-NME; INDICATION: Parkinsons Disease (PD); TARGET: Aromatic L-amino acid decarboxylase (AADC), Dopamine Receptor - Unspecified; THERAPY: Combination; LEAD SPONSOR: NeuroDerm Ltd.; CRITERIA: Inclusion Criteria: 1. Male and female patients, aged ≥30 years. 2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria. 3. Modified Hoehn & Yahr score ≤3 during ON state. 4. Average of ≥2.5 hours of OFF time (≥2 hours OFF time every day) during waking hours as confirmed by patient diary over 3 days. 5. Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg. Exclusion Criteria: 1. Atypical or secondary parkinsonism. 2. Severe disabling dyskinesias, based on Investigators discretion. 3. Previous neurosurgery for PD. 4. Use of duodenal levodopa infusion (LCIG) or apomorphine infusion. 5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks. 6. Previous participation in ND0612 studies. 7. History of significant skin conditions or disorders. ; PRIMARY OUTCOME: The change in daily ON time without troublesome dyskinesia; SECONDARY OUTCOME 1: The change in daily OFF time[/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 - TH3RESA (MBC); BRIEF: This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physicians choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physicians choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734. ; DRUG USED: Kadcyla; DRUG CLASS: Biologic; INDICATION: Breast Cancer; TARGET: Antibody-drug Conjugate (ADC), HER2/neu or ErbB-2, Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult participants ≥ 18 years of age. - Histologically or cytologically documented breast cancer. - Metastatic or unresectable locally advanced/recurrent breast cancer. - HER2-positive disease by prospective laboratory confirmation. - Disease progression on the last regimen received as defined by the investigator. - Prior treatment with an trastuzumab, a taxane, and lapatinib. - Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting. - Adequate organ function, as evidenced by laboratory results. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan. Exclusion Criteria: - Chemotherapy ≤ 21 days before first study treatment. - Trastuzumab ≤ 21 days before first study treatment. - Lapatinib ≤ 14 days before first study treatment. - Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine. - Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization. ; PRIMARY OUTCOME: Progression-free Survival; SECONDARY OUTCOME 1: Percentage of Participants With an Objective 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 - Blepharospasm; BRIEF: Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Neuromuscular Spasm and Spasticity; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Main Inclusion Criteria: - Male or female pretreated outpatients between ages 18 and 80 years (inclusive) - A clinical diagnosis of bilateral blepharospasm (BEB) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles - A need for injection of Botulinum toxin (defined by a Jankovic Rating Scale (JRS) severity subscore >= 2) - On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period - Source documentation of the last two consecutive injection sessions with BOTOX® and a stable satisfactory therapeutic response directly prior to trial entry - At least 10 weeks must have been passed between the last injection with BOTOX® for BEB and Baseline Main Exclusion Criteria: - Atypical variant of BEB caused by inhibition of levator palpebrae muscle - Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation) - The previous two injections with BOTOX® with more than 50 Units per eye - Hypersensitivity to human serum albumin, sucrose, or Botulinum toxin A - Neuroleptic induced blepharospasm - Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial - Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to Baseline and during the trial ; PRIMARY OUTCOME: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater); SECONDARY OUTCOME 1: Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)[/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 - ABS-AS-301; BRIEF: The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo. ; DRUG USED: ProAir RespiClick; DRUG CLASS: Non-NME; INDICATION: Asthma; TARGET: Beta Adrenergic Receptors; THERAPY: Monotherapy; LEAD SPONSOR: Teva Branded Pharmaceutical Products R&D, Inc.; CRITERIA: Inclusion Criteria: - Written informed consent/assent - General good health - Persistent asthma, with an FEV1 50-80% predicted. - Ability to perform spirometry in an acceptable manner as per protocol guidelines. - Ability to perform PEFR with a handheld peak flow meter. - Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1. - Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit. - Non-smokers. - Capable of understanding the requirements, risks, and benefits of study participation. - Other inclusion criteria apply. Exclusion Criteria: - Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV). - A known hypersensitivity to albuterol or any of the excipients in the formulations. - History of severe milk protein allergy. - History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV). - Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents. - History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation. - Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV). - Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including. - Other exclusion criteria apply. ; PRIMARY OUTCOME: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period; SECONDARY OUTCOME 1: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 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 - TARGET (vs. Vancomycin/Aztreonam); BRIEF: This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs). ; DRUG USED: Zeftera; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Basilea Pharmaceutica; CRITERIA: INCLUSION CRITERIA 1. Male or female, aged ≥18 years. 2. Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit: 1. Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 hours: - i. Rapidly spreading areas of erythema, edema, and/or induration with a minimum total lesion surface area of 75cm^2 - ii. No collection of pus apparent upon visual examination - iii. At least two of the following local signs of infection: - erythema - induration - localized warmth - pain or tenderness on palpation - swelling/edema 2. Major cutaneous abscess, defined as infection characterized by a collection of pus within the dermis or deeper that is apparent upon visual examination before or after therapeutic intervention and is accompanied by all of the following within 24 hours: - i. Erythema, edema and/or induration with a minimum total lesion surface area of 75 cm^2. - ii. At least two of the following local signs of infection: - fluctuance - incision and drainage required - purulent or seropurulent drainage - localized warmth - pain or tenderness on palpation 3. Wound infection, defined as infection of any apparent break in the skin characterized by at least one of the following: - i. Superficial incision/surgical site infection meeting all of the following criteria: - involves only the skin or subcutaneous tissue around the incision (does not involve fascia). - occurs within 30 days of procedure. - purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/ or induration with a minimum total lesion surface area of 75cm^2. - ii. Post-traumatic wound (including penetrating trauma, e.g., needle, nail, knife, insect and spider bites) meeting the following criterion within 24 hours: - Purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/or induration with a minimum total lesion surface area of 75cm^2. 3. At least one of the following regional or systemic signs of infection at the Screening visit: 1. Lymph node tenderness and volume increase, or palpable lymph node proximal to the primary ABSSSI. 2. Fever > 38 °C/100.4 °F measured orally, > 38.5 °C / 101.3 °F measured tympanically, > 37.5 °C / 99.5 °F measured by the axillary method, or > 39 °C / 102.2 °F measured rectally. 3. White blood cell (WBC) count > 10.0 × 10^9/L or < 4.0 × 10^9/L. 4. > 10% immature neutrophils (band forms). 4. Requirement for IV antibacterial treatment. 5. Willing and able to adhere to study procedures (including prohibitions and restrictions) as specified in this protocol. 6. Willing and able to remain hospitalized (in a hospital or equivalent medical confinement or clinical research unit) until completion of the early-clinical-response assessment for the primary endpoint. 7. Informed consent signed by the patient, or their legally acceptable representative if appropriate, indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate. EXCLUSION CRITERIA Patients meeting any one of the following: 1. Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug. Exception: Receipt of a single dose of a short acting (half-life ≤ 12 hours) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 hours of randomization). 2. Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy. 3. Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study. 4. The primary ABSSSI is an uncomplicated skin and skin structure infection, such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, or minor wound infections (e.g., stitch abscesses). 5. The primary ABSSSI is due to, or associated with, any of the following: 1. Diabetic foot infection, gangrene, or perianal abscess. 2. Concomitant infection at another site (e.g., septic arthritis, endocarditis, osteomyelitis), not including a secondary ABSSSI lesion. 3. Infected burns. 4. Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous). 5. Any evolving necrotizing process (e.g., necrotizing fasciitis). 6. Infections at vascular catheter sites, or involving thrombophlebitis. 6. The primary ABSSSI is associated with, or in close proximity to, a prosthetic device. 7. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI. 8. Patients expected to require more than two surgical interventions in the operating room for the ABSSSI. 9. Severe sepsis or septic shock. 10. Significant or life-threatening condition (e.g., endocarditis, meningitis) that would confound, or interfere with, the assessment of the ABSSSI. 11. Another severe, acute or chronic medical condition, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation or administration of the investigational product, or may interfere with the interpretation of study results, and which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 12. Receiving treatment for active tuberculosis. 13. Absolute neutrophil count < 0.5 × 10^9/L. 14. Recent history of opportunistic infections (i.e., within 30 days) if the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome [AIDS]). 15. Patients receiving systemic steroids (> 40 mg per day prednisolone, or equivalent), or receiving immunosuppressant drugs. 16. Requirement for peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration, or expected to require such treatment before the TOC visit. 17. Alanine transaminase (ALT) or aspartate transaminase (AST) levels ≥ 8× the upper limit of normal, OR severe hepatic disease with Child-Pugh class C. 18. Women who are pregnant or nursing. 19. Women who are of childbearing potential and unwilling to use an acceptable method of birth control during the study: female sterilization (bilateral tubal occlusion or oophorectomy, or hysterectomy) or male partner vasectomy; intrauterine device (IUD); combined (estrogen and progesterone containing) hormonal contraception (oral, vaginal ring, or transdermal patch) with an ethinylestradiol dose of at least 30 µg, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap; or total sexual abstinence. Women are not considered to be of childbearing potential if they are either ≥ 1 year post-menopausal (where menopause is defined as at least 12 months of amenorrhea), or have a serum follicle stimulating hormone (FSH) measurement consistent with post-menopausal status according to local laboratory thresholds. An FSH measurement at Screening is to be obtained for post-menopausal females aged < 50 years, or for those aged ≥ 50 years who have been post-menopausal for < 2 years. 20. Inability to start study-drug therapy within 24 hours of Screening. 21. Patients with illicit drug use within 12 months of screening, including heroin, other opioids (unless prescribed for medical reasons unrelated to heroin substitution), cocaine / crack cocaine, and amphetamine or methamphetamine. Exception: Cannabis use. ; PRIMARY OUTCOME: Early Clinical Response; SECONDARY OUTCOME 1: Investigator-assessed Clinical Success in the ITT Population[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase IIIa - PIONEER 1 (vs. Placebo, w/ Diet and Exercise Only); BRIEF: This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only. ; 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: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age above or equal to 18 years at the time of signing informed consent.For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening - HbA1c (glycosylated haemoglobin) between 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Treatment with diet and exercise for at least 30 days prior to day of screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.For Czech Republic only: Adequate contraceptive measures are always one highly reliable method (such as intrauterine device, sterilisation of one of the partners, hormonal birth control methods) plus one supplementary barrier method (such as condom, diaphragm) with a spermicide. In justified cases, this combination may be replaced with a double-barrier method with a spermicide. Total sexual abstinence may also be considered contraception. (Please note: hormonal contraception should always be discussed with a gynaecologist) - Any disorder, which in the investigators opinion might jeopardise subjects safety or compliance with the protocol - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) - Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation - Subjects presently classified as being in New York Heart Association Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Subjects with alanine aminotransferase above 2.5 x upper normal limit - Renal impairment defined as estimated glomerular filtration rate below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula - Treatment with any medication for the indication of diabetes or obesity in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) ; PRIMARY OUTCOME: Change in HbA1c; SECONDARY OUTCOME 1: Change in Body Weight (kg)[/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 - OSKIRA-X (Extension); BRIEF: The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA). ; DRUG USED: Tavalisse; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: Spleen Tyrosine Kinase (syk); THERAPY: Monotherapy; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib - Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003). Exclusion Criteria: - Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004) - Females who are pregnant or breast feeding - Poorly controlled hypertension - Significant liver function test abnormalities or physical symptoms of hepatotoxicity - Significant infection - Gastrointestinal intolerance - Cancer ; PRIMARY OUTCOME: Percentage of Patients Who Had at Least 1 Adverse Event in Any Category; SECONDARY OUTCOME 1: Mean DAS28-CRP 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 III - Pediatric; BRIEF: The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects. ; DRUG USED: Opana IR; DRUG CLASS: Non-NME; INDICATION: Chronic Pain; TARGET: Opioid receptors; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Is male or female <2 years of age at the time of surgery. 2. Must weigh at least 3 kg. 3. Is scheduled to have a surgical procedure for which opioid analgesia will be needed to manage postoperative pain for at least 18 hours following intraoperative and/or postoperative IV analgesia. 4. Is generally healthy as documented by medical history; physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms (EKGs); clinical laboratory assessments; and general observations. Any abnormalities or deviations from the acceptable range that might be considered clinically relevant by the study physician or investigator will be evaluated on a case-by-case basis, agreed upon by the Principal Investigator (or sub-investigator), and documented in study files before enrolling the subject in the study. 5. The subjects parent or guardian has been informed of the nature of the study and has provided written informed consent. Postoperative: 6. Is anticipated to require an analgesic regimen using a short-acting opioid (non-oxycodone or non-oxymorphone) analgesic after surgery (according to standard of care (SOC) as defined in the protocol). 7. Is an inpatient expected to be hospitalized for 24 hours after dosing with study drug. 8. Has an indwelling access catheter for blood sampling. 9. For Groups A and B: Has demonstrated signs of tolerating oral intake. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions. 10. Prior to administration of oxymorphone HCl oral solution, for Groups A and B, had demonstrated the ability to tolerate clear liquids, following surgery according to the SOC at each institution. All infants and children should be able to demonstrate strong suck and swallow reflexes and neurologic alertness and stability sufficient to handle oral secretions. The ability to tolerate small amounts (1 to 2 oz.) of clear liquids without emesis (over 30 to 60 minutes) would support readiness for study participation and oral intake once the physician has ordered the diet advanced to clear liquids and the subject has ingested fluids by mouth without nausea or vomiting. Exclusion Criteria: Subjects who meet any of the following criteria will not be eligible to participate in the study: 1. Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or nervous system(s) or psychiatric disease that would contraindicate participation, as determined by the Investigator. 2. Has any clinical laboratory test result outside the accepted range that has been confirmed upon re-examination and deemed to be clinically significant. 3. Has a clinically significant illness or condition any time before dosing with study drug that would contraindicate participation, as determined by the Investigator. 4. Has a life expectancy <8 weeks. 5. For age groups A and B: Has a malabsorption, gastroenterologic, or abdominal condition that would interfere with the absorption of study drug. 6. Has evidence of increased intracranial pressure. 7. Has a respiratory condition requiring intubation or resulting in active bronchiolitis, asthma, stridor, or difficulty breathing due to congestion and increased nasal secretions, including oxygen (O2) saturation ≤92%. 8. Has a history of seizures. 9. Subject (and/or mother if subject is nursing) has used medications with actions characteristic of monoamine oxidase inhibitors (MAOIs) within 14 days before the start of the study drug is prohibited. Standard daily pediatric multivitamins may be taken until enrollment into the study but will be restricted during the study. 10. Subject (and/or mother if subject is nursing) has received preoperative opioids for more than 72 consecutive hours. 11. Subject (and/or mother if subject is nursing) has received oxycodone or oxymorphone within 48 hours prior to screening. 12. Subject (and/or mother if subject is nursing) has ingested caffeine- or xanthine-containing products (eg, theophylline) within 48 prior to screening. These products are also prohibited during periods when blood samples are collected. 13. Has a history of relevant drug allergies, food allergies, or both (ie, allergy to oxymorphone or other opioid analgesics) that could interfere with the study. 14. Parent or legal guardian is unable to provide consent for any reason (eg, mental or physical disabilities, language barriers, or is unavailable). 15. Subject (and/or mother if subject is nursing) has participated in a clinical study of an unapproved drug within the previous 30 days. 16. Is not suitable for entry into the study in the opinion of the Investigator. ; PRIMARY OUTCOME: Cumulative Total Amount of Morphine Rescue Medication Required for Analgesia in the Active Treatment Group (Single Dose); SECONDARY OUTCOME 1: Assessment of Pain Using the Age Appropriate Scale, Face, Legs, Activity, Cry, Consolability (FLACC) or the Neonatal Infant Pain Scale (NIPS).[/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 - ALIZE; BRIEF: This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination ; DRUG USED: Fasenra; DRUG CLASS: Biologic; INDICATION: Asthma; TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1 - Weight of ≥40 kg - Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA) - Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2. - Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR - Airway reversibility documented in the previous 12 months prior to Visit 1 - An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR - Any condition assessed by patient recall over the previous 2-4 weeks Exclusion Criteria: - Clinically important pulmonary disease other than asthma - Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine - Receipt of an influenza vaccine within 90 days prior to randomization - Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma - Acute illness or evidence of significant active infection or known influenza infection during the current flu season ; PRIMARY OUTCOME: Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12; SECONDARY OUTCOME 1: Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - COVERS Exp; BRIEF: The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections. ; DRUG USED: Teflaro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Gram-Negative Bacteria, Penicillin Binding Proteins (PBP); THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female, aged 18 years or older - Complicated skin and skin structure infection (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose. Exclusion Criteria: - Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug - Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens - Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease - Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb - Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock ; PRIMARY OUTCOME: Clinical Response at TOC; 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 - REDECT; BRIEF: This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses. ; DRUG USED: Redectane; DRUG CLASS: Biologic; INDICATION: Renal Cell Cancer (RCC) - Imaging; TARGET: Carbonic Anhydrase, Radiopharmaceutical; THERAPY: Monotherapy; LEAD SPONSOR: Heidelberg Pharma AG; CRITERIA: Inclusion Criteria: - Subject is over 18 years of age. - Presence of a renal mass. - Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique). - Expected survival of at least 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status < 2. - The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L - Serum bilirubin ≤ 2.0 mg/dL - Aspartate aminotransaminase (AST) ≤ 2.5 x ULN - Alanine aminotransferase (ALT) ≤ 2.5 x ULN - Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance >45 ml/min) - Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study. - Recovered from toxicity of any prior therapy. - Able and willing to give valid written informed consent. Exclusion Criteria: - Metastasis of primary tumor other than Renal Cell Carcinoma (RCC). - Prior history of malignancy within the last 5 years. - Prior exposure to murine proteins or chimeric antibodies. - Intercurrent medical condition that may limit the amount of antibody to be administered. - Intercurrent medical condition that renders the patient ineligible for surgery. - New York Heart Association Class III/IV cardiac disease. - History of autoimmune hepatitis. - Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to 124I-cG250 infusion on day 1. - Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. - Lack of availability for immunological and clinical follow-up assessments. - Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrolment. - Women who are pregnant or breastfeeding. - Allergy to iodine, hyperthyroidism, or Graves Disease. - Known allergic reaction to human serum albumin. - Contraindication for contrast-enhanced CT or PET/CT. - Contraindication to potassium iodide intake (see package insert). ; PRIMARY OUTCOME: Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.; SECONDARY OUTCOME 1: Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging[/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 - VISTA (Extension Study); BRIEF: Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration. Patients will be monitored for safety throughout their participation in the study. Safety will be monitored by physical examination, inspection of injection sites, vital signs, clinical laboratory determinations (including fasting glucose, insulin, and lipids), 12-lead ECGs (for new treatment naïve subjects and subjects not previously exposed to somavaratan), PK/PD assessments, and immunogenicity assessments. Adverse events (AEs) and concomitant medications will be captured. AEs will be coded using CTCAE v 4.0. AEs will be coded using the MedDRA dictionary and CMs using the WHO Drug dictionary. ; DRUG USED: Somavaratan; DRUG CLASS: Biologic; INDICATION: Short Stature / Growth Hormone Deficiency; TARGET: Growth hormone receptor (GHR); THERAPY: Monotherapy; LEAD SPONSOR: Versartis Inc.; CRITERIA: Inclusion Criteria for Subjects Completing a Previous Somavaratan Study: 1. Completion of a somavaratan clinical study. 2. Willing and able to comply with all study procedures. Exclusion Criteria for Subjects Completing a Previous somavaratan Study: 1. Withdrawal from a somavaratan clinical study. 2. Use of certain medications with potential to alter responses to the test product. 3. Presence of a significant medical condition. Inclusion Criteria for New Treatment Naïve Subjects: 1. Chronological Age ≥ 3.0 years. 2. Pre-pubertal status. 3. Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0 ng/mL. 4. Normal thyroid function at Screening Visit in subjects not being treated for hypothyroidism. 5. Normal adrenal function at Screening Visit or within 6 months of the Screening Visit, in subjects not being treated for adrenal insufficiency. Subjects with adrenal insufficiency must receive glucocorticoid treatment for a minimum of 4 weeks before study drug administration. 6. Pathology relating to cause of GHD must be stable for at least 6 months prior to screening. 7. Legally authorized representatives must be willing and able to give informed consent. Exclusion Criteria for New Treatment Naïve Subjects: 1. Prior/concomitant treatment with any growth promoting agent. 2. Current, significant disease. 3. Chromosomal aneuploidy, significant gene mutations or confirmed diagnosis of a named syndrome. 4. Birth weight and/or birth length less than 5th percentile for gestational age. 5. Prolonged daily use of anti-inflammatory doses of oral glucocorticoids. 6. Prior history of malignancy. 7. Treatment with an investigational drug in the 30 days prior to screening. 8. Known allergy to constituents of the study drug formulation. 9. Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening. 10. Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation, and spina bifida variants. 11. Significant abnormality in screening studies. 12. History of pancreatitis or undiagnosed chronic abdominal pain. 13. History of spinal or total body irradiation. 14. Other pituitary hormone deficiencies that are not properly treated. ; PRIMARY OUTCOME: Safety; 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 - FINCH 3; BRIEF: The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA). ; DRUG USED: Jyseleca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Rheumatoid Arthritis (RA); TARGET: JAK/STAT ; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Gilead Sciences; CRITERIA: Key Inclusion Criteria: - Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria) and are ACR functional class I-III. - Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1. - Limited or no prior treatment with MTX Key Exclusion Criteria: - Previous treatment with any janus kinase (JAK) inhibitor - Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine - Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24; SECONDARY OUTCOME 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24[/INST]Yes</s>

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

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - AWARD-PEDS; BRIEF: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks. ; DRUG USED: Trulicity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: GLP-1 Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Eli Lilly and Company; CRITERIA: Inclusion Criteria: - Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening. - Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between >6.5 % to ≤9%. - Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50 kilograms (110 pounds). Exclusion Criteria: - Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome. - A history of, or at risk for pancreatitis. - Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening. - A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg. - Active or treated cancer. - A blood disorder where an accurate HbA1c may not be obtainable. - A female of childbearing age, sexually active and not on birth control. - Pregnant or plan to be pregnant during the study, or breastfeeding. - Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin). - Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day. - Using prescription weight loss medications in the last 30 days, or plan to use. - Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months. ; PRIMARY OUTCOME: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26; SECONDARY OUTCOME 1: Change From Baseline in HbA1c (Individual Doses) at Week 26[/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 - CHOOSE; BRIEF: The purpose of this study is to examine the safety and efficacy of Angiomax as an anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass (OPCAB) surgery. ; DRUG USED: Angiomax; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiac Valve Surgery; TARGET: Thrombin (Coagulation Factor IIa); THERAPY: Monotherapy; LEAD SPONSOR: The Medicines Company; CRITERIA: Inclusion: - Be at least 18 years of age. - Be accepted for OPCAB graft surgery (repeat CABG eligible) - New diagnosis or history of objectively documented HIT/HITTS Type II, defined as: 1. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for HIT antibodies (ELISA), AND/OR 2. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count has decreased by 50%, OR 3. HITTS: Thrombocytopenia (as defined in B above) PLUS any arterial or venous thrombosis (Deep-vein thrombosis, pulmonary embolism, mesenteric venouse or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion of limb arteries) diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venouse or arterial angiography, MRI/MRA, catheterization.) Exclusion Criteria: - Confirmed pregnancy, by urine or serum pregnancy test (if woman of child-bearing potential). - Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. - Intracranial neoplasm, arteriovenous malformation, or aneurysm. - Dependency on renal dialysis or creatinine clearance <30mL/min. - Ongoing treatment with warfarin (or other oral anticoagulant) at the time of enrollment. Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy. - Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any component of the product. - Patients receiving clopidogrel (Plavix®) within the previous 5 days may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with recent clopidogrel administration. - Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®), may be enrolled if in the opinion of the investigator the benefits of surgery outweigh the risk associated with not waiting the 48 or 12 hour time period prior to enrollment. - Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to enrollment. Patients currently receiving lepirudin or argatroban can be enrolled if they are switched to Angiomax at least 24 hours prior to the contemplated OPCAB. - Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the previous 12 hours may be enrolled if in the opinion of the Investigator the benefits of surgery outweigh the risk associated with not waiting the 12 hour time period. - Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization. - Refusal to undergo blood transfusion should it become necessary. - Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements. ; PRIMARY OUTCOME: Primary Endpoint; 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 - KIDS A-LONG (Pediatric); BRIEF: The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes. ; DRUG USED: Eloctate; DRUG CLASS: Biologic; INDICATION: Hemophilia A; TARGET: Coagulation Factor VIII, Coagulation Factor X; THERAPY: Monotherapy; LEAD SPONSOR: Bioverativ Therapeutics Inc.; CRITERIA: Key Inclusion Criteria: - Severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII - Male <12 years of age and weight ≥13 kg - History of at least 50 documented prior exposure days to FVIII - No current, or history of, inhibitor development to FVIII Key Exclusion Criteria: - Other coagulation disorders in addition to Hemophilia A - History of anaphylaxis associated with any FVIII or IV immunoglobulin administration NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply. ; PRIMARY OUTCOME: Occurrence of FVIII Inhibitor Development; SECONDARY OUTCOME 1: Annualized Bleeding Rate[/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 - PALOMA-3 - w/Fulvestrant (HR+/HER2-); BRIEF: The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic). ; DRUG USED: Ibrance; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Cyclin Dependent Kinase (CDK); THERAPY: Combination; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy - Confirmed diagnosis of HR+/HER2- breast cancer - Any menopausal status - Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy - On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization. - Measurable disease defined by RECIST version 1.1, or bone-only disease - Eastern Cooperative Oncology Group (ECOG) PS 0-1 - Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures - Patient must agree to provide tumor tissue from metastatic tissue at baseline Exclusion Criteria: - Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway - Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases - Major surgery or any anti-cancer therapy within 2 weeks of randomization - Prior stem cell or bone marrow transplantation - Use of potent CYP3A4 inhibitors or inducers ; PRIMARY OUTCOME: Progression-Free Survival (PFS) as Assessed by the Investigator; SECONDARY OUTCOME 1: Overall Survival (OS) - Number of Participants Who Died[/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 - SAkuraStar (Monotherapy); BRIEF: The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD. ; DRUG USED: Enspryng; DRUG CLASS: Biologic; INDICATION: Neuromyelitis Optica (Devics Syndrome, NMO); TARGET: IL-6 Receptor (IL-6R); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: 1. Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following: 1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging [MRI] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis [MS]; NMO-IgG seropositive status) 2. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral 2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening 3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening 4. Age 18 to 74 years, inclusive at the time of informed consent 5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Exclusion Criteria: 1. Clinical relapse onset (including first attack) within 30 days prior to baseline Exclusion Criteria Related to Previous or Concomitant Therapy: 2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time 3. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline 4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline 5. Treatment with any investigational agent within 3 months prior to baseline Exclusions for General Safety: 6. Pregnancy or lactation. 7. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug 8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline 9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML) 10. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency 11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline 12. Evidence of chronic active hepatitis B or C 13. History of drug or alcohol abuse within 1 year prior to baseline 14. History of diverticulitis that, in the Investigators opinion, may lead to increased risk of complications such as lower gastrointestinal perforation 15. Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection) 16. Evidence of active interstitial lung disease 17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline 18. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured) 19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions) 20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening 21. History of Stevens-Johnson syndrome 22. Following laboratory abnormalities at screening*. 1. White blood cells <3.0 x10^3/microliter (μL) 2. Absolute neutrophil count <2.0 x 10^3 /μL 3. Absolute lymphocyte count <0.5 x 10^3 /μL 4. Platelet count <10 x 10^4 /μL 5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal. - If retest is conducted, the last value of retest before randomization must meet study criteria. ; PRIMARY OUTCOME: Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period; SECONDARY OUTCOME 1: Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period[/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 - Explorer 8; BRIEF: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with the study medicine 1 time every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for up to 6.5 years. The length of time the participant will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (21 April 2026 at the latest). Participants will have to come to the clinic for up to 40 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in, and approximately 8 weeks for the rest of the study. If the participant attends extra visits due to the prescription medicine not being available for purchase in their country, these will be 14 weeks apart. Participants will be asked to record information in an electronic diary during the study and may also be asked to wear an activity tracker. ; DRUG USED: Concizumab; DRUG CLASS: Biologic; INDICATION: Hemophilia A and B - General Clotting Products; TARGET: Tissue Factor Pathway Inhibitor (TFPI); THERAPY: Monotherapy; LEAD SPONSOR: Novo Nordisk A/S; CRITERIA: Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. - Male aged 12 years or older at the time of signing informed consent. - Congenital severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%). Exclusion Criteria: - Known or suspected hypersensitivity to any constituent of the trial product or related products. - Known inherited or acquired coagulation disorder other than congenital haemophilia. - Presence of confirmed inhibitors 0.6 BU or greater at screening. - History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events.) ; PRIMARY OUTCOME: For haemophilia A patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes; SECONDARY OUTCOME 1: For haemophilia A patients without inhibitors: The number of treated spontaneous and traumatic bleeding episodes[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATLAS 1; BRIEF: Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections. ; DRUG USED: Vibativ; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Cell wall synthesis; THERAPY: Monotherapy; LEAD SPONSOR: Cumberland Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) either suspected or confirmed as the major cause of the infection: - major abscess requiring surgical incision and drainage - infected burn (see exclusion criteria for important qualifications) - deep/extensive cellulitis - infected ulcer (see exclusion criteria for important qualifications) - wound infections - Patients must be expected to require at least 7 days of intravenous antibiotic treatment Exclusion Criteria: - Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy prior to randomization - Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis. ; PRIMARY OUTCOME: Clinical Response; 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 - CF301 - EU/Australia; BRIEF: The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment. ; DRUG USED: Bronchitol; DRUG CLASS: Non-NME; INDICATION: Cystic Fibrosis (CF); TARGET: Osmosis/Osmotic Pressure; THERAPY: Monotherapy; LEAD SPONSOR: Pharmaxis; CRITERIA: Main Inclusion Criteria: - Written informed consent - Confirmed diagnosis of cystic fibrosis - Aged > 6 years - FEV1 >30 % and < 90% predicted - Able to perform all the techniques necessary to measure lung function Main Exclusion Criteria: - Terminally ill or listed for lung transplantation - Had a lung transplant - Using nebulised hypertonic saline - Significant episode of haemoptysis (>60 mL) in the three months prior to enrolment - Recent myocardial infarction or cerebral vascular accident - Breast feeding or pregnant, or plan to become pregnant while in the study participating in another investigative drug study, parallel to, or within 4 weeks of study entry - Allergy or intolerance to mannitol - Using beta blockers - Have a condition or be in a situation which in the Investigators opinion may put the subject at significant risk, may confound results or may interfere significantly with the patients participation in the study ; PRIMARY OUTCOME: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control; SECONDARY OUTCOME 1: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF on existing RhDNase treatment compared to control. (key objective)[/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 - ALTA-3 (Progressed on Crizotinib); BRIEF: Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: - Brigatinib tablets - Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later. ; DRUG USED: Alunbrig; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Anaplastic lymphoma kinase (ALK), EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Takeda; CRITERIA: Inclusion Criteria: 1. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 2. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent) or stage IV NSCLC. 3. Must meet one of the following criteria: - Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit or the Ventana ALK (D5F3) CDx Assay or Foundation Medicines FoundationOne CDx. - Have documented ALK rearrangement by a different test and be able to provide tumor sample to the central laboratory. (Note: central laboratory ALK rearrangement testing results are not required to be obtained before randomization). 4. Had PD while on crizotinib, as assessed by the investigator or treating physician. (Note: crizotinib does not need to be the last therapy a participant received. The participant may have received chemotherapy as his/her last therapy). 5. Treatment with crizotinib for at least 4 weeks before progression. 6. Have had no other ALK inhibitor other than crizotinib. 7. Have had no more than 2 prior regimens of systemic anticancer therapy (other than crizotinib) in the locally advanced or metastatic setting. Note: a systemic anticancer therapy regimen will be counted if it is administered for at least 1 complete cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if disease progression/recurrence occurred within 12 months upon completion of this neoadjuvant or adjuvant therapy. (Systemic therapy followed by maintenance therapy will be considered as one regimen if the maintenance therapy consists of a drug or drugs that were used in the regimen that immediately preceded maintenance). 8. Have at least 1 measurable (that is, target) lesion per RECIST v1.1. 9. Have recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE) v4.03 grade less than or equal to (<=)1. (Note: treatment-related alopecia or peripheral neuropathy that are grade greater than (>) 1 are allowed, if deemed irreversible). 10. Have adequate organ function, as determined by: - Total bilirubin <=1.5 times the upper limit of normal (ULN). - Estimated glomerular filtration rate greater than equal to (>=) 30 milliliter per minute (mL/min)/1.73 square meter [m^2], using the modification of diet in renal disease equation. - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <=2.5*ULN; <=5*ULN is acceptable if liver metastases are present. - Serum lipase <=1.5*ULN. - Platelet count >=75*10^9 per liter [/L]. - Hemoglobin >=9 gram per deciliter (g/dL). - Absolute neutrophil count >=1.5*10^9 / L. 11. Suitable venous access for study-required blood sampling (that is, including pharmacokinetic [PK] and laboratory safety tests). Exclusion Criteria: 1. Had participated in the control (crizotinib) arm of Study AP26113-13-301 (ALTA 1L). 2. Had received crizotinib within 7 days before randomization. 3. Have a history or presence at baseline of pulmonary interstitial disease, drug related pneumonitis, or radiation pneumonitis. 4. Have uncontrolled hypertension. Participants with hypertension should be under treatment for control of blood pressure upon study entry. 5. Had received systemic treatment with strong cytochrome P-450 (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days before randomization. 6. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before randomization. 7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. 8. Had received chemotherapy or radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy. 9. Had received antineoplastic monoclonal antibodies within 30 days of randomization. 10. Had major surgery within 30 days of randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed. 11. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening (participants with asymptomatic brain metastases or participants who have stable symptoms and did not require an increased dose of corticosteroids to control symptoms within 7 days before randomization will be enrolled). Note: If a participant has worsening neurological symptoms or signs due to CNS metastasis, the participant needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants) for 7 days before randomization. 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed. 13. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following: - Myocardial infarction within 6 months before randomization. - Unstable angina within 6 months before randomization. - New York Heart Association Class III or IV heart failure within 6 months before randomization. - History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician. - Any history of clinically significant ventricular arrhythmia. 14. Had cerebrovascular accident or transient ischemic attack within 6 months before first dose of study drug. 15. Have malabsorption syndrome or other gastrointestinal illness or condition that could affect oral absorption of the study drug. 16. Have an ongoing or active infection, including but not limited to, the requirement for intravenous antibiotics. 17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history. 18. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection. Testing is not required in the absence of history. 19. Any serious medical condition or psychiatric illness that could, in the investigators opinion, potentially compromise patient safety or interfere with the completion of treatment according to this protocol. 20. Have a known or suspected hypersensitivity to brigatinib or alectinib or their excipients. 21. Life-threatening illness unrelated to cancer. 22. Female patients who are lactating and breastfeeding. 23. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse. ; PRIMARY OUTCOME: PFS as Assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1; 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 - IMMvent; BRIEF: This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. ; DRUG USED: Skyrizi; DRUG CLASS: Biologic; INDICATION: Psoriasis; TARGET: IL-23 (Interleukin-23) ; THERAPY: Monotherapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion criteria: - Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. *Women of childbearing potential are defined as: - having experienced menarche and - not postmenopausal (12 months with no menses without an alternative medical cause) and - not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy). - Age ≥ 18 years at screening - Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient. - Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization): - Have an involved body surface area (BSA) ≥ 10% and - Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and - Have a static Physician Global Assessment (sPGA) score of ≥ 3. - Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator - Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator. - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: - Patients with - non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) - current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigators judgment - Previous exposure to ABBV-066 - Previous exposure to adalimumab (Humira®) - Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study. - Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study. - Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation). - Known chronic or relevant acute infections, such as active tuberculosis (TB), human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified protein derivative (PPD) skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then treatment should have been initiated and maintained according to local country guidelines. - Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. - Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the Screening Visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data. - History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients - Women who are pregnant, nursing, or who plan to become pregnant while in the trial - Previous enrolment in this trial ; PRIMARY OUTCOME: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A); SECONDARY OUTCOME 1: Percentage of Participants Achieving PASI75 at Week 16 (Part 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 - C329 (Third Molar Extraction); BRIEF: This is a Phase 3, randomized, double-blind, placebo-controlled study in subjects scheduled to undergo elective bilateral third molar extraction under local anesthesia. At least one lower mandibular third molar must involve full or partial bony impaction confirmed by visual or radiographic evidence. ; DRUG USED: Exparel; DRUG CLASS: New Molecular Entity (NME); INDICATION: Postsurgical Pain; TARGET: Sodium Channels; THERAPY: Monotherapy; LEAD SPONSOR: Pacira Pharmaceuticals, Inc; CRITERIA: Inclusion Criteria: 1. Male or female, ≥18 years of age at screening. 2. Scheduled to undergo bilateral third molar extractions (i.e., extraction of all four third molars) under local anesthesia. At least one lower mandibular third molar must involve full or partial bony impaction confirmed by visual or radiological evidence. 3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3. 4. Female subjects must be either surgically sterile, using a medically acceptable method of birth control, or at least 2 years postmenopausal, and must have a documented negative pregnancy test result during screening and on Day 1 prior to surgery. 5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. Exclusion Criteria: 1. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids. 2. Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone. 3. History of significant drug allergy (e.g., anaphylaxis or hepatotoxicity). 4. Positive test result from the urine drug screen at screening or prior to the surgical procedure. 5. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 6. History or active psychiatric illness (including major depression, bipolar disorder, or anxiety); Type 1 or Type 2 diabetes; severe renal or hepatic impairment; significant cardiovascular disease (including cardiac rhythm disturbance); migraine headaches, frequent headaches, other pain conditions, or other medical condition that, in the opinion of the Investigator, may increase the risk of surgery or interfere with the evaluation of the study drug. 7. History of infection requiring intravenous (IV) antibiotics within 45 days or oral (PO) antibiotics within 30 days prior to study drug administration for reasons other than dental prophylaxis. Subjects must be afebrile, without signs or symptoms indicative of active infection. 8. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin (except for low-dose aspirin used for cardioprotection), or acetaminophen within 3 days, or any opioid medication within 24 hours. 9. Initiation of treatment with any of the following medications within 1 month of EXPAREL infiltration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to EXPAREL administration. 10. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study. 11. Use of any concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the Investigators opinion may exert significant analgesic properties or act synergistically with the investigational product. 12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subjects participation in this study. ; PRIMARY OUTCOME: Area Under the Curve (AUC) of Numeric Rating Scale (NRS) Pain Intensity Scores Through 48 Hours; SECONDARY OUTCOME 1: Area Under the Curve (AUC) of Numeric Rating Scale (NRS) Pain Intensity Scores Through 24 Hours[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALERT; BRIEF: This is a Phase 3, open-label, repeat-dose study designed to assess liver safety, non-liver safety, and efficacy of lixivaptan in participants who previously experienced liver chemistry test abnormalities while treated with tolvaptan and were permanently discontinued from the drug for that reason. Up to 50 eligible participants will be enrolled and treated with lixivaptan for 52 weeks following titration to an optimal dose. ; DRUG USED: Lixivaptan; DRUG CLASS: New Molecular Entity (NME); INDICATION: Polycystic Kidney Disease; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Palladio Biosciences; CRITERIA: Inclusion Criteria: - Male or female, between 18 and 65 years of age (inclusive) at the time of Screening. - Documented diagnosis of ADPKD by imaging or genetic analysis previously treated with tolvaptan for that indication. - Screening eGFR ≥ 20 mL/min/1.73 m^2. - Body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) at the time of Screening. - Documented history of: - Based on upper limit of normal (ULN): At least 2 elevated alanine aminotransferase (ALT) levels; 1 ALT level >2 x ULN and 1 ALT level >3 x ULN while the participant was receiving tolvaptan, or within 4 weeks after tolvaptan discontinuation, with no other explanation for the ALT elevations. The 2 elevated ALT measurements could be recorded during the same instance of liver injury or during distinct instances; OR - Based on the participants stable baseline as determined by the Investigator: At least 2 elevated ALT levels; 1 ALT level >2 x the participants stable baseline level and 1 ALT level >3 x the participants stable baseline level while the participant was receiving tolvaptan, or within 4 weeks after tolvaptan discontinuation, with no other explanation for the ALT elevations; provided that at least one ALT elevation was >2 x ULN. The 2 elevated ALT measurements could be recorded during the same instance of liver injury or during distinct instances; OR - A pattern of ALT elevations deemed by the Investigator to be consistent with tolvaptan liver injury with no other explanation for the ALT elevations and agreement of the medical monitor and sponsor. - Permanent discontinuation of prior tolvaptan treatment because of the ALT abnormality. - If re-challenge with tolvaptan was performed, the ALT level must have increased to >2 x ULN upon rechallenge or the ALT level was increasing but tolvaptan was stopped for patient safety reasons before it reached > 2 x ULN after having previously normalized. - Appropriate control of hypertension including an angiotensin converting enzyme inhibitor or angiotensin receptor blocker (unless not considered appropriate for the participant) without the use of a diuretic in concert with Kidney Disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. - Willing to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential). - Able to provide informed consent. Exclusion Criteria: - Known sensitivity or idiosyncratic reaction to any compound present in lixivaptan and related compounds. - Hypovolemia at Screening. - Abnormal serum sodium concentration at Screening. - Subjects who have taken any investigational drug or used an investigational device within 30 days, or 5 half-lives, whichever is longer, prior to Screening. - Subjects who are taking, have taken within the past 2 weeks, or are expected to be taking, strong or moderate CYP3A4 or CYP2C8 inhibitors or inducers including regular use of grapefruit juice, Seville oranges, or St. Johns wort. - Simvastatin at total daily doses >10 mg or amlodipine at total daily doses >5 mg. - Use of tolvaptan within the 3 months prior to Screening or until a previously elevated ALT level has returned to ≤1 x ULN for at least 3 months. - Use of lixivaptan or participation in a clinical study with lixivaptan within the 3 months prior to Screening. - Use of conivaptan, somatostatin analogs (e.g., lanreotide, pasireotide, octreotide, etc.), metformin, nicotinamide, bardoxolone, venglustat, demeclocycline, or mammalian Target of Rapamycin (mTOR) kinase inhibitors (e.g., everolimus, sirolimus, etc.) to treat ADPKD within the 3 months prior to Screening. - Requirement for chronic diuretic use. - History of advanced diabetes (e.g., glycosylated hemoglobin [HgbA1c] >7.5%, and/or glycosuria by dipstick, significant proteinuria [>300 mcg albumin/mg creatinine]), other significant renal disease, transplanted kidney, recent kidney surgery within the 6 months prior to Screening (including cyst drainage or fenestration) or acute kidney injury within the 6 months prior to Screening. - Clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia). - New York Heart Association Functional Class 3 or 4 heart failure or other significant cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the participant. - Clinically significant liver disease or impairment or active chronic hepatitis at Screening. - Positive test results for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody. - History of infection with human immunodeficiency virus (HIV) unless the participant is stable and doing well on a non-CYP interacting anti-retroviral therapy (ART) regimen and who has not required more than 2 changes in their ART regimen. - ALT or aspartate aminotransferase (AST) values >1.5 x ULN during Screening/Baseline. - Total bilirubin values >1.0 x ULN during Screening/Baseline. - History of drug or alcohol abuse in the 2 years prior to Screening. - Any malignancy within the 5 years prior to Screening except for basal cell carcinoma successfully treated with local therapy. - Medical history or findings that preclude safe participation in the study or who are likely to be non-compliant with study procedures in the opinion of the Investigator or medical monitor. ; PRIMARY OUTCOME: Number of Participants Who Develop Serum Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment; SECONDARY OUTCOME 1: Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan 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 - MO28457/PrefMab (DLBCL/FLL); BRIEF: This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkins lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks. ; DRUG USED: Rituxan Hycela; DRUG CLASS: Biologic; INDICATION: Indolent Non-Hodgkins Lymphoma (Including Follicular Lymphoma) - NHL; TARGET: Cluster of Differentiation 20 (CD20); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult participants , >/= 18 and </= 80 years of age - Histologically confirmed, previously untreated CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular non-Hodgkins lymphoma (NHL) Grade 1, 2, or 3a, according to World Health Organization (WHO) classification - An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion >/= 7.5 cm, or Follicular Lymphoma International Prognostic Index (FLIPI; low, intermediate or high risk) - At least one bi-dimensionally measurable lesion defined as >/=1.5 cm in its largest dimension on CT scan - Eastern Cooperative Oncology Group (ECOG) performance status </= 3 Exclusion Criteria: - Transformed lymphoma or follicular lymphoma IIIB - Primary central nervous system (CNS) lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis - History of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for >/= 5 years prior to enrolment; participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible - Prior therapy for DLBCL or NHL, with the exception of nodal biopsy or local irradiation - Prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition, or prior use of an anti-CD20 drug - Prior use of monoclonal antibody within 3 months prior to randomization - Chemotherapy or other investigational therapy within 28 days prior to randomization - Ongoing corticosteroid use > 30 mg/day prednisolone or equivalent - Inadequate renal. hematologic or hepatic function - Active and/or severe infection or any major episode of infection within 4 weeks prior to randomization - Active hepatitis B virus or active hepatitis C virus infection - History of human immunodeficiency (HIV) seropositive status - A positive pregnancy test in women of childbearing potential - Life expectancy of less than 6 months ; PRIMARY OUTCOME: Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6; SECONDARY OUTCOME 1: Number of Participants With Treatment Emergent Adverse Events (AEs)[/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 - Sexual Function; BRIEF: Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment. ; DRUG USED: Avodart; DRUG CLASS: New Molecular Entity (NME); INDICATION: Androgenetic Alopecia; TARGET: steroid 5a-reductase; THERAPY: Monotherapy; LEAD SPONSOR: Stiefel, a GSK Company; CRITERIA: Inclusion Criteria: - Subject agrees to participate in the study and has signed and dated the informed consent form prior to the initiation of any study-related activities. - AGA classified utilizing the Norwood-Hamilton classification. - Men 18 to 50 years old, inclusively. - Fluent and literate in local language with the ability to comprehend and record information on the International Index of Erectile Function, Hair Growth Satisfaction Scale, and DLQI questionnaires. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%). - Have been in a stable heterosexual relationship during the last 6 months prior to screening and expect to maintain that relationship throughout the study. - Must be sexually active: a man is considered sexually active if he has engaged in sexual intercourse (at least once) during the 4 weeks prior to screening. - Men with a female partner of childbearing potential must agree to avoid exposure of his partner to semen by using a condom. Use of a condom must be from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e., a total of 4.5 months) to allow clearance of any residual drug in the semen after the last dose of study treatment. - Willing to comply with study requirements. Exclusion Criteria: - Current or pre-existing sexual dysfunction as determined by: History of erectile dysfunction defined as the consistent inability to achieve or maintain an erection sufficient to permit satisfactory sexual intercourse. Score of ≤25 on the erectile function domain (IIEF-EF) of the IIEF at screening or at the baseline visit. - Evidence of hypogonadism. - Have a communicable skin or sexually-transmitted disease, or any rash or lesions on the penis or in the surrounding area (as reported by subject and evaluated by investigator). - Serum prostate-specific antigen (PSA) >2.0 ng/mL at screening. - Serum creatinine >1.5xULN at screening. - Unstable liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria). - History of malignancy (including prostate cancer) within the past 5 years, except basal cell or squamous cell carcinoma of the skin. - History of prostate cancer before the age of 50 years in a first degree relative. - History of breast cancer or clinical breast examination suggestive of malignancy. - Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening; and uncontrolled diabetes or peptic ulcer disease that is uncontrolled by medical management. - History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or the medical monitor, interfere with the subjects safety, obtaining informed consent, or compliance with study procedures.Note: the investigator may consult with the GSK medical monitor if a condition could interfere with the subjects safety. - Global scalp hair thinning, including occipital areas. - Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, non-androgenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis). - History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to screening. - History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder). - Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to screening. - Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps) within 3 months prior to screening. - Hypersensitivity to any 5-alpha reductase inhibitor (5-ARI) or its components or excipients or drugs chemically related to the study treatment. - Use of dutasteride within 10 months prior to screening or use of finasteride within 6 months prior to screening. - Previous use of systemic cytotoxic agents. - Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to screening. - Use of the following prior to Baseline (within 1 week for topical products; within 1 week or 5 half-lives, whichever is longer, for systemic treatments): Phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); Minoxidil (oral or topical); Carpronium chloride; Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide); Topical or systemic estrogen or progesterone; Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens); Drugs potentially causing hypertrichosis or telogen effluvium (e.g., valproic acid); Anabolic steroids; - Participation in any study of an investigational or marketed drug (within 5 half lives of drug) or device that may affect hair growth or sexual function prior to screening for this study. Note: Subject must not participate in any other drug or device studies during the course of this study. ; PRIMARY OUTCOME: Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period; SECONDARY OUTCOME 1: Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CheckMate-274; BRIEF: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer. ; DRUG USED: Opdivo; DRUG CLASS: Biologic; INDICATION: Bladder Cancer; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis - Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days - Must have disease free status as determined by imaging within 4 weeks of dosing - Tumor tissue must be provided for biomarker analysis - Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy Exclusion Criteria: - Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy) - Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer - Subjects with active, known or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration - Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection ; PRIMARY OUTCOME: Disease Free Survival (DFS); SECONDARY OUTCOME 1: Non-Urothelial Tract Recurrence 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 - Long-Term Safety; BRIEF: The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction. ; DRUG USED: Amitiza; DRUG CLASS: New Molecular Entity (NME); INDICATION: Opioid Induced Constipation (OIC); TARGET: Chloride Channel 2 (CIC-2/CLCN-2); THERAPY: Monotherapy; LEAD SPONSOR: Sucampo Pharma Americas, LLC; CRITERIA: Inclusion Criteria: - Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428 - Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study - Willing to continue to abstain from use of disallowed medications as defined per protocol Exclusion Criteria: - Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)] - Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit. - Has plans to participate in another trial with an investigational drug or device during the course of the extension study ; PRIMARY OUTCOME: Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month; SECONDARY OUTCOME 1: Number of Participants Classified as Monthly Responders[/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 - R/R DLL3 (w/Dexamethasone); BRIEF: A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs). ; DRUG USED: Rova-T; DRUG CLASS: Biologic; INDICATION: Small Cell Lung Cancer (SCLC); TARGET: Antibody-drug Conjugate (ADC), Delta-like 3 (DLL3), DNA synthesis; THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Minimum life expectancy of at least 12 weeks. - Laboratory values meeting the criteria specified in the protocol. - Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen. - Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. - Measurable disease as described per protocol. - In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids. Exclusion Criteria: - Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug. - Recent or on-going serious infection. - History of other invasive malignancy that has not been in remission for at least 3 years. - History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation. - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells. - Documented history of capillary leak syndrome. - Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis. ; PRIMARY OUTCOME: Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE; SECONDARY OUTCOME 1: Change in Participant Reported Outcome EORTC QLQC15-PAL[/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 - Study 217 Long-Term Extension; BRIEF: This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD. ; 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: - Completed study ALK5461-217 - Be willing to abide by the contraception requirements as outlined in the study protocol - Be willing and able to follow the study procedures and visits as outlined in the protocol - Additional criteria may apply Exclusion Criteria: - Pregnant, planning to become pregnant, or breastfeeding - A positive urine drug test for drugs of abuse - Poses a current suicide risk - Additional criteria may apply ; PRIMARY OUTCOME: Number of Subjects With Treatment-emergent Adverse Events (TEAEs); 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 - ICON6 (MRC); BRIEF: The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment. ; DRUG USED: Recentin; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: VEGF Receptor (VEGFR); THERAPY: Combination; LEAD SPONSOR: Medical Research Council; CRITERIA: Inclusion Criteria: 1. Females aged >= 18 years with previous histologically proven diagnosis of - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma requiring treatment with further platinum-based chemotherapy > 6 months after their last cycle of first-line chemotherapy and 6 weeks after maintenance that is not chemotherapy based. 2. Signed informed consent and ability to comply with the protocol 3. Ability to commence treatment within approximately 2 weeks of randomisation 4. CT or MRI proven relapsed disease (measurable or non-measurable) 5. ECOG performance status 0-1 6. Life expectancy more than 12 weeks 7. If there is a past history of a solid tumour (other than ovarian cancer), this must have been treated curatively more than five years ago with no evidence of recurrence, with the exception of patients who have synchronous endometrial cancer (stage I G1, G2) with their ovarian cancer 8. If prior anthracycline or chest radiotherapy, Left Ventricular Ejection Fraction (LVEF) > institutional lower limit of normal. 9. Adequate bone marrow function - Absolute Neutrophil Count (ANC) >= 1.5 x 109/l - Platelets (Plt) >= 100 x 109/l - Haemoglobin (Hb) >= 9g/dl (can be post transfusion) 10. Adequate liver function (within 14 days before randomisation) - Serum bilirubin (BR) ≤ 1.5 x ULN - Serum transaminases ≤ 2.5 x ULN 11. Adequate renal function - Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance > 50 ml/min - Urine dipstick for proteinuria <2+. If urine dipstick is >= 2+ on two occasions more than one week apart then a 24 hour urine must demonstrate <=1g of protein in 24 hours or protein/creatinine ratio <1.5 Exclusion Criteria: 1. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum 2. Poorly controlled hypertension (persistently elevated > 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication) 3. History of inflammatory bowel disease (Crohns disease or Ulcerative Colitis) 4. Malignancies other than ovarian cancer within 5 years prior to randomisation, except for synchronous endometrial cancer (Stage I G1,G2) with ovarian cancer,adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer. Patients who have a past history of a solid tumour, treated curatively, more than five years prior to randomisation, with no evidence of recurrence, are still eligible to enter ICON6. 5. Previous radiotherapy within 21 days prior to anticipated start of treatment 6. Treatment with any other investigational agent within 6 weeks prior to entering this trial. Patients are still eligible for entry into ICON6 if they have received previous treatment for ovarian cancer with either bevacizumab, erlotinib, or a Cox-2 inhibitor as long as more than 6 weeks have elapsed since the last treatment. 7. Arterial thrombotic event (including transient ischaemic attack [TIA], cerebrovascular accident [CVA) and peripheral arterial embolus) within the previous 12 months. 8. GI impairment that could affect ability to take, or adsorption of, oral medicines including sub acute or complete bowel obstruction 9. Known hypersensitivity to cediranib or other VEGF inhibitors 10. Major surgery within 2 weeks before anticipated start of treatment 11. Significant haemorrhage of > 30ml in a single episode within 3 months or any haemoptysis 12. Evidence of severe or uncontrolled cardiac disease - Myocardial infarct [MI] or unstable angina within 12 months - New York Health Association (NYHA) ≥ grade 2 congestive heart failure (CHF) - Cardiac ventricular arrhythmias requiring medication. - History of 2nd or 3rd degree atrioventricular conduction defects. 13. Prolonged QTc (corrected) interval of > 470msec on ECG, or a family history of long QT syndrome. 14. Persisting ≥ Grade 2 CTC toxicity (except alopecia and neuropathy) from previous anti-cancer treatment. If peripheral sensory or motor neuropathy ≥ grade 2 then paclitaxel can be omitted from the chemotherapy at the discretion of the treating physician 15. History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory in the case of suspected brain metastases. Spinal MRI is mandatory in the case of suspected spinal cord compression. Patients with unstable, untreated brain or meningeal metastases are not eligible. 16. Inability to attend or comply with treatment or follow-up scheduling 17. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications 18. Fertile women of childbearing potential not willing to use adequate contraception for the duration of trial treatment and at least 6 months after. 19. Any other severe uncontrolled medical condition or disease 20. Concomitant use of potent inhibitors of CYP3A4 and 2C8 which cannot be stopped without a 2 week washout period before starting Trial Drug. ; PRIMARY OUTCOME: Progression-free survival; 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 II/III - Extension (Japan); BRIEF: Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinsons disease patients who are not concomitantly treated with L-dopa will be investigated with a doses. ; DRUG USED: Neupro; DRUG CLASS: New Molecular Entity (NME); INDICATION: Parkinsons Disease (PD); TARGET: Dopamine 1 (D1) Receptor, Dopamine 2 (D2) Receptor, Dopamine 3 (D3) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: - Subject completed the preceding trial 243-07-001 (NCT00537485) Exclusion Criteria: - Subject discontinued from the preceding trial 243-07-001. - Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-001. - Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-001. - Subject had persistent hallucination or delusion during trial 243-07-001. - Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. - Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and has a decrease of SBP from spine to standing position >= 30 mmHg at baseline. - Subject has a history of epilepsy, convulsion etc. during trial 243-07-001. - Subject develops serious ECG abnormality at the baseline. - Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-07-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline. - Subject has a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-001. - Subject has a total bilirubin >= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or >= 100 IU/L) at the end of the period in trial 243-07-001. - Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-001. - Subject who plans pregnancy during the trial. - Subject has dementia. - Subject is unable to give consent. - Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above. ; PRIMARY OUTCOME: Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters; SECONDARY OUTCOME 1: Total of Unified Parkinsons Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score[/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 - IMerge (Transfusion-Dependent Subjects); BRIEF: The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study. An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment. ; DRUG USED: Imetelstat; DRUG CLASS: New Molecular Entity (NME); INDICATION: Myelodysplastic Syndrome (MDS); TARGET: Telomerase; THERAPY: Monotherapy; LEAD SPONSOR: Geron Corporation; CRITERIA: Inclusion Criteria: - Man or woman greater than or equal to (>=) 18 years of age - Diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Cycle 1 Day 1 (C1D1) (Part 1) or randomization [Part 2 (Main Study)]. In Part 2 (Ventricular Repolarization Substudy), diagnosis of MDS or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to C1D1 - International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS - Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: - Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients - Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study - Prior treatment with imetelstat - Have received corticosteroids greater than (>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry - Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs) - Part 2 (Main Study): a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide Additional Exclusion Criteria for Part 2 (Ventricular Repolarization Substudy) - Concurrent therapy with medications known to prolong the QT interval and have been associated with Torsade de pointes arrhythmia (TdP) - Cardiac function abnormalities on screening ECG as follows: - Resting heart rate outside of 50 to 100 beats per minute - QTcF >470 millisecond (msec) (or QTcF >490 msec in the presence of a right bundle branch block or ventricular conduction delay [QRS >119 msec]), determined by central assessment based on the average value of a triplicate set of ECGs - Diagnosed or suspected congenital long QT syndrome - Family history of sudden unexpected death from cardiac-related causes if indicative of a pathogenic mutation of cardiac ion channels - Family history of congenital long QT syndrome - History of Mobitz II second degree or third degree heart block - Implantable pacemaker or automatic implantable cardioverter defibrillator - Complete left bundle branch block - Chronic or persistent atrial arrhythmia including atrial fibrillation and atrial flutter - History or presence of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia - Unusual T-wave morphology (i.e., bifid T-wave) likely to interfere with QT measurements - History or evidence for any of the following: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 12 months prior to Cycle 1 Day 1, New York Heart Association (NYHA) Class II to IV heart disease - Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥160 mmHg or diastolic BP ≥100 mmHg). Participants with a history of hypertension are permitted, provided that BP is controlled to within these limits by anti-hypertensive treatment - Any skin condition likely to interfere with electrocardiographic electrode placement or adhesion - History of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues ; PRIMARY OUTCOME: Part 1 and Part 2 (Main Study): Percentage of Participants Without any Red Blood Cell (RBC) Transfusion During any Consecutive 8-Week Period; SECONDARY OUTCOME 1: Part 1 and Part 2: Number of Participants with Adverse Events (AEs)[/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 - SAPPHIRE - AA Patients; BRIEF: In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV). ; DRUG USED: OT-101; DRUG CLASS: New Molecular Entity (NME); INDICATION: Brain Cancer (Malignant Glioma; AA and glioblastoma (GBM)); TARGET: Transforming Growth Factor-beta (TGF-beta) and Superfamily; THERAPY: Monotherapy; LEAD SPONSOR: Isarna Therapeutics GmbH; CRITERIA: Inclusion Criteria: - The patient has provided written informed consent prior to any study-related procedure. - The patient is at least 18 years of age and equal to or below 70 years. - The patient has a present diagnosis of AA or secondary GBM. - The patient has a measurable lesion (> 1 ccm in volume, central MRI review). - The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review). - The tumor is localized supratentorially (central MRI review). - All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA. - The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen. - The patient is eligible for chemotherapy. - The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening. - The patient is male or a non-pregnant, non-lactating female. - Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening. - Females of childbearing potential and males must practice strict birth control. - The patient must have recovered from acute toxicity caused by any previous therapy. - The patient has a life expectancy of at least 3 months. - The patient has a Karnofsky Performance Status of at least 70%. - The patient shows adequate organ functions as assessed by the following screening laboratory values: 1. Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal 2. Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL 3. INR < 1.5 and aPTT < 1.5 x ULN 4. Hemoglobin > 9 g/dL 5. Platelet count > 100 x 10E9/L 6. WBC > 3 x 10E9/L 7. ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L) Exclusion Criteria: - Patient unable or not willing to comply with the protocol regulations. - The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint). - Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a ≤48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery. - Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization. - Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization. - Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization. - Prior anti-TGF-beta 2 targeted therapy. - Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (≥ 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift ≥ 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study. - Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization. - History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma. - Presence of poorly controlled seizures. - Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization. - Known HIV, HBV or HCV infection. - Acute viral, bacterial, or fungal infection. - Acute medical problems that may be considered to become an unacceptable risk, or any conditions, which might be contraindications for starting study treatment. - Presence of high risk for pulmonary toxicities, defined as: 1. Lung function: vital capacity ≤ 70% 2. Status following sequential or concomitant thoracic irradiation 3. Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage. - History of allergies to reagents used in this study, history of celiac disease. - Drug abuse or extensive use of alcohol. - Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity. - Concomitant treatment with yellow fever vaccine. ; PRIMARY OUTCOME: Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only); SECONDARY OUTCOME 1: Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)[/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 - DEFEND-2; BRIEF: DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other standard of care treatments. ; DRUG USED: Otelixizumab; DRUG CLASS: Biologic; INDICATION: Diabetes Mellitus, Type I; TARGET: Cluster of Differentiation 3 (CD3); THERAPY: Monotherapy; LEAD SPONSOR: GlaxoSmithKline; CRITERIA: Inclusion Criteria: - Ages 12-17 - Diagnosis of diabetes mellitus, consistent with ADA criteria - No more than 90 days between diagnosis and administration of study compounds - Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds. In Canada, has to be using insulin at the time of dosing. - Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50 nmol/L - Positive for one or more of the autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total. Exclusion Criteria: •Other, significant medical conditions based on the study doctors evaluation ; PRIMARY OUTCOME: Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide Area Under Curve (AUC) (Normalized for 120-minute Time Interval) at Month 12; SECONDARY OUTCOME 1: Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide AUC (Normalized for 120-minute Time Interval) at Week 12 and 6 Months[/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 - Advanced Malignant Pleural Mesothelioma (Canada/Italy); BRIEF: Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show that this drug works by helping improve the bodys immune response to help fight cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth and/or spreading of cancer. ; DRUG USED: Keytruda; DRUG CLASS: Biologic; INDICATION: Mesothelioma; TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: Canadian Cancer Trials Group; CRITERIA: Inclusion Criteria: - Patients must have histologically confirmed malignant pleural mesothelioma. Patients must be eligible to receive standard chemotherapy with pemetrexed and cisplatin and have no contraindications to standard chemotherapy. - Patients must have unresectable advanced and/or metastatic disease, incurable by standard therapies. - All patients must have a cellular tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses (See Section 11.0) and the centre/pathologist must have agreed to the submission of the specimen(s). - Presence of radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows: - CT scan (with slice thickness of ≤ 5 mm): ≥ 10 mm --> longest diameter - Physical exam (using calipers): ≥ 10 mm - Lymph nodes by CT scan ≥ 15 mm --> measured in short axis - All radiology studies must be performed within 21 days prior to registration (exception: within 28 days if negative). - Age ≥ 18 years. - ECOG performance status 0 or 1. Previous Therapy Cytotoxic Chemotherapy: - Patients must not have received prior chemotherapy for any stage of advanced/metastatic disease. - Patients who received previous (neo)adjuvant cisplatin-based systemic chemotherapy must have received the last dose of chemotherapy at least 12 months before registration. Please contact CCTG PRIOR to randomization for such patients. Other Anti-Cancer Therapy: - Patients may not have received targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Radiation: - Patients may have had prior radiation therapy, but NOT to the thorax unless clear disease progression has been demonstrated and confirmed with CCTG. A minimum of 28 days must have elapsed between the end of radiotherapy and registration onto the study. Radiation must have involved < 30% of functioning bone marrow and there must be measurable disease outside the previously irradiated area (patients whose sole site of disease (for example pleural rind) is in a previously irradiated area are ineligible UNLESS there is evidence of progression, or new lesions have been documented, in the irradiated field). Please contact CCTG PRIOR to randomization if the patient has received prior thoracic radiation. Patients must have recovered from any acute toxic effects from radiation prior to registration. Previous Surgery: - Previous major surgery is permitted provided that it has been at least 28 days prior to patient registration and that wound healing has occurred. - Lab Requirements: - Absolute neutrophils ≥ 1.5 x 10^9/L - Platelets ≥ 100 x 10^9/L - Hemoglobin ≥ 90 g/L - Bilirubin ≤ 1.5 x ULN (upper limit of normal) - AST and ALT ≤ 2.5 x ULN - Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 50 mL/min - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. - Patients must be accessible for treatment, response assessment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. - In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient randomization. - Women/men of childbearing potential must have agreed to use two highly effective contraceptive methods during the study and for six months after discontinuation. - Patient must be able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires. Exclusion Criteria: - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at doses more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first and any dose of trial treatment. - Has active autoimmune disease that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or history of allogeneic transplantation. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. - Must not have received a live vaccine within 30 days of planned start of study therapy. - Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. - Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or who have had unstable angina congestive heart failure or myocardial infarction within the previous year. Patients with a significant cardiac history, this includes hypertension, even if controlled, should have a LVEF ≥ 50%. - Patients with a history of other malignancies unless having undergone curative therapy (i.e. resection, radiation, etc) and do not require concurrent anticancer therapy. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or any of the other chemotherapy agents. - Concurrent treatment with other investigational drugs or anti0cancer therapy. - Patients with serious illness or medical condition that would not permit the patient to be managed according to the protocol including, but not limited to: - History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements. - Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) [note: testing in asymptomatic patients is not required] or tuberculosis). - Known history of, or any evidence of active, non-infectious pneumonitis. - Any other medical conditions that might be aggravated by treatment. - Serious or non-healing wound, ulcer, or bone fracture. - Patients with evidence of interstitial lung disease. - Patients with severe/uncontrollable tumor pain that requires radiation prior to starting on systemic therapy. - Pregnant or lactating women. (N.B.: All women of childbearing potential must have a negative pregnancy test within 72 hours prior to registration). ; PRIMARY OUTCOME: Phase II: Progression free survival measured as time from randomization to first observation of objective disease relapse or progression; SECONDARY OUTCOME 1: Number and severity of adverse events[/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 - STRIDE; BRIEF: This study is done to see if semaglutide has an effect on walking ability compared with placebo (dummy medicine) in people with peripheral arterial disease (PAD) and type 2 diabetes. Participants will either get semaglutide or placebo (dummy) medicine - which treatment participants get is decided by chance. Semaglutide is a medicine for type 2 diabetes that can be prescribed by doctors in some countries. Participants will get the study medicine (semaglutide or placebo) in a pre-filled pen for injection. Participants must inject it once a week into the stomach area, thigh, or upper arm, at any time of the day. The study will last for about 59 weeks. Participants will have 8 clinic visits and 1 phone call with the study doctor. At some clinic visits, participants will have blood tests. At some visits participants will also do a treadmill test to measure how far they can walk. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. ; DRUG USED: Ozempic; DRUG CLASS: New Molecular Entity (NME); INDICATION: Cardiovascular Disease; 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. For Japan: Male or female, age above or equal to 20 years at time of signing informed consent - Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. - Symptomatic PAD with intermittent claudication corresponding to Fontaine stage IIa (Rutherford classification grade I, category 1 and 2) meeting all of the following: 1. Stable symptoms of PAD with intermittent claudication in Fontaine stage IIa (able to walk without stopping more than 200 m/656 feet/2 blocks) for at least 90 days prior to the day of screening based on patient interview. 2. Screening flat treadmill test (3.2 km/h (2 mph)): Pain-free walking distance of at least 200 meters/656 feet. 3. Screening constant load treadmill test with fixed inclination of 12% and a fixed speed of 3.2 km/h (2 mph): Walking distance equal to or less than 600 meters/1968 feet. 4. Ankle-brachial-index (ABI) equal to or below 0.90 or toe-brachial index (TBI) equal to or below 0.7 (the leg with lowest index is chosen in case of bilateral disease). Exclusion Criteria: - Current or previous treatment with any GLP-1 receptor agonist (GLP-1-RA) within 90 days prior to the day of screening. - Walking ability limited by conditions other than PAD (e.g. aortic aneurism, dysregulated arrhythmia or hypertension, angina pectoris, heart failure, chronic obstructive or restrictive pulmonary disease, Parkinsons disease, severe peripheral neuropathy, amputations, wheel chair or walker dependency, osteoarthritis, morbid obesity, severe varicose veins, etc.). - Planned orthopaedic surgery in the legs, or other major surgery known on the day of screening (surgery affecting walking ability). - Vascular revascularisation procedure of any kind 180 days prior to the day of screening. - Planned arterial revascularisation known on the day of screening. - Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischemic attack within 180 days prior to the day of screening. - Heart failure presently classified as being in New York Heart Association (NYHA) class III-IV. ; PRIMARY OUTCOME: Change in maximum walking distance on a constant load treadmill test; SECONDARY OUTCOME 1: Follow-up change in maximum walking distance on a constant load treadmill test[/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 - MAESTRO-NAFLD-OLE; BRIEF: A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196) ; DRUG USED: Resmetirom; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Alcoholic Steatohepatitis (NASH); TARGET: Thyroid hormone receptors (TRs); THERAPY: Monotherapy; LEAD SPONSOR: Madrigal Pharmaceuticals, Inc.; CRITERIA: Inclusion Criteria: - For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent. - For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results: - NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3 - NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH) - Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD <12, albumin ≥3.2, and bilirubin <2 - For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score <8) NASH cirrhosis (including minimal decompensation) and MELD <15 unless MELD >=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE . Exclusion Criteria: - A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1. - Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study. - Chronic liver diseases - Has an active autoimmune disease - Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes. ; PRIMARY OUTCOME: The effect of once daily, oral administration of resmetirom on the incidence of adverse events.; SECONDARY OUTCOME 1: Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DAHHS-2 (GT1, 4); BRIEF: New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy. It is likely that the synergistic effect of the hosts immune response and antiviral therapy when given during the first 6 months of HCV infection makes antiviral therapy during acute HCV infection more effective. In this study the investigators would like to document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss in efficacy. Study design and intervention: Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4 patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily combination tablet). Study population: 80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV treatment centers in the Netherlands and Belgium will be included. Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT study population (=genotype 1 and 4). ; DRUG USED: Zepatier; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease, Non-structural 5A protein (NS5A); THERAPY: Monotherapy; LEAD SPONSOR: Erasmus Medical Center; CRITERIA: Inclusion Criteria: 1. HIV positive 2. Acute HCV genotype 1 or 4 infection (≤26 weeks old at the baseline visit) Exclusion Criteria: 1. Not on cART and a CD4 <500 at the time of screening 2. Patients on cART for >6 months with a HIV viral load >400 copies 3. Disallowed co-medication that cannot be stopped or replaced 4. History of liver cirrhosis of any etiology. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA <below the limit of detection) is allowed if fibroscan excludes >F1 fibrosis 5. Protease inhibitor based and NNRTI based cART regimens are not allowed. Therefore, the inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors and an allowed third agent which can be raltegravir (Isentress®) 400mg BID, dolutegravir (Tivicay) 50mg QD or rilpivirine 25mg QD. ; PRIMARY OUTCOME: SVR12 (Reinfection Not Considered Failure); SECONDARY OUTCOME 1: SVR12 (Reinfection Equals Failure)[/INST]Yes</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - DIAPREVENT (USA); BRIEF: The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the bodys own insulin producing capacity in patients recently diagnosed with type 1 diabetes. Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated. ; DRUG USED: Diamyd; DRUG CLASS: Vaccine; INDICATION: Diabetes Mellitus, Type I; TARGET: Glutamic Acid Decarboxylase (GAD), Immune System; THERAPY: Monotherapy; LEAD SPONSOR: Diamyd Therapeutics AB; CRITERIA: Main Inclusion Criteria: - Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening - Fasting C-peptide level at time of screening above 0.1 nmol/L - Elevated GAD65 antibodies (GADA) at time of screening - Male and female patients between 10 and 20 years of age Main Exclusion Criteria: - Treatment with immunosuppressants or any anti-diabetic medications other than insulin - A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) - Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine - Participation in other clinical trials with a new chemical entity within the previous 3 months - Pregnancy or planned pregnancy within 1 year after the last Diamyd dose - Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study ; PRIMARY OUTCOME: Meal Stimulated C-peptide (area under the curve); SECONDARY OUTCOME 1: HbA1c[/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 - Japan - G060-A6 (Naive); BRIEF: This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C. ; DRUG USED: Incivek; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hepatitis C (HCV) (Antiviral); TARGET: HCV Protease; THERAPY: Combination; LEAD SPONSOR: Mitsubishi Tanabe Pharma Corporation; CRITERIA: Inclusion Criteria: - Genotype 1, chronic hepatitis C - Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C) - Able and willing to follow contraception requirements Exclusion Criteria: - Cirrhosis of the liver or hepatic failure - Hepatitis B surface antigen-positive or HIV antibodies-positive - History of, or concurrent hepatocellular carcinoma - History of, or concurrent depression, schizophrenia; or suicide attempt in the past - Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant ; PRIMARY OUTCOME: The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response); 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 - CD16 (Brazil); BRIEF: Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5). Disruption of the C-C chemokine ligand 5 (CCL5)-CCR5 axis via leronlimab-mediated CCR5 blockade might prevent pulmonary trafficking of pro-inflammatory leukocytes and dampen pathogenic immune activation in coronavirus disease 2019 (COVID-19). The purpose of the study is to assess the safety and efficacy of leronlimab plus standard of care in critically ill patients hospitalized with COVID-19 pneumonia who are requiring mechanical ventilation or extracorporeal oxigenation (ECMO). ; DRUG USED: Vyrologix; DRUG CLASS: Biologic; INDICATION: COVID-19 Treatment; TARGET: Chemokine Receptor 5 (CCR5); THERAPY: Monotherapy; LEAD SPONSOR: Hospital Israelita Albert Einstein; CRITERIA: Inclusion Criteria: 1. Male or females aged ≥ 18 years 2. Critically ill patients with COVID-19 (defined as Ordinal Scale score of 7): Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) for less than 72 hours. 3. Evidence of pneumonia (pulmonary infiltrates) at chest radiography or computed tomography compatible with COVID-19. 4. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR). 5. Subject (or legally authorized representative) provides written or oral informed consent prior to initiation of any study procedures. 6. Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study. Exclusion Criteria: 1. Subjects who had been on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) for >72 hours prior to the screening. 2. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible. 3. Inability to provide informed consent (from subject or legally authorized representative) or to comply with test requirements. 4. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigators judgment, make the participant inappropriate for the study. 5. Pregnancy or breast feeding. 6. Subject participating in another study with for an investigational treatment. 7. Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19), that may increase the risk for the study participant based on investigator judgement. 8. Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine). 9. Patients with estimated discharge or transfer for other hospital in the first 72 hours of study inclusion. 10. Patients with low probability of survival in the first 48 hours of study inclusion. ; PRIMARY OUTCOME: Cumulative proportion of clinical recovery; SECONDARY OUTCOME 1: Proportion of patients clinically recovered[/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 - 303 (Adjunctive); BRIEF: The studys purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD) ; DRUG USED: Troriluzole; DRUG CLASS: New Molecular Entity (NME); INDICATION: Obsessive-Compulsive Disorder (OCD); TARGET: Glutamine; THERAPY: Monotherapy; LEAD SPONSOR: Biohaven Pharmaceuticals, Inc.; CRITERIA: Key Inclusion Criteria: 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at screening; the duration of the subjects illness must be ≥ 1year 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response too current standard of car base on the YBOCS score. 3. Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trail as designed. Key Exclusion Criteria: 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourettes disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results. 3. Previous treatment in a study with troriluzole ; PRIMARY OUTCOME: The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS); SECONDARY OUTCOME 1: Frequency of SAEs and AEs leading discontinuation[/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 - IM101-301; BRIEF: The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA ; DRUG USED: Orencia; DRUG CLASS: Biologic; INDICATION: Juvenile Rheumatoid Arthritis; TARGET: Cluster of Differentiation 80 (CD80), Cluster of Differentiation 86 (CD86); THERAPY: Monotherapy; LEAD SPONSOR: Bristol-Myers Squibb; CRITERIA: Inclusion Criteria: - JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening - Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population - Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion. Exclusion Criteria: - Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded. - Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization. - Subjects who have failed more than two TNFα antagonists or other biologic DMARDs ; PRIMARY OUTCOME: Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17; SECONDARY OUTCOME 1: Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)[/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 - Impetigo (Ages 2+); BRIEF: This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo. ; DRUG USED: Xepi; DRUG CLASS: New Molecular Entity (NME); INDICATION: Skin and Skin-Structure Infections (Antibacterial); TARGET: Topoisomerase II (DNA gyrase) and IV; THERAPY: Monotherapy; LEAD SPONSOR: Ferrer Internacional S.A.; CRITERIA: Inclusion Criteria: - Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area. - Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1 Exclusion Criteria: - Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. - Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F) ; PRIMARY OUTCOME: Clinical Success; 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 - INTR@PID LUNG 037 (vs. Pembrolizumab); BRIEF: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules. ; DRUG USED: Bintrafusp Alfa; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2), Transforming Growth Factor-beta (TGF-beta) Receptor; THERAPY: Monotherapy; LEAD SPONSOR: EMD Serono Research & Development Institute, Inc.; CRITERIA: Inclusion Criteria: - Histologically confirmed diagnosis of advanced NSCLC - Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications - Have measurable disease based on RECIST 1.1 - Have a life expectancy of at least 3 months - Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment - PD-L1 high status as determined by central testing - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation - Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study - Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations - Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years - Other protocol defined exclusion criteria could apply ; PRIMARY OUTCOME: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC); SECONDARY OUTCOME 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Children/Adolescents; BRIEF: The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia. ; DRUG USED: Samsca; DRUG CLASS: New Molecular Entity (NME); INDICATION: Hyponatremia; TARGET: Vasopressin receptors; THERAPY: Monotherapy; LEAD SPONSOR: Otsuka Pharmaceutical Development & Commercialization, Inc.; CRITERIA: Inclusion Criteria: 1. Male and female subjects ≥ 4 years of age (or per local Health Authority age restriction) to < 18 years old and ≥ 10kg 2. Subjects hospitalized with euvolemic or hypervolemic hyponatremia resistant to initial standard background therapy (including fluid restriction and excluding a vasopressin antagonist) and who are deemed by the investigator as likely to benefit from a therapy that raises serum sodium levels 3. Persistent euvolemic or hypervolemic hyponatremia defined as being documented as present for at least 48 hours, evidenced by at least 2 serum sodium assessments < 130 mmol/L drawn at least 12 hours apart (these values can be documented using historical values previously obtained per standard of care); a third (STAT) serum sodium assessment < 130 mmol/L, which will serve as the baseline value for efficacy endpoints, is to be obtained within 2-4 hours prior to the final trial qualification and the first dose of IMP 4. Ability to swallow tablets 5. Ability to maintain adequate fluid intake whether orally or via IV support with adequate monitoring 6. Ability to comply with all requirements of the trial 7. Trial-specific written informed consent/assent obtained from a parent/legal guardian or legally acceptable representative, as applicable per age of subject or local laws, prior to the initiation of any protocol required procedures. In addition, the subject as required by local laws must provide informed assent at Screening and must be able to understand that he or she can withdraw from the trial at any time. All informed consent/assent procedures must be in accordance with the trial centers IRB/IEC and local regulatory requirements 8. Ability to commit to remain fully abstinent (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] or withdrawal are not acceptable methods of contraception) or practice double-barrier birth control during the trial and for 30 days following the last dose of IMP for sexually active females of childbearing potential Exclusion Criteria: 1. Has evidence of hypovolemia or intravascular volume depletion (eg, hypotension, clinical evidence of volume depletion, response to saline challenge); if the subject has systolic blood pressure or heart rate outside of the normal range for that age volume status should be specifically clinically assessed to rule out volume depletion 2. Has serum sodium < 120 mmol/L, with or without associated neurologic impairment (ie, symptoms such as apathy, confusion, or seizures) 3. Subjects ≤ 50 kg taking potent CYP3A4 inhibitors or subjects < 20 kg taking moderate CYP3A4 inhibitors within 72 hours prior to dosing 4. Lacks free access to water (inability to respond to thirst) or without ICU-level fluid monitoring and management 5. Has a history or current diagnosis of nephrotic syndrome 6. Has transient hyponatremia likely to resolve (eg, head trauma or post-operative state) 7. Has hyperkalemia defined as serum potassium above the ULN for the appropriate pediatric age range 8. Has eGFR < 30 mL/min/1.73 m2 calculated by the following equation: eGFR (mL/min/1.73 m2) = 0.413 x height (cm)/serum creatinine (mg/dL) 9. Has AKI from recent medical history defined as: - Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours; or - Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or - Urine volume < 0.5 mL/kg/h for 6 hours 10. Has severe or acute neurological symptoms requiring other intervention (eg, hyperemesis, obtundation, seizures) 11. Has had treatment for hyponatremia with: - Hypertonic saline (including normal saline challenge) within 8 hours of qualifying serum sodium assessments; - Urea, lithium, demeclocycline, conivaptan, or tolvaptan within 4 days of qualifying serum sodium assessments; - Other treatment for the purpose of increasing serum sodium concurrent with dosing of IMP 12. Has anuria or urinary outflow obstruction, unless the subject is, or can be, catheterized during the trial 13. Has a history of drug or medication abuse within 3 months prior to Screening or current alcohol abuse 14. Has a history of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril) 15. Has psychogenic polydipsia (subjects with other psychiatric illness may be included per medical monitor approval) 16. Has uncontrolled diabetes mellitus, defined as fasting glucose > 300 mg/dL (16.7 mmol/L) 17. Has screening liver function values (ALT/AST) > 3 x ULN 18. Has cirrhosis and meets any of the following conditions: a major GI bleed within the past 6 months, evidence of active bleeding (eg, epistaxis, petechiae/purpura, hematuria, or hematochezia), platelet count < 50,000/µL, or use of concomitant medications known to increase bleeding risk 19. Has hyponatremia due to the result of any medication that can safely be withdrawn (eg, thiazide diuretics) 20. Has hyponatremia (eg, hyponatremia in the setting of adrenal insufficiency, untreated hypothyroidism, or hypotonic fluid administration) that is most appropriately corrected by alternative therapies 21. Is currently pregnant or breastfeeding 22. Has any medical condition that, in the opinion of the investigator, could interfere with evaluation of the trial objectives or safety of the subjects. 23. Is deemed unsuitable for trial participation in the opinion of the investigator 24. Participation in another investigational drug trial within the past 30 days, without prior approval from the sponsor medical monitor 25. Subjects < 4 years of age or per local Health Authority age restriction, weight < 10 kg, or who are unable to swallow tablets are excluded until an alternate formulation becomes available ; PRIMARY OUTCOME: Change in serum sodium concentration; SECONDARY OUTCOME 1: Change of average daily AUC from baseline at each visit in serum sodium level.[/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 - Zotrip; BRIEF: This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo. ; DRUG USED: Qtrypta; DRUG CLASS: Non-NME; INDICATION: Migraine and Other Headaches; TARGET: Serotonin 5-HT1 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Zosano Pharma Corporation; CRITERIA: Inclusion Criteria: - Greater than 1 year history of episodic, acute migraine (with or without aura) with onset prior to 50 years of age. Diagnosis must comply with International Headache Society (IHS) diagnostic criteria. Diagnostic criteria must include a history of at least five attacks not attributed to any other disorder that include all of the following criteria: 1. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) 2. Headache has at least two of the following characteristics: (i) unilateral location (ii) pulsating quality (iii) moderate or severe pain intensity (iv) aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) c) During headache at least one of the following: (i) nausea and/or vomiting (ii) both photophobia and phonophobia - Migraine history during the 6-month period prior to the run-in period must include: 2-8 migraines per month and no more than 10 headache days per month - Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy during the trial, and must use an acceptable methods of birth control for the duration of the trial. - No significant ECG findings, defined by: 1. ischemic changes 2. Q-waves in at least two contiguous leads, 3. clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome), or 4. clinically significant arrhythmias (e.g., current atrial fibrillation) - Able to understand the operation of the electronic diary and is able to apply the demo study drug patch. Exclusion Criteria: - Contraindication to triptans - Use of any prohibited concomitant medications within 10 days of the Run-in Period - History of hemiplegic or basilar migraine - Participation in another investigational trial during the 30 days prior to the Run-in Period or during this study - Previous participation in a clinical trial of ZP-Zolmitriptan - Diagnosis of cancer (other than non-invasive skin cancer) within the 5 years prior to the Run-in Period - History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to the Run-in Period - Subjects who have known allergy or sensitivity to zolmitriptan or its derivatives or formulations - Subjects who have known allergy or sensitivity to adhesives - Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application site from two weeks prior to screening through the last day of study participation - Use of opiate analgesics or barbiturates more frequently than one day/week - Women who are pregnant, breast-feeding or plan a pregnancy during this study - Clinically significant liver disease - Clinically significant kidney disease - History of coronary artery disease (CAD), coronary vasospasm (including Prinzmetals angina), aortic aneurysm, peripheral vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or Raynauds syndrome) - Three or more of the following CAD risk factors: - Current tobacco use - Hypertension or receiving anti-hypertensive medication for treatment of hypertension - Hyperlipidemia or on prescribed anti-cholesterol treatment - Family history of premature coronary artery disease (< 55 years of age in male first degree relatives or < 65 years of age in female first degree relatives) - Diabetes mellitus - History of cerebral vascular accident, transient ischemic attacks, or seizures - Hospitalization within the 30 days prior to the Run-in Period - Any other household member currently participating in a ZP-Zolmitriptan study or relatives of site staff - Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible - History or current abuse or dependence on alcohol or drugs that would interfere with adherence to study requirements - Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the subject at risk To be eligible for Treatment, subjects must continue to meet all eligibility criteria and the following criteria observed during the Run-in Period: 1. An average of at least two qualifying migraines per 28-day period 2. No more than 10 headache days in the last 28 days prior to randomization 3. Demonstrated ability to properly use the eDiary and apply the demo study drug patch 4. Confirmation of continuing good general health, or stable non-serious disease that in the opinion of the Investigator will not place the subject at risk. ; PRIMARY OUTCOME: Proportion of Subjects With Pain Freedom; 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 - VELIA (w/Carboplatin/paclitaxel); BRIEF: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone. ; DRUG USED: Veliparib; DRUG CLASS: New Molecular Entity (NME); INDICATION: Ovarian Cancer; TARGET: Poly ADP-Ribose Polymerase (PARP); THERAPY: Combination; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: 1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation. 2. High-grade serous adenocarcinoma 3. Willing to undergo testing for gBRCA. 4. Adequate hematologic, renal, and hepatic function. 5. Neuropathy (sensory and motor) less than or equal to Grade 1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment. 8. Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms. 9. Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1. Exclusion Criteria: 1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenners tumor. 2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions. 3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocols therapy. 4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis. 5. Received prior chemotherapy for any abdominal or pelvic tumor. 6. Clinically significant uncontrolled condition(s). 7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug. 8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1. ; PRIMARY OUTCOME: Progression-Free Survival (PFS) in the BRCA-deficient Population; 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 - Spasticity of Limb(s) in Cerebral Palsy (Children); BRIEF: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy. ; DRUG USED: Xeomin; DRUG CLASS: Biologic; INDICATION: Neuromuscular Spasm and Spasticity; TARGET: SNARE Proteins (e.g. synaptobrevin, syntaxin, SNAP-25); THERAPY: Monotherapy; LEAD SPONSOR: Merz Pharmaceuticals GmbH; CRITERIA: Inclusion Criteria: Main clinical inclusion criteria for completers of study MRZ60201_3070_1: - Subject with lower limb [LL] spasticity who completed lead-in study MRZ60201_3070_1 in any of the three dose groups with duration of both injection cycles between 12 and 16 weeks. - Ashworth scale [AS] score ≥2 in plantar flexors (at least unilaterally). For subjects with an AS score of 1, the investigator has to decide on the clinical need for reinjection. - Clinical need for spasticity treatment with NT 201 according to the clinical judgment of the investigator for: Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus and need for additional 8 U/kg BW NT 201 (maximum of 200 U) for treatment of clinical pattern flexed knee or adducted thigh (ipsilateral) or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus on each side. No treatment of other clinical patterns is allowed. Main clinical inclusion criteria for subjects who did not participate in MRZ60201_3070_1: - Female or male subject of 2 to 17 years age (inclusive). - Uni- or bilateral CP with clinical need for BoNT injection to treat limb spasticity. - AS score ≥ 2 in plantar flexors (at least unilaterally). - Clinical need according to the clinical judgment of the investigator in one out of four treatment combinations: 1. For LL(s) treatment only (Gross Motor Function Classification System [GMFCS] levels IV): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides). 2. For combined unilateral UL and unilateral LL, (GMFCS levels I-III): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh plus Unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. 3. For combined unilateral UL and unilateral LL (GMFCS level IV-V): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum 200 U) into pes equinus, and 4 U/kg BW NT201 (maximum 100 U) into flexed knee or adducted thigh plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. 4. For combined unilateral UL and bilateral LL (GMFCS levels I-III): Bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides) plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. Exclusion Criteria: Exclusion Criteria for subjects who completed MRZ60201_3070_1: - Infection and/or inflammation in the area of the planned injection points. - Pregnancy for female with history of menarche. - Clinically relevant pathological findings indicating active disease of vital organs. Exclusion Criteria for subjects who did not participate in MRZ60201_3070_1: - Fixed contracture defined as severe restriction of the range of joint movement on passive stretch in the target clinical pattern(s) or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s). - Surgery in the pes equinus on side(s) intended to treat with BoNT injections within 12 months prior to Screening Visit (V1), within the screening period or planned for the time of participation in this study. - Hip flexion requiring BoNT injection. - Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30. - Vaccination within 2 weeks prior to Screening Visit (V1) and/or within the screening period. - Non-resolved fractures of the treated limb. - Ventilator dependency. - Severe neurological diagnosis and comorbidity outside the spectrum of cerebral palsy. - Pure dyskinetic CP or mixed CP with predominantly dyskinetic movements. - Treatment with BoNT (other than study drug in this study) for any body region within 14 weeks prior to Screening Visit (V1), within the screening period and/or intended to be administered during the study period. - Treatment with phenol or alcohol of any muscle within 6 months prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period. - Treatment with - drugs acting as peripheral muscle relaxants - intrathecal baclofen, or - oral anticoagulants administered within 2 weeks prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period. ; PRIMARY OUTCOME: Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle; SECONDARY OUTCOME 1: Investigators Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle[/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 - COMRADE-B (Branch RVO); BRIEF: This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards. ; DRUG USED: Lucentis; DRUG CLASS: Biologic; INDICATION: Macular Edema from Retinal Vein Occlusion (RVO) (Ophthalmology); TARGET: VEGF (Vascular endothelial growth factor); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients diagnosed with visual impairment due to macular edema following BRVO - Diagnosis of BRVO at maximum 6 months prior to Screening - BCVA using ETDRS charts of 20/40 to 20/400 in the study eye Exclusion Criteria: - Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs - Central retinal thickness (CRT) < 250 µm in the study eye - Prior episode of RVO in the study eye - Active formation of new vessels in the study eye - Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline - IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment - Improvement of > 10 letters on BCVA between Screening and Baseline Other protocol-defined inclusion/exclusion criteria may apply ; PRIMARY OUTCOME: Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline; SECONDARY OUTCOME 1: Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6[/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 - N01258 (Intravenous); BRIEF: This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days). ; DRUG USED: Briviact; DRUG CLASS: New Molecular Entity (NME); INDICATION: Partial Seizures (Epilepsy); TARGET: SV2A synaptic vesicle protein; THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written Informed Consent form signed and dated by the subject or by parent(s) or legal representative - Subjects from 16 to 70 years - Subjects with a body weight of >/= 40 kg - Female subjects without childbearing potential or female subjects with childbearing potential if they use a medically accepted contraceptive method - Subject/legal representative considered as reliable and capable of adhering to the protocol - Subjects with well-characterized focal or generalized epilepsy or epileptic syndrome - Subjects with a history of partial-onset seizures whether or not secondarily generalized or primary generalized seizures - Subjects being uncontrolled while treated with 1 to 2 permitted concomitant antiepileptic drugs (AEDs) - Permitted concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS) being stable and at optimal dosage for the subject from at least 1 month before Visit 1 and expected to be kept stable during the Run-In and Evaluation Periods Exclusion Criteria: - Mentally impaired subjects unable to understand the study purpose - History or presence of status epilepticus during 1 year preceding Visit 1 or Baseline - Subjects on felbamate with less than 18 months continuous exposure before Visit 1 - Subjects currently on vigabatrin - Subject taking any drug with possible relevant central nervous system effects except is stable from at least 1 month before Visit 1 and expected to be kept stable during the trial - Subjects taking any drug that may significantly influence the metabolism of Brivaracetam (BRV) except if the dose has been kept stable at least 1 month before Visit 1, and is expected to be kept stable during the trial - History of cerebrovascular accident in the last 6 months - Subjects suffering from severe cardiovascular disease or peripheral vascular disease - Presence of any sign suggesting rapidly progressing brain disorder or brain tumor - Any clinical conditions which impair reliable participation in the study or necessitate the use of medication not allowed by protocol - Presence of a terminal illness - Presence of a serious infection - Subjects with a history of sever adverse hematologic reaction to any drug - Subjects suffering from severe disturbance of hemostasis - Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) values of more than 3 times the upper limit of the reference range - Subjects having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated < 50 ml / min, platelets < 100,000 / µL, or neutrophil cells < 1,800 / µL - Clinically significant electrocardiogram (ECG) abnormalities according to the Investigator - History of suicide attempt - In the Investigators medical judgment, any current suicidal ideation or other serious psychiatric disorders requiring of having required hospitalization or medication - Known allergic reaction or intolerance to pyrrolidone derivatives and / or investigational product excipients - Known multiple drug allergies or severe drug allergy - Pregnant or lactating women - Known alcohol or drug addiction or abuse within the last 2 years - Subject institutionalized under judicial decision - Problems of venous accessibility - Subject taking part in another clinical / pharmacological study in the month preceding enrollment (Visit 1) - Investigators, coinvestigators, their spouses or children, or any study collaborators - Subjects previously treated with Brivaracetam (BRV) - Subject previously screened within this study ; PRIMARY OUTCOME: Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days); SECONDARY OUTCOME 1: Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)[/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 - RELEASE-2; BRIEF: Subjects will be screened for study eligibility within 14 days prior to enrolling in this study. Subjects with 2 treatment areas (bilateral buttocks) with moderate or severe levels of cellulite as independently assessed by the subject using the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and by the Investigator using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) will be eligible. The eligibility of the buttocks will be confirmed on Day 1. Once the eligibility of the buttocks is confirmed, subjects will be randomly assigned to a treatment group (EN3835 0.84 mg per buttock or placebo) in a 1:1 ratio within an investigational site. Each subject will receive a treatment course which consists of up to 3 treatment visits (sessions), separated by 21 days (ie, Days 1, 22, and 43). Each treatment visit will consist of 12 injections (0.3 mL per injection of EN3835 0.07 mg/injection or placebo; 0.84 mg in 3.6 mL per buttock) in each of the two buttocks for a total volume of 7.2 mL (1.68 mg). Selection of dimples to be treated in the buttocks will be at the discretion of the Investigator. End of study will occur at study day 71. ; DRUG USED: Qwo; DRUG CLASS: Biologic; INDICATION: Cellulite; TARGET: Collagen; THERAPY: Monotherapy; LEAD SPONSOR: Endo Pharmaceuticals; CRITERIA: Inclusion Criteria: 1. Voluntarily sign and date an informed consent agreement 2. Be a female ≥18 years of age 3. At Screening visit, have 2 bilateral buttocks with each buttock having: 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS) 4. At Day 1 visit, have 2 bilateral buttocks with each buttock having: 1. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 2. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS) 5. Be willing to apply sunscreen to the buttocks before each exposure to the sun while participating in the study (ie, Screening through end of study) 6. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at Screening 7. Have a negative serum pregnancy test at Screening and a negative urine pregnancy test before injection of study drug and be using a stable and effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 8. Be willing and able to cooperate with the requirements of the study 9. Be able to read, complete and understand the patient-reported outcomes rating instruments in English Exclusion Criteria: 1. Has any of the following systemic conditions: 1. Coagulation disorder 2. Evidence or history of malignancy (other than excised basal-cell carcinoma) unless there has been no recurrence in at least 5 years 3. History of keloidal scarring or abnormal wound healing 4. Concurrent diseases or conditions that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subjects well-being. Any questions about concurrent diseases should be discussed with the Medical Monitor 5. Evidence of clinically significant abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values 2. Has any of the following local conditions in the areas to be treated: 1. History of lower extremity thrombosis or post-thrombosis syndrome 2. Vascular disorder (eg, varicose veins, telangiectasia) in area to be treated 3. Inflammation or active infection 4. Severe skin laxity, flaccidity, and/or sagging 5. Active cutaneous alteration including rash, eczema, psoriasis, or skin cancer 6. Has a tattoo and/or a mole located within 2 cm of the site of injection 3. Requires the following concomitant medications before or during participation in the trial: a. Anticoagulant or antiplatelet medication or has received anticoagulant or antiplatelet medication (except for ≤150 mg aspirin daily) within 7 days before injection of study drug 4. Has used any of the following for the treatment of EFP on a buttock within the timelines identified below or intends to use any of the following at any time during the course of the study: 1. Liposuction in a buttock during the 12-month period before injection of study drug 2. Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; buttock implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) within a buttock during the 12-month period before injection of study drug 3. Any investigational treatment for EFP on a buttock during the 12-month period before the injection of study drug 4. Endermologie or similar treatments within a buttock during the 6-month period before injection of study drug 5. Massage therapy within a buttock during the 3-month period before injection of study drug 6. Creams (eg, Celluvera™, TriLastin®) and/or home therapies to prevent or mitigate EFP within a buttock during the 2-week period before injection of study drug 5. Is presently nursing or providing breast milk 6. Intends to become pregnant during the study 7. Intends to initiate an intensive sport or exercise program during the study 8. Intends to initiate a weight reduction program during the study 9. Intends to use tanning spray or tanning booths during the study 10. Has received an investigational drug or treatment within 30 days before injection of study drug 11. Has a known systemic allergy to collagenase or any other excipient of study drug 12. Has received any collagenase treatments at any time prior to treatment 13. Was a subject in a previous cellulite clinical trial of CCH: AUX-CC-830, AUX-CC-831, EN3835-102, EN3835-104, EN3835-201, EN3835-202, and/or EN3835-205 14. Any other condition(s) that, in the Investigators opinion, might indicate the subject to be unsuitable for the study ; PRIMARY OUTCOME: 2-level Composite Responders for the Target Buttock; SECONDARY OUTCOME 1: 1-level PR-PCSS Responders of the Target Buttock[/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 - RP11-3588; BRIEF: Some patients with chronic obstructive pulmonary diseases (COPD) have large number of specific white blood cells called eosinophils in their airways. These cells are also responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often cause irreversible damage to the airways . This subset of COPD patients often require oral steroids to bring down the number of eosinophils in their airways. Steroids have harmful effects on several of our body systems like bones, blood pressure, blood glucose control and can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils reducing the number in the airway. This drug has been shown to be effective in decreasing exacerbation rates and time to exacerbation in asthma patients with eosinophils in their airways. Targeting eosinophils in COPD patients has been shown to reduce severe exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will benefit similarly and have reduced rates and time to exacerbation. Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow obstruction (COPD) and eosinophilic bronchitis? ; DRUG USED: Nucala Lyophilized Powder Formulation; DRUG CLASS: Biologic; INDICATION: Chronic Obstructive Pulmonary Disease (COPD); TARGET: IL-5 (Interleukin-5) and IL-5 Receptor (IL-5R); THERAPY: Monotherapy; LEAD SPONSOR: McMaster University; CRITERIA: Inclusion Criteria: - Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society as follows: Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences - Sputum eosinophils > 3% at randomization and on at least one occasion in the past 2 years. If this historic data is not available, documented improvement in FEV1 of at least 12% with a course of prednisone in the past 2 years will be used as a surrogate for the presence of airway eosinophilia - FEV1/Vital Capacity (VC) < 70% and FEV1 < 60% of predicted normal values calculated using NHANES III reference equations at Screening Visit - At least one major exacerbation requiring prednisone in the preceding 12 months. If patients are currently well controlled by optimizing their sputum cell counts (eosinophils < 2%), they should have documented history of exacerbations when their eosinophilia was uncontrolled. - A signed and dated written informed consent prior to study participation. - Smoking History: Current or former cigarette smokers with a history of cigarette smoking of greater than 10 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit - Male or female adults. A female is eligible to enter and participate in the study if she is either of Non-child bearing potential or is of child bearing age and has a negative pregnancy test at screening, and agrees to acceptable contraceptive methods used consistently and correctly Exclusion Criteria: - Current asthma (12% reversibility to a bronchodilator) - Sputum eosinophils < 3% on fluticasone (or equivalent) of 250µg bid. - Inability to use salmeterol or tiotropium - Significant co-morbidity that prevents from participating in the study - Known bronchiectasis or immune deficiency disorders that would predispose the patients to recurrent infections. - Pregnancy or intent to become pregnant and lactating females - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Screening Visit ; PRIMARY OUTCOME: Percentage decrease of sputum eosinophils from baseline; SECONDARY OUTCOME 1: Proportion of patients with a major exacerbation[/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 - 034OLE; BRIEF: Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials ; DRUG USED: Oxbryta; DRUG CLASS: New Molecular Entity (NME); INDICATION: Sickle Cell Anemia; TARGET: Hemoglobin; THERAPY: Monotherapy; LEAD SPONSOR: Pfizer; CRITERIA: Inclusion Criteria: - Male or female study participants with SCD who participated and received study treatment in Study GBT440-031. Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained on study may be eligible for treatment in this study provided the AE does not pose a risk for treatment with voxelotor. - Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. - Female participants of child-bearing potential must use highly effective methods of contraception to 30 days after the last dose of study drug. Male participants must use barrier methods of contraception to 30 days after the last dose of study drug. - Participant has provided written informed consent or assent (the ICF must be reviewed and signed by each participant; in the case of pediatric participants, both the consent of the participants legal representative or legal guardian, and the participants assent must be obtained). Exclusion Criteria: - Female who is breast-feeding or pregnant. - Participant withdrew consent from Study GBT440-031. - Participant was lost to follow-up from Study GBT440-031. - Participant requiring chronic dialysis. - Any medical, psychological, safety, or behavioral conditions, which, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent. ; PRIMARY OUTCOME: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03; SECONDARY OUTCOME 1: Response in Hemolytic Anemia[/INST]No</s>

<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - Pediatric Subjects (EU); BRIEF: To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks. ; DRUG USED: Motegrity; DRUG CLASS: New Molecular Entity (NME); INDICATION: Chronic Idiopathic Constipation; TARGET: Serotonin 5-HT4 receptor; THERAPY: Monotherapy; LEAD SPONSOR: Shire; CRITERIA: Main Inclusion Criteria: 1. Boys and girls, aged ≥ 6 months and < 18 years. 2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria. Main Exclusion Criteria: 1. Children with underlying GI abnormalities and causes for defecation disorders. 2. Constipation is thought to be drug-induced. 3. Subjects suffering from secondary causes of chronic constipation. ; PRIMARY OUTCOME: Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period; SECONDARY OUTCOME 1: Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period[/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 - THUNDER; BRIEF: A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma. ; DRUG USED: QAW039; DRUG CLASS: New Molecular Entity (NME); INDICATION: Asthma; TARGET: Chemoattractant Receptor-Homologous Molecule (CRTH2); THERAPY: Monotherapy; LEAD SPONSOR: Novartis Pharmaceuticals; CRITERIA: Inclusion Criteria: - Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril. - Concomitant diagnosis of asthma for a period of at least 6 months prior to screening. - Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening. Exclusion Criteria: - Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit. - Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening - Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening. - Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period. - Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening. - History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible. - Patients with baseline ACQ-5≥1.5 ; PRIMARY OUTCOME: Change From Baseline in Nasal Polyp Score at Week 16; SECONDARY OUTCOME 1: Change From Baseline in Nasal Congestion Score at Week 16[/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 - GeparSepto; BRIEF: Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally. ; DRUG USED: Abraxane; DRUG CLASS: Non-NME; INDICATION: Breast Cancer; TARGET: Microtubules (Tubulin); THERAPY: Monotherapy; LEAD SPONSOR: German Breast Group; CRITERIA: Inclusion Criteria: Patients will be eligible for study participation only if they comply with the following criteria: - Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. - Complete baseline documentation must be sent to GBG Forschungs GmbH. - Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint. - Tumor lesion in the breast with a palpable size of >= 2 cm or a sonographical size of >= 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion. - Patients must be in the following stages of disease: - - cT2 - cT4a-d or - cT1c and cN+ or - - cT1c and pNSLN+ or - - cT1c and ER-neg and PR-neg or - - cT1c and Ki67 > 20% - - cT1c and HER2-pos - In patients with multifocal or multicentric breast cancer, the largest lesion should be measured. - Centrally confirmed ER/PR/HER-2, Ki-67 and SPARC status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridisation (ISH) ratio >2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the Dept. of Pathology at the Charité, Berlin prior to randomization. - Age >= 18 years. - Karnofsky Performance status index >= 80%. - Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results must be above the normal limit of the institution. For patients with HER2-positive tumors LVEF must be >= 55%. - Laboratory requirements: - Hematology - - Absolute neutrophil count (ANC) >= 2.0 x 109 / L and - Platelets >= 100 x 109 / L and - Hemoglobin >= 10 g/dL (>= 6.2 mmol/L) - Hepatic function - - Total bilirubin < 1.5x UNL and - ASAT (SGOT) and ALAT (SGPT) <= 1.5x UNL and - Alkaline phosphatase <= 2.5x UNL. - Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. - Complete staging work-up within 3 months prior to randomization. All patients must have bilateral mammography, breast ultrasound (<= 21 days), breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan done. In case of positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated. - Patients must be available and compliant for central diagnostics, treatment and follow-up. Exclusion Criteria: - Prior chemotherapy for any malignancy. - Prior radiation therapy for breast cancer. - Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment. - Inadequate general condition (not fit for anthracycline-taxane-targeted agents-based chemotherapy). - Previous malignant disease without being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer). - Known or suspected congestive heart failure (>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP >160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease. - History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent. - Persons who have been admitted to an institution by order of jurisdictional or governmental grounds. - Pre-existing motor or sensory neuropathy of grade 2 or more by NCI-CTC criteria v 4.0. - Currently active infection. - Definite contraindications for the use of corticosteroids. - Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol. - Concurrent treatment with: - - chronic corticosteroids unless initiated > 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent). - - sex hormones. Prior treatment must be stopped before study entry. - - other experimental drugs or any other anti-cancer therapy. - Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. - Male patients. ; PRIMARY OUTCOME: Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.; SECONDARY OUTCOME 1: Rates of ypT0/is ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0, and regression grade[/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 - ELARIS UF-EXTEND; BRIEF: This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids. ; DRUG USED: Orilissa; DRUG CLASS: New Molecular Entity (NME); INDICATION: Uterine Fibroids; TARGET: Gonadotropin-Releasing Hormone (GnRH) Receptor; THERAPY: Monotherapy and Combo Therapy; LEAD SPONSOR: AbbVie; CRITERIA: Inclusion Criteria: - Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817). - Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study - Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study. - Participants endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology. Exclusion Criteria: - Participant met criteria for removal from therapy in her respective Pivotal Study. - Participant is planning a pregnancy within the next 18 months. - Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study. - Participant has any new medical conditions that may be unsuitable for participation. - Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed. ; PRIMARY OUTCOME: Percentage of Participants Meeting the Criteria for Responder; SECONDARY OUTCOME 1: Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period[/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 - CRUISE-1; BRIEF: The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb). ; DRUG USED: Triferic; DRUG CLASS: Non-NME; INDICATION: Anemia Due to Chronic Renal Failure, Dialysis-Dependent; TARGET: Iron; THERAPY: Monotherapy; LEAD SPONSOR: Rockwell Medical Technologies, Inc.; CRITERIA: Stage 1: Main Inclusion Criteria: - Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study. - Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure. - Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL). - Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%. - Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L). - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received a total of > 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment - If being administered an ESA, route of administration change or ESA dose change > 35% (i.e., [max - min dose]/max dose > 0.35) over the 2 weeks prior to screening. - Serum albumin < 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment. - Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment. Stage 2: Main Inclusion Criteria: - Patient currently enrolled in the Stage 1 run-in period of study. - Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study. - Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization. - Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization. - Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization. - Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization. - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received any amount of IV iron during the 4 weeks prior to randomization. - If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization. - Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization. - RBC or whole blood transfusion during Stage 1. Stage 3: Main Inclusion Criteria: - Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks. Main Exclusion Criteria: - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above. ; PRIMARY OUTCOME: Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean; SECONDARY OUTCOME 1: Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.[/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 - VITAL - w/Docetaxel; BRIEF: The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants. ; DRUG USED: Zaltrap; DRUG CLASS: Biologic; INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: Placental growth factor (PlGF), VEGF (Vascular endothelial growth factor); THERAPY: Combination; LEAD SPONSOR: Sanofi; CRITERIA: Inclusion Criteria: - Histological/cytological proven locally advanced or metastatic non-small cell lung cancer - Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - Adequate renal, liver and bone marrow functions Exclusion Criteria: - Squamous histology/cytology - Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization - Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow - Prior docetaxel treatment - Uncontrolled hypertension The above information was not intended to contain all considerations relevant to participation in a clinical trial. ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/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 - ASTERIA I; BRIEF: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment. ; DRUG USED: Xolair; DRUG CLASS: Biologic; INDICATION: Urticaria; TARGET: Immunoglobulin E (IgE); THERAPY: Combination; LEAD SPONSOR: Genentech, Inc.; CRITERIA: Inclusion Criteria: - Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) refractory to H1 antihistamines at the time of randomization. Exclusion Criteria: - Treatment with an investigational agent within 30 days prior to screening. - Weight < 20 kg (44 lbs). - Clearly defined underlying etiology for chronic urticarias other than CIU. - Evidence of parasitic infection. - Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch. - Previous treatment with omalizumab within a year prior to screening. - Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. - Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening. - Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening. - Any H2 antihistamine use within 7 days prior to screening. - Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening. - Any H1 antihistamines at greater than approved doses within 3 days prior to screening. - Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved. - Hypersensitivity to omalizumab or any component of the formulation. - History of anaphylactic shock. - Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients. - Evidence of current drug or alcohol abuse. - Nursing women or women of childbearing potential, unless they meet the following definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. ; PRIMARY OUTCOME: Change From Baseline to Week 12 in the Weekly Itch Severity Score; SECONDARY OUTCOME 1: Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)[/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 - DECLARE-TIMI58 (CV Events); BRIEF: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors. ; DRUG USED: Farxiga; DRUG CLASS: New Molecular Entity (NME); INDICATION: Diabetes Mellitus, Type II; TARGET: SGLT; THERAPY: Combination; LEAD SPONSOR: AstraZeneca; CRITERIA: Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Female or male aged ≥40 years - Diagnosed with Type 2 Diabetes - High Risk for Cardiovascular events Exclusion Criteria: - Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time - Chronic cystitis and/or recurrent urinary tract infections - Pregnant or breast-feeding patients ; PRIMARY OUTCOME: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke; SECONDARY OUTCOME 1: Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.[/INST]Yes</s>